Reducing Tobacco Use A Report of the Surgeon General DEPARTMENT OF HEALTH AND HUMAN SERVICES U.S. Public Health Service CENTERS FOR DISEASE CONTROL AND PREVENTION Suggested Citation U.S. Department of Health and Human Services. Reducing Tobacco Use: A Report of the Surgeon General. Atlanta, Georgia: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2000. For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402, S/N 017-001-00544-4. Use of trade names is for identification only and does not constitute endorsement by the U.S. Department of Health and Human Services. Message From Donna E. Shalala Secretary of Health and Human Services This nation is faced with many challenges in its efforts to improve the health status of all people living in the United States. One of the biggest challenges is to remedy the fact that approximately one-fourth of our adults continue to smoke and that tobacco use rates among our youth have increased since the early 1990s. Tobacco use, particularly cigarette smoking, remains the leading cause of prevent- able illness and death in this country. Our overall success in improving the health status of the U.S. population thus depends greatly on achieving dramatic reduc- tions in the rate of tobacco use among both adults and young people. Reducing tobacco use is a key component of Healthy People 2010, the national action plan for improving the health of all Americans for the first decade of the 21st century. No fewer than 21 specific national health objectives related to to- bacco are listed, including a goal to more than halve the current rates of tobacco use among young people and adults. Attaining all of the Healthy People 2010 to- bacco use objectives will require significant commitment and progress in numer- ous areas. This Surgeon General’s report provides a major resource in our national ef- forts to achieve the Healthy People 2010 tobacco use objectives. The research find- ings reviewed indicate that many strategies and approaches have been shown to be effective in preventing tobacco use among young people and in helping to- bacco users end their addiction. The challenge to public health professionals, health care systems, and other partners in our national prevention effort is to implement these proven approaches. Through the Secretary’s Initiative to Prevent Tobacco Use Among Teens and Preteens, the Department works with federal and nonfederal efforts to reduce young people’s demand for tobacco products. This Surgeon General’s report highlights additional strategies and approaches that this initiative can expand upon. Only by a coordinated national effort will the tobacco use rates among our young people be reduced. Each day that we delay in developing a comprehensive national re- sponse to this problem, 3,000 additional teens and preteens become regular smok- ers. That statistic poses an urgent public health challenge and—given that we have at hand numerous strategies proven to be effective—a moral imperative. Foreword For more than three decades, the Surgeon General of the U.S. Public Health Service has released reports focused on tobacco use and the health of the Ameri- can people. The tone and content of these reports have changed over the years. Early on, there was a need for critical review of the epidemiologic and biologic aspects of tobacco use. Today, the deleterious effects are well documented, and the reports have begun to investigate the social, economic, and cultural conse- quences of these effects and what can be done to address them. The present report assesses past and current efforts to reduce the use of tobacco in this country and thereby ameliorate its disastrous health effects. Tobacco use is an extraordinary phenomenon. Although substantial progress has been made since the initial report of the Surgeon General’s Ad Hoc Committee in 1964, approximately a quarter of the U.S. adult population smokes, and the percentage of high school youth who smoke has steadily increased throughout the 1990s. Results from community-based interventions and statewide programs show that a comprehensive approach to tobacco control is needed to curtail the epidemic. This report summarizes several effective approaches to reducing tobacco use and presents the considerable evidence—as well as the attendant controversies— supporting their application. Multifaceted school-based education programs that are performed in conjunction with community-based campaigns have met with substantial success. The management of nicotine addiction in persons who al- ready smoke has the benefit of clinical tools, that is, systems for weaning persons from nicotine, the efficacy of which is clearly demonstrated. Product regulation, enforcement of clean indoor air standards, and protecting young people from the supposed attractiveness of cigarettes all promise substantial impact. By analyzing the economics of tobacco and by examining models that assess the effect of eco- nomic policies, we find that various approaches can mitigate the adverse outcomes associated with tobacco use—and can do so without the dire economic conse- quences claimed by those who profit from tobacco use. But if the evidence is clear that tobacco use is harmful and if the tools are available to reduce its use, why has the reduction in prevalence been less than would be expected? The answer is very complex. As described in Chapter 1 of this report, numerous forces influence a person’s decision to smoke, or if that per- son is a smoker, the forces that drive continued use. The most important force for smoking is the totality of industry activity, including advertising, promotion, organizational activity, support for ancillary issues, and political action, which maintains marketability and profitability of the product. Efforts to reduce tobacco use face a more than $5 billion annual budget that the tobacco industry dedicates to advertising and promotion aimed at sustaining or increasing tobacco use. None- theless, there is cause for optimism based on considerable public support for ef- forts to prevent children from becoming addicted to tobacco. If the recent pattern of increases in youth tobacco use can be reversed, we can make progress toward tobacco-free generations in the future. Jeffrey P. Koplan, M.D., M.P.H. Director Centers for Disease Control and Prevention and Administrator Agency for Toxic Substances and Disease Registry il Preface from the Surgeon General, U.S. Department of Health and Human Services Almost 50 years ago, evidence began to accumulate that cigarette smoking poses an enormous threat to human health. More than 30 years ago, an initial report from the Surgeon General's office made an unqualified announcement of tobacco’s harm. Beginning in 1969, the series of Surgeon General’s reports began meticulous documentation of the biologic, epidemiologic, behavioral, pharmaco- logic, and cultural aspects of tobacco use. The present report, an examination of the methods and tools available to reduce tobacco use, is being issued at a time of considerable foment. The past several years have witnessed major initiatives in the legislative, regulatory, and legal arenas, with a complex set of results still not entirely resolved. This report shows that a variety of efforts aimed at reducing tobacco use, particularly by children, would have a heightened impact in the absence of countervailing pressures to smoke. Besides providing extensive background and detail on historical, social, economic, clinical, educational, and regulatory efforts to reduce tobacco use, the report indicates some clear avenues for future research and implementation. It is of special concern to derive a greater understanding of cultural differences in response to tobacco control measures. Since racial and eth- nic groups are differentially affected by tobacco, elimination of disparities among these groups is a major priority. Perhaps the most pressing need for future research is to evaluate multifocal, multichannel programs that bring a variety of modalities together. For example, as Chapter 3 demonstrates, school-based education programs are more effective when coupled with community-based initiatives that involve mass media and other techniques. As pointed out in Chapter 4, a combination of behavioral and phar- macologic methods improves the success rate when managing nicotine addiction. Synergy among economic, regulatory, and social approaches has not been fully explored, but may offer some of the most fruitful efforts for the future. Chapter 7 provides the preliminary data on new statewide, comprehensive tobacco control programs, which offer great promise as new models for tobacco control and com- bine multiple intervention modalities. Although all aspects—social, economic, educational, and regulatory—have not been combined into a fully comprehensive effort, it is exciting to contemplate the potential impact of such an undertaking to eventually ensure that children are protected from the social and cultural influ- ences that lead to tobacco addiction, that all smokers are encouraged to quit as soon as possible, and that nonsmokers are protected from environmental tobacco smoke. David Satcher, M.D., Ph.D. Surgeon General and Assistant Secretary for Health itl Acknowledgments This report was prepared by the U.S. Department of Health and Human Services under the general direc- tion of the Centers for Disease Control and Preven- tion, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health. Jeffrey P. Koplan, M.D., M.P.H., Director, Centers for Disease Control and Prevention, Atlanta, Georgia. James S. Marks, M.D., M.P.H., Director, National Cen- ter for Chronic Disease Prevention and Health Promo- tion, Centers for Disease Control and Prevention, Atlanta, Georgia. Michael P. Eriksen, Sc.D., Director, Office on Smoking and Health, National Center for Chronic Disease Pre- vention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. The editors of the report were Richard B. Rothenberg, M.D., M.P.H., Senior Scientific Editor, Professor, Department of Family and Preven- tive Medicine, Emory University School of Medicine, Atlanta, Georgia. Terry F. Pechacek, Ph.D., Associate Scientific Editor, Associate Director for Science, Office on Smoking and Health, National Center for Chronic Disease Preven- tion and Health Promotion, Centers for Disease Con- trol and Prevention, Atlanta, Georgia. Frank J. Chaloupka, IV, Ph.D., Consulting Scientific Editor, Professor, Department of Economics, Univer- sity of Illinois, Chicago, Illinois. Michael C. Fiore, M.D., M.P.H., Consulting Editor, Pro- fessor, Department of Medicine, and Director, Center for Tobacco Research and Intervention, University of Wisconsin Medical School, Madison, Wisconsin. Gayle Lloyd, M.A., Managing Editor, Office on Smok- ing and Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Reducing Tobacco Use Frederick L. Hull, Ph.D., Technical Editor, Technical Information and Editorial Services Branch, National Center for Chronic Disease Prevention and Health Pro- motion, Centers for Disease Control and Prevention, Atlanta, Georgia. Contributing authors were Timothy B. Baker, Ph.D., Professor of Psychology, Associate Director, Center for Tobacco Research and Intervention, University of Wisconsin Medical School, Madison, Wisconsin. Michele Bloch, M.D., Ph.D., Health Policy Consultant, Rockville, Maryland. Ross C. Brownson, Ph.D., Professor and Chair, Depart- ment of Community Health, School of Public Health, Saint Louis University, St. Louis, Missouri. Frank J. Chaloupka, IV, Ph.D., Professor, Department of Economics, University of Illinois, Chicago, Illinois. Patricia Davidson, J.D., Staff Attorney, Tobacco Control Resource Center, Boston, Massachusetts. Richard A. Daynard, J.D., Ph.D., Chair, Tobacco Prod- ucts Liability Project, and Professor, Northeastern University School of Law, Boston, Massachusetts. Clifford E. Douglas, J.D., President, Tobacco Control Law and Policy Consulting, Ann Arbor, Michigan. Brian S, Flynn, Sc.D., Professor and Director, Office of Health Promotion Research, College of Medicine, Uni- versity of Vermont, Burlington, Vermont. Jean L. Forster, Ph.D., M.P.H., Associate Professor, Division of Epidemiology, School of Public Health, University of Minnesota, Minneapolis, Minnesota. Marc Galanter, J.D., John and Rylla Bosshard Profes- sor of Law, University of Wisconsin Law School, Madi- son, Wisconsin. Surgeon General's Report Lawrence O. Gostin, J.D., Professor of Law, Georgetown University Law Center, and Co-Director, Georgetown/ Johns Hopkins Program on Law and Public Health, Washington, D.C. Mark Gottlieb, J.D., Staff Attorney, Tobacco Control Resource Center, Boston, Massachusetts. Douglas E. Jorenby, Ph.D., Assistant Professor, Center for Tobacco Research and Intervention, University of Wisconsin Medical School, Madison, Wisconsin. Graham Kelder, J.D., Managing Attorney, Tobacco Control Resource Center, Boston, Massachusetts. Robert Kline, J.D., Staff Attorney, Tobacco Control Resource Center, Boston, Massachusetts. Jeff McKenna, M.S., Chief, Health Communications Branch, Office on Smoking and Health, National Cen- ter for Chronic Disease Prevention and Health Promo- tion, Centers for Disease Control and Prevention, Atlanta, Georgia. Thomas M. Piasecki, M.S., Research Associate, Center for Tobacco Research and Intervention, University of Wisconsin Medical School, Madison, Wisconsin. Raymond Porfiri, J.D., Staff Attorney, Tobacco Control Resource Center, Boston, Massachusetts. Michael Schudson, Ph.D., Professor, Department of Communication, University of California, San Diego, La Jolla, California. Donald Sharp, M.D., Medical Officer, Office on Smok- ing and Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. John Slade, M.D., Professor, New Jersey School of Public Health, University of Medicine and Dentistry of New Jersey, New Brunswick, New Jersey. David T. Sweanor, LL.B., Senior Legal Counsel, Non- Smokers’ Rights Association, Ottawa, Ontario, Canada. Edward L. Sweda, Jr., J.D., Senior Attorney, Tobacco Control Resource Center, Boston, Massachusetts. Gerald J. Thain, J.D., Consumer Law Professor, University of Wisconsin Law School, Madison, Wisconsin. vi David W. Wetter, Ph.D., Assistant Professor, M.D. Anderson Cancer Center, University of Texas, Hous- ton, Texas. John K. Worden, Ph.D., Research Professor, Office of Health Promotion Research, College of Medicine, University of Vermont, Burlington, Vermont. Reviewers were David G. Altman, Ph.D., Professor, Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina. Dileep G. Bal, M.D., Chief, Cancer Control Branch, California Department of Health Services, Sacramento, California. Scott D. Ballin, J.D., Vice President and Legislative Counsel, Office of Public Affairs, American Heart Association, Washington, D.C. Glen Bennett, M.P.H., Coordinator, Advanced Tech- nologies Applications in Health Education Programs, Office of Prevention, Education, and Control, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland. Neil Bracht, M.A., M.P.H., Professor Emeritus, School of Social Work and School of Public Health, Univer- sity of Minnesota, Minneapolis, Minnesota. Allan M. Brandt, Ph.D., Professor Emeritus, Depart- ment of Social Medicine, Harvard Medical School, Boston, Massachusetts. Jesse W. Brown, Jr., M. Div., President, National Asso- ciation of African Americans for Positive Imagery, Philadelphia, Pennsylvania. John C. Burnham, Ph.D., Professor of History and Pro- fessor of Psychiatry, Ohio State University, Columbus, Ohio. David M. Burns, M.D., Professor of Medicine, Depart- ment of Medicine, University of California, San Diego, California. Joseph A. Califano, Jr., President and Chairman, The National Center on Addiction and Substance Abuse, Columbia University, New York, New York. Julia Carol, Co-Director, Americans for Nonsmokers’ Rights, Berkeley, California. Nelba Chavez, Ph.D., Administrator, Substance Abuse and Mental Health Services Administration, Rockville, Maryland. Moon &. Chen, Jr., Ph.D., M.P.H., Professor and Chair, Division of Health Behavior and Health Promotion, School of Public Health, Ohio State University, and Editor-in-Chief, Asian American and Pacific Islander Journal of Health, Columbus, Ohio. Gregory Connolly, D.M.D., M.P.H., Director, Massa- chusetts Tobacco Control Program, Massachusetts Department of Public Health, Boston, Massachusetts. Stephen B. Corbin, D.D.S., M.P.H., Chief of Staff, Of- fice of the Surgeon General, and Chief Dental Officer, Public Health Service, Rockville, Maryland. Linda S. Crossett, R.D.H., Health Intervention Scien- tist, Division of Adolescent and School Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. K. Michael Cummings, Ph.D., M.P.H., Senior Research Scientist and Chair, Department of Cancer Control and Epidemiology, Roswell Park Cancer Institute, Buffalo, New York. Lisa Daily, Associate Director for Planning, Evaluation, and Legislation, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Ronald M. Davis, M.D., Director, Center for Health Promotion and Disease Prevention, Henry Ford Health System, Detroit, Michigan. Joseph R. DiFranza, M.D., Professor of Family and Community Medicine, University of Massachusetts, Worcester, Massachusetts. Fran Du Melle, Deputy Managing Director, American Lung Association, Washington, D.C. John P. Elder, Ph.D., M.P.H., Professor and Head, Division of Health Promotion, Graduate School of Public Health, San Diego State University, San Diego, California. Ellen Feighery, R.N., M.S., Research Associate, Stanford Center for Research in Disease Prevention, School of Medicine, Stanford University, Palo Alto, California. vit Reducing Tobacco Use Burke Fishburn, M.P.P., Health Policy Analyst, Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Julie Fishman, M.P.H., Lead Health Policy Analyst, Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Brian R. Flay, D. Phil., Director, Health Research and Policy Centers, University of Illinois, Chicago, Illinois. Adele L. Franks, M.D., Associate Director for Science, Division of Nutrition and Physical Activity, National Center for Chronic Disease Prevention and Health Pro- motion, Centers for Disease Control and Prevention, Atlanta, Georgia. John A. Gardiner, Ph.D., LL.B., Director of the Office of Social Science Research, University of IHinois, Chi- cago, Illinois. Gary A. Giovino, Ph.D., M.S., Senior Research Scien- tist, Department of Cancer Prevention, Epidemiology, and Biostatistics, Roswell Park Cancer Institute, Buf- falo, New York. Stanton Glantz, Ph.D., Professor of Medicine, Division of Cardiology, University of California, San Francisco, California. Mark M. Hager, J.D., Ph.D., Professor, Washington College of Law, American University, Washington, DC. William Hansen, Ph.D., President, Tanglewood Re- search, Clemmons, North Carolina. James A. Harrell, Commissioner, Administration on Children, Youth and Families, Administration for Chil- dren and Families, Washington, D.C. Jeffrey E. Harris, M.D., Ph.D., Professor, Department of Economics, Massachusetts Institute of Technology, and primary care physician, Massachusetts General Hospital, Boston, Massachusetts. Sandra W. Headen, Ph.D., Assistant Professor, Depart- ment of Health Behavior and Health Education, School of Public Health, University of North Carolina, Chapel Hill, North Carolina. Surgeon General's Report Jack E. Henningfield, Ph.D., Associate Professor of Behavioral Biology, Department of Psychiatry and Behavioral Sciences, The Johns Hopkins University School of Medicine, Baltimore, Maryland, and Vice President, Research and Health Policy, Pinney Associ- ates, Bethesda, Maryland. Thomas P. Houston, M.D., Director of Preventive Medi- cine and Environmental Health, American Medical Association, Chicago, Ulinois. Teh-wei Hu, Ph.D., Professor, School of Public Health, University of California, Berkeley, California. John R. Hughes, M.D., Professor, Departments of Psy- chiatry, Psychology, and Family Practice, University of Vermont, Burlington, Vermont. Corinne Husten, M.D., M.P.H., Chief, Epidemiology Branch, Office on Smoking and Health, National Cen- ter for Chronic Disease Prevention and Health Promo- tion, Centers for Disease Control and Prevention, Atlanta, Georgia. Jonathan B. Imber, Ph.D., Professor, Department of Sociology, Wellesley College, Wellesley, Massachusetts. Murray J. Kaiserman, Ph.D., M.B.A., Coordinator, Research and Surveillance, Office of Tobacco Control, Health Protection Branch, Health Canada, Ottawa, Ontario, Canada. Laura K. Kann, Ph.D., Chief, Surveillance Research Section, Division of Adolescent and School Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Nancy J. Kaufman, R.N., M.S., Vice President, The Robert Wood Johnson Foundation, Princeton, New Jersey. Beverly Kingsley, Ph.D., M.P.H., Epidemiologist, Of- fice on Smoking and Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Norman A. Krasnegor, Ph.D., Chief, Human Learning and Behavior Branch, Center for Research for Moth- ers and Children, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland. vill Rick Kropp, Executive Director, Tobacco Prevention and Policy Resources Center, Stop Tobacco Access for Minors Project and Stop Tobacco Advertising Aimed at Minors Project, Santa Rosa, California. Harry Lando, Ph.D., Professor, Division of Epidemi- ology, School of Public Health, University of Minne- sota, Minneapolis, Minnesota. Murray Laugesen, RF.P.H.M., ER.C.S., Public Health Physician, Health New Zealand, Auckland, New Zealand. Edward Lichtenstein, Ph.D., Research Scientist, Oregon Research Institute, Eugene, Oregon. Douglas S. Lloyd, M.D., M.P.H., Director, Center for Public Health Practice, Health Resources and Services Administration, Rockville, Maryland. Alan D. Lopez, Ph.D., Epidemiologist, Programme on Substance Abuse, World Health Organization, Geneva, Switzerland. Barbara S. Lynch, Ph.D., Consultant, Rockville, Maryland. Willard Manning, Ph.D., Professor, Department of Health Studies, Graduate School of Public Policy Stud- ies, University of Chicago, Chicago, Illinois. Paul Marantz, M.D., M.P.H., Associate Professor and Head, Division of Preventive Medicine, Department of Epidemiology and Social Medicine, Albert Einstein College of Medicine, Bronx, New York. Kristen L. McCall, M.P.A., Health Communications Specialist, Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Pro- motion, Centers for Disease Control and Prevention, Atlanta, Georgia. Sharon Natanblut, Deputy Director, Office of Tobacco Programs, Food and Drug Administration, Rockville, Maryland. Constance A. Nathanson, Ph.D., Professor, Department of Population and Family Sciences, School of Hygiene and Public Health, The Johns Hopkins University, Bal- timore, Maryland. Thomas E. Novotny, M.D., M.P.H., Centers for Disease Control and Prevention Liaison, Office of Global Health, World Bank, Washington, D.C. Judith K. Ockene, Ph.D., Professor of Medicine, Depart- ment of Medicine, and Director, Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, Worcester, Massachusetts. C. Tracy Orleans, Ph.D., Senior Program Officer, The Robert Wood Johnson Foundation, Princeton, New Jersey. Guy S. Parcel, Ph.D., Professor and Director, Center for Health Promotion Research and Development, Uni- versity of Texas Health Science Center, Houston, Texas. Cheryl L. Perry, Ph.D., Professor, Division of Epide- miclogy, School of Public Health, University of Min- nesota, Minneapolis, Minnesota. Michael Pertschuk, J.D., Co-Director, Advocacy Insti- tute, Washington, D.C. Richard Poilay, Ph.D., Professor of Marketing and Curator, History of Advertising Archives, Faculty of Commerce, University of British Columbia, Vancouver, British Columbia, Canada. Robert L. Rabin, Ph.D., J.D., A. Calder Mackay Profes- sor of Law, Stanford University, Stanford, California. Lars M. Ramstrom, Ph.D., Director, Institute for Tobacco Studies, Stockholm, Sweden. Nancy A. Rigotti, M.D., Director, Tobacco Research and Treatment Center, Massachusetts General Hospital, and Assistant Professor of Medicine, Harvard Medi- cal School, Boston, Massachusetts. Diane Rowley, M.D., M.P.H., Associate Director for Sci- ence, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Jonathan M. Samet, M.D., Professor and Chairman, Department of Epidemiology, School of Hygiene and Public Health, The Johns Hopkins University, Balti- more, Maryland. Joseph Sanders, Professor, University of Houston Law Center, Houston, Texas. Thomas C. Schelling, Ph.D., Professor, School of Pub- lic Affairs, University of Maryland, College Park, Maryland. ix Reducing Tobacco Use Steven A. Schroeder, M.D., President, The Robert Wood Johnson Foundation, Princeton, New Jersey. Gary Schwartz, Professor, School of Law, University of California, Los Angeles, California. Heather Selin, M.A., Health Policy Analyst, Office on Smoking and Health, National Center for Chronic Dis- ease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Donald R. Shopland, Coordinator, Smoking and Tobacco Control Program, National Cancer Institute, National Institutes of Health, Rockville, Maryland. Jesse L. Steinfeld, M.D., Surgeon General, U.S. Public Health Service, 1969-1973, San Diego, California. Charyn D, Sutton, President, The Onyx Group, Bala Cynwyd, Pennsylvania. Scott L. Tomar, D.M.D., Dr.P.H., Epidemiologist, Divi- sion of Oral Health, National Center for Chronic Dis- ease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Kenneth E. Warner, Ph.D., Richard D. Remington Col- legiate Professor of Public Health, Department of Health Management and Policy, School of Public Health, University of Michigan, Ann Arbor, Michigan. Judith Wilkenfeld, J.D., Senior Advisor for Tobacco Policy, Food and Drug Administration, Rockville, Maryland. Ernst L. Wynder, M.D., President, American Health Foundation, New York, New York. Mitchell R. Zeller, J.D., Director, Office of Tobacco Pro- grams, Food and Drug Administration, Rockville, Maryland. Other contributors were Milonne Ambroise, Program Assistant, Department of Family and Preventive Medicine, Emory University School of Medicine, Atlanta, Georgia. Ruth Atchison, Proofreader, Cygnus Corporation, Rockville, Maryland. Mary Bedford, Proofreader, Cygnus Corporation, Rockville, Maryland. Surgeon General's Report Maureen Berg, Desktop Publishing Specialist, Market Experts, Silver Spring, Maryland. Elizabeth A. Cooper, Program Assistant, University of Wisconsin Law School, Madison, Wisconsin. Judith A. Corr, Research Assistant, Office of Health Promotion Research, College of Medicine, University of Vermont, Burlington, Vermont. James H. Davis, Research Assistant, Institute for Legal Studies, University of Wisconsin Law School, Madison, Wisconsin. Susan R. Derrick, Program Analyst, Office on Smok- ing and Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Ellen C. Dreyer, R.N., M.S., Project Director, Cygnus Corporation, Rockville, Maryland. Jeffrey L. Fellows, Ph.D., Health Economist, Office on Smoking and Health, National Center for Chronic Dis- ease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Sue Frank, Technical Specialist, Tobacco Control | Resource Center, Boston, Massachusetts. Maritta Perry Grau, M.A., Copy Editor, The Write Touch: Editorial Services, Frederick, Maryland. Lucy G. Gritzmacher, M.S., Librarian, Cygnus Corpo- ration, Rockville, Maryland. Laura Hermer, J.D., Staff Attorney, Tobacco Control Resource Center, Boston, Massachusetts. Elizabeth Hess, Editor, Cygnus Corporation, Rockville, Maryland. Janis B. Hubbard, M.S., Indexer, Fredericksburg,. Virginia. Patricia L. Mallin, Director of Electronic Advocacy, Advocacy Institute, Washington, D.C. William T. Marx, M.L.1LS., Technical Information Specialist, Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Pro- motion, Centers for Disease Control and Prevention, Atlanta, Georgia. Brenda Mazzocchi, M.L.S., Technical Information Specialist, Technical Information and Editorial Services Branch, National Center for Chronic Disease Preven- tion and Health Promotion, Centers for Disease Con- trol and Prevention, Atlanta, Georgia. Paulette Clark McGee, Proofreader, Editus, Kearneys- ville, West Virginia. Linda A. McLaughlin, Word Processing Specialist, Cygnus Corporation, Rockville, Maryland. Robert H. Miller, Ph.D., Director, Tobacco and Peanut Analysis Division, Agricultural Stabilization and Con- servation Service, U.S. Department of Agriculture, Washington, D.C. Michael D. Morneault, J.D., Morgan, Lewis, and Bockius Law Firm, Pittsburgh, Pennsylvania. Paulette Murphy, M.L.LS., Technical Information Specialist, Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Pro- motion, Centers for Disease Control and Prevention, Atlanta, Georgia. ~ Leslie A. Norman; Public Affairs Specialist, Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Ward C. Nyholm, Desktop Publishing Specialist, Cygnus Corporation, Rockville, Maryland. Lisa Rogers, Administrative Program Manager, Cen- ter for Tobacco Research and Intervention, University of Wisconsin Medical School, Madison, Wisconsin. - Ann E. Schensky, Education and Outreach Program Manager, Center for Tobacco Research and Interven- . tion, University of Wisconsin Medical School, Madi- son, Wisconsin. . Peggy E. Williams, M.S., Proofreader, Marietta, Georgia. Trevor A. Woollery, Ph.D., Health Economist, Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Reducing Tobacco Use Chapter 1. Issues in Reducing Tobacco Use, Summary, and Conclusions 3 Introduction 5 Summary and Implications 12 Chapter Conclusions 22 References 25 Chapter 2. A Historical Review of Efforts to Reduce Smoking in the United States 27 Introduction 29 Early Events 29 The Rise of the Cigarette 30 Medical Warnings 38 Turning Point: The Surgeon General’s Report 40 The Diverse Momentum of the Movement to Reduce Smoking 43 From Antismoking to Nonsmokers’ Rights 46 The Impact of the Movement to Reduce Smoking 48 Conclusions 51 References 52 Chapter 3. Effective Educational Strategies to Prevent Tobacco Use Among Young People 59 Introduction 61 Recent Research on Educational Strategies for Smoking Prevention 64 Diffusing Programs to Prevent Tobacco Use 80 Conclusions 85 References 86 Chapter 4. Management of Nicotine Addiction 95 Introduction 97 Methods for Managing Nicotine Addiction 100 Contemporary Issues in Research on Tobacco Addiction 128 Conclusions 134 References 135 Chapter 5. Regulatory Efforts 157 Introduction 159 Advertising and Promotion 161 Product Regulation 178 Clean Indoor Air Regulation 193 Minors’ Access to Tobacco 207 Litigation Approaches 223 Conclusions 260 References 262 ‘urgeon General's Report Chapter 6. Economic Approaches 293 Introduction 295 Supply of Tobacco and Tobacco Products 295 Effect of Price on Demand for Tobacco Products 322 Taxation of Tobacco Products 337 Conclusions 359 References 360 Chapter 7. Comprehensive Programs 371 Introduction 373 Conceptual Frameworks 373 Description of Comprehensive Programs 374 Community Intervention Trials 376 Statewide Interventions 382 Components of Community Programs 403 Summary 416 Conclusions 417 References 418 Chapter 8. A Vision for the Future—Reducing Tobacco Use in the New Millennium 431 Introduction 433 Continuing to Build the Scientific Base 433 The Changing Tobacco Industry 434 The Need fora Comprehensive Approach 435 Identifying and Eliminating Disparities 436 Improving the Dissemination of State-of-the-Art Interventions 436 Tobacco Use in Developing Nations 437 Tobacco Control in the New Millennium 438 References 439 Abbreviations 441 List of Tables and Figures 443 Index 445 Chapter 1 Issues in Reducing Tobacco Use, Summary, and Conclusions Introduction 5 Development of the Report 5 Major Conclusions 6 Issues in Reducing Tobacco Use 6 Eliminating Disparities Related to Tobacco Use and Its Effects 11 Summary and Implications 12 Historical Review (Chapter 2) 12 Educational Strategies (Chapter 3) 12 Management of Nicotine Addiction (Chapter 4) 13 Regulatory Efforts (Chapter 5) 14 Advertising and Promotion 14 Product Regulation 15 Clean Indoor Air Regulation 16 Minors’ Access to Tobacco 16 Litigation Approaches 17 Overview and Implications 18 Economic Approaches (Chapter 6) 18 Comprehensive Programs (Chapter 7) 20 A Vision for the Future—Reducing Tobacco Use in the New Millennium (Chapter 8) 21 Chapter Conclusions 22 Chapter 2. Historical Review 22 Chapter 3. Educational Strategies 22 Chapter 4. Management of Nicotine Addiction 22 Chapter 5. Regulatory Efforts 22 Advertising and Promotion 22 Product Regulation 23 Clean Indoor Air Regulation 23 Minors’ Access to Tobacco 23 Litigation Approaches 23 Chapter 6. Economic Approaches 24 Chapter 7. Comprehensive Programs 24 References 25 Introduction Reducing Tobacco Use What works? It would be a boon if the answer were as easy to state as the question. Programs to reduce the use of tobacco have a long history in the United States and in other countries, and the accumulated experience has provided considerable empirical understanding of the prospects and pitfalls of such efforts. Rigorous answers to formal evaluation questions are difficult to obtain, however, in part because of the wide variety of influ- ences that are brought to bear on the use of tobacco. Researchers have little control over many of these influences and are only beginning to learn how to measure some of them. Nonetheless, a substantial body of literature exists on attempts to reduce the use of tobacco. This report provides an overview of the major modalities that have been studied and used intensively, and it at- tempts, where possible, to differentiate their techniques and outcomes. The report also attempts a more diffi- cult task: to provide some qualitative observations about how these efforts interact. The report is thus a prologue to the development of a coherent, long-term policy that would permit these modalities to be used as effectively as possible. Development of the Report This report of the Surgeon General was prepared by the Office on Smoking and Health, National Cen- ter for Chronic Disease Prevention and Health Promo- tion, Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Ser- vices, to report current information on the health ef- fects of cigarette smoking and smokeless tobacco use. Previous reports have dealt with some of the issues included in this report, but a composite assessment of efforts to reduce tobacco use is a new topic for this series. However, the current report must acknowledge the considerable contributions of three prior mono- graphs: Growing Up Tobacco Free, a report of the Insti- tute of Medicine (Lynch and Bonnie 1994), Healthy People 2000: National Health Promotion and Disease Pre- vention Objectives, and Healthy People 2010, an ongoing work of the Office of Health Promotion and Disease Prevention (U.S. Department of Health and Human Services [USDHHS] 1991, 2000). The current report is the result of the work of 16 experts in the field of reducing tobacco use who contributed initial drafts in major chapter areas. The chapters were reviewed separately by some 60 re- searchers and public health workers whose expertise was specific to particular subject areas. After revision, a preliminary draft volume was reviewed by an addi- tional 40 experts, including representatives of the in- stitutes and agencies within the Department of Health and Human Services that have special interests in re- ducing tobacco use. Several concerns guided preparation of the re- port. First, it was clear that the primary countervailing influence against reducing tobacco use is the effort of the tobacco industry to promote the use of tobacco products. Although this report was not conceived as a documentation of such industry efforts, repeated reference to them is necessary to underscore the diffi- culties both in achieving desired outcomes and in evaluating the effectiveness of efforts to reduce the use of the industry’s products. Second, the report has at- tempted to present the wide variety of techniques and methods used for tobacco control, but the disparate methods make comparisons difficult. The result is more a menu than a cookbook—a set of activities, as outlined in Chapter 7, whose combination depends on specific circumstances and the context in which they are undertaken. Third, a result of this methodological diversity is that rigorous evaluation of the ways in which tobacco reduction efforts interact remains part of the unfinished research agenda. Although interac- tion of interventive efforts is noted several places in the report (see, for example, the discussion of the in- teraction of school education with community-based programs in Chapter 3), such demonstration of syn- ergy has been elusive. Finally, during the report’s preparation, a cascade of legal and legislative events substantially changed the landscape where the diverse efforts to reduce to- bacco use take place. Several legal rulings, still under adjudication, and the Master Settlement Agreement between states and the tobacco industry to recover costs of government programs have altered prospects for reducing tobacco use through large-scale social maneuvers. Many of these issues are still unresolved, and they are likely to influence activities in the com- ing years. Issues in Reducing Tobacco Use 5 Surgeon General's Report Major Conclusions 1. _ Efforts to prevent the onset or continuance of to- bacco use face the pervasive, countervailing in- fluence of tobacco promotion by the tobacco industry, a promotion that takes place despite overwhelming evidence of adverse health effects from tobacco use. 2. The available approaches to reducing tobacco use—educational, clinical, regulatory, economic, and comprehensive—differ substantially in their techniques and in the metric by which success can be measured. A hierarchy of effectiveness is difficult to construct. 3. | Approaches with the largest span of impact (eco- nomic, regulatory, and comprehensive) are likely to have the greatest long-term, population im- pact. Those with a smailer span of impact (edu- cational and clinical) are of greater importance in helping individuals resist or abandon the use of tobacco. 4. Each of the modalities reviewed provides evi- dence of effectiveness: ¢ Educational strategies, conducted in conjunc- tion with community- and media-based activities, can postpone or prevent smoking onset in 20 to 40 percent of adolescents. ¢ Pharmacologic treatment of nicotine addic- tion, combined with behavioral support, will enable 20 to 25 percent of users to remain ab- stinent at one year posttreatment. Even less intense measures, such as physicians advising their patients to quit smoking, can produce cessation proportions of 5 to 10 percent. ¢ Regulation of advertising and promotion, par- ticularly that directed at young people, is very likely to reduce both prevalence and uptake of smoking. ¢ Clean air regulations and restriction of minors’ access to tobacco products contribute to a changing social norm with regard to smoking and may influence prevalence directly. * Anoptimal level of excise taxation on tobacco products will reduce the prevalence of smok- ing, the consumption of tobacco, and the long- term health consequences of tobacco use. 6 Chapter 1 5. The impact of these various efforts, as measured with a variety of techniques, is likely to be un- derestimated because of the synergistic effect of these modalities. The potential for combined effects underscores the need for comprehensive approaches. 6. State tobacco control programs, funded by excise taxes on tobacco products and settlements with the tobacco industry, have produced early, en- couraging evidence of the efficacy of the com- prehensive approach to reducing tobacco use. Issues in Reducing Tobacco Use Two themes have permeated the history of to- bacco use in the United States. First, and most obvi- ously, tobacco is an extraordinary economic fuel, and its powerful economic impact comes into direct con- flict with its vast social costs. Second, antitobacco ac- tivity has a continuous history characterized by waxing and waning and by a changing mix of motivations and strategies. These two themes are inextricably linked, and their interaction provides a backdrop for current efforts to reduce tobacco use. Such efforts take place in a complicated context. Chronic diseases have largely replaced infectious pro- cesses as the leading causes of death during the 20th century (Rothenberg and Koplan 1990). But this re- placement has occurred during a period of remark- able gains in life expectancy. Mortality is now less than half of what it was in 1900. The single most important risk associated with the leading chronic diseases is cigarette smoking; the evidence for that statement fills volumes of Surgeon General’s reports on smoking and health, and these volumes are merely summaries of a massive literature. Since the first of these reports in 1964, the prevalence of smoking has declined by nearly half, and it is clear that the declining use of tobacco has contributed to the observed decline in mortality. But paradoxically, as life expectancy increases, an in- creasing proportion of deaths are caused by the chronic diseases associated with smoking—primarily cancer, cardiovascular disease, and emphysema. This inter- play raises key questions. First, does the current smoking prevalence of about 25 percent represent a remarkable public health success, or is it evidence of continuing failure? The answer is yes to both questions. Health advocates can be both pleased with overall trends and loathe to de- clare success for a job unfinished, because goals and standards change with evolving efforts to reduce to- bacco use. If the worldwide public health response to smallpox can be used as an analogy, the control pro- gram reached a point at which a single case was deemed unacceptable. Second, why has the decline in smoking preva- lence been slow? In the face of voluminous evidence about adverse health effects, prevalence has declined sluggishly (an average of about 0.5 percent per year since the mid-1960s). Currently, the decline exhibits epidemiologic signs of pausing in its downward tra- jectory, and it has even reversed in some population subgroups. There is no single, facile explanation for the persisting practice of tobacco use. If rationality were the only force at work, tobacco use would have been abandoned long ago. But as is shown in Figure 1.1, the forces that can be brought to bear on current or potential smokers are more complex and subtle than the mere awareness that smoking is harmful to one’s health. A young person on the threshold of deciding to smoke may be subject to various influences, including the existence or nonexistence of targeted health educa- tion programs that discourage smoking, as well as of restrictions on access to cigarettes and a variety of regu- lations that determine the content and packaging of the product. Widespread and local norms, affecting this young person in the form of peer pressure, perceived smoking prevalence, and the commercial presentation of tobacco products, can affect the decision either way. The cost of cigarettes is likely to have significant influ- ence on a young person, and other economic policies— largely unseen by the potential smoker—can affect the outcome. Personal psychosocial factors undoubtedly Figure 1.1. Influences on the decision to use tobacco Antitobacco Health education Economic policy Minors’ access Product regulation Social advocacy Advertising restrictions Promotional restrictions Widespread social norms 1 Local community norms | [#7 Behavioral treatment Pharmacologic treatment , Ayoung ' nonsmoker Clean indoor air regulation porcccctt A current Personal litigation ' smoker --- Advertising 77 Regulation A former smoker Reducing Tobacco Use play a role and are likely to interact with these other influences. Arrayed among and against such factors are the variety of conduits—also largely unseen by the current or potential smoker—through which the influences of the tobacco industry are manifested: use of advertising and promotion to alter perceived social norms, alteration or prevention of legislation that would inhibit smoking, legal mechanisms to influence regulation, political mechanisms to influence economic policy, and countereducation that can serve to encour- age the uptake of smoking. Whatever the precise interplay of these influences, the net result has been a slower decline than would be warranted by awareness of the well-publicized public health threat that smoking poses. The forces that have tried to accelerate the decline may be thought of col- lectively as “interventions,” although the term, in a more narrow sense, is often reserved for circumscribed, planned, and measurable activities. Many of the ma- neuvers described in this report do not meet the nar- rower definition, but all share the common characteristic of being directed toward a reduction in tobacco use. With a broader definition in mind, Ramstr6m (1995) has classified tobacco interventions by the point they affect on the spectrum of tobacco use. These classifications, depicted in Figure 1.2, are creating a nonsmoking norm, reducing stimuli to smoke, strengthening motivation to quit, and reduc- ing impediments to quitting. Although the conceptu- alization is useful, a line could legitimately be drawn from each box to any other box in Figure 1.2, as these activities are all intimately tied to each other in both Protobacco i Psychosocial factors “&——--——_ Peer pressure Industry influence Perceived social norms Promotion Legislation Economic policy Education Issues in Reducing Tobacco Use 7 Surgeon General's Report process and outcome. To borrow from the language of statistics, the main effects of these efforts may be much less important than their interactions, both with each other and with the counterinfluences of the to- bacco industry. The result is a considerable challenge for evalua- tion. Suppose the young person in Figure 1.1 “decides” not to smoke, or the current smoker quits. Attribution of cause to this outcome in individual cases is highly unlikely. The totality of such decisions—which leads to a decline in prevalence—poses similar problems of attribution. Although the epidemiologic methods ex- ist, data are rarely available to make attributive judg- ments. The challenge of evaluating these separate ef- forts and strategies results from their disparate na- ture and the type of metric that may be appropriate to their evaluation (Table 1.1). Management of nicotine addiction (Chapter 4), for example, is usually studied by using standard epidemiologic study design—often a prospective comparison of a study group and a control group— and the effect is measured by some form of the rela- tive or attributable risk statistic. Educational strategies (Chapter 3), like other behavioral studies, may use similar statistics but usually invoke a different set of confounding factors to be considered; sorting out Figure 1.2. Overview of relationships among interventions Reduce morbidity and mortality Protect nonsmokers’ health and rights — Manage nicotine addiction Create a smoke-free XZ environment VA Prevent smoking uptake Personal litigation 5 Strengthen Reduce impedi- Create a Reduce stimuli motivation to quit ments to quitting nonsmoking norm to smoke Chapter Chapter Chapter Chapter Health education 3,4 Pharmacologic Rx 4 Health education 3 Advertising restrictions 5 Economic policy 6 Behavioral Rx 4 Economic policy 6 Promotion restrictions 5 Smoke-free policy = 5 Knowledge Rx 4 Product regulation 5 Sales restrictions 4 Comprehensive 7 Attitude Rx 4 Smoke-free policy = 5 Comprehensive 7 programs Comprehensive 7 programs programs Source: Adapted from Ramstrém 1995. 8 Chapter 1 Table 1.1. Characteristics of interventions Reducing Tobacco Use Type of Outcome intervention Targets Tools Study approaches measurements Educational Children and adoles- School curricula Epidemiologic and Relative risk cents, usually in school ioral: . y Interactive training behaviczal Attributable Administrative groups Targeted . ¢ Usually a comparison risk (e.g., members of argered’ services of “treatment” and “no Ber act ize h . * a health mointenance Mass media treatment” groups (absolute or * Control of confounding __ relative) General population by behavioral and Health care providers social variables Clinical Persons who smoke, Pharmacologic Epidemiologic and Relative risk lly i ‘oral: usta yinahealth care methods behavioral: Attributable 6 Behavioral ¢ Usually a comparison risk General population modification of treatment and “no Effect size ; ‘ Reinforcing treatment” groups (absolute or commercial or quasi- . t ° Control of confoundi relative) commercial setting environmen ontrol of confounding by behavioral and demographic variables Regulatory Product manufacture Local ordinance Observational Linear trend Product sale State regulation Knowledge/attitude/ Cross-sectional . i i i f Vendors and buyers Federal regulation practice studies comparison © Surveillance Proportions Public venues Federal law urV . C d Case analysis Public transportation Nongovernment ase Shicy results Worksites action fe. &., joint commission Health care sites accreditation of hospital organization) Economic Taxes Local ordinance Econometric analysis Linear trend Tariffs and trade State regulation Trend analysis Parameter . . ws estimates (e.g., Price supports Federal regulation Multivariate models elasticities) Federal law International agreements Social/Com- _ Legislators Media advocacy Observational Linear trends rehensive P Media Direct advocacy Case study Case study as . : ‘ ‘ analysis Communication Community General epidemiologic networks interventions methods Cross-sectional . : comparisons Case-by-case strategy Countermarketing Trend analysis P State/local programs Regulation Knowledge/attitude/ Policy formation practice studies Issues in Reducing Tobacco Use 9 Surgeon General's Report the relative influence of such factors often requires complex multivariate procedures. Regulatory efforts (Chapter 5) are frequently evaluated after the effect (with a pre- and post-type of study design) or are evaluated according to ecological correlations with changes in epidemiologic trends. Economic measures (Chapter 6) depend for their evaluation on economet- ric information—that is, on administrative data sets and survey results that are subjected to correlation and trend analysis. Finally, comprehensive program strat- egies are often evaluated using surveillance data sys- tems, trend analyses, and case studies. In each instance, some form of evaluation is pos- sible, but the ability to connect the intervention to the outcome differs greatly among these efforts, as does the ability to estimate impact. Theoretically, it might be possible to associate each effort with some pre- sumed number of persons who start smoking or some number who quit, but to do so would usually require numerous assertions and assumptions. For example, to estimate the number of persons who would benefit, through prevention or cessation of smoking, from an educational strategy, assumptions would be needed about its generalizability to the U.S. population, the variability of its impact, the use-effectiveness to which it is put, the proportion of the population reached, and the permanence of its effect. It is even more difficult to create a set of assumptions for the impact of a regu- lation that is promulgated in an environment of de- clining prevalence and whose existence may depend on the prior emergence of the very changes it wishes to create. For example, a ban on smoking during airline flights, a measure intended not only to protect nonsmokers from environmental tobacco smoke (ETS) but also to promote a norm of nonsmoking, was pos- sible only in an era when the dangers of ETS were widely known and when the danger and discomfort experienced by nonsmokers had begun to outweigh the inconvenience, discomfort, and even social ostra- cism experienced by smokers being subjected to such restrictions. It is virtually impossible to link a social strategy to a direct effect on prevalence, however suc- cessful by other criteria. (Many would argue, quite justly, that the impact measure of reducing prevalence by reducing uptake and increasing cessation is not the only outcome of interest. Unfortunately, proximal process measures are even more variable among the dif- ferent strategies, and the ultimate outcome measures— morbidity and mortality—are too distal to easily consider.) Without a common metric, the various types of efforts to reduce tobacco use are difficult to compare quantitatively, although several attempts have been 10. Chapter 1 made (USDHHS 1998a; U.S. Department of the Treasury, Office of Economic Policy, unpublished report, 1998). Per- haps a more qualitative approach could be used. One approach, illustrated in Table 1.2, would be to consider the potential span of impact (the proportion of the population, or population sectors) that the particular effort can exercise in the context of a qualitative esti- mate of its potential impact. Several examples of each type of effort are presented, and a qualitative assess- ment is made based on the data provided in the re- port. The assessments in Table 1.2 are by no means meant to be definitive but are meant to provide a framework for approaching the difficult issue of rela- tive effectiveness. Although some observers would urge a more quantitative approach (e.g., using only randomized controlled trials as a measure of effective- ness), a number of effective modalities would likely be falsely discredited. For example, advocacy activity played a critical role in the formulation of the Food and Drug Administration’s (FDA’s) policy regarding regulation of tobacco products (see “Product Regula- tion” in Chapter 5), yet linking that policy, or anteced- ent advocacy work, directly to changing prevalence would be difficult. Ina qualitative assessment of relative impact, the examples provide a basis for a hierarchy of activities, but that hierarchy requires still another framework: consideration of the entity conducting the activity (in- dividual, nongovernment citizens group, nongovern- ment agency, or government agency) and the organizational level at which the activity is conducted (local, state, national, or international). Thus, no single set of rules is available for invoking these efforts to reduce tobacco use, and relative efficacy depends on the context in which an effort takes place. For example, local efforts to reduce tobacco use might include regu- latory ordinances (with potentially large impact on many people), education programs in schools (smaller impact on fewer people), and promotion of treatment for nicotine addiction (targeting a still smaller group). Specific local circumstances would dictate the specific activities. The federal government would more likely act to put in place economic measures and a variety of regulatory efforts (both types of interventions having very large span and size of impact), depending on the specific political context. In summary, then, these efforts to reduce tobacco use line up side by side and not in relative order. Their use is predicated on the particular context in which they are to operate. Because they all face the same counterinfluence of the industry’s tobacco promotion (the right-hand side of Figure 1.1), a reasonable case can be made that the large-scale strategies (economic Table 1.2. Examples of a qualitative assessment of intervention impact Reducing Tobacco Use Type of intervention Specific modality Span of impact Size of impact Educational Clinical Regulatory Economic Comprehensive programs School curriculum Mass media Pharmacologic Behavioral (alone) Product manufacture Product sale Public venues Worksites Taxation Tariffs and trade Statewide programs Case-by-case strategy Large Moderate Large Small Small Moderate Small Very small Very large Very large Large Large Large Moderate Large Small Very large Very large Very large Very large Large Large Unpredictable Unpredictable Note: Examples use a five-point ordinal scale (very small, small, moderate, large, very large), with the additional use of “unpredictable.” (See text for the context for such assessment.) and regulatory) have the greatest direct impact on that barrier. But the context necessary for those large-scale efforts to work depends on public attitudes and social norms that must be influenced by other means. In the 1990s, it became increasingly apparent that a public health success in reducing tobacco use requires activity on all fronts. A comprehensive approach—one that optimizes synergy from a mix of strategies—has emerged as the guiding principle for future efforts to reduce tobacco use. Such an approach makes moot the issue of a hierarchy of interventions, since a compre- hensive approach presupposes an interdependence of the available strategies. A coordinated, cohesive in- frastructure makes intuitive sense, since it permits a modular approach to the interventions themselves, but has been challenged on analytic grounds. In sucha tramework, attribution of success to particular pro- gram elements is difficult, and there is no experimen- tal evidence (nor is there likely to be) that an approach that is comprehensive is superior to one that is not. Nonetheless, the 20th century’s difficult experience with tobacco control (as described in Chapter 2) and the previous decade’s success in changing social norms and generating assets (as discussed in Chapter 7) lend empirical credibility to the comprehensive approach. Eliminating Disparities Related to Tobacco Use and Its Effects The elimination of health disparities related to tobacco use poses a great challenge to this nation. This was not a main focus of the current report, because two other recent, important publications have emphasized the issue. The 1998 Surgeon General's report Tobacco Use Among U.S. Racial/Ethnic Minority Groups (USDHHS 1998b) was the first to address the diverse tobacco con- trol needs of the four major U.S. racial/ethnic minor- ity groups—African Americans, American Indians and Alaska Natives, Asian Americans and Pacific Island- ers, and Hispanics. Healthy People 2010 (USDHHS 2000) presents two overarching goals: increase qual- ity and years of healthy life and eliminate health dis- parities among different segments of the U.S. population. Evidence reviewed in these two publica- tions highlights the significant disparities that exist in the United States. These publications also discuss the critical need for a greater focus on this issue, both in research and in public health action. Issues in Reducing Tobacco Use 11 Surgeon General's Report Summary and Implications In fact, each of the approaches described in this report shows evidence of effectiveness. In some in- - stances, the synergism that might be expected through interaction among these various efforts has been docu- mented. The remainder of this chapter describes the major findings and implications for each type of activ- ity and presents the conclusions of the other chapters. Historical Review (Chapter 2) The forces that have shaped the movement to reduce tobacco use over the past 100 years are com- plex and intertwined. In the early years (1880-1920), antitobacco activity—some of it quite successful—was motivated by moral and hygienic principles. After important medical and epidemiologic observations of the midcentury linked smoking to lung cancer and other diseases, and after the subsequent appearance of the 1964 report of the advisory committee to the Surgeon General on smoking and health (USDHEW 1964), the movement to reduce tobacco use was fu- eled by knowledge of the health risks that tobacco use poses and by reaction against the continued promo- tion of tobacco in the face of such known risks. De- spite overwhelming evidence of adverse health consequences of smoking, the stubborn norm of smok- ing in the United States has receded slowly, in part because of such continued promotion that works syn- ergistically with tobacco addiction. Although strate- gies have varied, health advocates have focused in recent years on the prevention of harm to nonsmokers and on the concept of smoking as a pediatric disease, with the consequent need for protecting young per- sons from forces influencing them to smoke. Educational Strategies (Chapter 3) The design of educational programs for tobacco use prevention and the methods used to evaluate them have become increasingly refined over the past two decades. Early studies tended to be confined to the school context, to have short duration, and to be of low intensity. Studies tended to focus ona single mo- dality and to ignore the larger context in which pre- vention takes place. The reported size, scope, and duration of program effects have become larger in re- cent reports. In particular, several large programs have attempted a multifaceted approach that incorporates 12. Chapter 1 other than school-based modalities. Improvements in evaluation designs have increased confidence in the validity of these reports. The pattern of consistency across this group of large studies also provides assur- ance that these effects can be achieved in a variety of circumstances when programs include the critical multiple elements that have been defined by this re- search literature. To summarize the major findings, school-based social influences programs have significant and sub- stantial short-term impacts on smoking behavior. Those programs with more frequent educational con- tacts during the critical years for smoking adoption are more likely to be effective, as are programs that address a broad range of educational needs. These effects have been demonstrated in a range of imple- mentation models and student populations. The smok- ing prevention effects of strong school programs can be extended through the end of high school or longer when combined with relatively intensive efforts di- rected through other powerful channels, such as strat- egies that vigorously engage the influences of parents, the mass media, and other community resources. These conclusions have been codified in national guidelines for school programs to prevent tobacco use. Thus, an extensive body of research findings document the most effective educational programs for preventing tobacco use. This research has produced a wide array of curricula, protocols, and recommenda- tions that have been codified into national guidelines for schools. Implementing guidelines could postpone or prevent smoking onset in 20 to 40 percent of U.S. adolescents. Unfortunately, existing data suggest that evidence-based curricula and national guidelines have not been widely adopted. By one set of criteria, less than 5 percent of schools nationwide are implement- ing the major components of CDC's Guidelines for School Health Programs to Prevent Tobacco Use and Ad- diction (CDC 1994). Almost two-thirds of schools (62.8 percent) had smoke-free building policies in 1994, but significantly fewer (36.5 percent) reported such poli- cies that included the entire school environment. Schools, however, should not bear the sole respon- sibility for implementing educational strategies to prevent tobacco use. Research findings, as noted, indi- cate that school-based programs are more effective when combined with mass media programs and with community-based efforts involving parents and other community resources. In addition, CDC’s school health guidelines and numerous Healthy People 2010 objectives recognize the critical role of implementing tobacco-free policies involving faculty, staff, and students and relat- ing to all school facilities, property, vehicles, and events. Although significant progress is still required, the cur- rent evaluation base provides clear direction for the amalgamation of school-based programs with other modalities for reducing tobacco use. Management of Nicotine Addiction (Chapter 4) The management of nicotine addiction is a com- plex field that continues to broaden its understanding of the determinants of smoking cessation. Current lit- erature suggests that several modalities are effective in helping smokers quit. Although the overall effect of such intervention is modest if measured by each attempt to quit, the process of overcoming addiction is a cyclic one, and many who wish to quit are eventu- ally able to do so. The available approaches to man- agement of addiction differ in their results. Self-help manuals and minimal clinical interventions. Although self-help manuals have had only modest and inconsistent success at helping smokers quit, manuals can be easily distributed to the vast population of smokers who try to quit on their own each year. Adjuvant be- havioral interventions, particularly proactive telephone counseling, may significantly increase the effect of self- help materials. Process measures are not routinely in- corporated into self-help investigations, but the available Process data suggest that persons who not only have a self-help manual but also perform the exercises recom- mended in the manual are more likely to quit smoking than are persons who try to quit smoking without them. Substantial evidence suggests that minimal clini- cal interventions (e.g., a health care provider's repeated advice to quit) foster smoking cessation and that the more multifactorial or intensive interventions produce the best outcomes. These findings highlight the impor- tance of cessation assistance from clinicians, who have access to more than 70 percent of smokers each year. Moreover, minimal clinical interventions have been found to be effective in increasing smokers’ motivation to quit and are cost-effective (see “Cost-Effectiveness” in Chapter 4). However, research has not fully clarified the specific elements of minimal interventions that are most important to clinical success nor the specific changes they produce in smokers that lead to abstinence. Intensive clinical interventions. Intensive pro- grams—more formally systematic services to help people quit smoking—serve an important function in Reducing Tobacco Use the nation’s efforts to reduce smoking, despite the re- sources the programs demand and the relatively small population of smokers who use them. Such programs may be particularly useful in treating those smokers who find it most difficult to quit. Because intensive smoking cessation programs differ in structure and content, evaluation is often hampered by variation in methodology and by a lack of research addressing spe- cific treatment techniques. Because few studies have chosen to isolate single treatments, assessment of the effectiveness of specific approaches is difficult. None- theless, skills training, rapid smoking, and both intra- treatment and extra-treatment social support have all been associated with successful smoking cessation. When such treatments are shown to be effective, they are usually part of a multifactorial intervention. Little clear evidence has implicated particular psychologi- cal, behavioral, or cognitive mechanisms as the agents of change. The specific impact of intensive interven- tions may be masked by the efficacy of several multi- component programs, some of which have achieved cessation proportions of 30 to 50 percent. Thus, in their positive effect on smoking cessation and long-term abstinence rates, intensive interventions seem little different from other forms of counseling or psycho- therapy. With intensive interventions, as with coun- seling, it is difficult to attribute the efficacy to specific characteristics of the interventions or to specific change mechanisms. Pharmacologic interventions. Abundant evidence confirms that nicotine gum and the nicotine patch are effective aids to smoking cessation. The efficacy of nicotine gum may depend on the amount of behav- ioral counseling with which it is paired. The 4-mg dose (rather than the 2-mg dose) may be the better phar- macologic treatment for heavy smokers or for those highly dependent on nicotine. The nicotine patch ap- pears to exert an effect independent of behavioral sup- port, but absolute abstinence rates increase as more counseling is added to patch therapy. Nicotine inhal- ers and nicotine nasal spray are effective aids for smok- ing cessation, although their mechanisms of action are not entirely clear. All nicotine replacement therapies produce side effects, but these are rarely so severe that patients must discontinue use. Nicotine nasal spray appears to have greater potential for inappropriate use than other nicotine replacement therapies. Nicotine replacement therapies, especially the gum and the patch, have been shown to delay but not prevent weight gain following smoking cessation. All nico- tine replacement therapies are thought to work in part by reducing withdrawal severity. The available evi- dence suggests that they do ameliorate some elements Issues in Reducing Tobacco Use 13 Surgeon General's Report of withdrawal, but the relationship between withdrawal suppression and clinical outcome is inconsistent. Bupropion is the first nonnicotine pharmaco- therapy for smoking cessation to be studied in large- scale clinical trials. Results suggest that it is an effective aid to smoking cessation. In addition, bupropion has been demonstrated to be safe when used in conjunc- tion with nicotine replacement therapy. In the only direct comparison with a nicotine replacement prod- uct, bupropion achieved quit rates about double those achieved with the nicotine patch. Bupropion appears to delay but not prevent postcessation weight gain, and available literature contains inconsistent evidence about bupropion-mediated withdrawal relief. Bupropion does not appear to work by reducing postcessation symptoms of depression, but its mecha- nism of action in smoking cessation remains unknown. Evidence suggests that clonidine is also capable of improving smoking cessation rates. Clonidine is hypothesized to work by alleviating withdrawal symp- toms. Although clonidine may reduce the craving for cigarettes after cessation, it does not consistently ame- liorate other withdrawal symptoms, and its effect on weight gain is unknown. Unpleasant side effects are common with clonidine use. Antidepressants and anxiolytics are potentially useful agents for smoking cessation. At present, only nortriptylene appears to have consistent empirical evidence of smoking cessation efficacy. However, tri- cyclic antidepressants produce a number of side ef- fects, including sedation and various anticholinergic effects, such as dry mouth. In summary, research on methods to treat nico- tine addiction has documented the efficacy of a wide array of strategies. The broad implementation of these effective treatment methods could produce a more rapid and probably larger short-term impact on tobacco-related health statistics than any other com- ponent of a comprehensive tobacco control effort. It has been estimated that smoking cessation is more cost- effective than other commonly provided clinical pre- ventive services, including Pap tests, mammography, colon cancer screening, treatment of mild to moderate hypertension, and treatment of high levels of serum cholesterol. Contemporaneously with the appearance of this report, research advances in managing nicotine ad- diction have been summarized in evidence-based clinical practice guidelines by the Centers for Disease Control and Prevention (CDC). That document con- firms that less intensive interventions, such as brief physician advice to quit smoking, could produce ces- sation rates of 5 to 10 percent per year. More intensive 14. Chapter 1 interventions, combining behavioral counseling and pharmacologic treatment of nicotine addiction, can produce 20 to 25 percent quit rates at one year. Thus, the universal provision of even less intensive interven- tions to smokers at all clinical encounters could each year help millions of U.S. smokers quit (Fiore et al. 2000). Progress has been made in recent years in dissemi- nating clinical practice guidelines on smoking cessation. Healthy People 2010 Objective 27-8 calls for universal insurance coverage of evidence-based treatment for nicotine dependency by both public and private pay- ers. Similarly, CDC’s Best Practices for Comprehensive Tobacco Control Programs advises states that tobacco- use treatment initiatives should include ¢ Establishing population-based counseling and treatment programs, such as cessation help lines. * Making the system changes recommended by the CDC-sponsored cessation guidelines. ¢ Covering treatment for tobacco use under both public and private insurance. e Eliminating cost barriers to treatment for under- served populations, particularly the uninsured (CDC 1999, p. 24). Regulatory Efforts (Chapter 5) Advertising and Promotion Attempts to regulate advertising and promotion of tobacco products were initiated in the United States almost immediately after the appearance of the 1964 report to the Surgeon General on the health conse- quences of smoking. Underlying these attempts is the hypothesis that advertising and promotion recruit new smokers and retain current ones, thereby perpetuat- ing a great risk to public health. The tobacco industry asserts that the purpose of marketing is to maintain brand loyalty. Considerable evidence has accumulated | showing that advertising and promotion are perhaps the main motivators for adopting and maintaining to- bacco use. Attempts to regulate tobacco marketing continue to take place in a markedly adversarial and litigious atmosphere. The initial regulatory action, promulgated in 1965, provided for a general health warning on cigarette pack- ages but effectively preempted any further federal, state, or local requirements for health messages. In 1969, a successful court action invoked the Fairness Doctrine (not previously applied to advertising) to require broadcast media to air antitobacco advertising to counter the paid tobacco advertising then running on television and radio. Indirect evidence suggests that such counteradvertising had considerable impact on the public’s perception of smoking. Not surprisingly, the tobacco industry supported new legislation (adopted in 1971) prohibiting the advertising of to- bacco products on broadcast media, because such leg- islation also removed the no-cost broadcasting of antitobacco advertising. A decade later, a Federal Trade Commission (FTC) staff report asserted that the domi- nant themes of remaining (nonbroadcast) cigarette advertising associated smoking with “youthful vigor, good health, good looks and personal, social and pro- fessional acceptance and success” (Myers et al. 1981, p. 2-13). A nonpublic version of the report detailed some of the alleged marketing strategy employed by the industry; the industry denied the allegation that the source material for the report represented indus- try policy. Nonetheless, some of these concerns led to the enactment of the Comprehensive Smoking Educa- tion Act of 1984 (Public Law 98-474), which required a set of four rotating warnings on cigarette packages. The law did not, however, adopt other FTC recommen- dations that product packages should bear informa- tion about associated risks of addiction and miscarriage, as well as information on toxic compo- nents of cigarettes. In fact, many FTC-recommended requirements for packaging information that have been enacted in other industrialized nations have not been enacted in the United States. The role of advertising is perhaps best epitomized by RJ. Reynolds Tobacco Company’s Camel brand campaign (initiated in 1988) using the cartoon charac- ter “Joe Camel.” Considerable research has demon- strated the appeal of this character to young people and the influence that the advertising campaign has had on minors’ understanding of tobacco use and on their decision to smoke. In 1997, the FTC brought a complaint asserting that by inducing minors to smoke, R.J. Reynolds’ advertising practices violated the Fed- eral Trade Commission Act (Public Law 96-252). The tobacco company subsequently agreed to cease using the Joe Camel campaign. Although the FTC’s act grants no private right of enforcement, a private law- suit in California resulted in a settlement whereby the tobacco company agreed to cease its Joe Camel cam- paign; notably, the Supreme Court of California re- jected R.J. Reynolds’ argument that the Comprehensive Smoking Education Act of 1984 preempted the suit’s attempt to further regulate tobacco advertising. Reducing Tobacco Use Product Regulation Current tobacco product regulation requires that cigarette advertising disclose levels of “tar” (an all- purpose term for particulate-phase constituents of to- bacco smoke, many of which are carcinogenic or otherwise toxic) and nicotine (the psychoactive drug in tobacco products that causes addiction) in the smoke of manufactured cigarettes and that warning labels appear on packages and on some (but not all) adver- tising for manufactured cigarettes and smokeless to- bacco. The current federal laws preempt, in part, states and localities from imposing other labeling regulations on cigarettes and smokeless tobacco. Federal law (the Comprehensive Smokeless Tobacco Health Education Act of 1986 and the Comprehensive Smoking Educa- tion Act of 1984) requires cigarette and smokeless to- bacco product manufacturers to submit a list of additives to the Secretary of Health and Human Ser- vices; attorneys for the manufacturers released such lists in 1994 to the general public. Smokeless tobacco manufacturers are required to report the total nicotine content of their products, but these data may not be released to the public. Tobacco products are explic- itly protected from regulation in various federal con- sumer safety laws. No federal public health laws or regulations apply to cigars, pipe tobaccos, or fine-cut cigarette tobaccos (for “roll-your-own” cigarettes). Although much effort has been devoted to con- sidering the need for regulating nicotine delivery, tar content, and the use of additives, until recently no regu- lation had directly broached the issue of whether to- bacco should be subject to federal regulation as an addictive product. Responding in part to several pe- titions filed by the Coalition on Smoking OR Health in 1988 and 1992, the FDA began serious consideration of the need for product regulation. Motivated by the notion that the cigarette is a nicotine delivery system, by allegations of product manipulation of nicotine lev- els, and by the concept that smoking is a pediatric dis- ease and that young people are especially susceptible to cigarette advertising and promotion, in August 1995 the FDA issued in the Federal Register (1) a proposed rule of regulations restricting the sale and distribution of cigarettes and smokeless tobacco products to pro- tect children and adolescents and (2) an analysis of the FDA's jurisdiction over cigarettes and smokeless to- bacco. The final regulations published by the FDA on August 28, 1996, differed only slightly from the pro- posed regulation. The announcement prompted immediate legal action on the part of the tobacco in- dustry, advertising interests, and the convenience store industry, which challenged the FDA’s jurisdiction over Issues in Reducing Tobacco Use 15 Surgeon General's Report tobacco products. In April 1997, a federal district court upheld the FDA’s jurisdiction over tobacco products, but held that it lacked authority under the statutory provision relied on to regulate tobacco product advertising. Although many of the FDA’s regulations on to- bacco sales and distribution were incorporated, to some extent, in the June 20, 1997, proposed settlement of lawsuits between 41 state attorneys general and the tobacco industry, the settlement presupposed congres- sional legislation that would uphold the FDA's as- serted jurisdiction. After considerable congressional negotiation, no such legislation emerged. In August 1998, a three-judge panel of the United States Court of. Appeals for the Fourth Circuit held that the FDA lacked jurisdiction to.regulate tobacco products. In Novem- ber 1998, the full Court of Appeals rejected the government's request for rehearing by the entire court. On March 21, 2000, in a 5 to 4 decision, the United States Supreme Court affirmed the decision of the United States Court of Appeals for the Fourth Circuit and held that the FDA lacks jurisdiction under the Fed- eral Food, Drug, and Cosmetic Act to regulate tobacco products as customarily marketed. As a result of this decision, the FDA’s August 1996 assertion of ju- risdiction over cigarettes and smokeless tobacco and regulations restricting the sale and distribution of ciga- rettes and smokeless tobacco to protect children and adolescents (principally codified at 21 Code of Fed- eral Regulations Part 897) are invalid. Clean Indoor Air Regulation Unlike the regulation of tobacco products per se and of their advertising and promotion, regulation of exposure to ETS has encountered less resistance. This course is probably the result of (1) long-standing grassroots efforts to diminish exposure to ambient to- bacco smoke and (2) consistent epidemiologic evidence of adverse health effects of ETS. Since 1971, a series of rules, regulations, and laws have created smoke-free environments in an increasing number of settings: government offices, public places, eating establish- ments, worksites, military establishments, and domes- tic airline flights. As of December 31, 1999, smoking was restricted in public places in 45 states and the Dis- trict of Columbia. Currently, some 820 local ordi- nances, encompassing a variety of enforcement mechanisms, are in place. The effectiveness of clean indoor air restrictions is under intensive study. Most studies have concluded that even among smokers, support for smoking restric- tions and smoke-free environments is high. Research 16 Chapter 1 has also verified that the institution of smoke-free workplaces effectively reduces nonsmokers’ exposure to ETS. Although most studies indicate that smoke- free environments have not reduced smoking preva- lence, such environments have been shown to decrease daily tobacco consumption and to increase smoking cessation among smokers. Minors’ Access to Tobacco There is widespread approval for restricting the access of minors to tobacco products. Recent research, however, has demonstrated that a substantial propor- tion of teenagers who smoke purchase their own tobacco, and the proportion varies with age, social class, amount smoked, and factors related to local availability. In addition, research has shown that most minors can easily purchase tobacco from a variety of retail outlets. It has been suggested that a reduction in commercial availability may result in a reduced prevalence of tobacco use among minors. Several approaches have been taken to limiting minors’ access to tobacco. All states prohibit sale or distribution of tobacco to minors. More than two-thirds of states regulate the means of sale through restrictions on minors’ use of vending machines, but many of these restrictions are weak, and only two states have total bans on vending machines. Restrictions on vending machines are a subclass of the larger category of regu- lation of self-service cigarette sales; in general, such regulation requires that cigarettes be obtained from a salesperson and not be directly accessible to custom- ers. Such policies can reduce shoplifting as well, an important source of cigarettes for some minors. Regulations directed at the seller include the specification of a minimum age for sale (18, in all but two states and Puerto Rico), a minimum age for the seller, and the prominent in-store announcement of such policy. Providing merchant education and train- ing is an important component of comprehensive mi- - nors’ access programs. Penalties for sales to minors vary considerably; in general, civil penalties have been found to be more effective than criminal ones. Requir- ing licensure of tobacco retailers has been found to provide a funding source for compliance checks and to serve as an incentive to obey the law when revoca- tion of the license is a provision of the law. Applying penalties to business owners, instead of to clerks only, is considered essential to preventing sales to minors. Tobacco retail outlets and the tobacco industry have vigorously opposed this policy. An increasing num- ber of states and local jurisdictions are imposing sanc- tions against minors who purchase, possess, or use tobacco products. Sanctions against both buyers and sellers are enforced by a variety of agencies and mecha- nisms. Because regulations in general may be more effective if generated and enforced at the local level, considerable energy is devoted to the issue of oppos- ing or repealing preemption of local authority by states. Public health analyses have resulted in strong recom- mendations that state laws not preempt local action to curb minors’ access to tobacco. Litigation Approaches Private litigation shifts enforcement of public health remedies from the enterprise or the government to the private individual—typically, victims or their surrogates. In the tort system, the coalescence of in- stances in which injurers are forced to compensate the injured can create a force that generates preventive effects. Although relatively inefficient as a system for compensating specific classes of injuries, the tort sys- tem is justified by its generation of preventive actions and by its flexibility. Tobacco represents an atypical pattern of litigation and product modification, because private law remedies have not yet succeeded in insti- tutionalizing recovery for tobacco injuries or have not yet generated significant preventive effects. In the case of tobacco, regulation has been the predominant control, and such regulation has been distinctive in re- lying primarily on notification requirements rather than safety requirements. Private litigation against tobacco has occurred in several distinct waves. The first wave was launched in 1954 and typically used one or both of two legal theories: negligence and implied warranty. Courts proved unreceptive to both these arguments, and this approach had receded by the mid-1970s. In many of these and subsequent cases, legal devices and exhaus- tion of plaintiff resources figured prominently in the defendants’ strategy. A second wave began in 1983 and ended in 1992. In these cases, the legal theory shifted from warranty to strict liability. The tobacco industry based its defense on smokers’ awareness of risks and so-called freedom of choice. For example, plaintiffs argued that the addictive nature of nicotine limited free choice; defense counsel rebutted by point- ing to the large number of former smokers who suc- cessfully quit. Taking freedom-of-choice defense even further, counsel argued that the claimant's lifestyle was overly risky by choice or was in some way immoral. The case that symbolized the second-wave litigation was that filed by Rose Cipollone, a dying smoker, in 1983. The Supreme Court accepted the tobacco industry’s defense that federal law requiring warning Reducing Tobacco Use labels on product packages had preempted claims under state law that imposed liability for failure to warn. The Supreme Court left open several other ap- proaches, but the likelihood of recovery seemed small, and counsel for the Cipollone estate withdrew. In the third wave, begun soon after the Cipollone decision and still ongoing, diverse legal arguments have been invoked. This third wave of litigation dif- fers from its predecessors by enlarging the field of plaintiffs, focusing on a range of legal issues, using the class action device, and making greater attempts to use private law for public policy purposes. These new claims have been based on theories of intentional misrepresentation, concealment, and failure to dis- close, and such arguments have been joined to a new emphasis on addiction. For example, in one case that ended as a mistrial, plaintiffs were barred from pre- senting evidence that the tobacco companies may have manipulated nicotine levels. The class action device has figured prominently in these new cases, which have included claims of smokers as well as claims of those who asserted that they have been injured by ETS. Arguably the most notable series of third-wave claims brought against tobacco companies is the proposed 1997 settlement of suits brought by 41 state attorneys general attempting to recover the states’ Medicaid ex- penditures for treating tobacco-related illnesses. In the absence of congressional legislation needed to give that settlement the force of law, four states made indepen- dent settlements with the tobacco industry. Notably, each state obtained a concession guaranteeing that it would benefit from any more favorable agreement that another state might later obtain from the tobacco in- dustry. Subsequently, a multistate Master Settlement Agreement was negotiated in November 1998 cover- ing the remaining 46 states, the District of Columbia, and five commonwealths and territories. Another notable recent development is the filing of large claims by other third-party payers, such as large health care plans. Perhaps in partial response, the level of litiga- tion initiated by the tobacco industry itself has in- creased in recent years and has included a number of well-publicized cases, including a threatened suit against the media to prevent airing of a program that accused a tobacco company of manipulating nicotine levels. The company was successful in making the network withdraw the program, even though similar information was later made public in other contexts. Although the industry continues aggressive legal pur- suit of its interests on a number of fronts, litigation against the industry has had undoubted impact on Issues in Reducing Tobacco Use 17 Surgeon General's Report tobacco regulation and is likely to continue to play a key role in efforts to reduce tobacco use. Overview and Implications Tobacco products are far less regulated in the United States than they are in many other developed countries. This level of regulation applies to the manu- factured tobacco product; to the advertising, promo- tion, and sales of these products; and to the protection of nonsmokers from the involuntary exposure to ETS from the use of these products. As with all other con- sumer products, adult users of tobacco should be fully informed of the products’ ingredients and additives and of any known toxicity when used as intended. Additionally, as with other consumer products, the manufactured tobacco product should be no more harmful than necessary given available technology. The sale, distribution, and promotion of tobacco prod- ucts need to be sufficiently regulated to protect un- derage youth from influences to take up smoking. Finally, involuntary exposure to ETS remains a com- mon public health hazard that is entirely preventable by appropriate regulatory policies. Such are the basic, reasonable regulatory issues related to tobacco products. Yet these issues remain unresolved as the new millennium begins. When con- sumers purchase a tobacco product, they receive little information regarding the ingredients, additives, or chemical composition in the product. Although public knowledge about the potential toxicity of most of these constituents is negligible, findings in this report con- clude that the warning labels on cigarette packages in this country are weaker and less conspicuous than in other countries. Further, the popularity of “low tar and nicotine” brands of cigarettes has shown that consum- ers may be misled by another, carefully crafted kind of information—that is, by the implied promise of reduced toxicity underlying the marketing of these products. Current regulation of the advertising and pro- motion of tobacco products in this country is consid- erably less restrictive than in several other countries, notably Canada and New Zealand. The review of cur- rent case law in this report supports the contention that greater restrictions of tobacco product advertis- ing and promotion could be legally justified. In fact, the report concludes that regulation of the sale and promotion of tobacco products is needed to protect young people from smoking initiation. ETS contains more than 4,000 chemicals; of these, at least 43 are known carcinogens (Environmen- tal Protection Agency 1992). Exposure to ETS has serious health effects (USDHHS 2000b). Despite this 18 Chapter 1 documented risk, research has demonstrated that more than 88 percent of nonsmokers in this country aged 4 years and older had detectable levels of se- rum cotinine, a marker for exposure to ETS (Pirkle et al. 1996). The research reviewed in this report indi- cates that smoking bans are the most effective method for reducing ETS exposure. Four Healthy People 2010 objectives address this issue and seek optimal pro- tection of nonsmokers through policies, regulations, and laws requiring smoke-free environments in all schools, worksites, and public places. Despite the widespread support among the gen- eral public, policymakers, and the tobacco industry for restricting the access of minors to tobacco products, a high proportion of underage youth smokers across this country continue to be able to purchase their own tobacco. National efforts by the Substance Abuse and Mental Health Services Administration to increase the enforcement of state laws to comply with the Synar Amendment and by the FDA to implement the access restrictions defined in their 1996 rule have reduced the percentage of retailers in many states who sell to mi- nors. Unfortunately, nine states failed to attain their Synar Amendment targets in 1999. Additionally, the March 2000 Supreme Court ruling that the FDA lacks jurisdiction to regulate tobacco products has suspended all enforcement of the agency’s 1996 regulations. Although several states have increased emphasis on this issue as part of their state-funded program efforts, the loss of the FDA’s program removes a major infrastructure in support of these state efforts. The current regulatory environment poses considerable challenges for the interweaving of regulation into a comprehensive, multicomponent approach to tobacco use control and prevention. Economic Approaches (Chapter 6) The argument for using economic policy for re- ducing tobacco use requires considerable technical and analytic understanding of economic theory and data. Because experiments and controlled trials—in the usual sense—are not available to the economist, judg- ment and forecasting depend on the results of com- plex analysis of administrative and survey data. Such analyses have led to a number of conclusions regard- ing the importance of the tobacco industry in the U.S. economy and regarding the role of policies that might affect the supply of tobacco, affect the demand for to- bacco, and use different forms of taxation as a pos- sible mechanism for reducing tobacco use. Supply. The tobacco support program has success- fully limited the supply of tobacco and raised the price of tobacco and tobacco products. However, the princi- pal beneficiaries of this program are not only the farmers whose income is supported but also the own- ers of the tobacco allotments. If policies were initiated to ameliorate some short-run effects, the tobacco sup- port program could be removed without imposing substantial losses for many tobacco farmers. Elimi- nating the tobacco support program would lead toa small reduction in the prices of cigarettes and other tobacco products, which would lead to slight increases in the use of these products. However, because the support program has created a strong political con- stituency that has successfully impeded stronger leg- islation to reduce tobacco use, removing the support program could make it easier to enact stronger policies that would more than offset the impact that the result- ing small reductions in price would have on demand. Throughout the 1980s and 1990s, competition within the tobacco industry appeared to have de- creased as a result of the favorable deregulatory busi- ness climate and an apparent increase in collusive behavior. This reduction in competition, coupled with the addictive nature of cigarette smoking, has magni- fied the impact that higher cigarette taxes and stronger smoking reduction policies would have on demand. The recent expansion of U.S. trade in tobacco and tobacco products through multinational agreements, together with the U.S. threat of retaliatory trade sanc- tions were other countries to impede this expansion, is nearly certain to have increased the use of tobacco products worldwide. Such an increase would result in a consequent global rise in morbidity and mortality related to cigarette smoking and other tobacco use. These international trade policy efforts conflict with current domestic policies (and the support of compa- rable international efforts) that aim to reduce the use of tobacco products because of their harmful effects on health. Industry importance. Although employment in the tobacco industry is substantial, the industry greatly overstates the importance of tobacco to the U.S. economy. Indeed, most regions would likely benefit— for example, through redistribution of spending and changes in types of job—from the elimination of rev- enues derived from tobacco products. Moreover, as the economies of tobacco-growing regions have be- come more diversified, the economic importance of tobacco in these areas has fallen. Higher tobacco taxes and stronger prevention policies could be joined to other efforts to further ease the transition from tobacco in major tobacco-producing regions. Finally, trading Reducing Tobacco Use lives for jobs is an ill-considered strategy, particularly with the availability of stronger policies for reducing tobacco use. Demand. Increases in the price of cigarettes will lead to reductions in both smoking prevalence and ciga- rette consumption among smokers; relatively large re- ductions are likely to occur among adolescents and young adults. Limited research indicates that increases in smokeless tobacco prices will similarly reduce the use of these products. More research is needed to clarify the impact of cigarette and other tobacco prices on the use of these products in specific sociodemographic groups, particularly adolescents and young adults. Additional research also is needed to address the po- tential substitution among cigarettes and other tobacco products as their relative prices change. Taxation. After the effects of inflation are ac- counted for, federal and average state excise taxes on cigarettes are well below their past levels. Similarly, average cigarette excise taxes in the United States are well below those imposed in most other industrialized countries. Moreover, U.S. taxes on smokeless tobacco products are well below cigarette taxes. Studies of the economic costs of smoking report a wide range of es- timates for the optimal tax on cigarettes. However, when recent estimates of the costs of ETS (including the long-term costs of fetal and perinatal exposure to ETS) are considered, and when the premature death of smokers is not considered an economic benefit, a tax that would generate sufficient revenues to cover the external costs of smoking is almost certainly well above current cigarette taxes. The health benefits of higher cigarette taxes are substantial. By reducing smoking, particularly among youth and young adults, past tax increases have significantly reduced smoking- related morbidity and mortality. Further increases in taxes, indexed to account for the effects of inflation, would lead to substantial long-run improvements in health. The revenue potential of higher cigarette and other tobacco taxes—obviously not in itself a goal—is considerable; significant increases in these taxes would lead to sizable increases in revenues for many years. However, because of the greater price responsiveness of adolescents and young adults and the addictive nature of tobacco use, the long-run increase in revenues is likely to be less than the short-run gain. Neverthe- less, current federal and most state tobacco taxes are well below their long-run revenue-maximizing levels. In short, the research reviewed in this report sup- ports the position that raising tobacco prices is good public health policy. Further, raising tobacco excise taxes is widely regarded as one of the most effective Issues in Reducing Tobacco Use 19 Surgeon General’s Report tobacco prevention and control strategies. Research indicates that increasing the price of tobacco products would decrease the prevalence of tobacco use, particu- larly among minors and young adults. As noted, how- ever, this report finds that both the average price of cigarettes and the average cigarette excise tax in this country are well below those in most other industrial- ized countries and that the taxes on smokeless tobacco products are well below those on cigarettes. Making optimal use of economic strategies in a comprehen- sive program poses special problems because of the complexity of government and private controls over tobacco economics and the need for a concerted, mul- tilevel, political approach. Comprehensive Programs (Chapter 7) Community-based interventions were originally developed as research projects that tested the efficacy of a communitywide approach to risk reduction. A number of national and international efforts to con- trol cardiovascular disease (in the United States, nota- bly the Minnesota, Stanford, and Pawtucket studies) used controlled designs. The results from these and other studies were largely disappointing, particularly regarding prevention and control of tobacco use. Other large-scale research efforts, such as the Community In- tervention Trial (COMMIT) for Smoking Cessation, also failed to meet their primary goals for smoking re- duction and cessation. Similarly, the results to date from numerous worksite-based cessation projects sug- gest either no impact or a small net effect (Summarized in Chapter 4). As these studies were under way in the 1970s and 1980s, health promotion—an organized approach to changing social, economic, and regulatory environ- ments—emerged as a more effective mechanism for population behavior change than traditional health education. Although the aforementioned community- based research projects used a health promotion per- spective, they lacked the reach and penetration required for effective social change. In any event, the results made clear the distinction between a specific program (even one using multiple modalities) and a comprehen- sive multimessage, multichannel approach that used some or all of the modalities described in Chapters 3 through 6. The legal and economic events of the 1990s— most notably large excise tax increases and the settle- ments with the tobacco industry for reimbursement of Medicaid costs incurred by caring for smokers—have provided those states with the resources necessary to mount such a comprehensive approach. The early 20 Chapter 1 results are encouraging, as exemplified by results from California, Massachusetts, Oregon, and Florida. The well-funded, coherent, and organized approach to to- bacco prevention and control provides a credible coun- terweight to the advertising and promotional efforts of the tobacco industry and fosters a powerful nonsmok- ing norm. Ona broader scale, other social initiatives can also serve some of these same purposes through means that are not directly related to changing population behav- ior. For example, direct advocacy—the presentation of information to decision makers to encourage their support for nonsmoking policies—has been pursued vigorously by health advocates since the organization of grassroots movements for nonsmokers’ rights in the early 1970s. Much of the clean air legislation now in place may be attributed in part to such direct advo- cacy. An interesting observation that supports the logic behind comprehensive programs is that initial short- comings in direct advocacy activity may have been related to a failure of coordination among grassroots groups and professional organizations. In recent years, in part as the result of electronic networking and me- diating by the Advocacy Institute, a more unified ap- proach to reducing tobacco use has been achieved among the participating organizations. Media advocacy—the use of mass media to ad- vance public policy initiatives—has also been effective in placing smoking issues in the public eye and main- taining a continued impetus for reducing tobacco use. Case analysis of several instances of such activity— advocacy opposing the promotion of the “X” cigarette, the marketing of “Dakota” cigarettes, the Philip Morris-sponsored Bill of Rights tour, and the attempted marketing of “Uptown” cigarettes—highlights several successes but also indicates that such activities do not always achieve their immediate aims. Nonetheless, considerable experience has been gained in seizing such opportunities. Countermarketing activities can promote smok- ing cessation and decrease the likelihood of initiation. Countermarketing campaigns also can have a power- ful influence on public support for tobacco control ac- tivities and provide an educational climate that can enhance the efficacy of school- and community-based efforts. For youth, the CDC has estimated that the average 14-year-old has been exposed to more than $20 billion in imagery advertising and promotions since age 6, creating a “friendly familiarity” for tobacco products. The recent increase in movie depictions of tobacco use further enhances the image of tobacco use as glamorous, socially acceptable, and normal. In light of the ubiquitous and sustained protobacco messages, countermarketing campaigns need to be of comparable intensity and duration to alter the general social and environmental atmosphere supporting tobacco use. In sum, the comprehensive approach that has been developed: within the statewide tobacco control programs has produced results that led the Institute of Medicine (2000) to conclude that “multifaceted state tobacco control programs are effective in reducing to- bacco use” (p. 4). Although these initial results are encouraging, they need to be considered from the per- spective of the less favorable results from the commu- nity trials. Nevertheless, although our knowledge about the mechanisms by which these new compre- hensive tobacco control etforts function is imperfect, the results are sufficiently favorable to support the con- tinued application of this model. But, accountability and program evaluation must be emphasized in these new statewide tobacco control programs to improve our understanding of how the various components of the comprehensive programs work. Perhaps the most important aspect of comprehen- sive programs has been the emergence of statewide to- bacco control efforts as a laboratory for their development and evaluation. The number of states with such pro- grams grew slowly in the early and mid-1990s, but in recent years there has been a surge in funding for such efforts fueled by the state settlements with the tobacco industry. Although the data on the impact of these pro- grams on per capita consumption, adult prevalence, and youth prevalence are generally favorable, the uni- form data systems needed to conduct more controlled evaluations of these efforts are still emerging. The chal- lenge for the new millennium will be to ensure that these ever increasing comprehensive statewide tobacco con- trol programs are as efficient and effective as possible. The review of statewide tobacco control programs indicates that reducing the broad cultural acceptability of tobacco use necessitates changing many facets of the social environment. In addition, this report stresses— as does the Best Practices (CDC 1999) document—that these individual components must work together to produce the synergistic effects of a comprehensive Reducing Tobacco Use program. However, both of these findings highlight the complexity involved in evaluating these types of programs. Within the current statewide tobacco control pro- grams, each of these various modalities discussed in this report is represented with varying degrees of in- tensity. As noted above, some of the recommendations for actions within these modalities could most effec- tively be done at the national rather than the state level. Thus, the overall efficacy of these emerging statewide programs will depend in some ways on public health advances at the national level. Again, this synergy between the statewide and national efforts adds greater complexity to the evaluation issue. Finally, this report concludes that the span of impact of these educational, clinical, regulatory, eco- nomic, and social approaches indicates the importance of their sustained and long-term implementation. Pro- gram evaluation and research efforts are needed to improve our understanding of how these various ele- ments work. Although knowledge about the efficacy of comprehensive programs is imperfect, evidence points to early optimism for their continuance. With the expansion of tobacco control surveillance and evaluation systems and increases in the number and diversity of statewide tobacco control programs, criti- cal questions can be answered about how to make these efforts more efficient and effective. A Vision for the Future—Reducing Tobacco Use in the New Millennium (Chapter 8) Chapter 8 outlines broad strategies and courses of action for tobacco control in the future. Six future challenges are outlined: continuing to build the scien- tific base, responding to the changing tobacco indus- try, using a comprehensive approach in reducing tobacco use, eliminating health disparities, improving dissemination of state-of-the-art interventions, and influencing tobacco use in developing nations. Issues in Reducing Tobacco Use 21 Surgeon General's Report Chapter Conclusions Following are the specific conclusions for each chapter of the report. Note that Chapters 1 and 8 have no conclusions. Chapter 2. Historical Review 1. In the years preceding the development of the modern cigarette, and for some time thereafter, antismoking activity was largely motivated by moralistic and hygienic concerns. Health con- cerns played a lesser role. In contrast, in the second half of the 20th cen- tury, the impetus for reducing tobacco use was largely medical and social. The resulting plat- form has been a more secure one for efforts to reduce smoking. Despite the growing scientific evidence for ad- verse health effects, smoking norms and habits have yielded slowly and incompletely. The rea- sons are complex but attributable in part to the industry’s continuing stimulus to consumption. Chapter 3. Educational Strategies 1. Educational strategies, conducted in conjunction with community- and media-based activities, can postpone or prevent smoking onset in 20 to 40 percent of adolescents. Although most U.S. schools have tobacco use pre- vention policies and programs in place, current practice is not optimal. More consistent implementation of effective edu- cational strategies to prevent tobacco use will re- quire continuing efforts to build strong, multiyear prevention units into school health education cur- ricula and expanded efforts to make use of the influence of parents, the mass media, and other community resources. 