TRANSCRIPT OF PROCEEDINGS NATIONAL COMMISSION ON AIDS MEETING OF THE COMMISSIONERS Pages 1 thru 303 Washington, D.C. May 7, 1990 MILLER REPORTING COMPANY, INC. 507 C Street, N.E. Washington, D.C. 20002 546-6666 NATIONAL COMMISSION ON AIDS Monday, May 7, 1990 Washington, D.C. The meeting of the Commissioners of the National Commission on Acquired Immune Deficiency Syndrome convened at 8:15, a.m., in the Pan American Health Organization Building, 525 23rd Street, N.W., Washington, D.C., Dr. June E. Osborn, Chairman of the Commission, presiding. sg | MILLER REPORTING CO., INC. $07 C Street, NE. Washington, D.C. 20002 (202) 546-6666 ey wie q MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 AGENDA NATIONAL ACADEMY OF SCIENCES OVERVIEW Samuel O. Thier, M.D., President, Institute of Medicine Robin Weiss, M.D., Director, AIDS Activities, Institute of Medicine | Charles Turner, Ph.D., Director, Committee on AIDS Research and the Behavioral, Social, and Statistical Sciences, National Research Council DRUG DEVELOPMENT AND APPROVAL OVERVIEW Ellen C. Cooper, M.D., M.P.H., Director, Division of Antiviral Drug Products, Food and Drug Administration -- Gerald Quinnan, M.D., Deputy Director, Center for Biologics Evaluation and Research, Food and Drug Administration . Joel Solomon, Ph.D., Director, Division of Blood and Blood Products, Center for Biologics Evaluation and Research, Food and Drug Administration John C. Petricciani, M.D., Vice President, Medical and Regulatory Affairs, Pharmaceutical Manufacturers Association NATIONAL INSTITUTES OF HEALTH OVERVIEW Anthony S. Fauci, M.D., Director, Office of AIDS Research, National Institutes of Health Philip A. Pizzo, M.D., Chief of Pediatrics, Head, Infectious Disease Section, National Cancer Institute Janet Heinrick, Dr.P.H., R.N., Director, Division of Extramural Programs, National Center for Nursing Research COMMUNITY NEEDS AND PERSPECTIVES Sonia Singleton, Community, Outreach Education and Prevention Inc., Miami, Florida Rosa Martinez, Pediatric AIDS Advocate, Tampa, Florida Neil Schram, M.D., Chair, AIDS Task Force, American Association of Physicians for Human Rights | Luis Hernandez, Outreach Assistant Coordinator, Community Research Initiative, New York John Caldwell, Project Inform Jim Eigo, M.F.A., ACT UP COMMISSION BUSINESS PAGE 19 55 53 60 67 93 105 117 149 155 163 179 183 190 207 MILLER REPORTING CO., INC. 507 C Sureet, N.E. Washington, D.C. 20002 (202) 546-6666 PROCEEDINGS CHAIRMAN OSBORN: Let me ask the Commissioners here to take their seats. In the interest of a full morning schedule, I think we should get started. Several of our Commissioners are not yet in the room, but we are expecting full attendance, and I think we will fill them in on what they don’t get a chance to hear directly. Dr. Rogers is en route, but I think he is not touching down until 8:15 and I don’t think we should wait. So if the witnesses will forgive us fora little bit of slow arrival, but nevertheless start, we would much appreciate it. I am absolutely delighted to welcome Dr. Samuel Thier from the Institute of Medicine, Robin Weiss and Charles Turner from the Institute of Medicine to start our hearings today. and bringing the Commission up to date on where things stand in the biomedical sphere. DR. THIER: Thank you, Dr. Osborn and members of the Commission. We are delighted to be here. We are also delighted to see the Commission up and running and as effective as it is. The Institute has been interested in and involved MILLER REPORTING CO., INC. 507 C Street, N-E. Washington, D.C. 20002 (202) 546-6666 in the question of AIDS dating back to our annual meeting in 1985 at which time the membership explored the broad spectrum of questions raised by AIDS and looked at the response that was occurring from the various sectors in this country, and concluded that a more systematic analysis of the issues was worth taking. And we organized a six-month study beginning in early 1986 which led to a report called "Confronting AIDS: Directions for Public Health, Health Care and Research," and that was released in the summer of 1986, and it outlined a strategy for meeting the challenges of the epidemic, both at the research level and at the public health level. There was a modest response, at least at the research level, over the next year, but the response in general was significantly less than we had hoped for, so in 1987 the Institute of Medicine, with the National Academy of Sciences, set up an AIDS oversight committee which was chaired by Ted Cooper from UpJohn and was staffed by Robin Weiss. This group was both meant to maintain liaison with outside agencies and communications relative to tracking what was happening in the epidemic and what responses were, and within the National Academy complex this group, which represented not just the Institute but other components of MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 the National Research Council, was meant to oversee, stimulate and review activities. And it worked very closely then with activities such as that of the Commission on the Behavioral, Social Sciences and Education, with its Committee on AIDS Research and the Behavioral, Social and Statistical Sciences, which Charles Turner oversaw. This committee released another report which updated "Confronting AIDS" in 1988 and provided some new information up to that time, and again pressed for responses at the national level. - Based on that, and further input from our Council, we delivered to President Bush a white paper, one of four that the National Academy of Sciences group sent to him immediately after the election indicating what we hoped would happen in the response of the government to AIDS. The recommendations that we made were that the Commission, which was by that point identified, be put into action as quickly as possible and supported vigorously; that there be action taken to protect HIV infected persons from discrimination; that a comprehensive plan for financing care of those with HIV infection be put forward; that a greater effort be placed in the area of substance abuse as a target not only in its own right, but as a target of prevention for HIV infection; MILLER REPORTING CO., INC. 507 C Sureet, N.E. Washington, D.C. 20002 (202) 546-6666 that unambiguous educational programs be instituted and evaluated; that HIV testing and other public health measures be employed when their purposes were clear and the results productive; that surveillance efforts be bolstered; and that people be capable of gathering better information on risk behavior; and to be sure that the biomedical research continued to follow fruitful paths, particularly with attention to drug and vaccine development; and finally, as we had each time, we pleaded for attention to our international role in AIDS and our responsibilities in that arena which we felt had not been taken. We remain concerned in a number of the areas. We are delighted that you are in fact up and operating. We are delighted with the activities relative to discrimination. But a number of other areas, and particularly the area of the organization and financing of care, remains an area of major concern to us. As I said, we are delighted that you are formed and we are delighted to have the opportunity to talk to you about what other things we are doing in some detail. And with that brief overview of the history, let me ask Robin Weiss to talk to you a bit about what the IOM is doing, and then Charles Turner will talk to you about what the Committee MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 on Behavioral, Social Sciences is doing. DR. WEISS: Thank you Sam. I’m pleased to be here bright and early to tell you about the IOM AIDS activities. You have received written testimony from us, and also some other material that describe our studies, and I think I can be most helpful not by repeating the sort of bare bones descriptions, the process oriented descriptions of our studies, but by conveying the flavor of what they seek to accomplish and some of the hard issues that they seek to address. First I would like to talk about the study called "The Evaluation of the NIH AIDS Research Program." I think the Academy and the IOM are truly fulfilling their mandated mission to be a friendly adviser to the government by undertaking this study, because of its complexity. A committee of 15 members chaired by William Danforth and directed by Mike McGeary of the IOM staff began its work in September of 1989. The committee has been asked to address a series of questions posed by NIH -- it is NIH who asked us to conduct this study -- ranging from the adequacy of NIH’s response to the emerging epidemic, so a sort of historical question about NIH’s response; two, and I think more MILLER REPORTING CO., INC. 507 C Sereet, N.E. Washington, D.C. 20002 (202) 546-6666 important, the question of the balance of the components of NIH’s current and future AIDS program. The committee’s report will be issued in November of 1990 and I don’t want to and can’t preempt the committee in talking about conclusions, which in any case haven't been reached yet. But I do think it would be beneficial to tell you how the committee has reframed some of the questions that have been posed, because I think that alone is very illuminating and may help in your framing your own questions for the next two days of testimony. The NIH’'s AIDS program is probably leaving an era of 25 percent funding increases and entering an era more on the order of 7 percent funding increases, although recent events in the budget committee make that not necessarily a certainty, but I think we can be pretty certain that there will be a change in the level of funding. And this comes at a time when we are certainly told that there are new scientific opportunities, particularly in the vaccine research area, which means that these new opportunities will be vying for a smaller proportion of dollars. At the same time, our committee sees that NIH is moving and must move from a sort of reactive phase while they MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 were responding to the emerging epidemic to a more institutionalized management phase which is appropriate to the recognition that AIDS is a problem that is here, that isn’t going away, that will worsen in the coming decade, and the scientific challenges will certainly remain throughout this decade and probably beyond. What mechanism should the program invoke to allow it to become a stable, institutionalized force within NIH and yet retain its flexibility and its ability to respond to Reeren scientific opportunities and to the ever changing nature of the epidemic? How should the program be advised, what should the nature and composition of its advisory bodies be? And how should this advice synthesize public concern with scientific judgment? Those are some of the questions our committee is asking. | Another focus of the committee is the AIDS Clinical Trial Group. The ACTG, which as you know is an unusual program in some ways in that it is kind of a combination between a directed program -- it is a cooperative agreement, so it combines a directed approach where NIAID staff have some Say in the direction of the research -- and an investigator initiated approach where the scientists at the SS MILLER REPORTING CO., INC. 907 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 10 particular sites have a lot of input into the development of the protocols and into assigning priorities to the research protocols. This ACTG program takes up a very large proportion of NIH AIDS research funding, so it is appropriate to ask how efficient is the ACTG system, and what should the balance be between clinical trials -- which is an unusual way for NIH to be spending such a large amount of research dollars -- and other priorities in research, for instance vaccine research, behavioral research, and research in pathogenesis and other basic sciences which builds our basic knowledge base for everything that comes after. And finally, the NIH committee can’t avoid viewing the health care delivery system through the lens of scientific research. NIH funded clinical trials take place at academic centers that also have care missions and care responsibilities. Health care per se is not NIH’s mission, and yet, superimposing research on to what seems to be an inadequate health care delivery system ‘creates demands on NIH to fulfill what seem like implicit care promises. And I might add, the public I think to some extent views NIH’s response to the epidemic as equal to the federal MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 response to the epidemic, so the committee is asking the question, to what extent does that equation distort NIH’s ability to conduct scientific research, which is in fact its mission? So I guess one could say that all roads, even the scientific research road, lead to the question of health care delivery, and our committee is coming to that. I’d like to move on to the Roundtable for the Development of Drugs and Vaccines Against AIDS. The Roundtable is a forum, so it is kind of an unusual activity for the IOM, which usually constitutes study committees that make recommendations and then go out of business. The Roundtable we hope will continue for three years. It is about in its 15th month now, and it is a forum composed of leaders from the government, the pharmaceutical industry, academia, and patient advocates. Its mission is to speed the process of drug and vaccine development by grappling with some of the impediments to that process in the context of a forum. The hope is that these policymakers, who have a lot of leeway in their own institutions to make policy, will develop a common language, learn things together, and then go back to their home bases where they can implement