22. Chapter 1 Chapter 4. Management of Nicotine Addiction 1. Tobacco dependence is best viewed as a chronic disease with remission and relapse. Even though both minimal and intensive interventions in- crease smoking cessation, most people who quit smoking with the aid of such interventions will eventually relapse and may require repeated at- tempts before achieving long-term abstinence. Moreover, there is little understanding of how such treatments produce their therapeutic effects. There is mixed evidence that self-help manuals are an efficacious aid to smoking cessation. Be- cause these materials can be widely distributed, such strategies may have a significant public health impact and warrant further investigation. Programs using advice and counseling—whether minimal or more intensive—have helped a sub- stantial proportion of people quit smoking. The success of counseling and advice increases with the intensity of the program and may be im- proved by increasing the frequency and duration of contact. The evidence is strong and consistent that phar- macologic treatments for smoking cessation (nicotine replacement therapies and bupropion, in particular) can help people quit smoking. Clonidine and nortriptylene may have some util- ity as second-line treatments for smoking cessa- tion, although they have not been approved by the FDA for this indication. Chapter 5. Regulatory Efforts Advertising and Promotion 1. Since 1964, numerous attempts to regulate ad- vertising and promotion of tobacco products have had only modest success in restricting such activity. Current regulation in the United States is con- siderably less restrictive than that in several other countries, notably Canada and New Zealand. Current case law supports the contention that ad- vertising does not receive the protections of free speech under the First Amendment to the Con- stitution that noncommercial speech does. Product Regulation 1, Warning labels on cigarette packages in the United States are weaker and less conspicuous than those of other countries. Smokers receive very little information regard- ing chemical constituents when they purchase a tobacco product. Without information about toxic constituents in tobacco smoke, the use of terms such as “light” and “ultra light” on pack- aging and in advertising may be misleading to smokers. Because cigarettes with low tar and nicotine con- tents are not substantially less hazardous than higher-yield brands, consumers may be misled by the implied promise of reduced toxicity un- derlying the marketing of such brands. Additives to tobacco products are of uncertain safety when used in tobacco. Knowledge about the impact of additives is negligible and will remain so as long as brand-specific information on the identity and quantity of additives is unavailable. Regulation of tobacco product sale and promo- tion is required to protect young people from in- fluences to take up smoking. Clean Indoor Air Regulation 1. Although population-based data show declining ETS exposure in the workplace over time, ETS exposure remains a common public health haz- ard that is entirely preventable. Most state and local laws for clean indoor air re- duce but do not eliminate nonsmokers’ exposure to ETS; smoking bans are the most effective method for reducing ETS exposure. Reducing Tobacco Use Beyond eliminating ETS exposure among non- smokers, smoking bans have additional benefits, including reduced smoking intensity and poten- tial cost savings to employers. Optimal protec- tion of nonsmokers and smokers requires a smoke-free environment. Minors’ Access to Tobacco 1. Measures that have had some success in reduc- ing minors’ access include restricting distribu- tion, regulating the mechanisms of sale, enforcing minimum age laws, having civil rather than criminal penalties, and providing merchant edu- cation and training. Requiring licensure of to- bacco retailers provides both a funding source for enforcement and an incentive to obey the law when revocation of the license is a provision of the law. The effect of reducing minors’ access to tobacco products on smoking prevalence requires further evaluation. Litigation Approaches 1. Two historic waves of tobacco litigation were ini- tiated by private citizens, were based largely on theories of negligence and implied warranty, and were unsuccessful. A third wave has brought in new types of claim- ants, making statutory as well as common-law claims and using more efficient judicial proce- dures. Although several cases have been settled for substantial money and have yielded public health provisions, many other cases remain unresolved. Private law initiative is a diffuse, uncentralized activity, and the sum of such efforts is unlikely to produce optimal results for a larger policy to reduce tobacco use. On the other hand, the liti- gation actions of individuals are likely to be a valuable component in some larger context of strategies to make tobacco use less prevalent. Issues in Reducing Tobacco Use = 23 Surgeon General’s Report Chapter 6. Economic Approaches 1. The price of tobacco has an important influence on the demand for tobacco products, particularly among young people. Substantial increases in the excise taxes on ciga- rettes would have considerable impact on the prevalence of smoking and, in the long term, re- duce the adverse health effects caused by tobacco. Policies that influence the supply of tobacco, par- ticularly those that regulate international com- merce, can have important effects on tobacco use. Although employment in the tobacco sector is substantial, the importance of tobacco to the U.S. economy has been overstated. Judicious policies can be joined to higher tobacco taxes and stron- ger prevention policies to ease economic diver- sification in tobacco-producing areas. 24 Chapter 1 Chapter 7. Comprehensive Programs 1. The large-scale interventions conducted in com- munity trials have not demonstrated a conclu- sive impact on preventing and reducing tobacco use. Statewide programs have emerged as the new laboratory for developing and evaluating com- prehensive plans to reduce tobacco use. Initial results from the statewide tobacco control programs are favorable, especially regarding declines in per capita consumption of tobacco products. Results of statewide tobacco control programs suggest that youth behaviors regarding tobacco use are more difficult to change than adult ones, but initial results of these programs are gener- ally favorable. References Reducing Tobacco Use Centers for Disease Control and Prevention. Best Prac- tices for Comprehensive Tobacco Control Programs— August 1999. Atlanta: Centers for Disease Control and Prevention, National Center for Chronic Disease Pre- vention and Health Promotion, Office on Smoking and Health, 1999. Fiore M, Bailey W, Bennett G, Bennett H, Cohen S, Dorfman SF, Fox B, Goldstein M, Gritz E, Hasselblad V, Heishman S, Heyman R, Husten C, Jaén CR, Jorenby D, Kamerow D, Kottke T, Lando H, Mecklenburg R, Melvin C, Morgan G, Mullen PD, Murray E, Nett L, Orleans CT, Robinson L, Stitzer M, Tommasello A, Villejo L, Wewers ME, Baker T. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville (MD): US Department of Health and Human Services, Public Health Service, 2000. Lynch BS, Bonnie RJ, editors. Growing Up Tobacco Free: Preventing Nicotine Addiction in Children and Youths. Washington: National Academy Press, 1994. Myers ML, Iscoe C, Jennings C, Lenox W, Minsky E, Sacks A. Staff Report on the Cigarette Advertising Inves- tigation. Washington: Federal Trade Commission, 1981. Ramstrém LM. Consequences of tobacco dependence— a conceptual reappraisal of tobacco control policies. Paper presented at the 37th International Congress on Alcohol and Drug Dependence; Aug 22, 1995; San Diego (CA). Rothenberg RB, Koplan JP. Chronic disease in the 1990s. Annual Review of Public Health 1990;11:267-%6. US Department of Health and Human Services. Healthy People 2000: National Health Promotion and Disease Pre- vention Objectives. Washington: US Department of Health and Human Services, Public Health Service, 1991. DHHS Publication No. (PHS) 91-50212. US Department of Health and Human Services. Guide to Community Preventive Services [brochure]. Atlanta: US Department of Health and Human Services, Cen- ters for Disease Control and Prevention, 1998a. US Department of Health and Human Services. Tobacco Use Among U.S. Racial/Ethnic Minority Groups— African Americans, American Indians and Alaska Natives, Asian Americans and Pacific Islanders, and Hispanics: A Report of the Surgeon General. Atlanta: US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 1998b. US Department of Health and Human Services. Healthy People 2010 (Conference edition, in two volumes). Washington: US Department of Health and Human Services, 2000. US Department of Health, Education, and Welfare. Smoking and Health: Report of the Advisory Committee to the Surgeon General of the Public Health Service. Wash- ington: US Department of Health, Education, and Welfare, Public Health Service, 1964. PHS Publication No. 1103. Issues in Reducing Tobacco Use 25 Chapter 2 A Historical Review of Efforts to Reduce Smoking in the United States Introduction 29 Early Events 29 The Rise of the Cigarette 30 Popularity and Protest 30 The Attraction of Cigarettes 34 Women and Cigarettes 36 Winds of Change 37 Medical Warnings 38 Public Dissemination 38 Toward a Medical Consensus 39 Turning Point: The Surgeon General’s Report 40 A Stubborn Norm 40 Economic and Social Impedance 41 Delayed Effects and Delayed Actions 41 From Disease Treatment to Risk Management 42 The Diverse Momentum of the Movement to Reduce Smoking 43 Support From Business 43 The Attack on Advertising 45 Toward a National Policy to Reduce Smoking 45 From Antismoking to Nonsmokers’ Rights 46 Regulations, Legislation, and Lobbying for Nonsmokers 46 ETS: From Annoyance to Carcinogen 47 The Impact of the Movement to Reduce Smoking 48 Conclusions 51 References 52 Introduction Reducing Tobacco Use Like many other social phenomena, the use of tobacco has created a tapestry of themes, motivations, and social forces, woven together with a complexity that has begun to capture the interest of social histori- ans (Brandt 1990; Burnham 1993; Klein 1993; Tate 1999). Tobacco has economic, social, and political reverberations and is intimately tied to collective im- ages and attitudes. Nonetheless, some simplification is possible: the history of tobacco use can be thought of as the conflict between tobacco as an agent of eco- nomic gain and tobacco as an agent of human harm. An exhaustive history would not be content with such a simple contrast, but it serves the purpose of this chap- ter. The chief barrier to reducing tobacco use—the path of most resistance—is a powerful industry whose efforts to promote tobacco have continued to shape public opinion and social norms. Against this back- ground, the chapter considers the underlying forces Early Events that have motivated the movement to reduce smok- ing. Many recent events that are of critical historical importance for nonsmoking are considered in other segments of the report (e.g., social advocacy actions [Chapter 7]; taxation-based initiatives in states [Chap- ter 7]; Food and Drug Administration regulations re- garding minors as the target of tobacco advertising [Chapter 5]; and proposed national legislation, settle- ment and attempted settlement of various lawsuits against the tobacco companies, and criminal proceed- ings against tobacco companies [Chapter 5]). As noted in Chapter 1, some of the most dynamic changes in the history of smoking control efforts are currently taking place, and we are not sufficiently distanced from these events to evaluate them fully. This chapter will con- sider, rather, the changing thematic content-—religious, hygienic, medical, and social—of the movement to reduce smoking that has presaged the current events. In North America, the history of tobacco use pre- cedes written records. After American Indians intro- duced tobacco to the European colonists, tobacco was transported from the colonies to Europe, where it quickly became a widely used consumer item. Just as quickly, however, the use of tobacco became contro- versial. Critics of the day attacked tobacco use as morally irresponsible, extravagant, and a habit of people of base condition (Best 1979). In England, King James I published an antitobacco tract in 1604 that, among other things, offered an early critique of sec- ondhand smoke: the royal author expressed his con- cerns that a husband who smoked might “reduce thereby his delicate, wholesome, and cleane complex- ioned wife to that extremitie, that either shee must also corrupt her sweete breath therewith, or else resolve to live in a perpetuall stinking torment” (quoted in Apperson 1916, p. 206). In many countries of north- ern Europe, tobacco use was criminalized (Best 1979). Part of the objection in England and elsewhere was that trading gold to Spain for tobacco—the best tobacco came from Spain’s colonies—-was dangerous to the state economy. But with the English colonization of Virginia and the growing need in England, and else- where in Europe, for more state revenue, governments turned their policies around, despite continued moral objections to tobacco use. King James I himself set aside his previous objections and sought ways for the crown to profit from the tobacco trade (Morgan 1975; Best 1979). Of all the novel consumer goods the New World made available to the Old World, “tobacco enjoyed the most rapid diffusion” (Shammas 1990, p. 80) among people of different income levels, who bought it on a fairly regular basis. Closer to the source, mass consumption was even more pronounced: in the American colonies during the 18th century, yearly con- sumption averaged between 2 and 5 pounds per capita (Shammas 1990). When used medicinally, tobacco was favorably regarded; but in its widespread use for plea- sure, “it was considered harmful and faintly immoral” (Morgan 1975, p. 91; see also Stewart 1967). Historical Review 29 Surgeon General's Report Although that reputation for immorality never entirely vanished, by 1776, tobacco was not only a val- ued consumer good but also the economic foundation of the colonies’ independence movement. “King Tobacco Diplomacy” was a central element in gaining French support for the struggling colonies; tobacco, The Rise of the Cigarette one historian reports, “helped to buy American inde- pendence” (Morgan 1975, p. 6). Thomas Jefferson thought well enough of tobacco to propose that its leaves be carved into the pillars in one of the Capitol rotundas in Washington (U.S. House of Representa- tives 1969). Before the 20th century, tobacco was used pre- dominantly for chewing, pipe smoking, inhaling (as snuff), and cigar smoking. The cigarette was an inno- vation that appeared sometime early in the 19th cen- tury. The term “cigarette” first made its appearance in English in the 1840s (Apperson 1916). For reasons including cost and ease of use (discussed later in this chapter), the product quickly caught on among tobacco users. In the United States, cigarette smoking increased enough during the Civil War for cigarettes to become subject to federal tax in 1864 (Tennant 1950). But it was not until its manufacture was mechanized that the cigarette became a major tobacco product. James Albert Bonsack patented a cigarette roll- ing machine in 1881 that, by the late 1880s, produced cigarettes at 40 times the rate of a skilled hand worker (Tennant 1950; Chandler 1977). The mechanization of cigarette manufacture, like that of a number of other products in the late 19th century (such as prepared cereals, photographic film, matches, flour, and canned food products such as soup), precipitated a marketing revolution. Industries that developed “continuous process” production (Chandler 1977, p. 249) could increase unit production without increasing produc- tion costs—the main production problem of the day. The cigarette industry, like these others, could now pro- duce almost unlimited quantities of product at mini- mal cost per additional unit. When James Buchanan Duke installed two Bonsack machines in 1884 and arranged the next year an advantageous leasing ar- rangement with Bonsack, his cigarette output soared. Within a decade, his unit cost of producing cigarettes dropped to one-sixth of what it had been (Chandler 1977). In 1890, following a series of price wars made feasible by these cost savings, Duke merged with several competitors to form The American Tobacco Company. With the production problem solved and competition reduced, the focus of business thinking 30 Chapter 2 shifted to marketing. At a time when national adver- tising of many products was in its infancy, The Ameri- can Tobacco Company was innovative and expansive in its promotional efforts (U.S. Department of Health and Human Services [USDHHS] 1994). Popularity and Protest The growing popularity of cigarette smoking coincided with the years of populist health reform in the 19th century. Antitobaccoism was a standard fea- ture of various writings on personal health, which held that any “stimulant” was unhealthy (Nissenbaum 1980). Some of these health beliefs were tied to a reli- gious orientation. Ellen Gould Harmon White, the prophetess who founded the Seventh-day Adventists, spoke out strongly against tobacco. In 1848, her first vision concerning healthful living taught her the reli- gious duty of abstaining from tobacco, tea, and coffee. She attacked these products for the money squandered on them and for their dangers to health. White may have picked up these views from Captain Joseph Bates, a Millerite (follower of William Miller, whose millenarian group believed that the Second Coming of Christ would occur in 1843). Not until 1855, how- ever, did tobacco abstention become a larger theme among the Adventists. In that year, the group’s Review and Herald printed two lead articles attacking “the filthy, health-destroying, God-dishonoring practice of using tobacco” (quoted in Numbers 1976, p. 40). This protest was an integral part of the complex antitobacco crusading at the time. In addition to the religious motif, there was the considerable influence of the hygiene movement, which branded “tobacco- ism” a disease, tobacco a poison (Burnham 19839, p. 6), and dubbed cigarettes “coffin nails” (Tate 1999, p. 24). Spearheaded by the American Anti-Tobacco Society, which was founded in 1849, antitobacco critics found tobacco a cause of ailments ranging from insanity to cancer. During this time, cigarettes were often con- sidered narcotics because they seemed to have addict- ing qualities (Tate 1999). This litany of physiological ills ascribed to tobacco use did not prove to have the social power of the announcement, a century later, that numerous medical studies had found a direct link be- tween smoking and specific diseases that, as was un- derstood only in that later century, often took decades to manifest themselves. Between 1857 and 1872, George Trask published the Anti-Tobacco Journal in Fitchburg, Massachusetts, attacking the filth (especially of chew- ing tobacco), the dangers to health, and the costliness of tobacco (Tennant 1971). Early 19th century popular health movements tended to ally themselves with “nature” and “natural” remedies in opposition to pro- fessional medicine; by the late 19th century, health movements were more likely to take medical profes- sionals as their spokesmen (Burnham 1987). One such professional was Dr. John Harvey Kellogg, Seventh-day Adventist and director of the famous Adventist-founded Battle Creek (Michigan) Sanitarium, whose main concern was improving diet. Kellogg argued that tobacco was a principal cause of heart disease and other illnesses and that it adversely affected both judgment and morals (Schwarz 1970). Along with Ellen Gould Harmon White and her hus- band, a Millerite preacher, Kellogg organized the American Health and Temperance Association in 1878, which opposed the use of alcohol, tea, coffee, and tobacco. Later, Kellogg served as president of the Michigan Anti-Cigarette Society and, after World War I, as a member of the Committee of Fifty to Study the Tobacco Problem. Other organizational efforts directed specifically at cigarettes began in the last two decades of the 19th century. These efforts were generally directed at sav- ing boys and young men from the dangers of cigarette smoking. In New York City, the president of the board of education, a smoker himself, set up the Consolidated Anti-Cigarette League and won the pledges of 25,000 schoolboys not to smoke until they turned 21 (Troyer and Markle 1983). The first to call for cigarette prohibition was the National Woman’s Christian Temperance Union (WCTU) (Tate 1999). Led by Frances Willard, a friend of Harvey Kellogg, who was further inspired by her brother’s death from smoking-related illnesses, the WCTU as early as 1875 made plans to instruct mem- bers of its youth affiliate, the Juvenile Work, about the dangers of tobacco, as well as the hazards of alcohol. Reducing Tobacco Use In 1883, the WCTU established the Department for Overthrow of Tobacco Habit, which was renamed the Department of Narcotics in 1885 (Lander 1885; Tate 1999), The campaign against tobacco became a perma- nent part of the WCTU. Reports from their annual meetings documented the accomplishments of state and local chapters in combating smoking. In 1884, the superintendent of the Department for Overthrow of Tobacco Habit acknowledged the difficulty of the task before her: “With a spittoon in the pulpit and the vis- ible trail of the vice in countless churches, with its entrenchments bearing the seal of respectability, its for- tifications so long impregnable will yield slowly and unwillingly to the mightiest opposing forces” (WCTU 1884, p. v). She noted that tobacco was a habit costing people “more than the support of all [their] ministers of the gospel” or than the price of educating their chil- dren, that it caused disease, “especially the loss of sight, paralysis, prostration, and scores of ailments hitherto credited to other sources”; and that it “lower[ed] the standard of morality” (WCTU 1884, p. v). The WCTU was one group that pressed with some success for legislation to prohibit the sale of tobacco to minors.’ By 1890, such laws had been passed in 23 states. Connecticut and New York enacted pen- alties for both the underaged smoker and the merchant who sold to the minor (WCTU 1890). In New York, the strengthened law arose out of WCTU lobbying. “We found so many evasions of the law as it stood,” the WCTU reported at its annual meeting in 1890, “that we decided our only way to save the boys was to amend the law, so as to punish the boy who was found using tobacco in any public place, street or resort” (WCTU 1890, p. 185). The Department of Narcotics organized a letter-writing campaign that mobilized women, educators, and ministers (p. 185). By 1897, the Department of Narcotics report could proudly claim, “everything points to the death of the little cof- fin nail, if our women will only continue faithful” (WCTU 1897, p. 343). 'The laws prohibiting sales to minors began in New Jersey and Washington as early as 1883, Nebraska in 1885, and Maryland in 1886. By 1940, all states except Texas had laws of this sort on the books (Gottsegen 1940). By 1964, Texas had joined the list, but Louisiana and Wisconsin had repealed their laws as unenforceable (USDHHS 1989). The legality of the laws was confirmed by the United States Supreme Court (Austin v. Tennessee, 179 U.S. 343, 21 S. Ct. 132 [1900]), and a Federal Court of Appeals ruled in 1937 to uphold the authority of local jurisdictions to ban vending machine sales of cigarettes in the effort to protect minors (USDHHS 1989). Historical Review 31 Surgeon General’s Report Announcements of tobacco’s death were prema- ture, but cigarette sales declined in the last years of the 19th century. Most likely, the decline was precipi- tated by the “Plug War,” in which The American Tobacco Company bought several plug tobacco pro- ducers and sharply cut prices, attracting cigarette us- ers back to other tobacco products. Moreover, as the country came out of the depression of the 1890s, cigar smokers who had shifted to the cheaper cigarettes moved back to their preferred smoke (Sobel 1978). But the campaign against the cigarette certainly had a leg- islative impact. Cigarettes were prohibited for both adults and minors by law—if only temporarily—in North Dakota in 1895, Iowa in 1896, Tennessee in 1897, and Oklahoma in 1901. Eleven states had some gen- eral anticigarette legislation by 1901, and almost all state legislatures had considered curbs on cigarette sales (Outlook 1901). In 1899, Lucy Page Gaston, a WCTU activist, set up the Chicago Anti-Cigarette League (changed to the National Anti-Cigarette League in 1901 and to the Anti- Cigarette League of America in 1911). The league focused on the dangers of cigarettes to boys. Gaston sponsored frequent rallies, at which a chorus of young nonsmoking men provided the music (Duis 1983; Tate 1999). One of the innovations of Gaston’s crusade was the establishment of a smoking cessation clinic in Chi- cago (Troyer and Markle 1983). Gaston, whose long career against tobacco would culminate with her bid for the Republican presidential nomination in 1920 on an antitobacco platform (New York Times 1920), worked tirelessly lobbying for antitobacco legislation. Such legislation continued to pass, particularly in midwestern and some western states—Indiana, Nebraska, and Wisconsin in 1905; Arkansas in 1907; and Kansas, Minnesota, South Dakota, and Washing- ton in 1909. But evasion of the laws was apparently easy. Cigarette “makings” (e.g., cigarette papers and cigarette tobacco) were sold even if cigarettes were not, and some retailers sold matches for a higher-than- usual price and gave away cigarettes with them (Warfield 1930; Sobel 1978). Other retailers and smok- ers evaded the law through a product wrapped in a tobacco leaf rather than paper (New York Times 1905). The WCTU was not alone in its efforts. Several businesses and prominent individuals were outspo- ken in the crusade against tobacco use, some going so far as to support Gaston’s proposed (and defeated) 20th amendment to the Constitution that would have outlawed the manufacture and shipment of tobacco products (Junod 1997). Henry Ford attacked the habit of cigarette smoking and enlisted Thomas Edison to investigate its dangers (Brandt 1990). According to 32 Chapter 2 Harper's Weekly (1910), many railroads and other firms would not hire smokers. Sears, Roebuck and Com- pany and Montgomery Ward Holding Corporation refused to employ smokers (Porter 1947-48). The Non- Smokers’ Protective League of America was estab- lished in 1911 with a distinguished board of directors, including Harvey W. Wiley, chief chemist of the U.S. Department of Agriculture and father of the (1906) Pure Food and Drug Act; James Roscoe Day, chancel- lor of Syracuse University; and David Starr Jordan, president of Stanford University (New York Times 1911). Dr. Charles G. Pease, a physician and dentist, was the leader of this group. “Almost single-handed,” according to a New York Times report (1928, p. 7), Pease won a 1909 prohibition against smoking in the sub- ways. In 1917, he opposed sending tobacco to Ameri- can soldiers in Europe. But the New York Times reported in 1928 that “little has been heard from Dr. Pease since” (p. 7). Indeed, the anticigarette movement by then was waning. Cigarette prohibition was repealed in Indiana in 1909; Washington in 1911; Minnesota in 1913; Okla- homa and Wisconsin in 1915; South Dakota in 1917; Nebraska in 1919; Arkansas, Idaho, Iowa, and Tennes- see in 1921: Utah in 1923; North Dakota in 1925; and Kansas in 1927 (Gottsegen 1940). Legislatures in other states—including Lucy Page Gaston’s home state of Illinois—considered but did not enact anticigarette bills (Duis 1983). Even the WCTU, at the time judged “the most powerful and the most formidable organization which is actively opposing the use of tobacco” (Brown 1920, p. 447), in 1919 voted against supporting tobacco prohibition. The organization pledged to keep to an educational rather than a legislative campaign (New York Times 1919). A major weapon against the tobacco prohibition movement was the American soldier. Cigarettes had been popular among the armed forces since the Civil War. By 1918, during World War |, cigarettes were part of the army’s daily ration (Dillow 1981); soldiers used cigarettes for relief during the extremes of tedium and tension characteristic of the profession. General John Joseph Pershing himself is supposed to have said, “You ask me what we need to win this war. I answer tobacco, as much as bullets” (quoted in Sobel 1978, p. 84). “The soldiers, we are told, must have their tobacco,” a newspaper editorialized in 1915: “The ciga- rette is the handiest form in which this can be sent” (Lynn [Mass.] Evening News 1915, p. 4). Even the Young Men’s Christian Association altered its antitobacco stance and, along with the International Red Cross and other charitable and patriotic organizations, sent ciga- rettes off to the soldiers in the field (Schudson 1984). This outspoken, soldier-directed sentiment in favor of the cigarette was thus a large-scale factor in the reversal of anticigarette laws. A representative ques- tion that fueled the repeal effort in Kansas in 1927 was, “If cigaret[te]s were good enough for us while we were fighting in France, why aren’t they good enough for us in our own homes?” (Literary Digest 1927, p. 12; see also Smith 1973). Weakened but not vanquished by these legisla- tive setbacks, the war on tobacco persevered. In 1921, the Loyal Temperance Legion reported holding anti- cigarette essay contests, distributing antitobacco blot- ters in schools, and stubbing out 125,000 cigars and cigarettes (WCTU 1921). The Department of Narcot- ics held up its own end; in 1929, for instance, it held poster contests, cooperated in antitobacco work with Reducing Tobacco Use other civic organizations, sponsored 214 debates on tobacco, and ran essay contests producing more than 30,000 essays against tobacco use (WCTU 1929). Reli- gious denominations, including the Presbyterians, Methodists, and Baptists, also took a stand against tobacco (Troyer and Markle 1983). The antitobacco position was especially strong among the Mormons (Latter-day Saints). A motto of the Mormon youth or- ganization in 1920, “We stand for the non-use and non- sale of tobacco” (quoted in Smith 1973, p. 360), seems to have presaged the current low prevalence of tobacco use in Utah. Such dedicated opponents did not prevent the popularity of the cigarette—an inexpensive, easy-to- use form of tobacco product—from increasing in the 1920s (Figure 2.1; the demographic and epidemiologic Figure 2.1. Adult per capita cigarette consumption and major smoking and health events, United States, 1900-1999 1964 Surgeon 5000- General’s report Broadcast ad ban | , | Coalescence of v modern advocacy US. entry movement 4000- into WWII A \ Synar 4 Nonsmokers’ Amendment g rights movement enacted = 3000-] begins { & Federal cigarette 3 4 tax doubles S First modern ST : . % 920004 reports linking . = smoking and cancer Cigarette 5 Fairness Doctrine price drop Zz 7 USS. entry messages on into WWI broadcast media FDA proposed 1000 | rule “| Great Depression 0 ITETETTTUPTTTTITETTTTTATT TTT TPIT PT TUTTI TIT ITTV TTT TTT TTT TPIT TTT TTT TTT 1900 1910 1920 1930 1940 1950 1960 1970 1980 1990 Year Note: The 1999 data are preliminary. Sources: Adapted from Warner 1985; U.S. Department of Health and Human Services 1989; Creek et al. 1994; US. Department of Agriculture 2000. Historical Review 33 Surgeon General's Report details of cigarette consumption have been docu- mented in detail in prior reports [USDHHS 19839, 1994] and will not be repeated here). Men in substantial numbers either switched from other tobacco forms or took up smoking, and women in smaller but visible numbers began taking up tobacco use—in the form of cigarette smoking—for the first time, even as the fre- quently women-led antitobacco efforts continued. By the 1930s, cigarettes accounted for more than one-half of all tobacco consumption (Schudson 1984). In response to these trends, the WCTU cam- paigned for strict enforcement of laws forbidding the sale of tobacco to minors, attacked advertising that claimed or suggested health benefits, and criticized smoking among women. In 1927, the Department of Narcotics reported that chapters across the country had sponsored thousands of antismoking events and strat- egies. For example, the Portland, Oregon, chapter suc- cessfully protested a leading department store’s use of a female mannequin holding a cigarette. Members stubbed out 219,560 cigarettes and 39,713 cigars. The WCTU also lobbied for laws prohibiting smoking in places where food was displayed for sale and reported that 21 states had enacted such laws (Schudson 1993). As the cigarette’s popularity increased, so did concerns about its health consequences. Serious re- search of the day sought to link tobacco with a variety of conditions (Burnham 1989), but uncovered little new ground (Tate 1999), while sobering results were often lost amid a welter of overblown charges. For example, the common observation at the time that cigarette smokers seemed more dependent on their habits than other tobacco users, now explained by increased blood nicotine levels (Tate 1999), led one writer in 1912 to warn that users would naturally progress from tobacco to alcohol to morphine (Sinclair 1962). Similar unsub- stantiated charges have often made better headlines than the results of serious scientific studies over the years. In 1930, one doctor claimed that 60 percent of all babies born to mothers who smoked died before reaching the age of two (Sinclair 1962). Smoking was said to depress intelligence and academic achievement (Troyer and Markle 1983). One historian writing in 1931 recalled a widely distributed antismoking poster that wordlessly voiced these concerns by showing a woman who had a cigarette in her mouth and was holding a baby; the poster bore “no words—the mere presentment, it was hoped, would have a deterrent effect” (Corti 1931, p. 266). That image of mother and child projected an anti- smoking message that, typical of its time, contained both a moral and a medical objection to smoking. His- torian Allan M. Brandt has observed that antitobacco 34 Chapter 2 crusaders early in the century “saw no tension in see- ing the cigarette as ungodly and unhealthy; they equated moral dangers and health risks” (Brandt 1990, p. 159). A 1925 WCTU pamphlet held that because the brain’s higher functions develop last, youthful smok- ers would have “impaired morals, weak will, lack of religious and spiritual development, and a shocking incapacity for unselfishness and consideration of the rights of others” (p. 9). One of the moral dangers that remained a theme in anticigarette propaganda was the danger smoking posed to thrift, as cigarettes were a needless expense, especially among the poor (Brown 1920). Although anticigarette crusaders had medical objections to smoking, they did not have any medical consensus behind them. Medical opinion was gener- ally noncommittal. Most physicians counseled that tobacco in moderation was not harmful (Hygeia 1928; Tobey 1930; Johnson 1932). Media reports even located medical research that suggested that smoking had health benefits. During World War I, army surgeons praised cigarettes for providing the wounded relax- ation and relief from pain (New York Times 1918); a Paris physician claimed that tobacco use might prevent the development of microbial infections (New York Times 1923); and a famous mountain climber said that smok- ing helped breathing at high altitudes (New York Times 1922). Without a strong medical component, the objec- tion against tobacco use was scarcely distinguished from any number of other protest targets of the reform movement early in the century. Lacking as strong an opponent as, for example, the alcohol temperance movement, tobacco use continued unabated. In the instance of cigarettes, use proliferated. The Attraction of Cigarettes Throughout its boom period, from the 1920s un- til the mid-1960s, cigarette smoking was generally regarded as a consumer activity rather than as a medi- cal problem. In its commercial essence, the cigarette is simply a “package,” as a Philip Morris Companies Inc. memorandum has suggested, for a “product” (Cipollone v. Liggett Group, Inc., 505 U.S. 504, 112 S. Ct. 2608 [1992], cited in Lynch and Bonnie 1994, p. 60). In fact, the cigarette is by far the most commercially suc- cessful package for the product—tobacco, itself a delivery device for nicotine—yet devised. Such think- ing fits well with the notion that consumption is an act of imagination—that is, that one buys not the prod- uct but rather the attributes for which the product is merely the vehicle (Fox and Lears 1983). Each vehicle for nicotine delivery has different social propensities. The unique qualities of the cigarette as a tobacco form were critical in its role as the agent through which tobacco use was made both available and acceptable to all social classes. Put simply, ciga- rettes not only made tobacco cheaper (through auto- mated production) but also easier to use. This utility stemmed from several distinctive features that sepa- rated cigarettes from other modes of tobacco use and fueled the spread of the smoking habit. The first distinctive feature of the cigarette is its mildness. This attribute, along with its inexpensive unit cost, made the cigarette especially appealing to boys. Before the cigarette became popular, adolescent males were likely to first try smoking by using cigars, a practice that required a degree of skill to draw in but not inhale the strong smoke. The unpleasant side effects resulting from failing this tobacco rite of pas- sage were largely avoided when new smokers tried cigarettes, which used a milder form of tobacco that was meant to be inhaled. Many of the legislative ef- forts during the 1890s and after were directed not at tobacco use generally but at cigarettes exclusively be- cause they were so accessible to boys and young men and because they were inhaled (Outlook 1901). A 1907 Wisconsin court decision used this issue of adolescent accessibility to justify a regulatory distinction between cigarettes and other forms of tobacco. The cigarette, the decision stated, was able ”. . . to remove the pro- tection which nature placed in the way of acquiring habits of use of the more vigorous tobacco commonly used in cigars. Before the day of the cigarette, mas- tery of the tobacco habit was obstructed by agonies of nausea usually sufficient to postpone it to a period of at least reasonable maturity” (State v. Goodrich, 113 N.W. 388, p. 390 [Wis. 1907). Mildness was especially characteristic of ciga- rettes smoked after the 1870s, when cigarette tobacco was made milder by being flue-cured rather than fire- cured. Moreover, the stronger Turkish tobaccos that were popular in the early 20th century became unavail- able with the interruption of trade during World War I; thus, blended American tobaccos came into wider use, making the cigarette an even milder product than be- fore (Tennant 1950). The inhalability of the milder tobaccos used in cigarettes is the source of a second important distinc- tion between cigarettes and other forms of tobacco. Because the smoke of pipes, cigars, and dark tobacco is relatively alkaline, its nicotine dose is absorbed through the linings of the mouth and nose. Flue-cured “blond” or light-colored tobacco, from which Ameri- can cigarettes are normally blended, produces slightly Reducing Tobacco Use acidic tobacco smoke; the nicotine dose thus must be inhaled to be absorbed. Drawn into the lungs through cigarette smoking, nicotine is absorbed into the sys- temic circulation more quickly than in other forms of smoking—hence the greater potential for nicotine addiction (Lynch and Bonnie 1994). A third distinctive feature of the cigarette is its relative convenience and disposability. This mild and quickly consumed tobacco product seemed to contem- poraries “peculiarly adaptable to the temperament of the American people in an age when things are done hurriedly and yet with greater efficiency than at any previous time” (Young 1916, p. 119). The New York Times editorialized in 1925 that the cigarette was “short, snappy, easily attempted, easily completed or just as easily discarded before completion—the cigarette is the symbol of a machine age in which the ultimate cogs and wheels and levers are human nerves” (New York Times 1925, p. 24). Facility of use was further aug- mented by the introduction of the safety match just before World War I (Burnham 1989). In short, cigarettes had a “natural adaptability” to the rhythms of urban life (Tennant 1950, p. 142). Cigarettes fit more easily than other forms of tobacco into brief moments of relaxation, they were more readily used while working, and they were more eas- ily managed without the use of one’s hands. Ciga- rettes helped combat the tedium of industrial work. Particularly before workplace smoking restrictions were widespread, cigarettes could, in the words of one commentator, “not only help pace out a day—on the production line, in the typing pool, behind a lunch counter or waiting on a welfare line—but they could give you a steady flow of small rewards to keep on trucking” (Blair 1979, p. 33). Cigarettes organized and controlled the passage of time; a cigarette, writes Ri- chard Klein, is “a clock” (Klein 1993, p. 24). After World War I, cigarettes, which were less costly to use than cigars or pipe tobacco, became part of amore general “throwaway ethic” reflected in other consumer developments of the day (Busch 1983). The disposable razor blade came into widespread use dur- ing and after World War I (Schudson 1984); in 1927, US. wristwatch production surpassed pocket watch production, as the more conveniently consulted wrist- watch had won favor among soldiers (Busch 1983). Changing attitudes about hygiene also stimu- lated this predilection for convenience and disposa- bility. Between 1909 and 1936, 45 states banned the common drinking cup used in public facilities such as railroads; the railroads became the first principal customers for the paper cup and paper cup dispens- ers (Busch 1983). Disposable sanitary napkins and Historical Review 35 Surgeon General's Report Kleenex tissues also became mass-market items for the first time in the 1920s (Busch 1983). From a strictly hygienic perspective, the cigarette appeared to give a cleaner smoke than the cigar. A Lucky Strike adver- tisement directly contrasted the neatness of cigarettes to the messiness of cigars, which require more oral manipulation: “Spit Is an Ugly Word, but It’s Worse on the End of Your Cigar” (Tennant 1950, p. 286). This advertisement also played on an earlier scandal in which cigar makers were purported to have used spit to seal the cigar’s leaf wrapper (John C. Burnham, tele- phone conversation with Richard B. Rothenberg, May 25, 1995). For a generation working in offices and riding to work in subways, streetcars, and automobiles, milder smoke was less irritating to others. Both the strong fumes of cigar and pipe smokers and the unsightly by-products of snuff and chewing tobacco users were generally more objectionable than the smoke and ashes of cigarette smokers. Historian Cassandra Tate has concluded that one of the lessons of the first antismoking campaign is that “any success- ful social reform movement carries within it the seeds of a backlash” while “incessant warnings can fade into the ozone of the commonplace” (Tate 1999, p. 155). An important part of the cigarette’s convenience was its readiness of use. Some smokers still rolled their own cigarettes in the 1920s and 1930s, but these con- sumers were a small segment of the market (Tennant 1950). By far, most smokers during these key decades of rising cigarette popularity used cigarettes prerolled by the manufacturer. (Cigars were also prerolled, but by hand rather than by machine, and thus at consider- able expense to the buyer.) The cigarette’s ready-made convenience was immediately apparent when com- pared with, for example, the care required to load a pipe so that it burned neither too quickly (thereby over- heating the bowl) nor too slowly (thereby requiring frequent relighting). The cigarette was far more easily lit and drawn than other smoked tobacco products. One final distinctive feature of the cigarette is its cultural connotation as a minor moral transgres- sion. Smoking cigarettes is—and has always been— considered slightly illicit. A practice that “looked so strange, felt so pleasant, accomplished so little, and cost so much [although less than cigar or pipe smok- ing] could not be unopposed” (Tennant 1950, p. 115). The pleasure it offers is culturally mediated—that is, part of the pleasure of smoking is the guilt connected with it. None of the marketing efforts of the tobacco giants ever fully legitimized the image of smoking— and there is some suspicion that they never meant to (Burnham 1993). As one sympathetic cultural observer has put it, part of the seductive quality of the cigarette 36 Chapter 2 is “beauty [that] has never been understood or repre- sented as unequivocally positive; the smoking of ciga- rettes, from its inception in the nineteenth century, has always been associated with distaste, transgression, and death” (Klein 1993, p. xi). A modern parallel is the recent cachet of smoking as a sexual fetish, with images available on the Internet (Hwang 1996, p. 5). Culturally, in fact, interviews have shown that ciga- rettes became a generational marker for the transform- ing generation that had come of age during World War I, as well as for the reform-minded generation of the Viet- nam War era (Tate 1999). Women and Cigarettes Several features of the cigarette helped make it a particularly suitable product for, and symbol of, the liberation of women, who came to smoking in grow- ing numbers beginning in the 1920s. Just as the ciga- rette “fairly leaped” into its rightful position as “the smoke of manly men” with the aid of stories and pic- tures from the World War I front ([New York] Tobacco Leaf 1914, p. 6, quoted in Young 1916, p. 228), so for young women after the war smoking was “perhaps the one most potent symbol” of the new sense of free- dom and equality (Fass 1977, p. 292). For the growing number of women who attended college in the 1920s, smoking was “a welcome form of notoriety” (p. 293). Objections to women’s smoking betrayed a traditional double standard, for such opposition arose from the twin cultural perceptions that cigarettes were not moral and were not feminine. Smoking “implied a promis- cuous equality between men and women and was an indication that women could enjoy the same vul- gar habits and ultimately also the same vices as men” (p. 294). But while they were tokens of equality with men, cigarettes were also amorphic, making men ap- pear more manly and women more womanly (Tate 1999), Aware of (and perhaps sharing) these objections, cigarette manufacturers were initially cautious about targeting this potential new market. As late as 1924, the editor of a tobacco trade journal wrote that “all responsible tobacco opinion [found the idea of women smoking so] novel...that it would not be in good taste for tobacco men as parties in interest to stir a particle toward or against a condition with whose beginnings they had nothing to do and whose end, if any, no one can foresee” (Wessel 1924, p. 6). Even advertisements with women in mind did not dare picture them actu- ally smoking. This initial caution was dictated by canny atten- tion to the political environment. Cigarette manufac- turers feared a backlash in legislation or public opinion if they too aggressively sought female consumers (Tennant 1950). In light of anticigarette leg- islation arising during the 1920s, and particularly in light of the ongoing experiment in alcohol prohibition, this anxiety was reasonable. The cigarette industry’s caution was short-lived. As the 1920s advanced, appeals to women through tobacco marketing were increasingly direct. In 1926, the Chesterfield brand ran a then-controversial advertisement wherein a woman urged a male com- panion to “Blow Some My Way” (Ernster 1985, p. 336). In 1927, Lucky Strike advertisements showed a famous female opera star recommending Luckies as soothing to the throat and a famous actress assuring readers that Luckies did not irritate the throat (Schudson 1984). And in 1928, Luckies were advertised with the diet- conscious slogan, “Reach for a Lucky Instead of a Sweet” (Emster 1985, p. 336). Winds of Change The industry’s direct appeal to the new market of female smokers likely reflected less boldness than it did a recognition of a prevailing wind of cultural change, of which the women’s movement was only a single component. In the 1920s, on the heels of the 19th Amendment, women’s growing assertion of their equality with men was part of a larger shift in Ameri- car culture, the move to a more modern culture from the somewhat puritanical milieu that supported the populist reform movement. In the language of one observer, the change was froma culture of middle-class respectability to one of “lower-order parochialism” sponsored and encouraged by industries that catered to the minor vices (Burnham 1993, p. 16). The 1920s saw the triumph of “a new behavioral ethic” (Brandt 1990, p. 157), one of consumerism and self-indulgence rather than the self-denial that had been, for example, the traditional lot of women. Through the marketing of cigarettes, the tobacco companies strategically ex- ploited this development among the less puritanical and self-recriminating members of both sexes. Even at the time, opinion was divided on whether the massive marketing efforts of the cigarette giants motivated the change toward a society of smokers or only took advantage of a cultural and behavioral shift already under way. In 1940, by which time the Reducing Tobacco Use cigarette had clearly triumphed over other forms of tobacco, one study of the tobacco industry concluded, “how much of increased cigarette consumption is due to advertising and how much to fashion is impossible to determine. The latter influence is still imponder- able” (Gottsegen 1940, p. 204). Fashion and advertising were not the only two factors. Three other matters were potentially impor- tant: (1) the physical product itself was not a constant, (2) the price was variable, and (3) society changed in ways that influenced consumption. For example, before the explosion of cigarette marketing in 1914 (Burnham 1989), men smoked more than women, the rich smoked more than the poor, and urban dwellers smoked more than rural inhabitants. (For a more com- prehensive account of the demographic dynamics, see USDHHS 1989.) With growth in the movement for women’s equality, a rising per capita income in real dollars, and the long-term trend toward urbanization, there would likely have been an increase in cigarette sales even if tobacco companies had not marketed the product aggressively. Regardless of what directed the impetus, per capita consumption of all forms of tobacco was remark- ably steady from 1913 to 1945 (Figure 2.1), rising when real income per capita rose, falling when real income fell (Tennant 1950). The spectacular growth in ciga- rette consumption reflected not only the introduction into the tobacco market of new consumer groups (such as women) but also, as was previously noted, a major shift among existing male smokers from other forms of tobacco use to the cigarette. Annual per capita con- sumption of tobacco hovered at 7 pounds from 1915 through the late 1930s, except for a transient decline in the early 1930s that was coincident with a drop in per capita income in the early years of the Great De- pression (Tennant 1950). It is possible, however, that actual consumption of tobacco per unit of weight in- creased because of less work in both the manufactur- ing and the use of the increasingly popular cigarette. World War II, like World War I, served to increase and promote cigarette smoking, to which numerous war novels, movies, and other public images testify (Klein 1993). A 1943 treatise observed that the cigarette achieved a heroic standing from its association with soldiers during World War II (Gehman 1943). In short, between about 1920 and 1950, “cigarettes became an acceptable and noncontroversial part of U.S. life” (Troyer and Markle 1983, p. 124). Historical Review 37 Surgeon General's Report Medical Warnings Medical opinion at first took little heed of the growing popularity of cigarettes. Physicians tended to take an ambivalent or qualified position on the ciga- rette phenomenon. For instance, although Dr. James J. Walsh wrote in 1937, “We physicians of the older generation who have seen the smoking of cigarettes grow from what seemed scarcely more than a toy into what is now one of the most significant of social insti- tutions are under an obligation to the rising genera- tion to warn them of the serious dangers associated with the abuse of cigarettes in our day” (Walsh 1937, p- 665), even Walsh admitted to smoking an occasional cigarette himself. He further attested that many doc- tors he knew smoked 20 or 30 cigarettes a day and yet were “as healthy as the proverbial trout” (p. 665). He held that “not the cigarette smoke so much as the ex- cess of it” (p. 665) brought about serious conditions like Buerger’s disease. The Puritan temperament that had fueled anticiga- rette activity early in the century was on the defensive. Antipathy to Puritan moralism was strong enough to weaken faith in any research tainted by it. For example, Alton Ochsner’s suggestions in the 1930s and 1940s of a connection between cigarette smoking and lung can- cer were discounted by his colleagues because he was known to be “an anti-smoking enthusiast” (Burnham 1989, p. 18). During these crucial times when cigarette smoking became widespread, “physicians tended to absorb the common sense of the general population” (p. 11). By the 1930s, common sense, in some measure influenced by the advertising claims of the era, held that smoking in moderation was not a health hazard (Burnham 1993). In 1938, Raymond Pearl published one of the first significant epidemiologic studies that indicated smok- ing to be “statistically associated with an impairment of life duration” (Pearl 1938, p. 217, quoted in Breslow 1982, p. 134; see also Brandt 1990). But only in the late 1940s and early 1950s did definitive evidence begin to accumulate from various sources and studies show- ing the association between cigarette smoking and overall mortality. First retrospective and then large- scale prospective studies confirmed that smoking was associated with higher death rates; excess mortality was especially pronounced for coronary artery disease and lung cancer. In the late 1940s and early 1950s, research linked lung cancer to smoking. The initial report by Wynder 38 Chapter 2 and Graham (1950) just preceded an article by Doll and Hill (1950). Subsequent articles by Doll and Hill (1952), Levin (1953), and others confirmed the asso- ciation. Levin’s contribution was of particular inter- est, because he derived the formula for attributable risk in a footnote to the article—an overt demonstration of the link between the smoking etiology and the emerg- ing methodology of epidemiologic analysis. Public Dissemination The findings from these and other studies of the era were publicized in a 1952 Christian Herald article. In December 1952, that article was reprinted in the widely circulated magazine Reader’s Digest as “Can- cer by the Carton” (Norr 1952), Popular concerns aroused by this publicity apparently led to an almost immediate decline in cigarette consumption (Tennant 1971). The decline was temporary but severe enough to lead the tobacco companies to step up their market promotion of the relatively new filter-tip cigarette. Originally intended to attract new smokers by offer- ing a milder smoking experience, the filtered cigarette assumed a marketing prominence that was seen as a tacit acknowledgment that there might be a health risk in smoking (Fortune 1953). Whether for smoking com- fort or for supposed health advantage, the market share of filter brands increased from less than 1 per- cent in 1952 to 73 percent in 1968 (Tennant 1971). The nonprofit consumer advocacy organization Consumers Union paid attention to smoking through- out the 1950s. Early mentions in the organization’s monthly magazine Consumer Reports, like so much commentary elsewhere, warned only against excessive smoking. In 1953, Consumer Reports found the evidence connecting smoking to lung cancer “suggestive” and recommended that until further research results were available, “those who can” should reduce smoking to a “moderate” level, which was defined as not more than one pack a day (p. 74). In the same issue, how- ever, the magazine reminded readers that smoking had health benefits; specifically, smoking reduced “the inner nervous tensions and strains resulting from man’s exposure to the stresses and responsibilities imposed by society” (p. 74). Smoking, the magazine further observed, relieved such pressure in a way less harmful than alcohol or overeating (Consumer Reports 1953). In 1954, medical advisers for Consumers Union spoke more strongly about the research link between smoking and lung cancer, but the organization remained vague in its advice to smokers (Consumer Reports 1954). In the absence of further scientific sup- port, this tentativeness was not surprising. It was hard to imagine that a habit so widespread, so apparently normal, so integrated into American culture, and so ennobled by its wartime use could turn out to be fun- damentally destructive. In 1954, the American Can- cer Society’s (ACS) Tobacco and Cancer Committee adopted a resolution recognizing an association be- tween cigarette smoking and lung cancer (Breslow 1982), but the board of directors did not consider the possibility of a causal association. Efforts of the phy- sician members of the board were blocked by lay mem- bers in meetings that were themselves “filled with smoke” (Breslow 1977, p. 849). By 1958, Consumers Union agreed that the medi- cal research provided nearly definitive evidence on the risk of lung cancer posed by smoking. The organi- zation further argued that smokers should not try to allay their concerns by switching to filter cigarettes, as no evidence indicated that filters reduced the risk of cancer. Smokers were thus advised “to cut out or cut down” on cigarettes (Consumer Reports 1958, p. 636). Toward a Medical Consensus With growing sentiment, in and beyond the medical community, that there were serious risks to tobacco use, government agencies became more con- cerned about tobacco advertising that stated or implied health benefits to the cigarette. Several times during the 1950s, the Federal Trade Commission (FTC) issued orders against cigarette advertising that made health claims. Congress also took an interest in tobacco advertising; in 1957, Representative John A. Blatnik (D-MN) held hearings on deceptive filter-tip cigarette advertising (Neuberger 1963). The Surgeon General first brought the Public Health Service into the scene by establishing a scientific study group in 1956 to ap- praise the effects of smoking on health. The study group determined that there was a causal relationship between excessive smoking of cigarettes and lung cancer. Surgeon General Leroy E. Burney issued a statement in 1957 that “the weight of the evidence is increasingly pointing in one direction: that excessive smoking is one of the causative factors in lung can- cer” (Burney 1958, p. 44). In an article he subsequently published in the Journal of the American Medical Asso- ciation, Burney reiterated this view and went even Reducing Tobacco Use further: “The weight of evidence at present implicates smoking as the principal etiological factor in the increased incidence of lung cancer” (Burney 1959, p- 1835). Much of the medical profession, however, remained ambivalent on the issue. In an editorial sev- eral weeks after Burney’s article, the journal itself ar- gued against taking the Surgeon General too seriously: “Neither the proponents nor the opponents of the smoking theory [that cigarette smoking causes cancer] have sufficient evidence to warrant the assumption of an all-or-none authoritative position” (Talbott 1959, p. 2104). In June 1961, the presidents of the ACS, the American Public Health Association, the American Heart Association (AHA), and the National Tubercu- losis Association (later the American Lung Association [ALA]) urged President John F. Kennedy to establish a commission to study the health consequences of smoking (U.S. Department of Health, Education, and Welfare [USDHEW] 1964). Early in 1962, representa- tives of these organizations met with Surgeon General Luther L. Terry, who then proposed establishing an advisory committee to assess available knowledge and make recommendations concerning smoking and health. In April, Terry provided the Secretary of Health, Education, and Welfare a fuller proposal ask- ing to reevaluate the Public Health Service’s position onsmoking. Among the factors prompting his call for action, Terry cited new studies on the adverse conse- quences of smoking, the 1962 Royal College of Physi- cians report (which had been summarized that year in Reader's Digest [Miller 1962]), and other evidence of a shift in medical opinion against smoking as well as similar views among the national voluntary organiza- tions. Terry also pointed to efforts to reduce tobacco use in Britain, Denmark, and Italy; to Senator Maurine (Brown) Neuberger’s (D-OR) proposal that Congress create a commission on smoking; and to a request from the FTC for guidance on the labeling and advertising of tobacco products. In the summer, Terry announced the appoint- ment of a committee to review all of the data on the medical effects of smoking. The committee was es- tablished after consultation with representatives of relevant government agencies, the voluntary health or- ganizations, the American Medical Association (AMA), the American College of Chest Physicians, and the Tobacco Institute. Each organization was empowered to veto any names proposed for the committee; people who had taken public positions on the questions at issue were eliminated from consideration. Historical Review 39 Surgeon General's Report While the committee reviewed the data, actions were being urged or taken in response to the evidence that had emerged. Leroy Collins, former governor of Florida and president of the National Association of Broadcasters, urged broadcasters in 1962 to “make corrective moves” on their own to limit or regulate tobacco advertising to which children might be ex- posed. “We cannot ignore the mounting evidence that tobacco provides a serious hazard to health,” he as- serted (New York Times 1962, p. 71). Also in 1962—a busy year for efforts to reduce smoking—Air Force Surgeon General Major General Oliver K. Niess ordered an end to the distribution of free cigarettes in Air Force hospitals and flight lunches (Neuberger 1963). Smoking education was a growing phenom- enon in public schools, where materials were provided by the ACS and other voluntary organizations. Church groups (particularly the Seventh-day Adventists) and temperance organizations continued their campaign against smoking. And although the AMA remained silent on the issue, at least eight state medical societies had adopted resolutions on smoking and health. Turning Point: The Surgeon General’s Report Social movements may be precipitated or strengthened by events that “dramatize a glaring con- tradiction between a highly resonant cultural value [such as health] and conventional social practices [such as smoking]” (McAdam 1994, p. 40). Rarely in social history, however, cana single such.event be identified as a key source of social change. The publication of the 1964 Surgeon General’s report on smoking and health might qualify as such a rarity. The Surgeon General's report consolidated and legitimized 15 years of growing evidence of the dangers of smoking to health (USDHEW 1964). Its publication “marked the beginning of a revolution in attitudes and behaviors relating to cigarettes” (Brandt 1990, p. 156). “Begin- ning” should be stressed, because abandonment of cigarettes was not precipitous. Smoking prevalence did begin a persistent but hardly precipitate decline in 1965 of 0.5 percent per year (USDHHS 1989). Cigarette sales kept increasing and would not peak until the late 1970s. Although per capita cigarette con- sumption reached its highest level in 1963, the year before the report’s publication, it did not begin a steady year-to-year decline until 1973 (USDHHS 1994). Thus, the Surgeon General's report was certainly a pivotal event, but it did not change smoking pat- terns overnight. Why this was so—why people did not, upon learning of the report’s findings, immedi- ately cease either beginning or continuing to smoke— is a complex phenomenon, even if one disregards the major role of nicotine addiction. On the one hand, a change in behavioral norms can be precipitated by a change in what people generally believe. On the other hand, people do not always act in their own 40 Chapter 2 best interests, even in response to clearly stated facts (Schudson 1984; USDHHS 1989). The outcome in a conflict between cultural mores (in this instance, be- liefs instilled through the social, behavioral, and physi- ological habit of smoking; reinforced by marketing) and scientific fact (as represented in the widely publi- cized findings of the Surgeon General's report) often depends on how the latter is diffused—that is, on whether new information can become so broadly and effectively transmitted and received that it becomes accepted knowledge that then supplants habit. As one sociologist has observed, “The diffusion of new knowl- edge is a major cause of collective searches for new norms in the modern world” (Davis 1975, p. 53). A Stubborn Norm _ Inthe case represented by the Surgeon General's: report, the diffusion of new knowledge was impeded by the entrenched norm of smoking, a widespread practice fueled by the persistent and pervasive mar- keting of cigarettes (see “Advertising and Promotion” in Chapter 5). During the decade preceding the report, many social norms were established or strengthened through the dominant new.mass medium, television. Whatever effect television adver- tising had on cigarette sales, the constant presence of cigarettes both in advertisements and in the real and imaginary lives of the medium’s “stars” was a strong force in reinforcing smoking as a norm. Furthermore, TV-related marketing coincided with, and helped bring to the public’s attention, the availability of the filter- tipped cigarette—thereby not only reinforcing the smoking norm but also helping screen the imputed health hazards of smoking (USDHHS 1994). The smoking norm could be found in the most unlikely settings and thus gave rise to considerable cognitive dissonance. The first significant government response to the report was the FTC’s 1964 ruling that warning labels be required on cigarette packs and that tobacco advertising be strictly regulated (see “Attempts to Regulate Tobacco Advertising and Packaging” in Chapter 5). The resulting legislation that was passed, however (the Federal Cigarette Labeling and Adver- tising Act of 1965 [Public Law 89-92]), undermined much of the original proposal’s strength by requiring a more weakly worded warning label than the FTC had proposed (USDHHS 1994). Furthermore, the act not only preempted the FTC’s ruling but also prohibited the FTC or any other federal, state, or city authority from further restricting cigarette advertising until after the expiration of the law on June 30, 1969. In 1969, former Surgeon General Terry would refer to the 1965 act as a “hoax on the American people” (U.S. House of Representatives 1969, p. 267, citing Dr. Terry). This dissonance between legislative intent and legislative action was detectable, in more than one sense, in the smoke-filled congressional hearings at the time. In 1967, for example, when Dr. Paul Kotin, director of the Division of Environmental Health Sci- ences, National Institutes of Health, came to testify about the health hazards of cigarette smoking, Sena- tor Norris Cotton (R-NH) asked, “Is it going to preju- dice anybody if I smoke my pipe?” Dr. Kotin replied, “I trust it won’t prejudice anybody any more than my smoking my pipe will” (U.S. Senate 1968, p. 14). Dr. Kotin’s smoking was a topic of conversation again in congressional hearings in 1969. Dr. Kotin along with Surgeon General William H. Stewart, Dr. Kenneth Milo Endicott (director of the National Cancer Institute), and Dr. Daniel Horn (director of the National Clearing- house on Smoking and Health) came together to tes- tify in favor of stronger health warnings on cigarette packages and legislation requiring similar warnings in all cigarette advertising. At one point, Representa- tive Dan H. Kuykendall (R-TN) asked Surgeon General Stewart, “Isn’t [Dr. Kotin] one of the most know:edgeable men in this field?” When the Surgeon General replied affirmatively, Kuykendall returned, “Why doesn’t he quit smoking?” Kuykendall then directly asked Kotin whether he was sure that smok- ing a pipe did not cause lip cancer; Kotin responded, “A risk I am willing to take, sir” (U.S. House of Repre- sentatives 1969, p. 167). The next day, Representative Tim Lee Carter (R-KY) observed that, in fact, all four of the men in the delegation, including the Surgeon Reducing Tobacco Use General, were smokers (U.S. House of Representatives 1969). Actions undermine words, and scenes such as these were symbolic of a strong wish not to believe in the health consequences of smoking. Given that the nation’s chief health policymakers did not, or were not able to, apply to their own behaviors the very evidence they had gathered, the strength with which the smok- ing norm persisted among the general population is more easily comprehended. Economic and Social Impedance General economic conditions also supported the continuation of smoking. The 1960s and early 1970s was a time of general prosperity. Real cigarette prices rose in the 1960s but declined in the 1970s (USDHHS 1994). The affordability of cigarettes increased from 1965 to 1980 and served as an economic counterweight to the growing awareness of tobacco’s ill effects (Lynch and Bonnie 1994) (see also “Effect of Price on Demand for Tobacco Products” and “Taxation of Tobacco Prod- ucts” in Chapter 6). Another compelling social condition may have further limited the initial impact of the Surgeon General's report. From the early 1960s to 1973, Ameri- can military personnel were engaged in Vietnam. During this period, 8.7 million Americans served in the military, including 2.7 million in Vietnam (Moss 1990). Whether the Vietnam War encouraged smok- ing has not been a topic of speculation, probably because of that war’s more publicized role in suppos- edly encouraging the use of marijuana and other drugs (Klein 1993). But the norm of smoking would only have been strengthened by the mobilization of a large military force bringing several million young men and women into a setting where smoking was tradition- ally held to offer relief from both stress and boredom, and where it was part of a lingering cultural image of the heroic soldier. Moreover, the prevalence of ciga- rette smoking was and has remained higher in the military than in the population at large (in 1992, 35 vs. 26 percent) (Lynch and Bonnie 1994). Delayed Effects and Delayed Actions A significant biologic explanation for the delayed effect of the 1964 report can be found in the delayed progression of smoking-related diseases, which generally take substantial time to fully manifest themselves in chronic illness and death. The cigarette’s tremendous growth in popularity during the decades preceding the Surgeon General’s report would thus Historical Review 41 Surgeon General's Report have only begun to show its vast health consequences. In 1965, an estimated 180,000 persons died from smoking-related diseases (USDHHS 1989); over the next two decades, that yearly estimate increased to 337,000, even though smoking prevalence had been steadily declining since the early 1970s (USDHHS 1989). First-time or long-time smokers in the mid-1960s to mid-1970s thus had far less opportunity than the next generation to personally witness the tragic but convincing demonstration of the health consequences of smoking. It might be hypothesized that this som- ber proof of the Surgeon General’s report at last evoked a meaningful response among the surviving relatives and friends of the deceased. From Disease Treatment to Risk Management Another possible reason for the delayed response to the Surgeon General’s report was its less-than- traditional medical perspective. The report’s medical researchers were reporting not the kind of traditional clinical data that physicians were used to encounter- ing in their literature but rather data from epidemio- logic studies that indicated the risks of smoking. Eventually, such data would be persuasive enough to mark a perceptual shift to “a new kind of numeracy among medical researchers and clinicians alike” (Burnham 1989, p. 19). But in 1964, most physicians were not prepared to understand—much less be per- suaded by—the epidemiologic data represented in the report, nor to incorporate a public health model into their medical practice. Accordingly, the medical profession did not quickly jump on the smoking reduction bandwagon that began rolling with the Surgeon General's report. The American Medical Association Alliance House of Delegates, in fact, refused to endorse the report when it appeared in 1964 (Burnham 1989). Medical person- nel increasingly warned people against smoking, but this precept did not carry over into practice. In 1964, smoking remained as acceptable in medical settings as it was elsewhere. Moreover, although 95 percent of physicians in that year saw smoking as hazardous, 25 percent continued to smoke (Burnham 1989); even by the mid-1970s, nearly one in five physicians was a smoker (Nelson et al. 1994). The AMA was criticized by other health organizations for not taking a more aggressive stance to reduce tobacco use. As late as 1982, for example, the association was faulted for help- ing prepare for Newsweek a 16-page “personal health care” supplement, in which the only advice provided 42 Chapter 2 onsmoking was that a smoker should discuss the risks with a personal physician and should refrain from smoking in bed (Iglehart 1984). Soon thereafter, the AMA had become an active advocate (see “Toward a National Policy to Reduce Smoking,” later in this chap- ter). By 1990-1991, only 3.3 percent of physicians smoked, although smoking rates among nurses were significantly higher (Nelson et al. 1994). Some social critics of the time tacitly welcomed what they saw as a rare reluctance by the establish- ment to embrace a social movement. Sociologists and other outside observers of American medicine had noted a previous tendency of the establishment to “medicalize” social problems, such as tobacco use and alcohol abuse. From this perspective, medicine was viewed askance as an “institution of social control,” as a “new repository of truth, the place where abso- lute and often final judgments are made by suppos- edly morally neutral and objective experts” (Zola 1972, p. 487). Implicit in this criticism was the fear that the medical establishment was using its considerable clout—its professional domination of the world of facts—to translate all social ills into clinical terms that could be treated in a clinical setting. One such critic, medical sociologist Eliot Freidson, wrote that the phy- sician who calls alcoholism a disease “is as much a moral entrepreneur as a fundamentalist who claims it is asin” (Freidson 1974, p. 253). But the medical establishment's initial hesitancy to join the movement to reduce smoking likely had little to do with scruples about overstepping its pur- view. There is no dispute that cancer is a disease and little dispute that the medical profession is the expert social authority for defining and treating it. The “moral entrepreneurship” of the Surgeon General’s 1964 re- port was not to declare cancer a medical problem but rather to declare smoking a health risk—hence the cen- tral position of epidemiologic data in the report. Thus, while organized medicine followed slowly and sometimes reluctantly in the wake, and while so- cial skeptics worried about the Orwellian implications, a battery of public health officials, politicians, and con- sumer advocates, armed with the findings of the Sur- geon General’s report, moved against the persisting social and medical problem of smoking. Ultimately, the broad cultural current that distrusted medical moral entrepreneurship embraced these efforts. The “de- medicalizing” movement, which sought to make health care both a personal matter and a political matter rather than one wholly under the guardianship of physicians (Starr 1982), supported a practice of medicine that took a preventive stance instead of an exclusively therapeu- tic one. Preventive action—to prevent smoking, and thereby to prevent unnecessary illness and death from smoking-related illnesses—was precisely the solution Reducing Tobacco Use called for in the epidemiologically based recommen- dations of the 1964 Surgeon General’s report. The Diverse Momentum of the Movement to Reduce Smoking Another reason for the languid pace of change in smoking prevalence after 1964 is that it took time to assemble an active dissemination and lobbying force around the Surgeon General’s report. In the present period, so many different groups are active in anti- smoking activity, and so many different strategies are operating, that sorting them becomes difficult. Since 1964, the campaign to reduce smoking refers to “the entirety of changes in the social environment spawned by scientific and social interest in the hazards of smok- ing” (Warner 1989, p. 144); this movement covers not only specific activities but also “the changing social norms that have accompanied them” (p. 144). The span of activities involves persons, private organizations, and government agencies, all with different motiva- tions: those ideologically committed to a movement to reduce smoking, those who operate profit-making businesses, those seeking public office, and those in public office who mandate laws and regulations. Important actors have included national health orga- nizations, medical researchers, organized medicine, government regulatory agencies and health depart- ments, school officials, voluntary organizations in health, lobbying groups for reducing smoking, private firms dealing with the health or insurance needs of employees, smoking cessation clinics, and individual medical practitioners. The industry-funded Tobacco Institute began distributing smoking education materials in 1984 (USDHHS 1994), although with a different agenda. For example, the institute’s “It’s the Law” program pur- ports to discourage minors from purchasing cigarettes (Tobacco Institute 1990), but the program focuses on the legal responsibilities of the purchaser rather than the vendor, characterizes smoking as an “adult behav- ior” (which may make it more attractive to adoles- cents), does not address the dangers of smoking, and, in one assessment, was ineffective in preventing ille- gal sales (DiFranza et al. 1996). The work of the Tobacco Institute highlights what may be the foremost obstacle to changing the social norm of smoking: the multifaceted actions of the industry in preventing prevention. In an analysis of tobacco industry tactics, the Advocacy Institute (1995) has defined nine areas of activity: intimidation, alli- ances, front groups, campaign funding, lobbying, legislative action, buying expertise, philanthropy, and advertising and public relations (see the text box). In its discussion of well over 100 instances in these areas, documented largely from media reports, the Advocacy Institute does not accuse the tobacco industry of ille- gal activity but rather of a far-ranging and systematic effort to ensure the continued use of tobacco. Taken together, and backed by the enormous resources of the industry, these efforts have considerable impact in pro- moting tobacco use and retarding efforts to reduce or prevent it. Because of the considerable litigation now directed at the industry, however (see Chapter 5), the public is more aware of these efforts and may prove more resistant than previously to this powerful com- mercial subterfuge. Support From Business The supportive role of businesses in the move- ment to reduce smoking probably did not arise froma spontaneous realization that preventive measures could improve employee health. Already shoulder- ing new costs from complying with health-related (but non-tobacco-related) new federal legislation, such as the Occupational Safety and Health Act of 1970 (Pub- lic Law 91-596) and the Toxic Substances Control Act (1976) (Public Law 94-469), many companies in the 1970s sought ways to control the rapidly rising costs of health care (Iglehart 1982). Supporting or enacting policies to curb a proven health risk (such as smok- ing) that had expensive consequences simply made good business sense. A special case is insurance. Beginning with State Mutual Life Assurance Company of America in 1964, life insurance companies began offering discounted policies for nonsmokers (Cowell 1985). By 1987, approximately 80 percent of life insurance companies offered discounts to nonsmokers (Schauffler 1993). Historical Review 43 Surgeon General's Report Framework of Tobacco Industry Tactics ' "he Advocacy Institute has developed an overview of tobacco industry strategy, with extensive docu- mentation taken from current media reporting. The documentation provides examples of each of the strategies listed below. I. Intimidation A. B. Legal (harassing suits, subpoenas, in- junctions, outspending plaintiffs) Economic (withdrawal of advertising, withdrawal of business operations) Political (retribution directed at elected and other officials) Personal (harassing researchers, advo- cates, and reporters) II. Alliances A. Strong allies (subsidiaries, trade asso- ciations, advertising industry, tobacco farmers) Weak allies (labor unions, lawyers’ asso- ciations, doctors’ associations) UI. Front Groups A. B. moO OSD Cc. D. Political groups (Michigan Citizens for Fair Taxes, Californians for Statewide Smoking Restrictions) Scientific groups (Council for Tobacco Research U.S.A. Inc., Healthy Buildings International) Smokers’ rights groups (National Smok- ers Alliance) Iv. “ompaign Funding Candidate funding Continued contributions after election Direct funding of interest groups and caucuses Political party funding Funding state ballot initiatives, or fund- ing opposition to initiatives V. Lobbying A. Support of lobbyists at state and national levels Seeking alliances with other lobbying groups on specific issues Gifts and contributions to specific causes Generating grassroots activity Source: Advocacy Institute 1995 VI. Legislative Action VII. VU. Ix. A. Preemption B. Weakening or diluting legislation, or making it unenforceable C. Adding unrelated clauses to, or chang- ing, the contents of legislative bills D. Shifting debate (stressing personal free- dom rather than health; promoting smok- ers’ rights) Buying Expertise A. Enlisting outside experts (economists, epidemiologists, medical researchers, statisticians, legal counsel) B. Creating the Council for Tobacco Re- search U.S.A. Inc. Philanthropy A. Buying innocence by association (finan- cial support to wide range of organiza- tions) B. Funding (women’s groups, racial and eth- nic minority groups, homeless shelters, acquired immunodeficiency syndrome [AIDS] groups, arts groups, educational initiatives, community-based nonprofit organizations, sporting events) Advertising and Public Relations A. B. C. Issue framing (choice, civil rights, per- sonal freedom) Advertising to promote corporate char- acter Disinformation (health effects, economic importance of tobacco) 44 Chapter 2 Health insurance rates, in contrast, have not typically. distinguished between smokers and nonsmokers. Acceptable actuarial data on additional medical ex- penses incurred by smokers did not exist until the early 1980s; at present, discounts for nonsmokers or sur- charges for smokers have not been widely adopted by health insurance companies (Schauffler 1993). None- theless, both the health insurance and the life insur- ance industries have become active in smoking-related public policy. In 1977, the trade associations of the two industries formed the Center for Corporate Pub- lic Involvement to take up public policy issues that affected them. By 1980, the organization was urging its members to adopt workplace nonsmoking policies, and by 1984, it had become an active lobbyist support- ing legislation to reduce tobacco use (Schauffler 1993). The Attack on Advertising In the 1970s and 1980s, the movement to reduce smoking was in part the work of grassroots activity, in part the work of professional consumer advocates, and in part the work of the public health bureaucracy. In 1966, a complaint filed with the Federal Communica- tions Commission (FCC) by John F. Banzhaf III called for the application of the Fairness Doctrine to man- date reply time to cigarette advertising on television and radio broadcasts (see also “Attempts to Regulate Tobacco Advertising and Packaging” in Chapter 5). The FCC agreed with Banzhaf’s complaint and on June 2, 1967, ordered broadcasters to provide “significant” air time for antismoking messages. Banzhaf, antici- pating and forestalling an almost certain appeal from the tobacco industry, appealed his own victory (Whiteside 1971). Under the guise of seeking equal rather than significant broadcast time, Banzhaf succeeded in having his original ruling upheld and in having its application specified: television and radio stations were required to run one counter- advertisement, free of charge, for every three cigarette commercials. This policy lasted until 1971, when a ban on cigarette broadcast advertising went into effect. The campaign to ban or regulate cigarette adver- tising has been one of the most visible and emotion- ally compelling of all the subthemes in the campaign to reduce smoking. (Highlighted in this section, this theme is discussed in greater detail in “Attempts to Regulate Tobacco Advertising and Packaging” in Chapter 5.) All along, opponents have apparently “re- sented most of all the ubiquity and presumed power of cigarette advertising” (Patterson 1987, p. 224). These critics have argued that advertising is a powerful force blinding Americans to the health consequences of Reducing Tobacco Use smoking, but the tobacco industry has maintained a vigorous defense of its right to advertise (Patterson 1987). In'1969, congressional hearings considered ban- ning cigarette advertising on television and radio; strengthening health warnings on packages; extend- ing the warnings to all cigarette advertising; and ending the preemptive ban on FIC, state, and local regulatory activity. This time, the tobacco industry did not benefit, as they had during hearings in previous years, from the hesitancy of those conducting the hear- ings. Since 1964, public concern about the health haz- .ards of smoking had been growing, and although the tobacco industry had powerful supporters in the U.S. House of Representatives, in the Senate, Warren Grant Magnuson (D-WA) and Frank E. Moss (D-UT) were canny and committed antagonists. Recognizing it would have to make some concessions, the industry agreed to a television and radio advertising ban. This concession may not have been unwilling. There is some indication that since the Fairness Doc- trine was invoked in 1966, the resulting counter- advertisements were hurting cigarette sales more than the cigarette commercials were helping (Hamilton 1972). With the passage in 1969 of the Public Health Cigarette Smoking Act (Public Law 91-222), which con- tained the ban on cigarette advertising on television and radio, the counteradvertisements vanished. The tobacco industry shifted its advertising to print and, perhaps even more notable, shifted its marketing bud- get from advertising toward promotion. The latter move exposed vast audiences to cigarette brands through techniques such as sponsoring sports events and, later, merchandising brand-touting items such as T-shirts and caps. Nonetheless, the elimination of ciga- rette advertising from the nation’s most powerful medium was at the very least a stunning symbolic defeat for the tobacco industry. At the same time, the presence of cigarettes was gradually fading in televi- sion programming; by 1982, fictional television char- acters smoked nine times fewer cigarettes than they had before 1964 (Signorielli 1993). Toward a National Policy to Reduce Smoking Victories through federal administrative agencies or through direct assault on Congress were rare. The first chairman of the new (1973) Consumer Product Safety Commission claimed authority to set standards for cigarettes or even to ban them, but Congress in 1976 passed legislation to deny the commission that Historical Review 45 Surgeon General's Report authority (Walsh and Gordon 1986). In 1972, the Civil Aeronautics Board required a nonsmoking section on commercial air flights, in part because of some volun- tary action already taken; in 1983, responding to a Court of Appeals ruling that nonsmokers were inad- equately protected, the board banned smoking alto- gether on flight segments up to two hours—but almost at once Congress passed legislation to reverse this move (Walsh and Gordon 1986). In the executive branch, several voices spoke out against smoking. During his tenure as Surgeon Gen- eral and thereafter, Dr. Jesse L. Steinfeld was an active participant in the national and international movement to reduce smoking (Steinfeld et al. 1976). Joseph A. Califano, President Jimmy Carter’s Secretary of Health, Education, and Welfare, declared in 1978 that smoking was “Public Health Enemy Number One.” When Califano was designated Secretary, he had no notion that reducing smoking should be a significant effort of the Secretary’s department, but experts he consulted invariably urged that his public health efforts include a major campaign on that topic (Califano 1981). Over the years, the main voluntary organizations increased their aggressive posture against smoking. In 1982, the ACS, the ALA, and the AHA established the jointly sponsored Coalition on Smoking OR Health as a Washington-based lobbying organization. The coa- lition represented some 5 million volunteers across the country, at least some of whom were physicians and other civic leaders who could influence particular leg- islators (Pertschuk 1986). In 1985, the AMA called for a complete ban on tobacco advertising and promotion (Troyer 1989). Also that year, a rotating series of four more specific, more severe, and larger print warning labels replaced the traditional warning that “The Sur- geon General has determined that cigarette smoking is dangerous to your health” (Waxman 1985; see “Attempts to Regulate Tobacco Advertising and Pack- aging” in Chapter 5 for discussion of this regulatory process). From Antismoking to Nonsmokers’ Rights The rhetoric of the smoking controversy in the 1950s and 1960s focused on the scientific evidence link- ing smoking and disease. In the wake of the 1964 Sur- geon General’s report and subsequent research and reports, the battle over the credibility of the scientific evidence was essentially over. In what has been called “a remarkable demonstration of creative lobbying” (Jacobson et al. 1992, p. 39), the tobacco industry sought to shift the debate from the medical conse- quences of smoking to the legal implications of impeding the personal freedom of smokers to smoke and of tobacco companies to advertise their wares under the protection of the First Amendment. The tactic appeared to work. By the late 1970s, the effort to reduce smoking was foundering “on a traditional American libertarian ethic: ‘It’s my body and I'll do with it as I please’” (Brandt 1990, p. 167). Serious dis- cussion on the ethics of legislation to reduce smoking emerged (Goodin 1989). To bring a public health per- spective back into the center of the debate, a countershift to nonsmokers’ rights seemed strategi- cally sound (Jacobson et al. 1992). During the 1980s, this strategy acquired a conceptual foundation that was framed in a persuasive vocabulary when the 46 Chapter 2 terms (and the concerns they aroused) “passive smok- ing,” “ambient smoke,” “secondhand smoke,” and most commonly, “environmental tobacco smoke” (ETS) increasingly appeared in research reports and public debate. wo Regulations, Legislation, and Lobbying for Nonsmokers Evidence mounted in the 1970s and 1980s that smoking was not only an annoyance but also a health hazard to nonsmokers. The 1972 Surgeon General's report on smoking and health became the first of the series to include a review of the effects of ETS. A year earlier, Surgeon General Steinfeld had called for a na- tional “Bill of Rights for the Non-Smoker.” The call was answered when the National Interagency Coun- cil on Smoking and Health developed a Non-Smoker’s Bill of Rights and promoted the nonsmokers’ rights theme among its 34 member agencies (Schmidt 1975). At the same time, the first successful efforts were made to segregate smokers and nonsmokers in public places. In 1971, United Air Lines became the first major carrier to institute separated “smoking” and “nonsmoking” sections on its airplanes. Analogous to private citizens who were active in the antismoking movement early on, some private businesses took the initiative to introduce worksite regulations for reducing smoking. Typically, the pri- vate firms would begin with a mild antismoking policy that was made stricter over time. A life insurance com- pany in Connecticut, for instance, in 1976 restricted smoking in parts of the employee cafeteria. In 1983, smoking was prohibited throughout the cafeteria and was also banned from all conference rooms. In 1986, all smoking at the workplace was prohibited except in designated restrooms and lounges. Moreover, the com- pany instituted an educational campaign about smok- ing hazards and provided subsidies for employees who attended smoking cessation clinics (Petersen et al. 1988). Other firms have also turned to carrots as well as sticks, paying employees bonuses if they stop smok- ing for a given length of time (Fielding 1984). States began advancing legislation against ETS in the early 1970s. In 1973, Arizona passed the first statewide ban on smoking in public places. This im- portant step for nonsmokers’ rights, which was initi- ated by a private citizen, Betty Carnes, was defeated in a vote in 1972 but passed on its second try and a year later was further strengthened (Schmidt 1975). Two years later, Minnesota passed the first statewide act to keep indoor air smoke free; the legislation re- quired no-smoking areas in all buildings open to the public unless a posted sign explicitly permitted smok- ing. By 1975, legislation had passed in 10 states to regu- late smoking in public places (Schmidt 1975); more than 30 states and hundreds of local jurisdictions had done so by 1985 (Koop 1985). By 1990, smoking was restricted to some extent in public places or worksites in 44 states, and hundreds of cities and towns had passed their own, often more rigorous ordinances {Rigotti and Pashos 1991). In cities with populations of 25,000 or more, local smoking restrictions reached more than two-thirds of citizens in various public and private settings, and one-half of these restrictions could be judged comprehensive. The courts supported these public and private efforts to protect nonsmokers’ rights. In 1976, a Supe- rior Court of New Jersey ruled that an office worker with an allergy to tobacco smoke had the right to a smoke-free office. New Jersey was also the site of a comprehensive ruling in 1978 that restricted smoking in restaurants and other public places; this was the first such regulation to be enacted by administrative rule (through the State of New Jersey Department of Health) rather than by new legislation, though the rule Reducing Tobacco Use was never actually implemented (Regina Carlson, memorandum to John Slade, September 30, 1996). At the federal level, government acted not only legislatively to regulate public behavior in the states but also administratively to regulate domains the government itself directly controlled. For instance, ciga- rettes were removed from military C rations and K ra- tions in 1975, and smoking was restricted in all federal government buildings in 1979. Smoking was banned in the White House in 1993 (Stephanopoulos 1993). Behind many of these reforms in industry and government were the unified efforts of private citizens. How these grassroot activists could band together to form powerful lobbying groups for nonsmokers’ rights was shown in the transformation of a segment of the Group Against Smokers’ Pollution (GASP), Inc., a na- tional organization founded in 1971. In 1976, local California chapters of GASP banded together and tried but failed to effect statewide ordinances to protect nonsmokers. In 1981, the chapters became Californians for Nonsmokers’ Rights and began focusing on local legislative activity. Five years later, the group became a national organization that took its successful local- level approach to sites throughout the country. By 1986, more than 75 ordinances had been enacted in California alone; nationwide, more than 400 had been enacted by 1990 (Samuels and Glantz 1991). In 1985, Los Angeles banned smoking in most public places and in businesses employing four or more persons if nonsmokers requested it (Fritschler 1989). California has now banned smoking in practically all public places (Tobacco Education and Research Oversight Committee 1995). By the 1980s, the movement to reduce smoking proceeded along many avenues and through a wide set of loosely coordinated organizations. This lack of systematic action has concerned activists in the move- ment, who bemoan duplication of effort, lack of com- munication, organizational rivalries, and the lack of a federal effort and policy. At the same time, the move- ment has clearly benefited from its multiple locations; the movement is represented by active legislative ef- forts in hundreds of small communities as well as by a strong presence in Washington, DC, and in state capi- tals (see also “Direct Advocacy” in Chapter 7 for a dis- cussion of the influences of these advocacy activities). ETS: From Annoyance to Carcinogen The powerful call for nonsmokers’ rights added considerable momentum to the campaign to reduce smoking. The Surgeon General’s report in 1979 Historical Review 47 Surgeon General's Report reviewed further research on ETS. Considerable pub- lic interest was aroused by a Japanese study, published early in 1981, that found a high incidence of lung can- cer among nonsmoking women married to smoking men (Hirayama 1981; Newsweek 1981). While local- level smoking restrictions began to gather force, often proving more comprehensive than statewide legisla- tion, the evidence on passive smoking accumulated. On releasing his 1982 report on smoking and health, Surgeon General C. Everett Koop observed that ETS might be a serious public health problem (Troyer 1989); two years later, he spoke of solid evidence on this point (quoted in Molotsky 1984, p. 1). The growing urgency of a public health focus on ETS set the stage for two authoritative messages that ETS posed a definite danger to all. In 1986, the National Research Council report Environmental To- bacco Smoke: Measuring Exposures and Assessing Health Effects found that ETS exposure increased the risk for lung cancer by 30 percent in nonsmokers and had del- eterious effects on the respiratory health of children (National Research Council 1986). The same year, the Surgeon General released The Health Consequences of Involuntary Smoking, which concluded that “involun- tary smoking is a cause of disease, including lung can- cer, in healthy nonsmokers” (USDHHS 1986, p. 13). That report also found that children of smoking par- ents have an increased incidence of respiratory infec- tions and that separating smokers and nonsmokers within the same air space “may reduce, but does not eliminate” exposure of nonsmokers to tobacco smoke (p. 13). Critics charged that the evidence on passive smoking was weak, but the evidence and the authori- tative conclusions of the Surgeon General and the National Academy of Sciences added support for stronger acts to limit or prohibit smoking indoors. In 1987, Congress banned smoking on domestic air trips shorter than two hours; in 1990, the ban was effectively extended to all domestic commercial air travel. Two further developments raised public (and public policy) awareness of ETS to a level that posi- tioned it in the front ranks of the campaign to reduce smoking. In 1991, the National Institute for Occupa- tional Safety and Health, Centers for Disease Control, issued the report Environmental Tobacco Smoke in the Workplace, which concluded that ETS can cause lung cancer and other health problems (National Institute for Occupational Safety and Health 1991), More important, in December 1992, the Environmental Pro- tection Agency (EPA) classified ETS as a “Class A” carcinogen, the most dangerous class of carcinogens. The agency’s final report, Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders, con- cluded that ETS is a human lung carcinogen respon- sible for some 3,000 deaths annually from lung cancer among nonsmokers (EPA 1992). The Impact of the Movement to Reduce Smoking The campaign against tobacco promotion is, ina sense, a public health hybrid. It is in part a public health movement, like those oriented to ensure that food and drugs are pure and that water supplies and air quality are clean—movements that look to improve upon the collective provision of healthful environ- ments. But because the campaign to reduce smoking necessarily seeks to alter persona! behavior, it is per- ceived or cast by some as a moral reform movement. “We are in the midst of one of those periodic moments of repression,” writes one observer, “when the culture, descended from Puritans, imposes its hysterical visions and enforces its guilty constraints on society, legislat- ing moral judgments under the guise of public health, all the while enlarging the power of surveillance and 48 Chapter 2 the reach of censorship to achieve a general restriction of freedom” (Klein 1993, p. 3). Such critics worry about possible erosions of civil liberties and express irrita- tion with the puritanical cast of the movement to re- duce smoking (Berger 1986; Hitchens 1994; Leonard 1994; Laqueur 1995). One recent historian refers to health reform movements of this and the past century as “hygienic ideologies,” because the movements have sometimes reached levels of “devotion, asceticism, and zeal” that virtually mark them as “hygienic religion” (Whorton 1982, p. 4). In sum, the arguments have pit- ted this moralism against the freedom to choose (Sullum 1996). In doing so, issues of addiction and corporate responsibility are sidestepped (Hilts and Collins 1995). It would be hard to deny that moral zealotry has entered into the contemporary movement to reduce smoking. But it would be equally hard to argue that zealotry is the dominant element in the movement. The contemporary campaign to reduce smoking, like some elements of the early 20th-century efforts, has been fueled by medical research and, more recently, by revelations about the additional but secret medical research carried on by tobacco companies themselves on nicotine and other addictive substances (Kluger 1996). But leadership has been both medical and non- medical and has been oriented to conventional public policy mechanisms rather than to moral reformation. Where the broad contemporary health movement has “an ambivalent orientation toward science and technol- ogy” and “draws upon Americans’ significant and growing distrust of physicians” (Goldstein 1992, pp. 30-1), the movement to reduce smoking firmly em- braces establishment medical research. Its sometimes inventive and ingenious strategies notwithstanding, the movement has typically avoided ideological ends and has instead worked toward concrete, public policy ob- jectives. In this respect, it is self-consciously political, adopting a style found now in many health movements (e.g., AIDS, breast cancer, and even advocates of spe- cific health care reforms). Whether or not the movement to reduce smok- ing has avoided the finger-pointing associated with many ideological movements is debatable. On the one hand, the movement has tended to demonize the to- bacco companies rather than the smokers who use their products. This distinction may arise partly because, some cultural icons aside, smoking has rarely been perceived as a feature of personal behavior that is cen- tral to someone’s identity. Placing the burden else- where than on the smoker has been amply reinforced by the research-steered perceptual transition of smok- ing as “habit” to smoking as “addiction.” As codified by the 1988 Surgeon General’s report (USDHHS 1988) and reiterated more recently (Lynch and Bonnie 1994), smoking is now medically viewed as nicotine addic- tion, and as the title for Chapter 4 states, smoking ces- sation is now the management of such addiction. This transition has had considerable impact on overall strat- egy for reducing smoking, especially in litigation ap- proaches (see “Litigation Approaches” in Chapter 5). On the other hand, as regulations against smok- ing become more widespread, the tendency to stigma- tize smokers may increase (Troyer 1989). Moreover, some critics have complained of an ideology that smacks of political conservatism, in that the focus for the problem is turned away from the product source Reducing Tobacco Use (the manufacturer) and to the user-victim (the smoker); this blame-the-victim perspective also characterizes sociopolitical movements that divert public attention to personal behaviors and away from larger, corporate sources of environmental health risks, such as indus- trial pollution and workplace hazards (Crawford 1979). In at least one sense—that of social values— efforts to reduce smoking have been moralistic. The contemporary reform movement can fairly be charac- terized as middle-class—that is, its values are those connected with traditional values such as deferred gratification, self-control, and personal responsibility (Goldstein 1992). Nonsmokers may feel morally su- perior to smokers, and former smokers may pride themselves on their personal accomplishment and self- denial. As one cultural observer has pointed out, former smokers especially may be “tediously zealous about the addiction they have left behind” (Styron 1987, p. 284). The net result, whatever the role of moral issues, is the main emphasis the movement places on chang- ing the social conditions that enable, and the cultural conditions that legitimatize or romanticize, smoking. In this sense, the movement to reduce smoking is an old-fashioned populist movement that seeks to defend the “public interest” against the moneyed corpora- tions, the purveyors of death and disease. It is now less an “anti-smoking” political movement and more a campaign against tobacco promotion. A reflection of this broadly populist attitude has been the movement's lack of any real links to partisan politics. Senators Wallace F. Bennett (R-UT) and Rich- ard L. Neuberger (D-OR) were among the first to seek curbs on the tobacco industry (Fritschler 1989). In the early 1980s, Republican Senators Robert W. Packwood (R-OR) and Orrin G. Hatch (R-UT) introduced legisla- tion to require more explicit warning labels on ciga- rette packages (Troyer 1989). House Democrats have been both key defenders and key critics of the tobacco industry. In the White House, Democratic President Lyndon B. Johnson remained silent on the preemptive Federal Cigarette Labeling and Advertising Act of 1965, but White House pressure helped support the Tobacco Institute’s efforts to pass the bill (Pertschuk 1986); the President signed the act into law privately in his office, without guests or comment (Fritschler 1989). Similarly, Democratic President Jimmy Carter refused to take a position on tobacco (Fritschler 1989), but he regarded USDHEW Secretary Joseph Califano’s crusade against tobacco as “an enormous political liability” (Califano 1985, p. 360). The absence of po- litical affiliation for the antitobacco movement may be Historical Review 49 Surgeon General's Report altered, however, by recent changes in the party com- position of elected officials from tobacco-producing states. The efficacy of efforts to reduce smoking, inde- pendent of other social changes beginning early in the 20th century, is hard to determine. Students of 19th- century temperance, for example, have concluded that although the temperance efforts likely accelerated the antebellum decline in alcohol consumption, the decline may have been more deeply tied to independent changes in styles of liquor consumption (Aaron and Musto 1981). The antismoking movement of the early 20th century, despite temporary gains, had little long- term effect on stopping the rapid growth of smoking; though noteworthy, the emergence of antismoking legislation in some midwestern and western states was brief and showed little convincing evidence of enforcement. But neither the temperance movement of the 19th century nor the antismoking movement early in the 20th century commanded the significant allies and the range of weapons of the contemporary effort to reduce smoking. The critical factor has been definitive medi- cal research linking smoking to cancer, heart disease, chronic obstructive pulmonary disease, and adverse outcomes of pregnancy (USDHHS 1989). Beginning in 1964, the imprimatur of the Surgeon General of the United States provided a symbolic centerpiece that has given inestimable momentum to the campaign. The all-but-unanimous and compelling character of the epidemiologic research in that first report and its suc- cessors is the chief factor that leads to the-conclusion, “As a target of opportunity for public health action, smoking stands alone” (Walsh and Gordon 1986, p. 127). Measuring the overall impact of the rich and multifaceted effort to reduce smoking is difficult, in part because current prevalence should not be judged against an arbitrary historical benchmark (for instance, against prevalence at the time of the 1964 Surgeon General's report) but against an estimate of what prevalence would have been in the absence of such efforts. The events of the past decades that coincided with these efforts are clear: cigarette consumption rose steadily from the 1930s until 1963, fluctuated, then fell from 1973 to the present. But such broad-brush observations provide little insight into cause and ef- fect, especially given the multiplier effect of certain social actions, the differential changes in demographic and social subgroups, and the influence of forces ex- traneous to smoking (Warner 1989). 