some of what they have come to MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 12 understand. The Roundtable, as I said, has been in existence for 15 months, and it has had a very full agenda and has investigated a number of what I think are very essential questions. Its first report was called "The Potential value of Research Consortia in Developing AIDS Drugs and Vaccines." This report was requested by the PHS in response to a mandate by Congress, by Kennedy’s staff, by Kennedy, and the question was would AIDS drug and vaccine development benefit from a sort of Manhattan Project style.approach, a question what has been raised before over the course of the epidemic. And our workshop that the Roundtable sponsored pretty much concluded that while all of AIDS drugs and vaccines would not necessarily benefit from that kind of targeted approach, they felt that there was certainly some value in duplication and the kind of different approaches taken by the private sector. The did feel that there were a couple of topics that could benefit from a government encouraged private/public sector consortium approach, because the natural incentives in those areas did not exist. And those two areas were the development of animal models which are generically applicable -- so it is not necessarily in the MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 13 interest of one particular company to develop those models by themselves, and which are also very expensive to develop -- and opportunistic infection, drugs for opportunistic infection, which is another area where at least the perception is that the market isn’t great enough for the drug industry to make very large investments in opportunistic infection therapy. In addition there are other obstacles. There is probably a lack of trained investigators. Opportunistic infections are really an array of very different kinds of infections so they take many different kinds of approaches. And because of these obstacles, our Roundtable felt that probably opportunistic infection therapy research would benefit from a consortium sort of approach. The second report that the Roundtable issued was something you I think have in your folders on surrogate end points. It was titled "Surrogate Endpoints in Evaluating the Effectiveness of AIDS Drugs." Surrogate endpoints are laboratory measures that might be used to assess the potential effectiveness of experimental therapies earlier than the "true" endpoints -- I say that in quotes -- that are usually used in clinical drug MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 14 trials. And in AIDS, those are usually survival time or the occurrence of opportunistic infections. Because these laboratory measures might be detectable earlier than the true endpoints of interest -- we want to know whether a drug prolongs survival or prevents opportunistic infections, but we have to wait a long time to see that -- with surrogate endpoints, these laboratory measures, the hope is that the effectiveness of a drug could be judged earlier in its testing process and therefore approved earlier by the FDA for marketing and gotten out to patients sooner. Our Roundtable heard a two-day conference on this question, and actually the conference itself seemed to come to some conclusions, one of which was that the level of CD4 positive lymphocytes might be a surrogate endpoint that is promising enough at this stage for the FDA to use in its evaluation of experimental therapies. There are dangers, of course, to approving a drug and distributing it on the basis of surrogate endpoints. One is that the drug will actually turn out to be harmful, because it is not clear yet that the surrogate endpoint really measures the true endpoint of interest. Another is that good drugs might be overlooked if MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 15 the surrogate endpoint was used as the endpoint but the drug had some other mechanism of action and it really was an effective drug that looked ineffective by the measure that the surrogate reflects. But our Roundtable was able to make, I think, some constructive suggestions to the FDA, and we will be pursuing the question in the Roundtable context between the FDA, the pharmaceutical industry, and the researchers. The Roundtable also held workshops on the current state of vaccine therapy and they will be issuing a report really for their own use on that workshop to use as the basis for a further workshop on the logistics and policy related issues of vaccine research. And also, a conference on expanded access to investigational therapies, otherwise known as parallel track, and I can talk more about that in the question and answer period. There is certainly a lot to say there, but I think I will make one point, which is in the report "Confronting AIDS: Update 1988," our committee recommended then that the treatment IND, which was the kind of analog of parallel track in 1988 for getting new treatments out earlier, be carefully evaluated by an outside group as soon as enough time had elapsed to allow it to , MILLER REPORTING CO., INC. $07 C Sueet, N.E. Washington, D.C. 20002 (202) 546-6666 16 operate for awhile. And certainly the Roundtable felt that that is an essential component of the proposed parallel track program, that it is an experiment and there should be an evaluation component built in. A third project I would like to mention is a study of prenatal and newborn screening for HIV infection. This is a study committee chaired by Marie McCormick and directed by Leslie Hardy, that will develop guidelines for instituting screening of pregnant women and newborns for HIV infection. They will be considering HIV screening in the light of well developed screening principles for women and children that have been applied in other diseases, but with the understanding that HIV infection is unique and that its unique character in many ways needs to be also taken into account. The committee has held two very animated full meetings and will sponsor a public conference on this question next Monday and Tuesday at the Academy auditorium. The recommendations will make careful distinction between testing for diagnostic purposes of individuals and screening programs which really evoke the participation of a state and a whole mechanism that is much wider than individual MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 17 physicians deciding to test individual patients. And this particular committee is very cognizant of the history of screening programs in other diseases, which has its share of disasters, and also is very carefully examining the potential medical benefits of early detection of HIV, and I think that they will come up with dynamic recommendations. In other words, not just recommendations that at this point in time the screening should or shouldn’t be instituted for particular populations, but recommendations that will help states decide what conditions ought to prevail before they do embark or particular kinds of screening programs. So I think it will be applicable now and in the future as the epidemic changes. I’d like to mention briefly two more projects of the Institute of Medicine. One is the International Forum on AIDS Research, or IFAR, which is a relatively new activity although it was a long time in gestation. This is another forum activity and in this case it is a forum of North American funders of international research, predominantly in developing countries. The hope is that this body will coordinate, or will help those funders independently coordinate their research, which often in the past has not MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 346-6666 18 added up to more than the sum of its parts, or even up to a whole in itself. Many times international research, for instance in epidemiology, is funded in small bits and those small bits just don’t add up to give a coherent picture of what is going on in a country. An example of the kind of concerns that IFAR will be addressing is the situation where in a country, for instance in an African country, well trained investigators of that country are being pulled in so many different directions by various funders who are really vying for the participation of the few very well trained researchers who are in that country that it becomes a real burden for the host country in deciding where to go in their own research directions. So we are hoping that IFAR will be an effective mechanism for some increased coordination among funders in international research. And last, I would iike to mention a project that is not up and running but that we hope to embark on, which is looking at stress in AIDS caregivers. We believe, and have talked in our other reports, about the fact that physicians and nurses have obligations to care for HIV infected patients on the one hand, they face risks that are real in doing so, MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 19 and those risks have been characterized many different ways, and I think that it is most honest to say that there are risks and they need to be better understood. And they also face mounting pressures and psychological stresses in caring for HIV infected patients in a system that is not optimal for doing so. And we believe that those three components of AIDS care should be considered together in viewing the role of physicians and nurses and other health care workers in delivering care. The focus of this particular study would be how best to support caregivers in this very essential task of caring for HIV infected patients. So I'll stop there. There are some other projects that may come up in the discussion period, but I am trying to Stay within my allotted time. Thank you. DR. THIER: Let me let Charles Turner tell you what they are doing at CBASSE. DR. TURNER: Thank you, Sam. Like Dr. Thier and Dr. Weiss, I work at the National Academy of Sciences, although I work in a different branch at the National Research Council. Beginning in 1988, the National Research Council branch that deals with the behavioral, social and MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 20 statistical sciences embarked on a project that was spurred by "Confronting AIDS," the first IOM report. One of the primary conclusions of that report was that for the near future our best hope of preventing the further spread of HIV in the American population was by persuading large portions of the population to alter their behavior so that they don’t expose themselves or expose others to HIV infection. A corollary of that is that not only are behavioral and social sciences inherently and necessarily involved in the most critical tasks in stemming the flow of HIV infection, but that many of the most important data gathering techniques that provide the information about the spread of infection and about the behaviors that transmit infection in the population derive from the methods and procedures of the behavioral sciences. Following from that conclusion, the NRC put together a large committee and several panels to summarize what currently is known about the state of the epidemic, the spread of HIV infection in the American population, what is the current state of knowledge concerning the sexual and drug using behaviors that transmit infection, and what is known about intervention efforts that might be helpful in halting MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 21 or retarding the spread of HIV. We worked for about 15 months, and in February of 1989 we issued a report, "AIDS, Sexual Behavior and Intravenous Drug Use," 600 pages worth, which I believe you have each received a copy of the executive summary. Rather than describe all the various parts and all the various ' Operations that are currently ongoing under the auspices of the committee, of which Don DesJarlais is a member, I would like to mention just a few of the main points of issue and the conclusions the committee drew. The first concerns the current state of our understanding of the prevalence of HIV infection in the American population. This is, we believe, slowly becoming an issue of considerable political controversy. We have seen in the last three or four months several major claims that the epidemic is over. We all know that there are partisan political interests who would like us to believe that the day of AIDS is past. It is the conclusion of our committee that not only has AIDS not passed, nor will it pass-in the near future, but it is very likely that most of us will be working on AIDS 10 years from now, and it is quite likely that many of us, if the history of syphilis and gonorrhea is true, MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 22 regardless of medical breakthroughs, will be concerned about this problem until the day we retire. Given that perspective, the committee felt very strongly that we need to approach the providing of a substrate of data as a fundamental scientific task that we are doing now not only for ourselves and for people who are confronting the task of controlling the epidemic and understanding the way it is evolving today, but providing that same insight for future generations who will come 10 or 20 years later and want to understand how the epidemic has changed and where it has moved. What we found when we looked carefully at the available estimates of even as simple an elemental fact as the prevalence of infection -- which is not necessarily the most important question -- when we looked at the prevalence of infection in the population, while we did ultimately agree that a number on the order of one million infected with HIV as of a year ago was certainly a reasonable estimate, our review of the statistical underpinnings of the various methods to produce the different estimates that have been assembled led us to believe that a