50 Chapter 2 It is problematic, for example, to try to assess the relative impact of, on the one hand, government edu- cational actions and government regulatory actions and, on the other hand, changing social norms—two factors that are clearly interrelated. The impact of gov- ernment curbs on smoking in public places (see “Clean Indoor Air Regulation” in Chapter 5) may actually be bound up with “voluntary adjustments to new infor- mation” (Zimring 1993, p. 97). Similarly, doubts have been raised as to the influence of curbs on tobacco advertising (Schudson 1993; see “Advertising and Pro- motion” in Chapter 5), because such restrictions have occurred in conjunction with a growing stigmatization of smoking. Once nonsmoking is established as a norm, the minority status of smokers makes them “more vulnerable to negative social evaluations. . . . As smokers, the group most interested in defending the moral position of the cigarette smoker, become both less numerous and less influential, smoking behavior and the people who engage in it become more vulner- able to social reinterpretation” (Zimring 1993, p. 106). Such a reinforcing chain of events may permit curbs on advertising, rather than the reverse. It is equally difficult to gauge or predict the in- fluence of government restrictions. On the one hand, a regulation may be an educative force—for example, by reminding people to take their Surgeon General seriously. In some instances (such as indoor prohibi- tions and access restrictions), government actions in- terpose a physical barrier. On the other hand, legal or otherwise formal barriers could have an unintended effect on individual predisposition, as the abiding aura of antisocial behavior can be at least as great a stimu- lus for some as it is a deterrent for others. Finally, the psychological and social pathways by which economic actions of government affect smoking are complex. Sorting through this complexity is critical to understanding appropriate policy and action for re- ducing smoking. The ensuing chapters assess the available evidence to judge the efficacy of educational efforts (Chapter 3), the management of nicotine addiction (Chapter 4), regulatory efforts (Chapter 5), economic approaches (Chapter 6), and comprehensive programs (Chapter 7). This brief history of the anti- smoking movement provides a backdrop to such as- sessment and may furnish some perspective on future directions. Conclusions Reducing Tobacco Use In the years preceding the development of the modern cigarette, and for some time thereafter, antismoking activity was largely motivated by moralistic and hygienic concerns. Health con- cerns played a lesser role. In contrast, in the second half of the 20th cen- tury, the impetus for reducing tobacco use was largely medical and social. The resulting plat- form has been a more secure one for efforts to reduce smoking. Despite the growing scientific evidence for ad- verse health effects, smoking norms and habits have yielded slowly and incompletely. The rea- sons are complex but attributable in part to the industry’s continuing stimulus to consumption. Historical Review 51 Surgeon General's Report References Aaron P, Musto D. Temperance and prohibition in America: a historical overview. In: Moore MH, Gerstein DR, editors. Alcohol and Public Policy: Beyond the Shadow of Prohibition. Washington: National Academy Press, 1981:127-81. Advocacy Institute. 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Historical Review 57 Chapter 3 Effective Educational Strategies to Prevent Tobacco Use Among Young People Introduction 61 Trends in Tobacco Use Among Young People 61 Reasons Young People Smoke 62 Educational Models for Smoking Prevention 63 Recent Research on Educational Strategies for Smoking Prevention 64 Shorter-Term Follow-Up of School-Based Programs 65 Project Towards No Tobacco Use 65 Know Your Body 65 Project SHOUT 68 Longer-Term Follow-Up of School-Based Programs 69 Life Skills Training Program 69 Minnesota Smoking Prevention Program 70 Waterloo Smoking Projects 70 Project ALERT 71 Summary of Recent School-Based Research Studies 72 Research on Multifaceted Programs 73 Minnesota Heart Health Program: Class of 1989 Study 74 Midwestern Prevention Project 75 University of Vermont School and Mass Media Project 76 Observations on Research on Multifaceted Educational Programs 77 Diffusing Programs to Prevent Tobacco Use 80 National Guidelines 80 School Health Policies and Programs Study 80 A State-Based Assessment 82 Basic Curriculum 82 Supplemental Programs 82 Programs Including Families 83 Community Programs 83 Combined Activities 83 Monitoring Program Objectives 83 Interpreting the Diffusion Process 83 Conclusions 85 References 86 Introduction Reducing Tobacco Use Trends in Tobacco Use Among Young People Smoking prevalence among youth underwent a sustained and substantial decline for about a decade from the mid-1970s to the mid-1980s. The Monitoring the Future study, funded by the National Institute on Drug Abuse, has assessed the substance use behaviors of large representative samples of high school seniors annually since 1975 (Giovino et al. 1994; Johnston et al. 1994). The data from this multiyear study have shown that daily cigarette smoking reached a peak of about 29 percent among high school seniors in 1977. Daily smok- ing then declined steadily until 1986, falling below 19 percent, but has shown little change since. Detailed analyses of trends in smoking by adolescents in 1974- 1991, based on Monitoring the Future data and two other national health behavior survey series, also have shown consistent evidence that smoking prevalence among adolescents has generally been stable since about 1985 (Nelson et al. 1995). In 1997, daily cigarette smok- ing in the month before the survey was reported by 24.6 percent of high school seniors, the highest level since 1979, when 25.4 percent reported daily smoking. Long- term trends show that daily smoking among seniors was at a 25-year high of 28.8 percent in 1976 and 1977, declined to 21.3 percent in 1980, varied in the range of 18-21 percent from 1980 to 1991, and decreased to 17.2 percent in 1992. After that, seniors’ daily cigarette use increased steadily to reach 24.6 percent in 1997, then decreased to 22.4 percent in 1998 and remained statisti- cally unchanged at 23.1 percent in 1999 (Johnston et al. 1999). A recent report with more current prevalence estimates and trend data from 1991 through 1997 shows that current cigarette use increased overall and for white, black (the racial/ethnic terms “black” and “Af- rican American” are both used in this report, according to the usage in the study cited), and Hispanic high school students (Centers for Disease Control and Pre- vention [CDC] 1998). Even so, the prevalence of smok- ing among African American high school seniors was lower than that for Asian Americans/Pacific Islanders and for American Indians / Alaska Natives (US Depart- ment of Health and Human Services [USDHHS] 1998). Although the decade-long decline in smoking prevalence among young people stalled in the mid- 1980s, it has persisted among all major adult popula- tion groups in the United States (Giovino et al. 1994). Changes in prevalence among young people thus do not seem to be closely linked to changes among adults (Reid et al. 1992) and may be more heavily influenced by other social forces. Downward trends in smoking by adults may, for instance, be partly the result of the continued accumulation of scientific knowledge about the long-term health consequences of smoking and of secondary exposure to cigarette smoke (USDHHS 1989; Environmental Protection Agency 1992). That no such downward trend was observed among most groups of adolescents in the past decade may reflect other factors: prices of tobacco products decreased (see Chapter 6); during the 1980s, public education efforts to prevent tobacco use among young people dimin- ished; and youth-oriented marketing by cigarette manufacturers intensified (Nelson et al. 1995). More- over, because of the highly addictive nature of ciga- rette smoking, the recent increases in prevalence of smoking among young people could carry over into their adulthood and eventually arrest or reverse the long-term declines that have persisted for decades (CDC 1994a; Giovino et al. 1994). In a similar vein, a major portion of tobacco con- sumption at the beginning of the 20th century was in the form of spitting tobacco. The emergence of machine-made cigarettes as the dominant form of to- bacco use in the 1930s (see Chapter 2) was accompa- nied by a 38.4-percent decline in total smokeless tobacco production from 150.2 million to 92.5 million pounds between 1944 and 1968. In the early 1970s, however, the market for smokeless tobacco reemerged. Between 1970 and 1981, the production of fine-cut tobacco, used in the manu- facture of moist snuff, increased threefold from 4.8 million to 15.2 million pounds (USDHHS 1986). Sales of moist snuff have increased every year since the Fed- eral Trade Commission (FTC) began monitoring it, from 36.1 million pounds in 1986 to 55.3 million pounds in 1997 (FTC 1999). Loose leaf chewing to- bacco has seen a slight decline in sales over this pe- riod, from 65.7 million pounds in 1986 to 51.8 million pounds in 1997. The growth in the sales of moist snuff has been attributed to a smokeless tobacco advertising and marketing campaign that encourages young non- users to experiment with low nicotine starter products with the intent of graduating new users to higher nico- tine brands as dependence progresses (Connolly 1995). Effective Educational Strategies 61 Surgeon General's Report The basis and success of this “graduation” strategy is supported by laboratory and epidemiologic data as well as tobacco industry documents. Smokeless tobacco manufacturers appear to be able to manipu- late the nicotine-dosing characteristics of their prod- ucts and have developed moist snuff products with a wide range of bioavailable nicotine (Henningfield et al. 1995; Djordjevic et al. 1995; Food and Drug Administration 1996; Tomar and Henningfield 1997). A national longitudinal study found that young males were twice as likely to switch from a brand with low or medium nicotine delivery to a high nicotine deliv- ery product than to switch in the opposite direction (Tomar et al. 1995). Advertising and promotional expenditures have increased for nearly every year between 1986 and 1997, from $76.7 million to $150.4 million (FTC 1999). In 1997, $103.6 million was spent for advertising and promotion of moist snuff. Smokeless tobacco use is primarily a male behav- ior. Use of snuff and chewing tobacco by young males increased sharply through the 1970s and early 1980s. Data from the National Health Interview Survey indi- cate that the prevalence of smokeless tobacco use among males aged 18-24 years increased from 2.2 per- cent in 1970 to 8.9 percent in 1987 and declined slightly to 8.4 percent in 1991 (Giovino et al. 1994). Based on CDC’s Youth Risk Behavior Survey, the prevalence of past-month smokeless tobacco use remained at about 20 percent among high school males during most of the 1990s (CDC 1992; Kann et al. 1995). Recent data indicate that smokeless tobacco use may be starting to decline among high school males (CDC 1998). More vigorous steps are clearly required to pre- vent young people from beginning to use tobacco products. This chapter considers the effect of educa- tional programs in such prevention. Throughout the discussion, the term “education” is used to encompass the range of activities that impart knowledge, alter per- ceptions, and modify behavior. Reasons Young People Smoke The public health importance of smoking among young people has generated a substantial amount of research on why they take up the habit. The results of these efforts have provided several consistent insights that have been reviewed in detail and summarized in recent reports (Lynch and Bonnie 1994; USDHHS 1994). Development of tobacco addiction is a staged process that requires several years to progress from ini- tiation to acquisition of an established habit (Leventhal and Cleary 1980; McCarthy 1985; see also Flay 1993). 62. Chapter 3 The initial stages are consistently associated with a well-defined group of risk factors. Early adolescence (aged 11-15 years, or 6th-10th grades) is the period when people are most likely to try smoking for the first time. Especially at risk are adolescents whose parents or guardians smoke or have lower levels of income and education (USDHHS 1994). Young people’s perceptions of smoking behav- iors in proximal and wider social environments are among the most powerful psychosocial forces influ- encing whether they begin to smoke (USDHHS 1994). Cigarette smoking among friends, peers, siblings, and others from the young person’s immediate environ- ment is consistently associated with smoking initia- tion. The influence of friends and peers seems to be especially powerful in the early stages of developing a smoking habit. Perceptions of the larger social envi- ronment also seem to have considerable influence on smoking decisions. Adolescents tend to overestimate the prevalence of smoking among people their own age and among adults. Such perceptions—and in gen- eral, susceptibility to becoming a smoker—are likely to be strongly influenced by the effects of advertising (Evans et al. 1995). Yourig people who perceive high levels of smoking among their peers and who report that peers are more likely to approve of cigarette smok- ing are more likely to become smokers themselves. These external influences are likely supported or opposed by internal, personal factors. The personal factors most often associated with smoking initiation include the young person’s belief that cigarette smok- ing is linked with positive functions, such as having a positive social image and bonding with a peer group. Among young women, smoking may be viewed as a means of weight control (French et al. 1994). Adop- tion of such perceptions may reflect, in part, the influ- ence of a larger social environment in which smoking is presented through local and mass media as an adventurous and glamorous adult behavior. Thus, smoking provides some young people a perceived tran- sition from childhood to adulthood (USDHHS 1994). These findings, summarized in the 1994 Surgeon General’s report Preventing Tobacco Use Among Young People, strongly suggest that tobacco use is socially learned by children and adolescents and that it tends to have socially relevant meanings for them (USDHHS 1994). Smoking prevention programs should thus address the most salient psychosocial dimensions that can influence a young person to not begin smok- ing. These dimensions include enabling the young to cope with direct social pressure to smoke from their friends and peers and correcting or preventing misperceptions about the social effects and short-term health consequences of smoking, about peers’ and adults’ attitudes toward smoking, and about smoking prevalence. Educational Models for Smoking Prevention During the past two decades, several different theoretical orientations and program objectives have emerged for educational approaches to smoking pre- vention. Several changes have influenced these events: research and evaluation results that highlighted the ineffectiveness of the models used in earlier programs, the accumulation of consistent research characterizing the process of smoking initiation, advances in theo- ries of human behavior, and promising results obtained from initial tests of newer educational models. Another important change is the expansion from relatively simple strategies and educational techniques to more complex plans that use multiple educational channels. Complex sociobehavioral problems are thus being addressed with more intensive educational strategies. The earliest group (mostly from the 1960s and 1970s) of evaluated programs designed to prevent ado- lescents from beginning to smoke was based on an information deficit model (USDHHS 1994), This approach assumed that adolescents, as rational crea- tures, would refrain from cigarette smoking if they were supplied with adequate information demonstrat- ing that this habit causes serious harm to the body. The educational techniques associated with these pro- grams included lectures, demonstrations, films, post- ers, and books intended to raise levels of awareness and comprehension of health effects. Many programs based solely on this objective did increase knowledge among children and adolescents, as intended, but the programs were consistently found to be ineffective in dissuading young people from smoking (Goodstadt 1978; Thompson 1978; Kinder et al. 1980; Schaps et al. 1980, 1981). Although this approach alone was clearly inadequate, information about the health and social consequences of smoking was retained as an impor- tant component of later developments in smoking prevention education. The limitations of this approach led to efforts in the 1970s to identify a more complex set of personal factors related to cigarette smoking by young people. Once these factors were identified, educational pro- grams could be developed to try to modify them. Stud- ies conducted during these years often observed that the use of cigarettes was associated with negative or Reducing Tobacco Use antisocial patterns of adolescent behavior (USDHHS 1994). Educators interpreted these patterns as reflect- ing reduced levels of perceived self-worth and poor attitudes toward family, school, and community; these factors were hypothesized to be the root causes of smoking initiation. Various educational strategies to address these broad educational targets included programs focused on clarifying values, building self- esteem, and developing general skills for decision mak- ing, communication, and assertiveness. Such efforts to prevent smoking initiation by helping young people develop stronger intrapersonal resources and general social competence have been collectively referred to as the affective education model. Evaluations of these programs, however, dem- onstrated that they were not much more effective in reducing cigarette smoking among young people than programs based on the information deficit model (Schaps et al. 1981; Durell and Bukoski 1984; Hansen 1992). The affective education strategy did mark the beginning of promising trends in designing education programs to prevent smoking: many programs began more directly incorporating results from research about factors found to influence smoking initiation and began including more powerful theoretical models of behavior change. By the mid-1970s, results of analytic and theo- retical research began to highlight a complex set of psychosocial factors associated with smoking initiation. Numerous studies had consistently found that smoking experimentation by the young was as- sociated with peer smoking, smoking by others in the immediate social environment, and other social and psychological factors (USDHHS 1994). Although the resulting psychosocial intervention programs were developed through several different conceptual per- spectives, they tended to share a core set of compo- nents that compose what is generally called the social influences model (USDHHS 1991). This model focuses on the development of social skills to resist social influences that encourage smoking. The initial efforts to design programs based on these findings used a public health model: the prob- lem was conceptualized as a social contagion in which the habit spread through a population by passing from one person to another. This concept directed program efforts toward strengthening the resistance of non- smoking adolescents to the behavior of their smoking peers. For example, Evans and colleagues (1978) at the University of Houston used methods derived from communications and social learning theories to try “inoculating” young people against peer influences to smoke cigarettes; the study group of adolescents was Effective Educational Strategies 63 Surgeon General's Report shown videotaped models of credible peers who suc- cessfully resisted such influences (McGuire 1964). This approach was developed further in small- scale studies that added other objectives and used other educational technologies (Botvin et al. 1980; McAlister et al. 1980; Perry et al. 1980). The appeal of the overall conceptual approach and the generally positive results of this initial group of studies stimu- lated a sustained evolution of the approach through several stages of development; the result was a gener- ally recognized social influences model for school- based programs to prevent smoking (Flay 1985). The main goal of this approach was to equip younger adolescents with specific skills and other resources that would help them resist direct and indi- rect social influences to try smoking cigarettes. The specific objectives usually included having the young person learn the short-term negative social and health consequences of smoking and the advantages of re- maining a nonsmoker; learn that a relatively small proportion of young people and adults are regular smokers; recognize the social influences in the imme- diate environment and from the wider community and culture that promote smoking; and develop specific skills for managing direct social pressures from friends and peers, as well as indirect pressures from adult modeling, the mass media, and tobacco industry mar- keting. Although representing a significant departure from previous approaches, this model retained the provision of information on the negative short- term consequences of smoking (from the information deficit model) and continued to emphasize the devel- opment of social competencies (from the affective education model). Social influences strategies have typically been applied through school-based programs for students in sixth through eighth grades (primarily during early adolescence). These programs have taken various formats, used different delivery methods, and been offered to diverse student populations. By the mid-1980s, detailed analyses of research results indicated that social influences programs were consistently more effective than programs based on the information deficit or affective education models in preventing cigarette smoking (Tobler 1986, 1992; Rundall and Bruvold 1988; Hansen 1992; Bruvold 1993). Some reviewers, however, wondered whether this evidence was strong enough to justify developing public policies that would make these school-based programs a large-scale, key component of policies to prevent tobacco use (Flay 1985; Cleary et al. 1988; Kozlowski et al. 1989). Concern focused on the quality of the effects achieved, the quality of the evaluation research that provided the evidence, and the generalizability of the programs. The programs’ effects reported up to the mid-1980s were not consistently achieved, were of short duration, and tended to be small. For example, Drug Abuse Resistance Education (D.A.R.E.), a drug resistance program that included but was not pri- marily focused on tobacco use, has been in wide use since the mid-1980s. A recent meta-analysis of pub- lished and unpublished results concluded that the program's effect on tobacco use was small at best (Ennett et al. 1994). Limitations in evaluation methods—such as outcome measurement, attrition ef- fects, consistency between assignment and analysis units, and completeness of reported effects on total populations—precluded drawing clear conclusions about program effectiveness. These reviewers also were concerned that the programs might be too com- plex to be carried out in most schools by most class- room teachers. Since 1990, many of these questions have been addressed by research on these educational strategies (Graham et al. 1991). Recent Research on Educational Strategies for Smoking Prevention Most early research programs on smoking pre- vention were located exclusively in school settings. Schools provide direct access to target populations and have a mission consistent with smoking prevention education. Schools, however, have some inherent limitations that reduce their usefulness as exclusive 64 Chapter 3 channels for such education; the obvious one is that school programs cannot reach individuals who leave school. This section reviews shorter-term and longer- term studies of the effects of school-based smoking pre- vention programs (Table 3.1). The section also reviews studies of prevention programs that have tried to enhance such programs by combining them with edu- cational activities directed toward young people through parents, community programs, and the mass media or by combining them with programs that tar- geted multiple substances. Shorter-Term Follow-Up of School-Based Programs The group of studies summarized in this subsec- tion evaluated programs that were based, with few exceptions, exclusively on educational experiences provided in school classrooms. These studies gener- ally have addressed methodological problems com- monly found in earlier evaluations of smoking prevention efforts. Improvements include use of bio- chemical measures to enhance the accuracy of self- reported smoking behavior, attention to validity issues related to attrition, and improved consistency between units of assignment to treatment and units of analysis. Most of this initial group of studies also improved on earlier reports by using more diverse study popu- lations to test these programs and by following participants into the first year of high school to assess smoking prevention effects at an intermediate stage of adolescent development. The studies described and analyzed in this subsection thus represent the cur- rent state of the art in the evaluation of school-based smoking prevention. Project Towards No Tobacco Use Project Towards No Tobacco Use (Project TNT) was designed to assess the relative effectiveness of three main components of most smoking prevention pro- grams based on the social influences model (Sussman et al. 1993b, 1995). The investigators developed sepa- rate classroom curricula to address each of these com- ponents (Sussman 1991; Sussman et al. 1993a). The first curriculum provided social skills to help students more easily refuse direct offers of cigarettes from peers; the second provided methods to counteract the impact of indirect pressures to smoke cigarettes, such as smoking (real or perceived) by peers or adults, tobacco industry advertising, and exaggerated notions of the actual prevalence of smoking among peers and adults; and the third improved knowledge of the short-term and long-term negative effects of smoking. A fourth cur- riculum addressed all three of these areas and was similar to the social influences model used with many other school-based smoking prevention programs. Each curriculum included 10 lessons designed for Reducing Tobacco Use seventh-grade students. The curricula were delivered on 10 consecutive school days by trained health educa- tors employed by the project. A control group received the standard curriculum. The study included seventh graders from 48 junior high schools in 27 southern California school districts. Students from 8 schools were assigned to receive one each of the four curricula; students from the remaining 16 schools were assigned to receive the standard education program provided by their schools. These populations were relatively diverse: about 40 percent were from minority ethnic groups. Student reports of smoking behavior were measured immedi- ately after the curricula were completed in the seventh grade (n = 6,716) and one year later in the eighth grade (n = 7,052). Analyses of these data indicated that the curricu- lum that combined all three main objectives drawn from the social influences model achieved the lowest increase in weekly smoking prevalence (defined as smoking one or more cigarettes per week); this increase was 64 percent lower than the increase in the control group. The curricula that focused on indirect pressures to smoke cigarettes and on negative consequences of smoking also were significantly more effective than the control condition. The curriculum that focused on refusal skills did not yield results significantly differ- ent from the comparison condition. Changes in psychosocial mediators of program effects were con- sistent with these results (Sussman et al. 1993a). Simi- lar effects were obtained for smokeless tobacco use. A two-year follow-up survey, completed when the participating students were in ninth grade, showed that the combined curriculum continued to have a sig- nificant impact on weekly smoking rates after these students entered high school (Dent et al. 1995). Know Your Body The Know Your Body (KYB) program, a school- based effort to reduce risk factors for chronic disease among young people, addressed cigarette smoking status, dietary behaviors, and physical fitness through curricula for fourth- through ninth-grade students (Walter 1989: Walter and Wynder 1989). Program components included parent education and periodic student health examinations. Designed to meet the rapidly changing educational needs of young people in this age group, the six-year curriculum progressed from a focus on knowledge and beliefs to a focus on decision-making skills (Walter and Wynder 1989). In the fourth and fifth grades, the curriculum’s compo- nent on smoking prevention concentrated on students’ Effective Educational Strategies 65 Surgeon General's Report Table 3.1. School-based and multifaceted educational strategies Project name Educational methods School-based educational strategies with shorter-term follow-up Project TNT (Towards No Tobacco Use) Know Your Body SHOUT (Students Helping Others Understand Tobacco) 2 years; 10 class sessions delivered by project staff in grade 7 6 years; multiple risk factor curriculum delivered weekly by classroom teachers in grades 4-9, plus parent education 3 years; 18 class sessions in grades 7-8 delivered by project staff, plus telephone and mail contact in grade 9 School-based educational strategies with longer-term follow-up Life Skills Training Program Minnesota Smoking Prevention Program Waterloo Smoking Projects Project ALERT Multifaceted educational strategies Class of 1989 Study (Minnesota Heart Health Program) Midwestern Prevention Project University of Vermont School and Mass Media Project 3 years; 30 class sessions delivered by teachers in grades 7-9 1 year; 5 class sessions in grade 7 delivered by teachers and peers 3 years; 11 class sessions delivered by project staff in grades 6-8 2 years; 11 class sessions delivered by teachers and peers in grades 7-8 5 years; 17 class sessions delivered by teachers and peers in grades 7-9, plus related school courses and activities and very intensive community education directed toward adults 3 years; 15 class sessions delivered by teachers and peers in grades 6-7 or 7-8, plus parent education and participation in school curriculum, informational media, and community organization 4 years; 15 class sessions in grades 5-8 or 6-9 or 7-10 delivered by teachers, plus 540 television and 350 radio spot broadcasts each year 66 Chapter 3 Reducing Tobacco Use Design Results* Comment 5 conditions tested in 48 schools (n = 6,716) 2 conditions in 15 schools (n = 911) 2 conditions in 22 schools (n = 3,655) 3 conditions tested in 56 schools (n = 5,954) 4 conditions tested in 18 schools (n = 7,030) 2 conditions tested in 22 schools (n = 654) 3 conditions tested in 30 schools (n = 6,527) 2 conditions tested in 13 schools (n = 2,401) 2 conditions tested in 42 schools (n = 5,065) 2 conditions tested in 50 schools (n = 5,458) 64% less weekly smoking for full intervention group by end of grade 8 and 55% by end of grade 9 73% less smoking by end of grade 9 33% less monthly smoking by end of grade 9 18% less weekly smoking observed at grade 12 Program effects at grades 8 and 9 but not at grade 12 Program effects at grades 8 and 9 but not at grade 12 Program effects less at grades 8 and not at grade 12 39% less weekly smoking by end of grade 12 32% less monthly smoking after 1 year; 19% less monthly smoking by end of grades 9-10 40% less weekly smoking by end of grades 8-10; 31% less weekly smoking at end of grades 10-12 Very large short-term effect achieved by moderately intensive school program Very large short-term effect achieved by very intensive school program with parent education Large short-term effect achieved by intensive school program supplemented with other contacts Large sustained effects achieved by very intensive school program No long-term effects of less-intensive school program No long-term effects of moder- ately intensive school program No long-term effects of moder- ately intensive school program Large sustained effects achieved by intensive school programs supported by intensive commu- nity programs Large short-term effects achieved by intensive school program sup- ported by parent education, mass media, and community programs Large sustained effects achieved by intensive school program combined with intensive mass media intervention “Results are reported relative to a comparison group. Effective Educational Strategies 67 Surgeon General's Report health beliefs about smoking. Social influences, both direct and indirect, on decisions about smoking were addressed in the sixth through eighth grades. Psycho- logical influences, such as stress and self-image, were addressed in the ninth grade. The classroom program was delivered by the stu- dents’ usual classroom teachers, who had been trained by project staff. The overall curriculum required about two hours per week throughout the school year. If the curriculum gave equal attention to each of the three targeted behavioral areas, the smoking component would include about 24 hours of class time per year over six years. The parent education component of the program included participation in students’ homework from the curriculum, attendance at school meetings about the program, receipt of program news- letters, and self-assessment of risk factors for chronic disease. The program was initially tested with students attending the fourth grade in 15 elementary schools from suburban communities near New York City (Walter et al. 1989). Students in eight schools received the KYB educational program, and students in the remaining schools received only measurement acti- vities from the study. The follow-up survey in the ninth grade included 593 students (65 percent) from the origi- nal study cohort. Analyses of these data showed that students who had received the program were significantly less likely than students not receiving the program to smoke ciga- rettes (verified through salivary cotinine measures). Smoking prevalence in the ninth grade was 73 percent lower among students who had received the program. This smoking prevention effect was stronger among boys than among girls. Favorable changes in health knowledge, dietary behavior, blood cholesterol, and obesity were also observed (Walter et al. 1988; Walter and Wynder 1989). Project SHOUT The Students Helping Others Understand Tobacco (SHOUT) project was designed to assess the effectiveness of a prevention program delivered to sev- enth through ninth graders by trained college under- graduates through classroom activities and telephone and mail support (Elder et al. 1993b). The program began with 10 class sessions distributed throughout the seventh-grade school year. Components focused on pressures to smoke, refusal skills, negative social and health consequences of smoking, decision mak- ing, and commitment to nonsmoking. In the eighth 68 Chapter 3 grade, eight classroom sessions reviewed refusal skills and engaged students in community action projects, such as encouraging others to quit, writing letters about tobacco issues to mass media organizations and tobacco firms, and debating issues about tobacco use. Throughout the ninth grade, when students had transferred into secondary school, the college under- graduates trained by the program staff made four sup- portive telephone calls to each participant; 69 percent of participants were reached at least once (Elder et al. 1994a). Also during the ninth grade, five newsletters were mailed to students and two to their parents. This program was initially tested in 22 southern California schools. Students from 12 schools received the SHOUT program, and students from the remain- ing schools did not. About 45 percent of the students were from minority ethnic groups. The effectiveness of the program was assessed through classroom and mail surveys conducted at the end of each of the three years. The ninth-grade survey included 2,668 mem- bers (73 percent) of the original study cohort. By the end of the ninth grade, the prevalence of monthly smoking (defined as smoking one or more cigarettes per month) was about 33 percent lower among students who had received the program than among those who had not. The relative difference in the two groups’ reported smoking increased each year and was statistically significant at the end of the ninth grade. The results at the end of the ninth grade were particularly encouraging, because program contact (via telephone calls and newsletters) was less costly. It was not possible to assess whether program effects had accumulated during the seventh and eighth grades. Results for ethnic subgroups were consistent with these overall results but were not always statistically signifi- cant. Similar effects for ninth graders were obtained for weekly cigarette smoking and for smokeless to- bacco use. Assessments of cigarette refusal skills among students receiving and not receiving the pro- gram indicated that the program had positive effects on this mediator of smoking initiation at the end of the seventh grade but not subsequently (Elder et al. 1993a, 1994b). As was found with Project TNT, the results of the SHOUT program did not in general sup- port a strong link between refusal skills and smoking behavior. In an extension of this program, newslet- ters and supportive telephone calls were offered again in 11th grade to a subset of the original intervention group. Results of an additional follow-up survey suggested positive effects of providing continued smoking avoidance support to students throughout the secondary school years (Eckhardt et al. 1997). Longer-Term Follow-Up of School-Based Programs The preceding group of studies did not address whether the observed prevention effects were perma- nent or whether they simply represented delays in smoking initiation from middle school to later high school years. Because few people begin smoking after high school, programs that prevent young people from smoking throughout the high school years are likely to prevent young people from ever becoming regular smokers. Several studies of school-based programs to pre- vent smoking have followed participating students into the later years of high school to assess the dura- bility of effects several years after the programs were implemented. Life Skills Training Program The Life Skills Training (LST) Program was designed to help adolescents develop a wide spectrum of personal and social skills, including those related to preventing cigarette smoking and the use of alco- hol and other drugs (Botvin et al. 1990a). The core program consists of 12 curriculum units designed to be taught in 15 class periods to seventh graders. The problem-specific components of the LST Program are similar to those included in smoking prevention pro- grams focused more directly on the social influences model. These components include offering practice in assertively resisting peer pressure to smoke and providing information about the negative short-term social consequences of cigarette use, the decreasing social acceptability of use, and the actual prevalence of use among adolescents and adults. Other program components address the development of generic per- sonal and social competencies, such as communica- tion skills and ways to develop personal relationships. One of the notable strengths of this program is the relatively large number of separate trials reported by the investigators. The largest trial was conducted among students attending 56 suburban and rural schools in three geographic regions of New York (Botvin et al. 1990a). Students in 34 schools received the smoking prevention program, and students from the remaining schools did not. The smoking preven- tion program included the full 15-session LST Program in the seventh grade, followed by a 10-session booster program in the eighth grade and a 5-session booster in the ninth grade. These programs were delivered by the students’ usual classroom teachers, who had been trained either through group workshops followed Reducing Tobacco Use by monitoring, feedback, and reinforcement of imple- mentation procedures or through use of a training videotape. This study thus tested whether program effectiveness could be maintained while using low-cost methods for disseminating the program to large num- bers of schools, teachers, and students. Analyses of reports from the 4,466 students sur- veyed at the end of the ninth grade (75 percent of the original cohort) showed that the prevalence of ciga- rette smoking was significantly lower among students who had received the LST Program than among those who had not. The relative difference in the smoking scores was about 10 percent. Results were similar for both teacher training conditions. The analyses indi- cated that most of the knowledge, attitude, and skill variables that were targeted as mediators of effects showed significant changes consistent with program objectives. Program recipients also had significantly lower levels of marijuana use and alcohol intoxication. Ina long-term follow-up of the LST Program, data were collected from school, telephone, and mailed surveys administered six years after the initial 56 pub- lic schools had been randomized to treatment and control conditions (Botvin et al. 1995). The 3,597 pre- dominantly white, 12th-grade students sampled repre- sented 60.4 percent of the initial 7th-grade sample. Among all students included in the 12th-grade follow-up, weekly cigarette smoking was reported by about 22 percent of those receiving the intervention and by 27 percent of those in the comparison condition, rep- resenting an 18-percent relative reduction in smoking prevalence. For the subset of students receiving a rea- sonably complete version of the program, the relative reduction in smoking prevalence was 26 percent. The study is unique in demonstrating effects of a preven- tion program that lasted through high school. The generalizability of these results to other populations and school settings is an important area for exploration. Similar support for the effectiveness of the LST Program has been obtained from shorter-term studies of variations in implementation procedures and study populations. These studies have provided evidence for the effectiveness of booster sessions after the initial program delivery (Botvin et al. 1983) and have compared the use of peers and teachers as pro- gram facilitators (Botvin et al. 1990b). Other studies have replicated the short-term effectiveness of the pro- gram with African American and Hispanic adolescents (Botvin et al. 1989a,b, 1992). Components of the pro- gram also appear to have had positive effects when implemented outside the context of a research project (Bruvold 1990). These multiple tests of one approach to school-based smoking prevention provide a Effective Educational Strategies 69 Surgeon General’s Report well-rounded picture of the potential effectiveness of various approaches. The results also demonstrate that relatively intensive programs that address the core objectives of the social influences model in the context of a larger curriculum can reduce smoking prevalence in diverse target populations and school settings when the curriculum maintains a reasonable level of integ- rity to the program design. Minnesota Smoking Prevention Program Two replications of a smoking prevention pro- gram based on the social influences model were com- bined into a single study of long-term effects, the Minnesota Smoking Prevention Program (Arkin et al. 1981; Murray et al. 1984). The core program contained units that identified social pressures to smoke, offered practice in skills to resist direct social pressures, pro- vided information about actual levels of smoking among peers and adults, and provided information about the negative short-term social and physiologi- cal consequences of smoking. These objectives were addressed in five class periods delivered throughout the seventh grade; no additional educational compo- nents were offered in later grades. Both replications of the program compared the relative effectiveness of same-age peer leaders and adult leaders. The two studies included 7,030 seventh-grade students participating in baseline surveys in 18 sub- urban Minnesota schools. In the first study, students received a social influences program led by adults or by peers or received an adult-led program of simi- lar length on the long-term health consequences of smoking. In the second study, conducted a year later, seventh-grade students from the same 18 schools received the adult-led or peer-led social influences pro- gram, the adult-led health consequences program, or no specific smoking prevention program. Results from the first study indicated that among students who were nonsmokers at the start of seventh grade, those who received the peer-led smoking pre- vention program were significantly less likely than those who received the adult-led programs to have tried smoking by the end of the eighth grade; similar results were seen for students who at the start had al- ready tried smoking (Murray et al. 1984). Results from the second study indicated that at the end of the eighth grade, students who were initially nonsmokers and who received any of the test programs were signifi- cantly less likely than similar students from the schools receiving no program to have tried smoking (Murray et al. 1987). In the first study, differences among treat- ment groups had diminished by the ninth grade and 70 Chapter 3 were not statistically significant. In the second study, students who had initially tried smoking and who received the peer-led programs had a significantly lower smoking prevalence than students receiving the adult-led health consequences program (Murray et al. 1987). Modest effects of a peer-led program were detected in an 11th-grade follow-up conducted for the second study (Murray et al. 1988). The investigators surveyed members of the origi- nal study cohorts when the first study participants were one year beyond high school and the second study participants were in the 12th grade (Murray et al. 1989). Those still attending school in their original districts participated in a classroom survey, and oth- ers were interviewed by telephone; participation ex- ceeded 90 percent in both studies. Responses indicated that the programs had no lasting differential effects on smoking behavior. Waterloo Smoking Projects The Waterloo Smoking Projects (WSP) in Canada tested a social influences program designed to follow students from the sixth through eighth grades. The program included three main components common to social influences curricula (Best et al. 1984). The first component provided information on negative consequences of smoking, on smoking prevalences in the general population, and on social influences to smoke. The second component provided practice in skills to resist direct social pressures to smoke. The third component focused on decision making and public commitment to not smoke. These topics were delivered in six sessions during the first three months of the sixth grade. Information about social influences was reviewed in two booster sessions later in the sixth grade. Two additional booster sessions in the seventh grade and one in the eighth grade featured student presentations and discussions about smoking pres- sures and decisions. All sessions were presented by graduate students who were members of the project staff. The evaluation design for this study provided methodologically stronger evidence for potential longer-term effects than previous follow-up studies of school-based programs. The WSP was tested with stu- dents from 22 schools in two school districts in south- western Ontario (Flay et al. 1985). Students from half the schools received the program, and students from the other half did not. The schools were located in urban, suburban, and rural areas. The study sample included 654 students tested at the sixth-grade baseline classroom survey. At the end of the seventh grade, 18 months after the baseline survey, results were reported for the 498 students (76 percent) who had been present for all cross-sectional analyses at each time point. The analy- ses showed reduced experimentation with smoking in the entire target population receiving the program and reduced consumption among students who were regular smokers before involvement in the program (Flay et al. 1985). Longitudinal analyses showed significantly less smoking among program recipients who had already tried smoking before starting the program. Psychosocial mediators, such as knowledge and perceived control, showed changes throughout the target population that were consistent with program objectives (Flay et al. 1983). Results at the end of the eighth grade were re- ported for the 439 students (67 percent) who had par- ticipated in all six school surveys administered through that time (Best et al. 1984). These analyses indicated that the program significantly reduced the amount of experimental smoking among the subgroup that at the baseline survey had reported never smoking. Effects that had been detected at the end of the seventh grade among students with more smoking experience were still apparent but no longer statistically significant. The project surveyed original cohort members at the 12th grade by classroom survey, mailed question- naire, and telephone interview. This effort yielded long-term follow-up data for 560 members (86 percent) of the original study cohort (Flay et al. 1989). There were no program effects at the 12th grade for any smoking level in the overall study sample or for any subgroups defined by initial level of risk. Project ALERT The Adolescent Learning Experiences in Resis- tance Training (ALERT) school program was based on a social influences model that included many features common to this type of program (Ellickson et al. 1993a). The overall goal was to provide young people with the motivation and skills needed to avoid substance use, including alcohol and marijuana as well as cigarettes. The motivational component focused on reducing barriers to resisting social pressures, such as normative beliefs that most young people and adults smoke, that this behavior is widely acceptable and approved, and that smoking has positive physical and social consequences. The skill component focused on practicing skills to resist direct social pressures to smoke. Eight sessions covering these objectives were delivered one week apart during the seventh grade; Reducing Tobacco Use three booster sessions reviewed the main points dur- ing the eighth grade. This program was tested with students from 30 schools in eight school districts located in urban, sub- urban, and rural communities of California and Oregon (Ellickson and Bell 1990). In the initial school survey, about 33 percent of these students were from minority ethnic groups. Students in 20 schools received the ALERT curriculum, and students in the other 10 schools did not. In 10 of the program schools, the curriculum was delivered by classroom teachers alone; in the other 10 program schools, teachers were assisted by older peer leaders recruited from nearby high schools. The initial assessment of this program was re- ported for follow-up school surveys completed 15 months after the baseline survey. After substantial follow-up effort, about 60 percent of the baseline co- hort of 6,527 students were included in these reports (Ellickson and Bell 1990). Among students in the treat- ment group who had experimented with smoking be- fore the program, smoking was reduced by about 20 percent. Among students who had never smoked, however, the program did not achieve a statistically significant reduction. Psychosocial risk factors tar- geted by the program, including beliefs about the con- sequences of use and perceived norms for cigarette smoking, showed changes consistent with program objectives (Ellickson et al. 1993a). These findings were generally consistent across school districts in various geographic regions with differing ethnic and socioeco- nomic profiles; the results were not affected by whether an older peer assisted in delivering the program. An additional follow-up of these students was reported at the ninth grade, two years after the baseline survey (Bell et al. 1993). These analyses included about 75 percent of the baseline sample. Earlier effects on psychosocial risk factors persisted, but program effects on cigarette smoking and other substance use behav- iors had disappeared at this time (one year after the end of the program). A final follow-up survey was completed in the 12th grade, five years after the baseline survey and four years after completion of the program; 57 percent of the baseline sample were included in these analy- ses (Ellickson et al. 1993b). By the end of high school, the program had no detectable effect on cigarette smok- ing or other substance use behaviors; most program effects on cognitive risk factors had also disappeared by this time. Similar to the other longer-term follow- up studies, these outcomes indicated that program effects eroded rapidly when the program ended and that no effects on smoking behavior or related beliefs were detectable at a later time. Effective Educational Strategies 71 Surgeon General's Report Summary of Recent School-Based Research Studies These reports reflect a high level of consistency in approaches taken to prevent smoking initiation and in the results obtained. All studies used some form of muitiple-session school curriculum that was based on the social influences model and was delivered through classroom activities beginning in the sixth or seventh grade; all included a similar set of core curriculum components; and ail reported achieving significant differences in smoking behaviors for one year or more after the program was initiated. For most programs, significant differences were reported through the ninth grade (the first year of high school and more than two years after program initiation). Some specific features of these results strengthen the case for the effectiveness of school-based social influences curricula. The magnitude and scope of the effects achieved across studies were generally more impressive than those reported by earlier studies. The size of the reduction in smoking achieved at the eighth and ninth grades and the duration of these effects were larger than those of the short-term follow-up studies. Most of these studies also reported substantial effects on theory-based psychosocial mediators of cigarette smoking that were targeted for change by the pro- grams, such as relevant knowledge, attitudes, skills, and perceived norms. These results thus indicated important and persistent effects (at least for several years) across a wide range of outcomes anticipated by the theoretical approach. As discussed later in this section, however, the effects did not persist in the longer term. Programs that were successful in achieving pre- vention effects through the ninth grade tended to in- clude a larger number of educational contacts with students over a longer time period than most earlier programs. For example, Project ALERT included 11 class sessions over two years; SHOUT included 18 class sessions, four telephone contacts, and five newsletters over three years; the LST Program included 30 class sessions over three grades; and the KYB program in- cluded an even larger number of class sessions over six school years. These relatively intensive programs successfully deterred young people from smoking cigarettes and using other substances during the peri- ods that these curricula were provided. Comparable programs with smaller numbers of contacts over a more limited time have reported achieving a less sus- tained effect on smoking initiation (Biglan et al. 1987; Ary et al. 1990). These observations suggest a dose- response relationship between how much the students 72 Chapter 3 are exposed to the social influences program and how effective the program is in preventing students from smoking. These results suggest that larger numbers of educational contacts over a longer period of time may yield larger and more enduring smoking preven- tion effects. This conclusion is strongly supported by the long-term reductions in cigarette smoking preva- lence achieved by the relatively intensive LST Program. The results were also obtained within a wide range of curriculum formats. Some of the recent so- cial influences programs have tried to reduce the prevalence of several substance use behaviors often linked in the behavioral development of young people. These programs have included efforts within the same curriculum to prevent the use of smokeless tobacco, marijuana, and alcohol, as well as cigarettes. Includ- ing several substances in the program objectives, as might often be the case in ordinary school programs to prevent substance abuse, does not appear to have reduced the potential effectiveness of these programs in reducing cigarette smoking. In several cases, the positive effects on smoking behavior were also ob- served for other substance use behaviors. Similarly, social influences programs have been successful in diminishing smoking behavior when they have been incorporated in a larger health education program that successfully addressed other health behaviors, such as diet and physical activity. The success of programs under this broad diversity of curriculum formats in- creases confidence in the theoretical relevance and generalizability of this approach. These studies also tested the social influences model under various implementation conditions. Successful programs were reported from a diverse group of geographic areas and with urban, suburban, and rural populations. A much wider mix of ethnic student populations has been involved in these than in earlier studies. Some studies reviewed here have reported favorable program effects for African Ameri- can and Hispanic adolescents; similar programs have demonstrated positive effects for American Indian adolescents (Schinke et al. 1988, 1994; Moncher and Schinke 1994). Successful programs also used various personnel to deliver the programs. These included programs delivered by students’ usual classroom teachers with or without intensive training, programs delivered with and without the assistance of peer lead- ers, programs delivered by college undergraduate or graduate students, and programs delivered by profes- sional staff members of the research team. These diverse characteristics of successful programs further support the generalizability of the social influences model. The more recent studies can be interpreted with much greater confidence than was possible with the pioneering studies reviewed a decade ago because of improvements in study design, measurement, and data analysis methods. Internal validity has been im- proved by including larger numbers of schools and students in study samples to enable investigators to account for school-level effects on smoking behavior (Murray and Hannan 1990). This approach also has improved external validity by providing for tests of programs with more diverse populations and placing program activities farther from the direct control of the chief investigators. In general, these reports have thus provided stronger demonstrations than were pre- viously available of the benefits of social influences programs over other school health education programs tor preventing smoking. The reports also provide greater assurances that the results obtained could be achieved in many types of classrooms if this curricu- lum approach was implemented with a reasonable level of fidelity. The primary limitation of this promising record of success is its generally short-lived nature. Three of the studies that followed participants through the 12th grade consistently found that effects had faded over the high school years. The fourth, the LST Program, demonstrated a statistically significant impact through the 12th grade (Botvin et al. 1995). Thus, although the majority of programs based on the social influences model did not permanently protect young people from pressures or desire to begin smoking, the evidence shows that all of these programs successfully delayed this initiation for several years and that the most in- tensive of these programs reduced smoking prevalence through the end of high school. These results demon- strate that larger-scale implementation of intensive in- terventions based on this model can achieve long-term reductions in cigarette smoking among young people. Further suggestions for overcoming this duration limitation may be drawn from these recent school- based studies. The studies provide evidence not only for the importance of overall program intensity, or the amount of exposure to the program (discussed earlier), but also for the effectiveness of programs that target a relatively broad array of educational modalities for smoking prevention. The LST Program addresses a spectrum of developmental concerns in addition to using a core unit on resistance to social influences that promote smoking; this curriculum has been shown to be effective with a wide range of populations. The KYB program achieved smoking prevention effects with a curriculum that was embedded in a larger program to change health behaviors. The SHOUT Reducing Tobacco Use program included classroom-based community action and advocacy components in addition to conventional units based directly on the social influences model. Such broader approaches within school settings thus seem to be effective in addressing the diversity of smoking prevention needs among adolescents. This perspective receives additional support from a series of studies that have tried to identify more pre- cisely the strengths of the social influences model by testing main components separately. The design of the Project TNT program evaluation provided a direct comparison between the effects of four curricula focused on skills training for resisting peer pressures, on social norms about the prevalence and acceptabil- ity of smoking, on knowledge of the negative conse- quences of smoking, or on a combination of the three elements. Contrary to theory-based expectations, the social skills curriculum did not perform as well as the social norms or negative consequences curriculum; the combined curriculum had the best results (Sussman et al. 1993b). Asimilar study found that a curriculum based on correcting erroneous normative perceptions was more effective than a curriculum on training in resistance skills; the results also suggested that a com- bined curriculum addressing a variety of educational needs about social influences on smoking was more effective than curricula focused on individual compo- nents of the model (Hansen and Graham 1991). These studies thus indicate that attempts to reduce the scope of smoking prevention programs to skills training alone are likely to be ineffective. Al- though school programs are well suited to provide skills training through direct modeling and practice, as well as to convey knowledge about the conse- quences of smoking, they may not be as well equipped to influence young people’s perceptions of the preva- lence and acceptability of cigarette smoking among their wider peer group and adult society. As is discussed in the next section, more complex and intensive programs combining interventions within and outside of schools may be needed to overcome the powerful prosmoking cultural images fostered by the larger social environment. Research on Multifaceted Programs Another group of recent studies has expanded the traditional school-based scope of educational methods to prevent smoking. To counteract the multiple sources of social influences that promote smoking initiation, these projects enlist the positive influences of parents, community organizations, Effective Educational Strategies 73 Surgeon General's Report and the mass media in addition to offering strong school programs based on the social influences model. Relatively few examples of this new direction for smoking prevention efforts have been reported. Edu- cational objectives for these programs have generally been developed directly from programs that have school-based components only, but specific strategies reflect various approaches, as might be expected when new techniques are being developed. Results provide good evidence that these multifaceted educational programs can achieve substantial smoking prevention effects that persist throughout the high school years more consistently than programs based only in schools. Minnesota Heart Health Program: Class of 1989 Study The Class of 1989 Study of the Minnesota Heart Health Program (MHHP) tested the efficacy of a school- based smoking prevention program conducted in the context of a wide range of associated school and community programs designed to improve health behaviors. These programs focused collectively on the overall goal of reducing the risk of cardiovascular dis- ease among the adults of the targeted communities (Perry et al. 1992). Smoking prevention programs were provided in the seventh through ninth grades. The main compo- nent of this multifaceted effort was based on the Min- nesota Smoking Prevention Program (discussed in the previous section), which was one of the early success- ful designs for a social influences program (Perry and Jessor 1985). The Class of 1989 Study used a seven- session program delivered in weekly sessions during the seventh grade by peer leaders assisted by teachers (Perry et al. 1986). This program was followed by a two-session unit in the eighth grade that addressed smoking and exercise and by an eight-session unit in the ninth grade to prevent smoking and drug abuse. Similar curriculum units on eating and exercise behav- iors were added to the school curriculum after the smoking prevention unit in the seventh grade (Perry et al. 1988). These classroom components were supported in school by the development of health councils through which students participated in other projects related to the overall community program theme of cardio- vascular risk reduction. Altogether, the students in the Class of 1989 Study participated in five years of educational programs that were provided through their schools and were focused on smoking and other health behaviors. 74 Chapter 3 The school-based educational components were complemented and supported over the entire program period by community education and organization activities intended to reduce three cardiovascular risk factors—cigarette smoking, high levels of serum cho- lesterol, and elevated blood pressure—in adults of the targeted communities (Mittelmark et al. 1986; Perry et al. 1992; Luepker et al. 1994). The activities included individual risk factor screening and education, which was received by more than 60 percent of all adults; direct education sessions that were conducted in vari- ous community settings, which engaged more than 30 percent of all adults; food labeling education in gro- cery stores and restaurants; intensive mass media edu- cation; continued education of health professionals; and community organization to engage citizens, health professionals, and community leaders in developing and carrying out annual community education plans. Although the MHHP did not demonstrate a significant impact on adults (Luepker et al. 1994), a set curriculum and face-to-face training were found to increase the participation of teachers (Perry et al. 1990a). The effect of these interventions on the smoking behavior of the targeted students was assessed through an evaluation design in which students from one com- munity received these direct and indirect interventions and students from a matching community did not (Perry et al. 1992). At baseline, the target population consisted of all sixth graders attending the 13 elemen- tary schools in these two communities. Longitudinal analyses at each annual follow-up considered students who had been present since the baseline surveys. The 12th-grade survey included 45 percent of the original cohort of 2,401 students. Cross-sectional analyses in- cluded all students participating in each survey. Cohort analyses comparing weekly smoking prevalence and amount of smoking showed that students in the two communities did not differ sig- nificantly at the sixth-grade survey, which was admin- istered before exposure to any substantial amount of program activities. Significant differences appeared at the seventh-grade survey, which was administered af- ter completion of the core components of the smoking prevention program. Weekly smoking prevalence was about 40 percent lower in the treatment community co- hort. Similar effects were found in the cross-sectional analyses. These significant differences were maintained through the 12th-grade survey, three years after the end of direct smoking prevention education and one year after the end of general community education. This study was one of the first demonstrations in the United States that the effects of educational programs to prevent smoking could be maintained through late adolescence—and thus, theoretically, through life. Longer-term community programs sup- porting these school-based components appeared to play a key role in maintaining positive effects. Midwestern Prevention Project The Midwestern Prevention Project (MPP), a three-year school-based program for preventing substance use, was supported by several community interventions explicitly designed for this purpose (Pentz et al. 1989a). The school program consisted of 10 classroom sessions in the sixth or seventh grade (depending on the year of transition into middle school) and is the same as that reported by Hansen and Graham (1991). These sessions emphasized the negative consequences of cigarette, alcohol, and mari- Juana use; corrected misperceptions on actual levels of use among peers and adults; discussed direct and indirect pressures to use substances; practiced skills to resist pressures for substance use; and obtained public commitments to avoid substance use. These activities were presented by classroom teachers with the assistance of peer leaders. Ten homework sessions that involved parents’ participation accompanied the school program. These sessions.emphasized clarify- ing family rules on substance use, practicing tech- niques for avoiding substance use, and learning ways to counteract media and community influences to use substances. The mass media component of this pro- gram occurred throughout all three years of program effert and was equally available to program and con- trol group students. Media messages focused on news coverage of program activities through newspaper articles, brief television news segments, and radio and television talk show interviews with project staff. During the second year of the program (occur- ring in either the seventh or the eighth grade) for the target cohort, a five-session classroom booster program was combined with homework designed to keep par- ents actively engaged in prevention efforts (Pentz et al. 1989b). School administrators, parents, and stu: dents also planned and presented a parent education evening featuring communication skills and school policies on substance use (Rohrbach et al. 1995). Dur- ing the third year of the program, community leaders received training in organizing task forces to prevent substance use. This program component, like the media component, was equally capable of influencing students in the program or the control group (Johnson et al. 1990). Reducing Tobacco Use The overall program was tested in 42 schools from eight communities in the Kansas City metropoli- tan area. About 21 percent of the students from these sixth- and seventh-grade target groups were from mi- nority ethnic groups. Students from the target grades in these schools were assigned to the school and par- ent components (24 schools) or to a delayed-treatment control condition (18 schools). All students and par- ents were exposed to the mass media components and were potentially exposed to the effects of the com- munity organization component beginning with the third program year. Effects were evaluated by using a one-third sample of the large sixth- and seventh-grade target group. This study sample was obtained through baseline surveys of all targeted students in 16 schools and through a one-fourth sample from the remaining schools (total n = 5,065). Follow-up surveys combined sequential cross- sectional surveys, including all students present at a survey point, and longitudinal surveys of a subset of baseline cohort members. The.one-year follow-up sample included 5,008 members of the target popula- tion, who were then in the seventh and eighth grades. Monthly cigarette use was about 32 percent lower among students who had received the combined school, parent, and mass media programs than among students who had received the mass media informa- tion only. Similar effects were observed among the subset of students tracked longitudinally (Dwyer et al. 1989). ; Additional classroom surveys were completed with 3,875 students two years after baseline, when the students were in the eighth and ninth grades (Pentz et al. 1989b). Significant program effects on monthly and weekly smoking prevalence were maintained from the one-year follow-up, although the magnitude of the dif- ferences between program and control students was smaller. Similar results were obtained from the panel of students measured longitudinally (Pentz et al. 1989c). The longitudinal panel from the original sample was followed up into the 9th and 10th grades (Johnson et al. 1990). The baseline sample included 1,607 sixth- and seventh-grade students, of whom 1,105 (69 per- cent) provided complete data at both baseline and the three-year follow-up. Analyses indicated a significant treatment effect for monthly cigarette smoking. Stu- dents receiving the entire program reported about 19 percent less monthly smoking than students who received only the mass media and community organi- zation components. Effective Educational Strategies 75 Surgeon General's Report University of Vermont School and Mass Media Project The University of Vermont School and Mass Media Project (VSMM) evaluated the effects of supple- menting a school-based smoking prevention curricu- lum with intensive mass media campaigns carefully targeted to the needs of adolescents. Both the school and the mass media programs shared a set of objec- tives consistent with the social influences model. These common objectives stated that adolescents exposed to the programs would perceive fewer advantages of smoking, perceive more disadvantages of smoking, acquire social skills to resist peer pressures to smoke, and perceive that most people their age do not smoke (Worden et al. 1988). Other objectives concerned with smoking cessation and awareness of tobacco industry marketing to young people were introduced as the tar- get group matured. The school program included grade-specific lesson plans and teaching materials, and classroom teachers received annual training. Curriculum con- tent covered key elements of the social influences model, such as short-term social and health conse- quences, awareness of social pressures to smoke, skills for coping with peer pressures and other social pres- sures, and decision-making skills related to smoking behavior (Flynn et al. 1995). The three-grade study cohort received this program for four years, in either the 5th-8th grades, 6th—9th grades, or 7th-10th grades. The program required four class sessions for the units in the 5th-8th grades and three class sessions for the units in the 9th and 10th grades. The mass media campaigns used the common objectives and data from high-risk young people in six predefined age and sex groups. High-risk students were defined as those who had previous smoking experience or who knew at least two people in their immediate social environment who smoked, such as parents, siblings, or friends. High-risk girls and boys from three age groups participated in diagnostic re- search activities on two occasions during the study to provide information needed to tailor the mass media campaign to their needs (Worden et al. 1988), These data were used to develop pilot mass media spots, which were assessed by small samples of high-risk students. Mass media advertisements that clearly ad- dressed the common educational objectives and were attractive to their intended target groups were pro- duced for broadcast as 30- and 60-second television and radio spots. Spots targeted to the six specific target groups were broadcast on programs that school survey data had indicated were popular among these 76 Chapter 3 groups; 36 television and 17 radio spots were pro- duced. An average of 190 television broadcasts, 350 cable television broadcasts, and 350 radio broadcasts of these spots was purchased per year for four years in each target community. The evaluation design included four geographi- cally separate but demographically matched metro- politan areas from three states (Flynn et al. 1992). Students in two communities received the mass me- dia and school programs for four years. Students in the other two communities received only the school programs during these four years. The initial cohort included all students from the fourth through sixth grades from 50 elementary and middle schools; more than 99 percent of these students (n = 5,458) partici- pated in the first school survey. Interventions and annual follow-up surveys were conducted for the next four years, beginning at the 5th-7th grades in the 1985- 1986 school year and ending at the 8th-10th grades. A classroom and telephone follow-up survey attempted to reach all original cohort members during the 10th- 12th grades. Results after four years of the program concen- trated on the 47 percent of the original cohort who were fully exposed to the program components (n = 2,540). These analyses indicated that significant hypothesized differences in mediators of program effects occurred in the media-school communities beginning at the end of the second program year and that the amount and prevalence of cigarette smoking were significantly reduced at the beginning of the third program year (Flynn et al. 1992; Worden et al. 1996). By the end of the four-year program period, alternative measures of smoking prevalence and intensity indicated that stu- dents in the media-school communities reported 34-41 percent less smoking than students in the school- only communities. Two years later, when the study cohort was in the 10th-12th grades, differences between smoking prevalences in the two groups con- tinued to be statistically significant and of similar mag- nitude (Flynn et al. 1994). Among students who were at high risk for smoking in grades 4-6, further analy- ses showed that these interventions produced signifi- cant differences in weekly smoking prevalence at grades 10-12 (Flynn et al. 1997). Cost-effectiveness analyses indicated that the cost per student smoker averted as a result of these interventions was about $754 in 1996 dollars, and the cost per life year gained was about $696 (Secker-Walker et al. 1997). These findings show that carefully targeted mass media campaigns can add to school programs a sub- stantial and enduring effect on smoking prevention when the program efforts are sufficiently intensive and the educational objectives for these two channels are closely coordinated. These interventions did not include a substantial program component directed to- ward parents or other adults in the community. The results provide powerful evidence of the influence of mass media messages on health behavior decisions made by young people. Observations on Research on Multifaceted Educational Programs These studies are notable because they all repre- sent efforts to extend the impact of school programs by enlisting the influence, preferably throughout ado- lescence, of other powerful forces in the lives of voung people and because their effects more consistently ex- ceed those achieved by programs involving only the school (Table 3.1). This notion has added importance in view of the competition for curricular time within schools. The studies that were able to follow up study participants into the later high school vears have pro- vided the best evidence thus far that program effects can be extended when educational or other preven- tion strategies include multiple components and take place over longer terms. Because few people begin smoking after high school, these results suggest that long-term multifaceted programs can prevent signifi- cant proportions of young people from smoking not only during their junior and senior high school years but also for the rest of their lives. The interventions used in these three studies were based on a common core of approaches. The main shared theme was that a strong school program was necessary to achieve substantial effects. The school component of the MHHP included 17 class sessions explicitly directed toward smoking prevention objec- tives over three school years; the MPP school program included 15 class sessions over two school years, as well as other school-based student activities; and the VSMM included 14-16 class sessions over four school years. The intensity of these school programs was simi- lar to the intensity of successful school-only programs and approached that recommended by experts (Glynn 1989; CDC 1994b). A related theme was use of the so- cial influences model in designing programs. The re- search groups that developed the MHHP and the MPP included investigators who were key contribu- tors to the development of this model for school-based programs. The design of the VSMM program compo- nents also closely followed this model. The third shared theme for these studies was their focus on entire communities. The MHHP was pro- vided to, and evaluated in, all schools in a single Reducing Tobacco Use moderate-sized community and was supported by communitywide mass media and organizational pro- grams. Some components of the MPP were provided to students, parents, and community members in an entire large metropolitan area. The VSMM was pro- vided to adolescents in two entire moderate-size metropolitan areas, and the same large groups were the focus of targeted media campaigns. The educa- tional messages of the school-only programs, in con- trast, generally did not reach beyond the walls of the selected school. Directing messages to entire commu- nities of adults and adolescents may have increased the capacity of multifaceted studies to influence ado- lescents’ normative perceptions of the prevalence and acceptability of cigarette smoking. The importance of the school component was emphasized by results of a study conducted within the context of the Stanford Five-City Project. This study shared with the MHHP the goal of reducing car- diovascular risk factors in entire adult populations and shared many features of the programs for adults (Farquhar et al. 1990). The adolescent smoking feature of this study assessed whether reductions in cigarette smoking among adults (Fortmann et al. 1993) were reflected among adolescents. A seven-session smoking prevention program was provided to ado- lescents in 7th and 8th grades during the fourth pro- gram year (Telch et al. 1982; Winkleby et al. 1993), and a four-session cessation unit was provided to half of the 10th-grade classes (Killen et al. 1988). The effect of this combination of programs was assessed through cross-sectional population surveys conducted over a 10-year period. No statistically significant differences in smoking prevalence were detected among partici- pants aged 12-15, 16-19, or 20-24 years. The duration of the community programs in the MHHP was one year less than that of the Stanford study. The school programs in the MHHP, however, were much more intensive and of longer duration. Although differences in evaluation methods preclude direct com- parisons, results suggested that the MHHDP’s substan- tial impact on the smoking behavior of adolescents in the Class of 1989 Study depended on the presence of a strong school-based program that was enhanced by the supportive community environment in which it was conducted. The Stanford study’s lack of effects on ado- lescents suggested that intensive, communitywide pro- grams to reduce health risks among adults would not be sufficient to change adolescent smoking unless these programs were combined with more intensive school programs. These contrasting results affirm that a strong school program is important to the success of educa- tional strategies for prevention. Effective Educational Strategies 77 Surgeon General's Report The MHHP community activities were not spe- cifically designed as smoking prevention programs; they were directed toward adults and addressed sev- eral cardiovascular risk factors in addition to smok- ing. These efforts to reduce adolescent smoking may have resulted because young people were directly exposed to community program messages and appeals intended for adults, school programs had heightened intensity from being conducted in communities focused on developing healthy behaviors, or parents stimulated by the community programs gave greater attention to adolescent health behaviors. The inten- sity, pervasiveness, and duration of the community program may also have affected the general norms of the community on health behavior, which in turn may have influenced young people to decide against start- ing to smoke. Similar results were obtained by another youth smoking prevention study conducted in the context of pervasive community cardiovascular risk reduction campaigns. The North Karelia Youth Project in Fin- land included a school program with three sessions in grade seven, five sessions in grade eight, and two ses- sions in grade nine (Vartiainen et al. 1998). Intensive community programs on cardiovascular risk reduction were conducted for adults, including community organization and mass communication campaigns for cigarette smoking cessation, during the years the school program was delivered. Significant differences in cigarette smoking prevalence between young people in the intervention and comparison areas were found at each follow-up survey through age 21. At age 28, significant differences in smoking prevalence were found among those who were nonsmokers at the baseline survey, in seventh grade. These results pro- vide strong support for the findings of the MHHP Class of 1989 Study and emphasize the potential impact on youth smoking of combining school and community programs. The community component of the MPP was ex- plicitly designed to complement the school program to prevent substance use. Program activities that oc- curred outside the classroom were more focused on parents’ behaviors than is usually found in research studies on smoking prevention. These activities in- cluded 10 homework exercises in the first program year and a wide range of family norm-setting activities, similar exercises accompanied the second year of the school curriculum. Parents helped plan and present a parent education evening in participating schools in the second year and participated in community orga- nization activities in the third year. 78 Chapter 3 The only program components to directly reach or involve the wider community were the media mes- sages and community organization activities. The latter component was not introduced until the third program year and may not have had much effect on students’ smoking behaviors. Because parents, then, were the principal focus of educational efforts outside the classroom, the MPP effects were likely achieved mainly through strong and consistent parental sup- port of the objectives of this school-based program. The media messages may also have influenced ado- lescents’ perceptions of peer, family, and community smoking norms. Results of the MPP, the MHHP, and the North Karelia Youth Project thus offer the possible common interpretation that the programs’ effects depended on strong school programs supported by community pro- grams that may have affected students in two ways: through substantially increased efforts by parents and through young people’s perceiving that smoking is not normative. Although parental components similar to the MPP homework assignments have been included insome school-only smoking prevention programs, the full scope of parent-oriented efforts used by the MPP in support of the school curriculum has not been tested previously. Further exploration of combined school and parent programs may be a promising avenue for future educational research studies. Similarly, these results highlight the importance of program compo- nents designed to influence adolescents’ normative perceptions. The VSMM shared with the MPP and the MHHP the general strategy of supplementing a relatively strong school-based smoking prevention program with other forms of intervention but differed in several respects. The combined school and mass media pro- gram in the VSMM was directed toward the target ado- lescents, and no adult participation was anticipated outside of the classroom. The project’s resources thus were applied to influencing adolescents’ smoking behaviors directly through changes in the students’ beliefs, skills, and perceived norms. The VSMM also differed in focusing on use of the mass media as a sole supplement to the school pro- gram. This design provided a reasonably clear indi- cation that the magnitude and duration of a relatively strong school curriculum to prevent smoking could be significantly increased by a mass media component that concentrated exclusively on the target audience of adolescents. Three other large-scale tests of mass media ap- proaches to smoking prevention have been reported. One study conducted in North Carolina tested three mass media campaigns that were not combined with school-based programs (Bauman et al. 1988). The media campaigns included radio spots on the expected consequences of smoking, a similar radio campaign that featured a smoking prevention contest, and the radio and contest components with television spots added. The messages were broadcast during three four-week periods. at levels intended to reach 75 percent of the target audience four times during each period. Each campaign was conducted in two metro- politan areas; four other communities served as control areas. Adolescents aged 12-14 years were in- terviewed through household surveys at baseline (n =2,102); 78 percent of them were followed up 11-17 months later. Results indicated that the campaigns had effects on the recipients’ knowledge of the conse- quences of smoking and other mediators but not on cigarette smoking behavior (Bauman et al. 1991). In the Television, School, and Family Smoking Prevention and Cessation Project (TVSFP), Flay and colleagues (1988, 1995) tested a mass media supple- ment to a school program. The study design was similar to that used in the MPP. The main study was conducted in a single metropolitan area. The mass media component was generally available to members of the community, and the school program was offered only to members of the main treatment group. The main research question thus addressed whether a school program combined with a mass media cam- _ paign had a stronger effect than the mass media campaign alone. The school curriculum included 10 classroom sessions delivered by trained health educa- tors during the seventh grade. The media component included segments that ran for two months in evening television news shows that were linked to the class- room sessions. Students in the main intervention con- ditions were asked to view these segments with their parents and to complete related homework activities together. Seventh-grade students from 47 schools par- ticipated in the study; they were surveyed during the seventh, eighth, and ninth grades. Program effects were observed in the follow-up surveys for mediating variables but not for smoking behavior. More promising results have been reported fora three-year mass media campaign on youth smoking in Norway (Hafstad et al. 1997). This campaign used the novel approach of creating messages intended to stimulate antismoking interactions among young people through use of provocative messages that pre- sented starkly negative images of adolescent smokers. Unlike other mass media approaches, these messages were presented as movie and newspaper advertise- ments and posters, as well as through broadcast Reducing Tobacco Use media channels. Messages were broadcast or placed at a relatively high level of intensity over one three- week period each year for three years. Message themes were varied each year. The impact of these campaigns was evaluated over three years by comparing baseline and follow-up survey results among a cohort of 11,033 young people aged 14 and 15 years for one interven- tion county and one control county. Results showed that young people from the intervention county were less likely to start smoking and more likely to stop smoking at the follow-up survey. This study demon- strates the potential impact of relatively intensive, highly targeted mass media smoking prevention cam- paigns that are not combined with any other type of smoking prevention intervention. Results of these studies using mass media as a primary educational strategy suggested that better outcomes were associated with more intensive, multi- faceted program efforts on social influences. The TVSFP intervention included a substantial school curriculum for the seventh grade but did not include further sessions in later grades. The mass media campaign included a maximum of 10 exposures over a two-month period. The North Carolina study did not include a direct component for interpersonal edu- cation; the media component for this study did not directly address social influences on adolescent smok- ing and was delivered over a total period of three months. These program efforts contrast sharply with the three-year Norwegian media campaign and the 14- to 16-session school program combined with a mass media campaign delivered over four years in the VSMM. Because only relatively brief individual messages about cigarette smoking can be delivered to adoles- cents through the mass media, it is reasonable to hypothesize that behavioral effects can be achieved only when the media spots run frequently and over many months. Other evidence discussed here indi- cates that these types of media campaigns are most likely to be effective when combined with some form of coordinated interpersonal education, such as school- based smoking prevention programs. The VSMM results thus align with those of the MHHP and MPP in supporting the importance of school programs. The VSMM also directly targeted normative perceptions in its school and media components and demonstrated positive changes in these mediators of adolescents’ smoking behaviors. Several guidelines for designing future educa- tional efforts to prevent smoking can be drawn from this review of three successful multifaceted programs. The central role of school programs in Effective Educational Strategies 79 surgeon General's Report smoking prevention education was affirmed by the results of all three studies. The MHHP and the MPP results both suggested the power of influencing ado- lescents’ perceptions of cigarette smoking norms through community programs that enhance the effect of school programs; the MPP results demonstrated the effectiveness of parents’ participation as a specific strat- egy for enhancing school prevention programs; and the VSMM demonstrated that long-term mass media campaigns targeted to adolescents’ beliefs, skills, and perceived norms could enhance the effect of school programs. On a cautionary note, the theoretical and dem- onstrated ability of these programs to alter the smok- ing behavior of young people must be viewed in the larger context of their practicality. As noted earlier, the ability to disseminate such programs has been a matter of active public health engagement. The following section examines the current status of such dissemination. Diffusing Programs to Prevent Tobacco Use In the mid-1990s, several surveys were under- taken to assess the extent to which national guidelines for tobacco prevention in schools (CDC 1994b) were being implemented. One of these, the School Health Policies and Programs Study (SHPPS), queried state and local education districts directly about their ad- herence to guidelines (Collins et al. 1995). A second survey used health department tobacco coordinators as the primary information source about tobacco pre- vention programs in schools (J.K. Worden and B.S. Flynn, Tobacco use prevention education in the United States, 1994, unpublished data, September 1995). National Guidelines According to the CDC’s “Guidelines for School Health Programs to Prevent Tobacco Use and Addic- tion” (CDC 1994b), all schools should, for developmen- tally appropriate ages, provide instruction about the short-term and long-term negative physiological and social consequences of tobacco use, about social influences on tobacco use, about peer norms regard- ing tobacco use, and about refusal skills. Local school districts and schools are advised to “review these con- cepts in accordance with student needs and educa- tional policies to determine in which grades students should receive particular instruction” (CDC 1994b, p. 9). The guidelines recommend that students in kin- dergarten through the 12th grade receive curricula for preventing tobacco use. Because tobacco use often begins in the 6th-8th grades (USDHHS 1994), more intensive instructional programs should be provided in these grades, and students should receive annual prevention education thereafter through the 12th 80 Chapter 3 grade. The guidelines also recommend that programs include support from families, support from commu- nity organizations, tobacco-related policies, and adver- tising campaigns for preventing smoking, because school-based efforts appear to be enhanced by comple- mentary programs in the community. Finally, an on- going assessment should monitor whether an adequate tobacco education program is being maintained. School Health Policies and Programs Study The SHPPS survey, in a follow-up to a similar survey conducted by the American School Health As- sociation in 1989, examined state-, district-, school-, and classroom-level data (Collins et al. 1995). SHPPS ex- amined specific instruction provided in six critical ar- eas: intentional and unintentional injury, alcohol and other drug use, tobacco use, sexual behaviors, dietary patterns, and physical activity. The education agencies in all 50 states and the District of Columbia, a national sample of 413 school districts, a national sample of 607 middle/junior and senior high schools, and 1,040 randomly selected health education teachers were sur- veyed. State and district data were collected with self- administered questionnaires mailed to the person most knowledgeable about or responsible for each compo- nent of the school health program. School and class- room data were collected through on-site personal interviews with lead health education and classroom teachers. The multiple levels of data collection were necessitated by the embedded tradition of local control in determining educational requirements and content of instruction. The data from SHPPS are most clearly assessed by their relationship to the CDC guidelines. Guideline: All schools should develop and enforce a school policy on tobacco use. Policies should prohibit tobacco use by all students, staff, and visitors during school-related activity. Almost two-thirds of schools had smoke-free building policies in place in 1994, though significantly fewer (37 percent) had prohibited the use of tobacco products by all persons on school property, in school vehicles, and at school-sponsored functions away from the school site. Most schools (83 percent) prohibited tobacco use by athletes and coaches during school- sponsored events, and most (89 percent) provided writ- ten copies of the policy to students, staff, and parents. Schools were significantly more likely to have used exclusively punitive consequences (58 percent) in response to the most recent violation of their school’s tobacco use policy than exclusively remedial conse- quences (2 percent) or a combination of punitive and remedial consequences (30 percent); few (8 percent) invoked attendance at a tobacco use prevention pro- gram as remediation for violations. Only 30 percent of schools offered tobacco cessation services in or through the school. Guideline: All schools should provide tobacco prevention education in kindergarten through 12th grade. The instruc- tion should be especially intensive in middle and junior high school and reinforced in high school. In 1994, tobacco use prevention education was required in 37 states (72 percent) and in 83 percent of school districts. At the school level, 91 percent of middle/junior high schools and 82 percent of senior high schools included tobacco use prevention educa- tion in a required course. However, only 55 percent of middle/junior high school teachers and 47 percent of senior high school teachers of health education re- ported tobacco use prevention as a “major” topic in their courses. Of the middle/junior and senior high school teachers who included tobacco use prevention education as a major topic, only 21 percent spent six or more class periods on the topic. Guideline: Schools should provide instruction about the immediate and long-term consequences of tobacco use, about social norms regarding tobacco use and the reasons why adolescents say they smoke, and about social influences that promote tobacco use. Schools should provide behavioral skills for resisting social influences that promote tobacco use. Of the approximately 50 percent of teachers who taught tobacco use prevention as a major topic, 74 percent taught both short- and long-term effects of cigarette smoking. Fewer (61 percent) taught both Reducing Tobacco Use short- and long-term effects associated with using smokeless tobacco. Although 61 percent of teachers addressed group attitudes (i.e., social norms) about tobacco use, only 42 percent taught about the actual amount of smoking and tobacco use among adoles- cents and adults. Less than half (48 percent) of this group of teachers provided instruction about “healthy alternatives” to tobacco use. Sixty-eight percent in- cluded instruction on social influences. Most teachers taught behavioral and social skills, though it is unclear if these skills were taught specifically within the context of tobacco use prevention education. For ex- ample, 89 percent of teachers taught decision-making skills, 87 percent taught skills for resisting social pres- sures, 81 percent taught communication skills, and 78 percent taught goal-setting skills. Guideline: Improve curriculum implementation and overall program effectiveness. In 1994, 82 percent of states had offered in- service training on teaching tobacco use prevention during the past two years. However, only 24 percent of school districts had offered in-service training on tobacco use prevention. Consequently, it is not sur- prising that only 9 percent of teachers of health edu- cation received training on tobacco use prevention education during the same time period. Although state-level training is typically designed for district staff, district-level training is the most common source of training for teachers. Increased training opportu- nities for teachers are needed to improve the effective- ness of tobacco use prevention education. The 1994 SHPPS data were analyzed to examine the extent to which U.S. schools were implementing the CDC’s “Guidelines for School Health Programs to Prevent Tobacco Use and Addiction” (Crossett et al. 1999). Although data do not exist in SHPPS that spe- cifically assess adherence to each of the six recom- mended program areas, three criteria were selected that reflect a “comprehensive” approach to tobacco use prevention (Crossett et al. 1999): (1) a tobacco-free policy consistent with CDC guidelines, (2) at least one teacher who taught tobacco as a major topic and cov- ered four essential content areas (short-term health effects, groups’ attitudes toward tobacco, social influ- ences, and life/refusal skills), and (3) access to tobacco cessation services for students. Only 4 percent of middle schools, junior high schools, and high schools nationwide met all three criteria. Twenty-six percent met two of the three criteria, and 41 percent met one of the three. More than one-fourth of schools (29 per- cent) met none of the three criteria. This analysis is Effective Educational Strategies 81 Surgeon General's Report limited, because not all of the CDC guideline recom- mendations could be measured directly by SHPPS. Nevertheless, these findings indicated that very few schools were fully implementing the CDC recommen- dations in 1994, Schools are faced with many competing demands for instruction and classroom content. Currently, most of this nation’s schools are providing students with some basic tobacco use prevention education. How- ever, the recent increases in tobacco use prevalence among youth and the overwhelming documentation of the health consequences of tobacco addiction em- phasize the need for improvement in what schools are doing to reduce tobacco use and nicotine addiction among their students, faculty, and staff. A State-Based Assessment To estimate current program activity in smoking prevention education across the United States, tobacco control coordinators in all 50 states and the District of Columbia were asked to participate in a survey (Worden and Flynn, unpublished data; unless other- wise noted, cited data in this section are derived from this survey). The position of tobacco control coordina- tor was established to oversee tobacco control and edu- cation efforts in each state health department, through either the American Stop Smoking Intervention Study (ASSIST) program of the National Cancer Institute (NCI) (Shopland 1993) or the Initiatives to Mobilize for the Prevention and Control of Tobacco Use (IMPACT) program of the CDC (USDHHS 1995). The survey was conducted between December 1994 and March 1995. The tobacco control coordinators were asked to describe any educational programs to prevent tobacco use—including school, community, and mass media activities—that were being imple- mented in their state during 1994 and to send writ- ten descriptions or examples of materials used in these programs. This survey differed from SHPPS in its primary reliance on health department rather than education department personnel and in the absence of a multilevel sampling approach. The state-based survey, on the other hand, focused more on the types of materials used. Basic Curriculum The state-based survey determined that school systems were generally left to create their own tobacco use prevention programs or to decide which of several available commercial programs would be imple- mented. Examples such as Here’s Looking At You, 82. Chapter 3 2000 or the LST Program (Bosworth and Sailes 1993; Glynn 1994) were mentioned by a few of the states. A number of states had implemented some school-based educational programs on tobacco use that were supple- mental to statewide school curricula. Among the supplementary programs, the most popular was Teens As Teachers (American Nonsmokers’ Rights Founda- tion 1994). Reported in 10 states, this program trains older high school youth to discuss with younger students the physiological and social consequences of tobacco use. The older youth also may convey the accurate norm that most young people do not use to- bacco. Six states reported using the Tar Wars program, in which medical professionals discuss the conse- quences of tobacco use with junior high school students (Tar Wars 1995). Save a Sweet Heart, a program that emphasizes social influences on tobacco use for junior high school and high school youth (American Heart Association 1989), was reported in three states. Spo- radic use was reported for several other programs, in- cluding Growing Healthy*; Teenage Health Teaching Modules, a version of D.A.R.E. that includes tobacco use prevention; the Minnesota Smoking Prevention Program; and a curriculum developed at the Univer- sity of Vermont (Bosworth and Sailes 1993; Gerstain and Green 1993; Glynn 1994). In several states, either a vol- untary health agency or a community or school group originated its own supplement to a school program. Supplemental Programs During 1994, two states—Massachusetts and Cali- fornia (see Chapter 7)—were particularly active in developing and implementing supplemental programs (i.e., in addition to statewide curricula) using mass media in smoking prevention. Although smoking prevention was one of several aims of the generic me- dia campaigns funded through tobacco tax revenues in each state, the topic was clearly emphasized in a set of media spots specifically targeting youth in 1994 in each state. The Massachusetts campaign was compre- hensive; seven messages addressed various topics suggested in the CDC guidelines (Massachusetts De- partment of Public Health 1994). The 1994 California campaign used seven television spots and six radio spots to describe the physiological consequences of smoking. Using humorous vignettes, the campaign identified toxic substances in cigarette smoke, such as arsenic, formaldehyde, ammonia, methane, and dichlorodiphenyltrichloroethane (DDT). On a smaller scale, supplemental efforts with comprehensive coverage also occurred in West Virginia and in Denver, Colorado. In West Virginia, through a contest sponsored by the American Cancer Society, four winning scripts for radio spots on smokeless to- bacco use and on environmental tobacco smoke were selected from more than 300 entries from students in kindergarten through the 12th grade. The spots were broadcast on 22 stations and included several topics, although the only one related to the CDC guidelines concerned the physiological consequences of tobacco use. In Denver, a three-month billboard campaign promoted the theme “Smoking Doesn’t Add Up,” which suggested the financial consequences of tobacco use (Colorado ASSIST Alliance 1994). Programs Including Families Only two states reported large-scale supplemental programs that included families: New Jersey in its community grants programs and Oregon ina program entitled Parenting for a Positive Future. Three other states reported using the Unpuffables program, which requires parents’ participation and includes the topics of social influences and refusal skills (Perry et al. 1990b). It should be noted, however, that this estimate of parental involvement is likely to be low, since districts and schools, which vary considerably in the degree to which they involve parents in school activi- ties, were not queried directly. Community Programs In general, virtually no states reported community organization programs dedicated to supplementing educational programs to prevent tobacco use. Several programs—including the Kids Against Tobacco program, which involved 5,000 young people in northwestern Louisiana—combined tobacco education and advocacy, but the main emphasis was on inspiring young people to advocate against tobacco use. Combined Activities At the time of the Worden and Flynn survey, only Pennsylvania reported combining a mandated school curriculum with supplemental school, community, and mass media programs in an educational strategy to prevent tobacco use. The statewide Youth Against To- bacco program was sponsored by the state’s health and education departments along with the American Can- cer Society and the Pennsylvania Medical Society. These sponsors asked community organizations throughout the state to participate in the program, which ran from 1992 through 1995. More than 175,000 young people in 47 counties participated with local Reducing Tobacco Use Boy Scouts and Girl Scouts, Boys’ & Girls’ Clubs, health organizations, Students Against Driving Drunk, D.A.R.E., and other groups. Community events in- cluded the 1994 Farm Show, in which 8,444 young people pledged not to smoke. The 1994 mass media program included a rap radio message aired by 223 stations in January and 280 stations in June. Declar- ing it “not cool” to smoke, the message described the social consequences of smoking (Pennsylvania Depart- ment of Health 1992). Monitoring Program Objectives Only Vermont reported having a system in place to annually assess school program activity. Act 51 stipulates that schools in Vermont annually report the number of schools implementing a curriculum. In 1994, 219 schools reported using the Here’s Looking At You, 2000 program, 25 used the LST Program, and 19 used other programs (Glynn 1994). Arkansas, In- diana, Missouri, Pennsylvania, and Rhode Island were able to report the estimated number of students re- ceiving specific programs run by voluntary agencies or local school districts. For example, Indiana reported that 15 percent of its students received the Growing Healthy program. Interpreting the Diffusion Process Because of the methodological differences, the results of SHPPS cannot be compared directly with those of the state-based survey conducted by Worden and Flynn. In particular, it is likely that the latter underestimated the type and amount of tobacco use prevention activity that may have been occurring on the local level. The two surveys concurred, however, in their overall assessment: considerable progress has been made, but comprehensive school health educa- tion can be improved in some areas, including tobacco use prevention. SHPPS, which focused on multiple activity levels, concluded that few schools met all the major criteria provided in the CDC guidelines (CDC 1994a; Crossett et al. 1999). Asa result of its focus, the state-based survey concluded that optimal use had not yet been made of the available research on multichan- nel methods for maximizing the impact of school health education programs for tobacco use prevention. Thus, the review of reported program activity in 1994 indicated that we are far from attaining an ideal, national level of educational programs to prevent to- bacco use. By one set of criteria, only 4 percent of the middle, junior, and high schools in this nation were Effective Educational Strategies 83 Surgeon General's Report meeting three criteria of a comprehensive tobacco use prevention program in 1994 (Crossett et al. 1999). Sev- eral reasons have been offered for this shortcoming at the time. One reason is that the year 1994 fell between two periods that may have been more active. The first period was the late 1980s and early 1990s, when the states of Minnesota and California were implement- ing large-scale campaigns to reduce tobacco use that were financed by tax revenues from cigarette sales. For a brief time, Michigan also developed mass media spots for preventing smoking among adolescents. Resources for these efforts apparently shrank (Begay et al. 1993), and the campaigns faded by 1994. A sec- ond period, which follows the 1994 activities reported here, arguably began with the 1994 publication of the Surgeon General's report Preventing Tobacco Use Among Young People (USDHHS 1994). That report seems to have stimulated development of a new set of guide- lines. In addition, by this time all states had received support to coordinate their education and policy efforts to reduce tobacco use. This support came through the ASSIST program, which began such activities as early as 1991, and through the IMPACT program, which supplemented ASSIST coverage. Therefore, 1994 may represent an interregnum in the enthusiasm for tobacco prevention education. This view is supported by the events of the late 1990s. The major legal and legislative activities (see Chapter 5) were instrumental in mobilizing several states to intensify multichannel efforts at tobacco prevention (described in detail in Chapter 7). A second reason is that there has been little evidence that the community-based approaches to prevent tobacco use that have been shown to be effec- tive in controlled research studies have been adapted effectively to statewide use. Two states, California and Minnesota, have attempted some evaluation of community-based programs to prevent smoking on a statewide scale. In both cases, marketing research tech- niques similar to those described as diagnostic and formative research in the VSMM (Worden et al. 1988, 1996) were applied in developing mass media cam- paigns. Several creative messages for preventing smoking were developed in each state, but the num- ber of messages dedicated to young people was limited; exposure also was limited, because paid ad- vertising slots were allocated to target groups of adults as well as youths (Kizer et al. 1990; Minnesota Depart- ment of Health 1991). Although awareness of each of these campaigns appeared to be high among adolescents, there was no reduction in smoking behavior (Murray et al. 1994; Pierce et al. 1994; Popham et al. 1994). Part of the 84 Chapter 3 difficulty may have been the absence of a sufficiently strong school-based program having similar educa- tional objectives. It is also possible that, with funds divided to reach many targeted groups, the media could not be concentrated sufficiently on smoking pre- vention among youth to have a measurable effect. A third reason is that programs implemented on a day-by-day basis over the years often lack the essen- tial ingredients for success that were evident when they were created and evaluated by researchers. To be ef- fective, programs should be taught as designed (Rohrbach et al. 1993). For many curricula, teachers require training—if not to encourage adoption of the program, then at least to ensure that the curriculum is correctly and completely delivered (Perry et al. 1990a; Smith et al. 1993). Many teachers are resistant to train- ing (Brink et al. 1991), and teachers who smoke may be particularly uncomfortable with a curriculum that discourages smoking. Such resistance may not affect the quality of a brief, single-pronged program format, such as the Smoke Free Class of 2000, but may jeopar- dize the integrity of more long-term and comprehen- sive curricula. It also has been found that a school system’s decision to use a curriculum is simply not enough to ensure successful implementation; teach- ers should be brought in at the earliest stages of adop- tion (Rohrbach et al. 1993). Teachers and school administrators with prior experience in tobacco use prevention education should be involved in orienting and inspiring other teachers, who will then be more likely to deliver the curriculum faithfully and effec- tively (Smith et al. 1993). Successful implementation also depends on the size of the school organization; smaller organizations are more likely to adopt new programs quickly, whereas larger organizations are more likely to maintain a program once it is adopted (McCormick et al. 1995). A fourth reason is that there appears to be a short- age of linking agents, who have been found to be essential for maintaining educational programs to pre- vent tobacco use (Dijkstra et al. 1993) and have been recommended in several diffusion studies (Brink et al. 1991; Goodman et al. 1992; Rohrbach et al. 1993), Link- ing agents are persons or groups that have a strong incentive for maintaining a program and promoting its continuation by consistently and faithfully coordi- nating all of the necessary resources for implementa- tion. Potential candidates for local linking agents are school health teachers, principals, volunteers, and health professionals; each could ensure that school curricula include a strong component for preventing tobacco use, much as local voluntary agencies have supported the Smoke Free Class of 2000 effort (Brink et al. 1991). These individuals, working through a coalition, could also coordinate community program efforts involving families, community organizations, and mass media. Ona state level, the natural linking agents would be the tobacco control coordinators, who could work through coalitions or other state agencies to accom- plish several long-term, comprehensive aims: (1) es- tablish legislation mandating school-based tobacco use prevention with guidelines specifying effective cur- ricula; (2) establish a curriculum training program, through the state education department, that would involve school administrators and teachers in the on- going implementation of school-based curricula to prevent tobacco use; (3) establish a monitoring and support system to determine the penetration and qual- ity of programs throughout the school system and improve instruction with ongoing teacher training; (4) work with parents’ groups and volunteer organi- zations to support the schoo] program; and (5) work with interested citizens to place media messages that support each of the content areas recommended by the CDC guidelines. On a national level, linking agents could be agen- cies, such as the NCI or the CDC, that could support local and state efforts to reduce tobacco use with funding and continued coordination, such as by regu- larly convening state coordinators to share program ideas. These national linking agents might focus their diffusion efforts on using the mass media, because youth in different markets respond equally well to media-based messages for preventing tobacco use (Flynn et al. 1992). Considerable opportunity exists Conclusions Reducing Tobacco Use for enhanced diffusion of programs that have demon- strated effectiveness (Parcel et al. 1989a,b, 1995; O’Hara et al. 1991; Brink et al. 1995; Parcel 1995; McCormick and Tompkins 1998; Siegel and Biener 2000). As an example of such diffusions, the CDC’s Division of Adolescent and School Health initiated the Research to Classroom project. Through this project, CDC iden- tified programs with credible evidence of effectiveness in reducing health risk behaviors among young people. So far, CDC has identified curricula for sexuality and tobacco use prevention. The CDC staff review elec- tronic databases, literature reviews, meta-analyses, and reports to identify evaluation studies that meet the criteria for consideration in the Research to Classroom project. Two external panels, one of evaluation experts and the other of program experts, review the curricula and their evaluations. If both panels recommend adop- tion of the curriculum, based on attainment of identi- fied criteria, CDC designates the curriculum as a Program that Works. The Research to Classroom project identified Project Towards No Tobacco Use and Life Skills Training as appropriate tobacco use preven- tion curricula. Research to Classroom also provides information and training on these curricula for inter- ested educators from state and local education agencies, departments of health, and national nongov- ernmental organizations. The CDC identifies and disseminates information on Programs that Work to help inform local and state choices. The choice to adopt a curriculum ultimately rests with local deci- sion makers and must address community standards and needs. 1. Educational strategies, conducted in conjunction with community- and media-based activities, can postpone or prevent smoking onset in 20 to 40 percent of adolescents. 2. Although most U.S. schools have tobacco use pre- vention policies and programs in place, current practice is not optimal. 3. 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Chapter 4 Management of Nicotine Addiction Introduction 97 Methods for Managing Nicotine Addiction 100 Self-Help Manuals 100 Efficacy 100 Relevant Process Measures 101 Summary 102 Minimal Clinical Interventions 102 Efficacy 104 Relevant Process Measures 105 Summary 105 Intensive Clinical Interventions 105 Problem Solving/Skills Training 106 Rapid Smoking 107 Other Aversive-Smoking Strategies 108 Cue Exposure 108 Nicotine Fading 109 Motivational Rewards 710 Social Support 110 Weight Control 111 Hypnosis 112 Acupuncture 112 Summary of Intensive Clinical Interventions 112 Pharmacologic Interventions 113 Nicotine Polacrilex 113 Transdermal Nicotine 116 Nicotine Nasal Spray 118 Nicotine Inhaler 120 Bupropion 121 Clonidine 122 Nortriptylene 123 Other Antidepressants and Anxiolytics 124 Summary of Pharmacologic Interventions 124 Large-Scale Public Health Programs 125 Media-Based Programs 125 Worksite Programs 126 Community Programs 127 Statewide Programs 128 Summary of Large-Scale Public Health Programs 128 Contemporary Issues in Research on Tobacco Addiction 128 Epidemiologic Concerns and Clinical Issues 128 Nicotine Dependence 129 Stages of Change 129 Negative Affect 130 Sen-ppecitic Differences 130 Withdrawal Svmptoms = /30 Weight Gain 131 Early Relapse 131 Dose-Response 131 Treatment Components 732 Individualized Treatment 732 Dissemination and the Role of the Clinician 132 Cost-Effectiveness 733 Conclusions 134 References 135 Introduction Reducing Tobacco Use Preventing tobacco addiction among young people and promoting abstinence among current smokers are the final common denominators for pub- lic health strategies to reduce smoking prevalence. Al- though prevention efforts are increasingly regarded as the most promising long-term approach for reducing tobacco use (Lynch and Bonnie 1994; U.S. Department of Health and Human Services [USDHHS] 1994), about 1.2 million youths become regular smokers each year in the United States—adding to the millions of adult smokers who are candidates for addiction manage- ment (Leventhal et al. 1991; Centers for Disease Con- trol and Prevention [CDC] 1998; see “Trends in Tobacco Use Among Young People” in Chapter 3). Effective treatments do exist for smoking cessation, and they are available for both the clinical and the public health context (Fiore et al. 1996). These treatments compose an important modality in the effort to eradicate tobacco use. Many of the adverse health effects of tobacco use are reversible by cessation (USDHHS 1989)—a fact im- portant to the millions of adults who already smoke, as well as to the large numbers of young people who continue to take up smoking. Since the 1964 release of the first Surgeon General's report on the health consequences of smok- ing, the prevalence of cigarette smoking among adults in the United States has decreased by 41 percent, fall- ing from 42.2 percent in 1965 to 24.7 percent in 1997 (Giovino et al. 1994; CDC 1999a). Although these data represent significant progress in the public health cam- paign against tobacco use, the steady decline of 0.5 percentage points per year observed from 1965 to 1985 has lessened in recent years. In 1997, approximately 48 million adult Americans smoked; the prevalence was higher among men (27.6 percent) than among women (22.1 percent) and among American Indians and Alaska Natives (34.1 percent) than among blacks (26.7 percent), whites (25.3 percent), Hispanics (20.4 percent), or Asian Americans and Pacific Islanders (16.9 percent) (Table 4.1). Smoking prevalence was also lower among college graduates (11.6 percent) than among high school dropouts (35.4 percent) and higher among those below the poverty level (33.3 percent) than above it (24.6 percent) (CDC 1999a). Since smok- ing prevalence did not decline at a more rapid rate than that observed in the past few years, the Healthy People 2000 goal of an adult smoking prevalence of 15 percent or less by the year 2000 (USDHHS 1991) was not met. Unless smoking prevalence declines at a more rapid rate than that observed in the past, we will not achieve the Healthy People 2010 goal of an adult smok- ing prevalence of 12 percent or less by the year 2010 (USDHHS 2000). Considered over the time frame of the last 30 years, however, smoking cessation has increased dra- matically. Self-reported data from 1997 suggest that almost 50 percent (44 million) of people who have ever smoked have successfully quit smoking (Thomas and Larsen 1993). In 1991, the earliest year for which so- cioeconomic data are available, the prevalence of smoking cessation was greater among male, white, older, more educated, and wealthier persons (Table 4.2) (Giovino et al. 1994). An encouraging finding from the 1993 National Health Interview Survey was that most (70 percent) current adult smokers were inter- ested in quitting. Such interest was higher among women, African Americans, and younger persons (Thomas and Larsen 1993). : Cessation represents a desired end result to what is usually a lengthy, demanding, and often frustrating undertaking. Data on cessation should be interpreted in light of the fact that for every successful attempt to quit using tobacco, many more attempts fail. Although millions of Americans say they want to quit smoking, studies suggest that only about 6 percent of persons who try to quit smoking at any given time are suc- cessful for more than one month (CDC 1993a). Re- search into tobacco cessation seeks tools that will translate the desire to quit into prolonged abstinence from tobacco. Such treatments hold a greater poten- tial for immediate public health returns than do pre- vention methods, and cessation treatments may also be cost-effective (see “Cost-Effectiveness” later in this chapter). In the course of this chapter, the terms “smoking cessation” and “management of tobacco addiction” are used interchangeably. Though the former is the more familiar, the latter better conveys a more rigorous and systematized approach to a complex addiction behav- ior. Value judgments on the impact of a particular modality should be interpreted within a qualitative system for judging costs and benefits. A small impact may be viewed favorably if achieved with minimal intervention. More intense intervention may have a larger impact, but may not be justified by the resources it requires. Management of Nicotine Addiction 97 Surgeon General's Report Table 4.1. Percentage of adults aged 218 years who were current cigarette smokers,* by sex, race/ethnicity, education, age, and poverty status—United States, National Health Interview Survey, 1997 Men Women Total (n = 15,361) (n = 20,455) (n = 35,816) Characteristic % (95% CI*) % (95% CI) % (95% Cl) Race/Ethnicity! White, non-Hispanic 27.4 (+1.0) 23.3 (+0.8) 25.3 (£0.7) Black, non-Hispanic 32.1 (+2.4) 224 (+17) 26.7 (41.4) Hispanic 26.2 (42.1) 14.3 (+1.4) 20.4 (41.4) American Indian/ Alaska Native$ 37.9 (+13.7) 31.3. (+8.8) 34.1 (47.7) Asian American/ Pacific Islander 21.6 (+44) 12.4 (43.5) 16.9 (42.7) Education (years)4 <8 29.9 (+3.0) 15.1 (42.2) 22.5 (41.9) 9-11 41.3 (43.1) 30.5 (42.4) 35.4 (42.0) 12 31.8 (41.7) 25.7 (+1.3) 284 (+1.0) 13-15 27.4 (+1.7) 23.4 (41.4) 25.1 (+1.1) 216 13.0 (41.2) 10.1 (41.0) 11.6 (40.8) Age (years) 18-24 31.7 (42.8) 25.7 (42.4) 28.7 (+1.9) 25-44 31.2. (+1.3) 26.1 (41.1) 28.6 (+0.8) 45-64 27.6 (+1.5) 21.5 (41.3) 24.4 (41.0) 265 12.8 (+1.4) 11.5 (41.1) 12.0 (40.9) Poverty status! At or above 27.3 (#+1.0) 21.8 (40.8) 24.6 (+0.7) Below 38.7 (42.8) 29.8 (41.9) 33.3. (1.7) Unknown 23.4 (+2.0) 18.2. (41.5) 20.5 (41.2) Total 27.6 (+0.9) 22.1 (+0.7) 24.7 (40.6) *Persons who reported having smoked at least 100 cigarettes during their lifetime and who reported currently smoking every day or some days. Excludes 300 respondents with unknown smoking status. t95% confidence interval. +Excludes 74 respondents of unknown, multiple, and other racial/ethnic categories. SWide variances on estimates reflect the small sample sizes. APersons aged > 25 years. Excludes 305 respondents with unknown years of education. ‘IPublished 1996 poverty thresholds from the Bureau of the Census are used in these calculations. Source: Centers for Disease Control and Prevention 1999a. 98 Chapter 4 Reducing Tobacco Use Table 4.2. Percentage of adults* who abstained from smoking cigarettes in the previous year, by sex, race/ethnicity, age, education, and poverty status—United States, National Health Interview Survey, 1991' Maintenance? among all persons who Abstinence for Maintenance were daily smokers 21 day among abstainers 1 year earlier® Characteristic % (95% CB) % (95% CI) % (95% CI) Sex Male 42.6 (40.8~44.4) 13.8 (12.0-15.6) 5.8 (5.0-6.6) Female 41.5 (40.0-43.0) 13.7 (12.0-15.4) 5.6 (4.9-6.3) Race/Ethnicity White4 40.3 (39.0~41.6) 14.0 (12.6-15.4) 5.6 (5.0-6.2) Black* 48.7 (45.2-52.2) 7.9 (5.1-10.7) 3.8 (2.45.2) Hispanic 52.1 (46.4-57.8) 16.3 (10.3-22.2) 8.5 (5.2-11.8) American Indian/ 53.3 (39.7-67.0) NA? NA! Alaska Native Asian American/ 45.0 (33.7-56.3) NA1 NA! Pacific Islander Age (years) 18-24 56.7 (52.9-60.5) 14.0 (9.9-18.1) 7.9 (5.6-10.3) 25-44 43.4 (41.8-45.0) 12.7. (11.0-14.4) 5.4 (4.7-6.1) 45-64 36.1 (33.9-38.3) 14.1 (11.4-16.8) 5.0 (4.0-6.0) 265 35.7 (32.2-39.2) 19.4 (14.6-24.2) 6.8 (5.1-8.5) Education (years) <12 36.5 (34.1-38.9) 12.9 (10.2-15.6) 4.7 (3.7-5.7) 12 42.5 (40.8-44.2) 12.8 (10.9-14.7) 5.3 (4.5-6.1) 13-15 46.9 (44.2-49.6) 14.3. (11.4-17.2) 6.6 (5.2-8.0) 216 45.9 (42.5-49.3) 18.8 (14.9-22.7) 8.5 (7.0-10.0) Poverty status** At or above 42.7 (41.4-44.0) 14.8 (13.4-16.3) 6.2 (5.6-6.8) Below 42.9 (39.5-46.3) 7.5 (4.7-10.3) 3.2 (2.0-4.4) Unknown 35.2 (31.2-39.2) 12.6 (8.3-16.9) 4.4 (2.9-6.0) Total 42.1 (40.9-43.3) 13.8 (12.5-15.1) 5.7 (5.2-6.3) "Persons aged 218 years who reported having smoked at least 100 cigarettes in their lifetime and smoked cigarettes daily 1 year earlier and who provided information of their current smoking status. ‘Sample size = 9,703; race/ethnicity variable excludes 34 respondents of other, unknown, or multiple race; education variable excludes 24 respondents of unknown education level. Abstinence from smoking cigarettes for at least 1 month at the time of the survey. Excludes 92 respondents who were abstinent from cigarettes for <1 month or for whom duration of abstinence was unknown. SConfidence interval. “Excludes persons of Hispanic origin. ISample sizes too small to derive reliable estimate. **Poverty statistics are based on definitions developed by the Social Security Administration, which includes a set of income thresholds that vary by family size and composition. Source: National Center for Health Statistics, public use data tape, 1991. Management of Nicotine Addiction 99 Surgeon General's Report Methods for Managing Nicotine Addiction Historically, the great majority of smokers (more than 90 percent) who successfully quit smoking did so “on their own”—that is, without the assistance of formal cessation programs (USDHHS 19839; Fiore et al. 1990). With the advent of new treatments, including pharmaceuticals, more smokers (20 percent) are using some form of assistance when trying to quit (Zhu et al. 2000). The success rate among this large group of unassisted quitters is half that observed for those who use some form of assistance. Although more than 1 million smokers quit each year, 75-80 percent relapse within six months (Carmody 1992). Those who quit may relapse at any time (even after a period of years), and a substantial portion of quitters go through cycles of quitting and relapse (Cohen et al. 1989a). Given this complex context in which the natural history of smoking occurs (an important leitmotif in the man- agement of tobacco addiction), it is difficult to assign a single number to the proportion who quit on their own. Nonetheless, in the current environment of declining prevalence, the end result of this cyclic pro- cess, and of all the interventional efforts brought to bear on it, is that each year about 3-5 percent of smok- ers quit for a year, for longer, or for good. The success of smoking cessation methods should be evaluated in terms of both process and out- come measures. Process measures are designed to as- sess those variables that are affected by treatments and that influence outcomes. Ideally, process measures should target the specific change mechanisms that treatments are intended to influence. For instance, if a treatment is intended to provide smokers with coping skills, process measures might assess a patient’s abil- ity to anticipate and generate appropriate responses to stresses. If a treatment is intended to promote ces- sation by reducing withdrawal symptoms, then a with- drawal symptom scale might be used as a process measure. Clinically significant outcome measures in- clude attempts at quitting and abstinence success. Withdrawal symptom severity and concomitants of cessation attempts, such as weight gain, may be viewed as outcomes as well. Some of the efficacy evaluations reported here incorporate the results of published meta-analyses. Meta-analysis is a statistical technique that assesses the impact of a variable (or, in this context, a treatment) across a set of related investigations (Dickersin and Berlin 1992). Meta-analyses may present a more 100 Chapter 4 objective assessment of accumulated research findings than do traditional narrative reviews (e.g., Cooper and Rosenthal 1980) and can be useful for identifying study or treatment characteristics that are associated with differences in study outcomes (Dickersin and Berlin 1992). Meta-analyses of smoking cessation treatments have used different techniques for estimating the size of treatment effects. The precise methods used to cal- culate and pool these estimates vary (for detailed de- scriptions, see Fleiss 1981 and Cooper and Hedges 1994). In both meta-analyses and individual studies, the most frequently encountered measures are the odds ratio (an estimate of the relative risk for the outcome in control versus treatment groups) and some form of effect size (difference in effect between treatment and control groups). Self-Help Manuals Because of the size of the population who try quitting on their own, the broad dissemination of ma- terials that can help them in their efforts—without re- quiring them to participate in a formal cessation program—may be a potent strategy at the national level for decreasing the prevalence of smoking (Glynn et al. 1990a; Curry 1993). A wide array of self-help strategies has been developed for smoking cessation (Curry 1993). This section discusses the efficacy of written manuals, the most extensively investigated self-help materials (Curry 1993). The discussion is lim- ited to studies of such manuals distributed to relatively small populations of smokers. Self-help materials de- livered to large populations are discussed later in the chapter in association with nonprint messages and pro- grams (self-help or supervised) included in mass me- dia and community-based efforts. Efficacy Ina review of the research literature on self-help manuals, the median long-term prevalence of cessation associated with manual-based interventions was about 5 percent (Curry 1993). This proportion is lower than those of face-to-face cessation programs (Schwartz 1987; Lichtenstein and Glasgow 1992; Lando 1993). Further- more, recent evidence suggests that self-help manuals, when used by themselves, may produce negligible increases in long-term cessation (Gritz et al. 1992; Petersen et al. 1992; Gomel et al. 1993; Fiore et al. 2000). Because self-help manuals can be distributed, at low cost, to very large numbers of smokers, even rela- tively small cessation success could translate into large numbers of successful quitters. Since 30-40 percent of smokers each year make a serious effort to quit, self- help aids could have a vast influence on public health (Hatziandreu et al. 1990; CDC 1993b, 1999b). The avail- able evidence suggests that self-help manuals work better for smokers who are less dependent on nico- tine, more motivated, and more confident of quitting (Curry 1993), but the relationship between motivation and success is complex. Less addicted smokers may be less likely to seek formal treatment (Fiore et al. 1990; Zhu et al. 2000) and are therefore an apt audience for self-help manuals. More addicted smokers are more likely to seek formal self-help programs (Wagner et al. 1990) but may be less successful in quitting (Schoen- bach et al. 1992). Thus, in view of both their uncertain effectiveness and their potential to be cost-effective, it is important to determine whether self-help manuals have a consistent, albeit small, benefit. Although many self-help manuals have been de- veloped, there is little evidence that they differ in their effectiveness (Cummings et al. 1988; Glynn et al. 1990a; Curry 1993). Accordingly, an Expert Advisory Panel convened by the National Cancer Institute (NCI) has recommended that public health professionals try to increase the availability of existing manuals rather than refine them or develop new ones (Glynn et al. 1990a). The committee also concluded that if new materials are deemed necessary, they should, ata minimum, contain the following components: (1) information about the social and health effects of smoking; (2) specific strategies and exercises for quitting; and (3) specific strat- egies and exercises to avoid relapse and, in the event of relapse, to try quitting again (Glynn et al. 1990a). Manuals tailored to special populations of smok- ers, such as pregnant women, older adults, African Americans, and Hispanics, have been developed and tested (Windsor et al. 1985; Glynn et al. 1990b; Davis et al. 1992; USDHHS 1998). Although manuals tar- geted to specific populations have not had consistently greater success than generic manuals at helping mem- bers of relevant populations quit (Curry 1993; Rimer et al. 1994), such manuals have the potential to reach smokers missed by traditional materials (Curry 1993). It appears that combining multiple types of seli-help materials (manuals, videotapes, etc.) does not improve long-term cessation rates. A meta-analysis of 21 studies using multiple types of self-help without person-to-person contact found no significant difference Reducing Tobacco Use between multiple types of self-help and no self-help at all (Fiore et al. 2000). Reading level has been increasingly recognized as an important attribute of self-help manuals. Since the early 1970s, trends in smoking prevalence have been different for those with differing levels of educa- tional attainment (Pierce et al. 1989). Smoking preva- lence has dropped sharply among persons with a college education (10.1 percentage points between 1974 and 1985) but has declined only marginally among high school dropouts (2.1 percentage points during the same period). Concerns about literacy have led to the recommendation that self-help materials for smoking cessation be written at no more than a seventh-grade reading level (Glynn et al. 1990a), although this level may be too high in some situations. Adjuncts to self-help manuals, such as telephone counseling (Orleans et a]. 1991; Curry et al. 1992; Lando et al. 1992), hot lines (Ossip-Klein et al. 1991), and per- sonalized feedback (Curry et al. 1991; Prochaska et al. 1993), have also been evaluated. These adjunctive in- terventions have met with varying success (Curry 1993). For example, self-help treatments that include nicotine gum as well as smoking cessation manuals have not had greater long-term efficacy than the manuals alone (Harackiewicz et al. 1988; Killen et al. 1990b). Computer-generated personalized feedback (Curry et al. 1991) and telephone outreach, however, have im- proved cessation success (Orleans et al. 1991; Lando et al. 1992; Prochaska et al. 1993; Strecher et al. 1994). At present, research suggests that such adjuvants materi- ally improve the effectiveness of self-help manuals. Adjunctive interventions that require financial and personnel resources, however, may undercut the potential population impact of self-help interventions. The addition of other components to self-help manu- als may also mark the point at which the self-help modality merges with more formal assistance, which, as mentioned earlier, have not appealed to as large a population of smokers motivated to quit. But at least one such treatment, proactive telephone counseling (as opposed to reactive approaches, such as help lines smokers must call), appears to be effective when used as an adjuvant (Fisher et al. 1993). Relevant Process Measures Most studies of self-help manuals lack process measures, and the specific measures used across stud- ies vary considerably (Curry 1993). Two distinct pro- cess measures, manual reading and manual use, have been assessed in some studies of self-help manuals for smoking cessation. Reading measures simply ask Management of Nicotine Addiction 101 Surgeon General's Report smokers whether they read most or all of the manual. Use measures assess the extent to which smokers performed the specific exercises recommended in the manual. In theory, persons who actually read a manual or practice manual-recommended exercises should be more successful than those who merely possess a manual. Curry (1993) concluded that although read- ing has sometimes been related to program success, use has been more consistently related to improved outcomes. Further work is needed to determine with some certainty whether the information conveyed by the manuals, rather than nonspecific motivational ef- fects, is responsible for their efficacy. Summary Although self-help manuals have had only mod- est and inconsistent success at helping smokers quit, manuals can be easily distributed to the vast popula- tion of smokers who try to quit on their own each year. Adjuvant behavioral interventions, particularly pro- active telephone counseling, may increase the effect of self-help materials. Process measures are not rou- tinely incorporated into self-help investigations, but the available process data suggest that persons who not only have a self-help manual but also perform the exercises recommended in the manual are more likely to quit smoking. Minimal Clinical Interventions Minimal clinical interventions are those that can be delivered briefly to smokers by health care profes- sionals during the course of a regular health care en- counter. These strategies may be as simple as advising smokers to quit, or they may be as complex as using computers to tailor the intervention to the individual smokers. Minimal clinical interventions could have a great influence at a national level on smoking cessa- tion, but they have been underused. Findings from a 1985 (Ockene et al. 1987), a 1991 (CDC 1993b), and a 1992 national survey (Tomar et al. 1996) suggest that nearly 70 percent of American smokers (nearly 36 mil- lion) make at least one outpatient health care visit each year; however, only 40-52 percent of the smokers in the surveys reported that during the preceding year they had been advised by a health care professional to quit smoking. Ina separate study, 48.8 percent of 2,710 current smokers had been advised by their physician to stop smoking or to smoke less (Frank et al. 1991). More than 50 percent of adult smokers in the United States saw a dentist in 1992, but fewer than 25 percent 102 Chapter 4 of those who saw a dentist in the preceding year re- ported that the dentist had advised them to quit smok- ing (Tomar et al. 1996). Among adult users of smokeless tobacco, 18 percent reported that they had ever been advised by a dentist and 15 percent had ever been advised by a physician to quit (Tomar et al. 1996). Many clinicians may believe that they are not equipped to help smokers quit (Wells et al. 1984; Glynn 1988) or that a physician can help a smoker quit (Ockene et al. 1988a). Training programs for clinicians have been developed to address this problem (Ockene et al. 1988b; Cummings et al. 1989a,b; Duncan et al. 1991; Manley et al. 1991; Strecher et al. 1991); however, data suggest that simply training clinicians may not be effective (Dietrich et al. 1992; Carney et al. 1995; Klein et al. 1995). However, implementing reminder systems in the clinic has been shown to triple clinician intervention with smokers (Fiore et al. 1996, 2000). Some evidence suggests that the delivery of these mini- mal clinical interventions is becoming more common (Gilpin et al. 1992). Surveys suggest that smokers who are white, fe- male, older, better educated, or ill, or who smoke more cigarettes per day are more likely than others to re- ceive clinical advice to quit (Ockene et al. 1987; Frank et al. 1991; Gilpin et al. 1992; CDC 1993b). At present, clinicians apparently do not ensure that all of their patients who smoke receive cessation advice and as- sistance, in part because of structural and policy is- sues (such as reimbursement) related to medical care delivery. Nonetheless, such efforts might be more com- mon if clinicians were trained to view smoking as a chronic disease, marked by periods of remission and relapse, rather than as an acute disorder (Fiore and Baker 1995). Researchers have shown that institutional changes can increase the systematic delivery of minimal clinical interventions for smoking cessation. For example, brief physician training, availability of nicotine gum, and patient chart stickers documenting smoking status can increase the amount of time physicians spend in cessa- tion counseling and increase successful cessation by a factor of 2 to 6 (Cohen et al. 1989b; Ockene et al. 1991). One proposed change is to expand patient vital signs to include an assessment of tobacco use (Fiore 1991). This simple institutional change has been shown to increase markedly the proportion of patients who re- port that their health care providers asked and coun- seled them about smoking cessation (Fiore et al. 1995; Robinson et al. 1995). Finally, institutional changes are critical for prompting more clinicians to play a role in smoking cessation. Currently, clinicians are only sporadically reimbursed for clinical and pharmacologic treatments to help patients quit smoking (Group Health Associa- tion of America, Inc. 1993; Schauffler and Parkinson 1993). Appropriate reimbursement may be essential to ensuring greater clinical attention to tobacco addic- tion (Schauffler and Parkinson 1993; Fiore and Baker 1995; Kaplan et al. 1995). The Public Health Service-sponsored Clinical Practice Guideline Treating Tobacco Use and Dependence has recommended that health care professionals use the “five A’s” to help their patients quit smoking: (1) ask about smoking, (2) advise all smokers to quit, (3) address willingness to make a quit attempt, Reducing Tobacco Use (4) assist patients who want to quit, and (5) arrange follow-up visits (Manley et al. 1991; Glynn and Manley 1993; Orleans et al. 1993; Houston et al. 1994; Fiore et al. 2000). These recommendations, based on a comprehensive review of the empirical literature, constitute a proscriptive algorithm for clinical inter- ventions (see the text box). Additional follow-up visits, at increasing inter- vals, with patients who continue not to smoke have been associated with greater long-term abstinence (Kottke et al. 1988; Wilson et al. 1988; Orleans et al. 1991). Patients who have relapsed should be helped to quit again at follow-up visits and subsequent visits. The Five A’s T° help their patients quit smoking, clinicians can use the “five A’s” approach: (1) ask patients about smoking, (2) advise all smokers to quit, (3) as- sess willingness to make a quit attempt, (4) assist those who want to quit, and (5) arrange follow-up visits with those trying to quit (Glynn and Manley 1993). These brief clinician interventions, which are described in this text box, can be completed within two to three minutes at each visit and have been associated with a cessation prevalence of 5 percent (Glynn 1988) to 8 percent (Kottke et al. 1988). All patients seen in a primary care setting should be routinely asked about their smoking sta- tus. One means of institutionalizing the identifica- tion of smokers is to expand the vital signs to include smoking status (Fiore 1991). Another means is to use stickers or other markers to clearly identify | charts and prompt clinicians to help their patients | who smoke quit (Cohen et al. 1989b; Ockene et al. 1991). | All patients who smoke should be advised to | quit. This advice should be clearly stated and per- _ sonalized. After giving this advice, clinicians should assess whether smokers desire to quit at the present time. Clinicians should provide motivational ma- terials and messages to those not willing to quit. These patients should be asked about smoking and advised to quit at all subsequent visits. Clinicians should assist patients who want to quit. The clinician should work together with the patient to set a date to quit (preferably within two weeks of the clinic visit) and should provide the patient with practical advice about how to quit and self-help materials. Clinicians should determine whether the pa- tient is likely to require adjunctive help and whether the patient is a candidate for pharmacotherapy. Pharmacotherapy should be considered for all pa- tients motivated to make a quit attempt, except in the presence of specific contraindications (Fiore et al. 2000). The choice may take into account previ- ous patient experience, preferences, and other fac- tors (see “Pharmacologic Interventions,” later in this chapter). Clinicians should also present other treat- ment options to their patients who want to quit. In particular, patients should be made aware of com- munity cessation resources (such as those offered by the American Cancer Society and the American Lung Association) and of intensive clinical inter- ventions (see “Intensive Clinical Interventions,” later in this chapter) available in the community. The primary care clinician, however, should con- tinue to monitor and assist those patients who elect to undergo intensive treatments. Clinicians should arrange for a follow-up visit to discuss smoking cessation within two weeks of the chosen date to quit. Researchers have docu- mented that scheduling follow-up visits or making follow-up telephone calls improves cessation suc- cess (Kottke et al. 1988; Wilson et al. 1988; Ockene et al. 1991, 1992; Orleans et al. 1991). Follow-up visits should be arranged whether the patient has been referred to another clinic or treated by the pri- mary care clinician. Management of Nicotine Addiction 103 Surgeon General's Report Modifications in treatment, including a discussion of more intensive efforts, should be considered for relaps- ing patients at each iteration. An area of current active research in minimal in- terventions is the use of computer-tailored messages for individual smokers who want to quit. Computer software that approximates deductive or inductive human reasoning has been proposed as an efficient and cost-effective mechanism for this modality (Velicer et al. 1993). In a large trial of one such system, interac- tive computer reports plus individualized manuals produced higher current abstinence (20 percent) and prolonged abstinence (11 percent) than did standard manuals, individualized manuals alone, or personal- ized counselor calls (Prochaska et al. 1993). Similarly, analyses of two separate controlled trials found that computer-tailored letters generated significantly greater cessation proportions in groups receiving them than in control groups (Strecher et al. 1994). Although these mechanisms have not been extensively evaluated, they are a promising avenue for further investigation. Efficacy Kottke and colleagues (1988) performed a meta- analysis of 39 smoking cessation trials conducted in medical practice settings. Most of these trials involved relatively minimal interventions, but some more in- tensive treatments were included. Participants had a mean of 4.8 (standard deviation = +4.4) contacts with these clinic-based programs. The major conclusion of this analysis was that success increased with the num- ber of intervention modalities employed, the number of health care professionals involved in the effort, and the number of follow-up assessments. Duration of follow-up (as opposed to number of follow-ups) was not predictive of success. Using diverse techniques may be a key characteristic of successful clinic-based smoking cessation programs (Fiore et al. 2000). A suc- cessful program might be one in which face-to-face counseling or advice is given; dates for quitting are set; pamphlets are distributed; reminders by telephone are made; smokers are advised and counseled on quit- ting by physicians, nurses, and other health profes- sionals; and multiple clinic visits or telephone calls are made after the smoker’s quitting day. In the meta- analysis by Kottke and colleagues (1988), cessation assistance delivered by nonphysicians tended to be slightly more effective than that performed by physi- cians, but a more recent meta-analysis (Fiore et al. 2000) found no difference in effectiveness between physi- cians and nonphysicians. Both individual and group counseling was effective (Fiore et al. 2000). 104 Chapter 4 The meta-analysis by Kottke and colleagues (1988) also suggested, however, that complex interventions are not necessary for clinic-based success. Compared with smokers who received no assistance, smokers who received help consisting of advice only or brief coun- seling had a 13.1-percentage point increase in cessation 6 months after treatment and a 3.8-percentage point in- crease after 12 months. Comparable estimates for smokers whose only treatment was to receive written self-help materials from health care professionals were 1.6 percent at 6 months and 2.0 percent at 12 months. The impact of brief intervention is illustrated in one study by Russell and colleagues (1979), who found that providing advice in a primary care setting produced a biochemically confirmed increase in abstinence of 3.3 percentage points; when smokers were told they would be followed up and when self-help materials were distributed in conjunction with the advice, the resulting one-year increase in abstinence was 5.1 percentage points. Trials postdating the meta-analysis of Kottke and colleagues (1988) have also indicated that brief clini- cal interventions have a small but reliable impact on smoking cessation success (Cummings et al. 1989a; Risser and Belcher 1990; Taylor et al. 1990; Ockene et al. 1991, 1994; Weissfeld and Holloway 1991; Hollis et al. 1993; Strecher et al. 1994). A meta-analysis of seven studies found that physician advice to quit increases cessation by 30 percent (Fiore et al. 2000). The consis- tency of these findings over a considerable time span and in multiple settings lends credence to the useful- ness of minimal interventions. Smokeless tobacco use may be particularly ame- nable to minimal clinical interventions, especially in dental office settings. Oral lesions caused by smoke- less tobacco are quite common among users of these products (Ernster et al. 1990; Tomar et al. 1997) and provide the opportunity for the dentist to point out the direct adverse health effects of smokeless tobacco. Several trials have examined the efficacy of minimal clinical interventions in smokeless tobacco cessation. In a randomized trial conducted in a dental health maintenance office clinic to test a minimal clini- cal intervention, Stevens and colleagues (1995) re- ported significantly higher smokeless tobacco quit rates in the intervention group than in the usual-care group at both 3 months (32.2 vs. 21.3 percent) and 12 months (33.5 vs, 24.5 percent). In a randomized clini- cal trial conducted in private dental offices, Severson and colleagues (1998) also found that a minimal inter- vention significantly increased smokeless tobacco quit rates in the intervention group compared with rates in the usual-care group at 3 months (17.8 vs. 8.8 percent) and 12 months (10.2 vs. 3.3 percent). A mini- mal intervention trial for smokeless tobacco use among college athletes, which included dental examinations to demonstrate oral lesions, 15-20 minutes of counsel- ing by dental hygienists, and follow-up telephone calls, found that three-month biochemically assayed quit rates were 24 percent in the intervention group and 16 percent in the control group (Masouredis et al. 1997). Relevant Process Measures Although minimal clinical interventions provide smokers with some practical advice about quitting, their primary purpose is to increase smokers’ motivation to quit. Specific process measures—such as measures of this motivation—are seldom incorporated into minimal clinical interventions. The nonspecific measures some investigators use do not associate clinical success with changes (such as greater awareness of disease risk or enhanced belief in one’s ability to quit). Nonetheless, the available evidence suggests that minimal clinical interventions can enhance smokers’ desire and inten- tion to quit (Russell et al. 1979), decrease the number of cigarettes smoked per day (Folsom and Grimm 1987), and increase the number of attempts to quit smoking (Folsom and Grimm 1987; Cummings et al. 1989b; Strecher et al. 1991). In addition, patients have reported that physicians trained to perform more intensive in- terventions are more helpful than physicians without such training (Ockene et al. 1991). Summary Substantial evidence suggests that minimal clini- cal interventions (e.g., a health care provider’s repeated advice to quit) foster smoking cessation and that the more multifactorial or intensive interventions produce the best outcomes. These findings highlight the im- portance of cessation assistance by clinicians, who have a unique access to more than 70 percent of smokers each year. Moreover, minimal clinical interventions have been found to be effective in increasing smokers’ motivation to quit and are cost-effective (see “Cost- Effectiveness,” later in this chapter). However, re- search has not clarified fully the specific elements of minimal interventions that are most important to clini- cal success nor the specific types of changes they pro- duce in smokers that lead to abstinence. Reducing Tobacco Use Intensive Clinical Interventions Intensive clinical interventions (sometimes called “formal” or “organized” cessation treatments) are multisession counseling programs involving extensive contact between a health care provider and a smoker. The value of intensive interventions has been ques- tioned because they are more expensive and reach fewer smokers than self-help and minimal clinical in- terventions do (Chapman 1985). However, more in- tensive interventions continue to attract interest because they are more successful at helping people quit smoking (Schwartz 1987). Despite their comparatively high cost, they are cost-effective (Elixhauser 1990), and they may be especially well-suited for treating the most addicted smokers (Lichtenstein and Glasgow 1992; Orleans 1993). Intensive clinical interventions may be charac- terized by structure and content. Structural variables include providers’ credentials and training; individual, telephone, or group format; session length; total num- ber of sessions; and duration of follow-up. Relatively little research into intensive treatments has been de- signed to assess the effects of different structural vari- ables (Lichtenstein and Glasgow 1992). Increased patient contact results in better outcomes (Lando 1981; Decker and Evans 1989; Lichtenstein and Glasgow 1992; Fiore et al. 2000). In a meta-analysis of research on the nicotine patch (Fiore et al. 1994c), researchers found that the following counseling features were as- sociated with significant increases in six-month absti- nence rates: counseling being a main reason for clinician-patient contact, at least weekly clinician- patient meetings during the first 4 weeks of treatment, and more than six clinician-patient meetings in the first 12 weeks of treatment. A more recent meta-analysis that was not restricted to nicotine patch studies (Fiore et al. 2000) found that quitting success increased with increasing contact time (up to 90 minutes of total con- tact) and that there was a dose-response relationship between number of sessions and treatment efficacy (Fiore et al. 2000). Thirty to 90 minutes of total coun- seling and four or more sessions were two to three times more effective in producing long-term smoking cessation than no contact controls. This research sup- ports the notion that in general, as the intensity of clinician-patient counseling increases, so does the long- term effectiveness of treatment. Because so little information is available on how structural variables affect intensive treatment outcomes, this section concentrates on a review of con- tent variables. Content refers to the specific informa- tion, materials, and techniques to which smokers are Management of Nicotine Addiction 105 Surgeon General's Report exposed during the course of treatment. The various contents of intensive smoking cessation interventions are not easy to evaluate, partly because the method- ological quality of clinical trials tends to differ across content areas. For example, trials of relatively unor- thodox treatments, such as acupuncture and hypnosis, tend to use shorter follow-up periods than assessments of efforts involving pharmacologic and behavioral treat- ments (Schwartz 1987; Ter Riet et al. 1990); inflated effi- cacy estimates may thus result for unorthodox treatments. These methodological concerns are handled here by limiting the review primarily to studies report- ing outcomes with at least five months of follow-up. Another problem in evaluating the content of intensive interventions is that the evolution of treat- ments over the past 40 years prevents a cumulative assessment of specific intensive interventions. More- over, changing research interests and methodologies make it difficult to integrate findings from over the entire period. For instance, pharmacotherapies have changed greatly during this period and are now in- corporated routinely into intensive treatments. In ad- dition, treatment response may be affected by changes in the nature of the smoking population; for instance, compared with 40 years ago, a higher proportion of today’s smokers are women. Methodological and sta- tistical changes have also altered the nature of the stud- ies themselves: sample sizes are larger to increase statistical power, and biochemical confirmation of ab- stinence is now routine, as is the application of the “intent to treat” principle in analyses. Because of these refinements, early cessation research is now often ne- glected, perhaps because it is difficult to integrate with newer work. On the other hand, some apparently ef- fective methods, such as rapid smoking, have often not been evaluated by newer methods. The older lit- erature on such strategies is included selectively in this review. A related problem, complicating the interpreta- tion of relatively recent research, arises from what Lichtenstein and Glasgow (1992) have referred to as a shift from a “clinical” to a “public health” (p. 518) ori- entation among smoking cessation researchers. This shift has resulted in a dearth of theory-driven research into intensive interventions. In fact, one observer has suggested that the long-term research trajectory favors modifying established models over applying innova- tion in the basic approach to treatment (Shiffman 1993b). Recent emphasis on public health has also produced a research climate that favors the evaluation of treatment packages and minimal interventions over treatment components (Lichtenstein and Glasgow 1992). One reason for this shift is the high cost and 106 Chapter 4 large sample sizes required to evaluate individual com- ponents. Thus clinical trials rarely allow assessment of a given treatment’s independent contribution. Smoking cessation trials now tend to combine specific treatment components into multicomponent interven- tions. Moreover, within the same study, not only may groups receive different treatment packages but the packages may differ in their structural components. Finally, the question of selection bias remains a challenge to interpreting the literature on intensive interventions. Investigators typically recruit highly motivated volunteers to serve as subjects, because the efficacy of intensive interventions can be tested only if the patients under study actually receive the entire treatment. Efficacy estimates derived from this atypi- cal population may not be appropriate for making pre- dictions about the larger population of smokers. The principal types of intensive interventions must be evaluated in the context of these limitations stemming from the nature of the available evidence. Problem Solving/Skills Training Various strategies try to impart to smokers the knowledge and skills necessary to cope with cessation— that is, both to attain and to maintain abstinence when confronted with withdrawal symptoms or the temp- tation to smoke (Marlatt and Gordon 1985; Curry and McBride 1994). This approach (hereafter referred to as problem solving/skills training) springs from the observation that most relapse efforts seem to be asso- ciated with a finite number of factors, such as alcohol use, negative affect (e.g., depression), and the presence of others smoking (Shiffman 1982; Baer and Lichten- stein 1988; Brandon et al. 1990). Problem solving /skills training tries to help people who have recently quit smoking anticipate these “high-risk” situations and learn to cope with them when they arise. Such inter- ventions also train participants to cope with with- drawal symptoms, replace positive reinforcements they had linked to smoking, and meet other challenges that might be encountered during or after an attempt to quit smoking. General problem solving/skills training targets challenges that occur early in the quitting process (e.g., withdrawal discomfort). Because newly abstinent smokers often return to regular smoking (Curry and McBride 1994), one specialized type of intervention teaches skills to help the former smoker maintain ab- stinence (Marlatt and Gordon 1985). These interven- tions also train former smokers to prevent any relapse from becoming a long-term return to smoking. Former smokers are encouraged to view relapses as a normal part of the quitting process rather than as an indica- tion of failure (Curry et al. 1988). Another type of problem solving/skills training focuses on coping with the immediate negative affects of quitting smoking. The growing body of research on dysphoria (feeling unhappy or unwell) after smok- ing cessation (Glassman et al. 1988; Covey et al. 1990; Brandon 1994; Hall et al. 1994) suggests that strategies that help smokers who have just quit resist negative moods may be particularly successful (Shiffman 1993b). However, a recent meta-analysis (Fiore et al. 2000) did not find that interventions that targeted nega- tive affect improved cessation rates. These interven- tions were used with the general population as well as smokers with a history of depression. It is possible that the results might be more positive if the studies were restricted to high-risk populations. Efficacy Because nearly every state-of-the-art smoking cessation program contains elements of problem solv- ing/skills training (Curry and McBride 1994), the tech- nique is difficult to assess as an individual treatment. Some investigators have failed to uncover evidence that this technique increases cessation success relative to comparison groups (Curry et al. 1988; Emmons et al. 1988; Omenn et al. 1988; Minneker-Hiigel et al. 1992; Zelman et al. 1992). Other studies have found benefi- cial effects, but these benefits have often been modest and have come only through protracted treatment (Hall et al. 1984b; Davis and Glaros 1986; Goldstein et al. 1989; Stevens and Hollis 1989). Even in studies that report success in long-term abstinence through skills train- ing, the overall relapse curves for treatment subjects have paralleled those for comparison groups (Glasgow and Lichtenstein 1987; Goldstein et al. 1989; Stevens and Hollis 1989; Mermelstein et al. 1992; Minneker- Hiigel et al. 1992; Gruder et al. 1993). A recent meta- analysis (Fiore et al. 2000) of 104 studies, however, reported that problem solving /skills training increased quitting success by 50 percent. Some evidence sug- gests that problem solving/skills training may be par- ticularly useful for female smokers (Curry et al. 1988), those who smoke fewer cigarettes (Hall et al. 1984b), those who smoke to cope with emotional stress (O’Connor and Stravynski 1982), and those who are less prone to negative affect (Zelman et al. 1992). Although multicomponent skills-training programs have sometimes included information about managing the dysphoria associated with smoking ces- sation (Tiffany et al. 1986; Kristeller et al. 1993), relevant behavioral interventions have only recently Reducing Tobacco Use begun (Hall et al. 1994). Initial results suggest that such strategies are promising, but these findings re- quire replication and extension. In sum, the evidence on problem solving /skills training suggests a beneficial impact (Fiore et al. 2000). Such training can offer practical strategies about quit- ting and inculcate desired coping skills. Relevant Process Measures Skills training rests heavily on two assumptions: (1) coping skills will help former smokers remain ab- stinent in the face of temptation, and (2) smokers can be taught these skills. Some cross-sectional research (Shiffman 1984) and skills-training intervention trials (Hall et al. 1984b; Davis and Glaros 1986; Zelman et al. 1992) have suggested that coping strategies help avert relapse. The available evidence also indicates that patients given skills training acquire coping skills (Hall et al. 1984b:; Davis and Glaros 1986; Zelman et al. 1992), and there is evidence that the level of skill acquisition predicts long-term abstinence (Zelman et al. 1992). Although the results of one trial suggest that coping skills are not retained for very long (Davis and Glaros 1986), consistent self-monitoring of smoking during treatment is associated with longer-term maintenance (Kamarck and Lichtenstein 1988); this finding suggests the importance of behavioral characteristics that fos- ter maintenance. One of the goals of skills training is to encourage relapsed former smokers to renew their efforts to quit smoking. Curry and colleagues (1988) found evidence that smokers who had received skills training were more likely to try quitting again if they relapsed. Rapid Smoking Rapid-smoking strategies typically require that smokers inhale deeply from a cigarette about every six seconds until they become nauseated. In theory, this aversive conditioning transforms the subject's perception of smoking from a pleasurable activity into an unpleasant one, thereby making it easier for smok- ers to give up cigarettes. Medical complications produced by rapid smok- ing can include elevations in heart rate, blood pres- sure, and carboxyhemoglobin blood levels as well as electrocardiogram abnormalities (Horan et al. 1977). Because of these potential problems, candidates for rapid smoking should be selected carefully (Lichtenstein and Glasgow 1977). Older persons and persons with cardiovascular or pulmonary conditions are generally excluded from rapid-smoking strategies, Management of Nicotine Addiction — 107 Surgeon General's Report but some evidence suggests that rapid smoking can be conducted with these persons if appropriate pre- cautions are taken (Hall et al. 1984a). Efficacy The 1988 Surgeon General’s report on smoking and health (USDHHS 1988) reviewed the literature on rapid smoking and reached two conclusions: (1) al- though its effectiveness is variable when used alone, rapid smoking yields moderately high long-term ab- stinence success (40 percent of subjects were abstinent 6-12 months after treatment) when incorporated in multicomponent behavioral interventions, and (2) aux- iliary treatment factors, such as patient expectations, patient-therapist rapport, and admonitions not to smoke between sessions, can influence how success- ful rapid-smoking strategies are. Few rapid-smoking trials have appeared since the 1988 report. The mid-1980s advent of pharmacologic treat- ments for smoking cessation greatly reduced research interest in rapid smoking. Pharmacologic aids, such as nicotine gum, appear as efficacious as rapid smoking (Zelman et al. 1992) and are probably more acceptable to smokers and program administrators. Nonetheless, the doubling of long-term success associated with rapid smoking (Fiore et al. 2000) suggests that it may remain an option for smokers who are unable to quit through other methods and for whom such aversive condition- ing is acceptable. Relevant Process Measures Rapid smoking is intended to produce aversive conditioned responses to stimuli associated with smok- ing (USDHHS 1988). The technique reliably produces tachycardiac responses to cigarettes, and the magnitude of these responses is directly related to treatment out- come (Tiffany et al. 1986; Zelman et al. 1992). More eas- ily observable variables, such as the number of cigarettes smoked during a rapid-smoking session or the degree of nausea reported by patients, have not been shown to be consistently related to outcome (USDHHS 1988). Other Aversive-Smoking Strategies Three other techniques intended to produce aver- sion to cigarettes have been investigated: satiation therapy, rapid puffing, and focused smoking. Con- cern over the safety of rapid smoking (Horan et al. 1977) was partly responsible for investigation of these alternative aversion techniques. Some evidence sug- gests that they are less unpleasant and less risky than rapid smoking (Glasgow et al. 1981; Tiffany et al. 1986). 108 Chapter 4 Satiation therapy requires that patients smoke many more cigarettes per day than they normally do, usu- ally about twice as many (Best et al. 1978). Rapid puff- ing is similar to rapid smoking, but patients are instructed not to inhale cigarette smoke (Tiffany et al. 1986). Focused smoking requires patients to smoke for an extended period of time at a normal rate while concentrating on the negative sensations smoking pro- duces (Lowe et al. 1980). Efficacy Satiation therapy alone produces relatively little cessation success (15 percent at one year) (Lando 1982), but the technique may be more effective when incor- porated into multicomponent programs (USDHHS 1988). Focused smoking and rapid puffing produce long-term abstinence rates that are equivalent to, or slightly lower than, those produced by rapid smoking (USDHHS 1988; Fiuce et al. 2000). Because these tech- niques do not appear to result in significant tachycar- diac responses (USDHHS 1988), their efficacy is probably accounted for by mechanisms other than aversive conditioning. Cue Exposure Cue exposure therapy is based on the premise that smokers become conditioned to certain cues or contextual signals correlated with smoking behavior. When persons who have recently quit smoking are exposed to these cues, they are motivated to begin smoking again (Rohsenow et al. 1990-91; Brandon et al. 1995). In cue exposure therapy, persons trying to quit smoking are repeatedly exposed to these signals in a therapeutic context in which smoking is prohib- ited; the resulting reduced association between smok- ing and previous cues is hypothesized to reduce some of the temptation for relapse that former smokers will face in the natural environment. Because cue exposure therapy has produced promising results with other addictive disorders (Monti et al. 1993), several researchers have suggested that such strategies be developed for smoking cessation (Hodgson 1989; Heather and Bradley 1990). These strategies may be particularly important for women, whose responsiveness to nicotine replacement therapy appears to be less than that of men (Perkins 1996). Women may be less controlled by nicotine and more influenced by nonnicotine factors (sensory stimuli, en- vironmental factors) (Perkins et al. 1999) and may there- fore respond better than men to behavioral approaches. Efficacy Studies conducted to date that have evaluated cue exposure have failed to find significant differences in outcome between cue exposure and comparison interventions (Lowe et al. 1980; Raw and Russell 1980; G6testam and Melin 1983; Corty and McFall 1984). However, clinical research on cue exposure for smok- ing cessation is sparse, and interpretation of most ex- isting trials is hampered by methodological flaws (Brandon et al. 1995). Relevant Process Measures Environmental associations with cigarette smok- ing can be strong enough to provoke the desire to smoke (Herman 1974; Rickard-Figueroa and Zeichner 1985; Tiffany and Hakenewerth 1991). These provoked responses may affect treatment outcome (Niaura et al. 1989). However, because cue reactivity has not been assessed in existing clinical trials of cue exposure therapy, it is impossible to determine whether such interventions extinguish motivational responses to smoking-related cues. Nicotine Fading Nicotine fading is based on the assumption that withdrawal symptoms will be lessened through a gradual reduction of nicotine intake (Foxx and Brown 1979; McGovern and Lando 1991). Nicotine fading can be accomplished either by progressively switching to brands of cigarettes yielding less nicotine or by using a series of graduated filters (McGovern and Lando 1991). Once the lowest nicotine level is reached, ces- sation is attempted. Nicotine fading should be distin- guished from cigarette fading, in which the number of cigarettes smoked per day is gradually reduced. Cigarette fading has generally not been shown to be an effective smoking cessation technique; participants generally reach a level beyond which they find it diffi- cult to reduce cigarette consumption (Lando 1993; Fiore et al. 2000). Efficacy Foxx and Brown (1979) reported that 4 of 10 sub- jects who tried nicotine fading had quit smoking at 18 months, but subsequent investigations have found more modest long-term results (usually around 20 percent) (Beaver et al. 1981; Lando and McGovern 1985; Burling et al. 1989). Some evidence suggests that nico- tine fading can increase abstinence success indepen- dently within a larger smoking cessation program Reducing Tobacco Use (Burling et al. 1989). In a community setting where participants were allowed to select their treatment, about 25-30 percent of those who chose multicompo- nent interventions containing nicotine fading achieved long-term abstinence (Lando et al. 1990; Lando 1993). Brand switching and graduated filters have produced equivalent outcomes (McGovern and Lando 1991). Cinciripini and colleagues (1995) found that 44 per- cent of persons using a combined nicotine fading and skills-training package were abstinent from nicotine at one year, a proportion significantly higher than that produced by matched conditions. Relevant Process Measures Nicotine fading is presumed to exert its effects by gradually weaning smokers from nicotine, thereby reducing withdrawal symptoms. Reductions in nico- tine intake and withdrawal indexes are thus the pro- cess measures of primary importance to nicotine fading. One early study suggests that nicotine fading reduces the severity of withdrawal symptoms (West et al. 1984a,b). The process measure of reduced nicotine intake is problematic, because smokers’ nicotine consump- tion seldom matches a given brand’s machine-rated nicotine yields (McMorrow and Foxx 1983). Smokers are able to compensate for reduced nicotine yield by adjusting how they smoke—by inhaling more strongly, holding smoke in longer before exhaling, inhaling more frequently, or smoking the cigarette closer to its high-yield butt (Benowitz et al. 1983; Kozlowski et al. 1988). Smokers can also compensate for nicotine fad- ing by blocking the air inlet holes on the filters that are used to decrease nicotine intake (McGovern and Lando 1991). The best available evidence indicates that although nicotine consumption is indeed reduced by nicotine fading, the extent of these reductions is smaller than would be expected (i.e., based on machine rat- ings); apparently, some compensatory smoking occurs (Lando 1993). For example, one study (McGovern and Lando 1991) compared two nicotine fading regimens, brand switching and graduated filter use, each of which was designed to reduce nicotine intake by 80 percent by the final stage. Each regimen significantly reduced nicotine consumption but by far less than 80 percent: brand switching reduced intake by 42.5 per- cent and graduated filters by 55.2 percent. Lando and McGovern (1985) suggested that nico- tine fading increases smokers’ self-efficacy by provid- ing them with a series of concrete steps that are mastered before cessation. Self-efficacy does increase during the fading process (McGovern and Lando 1991), Management of Nicotine Addiction — 109 Surgeon General’s Report although no more than with comparison treatments (Burling et al. 1989). Moreover, increased self-efficacy has not been shown to predict treatment outcome for nicotine fading (McGovern and Lando 1991). Motivational Rewards Strategies that use motivational rewards are rooted in operant conditioning theory. These efforts are designed to provide reasons for remaining absti- nent to smokers who have just quit—reasons more tan- gible and immediate than the important but delayed outcomes that typically motivate cessation attempts (e.g., improvements in health). In a typical motiva- tional rewards intervention, the provider collects a deposit from each participant at the outset of treatment and refunds a portion of this sum at each follow-up assessment at which the participant demonstrates ab- stinence (Paxton 1983). Other variations of this tech- nique have used nonmonetary rewards (Lando 1982), punished smokers for every cigarette smoked (Murray and Hobbs 1981), instructed participants to reward themselves for abstinence (Tiffany et al. 1986), and rewarded participants who had reduced their carbon monoxide levels (Stitzer and Bigelow 1985). Curry and colleagues (1991) used a theoretical framework that tested intrinsic motivation (personalized feedback) against extrinsic motivation (financial incentive). Ab- stinence at 3 and 12 months was two times higher in the intrinsically motivated groups. Efficacy When used alone, motivational rewards foster relatively high abstinence success in the short term, but these gains do not appear to be durable (Antonuccio et al. 1992). Participants often return to smoking after the term of the contract expires (Paxton 1980, 1981). At- tempts to prolong abstinence by varying factors such as duration and frequency of reward have generally been unsuccessful (Paxton 1981, 1983). Multicompo-. nent treatments using motivational rewards have some- times fared better than comparison treatments, but these comparisons are generally confounded by other factors (Jason et al. 1990; Lando-et al. 1990) and may lead to type Il errors. A meta-analysis of 62 studies comparing components of behavioral controls found that motiva- tional rewards (contingency contracting) did not sig- nificantly alter long-term cessation rates (Fiore et al. 2000). In the final results of the Minnesota Heart Health Program, the failure of community education methods (which included motivational rewards for smoking cessation) to produce results that exceeded 110 = Chapter 4 secular trends is an important demonstration of the difficulties in evaluating such modalities (Lando et al. 1995), Relevant Process Measures The process measures most relevant to this strat- egy are presumably motivational; making rewards contingent on abstinence should increase a smoker’s resolution to remain abstinent. However, motivational measures have been neglected in research on this intervention. Many programs require participants to administer their own rewards or punishments. Evalu- ations of these strategies should routinely assess how well participants take on this responsibility; to date, evaluations have not made this assessment. Social Support Social support interventions try to ease the smok- ing cessation process by enlisting the support of sig- nificant persons in smokers’ lives (extratreatment social support) and by providing support from clini- cians (intratreatment social support). Both strategies may range from intense and pervasive to relatively minimal and limited. Intensive extratreatment social support may train participants to elicit aid and sup- port of family and friends, whereas training clinicians to communicate caring, concern, and encouragement increases intratreatment social support. Increasing the cohesiveness of smoking cessation groups can enhance both forms of social support (Hajek et al. 1985; Lando and McGovern 1991). At the basic level, the simple use of a group rather than an individual format can be viewed as a social support intervention. Efficacy __ Strategies that add social support to pharmaco- logic treatment appear to significantly increase long- term quit rates compared to treatments without social -’ support, although some intensive interventions have reported mixed results (Glasgow et al. 1986; McIntyre- Kingsolver et al. 1986). A recent meta-analysis of 19 studies (Fiore et al. 2000) reported that interventions to increase social support in the smoker’s environment increase long-term cessation by 50 percent. A meta- analysis of 50 studies (Fiore et al. 2000) reported that within-treatment social support increased cessation by 30 percent. The importance of intratreatment social support may well be reflected in the finding that indi- vidual and group counseling are both much more ef- fective than no contact interventions (Kottke et al. 1988; Fiore et al. 1996). Relevant Process Measures Studies of intensive social support interventions have regularly included measures of smokers’ per- ceived support. These investigations have found that the amount of support a smoker perceives is directly related to outcome (Malott et al. 1984; Glasgow et al. 1986; MciIntyre-Kingsolver et al. 1986; Gruder et al. 1993), but the trials have typically failed to find evi- dence that the support itself has increased this per- ception (Maloitt et al. 1984; Glasgow et al. 1986). In one study that found social support intervention to be effective, the strategy was itself associated with an in- crease in received support (Gruder et al. 1993). More- over, this increase in support was statistically related to the differential outcome. Because support measures have rarely been incorporated into the evaluation of group treatments for smoking cessation, little is known about whether group formats enhance perceived sup- port and about what influence such support has on treatment outcome (Hajek et al. 1985). Weight Control Most people who quit smoking gain weight (Klesges et al. 1989), and this effect may be greater for women than for men (Williamson et al. 1991; Fant 1996). This effect has been hypothesized to result from nicotine’s ability to modify various mechanisms in the central nervous system that regulate body weight (Schwid et al. 1992; Perkins 1993). Apprehension about weight gain may serve as a barrier to cessation at- tempts, especially among young women (Gritz et al. 1989). Cessation strategies that address this barrier have only recently begun to be assessed. Efficacy Two important trials have examined the contri- bution of a weight control component to a multicom- ponent smoking cessation program. One study (Hall et al. 1992) compared a specialized weight control pro- gram with both a nonspecific weight control program and a standard program. Patients in the specialized group learned behavioral self-management, reduced their caloric intake under the direction of a dietitian, and received an individualized activity plan from an exercise counselor. Patients in the nonspecific group attended several group sessions devoted to discuss- ing weight-related issues. Results showed that par- ticipants in both of these weight control programs were less likely to be abstinent after one year (21 percent success for both groups combined) than participants treated with the standard protocol (35 percent success). Reducing Tobacco Use Another study (Pirie et al. 1992) examined the ef- fects of adding nicotine gum, weight control counsel- ing, both, or neither to a standardized smoking cessation program in a sample of women who had indicated that they were concerned about postcessation weight gain. After 12 months, the group that added nicotine gum to the standard program had much greater success (44.4 percent had quit smoking) than the groups that added weight control counseling to the standard package (27.8 percent success for the group that added weight con- trol only and 27.6 percent success for the group that added both weight control and nicotine gum). How- ever, the standard package alone was the least success- ful program (19.4 percent had quit smoking) and was viewed by participants as less appealing than the weight control component (Pirie et al. 1992). A meta-analysis of six studies (Fiore et al. 2000) that looked at the effect of dieting and physical activ- ity on smoking cessation did not find that these inter- ventions increased cessation success. A recent single study (Marcus et al. 1999) found that vigorous physi- cal activity increased quit rates. Relevant Process Measures Weight gain has not been a consistent predictor of smoking relapse (Gritz et al. 1989), and it has pre- dicted abstinence as well (Hall et al. 1986; Gritz et al. 1989; Hughes et al. 1991b). Nonetheless, actual con- trol of weight is an important process measure for weight control interventions—the primary purpose of which is relapse prevention—because they explicitly assume that preventing weight gain will boost absti- nence rates (Hall et al. 1992; Pirie et al. 1992). Neither published trial of weight control interventions found differences in weight gain among abstinent subjects across treatment conditions (Hall et al. 1992; Pirie et al. 1992). One of the studies (Hall et al. 1992) found evidence for lower caloric intake in specialized weight control interventions, especially among women, but failed to find differences in activity levels across treat- ment conditions. In sum, despite the intuitive appeal of weight control interventions to promote smoking cessation, there is mixed evidence relating such inter- ventions to cessation success (Fiore et al. 2000). Hall and colleagues (1992) suggested that such interventions may interfere with cessation. However, Marcus and colleagues (1999) found that a vigorous exercise inter- vention increased quit rates while contributing to weight management. Pharmacotherapies, including bupropion sustained release (SR) and nicotine gum, may help to delay weight gain after cessation (Emont and Cummings 1987; Doherty et al. 1996; Jorenby et al. 1999). Management of Nicotine Addiction 111 surgcon General's Report Hypnosis Some smokers try hypnosis therapy to help them quit (Schwartz 1987). Strategies for hypnosis interven- tions include direct hypnotic suggestions to quit, sug- gestions intended to produce aversion to smoking, and training in self-hypnosis to reinforce formal treatment (Simon and Salzberg 1982). Efficacy The methodological shortcomings of hypnosis research make it difficult to estimate the value of this therapy for smoking cessation (Schwartz 1987). Re- viewers have noted that, in general, hypnosis is not very effective when used alone, but it may be useful as part of a multicomponent intervention in which subjects see a therapist many times (Holroyd 1980; Schwartz 1987). In methodologically sound studies, hypnosis often fails to outperform comparison tech- niques, such as self-help strategies (Rabkin et al. 1984; Lambe et al. 1986). Hypnosis techniques may work best for the relatively small proportion of people highly susceptible to hypnosis (Barabasz et al. 1986; USDHHS 1988). Since the late 1980s, there have been only two trials of hypnosis in smoking cessation, with incon- clusive results. Johnson and Karkut (1994) conducted an uncontrolled clinical trial of hypnosis plus aversion treatment and reported about 90 percent abstinence at three months. A similar uncontrolled study of 226 smokers reported a 23-percent abstinence at two years (Spiegel et al. 1993). A recent review of hypnosis by the Cochrane group (Abbot et al. 2000) found insuffi- cient evidence to support hypnosis as a treatment for smoking cessation. Relevant Process Measures Appropriate process measures for studies of hypnosis are those that assess the various means of hyp- notic induction and the motivational changes that are presumed to accrue from them. Because measures have rarely been collected, little is known about the mecha- nisms of hypnotic treatments for smoking cessation (Holroyd 1980; Schwartz 1987; USDHHS 1988). Acupuncture The typical acupuncture treatment for smoking cessation involves the insertion of needles or staples into the outer ear, but a number of other techniques have been investigated (Schwartz 1988). The most commonly cited rationale for using acupuncture is that it relieves the discomfort of nicotine withdrawal. 1712.) Chapter 4 Efficacy The available evidence suggests that acupunc- ture is no more effective in smoking cessation than placebo treatments (Schwartz 1987). For example, Schwartz (1988) reviewed eight studies in which acu- puncture at a theoretically appropriate site was con- trasted with acupuncture at a placebo site. Only one of these studies found greater success among partici- pants undergoing the procedure with theoretically appropriate sites (MacHovec and Man 1978). A recent meta-analysis of five studies (Fiore et al. 2000) found that acupuncture was no more effective than placebo. Relevant Process Measures Acupuncture is commonly presumed to exert its effects by easing tobacco withdrawal. At present there is no evidence that acupuncture is capable of relieving withdrawal symptoms associated with smoking cessa- tion (Clavel et al. 1987; Schwartz 1987; USDHHS 1988). Summary of Intensive Clinical Interventions Intensive programs serve an important function in the nation’s efforts to reduce smoking, despite the resources the programs demand and the relatively small population of smokers who use them. Such pro- grams may be particularly useful in treating smokers who find it most difficult to quit. Because intensive smoking cessation programs differ in structure and content, evaluation is often ham- pered by variation in methodology and by a lack of research addressing specific treatment techniques. Because few studies have chosen to isolate single treat- ments, assessment of the effectiveness of specific ap- proaches is difficult. Nonetheless, skills training, rapid smoking, and both intratreatment and extratreatment social support have been associated with successful smoking cessation. When such treatments are shown to be effective, they are usually part of a multifactorial intervention. Little clear evidence has implicated par- ticular psychological, behavioral, or cognitive mecha- nisms as the agents of change. The specific impact of intensive interventions may be masked by the efficacy of several multicomponent programs, some of which have achieved cessation proportions of 30-50 percent (Lando 1993). Thus, in their positive effect on smoking cessa- tion and long-term abstinence rates (Kottke et al. 1988; Fiore et al. 1994a), intensive interventions seem little different from other forms of counseling or psy- chotherapy. With intensive interventions, as with counseling, it is difficult to attribute the efficacy to specific characteristics of the interventions or to spe- cific change mechanisms (Luborsky et al. 1975; Elkin et al. 1989). Pharmacologic Interventions At first look, nicotine replacement therapy ap- pears to be the treatment of a disease with its cause. The rationale, however, is well established. Observa- tions on the beneficial effects of nicotine replacement in abstinent smokers were first made in 1967 (Lucchesi et al. 1967), and the process has its medical precedent in the use of methadone for opiate dependence. Nico- tine use, in the form of 10 or more cigarettes a day, provides continuous neuroexposure (Benowitz 1993). The resulting tolerance and physical dependence pro- duce classic withdrawal symptoms (USDHHS 1988). As Benowitz (1993) has summarized, “Nicotine re- placement therapy serves primarily to break the daily addiction cycle by relieving withdrawal symptoms, thereby facilitating behavioural modification that is necessary for permanent smoking cessation” (p. 158). However, as will be discussed later in this chapter, re- cent data suggest that nicotine replacement may be effective without behavioral support or counseling. A number of candidate delivery systems have now been extensively evaluated with clear and consistent results. In addition, nonnicotine pharmacotherapies for treat- ment of tobacco use are now available. Nicotine Polacrilex Nicotine polacrilex (nicotine gum) was approved by the Food and Drug Administration (FDA) for use as an aid to smoking cessation in a 2-mg dose in 1984 and ina 4-mg dose in 1994. The nicotine in the gum is bound to an ion-exchange resin. Chewing the gum liberates the nicotine, which is absorbed through the buccal mucosa. Currently, both doses of nicotine polacrilex are approved for use as over-the-counter preparations by adults. The package insert instructs patients to use the gum as needed with the constraint that they not exceed a daily dose of 20 pieces of 4-mg gum or 30 pieces of 2-mg gum. Efficacy With more than 50 studies on its efficacy, nico- tine gum is the most extensively investigated pharma- cologic treatment for smoking cessation. This body of research has been summarized by several major meta-analyses (Lam et al. 1987; Cepeda-Benito 1993; Silagy et al. 1994; Tang et al. 1994). The most recent Reducing Tobacco Use meta-analysis (Fiore et al. 2000) is summarized in Table 4.3. All meta-analyses found the gum to be effective in helping smokers quit. Lam and colleagues (1987) performed a meta- analysis of nine randomized, controlled trials of the 2-mg nicotine gum. These authors performed sepa- rate analyses on the trials conducted in specialized smoking cessation clinics and on those conducted in general medical settings. In the specialized clinics, ces- sation success was greater with nicotine gum than with placebo gum. In general medical practice settings, however, nicotine gum was no more successful than placebo gum; both types of gum were more successful than usual care. The authors suggested that partici- pants at the specialized cessation clinics had greater success because such participants may have been more motivated to quit and may have received more inten- sive adjuvant behavioral support than those at the generalized settings. The authors also speculated that patients who seek treatment in specialized clinics may be more physically dependent on nicotine and thus more likely to benefit from nicotine replacement than the average patient seen in a general medical clinic. Cepeda-Benito (1993) performed a meta-analysis of 33 trials of the 2-mg gum. As in the review by Lam and colleagues (1987), the trials were categorized ac- cording to whether the adjuvant behavioral support was intensive or brief and according to whether the control group used placebo gum or no gum. Pooled estimates of efficacy were derived for short-term (0-8 weeks after treatment) and long-term (12 + 2 months) outcome measures within each category. Effect sizes were not systematically related to the type of control treatment used but were related to the intensity of be- havioral support provided. When used in intensive interventions, the gum was associated with greater abstinence success than the control treatments at both long-term and short-term follow-up. When used in brief behavioral interventions, however, the gum out- performed the control interventions only at short-term follow-up. The author concluded that nicotine gum is an effective aid to smoking cessation but questioned its long-term value in the absence of adjuvant psycho- social support. In the context of a larger review of available nico- tine replacement therapies, Tang and colleagues (1994) performed a meta-analysis of 28 randomized, controlled trials of the 2-mg gum and 6 randomized, controlled trials of the 4-mg gum. The authors found that among participants recruited through advertise- ments to attend specialized cessation clinics, the 2-mg gum was associated with an 11-percent increase in success over control treatments. However, among Management of Nicotine Addiction 113 Surgeon General's Report smokers who were directly invited to participate ina general smoking cessation trial conducted by a non- specialist physician, the 2-mg gum increased absti- nence success by only 3 percentage points over control conditions. Consistent with the analysis by Lam and colleagues (1987), the authors suggested that these findings reflect (1) the greater motivation of the smok- ers who referred themselves (i.e., responded to adver- tisements instead of being directly invited), (2) the greater degree of nicotine dependence in the self- referred group, and (3) the more extensive encourage- ment and more detailed instructions provided by therapists in the specialized settings in which the self- referred smokers were treated. Six of the 28 trials of the 2-mg gum (Fagerstrom 1982, 1984; Jarvik and Schneider 1984; Areechon and Punnotock 1988; Hughes et al. 1989b; Jensen et al. 1990) reported abstinence success as a function of nicotine dependence as assessed by the Fagerstrom Tolerance Questionnaire (described later in this chap- ter), The authors aggregated these data and found that the 2-mg gum improved cessation success by 16 percentage points among smokers scoring high (indicating considerable nicotine dependence) on the Table 4.3. Meta-analyses of efficacy (estimated odds ratio and abstinence rates) for seven pharmacotherapies used in tobacco dependence treatment Estimated Estimated Number of odds ratio abstinence rate Pharmacotherapy study groups (95% CI*) (95% CI) Bupropion SR' (n = 2°) Placebo 2 1.0 17.3 Bupropion SR 4 2.1 (1.5, 3.0) 30.5 (23.2, 37.8) Nicotine gum, 2 mg (n = 13) Placebo 16 1.0 17.1 Nicotine gum 18 1.5 (1.3, 1.8) 23.7 (20.6, 26.7) Nicotine inhaler (n = 4) Placebo 4 1.0 10.5 Nicotine inhaler 4 2.5 (1.7, 3.6) 22.8 (16.4, 29.2) Nicotine nasal spray (n = 3) Placebo 3 1.0 13.9 Nicotine spray 3 2.7 (1.8, 4.1) 30.5 (21.8, 39.2) Transdermal nicotine (the nicotine patch) (n = 27) Placebo 28 1.0 10.0 Transdermal nicotine 32 1.9 (1.7, 2.2) 17.7 (16.0, 19.5) Clonidine (n = 5) Placebo 6 1.0 13.9 Clonidine 8 2.1 (1.4, 3.2) 25.6 (17.7, 33.6) Nortriptyline (n = 2) Placebo 3 1.0 11.7 Nortriptyline 3 3.2 (1.8, 5.7) 30.1 (18.1, 41.6) *Confidence interval. *SR = sustained release. ‘Number of studies. Source: Fiore et al. 2000. 114 Chapter 4 questionnaire but produced only a 2-percentage point increase among smokers whose scores indicated low levels of nicotine dependence. When data from the 4-mg gum trials (Puska et al. 1979; Kornitzer et al. 1987; Tonnesen et al. 1988a,b; Blondal 1989; Hughes et al. 1990a) were aggregated, the influence of nicotine dependence paralleled that seen in trials using the lower dose. Among smokers highly dependent on nicotine, those who used the 4-mg gum had a 21-percent greater success at cessa- tion than those using the 2-mg gum. In contrast, among smokers low in nicotine dependence, those who used the 4-mg gum had an 18-percent lower success than those using the 2-mg gum. Highly dependent participants using the 4-mg gum had a 35-percent greater success than those using the placebo gum, but this comparative improvement was only 5 percent greater among less dependent participants. Tang and colleagues (1994) concluded that nico- tine gum is an effective aid to smoking cessation and suggested that its efficacy is a direct function of the dependence of the smoker. On the basis of their re- view of other nicotine replacement therapies (includ- ing the nicotine patch), the authors concluded that the 4-mg gum is the most effective form of nicotine re- placement for highly dependent smokers. Silagy and colleagues (1994) examined 42 nico- tine gum trials in their meta-analysis of nicotine re- placement interventions. To compute effect sizes for each analysis, the authors combined data from the longest follow-up assessments (mainly 12 months) from available trials, regardless of gum dose or type of control treatment. Across all 42 trials, 42 percent of participants using nicotine gum quit smoking, whereas only 18 percent of participants in the control groups, who used either placebo gum or no gum, succeeded in quitting. The pooled odds ratio (OR) for the gum- to-control comparison across all trials was 1.61 (95 percent confidence interval [CI], 1.46-1.78). Differ- ences between gum and control conditions did not vary according to the intensity of adjuvant behavioral support. Fiore and colleagues (1990) conducted a meta- analysis of 13 randomized controlled trials of 2-mg nicotine gum therapy with at least five months of fol- low-up (Table 4.3). Nicotine gum treatment was asso- ciated with a 50-percent increase in quit rates (23.7 percent quit rate vs. 17.1 percent) in the control group. There were too few studies done in the over-the- counter setting to allow meta-analysis of the over-the- counter effect of nicotine gum. Reducing Tobacco Use Taken together, these meta-analyses suggest that nicotine chewing gum is an effective aid to smoking cessation. This conclusion continues to be borne out as evidence continues to accumulate. In an ongoing project, Silagy and colleagues (1999) have been regu- larly searching medical databases for new nicotine re- placement trials, recalculating effect sizes as new data sources are identified, and frequently publishing the updated meta-analyses. In the most recent edition of this meta-analysis, the pooled gum-to-control OR was estimated at 1.63. That in most settings nicotine- containing gum is associated with greater cessation success than placebo gum suggests that the gum’s ef- ficacy is due to its pharmacologic properties. Some evidence indicates that the efficacy of the 2-mg gum depends on the presence of intensive adjuvant behav- ioral support. The meta-analysis by Silagy and col- leagues (1994) suggests that nicotine gum may be beneficial even without intensive adjuvant therapy. In this analysis, however, because 2-mg and 4-mg gum studies are combined, definitive conclusions about the . efficacy of either dose alone in the absence of behav- ioral support cannot be drawn. This finding under- scores the importance of selecting those smokers for whom nicotine gum is likely to be beneficial. The avail- able evidence suggests that traditional measures of nicotine dependence may be a useful basis for select- ing gum candidates. Both doses of the gum appear to be of greater value to smokers who are more depen- dent on nicotine. The 4-mg gum may be particularly effective for the most dependent smokers. Relevant Process Measures Nicotine gum is presumed to exert its effects by replacing a portion of the nicotine that smokers usu- ally obtain through smoking; in therapy, the gum ame- liorates aversive tobacco withdrawal (Benowitz 1991, Hughes 1993). Some evidence suggests that nicotine gum reliably reduces some withdrawal symptoms. Patients receiving the 2-mg nicotine gum have consistently reported having less total withdrawal dis- comfort than patients treated with placebo gum (Jarvis et al. 1982; Hughes et al. 1984, 1989a, 1991b; Gross and Stitzer 1989; Hatsukami et al. 1991). However, studies have found that withdrawal severity is not consistently related to smoking relapse (West 1992; Hughes 1993), and the withdrawal suppression produced by nicotine gum appears to be somewhat independent of its effi- cacy. Moreover, the suppression reported seems to accrue through the lessening of a relatively small sub- set of withdrawal symptoms (Hughes et al. 1990b). The 2-mg gum consistently alleviates symptoms such as Management of Nicotine Addiction 115 Surgeon General's Report anxiety and irritability but does not appear to reliably ameliorate craving, hunger, sleep disturbance, or dif- ficulty concentrating (West et al. 1984a,b; Gross and Stitzer 1989; Hughes et al. 1989a, 1990a; Hatsukami et al. 1991). One trial (Hughes et al. 1990a) has found that the 4-mg gum was no more effective than the 2-mg gum either in suppressing total withdrawal se- verity or in relieving any of the individual symptoms of withdrawal. Future research must explore whether these counterintuitive findings are a result of poor measurement of withdrawal severity or whether other mechanisms explain how nicotine gum produces clini- cal success (Hughes 1993). Effect on Postcessation Change in Body Weight Evidence suggests that the 2-mg gum is capable of delaying, but not preventing, postcessation weight gain. Early in the cessation process, smokers given the 2-mg gum tend to gain less weight than smokers treated with placebo gum (Gross et al. 1989). During this period, weight gain among the 2-mg gum users is inversely related to the amount of gum used (Emont and Cummings 1987; Fagerstrom 1987; Killen et al. 1990a; Nides et al. 1994). However, differences in weight gain between smokers using the 2-mg gum, using placebo gum, and using no gum (Gross et al. 1989; Nides et al. 1994) disappear when follow-up is conducted after gum therapy has ended. Relatively little is known about the weight- related effects of the 4-mg gum. Early trials did not show it to diminish weight gain any more than either the 2-mg gum (Kornitzer et al. 1987; Tonnesen et al. 1988a) or the placebo gum (Puska et al. 1979; Tonnesen et al. 1988a). These trials, however, tended to use dif- ferent weight measures and more distal end points than the typical trial with 2-mg gum, and one trial used a mixed-dose regimen (Tonnesen et al. 1988a). Amore recent study, however, reported that nicotine gum sup- pressed weight gain with greater suppression occur- ring with the 4-mg dose (Doherty et al. 1996). Analysis of salivary cotinine showed that smokers who replaced a greater percentage of their baseline cotinine levels gained less weight. Side Effects and Likelihood of Inappropriate Use Common side effects reported by the 2-mg gum users include mouth soreness, hiccups, indigestion, jaw ache, and unpleasant taste (American Medical As- sociation [AMA] 1993; Tang et al. 1994). Most of these symptoms are relatively mild and transient, and many can be resolved by correcting the user’s chew- ing technique. Symptoms observed less frequently (in 116 Chapter 4 less than 2 percent of patients) include irritability, lightheadedness, headache, excessive salivation, and anorexia (AMA 1993). Moreover, absorption of nico- tine from the gum is highly dependent on the pH of the mouth (Henningfield et al. 1990). Because nico- tine is inactivated by an acidic environment, patients are urged to refrain from eating or drinking anything but water for 30 minutes before using the gum. Ap- proximately 10-25 percent of successful abstainers con- tinue to use the gum for one year or longer (Hajek et al. 1988; Hughes 1988; Hughes et al. 1991a). Although discontinuance of use should be encouraged, contin- ued use confers a substantial reduced health risk com- pared to a return to smoking. The 4-mg gum appears to have similar side effects, but it may produce slightly more dyspepsia and hiccuping than does the 2-mg gum (Tennesen et al. 1988a,b). Transdermal Nicotine In 1991, the FDA approved the use of transdermal nicotine patches as an aid to smoking cessation. Nico- tine patches contain a reservoir of nicotine that diffuses through the skin and into the wearer’s bloodstream at a constant rate. Patients are usually instructed to apply one patch each day. Specific dosing regimen may vary. All currently marketed brands are designed to deliver approximately 0.9 mg per hour of nicotine over the weaning period. Most are intended for 24-hour wear and deliver 21-22 mg of nicotine; one is intended for waking hours wear (16 hours per day) and deliv- ers 15 mg of nicotine. Full-strength patches typically produce serum nicotine levels similar to trough levels of serum nicotine in moderate to heavy smokers (Mulligan et al. 1990). On July 3, 1996, the FDA ap- proved the transdermal nicotine patch for over-the- counter sales at a dose of 15 mg for use as part of a comprehensive behavioral program of smoking ces- sation, although the FDA’s proscription does not pro- vide a clear statement of the constituents of such a program. Since that time, all varieties of nicotine patches have become available over the counter, some as “house brands.” Efficacy Several meta-analyses of the efficacy of the nico- tine patch have been published (Po 1993; Fiore et al. 1994c; Gourlay 1994; Silagy et al. 1994; Tang et al. 1994; Fiore et al. 2000). Each meta-analysis has concluded that the patch is an effective aid to smoking cessation. Po (1993) combined data from 11 nicotine patch trials and found that persons using the nicotine patch had greater cessation success than persons using a placebo patch. This finding held for both short-term follow-up (3-10 weeks; combined OR = 3.10 [95 per- cent CI, 2.65-3.62]) and long-term follow-up (6-12 months; combined OR = 2.26 [95 percent CI, 1.80- 2.86]). Gourlay (1994) pooled the results of six trials and found that the nicotine patch produced greater cessation success than a placebo patch at all follow-up assessments (2-3 months, 6 months, and 12 months; all pooled ORs were between 2.2 and 2.4 [95 percent CI, 1.6-3.4]). Tang and colleagues (1994) conducted a meta-analysis of six patch trials. Overall, at long-term (12-month) follow-up, persons using nicotine patches had a 9-percent (6-13 percent} greater success at ces- sation than did persons using placebo patches. Nico- tine patches were found to be more effective among self-referred subjects than among invited subjects and slightly more effective among smokers who were more dependent on nicotine. Silagy and colleagues (1994) combined data from nine patch trials and found that at long-term (12-month) follow-up, nicotine patches were associated with a combined OR of 2.07 (95 per- cent Cl, 1.64-2.62) when compared with control con- ditions (placebo patches or no patch). Secondary analyses indicated that the patch’s relative efficacy was not affected by the intensity of adjuvant support. Fiore and colleagues (1994c) examined 17 nicotine patch tri- als and found a combined OR of 2.6 (95 percent CI, 2.2-3.0) at the end of the treatment and 3.0 (95 percent CI, 2.4-3.7) at 12-month follow-up. More intensive ad- juvant support was found to produce higher absti- nence rates at six months (26.5 vs. 19.5 percent for low-intensity interventions) but did not increase the relative advantage of nicotine patches over placebo patches. The 16- and 24-hour patches were found to be equally effective. Neither weaning nor extending treatment beyond eight weeks was found to improve outcome. A recent meta-analysis (Fiore et al. 2000) of 27 studies reported that transdermal nicotine increased long-term cessation by 90 percent (Table 4.3). A meta- analysis of three studies reported that over-the-counter nicotine patch use increased successful long-term cessation by 80 percent (Fiore et al. 2000). These meta-analyses strongly indicate that the nicotine patch is an effective aid to smoking cessation. This conclusion is buttressed by the findings of a con- tinuing, regularly updated review of the existing re- search literature on transdermal nicotine (Silagy et al. 1999). In the most recent release of this evolving meta- analysis, Silagy and colleagues (1999) found a pooled patch-to-control OR of 1.84 (95 percent CI, 1.60-2.10). The data continue to suggest that 16- and 24-hour patches are equivalent in efficacy, that there is no ad- vantage associated with weaning or tapering of patch Reducing Tobacco Use dose, and that the relative efficacy of the patch is fairly independent of the intensity of adjuvant therapy. Nico- tine patches have been consistently found to outper- form placebo patches regardless of dosing regimen and ina variety of investigational settings. For example, a study of “real-world” use of the patch—based on a follow-back of older persons who had filled patch prescriptions—produced a self-reported cessation pro- portion of 29 percent at six months (Orleans et al. 1994). The patch is more effective than placebo treatment when paired with only brief support, and it is associ- ated with the higher long-term success when paired with more intensive counseling or behavioral interven- tions (Fiore et al. 1994b). Though the nicotine patch does increase success rates when used with minimal formal counseling, many nicotine patch clinical trials involve frequent follow-up assessments. Such contacts might boost success rates obtained with the patch. In support of this possibility, Jorenby and colleagues (1995b) found that the combination of nicotine patch treatment plus frequent assessments produced follow- up outcomes equivalent to the nicotine patch plus in- tensive behavioral therapy. Further assessment of this issue is important, as frequent follow-up contact does not usually accompany nicotine patch use outside of clinical trials (Cummings et al. 1994; Swartz et al. 1995). A meta-analysis of three studies of over-the-counter nicotine patches, however, indicated that patch therapy was superior to placebo (Fiore et al. 2000). Effects on Discomfort of Nicotine Withdrawal Some evidence suggests that the nicotine patch reduces overall measures of nicotine withdrawal dis- comfort (Daughton et al. 1991; Transdermal Nicotine Study Group 1991; Jorenby et al. 1996), but this find- ing has not been consistent (Abelin et al. 1989; Tonnesen et al. 1991; Merz et al. 1993). Use of the nico- tine patch has been repeatedly found to reduce the craving for cigarettes (Abelin et al. 1989; Rose et al. 1990; Tonnesen et al. 1991; Transdermal Nicotine Study Group 1991; Merz et al. 1993; Sachs et al. 1993; Westman et al. 1993; Fiore et al. 1994b; Levin et al. 1994; Jorenby et al. 1996), but other symptoms of nicotine withdrawal are affected less reliably (Palmer et al. 1992). Ina study designed to clarify the impact the patch has on with- drawal symptoms, the patch reliably reduced craving, anxiety, and irritability but did not alleviate depressed mood, restlessness, or sleep disruption (Jorenby et al. 1996). The authors noted that with or without the patch, most withdrawal symptoms disappeared within three to four weeks. Management of Nicotine Addiction 117 Surgeon General's Report Effect on Postcessation Change in Body Weight Nicotine patches can attenuate postcessation weight gain while they are in use (Abelin et al. 1989; Sachs et al. 1993; Jorenby et al. 1995a; Dale et al. 1998), but this short-term effect has not always been observed (Rose et al. 1990; Tannesen et al. 1991; Transdermal Nicotine Study Group 1991; Fiore et al. 1994b). More- over, studies that follow up effects after treatment has ended have not found that persons who used the nico- tine patch gained less weight than those who used a placebo patch (Tonnesen et al. 1991). Side Effects and Likelihood of Inappropriate Use Most side effects of nicotine patch use are rela- tively mild; less than 5 percent of patients need to dis- continue patch therapy because of side effects (Hughes and Glaser 1993). Minor skin irritation at the patch site is reported by 30-50 percent of patch users and can be relieved by moving the patch to another site. Insomnia is reported by 1-23 percent of patch users (AMA 1993). Comparatively rare side effects include headache, dizziness, fatigue, gastrointestinal distress, sweating, limb pain, and palpitations (Palmer et al. 1992). Studies have found little evidence that people will inappropriately use transdermal nicotine systems (Palmer et al. 1992; Hughes 1993; Jorenby et al. 1995b). The risks associated with using the nicotine patch during pregnancy are largely unknown. Nicotine it- self poses risks to the fetus, including neurotoxicity (Slotkin 1998), and