number as low as half a million, or a number as high as two million was consistent MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 23 with the available evidence. Given that range of variability, there are very different conclusions one would draw about the near term and medium term demands the epidemic will make upon various institutions in the country. It is understandable that the numbers are, or were soft three or four years ago. It is, however, equally clear that well targeted, well conducted studies that draw upon probability samples of well identified populations are a prerequisite to establishing a statistical system that will let us understand how the epidemic is evolving and that will leave investigators 10 years from now in a better situation than we find ourselves now where we are largely relying upon seroprevalence data gathered from convenient samples. The committee was very concerned that data collection systems that are now being put in place do not make maximum use of probability samplings, even when they target populations that are conveniently available, such as hospital patients. We are therefore left with studies of, for example, patients at 40 hospitals, or 40 STD clinics, in 30 cities, rather than samples of hospital patients in 40 cities. The MILLER REPORTING CO., INC. 507 C Sueer, N.E. Washington, D.C. 20002 (202) 5346-6666 24 committee believes that rectifying those sorts of design problems are crucial to providing a better statistical system to understand how the epidemic is changing over time. The second major concern the committee had had to do with the substrate of data upon the sexual and drug using behaviors that transmit HIV. Most of you know that when the original Cool Font [?] estimates were developed back in 1986, if you look carefully you will find a footnote that refers to where the estimate of number of men who have sex with men is derived from. And the footnote says, Kinsey, et al., 1948, "Sexual Behavior of the Human Male." At the time that that was done, Roy Widis was directing the IOM project that was producing "Confronting AIDS," and several of us said to Roy, are you serious, 1948? And we all know from our methodology textbooks in the behavioral sciences that Kinsey was not a probability sample, you don’t use those sorts of. data to generate national estimates. And my God, there must be something better out there. Well, the committee as part of its charge took a good hard look at what was out there and we were able to unearth another data set from 1970 that gave estimates based MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 25 upon a probability sample which were somewhat different, but even 1970 estimates are not what we need. What we really need are estimates upon the sexual behaviors of the American populations as they exist now and as they change over time. Efforts by the National Institutes of Health, and the Public Health Service in general, to provide those estimates are, as most of you know, currently in limbo. One Might hope that that situation will change and that the Commission might be a part of changing that situation. our committee recommended very strongly, as have the Presidential Commission on HIV Infection, the Public Health Service’s own Charlottesville meeting of last year, two Institute of Medicine reports, the General Accounting Office, that efforts of that sort are dearly needed. It appears, however, that asking questions about behaviors that are very commonly practiced is nonetheless politically very difficult. In terms of understanding and arguing why that sort of data are necessary, I would offer two or three arguments that the committee found persuasive. The first is that the argument that if we had good seroprevalence data -- which we don’t -- we would know how the epidemic was affecting the population and where it was moving and therefore we really MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 26 don’t need to know about the behaviors, is faulty for a inform reasons. First, the seroprevalence data tell us basically where our intervention efforts have failed. They tell us who has got infected. They don’t necessarily tell us who is protected. They tell us who is not infected. If Wwe . want to know whether or not the good citizens of Wyoming have a low prevalence rate because they have behavioral patterns that insulate them from infection, we can only know that by asking the questions. Similarly, if we wish to know if the hundreds of millions of dollars that are being spent on intervention and education efforts are having an effect, we need to know whether or not the behaviors that they target are changing over time. And if you want to know whether or not people are using condoms when they have sex in situations that are risky, there is no other way of knowing, at least that we know of, than asking the question. In this situation, modesty doesn’t seem to be a virtue that ought to be given high priority. We find a similar set of issues, although they have a slightly different cast -- and since Don is here I’m not going to go into them at great length, since he is much more MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 27 knowledgeable that I am -- but we find when we look at drug use behavior a similar situation, although in this case apparently affected by the ebb and flow of interest in drugs as a problem in this society, with drug wars being declared and then being left to wither, or victory being declared. We see research funding that rises more precipitously than there probably are able investigators to absorb, and then equally quickly dropping off. So that much of the data we have either doesn’t exist or isn’t readily accessible. One simple anecdote to illustrate that point, when the committee went to assemble the available data on drug using behavior, we discovered that an archive had been established to hold out all the data sets on drug using behavior that have been funded by the federal government in the last 10 years. We we went to the archive, we discovered the archive had been closed for lack of funding. The third and final area in which the committee focused considerable attention as it related to research and data gathering had to do with the evaluation of the effects of intervention programs. The committee was very concerned that what we have seemingly done in the last 10 years is try as hard as we can to intervene to stop the infection using MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 28 the best ideas we had as to what would be effective. But we have not at the same time made a commitment to doing the science that should have gone along with that to tell us whether or not our efforts -- our individual efforts -- were working, and which efforts were working best. There has been over the last 20 years a substantial advance in the use of experimental and quasi experimental designs to evaluate the effect of social programs. The examples range from studying the effect of negative income tax to looking at the effect of early intervention and early education such as Headstart for children. We have a large body of research finding, and a fairly good methodology for understanding whether or not when, for example, you send out a. brochure to every household in the United States you have produced the effect that you want to. It remains the case that we still to this date have not mounted a reasonable rigorous program of carefully controlled studies to assess the effectiveness of the intervention The fact is we are now paying large amounts of money for. The committee felt that this was an area in which remedy could be quickly had, and indeed, the Centers for Disease Control asked the committee to undertake a special MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 29 study to advise it on how to do evaluation studies of the major intervention programs it is launching. A report of that has been separately issued, and I believe each you have received a copy of it. The committee feels that that is one of the most important things to see done, because it is only by evaluating what we are doing now that we can put more money into the programs that are working, redesign or eliminate the programs that aren’t working, and over time develop a better basis for understanding what intervention works and how you go about the difficult task of changing behavior in an area which is highly charged both emotionally and personally. In that light, I would like to conclude by noting a few things that we are doing and noting the sometimes difficult situation that the behavioral and statistical sciences find themselves in with regard to funding. In terms .of changing behavior, one of. the things that was of great interest to me recently as I a looked at the studies that have been done of sexual behaviors in monogamous couples where one was infected with HIV was to note that a very large proportion of those couples, despite counseling as to the dangers that attach to unprotected sex, still engaged in MILLER REPORTING CO., INC. 507 C Street, N.E. Washington. D.C. 20002 (202) 546-6666 30 unprotected sex. And I recently had occasion to talk to one of the project directors for one of the large cohort studies, and I said to him, I was reviewing the studies done and I noticed that your studies show that you have got 60, 70 percent of the men reporting unprotected anal intercourse during the last year. Did you follow-up on that? What are you doing? Why is this occurring and what are you doing to understand why it is occurring and to alter that behavior? And he told a long story, the bottom line of which was, we find it very difficult to obtain funding for behavioral research of that sort, funding an NIH agency which Supports the cohort study, because we understand these cohort studies to be natural history and the Institute understands its mission to be natural history, and behavioral science is not a large part of the mission of the Institute, and therefore, this has been an area in which funding has been extremely hard to come by. I would close by noting that the committee has another report which will be issued in June looking at what we believe to be the major issues for the epidemic in the next 10 years, and looking at some key target populations MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 31 where we believe there are important issues that deserve attention. Unfortunately, and I apologize for doing this, but particularly with Sam here, I certainly couldn't tell you anything about what is in the report before it is released. But we'll be sure that all of you have copies of it as soon as it comes out. DR. THIER: Thank you, Dr. Osborn, that concludes what we had to say. CHAIRMAN OSBORN: Well, I want to thank Dr. Thier, Dr. Weiss and Dr. Turner very much for extraordinarily succinct and rich testimony, and I think the Commissioners may have lots of questions. I want to welcome Dr. Rogers who has made it safely, and the other Commissioners who have come in since we started. Questions. Harlan Dalton. COMMISSIONER DALTON: I have four questions for Dr. Turner. The first two are really quite simple. In the information given in our briefing book, I understand that there is a second report that is to be put out by the panel on evaluation of AIDS interventions. Is that out yet? DR. TURNER: No, it will be out about the beginning of July. It is in our review process, which is to say that MILLER REPORTING CO., INC. 507 C Sueet, N.E. Washington, D.C. 20002 (202) 546-6666 32 half a dozen people are deciding whether or not they like it. That report is a supplement to the first report, which looked at experimental methods for evaluating AIDS intervention programs. This one focuses upon non-experimental or quasi experimental methods, that is, methods that don’t require random assignment of subjects in different treatments. COMMISSIONER DALTON: The same question with respect to the report of the panel on AIDS Intervention and Research. DR. TURNER: That report will be released on June 20th. COMMISSIONER DALTON: Okay. And I take it we will have copies of both of those? DR. TURNER: As soon as it is available. COMMISSIONER DALTON: The third question, moving right along. Clearly one of the questions with respect to the development of new drugs, that is central is whether or not with the availability of parallel track persons will in fact much prefer parallel track over controlled clinical trials. And my question is whether or not the Research Council or other behavioral scientists have focussed on that question of how people in fact behave when given a choice of 33 two ways to go in terms of experimental drugs? © _ DR. TURNER: Well, that is not a question which goes to my particular competence as to the clinical side of it, but I would offer two comments, and then Robin and Sam may wish to offer their own. We do note that it is very hard to run experiments in situations where the stakes are large for the subjects. We believe, and the committee recommended even in areas where what is being offered are education and alternative types of interventions that are behavioral, that there are Situations in which it is perfectly appropriate, including situations in which there just is not enough to go : @ around, when there is not enough to go around of whatever it is, then clearly some method has to be developed for deciding who receives. And the committee felt that it was reasonable in those situations to think about devises that randomized, essentially. On the other hand,. we do know that compliance to treatment regimens in any circumstance are often large -- that is noncompliance -- and that these ultimately work against the ability of the design to yield the answers that it is intended to produce. © COMMISSIONER DALTON: My question really is, you MILLER REPORTING CO., INC. 507 C Sueet, N.E. Washington, D.C. 20002 (202) 546-6666 MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 34 say "we know," I have seen assertions on both sides. That is, assertions that individuals given the parallel track will vastly prefer that to controlled studies, and I have seen the opposite assertions, and I’m just asking is there a body of data looking at this question? DR. WEISS: I think that falls into my bailiwick somewhat in that that is an empirical question, and the question really is what mechanism is being set into place to watch as the drama unfolds and really ascertain whether people -- I guess another way of framing the question is will clinical trial accrual be hurt by the availability of parallel track drugs. And I don’t believe we know the answer to that question. I think with DDI, which was not officially a parallel track drug but which was sort of the prototype of the parallel track, the clinical trials weren’t up and running so that the race didn’t have an even start. I think there are advantages to being in clinical trials that some people may perceive over parallel track, and some of those advantages -- well, our committee felt that the advantages of being in parallel track and the advantages of being in Clinical trials were still more available to people with private doctors and health insurance and in higher MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 35 socioeconomic circumstances than others. So that parallel track will not solve problems of access to drugs. It will probably make access easier for the same group of people who are for the most part participating in trials. But again, it is an empirical question and I think the trick is going to be to watch in a systematic, planned out way as parallel track unfolds, and not just sort of ask the same question two years from now and not have the data. COMMISSIONER DALTON: Thank you. My final question for Dr. Turner is -- and maybe it is because my coffee hasn't kicked in -- in the part of your testimony in which you were essentially making a pitch for son and daughter of Kinsey, I guess I want to ask you specifically what it is you would like for this Commission to do in helping that quite stalled project get off the ground? DR. TURNER: well, I think it is for the Commission to decide what its political, agenda is, but I would say that it is clear that the survey has not -- the pilot for the survey has not yet happened, and that is despite the weighing in of various prestigious scientific bodies. And I would think that it is for you to figure out how you could work out your own agenda on that issue. I’m just punting the MILLER REPORTING CO., INC. $07 C Street, NE. Washington, D.C. 20002 (202) 546-6666 question, obviously. CHAIRMAN OSBORN: Belinda Mason. COMMISSIONER MASON: My question is for Dr. Weiss. In your part where you talked about the Roundtable, I think it was, you mentioned that you were exploring some of the obstacles to drug development for opportunistic infections. As a person with AIDS, that was very alarming for me to hear, but I am really not surprised that profitability has in fact driven the market for drug development as opposed to humanitarian goals or whatever. Since all people with HIV infection die from opportunistic infections rather than the underlying HIV disease, it seems that it is pretty important for somebody to take up the banner of figuring out why we don’t have more drugs and figuring out how we can get them. So apart from having a roundtable and saying you guys should work on development of drugs for OIs, what can you really do? I mean, what can you really do except say you ought to do it? I mean, if the underlying assumption -- it seemed like to me when you said it in the testimony it was just a given, you know, that it was not even a thing that should be questioned, that opportunistic infection drugs are kind of MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 37 step-children. So I’d like to hear you elaborate on that a little bit and give me some ideas about how you are going to really bring people into line about this. If it is going to be all about money, then we can’t get people in the boat, because the money will never be in that kind of drug. But those in fact are the drugs that save peoples lives, as opposed to DDI and AZT. DR. WEISS: First of all, I don’t want to give the impression that those kinds of decisions are completely driven by the marketplace, because there is another force at work, which is this. It is the theory that if we find a drug to treat HIV infection, that will take care of the problem of opportunistic infections, so it is also a scientific and in some sense humanitarian decision to concentrate -- if there are limited resources, to say, let’s find a drug that defeats HIV infection and therefore we won't have to worry about opportunistic infections. So that theoretical underpinning. Then, for any given company with a limited amount of resources, once they make that decision they have much less left over to look at drugs for opportunistic infection. I do think also that assessing the potential market always plays a part in private enterprise, and that that is also a MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 38 consideration. And again, the other kinds of obstacles are the fact that opportunistic infections really comprise a large number of infections that are very different from each other and smaller numbers of patients get them, so there are sort of scientific obstacles to conducting the research. And investigators, because opportunistic infections used to be rare, haven’t grown up to fill the need yet in terms of supplying the number of researchers needed. Well, there are two things that we are doing -- actually three considerations. One is this idea that arose in the consortium report. The question there was should government sort of provoke consortium approaches to research that won’t happen by themselves in private enterprise. And we -- I think the Roundtable has a responsibility to follow-up on that report and sort of see how that will evolve, if that will evolve into any program that could catalyze more research. Another is, in the NIH study one of the questions has to do with allocating resources among pathogenesis, vaccine development, drug trials and opportunistic drug trials. And so that is another group that is looking at whether or not they believe that NIH in this case should be MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 39 putting more money into opportunistic research. And the third avenue is again the Roundtable, which I believe in the next year and a half will be looking more at the scientific obstacles, and that might eventuate into some recommendations about stimulating the development of more training programs in that area, or other ways to increase opportunistic infection focus. DR. THIER: Let me point out, this is not unique problem to the opportunistic infection in AIDS. This is a problem that has been faced in, quote, “orphan drugs" for some time. That is, drugs that if they were developed would be attaching to populations, in other cases, that were too small to make it viable. There are a series of incentives and disincentives that you can build in, and what I would recommend is that you examine those carefully. The companies do respond. They will not respond as a sinking kind of circumstance, but they will respond to incentives and disincentives which will allow them at least to keep afloat and to get into that area. So I think that I would approach this as I would approach the orphan drug problem and say that when you can’t, through the usual marketplace kind of activities, have the MILLER REPORTING CO., INC. 507 C Street, NE. Washington, D.C. 20002 (202) 546-6666 40 development of a drug, then you need to stimulate it through other mechanisms, and it has worked in at least parts of the cancer community. CHAIRMAN OSBORN: And Dr. Thier, I think it might be helpful, not everybody is aware of the freestanding nature of the Institute of Medicine and National Academy as opposed to government agencies, and that may be part of Ms. Mason's concern, is there are people who think that the Institute of Medicine has a governmental authority of some sort, and you might want to clarify that. DR. THIER: Yes. We have no authority. But for anybody who is not clear, the Institute is part of the National Academy complex. The National Research Council is under the National Academy complex. We are a private sector independent group. COMMISSIONER ROGERS: I’m sorry I wasn’t here to hear my distinguished colleagues. A question for both Sam and Robin. This follows on Belinda’s question. Robin, is part of it lack of investigators? Clearly we have got too few docs willing or able to take care of sick people with AIDS. Does the same apply in terms of the studies of opportunistic infections? Do we not have MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 41 enough people who are well trained in that area? DR. WEISS: My understanding is that it is not so much lack of willingness as it is just lack of a critical mass of trained investigators whose major interest is looking at opportunistic infection in immune compromised persons. SO there is a potential role there for increasing training in that area. DR. THIER: As you know David, that was an area of specialization which developed during the development of aggressive cancer chemotherapy and transplantation, which became the two groups of immunocompromised people, and we always had a shortage. Now with the expansion of the need, I don’t think we have met it at all. CHAIRMAN OSBORN: Don DesJarlais. COMMISSIONER DESJARLAIS: This is something of a follow-up to Harlan’s earlier question about access to clinical trials and parallel. track. Robin, you mentioned that we don’t really know what that access is now, it is an empirical question, and my question then would be what mechanisms are currently in place to study that question over time, of who is getting into clinical trials, who is getting into parallel track, and who MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 is being left out. DR. WEISS: Well, as you probably know, the parallel track proposal -- and Jim Allen can tell me where it is right now, but I think it is out of the Secretary’s office and on to someplace else -- but it is not in gear yet. So there is no mechanism in place yet. But I must say that as written, and certainly as carried out in its prototype form by Bristol Meyers Squibb for DDI, the drug company is responsible for collecting a lot of information from physicians, who are the ones who give the drug to the patients. So, first of all, the drug industry is the first level of information collection. But in terms of looking over the whole system and comparing what happens with parallel track to what happens in accrual to potentially competing clinical trials that may be conducted across drug companies and within the NIH ACTG) system, I don’t think that there is a comprehensive mechanism in place that will start up when the parallel track proposal is put into gear. DR. THIER: One problem that I would just add to that -- and you may wish to communicate with him -- Peter Barton gave a presentation at this expanded access conference MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 43 in which he looked at the variations available for alternate ways of getting experimentai drugs in critical illnesses, and came up with the fact that there were a minimum of six to seven different programs with different rules and entry points and overlaps, and doubted if there was any single person who could explain all of them. And it seems to me that we are at a point here -- and this may be a good way of getting at it -- where that whole system needs to be rationalized, and in that rationalization you might save a lot of administrative complexity and put some of that into the tracking of these data. COMMISSIONER DESJARLAIS: It doesn’t really seem like there is going to be anybody collecting data from people not getting into care, but who perhaps should be getting in. DR. THIER: I think Charles was making that point in another way. CHAIRMAN OSBORN: Harlan, and Don, and Dianne. COMMISSIONER DALTON: I have a couple of questions for Dr. Thier. You were maybe a little bit modest before in talking about the lack of, or suggesting some lack of influence on the government of the IOM. Among other things, I gather you all are charged to evaluate the NIH’s health MILLER REPORTING CO., INC. 507 C Sueet, N.E. Washington, D.C. 20002 (202) 546-6666 AIDS research program, and so you certainly have some influence, and it seems to me it is worth our time to press you about these issues. The specific question I wanted to ask you has to be with incentives. In response to Ms. Mason you pointed out that with respect to orphan drugs traditionally, and certainly in the context of AIDS, there are incentives that can be managed to try to get companies to operate in an arena that otherwise wouldn’t be profitable. My question has to do with incentives that would operative on scientists, on researchers. One gets the impression from some of the literature that working in opportunistic infections is particularly sexy for scientists, that the Nobel prize going to go to the person who comes up with a perfect antiviral and certainly to the person who comes up with a vaccine, and that slogging around trying to deal with opportunistic infections is not really a career maker, or for that matter, is remunerated as some other activities. Now, that may be wrong, and I would be happy to be told as much. But what can be done about adjusting the incentives for research by scientists so that opportunistic infections can receive more than, what is it, it is