pregnant women should first be encouraged to quit without pharmacotherapy. Because exposure to nicotine through maternal use of the patch probably poses less danger to the fetus than does con- tinued maternal smoking (Hackman et al. 1999), how- ever, nicotine replacement therapy may be indicated for pregnant women who are unable to quit smoking (Benowitz 1991; Lewis and Fiore 1994). However, if a decision is made to use nicotine replacement therapy during pregnancy, the physician should consider moni- toring blood nicotine levels, using doses at the low end of the effective range, and choosing intermittent de- livery systems (such as nicotine gum) (Fiore et al. 2000). The issue is under active investigation. Continued smoking while using the patch may be a significant problem. In an observational study of self-reported patch use, almost one-half the respon- dents stated that they smoked while using the patch; 20 percent of the respondents did so every day (Or- leans et al. 1994), A small number of adverse cardio- vascular events were reported in patients who continued to smoke while using the patch. When these events received much attention from the popular press, 118 Chapter 4 several analyses, including one by an FDA advisory committee, have documented no association between nicotine replacement therapy and cardiovascular events even in patients who continue to smoke inter- mittently (Working Group for the Study of Transdermal Nicotine in Patients with Coronary Ar- tery Disease 1994; Joseph et al. 1996; Benowitz and Gourlay 1997; Mahmarian et al. 1997). Caution should be used, however, for patients with acute cardiovas- cular disease (immediately post-myocardial infarction or in the presence of serious arrhythmias or serious or accelerating angina pectoris). Relevant Process Measures Like nicotine gum, the nicotine patch is intended to reduce tobacco withdrawal symptoms (Palmer et al. 1992; Glover 1993b; Hughes and Glaser 1993). Al- though the nicotine patch appears to reduce with- drawal severity, particularly craving for cigarettes, withdrawal suppression may or may not be respon- sible for the patch’s efficacy (Hughes 1993). For ex- ample, one trial failed to reveal reliable differences in withdrawal severity between persons using nicotine patches and those using placebo patches (Merz et al. 1993); the trial nevertheless found that participants who used the nicotine patch were nearly twice as likely to quit smoking. Another trial employing two doses of transdermal nicotine found that the higher-dose patch produced significantly greater cessation success than the lower-dose patch, even though both doses provided about the same amount of relief from with- drawal symptoms (Transdermal Nicotine Study Group 1991; Hughes 1993). Clearly, other potential mecha- nisms of the patch’s action, as well as the action of nico- tine replacement therapy in general, need to be explored. Nicotine Nasal Spray Nicotine nasal spray was approved for prescrip- tion use in the United States in March 1996. The spray consists of a pocket-sized bottle and pump assembly, which is fitted to a nozzle designed for insertion into the nose. Each metered spray delivers 0.5 mg of nico- tine to the nasal mucosa. The recommended dose is 1 mg, or one 0.5-mg spray per nostril, as needed (Sutherland et al. 1992). Efficacy A number of clinical trials have assessed the effi- cacy of the nicotine nasal spray as an aid to smoking cessation. Sutherland and colleagues (1992) found that 26 percent of participants given nicotine nasal spray were abstinent after one year, compared with only 10 percent of participants given placebo. Hjalmarson and colleagues (1994) found similar results in a placebo- controlled trial; at one-year follow-up, abstinence rates were 27 percent and 15 percent, respectively, for par- ticipants given active spray or placebo. Schneider and colleagues (1995) again replicated this effect, finding continuous abstinence rates of 18 percent and 8 per- cent among participants given active or placebo spray. Another study (Bléndal et al. 1997) did not find a sig- ~ nificant difference in abstinence rates between active spray and placebo groups at one year (25 vs. 17 per- cent); active spray was associated with higher absti- nence rates at six months and earlier in this trial. Recently, Bl6ndal and colleagues (1999) provided all participants in a second trial with active nicotine patches, then studied the incremental efficacy of add- ing nasal spray therapy to the patch regimen in a double-blind, placebo-controlled fashion. Results showed that participants given the active spray were more likely to be abstinent after one year than partici- pants given placebo (27 vs. 11 percent). Participants given active spray had a higher rate of abstinence than participants given placebo a full six years after the start of treatment (16 vs. 9 percent), but this effect was only marginally significant. Taken together, the results of these studies suggest that nicotine nasal spray is an aid to smoking cessation. A meta-analysis by Silagy and colleagues (1999) reported a pooled spray-to-control OR of 2.27, and a recent meta-analysis (Fiore et al. 2000) reported an OR of 2.7 (30.5 percent long-term abstinence rate) (Table 4.3). Effect on Discomfort of Nicotine Withdrawal Evidence regarding the nicotine nasal spray’s effects on nicotine withdrawal discomfort is sparse. The results of two studies suggest that the spray may be useful for coping with craving, but may not be ef- fective in alleviating other withdrawal symptoms. One study (Sutherland et al. 1992) found that, compared with participants using placebo spray, participants treated with nicotine spray reported having less total withdrawal discomfort during the 48 hours immedi- ately after smoking cessation and reported less crav- ing for cigarettes during this period. After 48 hours, however, the two groups reported equivalent levels of withdrawal discomfort and craving. When craving did arise, the nicotine spray was consistently rated more effective than the placebo spray. The other study (Hjalmarson et al. 1994) found that during the first 48 hours of smoking cessation, Reducing Tobacco Use users of nicotine spray reported somewhat less severe _ withdrawal discomfort than placebo users, but this effect was not statistically significant. The severity of craving was found to be similar across both groups, but the nicotine spray was more helpful in quelling craving than the placebo spray was. Other clinical tri- als have not reported comparisons between active and placebo spray groups with regard to withdrawal mea- sures (e.g., Schneider et al. 1995; Bl6ndal et al. 1999). Effect on Postcessation Change in Body Weight The limited evidence available suggests that the nicotine nasal spray may be capable of delaying, but not preventing, postcessation weight gain. In one of the trials (Sutherland et al. 1992), participants were allowed to use the spray they were assigned for as long as one year. Weight effects in that study differed as a function of duration of spray use: abstinent subjects who had continued to use the nicotine spray for the entire year of the study had gained significantly less weight than subjects still using the placebo spray. However, change in body. weight was equivalent for abstinent patients who had stopped using either type of spray during the year. Another study (Hjalmarson et al. 1994) failed to find any statistically significant differences in weight gain between participants using nicotine spray and those using placebo spray. The authors observed, how- ever, that participants still using nicotine spray at the 12-month follow-up tended to gain less weight than both participants continuing to use a placebo spray and participants who had stopped using the nicotine spray before that time. Side Effects and Likelihood of Inappropriate Use Unpleasant side effects are common with the nasal spray. Between 75 and 100 percent of nasal spray users reported experiencing irritant effects, such as runny nose, sneezing, throat irritation, nasal irritation, watering eyes, and coughing (Sutherland et al. 1992; Hjalmarson et al. 1994; Schneider et al. 1995). Some authors have reported that these sensory irritation ef- fects are actually viewed as desirable by many smok- ers and have suggested that they may help bridge the gap between cigarette smoking and nicotine replace- ment (Glover 1993a; Schneider 1993). Less common side effects, present in 15-25 percent of users, include nausea, sweating, headache, dizziness, and cold hands and feet. Because the spray rapidly delivers nicotine to the user, the potential for inappropriate use (e.g., using more often or at a higher dose than recommended) is Management of Nicotine Addiction 119 Surgeon General's Report high. The results of both clinical trials lend some cre- dence to these speculations. Sutherland and colleagues (1992) found that 43 percent of abstinent study par- ticipants who had been given the nicotine spray chose to continue using it for the entire year of the study; moreover, mean plasma nicotine concentrations in- creased over the follow-up period among participants who continued to use the spray. Participants in the trial conducted by Hjalmarson and colleagues (1994) were explicitly encouraged to begin weaning them- selves from the spray (whether nicotine or placebo) after three months. Nonetheless, 30 percent of absti- nent participants who had been given the nicotine spray continued to use it after one year. Schneider and colleagues (1995) required that participants in their trial use the spray daily for six weeks, then allowed participants to use spray for up to six months postcessation as needed. Thirty-two percent of par- ticipants given active spray continued using it daily for six months, compared with 13 percent of partici- pants given placebo. The authors also reported that some continuous abstainers assigned to active spray reported being concerned that they were dependent upon the spray at six months postcessation. However, a substantial proportion of these individuals remained abstinent many months after drug weaning. Relevant Process Measures Nicotine nasal spray, like other nicotine replace- ment products, is intended to aid smoking cessation by relieving withdrawal symptoms. Although the spray has been found effective in promoting cessation, its circumscribed impact on total withdrawal severity suggests that withdrawal relief is not itself responsible for the spray’s usefulness. The spray’s documented ability to alleviate craving may be what makes it an effective smoking cessation treatment. More research is needed to advance definitive conclusions about the spray’s mechanism of action. Nicotine Inhaler In May 1997, the FDA approved the nicotine in- haler for prescription use. The inhaler consists of a plastic tube, about the size of a cigarette, that contains a plug impregnated with nicotine. Menthol is added to the plug to reduce throat irritation. Smokers are instructed to puff on the inhaler as they would ona cigarette. An average puff delivers approximately 13 pg of nicotine (about 1/80th the amount of nicotine contained in an average cigarette puff), which is ab- sorbed primarily by the buccal route (Glover 1993a; 120 Chapter 4 Tonnesen et al. 1993). Each inhaler contains enough nicotine for approximately 300 puffs. Smokers are in- structed to use between 6 and 16 inhalers per day. Efficacy A handful of published trials have examined the efficacy of the nicotine inhaler as an aid to smoking ces- sation. Tonnesen and colleagues (1993) found that 17 percent of participants randomized to active inhalers had quit smoking at six months, compared with 8 per- cent of participants given placebo. Corresponding rates at one year were 15 vs. 5 percent. Schneider and col- leagues (1996) found active-placebo abstinence rates of 17 vs. 9 percent and 13 vs. 8 percent at six months and one year, respectively. These differences were not sig- nificant in the Schneider trial, although active inhalers were superior to placebo at all follow-ups through three months postcessation. Hjalmarson and colleagues (1997) found continuous abstinence rates of 35 percent and 28 percent for active inhaler users at 6 and 12 months, compared with 19 percent and 18 percent, respectively, among placebo users. Active-placebo comparisons were statistically significant at all follow- ups in this trial. The most recent edition of a regularly updated meta-analysis of nicotine replacement prod- ucts (Silagy et al. 1999) found an inhaler-to-control pooled OR of 2.08, and another recent meta-analysis of four studies (Fiore et al. 2000) reported a pooled OR of 2.5 (Table 4.3). Taken together, the results suggest that the nico- tine inhaler is an effective aid to smoking cessation. However, the findings of Schneider and colleagues (1996) suggest that the inhaler may be most useful for producing initial abstinence and that additional inter- ventions may be needed to prevent relapse among users of the inhaler. Effects on Discomfort of Nicotine Withdrawal Limited information is available regarding the effects of the nicotine inhaler on nicotine withdrawal symptoms. Two studies (Schneider et al. 1996; Hjalmarson et al. 1997) showed that active inhaler use was associated with decreased craving during the first several days of the quit attempt but not thereafter. Hjalmarson and colleagues (1997) assessed a wide ar- ray of withdrawal symptoms across the cessation at- tempt, but did not find any effects of active inhalers on these other than the fleeting effects on craving. However, this may have been influenced by a floor effect, as mean withdrawal scores were very low in both groups across all assessments. Side Effects and Likelihood of Inappropriate Use The most common side effects associated with inhaler use are throat irritation and coughing. These are reported by between 20 to 50 percent of active in- haler users and are less common among placebo inhaler users (Tonnesen et al. 1993; Schneider et al. 1996; Hjalmarson et al. 1997). Other less common side effects include nausea, bad taste in the mouth, dizzi- ness, gastrointestinal disturbances, and oral burning or smarting. Few (0-9 percent) active inhaler users have withdrawn from clinical trials or stopped using the inhaler because of side effects. The potential for inappropriate use appears to be fairly low, with between 2 to 16 percent of active inhaler users continuing to use the device at six months postcessation in clinical trials allowing unrestricted inhaler use (Tonnesen et al. 1993; Schneider et al. 1996; Hjalmarson et al. 1997). Effect on Postcessation Change in Body Weight Two placebo-controlled inhaler trials have exam- ined postcessation weight gain (Tonnesen et al. 1993; Hjalmarson et al. 1997). Neither study found evidence that active inhaler use prevented or reduced weight gain among successful quitters. Relevant Process Measures The nicotine inhaler is thought to act by reliev- ing withdrawal symptoms (Glover 1993a; Leischow 1994), but little published evidence to date supports this contention. It is often suggested that the inhaler may be effective because it more closely resembles smoking than other pharmacotherapies do, replacing some of the orosensory and behavioral aspects of smoking (Glover 1993a; Tennesen et al. 1993; Leischow 1994; Schneider et al. 1996; Hjalmarson et al. 1997). Schneider and colleagues (1996) asked partici- pants to rate their assigned inhalers relative to their usual brand of cigarettes in terms of sensory effects, preference, and satisfaction. Results showed that par- ticipants given the active inhaler rated their devices more highly than did participants given placebo. How- ever, the absolute magnitude of the ratings revealed that the inhalers did not compare very favorably to cigarettes in either group. The mechanism of action of the nicotine inhaler would seem to require further scrutiny. Bupropion Bupropion is an atypical antidepressant that is believed to work by blocking neurotransmitter reuptake in noradrenergic and dopaminergic sites in Reducing Tobacco Use the central nervous system (Ascher et al. 1995). Anec- dotal reports of spontaneous smoking cessation in patients prescribed bupropion for depression, coupled with a growing appreciation of the importance of nega- tive affect and clinical depression in smoking mainte- nance (Hall et al. 1994; Piasecki et al. 1997) have recently stimulated clinical investigations of a sustained-release bupropion preparation as an aid to smoking cessation. These investigations led to the approval of a smoking cessation indication for bupropion by the FDA in 1997. The typical dosing regi- men for smoking cessation consists of 150 mg sustained-release bupropion per day for three days, followed by 150 mg twice a day thereafter. Therapy is initiated one to two weeks before the target quit date and is generally continued for three months. Efficacy Two large-scale clinical trials of bupropion’s ef- ficacy as a smoking cessation aid have been published to date. Hurt and colleagues (1997) compared three doses of bupropion (100 mg, 150 mg, and 300 mg) with placebo. Abstinence rates in the 150-mg and 300-mg groups were significantly higher than those of the pla- cebo group at 12 months. All active treatment groups were found to have higher abstinence rates than the placebo group at earlier end points. Jorenby and col- leagues (1999) studied active and placebo patches and active and placebo bupropion in a 2 x 2 factorial de- sign. Abstinence rates after one year showed no dif- ference between patch-only and placebo groups (16 percent and 15 percent, respectively). Both placebo and patch treatments were associated with higher ab- stinence rates when given with bupropion. Thirty percent of the bupropion-only group (150 mg twice a day) were abstinent at 12 months, whereas 36 percent of participants given active patches and bupropion were counted as abstinent. A recent meta-analysis (Fiore et al. 2000) of two studies reported a pooled OR of 2.1 and an estimated abstinence rate of 30.5 percent (Table 4.3). Thus, the available evidence suggests that bupropion is an ef- fective aid to smoking cessation, and that it may im- prove quit rates over those observed with conventional nicotine replacement therapies, although further stud- ies will be needed to demonstrate such efficacy. Effect on Discomfort of Nicotine Withdrawal The evidence concerning bupropion’s ability to suppress withdrawal symptoms is somewhat mixed. Hurt and colleagues (1997) found that their groups using 150 mg and 300 mg reported withdrawal Management of Nicotine Addiction 121 Surgeon General's Report symptoms that were equivalent to those reported by placebo participants. Individuals assigned to the 100-mg group, however, reported withdrawal that was significantly worse than that among either the placebo group or the other bupropion groups. The authors sug- gested that this effect may have arisen because the 100-mg dose produced side effects similar to with- drawal symptoms but was not strong enough to re- duce true withdrawal symptoms. Jorenby and colleagues (1999) found that all three groups receiv- ing active treatments compared with the placebo group reported reduced withdrawal. The group given both active patches and active bupropion reported the most consistent withdrawal relief. Further research is needed to characterize the reliability and magnitude of bupropion effects on withdrawal symptoms. Relevant Process Measures Although nicotine replacement therapies are strongly predicated on the assumption that nicotine will relieve withdrawal symptoms, withdrawal relief represents only one of several rationales for using bupropion as a smoking cessation aid. One hypoth- esis is that bupropion may selectively reduce depres- sive symptoms after cessation. However, both trials mentioned previously excluded individuals with cur- rent major depression. Both clinical trials (Hurt et al. 1997; Jorenby et al. 1999) also included multiple as- sessments of postcessation depressive symptomatol- ogy, and neither found any differences among treatment groups on these measures. These findings suggest that bupropion does not work through its an- tidepressant effects per se in relatively healthy clinical trial participants. Bupropion moderates dopaminergic activity in the central nervous system, and dopaminergic circuits are known to play a role in drug reinforcement (Nutt 1997). This raises the possibility that bupropion may exert its effects by replacing positive reinforcement associated with smoking (Hurt et al. 1997). To date, there is no evidence directly bearing on this hypothesis, and it is clear that this process is not easily studied in clinical trials. Laboratory-based pharmacokinetic and neuroimaging studies should be performed to explore this hypothesis. Effects of Postcessation Change in Body Weight Hurt and colleagues (1997) found evidence for a dose-response effect among continuous abstainers, suggesting that participants given the highest doses gained less weight after quitting. Moreover, the dis- parities between treatment groups in terms of weight 122 Chapter 4 gain increased across time while medication was dis- pensed. At six-month follow-up, 17 weeks after par- ticipants went off the assigned medication, no differences in weight gain were observed. These com- parisons were limited to a small subsample of continu- ous abstainers. In the Jorenby and colleagues (1999) trial, members of all active treatment groups tended to gain less weight than did placebo participants over the first seven weeks of cessation. Weight gain suppression was greatest for the combined patch- bupropion group. However, none of the groups dif- fered in weight gain after seven weeks after quitting. Together, the results of these trials suggest that bupropion treatment may delay, but not prevent, postcessation weight gain. Side Effects In both clinical trials, two side effects were re- ported more commonly among participants given bupropion than among those given placebo. Dry mouth was reported by 10 to 15 percent of bupropion users, and insomnia was reported by about 30 to 40 percent of bupropion users. Bupropion may increase the risk of seizure and is thus contraindicated for in- dividuals who are seizure prone, such as individuals with a history of alcoholism or alcohol abuse, eating disorder, seizure disorder, or using MAO inhibitors. No seizures were reported in either clinical trial, but participants with risk factors for seizure were excluded from each before enrollment. Clonidine Clonidine is a centrally acting a,-adrenergic agonist that dampens sympathetic nervous system activity. Clonidine is most commonly used in the man- agement of hypertension; it has not been approved by the FDA as an aid to smoking cessation. Clonidine is available for prescription in oral and transdermal forms; both of these preparations have been investi- gated in smoking cessation trials. Smokers using clonidine as an aid to smoking cessation are generally started on the drug several days before quitting and are maintained ona fixed daily dose for several weeks. Efficacy Covey and Glassman (1991) conducted a meta- analysis of nine early trials of clonidine for smoking cessation. They found that persons given clonidine were more successful at quitting than those given a pla- cebo (OR = 2.36). Five of the nine trials assessed out- come after the therapy was discontinued; only one (Glassman et al. 1988) showed a significant overall ad- vantage for clonidine. Clonidine trials using adjunc- tive behavioral therapy were associated with greater relative success (OR = 4.2) than were trials in which treatment essentially consisted of dispensing the drug (OR = 1.7). Trials using transdermal clonidine produced somewhat greater relative success (OR = 3.2) than did trials using oral clonidine (OR = 2.2). The two trials that analyzed efficacy according to sex found clonidine to be much more effective, relative to placebo, among women (OR = 11.0) than among men (OR = 0.9). There is no obvious explanation for this finding. Since the Covey and Glassman (1991) meta- analysis, several large-scale clonidine trials have ap- peared (Prochazka et al. 1992; Glassman et al. 1993; Hilleman et al. 1993; Niaura et al. 1996). These studies indicated a therapeutic effect for clonidine, with some evidence suggesting that clonidine was more effective among women (Glassman et al. 1993; Hilleman et al. 1993) and among those most dependent on nicotine (Glassman et al. 1993). A recent meta-analysis (Fiore et al. 2000) of five clinical trials reported a pooled OR for long-term effectiveness of 2.1 (25.6 percent abstinence rate) (Table 4.3). In these studies, the clonidine dose ranged from 0.1 mg to 0.75 mg per day and was delivered either orally or transdermally. Because of the side effects, the lack of a specific dosing regimen, the prob- lems with abrupt discontinuation of the drug, and the lack of FDA approval, clonidine has been recom- mended as a second-line agent for smoking cessation (Fiore et al. 2000). Effect on Discomfort of Nicotine Withdrawal An early report (Glassman et al. 1984) that clonidine could reduce tobacco withdrawal symptoms, especially craving, spurred the initial investigations of clonidine’s usefulness in smoking cessation. Since that report, evidence for this effect has been mixed. Clonidine- and placebo-treated patients have had equivalent levels of withdrawal severity (Wei and Young 1988; Franks et al. 1989; Gourlay et al. 1994). Studies have fairly consistently found that clonidine diminishes the specific symptom of craving (Glassman et al. 1984; Ornish et al. 1988; Prochazka et al. 1992; Gourlay et al. 1994), and some studies have found some effects on withdrawal symptoms, such as anxiety and irritability (Ornish et al. 1988; Prochazka et al. 1992). Side Effects Unpleasant side effects are commonly associated with clonidine use (Gourlay et al. 1994), and as many Reducing Tobacco Use as 25 percent of patients may discontinue clonidine therapy because of them (Covey and Glassman 1991). The most frequently observed symptoms are dry mouth, fatigue, and dizziness. Local skin irritation is common with transdermal clonidine therapy. The in- cidence of side effects appears to be dose dependent (Gourlay et al. 1994). Care must also be taken to dis- continue clonidine gradually to prevent rebound hy- pertension. No published clinical trials have assessed the effect of clonidine on postcessation weight gain. Relevant Process Measures Clonidine is presumed to exert its effects by ame- liorating withdrawal discomfort (Glassman et al. 1984; Franks et al. 1989). Although a few studies have found that clonidine reduces withdrawal discomfort, find- ings froma well-designed, large-scale multicenter trial (Prochazka et al. 1992) have suggested that this effect does not necessarily lead to greater abstinence. Nortriptyline Nortriptyline is a tricyclic antidepressant that blocks reuptake of norepinephrine and serotonin. As with clonidine, smoking cessation is not an FDA- approved indication for nortriptyline; its primary indication is for the treatment of depressive symptoms. It is a prescription medication and is available in ge- neric form. In smoking cessation studies conducted to date, treatment was initiated 2-4 weeks before the target quit date with gradual titration of dose. Efficacy Two studies have assessed the efficacy of nortrip- tyline for smoking cessation. Hall and colleagues (1998) conducted a 2 (nortriptyline vs. placebo) x 2 (his- tory vs. no history of major depression) x 2 (cognitive behavioral vs. health education therapy) trial that pro- duced a 24-percent sustained abstinence rate in nortrip- tyline users compared with 12 percent in the placebo group. There was no difference in cessation rates as a function of previous history of major depression. Ina straight comparison of nortriptyline to placebo, Prochazka and colleagues (1998) found cessation rates at six months of 14 percent in participants given nortriptyline and 3 percent in participants given pla- cebo. A meta-analysis (Fiore et al. 2000) of these two studies reported a pooled OR of 3.2 and a 30.1-percent abstinence rate (Table 4.3). Both studies provide clear evidence of nortriptyline’s therapeutic effect. Management of Nicotine Addiction — 123 Surgeon General's Report Effect on Discomfort of Nicotine Withdrawal The Hall and colleagues (1998) study assessed both nicotine withdrawal symptoms and negative af- fect in the first eight days following the target quit date. There were no significant differences between the drug therapy groups on nicotine withdrawal severity, sug- gesting that as with many of the other smoking cessa- tion pharmacotherapies, withdrawal relief may not be the primary mechanism of action. The negative affect measure, however, increased in the first three days in the placebo group and declined in the nortriptyline group. This suggests that a negative affect assessment may be more sensitive to some of nortriptyline’s thera- peutic effects than a conventional nicotine withdrawal symptom scale. Side Effects Tricyclic antidepressants are known to produce a number of side effects, including sedation and vari- ous anticholinergic effects. In the smoking cessation studies, commonly reported side effects included dry mouth (64-74 percent), lightheadedness (49 percent), shaky hands (23 percent), and blurry vision (16 per- cent) (Hall et al. 1998; Prochazka et al. 1998). Other Antidepressants and Anxiolytics Investigators have begun to explore the poten- tial use of other antidepressants and anxiolytics as pharmacologic aids to smoking cessation, because population-based epidemiologic samples have found that depression and anxiety are associated with ciga- rette smoking (Breslau et al. 1991; Kendler et al. 1993). Research has also shown that smokers with a history of depression are more likely to experience depressive symptoms (Covey et al. 1990) and to relapse after quit- ting (Glassman et al. 1988; Anda et al. 1990) than are smokers without such a history. Some anxiolytics (Glassman et al. 1984; Hilleman et al. 1992) have been shown to ameliorate symptoms of tobacco withdrawal, and preliminary smoking cessation trials using anti- depressants (Edwards et al. 1989) and anxiolytics (Hilleman et al. 1994) have yielded encouraging re- sults. Among the drugs that have been studied or hypothesized to be useful for smoking cessation are buspirone hydrochloride, doxepin hydrochloride, and fluoxetine hydrochloride. Although promising, this avenue of research is not yet developed enough to permit the multipart discussion given to other phar- macologic agents in this chapter. 124 Chapter 4 Summary of Pharmacologic Interventions Abundant evidence confirms that both nicotine gum and the nicotine patch are effective aids to smok- ing cessation. The efficacy of nicotine gum may de- pend on the amount of behavioral counseling with which it is paired. The 4-mg dose may be the better pharmacologic treatment for heavy smokers or for those highly dependent on nicotine. The nicotine patch appears to exert an effect independent of behavioral support, but absolute abstinence rates increase as more counseling is added to patch therapy. Nicotine nasal spray and nicotine inhalers are effective aids for smok- ing cessation, although their mechanisms of action are not entirely clear. All nicotine replacement therapies produce side effects, but these are rarely severe enough that patients must discontinue use. Nicotine nasal spray appears to have greater potential for inappro- priate use than other nicotine replacement therapies. Nicotine replacement therapies, especially the gum and the patch, have been shown to delay but not pre- vent weight gain. All nicotine replacement therapies are thought to work in part by reducing withdrawal severity. The available evidence suggests that they do ameliorate some elements of withdrawal, but the relationship between withdrawal suppression and clinical outcome is inconsistent. Bupropion is the first nonnicotine pharma- cotherapy for smoking cessation to be studied in large- scale clinical trials. Results suggest that bupropion is an effective aid to smoking cessation. In addition, bupropion has been demonstrated to be safe when used jointly with nicotine replacement therapy. In the only direct comparison with a nicotine replacement product, bupropion achieved quit rates about double those achieved with the nicotine patch. Bupropion appears to delay but not prevent postcessation weight gain. The available literature contains inconsistent evidence regarding bupropion-mediated withdrawal relief. Bupropion does not appear to work by reduc- ing postcessation depressive symptomatology, but its mechanism of action in smoking cessation remains unknown. Further research is needed to characterize bupropion’s central nervous system effects, particu- larly to assess whether the drug partially replaces smoking-related positive reinforcement. _Evidence suggested that clonidine is capable of improving smoking cessation rates. Clonidine is hy- pothesized to work by alleviating withdrawal symp- toms. Although clonidine may reduce craving for cigarettes after cessation, it does not consistently ame- liorate other withdrawal symptoms, and its effects on weight gain are unknown. Unpleasant side effects are common with clonidine use. Antidepressants and anxiolytics are potentially useful agents for smoking cessation. At present, only nortriptyline appears to have consistent empirical evi- dence of smoking cessation efficacy. However, tricy- clic antidepressants produce a number of side effects, including sedation and various anticholinergic effects. Large-Scale Public Health Programs The shift in recent years from a clinical to a pub- lic health perspective in smoking cessation research has led to an increased emphasis on developing and evaluating cost-effective strategies that can be widely disseminated (Lichtenstein and Glasgow 1992). This emphasis is reflected in the proliferation of research on self-help manuals (see “Self-Help Manuals,” ear- lier in this chapter and “Community Programs,” later in this chapter) and on media- and community-based interventions (Flay 1987; Gruman and Lynn 1993). As is true for self-help strategies, media-, worksite-, and community-based programs have promise because they can potentially reach many smokers who may try to quit without formal, face-to- face assistance (Fiore et al. 1990). Moreover, some evi- dence suggests that less educated smokers profit from media campaigns at least as much as more highly edu- cated smokers do (Macaskill et al. 1992). (Other large- scale interventions—educational [Chapter 3] and social [Chapter 7]—are discussed separately.) Investigators have evaluated an array of such programs, but methodological variations across the individual trials have hampered comparisons among studies (Flay 1987; Schwartz 1992). Moreover, meth- odological challenges compromise how research on these programs may be interpreted. For instance, on- going coverage of smoking and its health consequences in the general media may alter the effect of research- based media information. Similarly, secular trends and events that could individually affect large populations of smokers (e.g., the introduction of a new nicotine replacement product) may alter the impact—and complicate the assessment—of media campaigns conducted around the time of such events. Such chal- lenges may account for the inconsistencies seen in this area of research. Media-Based Programs Media used to transmit smoking cessation mes- sages have included television (Brannon et al. 1989; Korhonen et al. 1992; Mudde and De Vries 1999), ra- dio (Farquhar et al. 1990; COMMIT Research Group 1991), the telephone (Ossip-Klein et al. 1991; Pierce et Reducing Tobacco Use al. 1992), newspapers (Cummings et al. 1987), and the mail (Gritz et al. 1992; McFall et al. 1993). The intensity of media-based programs has var- ied greatly, and these variations may be related to pro- gram success. For example, one study (Gritz et al. 1992) evaluated a minimal mail-based intervention. The in- vestigators mailed self-help smoking materials to a sample of nonvolunteer women who smoked and who belonged to a health maintenance organization. The intervention had no impact; at no point during the 18- month follow-up period were women who had re- ceived the materials more likely to quit smoking or report changes in their motivation to quit than women who had not. In contrast, a more intense media cam- paign evaluated in another study (Orleans et al. 1991) yielded encouraging findings, albeit among treatment volunteers. The investigators tested the impact of add- ing telephone calls from a smoking cessation counse- lor to an intervention that mailed self-help manuals to the volunteers. After 16 months, abstinence from smoking was reported by 23.0 percent of the volun- teers who had received adjuvant telephone counsel- ing and by 15.2 percent of those receiving the self-help materials alone. Mass media campaigns of intermediate intensity, such as televised programs (Flay et al. 1989), gener- ally produce modest increases in abstinence—increases that fall short of the moderate effect of telephone coun- seling found among volunteers (Orleans et al. 1991). The influence of intermediate-intensity interventions is difficult to determine precisely, because the results of individual trials may be affected by the peculiari- ties of the specific communities in which they are tested and (as previously discussed) by concurrent changes in secular attitudes toward smoking behavior. These problems are compounded by the designs of communitywide and mass media programs frequently failing to include matched control communities for com- parison. Although more intensive interventions appear to increase cessation over time (Flay 1987), the absence of well-controlled experimental media trials limit any conclusions about a dose-response relationship for media-based programs. The content of various media-based programs can be divided into three categories: (1) programs that present information about the negative health effects of smoking and exposure to secondhand smoke and attempt to motivate smokers to quit; (2) programs that promote the performance of simple cessation-related activities, such as calling a hot line, requesting self- help materials, or enrolling in a smoking cessation contest; and (3) programs that mimic intensive clini- cal interventions (Flay 1987). In general, informational Management of Nicotine Addiction — 125 Surgeon General's Report or motivational campaigns can be effective in chang- ing smokers’ attitudes, but the effect of such campaigns on behavior is not clear, in part because of the paucity of well-controlled trials that yield a consistent pattern of findings. Research suggests that other types of cam- paigns have greater potential than informational pro- grams to influence smoking behavior, especially if the campaign has multiple components and intense ex- posure (Flay 1987; CDC 1996, 1999b; Pierce et al. 1998). Worksite Programs For many years, advocates for tobacco control have been enthusiastic about worksite-based programs, because worksites appear to furnish an ideal setting: a contained audience, an opportunity for smoker partici- pation, an environment in which to convey coherent and consistent messages, and an opportunity to tie in- dividual smoking cessation to overarching institutional policy. Much of the early work in this area provided some justification for the enthusiasm (USDHHS 1986; Glasgow 1987; Fielding and Piserchia 1989), but more recent data, described later in this section (Glasgow et al. 1995; Sorensen et al. 1996), give pause. The main components of smoking cessation efforts in the workplace are nonsmoking policies and specific assistance for cessation attempts (Gruman and Lynn 1993). The evolution of worksite smoking policies, in- timately tied to concerns about the health effects of en- vironmental tobacco smoke (ETS) (Eriksen 1986; USDHHS 1986), is described in some detail in Chapter 5. Although early assessment suggested that restric- tive policies had little effect on smoking outside of work (Glasgow 1987; Rigotti 1989; Tager 1989), most recent studies have demonstrated either reductions in daily consumption of cigarettes (Stillman et al. 1990; Borland et al. 1991; Jeffery et al. 1994) or increases in smoking cessation (Stave and Jackson 1991; Patten et al. 1995; Longo et al. 1996). As described in Chapter 5 (see “Clean Indoor Air Regulation”), there is persistent movement toward increasing restrictions in public workplaces. The strategies for smoking cessation within workplaces are largely those discussed earlier in this chapter: self-help, physician's advice, and formal treat- ment (Gruman and Lynn 1993). As of 1989, about one- half of worksites that sponsored cessation activities offered self-help materials (Fielding and Piserchia 1989). Although initial dropout rates were high, 20-26 percent of participants had quit smoking by 6-12 months after the worksite programs had begun (Orleans and Shipley 1982; Glasgow 1987). Such proportions compare favorably with those observed in general populations. Physician’s advice to quit 126 Chapter 4 smoking was a component of only about 15 percent of the company programs, but in a number of studies, this modality seemed to exert an effect similar to that observed in general populations: 15-30 percent of par- ticipants had quit smoking at the one-year follow-up (Gruman and Lynn 1993). The programs offering for- mal treatment appeared to produce results at the worksite that were similar to those found for such pro- grams outside the workplace. A special feature of worksite cessation programs is the opportunity to provide incentives, such as com- petitions. Several studies have documented some ef- ficacy in this approach. For example, in one study, 33 percent of participating workers and 25 percent of all workers remained abstinent at work (Glasgow 1987). Ina second study, the use of a competition was associ- ated with significantly greater success at quitting than was reported for persons not participating in the com- petition (Klesges et al. 1988). In a review of incentive programs, from 15 to 60 percent of participants quit smoking; the average was around 40 percent (Gruman and Lynn 1993). Some disadvantages of incentives are that (1) determining the award may be difficult, (2) employees may falsely claim cessation, and (3) non- smokers may feel slighted (Fiore et al. 1996). On a population basis, incentives have not been found to be effective. In these settings, incentives may be most attractive to smokers who were going to attempt quit- ting in any case (Chapman et al. 1993). In contrast, a trial of the Take Heart program, which involved 26 heterogeneous worksites, a low-cost intervention, random assignment, and use of worker and management steering committees, failed to pro- duce short-term improvements in smoking cessation that exceeded the secular trend (Glasgow et al. 1995). These results were particularly disheartening in view of the methodological strengths of the study and the diversity of the workplace settings. The authors offer a number of potential reasons for the lack of impact: the cessation activities may have been inappropriate; the behaviors may have been more resistant to change than previously assumed; workers may have had in- sufficient “ownership” of the project; secular trends may have been so strong that they canceled out a mod- est effect; the variability among worksites may have been too great; and, in general, worksite programs may not work. Similar negative findings were observed by Sorensen and colleagues (1996) in an even larger trial of 111 worksites randomized to sites receiving or not receiving the cessation program. The Working Well Trial involved more than 28,000 workers in 16 states and compared seven-day abstinence, six-month abstinence, and changes in smoking prevalence for both types of worksites. Changes occurred in the di- rection hypothesized, but they were small and non- significant; for exa mple, the six-month abstinence rate was only 1.5 percent higher in the program group. Similarly, the program sites showed a nonsignificant trend toward greater adoption of smoking bans. The authors observed that the overall cessation proportions at both types of sites compared favorably with those in other worksite programs. The lack of difference may have resulted from the higher than expected cessation at control sites, which is a phenomenon reflecting a general increase in antismoking awareness. These studies postdate recent reviews of worksite cessation efforts. Several early reviews expressed op- timism about the value of worksite programs but did not provide a quantitative assessment (Hallett 1986; Bibeau et al. 1988). In a detailed meta-analysis of 20 worksite programs involving 34 comparisons, Fisher and colleagues (1990) found that the mean weighted effect size was significantly positive and that an aver- age of 13 percent of participants had quit smoking af- ter treatment. Although modest, these effects provide some quantitative basis for the enthusiasm for worksite programs. The addition of the two recent large projects (Glasgow et al. 1995; Sorensen et al. 1996) may well alter the meta-analytic balance. Although the worksite setting has aforemen- tioned features favorable to large-scale programs (in- cluding the importance of adding to a generalized reduction in exposure to ETS), the strategy cannot be recommended without qualification. Nonetheless, the role of such activities, perhaps enlightened by further targeted research, may be important in multicompo- nent efforts at smoking cessation. Community Programs Results from a number of long-term trials of communitywide programs have recently appeared. (See Chapter 7 for a more detailed discussion of these projects in the context of approaches used in the 1990s.) These trials typically incorporate mass media strate- gies into larger health education programs. Some, such as the Stanford Five-City Project (Farquhar et al. 1990), the Minnesota Heart Health Program (Perry et al. 1992; Luepker et al. 1994), and the Pawtucket Heart Health Program (Elder et al. 1986; Carleton et al. 1995), have been aimed at modifying smoking, as well as other risk factors for cardiovascular disease. Final reports suggest that these trials have met with little success in promoting smoking cessation. Reducing Tobacco Use The Stanford Five-City Project (Farquhar et al. 1990; Fortmann et al. 1993) tested an intensive mullti- media approach, including television, radio, newspa- per, and mass-distributed printed materials. All materials contained information about modifiable risk factors for cardiovascular disease. The average resi- dent of a community receiving the program was ex- posed to more than 500 educational episodes over the course of the five-year program. By the end of this period, smoking prevalence—the only risk factor on which an impact could be demonstrated—had declined 13 percent more in the program communities than in the control ones. The Minnesota Heart Health Program failed to demonstrate an appreciable impact (Lando et al. 1995). The Pawtucket Heart Health Program had little impact on smoking behavior; its first attempt at a smoking cessation program prompted only 11 smokers to quit (Elder et al. 1986, 1987). The final results con- firmed the lack of impact (Carleton et al. 1995). One ambitious community project—COMMIT (Community Intervention Trial for Smoking Cessation)—focused on smoking cessation and on policy strategies to reduce prevalence (COMMIT Re- search Group 1991; Gruman and Lynn 1993). In 1986, the NCI began COMMIT, the largest randomized smoking intervention trial in the world. The design of COMMIT included 11 pairs of matched communities— 10 from across the United States and 1 in Canada. One community from each pair was randomly selected to be the site in which volunteers and local agencies car- ried out COMMIT’s 58 mandated program activities. Designed to augment existing community-based efforts to reduce smoking, these activities occurred between 1988 and 1992. The primary end point for COMMIT was smok- ing cessation among heavy smokers. Main goals in- cluded increasing the priority of smoking as a public health issue, increasing the community’s ability to in- fluence smoking behavior, strengthening the community’s existing economic and policy factors designed to discourage smoking, and fortifying social norms and values that stressed nonsmoking (Gruman and Lynn 1993). Main strategies included training health care providers to routinely assess and manage nicotine dependence, working with community insti- tutions and private organizations to create smoke-free environments, increasing the availability and visibil- ity of smoking cessation services, and using the mass media and schools to educate communities about the dangers of tobacco use. Results of COMMIT indicate that even intensive community-based programs may not have a demon- strable impact on smoking behavior (COMMIT Managentent of Nicotine Addiction 127 Sirgeon General's Report Research Group 1995a,b). Declines in smoking preva- lence were no greater in program communities than in control communities (COMMIT Research Group 1995b). Although the overall populations in the pro- gram communities became more aware of available resources for smoking cessation, the prevalence of smoking cessation among persons who smoked more than 25 cigarettes per day did not differ between pro- gram (18.0 percent) and control communities (18.7 percent). Persons who smoked fewer than 25 cigarettes per day were significantly more likely to quit in pro- gram communities than in control communities (30.6 vs. 27.5 percent), and that result was attributable to success among light smokers with less than a college education (COMMIT Research Group 1995a). Statewide Programs Recent statewide initiatives have integrated to- bacco policy and smoking cessation programs. Al- though Minnesota was the first state to implement a statewide initiative to reduce tobacco use, California has provided what is perhaps the most ambitious ex- ample. Massachusetts has also conducted a similar statewide effort based on a tax increase and incorpo- rating a mass media campaign, policy initiatives, and smoking cessation services. These initiatives and oth- ers are discussed in detail in Chapter 7. The state findings are promising. If this success is replicated by other states that adopt a dedicated in- crease in cigarette excise taxes, or that are able to use resources from settlements with the tobacco industry, statewide and nationwide initiatives may play an important role in achieving the public health goal of reducing smoking prevalence among U.S. adults to less than 12 percent by the year 2010 (USDHHS 2000). Summary of Large-Scale Public Health Programs Community- and media-based programs have the potential to reach large numbers of smokers who are reluctant to seek formal treatment. Such programs could greatly influence smoking prevalence in the United States. The results from major randomized tri- als and community-based efforts are thus especially _disappointing. Though these projects have set new standards for such research and have produced nu- merous ancillary results of interest, the overall con- clusions suggest that even large-scale, well-funded programs may have difficulty promoting changes in smoking behavior. Similarly, the results to date from numerous worksite cessation projects suggest either no impact or a small net effect. On the other hand, results of the California and Massachusetts initiatives (see Chapter 7) suggest that tobacco taxes may be an effective means of funding efforts to reduce tobacco use. The states that have devoted money obtained from Medicaid settlements with the tobacco industry have also had considerable success in implementing a comprehensive approach (Chapter 7). Their results suggest that the disappointing outcomes from research programs may be related to the reach and penetration of these programs and the isolated context in which they were conducted. Contemporary Issues in Research on Tobacco Addiction Epidemiologic Concerns and Clinical Issues Because smoking cessation research has focused more on improving standard paradigms than on in- novative approaches (Shitfman 1993b), much of the current energy is directed to pursuing well-trod paths. But current directions have an internal logic, because no new paradigms loom large. Established approaches are perhaps unfairly criticized for lacking innovation. As the foregoing discussion demonstrated, valid meth- ods for treating nicotine addiction are available, but {28 Chapter 4 they must be better understood and can be improved. Despite considerable research on smoking cessation during the past 40 years, the essential elements or com- bination of elements necessary for successful programs are difficult to extract. In a number of key areas, how- ever, careful research can sharpen interpretation of existing results and provide direction for future inves- tigation and perhaps even innovation. Nicotine Dependence Dependence, a central construct in research on drug abuse, has been defined as “self-administration of a psychoactive drug in a manner that demonstrates that the drug controls or strongly influences behav- ior” (USDHHS 1988, p. 248). Evidence strongly sug- gests that most smokers are dependent on nicotine (USDHHS 1988). However, most researchers agree that individual smokers differ in the degree to which they are dependent (Fagerstrém 1978; McMorrow and Foxx 1983; Pomerleau et al. 1983; Shiffman 1989: Killen et al. 1992; Niaura et al. 1994). Some occasional smokers may not meet the criteria for physical dependence (Shiffman et al. 1991). These differences in degree of nicotine dependence have important implications for treatment and research. Flaws in the assessment of nicotine dependence have impeded progress toward understanding its role in smoking cessation. For example, nicotine depen- dence consists of both physical and behavioral com- ponents (USDHHS 1988). However, most smoking cessation researchers have used the term to refer to physical dependence exclusively. Although items in two widely used nicotine-dependence assessment in- struments (the Fagerstro6m Tolerance Questionnaire and its successor, the Fagerstrom Test for Nicotine De- pendence) assess the extent to which nicotine controls behavior, the instruments are intended to measure physical dependence (Fagerstrém 1983; Fagerstrom and Schneider 1989; Heatherton et al. 1991). Other in- vestigators have measured dependence by how much nicotine smokers typically self-administer (Hurt et al. 1994) or by the severity of withdrawal symptoms (Brigham et al. 1990-91); these two measures are typi- cally not highly correlated with each other, and nei- ther is highly correlated with the Fagerstrom questionnaires (Kenford et al. 1994), Furthermore, the scales themselves, especially the Fagerstrom Tolerance Questionnaire, suffer from psychometric limitations (Lichtenstein and Mermelstein 1986; Pomerleau et al. 1989; Tate and Schmitz 1993). In sum, tobacco research is hampered by an inadequate conceptualization of nicotine dependence and an inadequate assessment of the nicotine dependence construct. Because widely used dependence instruments such as the Fagerstrém questionnaire are thought to measure physical dependence, it has been hypothesized that they can help identify patients who would benefit from nicotine replacement therapies (Fagerstrom and Schneider 1989) or from higher doses of these thera- pies. The evidence for this assertion is mixed, with support somewhat more consistent for the nicotine Reducing Tobacco Use gum than for the nicotine patch (Abelin et al. 1989; Fagerstr6m and Schneider 1989; Transdermal Nicotine Study Group 1991; Killen et al. 1992; Kenford et al. 1994; Niaura et al. 1994; Tang et al. 1994). To the ex- tent that current measures capture variation in depen- dence, they would be expected to predict outcome in trials not using nicotine replacement and in groups of subjects treated with placebo nicotine replacement. Although this hypothesized correlation between de- pendence measures and outcome has been found in several studies (Fagerstrém and Schneider 1989), the correlations have tended to be weak (Gritz et al. 1991; Kozlowski et al. 1994) and have usually been signifi- cant only at relatively short-term follow-up points (Hall and Killen 1985; Pinto et al. 1987; Gritz et al. 1991; Norregaard et al. 1993). Specialized assessments of nicotine dependence are not recommended in current treatment guidelines, and pharmacotherapy is recom- mended for all tobacco users interested in quitting. The one exception is that highly dependent smokers may derive more benefit from 4-mg (as compared with 2-mg) nicotine gum (Fiore et al. 2000). Other measures of nicotine dependence have been developed, but these have fared no better than the Fagerstr6m questionnaire. For example, the Heaviness of Smoking Index, a derivative, offers no advantage in predicting cessation (Kozlowski et al. 1994). Older mea- sures of smoking motives, such as the Horn-Waingrow Reasons for Smoking Scale (Horn and Waingrow 1966) and McKennell’s occasion for smoking scales (McKennell 1970), have good psychometric properties but questionable construct validity (Shiffman 1993a). Continued reconceptualization of nicotine de- pendence and improved consensus on mechanisms for measuring it are critical issues for future study. Stron- ger ties to generic issues of substance abuse—already begun but not discussed in detail here (see Orleans and Slade 1993)—can facilitate such research and im- prove recognition of behavioral mechanisms that are common to the use of all addictive substances. Stages of Change Smokers differ in their motivation to quit smok- ing, and these differences are thought to affect treat- ment prognosis. The transtheoretical model, advanced by Prochaska and DiClemente (1983), provides a theo- retical structure for assessing these differences and has greatly influenced smoking cessation research in re- cent years. Briefly, the model proposes that smokers go through a series of stages (not necessarily linearly) on the way to achieving prolonged abstinence from smoking: not thinking seriously about quitting in the Management of Nicotine Addiction 129 Surgcolt General's Report next six months, thinking seriously about quitting in the next six months, planning to quit in the next month, actually trying to quit, and trying to remain abstinent. If relapse occurs, smokers return to an earlier stage in the model. It is hypothesized that smokers in the ini- tial stages are less ready to quit and thus less likely to profit from traditional treatments (see Orleans 1993 for a more detailed discussion). Some evidence supports the notion that smok- ers in earlier stages of change fare worse in smoking cessation than do smokers in later stages (DiClemente et al. 1991; Kristeller et al. 1992; Ockene et al. 1992; Rohren et al. 1994). The finding of interactions between treatment assignment and stage membership (Prochaska et al. 1993) has led to the recommendation that clinical protocols for smoking cessation be based on stage assessments (Abrams 1993; Orleans 1993; Velicer et al. 1993; Hughes 1994). Evidence is not available, however, that linking motivational stage to a stage-appropriate strategy leads to better outcomes than do nontailored interven- tions of equal intensity (see Prochaska et al. 1993; Fiore et al. 2000), perhaps because motivation to change is more a continuum than a set of discrete states (Lichtenstein et al. 1994). Nonetheless, the stages-of- change model has considerable theoretical and empiri- cal appeal as a typology that is easy to use in day-to-day decision making (Wiggins 1988). Further refinement and clarification of this model, coupled with continued assessment of its relationship to smok- ers’ probability of quitting, is a potentially fruitful re- search area. Negative Affect A negative affective reaction to quitting tobacco use (Baker et al. 1987; Brandon 1994; Hall et al. 1994) may be an important predictor of relapse (Shiffman 1982; Brandon et al. 1990; Piasecki et al. 1997). As mentioned previously, depressed persons are less likely to quit smoking successfully than persons with- outa history of depression (Glassman et al. 1988; Anda et al. 1990), and depressed persons suffer an increase in symptoms after quitting (Covey et al. 1990; Hall et al. 1991). These related findings have special impor- tance because the frequency of clinical depression among smokers may exceed that among nonsmokers (Frederick et al. 1988; Hall et al. 1991; Brandon 1994). The role of adverse psychological states—even mild conditions—in prolonging smoking and imped- ing cessation is an important avenue for further in- vestigation. For example, depressed or otherwise affectively disturbed persons may require special 130 Chapter 4 interventions to succeed in smoking cessation; at least two studies have identified behavioral treatments that have boosted success rates among such persons (Zelman et al. 1992; Hall et al. 1994). As noted, antide- pressants and anxiolytics have been proposed as smok- ing cessation aids and are undergoing clinical trials because of their ability to ameliorate negative affects. Sex-Specific Differences Some studies (Pomerleau et al. 1991; Kenford et al. 1993; Swan et al. 1993), but not all (Derby et al. 1994; Whitlock et al. 1997; Gritz et al. 1998), have suggested that women find it more difficult than men to quit smoking. The quit ratio (the proportion of persons who have quit smoking out of those who ever smoked) has increased at the same rate or at a faster rate among women than men in recent years (Fiore et al. 1989; Giovino et al. 1994; Husten et al. 1996). An extensive review of difference in nicotine effects between men and women (Perkins et al. 1999) cites complex differ- ences in psychological and biologic aspects in the main- tenance of nicotine self-administration. Women may differ from men in the response to withdrawal, possi- bly mediated by menstrual cycle phase (Perkins et al. 2000), as well as a variety of nonnicotine effects (Perkins et al. 1999). For example, although the same treatments benefit both women and men, some treatments (e.g., nicotine replacement therapies) may be less efficacious in women (Perkins 1996; Wetter et al. 1999; Fiore et al. 2000). Other reviews of this phenomenon (Fant et al. 1996; Christen and Christen 1998) confirm the need for further exploration of such differences. A further difference between men and women may be related to genetic factors, particularly differ- ences by sex in the metabolism of nicotine (Messina et al. 1997; Tyndale et al. 1999). These studies have fo- cused on differences in the roles of enzymes involved in the metabolism of nicotine to cotinine (enzymes CYP2A6 and CYP2D6). The considerable variability in nicotine metabolism appears to be due to variable expression of CYP2A6 (Messina et al. 1997) and may play a role, as yet undefined, in gender response to therapeutic modalities. Other researchers, using stud- ies of twins, have postulated that genetic factors may play a role in predicting which cigarette smokers progress to long-term addiction, an effect that may be stronger for men than for women (Heath et al. 1998). Withdrawal Symptoms The vast majority of smokers become physically dependent on nicotine, and these persons commonly display several withdrawal symptoms when deprived of the substance (Shiffman and Jarvik 1976; USDHHS 1988; Hughes et al. 1991b). Conventional wisdom holds that two persons who have different degrees of nico- tine dependence will have different degrees of with- drawal severity when they quit smoking (Fagerstrom 1978; Gritz et al. 1991; Hughes 1993). Withdrawal symptoms are presumed to give a conflicting (and of- ten canceling) motivation to people who have other- wise been motivated to quit (West 1984; Hughes et al. 1991b). The severity of the withdrawal is thus expected to be a strong predictor of eventual relapse (Gritz et al. 1991; West 1992; Hughes 1993). Some research sug- gests that the various discomforts of abstinence are valid indicators of eventual relapse (Baker et al. 1987; Anda et al. 1990; Hughes 1992; Zelman et al. 1992). Despite the intuitive appeal of this proposed associa- tion, other studies have found an inconsistent relation- ship between withdrawal severity and relapse (Hughes et al. 1984; Hughes and Hatsukami 1986; Stitzer and Gross 1988; West et al. 1989; Transdermal Nicotine Study Group 1991; Prochazka et al. 1992; West 1992; Hughes 1993). Interpretation of this literature remains complicated because researchers use different instru- ments to assess withdrawal, sometimes reporting total withdrawal discomfort and other times reporting re- sults on a symptom-by-symptom basis, and because they assess symptomatology at different time points. Improved assessment of withdrawal and consensual definitions, coupled with epidemiologic assessment, may better clarify the critical connection between the withdrawal syndrome and the likelihood of relapse. Recent studies demonstrate that there is considerable between-subject variability in the time course of smok- ing withdrawal and suggest that more consistent links between withdrawal and relapse may be found if this variability is systematically assessed (Piasecki et al. 1998). Weight Gain As noted earlier in the discussion of specific modalities, weight gain is a common concomitant of smoking cessation (Klesges et al. 1989). The average smoker gains 5-10 pounds after cessation, and a small percentage of smokers gain more than 25 pounds (Klesges et al. 1989; Williamson et al. 1991). The con- cern that smokers express about gaining weight may be great enough to prevent them from attempting to quit (Klesges et al. 1988; Gritz et al. 1989; French et al. 1992). Similarly, persons who quit smoking and who do subsequently gain weight may be more likely to relapse (Wack and Rodin 1982; Hall et al. 1986). Two Reducing Tobacco Use prospective studies, however, found that concern about weight did not predict cessation success (French et al. 1995; Jeffery et al. 1997). Innovative strategies have failed to reduce weight gain or to improve absti- nence rates among persons concerned about gaining weight (Hall et al. 1992; Pirie et al. 1992). Because weight change is a complex metabolic phenomenon (about which there is a considerable epidemiologic and biologic literature, not reviewed here) that is subject to the interplay of behavioral and pharmacologic in- fluences, further research on the behavior and physi- ological mechanisms that produce postcessation weight gain may suggest new strategies for dealing with this problem and may provide insights into mechanisms of addiction. Early Relapse Three recent reports from four trials of the nico- tine patch have found that any smoking during the first two weeks of using either the nicotine or the pla- cebo patch is a strong predictor of relapse at long-term follow-up (Hurt et al. 1994; Kenford et al. 1994; Stapleton et al. 1995). For example, Kenford and col- leagues (1994) analyzed data from two patch trials. In both trials, large proportions (97.1 and 83.3 percent) of patients treated with the nicotine patch who smoked during the second week of treatment had relapsed by the six-month follow-up. Early relapse may predict longer-term failure—regardless of the cessation strat- egy, if any—because physiological and behavioral forces may present their most significant challenges to smokers during the first two weeks they try to quit. Strategies that could shepherd smokers through the first two weeks without a single cigarette might be expected to improve treatment outcome. According to another view, most lapses during the first two weeks of treatment merely identify those smokers who will find it difficult to quit no matter what the interven- tion. Even if given adjunctive interventions to help them pass this two-week period without smoking, these smokers would be expected to relapse soon af- ter these adjuncts were withdrawn. Research on treat- ments for persons who are strongly addicted and likely to relapse early (should they attempt cessation at all) is a great challenge for cessation research. Dose-Response More intense interventions yield better outcomes (Kottke et al. 1988; Lichtenstein and Glasgow 1992; Fiore et al. 1994c, 2000). Although this general rela- tionship has not been precisely explained, outcomes Management of Nicotine Addiction 131 Surgeon General's Report may be influenced by a host of structural factors, in- cluding session length, session frequency, total num- ber of sessions, and number and types of treatment modalities (e.g., telephone contacts and individual vs. group formats). More specific issues must be clarified, such as determining what level of adjuvant behavioral sup- port is most cost-effective when used with pharmaco- therapy. However, a central question surrounding the use of intensive interventions is whether a greater pro- portion of smokers can be motivated to enroll in such treatment. Debate over whether program refinements can improve outcomes may be moot, from a public health perspective, if most smokers continue to shy away from—or cannot afford to spend the time or money needed for—intensive interventions (Fiore et al. 1990; Lichtenstein and Hollis 1992). A final area for dose-response research concerns the optimal dose for nicotine replacement. Two recent studies (Jorenby et al. 1995b; Hughes et al. 1999) have found that dou- bling the normal patch dose does not improve cessa- tion outcomes. There may be some benefit, however, to combining different smoking cessation pharmaco- therapies (Blondal et al. 1999; Jorenby et al. 1999), in- cluding two different nicotine pharmacotherapies (Fiore et al. 2000). Treatment Components Defining the individual impact of treatment com- ponents will require controlled trials that systemati- cally manipulate individual treatment components against a background of constant treatment intensity. As Lichtenstein and Glasgow (1992) have noted, smok- ing cessation researchers have largely abandoned this line of research because most comparison studies (though not all; see Stevens and Hollis 1989) failed to find significant treatment effects. Nonetheless, until the combined effects of treatment components can be determined, empirical design of multicomponent treat- ments will be difficult. Individualized Treatment Investigators have become increasingly inter- ested in seeking interactions between treatment con- tent and smokers’ characteristics. Identifying such interactions would allow individual smokers to be given specific interventions to maximize their chances of attaining long-term abstinence. Although subject- by-treatment interactions have been obtained (Zelman 132 Chapter 4 et al. 1992; Niaura et al. 1994), these relationships re- main too elusive to suggest an overall strategic theory. Research that incorporates unconfounded compari- sons of specific ingredients may suggest algorithms for matching patient and treatment. In view of the increasing presence of the computer in many people’s lives, computer-assisted tailored treatments warrant further exploration. Some tailoring and individual- ization may be appropriate for older smokers whose other medical problems and pharmacologic treatment must be given special consideration (Rimer and Or- leans 1993). Currently, however, there is insufficient evidence to recommend individually tailored interven- tions (Fiore et al. 2000). Analternative to treatment matching is the strat- egy of offering smokers increasingly more intensive treatments as they continue to have trouble quitting (Abrams 1993; Orleans 1993), despite the risk that this strategy will reinforce failure. There is insufficient evidence, however, to recommend sucha stepped-care approach (Fiore et al. 2000). Research must first re- veal hierarchies of treatment as well as determine when patients should be given more intensive interventions. Dissemination and the Role of the Clinician Because self-help and minimal clinical interven- tions are likely to continue to be the preferred method of cessation for most smokers, innovative strategies must be developed to improve efficacy and delivery (Cohen et al. 1989b; Orleans et al. 1991; Fiore et al. 1995). Some of the most effective of the minimal clini- cal interventions include the institutionalization of system changes as core components of health care (Glynn and Manley 1993; Fiore et al. 2000). For ex- ample, having a screening system in place to identify smokers triples clinician intervention (Fiore et al. 2000). Dissemination is intimately tied to the willing- ness of clinicians to advise their patients about smok- ing. An important area for ongoing research is the investigation of strategies that foster this behavioral role not only among physicians but also among a broad range of health care providers, including dentists, nurses, pharmacists, chiropractors, psychologists, phy- sician assistants, and pulmonary technicians. But it is unlikely that behavioral modification for clinicians would be sufficient to produce the required dissemi- nation. Reimbursement policies, financial incentives, and underlying institutional support are all critical for the effective management of tobacco addiction through clinical interventions (Kaplan et al. 1995; Rothenberg et al. 1998). Cost-Effectiveness Ultimately, the test of clinical modalities for treat- ment of nicotine addiction will be their survival in the current environment of cost containment and managed care. Private insurers are unlikely to embrace such treat- ment unless “they are convinced that there is a market for such a product and that it is viable financially” (Schauffler and Parkinson 1993, p. 189). For public in- surers, demonstration of cost-effectiveness has become the de facto standard for adoption of new technology (G. Wilensky, cited in Schauffler and Parkinson 1993, reference 17), though some may insist on cost-savings, a strict standard of proof, for preventive practices. Smoking cessation has been called the “gold stan- dard” of cost-effective interventions (Eddy 1992). A number of studies (and several reviews [Elixhauser 1990; CDC 1992; Tsevat 1992]) have addressed issues of cost-effectiveness in behavioral counseling. Cummings and colleagues (1989c) calculated that the cost-effectiveness of brief office counseling during a routine visit ranges from $705 to $988 per year of life saved for men and from $1,204 to $2,058 for women. The use of nicotine gum increases the cost-effectiveness fourfold. Oster and colleagues (1986) performed a similar study incorporating nicotine gum with brief office counseling. The costs per year of life saved ranged from $4,113 to $6,465 for men and from $6,880 to $9,473 for women. Both studies noted that these costs compare favorably with those derived for other widely accepted preventive practices. Altman and colleagues (1987) found that self-help materials cost $22-144 per person who quit, a cessation contest costs $129-239, and a cessation class costs $235-399. In the setting of acute myocardial infarction, Krumholtz and colleagues (1993) concluded that a nurse-managed smoking cessation program after myocardial infarction was cost-effective, particularly when compared with other modalities. (These studies are not necessarily reported in standardized dollars.and are then only roughly com- parable.) An analysis of the cost-effectiveness of imple- menting the 1996 Agency for Health Care Policy and Research-sponsored Clinical Practice Guideline Smok- ing Cessation reported that cost per quality-adjusted- life-year saved ranged from $1,108 to $4,542. This compares very favorably with $61,744 for annual mam- mography for women aged 40-49 years and $23,335 for hypertension screening in 40-year-old men (Crom- well et al. 1997). Because smoking during pregnancy is associated with lower birth weight, which in turn has been linked to various adverse outcomes of pregnancy, cessation of Reducing Tobacco Use smoking in pregnancy has been the subject of a num- ber of economic analyses. Several of these have been performed in a managed care setting. Using patients in a study performed by the Maxicare Research and Educational Foundation, Ershoff and colleagues (1990) weighed the intervention’s programmatic costs against the smoking-related increased costs of medical care in- curred by mothers who continue smoking and by their infants. The program consisted of an initial interview, smoking counseling by a health educator, and a series of self-help books mailed to participants. The nonsmok- ing message was reinforced at prenatal care visits. The investigators concluded that in a health maintenance organization of 100,000 members, the cost savings from the cessation program was $13,432, the net benefit was $9,202, and the benefit-to-cost ratio was 3.17:1. Windsor and colleagues (1988) compared three cessation protocols for women in public health mater- nity clinics: standard care, standard care combined with use of a cessation manual developed by the Ameri- can Lung Association, and standard care combined with the use of that manual and a pregnancy-specific manual. At the end of pregnancy, smoking cessation had been achieved by 2 percent, 6 percent, and 14 per- cent, respectively, of women in the three groups. The investigators calculated cost-effectiveness as the cost per patient divided by the percentage who quit. The respective values were $104.00, $118.83, and $50.93. In a second study (Windsor et al. 1993), the treatment group in a multicomponent intervention involving counseling and support had a cessation rate of 14.3 percent, and the control group had a rate of 8.5 per- cent. Under varying assumptions, the economic analy- sis found that benefit-to-cost ratios ranged from 6.72:1 to 17.18:1 and that estimated savings from statewide use of the program ranged from $247,296 to $699,240. Marks and colleagues (1990) estimated the ben- efits that would accrue from shifting low-birth-weight infants into the normal-birth-weight category, from averting deaths attributable to prematurity, and from avoiding the long-term costs associated with the care of premature infants. They concluded that the ratio of savings to costs would be as high as 6:1. If long-term costs were omitted, the ratio would still be $3.31 for each $1 spent. Finally, in a somewhat different ap- proach to the problem, Shipp and colleagues (1992) tried to identify the break-even point for the cost of a smoking cessation program. Under general circum- stances, the break-even cost was $32 per pregnant woman, but this cost varied from $10 to $237, depend- ing on the probability of adverse outcomes in various populations. Management of Nicotine Addiction 133 Surgeon General's Report As Schauffler and Parkinson (1993) point out, economic analyses of smoking cessation are often based on hypothetical populations, start with differ- ent assumptions about prevalence and intervention effectiveness, and differ in their estimation of out- comes. Although initial results are encouraging, con- siderable work is needed to codify the results and make them appealing to insurers and employers. In a re- cent survey, only 8.6 percent of large corporations in California had even considered using smoking status in their risk ratings, and only 2.2 percent had imple- mented such a rating. About 20 percent of companies offered plans that covered smoking cessation services (Schauffler and Parkinson 1993). Perhaps observations comparing long-term hospitalized care of smokers and nonsmokers will alter this policy. A recent study esti- mated that helping one smoker to quit reduces antici- pated medical costs associated with acute myocardial infarction and stroke by $893 over seven years (Lightwood and Glantz 1997). Wagner and colleagues (1995) point out that smokers have consistently Conclusions increasing rates of hospitalization over five to six years of follow-up. In contrast, smokers who quit have increased hospitalization during the year in which they quit (probably associated with the medi- cal reason—e.g., emphysema—for quitting in many cases); this rate declines thereafter. The authors note that the cost savings that accrue from reduced utili- zation would more than pay for effective cessation interventions within three to four years. The alteration of terminology—from “smoking cessation” to “treatment of nicotine dependence” — acknowledges the need to make cessation activity con- sonant both with modern medical practice and with the current climate for health care delivery. The cur- rent body of evidence suggests that efficacious and cost-effective therapeutic modalities are available and that such consonance can be achieved. Further inves- tigation not only of theoretical cost-effectiveness but also of actual use-effectiveness will have considerable impact on institutionalizing the treatment of nicotine addiction. 1. Tobacco dependence is best viewed as a chronic disease with remission and relapse. Even though both minimal and intensive interventions in- crease smoking cessation, most people who quit smoking with the aid of such interventions will eventually relapse and may require repeated at- tempts before achieving long-term abstinence. Moreover, there is little understanding of how such treatments produce their therapeutic effects. 2. There is mixed evidence that self-help manuals are an efficacious aid to smoking cessation. Be- cause these materials can be widely distributed, such strategies may have a significant public health impact and warrant further investigation. 13-4 Chapter 4 3. Programs using advice and counseling—whether minimal or more intensive—have helped a sub- stantial proportion of people quit smoking. 4. The success of counseling and advice increases with the intensity of the program and may be im- proved by increasing the frequency and duration of contact. 5. 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Management of Nicotine Addiction — 155 Chapter 5 Regulatory Efforts Introduction 159 Food and Drug Administration (FDA) Regulations 159 Initial Attempts at Multistate Settlement and Federal Legislation 160 Public and Private Litigation 160 Advertising and Promotion 161 Introduction 161 Attempts to Regulate Tobacco Advertising and Packaging 163 Cigarette Warning Labels 163 Broadcast Advertising Ban 165 A Midcourse Assessment 166 Smokeless Tobacco Warning Labels 167 Regulation of Tobacco Packaging 168 Examples of Product Labeling in Other Countries 169 Tobacco Advertising, Commercial Speech, and the First Amendment 170 Constitutionality of Regulating Advertising 171 Constitutionality of Regulating Tobacco Advertising 172 A Critical Example: Joe Camel 177 Product Regulation 178 Introduction 178 The Constituents of Smoke From Manufactured Cigarettes 179 Regulation by Tar Levels 179 Implications of Nicotine Levels 180 Other Constituents in Cigarette Smoke 181 Additives to Tobacco Products 182 Cigarette Additives 182 Smokeless Tobacco Additives 183 The Low-Tar “Alternative” 184 Compensatory Smoking 184 Health Risks From Low-Tar Cigarettes 184 Nicotine Replacement Products 185 Product Regulations for Consumer Education 185 Tobacco Packaging and Informed Choice 186 Tobacco Use and Informed Consent 186 Further Regulatory Steps 187 Judicial Developments and the Status of FDA Regulations 189 The Court of Appeals Ruling on FDA Authority 190 The U.S. Supreme Court Ruling on FDA Authority 191 Legislative Developments 191 Master Settlement Agreement 193 Clean Indoor Air Regulation 193 Introduction 193 Health Consequences of Exposure toETS 195 Other Consequences of ETS 196 Prevalence of Exposure toETS 196 Legal Foundation for Regulation of Public Smoking 197 Status of Restrictions to Limit Smoking in Public Places 197 Government Restrictions 199 Private Sector Restrictions on Smoking in Workplaces 201 Effectiveness of Clean Indoor Air Restrictions 202 Population-Based Studies 202 Effects of Restrictions on Smoking Behavior 203 Case Studies of State and Local Smoking Restrictions 206 Minors’ Access to Tobacco 207 Introduction 207 Efforts to Promote Adoption and Enforcement of Minors’ Access Laws 209 Restrictions on Distribution of Samples 211 Regulation of Means of Sale 211 Regulation Directed at the Seller 214 Regulation Directed at the Buyer 216 Enforcement of Laws on Minimum Ages for Tobacco Sales 216 State Settlements 222 Preemption of Local Action by State Policy 223 Litigation Approaches 223 Introduction 223 Private Law as a Means of Risk Control 224 Tort as a Private Law Control 224 U.S. Reliance on Private Law Controls 224 Potential Public Health Benefits of Tobacco Litigation 224 The First Two Waves of Tobacco Litigation 225 The First Wave 225 The Second Wave 226 The Aftermath of the First Two Waves 227 The Third Wave of Tobacco Litigation 229 Common-Law Claims 230 Statutory Claims 231 Individual Third-Wave Cases 235 Aggregation Devices 235 Class Actions 235 Recovery Claims by Third-Party Health Care Payers 238 Small Claims Tribunals to Recover the Cost of Quitting 243 Other Cost Reduction Procedures 243 Claims of Nonsmokers 243 Enhancing Prohibitory Regulation by Private Litigation 250 The International Dimension of Tobacco Litigation 251 Counterthrust: Tobacco Industry Initiation of Litigation and Other Tactics 252 Anticipatory Effects 255 Criminal Proceedings 256 Nature, Extent, and Focus of the Criminal Investigation 257 Key Sources of Evidence 258 Initial Results of the Criminal Investigation 258 Prognosis for Future Actions Through the Criminal Justice Process 259 Comment 259 Conclusions 260 References 262 Introduction Reducing Tobacco Use Efforts to regulate the use of tobacco date back to its introduction to European colonists of North America (see Chapter 2). As noted, these early move- ments to restrict tobacco use were motivated less by health concerns than by complex political, economic, and social factors. With the appearance in the 1950s of substantial scientific evidence on specific health risks of smoking, and with subsequent dissemination of that information in the 1960s, general support for a gov- ernment regulatory response emerged. As noted in Chapter 1, such regulatory activities do not necessarily fit the traditional concept of “inter- vention,” but their effect is to change the way people use tobacco. Because advertising and promotion are perhaps the chief social force for continued tobacco use, their regulation—or the failure to regulate them— can have substantial effects on smoking prevalence. The manner in which the product is manufactured, packaged, and distributed can similarly influence people’s decision to smoke. Regulation of smoking in public places provides an opportunity to reduce the quantity of tobacco used, the prevalence of smoking, and the exposure of nonsmokers to environmental to- bacco smoke. The regulation of minors’ access to ciga- rettes has considerable potential for postponing or preventing the uptake of smoking, thereby making a long-term impact on the smoking epidemic. Finally, personal litigation and the tort system can influence the policies and practices of the tobacco industry and can have an impact on social perceptions of smoking. Thus, if a broad definition of intervention can be entertained, each of these regulatory processes can be assessed for the nature of its influence on the use of tobacco. Unlike assessments of more traditional in- terventions (see Chapters 3 and 4), evaluation of regu- latory processes must invoke a different set of measurement tools that are less quantitative but not necessarily less compelling (see Chapter 1). Several key developments in the mid-to-late 1990s have propelled tobacco regulation in new direc- tions and into new forums. Three key events have catalyzed these changes. They are discussed briefly in the next sections and in greater detail later in this chapter in “Further Regulatory Steps” and “Litigation Approaches.” Food and Drug Administration (FDA) Regulations First, on August 28, 1996, after receiving public comment on a proposed rule, the FDA issued final regulations restricting the sale, distribution, advertis- ing, and promotion of cigarettes and smokeless tobacco (Federal Register 1996). Several tobacco companies, re- tailers, and advertisers sued the FDA to block the implementation of the regulations, arguing that the agency lacked the jurisdiction or authority to regulate these products and that the proposed advertising re- strictions violated the First Amendment of the United States Constitution (Coyne Beahm, Inc. v. Food and Drug Administration, No. 2:95CV00591 [N.C. Aug. 10, 1995], cited 111 10.5 Tobacco Products Litigation Reporter [TPLR] 3.379 [1995]). On April 25, 1997, the federal district court in Greensboro, North Carolina, ruled that the FDA had the authority to regulate cigarettes and smokeless to- bacco products, as drug delivery devices, under the Federal Food, Drug, and Cosmetic Act (Coyne Beahmn, Inc. v. U.S. Food & Drug Administration, 966 F. Supp. 1374 [M.D.N.C. 1997]}. The court upheld all of the FDA’s 1996 restrictions involving youth access to to- bacco products and regulating product labeling. How- ever, the court “stayed,” or temporarily blocked, implementation of most of these provisions. The only FDA regulations that escaped this stay were the pro- hibition on sales of cigarettes and smokeless tobacco to minors and the requirement that retailers check photo identification of customers who appear to be under 27 years of age. These provisions went into ef- fect on February 28, 1997. The age and identification provisions remained in force until the Supreme Court's March 21, 2000, decision. Most notably, the court invalidated the FDA's restrictions on the advertising and promotion of ciga- rettes and smokeless tobacco. Both sides in the FDA case appealed the decision to the Fourth Circuit of the United States Court of Appeals in Richmond, Virginia. A three-member panel of the court overturned the lower court's decision and ruled that the FDA lacked the authority to regulate tobacco products. The full Fourth Circuit Court of Appeals declined to review Regulatory Efforts 159 Surgeon General’s Report this reversal. The government petitioned the United States Supreme Court for review, and the Supreme Court accepted the case in April 1999. Oral argument was held December 1999, and the Court, in a5 to 4 decision, upheld the Fourth Circuit's decision on March 21, 2000. The FDA continued to enforce the age and photo identification provisions while the case was appealed to the United States Supreme Court. On March 21, 2000, the Supreme Court ruled that although premature deaths from tobacco use present “one of the most troubling health problems facing our nation to- day” (Food and Drug Administration v. Brown & Williamson, 529 U.S. [2000], 120 S. Ct. 1291), the FDA lacks the authority to issue and enforce its tobacco regulations. These developments, central to most of the regu- latory efforts covered in this chapter, are discussed in detail in the major section “Product Regulation,” later in this chapter. Initial Attempts at Multistate Settlement and Federal Legislation Second, on June 20, 1997, a group of 41 state at- torneys general presented a tobacco settlement pro- posal to the American public (Tobacco Products Litigation Reporter 1997a; see “Legislative Developments” and “Master Settlement Agreement,” later in this chapter). In essence, the proposal was intended to settle all pend- ing lawsuits against the tobacco industry brought by states and other governmental entities as well as all pending class action lawsuits. Although the settlement did not include 9 of the 50 states, its scope was inher- ently national: to enact its stipulated regulations of the tobacco industry, the settlement presumed the pas- sage of congressional legislation that would necessar- ily affect the legal rights of all Americans. The settlement included provisions for FDA authority, new warning labels, advertising restrictions, youth access prohibitions, rules to reduce public exposure to envi- ronmental tobacco smoke, and a provision designed to provide financial incentives for tobacco manufac- turers to reduce sales to underaged consumers. Despite its intuitive appeal—that the slow, and largely unsuccessful, course of change possible through individual lawsuits would be retired for a sweeping, national, unified policy that dealt with the tobacco problem—the settlement raised concerns from the start. Public health advocates recognized that given the settlement’s national scope, it was taking on the role of being the chief public health policy tool for reducing tobacco use. These critics feared that the 160 Chapter 5 settlement (and moreover the legislation it presumed) would fail in this role. In particular, by limiting future lawsuits against the tobacco industry, the settlement might in the end benefit the industry more than the public. A number of bills filed in Congress in 1997 and 1998 intended to codify the terms of the proposed na- tional settlement. One of the bills, S. 1415 (National Tobacco Policy and Youth Smoking Reduction Act, 105th Cong., 2nd Sess., S. 1415, Congressional Record, 144:55034-S5084), which ultimately departed from the settlement proposal in a number of areas, was debated on the Senate floor for several weeks. It was vehe- mently opposed by the tobacco industry and rejected by the Senate almost one year to the day after the at- torneys general announced the proposed national settlement. The regulatory implications of the national settlement proposal are discussed together with the FDA rules, primarily in the “Product Regulation” sec- tion of this chapter. Ultimately, this activity served as prologue to a Master Settlement Agreement that was negotiated in November 1998. On November 23, 1998, the agree- ment was reached between state attorneys general and major U.S. tobacco companies to settle pending and prospective lawsuits by states to recover Medicaid expenditures incurred as a result of tobacco use. Forty- six states signed the agreement, pending the required ratification in state courts (four states settled separate, individual lawsuits with the industry). The agreement requires tobacco companies to pay $246 billion to states over 25 years and to adhere to specified restrictions on tobacco advertising and promotion. Some provi- sions are also made for improved disclosure of tobacco industry documents released in litigation. A separate, parallel agreement with the United States Tobacco Com- pany was negotiated for smokeless tobacco products. Public and Private Litigation Third, throughout 1997 and 1998, while federal legislation was being filed and debated, the states of Mississippi, Florida, Texas, and Minnesota settled their lawsuits against the tobacco industry. Besides produc- ing sizable settlement funds for the individual states, these settlements (in all but Mississippi) feature provi- sions akin to public health regulations. For example, the Florida settlement (Florida v. American Tobacco Co., Civil Action No. 95-1466 AH, secs. JI.A.1 and IL.A.2 [Fla., Palm Beach Cty. Aug. 25, 1997]) was the first to incorporate a ban on outdoor advertising and to call for statewide restrictions on vending machines. The Minnesota settlement (Minnesota v. Philip Morris Inc., No. C1-94-8565 [Minn., Ramsey Cty. May 8, 1998], cited in 13.2 TPLR 3.39 [1998]), which followed a trial and the release of thousands of incriminating internal docu- ments from the tobacco industry, contains an even wider array of public health restrictions, including a ban on promotional items and a national prohibition on com- mercial placement of tobacco products in movies. Settlements of other private suits against the in- dustry in the late 1990s have also resulted in impor- tant regulatory measures. For example, ina class action lawsuit alleging that flight attendants were injured by exposure to environmental tobacco smoke (Broit 2. Philip Morris Inc., No. 91-49738 CA [22] [Fla., Dade Cty. Oct. 9, 1997], cited in 12.6 TPLR 3.397 [1997]), the to- bacco industry agreed to support legislation banning smoking on all airlines departing from or landing in the United States. In a California case, RJ. Reynolds Advertising and Promotion Reducing Tobacco Use Tobacco Company agreed to accept advertising restric- tions and to fund counteradvertising programs for teens. The latter provision was based on a claim that the company was violating the California consumer protection law by using their Joe Camel advertising campaign to target minors (Mangini v. R.J. Reynolds Tobacco Co., No. 939359 [Calif. Sept. 8, 1997], cited in 12.5 TPLR 3.349 [1997]). As of September 1998, these nonnational litiga- tions against the tobacco industry had had a greater and more immediate impact on tobacco regulation than the delayed FDA rules, proposed national settle- ment, and defeated federal legislation. Regulation through litigation is a new tool for reducing tobacco use. Specific regulatory measures contained in these smaller-scope settlements are discussed in relevant sections of this chapter. Introduction Industries use various marketing tools and strat- egies to influence consumer preference, thereby in- creasing market share and attracting new consumers. The tobacco industry is among the most intense in its efforts; among U.S. manufacturers, only the automo- bile industry markets its products more heavily (Cen- ters for Disease Control [CDC] 1990a). It may be assumed that cigarette manufacturers, like other in- dustrial entities, direct their money and marketing ef- forts in ways that will reach consumers they believe are most likely to purchase their products. The ensu- ing discussion focuses on direct product marketing and excludes other promotional and public relations efforts that are not product specific. The potential influence of cigarette advertising and promotion on smoking prevalence has been a sub- ject of concern and debate for many years (U.S. De- partment of Health and Human Services [USDHHS] 1994).! Much of the concern has focused on whether consumers know about the adverse health effects of smoking and can make informed choices; whether children and adolescents are exposed to and are af- fected by tobacco advertising and promotion; and whether tobacco companies inappropriately target advertising and promotion to specific consumer groups. A contentious debate has persisted about whether marketing induces demand and what the appropriate role of government is in protecting the consumer. Although some of these issues are not fully settled, they provide the background for considering the reduction of smoking through regulating cigarette advertising, promotion, product availability, and prod- uct presentation. In May 1981, a Federal Trade Commission (FTC) staff report (see “A Midcourse Assessment,” later in this chapter) concluded that consumer knowledge about the health effects of cigarette smoking was gen- erally inadequate (Myers et al. 1981). Since then, adult smoking prevalence has declined substantially (from 33.5 percent in 1980 [Giovino et al. 1994] to 24.7 per- cent in 1995 [CDC 1997a]), and the general population’s knowledge about the adverse health effects of tobacco use has improved (in recent years, 80-90 percent of ‘In the following discussion, advertising refers to company- funded advertisements that appear in paid media (e.g., broad- casts, magazines, newspapers, outdoor advertising, and transit advertising), whereas promotion includes all company-sponsored nonmedia activity (e.g., direct-mail promotion, allowances, coupons, premiums, point-of-purchase displays, and entertain- ment sponsorships). Regulatory Efforts 161 Surgeon General’s Report the general population has known that smoking is a health hazard [USDHHS 1989, 1998b]). During the same period, revenue devoted to advertising and pro- motion by the tobacco companies has increased from $1.24 billion in 1980 to a high of $6.03 billion in 1993 (FTC 1999) and $5.10 billion in 1996 (FTC 1999). To- bacco companies spent $5.66 billion on advertising and promotion in 1997 (FTC 1999). The relationship among these three events is not straightforward, and consid- erable ancillary information is needed for proper in- terpretation. In particular, the effects that both knowledge and advertising and promotion have on smoking prevalence are complex. For example, the increase in smoking uptake among women beginning in 1967 was associated with the marketing of specific cigarette brands for women (Pierce et al. 1994a). Simi- larly, an increase in smoking initiation among adoles- cents during 1985-1989 has been ecologically associated with considerable increases in promotion expenditures, as exemplified by the Joe Camel cam- paign (see “A Critical Example: Joe Camel,” later in this chapter) (CDC 1995b). Regardless of how these associations are interpreted, the actions of the tobacco industry bespeak the industry’s belief in corporate benefit from a major investment in advertising and promotion—an investment that may be interpreted as even exceeding an economically optimal level (see Chapter 6). The tobacco industry has argued that its main purpose in advertising is to maintain brand loyalty and to capture a greater market share of current smokers (USDHHS 1994). Intensive review of the available data, however, suggests a positive correlation between level of advertising and overall tobacco consumption— that is, as advertising funds increase, the amount of tobacco products purchased by consumers also in- creases (USDHHS 1989, 1994; Smee 1992; Pierce and Gilpin 1995; also see Chapter 6). Furthermore, several judicial opinions (reviewed in “Constitutionality of Regulating Tobacco Advertising,” later in this chap- ter) have questioned whether the enormous invest- ment in advertising serves only brand loyalty. It has also been argued that a significant part of the expand- ing budget for tobacco marketing is for promotion to specific market segments (Hollie 1985). Other observ- ers have suggested that marketing campaigns heavily target cultural and ethnic minorities through product development, packaging, pricing, and brand promo- tion (Warner et al. 1986; Ernster 1993). Underlying these observations is awareness of a basic commercial principle: to continue to be suc- cessful, a product must not only retain consumers but also, over time, gain new consumers. Gaining new 162 Chapter 5 consumers is necessarily of particular concern to the tobacco industry. Advocates for reducing tobacco use have pointed out that if the tobacco industry is to main- tain current consumption or even slow the ongoing decline in smoking, the industry must aggressively seek replacement smokers for the estimated 3,500 Americans who quit smoking each day and for the additional 1,200 tobacco customers and former cus- tomers who die each day of smoking-related illnesses (CDC 1993b, 1997b). The facts about uptake of tobacco use strongly suggest where the industry’s replacement smokers will come from. Epidemiologic studies show that nearly all first use of tobacco occurs before high school gradu- ation (USDHHS 1994). Whether tobacco companies deliberately market their products to preadults is dif- ficult to ascertain. Nonetheless, indirect evidence of the importance of advertising and promotion to the tobacco industry is provided by surveys that suggest that most adolescents can recall certain tobacco adver- tisements, logos, or brand insignia; these surveys cor- relate such recall with smoking intent, initiation, or level of consumption (Alexander et al. 1983; Goldstein et al. 1987; Pierce et al. 1991; Evans et al. 1995). The American Medical Association (Utah Delega- tion 1989), together with a broad range of public health organizations, has called for stricter regulation of ciga- rette advertisements and even for a complete ban— resolutions that were reiterated in 1995 (American Medical Association House of Delegates 1995). Many public health and smoking prevention groups specifi- cally seek government regulation to address what they consider discriminatory practices of tobacco manufac- turers in targeting members of minority groups (Warner et al. 1986). These groups claim that adver- tisements overwhelm smoking prevention messages and increase the number of people who smoke each year beyond the number that would smoke if adver- tising and promotion affected only market share. In- dustry officials deny targeting and argue that because most of the population is now aware of the risks asso- ciated with tobacco products, citizens can make in- formed decisions for themselves. More important, the tobacco industry claims its First Amendment consti- tutional right to promote its products (Cotton 1990; Tollison and Wagner 1992; see the discussion in “Con- stitutionality of Regulating Tobacco Advertising,” later in this chapter). Such arguments and counterarguments have been at the heart of a 30-year endeavor to regulate advertising and promotion in the tobacco industry. A review of this effort, with some specific examples from the United States and other countries, provides insight into the strengths and weaknesses of both sides of the argument and suggests several areas for policy development. Attempts to Regulate Tobacco Advertising and Packaging Regulatory efforts to restrict the advertising and promotion of cigarettes were among the earliest re- sponses to the 1964 landmark report of the Surgeon General’s Advisory Committee, which set forth over- whelming scientific evidence on the health hazards of cigarette smoking. A week after the January 11, 1964, release of the report, the FTC filed a Notice of Rule- Making Proceeding (January 17, 1964) that appeared in the January 22, 1964, Federal Register. The notice set forth the agency’s tentative views of how the require- ments of the Federal Trade Commission Act (Public Law 96-252) would apply to the advertising and la- beling of cigarettes in light of the Advisory Committee’s report (Federal Register 1964). In a perti- nent part, section 5 of the Federal Trade Commission Act states that “unfair or deceptive acts or practices [are] declared unlawful” and that the commission has the power to proceed against them as an administra- tive agency. In its notice of rulemaking, the FTC stated its concern with “two ways in which cigarette advertis- ing may be unlawfully misrepresenting or concealing the health hazards of smoking. First, the Commission has reason to believe that many current advertisements falsely state, or give the false impression, that ciga- rette smoking promotes health or physical well-being or is not a health hazard, or that smoking the adver- tised brand is less of a health hazard than smoking other brands of cigarettes” (Federal Register 1964, p. 530). The FTC also stated that much cigarette ad- vertising then current portrayed cigarette smoking as pleasurable, desirable, compatible with physical fit- ness, or indispensable to full personal development and social success—all without informing the con- sumer of the health hazards of cigarette smoking. The FTC posited that the dangers to health from cigarette smoking are so serious that knowledge and appreciation of them would be a material factor in in- fluencing a person’s decision to smoke cigarettes or to smoke a particular brand. (This point is considered in detail in “Tobacco Packaging and Informed Choice,” later in this chapter.) Affirmative disclosures of these health hazards might thus be necessary in cigarette advertising that could cloud or obscure public con- sciousness of these health hazards. After receiving Reducing Tobacco Use written comments and materials from interested parties and after conducting hearings in March 1964 on the proposed rule (see the text box “Response From the Tobacco Industry—1964”), the FTC issued on June 22,1964, the “Statement of Basis and Purpose” regard- ing its proposed Trade Regulation Rule. (A Trade Regulation Rule is, in effect, an administrative statute with the force of law.) In this document, the commis- sion announced that it would require warnings on ciga- rette packages and in advertisements for cigarettes that cigarette smoking is dangerous to human health. Cigarette Warning Labels After participating in hearings before the U.S. House of Representatives Committee on Interstate and Foreign Commerce on cigarette labeling and FTC rules, the commission postponed until 1965 the implemen- tation of any Trade Regulation Rule. In that year, the Federal Cigarette Labeling and Advertising Act of 1965 (Public Law 89-92) required that the warning “Cau- tion: Cigarette Smoking May Be Hazardous to Your Health” (Federal Cigarette Labeling and Advertising Act, sec. 4) be placed in small print on one of the side panels of each cigarette package. The act permitted no additional labeling requirement under any federal, state, or local law, thus effectively preempting any other health messages on cigarette packages. The act also suspended for three years the FTC’s authority to require health warnings on cigarette advertising. This preemption was strongly opposed in the minority view of Representative John E. Moss (D-CA), who presented the argument as follows: I most strongly object to sections 6 and 7 of this bill. Section 6 would prevent the Federal Trade Commission, the Food and Drug Administration, and the U.S. Public Health Service in administer- ing their respective laws from imposing any addi- tional requirement with regard to the labeling of cigarettes involving a health warning. The bill would also preclude State and local health authori- ties from imposing such requirements. Section 7, the preemption provision of the bill, provides that no cautionary statement with respect to smoking and health other than specified in this legislation shall be required on any package; and that no such statement with respect to smoking and health shall be required in advertising for ciga- rettes packaged in conformity with the labeling provisions of this legislation. Regulatory Efforts 163 Surgeon General's Report The Secretary of Health, Education, and Welfare has said that preventing any regulatory agency from imposing a label warning requirement other than that prescribed in the bill is “a position which we consider too inflexible.” The National Interagency Council on Smoking and Health submitted a petition to the committee ask- ing us “not to approve any legislation which will prevent the Federal Trade Commission from car- rying out its reaffirmed intention of requiring health warnings in cigarette advertising” (Moss 1965, pp. 2365-6). Representative Moss concluded his minority report with a strong condemnation: In summary, I am strongly opposed to those fea- tures of this legislation which would preclude the imposition of more stringent labeling requirements or the imposition of health warnings in advertise- ments which Federal, State, or local health authori- ties may deem necessary in the future in the proper exercise of their respective powers. We must face the facts as presented to us by the Surgeon Gen- eral, American Cancer Society, American Medical Association, American Heart Association, and the National Tuberculosis Association. We must first concern ourselves with public health and welfare, not legislate to the whims of a special interest (Moss 1965, p. 2367). In commenting on the 1965 labeling law, the Sec- retary of the Department of Health, Education, and Welfare outlined an alternative view of effective health warnings on cigarette packages (Celebrezze 1965). Secretary Anthony J. Celebrezze recommended that the warning appear in large type on the main faces of the package. He commented: The statute should require the warning to be prominent and conspicuous but should leave the precise location and size of the warning on the la- bel, and related matters, to regulation in the light of the expertise and experience of the regulatory agency. . . . [Ten]-point type, which is 2 points smaller than the type size used in typing this let- ter, is hardly calculated to invite the consumer’s attention. ... If the required warning is in effect negated or dis- claimed on the label or in accompanying literature by words, statements, designs, or other graphic material, the warning requirement shall be deemed Response From the Tobacco Industry—1964 n April 1964, in rapid response to the Surgeon General’s report, the tobacco industry published a voluntary code for advertising and marketing prac- tices (Gray 1964). The stated purpose of the code was “to establish uniform standards for cigarette advertising and to provide means whereby compli- ance with this code can be ascertained promptly and fairly and on a consistent basis” (p. 141). The code was designed to restrict cigarette advertisements aimed at young people, to limit implied or direct health claims to those that could be medically and scientifically proved, and to curb the so-called viril- ity theme in cigarette advertisements. The code spe- cifically prohibited advertising that suggested that cigarette smoking was essential to “sexual attrac- tion,” “success,” sophistication, athletic abilities, physical stamina, and “social prominence” (p. 143)— images that the industry recognized as influencing smoking by young people. At hearings before the House Interstate and Foreign Commerce Committee on June 25, 1964, Bowman Gray, Chairman of the Board of R.J. Reynolds Tobacco Company, speaking on behalf of the industry, told Congress, “This advertising code represents a sincere effort by the industry to respond to criticism of the industry’s advertising which has been voiced in some quarters. It is an earnest effort at industry self-regulation. I hope the industry will be given reasonable opportunity to implement this code” (Gray 1964, p. 141). The code was to be enforced by an indepen- dent administrator. All advertisements were to be precleared, and violations of the code were subject toa fine of $100,000. Enforcement provisions of the code were dropped shortly after passage of the Fed- eral Cigarette Labeling and Advertising Act in 1965. 