certainly MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 45 less than 20 percent of the dollar, and you can tell me what that is too. DR. THIER: Well, I think that the problems are two-fold. Most of the time people will follow the resources, and that is the way the cancer program grew from an area of very little interest to an area of major interest. It would really simply require two areas of investment. One would be at the investigative level, and that would be through NIH programs, largely. It might be to some extent some CDC programs for certain other kinds of questions. And it would be industry investing also, because one of the problems we have here is there are some important observations you can make about the organisms in opportunistic infections, maybe even about chemical entities that would affect them, but then the translation of that to the development of an actual drug that would be used really moves over so that we would have to kick into the area of pharmaceutical industry production. And it seems to me some patent opportunities such as with orphan drugs, and even as you might in certain vaccine areas, the guarantee of certain purchase levels may be part of what would be necessary to get people to move into these areas. I don’t think the investigators will find it hard MILLER REPORTING CO., INC. $07 C Sereer, N.E. Washington, D.C. 20002 (202) 546-6666 46 to move into if there are resources. Particularly right now the investigators are looking for where the resources are, and they will follow them, I think, fairly closely. CHAIRMAN OSBORN: Mr. Goldman. COMMISSIONER GOLDMAN: Thank you. Maybe I’m misunderstanding a response, but regardless of any comprehensive review of a parallel track system, are there any studies planned, comprehensive or ineffectual, of the methodology that is being used in terms of the parallel track system, who is going to be included, who is going to be excluded, and what the behavioral factors are in terms of who chooses to go into what route or the other route, in terms of that system? DR. WEISS: I’m certainly not aware of any studies planned on the behavioral aspects of the decision. That I can feel pretty confident about. Now, on the other aspect of who actually chooses to do what, there be will be data collected, as is happening. The drug company will collect data, the Public Health Service will have access to that information. But as far as sort of an analysis of that goes, I don’t know of any. And again, I would need to defer to Jim Allen, because there may be more going on than I know of in MILLER REPORTING CO., INC. 507 C Street, NE. Washington, D.C. 20002 (202) 546-6666 ® that area. COMMISSIONER GOLDMAN: I have a question for Dr. Thier. A year ago you made a series of recommendations. As part of the Institute’s work, will there be some kind of report, or can you tell us now whether or not the committee's views on the reaction to its recommendations as to whether or not they have been followed or not followed or where things stand in terms of that area? DR. THIER: We have issued a whole bunch of things over the last few years. What we do is we have tracked what we have put forward and we can probably give you a little bit more crisp analysis than I can give you off the top of my head. But we know, for example, on the recommendations that we made both times around, in terms of research directions, level of support, emphasis and so on, that those were followed rather closely and that the responses of NIH and CDC seemed to be rather crisp in, terms of dealing with that. Some of the concerns on the kinds of data collection that were raised by Charles have not been responded to and, in fact, as you have heard, something as what would seem to a scientist as straightforward as getting a pilot study organized to determine whether the concerns of MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 48 people about a large study are in fact valid has not been able to be pulled off at this stage. There are areas in the development of the consortia where we have made recommendations which we would like to see followed up more aggressively, for example, the catalyzing of a consortia of animal resources. I will point out to you, there are some fascinating problems you might want to look it in terms of the animal resource question. For example, one major model which would appear to be promising depends upon the use of human fetal tissue transplanted into mice which then develop a human immune system and can be infected with the virus and you therefore have a model in which you can be testing in animals the human immune cells, the HIV infection in an animal, and yet that, as I understand it, would have difficulty being supported because it requires human fetal tissue transplant into the animal. That has not been followed up, that consortia question. And the other area we were hoping to see something happen more rapidly, it seemed to us that there was a very dramatic consensus in the use of CD4 as a surrogate endpoint which might then be moved into use in drug trials. We are not saying that that is a clear cut circumstance, but what we MILLER REPORTING CO., INC. $07 C Suet, N.E. Washington, D.C. 20002 (202) 546-6666 49 would like to see happen next would be an addressing by the FDA of the question of at what level of scientific rigor would they then accept that that was ready to go and then say we either are there or not there, or at least telling us when we are there and we will know what to expect. At this point it looks extremely promising, but how it will get translated the next step has not occurred. So that is an area we are still concerned about. We tend to recycle on these things if we don’t see much happening. CHAIRMAN OSBORN: Dianne Ahrens. COMMISSIONER AHRENS: Dr. Weiss, yours is really a foreign field for me and I don’t have the capacity to read into some of the things that you are telling us that perhaps some other members of this panel can, and I’d like you to talk a little bit more and help me understand what you meant when you said that there would be guidelines I think for screening for states and that these would be dynamic. Would you talk a little more about that? DR. WEISS: Yes. I guess the decision to screen a whole population for a disease depends on many factors. One is whether you can accomplish something by identifying people who have the disease, and that, of course, depends on whether MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 50 there is a good medical intervention or behavioral intervention or something that will clearly benefit the patient who is being screened. Because being screened can also be seen as being subjected to something. It is a level of intrusion. It is giving blood. It is forfeiting some sort of personal rights. So there has to be a good reason, a good benefit to the patient, and/or a benefit to the society. There are other aspects of screening, of deciding to screen. One for a particular locality might have to do with the prevalence of infection, how bad the disease is in that area. And others have to do with whether or not there are known ways of preventing transmission, for instance. If you tell someone that they have an illness, is it possible for them to take an action that is acceptable to them that will prevent transmission? Another factor is how good are the tests that you employ when doing the screening? Because if you have a test that identifies someone as positive but there is say a 50 percent chance that they may actually be negative and they go through all the sort of psychological trauma and expense and other problems to be tested and to think they are positive and they turn out to be negative, that would tend to make you . MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 51 not to want to employ screening on a broad scale. So all those considerations need to be taken into account when deciding whether to institute a large screening program. And all those things change. The technology for screening has improved. We have seen it improve and, in fact, tests for HIV infection are very, very good tests compared to other medical tests in terms of their sensitivity, their accuracy. Certainly the level of the benefits of medical intervention change and improve, and one question this committee will be asking is at what point short of a cure are the medical benefits to early intervention powerful enough that you would want to recommend that say everyone be screened for HIV infection. That is a hypothetical question, but it is a question that the committee would be asking. And the prevalence of infection changes as the epidemic grows. We heard a presentation by Tim Dondaro of the CDC on their seroprevalence studies that really challenges the notion that there are known hot spots around urban centers. There are places that you would just -- and you know, I guess, because of your recent trip to Georgia -- there are areas in the country that you would never suspect MILLER REPORTING CO., INC. 507 C Screet, N.E. Washington, D.C. 20002 (202) 546-6666 52 of being high prevalence areas that are. So if you base screening decisions on a notion that may be wrong about where the high prevalence areas are, that would be a bad policy. So what I meant by dynamic is I think this committee will try to develop guidelines that any locality or state could understand and could apply to their own Situation and that, in fact, the Public Health Service and other more overarching groups could apply to the country as a whole in terms of looking at the disease process, looking at the state of medical intervention, and looking at the diagnostic tests and their development in making recommendations about screening. COMMISSIONER AHRENS: In the interest of the schedule, and I know that some of our witnesses have schedule pressures too, on behalf of the Commission I want to thank you very much for very rich testimony indeed, and we may talk to you again in the future, but we really appreciate the update at this points. DR. THIER: Thank you, June. If there are specific questions where we could provide some more data, such as on Don Goldman’s question, we will try and put that together. If you will let us know, we'll try and provide that. MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 53 CHAIRMAN OSBORN: Thank you so much. Our next panel will be talking about drug development an approval overview. Dr. Paul Parkman, who was going to join us, had a last minute complication which has made it impossible, and so in addition to Dr. Allen Cooper, and Dr. Gerald Quinnan and Dr. Joel Solomon, all from FDA will be talking with us, and Dr. John Petricciani, who is Vice President for Medical and Regulatory Affairs, the Pharmaceutical Manufacturers Association. Dr. Cooper has one of the most difficult jobs I know about and we are particularly glad to welcome you. Well, I don’t know if you know how you want to proceed. | Ellen, I would assume you might start off. Jerry, are you going to talk first? Dr. Quinnan. DR. QUINNAN: Thank you. Let me first offer regrets for Paul Parkman. There was a very important safety issue that he felt demanded his personal attention and he really wished he could have been here. I’m here representing Paul in two capacities, I guess. One is in his position as Director of the Center for Biologics Evaluation and Research, and the other, more importantly, in his position as AIDS Coordinator for the Food MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 and Drug Administration. AIDS, as you know, has had dramatic effects on the way the Food and Drug Administration does its business, and it has affected many aspects of our program. One of the areas that Dr. Cooper is here to represent is that of therapeutics, and conventional drugs have many applications in AIDS and HIV infection that have just been discussed ina certain amount of detail. There are also a wide variety of biological therapeutics relevant to AIDS, such as interferon, erythropoietin, colony stimulating factors, and various forms of immunotherapy, AIDS vaccines which have spurred us to develop over the last few years standards, on an informal basis, for dealing with many new types of biotechnology drive products, and is kind of leading us into exciting new areas in the regulatory arena in that sense. Progress in vaccines development for AIDS has been arduous but recently there has been a great amount of exciting information collecting and I think the future holds some certain amount of promise. Another major area that has changed dramatically as a result of the AIDS epidemic is that of blood and blood MILLER REPORTING CO., INC, $07 C Sueet, N.E. , Washington, D.C. 20002 (202) 546-6666 55 products. Dr. Joel Solomon, who is Director of the Division of Blood and Blood Products in the Center for Biologics Evaluation and Research will address that. There are many wide ranging aspects of that issue and he will get into some of them in a certain amount of detail. Some of the important areas include blood donor qualification and testing, test kit evaluation and approval, evaluation of blood supply issues, education and counseling and follow-up for blood donors, safety of plasma derivatives and a variety of other issues. I think, related to the issue of blood and blood products, it is a privilege to be on the same panel with Dr. John Petricciani, who has previously been with our Center in a variety of capacities, one of which has involved a role in blood and blood products as well. So with that I'll introduce Dr. Ellen Cooper, who is Director of the Division of Antiviral Drugs in the Center for Drug Evaluation and Research. DR. COOPER: Thank you. I certainly would be happy to answer questions afterwards. I have kept my remarks brief and fairly general. What I would like to do is just explain how the FDA is responding to the challenges that the AIDS MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 56 crisis presents to drug development in this country and what we have done to help expand early access to investigational agents. Since early 1985 when the first drug sponsor contacted FDA to express an interest in developing an anti-retroviral drug, FDA reviewers have been in frequent close communication with drug developers. This was a somewhat informal arrangement, but it worked very little with AZT, and in October of 1988 the agency proposed new regulations that commit the agency to a more proactive role in expediting drug development of drugs for life threatening and seriously debilitating diseases, including, of course, AIDS. In accord with these regulations, FDA staff will work with drug sponsors from the earliest stages and throughout drug development to assist them in identifying the most efficient animal and human research programs aimed at developing the safety and efficacy of the drug. This FDA sponsored interaction is critical to gathering in the shortest possible time the scientifically sound data upon which regulatory decisions must be based. In this program, the drug sponsor is invited to contact FDA as soon as preliminary information suggests that MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 57 the drug may have activity to discuss the design of a preclinical program. When the preclinical studies have been completed, the sponsor is again encouraged to contact FDA to discuss the results and to begin working to design the first studies in humans. It is important that the initial human trials, usually referred to as phase one, be designed to minimize risk to patients while obtaining as much information as possible on the drug's safety profile, activity and pharmacokinetics. Upon completion of phase one trials, the sponsor is requested to meet with FDA to discuss the study results and to reach agreement on the design of the phase two controlled studies that may eventually provide efficacy data sufficient to support approval of the drug for general marketing. If preliminary results from these studies provide relative evidence of safety and potential efficacy, and if the other criteria for treatment IND approval are met, the sponsor may submit, or the FDA may request, that a treatment IND be ‘submitted to allow earlier access to the product while review or clinical investigations continue. The statutory requirement for adequate demonstration of safety and substantial evidence of efficacy MILLER REPORTING CO., INC. 507 C Sueet, N.E. Washington, D.C. 20002 (202) 546-6666 58 derived from adequate and well controlled trials remain the standard for new drug approval, regardless of whether the drug has undergone more traditional drug development or expedited drug development. For this reason, the success of an expedited program is heavily dependent on the appropriate design, prompt initiation, and careful conduct of studies at every stage of drug development. Another key feature of expedited drug development is the important role of post-marketing studies. When approval of a new drug is based on an adequate but limited database derived from the phase one and phase two trials, rather than the larger more, comprehensive database developed during the traditional phase one, two and three drug development scheme, the additional data generated in post-approval studies assumes greater importance. Thus sponsors of drugs developed under these regulations are frequently asked to develop a post-marketing program to address important outstanding issues. While the new regulations for expedited drug development and approval and a closer communication between FDA and the sponsor can hasten the progress of new drugs toward marketing approval, the time required for drug MILLER REPORTING CO., INC. 907 C Sereet, N.E. Washington, D.C. 20002 (202) 546-6666 59 development and approval remain mine substantial. In large part this is due to the chronic nature of HIV infection and the fact that to date no drug has been found to be a cure. Because treatment options available to many patients are limited, the agency is constantly working with. sponsors to make promising but unproven new therapies available to desperate patients as quickly as possible. Many investigational new drugs have been made available to specific populations of patients under the treatment IND regulations published in May of 1987. These regulations set out specific criteria that must be met before FDA may approve a treatment use request. When the treatment IND mechanism for expanding access to promising investigational drugs is not appropriate, other investigational protocols, such as open label safety studies, may be employed to make new drugs more widely available to certain patients with life threatening diseases who have no alternative therapies. The recently proposed parallel track program, currently under development, is specifically aimed at addressing this need..: The effectiveness of these measures to expedite drug development depend in large part on the experience, commitment, and good faith of the participants in the drug MILLER REPORTING CO., INC. 507 C Sueet, N.E. Washington, D.C. 20002 (202) 546-6666 60 development process. No one participating in this process can achieve the desired outcome alone, but the inaction or look of cooperation of any single participant can certainly slow the process, or even bring it to a halt. FDA has been and intends to continue to be one of the active accelerative forces in this process. Thank you. DR. QUINNAN: Dr. Joel Solomon from the Division of Blood and Blood Products will address that area. DR. SOLOMON: Thank you, Dr. Quinnan. For those of you who may not be familiar with all of the activities of the Division of Blood and Blood Products, let me begin by saying that we have not only the responsibility for the review and approval of products that are used in blood banks, but also for the licensure, registration, and inspection of those facilities which put those products in use, and therefore are quite responsible and quite busy in developing, procedures and reviewing procedures used by blood banks and plasma centers that employ the products. So our involvement in research is involvement not only in the development of new products, but the development of new procedures and the investigation of those procedures once they are put into use. MILLER REPORTING Cco., INC, $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 61 The tragedy of AIDS transmission by transfusion has been almost completely eliminated by measures instituted since 1983. Published estimates of the current risk of transmission of HIV by a blood component range from one in 38,000 to one in 153,000. Although this level of risk is low in comparison with many other medical risks, the public expects and demands a continued effort to eliminate HIV transmission by transfusion, and this has remained a charge to the Food and Drug Administration to which it continues respond. Assuring safety of the blood supply in the AIDS era depends on a multifaceted approach, including donor education and deferral, product testing, and viral inactivation. Risk reduction also involves monitoring of procedures in blood establishments and development of medical alternatives to the use of homologous blood. I would like to provide a brief overview of current research activities at the Food and Drug Administration and elsewhere which is focussed in each of these areas, and I believe each of you has a copy of my comments. I will abbreviate them. You have the fuller description in front of you. MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 Education remains the cornerstone of AIDS prevention. Blood centers have been in the vanguard of developing educational materials to instruct potential donors about the methods of transmission of the AIDS virus and the identification of behavior which may result in increased risk of infection. It has been estimated that voluntary donor deferral is effective in preventing 98 percent of donations by persons at risk. Nevertheless, approximately 80 percent of blood donations which test positive for antibodies to HIV come from donors who could have self-excluded. For this reason, the FDA has supported contract research designed to improve communication with prospective donors through the development of culturally appropriate, behaviorally sound messages and media instruments. The fruits of this labor will be released publicly in the next several months. Because of the increasing importance of heterosexual exposure as an AIDS risk factor, future efforts in this area will include special attention to the design of questions which may address this risk. Efforts to improve donor understanding of the procedure for confidentially including use of a collected unit are also under study. FDA MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 63 is also investigating ways to promote and improve quality assurance at blood establishments, especially through optimal use of management systems and computerization so as to reduce the problem of clerical errors causing inappropriate release of marker-positive units from quarantine. Antibody testing for HIV is both highly sensitive and specific and prevents approximately 3,000 cases per year of HIV exposure to recipients of blood components. Nevertheless, blood safety could be improved by the development of even more sensitive tests. The FDA is involved in research on new HIV tests, both in the process of product license reviews and through investigations of new assay technology. Recently the FDA provided major funding and laboratory collaboration for a study of the efficacy of HIV antigen tests for donor screening. It had been presumed that a test for antigen, a direct virus marker, would improve the sensitivity of screening, because antigen may sometimes be detected prior to antibody early in HIV infections. In the study, which involved testing more than 500,000 donations in a six-month period, no cases were found which were antigen positive but antibody negative. This result led to an FDA recommendation against the use of a MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 64 licensed antigen test to screen donated blood. Although this outcome did not alter the current level of safety, it prevented the waste of over $50 million per year in ineffective testing. The concept of developing a screening test for a direct virus marker rather than for antibody remains sound, however. For this reason, FDA and others are engaged in research evaluation of gene detection by the polymerase chain reaction, or PCR, which shows great promise as a more sensitive and specific assay than either culture or antibody tests. Clinical studies have been conducted which appear to demonstrate detection of HIV infection in some seronegative individuals, particularly spouses of hemophiliacs who have been repeatedly exposed to HIV by their infected sexual partners. Additional studies are planned to confirm this result and to determine whether such silent infections, if they exist, are transmissible. Conversely, negative results of PCR were useful in establishing a lack of HIV infections in blood donors with persistently indeterminate results of testing by Western Blot. The PCR method has also been used to develop a test for combined detection of HIV and hepatitis B genetic MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 65 material in plasma samples. This latter methodology was developed in our laboratories at FDA. Many additional research efforts exist in this area but cannot be discussed in this brief time. They are, however, included in the comments that were provided to you. Inactivation of HIV in all blood products is an ultimate goal for ensuring safety. Studies performed at the FDA were among the first to validate the safety of immune globulins by demonstrating clearance and inactivation of HIV by the Cone-Onkly [phonetic] fractionation process. FDA cooperation with industry has resulted in validation of HIV inactivation in an entire new generation of anti-hemophilic factors which include virus inactivation or removal steps such as heating, chemical extraction, and affinity purification. The problem of virus inactivation is more difficult for cellular blood components which must remain intact and functional. Current studies have been in progress at the FDA on the possible use of laser irradiation and light activated pigments for virus inactivation and platelet concentrates, but I must in honesty tell you that those studies are going very, very slowly. Along with other federal agencies, the FDA is MILLER REPORTING CO.,. INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 66 concerned with monitoring the safety of the blood supply. When questions have arisen about the viral safety of specific blood components, laboratory and epidemiological investigations have been conducted to resolve the issue. Recent examples include studies which demonstrated the safety of an Rh immune globulin following an invalid report of HIV seroconversion by a recipient, and confirmatory studies by PCR of three lots of a now discontinued Factor 8 product which transmitted HIV infection in Canada. Through its systems of adverse reaction reporting and product recalls, the FDA maintains awareness of hazards associated with the use of blood products. Reduction in the use of homologous blood is another effective method for limiting the risk of AIDS transmission. Many approaches have been taken toward this goal, including physician education, increased use of self-donation for elective surgery, intraoperative blood salvage, and intraoperative hemodilution. FDA has had a facilitating role in this area by developing guidelines for the