164 Chapter 5 not to have been met. . . . [Congress should con- sider giving the department] specific authority to prohibit or regulate the use of statements that while not clearly negating the warning and while literally true or at least not demonstrably false, may give the consumer the misleading impression that a given cigarette is safer than others (Celebrezze 1965, p. 2359). These recommendations predate by three decades simi- lar implementation of warnings in other countries (de- scribed in “Examples of Product Labeling in Other Countries,” later in this chapter); such an approach, however, has not been taken in this country. The 1965 law also required that the FTC annu- ally transmit to Congress a report on the effectiveness of cigarette labeling, on current cigarette advertising and promotion practices, and on recommendations for legislation. In June 1967, in its first report to Congress, the FTC recommended that the package label be changed to “Warning: Cigarette Smoking Is Danger- ous to Health and May Cause Death from Cancer and Other Diseases” (FTC 1967, p. 30). Broadcast Advertising Ban In 1969 Congress passed the Public Health Ciga- rette Smoking Act (Public Law 91-222), which prohib- ited cigarette advertising on all media subject to Federal Communications Commission (FCC) regula- tion, especially radio and television broadcasting, and required that each cigarette package contain the label “Warning: The Surgeon General Has Determined That Cigarette Smoking Is Dangerous to Your Health” (Pub- lic Health Cigarette Smoking Act, sec. 4). This new law also preempted any other health warning require- ments for cigarette packages. The prohibition on broadcast media advertising became effective on Janu- ary 2, 1971. The FIC issued complaints against the cigarette companies that eventually led to a consent decree requiring the companies to add the statutory label warning to their advertising in magazines, news- papers, and outdoor displays (Trade Regulation Reporter 1973). The prohibition on television and radio advertis- ing was challenged—not by the cigarette companies, but by a group of broadcasters—in Capital Broadcasting Co. v. Mitchell (333 F. Supp. 582 [D.D.C. 1971]). That case upheld the constitutionality of the congressional prohibition by a 2 to 1 vote. Despite this victory, a so- bering note was struck in the dissenting opinion of Judge]. Skelly Wright. Far from casting his vote against smoking prevention, Judge Wright was concerned that Reducing Tobacco Use upholding the act, and thus upholding the prohibition on broadcast advertising, would actually aid the tobacco industry. His reasoning—which proved correct—was that the ban would put an end not only to tobacco ad- vertising but also to the cost-free counteradvertising that had been running in the electronic media since 1969, when the FCC’s Fairness Doctrine was first held appli- cable to cigarette advertising. The Fairness Doctrine, which was put forth in 1949 (and ceased applying to tobacco in 1971 after ciga- rette advertising on radio and television ended), re- quired that whenever material covering “‘a controversial issue of public importance’ ” (Banzhaf v. FCC, 405 F.2d 1082, 1086 [D.C. Cir. 1968], cert. denied, 396 U.S. 842, 90S. Ct. 50 [1969]) was aired, the broad- caster had an obligation to present, to some degree, both sides of the issue. Although the Fairness Doc- trine had not previously been interpreted to apply to advertising, in Banzhaf the Federal Circuit Court of Appeals ruled that the FCC had the authority, through the Fairness Doctrine, to require that radio and televi- sion stations carrying cigarette advertising devote (i-e., without charging advertising fees) a significant amount of broadcast time to presenting the case against smoking. (For more on the plaintiff, John F. Banzhaf, see “The Attack on Advertising” in Chapter 2.) In the court’s ruling, Chief Judge David Bazelon observed that “if we are to adopt [the tobacco industry’s] analy- sis lof Congress’ intention in enacting the Federal Ciga- rette Labeling and Advertising Act], we must conclude that Congress legislated to curtail the potential flow of information lest the public learn too much about the hazards of smoking for the good of the tobacco industry and the economy. We are loathe to impute such a purpose to Congress absent a clear expression” (Banzhaf, p. 1089). However, three years later, in Capital Broadcast- ing Co. v. Acting Attorney General (405 U.S. 1000 [1972], aff'd sub nom. Capital Broadcasting Co. v. Mitchell, 333 F. Supp. 582 [D.D.C. 1971]), it was Judge Wright’s view that the television and radio counteradvertising that had arisen from the Fairness Doctrine was so effective that the tobacco companies actually favored the chal- lenged ban. There is some support for this view. Per capita cigarette consumption in the United States, which had declined (with some fluctuation) generally since the 1964 report to the Surgeon General on the health effects of smoking, had leveled off and then in- creased after cigarette advertising was removed in 1971 from radio and television. Some analysts have asserted that these changes indicate that the cost-free counteradvertisements opposing cigarette use, which along with the commercials promoting cigarettes, Regulatory Efforts 165 Surgeon General's Report largely disappeared from the airwaves except for a relatively few public service announcements, were more effective in discouraging consumption than ciga- rette commercials were in encouraging consumption (Warner 1979). Moreover, the prohibition of cigarette advertising on broadcast stations has allowed the to- bacco companies to avoid the significant expense of advertising on national television and to devote their promotional dollars to other media. A Midcourse Assessment Adecade after the broadcast ban, the FTC issued a staff report in May 1981 on cigarette advertising (Myers et al. 1981). This report asserted that “the domi- nant themes of cigarette advertising are that smoking is associated with youthful vigor, good health, good looks and personal, social and professional acceptance and success, and that it is compatible with a wide range of athletic and healthful activities” (p. 2-13). Although such advertising included the required general warn- ing about the health hazards of cigarette smoking and listed the cigarette’s tar and nicotine contents (as de- termined by FTC testing methods), the advertisements otherwise made no mention of the adverse health con- sequences of smoking cigarettes. The overriding mes- sage of cigarette advertising was thus that smoking is a positive, desirable experience. Details from a nonpublic version of the FTC re- port revealed, for example, that a primary theme for the marketing of Salem cigarettes was the association of the cigarette with the lifestyle of young adult males who were (in the words of the company’s campaign notes) “masculine, contemporary, confident, self- assured, daring /adventurous, mature” (Banzhaf 1982, p. 260). The report quoted from a Doral cigarette cam- paign that sought to project the image of “an indepen- dent, self-reliant, self-confident, take-charge kind of person” (p. 260) and a campaign that depicted a “Win- ston man” as “a man’s man who is strong, vigorous, confident, experienced, mature” (p. 260). Taking an- other tack, the Eve cigarette campaign sought to por- tray the smoker as a “sophisticated, up-to-date, youthful and active woman who seems to have dis- tinct ideas about what she wants” (p. 261). The cam- paign for the Lark brand was designed to position it as a “youthful, contemporary brand that satisfies the lifestyles of the modern smoking public” (p. 260) and emphasizes “moments of post-tension and relaxation” (pp. 260-1). The nonpublic version of the FTC report also detailed and quoted from the conclusion of a market- ing and research firm that had conducted focus group 166 = Chapter 5 interviews to help Ted Bates and Company, Inc., de- velop a marketable image for Viceroy cigarettes. The report, summarizing the results of the research, as- serted that many smokers perceived the smoking habit as a dirty and dangerous one engaged in only by “very stupid people” (Banzhaf 1982, p. 262). The report con- cluded: “Thus, the smokers have to face the fact that they are illogical, irrational and stupid. People find it hard to go throughout life with such negative presen- tation and evaluation of self. The saviors are the ra- tionalization and repression that end up and result in a defense mechanism that, as many of the defense mechanisms we use, has its own logic, its own ratio- nale” (p. 262). This marketing analysis went on to state that because there “are not any real, absolute, positive quali- ties or attributes in a cigarette” (Banzhaf 1982, p. 262), the most effective advertising is designed to “reduce objections” (p. 262) to the product by presenting a pic- ture or situation ambiguous enough to provide smok- ers with a rationale for their behavior and a means of repressing their health concerns about smoking. The advertisement must thus project the image that ciga- rettes have clearly beneficial functions, such as improv- ing the smoker’s self-image and self-acceptance or serving as a stimulant or tranquilizer that offers an ac- ceptable means of self-reward. Accordingly, the analy- sis recommended that advertisers should start from “the basic assumption that cigarette smoking is dangerous to your health” (p. 263) and then try to circumvent the problem rather than fight what would be a losing battle. A particularly notable element of the report was how to persuade young people to smoke: For the young smoker, the cigarette is not yet an integral part of life, of day-to-day life, in Spite of the fact that [young smokers] try to project the image of a regular, run-of-the-mill smoker. For them, a cigarette, and the whole smoking process, is part of the illicit pleasure category. . . . In the young smoker’s mind a cigarette falls into the same category with wine, beer, shaving, wearing a bra (or purposely not wearing one), declaration of independence and striving for self-identity. For the young starter, a cigarette is associated with in- troduction to sex life, with courtship, with smok- ing “pot” and keeping late studying hours (Banzhaf 1982, p. 263). The survey then recommended a strategy for attract- ing young people to start cigarette smoking: present the cigarette as one of a few initiations into the adult world and show the cigarette as part of the illicit pleasure category of products and activities. To the degree possible under legal constraints, the strategy advised relating the pleasure of smoking cigarettes to the pleasures of adult or illicit activities, such as drink- ing alcohol, smoking marijuana, or having sex (Myers et al. 1981). Brown & Williamson Tobacco Corpora- tion stated that these proposals were never imple- mented and did not represent their policy. In sum, the marketing and research firm recom- mended that successful cigarette advertising must ei- ther consciously or unconsciously deal with smoking and health issues by repressing the health concerns of the consumers of the product and providing a ratio- nalization for consumption. The 1981 FTC report also concluded that the federally mandated health warn- ing had little impact on the public’s level of knowl- edge and attitudes about smoking. The report further observed that the warning was outworn, abstract, dif- ficult to remember, and not perceived as personally relevant (Myers et al. 1981). These concerns contrib- uted to Congress’ enactment of the Comprehensive Smoking Education Act of 1984 (Public Law 98-474), which required four specific, rotating health warnings on all cigarette packages and advertisements (Com- prehensive Smoking Education Act, sec. 4): SURGEON GENERAL'S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, and May Complicate Pregnancy. SURGEON GENERAL'S WARNING: Quitting Smoking Now Greatly Reduces Serious Risks to Your Health. SURGEON GENERAL'S WARNING: Smoking by Pregnant Women May Result in Fetal Injury, Pre- mature Birth, and Low Birth Weight. SURGEON GENERAL'S WARNING: Cigarette Smoke Contains Carbon Monoxide. The Comprehensive Smoking Education Act of 1984 thus amended the Federal Cigarette Labeling and Advertising Act and required warnings to be placed on advertisements as well as on cigarette packages. The act preempts state and federal attempts to place additional warnings on packages, but it preempts only state action with regard to advertising. The FITC re- tains such jurisdiction under section 5. From the first, the exact appearance of warning labels (wording, layout, and positioning on packages and advertisements) has represented compromises between the recommendations of the FTC and smok- ing prevention advocates and those of the tobacco Reducing Tobacco Use industry. In 1969, for example, the FTC recommended a warning on cigarette packages that specifically men- tioned death, cancer, heart disease, chronic bronchitis, and emphysema. The resulting legislation required the legend to provide the general warning only that smoking is “dangerous” to one’s health (Public Health Cigarette Smoking Act of 1969, sec. 4). Similarly, in its 1981 report on cigarette advertising, the FTC recom- mended that new warning labels use a “circle-and- arrow” format that would be more effective than the traditional rectangular format, but Congress did not take this approach in the Comprehensive Smoking Education Act of 1984. Also, the new labels did not incorporate the FTC’s recommendations to contain specific references to addiction, miscarriage, and death and to disclose the brand’s yields of tar, nicotine, and carbon monoxide. Smokeless Tobacco Warning Labels Requirements for warning labels on smokeless tobacco products lagged behind those on cigarettes by more than 20 years. By the mid-1980s, the strong evi- dence that smokeless tobacco causes oral cancer, nico- tine addiction, and other health problems and that its use was increasing among boys led Massachusetts to adopt legislation requiring warning labels on packages of snuff and caused 25 other states to consider similar legislation (USDHHS 1989). The Massachusetts law was preempted, before it could take effect, by the federal Comprehensive Smokeless Tobacco Health Education Act of 1986 (Pub- lic Law 99-252). This law not only required three ro- tating warning labels on smokeless tobacco packaging and in all advertising (except billboards) but also stipu- lated that the labels have the circle-and-arrow format that the FTC had recommended earlier for cigarette warnings. The three rotating labels read as follows (Comprehensive Smokeless Tobacco Health Education Act of 1986, sec. 3): WARNING: This product may cause mouth cancer. WARNING: This product may cause gum disease and tooth loss. WARNING: This product is not a safe alternative to cigarettes. Initially, the FTC excluded utilitarian items—such as hats, T-shirts, lighters, and jackets—bearing the name or logo of smokeless tobacco products. A consortium Regulatory Efforts 167 Surgeon General’s Report of Public Citizen and several prominent health orga- nizations sued the FTC, arguing that this exclusion was contrary to the provisions of the act, which sought a comprehensive rather than a narrow use of health warnings (Public Citizen v. Federal Trade Commission, 869 F.2d 1541 [D.C. Cir. 1989]). The Court of Appeals for the District of Columbia ruled for the plaintiff, stating that the act was intended to cover utilitarian items, since those were among the smokeless tobacco industry’s most effective means of promoting its prod- ucts to adolescents. The court elaborated its point, saying that adolescents were less likely than adults to read magazines and newspapers and thereby less likely to encounter the mandated warnings there. Adolescents were also likely to have passed the criti- cal moment of decision by the time they obtained the product itself and encountered its warning label. Ac- cordingly, in 1991, the FTC issued a final rule requir- ing health warnings to be displayed on utilitarian items and providing for the manner in which the warnings were displayed. All advertising of smokeless tobacco products is also banned on any medium of electronic communi- cation subject to the jurisdiction of the FTC. Under this act, federal agencies and state and local govern- ments are preempted from imposing additional health warnings on smokeless tobacco products and adver- tisements (except for billboards, which were excluded from this act). Furthermore, instead of stipulating where the labels must be positioned, the act required only “conspicuous and prominent” placement (Com- prehensive Smokeless Tobacco Health Education Act of 1986, sec. 3). Implementation was left to the FTC, which enacted enabling regulations on November 4, 1994. Regulation of Tobacco Packaging Package size of tobacco products has been an- other area of public health concern and action. Evi- dence that levels of tobacco consumption reflect the affordability of tobacco products (see Chapter 6) has raised concern about selling cigarettes in packs con- taining fewer than the usual 20 cigarettes. In many countries, cigarettes are sold in packages of 15,10, or5 cigarettes. These smaller package formats have been dubbed “kiddie” packs in Canada by smoking preven- tion activists (Chrétien 1994). Research has shown that young people account for many sales of smaller ciga- rette packages (Wilson et al. 1987; Nova Scotia Coun- cil on Smoking and Health 1991; IMPACT Research 1993), probably because of their low price and ease of concealment. 168 Chapter 5 These findings have led some jurisdictions to prohibit the marketing of packages containing fewer than 20 cigarettes. An Australian state legislature has also passed such a ban (the Western Australia Tobacco Control Act of 1990). In Canada, several provinces have banned small package sizes, and the revised fed- eral Tobacco Sales to Young Persons Act of 1993 na- tionally banned packages of fewer than 20 cigarettes. Another issue of concern regarding tobacco pack- aging is the use of potentially misleading descriptive words in the labeling of some tobacco products (Davis et al. 1990). A recent Gallup poll found that words such as “slim,” “low tar,” and “light” conveyed mes- sages viewed as healthful (Gallup Organization, Inc. 1993, pp. 23, 25). Cohen (1992) reported that tobacco companies have long known that their customers equate the marketing term “low tar” (p. 85) with health benefits. Chapman and colleagues (1986) reported that smokers tend to systematically underestimate the ac- tual tar deliveries of their particular brands, and Gori (1990) found that one-half of smokers interviewed in the United States and Europe assume that the lower the tar rating, the lower the brand’s propensity to cause disease. The Coalition on Smoking OR Health (1988) has further analyzed how promoting cigarette brands as having low tar and low nicotine content communi- cates a message to consumers that these brands have health benefits. The use of such descriptive words in cigarette brand names has been called into question because variations in the way cigarettes are actually smoked may mean that the actual yield of toxic constituents from cigarettes differs from the levels determined by currently accepted testing procedures (Henningfield et al. 1994; see “Compensatory Smoking,” later in this chapter). For example, smokers of reduced-tar cigarettes may (deliberately or not) inhale harder to draw more smoke through the denser filter and deep into the lungs and may smoke the cigarette down closer to the filter, thereby inhaling greater concentra- tions of toxins. This concern led to the appointment of an ad hoc committee of the President’s Cancer Panel of the National Cancer Institute (NCI) to evaluate the current FTC protocol for testing tar, nicotine, and car- bon monoxide. One of the conclusions of this panel was that “brand names and brand classifications such as ‘light’ and ‘ultra light’ represent health claims and should be regulated and accompanied, in fair balance, with an appropriate disclaimer” (NCI 1996, p. vii). This recommendation has not yet been carried out. A further aspect of tobacco packaging that is cur- rently receiving significant attention, although prima- rily outside the United States, is the possibility of legislated plain (or “generic”) packaging for tobacco products. This initiative is partly motivated by the belief that removing much of the brand image of to- bacco products would not only make the product less attractive but also weaken the connection with—and thus lessen the effect of—visual and verbal image- linked efforts to promote particular brands (Mahood 1995). There is evidence that young people find plain packaging less attractive (Beede and Lawson 1992; Centre for Health Promotion 1993) and that plain pack- aging makes health messages more noticeable (Centre for Behavioural Research in Cancer 1992). In Canada, the federal government has considered using plain packaging for tobacco products (Standing Committee on Health 1994; Health Canada 1995b), and the prov- ince of Ontario, in enacting the Tobacco Products Control Act in 1994, authorized the requirement for plain packaging on all cigarettes sold in Ontario. Such packaging reforms have not yet been enacted in any jurisdiction. Examples of Product Labeling in Other Countries In recent years, many countries have taken sig- nificant action on specifying packaging and warning labels for tobacco products. All countries of the Euro- pean Union must comply with a May 15, 1992, direc- tive (Council Directive 92/41/EEC 1992 OJ. [L 158]) that requires stipulated health warnings on each of the main package panels. In Thailand, pursuant to its To- bacco Products Control Act, which was based on prin- ciples developed in Canadian regulations (discussed later in this section), prominent black-and-white health messages are required on the front of the package. South Africa and New Zealand require detailed health messages on the main package panels; the messages are based largely on Australian packaging. The messages appearing on Australian cigarette packages are based on the work of the Centre for Behavioural Research in Cancer (1992). These mes- Sages were required as of January 1, 1995, and were incorporated into a broad effort “to inform smokers of the long-term health effects of tobacco use” (Lawrence 1994, p. 1). The Australian system uses six rotating messages covering 25 percent of the front of the ciga- rette packets. One side of the packet is entirely given to the labeling of dangerous constituents, and all the labels must be in black and white. Thirty-three percent of the rear main packet panel must be covered by the same health message given on the front of the pack and followed by an elaboration of that message (Chapman 1995). Reducing Tobacco Use Of special interest are the package regulations currently in place in Canada. The Canadian health messages were established by regulatory power granted under the 1988 federal Tobacco Products Con- trol Act, which came into effect on January 1, 1989. This legislation gives broad regulatory powers over tobacco product packaging. It also gives regulatory authority to require package inserts, although this power has not yet been acted on. By eventually delegating formula- tion of the precise warnings to administrative regula- tion, this legislation took the approach that had been recommended 25 years earlier by the U.S. Department of Health, Education, and Welfare (Celebrezze 1965; see also “Cigarette Warning Labels,” earlier in this chap- ter). This law also makes clear that the various prov- inces of Canada can require additional messages and that the provision of federal messages does not pre- empt other messages. The first set of regulations fol- lowing this law required that four specific rotating health messages be placed on the two main panels of cigarette packages and be printed in a large typeface; this set of regulations stipulated that the messages must be “prominently displayed in contrasting colours” (De- partment of National Health and Welfare 1989, p. 64) and cover at least 20 percent of the panel face. When the mandated Canadian health messages started appearing on tobacco products in 1989, it was clear to many public health workers that the language of the regulations had left the tobacco companies too much room for interpretation and had resulted in less prominence and contrast than the regulations had in- tended. Minister of National Health and Welfare Henry Perrin Beatty commented, “It’s very clear that, when you look at [the health warning on cigarette packs], it’s not designed to stand out. If our experts [at the Department of National Defence] knew as much about camouflage as the tobacco company did, nobody’d ever find our fellows” (Spectator 1989). This situation gained more attention when it was revealed that a prominent tobacco lobbyist had apparently in- fluenced development of the regulations (Fraser 1989). Health advocates subsequently campaigned to attain more prominent messages through revising the regu- lations (Mahood 1995). New legislation was enacted on August 11, 1993 (Department of National Health and Welfare 1993), and all packaging for tobacco products destined for sale in Canada had to comply by September 11, 1994. Among these precedent-setting regulations (Mahood 1995) were the following requirements: e The message must cover at least 25 percent of the top of each main panel. Regulatory Efforts 169 Surgeon General's Report * The message must be framed by a stipulated bor- der (on many packs, this border yields a total mes- sage area that uses over 40 percent of the surface). ¢ Each of eight rotating messages must be presented one-half of the time in black on a white background with a black border. The other one-half of the time, the messages must be white on a black background surrounded by a white border. * One entire side panel must be used to present in- formation on the toxic constituents. ¢ Every side panel of tobacco cartons must display a black-on-white message covering 25 percent of the panel area and stating “Cigarettes are addictive and cause lung cancer, emphysema, and heart disease” (Department of National Health and Welfare 1993, p. 3278). ¢ The message must bear no attributions. One ironic result of these requirements was that cigarettes manufactured in the United States for the Canadian market were produced, albeit only for ex- port, with health messages that conform with the rec- ommendations provided in 1965 by the U.S. Department of Health, Education, and Welfare. The Canadian regulations were reversed in 1995, when the Supreme Court of Canada held that the country’s complete ban on overt tobacco advertise- ments (another key component of the 1993 regulations) and its requirement of unattributed health warnings on packages were in violation of the tobacco industry’s freedom of expression and the Canadian Charter of Rights and Freedoms (RJR-MacDonald Inc. v. Attorney General of Canada, File Nos. 23460, 23490 [Can. Nov. 29-30, 1994, Sept. 21, 1995], cited in 10.6 TPLR 2.167 [1995]). These central elements of Canada’s Tobacco Products Control Act fell because the Canadian gov- ernment did not meet its constitutional obligation of proving that the approach taken was the least drastic means of achieving a public health objective. These narrow evidentiary grounds on which the decision was made left room for the Canadian government to counter. The government offered a new proposal, called Tobacco Control: A Blueprint to Protect the Health of Canadians, that reinstated the advertising ban, im- posed restrictions on brand-name promotion and sponsorship, instituted controls over packaging and labeling, and increased product regulation and report- ing requirements. In creating a new legal framework, the Canadian government would make tobacco a de facto illegal product whose sale could be permitted but would be 170 = Chapter 5 subject to specific conditions. This reversal of the burden of proof gives constitutional allowance to the advertising restrictions in Canada. Following the un- veiling of the Blueprint, the tobacco industry brought forward a voluntary proposal to restrict advertising. Subsequent resumption of advertising has been con- troversial, and the industry has been accused of breach- ing its own code (LeGresley 1996). Tobacco Advertising, Commercial Speech, and the First Amendment Regulation of tobacco advertising in the United States is legally problematic. Although protections afforded by the First Amendment to the U.S. Consti- tution may be modified for commercial speech, includ- ing advertising, such modification is an area of intensive legal debate. The two decades of lawsuits described in this section make it clear that a concerted and persistent government interest is essential if such restriction of free speech is to be upheld in courts. To satisfy legal scrutiny, the government's efforts must clearly show that any restrictions directly and materi- ally advance its asserted interest—protecting the health of the American people. The United States Supreme Court has defined commercial speech as “expression related solely to the economic interests of the speaker and its audience” (Central Hudson Gas & Electric v. Public Service Commis- sion of New York, 447 U.S. 557 [1980]). Commercial speech thus includes advertisements by cigarette manufacturers that invite consumers to buy their prod- uct. As the Supreme Court has observed, “For most of this Nation’s history, purely commercial advertising was not considered to implicate the constitutional pro- tection of the First Amendment” (United States v. Edge Broadcasting Co., 113 S. Ct. 2696, 2703 [1993]). Restric- tions on commercial speech were viewed as being simi- lar to economic regulation and were routinely upheld. A midcentury example key to later efforts to restrict tobacco advertising occurred when the Supreme Court, in Valentine v. Chrestensen (316 U.S. 52 [2d Cir. 1942], rev'd), held that the state could prohibit the street dis- tribution of handbills containing commercial adver- tising matter (see also Village of Schaumburg v. Citizens for a Better Environment, 444 U.S. 620 [1980]). Such pre- cedents enabled the courts to uphold the 1972 congres- sional ban on tobacco advertising on radio and television (Capital Broadcasting Co., 405 U.S. 1000). Subsequent legal scrutiny, however, has acted to re- verse this trend. Constitutionality of Regulating Advertising In 1975, the United States Supreme Court held for the first time that commercial advertising in gen- eral was entitled to protection under the First Amend- ment. In Bigelow v. Virginia (421 U.S. 809 [1975]), the Court struck down a state statute banning commer- cial advertisements for abortion referral services. The Court found that “the relationship of speech to the marketplace of products or services does not make [commercial advertising] valueless in the marketplace of ideas” (p. 826). However, the Court emphasized that it was defending not merely commercial speech, but speech that contained “material of clear ‘public interest’ ” (p. 822). The Court also defended commercial speech in a case involving advertising of the price of pharmaceu- ticals. In Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, Inc. (425 U.S. 748 [1976]), the Court found that the constitutional protection af- forded to advertisements of the price of pharmaceuti- cals was shared by advertisers and recipients of the information. The Court noted the importance of in- formation to consumers: “As to the particular consumer’s interest in the free flow of commercial in- formation, that interest may be as keen, if not keener by far, than his interest in the day’s most urgent politi- cal debate” (p. 763). The Court pointed out that ad- vertising is disseminating information to the consumer about who is producing the product, for what reason, and at what price, even if it does not “editorialize on any subject, cultural, philosophical, or political” (p. 761). In that same ruling, however, the Supreme Court emphasized that commercial speech would not be af- forded the same level of protection as other forms of speech and therefore that the state can regulate adver- tising if such regulation is in conformity to a valid public interest. These interests include avoiding de- ceptive and misleading claims; preventing unlawful activities, such as the sale of alcoholic beverages to minors; and protecting public health. “The First Amendment . . . does not prohibit the State from in- suring that the stream of commercial information flow cleanly as well as freely” (Virginia State Board of Phar- macy, pp. 771-2). Most cases involving regulated advertising are assessed through a four-pronged test to determine whether the regulations violate the First Amendment. This test was set forth in Central Hudson (447 U.S. 557). First, the speech being suppressed must have forfeited its First Amendment protection by being unlawful or deceptive or fraudulent: “The First Amendment's Reducing Tobacco Use concern for commercial speech is based on the infor- mational function of advertising. . . . Consequently, there can be no constitutional objection to the suppres- sion of commercial messages that do not accurately inform the public about lawful activity. The govern- ment may ban forms of communication more likely to deceive the public than to inform it” (p. 563). Second, the government must assert a substantial interest in regulating the speech. Third, regulating commercial speech must directly and materially benefit this gov- ernment interest. Fourth, the government must show that the means chosen to benefit its interest are no more extensive than necessary. (This four-pronged test is discussed more fully in “Constitutionality of Regulat- ing Tobacco Advertising,” later in this chapter.) The level of deference the Supreme Court gives to legislatures in meeting these four requirements seems to vary. In some cases, the Court defers to the legislative judgment that the speech restriction will be effective (Posadas de Puerto Rico Associates v. Tourism Company of Puerto Rico, 478 U.S. 328 [1986]; Edge Broad- casting), while in other cases the Court demands more empirical support for the legislature’s assumptions and conclusions (Rubin v. Coors Brewing Co., 514 U.S. 476, 115 S. Ct. 1585 [1995]; 44 Liquormart, Inc. v. Rhode Is- land, 517 U.S. 484, 116 S. Ct. 1495 [1996)). In Posadas de Puerto Rico, the Supreme Court up- held a statute that prohibited advertising legal gam- bling casinos to residents. The Court found that even though nonfraudulent advertising that concerned a legal activity deserved First Amendment protection, the commonwealth’s legislature could take steps to regulate it. The government has a substantial interest in protecting the health, safety, and welfare of its citi- zens, and this interest includes reducing the demand for gambling among residents through the regulation of advertising. The Court accepted the argument by the commonwealth that resident gambling would dis- rupt moral and cultural patterns, cause an increase in crime, foster prostitution, and develop corruption. In Board of Trustees of the State University of New York v. Fox (492 U.S. 469 [1989]) (also known as Fox IID, the Court deferred to the legislature and refused to set aside a State University of New York statute that pro- hibited private commercial enterprises from operat- ing on campus. In Edge Broadcasting (113 S. Ct. 2696), the Court upheld a federal statute that prohibited the broadcast of lottery advertisements generally but per- mitted advertisements of state-run lotteries on stations licensed to a state that conducts lotteries. The Court held that “the State [has] ‘a strong interest in adopting and enforcing rules of conduct designed to protect the public’ ” (p. 2706). Citing Fox II with approval, the Regulatory Efforts 171 Surgeon General's Report Court said, “Within the bounds of the general protec- tion provided by the Constitution to commercial speech, we allow room for legislative judgments” (p. 2707). In contrast, in 44 Liquormart, the Supreme Court looked closely at the logic of the Rhode Island gov- ernment in the ban it imposed on liquor price adver- tising. The Court considered that the Rhode Island restriction was a total prohibition and that there was too weak a connection between banning speech regard- ing prices and the state’s assertion that this restriction would reduce liquor consumption. Furthermore, the Court was aware of the concern that the legislature had been captured by one group of economic competi- tors (small liquor stores that could not otherwise com- pete in price wars) and that the law was then drafted at the expense of the disfavored economic competitor (larger liquor chains). In the 44 Liquormart decision citing the dissent in Rhode Island Liquor Stores Associa- tion v. Evening Call Pub. Co. (497 A.2d 331 [R.1. 1985), it was “suggested that the advertising ban was moti- vated, at least in part, by an interest in protecting small retailers from price competition” (p. 491, FN4). In Coors Brewing Co., the Supreme Court struck down a regulation restricting the printing of alcohol strength on beer labels. The Court found that the re- striction did little to advance the government interest in preventing “strength wars” between competing beer manufacturers, particularly when other types of alco- hol were required to list the alcohol potency on their labels. Finding that the speech restriction lacked a logi- cal foundation, the Court viewed the regulation skeptically. The pattern that emerges from these legal judg- ments is that where a law restricting commercial speech has a solid grounding in logic and empirical data, the Court will uphold it. If the regulatory system has a faulty connection between its goal and its method, the law will fail the third prong of the Central Hudson test and be struck down. In 44 Liquormart, Justice John Paul Stevens’ plurality opinion required that the social science evidence supporting the legislative rationale di- rectly and materially tie the government's goal (reduc- ing liquor consumption) to its methodology (restricting liquor price advertising); the government failed to meet this legal requirement. Furthermore, the Court views harshly laws that impose a total ban on speech and thus paternalistically deprive consumers of information be- cause the government perceives that the ban is “for their own good.” 172. Chapter 5 Constitutionality of Regulating Tobacco Advertising Government regulations of tobacco product ad- vertising can withstand legal scrutiny if they are care- fully crafted and are not overbroad (Edge Broadcasting, p. 2705 [citing Fox III, p. 480]). Courts have found state and local regulations of tobacco advertising to be pre- empted by the Federal Cigarette Labeling and Adver- tising Act when they conclude that the regulation is based on “smoking and health.” If the regulation is not preempted, then it must pass the four-pronged test advanced in Central Hudson. Reasonable regulations on tobacco advertising are likely to be upheld. Preemption and the Federal Cigarette Labeling and Advertising Act The Federal Cigarette Labeling and Advertising Act preempts a “requirement or prohibition based on smoking and health . .. imposed under State law with respect to the advertising or promotion of any ciga- rettes the packages of which are labeled in conformity with the provisions of this chapter” (15 U.S.C. [United States Code] 1334[b]). In Cipollone v. Liggett Group Inc. (505 U.S. 504, 112 S. Ct. 2608 [1992]), the Supreme Court interpreted that language narrowly, allowing Cipollone to sue the tobacco industry if the claim were not based on a failure to warn about smoking and health issues in product advertising or promotion. The claim would not be preempted if it were based on more generalized state interests, such as preventing inten- tional fraud or enforcing manufacturer warranties. In Mangini v. R.J. Reynolds Tobacco Co. (22 Cal. App. 4th 628 [1993]), the California Court of Appeals restated the Cipollone holding by declaring that regulations are preempted only if they demand a “requirement or pro- hibition based on smoking and health. . . . imposed under State law with respect to. ... advertising or pro- motion.” If one of these elements is missing, the state law is not preempted. State and local governments can still regulate to- bacco advertising if they justify the law with a valid rationale not related to health. For example, Baltimore asserted that its ordinance restricting tobacco adver- tising on billboards was a reasonable and necessary measure for reducing illegal consumption of cigarettes by minors (Penn Advertising of Baltimore, Inc. v. Mayor and City Council of Baltimore, 862 F. Supp. 1402 [Md. 1994]). The city claimed that the focus of the ordinance was not on protecting the health of young people; the language of the ordinance was instead exclusively re- lated to preventing youth from engaging in illegal transactions. (This assertion was made even though Baltimore does not criminalize youth purchase or possession of tobacco products; Baltimore criminalizes the sale of tobacco to minors.) The district court ac- cepted this stated intent of the ordinance. Even when legislators who supported the ordinance made certain health-related comments, the court discounted these as not necessarily being representative of the motives of the city council as a whole. On appeal by the advertising company that was the plaintiff in the case, the Fourth Circuit Court of Appeals further held that the Baltimore ordinance was not preempted by the Federal Cigarette Labeling and Advertising Act because it did not relate to the con- tent of advertising, but rather to billboard location (Penn Advertising of Baltimore, Inc. v. Mayor and City Council of Baltimore, 63 F.3d 1318 [4th Cir. 1995]). The court interpreted the ordinance as a limited physical restriction in a limited media, for Baltimore allows such billboards in parts of the city zoned for commercial and industrial use. The court also observed that the Baltimore ordinance did not restrict tobacco industry advertising in other media, such as newspapers and magazines. State or local governments that cannot separate such ordinances from health-related issues, however, will have difficulty passing the preemption test. In Minnesota, for example, the court struck down a municipal statute that restricted tobacco advertising explicitly to protect health (Chiglo v. City of Preston, 909 F. Supp. 675 [D. Minn. 1995]). The Four-Pronged Test Is the Advertising Unlawful or Misleading? A central justification for affording constitutional protection to advertising is the consumer’s interest in the free flow of information (Central Hudson). Public health and smoking prevention groups often question whether attractive images that portray smoking as a socially acceptable, sexual, and athletic activity have any informational use to the consumer (Lowenstein 1988). Despite the emotive, noninformative character of cigarette advertising, the tobacco industry might argue that restricting such advertising should fail the first prong of the Central Hudson test because the prod- uct being advertised is lawful for adults and its pro- motion is not directly deceptive or fraudulent. Certainly, advertisements that use images to con- nect health, vitality, and the good life with cigarette smoking distort the truth (Law 1992). Yet the United States Supreme Court's definition of “inherently mis- leading” refers to advertisements that promote fraud, represent overreaching, or create consumer confusion (Ohralik v. Ohio State Bar Assn., 436 U.S. 447, 462 [1978]). Proscriptions against misleading advertising have not Reducing Tobacco Use traditionally extended to “puffery” or imagery alone (Zauderer v. Office of Disciplinary Counsel of the Supreme Court of Ohio, 471 U.S. 626 [1985]). For example, courts have held that advertisements for alcoholic beverages that project images of drinkers as successful and fun- loving and do not warn of the dangers of alcohol abuse are not legally “misleading” (Oklahoma Telecasters As- sociation v. Crisp, 699 F.2d 490, 500 [10th Cir. 1983], rev'd on other grounds sub nom.; Capital Cities Cable, Inc. v. Crisp, 467 U.S. 691 [1984]). By analogy, courts may not find that promotions are directly misleading simply because they project images of smokers as glamorous people and do not mention the associated dangers of smoking. A cigarette advertisement would be found to be misleading, however, if it included unsubstantiated health claims. Advertisements could not assert that cigarette smoking poses little or no risk to health or does not affect breathing. For example, the FTC chal- lenged as false and misleading a newspaper advertise- ment (or advertorial), paid for by R.J. Reynolds Tobacco Company, that claimed smoking is not as hazardous to health as the public has been led to believe. Al- though the tobacco company initially stated that the statement was not commercial speech because it did not invite the public to purchase a particular product, the parties entered into a consent decree under which RJ. Reynolds agreed to stop the advertisement and to avoid future misrepresentation of scientific studies (Bureau of National Affairs, Inc. 1990). Some proponents of restricting tobacco advertis- ing argue that courts in the future could find the vi- sual images projected in cigarette advertisements to be inherently deceptive or misleading. A legal opin- ion for the American Medical Association concluded, “Given what the cigarette advertising does portray, what it fails to say, and the vast public ignorance of the dangers and addictive quality of smoking, particu- larly among young persons, it is plain to us that this kind of advertising can be proscribed as deceptive or misleading” (Blasi and Monaghan 1986, p. 506). Analo- gously, the Supreme Court has construed the preemp- tive provisions of the cigarette labeling act to permit tort actions against cigarette manufacturers in the in- stance of fraudulent misrepresentation or conspiracy to misrepresent or conceal material facts (Cipollone). Furthermore, to the extent that recent documents from the tobacco industry show that the industry pur- posefully marketed to minors, the courts may find this to be a deceptive advertising practice that leads to an illegal act. There is no constitutional speech protec- tion for proposing illegal transactions, such as sales of cigarettes to minors. The tobacco company Liggett Regulatory Efforts 173 Surgeon General's Report Group Inc. has admitted that the entire tobacco indus- try conspired to market cigarettes to children (Settle- ment Agreement Between Settling States and Brooke Group LTD, Liggett & Myers, Inc. and Liggett Group, Inc., cited in 13.1 TPLR 3.11 [1998]), and documents obtained in litigation from the other tobacco companies and re- cently made public confirm that tobacco companies have purposefully marketed to children as young as 14 years old (Coughlin et al. 1999). Regulation of some tobacco advertising may thus pass the first prong of the Central Hudson test (see the discussion of the Mangini case in “A Critical Example: Joe Camel,” later in this chapter). Is the Government's Interest Substantial? Appellate courts have consistently found that states have a substantial interest in limiting tobacco advertisements (see, for example, Penn Advertising; Oklahoma Telecasters; and Dunagin v. City of Oxford, 718 F.2d 738 [5th Cir. 1983], cert. denied, 467 U.S. 1259 [1984]). Because of the strong epidemiologic evidence associating smoking with lung cancer, heart disease, and other causes of morbidity and mortality (USDHHS 1989), no court would deny that the federal govern- ment has a compelling interest in reducing smoking. As evidence mounts concerning the health hazards of environmental exposure to cigarette smoke (Environ- mental Protection Agency [EPA] 1992; Leary 1993; Reynolds 1993; Bero et al. 1994; California EPA 1997), the federal government may also exercise its police powers to protect nonsmokers. The Federal Cigarette Labeling and Advertising Act preempts state and local governments from regu- lating cigarette advertising based on “smoking and health.” Instead, as noted, many governments (such as those of Baltimore and New York City) are assert- ing an interest in preventing minors from being in- volved in illegal transactions. Additional nonhealth rationales include avoiding deceptive advertising and providing economic (as opposed to health-based) con- sumer protection. Does the Regulation Directly Benefit the Public Interest? The third prong of the Central Hudson test requires that governmental regulation of commercial speech must advance the government interest. The Supreme Court has not yet given clear direction as to what level of evidence is required to show that such regulation directly advances the government interest, but the Court is beginning to demand some scientific or statistical evidence of efficacy. In Florida Bar v. Went For It, Inc. (515 US. 618, 632 [1995]), the Court was satisfied with a general assertion by the state that common sense 174 Chapter 5 dictated that restricting attorneys from advertising by direct mail would reduce ethical violations by attorneys and have a positive effect on the public’s opinion of at- torneys. Limited social science evidence was presented, yet the restriction was upheld. On the other hand, in 44 Liquormart, Justice Stevens’ plurality opinion stated that one reason the Rhode Island statute was struck down was that the state had not produced evidence that its speech restriction would directly and materi- ally produce the results desired to advance the gov- ernment interest. Even if the courts require empirical support of efficacy, tobacco advertising restrictions can still sat- isfy the third prong of the Central Hudson test. There is extensive social science research regarding the ef- fect of tobacco advertising on the purchasing habits of teen smokers and on the positive imagery with which children regard and recognize tobacco advertising images. After R.J. Reynolds Tobacco Company intro- duced the Joe Camel advertising campaign in the late 1980s, the market share of Camel cigarettes among teenagers increased at least 20-fold; from the same point in time, the previous decline in overall teenage smoking prevalence was reversed (CDC 1994b). An association between a rise in young girls’ smoking habits and the tobacco industry’s decision to target marketing to adolescent girls has also been docu- mented (Pierce et al. 1994a). Some relevant legal judgments suggest that al- though the courts tend to require more than a commonsense assertion of the government's interest in restricting commercial speech, something less than empirical evidence may suffice. For example, although Justice Stevens in 44 Liquormart demanded empirical evidence, he also recognized there is “some room for the exercise of legislative judgment” (p. 508). The Su- preme Court in Edenfteld v. Fane (1135. Ct. 1792 [1993]) suggested the need for a scientific validation of a con- nection between regulation and the achievement of a substantial state interest: the Court stated that the government “must demonstrate that the harms it re- cites are real and that its restriction will in fact allevi- ate them to a material degree” (p. 1800). In cases involving advertising restrictions for al- coholic beverages, the courts have consistently accepted—even in the absence of objective scientific studies—the reasonable legislative belief that such re- strictions would lower consumption. The Tenth Cir- cuit Court of Appeals found it not “constitutionally unreasonable for the State of Oklahoma to believe that advertising will not only increase sales of particular brands of alcoholic beverages but also of alcoholic beverages generally” (Oklahoma Telecasters, p. 501). Similarly, the Ohio Supreme Court found that the ad- vertising of drink prices would encourage and stimu- late consumption of alcoholic beverages (Queensgate Investment Co. v. Liquor Control Commission, 433 N.E.2d 138, 142, 69 Ohio St: 2d 361 [Ohio 1982]). The adver- tising prohibition was thought to be closely connected to the state’s interest in preventing consumption. Courts have found a direct relationship between advertising and consumption or abuse. in other dan- gerous products and activities (see, for example, Will- "jams v. Spencer, 622 F.2d 1200 [4th Cir. 1980]; Capital Broadcasting). In Central Hudson, the Supreme Court | found an immediate connection between advertising and the demand for electricity. The Court in Metromedia, Inc. v. City of San Diego (453 U.S. 490 [1981]) similarly found a link between billboard advertisements and traf- fic safety. The Court stated that this link is established - by the “accumulated, common-sense judgments of local lawmakers” (p. 509). Claims made on behalf of the tobacco and ad- vertising industries that tobacco advertising is de- signed not to increase consumption but only to develop brand loyalty and gain an increased market share (Boddewyn 1989) may be unpersuasive to the courts (Chetwynd et al. 1989; Joossens 1989). Although some of the studies showing that advertising increases to- bacco consumption have methodologies that are controversial—such as econometric (Lewit et al. 1981; Schneider et al. 1981; Seldon and Doroodian 1989), cross-cultural (Hamilton 1976; Reuijl 1982), and adver- tising recognition (Goldstein et al. 1987; DiFranza et al. 1991; Fischer et al. 1991a)—the courts would likely accept the legislature’s reasonable belief that what the Studies show is true. For example, the Ninth Circuit, in a 1997 opinion after 44 Liquormart, maintained that “common sense suggests that advertising increases participation” (Valley Broadcasting Co. v. United States, 107 F.3d 1328, 1344 [9th Cir. 1997]). This portion of Posadas de Puerto Rico has survived 44 Liquormart. In an analogous situation, alcohol industry argu- ments against the relationship between advertising and consumption were rejected by the Fifth Circuit Court of Appeals, which held that Mississippi's ban on intra- state liquor advertising directly promoted the state’s interests in the health and safety of its citizens. The court said that it did not “. . . believe that the liquor in- dustry spends a billion dollars a year on advertising solely to acquire an added market share at the expense of competitors. ... we hold that sufficient reason exists to believe that advertising and consumption are linked to justify the ban, whether or not ‘concrete scientific evi- dence’ exists to that effect” (Dunagin, p. 750). Because the tobacco industry spends six times as much as the Reducing Tobacco Use liquor industry on advertising and promotion (FTC 1995), because smoking remains the leading cause of avoidable death in America (McGinnis and Foege 1993), and because about 50 million Americans still smoke, even small reductions in smoking behavior—whether consumption or uptake—resulting from reduced adver- tising could achieve significant health benefits. Cases trying to restrict alcohol advertising have also, however, set precedents that may. stand in the way of comparable cases involving tobacco advertis- ing. Most notably, in 44 Liquormart, Inc. v. Racine (829 FE. Supp. 543 [R.L. 1993]), the Rhode Island District Court — judge found that the state’s specific statute banning liquor price advertising had had “no significant im- pact on levels of alcohol consumption” (p. 549). Jus- tice Stevens, in his plurality opinion, found that the statute could not survive without social science evi- dence because “speculation certainly does not suffice when the State takes aim at accurate commercial in- formation for paternalistic ends” (44 Liquormart, Inc. v. Rhode Island, p. 507). Yet the Fourth Circuit Court of Appeals, the high- est court to rule on tobacco advertising restrictions, has twice upheld Baltimore’s limitation on tobacco advertising. The Fourth Circuit noted several differ- ences between the liquor price advertising prohibition in 44 Liquormart, Inc. v. Rhode Island and the limited re- strictions in the Baltimore ordinance. 44 Liquormart dealt with a total ban on speech directed to adults, whereas the Baltimore ordinance was a partial restriction of speech that targeted children as consumers of an adult product. The Fourth Circuit Court also held there was a close connection between the government's goal of preventing teen participation in illegal transactions and the limited speech restriction intended to support that goal (Penn Advertising, 63 F.3d 1318; Penn Advertising of Baltimore, Inc. v. Mayor and City Council of Baltimore, 101 F.3d 332 [4th Cir. 1996]). By contrast, a notable reason for the Supreme Court's rejection of advertising restric- tions in 44 Liquormart was that the government had not proved a clear tie between its interest and the re- strictions supposedly supporting that interest. The Fourth Circuit reaffirmed its decision in Penn Advertising after the Supreme Court had asked it to review the decision in light of 44 Liquormart. The Fourth Circuit specifically stated, “We have read the opinion in 44 Liquormart and have considered its im- pact on the judgment in this case ... we conclude that 44 Liquormart does not require us to change our deci- sion” in this case (Penn Advertising of Baltimore, Inc. v.. Mayor and City Council of Baltimore, 101 F.3d 332 [4th Cir. 1996], cert. denied, 117 S. Ct. 1569 [1997]). Regulatory Efforts 175 Surgeon General’s Report Because a restriction like that upheld in Penn Advertising cannot constitutionally be a complete ban on all advertising of the product, some minors will be exposed to some level of adult tobacco advertising. This limit in scope does not constitute serious grounds for an appeal. A recent decision involving liquor regulation notes that the “Supreme Court has made it clear in the commercial speech context that underinclusiveness of regulation will not necessarily defeat a claim that a state interest has been materially advanced” (Bad Frog Brewery, Inc. v. New York State Li- quor Authority, 134 F.3d 87, 99 {2d Cir. 1998]). In sum, the regulation need not cure all ills but it does need to advance the state interest ina demonstrably significant, rather than a small or otherwise circumstantial, way. Is the Regulation of Advertising a Reasonable Fit? The Supreme Court has made it clear that this standard is not to be confused with the “least restric- tive means” test. In Edge Broadcasting (p. 2705), the Court said that the “requirement of narrow tailoring was met if ‘the . .. regulation promotes a substantial government interest that would be achieved less ef- fectively absent the regulation,’ provided that it did not burden substantially more speech than necessary to further the government's legitimate interests.” The existence of less restrictive methods of achieving the government's goals does not automatically defeat the legislation as it would in political speech cases. In- stead the Court looks to see if the restriction does not sweep more broadly than necessary. In Florida Bar the Court stated, In Fox, we made clear that the “least restrictive means” test has no role in the commercial speech context... “What our decisions require,” instead, “is a ‘fit’ between the legislature’s ends and the means chosen to accomplish those ends, a fit that is not necessarily perfect, but reasonable; that rep- resents not necessarily the single best disposition but one whose scope is ‘in proportion to the inter- est served,’ that employs not necessarily the least restrictive means but .. . a means narrowly tai- lored to achieve the desired objective” (citations omitted) (p. 632). In practical terms, the decision implies that re- strictions on tobacco advertising that target areas where children gather, such as schools and play- grounds, do not create a total ban, because the tobacco industry will still have many alternative channels to communicate with its adult customers. Adults can still receive information on price, quality, comparative product features, and any other information to help 176 Chapter 5 them make an informed decision on tobacco products. Even if the tobacco industry were limited to commu- nicating in tombstone format (black letters on a white background), the government would not have prohib- ited the flow of information. For a similar reason, 44 Liquormart, Inc. v. Rhode Island does not change this analysis. The rationale the Supreme Court used there in overturning Rhode Island’s alcohol advertising restriction—that the statute was a paternalistic ban on the free flow of truth- ful information—does not apply in tobacco advertis- ing regulations like those upheld in Penn Advertising, because the tobacco industry would still have many avenues of communication open to it and could com- municate all aspects of information. Justice Stevens in 44 Liquormart also generally rejected a vice exception to commercial speech restric- tions. In Posadas de Puerto Rico, the Court was willing to allow the legislature broad deference to curb speech that promoted “vice” activities such as gambling. Jus- tice Stevens rejected this approach that allowed legis- latures to ban speech rather than the vice itself. He stated, however, that “a ‘vice’ label that is unaccom- panied by a corresponding prohibition against the commercial behavior at issue fails to provide a prin- cipled justification for the regulation of commercial speech about that activity” (44 Liquormart, Inc. v. Rhode Island, p.514). In the case of restricting tobacco adver- tising aimed at children, the restriction matches the prohibition. It is illegal to sell tobacco products to minors, and therefore the legislature has a principled reason to prevent commercial speech in the limited area where it has already prohibited the commercial activity. This is in accord with Justice Clarence Thomas’ view that a jurisdiction “may not restrict ad- vertising regarding commercial transactions except to the extent that it outlaws or otherwise directly restricts the same transactions within its own borders” (p. 525). In 44 Liquormart, Justice Sandra Day O’Connor’s concurrence set out the guideposts she would use to judge commercial speech restrictions. “The availabil- ity of less burdensome alternatives to reach the stated goal signals that the fit between the legislature’s ends and the means chosen to accomplish those ends may be too imprecise to withstand First Amendment scru- tiny. If alternative channels permit communication of the restricted speech, the regulation is more likely to be considered reasonable” (44 Liquormart, Inc. v. Rhode Island, pp. 529-30 [internal citations omitted]). The ruling presupposes that other less restrictive alterna- tives, such as price increases and access restrictions, have been tried (if enacted) and have not completely solved the problem. It is reasonable for a legislature to conclude that limited restrictions on commercial speech aimed at youth must be a component of an overall plan to limit youth involvement with tobacco products. At the same time, the tobacco industry will have alternative channels to communicate to adults all the information in which adults are interested, in- cluding price, tar and nicotine levels, and taste. In the context of alcohol advertisements, courts have asserted that “the state’s concern is not that the public is un- aware of the dangers of alcohol. . . . The concern in- stead is that advertising will unduly promote alcohol consumption despite known dangers” (Dunagin, cert. denied, 467 U.S. 1259). The preceding review of relevant cases suggests that carefully designed, reasonable government restric- tion of cigarette advertising would likely meet the Supreme Court’s four criteria for restricting commercial speech and would therefore be found constitutional. A Critical Example: Joe Camel Perhaps the most discussed tobacco promotion of the 1990s—and one that brings together many of the issues discussed in the preceding section—is the advertising campaign for Camel cigarettes that features a cartoon camel character called Old Joe (often referred to as Joe Camel). Assertions have been made that this campaign improperly targeted minors, seeking to at- tract them to cigarette smoking. These concerns were heightened in the wake of the 1994 Surgeon General’s report on smoking and health, which focused on ado- lescents (USDHHS 1994). That report’s major conclu- sions included the following: those who smoke usually begin by age 18; most adolescent smokers become ad- dicted to nicotine; tobacco addiction is associated with the later development of other drug addiction; tobacco use is related to psychosocial risk factors; and some cigarette advertising appears to be particularly effec- tive on adolescents. Critics argue that the cartoon character of Joe Camel, which has been used by R.J. Reynolds Tobacco Company in its advertising campaign for Camel ciga- rettes since 1988, has had substantial impact on smok- ing among underaged youth (DiFranza et al. 1991; Fischer et al. 1991a; Breo 1993; CDC 1994b). The char- acter appears in print advertising and on promotional products disseminated by the company, such as mugs, matchbooks, store exit signs, and soft drink can hold- ers. After a staff investigation, in 1994 the FTC de- clined, by a 3 to 2 vote, to issue a complaint charging that advertising using the Joe Camel character violated Reducing Tobacco Use section 5 of the Federal Trade Commission Act by in- ducing minors to smoke. Subsequently, the FTC did bring a complaint against R.J. Reynolds on May 28, 1997, alleging that “the purpose of the Joe Camel cam- paign was to reposition the Camel brand to make it attractive to younger smokers. ... The Joe Camel cam- paign induced many of these children and adolescents under the age of 18 to smoke Camel cigarettes or in- creased the risk that they would do so.... RJ. Reynolds’ actions . . . have caused or were likely to cause substantial and ongoing injury to the health and safety of children and adolescents under the age of 18 that is not offset by any countervailing benefits and is not reasonably avoidable by these consumers” (In re RJ. Reynolds Tobacco Co., Docket No. 9285 [FTC, May 28, 1997], cited in 12.3 TPLR 8.1, 8.2 [1997]). As late as the spring of 1998, Joe Camel memorabilia were still being offered for sale in RJ. Reynolds catalogs. The FTC ultimately dismissed its complaint as no longer necessary after the November 23, 1998, Master Settle- ment Agreement banned the use of all cartoon charac- ters, including Joe Camel, in the advertising, promotion, packaging, and labeling of any tobacco product. The Federal Trade Commission Act grants no private right of enforcement (Holloway v. Bristol-Myers Corp., 485 F.2d 986 [D.C. Cir. 1973]). However, the California Unfair Competition Law authorizes actions for injunctive relief (a measure sought to prevent a given course of action) not only by specified state and local officers but also by persons acting for the inter- est of themselves or the general public. A private ac- tion was brought in California state court by Janet Mangini, who asserted that R.J. Reynolds’ advertising practices in the Joe Camel campaign violated the Fed- eral Trade Commission Act and the California statu- tory law of unfair competition (Mangini v. R.J. Reynolds Tobacco Co., 7 Cal. 4th 1057, 875 P.2d 73 [Cal. 1994], cert. denied, 1994 U.S. LEXIS 8361 [Nov. 28, 1994]). Unfair competition is defined to include “any unlawful, un- fair or fraudulent business act or practice and unfair, deceptive, untrue or misleading advertising” (Califor- nia Business & Professions Code, sec. 17200). RJ. Reynolds, in contesting Mangini’s action, asserted that federal law preempted any action in the state courts. The Federal Cigarette Labeling and Advertising Act, as amended by the Public Health Cigarette Smoking Act of 1969, provides that “no requirement or prohibition based on smoking and health shall be imposed under State law with respect to the advertising or promotion of any cigarettes the packages of which are labeled in conformity with the provision of this Act” (Public Health Cigarette Smoking Act of 1969, sec. 5{b]). Regulatory Efforts = 177 Surgeon General's Report The Supreme Court of California rejected the preemption argument and held that the cause of ac- tion against the advertising—that it improperly targeted minors—would stand. According to the court, the advertising had apparently been effective in tar- geting adolescents: Camel cigarettes were chosen by an estimated 0.5 percent of teenage smokers in 1988 (the last full year of sales before the Joe Camel cam- paign) and by an estimated 25-33 percent in 1992 (as quoted in the decision; other sources cite a substan- tial, although smaller, increase [CDC 1994b]). In 1992, teenage smokers accounted for about $476 million of Camel sales, a vastly greater amount than the $6 mil- lion in sales for 1988 (Mangini, p. 1060). The portion of the Mangini lawsuit regarding the Joe Camel adver- tising campaign was settled September 8, 1997, when RJ. Reynolds agreed to cease placing Joe Camel on California billboards, placing Joe Camel materials in magazines and newspapers, and distributing promo- tional materials through retail mechanisms (Mangini v. RJ. Reynolds Tobacco Co., cited in 12.5 TPLR 3.349 [1997]). It also agreed to pay the cities and counties that had joined the action as co-plaintifts $9 million for a counteradvertising campaign, presumably to dis- pel the lingering effects of the Joe Camel marketing. In another state, Washington, a private action using that state’s law failed to prohibit advertising using Joe Camel (Sparks 0. R.J. Reynolds Tobacco Co., No. C94-783C [W.D. Wa. Dec. 9, 1994], cited in 9.6 TPLR 2.171 [1994]). Nonetheless, the decision of the Supreme Court of California indicates that at least in some in- stances in some jurisdictions, private parties acting as representatives of the general public can bring an Product Regulation action normally brought only under specific federal or state law against cigarette advertising. Thus, as with a number of other legal issues (see “Litigation Approaches,” later in this chapter), the judicial response to aggressive pursuit of legal policy options is still unfolding. Although the process of le- gally regulating tobacco advertising and promotion has been under way for decades, the extent of such regulation and its ultimate limits are not yet known. The most significant developments in this area revolved around the release of—-and subsequent reaction to—the FDA’s August 10, 1995, preliminary de- termination. The determination accompanied a pro- posed rule that sought to restrict the availability and marketing of tobacco products to children and adoles- cents. The FDA’s final determination that it had au- thority to regulate cigarettes and smokeless tobacco products (released on August 28, 1996) is discussed later in this chapter, where the analysis of product regula- tion focuses on “Further Regulatory Steps.” Arguably the second most important develop- ment in this area was the June 20, 1997, proposed agree- ment that would have settled lawsuits between 41 state attorneys general and the tobacco industry. Because the advertising and promotion provisions of that agree- ment directly presupposed legislation that would have upheld the FDA's asserted jurisdiction to regulate to- bacco products, this key multistate agreement is, like the FDA announcement, discussed later in this chap- ter, where the analysis of product regulation focuses on “Legislative Developments” and “Master Settle- ment Agreement.” Introduction Cigarette smoke contains approximately 4,000 chemicals, including a number of carcinogens and other toxic chemicals, such as hydrogen cyanide and oxides of nitrogen (USDHHS 1989). Regulating tobacco prod- ucts requires appropriate assessment of these primary and secondary products of combustion and other sub- stances that may be inhaled. Current tobacco product regulation requires that cigarette advertising disclose levels of “tar” (an all-purpose term for particulate- phase constituents of tobacco smoke, many of which 178 Chapter > are carcinogenic or otherwise toxic) and nicotine (the psychoactive drug in tobacco products that causes ad- diction [USDHHS 1988]) in the smoke of manufactured cigarettes and that warning labels appear on packages and on some (but not all) advertising for manufactured cigarettes and smokeless tobacco; the current federal "In California, a state suit against tobacco manufacturers for failure to comply with the state’s Safe Drinking Water and Toxic Substances Enforcement Act of 1986 led to an agreement requiring that a warning about the possibility of reproductive harm and cancer appear on packages not covered by federal requirements (USDHHS 1989). laws preempt, in part, states and localities from impos- ing other labeling regulations on cigarettes and smoke- less tobacco (see the previous major section, “Advertising and Promotion”). Since the mid-1980s, federal law has required makers of manufactured cigarettes and of smokeless tobacco products to submit lists of additives to the tobaccos (but not to filters or papers) in their products to the Secretarv of Health and Human Services (Com- prehensive Smoking Education Act, Public Law 98-474, sec. 5; Comprehensive Smokeless Tobacco Health Edu- cation Act of 1986, Public Law 99-252, sec. 4). Infor- mation about the quantity of additives used and their placement in specific brands is not required, and the Secretary is bound by law to safeguard the lists from public disclosure. In 1994, attorneys for six manufac- turers released to the public the list of ingredients added to tobacco in 1993. Tobacco products are explicitly protected from regulation in various federal consumer safety laws (USDHHS 1989). Although regulation requires pub- lic reporting of some constituents in cigarette smoke, cigarette manufacturers are not required to report toa governmental body (or to include on product labels for consumers) brand-specific information about the nicotine content or any other property (e.g., nitro- samine levels, ammonia level, pesticide residues, heavy metals [lead, cadmium, mercury, or chromium], pH, or sugar content) of the material that forms the tobacco rod of their products. At the very least, knowl- edge of the upper bound of nicotine in the tobacco rod of cigarettes is important because actual smoking may produce constituent levels that varv considerably from that in smoke delivery vields reported to the FTC (USDHHS 1988; see also “Compensatory Smoking,” later in this chapter). Those measurements were con- ducted by the Tobacco Institute Testing Laboratory. The Comprehensive Smokeless Tobacco Health Education Act of 1986 requires smokeless tobacco manufacturers to report the total nicotine content of their products to the Secretary of Health and Human Services (Public Law 99-252, sec. 4), but the Secretary may not release the data to the public. A uniform pro- tocol implementing this provision was published in the March 23, 1999, Federal Register. No federal public health laws or regulations apply to cigars, pipe tobac- cos, or fine-cut cigarette tobaccos (for “roll-your-own” cigarettes) in any manner other than prohibiting the advertising of small cigars through electronic media (USDHHS 1989). Reducing Tobacco Use The Constituents of Smoke From Manufactured Cigarettes Since 1967, the FTC has regularly published tables of tar and nicotine delivery of smoke from manu- factured cigarettes. Since 1980, the tables have also included a measurement for carbon monoxide delivery. The data are based on results of a standard- ized, machine-driven test procedure (Pillsbury et al. 1969) that provides a basis of comparison among vari- ous brands of cigarettes. Manufacturers are not re- quired to print these values on the product package, but “ultra low” cigarette brands often include tar and nicotine deliveries on the package, presumably to dif- ferentiate these brands (Davis et al. 1990). No brand having a tar yield above 11 mg prints this information on the package. Carbon monoxide deliveries are not listed either on packages or in advertising (USDHHS 1989). Regulation by Tar Levels The FTC’s tables of tar levels have provided some jurisdictions with criteria for regulating tar content by levving taxes on higher-tar cigarettes or, in the case of countries in the European Union, by altogether ban- ning high-tar cigarettes. The apparent assumption be- hind such actions—that discouraging or banning consumption of higher-tar cigarettes will result in reduced morbidity and mortality from smoking- related diseases—has been questioned, as is discussed in the section “Compensatory Smoking,” later in this chapter. Tar content has in several instances served as the basis for cigarette taxation, on the presumption that the taxing structure would provide a competitive ad- vantage to low-tar brands—an advantage of interest, for supposed public health reasons, to the jurisdiction levying the tax. For several years beginning in 1971, New York City taxed cigarettes that had either tar yields over 17 mg or nicotine yields over 1.1 mg an additional 3 cents per pack and cigarettes that exceeded both thresholds, 4 cents (Long Island Tobacco Co., Inc. 0. Lindsay, 74 Misc. 2d 445, 343 N.Y.S.2d 759 [N.Y. 1973]). Although the levy was upheld by the courts, the law seems to have been repealed because of allegations that unequal taxation across political boundaries was fos- tering smuggling (Ranzal 1973). There are no reports on the effects this tax may have had on consumption patterns. In 1978, the British government imposed a supplementary tax on cigarettes having a measured tar vield greater than 20 mg (Gray and Daube 1980 Reeilatory Efforts 179 Surgeon General's Report Figure 5.1. Sales-weighted nicotine and tar levels in smoke as percentage of 1982 levels 7 Average of all brands* pent ty Percentage of 1982 levels 90 T 1982 T ! 1 T T 1 T T T T 1990 1992 1994 1996 Year TTT T 1984 1986 1988 7 Low-tar category (6-15 mg tar)* Percentage of 1982 levels 90 T T TTT 1988 t T t y T T 1 T 19990 1992 1994 1996 Year T 1982 1984 1986 — Nicotine *By Federal Trade Commission method. | High-tar category (>15 mg tar)* 1207 3 ? 7 a x x = 10-4 o a _ = 2 100 44 90 Tt 1982 1984 1986 1988 1990 1992 1994 1996 Year | Ultra-low-tar category (<6 mg tar)* ~ 1204 = - & = 110- St = & 2 100-4 90 TTT TTT 1982 1984 1986 1988 1990 1992 1994 1996 Year ome «Jar Source: Kessler 1994b; Federal Trade Commission, unpublished data, 1998. [note misprint in this publication: on page 93, line 3, “more” should have been “less”; correction furnished by Michael Daube, February 13, 1996]). Within three months of the imposition of the tax, the market share of such brands fell from 13 to 3 percent (Michael M. Daube, letter to John Slade, February 24, 1995). A simi- lar tax was used in Sweden, but it was repealed to achieve uniformity with tax policies of the European Union (Paul Nordgren, letter to David T. Sweanor, December 23, 1994). Among countries in the European Union, a fixed ceiling on tar content has been used as a regu- latory method. The European Union has imposed a 180 Chapter 3 graduated decline in the upper limit of tar deliveries permitted for cigarettes sold in member countries. Be- ginning January 1, 1993, the ceiling was 15 mg tar delivery per cigarette; after December 31, 1997, the ceiling was 12 mg (Council Directive 90/239/EEC 1990 O.J. [L 137]). Implications of Nicotine Levels The FTC’s tables on nicotine levels have revealed a recent change in the ratio of tar to nicotine in ciga- rettes. Kessler (1994b) has reported that for 1982-1991, the ratio of average sales-weighted nicotine yield to tar yield’ in cigarette smoke has risen steadily for each of three major tar-yield categories and for the overall market (Figure 5.1). Given the addictive properties of nicotine and its contribution to cardiovascular disease (USDHHS 1988), this change may have important pub- lic health implications. Moreover, “low-vield” and “ultra low-vield” cigarettes in the same period had higher nicotine yield to tar ratios than did brands in the high tar-vield categories. Consumers who pay more heed to the “numbers” for tar levels than to the much smaller (but no less important) numbers for nicotine levels may be under the illusion that they are reducing their health risks and increasing their chances of quitting by smoking “low-tar” cigarettes. (This illusion is further discussed in “The Low-Tar ‘Alternative,’ ” later in this chapter.) A manufactured cigarette generally contains 8-10 mg of nicotine (USDHHS 1988), regardless of the machine-measured nicotine delivery in the smoke. Un- der usual smoking conditions, consumers absorb about 10-30 percent of the nicotine contained in the tobacco rod of the cigarette (USDHHS 1988; Benowitz and Henningfield 1994). Some thought has recently been given to systematically lowering the nicotine content of tobacco products to levels that would not pose a threat of addiction (Benowitz and Henningtield 1994; Douglas 1994). Benowitz and Henningfield (1994) have suggested that addiction is unlikely to be sustained below a nicotine dose of about 5 mg per day. This dose is about one-fourth the daily dose commonly ingested by tobacco users. To achieve such a ceiling for ciga- rettes, the nicotine content of the tobacco rod would have to be 0.5 mg or Jess, assuming that the smoker consumes about 30 cigarettes per day and receives 30 percent of the nicotine available. However, cigarettes with such low levels of nicotine may not be popular (Campbell 1994). The experience of Philip Morris Companies Inc. in trying to sell a low-nicotine-content cigarette, “Next,” illustrates this point; the company ‘ judged the test-marketing of this cigarette a failure. Such failure provides indirect support for the impor- tance of nicotine addiction to the tobacco industry. Mandating the reduction of nicotine for the purpose of weaning smokers from tobacco products was contemplated as a strategy available to the FDA in legislation proposed to enable the multistate settle- ment agreement with the tobacco companies (see ‘Average sales-weighted nicotine-to-tar vield means that the average amount reported here was calculated by taking the vield from all brands of cigarettes and weighting each vield by its sales tigures. Thus, the vield for a popular cigarette would “count” more in the average of all brands than the vield for a less popular brand. Reducing Tobacco Use “Legislative Developments” and “Master Settlement Agreement,” later in this chapter). A similar strategy is used in some voluntary stop-smoking programs (e.g., Gahagan 1987). But this strategy cannot work unless accurate measures are available of the actual nicotine uptake that smokers and other tobacco users receive. In 1994, the NCI convened an ad hoc expert com- mittee to determine the adequacy of the standard, smoking-machine-based, FTC protocol for determin- ing the tar and nicotine content of cigarettes. The com- mittee concluded that “the FTC test protocol was based on cursory observations of human smoking behavior. Actual human smoking behavior is characterized by wide variations in smoking patterns, which result in wide variations in tar and nicotine exposure. Smok- ers who switch to lower tar and nicotine cigarettes fre- quently change their smoking behavior, which may negate potential health benefits” (NCI 1996, p. vi). In 1996, Massachusetts enacted a law designed to obtain reports of brand-specific nicotine levels that more closely approximate the uptake by actual smok- ers of these brands. The statute instructs the state Department of Public Health to establish standards for nicotine yield ratings that “accurately predict nicotine intake for average consumers” (Mass. Gen. Laws ch. 94, sec. 307B). Each cigarette and smokeless tobacco manufacturer must then report, in a manner consis- tent with these standards, the nicotine yield rating of each brand of tobacco products it produces. These reports become public records. Other Constituents in Cigarette Smoke Tar and nicotine measurements have tradition- ally been used as surrogate measures for other toxic constituents in cigarette smoke, because changes in tar and nicotine levels presumably are predictive of changes in the levels of most other particulates. Stud- ies suggest otherwise. For example, tar level as mea- sured by smoking machines is not a good predictor of benzo[a]pyrene level (Kaiserman and Rickert 1992). In general, declared tar values are not predictive of tobacco-specific nitrosamine levels (Fischer et al. 1990, 1991b). Similarly, tar delivery is a poor predictor of the delivery of gas-phase constituents, such as carbon monoxide, hydrogen cyanide, and acrolein (Young et al. 1981). In Canada, the Department of National Health and Welfare (Health Canada) has undertaken a program to develop methods for collecting and analyzing toxic constituents, other than tar, nicotine, and carbon mon- oxide, in tobacco smoke. Methods have been devel- oped to measure the levels of benzo[a]pyrene, the Regulatory Efforts 181 Surgeon General's Report tobacco-specific nitrosamines, hydrogen cvanide, ben- zene, formaldehvde, 4-amino-biphenyl, and heavy metals such as lead and cadmium (Health Canada 1995a). The Department of National Health and Wel- fare intends to require manufacturers to use these test methods to provide quantitative reports on these chemi- cals in tobacco smoke or, in the case of heavy metals, in the tobacco itself (Health Canada 1995a). Rickert (1994) has described the presence of the potent bladder carcinogen 4-amino-biphenyl in the sidestream smoke from all 10 brands of cigarettes tested in a study for Health Canada. Under occupa- tional safetv regulations, the permissible level of ex- posure to 4-amino-biphenyl is zero. Applying these standards to cigarette smoke would require either that this material be absent from cigarette smoke entirely or that cigarette smoke not be permitted in spaces sub- ject to regulation. An important development indicating a possible design flaw in the manufacture of cigarettes has been the report that cellulose acetate fibers are shed from ciga- rette filters. Such fibers, coated with tar, have been ob- served in the lungs of smokers; this observation suggests that these fibers mav be long-lived in human tissue and may be associated with disease (Pauly et al. 1995). Additives to Tobacco Products Hundreds of ingredients besides tobacco are used in the manufacture of tobacco products. Additives make cigarettes more acceptable to the consumer; thev can make smoke seem milder (and easier to inhale), prolong shelf life, prolong burning, and improve taste. These additives may be a single chemical used as a humectant or a complex mix of chemicals used as a flavorant. Cigarette Additives The six major cigarette manufacturers reported a pooled list of 599 ingredients that were added to the tobacco of manufactured cigarettes as of 1994 (RJ. Reynolds Tobacco Company 1994). The list is anno- tated with references to which materials are approved for use as food additives by the FDA (under the cat- egory “Generally Recognized as Safe”) and are thought to be safe by the Flavor and Extract Manufacturers Association of the United States. However, that a material is regarded as safe when ingested in foods provides no assurance of its safety ina tobacco prod- uct, where it will be combined with other substances, heated to high temperatures, and may be inhaled into the lungs. 182. Chapter 5 The American Health Foundation (1990) has pointed out the toxic potential of numerous cigarette tobacco additives under expected conditions of use. Heating and burning may lead to the formation of car- cinogens from some of the additives used. For in- stance, amino acids used as additives are known to form compounds of various elements, including genotoxic agents (known to damage DNA) and experi- mental carcinogens, during heating. Licorice root ex- tract contains glycyrrhizin, and both are used as additives in cigarettes; glycyrrhizin produces carcino- genic by-products when burned. The leukemia- producing agent benzene is a component of cigarette smoke that may be formed from the combustion of many cigarette additives. Because the Federal Food, Drug, and Cosmetic Act requires that a food additive “be safe under the conditions of its intended use” (sec. 321), tobacco additives in manufactured cigarettes may not fulfill the specifications of the law were the law applied to tobacco. The use of additives may reinforce cigarette smoking by strengthening the addictive effects of nico- tine. At least one major domestic cigarette maker uses some additives to boost the absorption of nicotine in cigarette smoke (Kessler 1994c). Ammonia compounds alter the pH of nicotine in tobacco, converting it from the protonated, bound form (various nicotine salts) to the unprotonated, freebase form. Freebase nicotine more readily enters the smoke stream and has been predicted to cross lung and oral cavity membranes more quickly than nicotine salts do (Henningfield et al. 1995). The broader issue of enhancing the delivery of nicotine is discussed in the introductory section of “Further Regulatory Steps,” later in this chapter. Several European countries regulate cigarette ad- ditives, but only to a modest extent. In France, the to- tal percentage of the cigarette that consists of additives is listed on the side of the package. Among representa- tive brands manufactured in the United States but sold in France (e.g., Camel, Kent, Marlboro, and Winston), the cigarette labels indicate that between 6.2 and 10.0 percent of each cigarette is composed of additives. The British government maintains a list of “permitted” or “approved” additives for smoking tobacco and ciga- rette paper (Lewis and Davis 1994, p. 206). The list, which had 474 ingredients in 1988, specifies the maxi- mum level permitted for each specific additive (Lewis and Davis 1994). In Canada, the Tobacco Products Con- trol Act (sec. 10; Department of National Health and Welfare 1989) requires manufacturers to report a quar- terly list of ingredients used in their products. Cana- dian producers use far fewer additives—about 50 in all—than do American manufacturers. Massachusetts, Minnesota, and Texas have en- acted laws to require the disclosure of nontobacco in- gredients in tobacco products (Mass. Gen. Laws ch. 94, sec. 307B; Minn. Laws ch. 227 [1997]; Vernon’s Texas Statutes and Codes Annotated ch. 161, sec. 161.252 (1997]). Health officials in the Canadian province of British Columbia have announced their intention of taking similar steps there. The Massachusetts law, applicable to cigarettes and smokeless tobacco, requires the manufacturer to report, in descending order by weight, measure, or nu- merical count, the identity of each brand’s added con- stituents other than tobacco, reconstituted tobacco sheet, or water. Ingredients that are recognized as sate when burned and inhaled are exempted. The Depart- ment of Public Health is then instructed to disclose the reported information to the public to the extent that “there is a reasonable scientific basis for concluding that the availability of such information could reduce risks to public health” (Mass. Gen. Laws ch. 94, sec. 307B). The tobacco industry challenged the statute in court on both preemption and trade secret grounds. The Federal District Court ruled that nothing in fed- eral law preempted Massachusetts from taking this action, and the court of appeals affirmed (Philip Mor- ris Inc. v. Harshbarger, 122 F.3d 38 (1st Cir. 1997]). How- ever, the same Federal District Court thereafter issued a preliminary injunction that prevented the state from enforcing the ingredient disclosure provision of the statute; the court ruled that doing so would expose the trade secrets of the manufacturers (Philip Morris Inc. 2. Harshbarger, Civil Action No. 96-11599-GAO, Civil Action No. 96-11619-GAO, 1997 U.S. Dist. LEXIS 21012 [D. Mass. Dec. 10, 1997]). That ruling is cur- rently under appeal. Texas has adopted a similar stat- ute requiring the tobacco industry to submit a list of ingredients and nicotine yield ratings to the Texas Department of Health by December 1998 (Vernon’s Texas Statutes and Codes Annotated ch. 161, secs. 161.252, 161.254, 161.255). The Minnesota statute requires manufacturers of tobacco products to publicly disclose, for each brand, whether the product contains detectable levels—in either its unburned or its burned states—of ammonia or ammonia compounds, arsenic, cadmium, formal- dehyde, or lead. The industry filed suit in Federal Dis- trict Court to enjoin the enforcement of the statute but agreed to drop the suit as part of its May 1998 settle- ment of the state’s Medicaid reimbursement lawsuit (discussed in “Recovery Claims by Third-Party Health Care Payers,” later in this chapter) (Mimesota v. Philip Morris Inc., cited in 13.2 TPLR 3.39, 3.45 [1998]). Reducing Tobacco Use Most recently, British Columbia health officials announced plans to require cigarette manufacturers to disclose to the government al] ingredients, includ- ing additives used to treat the papers and filters. Manufacturers would also have to test and report on 44 poisons that the health officials claim are contained in cigarette smoke (Reuters 1998). Smokeless Tobacco Additives In 1994, ten manufacturers of smokeless tobacco products released a list of additives used in their prod- ucts (Patton, Boggs & Blow 1994). As with the addi- tive list for cigarette tobacco, the smokeless tobacco list notes which of the 562 materials listed have been approved for use in foods by the FDA and also notes which are regarded as safe by the Federal Emergency Management Agency. As with cigarette tobacco, ap- plving these safetv standards to nonfood substances is problematic; however, smokeless tobacco used in an unaltered (unburned) state lessens some of the con- cern over the possible hazards of additives. The list of additives to smokeless tobacco in- cludes sodium carbonate and ammonium carbonate, which are alkalinizing agents that increase the level of “free” (chemically uncombined) nicotine in moist snuff by raising the pH level (Slade 1995). A division af the Swedish Tobacco Company has stated that so- dium carbonate is added to its moist snuff brands to alkalinize the tobacco and thus enhance nicotine absorption (Kronquist 1994). The pH of moist snuff products—which is not reported to consumers— varies from acidic to alkaline, providing a wide range of free-nicotine levels in various products (Djordjevic et al. 1995; Henningfield et al. 1995). Products for per- sons entering the market (such as those that have easy- to-use unit dosages) are acidic (thus reducing absorption) and have very low levels of free nicotine, whereas products for more experienced users (such as the Copenhagen brand) are alkaline and have high levels of free nicotine. The epidemiology of moist snuff use among teenagers and young adults indicates that most novices start with brands having low levels of free nicotine and then graduate to brands with higher levels (Tomar and Henningfield 1992; Tomar et al. 1995). These patterns are consistent with the industry’s marketing strategies as reflected in their advertising and marketing activities and their internal documents (Connolly 1995). Sweeteners and flavorings, such as cherry juice concentrate, apple juice, chocolate liqueur, and honey, are used in various smokeless tobacco products, and dominant flavors are often mentioned in the product Regulatory Efforts 183 Surgeon General's Report name (e.g., the Skoal Cherry Long Cut brand). As with manufactured cigarettes, these additives increase pal- atability and may intensify use of smokeless tobacco, at least among novices (Freedman 1994). The Low-Tar “Alternative” As the health hazards of smoking have been in- creasingly documented, the production of lower-tar cigarettes has increased. The FTC’s tables on average sales-weighted tar levels for cigarettes on the U.S. market from 1968 through 1987 reflect this shift toward lower-tar cigarette brands (USDHHS 1981, 1989)." The public health implications of this shift merit closer inspection. Compensatory Smoking Considerations of product regulation must take into account the variability in toxic exposure attribut- able to specific smoking practices. The overall evi- dence suggests that many smokers compensate when smoking low-delivery cigarettes by inhaling more tar and nicotine than are measured by smoking machines under standard conditions. Any potential health ben- efit implied by machine measurements of lower tar and nicotine vields may thus be mitigated by such com- pensatory smoking. Studies have shown that as consumers switched to lower-yield cigarettes in Great Britain, they tended to smoke more cigarettes each day (Ferris 1984), ap- parently to compensate for the lower nicotine vield per cigarette. Similar compensatory measures May have occurred in the United States. For example, smok- ers in Cancer Prevention Study I, conducted during the 1960s when lower-vield brands were rare, smoked fewer cigarettes per day than smokers in Cancer Pre- vention Study H, which was conducted during the 1980s, by which time most smokers used lower-vield brands (Thun et al. 1997). Strong evidence suggests that smokers increase the number of cigarettes con- sumed as nicotine availability is reduced, and vice versa (USDHHS 1988; Kaufman et al. 1989; Palmer et al. 1989; Stellman and Garfinkel 1989; Negri et al. 1993: Thun et al. 1997). In addition, lower nicotine delivery in the FTC test is associated with smoking a greater number of cigarettes (USDHHS 1988). This 4Some reports have included data from 1957 to 1967 (eg. USDHHS 19839, p. 88). However, those data are unpublished and first appeared ina chart attributed to a personal communication from Dr. Helmut Wakeham, then a research scientist with Philip Morris Companies Inc. (Wynder and Hecht 1976, p. 151). 