collection, testing and labeling of autologous products. In addition, products such as DDAVP, desmopressin, hemopoietic growth factors, blood substitutes, and MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 67 recombinant DNA derived blood proteins may offer other alternatives. Current research also includes preliminary “work on hemoglobulin solutions and models for gene therapy. I hope that this brief overview has provided you with an orientation to the wide-ranging activities of ongoing research in the area of AIDS related to the safety of the blood supply, and I will be pleased to answer questions in the comment period. CHAIRMAN OSBORN: Thank you very much, Dr. Solomon. Dr. Petricciani. DR. PETRICCIANI: Thank you, Dr. Osborn and members of the Commission. The Pharmaceutical Manufacturers Association appreciates the opportunity to appear before you today to discuss the research-based industry’s efforts in drug and vaccine development. The written statement provides a fair amount of material in addition to the attachments, which I won’t try to address, but I’d like to give you a brief sketch of our commitment to drug and vaccine development, and then go on to discuss a couple of the issues that we see as important in the rapid evaluation and approval of new medicines for AIDS. In the past the pharmaceutical companies’ research MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 68 and development efforts usually were not made public. However, because of the impact of AIDS on society and the high level of public interest in knowing what progress there was, the U.S. pharmaceutical industry agreed in 1987 to provide periodic status reports on the human clinical trials of AIDS drugs and vaccines that the companies were sponsoring. The first survey of those efforts on the part of the research-based industry came in 1987, and it was about that time that the American Foundation for AIDS Research, AmFAR, was also publishing its directory on clinical trials. Because both AmFAR and PMA were very directly interested in development of therapies for people with AIDS and its associated medical complications, it seemed to us both practical and logical to work together on this project. So as a starting point last year we agreed that our two organizations will jointly collect and share data for our respective publications. The result of that effort jointly is that both of the publications are now more comprehensive and it also eliminated redundant effort and allowed those resources to be used in other areas for AIDS. The finding of the first survey that we published, MILLER REPORTING CO., INC. 507 C Sueet, N.E. Washington, D.C. 20002 (202) 546-6666 69 compared with those in the February 1990 survey, are significantly different. In the summer of 1987 the number of drugs and vaccines that were in development compared to 1990 doubled. There were 40 companies developing 35 products in the first survey, and in February of 1990 there were 41 companies with 71 medicines or combinations of medicines in human clinical trials. This does not include studies at the preclinical stage, only those that are currently in human studies. Only a few of the medicines listed in the first chart were under development exclusively for AIDS. Since then, because a great deal has been learned about the biology of HIV, the latest survey contains several experimental therapies that were specifically designed to attack different phases of the AIDS virus life-cycle. There was only a single product in 1987 listed as approved, and that was AZT. While that drug remains the only therapy approved to treat the underlying infection for HIV itself, the latest survey lists nine other drugs that have been approved to treat AIDS-related conditions, and two additional drugs are available through treatment INDs. It is also of importance to note that there are now MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 346-6666 70 a number of products that were sufficiently promising in the first stage of human clinical studies to justify enrolling larger numbers of patients in later phases, phase two/three studies, to establish the basic database on safety and efficacy to allow moving forward with a new drug’ application to the FDA. All of these advances are creating a new sense of confidence in the biomedical community and in patients themselves. Now, in fact, there is real hope that HIV infection will become amenable to medical control. Progression from the asymptomatic stage to overt AIDS might eventually be slowed or arrested, and AIDS itself may eventually be preventable in the near future. However, only well designed and conducted clinical trials can establish if laboratory suggestions of efficacy translate into real clinical efficacy with an acceptable level of toxicity. The clinical testing of each promising drug is a formidable undertaking and it requires a major financial commitment. Different doses and treatment regimens must be tested, different stages of the disease must be considered, and decisions must be made on whether to test it alone, or fortunately at the present time, in combination with other MILLER REPORTING CO., INC. 507 C Street, NE. Washington, D.C. 20002 (202) 546-6666 71 drugs. AIDS has drawn together a number of independent organizations to work toward the common goal of reducing the amount of red tape in the FDA review and approval process so that promising new drugs can get to the patients who need them as fast as possible. In that regard, PMA has been actively supporting responsible efforts on two fronts. First, as you have already heard from Dr. Robin Weiss, we - have joined with the Public Health Service in funding a series of AIDS Roundtables sponsored by the IOM. And these, as you have heard already, review various aspects of AIDS vaccine and drug development. The second forum in which we have tried to offer constructive criticisms, along with many other groups, is the hearings of the National Committee to Review Current Procedures for the Approval of New Drugs to Treat Cancer and AIDS. And I have provided you with a copy of some of our recent input into that committee. AIDS has created and heightened many problems that you are intimately aware of, but it has also provided opportunities for cooperation in addressing those problems. One of the these opportunities is to expand the role that MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 72 community-based organizations might play in the evaluation of new drugs. As HIV infection has continued to spread and case numbers continue to grow, and aS economic pressures in the health field have continued to underscore the need for community-based care, it has become critical to the success - of therapeutic research on HIV to develop mechanisms to involve community health care providers and community -organizations in scientifically sound clinical research. There exists today a unique opportunity where many thousands of HIV infected individuals have declared their willingness to be participants in HIV related research study while physicians in several areas of the country have come together to evaluate potential anti-AIDS therapies. The result has been ground-breaking efforts initiated by primary care physicians and by persons with HIV infection who desire participation in HIV related research that is clearly directed towards clinical endpoints or relevance in the day-to-day management of HIV-related disease. AmFAR and NIAID have launched significant efforts to support this movement, and PMA is exploring ways in which it can assist them in their education and quality assurance program by drawing on the considerable expertise in those areas that MILLER REPORTING CO., INC. 507 C Sueet, N.E. Washington, D.C. 20002 (202) 546-6666 73 exist within industry. In the interest of time, I think I will conclude my remarks here and be happy to answer any questions during the discussion period. CHAIRMAN OSBORN: Thank you very much, John, and thank you all. I think we have time for some questions from the Commissioners. Don Goldman. COMMISSIONER GOLDMAN: Thank you, I have a few questions. First of all, it is exciting to know the research that is being done through the FDA. Most of us think of research being the purview of the NIH and we think of the FDA as a regulatory body, and it is important for us to understand the important research that in fact is being done in your agency and we appreciate it. I would like to ask really two questions of Dr. Solomon if I might. One of them, I was wondering if he could tell us something about any areas of concern that he may have or the agency may have in the areas of quality control and in the process of the donor screening and fractionation processes. And secondly, I was wondering if you might be able to just update us. You noted, and we note, that there are new generations of anti-hemophilic factors which provide MILLER REPORTING CO., INC. 507 C Street, NE. Washington, D.C. 20002 (202) 546-6666 74 for virus inactivation. That applies to Factor 8 products, what about Factor 9 products? DR. SOLOMON: Well, let me take your first question first. The problem of quality assurance, which I think is what you are asking about, particularly in blood centers or hospital blood banks where blood is collected, has become one that has only recently been recognized by these areas of manufacturing as major problems to the blood community. I think until this past two years with a great deal of activity expended by the FDA during the inspection process, it was never clear, to blood centers in particular, who are very large collectors of blood, that they have by virtue of the fact that they have increased the volume of testing, that they have modified dramatically their modes of inventory control now that they have to deal not only with homologous blood but as well directed donations and autologous donations, that they have become, or at least recognize that they have become, what they always were, manufacturers, and that as manufacturers they have a responsibility to develop the same sorts of quality assurance procedures that are common in other kinds of manufacturing environments. What that means in the blood banking environment is MILLER REPORTING CO., iNC. 507 C Suet, N.E. Washington, D.C. 20002 (202) 546-6666 75 recognition that they can’t simply depend on people with Supervisory positions. The medical directors simply cannot depend on people with supervisory positions to actually be doing their job without periodically determining that those jobs are being done. In actuality it requires daily or at least periodic, audits of the quality of the work that is being done, not just the writing of standard operating procedures, but determination that those operating procedures are actually being followed, not just the maintenance of records but the determination that those records are complete and accurate. I think until recently they have turned over much of that audit responsibility to the FDA, and therefore have been audited on an every two-year basis, or until fairly recently, an every-year basis, and found in the most recent inspections that they were wanting. And having recognized that, I think we are also beginning to see dramatic turns in how they approach quality assurance in the future. We have, as I mentioned in the prepared comments, elected to do somewhat similar things for the blood community with respect to quality assurance as we have for the development of donor recruitment materials and self-exclusion MILLER REPORTING CO., INC, $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 76 materials, that is, contract out to firms for the development of quality assurance programs that are specific for blood banking, because blood banks develop products that are very different from products in a manufacturing environment and pharmaceuticals or even medical devices. They are making one at a time custom products. As for your second question about inactivation of Factor 9 concentrates, that process is proceeding somewhat more slowly, and unfortunately I can’t get into very great detail about it because I would be violating the confidentiality of license files. I don’t know whether Dr. Petricciani knows anything about it or could speak about it based on things that firms might have told him, but there are some applications that are proceeding and that’s really all that I can say at the moment. COMMISSIONER GOLDMAN: Are there any problems from the FDA perspective in terms. of those applications in which any delays are being occasioned by a lack of manpower, a lack of staff, or similar considerations, or are they things that are inherent in the nature of the application themselves? DR. SOLOMON: Some of them are things inherent in the applications, and some of them right at the moment are in MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 346-6666 77 the manufacturers’ court. I think it is fair to say that pretty nearly everything that is being done in our division, and I suspect within the Center for Biologics, are in some way impacted by deficiencies in staff. It should be apparent that we are in truth, as you said in your remarks at the beginning, we are in truth a regulatory agency and that is our requirement under law. We try to do our research to Support that regulation. But there has been such dramatic growth in every area that has to do with blood products that we are sadly deficient in dealing with both the research and the regulation, and we are definitely in need of more people and more space. I’m not sure that budget is our major problem, but we certainly have a problem with space, which will be ameliorated toward the end of the year as we move into new quarters in Rockville, unfortunately, divorcing ourselves from our main building on the Bethesda NIH campus. And we hope