184 Chapter 5 compensatory effect has been confirmed in other stud- ies (Benowitz et al. 1983; Bridges et al. 1990; Hofer et al. 1991; Woodward and Tunstall-Pedoe 1992; Coultas et al. 1993); only one published study found no such effect (Rosa et al. 1992). In an abstract, Byrd and col- leagues (1994) reported no compensatory effect, but their small study population may not have been rep- resentative of all smokers; for instance, the nicotine intake seen among the group that smoked the ultra low-delivery cigarettes was smaller than that observed by others. Health Risks From Low-Tar Cigarettes Even when compensatory smoking is not ac- counted for and calculations are derived from machine-rated tar levels, the risk of lung cancer is only slightly lower from using low-tar cigarettes than from using high-tar cigarettes, and reduced tar level has little if any impact on the occurrence of other cigarette- caused lung disease or of heart disease (USDHHS 1981, 1989; Parish et al. 1995; Wannamethee et al. 1995). Giovino and colleagues (1996) have examined results from several national surveys of tobacco use for attitudes and behaviors related to the use of low- tar cigarettes. In these surveys, current smokers of low- tar brands were found to be more likely than smokers of high-tar brands to acknowledge the health risks of smoking, to express concerns about these risks, to re- port that they had been advised by a physician to stop, and to report that they had experienced negative health consequences from smoking. These smokers were also more likely, however, to believe that smoking a low- tar brand reduced those risks. For example, in the 1987 National Health Interview Survey, 44 percent of smok- ers reported that they had switched to a low-tar cigarette to reduce their health risk, and 48 percent of low-tar brand users thought their brand was less haz- ardous than most other brands (Giovino et al. 1996). These attitudes were confirmed by a 1993 Gallup poll in which 49 percent of respondents stated that they believed that the advertising message in terms such as “low tar,” “low nicotine,” or “lower yield” was that the “brand [was] safer”; only 4 percent believed that the advertisements were “false/misleading” (Gallup Organization, Inc. 1993, p. 23). The analysis by Giovino and colleagues (1996) also suggested that many smokers of low-tar cigarettes may have used these brands instead of quitting. Low- tar users were more likely than high-tar users to have tried unsuccessfully to stop smoking. Similarly, a greater proportion of people who had successfully quit smoking had been high-tar cigarette users. This latter observation has been confirmed in another survey: those who had stopped smoking tended to have been higher-tar cigarette smokers (Cohen 1996). As was previously suggested (Kessler 1994b), the higher ra- tios of nicotine yield to tar yield in lower-tar cigarettes than in higher-tar cigarettes could impede efforts to quit among persons who smoke lower-tar cigarettes. Assessment of consumer attitudes, as well as epidemiologic consideration of health risks from lower-yield cigarettes, has raised concerns about the reporting of FTC test results (Henningfield et al. 1994). Anad hoc committee of the President’s Cancer Panel, convened in December 1994 (Jenks 1995), concluded that consumers misunderstand the FTC test results and should be given a range of values for smoke deliver- ies (reflecting the way cigarettes are actually smoked) and that these values should be included on each pack- age and in all advertisements (NCI 1996). The com- mittee also concluded that terms such as “light” and “ultra light” are in fact health claims that mislead consumers. Nicotine Replacement Products The “safe cigarette,” long sought, has not been found (Gori and Bock 1980; USDHHS 1981, 1989; Slade 1989, 1993), and the axiom that no tobacco product is safe when used as intended remains true (USDHHS 1989). As long as tobacco products are sold, some people will be unable to stop using nicotine (Kozlowski 1987). Novel nicotine delivery devices have been tried in test markets (R.J. Reynolds Tobacco Company 1988; Slade 1993; Hilts 1994), and several tobacco compa- nies have patents for various designs (David A. Kessler, letter to Scott D. Ballin, February 25, 1994; Slade 1994; Hwang 1995b). All designs share the ability to deliver nicotine for inhalation with a minimum of, or no, tar— thereby avoiding the smoking-associated increased risk of cancer (although not the nicotine-associated increased risk of cardiovascular disease) (USDHHS 1988). Nicotine replacement products have been devel- oped and marketed by pharmaceutical companies as adjuncts to help people stop smoking UJarvik and Henningfield 1993). As was discussed in Chapter 4 (see “Pharmacologic Interventions”), concerns over possible intentional or unintentional misuse of these products have been weighed against the health ben- efits resulting from their effectiveness as a cessation aid. Nicotine gum and nicotine patches, previously approved by the FDA as prescription drugs for brief use (months), were approved in 1996 for over-the- counter use, concluding an intense examination of the Reducing Tobacco Use issues of nicotine availability. Both a nicotine nasal spray and a nicotine inhaler were approved for pre- scription use. The Drug Abuse Advisory Committee (1994) of the FDA has expressed concern about the potential abuse liability of the spray and the inhaler, because the pharmacokinetics of their delivered dose of nicotine comes closer than the gum or patch to what occurs through using tobacco products. Benowitz and Pinney (1998) concluded that the benefits from over- the-counter availability of the gum and patch would outweigh the risks. In December 1996, the FDA’s Drug Abuse Advisory Committee recommended approval of the nicotine inhaler for prescription use (FDA Drug Abuse Advisory Committee, draft minutes of Decem- ber 13, 1996, meeting). Nicotine maintenance is not an approved thera- peutic approach, but some observers have called for a coordinated clinical and public health program to ex- plore this option (Slade et al. 1992). A useful program not only must substantially reduce health risks and satisfy addicted individuals who cannot otherwise stop using tobacco products but also must include realistic safeguards to prevent the new onset of nicotine de- pendence among the young, to prevent relapse among those who have already stopped, and to further re- duce overall smoking prevalence. The elements of such a program would include research to (1) fully characterize the population that would benefit from nicotine maintenance, (2) identify potential delivery devices for nicotine or an appropri- ate analogue, (3) explore fully the safety of these de- vices as well as the safety of nicotine or the chosen analogue (including assessments of potential cardio- vascular, fetal, cognitive, and performance problems consequent to use of the drug, as well as other poten- tial health effects), and (4) design a drug distribution system that would be acceptable to intended users but that would substantially limit access by novices to to- bacco use and by those who have already been suc- cessful at achieving abstinence from nicotine (Slade et al. 1992). Product Regulations for Consumer Education The previous discussion of product regulation centered on the contents of the tobacco product itself. Another critical focus for product regulation is pack- aging, a promising field for public information and education on smoking and health. Government ac- tions in this area have included product packaging to convey health messages (see “Attempts to Regulate Regulatory Efforts 185 Surgeon General's Report Tobacco Advertising and Packaging,” earlier in this chapter). The goal of this packaging strategy, as dis- cussed in the following section, is to help ensure that the purchase of tobacco products occurs only asa trans- action involving informed consumer choice. Also dis- cussed is a related, more complex goal for this strategy: to help ensure a situation of informed consumer con- sent rather than simply choice. Tobacco Packaging and Informed Choice The current required warning labels on US. to- bacco packages are but a single, narrow means by which package-based messages can promote informed choice among consumers. The vast amount of infor- mation available on the adverse health effects of to- bacco use constitutes a wide range of messages that can be presented this way (USDHHS 1989). This in- formation can appear on packages in many ways, given the numerous variables such as size, wording, placement, colors, graphics, typefaces, and package inserts. The potential public education value of package- based health messages is inherent in their exception- ally large rate of exposure to consumer view. In the United States, about 478 billion cigarettes were con- sumed in 1997 (Tobacco Institute 1998). Each of these cigarettes will be removed from a package that could be viewed by many cigarette users at exactly the time they are preparing to engage in the activity such mes- sages are intended to prevent. These messages can be seen not only immediately before use but also at the point of sale or at any time the package is in the pos- session of the user. The messages do not have to be directed only at tobacco users; anv exposed package can be viewed by, and can provide information equally germane to, users and nonusers alike. An example of the potential inherent in package messages is provided from Canada. In legislation supplementing the Tobacco Products Control Act (sec. 9), the federal government of Canada not only increased the number of rotating messages from four to eight but also made new stipulations regarding the messages’ size, location, and color (Department of National Health and Welfare 1993; for details on these changes, see “Examples of Product Labeling in Other Countries,” earlier in this chapter). These changes followed stud- ies undertaken to determine the existing messages’ leg- ibility, readability, believabilitv, and ease of understanding. These studies had indicated that health warnings were read about 1.4 times per day (women, 1.8 times; men, 1.2 times) and that cigarette packs were a primary source of tobacco-related health information 186 9 Chapter 5 for 55 percent of smokers, second only to television (59 percent) and well ahead of newspapers (17 percent) (Tandemar Research Inc. 1992; Kaiserman 1993). Tobacco Use and Informed Consent Although many discussions of tobacco use in- yoke “free choice,” the more rigorous legal concept is “informed consent.” As applied to tobacco use, in- formed consent would obtain only when potential purchasers of tobacco products could make fully in- formed purchase decisions after carefully weighing the health risks of using those products. Thus, like pa- tients considering whether to undergo potentially harmful medical procedures, consumers considering whether to use tobacco would have to know which health problems are caused by the product's use, what increases in personal risk of these various problems occur through this use, what the prognosis is should any of these problems arise, and what effect ending or adjusting the use could have on these problems. Courts of law in this country and elsewhere have ar- ticulated the duty of product manufacturers to warn consumers about product hazards. A particularly clear statement of the principles involved in informed con- sent is found in an Ontario Court of Appeal decision concerning oral contraceptives: Once a duty to warn is recognized, it is manifest that the warning must be adequate. It should be communicated clearly and understandably in a manner calculated to inform the user of the na- ture of the risk and the extent of the danger; it should be in terms commensurate with the grav- ity of the potential hazard, and it should not be neutralized or negated by collateral efforts on the part of the manufacturer. The nature and extent of any given warning will depend on what is rea- sonable having regard to all the facts and circum- stances relevant to the product in question (Buchan v. Ortho Pharmaceutical [Canada] Ltd., [1986] 54 O.R.2d 101 [Ct. App.] [Can.]). Similarly, a U.S. court has described an adequate prod- uct warning in the following way: In order for a warning to be adequate, it must pro- vide “a complete disclosure of the existence and extent of the risk involved” (Pavlides v. Galveston Yacht Basin, Inc., 727 F.2d 330 [5th Cir. 1984]) citing Alman Brothers Farms & Feed Mill, Inc. v. Diamond Laboratories, Inc., 437 F.2d 1295, p. 1303 [5th Cir. 1971]). ... A warning must (1) be designed so it can reasonably be expected to catch the attention of the consumer; (2) be comprehensible and give a fair indication of the specific risks involved with the product; and (3) be of an intensity justified by the magnitude of the risk (Pavlides, p. 338). At issue, then, is whether consumers have re- ceived adequate warning for informed consent to ap- ply to tobacco use. Although public knowledge about the health effects of tobacco use has improved over the past 15 vears (FTC 1984; USDHHS 1989), evidence persists of gaps in understanding. An American Can- cer Society (ACS) study showed respondents a list of selected causes of death and asked which was respon- sible for the greatest number of deaths (Marttila & Kiley, Inc. 1993). The study found that only one in five Americans could correctly identify cigarette smoking as the listed cause associated with the most deaths. Simi- lar studies in other countries (Hill and Gray 1984; Gallup Canada, Inc. 1988;.Environics Research Group Limited 1991; Health and Welfare Canada 1992 [unpublished data]) have found a similar lack of knowledge. These studies indicate that the public continues to underestimate the magnitude of the risks arising from tobacco use. The resulting inability of consum- ers to make fully informed decisions about tobacco use could be interpreted as a failure on the part of the manufacturer to achieve informed consent from users of the product. To date, this issue has not been legally addressed, and the previously discussed notion of in- formed choice, which carries clearer legal implications, is generally invoked. Further Regulatory Steps Although some of the aforementioned product regulations address the chemical constituents of to- bacco use, none directly broaches the issue of whether tobacco, as a nicotine delivery system, should be sub- ject to federal regulation as an addictive product. In March 1994, the Coalition on Smoking OR Health ([CSH] composed of the American Heart Association, the American Lung Association, and the American Cancer Society) filed a petition with the FDA to de- clare all cigarette products to be drugs under section 201 of the Federal Food, Drug, and Cosmetic Act (CSH 1994a). This petition followed an earlier one bv the same coalition requesting the classification of low-tar and low-nicotine cigarettes as drugs and similarly clas- sifying the proposed new R.J. Reynolds Tobacco Com- pany “smokeless cigarette” as a drug (CSH 1988). Reducing Tobacco Use A few weeks earlier, the FDA had made public that it was investigating whether it might assert juris- diction over tobacco products (Kessler 1994a). The legal basis for such a move requires demonstrating that the manufacturers of tobacco products intend to af- fect the structure or function of their customers’ bod- ies (21 U.S.C. section 321 [g] [1]). The Commissioner of the Food and Drug Administration, David A. Kessler, M.D., had indicated in testimony before Con- gress that there was evidence that pointed to this con- clusion (Kessler 1994b,c). The FDA has concluded that words used by to- bacco companies to describe some effects of smoking (e.g., “satisfaction,” “strength,” and “impact”) are eu- phemisms that actually describe pharmacologic effects of nicotine (Kessler 1994b, p. 150). Dr. Kessler has noted that cigarettes are sophisticated, carefully de- signed devices. Industry patents disclose a detailed knowledge of nicotine pharmacology and describe as desirable those product refinements that increase the efficiency of nicotine delivery. One company has pat- ented a series of nicotine analogues having desired pharmacologic effects, much as a conventional phar- maceutical company might develop a new drug that produces effects similar to those of an existing drug. The FDA has disclosed several specific examples of product manipulation to adjust the delivered dose of nicotine in cigarettes (Kessler 1994c). The Brown & Williamson Tobacco Corporation has used in cigarettes sold in the United States a strain of tobacco (Y-1) that had been genetically engineered to have a high nico- tine content. According to a major American tobacco company’s handbook on leaf blending and product development, ammonia compounds can be used as additives to boost the delivery of nicotine in smoke to enhance the “impact” and “satisfaction” from smoke (Kessler 1994c, p. 365). In an official prosecution memorandum to the U.S. Attorney General, Represen- tative Martin T. Meehan (D-MA) has asserted that product manipulation of Eclipse brand cigarettes has taken place. Meehan cites the addition of high-nicotine-content tobacco near the filter and the addition of potassium carbonate to change the pH of the tobacco (or to enhance absorption through the mu- cous membranes) (Meehan 1994; see “Criminal Pro- ceedings,” later in this chapter). Moreover, information obtained from internal industry documents suggests that at least some tobacco companies have long had an accurate and detailed knowledge of nicotine phar- macology. Dr. Kessler told Congress that “such re- search would be of interest to the industry only if the industry were concerned with the physiological and pharmacological effects of nicotine. Certainly, this is Regulatory Efforts 187 Surgeon Generals Report not consistent with the industry's representation that nicotine is of interest to it only because of flavour and taste” (Kessler 1994c, p. 367). Following his testimony before Congress, in a speech at Columbia University School of Law, Dr. Kessler emphasized the importance of preventing nico- tine dependence among children and teenagers. Call- ing it “a pediatric disease” (David A. Kessler. Remarks. Presented at the Samuel Rubin Program, Columbia University School of Law, New York City, March 8, 1995, unpublished), he outlined a number of specific priorities for public health action: A comprehensive and meaningful approach to preventing future generations of young people from becoming addicted to nicotine in tobacco is needed. Any such approach should: First, reduce the many avenues of easy access to tobacco prod- ucts available to children and teenagers; second, get the message to our young people that nicotine is addictive, and that tobacco products pose seri- ous health hazards—and not just for someone else; and third, reduce the powerful imagery in tobacco advertising and promotion that encourages young people to begin using tobacco products (p. 19). On August 10, 1995, the FDA announced the result of its investigation. The agency stated that evi- dence appears to indicate that “nicotine in cigarettes and smokeless tobacco products is a drug and [that] these products are nicotine delivery devices under the Federal Food, Drug, and Cosmetic Act” (Federal Regis- ter 1995a). In August 1995, the FDA issued in the Fed- eral Register (1) a proposed rule of regulations restricting the sale and distribution of cigarettes and smokeless tobacco products to protect children and adolescents and (2) an analysis of the FDA's jurisdic- tion over cigarettes and smokeless tobacco. The FDA requested comments on its proposed regulations and analysis of its jurisdiction, and indicated that it would give serious consideration to comments filed with the agency concerning the evidence amassed during its investigation. The Clinton administration also sug- gested that Congress could eliminate the need for this rulemaking by passing new legislation to aftirm the FDA’s authority over tobacco products and address the issue of tobacco use among, minors. In its legal analysis of its proposed jurisdiction over tobacco products, the FDA argued that cigarettes and tobacco products “affect the structure or any func- tion of the body” (key language for invoking the agency’s authorizing legislation) and that it is the in- tent of tobacco manufacturers that their products have 188 9 Chapter 3 addictive effects (Federal Register 1995a). The argument was presented as a logical chain of inference: the ad- dictive properties of tobacco are “widely known and foreseeable” by tobacco manufacturers; consumers use the product to satisfy their addiction; and tobacco manufacturers know of the addiction, know of con- sumers’ use, and have facilitated that use (Federal Reg- ister 1995a). An extensive analysis, including internal documents from tobacco companies, was used to elu- cidate these assertions (Federal Register 1995a). The FDA presented a further legal discussion of whether the cigarette is a device and postulates that the ciga- rette is “a consciously engineered instrument . . . to effectuate the delivery of a carefully controlled amount of the nicotine to a site in the human body where it can be absorbed” (Federal Register 1995a). The proposed regulations centered on restricting the availability and appeal of tobacco products to chil- dren and adolescents and consisted of the following provisions: ° The tobacco industry would be required to spend at least $150 million per year to support smoking prevention education for children. ¢ Tobacco sales would be prohibited to those under 18 years of age, and vendors would be required to see photo identification as proof of age. « Vending machines, self-service displays, and mail- order sales would be prohibited, as would the sale of individual cigarettes or packs of fewer than 20 cigarettes. * The sale or gift of promotional items bearing brand names, logos, or other brand identity would be prohibited. e« Free samples would be banned. ¢ Only black-and-white text advertising for cigarette products would be permitted in publications for which more than 15 percent of the readership is under age 18 and in publications with more than 2 million young readers. © Outdoor tobacco advertising would be prohibited within 1,000 feet of schools and playgrounds. All other outdoor tobacco advertising would have to be in black-and-white text. * Sponsorship of sporting or entertainment events using specific brand names or product identifica- tion would be prohibited, although the use of com- pany names would not. The proposed regulations stirred immediate action from the tobacco industrv. Four lawsuits were filed immediately after the Federal Register announcement. A lawsuit filed bv tobacco companies in federal court in Greensboro, North Carolina, as- serted that the FDA had no jurisdiction over cigarettes. The plaintitfs were Brown & Williamson Tobacco Cor- poration, Liggett Group Inc., Lorillard Tabacco Cam- pany, Philip Morris, and R.J. Reynolds Tobacco Company (Wall Street Journal 1995). Parts of the ad- vertising industry, which has a large stake in the out- come of the proposed regulations, also filed suit on the grounds of infringement of First Amendment rights (American Advertising Federation 0. Kessler, Civil Action No. 2:95CV00593 [M.D.N.C. Aug. 10, 1995], cited mr 10.5 TPLR 3.401 [1995]}). In addition, a smokeless tobacco company (United States Tobacco Co. v. Food and Drug Administration, Civil Action No. 6:95CV00665 [M.D.N.C. Sept. 19, 1995]) and a trade group repre- senting convenience stores (National Association of Coi- venience Stores v. Kessler, Civil Action No. 2:95CV00706 [M.D.N.C. Oct. 4, 1995]) filed suit. By the January 2, 1996, close of the public com- ment period on the proposed rules, the FDA had re- ceived more than 95,000 individual comments, the largest outpouring of public response in the agencv’s history. From March 18 to April 19, 1996, the FDA re- opened the comment period for the limited purpose of seeking comments on the statements of three former Philip Morris employees about that companv’s alleged manipulation of nicotine in the design and production of cigarettes and to seek comments on further expla- nations of certain provisions in the proposed rule. The review process culminated in a Rose Gar- den ceremony at the White House on August 23, 1996, in which President Clinton announced the publication of the final FDA rules. To emphasize that the FDA‘s central intent was to reduce tobacco use among young people, these final rules essentially regrouped the regu- lations from the original announcement into two cat- egories: reducing minors’ access to tobacco products and reducing the appeal of tobacco products to mi- nors. The only notable changes to the former rules were that the ban on mail-order sales was eliminated and the ban on vending machines and self-service displays was relaxed to allow exceptions for certain nightclub and other “adults-only” facilities totally in- accessible to persons under the age of 18. Similarly, the limitation to black-and-white text for in-store advertising excepted adults-onlv facilities if the adver- tising was not visible from the outside. In place of its original regulation requiring the tobacco industry to spend at least $150 million each Reducing Tobacco Use vear to support tobacco prevention education for chil- dren, the final rules were less explicit. The FDA pro- posed to require the six tobacco companies with a significant share of sales to minors to educate that population about the health risks of using tobacco products. This action would be pursued under pro- cesses dictated by section 518(a) of the Federal Food, Drug, and Cosmetic Act (FDCA). Under the act, the FDA may require manufacturers to inform the consumer about unreasonable health risks of their products. The various provisions were to be phased in be- tween six months and two years from August 28, 1996, the date of publication in the Federal Register. Two prin- cipal hurdles to quick and full implementation of the FDA regulations soon emerged. First, as noted above, several tobacco companies, retailers, and advertisers had sued the FDA to block implementation of the regu- lations. Second, various legislative proposals, which began circulating in Congress both before and after publication of the FDA’s final rule, threatened to alter or bar the FDA‘s regulation of tobacco products. Judicial Developments and the Status of FDA Regulations Three briets filed on October 15, 1996, on behalf of the plaintiffs in these suits moved for summary judg- ment, arguing that the proposed regulations exceed the agency’s jurisdiction and are contrary to congres- sional intent, that tobacco products are not “drugs” or “devices” within the agency’s statutory grant of au- thority, and that the advertising restrictions are a vio- lation of the First Amendment (Mealey’s Litigation Reports: Tobacco 1996b). On April 25, 1997, the federal district court in Greensboro, North Carolina, ruled that the FDA pos- sessed the authority to regulate cigarettes and smoke- less tobacco products as drug delivery devices under the FDCA (Coyne Beal, Inc. v. U.S. Food & Drug Ad- nuiistration, 966 F. Supp. 1374 [M.D.N.C. 1997]). The ruling, however, marked a considerably qualified vic- tory for the FDA. Although the court upheld all of the agency’s restrictions involving youth access and label- ing, the court temporarily blocked implementation of most of these provisions. Only the FDA's prohibition on sales of cigarettes and smokeless tobacco to minors and the requirement that retailers check photo identifi- cation of customers who are under 27 years of age es- caped the court’s stay. These provisions went into effect on February 28, 1997, and remained in force until March 21, 2000, the date of the Supreme Court decision. Regulatory Efforts 189 Surgeon Gererdl’s Report Notably, the court invalidated the FDA's restric- tions on advertising and promotion of cigarettes and smokeless tobacco on the basis that thev exceeded the agency’s statutory jurisdiction. The pertinent federal statute, 21 U.S.C. section 360j(e), provides, in part, that the government may “require that a device be re- stricted to sale, distribution or use... upon such other conditions as the Secretary may prescribe.” The FDA had argued that it was authorized to restrict the “sale, distribution or use” of tobacco products pursuant to section 360j(e) and that its advertising and promotion restrictions were valid because advertising and pro- motion constitutes an “offer of sale” (Coyne Bealin, p. 1398). Judge William L. Osteen Sr. disagreed. The court reasoned that the word “sale” as employed in the statute did not encompass the advertising or pro- motion of a product. The court also ruled that the “section’s grant of authority to FDA to impose ‘other conditions’ on the sale, distribution, or use ot restricted devices [does] not authorize FDA to restrict advertis- ing and promotion” (p. 1398). Furthermore, because the court ruled that the FDA was not authorized to restrict advertising and promotion, the court did not reach or discuss arguments that these provisions violated the First Amendment to the United States Constitution. Most important, however, Judge Osteen agreed with the FDA’s contention that tobacco products fall within the “drug” and “device” definitions of the FDCA. To position its authority within these defini- tions, the FDA had to have demonstrated that tobacco products are “intended to affect the structure or any function of the body” (21 U.S.C. section 321 [gM ULC). Judge Osteen ruled that the effects of tobacco prod- ucts are “intended” within the meaning of the FDCA and that tobacco products affect the structure or func- tion of the body within the meaning of that act. The court also ruled that pursuant to its “device authori- ties,” the FDA could regulate tobacco products as medical devices. Both sides in the case appealed the decision to the Fourth Circuit of the United States Court of Appeals in Richmond, Virginia. The government and the tobacco companies presented oral arguments to a three-member panel of this court on August 11, 1997. The case became inactive following the death of one of the panel judges on February 22, 1998. Anew judge was appointed, and on June 9, 1998, the three- member panel conducted a secand hearing on the appeal. 190 Chapter 5 The Court of Appeals Ruling on FDA Authority On August 14, 1998, the Fourth Circuit Court of Appeals overturned the lower court decision and ruled ‘n.a2 to 1 decision that the FDA Jacks the authority to regulate tobacco products (Brow & Williamson Tobacco Corp. v. Food & Drug Administration, No. 97-1604 [4th Cir, 1998]). The majority opinion Judge H. Emory Widener Jr.) found that the FDA had based its deter- mination of authority solely on literal interpretations of “drug” and “device” in the FDCA but did not con- sider statutory language as a whole, the legislative his- tory, and the history of evolving congressional regulation in the area, including consideration of other relevant statutes. Judge Widener held that there is an internal inconsistency in the FDA’s claim of authority to regulate tobacco under the FDCA, since a declara- tion that cigarettes are unsafe (the basis of the FDA’s claim) necessitates a ban on cigarette sales—an action that would be opposed by powerful economic and political forces. Widener reasoned that although the FDA would have the authority to grant exemptions to the ban because potential public health benefits might outweigh harms, such exemptions would undermine the agency’s essential view that cigarettes are unsafe. The only exemption open to the FDA would thus be based on social and economic rather than health- related considerations. A well-known catch would then come into play: social and economic consider- ations are within the purview of Congress, not the FDA. Judge Widener pointed out that Congress had been aware for decades that the FDA lacked the au- thority to regulate tobacco on social and economic grounds, had rejected attempts to give the FDA such authority, and had enacted numerous pieces of legis- lation that did not grant such authority. The dissenting opinion Judge Kenneth K. Hall) took the position that the intrinsic contradiction in the FDA’‘s authority under the FDCA is irrelevant: whether the regulations contravene the statute is a question wholly apart from whether any regulations could be issued. .. . It is no argument to say that the FDA can do nothing because it could have done more” © (Brown & Williamson, p. 48). The opinion proposed that the FDA‘s current position is a response to “the increasing level of knowledge about the addictive nature of nicotine and the manufacturer's deliberate design to enhance and sustain the addictive effect of tobacco products” (p. 50). Judge Hall stated that prec- edents in administrative law clearly indicate latitude for an agency to change its approach in the light of new information. He further asserted that earlier con- gressional action did not have the benefit of the level of evidence gathered by the FDA in forming its cur- rent position. Finally, he pointed out that the term “sale, distribution and use” (p. 38) is not fully defined in the FDCA and is therefore subject to agency inter- pretation. This term “can reasonably be construed to include all aspects of a product's journey from the fac- tory to the store and to the home” (p. 58). Thus, the judge reasoned, the authority to regulate tobacco pro- motion should be upheld. The full Fourth Circuit Court of Appeals declined to review this reversal. The government petitioned the United States Supreme Court for review, and the United States Supreme Court accepted the case in April 1999. Oral argument was held December 1999, and the Court, in a 5 to + deci- sion, upheld the Fourth Circuit's decision on March 21, 2000. The U.S. Supreme Court Ruling on FDA Authority On March 21, 2000, bv a 5 to + vote, the United States Supreme Court affirmed the Fourth Circuit de- cision and overturned the FDA's assertion of jurisdic- tion over cigarettes and smokeless tobacco products (Food and Drug Administration ¢. Brown & Williamson Tohacco Corp., 529 US. [2000], 120.5. Ct. 1291). Asa result, the FDA no longer has regulatory author- itv to enforce the final rule it issued in 1996. Justice Sandra Day O'Connor wrote the majority opinion for the Court. In ruling against the FDA, she noted that “The agency has amply demonstrated that tobacco use, particularly among children and adoles- cents, poses perhaps the single most significant threat to public health in the United States” (p. 1315). Nev- ertheless, the majority ruled that Congress had pre- cluded the FDA from asserting jurisdiction over tobacco products as customarily marketed because “Such authority is inconsistent with the intent that Con- gress has expressed” (p. 1297) in the Federal Food, Drug, and Cosmetic Act and other tobacco-specific statutes. Justice O’Connor noted the unusual nature of both the case the Court was deciding and the role of tobacco in the United States. She wrote: Owing to its unique place in American historv and society, tobacco has its own unique political history. Congress, for better or for worse, has created a dis- tinct regulatory scheme for tobacco products, squarely rejected proposals to give the FDA juris- diction over tobacco, and repeatedlv acted to pre- clude any agency from exercising significant policymaking authority in the area (p. 1315). Reducing Tobacco Use Justice Stephen Brever wrote the dissenting opin- ion. He disagreed with the majority view that Con- gress never intended the FDA to have the authority to assert jurisdiction over tobacco products. In summa- rizing why the four justices in the dissent believed the FDA had acted lawfully, Justice Breyer wrote: The upshot is that the Court today holds that a regu- latory statute aimed at unsafe drugs and devices does not authorize regulation of a drug (nicotine) and a device (a cigarette) that the Court itself finds unsafe. Far more than most, this particular drug and device risks the life-threatening harms that administrative regulation seeks to rectify (p. 1331). Legislative Developments In an effort to clarifv the public health perspec- tive on potential legislation, on September 17, 1997, President Clinton outlined the principles he believed must be at the heart of any national tobacco legisla- tion (Hohler 1997): * A comprehensive plan to reduce youth smoking, including tough penalties if targets are not met. « Full authority for the FDA to regulate tobacco products. * An end to the tobacco industry’s practice of marketing and promoting tobacco to children. *« Broad document disclosure (especially of those documents relating to marketing tobacco to children). ¢ Progress toward other public health goals, such as reducing environmental tobacco smoke (ETS), ex- panding smoking cessation programs, strengthen- ing international efforts to control tobacco, and providing funds for health research. e Protection for tobacco farmers and their communities. A number of bills intended to enable the enact- ment of the June 20, 1997, multistate settlement agree- ment were introduced into the U.S. Senate in late 1997 and early 1998. In March 1998, the Senate Commerce Committee bill introduced by Senator John McCain (R-AZ) became the focus of all settlement-related legislative activity in the Senate. The Commerce Committee endorsed a preliminary version of a sub- stitute bill, S. 1415, on March 30, 1998, by a vote of 19 to1. On May 1, 1998, the Commerce Committee's ver- sion of the bill—S. 1415.RS (the “McCain Committee Regulatory Efforts 197 Surgeon General's Report Bill”)—was reported by Senator McCain to the full Senate. Among other things, the McCain Committee Bill would have done the following: ¢ Required the tobacco industry to pay $516 billion ($147.5 billion more than was specified in the June 20th multistate settlement agreement) over 25 years to help states and the federal government bear the medical costs of smoking-related illness. ° Raised cigarette taxes by $1.10 per pack over five years. ° Preserved the FDA's ability to regulate the tobacco industry in ways that the June 20th agree- ment did not. * Drastically reduced cigarette marketing, advertis- ing, and promotion (Kelder 1998). In addition, the Floor Manager’s Amendment to the bill would have established a detailed regulatory scheme to be administered by the FDA (S. 1415.RS [Floor Manager’s Amendment of May 18, 1998, 105th Cong., 2nd Sess.]). First, the FDA could designate de- monstrably safer products as “reduced risk tobacco products” (sec. 913fa][2][A)). Second, the FDA would have the authority to promulgate performance stan- dards, including “the reduction or elimination of nico- tine vields” (sec. 907[a][2][A][I}) and “the reduction or elimination of other constituents or harmful com- ponents of the product” (sec. 907[al[2]{[Al fii). The agency would follow normal administrative proce- dures, unless it sought to eliminate “all cigarettes, all smokeless tobacco products, or any similar class of tobacco products” (sec. 907[b][3][A]) or to require “the reduction of nicotine vields of a tobacco product to zero” (sec. 907[b][3][B]). In that event, the amendment stipulated, “the standard may not take effect before a date that is 2 vears after the President natifies the Con- gress that a final regulation imposing the restriction has been issued” (sec. 907[b][3][B). Third, the Floor Manager’s Amendment would have required that the FDA be given the additive information specified in the settlement agreement within six months of enactment (sec. 904[a][3)). The amendment would also have required that manufacturers share with the FDA “all documents . .. relating, to research activities, and research findings, conducted, supported, or possessed by the manufac- turer (or agents thereof) to the health, behavioral, or physiologic effects of tobacco products, their con- stituents, ingredients, and components, and tobacco additives” (sec. 904[a][4]) or “to marketing research 192. Chapter 5 involving the use of tobacco products” (sec. 904[a]15)). Tobacco product advertising would be required to in- cludea “brief statement of the uses of the tobacco prod- uct and relevant warnings, precautions, side effects, and contraindications” (sec. 903[a][8][BILi}). Further- more, the FDA would be given explicit power to im- pose “restrictions on the access to, and the advertising and promotion of, the tobacco product” (sec. 906[d][1]). Senate bill 1415 was vehemently opposed by the tobacco industry. On April 8, 1998—nine days after the Commerce Committee endorsed the preliminary version of the McCain Committee Bill—Steven F. Gold- stone, RJR Nabisco’s chief executive officer, announced that his company was pulling out of the congressional process for developing comprehensive tobacco legis- lation. Blaming Congress for failing to stick to the terms of the June 20th agreement, Mr. Goldstone, speaking to the National Press Club in Washington, DC, declared his company’s intention not to sign the consent decrees to voluntarily limit advertising that were part of the McCain Committee Bill. Philip Mor- ris, Brown & Williamson, United States Tobacco, and Lorillard made similar announcements shortly after Mr. Goldstone’s speech. In retrospect, one can conclude that this tobacco company brinkmanship—when paired with a widely disseminated, industry-sponsored advertising cam- paign that portrayed the McCain Committee Bill as a vast “tax-and-spend” proposal—was a major force in scuttling the proposed legislation. Emboldened by the effect that the industry-sponsored advertising campaign had on public opinion, the tobacco industry’s Senate allies greatly altered the McCain Committee Bill, cul- minating in the Floor Manager’s Amendment on May 18, 1998. Some of these amendments would have in- creased the bill's potential harmful impact on public health. For example, in this final form, the bill had been shorn of almost all of its funds for initiatives to fund tobacco use reduction, and the tobacco industry had been given a potential means of immunity in the form of caps on plaintiffs’ attorneys’ fees (Kelder 1998). On June 17, 1998, the McCain Committee Bill died atter four weeks of intense debate and political ma- neuvering. In the absence of congressional action to enact the proposed settlement, individual state law- suits proceeded. Four states—Mississippi, Florida, Texas, and Minnesota—have settled their suits with the tobacco industry. Because these settlements in- volve the recovery of Medicaid payments made by the states, they are discussed with other such litigation approaches, later in this chapter (see “Recovery Claims by Third-Party Health Care Payers”). Master Settlement Agreement On November 23, 1998, 11 tobacco companies executed a legal settlement with 46 states, the District ot Columbia, and five commonwealths and territories. The plaintiffs had sued the tobacco industry to recoup Medicaid costs for the care of persons injured by tobacco use. The suit alleged that the companies had violated antitrust and consumer protection laws, had conspired to withhold information about adverse health effects of tobacco, had manipulated nicotine lev- els to maintain smoking addiction, and had conspired to withhold lower-risk products from the market. In the settlement, the companies agreed to pay states $246 billion over 25 vears. But in addition, the settlement agreement contained a number of impor- tant public health provisions (see the text box). The agreement placed significant marketing restrictions on the industry by prohibiting direct advertising and pro- motion aimed at young people, by limiting brand name sponsorship at events that might be frequented by youth, by requiring the removal of street advertising without restrictions on counteradvertising, by placing substantial restrictions on lobbving and on the suppres- sion of research findings, and by requiring major can- tributions from the industry to cessation and prevention Clean Indoor Air Regulation Reducing Tobacco Use activities (Wilson 1999). In addition, the agreement dealt with such issues as legal fees, court supervision, civil liabilities restrictions, and public disclosure. Unlike the 1997 settlement, the 1998 settlement contained no pro- visions regarding FDA authority. The agreement raised a number of issues for states, but foremost among these has been the compe- tition between tobacco contro! efforts and other state spending priorities. The National Governors Associa- tion issued a policy statement that reaffirmed states’ entitlement and asserted that the federal government had no legitimate claim to settlement funds. The asso- ciation committed to spending “a significant portion of the settlement funds on smoking cessation programs, health care, education, and programs benefitting chil- dren” but reserved the right to make funding decisions tailored to states’ individual needs (National Governors Association 1999). By mid-1999, 27 states had allocated their first and second settlement payments. Of these, 23 had specified some portion of the monev for public health activities, and 16 had specifically designated spending for tobacco control and prevention efforts. Specific issues related to the allocation of Master Settle- ment Agreement funds to tobacco control efforts in states are discussed in Chapter 7. Introduction If the regulation of tobacco products themselves has been characterized by slow and incremental ad- vances, the regulation of where and how tobacco prod- ucts are used—that is, the regulation of exposure, particularly of nonsmokers, to ETS—has encountered comparatively little resistance. Public and private steps to regulate ETS have become both more com- mon and more restrictive over the past several decades. There are various reasons for this broad and rapid implementation. One reason is that the public health necessity of regulating ETS exposure is manifest: ETS is known to cause acute and chronic diseases in non- smokers (National Academy of Sciences 1986; USDHHS 1986; National Institute for Occupational Satety and Health 1991; EPA 1992; California EPA 1997). Moreover, this demonstrated health threat is unentangled with legal or ethical issues ot “informed choice” or “informed consent” (see “Product Regula- tion,” earlier in this chapter)—hence a popular name for this exposure, passive smoking. Regulating ETS exposure also has important implications for reduc- ing smoking: studies have shown that restricting smoking in public settings increases the likelihood that smokers in these settings smoke fewer cigarettes or quit smoking entirely (Petersen et al. 1988; Borland et al. 1990a; Stillman et al. 1990; Sorensen et al. 1991a; Woodruff et al. 1993). It has been estimated that the combined effect of general smoking cessation and smoking reduction in public settings could decrease total cigarette consumption by as much as 40 percent (Woodruff et al. 1993), although this conclusion may be questioned based on assessment of worksite inter- ventions (see “Worksite Programs” in Chapter 4). A second reason for the expansion of ETS regulations is that their public support, a key marker for successful Regulatory Efforts 193 Surgeon General's Report t Major Provisions of the Master Settlement Agreement n addition to the monetary payments from the tobacco industry to states, the settlement pro- vided for other requirements and restrictions: Youth Access No free samples except in an enclosed area where operator ensures that no underage persons are present. No gifts to youth in exchange for buying tobacco products. No gifts through the mail without proof of age. Prohibits sale, manufacture, or distribution of cigarettes in packages of fewer than 20 until December 31, 2001. Marketing No brand name sponsorship of concerts, team sporting events, or events with a significant youth audience. No sponsorship of events in which paid partici- pants are underage. Bans use of tobacco brand names in stadiums and arenas. Bans use of cartoon characters in tobacco adver- tising, packaging, and promotions. Bans pavments to promote tobacco products in entertainment settings, such as movies. Bans distribution and sale of merchandise with brand name tobacco logos. Lobbying 194 Prohibits industrv from supporting diversion of settlement funds to nonhealth uses. Restricts industry from lobbying against restric- tions of advertising on or in school grounds. Prohibits new challenges by the industry to state and local tobacco contro] laws enacted betore June 1, 1998. Chapter 5 Outdoor Advertising Bans transit and outdoor advertising, including billboards. Tobacco billboards and transit ads to be removed. At industry expense, states could substitute advertising discouraging youth smoking. Cessation and Prevention The tobacco industry will contribute $25 million annually for 10 years to support a charitable foundation established by the National Associa- tion of Attorneys General to study programs to reduce teen smoking and to prevent diseases associated with tobacco use. The foundation, since named the American Legacy Foundation, is governed by a board and will carry out a sus- tained national advertising and education pro- gram to counter tobacco use by young people and educate consumers about the health hazards of tobacco use. It will also evaluate the etfec- tiveness of counteradvertising campaigns, model classroom educational programs, and ces- sation programs and will disseminate the results. Other activities include commissioning and funding studies on the factors that influence vouth smoking, developing training programs for parents, and monitoring youth smoking to determine the reasons for increases or failures to decrease tobacco use rates. The industry will contribute $1.45 billion over five years to support the National Public Edu- cation Fund, which will carry out a national sus- tained advertising and education program to counter youth tobacco use and to educate con- sumers about tobacco-related diseases. The to- bacco industry will continue to contribute $300 million annually to the fund as long as the par- ticipating tobacco companies hold 99.05 percent of the market. implementation, is implicit: national studies suggest that most of the U.S. public experiences discomfort and annoyance from ETS exposure (CDC 1988, 199?b), and smaller-scale surveys have found that the great ma- jority of both nonsmokers and smokers favors smok- ing restrictions in various public locations, including the workplace, restaurants, and bars (CDC 1991). A third reason is that employers might be expected to support ETS regulations, because prohibiting smok- ing in the workplace can help employers realize lower maintenance and repair costs of buildings and prop- erty, lower insurance costs, and higher productivity among nonsmokers (Mudarri 1994). Emplover sup- port, however, may be influenced by other factors (see “Effectiveness of Clean Indoor Air Restrictions,” later in this chapter). Not surprisingly, during the 1980s the tobacco industry identified ETS regulation as the single most important issue confronting the industry’s economic future (Chapman et al. 1990). The industry is con- cerned that the increasing focus on ETS may cause the public and policymakers to view smoking as an envi- ronmental issue with broad social consequences in- stead of as a personal behavior involving individual choice. The tobacco industry is also concerned about legal backlash from possible ETS-related litigation against employers and about revenue losses from pos- sible decreased cigarette consumption due to smok- ing restrictions (Chapman et al. 1990). An example of the latter concern may be found in California, where workplace restrictions extant in 1990 have reduced consumption by an estimated 148 million packs per vear, at a value of $203 million in pretax sales (Wood- ruff et al. 1993). Health Consequences of Exposure to ETS The detrimental health effects of exposure to ETS are well established (National Research Council 1986; USDHHS 1986, 2000b; EPA 1992; California EPA 1997). The most comprehensive review of the respiratory ef- fects of ETS to date is the 1992 report of the EPA, which states that ETS is a human lung carcinogen that annu- ally accounts for approximately 3,000 lung cancer deaths among adult nonsmokers in the United States. Autopsy reviews (Trichopoulos et al. 1992) and stud- ies of ETS metabolites in body fluids (Hecht et al. 1993) provide biologic support for epidemiologic studies linking ETS and lung cancer. ETS also has subtle but significant effects on the respiratory health (including cough, phlegm production, and reduced lung function) of adult nonsmokers. Reducing Tobacco Use Among children, ETS has far-reaching health ef- fects. ETS causes bronchitis and pneumonia, account- ing for an estimated 150,000-300,000 annual cases in infants and young children, and causes middle ear diseases (infections and effusions). ETS causes addi- tional episodes of asthma and increases its severity, worsening an estimated 400,000-1,000,000 cases annually. As a risk factor for new cases of asthma, ETS may account for 8,000-26,000 annual cases (EPA 1992; California EPA 1997). In an important ruling, Judge Osteen of the U.S. District Court annulled Chapters 1-6 and the Appen- dices to the EPA’s 1992 report (EPA 1992; Flue-Cured Tobacco Cooperative Stabilization Corp. v. United States Environmental Protection Agency, 4 F. Supp. 2d 435 [M.D.N.C. 1998]). The decision was a mix of proce- dural and scientific concerns. Judge Osteen found that the EPA had not complied with the procedural require- ments of the Radon Gas and Indoor Air Quality Re- search Act of 1986, had acted beyond congressional intent, and had violated administrative law procedure by drawing conclusions about ETS prior to conclud- ing a scientifically sound risk-assessment study. The judge was also concerned with the amount of evidence in the record supporting EPA’s final basis for its plau- sibility hypothesis, with some of the animal labora- torv tests that he felt were inconclusive but were cited as compelling evidence of the dangers of ETS, and with the EPA’s choice of epidemiologic studies to support its findings. Considerable information appeared after the EPA’s 1992 report that supported its general conclu- sions (Brownson et al. 1992a; Stockwell et al. 1992; Fontham et al. 1994; Cardenas et al. 1997). A recent meta-analysis of workplace ETS exposure and increased risk of lung cancer also provided needed epidemiologic support (Wells 1998). The ninth EPA report on carcino- gens was released in the year 2000 and lists ETS as a known carcinogen for the first time (USDHHS 2000). Since the 1992 EPA report, further evidence link- ing ETS and heart disease has been assembled as well. (Glantz and Parmley 1995; Steenland et al. 1996; Cali- fornia EPA 1997; Kawachi et al. 1997; Law et al. 1997; Howard et al. 1998; Valkonen and Kuusi 1998; Wells 1998). If ETS is a causal risk factor for coronary heart disease, it likely accounts for many more deaths from heart disease than from lung cancer (EPA 1992; Wells 1994). A review of 12 epidemiologic studies has esti- mated that ETS accounts for as many as 62,000 annual deaths from coronary heart disease in the United States (Wells 1994). However, because smoking is but one of the many risk factors in the etiology of heart disease, Regulatory Efferts 195 Surgeon General ’s Report quantifying the precise relationship between ETS and this disease is difficult. Strong evidence is also accumulating that ETS isa risk factor for sudden infant death syndrome (Jinot and Bayard 1994, DiFranza and Lew 1995; Klonoff-Cohen et al. 1995; Anderson and Cook 1997; California EPA 1997: Alm et al. 1998; Dybing and Sanner 1999). Ina large U.S. study, maternal exposure during pregnancy and postnatal exposure of the newborn to ETS increased the risk of this syndrome (Schoendorf and Kiely 1992). Other Consequences of ETS Separate from their concerns about direct health effects, most nonsmokers are annoyed by ETS expo- sure (CDC 1988; Brownson et al. 1992b). U.S. survey data have suggested that 71 percent of all respondents, including 43 percent of current smokers, are annoyed by ETS (CDC 1988). Similarly, data from urban St. Louis and Kansas City, Missouri, have shown that 66 percent of all respondents and nearly 40 percent of current smokers were annoyed by ETS exposure (Brownson et al. 1992b). The term “annovance,” a seemingly minor attribute, has some nontrivial rami- fications. Public attitudes toward smoking, an amal- gam of concerns about health and social interactions, have changed in the past decade, as is discussed in greater detail in the section “Effectiveness of Clean Indoor Air Restrictions,” later in this chapter. The find- ings from one survey suggested that the proportion of Americans who favored a total ban on smoking in res- taurants and workplaces increased from less than one- fifth in 1983 to almost one-third in 1992 (Gallup Organization, Inc. 1992). The proportion favoring no restrictions fell from as high as 15 percent in 1983 to 5 percent in 1992. Similarly, by 1992, more than 90 per- cent of respondents favored restrictions or a total ban on smoking in trains and buses as well as in hotels and motels. More than 90 percent “agreed” or “strongly agreed” that ETS is injurious to children, pregnant women, and older adults. Thus, an impor- tant consequence of information on ETS has been a changing social norm regarding smoking and an evoly- ing foundation for clean indoor air regulations. Because of the consequences of ETS, employers are likely to save costs by implementing policies for smoke-free workplaces. Savings include those associ- ated with fire risk, damage to property and furnish- ings, cleaning costs, workers compensation, disability, retirement, injuries, life insurance, absenteeism, pro- ductivity losses, and synergistic occupational risks such as asbestos exposure (Kristein 1989). Such costs were estimated at $1,000 per smoking employee in 1988 196 Chapter 5 dollars. In a recent report on the savings associated with a nationwide, comprehensive policy on clean in- door air, the EPA estimated that sucha law would save $4 billion to $8 billion per year in operational and maintenance costs of buildings (Mudarri 1994). Prevalence of Exposure to ETS Exposure to ambient tobacco smoke is wide- spread. The 1988 National Health Interview Survey reported that an estimated 37 percent of the 79.2 mil- lion U.S. nonsmoking workers worked in places that permitted smoking in designated and other areas and that 59 percent of these experienced moderate or great discomfort from ETS exposure in the workplace (National Center for Health Statistics 1989). Since the advent of urinary cotinine screening, firmer documen- tation of ETS has become available. In a study of 663 nonsmokers attending a cancer screening, Cummings and colleagues (1990) found that 76 percent of partici- pants were exposed to ETS in the four days preceding the interview. The authors concluded that the work- place and the home were the primary sources of ETS exposure among these nonsmokers. The best single predictor of urinary cotinine was the number of smok- ers among friends and family members seen regularly by the study participant. Ina study of 881 nonsmok- ing volunteers, Marcus and colleagues (1992) found that employees in workplaces that were “least restric- tive” (.e., allowed smoking in numerous locations) were more than four times more likely to have detect- able saliva cotinine concentrations than employees from smoke-free workplaces were (p. 45). The largest study of population exposure to ETS with biochemical markers is the CDC’s Third National Health and Nutrition Examination Survey, conducted from 1988 to 1991 ona nationally representative sample of 16,818 persons aged 2 months and older (Pirkle 1996). Serum cotinine was measured in 10,642 partici- pants aged 4 years and older. The data indicate high concordance between reported ETS exposure and se- rum cotinine level. Among nontobacco users, 87.9 percent had detectable levels of serum cotinine, and the level was significantly and independently associ- ated with both the number of smokers in the hause- hold and the number of hours of work exposure. The authors concluded that both the work and the house- hold environments make important contributions to the widespread exposure to ETS experienced by chil- dren and adults. Some improvement in ETS exposure has been noted. A study from California found that nonsmokers’ self-reported exposure to ETS at work declined from 29 percent in 1990 to 22 percent in 1993 (Patten et al. 1995b). This decline was not as pronounced, however, among some sociodemographic subgroups, such as African Americans, Asian Americans, and persons with less than a high schoo! education. During the same period, the percentage of employees reporting that they worked in smoke-free workplaces greatly increased (from 35 to 65 percent). Survey data from Missouri in 1993 indicated that 41 percent of the popu- lation were exposed to ETS in the workplace and 18 percent in the home environment (Brownson et al. 1995a). Among subgroups, younger persons, men, Hispanics, and persons with less than a high school education had more workplace exposure to ETS. Simi- larly, data from rural Missouri showed higher preva- lence of workplace ETS exposure among younger persons, men, African Americans, and persons with less than a high school education (Brownson et al. 1995a). Emmons and colleagues (1992) analyzed en- tries in diaries recording ETS exposure among 186 persons who were former smokers or had never smoked. Approximately 50 percent of the daily ETS exposure was attributed to the workplace, and 10 per- cent was attributed to the home environment. How- ever, for persons who lived with a smoker, more exposure occurred in the home than in the workplace. Relatively few population-based data that spe- cifically examine the levels of ETS exposure in the workplace have been collected. Such data may be important, because exposure levels likely vary greatly by workplace, and recent studies have indicated that higher levels of ETS (measured by intensity or dura- tion of ETS exposure) increase the risk of lung cancer in nonsmokers (Brownson et al. 1992a; Stockwell et al. 1992; Fontham et al. 1994). Ina review of existing stud- ies, Siegel (1993) found that ETS concentrations var- ied widely by location; mean levels of nicotine measured in the ambient air were 4.1 g/m’ for of- fices overall, 4.3 ug/m* for residences with at least one smoker, 6.5 ug /m‘ for restaurants, and 19.7 ug /m°* for bars. In a survey of 25 Massachusetts worksites, Hammond and colleagues (1995) found that the type of worksite smoking policy had a great effect on nico- tine concentrations. Levels of nicotine ranged from 8.6 ug/m* in open offices that allowed smoking to 0.3 ug/m* in worksites that banned smoking. Legal Foundation for Regulation of Public Smoking The legal foundation for regulating public smoking is based on case law pertaining mainly to the Reducing Tobacco Use protection of the health of workers. Under common law (the body of law based on court decisions rather than government laws or regulations), employers must provide a work environment that is reasonably free of recognized hazards. Courts have ruled that common- law duty requires employers to provide nonsmoking emplovees protection from the proven health hazards of ETS exposure (Sweda 1994). Three pioneering cases have demonstrated the basis for this protection. In Shimp v. New Jersey Bell Telephone Co. 368 A.2d 408, 145 N.J. Super. 516 [1976]), a secretary who was allergic to cigarette smoke sought an injunction requiring a smoking ban. The court or- dered the emplover to provide a safe working envi- ronment by restricting smoking to a nonwork area. Similarly, in the case of Siith v. Western Electric Co. (643 S.W.2d 10 [Mo. App. 1982]), the Missouri Court of Appeals overturned a lower court and forced the employer to “assume its responsibility to eliminate the hazardous conditions caused by tobacco smoke” (p. 13). Finally, in Lee v. Departinent of Public Welfare (No. 15385 [Mass. Mar. 31, 1983], cited in 1.2 TPLR 2.82 [1986]), a social worker sued her employer, seeking relief from ETS exposure at work. The Massachusetts Superior Court ruled in favor of the plaintiff and re- quired a smoke-free workplace. Additional protections to employees are extended by federal statute, such as the Americans with Disabilities Act of 1990 (ADA) (Public Law 101-336), and by rulings in workers com- pensation claims. Status of Restrictions to Limit Smoking in Public Places Although the health risks of ETS exposure be- gan to be publicized in the early 1970s (NCI 1991), momentum to regulate public smoking increased only in 1986, when reports by the Surgeon General (USDHHS 1986) and the National Academy of Sciences (1986) concluded that ETS is a cause of lung cancer in nonsmokers. Since then, government and private busi- ness policies that limit smoking in public places have become increasingly common and restrictive (Rigotti and Pashos 1991). The designation of ETS asa class A (known human) carcinogen by the EPA (1992) stimu- lated further restrictions on smoking in public places (Brownson et al. 1995a), but a recent court ruling set aside that report (see “Health Consequences of Expo- sure to ETS,” earlier in the chapter). Although many of the regulatory efforts discussed herein focus on government's passage of a law or an ordinance, other regulations can be implemented by Regulatory Efforts 197 Surgeon General's Report Table 5.1. Summary of landmark events in the development of U.S. policies for clean indoor air Year Event 1971 The Surgeon General proposes a federal smoking, ban in public places. 1972 The first report of the Surgeon General to identify environmental tobacco smoke (ETS) as a health risk is released. 1973 Arizona becomes the first state to restrict smoking in several public places and to reduce ETS exposure because it is a health risk. The Civil Aeronautics Board requires no-smoking sections on all commercial airline flights. 1974 Connecticut passes the first state law to apply smoking restrictions to restaurants. 1975 Minnesota passes a comprehensive statewide law for clean indoor air. 1977 Berkeley, California, becomes the first community to limit smoking in restaurants and other public places. 1983 San Francisco passes a law to place private workplaces under smoking restrictions. 1986 A report of the Surgeon General focuses entirely on the health consequences of involuntary smoking; ETS is proclaimed a cause of Jung cancer in healthy nonsmokers. The National Academy of Sciences issues a report on the health consequences of involuntary smoking. Americans for Nonsmokers’ Rights becomes a national group; it had originally formed as California GASP (Group to Alleviate Smoking Pollution). 1987 The U.S. Department of Health and Human Services establishes a smoke-free environment in all of its buildings, affecting 120,000 employees nationwide. Minnesota passes a law requiring all hospitals in the state to ban smoking by 1990. A Gallup poll finds, for the first time, that a majority (55 percent) of all U.S. adults favor a complete ban on smoking in all public places. 1988 A congressionally mandated smoking ban takes effect on all domestic airline flights of two hours or less. New York City’s ordinance for clean indoor air takes effect, banning or severely limiting smoking in various public places and affecting 7 million people. California implements a statewide ban on smoking aboard all intrastate airplane, train, and bus trips. 1990 A congressionally mandated smoking ban takes effect on all domestic airline flights of six hours or less. The U.S. Environmental Protection Agency (EPA) issues a draft risk-assessment on ETS. 1991 CDC’s National Institute for Occupational Safety and Health issues a bulletin recommending that secondhand smoke be reduced to the lowest feasible concentration in the workplace. 1992 Hospitals applying for accreditation by the Joint Commission on the Accreditation of Healthcare Organizations are required to develop a policy to prohibit smoking by patients, visitors, employees, volunteers, and medical staff. The EPA releases its report classifying ETS as a group A (known human) carcinogen, placing ETS in the same category as asbestos, benzene, and radon. 198 Chapter 5 Reducing Tobacco Use Table 5.1. Continued Year Event 1993 Los Angeles passes a ban on smoking in all restaurants. 1994 1995 1996 1997 1998 The U.S. Postal Service eliminates smoking in all facilities. Congress enacts a smoke-free policy for WIC (Special Supplemental Food Program for Women, Infants, and Children) clinics. A working group of 16 state attorneys general releases recommendations for establishing smoke-free policies in fast-food restaurants. Vermont bans smoking in all public buildings and many private buildings open to the public. The U.S. Department of Defense prohibits smoking in all indoor military facilities. The Occupational Safety and Health Administration proposes a rule that would ban smoking in most U.S. workplaces. San Francisco passes a ban on smoking in all restaurants and workplaces. The Pro-Children’s Act requires persons providing federally funded children’s services to prohibit smoking in those facilities. New York City passes a comprehensive ordinance effectively banning smoking in most workplaces. Maryland enacts a smoke-free policy for all workplaces except hotels, bars, restaurants, and private clubs. California passes comprehensive legislation that prohibits smoking in most enclosed workplaces. Vermont's smoking ban is extended to include restaurants, bars, hotels, and motels, except those holding a cabaret license. The U.S. Department of Transportation reports that about 80 percent of nonstop scheduled U.S. airline flights between the United States and foreign points will be smoke free by June 1, 1996. President Clinton signs an executive order establishing a smoke-free environment for federal employees and all members of the public visiting federally owned facilities. The California EPA issues a report determining that ETS is a toxic air contaminant. Settlement is reached in the class action lawsuit brought by flight attendants exposed to ETS. The U.S. Senate bans smoking in the Senate’s public spaces. California law takes effect banning smoking in bars unless a bar has a separately ventilated smoking area. agencies with special authority. An example of a non- Government Restrictions government regulatory action is the recent adoption of an accrediting standard that prohibits smoking in hos- pital buildings Joint Commission on Accreditation of Healthcare Organizations 1992; Longo et al. 1995). Several of the noteworthy events in clean indoor air regulation are shown in Table 5.1. These events include federal, state, and local activities. Regulatory Efforts 199 Surgeon General's Report Federal Laws and Regulations The most notable federal regulation of ETS is the requirement that domestic airline flights be smoke free. The regulation was first enacted in 1988 for domestic flights lasting two hours or less and was renewed in 1989 for domestic flights lasting six hours or less (Table 5.1). Since the early 1970s, the Interstate Commerce Commission (ICC) has required that smoking on interstate buses be confined to the rear of the bus and that smoking sections constitute no more than 10 percent of total seating capacity. Similar ICC regula- tion for trains was repealed in 1979. In 1987, congres- sional legislation that threatened to withhold federal funds influenced the State of New York’s Metropoli- tan Transportation Authority to ban smoking on the MTA Long Island Rail Road (USDHHS 1989). Currently, the Occupational Safety and Health Admin- istration is considering regulations that would either prohibit smoking in all workplaces or limit it to sepa- rately ventilated areas (Federal Register 1994). Further- more, the federal government has instituted increasingly stringent regulations on smoking in its own facilities, and the Pro-Children’s Act of 1994 (Pub- lic Law 103-227, secs. 1041-1044) prohibits smoking in facilities in which federally funded children’s services are provided on a regular or routine basis. State Laws and Regulations As of December 31, 1999, smoke-free indoor air to some degree or in some public places was required by 45 states and the District of Columbia. These re- strictions vary widely, from limited restrictions on public transportation to comprehensive restrictions in worksites and public places (CDC, Office on Smoking and Health, State Tobacco Activities Tracking and Evaluation System, unpublished data). In 1973, Ari- zona became the first state in which public smoking was regulated in recognition of ETS as a public health hazard (Table 5.1). Five states (Alabama, Kentucky, New Mexico, North Carolina, and Wyoming) have ei- ther no legislation or legislation that preempts locali- ties from enacting any law to restrict smoking in public places (see also Figure 5.2). As of December 31, 1999, laws restricting smok- ing in government worksites were present in 43 states and the District of Columbia: 29 limit smoking to des- ignated areas, 2 require either no smoking or desig- nated smoking areas with separate ventilation, and 11 prohibit smoking entirely. Twenty-one states have laws restricting smoking in private worksites: 20 limit smoking to designated areas, and 1 (California) re- guires either no smoking or separate ventilation for smoking areas. Thirty-one states have laws that Figure 5.2. Cumulative number of state laws and amendments enacted for clean indoor air, 1963-1998 3005 250 emer Public places 200-4 eee Workplaces 150 Restaurants 100 Number of ordinances 1963 1965 1967 1969 1971 1979 1981 1983 1985 1987 1989 1991 rrrTteereee tT OTOP UT dT 1993 1995 1997 Year Note: The category “state” includes the District of Columbia. Source: National Cancer Institute, State Cancer Legislative Database, unpublished data, August 31, 1998. 200 Chapter 5 regulate smoking in restaurants; of these, only Utah and Vermont completely prohibit smoking in restau- rants, and California requires either no smoking or separate ventilation for smoking areas (CDC, Office on Smoking and Health, State Tobacco Activities Evaluation System, unpublished data). In 1994, Maryland proposed a regulation that would prohibit smoking in most workplaces in the state, including restaurants and bars (Maryland Register 1994). Despite strong support among both nonsmokers and smokers for restrictions on public smoking in the state (Shopland et al. 1995), this proposal was aggressively challenged by the tobacco industry (Spayd 1994), which questioned the state’s legal authority to regulate smok- ing through administrative rule rather than law. In early 1995, the original regulation was modified by legisla- tive action to permit some exceptions for the hospital- ity industry, and the rules went into effect. In October 1994, the state of Washington also enacted an extensive indoor workplace ban. In this instance, a temporary injunction was dismissed by the state court, and the ban went into effect without litigation (CSH 1994b). In North Carolina, legislation was enacted on July 15, 1993 (HB 957), that required that smoking be per- mitted in at least 20 percent of space in state-controlled buildings but also formally required nonsmoking areas. An important preemption clause prohibited local regulatory boards from enacting more restrictive regulations for public or private buildings after Octo- ber 15, 1993. During that three-month “window of op- portunity,” 89 local agencies passed new measures providing some increased protection trom ETS. De- spite the rush to new restrictions, researchers estimated that by the year 2000, the preemption would prevent 39 percent of private emplovees in North Carolina from being protected from ETS (Conlisk et al. 1995). Local Ordinances The modern era of local ordinances for clean in- door air began in the early 1970s (Pertschuk 1993). In 1977, Berkeley, California, became the first community to limit smoking in restaurants and other public places (Table 5.1). After the release of the 1986 Surgeon General's report on the health consequences of ETS, the rate of passage of local ordinances accelerated (Figure 5.3). By 1988, nearly 400 local ordinances to restrict smoking had been enacted throughout the Lnited States (Pertschuk and Shopland 1989). The trend toward smoke-free local ordinances has accelerated since 1989 (Rigotti and Pashos 1991; Pertschuk 1993). As of June 30, 1998, public smoking was restricted or banned in 820 local ordinances. Of those that specified which Reducing Tobacco Use agency was responsible for enforcement, 44 percent cited health departments or boards of health, 19 percent named city managers, 5 percent said police departments, and 6 percent identified other agencies (Americans for Nonsmokers’ Rights, unpublished data, June 30, 1998). The effectiveness of various enforcement mechanisms and the level of compliance achieved are not known. Data from Wisconsin suggest that implementation may be just as important as legislation in achieving policy goals (Nordstrom and DeStefano 1995). One study examined the impact a local ordinance had on restaurant receipts (CDC 1995a). Contrary to some prior claims, an analysis of restaurant sales after a ban on smoking in this community (a small suburb of Austin, Texas) showed no adverse economic effect. Ina series of ecologic analyses, Glantz and Smith (1994, 1997) analyzed the effect of smoke-free restaurant and bar ordinances on sales tax receipts. Over time, such ordinances had no effect on the fraction of total retail sales that went to eating and drinking places. The authors asserted that claims of economic hardship for restaurants and bars that establish smoke-free policies have not been substantiated. Private Sector Restrictions on Smoking in Workplaces Two national data sets are available to ascertain the level of workplace smoking restrictions among pri- vate firms in the United States. A survey conducted by the Bureau of National Affairs, Inc. (1991), estimated that 85 percent of large workplaces had policies restricting smoking. The percentage of smoke-free workplaces has increased dramatically, from 2 percent in 1986 to 7 percent in 1987 and to 34 percent in 1991. Similarly, data from the 1992 National Survey of Worksite Health Promotion Activities indicated that 87 percent of workplaces with 50 or more employees regu- lated smoking in some manner and that 34 percent were smoke free (USDHHS 1993). The 1995 Update of the Business Responds to AIDS Benchmark Survey con- ducted by CDC also found that 87 percent of worksites with 50 or more employees had a smoking policy of some kind (National Center for Health Statistics 1997). The prevalence of smoking policies in small workplaces, where the majority of Americans work, is less well studied. A comprehensive examination of workplace smoking policies from the NCI’s tobacco use supplement to the Current Population Survey (n = 100,561) indicated that most indoor workers sur- veyed (81.6 percent) reported that an official policy governed smoking at their workplaces, and nearly half reported that the policy could be classified as Regulatory Efforts 201 Surgeon General's Report “smoke-free” —that is, that smoking was not permit- ted either in workplace areas or in common public- use areas (Gerlach 1997). This proportion varied by sex, age, ethnicity, and occupation: blue-collar and service occupations had significantly less access to smoke-free environments. Though data were not spe- cifically reported by workplace size, the range of occu- pations suggests that the survey included a substantial proportion of persons who work in smaller workplace environments. But for all workplace sizes, the data suggest that access to smoke-free environments could be substantially improved. Effectiveness of Clean Indoor Air Restrictions Although it is generally accepted that regulatory changes influence nonsmokers’ exposure to ETS and smokers’ behavior, relatively few evaluation studies quantify these effects over time. Evaluating such changes is hampered by the complex interaction of social forces that shape behavior, bv the decline in smoking and smoke exposure in the overall popula- tion, and by the overlapping effects of concomitant regulatory policies (e.g., a new law for clean indoor air passed at or around the time of an increase in the cigarette excise tax). Controlling for such potential confounding factors in studies is difficult. Population-Based Studies Effects on Nonsmokers’ Exposure to ETS Despite the widespread implementation of re- strictions against public smoking, few population- based studies have examined whether these restrictions have reduced nonsmokers’ exposure to ETS. One such study from California used data col- lected in 1990 and 1991 to examine the association be- tween the strength of local ordinances for clean indoor air and cross-sectional data on nonsmokers’ exposure to ETS in the workplace (Pierce et al. 1994b). Expo- sure to ETS in the workplace ranged from 25 percent of workplaces in areas with a strong local ordinance to 35 percent in areas with no local ordinance. Figure 5.3. Cumulative number of local laws and amendments enacted for clean indoor air, 1979-1998 800 700 4 or a , 0004 z a 500 4 emmmee Public places 7 s / & 400 — ——=— Restaurants , e Workplaces* 5 3004 s 2 2004 100 4 o> rT TT TT oT TT 1979 1981 1983 1985 1987 1989 199] 1993 1995 1997 Year Note: Ordinances must specifically mention these locations to be counted. Therefore, other ordinances may cover these areas without being included in these figures. *Before 1983, there were four workplace ordinances: one passed in 1975, one in 1979, and two in 1980. These are not included in this chart, because data for consecutive years only became available beginning in 1983 for workplaces. Source: American Nonsmokers’ Rights Foundation, unpublished data, June 30, 1998. 202) Chapter 5 In measuring the impact of a statewide law for clean indoor air, researchers in Missouri examined self- reported data on ETS exposure from 1990 through 1993 (Brownson et al. 1995a). Nonsmokers’ exposure to ETS in the workplace declined slightly the vear the law was passed and substantially more after the law went into effect. Exposure to ETS in the home remained con- stant over the study period; this finding suggests that the declining workplace exposure was more likely linked to the smoking regulations than to the overall declining smoking prevalence observed during the study period. Despite improvements over time, ETS exposure in the workplace remained at 35 percent in the final vear of the study (1993). Other data from California indicate that nonsmokers emploved in workplaces with no policy or a policy not covering their part of the workplace were eight times more likely to be exposed to ETS (at work) than those emploved in smoke-free workplaces (Borland et al. 1992). Attitudes Toward Restrictions and Bans Studies of awareness and attitudes toward work- place smoking restrictions and bans have been con- ducted in cross-sectional samples of the general population and among emplovees affected by bans. Ina 1989 survey of 10 U.S. communities, most respon- dents favored smoking restrictions or smoke-free environments in all locations, including workplaces, government buildings, restaurants, hospitals, and bars (CDC 1991), Although support for smoking restric- tions was higher among nonsmokers, across the 10 communities, 82-100 percent of smokers favored re- strictions on smoking in public places. Support was highest for smoking bans in indoor sports arenas, hos- pitals, and doctors’ offices. A 1993 survey from eight states showed greater support for ending smoking in fast-food restaurants and at indoor sporting events than in traditional restaurants and indoor shopping malls (CDC 1994a). Support for proposed changes may differ from support for actual, implemented changes. Yet in stud- ies of smoke-free hospitals, patients, emplovees, and physicians have overwhelmingly supported the policy (Rigotti et al. 1986; Becker et al. 1989; Hudzinski and Frohlich 1990: Baile et al. 1991; Offord et al. 1992). In some instances, a majority of smokers support a smoke-free hospital (Becker et al. 1989). Studies of smoking restrictions and bans in other industries also have found that nonsmokers overwhelmingly tavor smoke-free workplaces (Petersen et al. 1988; Borland et al. 1990b; Gottlieb et al. 1990; Sorensen et al. 1991b). Time—and consequent habituation—can Reducing Tobacco Use make changes more acceptable. In a prospective study of a smoking ban in a large workplace, Borland and colleagues (1990b) found that attitudes of both non- smokers and smokers toward the smoke-free work- place were more favorable six months after such a policy was implemented. Although most smokers re- ported being inconvenienced, they also reported that they recognized the overall benefits of the policy. Two studies from Massachusetts found that one and two years after two local laws for clean indoor air were enacted, 65 percent of the businesses surveyed favored the law (Rigotti et al. 1992, 1994). The authors con- cluded that a self-enforcement approach achieved high levels of awareness (about 75 percent) and intermedi- ate levels of compliance (about 50 percent) (Rigotti et al. 1994), Effects of Restrictions and Bans on Nonsmokers’ Exposure to ETS As has been found in population-based research, studies conducted in individual workplaces have found that smoke-tree workplaces have been effective in reducing nonsmokers’ exposure to ETS. Effective- ness has been measured by the perceived change in air quality in the workplace after a smoke-free policy was instituted (Biener et al. 1989; Gottlieb et al. 1990) and by measurement of nicotine vapor before and af- ter such a policy (Stillman et al. 1990). Conversely, workplace policies that allow smoking in designated areas without separate ventilation result in substan- tial exposure to ETS for nonsmokers (Repace 1994). An analysis of the effects of a smoke-free workplace in The Johns Hopkins Medical Institutions found that concentrations of nicotine vapor had de- clined in all areas except restrooms at one to eight months after the ban (Stillman et al. 1990). In most areas, nicotine concentrations after the ban were be- low the detectable level of 0.24 ug/m*. Effects of Restrictions on Smoking Behavior An additional benefit from regulations for clean indoor air may be a reduction in smoking prevalence among workers and the general public. For example, ina multivariate analysis, moderate or extensive laws for clean indoor air were associated with a lower smok- ing prevalence and a higher proportion of quitters (Emont et al. 1993). Another study also found an as- sociation between local smoking restrictions and smok- ing prevalence (Rigotti and Pashos 1991). Regulatory Efforts 203 Surgeon General's Report Table 5.2. Summary of studies on the effects of a smoke-free workplace on smoking behavior Authors/year Location Industry Sample size Andrews 1983 Boston, Massachusetts Hospital 965 Rigotti et al. 1986 Boston, Massachusetts Hospital pediatric unit 93 Rosenstock et al. 1986 Puget Sound, Washington Health maintenance 447 organization Petersen et al. 1988 Connecticut Insurance company 1,210 Becker et al. 1989 Baltimore, Maryland Children’s hospital 704 Biener et al. 1989 Providence, Rhode Island Hospital 535 Scott and Gerberich 1989 Midwestern United States Insurance company 452 Borland et al. 1990b Australia Public service 2,113 Centers for Disease Pueblo, Colorado Psychiatric hospital 1,032 Control 1990¢ Gottlieb et a]. 1990 Texas Government agency 1,158 Hudzinski and Frohlich 1990 New Orleans, Louisiana Hospital 1,946 Stillman et al. 1990 Baltimore, Maryland Hospital 2,877 Baile et al. 1991 Tampa, Florida Hospital 349 Borland et al. 1991 Australia Telecommunications 620 company Sorensen et al. 1991a New England Telephone company 1,120 Brenner and Mielck 1992 Germany National random 439 sample Goldstein et al. 1992 Augusta, Georgia Hospital 1,997 Offord et al. 1992 Rochester, Minnesota Hospital] 10,579 Wakefield et al. 1992b Australia Representative 1,929 sample Jeffery et al. 1994 Minneapolis-St. Paul, Minnesota Diverse worksites 32 worksites; total number of individuals not reported 204 Chapter 5 Change in individual or overall smokers’ consumption Not reported -2.3 cigarettes per shift (P < 0.01) at 12 months follow-up; no change in overall consumption -2.0 cigarettes per day (P < 0.003) at 4 months follow-up -5.6 cigarettes per day at 12 months follow-up No change at 6 months follow-up -3.9 cigarettes per day at work at 12 months follow-up 22.5% of smokers decreased consumption at 7 months follow-up -7.9 cigarettes per dav in smokers of 25 or more cigarettes per dav i 5 \ at 6 months follow-up -3.5 cigarettes per day at work at 13 months follow-up; ~1.8 cigarettes per day over 24 hours 12.0% reduction in consumption of 15 or more cigarettes per day at work at 6 months follow-up (P < 0.001) 25% of smokers no longer smoked at work at 12 months follow-up -3.3 cigarettes per day at 6 months follow-up (P = 0.0001) 40% of smokers decreased consumption at 4 months follow-up ~3.5 cigarettes per day at 18 months follow-up (P < 0.05) Not reported -1.8 cigarettes per day in men, -1.4 cigarettes per day in women 57% of smokers reported they had cut down on number of cigarettes smoked Not reported -5 cigarettes per day on workdays vs. leisure days ~1.2 cigarettes per day Reducing Tobacco Use Change in prevalence -8.5% at 20 months follow-up No significant change No significant change 1.6% at 12 months follow-up -1.2% at 6 months follow-up No significant change -5.1% at 7 months follow-up -1.0% at 6 months follow-up -4.0% at 13 months follow-up -3.4% at 6 months follow-up Not reported -5.5% at 6 months follow-up -1.5% at 4 months follow-up -3.1% at 18 months follow-up 21% of smokers quit at 20 months follow-up Cessation proportion of 30% 9% of smokers stated they had quit because of the ban -2.9% at 30 months follow-up Not reported -2% at 24 months follow-up Regulatory Efforts 203 Surgeon General's Report In recent vears, researchers have increasingly recognized the role of the environment’ in influencing individual smoking behavior through perceived cues (NCI 1991; McKinlay 1993; Brownson etal. 1995b), many of which have their origins in generally held rules about acceptable behaviors (i.e., social norms) (Robertson 1977). Smokers frequently respond to environmental cues when deciding whether to smoke at a given time (NCI 1991). For example, a smoker may receive a per- sonal, habit-derived cue to smoke after a meal or ona work break, but this cue may be weakened (and even- tually even canceled) by a social, policy-derived cue not to smoke if the person is in a smoke-free restaurant or worksite (Brownson et al. 1995b). Numerous studies have assessed the potential etfects of workplace smoking bans on employee smoking behavior (Table 5.2). These studies have been conducted in health care settings (Andrews 1983; Rigotti et al. 1986; Rosenstock et al. 1986; Becker et al. 1989: Biener et al. 1989; CDC 1990c; Hudzinski and Frohlich 1990; Stillman et al. 1990; Baile et al. 1991, Goldstein et al. 1992; Offord et al. 1992), government agencies (Gottlieb et al. 1990), insurance companies (Petersen et al. 1988; Scott and Gerberich 1989), and telecommunications companies (Borland et al. 1991; Sorensen et al. 1991a) and among random samples of the working population (Brenner and Mielck 1992, Wakefield et al. 1992b). Most of the studies based in hospitals or health maintenance organizations that banned smoking found a decrease in the average num- ber of cigarettes smoked per day. Several of the hos- pital studies found significant declines in the overall prevalence of smoking among employees at 6-20 months follow-up (Andrews 1983, Stillman et al. 1990). Studies of smoking behavior in other industries have found similar results; in most settings, daily consump- tion, overall smoking prevalence, or both had de- creased at 6-20 months after workplaces were made smoke free. In a population-based study of California resi- dents, the prevalence of smoking was 14 percent in smoke-free workplaces and 21 percent in workplaces with no smoking restrictions (Woodruff et al. 1993). Consumption among continuing smokers was also lower in smoke-free workplaces, and the percentage of smokers contemplating quitting was higher. In 1992, Patten and colleagues (1995a) followed up a large sample of persons (first interviewed in 1990) to deter- mine the influences a change in worksite setting might have had on smoking. These researchers observed a statistically nonsignificant increase in smoking The term “environment” is detined broadly to include the legal, social, economic, and physical environment (Cheadle et al. 1992). 206 Chapter 5 prevalence among the group that changed from a smoke-free workplace to one at which smoking was permitted. The prevalence of smoking among other groups was unchanged or had declined. Although these results are tentative, particularly in view of sam- pling difficulties during, the follow-up interview, they signal the potential impact workplace policies can have on smoking behavior. Case Studies of State and Local Smoking Restrictions Recent reviews have presented case studies on the passage of state and local laws for clean indoor air (Samuels and Glantz 1991; Fourkas 1992; Jacobson et al. 1992; Traynor et al. 1993). These studies describe the issues that states and local communities dealt with in enacting smoking restrictions in public places. Ina case study of six states, the ability of key leg- islators to support legislation and the existence of an organized smoking prevention coalition were key de- terminants of whether statewide legislation was en- acted for clean indoor air Jacobson et al. 1992). Although the enactment of such legislation was not guaranteed when these factors were favorable, enact- ment was unlikely when they were unfavorable. Two other factors were cited as key in enacting legislation in the six states studied: an active executive branch that pressured the legislature to act, especially by mak- ing such legislation an executive policy priority, and existing local ordinances that created a policy environ- ment favorable to the enactment of statewide smok- ing restrictions. The study found that coalitions that succeeded in enacting legislation to restrict smoking in public places featured organized commitment, including both a full-time staff and a professional lobbyist. Success- ful coalitions also had established close working rela- tionships with key legislative sponsors to develop appropriate policy alternatives and to coordinate leg- islative strategy. Finally, effective coalitions used me- dia and grassroots campaigns to mobilize public support for smoking restrictions. Another important component in the legislative debate was how the issue of smoking restrictions was framed. In all six states reviewed, the tobacco industry tried to shift the focus from the credibility of the scien- tific evidence on the health hazards of ETS to the con- troversial social issue of personal freedom, specifically, the industry lobbied extensively for including nondis- crimination clauses in legislation to restrict smoking (Malouff et al. 1993). Another common strategy that the tobacco industry has used is to support the pas- sage of state laws that preempt more stringent local ordinances (Brownson et al. 1995b). Because of the possible counteretfect of preemp- tive legislation and because of the difficulty in enact- ing statewide legislation, public health advocates have suggested that advocates for reducing tobacco use should devote more resources to enacting local ordinances (Samuels and Glantz 1991; Fourkas 1992; Minors’ Access to Tobacco Reducing Tobacco Use Jacobson et al. 1992). A local strategy can usually im- pose more stringent smoking restrictions than state- wide legislation does. Like the study of Jacobson and colleagues (1992) on statewide initiatives, a study of local initiatives found that two key ingredients for success were the presence of a strong smoking pre- vention coalition and sympathetic political leadership within the elected body (Samuels and Glantz 1991). Introduction Minors’ access to tobacco products is an area of regulation relatively free from the social and legal de- bate that often arises from other regulatory efforts. Even the staunchest opponents of reducing tobacco use concede that tobacco use should be limited to adults and that retailers should not sell tobacco products to children and adolescents. Yet as was discussed in de- tail in the Surgeon General's report on smoking among voung people, a significant number of minors use to- bacco, and a significant number of them obtain their tobacco through retail and promotional transactions, just as adults do (USDHHS 1994; CDC 1996a,b; Kann et al. 1998). Whether intended exclusively for adults or not, these commercial transactions are supported by vast resources. The multibillion-dollar tobacco in- dustry spends a large proportion of its marketing dol- lars to support a vast network of wholesale and retail activity. In 1997, cigarette makers spent $2.44 billion on promotional allowances to the wholesale and re- tail trade and an additional $1.52 billion on coupons and retail value-added promotions (FTC 1999). These figures were 42 percent and 26 percent, respectively, of the entire $5.1 billion spent on advertising and pro- moting cigarettes in the United States that vear. In general, the availability of cigarettes to the adult population has not been a regulatory issue since the first quarter of the 20th century (see Chapter 2), although recent FDA statements about nicotine levels in cigarettes have raised the possibility of some regu- lation of adult use (see “Further Regulatory Steps,” earlier in this chapter). The primarv regulatory focus tor cigarette access has been on reducing the sale of ‘obacco products to minors (Forster et al. 1989; Hoppock and Houston 1990; Thomson and Toffler 1990; Altman et al. 1992; CDC 1992a; Cummings et al. 1992; Federal Register 1993, 1996). Broad-based public support for limiting minors’ access to tobacco has de- veloped in the relatively brief time (since the mid- 1980s) that this issue has been in the public eye (DiFranza et al. 1987, 1996; CDC 1990a,b,c, 1993a, 1994a, 1996a,d; Jason et al. 1991; Hinds 1992; Keay et a]. 1993; Landrine et al. 1994, 1996; USDHHS 1994). Reducing the commercial availability of tobacco to minors is a potential avenue for reducing adoles- cent use. Growing evidence suggests that tobacco products are widely available to minors. Uniformly, surveys find that teenagers believe they can easily obtain cigarettes (see, for example, Forster et al. 1989; Johnston et al. 1992; CDC 1996a; Cummings et al. 1998; University of Michigan 1999). As noted, this access is by no means confined to borrowing cigarettes from peers or adults or stealing them at home or from stores; purchase from commercial outlets is an important source for minors who use tobacco. An estimated 255 million packs of cigarettes were illegally sold to mi- nors in 1991 (Cummings et al. 1994), and daily smok- ers aged 12-17 years smoked an estimated 924 million packs of cigarettes in 1997 (DiFranza and Librett 1999). Between 20 and 70 percent of teenagers who smoke report purchasing their own tobacco; the proportion varies by age, social class, amount smoked, and fac- tors related to availability (Forster et al. 1989; Response Research, Incorporated 1989; CDC 1992a, 1996a,d; Cummings et al. 1992, 1998; Cummings and Coogan 1992-93; Mark Wolfson, Ami J. Claxton, David M. Murray, and Jean L. Forster, Socioeconomic status and adolescent tobacco use: the role of differential avail- ability, unpublished data). In a review of 13 local Regulatory Efforts 207 Surgcon General's Report over-the-counter access studies published between 1987 and 1993, illegal sales to minors ranged from 32 to 87 percent with an approximate weighted-average of 67 percent. Several local studies published in 1996 and 1997 found somewhat lower over-the-counter sales rates to minors: 22 percent (Klonoff et al. 1997) and 29 percent (CDC 1996) in two separate studies in California and 33 percent in Massachusetts (DiFranza et al. 1996). Nine studies of vending machine sales to minors published between 1989 and 1992 found ille- gal vending machine sales ranging from 82 to 100 per- cent with an approximate weighted-average of 88 percent (USDHHS 1994). Comparison of the results of these research studies with the results of later statewide Synar surveys (see below) is problematic for four reasons: (1) the research studies were generally local surveys of a town, city, or county, whereas the Synar surveys are based on statewide samples; (2) the sam- pling methods vary across the research studies; (3) store inspection methodologies vary, and (4) some of the research studies contain results of several surveys, often pre- and post-intervention (¥USDHHS 1998a). Several factors suggest that widespread reduc- tion in commercial availability may result in reduced prevalence or delaved onset of tobacco use by voung people: the reported importance of commercial sources to minors, the easy commercial availability that has been demonstrated, and the reductions in commercial availability demonstrated when legal re- strictions have been tightened, as outlined below (a- son et al. 1991; DiFranza et al. 1992; Hinds 1992; Forster et al. 1998). One psychological study supports the po- tential impact of limiting minors’ access to cigarettes (Robinson et al. 1997). In this investigation of 6,967 seventh graders of mixed ethnicity, the best predictor of experimentation with cigarettes was the perception of easy availability. Regular smoking was heavily in- fluenced by cost (see Chapter 6). Direct studies of factors that influence minors’ access have produced mixed results, however. Sev- eral investigators found that state laws on minimum age for purchasing tobacco products did not by them- selves have a significant effect on cigarette smoking among youth (Wasserman et al. 1991; Chaloupka and Grossman 1996). Other studies have provided evi- dence in single communities (without comparison groups) that compliance with youth access regulations does lead to reductions in regular smoking by adoles- cents (jason et al. 1991; DiFranza et al. 1992). Ina nonrandomized, controlled community trial (three wntervention and three control communities), Rigotti and colleagues (1997) found that although illegal sales rates to minors decreased significantly more in the 208 — Chapter 5 control communities than in the intervention commu- nities, there was no difference between control and intervention communities in either self-reported access to tobacco from commercial sources or in smok- ing behavior among youth. The authors suggest that illegal sales rates were not reduced sufficiently in the intervention communities to cause a decrease in com- mercial access that was substantial enough to impact youth smoking. Noting that these studies were lim- ited by their scope or sample size, Chaloupka and Pacula (1998) analyzed data from the 1994 Monitor- ing the Future surveys on 37,217 youths. Using per- sonal and ecologic variables in a two-part multivariate model to estimate cigarette demand by youth and av- erage daily cigarette consumption, the investigators found that adolescents are less likely to smoke and that those who smoke consume fewer cigarettes in the fol- lowing settings: where prices are higher, in states that use cigarette excise tax revenues for tobacco control activities, where there are stronger restrictions on smoking in public places, and in states that have adopted comprehensive approaches to measuring re- tailer compliance with youth access laws. The authors concluded that comprehensive approaches, including enforcement of minors’ access laws, will lead to a re- duction in youth smoking. A large, community-based clinical trial—seven intervention and seven control communities—also found an intervention effect (Forster et al. 1998). In this study, communities that developed new ordinances, changes in merchant poli- cies and practices, and changes in enforcement prac- tices experienced a significantly smaller increase in adolescent smoking than did the control communities. Further exploration of this issue may be required to substantiate the impact of the enforcement of minors’ access laws. As commercial sales to minors are decreased, there is evidence that minors may shift their attempts to obtain cigarettes to “social” sources, €.., other ado- lescents, parents, or older friends (Hinds 1992; Forster et al. 1998). One study found that adult smokers aged 18 and 19 years were the most likely group of adults to be asked by a minor for cigarettes (Ribis] 1999). This study did not assess how frequently minors asked other minors for tobacco. There is also evidence, how- ever, that minors who provide tobacco to other minors are more likely to purchase tobacco than other minors who smoke (Wolfson 1997), and in any event, some of the cigarettes provided by minors to other minors were initially purchased from commercial sources (Forster et al. 1997). Whether the source is social or commer- cial, it is clear that a comprehensive approach to re- ducing minors’ access is needed; smokers of all ages in addition to tobacco retailers must avoid provision of tobacco to minors. Efforts to Promote Adoption and Enforcement of Minors’ Access Laws Public organizations at the federal, state, and lo- cal levels have become active in encouraging state and local jurisdictions to adopt and enforce minors’ access laws. The NCI-ACS collaboration known as ASSIST (American Stop Smoking Intervention Study) has iden- tified reducing minors’ access to tobacco products as one of its goals for its 17 demonstration states. The Robert Wood Johnson Foundation’s SmokeLess States program also encourages funded states to address minors’ access. The USDHHS has widely distributed a model state law as a result of an investigation by the Office of Inspector General (OIG) reporting little or no enforcement of state laws on minimum ages for to- bacco sales (OIG 1990; LSDHHS 1990). Growing Up Tobacco Free: Preventing Nicotine Addiction in Children aid Youth, a report from the Institute of Medicine (JOM), includes an extensive study of minors’ access and a series of recommendations about state and local laws in this area (Lynch and Bonnie 1994). A group of 25 state attorneys general formed a working group on the issue and released a set of recommendations re- garding retail sales practices and legislation aimed at reducing tobacco sales to minors (Working Group of State Attorneys General 1994). Efforts to curb illegal sales to minors have also occurred at the federal level. The former FDA pro- gram (see description in Chapter 7) was a major effort for several years. Probably the most sustained and widespread attention to the issue of minors’ access laws and their enforcement was precipitated by the U.S. Congress, which in 1992 adopted the Svnar Amendment as part of the Alcohol, Drug Abuse, and Mental Health Administration Reorganization Act (Public Law 102-321, sec. 1926), which amended the Public Health Service Act. This provision requires states (at the risk of forfeiting federal block grant funds for substance abuse prevention and treatment) to adopt laws establishing minimum ages for tobacco sales, to enforce the law, and to show progressive reductions in the retail availability of tobacco products to minors. The implementation of the Synar Amendment, which initially was to go into effect during fiscal year 1994, was delayed because regulations about how states were to implement the statute had not yet been final- ized. During the considerable lag between passage of the amendment and the issuance of final regulations, Reducing Tobacco Use advocates for Synar-like restriction of youth smoking and those opposed to the Synar approach used the draft regulations to encourage states to adopt laws that in these parties’ differing views were the minimum necessary for states to comply with the Synar Amend- ment (Federal Register 1993; DiFranza 1994c; DiFranza and Godshall 1994). These anticipatory responses, to- gether with the opinions and concerns they elicited, were analyzed in a study conducted in 1995 by Downey and Gardiner (1996). An interim report from the OIG in 1995 indicated that states were finding the implementation process difficult. Although 85 percent of states performed some inspections, the majority did not use a rigorous sampling scheme. Fifty-six percent reported no statewide enforcement activity (OIG 1995). The draft regulations were finalized in early 1996 atter a review of comments from the health commu- nity, state agencies, and the tobacco industry. Respon- sibility for implementation was placed with the Substance Abuse and Menta! Health Services Admin- istration (SAMHSA), which in the course of 1996 con- ducted two technical assistance meetings with states and issued three separate guidance documents. Un- der these regulations, the Synar Amendment requires the 30 states, the District of Columbia, and U.S. juris- dictions to do the following: ¢ Have ineffect a law prohibiting any manufacturer, retailer, or distributor of tobacco products from sell- ing or distributing such products to any person under the age of 18. ¢ Enforce such laws in a manner that can be reason- ably expected to reduce the extent to which tobacco products are available to persons under the age of 18. © Conduct annual random, unannounced inspections to ensure compliance with the law; inspections are to be conducted to provide a valid sampling of out- lets accessible to underaged youth. * Develop a strategy and time frame for achieving an inspection failure rate of less than 20 percent among outlets accessible to underaged youth. ¢ Submit an annual report detailing the state’s ac- tivities in enforcing the law, the success achieved, methods used, and plans for future enforcement. In the event of noncompliance with these regu- lations, the Secretary of Health and Human Services is directed by statute (42 U.S.C. section 300X-26[c]) to make reductions of from 10 percent (for the first applicable fiscal vear) to 40 percent (for the fourth Regulatory Efforts 209 Surgeon General's Report applicable fiscal vear) in the noncompliant state's fed- eral block grant for substance abuse programs. Al- though no additional monies have been appropriated to offset the costs of complying with these regulations, states mav use block grant funds for certain Synar- related administrative activities, such as developing and maintaining a list of retail outlets, designing the sampling methodology, conducting Synar survey in- spections, and analyzing the survey results. In the several years following the issuance of the final Synar regulation, some significant advances have been made in enforcement of youth access laws. All states have laws prohibiting sale or distribution and they are enforcing those laws (USDHHS 1998a). Fur- ther, the median rate at which retailers failed to com- ply with laws prohibiting tobacco sales to minors in 1998 was 24.4 percent compared with the median rate of 40 percent in 1997 and pre-1997 studies that found violation rates ranging from 60 to 90 percent (LSDHHS, in press). In the course of implementing Synar, every state has been required to establish a sam- pling methodology that measures the statewide retailer violation rate within a known confidence interval and to establish inspection protocols for conducting, the statewide survey of tobacco retailers. These protocols include restrictions on the ages of minor inspectors and to establish procedures for recruiting and training of both minor inspectors and adult escorts. Addition- ally, the random, unannounced inspections conducted by the states in compliance with the Synar regulation provide the largest body of statewide data available on the level of retailer noncompliance. Twenty-two states and two U.S. jurisdictions modified their vouth access laws within a year of implementing Synar inspections. These changes im- proved the states’ ability to enforce the law by clarify- ing responsibility for enforcement, defining violations, clarifying penalties, restricting vending machine sales, and establishing a list of tobacco vendors through re- tail licensure or vendor registration (USDHHS, in press). In spite of these advances in enforcement of youth access laws, states also encountered difficulties while attempting to comply with the Synar mandate. The Svnar regulation does not allow for the allocation of federal dollars (e.g., the Substance Abuse Preven- tion and Treatment Block Grant) to be used for enforce- ment. For manv states, this proved to be a significant problem, because enforcement of youth access laws had not been previously viewed as a priority, and states were unwilling to redirect already limited funds for prevention and treatment services to law enforcement. Some states addressed the problem by earmarking 210 = Chapter 5 revenue derived from fines, fees, or taxes. Other states implemented collaborative enforcement efforts among several agencies so that the financial burden would be shared. And still other states relied heavily on the use of volunteer youth inspectors and adult escorts (USDHHS 1998a). As the FDA became active in the youth access issue, a few states were able to use FDA funding for enforcement to cover some of the cost of Synar inspections in 1998. Another obstacle to enforcement involved devel- oping a valid random sample of tobacco outlets in the state when there was no accurate or current list of ven- dors available. Although a few states addressed this problem by working to pass retailer licensing laws at the state level, states initially had to build lists by rely- ing on information from wholesale tobacco distribu- tors and vending machine distributors and by searching existing lists that inadvertently identify to- bacco vendors (e.g., convenience store association membership lists) (USDHHS 1999). Other less frequently cited obstacles to enforce- ment included fear of lawsuits from cited vendors, concerns with the liability issues associated with work- ing with youth, and opposition to conducting enforce- ment from state and local officials, law enforcement, and the general public in regions of the country where the economy is tied to the production of tobacco (USDHHS 1999). In addition to federal and state efforts targeting illegal tobacco sales to minors, a great amount of local activity has occurred. Many local ordinances have re- sulted from the work of various groups, particularly in California, Massachusetts, and Minnesota (DiFranza 1994a,b; Kropp 1995; Forster et al. 1996, 1998). These ordinances—which may, for example, prohibit vend- ing machine sales or all self-service sales of tobacco, require the tobacco sellers to be aged 18 years or older, require checking identification before sale, specify civil penalties for violators of the minimum-age law, require posting that law at the point of purchase, and require compliance checks with a specified timetable—permit creative responses at the local level to the minors’ ac- cess problem. Compared with state officials, local of- ficials deal with fewer retailers and a more limited set of constraints and are freer to tailor their policy to lo- cal conditions. Tobacco interests are less influential at the local level, because industry representatives are more likely to be perceived as outsiders, and their cam- paign contributions are less likely to be important to local officials; moreover, community members and local advocacy groups are often more effective against tobacco interests at this level than they are in statewide policy arenas (Sylvester 1989). Policy implementation is also likely to be more consistent at the local level, be- cause local advocates can monitor the process and be- cause enforcement officials are more likely to have been a part of the policy’s adoption. However, many of the policies at the tederal, state, and local levels are inter- related: the federal Synar Amendment is implemented through state laws and has led to enforcement at the state and local level (USDHHS 1998a). The former FDA enforcement program operated through contracts with state agencies or organizations to conduct compliance checks in communities across the states. State agen- cies often fund local coalitions and projects, and local efforts influence and support efforts at the state level. For example, much of the local activity in California and Massachusetts would not have been possible without actions implemented at the state level, spe- cifically designated funding. Laws enacted by states pertaining to minors’ ac- cess to tobacco as of December 31, 1999, have been compiled by the CDC (CDC, Office on Smoking and Health, State Tobacco Activities Tracking and Evalua- tion System, unpublished data)(Table 5.3). Dates of enactment or amendment indicate that some legisla- tive change occurred in all but one state from January 1990 to December 1997 (National Cancer Institute, State Cancer Legislative Database, unpublished data, Octo- ber 6, 1998). Restrictions on Distribution of Samples Tobacco product samples provide a low-cost or no-cost initiation to their use and thus encourage ex- perimentation at early ages. Many states or other ju- risdictions have laws that prohibit not only sales but also any samples distribution of tobacco to minors, whereas some laws specify exceptions permitting par- ents or guardians to provide tobacco to their children. All states have a specific restriction on the distribu- tion of free samples to minors, and a few states or lo- cal jurisdictions prohibit free distribution altogether because of the difficulty of controlling who receives these samples. A ban on product sample distribution can extend to coupons for free tobacco products. In Minnesota, the attorney general levied a $95,000 civil penalty against the Brown & Williamson Tobacco Cor- poration for allowing such coupons to be redeemed in the state (Minnesota Attorney General 1994). The re- ports from both the IOM (Lynch and Bonnie 1994) and the Working Group of State Attorneys General (1994) recommended a ban on the distribution of free tobacco products. The final FDA rules issued in August 1996 would have prohibited the distribution of free samples (see “Further Regulatory Steps,” earlier in this Reducing Tobacco Use chapter). The proposed multistate settlement pre- sumed congressional legislation that would uphold those rules (see “Legislative Developments” and “Mas- ter Settlement Agreement,” earlier in this chapter). Regulation of Means of Sale How tobacco can be sold may also be regulated to make it more difficult for minors to purchase it. His- torically, the first such restrictions adopted have been regulations of cigarette vending machines, which are an important source of cigarettes for younger smok- ers (Response Research, Incorporated 1989; Cummings et al. 1992, 1998: CDC 1996d). These regulations have taken the form of total bans, restrictions on placement (e.g., being within view of an employee instead of in coatrooms or entrances, or not being near candy or soda machines), restrictions on the types of businesses where vending machines may be located (e.g., limited to liquor-licensed businesses, private businesses, or businesses where minors are not permitted), and re- strictions on characteristics of the machines themselves (e.g., requiring electronic locking devices or coin slugs purchased over a sales counter) (Forster et al. 1992a; DiFranza et al. 1996). The final FDA rules would have prohibited vending machines except in certain night- clubs and other adults-only facilities totally inaccessible to persons under age 18. The proposed multistate settle- ment anticipated legislation supporting this prohibition. Forty-one states and the District of Columbia have laws that restrict minors’ access to vending ma- chines, including two states, Idaho and Vermont, that have enacted legislation totally banning vending ma- chines. However, many of the state vending machine laws are weak. For example, 21 states and the District of Columbia do not restrict placement if the machine is supervised, and New Jersey bans vending machines in schools only (CDC, Office on Smoking and Health, unpublished data, 2000). However, more than 290 lo- cal jurisdictions, including New York City, have been able to adopt and enforce outright bans on cigarette vending machines or to severely restrict them to loca- tions, such as taverns, where minors are often excluded (American Nonsmokers’ Rights Foundation, unpub- lished data, 2000). Representatives of tobacco manufacturers and retailers have strongly opposed bans on cigarette vend- ing machines and have argued instead for weaker re- strictions, if any, especially for what they term “adult” locations (Minnesota Automatic Merchandising Council 1987; Adkins 1989; Parsons 1989; Grow 1990; Movlan 1990; Pace 1990; Gitlin 1991). Many of these locations, including bars and other liquor-licensed Regulatory Efforts 271 Surgeon General's Report Table 5.3. Provisions of state laws relating to minors’ access to tobacco as of December 31, 1999 Prohibits purchase, Minimum age Tobacco Vending possession, for tobacco license machine Enforcement Sign-posting and/or use State sales required restrictions authority requirements* by minors Alabama 19 yes no yes no yes Alaska 19 yes’ yes no yes yes! Arizona 18 no yes no no yes Arkansas 18 yes yes yes yes yes California* 18 no yes no yes yes Colorado 18 no yes yes yes yes Connecticut® 18 yes’ es yes es yes 5 y j y j Delaware® 18 yes yes yes es es . . - - - y y District of Columbia 18 yes' yes no yes no Florida® 18 yes yes es es es j ) y y ¥ Georgia 18 ves yes yes yes yes Hawaii 18 no yes no yes yes Idaho 18 no yes* yes no yes Ilinois® 18 no yes yes no! yes Indiana® 18 no yes yes yes yes Iowa® 18 ves ves* yes no yes Kansas 18 yes! yes no yes yes Kentucky* 18 ves! ves yes yes yes Louisiana® 18 yes yes yes yes yes** Maine 18 yes yes yes yes yes Maryland 18 yes’ no no no yes Massachusetts* 18 ves no no yes no Michigan* 18 yes ves no yes yes” Minnesota 18 ves ves yes no yes Mississippi" 18 yes yes yes yes yes** *Refers to the requirement to post the minimum age for purchase of tobacco products. “Excludes chewing tobacco or snuff. ‘Except minors at adult correctional facilities. Some or all tobacco control legislation includes preemption. ‘Requires businesses that have vending machines to ensure that minors do not have access to the machines; however, the law does not specify the type of restriction, such as limited placement, locking device, or supervision. “Signage required for sale of tobacco accessories, but not for tobacco. **Except persons who are accompanied by a parent, spouse, or legal guardian 21 years of age or older or ina private residence. *A pupil may not possess tobacco on school property. Source: Centers for Disease Control and Prevention, Office on Smoking and Health, State Tobacco Activities Tracking and Evaluation System, unpublished data. 212) Chapter 5 Table 5.3. Continued State Missouri Montana* Nebraska Nevada® New Hampshire New Jersey* New Mexico*® New York? North Carolinas North Dakota Ohio Oklahoma® Oregons Pennsylvania® Rhode Island South Carolina® South Dakota® Tennessee® Texas Utah? Vermont Virginia® Washington* West Virginia* Wisconsin Wyoming> Total Minimum age for tobacco sales 18 18 18 18 18 18 18 18 18 18 18 18 18 18 18 18 18 18 18 18 18 18 18 18 18 18 51 Tobacco license required no ves ves** ves™ ves yes’ no ves n ots XS ves* yes” ves’ no ves” ves” yes no no ves yes yes no ves’ no yes no 35 Vending machine restrictions no ves yes ves ves ves ves ves yes ves yes ves ves no ves no ves ves yes yes yes ves yes no yes yes 44 Enforcement authority no yes no no ves ves no yes no yes ves ves ves ves yes yes no no 33 Reducing Tobacco Use Prohibits purchase, possession, Sign-posting and/or use requirements by minors yes no yes yest no yes no no ves yes yes no ves yes yes no yes yes no yes yes no yes yes ves yes no no# yes yes"? no no no yes yes yes yes yes no yes yes yes yes yes yes yes no yes yes yes yes yes 36 42 14 pupil may not possess or use tobacco on school property. “Except vending machines. ‘SA retail license exists for those retailers who manufacture their own tobacco products or deal in nonpaid tobacco products. “On any public street, place, or resort. Regulatory Efforts i) ~ Qe Surgeon General's Report businesses, do not prohibit minors’ entry and have been shown to be readily accessible to underaged buy- ers (Forster et al. 1992b; Wakefield et al. 1992a; Cismoski and Sheridan 1993). Because less-restrictive measures must be consistently implemented to be ef- fective, and because such implementation is difficult, the USDHHS (1994) and the IOM (Lynch and Bonnie 1994) recommend a total ban on cigarette vending machines. The 1996 FDA rules would have excluded locations that are inaccessible to minors, but the multistate settlement proposed a total ban. Restrictions on vending machines are a category of regulation of self-service cigarette sales. A general ban on self-service would require that tobacco be physically obtained from a salesperson and be stored so that products are not directly accessible to custom- ers. In one study of 489 over-the-counter purchase attempts, minors were successful at purchasing in 33 percent of locations where cigarettes were behind the counter and 45 percent of locations where cigarettes were openly available (Forster et al. 1995). In another study, stores that did not give customers access to to- bacco products were less likely to sell to minors (12.8 percent) than stores that permitted direct contact with tobacco products (30.6 percent)(Wildey et a]. 1995a). Finally, data suggest that shoplitting is an important commercial source of tobacco to underaged youth (Cummings et al. 1992, 1995; Cismoski and Sheridan 1994; Lynch and Bonnie 1994; Forster et al. 1995; Wildeyv et al. 1995b; CDC 1996d; Roswell Park Cancer Insti- tute 1997). Shoplifting may be deterred by regulations that specify that until the moment of purchase, single packs, any amount less than a carton, or all tobacco products must be physically handled by an emplovee only (Cismoski 1994; Wildev et al. 1995a; Caldwell et al. 1996). Several states have addressed the issue of self- service sales of tobacco products. For example, Idaho and Minnesota restrict self-service sales to only those stores that do not allow minors to enter and that ob- tain most of their sales from tobacco. Texas prohibits self-service sales in any location accessible to minors. Three hundred and ten localities have chosen to re- strict tobacco sales by prohibiting self-service displays (American Nonsmokers’ Rights Foundation, unpub- lished data, 2000). Opposition to this measure is generally organized by tobacco distributors and retailers, who fear the loss of slotting fees—payments (often substantial) to retailers for advantageous placement of tobacco products and for point-of- purchase advertising in their business (Gersten 1994; Thomas A. Briant, letter to Litchfield Tobacco Retail- ers, February |6, 1995; Caldwell et al. 1996). The IOM 2]4 Chapter 5 recommends a ban on self-service displays (Lynch and Bonnie 1994), and the Working Group of State Attor- neys General (1994) recommends to tobacco retailers that they eliminate such displays. That this recom- mendation is not unreasonably burdensome has been demonstrated by one study in which 28 percent of re- tailers in 14 communities complied voluntarily (Forster et al. 1995) and by another study involving 15 cities in northern California (Kropp 1995). The 1996 FDA rules would also have prohibited self-service displays except in certain adults-only facilities; the proposed national settlement further stipulated that in non-adults-only facilities, tobacco products must be out of reach or otherwise inaccessible or invisible to consumers. Anecdotal reports have suggested that single or loose cigarettes are sold in some locations. Such sales are often prohibited by state or local law, at least im- plicitly because single cigarettes do not display the required state tax stamp or federal warning. Fre- quently, single cigarettes are kept out of sight and are available only by request. Researchers in California found that even after a state law explicitly banned the sale of single cigarettes, almost one-half of tobacco re- tailers sold them to their customers (Klonoff et al. 1994). The study found that the stores that made loose ciga- rettes available sold them to almost twice as many minors as they did to adults. That finding lends sup- port to the argument that single cigarette sales are an important avenue to addiction for some youth. A re- cent study in Central Harlem has produced similar results: 70 percent of the licensed outlets sold single cigarettes to minors (Gemson et al. 1998). The IOM, the 1996 FDA rules, and the proposed multistate settle- ment have all recommended that the sale of loose or single cigarettes be explicitly prohibited (Lynch and Bonnie 1994). Regulation Directed at the Seller All states now have a law specifying the mini- mum purchaser’s age for legal sale of tobacco prod- ucts. For all but two states, that age is 18; Alabama and Alaska specify age 19. Almost two-thirds of the states and many local jurisdictions require tobacco retailers to display signs that state the minimum age for sale. Some regulations specify the size, wording, and location of these signs. Other regulations specify the minimum age for salespersons; these regulations recognize the difficulty young sellers may experience in refusing to sell cigarettes to their peers. Most of these laws define violation either as a criminal offense (e.g., misdemeanor or gross misdemeanor), with accompanving penalties, or as a civil offense, with specified civil penalties (e.g., fines and license suspension). Civil offense laws are thought to make enforcement easier and are therefore more likely to be carried out, since they do not generally require court appearances. Many state or local laws specify penalties only against the salesperson. Apply- ing penalties to business owners, who generally set hiring, training, supervising, and selling policies, is considered essential to preventing the sale of tobacco to minors, although tobacco retailers have vigorously opposed these measures (Skretny et al. 1990; Feighery et al. 1991; McGrath 1993a,b). More than one-half of the states and some local jurisdictions require that tobacco retailers obtain li- censes for over-the-counter sales, but smokeless to- bacco is exempted by 13 of these states (CDC, Office on Smoking and Health, unpublished data). Licen- sure sometimes is simply a mechanism tor collecting taxes or generating revenue; in other states and cities, conditions are attached that relate to minors’ access. In addition to civil penalties, retail licensure for tobacco represents another approach tor facilitating youth ac- cess law enforcement efforts and strengthening sanc- tions for violators of the law. Retail licensure can facilitate the identification of retailers. The lack of a current and accurate list of tobacco vendors has been cited by manv states involved in Synar enforcement as a serious impediment to efficient enforcement (USDHHS 1999). Retail licensure can also create an incentive for retail compliance. License suspensions or revocations could be imposed as penalties for vio- lation of vouth access laws, resulting in revenue loss tor retailers. Licensure would also provide a source of funds to pay for enforcement and retailer educa- tion when licensing fees or fines for violations are ear- marked for such education purposes. Finally, retail licensure provides a mechanism for administrative adjudication of youth access law violations. License holders who fail to comply with the law could be held accountable before the licensing authority. No published empirical research examines the effects of tobacco retail licensure on either enforcement efforts or retail compliance. Studies on policies tar- geted to increase retail compliance, however, suggest several specific elements of licensure policies that should be present in order to increase the likelihood of positive effects. The points below outline the ways in which licensure policies could be used to enhance retail compliance efforts. Reducing Tobacco Use ¢ Licensure laws must explicitly link the privilege of selling tobacco products to retail compliance with youth access laws (Levinson 1999). ¢ Licensure should cover both retail stores and vend- ing machines (Levinson 1999). * License holders should be required to renew their license annually (Levinson 1999; USDHHS 1999). * License holders should be fined for violation of youth access laws (Levinson 1999). ¢ Fines should be high enough to encourage vendors to comply with youth access laws but not so high as to risk loss of community or judicial support for the imposition of penalties (Lynch and Bonnie 1994). ¢ Fines should be graduated so that greater conse- quences are associated with increased number of violations. Repeated violations should lead to li- cense suspension or revocation (CDC 1995a; NCI n.d.). ¢ License fees should be sufficient to cover the aver- age cost of compliance checks (CDC 1995a). ¢ The revenue from fines should subsidize the costs of enforcement (Working Group of State Attorneys General 1994). In addition to these items, several other policy elements have been suggested for incorporation into licensure laws. These licensure policy components should communicate clear and consistent messages about the illegality of tobacco sales to minors and should promote societal norms intolerant of youth ac- cess law violations (Kropp 1996). These elements in- clude mandatory posting of warning signs within clear sight of consumers, mandatory checking of age iden- tification, state provision of merchant and clerk edu- cation about youth access law requirements (i.e., consequences for violations and techniques for im- proving merchants’ and clerks’ skills at detecting un- derage youth and refusing sales), restrictions or bans on self-service displays, and ensuring that clerks are at or above the legal purchase age. Without enforcement provisions, however, li- censing laws are not effective measures to restrict mi- nors’ access. Before 1996, only 16 states with licensing laws specified the agency with enforcement responsi- bility, despite recommendations (USDHHS 1990; Lynch and Bonnie 1994; Working Group of State At- torneys General 1994) that states adopt a licensing re- quirement that has civil penalties and a designated Regulatory Efforts 215 Surgeon General's Report enforcement agent. In its 1998 report, SAMHSA indi- cates that all but one state requiring licenses have a designated enforcement agency (USDHHS 1998a; see “Enforcement of Laws on Minimum Ages for Tobacco Sales,” later in this chapter). State laws and local ordinances can be a mecha- nism for increasing retailer awareness of youth access laws and retailer ability to comply with the law. Of- ten referred to as responsible vendor laws, this type of legislation can require retailer education and training as a condition of retail tobacco licensure or simply re- quire education and training for all tobacco vendors. Numerous studies have shown the potential benefit of comprehensive merchant education and training programs in helping to reduce illegal sales to minors (Altman et al. 1989, 1991, 1999; Feighery 1991, Keay 1993; Cummings et al. 1998). In many instances, rep- resentatives of tobacco retailers have supported the passage of responsible vendor laws (McGrath 1995a,b; Thomas A. Briant, Letter to Litchfield Tobacco Retail- ers, February 16, 1995) when these laws also exempt business owners from penalties or specify lower pen- alties for tobacco sales to minors if owners have trained their employees. Under such conditions, employee training would relieve retailers of responsibility for on- going supervision and monitoring of employee behav- ior and likely result in decreasing the impact of youth access laws. It should be noted, however, that as a result of both Synar and FDA attention to the problem of youth access to tobacco, several states have worked to ensure the modification of youth access and/or re- tail licensure laws to mandate vendor education and training without the incorporation of clauses reliev- ing retailer responsibility (USDHHS 1998a). These ef- forts recognize that responsible vendor laws have the potential to be an effective way to increase the ability of retailers and clerks to comply with the law by accu- rately detecting underage purchases and confidently and safely refusing sales. The general availability of tobacco products in retail outlets that have pharmacies has led to some concerns. In the United States, stores that have phar- macies usually sell tobacco products, contrary toa 1971 policy recommendation of the American Pharmaceu- tical Association (1971) that cited the inconsistency of selling cigarettes with their function as health institu- tions. A few small chains and a growing number of independent stores with pharmacies are tobacco free, but all large chains and most independent stores sell tobacco products. Pharmacies (and stores that have pharmacies) that sel] tobacco products are as likely as other outlets to sell to minors (Brown and DiFranza 1992). On the other hand, a study has shown that 216 Chapter 5 pharmacists who work in stores that do not sell to- bacco have a better understanding of the dangers of tobacco than do pharmacists who work in stores that sell tobacco, and they also feel more confident that they can help customers who use tobacco stop (Davidson et al. 1988). Two-thirds of pharmacists surveyed in Minnesota believed that members of the profession should not work in stores that sell tobacco products (Martinez et al. 1993), and many felt that the contigu- ity of tobacco products and pharmaceuticals produces professional dissonance (Taylor 1992; Kamin 1994). Both the Canadian Medical Association and the Ameri- can Medical Association are opposed to tobacco sales in pharmacies and in stores that have pharmacies (Staver 1987; Sullivan 1989). The Canadian provincial government of Ontario banned such sales in 1994 (An Act to Prevent the Provision of Tobacco to Young Per- sons and to Regulate its Sale and Use by Others, Stat- utes of Orleans, ch. 10, sec. 3[6] [1994] [Can.]). Regulation Directed at the Buyer State and local jurisdictions are increasingly im- posing sanctions against minors who purchase, at- tempt to purchase, or possess tobacco products (CDC 1996c; Forster et al. 1996). These laws are favored by some law enforcement officials and tobacco retailers because of the potential deterrent value (Parsons 1989; Talbot 1992). Some advocates for reducing tobacco use argue, however, that such laws are part of an effort to deflect responsibility for illegal tobacco sales from re- tailers to underaged youth; that these laws are not an efficient substitute for laws regulating merchants, be- cause sO Many more minors than retailers are involved; and that sanctions against minors are more difficult to enforce than those against retailers (Carol 1992, Cismoski 1994; Lynch and Bonnie 1994; Mosher 1995; Wolfson and Hourigan 1997). Other advocates have insisted that some of the responsibility must devolve on the purchaser and that laws prohibiting possession should be vigorously enforced (Talbot 1992). Although not taking a stand on the advisability of purchase and possession laws, the Working Group of State Attor- neys General (1994) recommended that such laws should be considered only after effective retail regula- tions are already in place. Enforcement of Laws on Minimum Ages for Tobacco Sales Although laws on the minimum age for tobacco sales have been part of many state statutes for decades, only in the past few years has attention been focused on enforcing these laws by federal, state, or local agen- cies (Lynch and Bonnie 1994; Federal Register 1996, USDHHS, in press). As more information has become available about the implementation and effects of vari- ous minors’ access laws, it is becoming clear that orga- nized enforcement efforts are essential to realizing the potential of these laws. Enforcement of minimum-age laws is more likely to occur when enforcement is self- supporting through license fees and revenues from pen- alties and when the penalty schedule includes civil penalties that are large enough to be effective but are seen as reasonable and simple to administer (Working Group of State Attorneys General 1994). Law enforce- ment officials have sometimes balked at applying crimi- nal penalties against clerks and retailers for selling tobacco to minors. Enforcement may be more effective if sanctions can be imposed on managers or business owners rather than, or in addition to, salespersons (Working Group of State Attorneys General 1994). Moreover, the 1992 enactment of the Synar Amendment (Public Law 102-321, sec. 1926, discussed in the introduction to this section) has forcibly brought this issue to the fore, because the amendment requires states to enact and enforce legislation restricting the sale and distribution of tobacco products to minors. As a result, all states have laws prohibiting the sale and distribution of tobacco to minors and all states enforce these laws through a statewide coordinated program. Additionally, all states have now designated a lead agency and all but one have an agency respon- sible for enforcing their minimum-age law (Table 5.4) (USDHHS, in press). In addition to federal and state enforcement efforts, a number of local jurisdictions around the country have begun actively enforcing the law against tobacco sales to minors, and local ordi- nances can include a schedule of required compliance checks (Lynch and Bonnie 1994; Working Group of State Attorneys General 1994; Forster et al. 1996; DiFranza et al. 1998). Compliance checks are most often carried out by having an underaged buyer, under the supervision of a law enforcement officer, licensing official, or some other designated adult, attempt to purchase tobacco. In jurisdictions where the minor is held legally at fault if a purchase is made (and where no exceptions are made for compliance checks), minors participating in compliance checks are sometimes instructed not to complete the purchase even if the salesperson is will- ing; in these cases, the retailer is considered to be in noncompliance with the youth access law if the pur- chase is entered into the cash register (Hoppock and Houston 1990; Cummings et al. 1996). Reducing Tobacco Use Several innovative civil enforcement approaches have been attempted in California. The district attor- neys in Sonoma and Napa Counties have used the Cali- fornia Business and Professions Code section 17200 to file civil lawsuits against store owners whose outlets repeatedly sold tobacco to minors. Civil enforcement has proved to be more efficient than criminal citations and has resulted in fines and penalties as well as reduc- tions in tobacco sales to minors (Kropp and Kuh 1994). Increased emphasis on enforcement, coupled with passage of laws against possession of tobacco by minors, may result in enforcement resources being selectively funneled to apprehending underaged smokers rather than penalizing the merchants who sell tobacco to these minors. A survey of 222 police chiefs in Minnesota revealed that although more than 90 per- cent were enforcing the law against minors’ posses- sion, 40 percent reported applying penalties to minors, and only 6 percent reported any enforcement against merchants (Forster et al. 1996). A vigorous and multidimensional campaign has been mounted by the tobacco industry and its allies to prevent or undermine effective enforcement of minors’ access laws and to resist the proposal that retailers be held accountable for their stores’ compliance. Since 1992, laws sponsored by the tobacco industry but os- tensibly intended to bring states into compliance with requirements of the Synar Amendment have been passed in Georgia, Idaho, Kentucky, Louisiana, Mary- land, Mississippi, North Carolina, Oklahoma, South Dakota, and Tennessee (DiFranza 1994c; DiFranza and Godshall 1994). Tobacco industry representatives and their allies have lobbied successfully for the inclusion of language such as “knowingly” or “intentionally” in the law prohibiting sale of tobacco to minors; the impact of such language may be to render the law unenforceable. Industry interests have sought to in- clude various restrictions on how, how often, and by whom enforcement or compliance testing can be con- ducted. Examples of these restrictions include oppos- ing employing teens in compliance testing or requiring that only very young teens can function as buyers, in- sisting that enforcement be done only by the alcohol control authority or some other state agency, oppos- ing compliance checks carried out by advocacy groups or for public health research, and opposing require- ments that compliance checks occur on a specified schedule. The industry has further proposed imme- diate reentry and confrontation after an illicit sale—a procedure that could compromise collecting evidence. Industry representatives have also consistently main- tained that merchants ought not to be responsible for the costs incurred in complying with minimum-age Regulatory Efforts 217 Surgeon General's Report Table 5.4. Agencies responsible for enfor year 1998 State/Territory cing state laws on minimum age for tobacco sales as of fiscal Lead agency Enforcement agency Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana lowa Kansas Kentucky Alcoholic Beverage Control Board Department of Health and Social Services, Division of Alcoholism and Drug Abuse Department of Health Services, Office of Substance Abuse and General Mental Health Department of Health, Bureau of Alcohol and Drug Abuse Prevention Department of Health Services Department of Human Services, Alcohol and Drug Abuse Division Department of Mental Health and Social Services, Office of Addiction Services Department of Public Safety, Alcoholic Beverage Control Commission Department of Human Services, Addiction Prevention and Recoverv Administration Department of Business and Professional Regulation, Division of Alcoholic Beverages and Tobacco Department of Public Safety Department of Health, Alcohol and Drug Abuse Division Department of Health and Welfare, FACS Division, Bureau of Mental Health and Substance Services Liquor Control Commission Family and Social Services Administration, Division of Mental Health Department of Public Health, Division of Substance Abuse and Health Promotion Department of Social and Rehabilitation Services, Alcohol and Drug Abuse Services Department of Alcoholic Beverage Control Alcoholic Beverage Control Board Attorney General’s Office Department of Health Services, Office of Substance Abuse and General Mental Health Tobacco Control Board Department of Health Services State and local law enforcement Department of Revenue Services Department of Public Safety, Alcoholic Beverage Control Commission Department of Consumer and Regulatory Affairs and the Metropolitan Police Department Department of Business and Professional Regulation, Division of Alcoholic Beverages and Tobacco Department of Public Safety Department of Health with Department of the Attorney General Department of Health and Welfare, FACS Division, Bureau of Mental Health and Substance Services No one agency responsible for enforcement Indiana Alcoholic Beverage Commission Excise Police Department of Public Health, Division of Substance Abuse and Health Promotion Department of Revenue, Alcoholic Beverage Control Board Department of Agriculture (specified state law) with the Department of Alcoholic Beverage Control (appointed) Source: U.S. Department of Health and Human Services, in press. 218 9 Chapter 5 Table 5.4. Continued State/Territory Louisiana Maine Marvland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Lead agency Department of Revenue and Taxation, Office of Alcoholic Beverage and Tobacco Control Department of Mental Health and Mental Retardation, Office of Substance Abuse Department of Health and Mental Hvgiene, Alcohol and Drug Abuse Administration Department of Public Health, Bureau of Substance Abuse Services Department of Community Health, Bureau of Substance Abuse Services Department of Human Services, Chemical Dependency Program Division Department of Mental Health, Division of Alcohol and Drug Abuse Department of Mental Health, Division of Alcohol and Drug Abuse Department of Public Health and Human Services, Division of Addictive and Mental Disorders Department of Health and Human Services Attorney General of the State of Nevada Department of Health and Human Services, Bureau of Substance Abuse Services Department of Health and Senior Services Department of Regulation and Licensing, Alcohol and Gaming Division Department of Health, Office of Alcoholism and Substance Abuse Services Department of Human Resources, Division of Mental Health, Developmental Disabilities and Substance Abuse Services Department of Human Services, Division of Mental Health and Substance Abuse Services Reducing Tobacco Use & Enforcement agency Department of Revenue and Taxation, Office of Alcoholic Beverage and Tobacco Control Department of Mental Health and Mental Retardation, Office of Substance Abuse State Comptroller’s Office Department of Public Health, Tobacco Control Program with the Attorney General’s Office Department of Community Health, Bureau of Substance Abuse Services Department of Human Services, Chemical Dependency Program Division Office of Attorney General Department of Mental Health, Division of Alcohol and Drug Abuse Department of Public Health and Human Services, Division of Addictive and Mental Disorders Nebraska State Patrol State Attorney General Department of Health and Human Services, Bureau of Substance Abuse Services Department of Health and Senior Services with local health agencies Department of Regulation and Licensing, Alcohol and Gaming Division (statutory), Department of Health and Department of Public Safety (by executive order) 37 local county health units and 10 district offices of the state’s Department of Health Local police and sheriff’s departments State and local law enforcement agencies are responsible for enforcing state and local laws prohibiting tobacco sales to minors. The Department of Human Services, Division of Mental Health and Substance Abuse Services, is responsible for conducting compliance surveys. Regulatory Efforts 219 Surgeon General's Report Table 5.4. Continued State/Territory Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming American Samoa Guam Marshall Islands Lead agency Enforcement agency Department of Alcohol and Drug Addiction Services Alcoholic Beverage Law Enforcement Commission Department of Human Resources, Office of Alcohol and Drug Abuse Programs Department of Health, Office of Alcohol and Drug Abuse Programs Department of Health, Division of Substance Abuse Department of Alcohol and Other Drug Abuse Services Department of Human Services, Division of Alcohol and Drug Abuse Department of Agriculture Commission on Alcohol and Drug Abuse and Department of Health Department of Human Services, Division of Substance Abuse Department of Liquor Control Department of Agriculture and Consumer Services Department ot Social and Health Services, Division of Alcoho! and Substance Abuse Department of Health and Human Resources, Division of Alcoholism and Drug Abuse Department of Health and Family Services, Bureau of Substance Abuse Services Department of Health, Division of Behavioral Health and Substance Abuse Program Department of Human and Social Services, Social Services Division Department of Mental Health and Substance Abuse Office of the Attorney General Department of Alcohol and Drug Addiction Services Alcoholic Beverage Law Enforcement Commission Oregon State Police Department of Health, Office of Alcohol and Drug Abuse Programs Department of Health, Division of Substance Abuse (The Division of Substance Abuse transferred from the Rhode Island Department of Health to the - Department of Mental Health, Retardation, and Hospitals on September 1, 1998.) Department of Revenue and Taxation Division of Alcohol and Drug Abuse coordinates enforcement with the Attorney General's Office and 66 county state’s attorneys Department of Agriculture State Comptroller Department of Human Services, Division of Substance Abuse Enforcement and Licensing Division of the Department of Liquor Control Alcohol Beverage Contro! Board Liquor Control Board Alcohol Beverage Administration Department of Health and Family Services, Bureau of Substance Abuse Services Local law enforcement agencies Department of Public Health Department of Mental Health and Substance Abuse Chief Prosecutor of the Office of the Police Commissioner 220) Chapter 5 Table 5.4. Continued State/Territory Lead agency Reducing Tobacco Use Enforcement agency Micronesia Northern Marianas Palau Puerto Rico Virgin Islands Department of Health Department of Public Health Ministry of Justice, Bureau of Public Safety with Ministry of Commerce and Trade (responsible for licensing) Department of Health, Mental Health and Anti-Addiction Services Administration Department of Health, Division of Mental Health, Alcoholism and Drug Dependency No single agency; enforcement by local police and health departments Department ot Public Health Bureau of Public Safety Department of Treasury Department of Licensing and Consumer Affairs Services laws, such as the costs of making tobacco inaccessible to minors or of having merchants monitor their own staff (DiFranza 1994c; DiFranza and Godshal] 1994). Despite, or in some cases in response to, these indus- try efforts, many states have successfully strengthened their youth access laws and/or removed industry- inspired loopholes and provisions for affirmative de- fense. Six states amended state law to permit minors to participate in compliance checks conducted for en- forcement purposes. Twenty-three states now have this provision in their minors’ access law. Two states passed legislation that will provide a more accurate list of tobacco retailers for compliance checks and three states added provisions that address funding for en- forcement and education programs (USDHHS, in press). The reports from both the IOM (Lynch and Bonnie 1994) and the Working Group of State Attor- nevs General (1994) include strong recommendations that active enforcement of minors’ access laws be implemented, that merchants be held responsible for sales in their stores, and that access laws supported by the tobacco industry be rejected. Using another type of enforcement, some private groups and states have conducted lawsuits against commercial outlets that violate minors’ access laws. A selection of these cases, one of which also named a tobacco company as a codefendant, is discussed in “Enhancing Prohibitory Regulation by Private Litiga- tion,” later in this chapter. Traditional law enforcement agencies often re- sist conducting tobacco enforcement for a number of reasons. They believe that tobacco enforcement diverts limited resources from other more pressing crime and that the public does not support the use of officers for such enforcement. Thev have also argued that the ill- feeling of members of the business community gener- ated by the issuance of citations negatively affects other enforcement efforts. Finally, the officers themselves frequently resist because they do not want to facilitate potential job loss for a clerk for what they perceive to be a “minor” infraction or because they believe that prosecutors and judges will be reluctant to penalize (USDHHS 1999). Other agencies can be a suitable alternative for the conduct of enforcement. Chief among them are public health departments, which recognize the im- portance of conducting enforcement, and alcohol bev- erage control agencies (ABCs), which are highly experienced in conducting undercover compliance checks. ABCs retain a staff of inspectors that are fa- miliar with the protocols that may be employed dur- ing retail inspections (i.e., consummated and unconsummated buys). ABCs also tend to recognize a connection between alcohol and tobacco enforcement and accept the importance of conducting tobacco in- spection for practical reasons if not for health reasons. This, in turn, results in less of a philosophical resis- tance to actually issuing citations for violations. Fi- nally, because ABC authorities regularly engage in enforcement directed at retailers, tobacco enforcement conducted by this agency will not likely generate as negative a backlash from retailers and the general public as enforcement conducted by traditional law enforcement (USDHHS 1999). Regulatory Efforts 221 Surgeon General's Report State Settlements All four states that settled their lawsuits against the tobacco industry in 1997-1998 won youth access re- strictions in their settlement agreements. (The events leading up to these four settlements, along with their implications as a litigational tool for reducing tobacco use nationwide, are discussed in “Recovery Claims by Third-Party Health Care Payers,” later in this chapter.) For example, the tobacco industry defendants in the state of Florida case agreed to support new state laws or regu- lations to prohibit the sale of cigarettes in vending machines, except in adult-only locations or facilities (Florida v, American Tobacco Co., Civil Action No. 95-1466 AH, sec. ILA.2 [Fla., Palm Beach Cty. Aug. 25, 1997). The industry also agreed to support new state laws in Florida to increase civil penalties for sales of tobacco products to minors (including retail license suspension or revocation) and to strengthen civil penalties for the possession of tobacco by minors. The Florida settlement (sec. I1.B) further requires the tobacco industry to pay $200 million for a two-year pilot program to reduce to- bacco use by minors, including enforcement, media, educational, and other vouth-directed programs. Youth access provisions of the Texas settlement that pertain to new state laws mirror the terms of the Florida agree- ment (Texas v. American Tobacco Co., No. 5-96CV-91 [E.D. Tex. Jan. 16, 1998], secs. 7fa-c)). The state of Minnesota won the most compre- hensive array of public health and vouth access restric- tions to date when it settled its case after a highly publicized trial in 1998 (Minnesota v. Philip Morris Ine., cited in 13.2 TPLR 3.39). One provision of the Minne- sota settlement forbids tobacco manufacturers from di- rectly or indirectly opposing state statutes or regulations intended to reduce tobacco use by minors. A list of legislative proposals covered by the prohibi- tion is attached to the settlement agreement (Schedule B) and includes the following measures: * Expansion of self-service restrictions and removal of the current exception for cigars. * Amendment of the current law for restricting youth access to vending machines to clarify that machines with automatic locks and machines that use tokens are covered. e “Enhanced or coordinated funding” for enforce- ment efforts under sales-to-minors provisions of the criminal code or the statute and ordinances involv- ing youth access. 222) Chapter 5 ° Laws to “encourage or support the use of technol- ogy to increase the effectiveness of age-of-purchase laws” (e.g., programmable scanners or scanners to read drivers’ licenses). ¢ Restrictions on wearing, carrying, or displaying to- bacco indicia in school-related settings. ° Establishment or enhancement of nonmonetary in- centives for youth not to smoke (e.g., expand com- munity services programs for youth). Moreover, prohibiting tobacco companies from - challenging the enforceability or constitutionality of current Minnesota laws encompasses some key youth | access statutes, such as those pertaining to the sale of tobacco to minors (Minnesota Statutes sec. 609.685) and . the distribution of samples (Minnesota Statutes sec. 325.77) (Minnesota v. Philip Morris Inc., cited 113.2 TPLR- 3.39, sec. IV.A.2). Another injunctive provision, forbid- ding the tobacco industry from targeting children through advertising, promotion, or marketing, also prohibits the industry from “taking any action the pri- mary purpose of which is to initiate, maintain or in- crease the incidence of underage smoking in Minnesota” (Minnesota v. Philip Morris Inc., No, C1-94- 8563 [Minn., Ramsey Cty. May 8, 1998], cited 11 13.2 TPLR 2.112, 2.113 [1998}). The Minnesota settlement also includes a large industry-funded program to reduce teen smoking. The program includes counteradvertising, classroom edu- cation, community partnerships, research, advocacy, and prevention components (Minnesota v. Philip Maer- ris Inc., cited in 13.2 TPLR 3.39, sec. VII.A.2). Although Mississippi (the first state to settle) did not initially secure public health restrictions, it later imported some of those contained in the sweeping, Minnesota settlement by exercising the “most favored nation” clause (discussed in “Recovery Claims by Third-Party Health Care Payers,” later in this chapter) in its original settlement agreement (PR Newswire 1998a). Intended to ensure that Mississippi would re- ceive the benefits any later similar settlement might receive, the most favored nation clause also enabled the state to substantially increase the dollar amount of its settlement with the industry. Furthermore, although the revised agreement prohibits Mississippi from gain- ing any additional monetary benefit based on future state settlements, it does not limit the incorporation of additional public health provisions or financial adjust- ments in the event that Congress adopts national to- bacco legislation. Preemption of Local Action by State Policy As noted earlier in this section (see “Efforts to Promote Adoption and Enforcement of Minors’ Access Laws”), the initiative to address minors’ access, as well as many creative solutions, has come from the local level. In state legislatures, the balance of power be- tween forces for and against reducing tobacco use is most often tipped in favor of tobacco use. The reverse is often true at the local level, where jurisdictions have enacted innovative approaches that have been evalu- ated by researchers. At the state level, however, to- bacco industrv representatives have sought to preclude legislative or enforcement authority at the local level by including preemption language, usually attached to weak statewide restrictions. As of 1998, 30 states had preemptive tobacco con- trol laws, although thev vary widely in the kind of re- strictions they preempt (CDC 1999). No preemptive tobacco control laws have been enacted since July 1996. The tobacco industry has adopted preemption as a main strategy to undermine, overturn, and prohibit future efforts to adopt local policies to reduce tobacco use (Siegel et al. 1997; Gorovitz et al. 1998). For in- stance, in 1991 and 1992, the tobacco industry spent more than $2 million to lobby for the repeal of local clean indoor air ordinances (Traynor et al. 1993). In California in one year alone, the industry spent 518.9 million on an initiative to repeal all local ordinances for reducing tobacco use and to eliminate local author- itv to enact new ordinances (Siegel et al. 1997). A memorandum of the 1991 Smokeless Tobacco Council described a strategy to oppose local ordinances Litigation Approaches Reducing Tobacco Use and advance statewide antitobacco bills containing preemption clauses (Siegel et al. 1997). In addition, the Tobacco Institute stated that a priority for 1993 was to “encourage and support statewide legislation pre- empting local laws, including smoking, advertising, sales, and vending restrictions” (Tobacco Institute 1992). This strategy would work against the passage of strong tobacco control laws at the local level and would relieve logistical difficulties of the tobacco in- dustry in devoting resources toward multiple local jurisdictions (Siegel et al. 1997; Gorovitz et al. 1998). Even when a preemption clause is not specifi- cally included, tobacco industry representatives have argued that state laws that address minors’ access are intended to preempt local action, and that argument has been used by at least one court to invalidate more restrictive local ordinances (DiFranza 1993). Both the 1OM (Lynch and Bonnie 1994) and the Working Group of State Attorneys General (1994) recommend that state laws include language specifically stating that they are not meant to preempt stronger local ordinances. One of the U.S. health objectives for 2000 was to reduce to zero the number of states with preemptive smoke-free indoor air laws (Objective 3.25) (National Center for Health Statistics 1997); an objective proposed for 2010 is to reduce the number of states with any pre- emptive tobacco control laws to zero (USDHHS 2000a). Most states have preemptive tobacco control laws, and 19 have preemptive provisions for minors’ access laws. Thus, achievement of the 2000 objective is unlikely (CDC 1999), Introduction Society deploys various regulatory controls to confront risks arising from dangerous products or practices. As has been discussed in previous sections in this chapter, these controls include those intrinsic to the practice itself, such as preventive design and safety procedures built into a product or into the tech- nology of its use, as well as external regulation by gov- ernment agencies and private parties, such as property owners, employers, or insurers. Certain institutions also absorb and spread losses when a practice does result in injuries, such as relief institutions that assist victims and social and private insurance that compen- sates the injured. Another regulatory control, intro- duced here, is private law (referred to generally in this section as litigation and held distinct from the more sweeping legislative scope of public law). In the course of vindicating the claims of injured persons, private law generates, broadcasts, and reinforces safety standards. The various controls are not independent but interact in complex ways. For example, preven- tive design may stem from the imposition or anticipa- tion either of government regulation or of liability Regulatory Efforts 223 Surgeon General's Report established through private law; similarly, emplovers or insurers may institute preventive regulations to limit the cost of remedial measures resulting from private law decisions. Private Law as a Means of Risk Control Private law remedies combine existing public standards with a public institution—the courts—that is passive in accepting these standards but is also, ac- cordingly, reactive when the standards change. In pri- vate law, the initiative to enforce a change or decision is shifted awav from an enterprise or a government to private actors—typically, victims or their surrogates. This diffusion of the enforcement initiative is matched by the decentralized pronouncement of liability stan- dards, which are less often established at a given mo- ment than they are formulated over time, largelv by courts responding incrementally to specific cases brought before them. Private law standards are con- text sensitive, incorporating changing popular values and understandings. In the Lnited States, this incor- poration of popular views is accelerated by the use of civil juries. Tort as a Private Law Control In the tort svstem, which applies to actionable wrongful acts other than breach of contract (tort is a Middle English word meaning “injurv”), information about instances in which injurers (and their insurers) are forced to compensate victims coalesces slowly into a body of knowledge that, acknowledged by other potential injurers, generates various preventive effects (Calabresi 1970). However, because each instance ot remedy involves individualized determination of h- ability and damages, the production of these preven- tive effects by the tort system is highly inefficient. The process is also very expensive, because a large portion of the money that the tort system extracts from injur- ers is consumed by the tort process itself (Kakalik and Pace 1986). Nonetheless, although relatively inefficient for compensating specific classes of injuries, the tort system effectively generates overall preventive effects and is flexible and adaptive (American Law Institute 1991; Galanter 1994). U.S. Reliance on Private Law Controls Societies differ in the way they deploy this alter- native set of controls. The United States has tended to rely more heavily on private law controls than do other industrialized countries (Kagan 1991; Galanter 1994). 22.4 Chapter 3 The expansive U.S. system of private remedy is con- joined witha lesser emphasis on administrative controls and social insurance (Pfennigstorf and Gifford 1991). Where excessive risks are associated with a prod- uct or practice, the U.S. tort system typically acts to shift part of the cost of these risks back to the produc- ers and users. Such litigation campaigns follow a fa- miliar course toward preventing particular risks: after a period of innovation and experimentation, a few successful lawsuits provide a model and incentive for other lawyers and plaintiffs; the threat of a mounting tide of litigation (and occasionally an actual tide) leads to a flow of compensation, modifications in the use or design of the product, and occasionally bankruptcy of the defendant; and eventually the litigation abates as product modifications break the link to risk (McGovern 1986; Galanter 1990; Sanders 1992; Hensler and Peterson 1993; Durkin and Felstiner 1994; Schmit 1994). Potential Public Health Benefits of Tobacco Litigation As applied to lawsuits against the tobacco indus- try, private litigation has the potential to do the following: e Enlist a new cadre of skilled, resourceful, and re- ientless advocates on the side of reducing tobacco use—-the incentive being the contingency fees plaintifts’ attorneys would receive if they won or settled cases against the industry. e Force the industry to raise prices dramatically to- cover their actual or anticipated liabilities. Studies suggest that such higher costs would lower tobacco- consumption—especially among children and- teenagers, who are more price-sensitive than adults (Daynard 1988; Hanson and Logue 1998). For ex- ample, after Philip Morris raised its wholesale ciga- rette prices by 10 percent in one year to cover legal settlements with four states, a Wall Street stock ana-- lyst estimated that these increases reduced overall consumption of [Philip Morris] cigarettes by nearly 3 percent (Hwang 1998). e Encourage the manufacture of safer (to the extent possible) products, which have lower liabil- ity risks. For instance, a noncarcinogenic nicotine delivery device, though retaining the health risks of nicotine, could create less liability both to indi- vidual users and to third-party health care payers. * Discontinue dishonest practices that increase the risk of liability, especially for punitive damages. Deterring such “intentional torts” is a main goal of the civil justice system. ¢ Delegitimize the industry politically by exposing patterns of unsavory practices. For example, many politicians discontinued taking tobacco company contributions in the late 1990s, largely because the discovery process in pending lawsuits revealed in- dustry misconduct (Abramson 1998). Loss of po- litical esteem or loyalty would ease the wav for effective tobacco control legislation. * Educate the public about the risks of tobacco use, since lawsuits attract extensive, free media coverage. * Compensate injured parties, including smokers, afflicted nonsmokers, their families, and the health care compensation system (Daynard 1988). The First Two Waves of Tobacco Litigation Starting in the 1950s, injured smokers tried to use the emergence of product liabilitv to secure remedies from the tobacco companies. During the first two waves of tobacco litigation, hundreds of lawsuits were filed against U.S. tobacco companies by individuals claiming tobacco-related injuries to health. (By one count, 808 cases were filed between 1954 and 1984 [Bernstein Research 1994].) Not one of the claims re- sulted in any plaintiff, or plaintiff's attorney, receiv- ing anv financial compensation. The First Wave The first wave of tobacco litigation was launched in 1954, inspired by the appearance in the early 1950s of scientific reports and popular magazine articles that indicated that smoking caused lung cancer. Although convinced that this new information would weigh in as evidence of culpability, the plaintiffs’ attorneys were overmatched. The tobacco companies presented a con- certed defense in every claim, no matter how small the damages sought, and through all stages of litiga- tion. From the earliest cases, the tobacco companies retained lawyers from the country’s most prestigious law firms and directed them to spare no expense in exhausting their adversaries’ resources before trial (Rabin 1993). Plaintiffs’ attornevs, typically operating from small practices under a contingent fee arrange- ment with chents who could not afford protracted liti- gation, found themselves both outnumbered and outspent on all fronts. Only a handful of the first-wave tobacco cases ever came to trial. Those that did found the courts Reducing Tobacco Use unwilling to impose strict liability on the tobacco in- dustry. Plaintiffs typically brought suit against tobacco companies under one or both of two theories: negli- gence and implied warranty. Under a theory of negli- gence, plaintiffs tried to show that the tobacco companies knew enough about the potential harm of tobacco products to induce them to “engage in [fur- ther] research... adopt warnings, or, at a minimum, refrain from advertising that suggested the absence of anv health concerns” (Rabin 1993, p. 114). However, because plaintiffs’ attorneys could offer no evidence at that time that the tobacco industry was aware of the potential harm of their products, this negligence theory met with failure. Most plaintiffs’ cases relied on the theory of im- plied warranty, which imputes strict liability even in the absence of negligence. The mere marketing of a product that was not of merchantable quality or rea- sonably fit for use would thus support legal recovery of damages (Rabin 1993). The plaintiff’s ability to rely on negligence or implied or express warranty was greatly constrained by two circumstances: since 1965, health warnings had been mandated on tobacco prod- ucts and on some advertising (see “Cigarette Warning Labels,” earlier in this chapter), and the tobacco in- dustry had avoided making direct claims that their products had positive health effects. Since early 1966, then, smokers could no longer argue (or at least not easily) that the tobacco companies had not warned them of the hazards posed in using their products (Schwartz 1993). The doctrine of implied warranty, in particular, thus seemed invalid to plaintiffs who were seeking damages from the tobacco industry. In general, the courts of that time were unrecep- tive to strict liability arguments. The courts regarded the manufacturer as “an insurer against foreseeable risks—but not against unknowable risks” (Lartigue v. R.J. Reynolds Tobacco Co., 317 F.2d 19, 37 [5th Cir. 1963], cert. dented, 375 U.S. 865 [1963]) or against “the harm- ful effects of which no developed human skill or fore- sight can afford” (p. 23). The American Law Institute, a prestigious and influential association of lawyers, judges, and academics, adopted this outlook in its 1973 commentary on section 402A of the Restatement (Sec- ond) of Torts, which deals with strict liability for de- fective products. The nonbinding yet authoritative influence of the restatement sounded “the death knell for the first wave of tobacco litigation” (Rabin 1993, p. 117; Givelber 1998). Regulatory Efforts 225 Surgeon General's Report The Second Wave A second wave of tobacco litigation began in 1983, inspired by the success that lawvers had recently achieved in suing asbestos companies: they had not only recovered substantial verdicts (and fees) but also effectively ended the production and use of asbestos in the United States. As was the case with the first wave of tobacco litigation, in the second wave the “Jawyers’ litigation strategies rather than their legal arguments . . . consti- tuted the first line of defense” (Rabin 1993, p. 121). The tobacco industry continued to successfully pursue the strategy it had developed during the first wave, tak- ing countless depositions and filing and arguing ev- ery motion it could, thus threatening to inflict heavy financial losses on any plaintiff’s attorney (Daynard 1994a,b). This strategy was summarized by J. Michael Jordan, an attorney who successfully defended RJ. Reynolds Tobacco Company in the 1980s, in an inter- nal memo to his colleagues: “[T]he aggressive pos- ture we have taken regarding depositions and discovery in general continues to make these cases ex- tremely burdensome and expensive for plaintiffs’ law- yers.... To paraphrase General Patton, the wav we won these cases was not by spending all of [RJR]’s money, but by making that other son of a bitch spend all of his” (Haines v. Liggett Group. Inc., 814 F. Supp. 414, 421 [D.N.J. 1993). To try to overcome the disparity of legal resources that had overwhelmed the first-wave cases, plaintiffs’ attorneys sometimes pooled resources on a case-bv- case basis. The Tobacco Products Liability Project, a nonprofit advocacy group established at Northeastern University in 1984 to encourage lawsuits against the tobacco industry as a public health strategy, served as a clearinghouse of relevant information for attorneys, potential plaintiffs, medical experts, and the media. It began holding annual conferences in 1985, at which participants share information about new legal tactics, as well as solve problems about emerging difficulties. Besides pooling resources and sharing strategies, plaintiffs’ attornevs needed to find an effective legal strategy. To find a new theory, plaintiffs’ counsel shifted their focus from implied or express warranty to strict liability, which became a more attractive strat- egy as courts applied strict liability and comparative fault principles to defective product cases concerning many other products (Edell 1987; Rabin 1993). Smok- ers’ awareness of risks and, accordingly, their “freedom of choice” (Rabin 1993, p. 122) became the linchpins of the tobacco industry's defense against these liability tactics. Though consistently denying the 226 = Chapter 3 reality of the risks, the tobacco industry paradoxically argued (with great success) that smokers had freely cho- sen to smoke and had thereby assumed what risks there might be of smoking and had negligently contributed to their own harm. To prove the plaintiff's assumption of risk, counsel for the tobacco industry generally needed to show that the injured smoker, knowing the dangers and risks involved in smoking, chose to smoke anyway. To prove contributory negligence, the tobacco defense typically showed that, by smoking, the injured smoker breached a personal duty to protect himself or herself from injury and thereby contributed to the harm suffered (Kelder and Daynard 1997). Just as it had aided the tobacco industry in ne- gating charges of negligence and warranty during the first wave of tobacco litigation, the Federal Cigarette Labeling and Advertising Act’s imposition of a warn- ing label on cigarette packaging and advertising greatly strengthened the industry's countercharge that plaintiffs had legally assumed their own health risk and were guilty of contributory negligence. As a re- sult, jurors were responsive to the industry’s defense. In essence, jurors tended to blame plaintiffs for their disease instead of identifying the tobacco industry as the makers of the product that caused the disease (Daynard 1994a,b). When counsel for plaintiffs pointed to the addictive nature of tobacco, which arguably lim- ited the smoker’s ability to make a free choice, defense counsel rebutted by pointing to the large number of former smokers who successfully quit (Rabin 1993). Taking the freedom-of-choice defense one step further, defense counsel typically drew on, and pre- sented to the jury, information demonstrating that the claimant's lifestyle was overly risky by choice or was even in some way immoral. By presenting this some- what extraneous material obtained through aggressive pretrial discovery, the defense “appearled] to have had considerable success in trying not just the plaintiff’s decision to smoke but his or her character more gen- erally” (Rabin 1993, p. 124). The resulting “full-dress morality play” seemed to have effectively negated any jury svmpathy for the plaintiff's plight (p. 124). The case that culminated and best symbolized the uphill battle of second-wave plaintiffs was filed by Rose Cipollone, a dying smoker, in 1983. The case reached the jury in 1988, four years after her death, and the jury awarded the plaintiffs $400,000. But this verdict, subsequently overturned on appeal, was only one moment in a protracted legal battle. As one analyst describes, in Cipollone v. Liggett Group Inc., “. . . over 100 motions were filed, and most of the motions were argued. There were also four interlocutory applications, one resulting in the grant of an appeal and the Third Circuit's initial decision on preemption, . . . an appeal from the final judgment to the Court of Appeals fol- lowing a trial of about four months, ... and two peti- tions for certiorari to the Supreme Court of the United States, one of which was granted resulting in the his- toric argument before that Court” (Kelder 1994, p. 4). After nearly a decade, Cipollone, the quintessen- tial second-wave case, was sent back to the trial court bv the United States Supreme Court. The Court ruled that although the Federal Cigarette Labeling and Ad- vertising Act of 1965 did not invalidate any claims in private litigation, its successor, the Public Health Ciga- rette Smoking Act of 1969, preempted anv claims based on the manufacturers’ failure to warn after 1969 in its advertising and promotions (Cipollone v. Liggett Group Inc., 505 U.S. 504, 112 S. Ct. 2608 [1992]), However, the Court left open to the plaintiff the option of proceed- ing under a wide range of legal theories, including theories of breach of express warranty, defective de- sign, fraudulent misrepresentation, and conspiracy to defraud. But the difficulties of mustering a sufficient showing that such violations by the defendants were the proximate cause of Mrs. Cipollone’s injuries (as well as the cause of her death in 1984) persuaded the plaintiff's counsel that there was little likelihood of a significant recoverv (Lowell 1992), In 1992, five months atter the Supreme Court ruling, the New Jersey fed- eral district court approved the request of the Cipollone estate’s lawyer to withdraw from the case. It had been a lengthy, expensive effort for the plaintiff’s counsel: $500,000 in out-of-pocket expenses and approximately $2 million in attorney and para- legal time (Kelder 1994). Posttrial proceedings cost an additional $150,000 in out-of-pocket expenses and $900,000 in attorney and paralegal time. Tinie maga- zine estimated that the cigarette industry spent at least $75 million defending the Cipollone case (Koepp 1988). Michael Pertschuk, co-director of the Advocacy Institute, a public interest group dedicated to reduc- ing tobacco use, has estimated that altogether tobacco companies were spending approximately $600 million per year defending the 50 or so cases pending against them (Stone 1994). Tobacco defendants’ reputation for relentless legal battle dissuaded many lawyers from entering the fray. Even formidable litigants such as the asbestos producers refrained from trying to em- broil the tobacco manufacturers as being jointly respon- sible for asbestos injuries (Rabin 1993). The Aftermath of the First Two Waves The collapse of the Cipollone case was widely viewed as signaling the end of the second wave of Reducing Tobacco Use tobacco litigation. Commentators advanced various explanations for the failure of tobacco litigation, in- cluding superior lawyering resources, coordination, and tactics (Rabin 1993), as well as popular resistance in the form of jury reluctance to award damages to smokers (Schwartz 1993). Many observers concluded that product liability litigation had a limited role to play in the regulation of tobacco. Rabin (1993) found that tobacco presents an instance of “the effective lim- its of tort law,” because “tort law and tort process seem to conspire against any effective role for the tobacco litigant” (p. 127). Schwartz (1993) concurred “that tort law does not have a major role to play in the develop- ment of public policy for smoking in the 1990s” (p. 132). At that juncture, tobacco litigation seemed to il- lustrate that the incidence and outcome of litigation are influenced by the identity, resources, and status of the parties and by the incentives and strategies of their lawvers. Striking differences have been noted between the large organization with a continuing interest in an area of legal controversy and the individual litigant who typically seeks a remedy only once (Galanter 1974). One-time litigants tend to be represented by lawvers who practice in smaller units that have less capacity for coordination and less capacity to invest strategically in litigation. The monetary stakes—and thus the incentives—are also lower for these smaller litigants than for their corporate opponents, who can extract full benefit from the information and experi- ence generated by litigation expenditures (Galanter 1974; Schwartz 1993). Nonetheless, at the end of the second wave of to- bacco litigation, it was argued that the tobacco indus- try was not untouchable and that its proud record of never, at that point, having paid a penny to its victims masked a high vulnerability to litigation (Daynard 1988, 1993a,b, 1994a,b; Daynard and Morin 1988). The industry’s “scorched earth” litigation tactics (Daynard 1994a) had indeed made suing tobacco companies pro- hibitively expensive for most plaintiffs and their attor- neys. Also, the industry’s firm and widely publicized policy of never settling cases further discouraged liti- gation, because plaintiffs’ attorneys, working on con- tingency fees, realized that they could not expect to be paid unless and until they had succeeded at trial and on subsequent appeals. Furthermore, the low volume of cases in the first and second waves allowed the in- dustry to concentrate its legal resources against the few plaintiffs’ attorneys who ventured forth against it. But a very different scenario was also possible. Although the low-volume litigation environment of the first and second waves favored the defendants, a high-volume environment might favor plaintiffs. As Regulatory Efforts 227 Surgeon General’s Report happened with asbestos litigation, courts facing the problem of clearing large numbers of tobacco cases oft their dockets would need to find ways to expedite them. Firm trial deadlines, case consolidations, and class actions would likely be favored; scorched earth defense tactics would no longer be permitted. Defen- dants would no longer be able to focus all their atten- tion and legal resources on defeating a few plaintiffs. Some cases thus might break through the industry’s defenses, and these victories would provide both prac- tical examples and moral support for plaintiffs’ attor- neys. Atsome point, the defendants might realize that their nonsettlement policy had ceased to discourage plaintiffs and would begin settling. At that point, the third wave of tobacco litigation—virtually a tidal wave—would have begun (Daynard 1994a). Givena pre-1994 legal environment characterized by a low volume of tobacco litigation, few lawyers could afford to ignore the highly unfavorable cost / benefit ratio that would likely meet any effort to bring a lawsuit against the tobacco industry. No single law- ver, however motivated, could hope to change this situ- ation through his or her own efforts. The transition from the low-volume to the high-volume scenario would require public events that signaled clearly to lawyers that the environment was changing (Daynard 1994a). Paradoxically, although the Cipollone case was widely viewed as emblematic of why plaintiffs’ attor- neys were well advised to avoid tobacco litigation, it was alsoa crucial forerunner for the events that would soon change the litigation environment. Specifically, the Supreme Court’s 1992 decision in the case— though of no avail to the resource-depleted plaintiffs’ attorneys—presented other plaintiffs’ attorneys with a range of potentially devastating legal theories. The trial itself had provided documentary evidence— which, as it turned out, represented the tip of the iceberg—that could be used to help establish the ele- ments of a plaintiff's claims against the cigarette manu- facturers (Daynard and Morin 1988; Daynard 1993a,b). Among the legal theories advanced in the first two waves that remained viable after Cipollone were (1) a theory that cigarettes were detective and unnec- essarily dangerous, because evidence discovered by plaintiffs’ attorneys and antismoking activists strongly suggested that the tobacco industry had known for many years how to make cigarettes that were less likelv to cause cancer; (2) a theory that cigarettes were defective, because they contained tobacco adulterated with many nontobacco carcinogenic substances; (3) a theory that cigarettes were defective, because of the dangers inherent to tobacco; (4) a theory of civil con- 228 Chapter 5 spiracy based on evidence that cigarette manufactur- ers had joined together beginning in the 1950s to plan and carry outa strategy for marketing cigarettes while concealing the harmful and addictive nature of this product in the face of the developing scientific evidence of their dangers; and (5) a “Good Samaritan” theory, whereby plaintiffs could argue that the tobacco com- panies, having pledged in 1954 to objectively investi- gate the possible dangers of smoking, were obliged to carry out their promise and take reasonable action on what they found (Daynard 1988). Potential support for some or all of these ap- proaches had surfaced during the tortuous process of the Cipollone case. Documents uncovered in the case provided evidence that the tobacco industry had fraudulently misrepresented the safety of their prod- uct and deliberately concealed knowledge about the harmful and addictive nature of cigarettes. The evi- dence suggested that the tobacco industry had con- spired to defraud the American public by pretending that it was conducting good-faith efforts to uncover the links between smoking and health and by falsely assuring the public that the results were negative or inconclusive (Daynard and Morin 1988). Some ana- lysts predicted that future fraud and conspiracy claims would be strengthened when the court documents from Haines were released to plaintiffs’ attorneys or when other documentary evidence of tobacco indus- try misdeeds was uncovered (Daynard 1993a,b). In the additional trove of documents reviewed by Judge H. Lee Sarokin in Haines—many of them relating to the Council for Tobacco Research's “special projects” division—was information that might support a find- ing that “the industry research which might indict smoking as a cause of illness was diverted to secret research projects and that the publicized efforts were primarily directed at finding causes other than smok- ing for the illnesses being attributed to it” (Haines v. Liggett Group, Inc., Civil No. 84-678 [HLS] [D.N J. 1992], cited in 7.1 TPLR 2.1 {1992]). Calling the tobacco in- dustry “the king of concealment and disinformation” (Haines v. Liggett Group Inc., 975 F.2d 81, 88 [3d Cir. 1992])—a remark that led an appellate court to dis- qualify Judge Sarokin from further consideration of the case on the grounds that he failed to appear im- partial (p. 98)—Judge Sarokin concluded that the docu- ments he had reviewed were not protected by the attorney-client privilege, as the industry had claimed, because the industry’s attorneys had been participating in an ongoing fraud, and the documents were therefore discoverable under the well-recognized crime/fraud exception (Haines, cited 7.1 TPLR 2.1). The same court that disqualified Judge Sarokin from further consideration of the case also agreed that the evidence cited by him would support his conclusion that the crime/fraud exception would apply (Haines, 975 F.2d 81). The Third Wave of Tobacco Litigation The third wave of tobacco litigation was sparked by two key events. On February 25, 1994, FDA Com- missioner David Kessler, relying primarily on a docu- ment discovered in the Cipollone case, sent a letter to the CSH reporting that the FDA had received “mount- ing evidence” that “the nicotine ingredient in cigarettes is a powerfully addictive agent” and that “cigarette vendors control the levels of nicotine that satisfy this addiction” (Kessler 1994a). The letter made front-page news. The second event occurred three days later, when an ABC television Day One report alleged that tobacco companies manipulated the nicotine levels in cigarettes (Daynard 1994b). A series of journalistic and congressional inves- tigations ensued in the spring of 1994, and internal Brown & Williamson Tobacco Corporation documents were leaked to the press. These documents indicated that the company had studied nicotine for vears, that its internal stance on several issues related to smoking and health differed from what it was telling the public, that it possessed findings regarding the addictiveness of nicotine and the health dangers of smoking and ETS that had been withheld, and that Brown & Williamson attorneys were involved in the management of the research projects (Hanauer et al. 1995). When on April 14, 1994, the chief executive officers of the seven leading U.S. tobacco comp- anies testified under oath before a congressional subcommittee—and a large television news audience— that they did not believe that nicotine was addictive, the industry’s public credibility plummeted. Suddenly the industry appeared to millions of people, includ- ing plaintiffs’ attorneys, as dishonest, disreputable, and legally vulnerable (Daynard 1994a; Seattle Post- Intelligencer 1994; see “Nature, Extent, and Focus of the Criminal Investigation,” later in this chapter). Further revelations about the tobacco industry's knowledge of the harmfulness of smoking and the addictiveness of nicotine, as well as about the industry’s misbehavior, subsequently surfaced in sev- eral forms: * Philip Morris documents indicated that the company’s researchers studied and wrote about the pharmacologic effects of nicotine on smokers (Hilts and Collins 1995). Reducing Tobacce Use Documents obtained from Brown & Williamson and its parent, British-American Tobacco Company, were analyzed (Hanauer et al. 1995). Investigative journalists obtained documents from R.J. Reynolds Tobacco Company (Levy 1995). In November 1995, Dr. Jeffrey Wigand, Brown & Williamson’s former vice president for research, tes- tified under deposition (Tobacco Products Litigation Reporter 1995c). Sworn statements were given to the FDA (first made public on March 18, 1996) in which three former Philip Morris emplovees (Ian L. Uydess, Ph.D., a former associate senior scientist; Jerome Rivers, a shift manager at a cigarette manufactur- ing plant in Richmond, Virginia; and William A. Farone, Ph.D., the director of applied research at Philip Morris’ tobacco unit) stated that Philip Mor- ris not only believes it is in the nicotine delivery business but also controls nicotine levels in its brands (Tebacco Products Litigation Reporter 1996a,b,c). The FDA analyzed both the public evidence and the additional evidence that its investigators gath- ered about the tobacco industry’s past and present knowledge of, and behavior toward, the addictive quality of the nicotine in its products (Federal Reg- ister 1995p). On March 20, 1997, Liggett Group Inc., the smallest domestic cigarette manufacturer, admitted that nico- tine was addictive and that the industry had tar- geted minors. Liggett turned over incriminating industry documents to the attorneys general and class action attorneys whose cases the company had agreed to settle (Attorneys General Settlement Agree- ment, cited 117 12.1 TPLR 3.1 [1997]). Beginning in 1997, first hundreds, then thousands, and finally millions of industry documents began to surface after being uncovered through the discovery process in litigation by the Minnesota attorney gen- eral and Blue Cross and Blue Shield. These docu- ments began appearing on Internet Web sites of the Commerce Committee of the U.S. House of Repre- sentatives (http://www.house.gov/commerce), Minnesota Blue Cross and Blue Shield (http:// www.mnbluecrosstobacco.com), and the Minnesota District Court (http://www.courts.state.mn.us/ district). The analysis of these documents has only begun, but they appear to support a wide range of legal claims against the industry. ho i) LO Regulatory Efforts Surgeon General’s Report This third wave of tobacco litigation is more di- verse than its predecessors, in part because of the new wealth of factual information available to plaintiffs’ attorneys. The series of revelations described above has generated a new set of allegations. For example, the industry has consistently claimed that nicotine is not pharmacologically active, that it is not addictive, and that anyone who smokes makes a free choice to do so. But as was made clear by the FDA's 1995 State- ment of Jurisdiction over cigarettes as drug-delivery devices; the documents of Philip Morris Companies Inc., Brown & Williamson-British-American Tobacco Company, and R.J. Reynolds Tobacco Company relat- ing to nicotine; and the information being provided by whistle-blowers such as Jeffrey Wigand and lan Lydess, the industry was well aware of the pharma- cologically active, addictive, and harmful nature of its products and was not forthright with its customers, the public, and public authorities about these facts. There is also evidence that the industry understood its consumers’ need for adequate nicotine to sustain their addictions and that the industry designed its products accordingly. The tobacco industry also has claimed that there is no definitive proof that smoking causes dis- eases such as cancer and heart disease. Yet the discov- ered company documents show that by the 1960s various tobacco companies had proved in their own laboratories that cigarette tar causes cancer in labora- tory animals (Daynard and Morin 1988; Hanauer et al. 1995). Finally, the industry has claimed that it is committed to determining the scientific truth about the health effects of tobacco by conducting internal inves- tigations and by funding external research. However, the Brown & Williamson-British-American Tobacco Company documents indicate that rather than con- ducting objective scientific research, Brown & Williamson attorneys have been involved in selecting and disseminating information from internal as well as external scientific projects for decades. An example of the latter is the industry’s misrepresenting the work of the Council for Tobacco Research as objective scien- tific research on smoking and health. All research find- ings from this council are sent through the industry’s attorneys, thereby gaining the protection of attorney- client privilege and potentially enabling the industry to choose which findings it will release and how it will present those findings to the public. The potential for this practice was suggested when certain Brown & Williamson-British-American Tobacco Company documents were found to include directions for dis- posing of damaging documents held by the company’s research department (Hanauer et al. 1995). This 230 9 Chapter 5 conduct by the industry arguably misled the public and caused them to buy tobacco products; it also de- flates the free choice argument the tobacco industry has used to deter further government regulation of its products and to defend itself in products liability law- suits (Hanauer et al. 1995). The information outlined above has generated a host of claims put forward by plaintiffs in the third wave of tobacco litigation. Some of these are similar to claims raised in the first two waves but have a much fuller factual support. These common-law (judge-created) legal theories include fraud, fraudulent concealment, and negligent misrepresentation; negligence; negligent performance of a voluntary undertaking; breach of express and implied warranties; strict liability; and conspiracy. Other, statutory (statute-created) claims new to tobacco litigation include violation of consumer protection statutes, antitrust claims, unjust enrichment/ indemnity, and civil violations that invoke prosecu- tion under the federal Racketeer Influenced and Cor- rupt Organizations Act (Kelder and Daynard 1997). Common-Law Claims An illustrative use of currently available evidence to support a common-law legal theory of fraudulent misrepresentation is Count Five of the complaint filed in April 1998 by 21 Blue Cross and Blue Shield plans against the tobacco industry (Blue Cross and Blue Shield of New Jersey v. Philip Morris [E.D.N.Y. Apr. 29, 1998], cited in 13.2 TPLR 3.51 [1998]). Among the allegations listed in Count Five are the following (Blue Cross and Blue Shield, p. 3.95): 301. Defendants represented and promised to those who advance and protect the public health and provide or pay for health care and health care services that they would discover and disclose all material facts about the effects of cigarette smok- ing and other tobacco product use on human health, including addiction. 302. Defendants have made and continue to make representations, statements and promises about the safety of cigarettes, other tobacco products and nicotine in general and their effect on human health and addiction. Such representations, state- ments and promises were and remain materially false, incomplete and fraudulent at the time Defendants made them, and Defendants knew or had and continue to have reason to know of their falsity. Only Defendant Liggett has recently con- ceded that the nicotine in cigarettes is addictive; Liggett made this admission for the first time only in March 1997, 303. In testimony before Congress in January 1998, executives of other Tobacco Companies tried to have it both ways concerning the question of ad- diction. They stated that they personally did not think nicotine was addictive, but conceded that under some definitions, it would be considered addictive. 304. In view of the documentary record establish- ing that the Tobacco Companies have known for years with certainty that nicotine is addictive, such testimony is dishonest and part of an on-going attempt to disseminate false and misleading information. 305. At all relevant times Defendants intention- ally, willfully or recklessly misrepresented mate- rial facts about the human health hazards of tobacco use, including addiction, and the associa- tion of cigarette smoking and other tobacco prod- uct use with various diseases of the heart, lung and other vital organs. 306. Because of Defendants’ secret internal re- search, Defendants’ knowledge of the material facts about tobacco use, health and addiction was and is superior to the knowledge of the BC/BS [Blue Cross and Blue Shield] Plans’ members who purchased, used and consumed the Tobacco Com- panies’ cigarettes and other nicotine tobacco prod- ucts. Defendants’ knowledge of the material facts about tobacco use, health and addiction was and is also superior to that of the BC/BS Plans, which undertook to provide health care financing for their members. Public access to these facts is limited because such facts are exclusively within Defendants’ control. 313. The BC/BS Plans reasonably and justifiably relied on Defendants’ materially false, incomplete and misleading representations about tobacco use, health and addiction. As a result of such reliance, the BC/BS Plans did not take, or would have taken sooner, actions to minimize the losses resulting from tobacco-related injuries and diseases and to discourage and reduce cigarette and other nicotine product use and the costs associated therewith by the BC/BS Plans’ members. Reducing Tobacco Use 314. Asa direct, foreseeable and proximate result of the foregoing conduct of Defendants, the BC/ BS Plans have suffered damages through payments for the costs of medical care due to smoking. 315. As direct and proximate result of Defendants’ fraudulent misrepresentations and nondisclosures, the BC/BS Plans have suffered and will continue to suffer substantial injuries and damages for which the BC/BS Plans are entitled to recovery, and for which Defendants are jointly and sever- ally liable. Statutory Claims The newer claims include a variety of theories based on federal and state statutes. As with the common-law claims, these statute-based actions are illustrated in the April 1998 complaint that 21 Blue Cross and Blue Shield plans filed against the tobacco industry. Consumer Protection Consumer protection claims are based on state statutes, which vary somewhat from state to state but generally forbid unfair methods of competition and unfair or deceptive acts or practices in commerce. A typical set of consumer protection allegations is that of Blue Cross and Blue Shield of Florida (Blue Cross and Blue Shield, p. 3.102). It makes the following allegations: 378. In the conduct of trade or commerce, De- fendants have engaged and do engage in unfair methods of competition, unconscionable acts or practices and unfair or deceptive acts or practices including but not limited to the following: a. Intentionally, willfully and knowingly seeking to addict persons, including BC/BS Florida members and their children, to the use of haz- ardous cigarettes and other nicotine tobacco products, knowing that such addiction physi- cally changes and damages smokers’ brain structures and creates and constitutes a sub- stantial unfair impediment or interference in the smokers’ ability to choose whether to con- tinue smoking, making the transaction no longer an arm’s length one between an equally willing buyer and seller, which is similar to many other deceptive and/or unfair devices Regulatory Efforts 237 Surgeon General's Report 232 and practices that affect bargaining power or relative information, b. Targeting people with deceptive advertising by misrepresenting the characteristics, ingre- dients, uses or benefits of Defendants’ tobacco products; and c. Engaging for decades in a wide variety of mis- representations and fraudulent concealment of material facts, directly or by implication, in- cluding but not limited to: (1) misrepresenta- tions and fraudulent concealment of the addictive nature of nicotine and of the adverse health consequences of nicotine tobacco prod- ucts; (2) misrepresentations and fraudulent concealment about Defendants’ ability to ma- nipulate and their practice of manipulating nicotine levels and the addictive qualities of nicotine tobacco products; (3) misrepresenta- tions that the Defendants would provide the public and governmental authorities with ob- jective, scientific information regarding ciga- rettes and other tobacco products; (4) fraudulent concealment of certain aspects of cigarettes and other tobacco products, includ- ing the availability of safer, less-addictive products asa substitute to cigarettes and other tobacco products; (5) causing, a likelihood ot confusion about the source, sponsorship, ap- proval or certification of cigarettes and other tobacco products; (6) misrepresenting that nicotine tobacco products have sponsorship, approval, characteristics, ingredients or ben- efits that they do not have and that Detendants knew that they did not have; (7) misrepresent- ing that cigarettes and other tobacco products were of a particular quality or grade, when Defendants knew that they were not; (8) en- gaging in unconscionable trade practices, (9) fraudulently promoting filter and low-tar cigarettes as safer; (10) fraudulently manipu- lating scientific research into the health haz- ards of smoking; and (11) fraudulently creating their “research councils” and using them to spread false information about their products and to promote false information that ciga- rettes or other tobacco products were safe or that adverse health effects had not been established. 379. The conduct described above and through- out this Complaint constitutes deceptive and Chapter 5 unfair methods of competition, unconscionable acts or practices and unfair or deceptive acts or practices all impacting the public interest, in vio- lation of Fla. Stat. § [section] 501.204. 380. Asa direct and proximate result of such wrongful activity, BC/BS Florida has suffered losses and will continue to suffer substantial losses and injuries to its business or property, including but not limited to its being required to pay and paying the costs of medical care for disease, ill- ness, addiction and adverse health consequences caused by cigarettes and other tobacco products. Antitrust The federal government and most states have antitrust laws. These are designed to prevent busi- nesses in the same industry from cooperating in ways that deprive consumers or other entities of benefits they would otherwise receive from a competitive marketplace. Count Three of the complaint by the 21 Blue Cross and Blue Shield plans explains how antitrust theory applies in a tobacco case (Blue Cross and Blue Shield, p. 3.93): 281. Since the early 1950s, and continuing until the present date, the Defendant Tobacco Compa- nies, aided and abetted by the other Defendants herein, have violated Section 1 of the Sherman Act, 15 U.S.C. § 1, by entering into, adhering to and continuing to observe the terms of a combination or conspiracy in unreasonable restraint of trade and commerce in the market for cigarettes in the United States. Such illegal concerted action has eliminated commercial competition that would have existed but for the conspiracy. Specifically, Defendants have conspired: (1) to suppress inno- vation and competition in product quality by agreeing not to engage in research, develop- ment, manufacture and marketing of less harmful cigarettes and other nicotine products; (2) to sup- press output in a market, and to engage in con- certed refusal to deal, by agreeing to keep at zero the output of less harmful cigarettes and other nicotine products; and (3) to suppress competition in marketing by agreeing not to take business from one another by making claims as to the relative safety of particular brands, whether or not such claims would have been truthful. But for the conspiracy, competition in the market for cigarettes in the United States would have been far more vigorous, and consumers and others would have reaped enormous benefits. 282. But for the conspiracy, one or more of the Tobacco Companies would have developed a com- mercially successful, less harmful cigarette; such a cigarette would have garnered a substantial share of the cigarette market; and those who used that product rather than conventional cigarettes would have had significantly fewer health problems. As a consequence of the above, the BC/BS Plans would have incurred substantially lower costs. 283. Arelevant market in which Defendants’ vio- lations occurred is the manufacture and sale of cigarettes and other nicotine products in the United States. Because, inter alia, such products are physically addictive, they are not reasonably interchangeable with other consumer products, nor are they characterized by cross-elasticity of price with other consumer products. Within this broad relevant market there would have existed, but for Defendants’ conspiracy, a relevant submarket for the manufacture and sale in the United States of less harmful cigarettes and other nicotine products which would still have delivered nicotine but which would have had materially less deleterious health effects than the products actu- ally manufactured and solid by Defendants. Such products would have proven attractive to many smokers, who would have chosen to buv them if they had been available. 284. Because Defendants have conspired to sup- press output of less harmful cigarettes and other nicotine products, and to refuse to deal in such products, their conduct is unreasonable per se under the Section 1 of the Sherman Act. There is, moreover, no colorable justification for the con- certed action alleged herein, which is unrelated to any lawful business transaction, does not promote efficiency, does not advance the interests of con- sumers and does not promote interbrand or intrabrand competition. 285. Antitrust law protects competition over in- novation and product quality just as it protects price competition. Defendants willfully violated antitrust law by agreeing to suppress competition related to the safety of their products. It was clearly foreseeable that this antitrust violation would injure smokers’ health, and it was just as foresee- able that the violation would, at the same time, Reducing Tobacco Use cause those financially responsible for smokers’ health care to suffer an injury in their business or property, by paying increased costs and expenses for health care services and products, These two kinds of injury are inextricably intertwined. Each flows directly from the anticompetitive effects of the illegal conduct. The harm suffered by the BC/ BS Plans is the precise type of harm that a con- spiracy to suppress competition related to prod- uct safety would be likely to cause. Accordingly, this harm reflects the anticompetitive effects of the violation. Antitrust violations permit the injured party to receive treble damages as well as attorneys’ fees. Federal Racketeer Influenced and Corrupt Organizations (RICO) Act The federal government and some states have statutes designed to control or eradicate “racketeer influenced and corrupt organizations.” “Racketeer- ing” is defined as a pattern of violations of specified criminal statutes (“predicate acts”) (18 U.S.C. section 1961{1]). Among these statutes are those criminalizing mail and wire fraud (18 U.S.C. sections 1341, 1343). The evidence put forth that the industry committed these predicate acts is similar to the evidence that it committed common-law fraud (Blue Cross and Blue Shield, p. 3.88, para. 260[a]): The Defendants engaged in schemes to defraud members of the public, including the BC/BS Plans and their members, regarding the health conse- quences associated with using nicotine tobacco products. Those schemes have involved suppres- sion of information regarding the health conse- quences associated with smoking, as well as fraudulent misrepresentations and omissions rea- sonably calculated to deceive persons of ordinary prudence and comprehension. Defendants’ mis- representations and fraudulent concealment of material facts, directly or by implication, include but are not limited to the following: misrepresen- tations and fraudulent concealment of the addic- tive nature of nicotine and the adverse health consequences of tobacco products; misrepresen- tations that such health effects of addictiveness were unknown or unproven; misrepresentations about Defendants’ ability to manipulate and about the manipulation of nicotine levels and the addic- tive qualities of cigarettes; misrepresentations that Regulatory Efforts 233 Surgeon General's Report they would provide the public and governmental authorities with objective, scientific information regarding all phases of smoking and health; and fraudulent concealment of certain aspects of smok- ing and health, including the availability of safer cigarettes and less addictive cigarettes. Defendants executed or attempted to execute such schemes through the use of the United States mails and through transmissions by wire, radio and televi- sion communications in interstate commerce. The federal RICO Act makes it unlawful to receive in- come derived, directly or indirectly, from a pattern of racketeering activity or to participate, directly or indi- rectly, in the conduct of an enterprise’s affairs through a pattern of racketeering activity. The relevance of the RICO Act to tobacco litigation was also delineated in the Blue Cross and Blue Shield plans’ complaint (Blue Cross and Blue Shield, p. 3.92): 234 271. At all relevant times, the Tobacco Institute, CTR (formerly TIRC) and STRC [the Smokeless To- bacco Research Council] have constituted an en- terprise within the meaning of 18 U.S.C. § 1961(4) or, in the alternative, each Defendant has consti- tuted an enterprise within the meaning of 18 U.S.C. § 1961(4). Each enterprise is an ongoing organiza- tion. Each enterprise and its activities affect inter- state commerce in that the enterprise is engaged in the business of maximizing the sales of ciga- rettes and other nicotine products. 272. As alleged above, Defendants have engaged in a pattern of racketeering activity that dates from 1953 through the present and threatens to continue into the future. These racketeering acts generated income for Defendants because they contributed to: the suppression and concealment of scientific and medical information regarding the health et- fects of nicotine products; the suppression of a market for alternative safer or less addictive to- bacco products; the manipulation of nicotine to create and sustain addiction to Defendants’ prod- ucts; the targeting of teenagers and children and minorities with marketing and advertising designed to addict them, all to protect and ensure continued sales of Defendants’ unsafe and addic- tive tobacco products; and the avoidance and shift- ing of smoking related health care costs to others including the BC/BS Plans by the methods stated above, including illicit litigation tactics such as unfounded claims of attorney-client privilege and other means. Chapter 5 273. Defendants have used or invested their illicit proceeds, generated through the pattern of rack- eteering activity, directly or indirectly in the ac- quisition of an interest in, or in the establishment or operation of each enterprise, in violation of 18 U.S.C. § 1962(a). Defendants’ use and investment of these illicit proceeds in each enterprise is for the specific purpose and has the effect of control- ling the material information distributed to the public concerning the health effects of smoking; suppressing and concealing scientific and medi- cal information regarding the adverse health ef- fects of smoking and the alternatives of safer or less-addictive cigarettes; devising means for ma- nipulating nicotine to create and sustain addiction to Defendants’ products; directing marketing and advertising toward minorities, teenagers and chil- dren to addict them; and enticing more individu- als to smoke or to use Defendants’ unsafe nicotine tobacco products. 274. Each Defendant also conspired to violate 18 - U.S.C. § 1962(a), in violation of 18 U.S.C. § 1962(d). As detailed above, the conspiracy began in 1953, continues to the present and threatens to continue into the future. The object of the conspiracy was and is to protect the Tobacco Companies’ business operations by investing their illicit proceeds, gen- - erated through a pattern of racketeering activity, in each enterprise. Each Defendant agreed to join the conspiracy, agreed to invest racketeering- generated proceeds in each enterprise in order to - continue enterprise operations and agreed to the commission of and knowingly participated in at least two predicate acts within ten years of each other. Each Defendant knew that those predicate acts were part of racketeering activity that would further the conspiracy. 275. Defendants’ violations of 18 U.S.C. §§ 1962 (a) - and (d) have proximately caused direct injury to the business and property of the BC/BS Plans because the BC/BS Plans have been required to incur significant, concrete financial costs and ex- penses attributable to tobacco-related diseases; have been unable to participate in a market for alterna- tive less harmful or less addictive nicotine prod- ucts, or to advise, suggest, promote, subsidize or require their members to use alternative products such as safer or less addictive tobacco products or other nicotine delivery devices; and have not been as effective as they would otherwise have been in helping their members not to use hazardous tobacco ° products. In absence of the Defendants’ violation of 18 U.S.C. 8§ 1962 (a) and (d), these costs and ex- penses would have been substantially reduced. Finally, the RICO Act provides a civil remedy for enti- ties that have been financially injured as a result of RICO violations (18 U.S.C. section 1964[c]). As with the antitrust laws, the remedy includes treble damages and the recovery of attorneys’ fees. Taken together, the allegations in the case brought by the 21 Blue Cross and Blue Shield plans provide an important summary of the legal approaches that are now available to plaintiffs but were not available to earlier third-wave cases. Individual Third-Wave Cases Some third-wave cases involve only minor modi- fications of standard second-wave product liability claims by individual smokers against cigarette mak- ers. In September 1995, one such case achieved the distinction of being the first clear plaintiff's victory after Cipollone. A state court jury awarded $2 million, including $700,000 in punitive damages, to a smoker who had developed mesothelioma (a cancer associated with asbestos exposure) after smoking asbestos-filtered Kent cigarettes in the 1950s. The defendant had won four of these filter cases since 1991. While awaiting appeals, observers speculated whether the result sig- nified a change in public perceptions (Hwang 1995a; MacLachlan 1995c). Ultimately, the jury’s awards of both compensatory and punitive damages were up- held on appeal (Horowitz v. Lorillard Tobacco Co., No. 965-245 [Super. Ct. San Francisco Cty. 1995], cert. de- nied, 118 S. Ct. 1797 [1998]). In what is perhaps the most important damage recovery case to date (Tebacco Products Litigation Re- porter 1996d), on August 9, 1996, a jury in Jacksonville, Florida, awarded $750,000 to Grady Carter, a former air traffic controller who smoked from age 17 in 1947 until cancer was diagnosed in 1991. Grady and his wife, Mildred, sued Brown & Williamson Tobacco Corporation on the grounds of negligence and strict liability. The jury found that the Lucky Strike ciga- rettes that were manufactured by the defendant were “unreasonably dangerous and defective” (Tobacco Products Litigation Reporter 1996d, p. 1.114). Of special significance was that the plaintiff’s attorney did not have to undergo the burdensome discovery process that industry attorneys had used successfully in the past. The means of avoiding this process was a spe- cial court order issued to ease the management of the large number of tobacco liability cases filed in that Reducing Tobacco Use jurisdiction (11 re Cigarette Cases [Fla., Duval Cty. Jan. 23, 1996], cited in 11.1 TPLR 2.3 [1996]; Ward 1996). Doubt was cast on the impact of the case, however, when a Florida appellate court overturned the jury’s findings on the basis that the plaintiff had failed to file his claim within Florida’s four-year statute of limita- tions (Brown & Williamson Corp. v. Carter, No. 96-4831, 1998 Fla. App. LEXIS 7477 [Fla. Dist. Ct. App. June 22, 1998]). In an individual damage recovery action similar to Carter and brought by Norwood Wilner (the same plaintiff attorney who had successfully argued the Carter case), a jury found Brown & Williamson Tobacco Corporation liable for the wrongful death of smoker Roland Maddox and awarded his family just over $1 million in compensatory and punitive damages (Widdick/Maddox v. Brown & Williamson Tobacco Corp., No. 97-03522-CA, Div. CV-H [Fla. 4th Cir. Jacksonville 1998]). Attorney Wilner has taken two other tobacco cases to trial that have resulted in jury verdicts for the defense, and it is estimated that he had 150 additional cases pending as of July 1998 (Connor v. RJ. Reynolds Tobacco Co., No. 95-01820-CA, Div. CV-H [Fla. Cir. Duval Cty. May 5, 1997]; Karbiwityk v. R.J. Reynolds To- bacco Co., No. 95-04697-CA, Div. CV-H [Fla. Cir. Duval Cty. Oct. 31, 1997]; Economist 1998). The growth of individual tobacco litigation dur- ing the third wave has been exponential. For example, R.J. Revnolds Tobacco Company reported in July 1995 that 68 cases of all sorts were pending against it; the number had risen to 203 cases in July 1996 and to 448 cases as of August 7, 1997 (Daynard 1997). Aggregation Devices The third wave got much of its impetus from the use of procedural devices and legal theories that ag- gregated claims. Aggregation raised the potential value of each case for plaintiffs’ attorneys, increasing their willingness to invest large amounts of money and time in pursuing them. This process denied the in- dustry the ability to discourage such cases by escalat- ing litigation costs, a strategy that had served it well during the previous two waves of tobacco litigation (see “The Aftermath of the First Two Waves,” earlier in this chapter). The most important of these aggrega- tion devices have been class actions and third-party payer reimbursement actions. Class Actions The class action device figures prominently in the third wave of tobacco litigation. This set of procedures Regulatory Efforts 235 Surgeon General's Report enables a group of persons suffering from a common injury to bring a suit to secure a definitive judicial rem- edy for that injury on behalt of all members of the group. Class action procedures have two principal forms—one for cases that seek a single remedy for the common benefit of a category of plaintiffs (Federal Rules of Civil Procedure, Rule 23[b][1]), and a some- what more complicated one known as (Rule 23[b]{3] procedures) for cases that seek the resolution of a large number of individual claims that share common fac- tual or legal issues (Federal Rules of Civil Procedure, Rule 23[b][3)). Tobacco class actions have, in the main, raised two types of issues. One type, exemplified by the claims in the Castano case (Castano v, American Tobacco Co., No. 94-1044 [E.D. La. Feb. 17, 1995], cifed m1 10.1 TPLR 2.1 [1995], rev'd 84 F.3d 734 [5th Cir. 1996]) and its progeny, seeks recovery for the cost of treating ad- dicted smokers for their addictions and for monitor- ing their medical condition for signs of impending disease. It does not, however, seek recovery for the cost of treating tobacco-caused diseases, nor for the other costs (tangible or intangible) to smokers and their families that flow from tobacco-caused disease. The other type of issue, exemplified by the claims in the Engle case (Engle v. R.J. Reynolds Tebacce Ca., No. 94- 08273 CA [20] [Fla., Dade Ctv. Oct. 31, 1994], cited in 9.5 TPLR 2.147 [1994], aff'd 672 So. 2d 39 [1996]), seeks damages for the full range of costs that flow from tobacco-caused diseases. The Castano case involves a much larger number of plaintiffs than Evigle, but each plaintiff seeks a much smaller recovery. To date, both Castano- and Engle-type claims have been brought under the more complex Rule 23(b)(3) class action procedures designed for the resolution of individual claims that share common legal or factual issues. Courts have generally been reluctant to allow these procedures for Castano-type claims, with the courts particularly concerned about the individualized proceedings on behalf of millions of addicted smok- ers, each making relatively smail claims, that would follow from a favorable resolution of the common is- sues (Castano v. American Tobacco Co., 84 F.3d 734 [5th Cir. 1996]; Small v. Lorillard Tobacco Co., 1998 WL 398176 [N.Y.A.D. 1 Dept. July 16, 1998]; Barnes v. American Tobacco Co., No. 96-5903 [E.D. Pa. Aug. 22, 1997], va- cated 176 ER.D. 479 [1997], cited in 12.4 TPLR 2.227 [1997]). The possibility of using the simpler class ac- tion procedure for Castano-type claims, which would seek a single judicial order setting up an insurance- type fund that claimants could draw on as thev used addiction-related medical or pharmaceutical services, has not been fully explored. By contrast, courts have 236 Chapter 5 been more willing to permit Rule 23(b)(3)-type proce- dures for Engle-type claims, where class action proce- dures promise to simplify the trials of a smaller (but still very large) number of serious individual claims (Engle, 672 So. 2d 39; Broin v. Philip Morris Cos., No. 92- 1405 [Fla., Dade Cty. Mar. 15, 1994], cited in 9.1 TPLR 2.1 [1994]; Richardson v. Philip Morris, Inc., No. 96145050 /CE212596 [Md. Cir. Ct. Baltimore City Jan. 28, 1998]). For a class action of either type to be certified, four technical requirements must be met. First, the members of the proposed plaintiff class must be so numerous that joining each plaintiff to the suit would be impractical. Second, the claims of each member of the class must turn on some questions of law or fact that are common to all the members of the class. Third, claims of the class representatives must not be antago- nistic to those of the other members of the class. Fourth, the representative plaintiffs and their attorneys must be able to fairly and adequately represent the interests of the entire class (Federal Rules of Civil Pro- cedure, Rule 23[a]). Where members of the class have conflicting interests, the class may be divided into sub- classes represented by different attorneys (Federal Rules of Civil Procedure, Rule 23[c][4][A]). Besides meeting these four requirements, a Rule 23(b)(3) class action needs to surmount two other sig- nificant hurdles. First, the court must determine that the action is “manageable,” meaning that a reasonable plan for trying the entire case, including the individual claims, can be devised. Second, the common issues must “predominate” over the individual issues, leav- ing the court to make the judgment whether the ben- efits likely to be obtained from trying the case as a class action outweigh the difficulties likely to be encoun- tered in doing so (Federal Rules of Civil Procedures, Rule 23{b]{3). Once a Rule 23(b)(3) class is certified, the class representatives must undertake the onerous and ex- pensive process of notifying each member of the class. This is necessary because Rule 23(b)(3) class members have the significant right to opt out of the class and pursue their claims individually. The class action device solves the problem 0} aggregation, reduces the imbalance of resources ofter found between the parties, achieves economies of scale and avoids duplicative litigation. The great advan. tage of the class actions being pursued in the thire wave of tobacco litigation is that resources art expended on behalf of thousands or millions of clas: members rather than on behalf of a single individua (Kelder and Daynard 1997). This advantage provide: more of a level playing field and means that th tobacco companies will not be able to successfully pur- sue their usual first- and second-wave strategy of forc- ing opponents to spend exorbitant sums of monev unti], nearly bankrupted, they are forced to withdraw (Kelder and Daynard 1997). In its unanimous deci- sion, the appellate court in Broii, after considering and rejecting defense objections to the plaintiffs’ request for class certification, alluded to the great promise that the class action strategy holds for plaintiffs challeng- ing the tobacco industry: “... if we were to construc the rule to require each person to file a separate law- suit, the result would be overwhelming and financially prohibitive. Although defendants would not lack the financial resources to defend each separate lawsuit, the vast majority of class members, in less advantageous financial positions, would be deprived of a remedy. We decline to promote such a result” (Brom, cited in 9.1 TPLR 2.4). But with these benefits come new problems. Only common issues can be dealt with in a class pro- ceeding, thus leaving individualized features to be dealt with in separate trials. As noted, some or many potential class members may choose to opt out of the class to pursue individual cases, thereby reducing the advantage of eliminating duplicative litigation. If some class members are more severely injured than others, intractable conflict may arise over distributing the proceeds (Coffee 1986, 1987). If the injury is con- tinuing outside the class, as it is in the case of tobacco use, there is the problem of providing for future plain- titfs (Hensler and Peterson 1993). These problems are overlaid and compounded by issues involving the le- gal agents representing the plaintiffs. Class actions are organized and managed by entrepreneurial law- vers, and their interests and those of the client class may diverge (Coffee 1986). Finally, there is the dan- ver that the class action device elevates the stakes so high that defendants and plaintiffs settle without reso- lution of other (nonmonetary) merits of the claim. Just which of these problems are sufficiently salient to dis- courage use of the class action device in the several varieties of tobacco cases is still an issue. Castano v. American Tobacco Co., filed March 29, 1994, in federal court in New Orleans (MacLachlan 1994-95), was an unparalleled attempt by a coalition of traditional plaintiffs’ lawyers, mass disaster lawyers, and class action specialists from around the country to diminish the organizational advantages enjoyed by the tobacco industry during the first two waves of tobacco litigation. Each of a coalition of 62 law firms pledged 2100,000 annually to fund a massive class action suit, en behalf of millions of nicotine-dependent smokers, charging the tobacco industry with promoting Reducing Tobacco Use addiction and thus disabling smokers from quitting Janofsky 1994a; Shapiro 1994a; Curriden 1995). The plaintiffs requested damages for economic losses and emotional distress, as well as medical monitoring and injunctive relief. In February 1995, the district court granted the plaintiffs’ request for class certification conditionally and in part (Castano, cited in 10.1 TPLR 2.1). Judge Okla Jones II granted certification for is- sues of fraud, breach of warranty (express or imphed), intentional tort, negligence, strict liability, and con- sumer protection issues. Certification was d