that we’ll get some more people, but when you increase the number of products, as we have in the testing area, when you increase the number of procedures, as we have in the blood banks, and we are required then to write new recommendations for the implementation of those procedures, MILLER REPORTING CO., INC. $07 C Sureet, N.E. Washington, D.C. 20002 (202) 546-6666 78 all of those take time and people to carry out. DR. QUINNAN: If I could, I would like to build just a little bit on the concept of evolution of quality assurance in blood banking. The picture should rightfully be viewed as one of very dramatic development, of increased complexity and increased sophistication in parallel over the last several years. The number of products that a blood bank puts out, the number of procedures involved in donor evaluation, screening, testing, the way data is managed and products are qualified for transfusion and other applications in blood banks, the procedures in developing SOPs for those things as well as for things like computer management and software development, et cetera, have all been a very Significant aspect of blood bank regulation that has been largely, but not wholly, related to products developed for AIDS screening. The concepts that Dr. Solomon was just referring to -- increased frequency of evaluation and inspection of blood banks, increased scrutiny cf adherence to these more sophisticated SOPs and of developing new ways of dealing with data so that SOPs can be made more straightforward and dealt with in a more business like fashion I think are all dramatic MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 79 examples of how the blood industry has come of age ina remarkable way, and I would hope it would not be perceived as a growing deficiency but instead an aspect of the industry for which the industry itself deserves a tremendous amount of credit. I think those things have occurred in a way which has provided progressively increasing assurance of safety of the blood supply as the ability to screen out more infectious agents and to develop more sophisticated products has come forward over the last 10 years or so. Thank you. CHAIRMAN OSBORN: Thank you. Jim Allen, Belinda Mason, Don DesJarlais. MR. JIM ALLEN: I have a question for Dr. Petricciani. John, you heard the discussion earlier this morning when the National Academy of Sciences panel was here about the need for development of additional therapies for treatment or prophylaxis of Opportunistic infections, and there was a brief discussion about the orphan drug law also. Would you comment from the industry’s point of view on the development of these therapies, where they stand, what some of the impediments are, and comment briefly on the orphan drug law and whether you feel there are changes needed MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 in it, and if so what action is being taken? DR. PETRICCIANI: To some degree the comments that were provided to you by Dr. Weiss were, I think, on the mark in that respect. As far as incentives go, the Orphan Drug Act in fact does provide economic incentives for industry to move into an area which otherwise might be unattractive, and those relate to patent term extensions. If you look at the chart which I provided as an addition to my written statement, I think you will find in there that there are a number of drugs that are currently in clinical trials to treat opportunistic infections. There may not be as many as one might like, but I think that there is a level of activity there. It is not totally a dry well by any means. | The other point which was mentioned, which I would reemphasize, is that there are multiple responsibilities in the development of drugs for. what we might call rare diseases that would fit into the orphan drug area. One of those is in fact responsibility of the federal government, within NIAID in this particular instance, in doing perhaps some of the initial work, although not to the exclusion of industry’s responsibility. And there are opportunities for MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 81 collaborative developments now available where a company may pick up some of the drugs which are at the early clinical research stage or early preclinical stages that show some promise that are in the NIH system. So I think the answer is really a cooperative kind of a system in which both the government as well as industry assumes some of the developmental tasks. CHAIRMAN OSBORN: Belinda Mason. COMMISSIONER MASON: I first have a couple of questions for Dr. Cooper, and then one for Dr. Petricciani. Dr. Cooper, I wish you would comment for me on aerosolized pentamidine. I realize that your position is of an antiviral nature, but I wonder about the gap between the actual use of aerosolized pentamidine by primary care physicians in communities of people with HIV infection and the eventual approval of AP as a sanctioned prophylactic therapy. There have been estimates by many of the advocacy communities that the lag there cost us about 9,000 deaths, so I would like to hear what kind of remarks or observations that you might have on the FDA’s role in the eventual approval of that drug and why it took so long, and maybe this is the NIH, maybe you can blame it on them, I don’t know. MILLER REPORTING CO., INC. 507 C Street, NE. Washington, D.C. 20002 (202) 546-6666 82 And then my second question is what about drugs that are in use in other countries that people have looked at? For instance, dextran sulfate, compound Q, what about some drugs that have been widely used in other countries for a long time, why is it necessary to have phase one trials of drugs that have already been proven effective say for people in Japan? Are people in America substantially biologically different than Japanese people? No, I really am being quite serious. So those are my two questions for you. DR. COOPER: First, regarding aerosolized pentamidine, as you may be aware, I think you are aware, the FDA, although it does do some research in certain areas supporting its regulatory function, it does not do the clinical research that is required to demonstrate efficacy to Support marketing approval. So although certainly we were aware of the use of aerosolized pentamidine, the off-label use for prophylaxis, we were, really unable certainly to make a decision without data to support the efficacy of the product for that indication, and as you know, the San Francisco Community Consortium did in I believe it was the fall of 1987 begin enrolling patients in a community-based trial. And although I don’t think that they may have MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 certainly realized that it would be the pivotal study to support approval, fortunately in that disease the data was sufficient to provide the pivotal data to support marketing approval, and that study took I guess about a year. It ended in the end of 1988, and as you know, shortly after that February of ‘89 there was a treatment IND, ,and then in of ‘89 the drug was approved for that use. The manufacturer, LifeMed, was the sponsor of that application. There was a lot of work involved in going back into the community and bringing and looking at the source records and things and analyzing the data and submitting it for approval. In terms of your second question, drugs that have been either in humans overseas or even approved for other uses overseas, certainly the human experience in whatever disease with a drug is relevant to whatever use may be under investigation or proposed for investigation in this country. We certainly look at that data and it is relevant. So it is not that phase one studies necessarily need to be repeated in this country. Certainly in terms of looking at a drug for the first time in HIV infected patients, and particularly in the more advanced patients, as you know, patients with AIDS MILLER REPORTING CO., INC. - $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 84 do sometimes tolerate drugs less well than other patients. And I think an additional point here is what we call phase one in AIDS drug development is really probably more properly called phase one/two if you look at the traditional phases of drug development, in that patients with the disease are usually the subject of initial studies. And therefore there is preliminary evidence of activity as well as, of course, the safety and pharmacokinetic data that are obtained in the initial studies. And then the first controlled studies, which I, for example, referred to as phase two probably should be called phase two/three in order to keep with the analogy of more traditional drug development. So drugs that are available overseas, if they are -- and I don’t think there are any examples of this -- certainly if they have been investigated for AIDS and approved for AIDS overseas, that is very different than if they are proved for another indication. You obviously still ‘don't know whether they work for HIV infection and therefore they are investigated for that purpose in this country. But the human data is very relevant. COMMISSIONER MASON: Okay. Thank you. MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 85 Dr. Petricciani, I a referring to the copy of your testimony here to the Lasagna Committee. I always hate to say that. I feel like it is just, you know, a joke. Every time I hear "Lasagna Committee," I think yeah, right. Anyway, I guess it really is the Lasagna Committee. CHAIRMAN OSBORN: Dr. Lasagna is no joke. COMMISSIONER MASON: And his name is really Lasagna. JI bet he had a hard growing up. I noted that you said -- I think you have been rather polite and maybe constrained perhaps because of the company that you have seated with you today at the table, but I noticed in your testimony to the Lasagna Committee that you said this -- or maybe it wasn’t you, maybe it was somebody else, "The FDA has drifted far from the basic intent of Congressional legislation and certain significant revisions in its procedure are needed to help the agency comply with existing law." I wish you could just give me a real brief three or four things that you would have suggested. I know you go into it in this testimony, but how come there isn’t a happy marriage between the pharmaceuticals and the FDA, and what can be done to kind of -- what am I looking for? I’m lost. MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 86 But anyway, how can we do better for people who need drugs? What in the FDA’s regulatory process, in the view of pharmaceutical manufacturers, are impediments to speedy approval of drugs? DR. PETRICCIANI: That is, aS you can imagine, an: enormous questions, and the Lasagna committee, in fact, has spent something like 14 to 16 months trying to sort all of that out, and I wouldn’t begin to presume what is in their final report. But in terms of the kinds of issues that we presented to the committee, I’1ll just list a couple, just to highlight. One of the major areas that is of concern to us, as well as to patients themselves, is the length of time that it takes for a drug to get through the review and approval system. A recent study on average that was actually -- it is not yet published but it was described recently -- suggests that for the average drug it takes 12 years from the initial research through the approval process. That’s not 12 years in the FDA system, but FDA contributes a certain part of that 12-year period. The statute says that a drug should be acted upon, either accepted and put on the market or rejected, within 180 days. Most of the drugs that go through the system certainly MILLER REPORTING CC., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 87 do not meet the statutory requirement of 180 days, and we suggest that the agency try harder to meet what the statute said it should do. That’s one. There are other administrative aspects to the review process that, while they may not relate to new drugs being approved, they are also potentially very important, and these are called supplemental. applications. The drug is already on the market, a new use or different route of administration may be the issue which is being presented to the agency. There has been a chronic problem in reviewing supplemental applications and getting them acted upon with the agency. There is a backlog that has been existing for a number of years and that needs attention, because those new uses or new routes of administration may be extremely important to patients, in some cases just as important as a new drug. The way to remedy those problems is probably a factor that you can divide into two parts. One is personnel, and we have been always supportive of the agency’s requests during the budget process in Congress for resources, and we have also been supportive of requests for additional personnel to get through the backlog. MILLER REPORTING CO., INC. 507 C Sueet, N.E. Washington, D.C. 20002 (202) 546-6666 On the other hand, there is a side of the coin which is the administration of the resources that the agency has, and to deploy those resources in the most productive way we think also needs some attention. And this is consistent with what recent GAO reports suggested. CHAIRMAN OSBORN: Ellen. DR. COOPER: I feel compelled to make a couple of comments here. One is I think we have to understand that Dr. Petricciani is referring to drugs in general and not specifically to AIDS drugs or to drugs being developed under Sub-part E. You know, without going into the specifics of what he said, I think it is important to know that for AIDS drugs there are essentially -- well, there are none pending, certainly none past 180 days, NDAs and supplements as well, efficacy supplements, and, of course, the most recent ones are the AZT supplements, both for expanded indications, the lower dose, pediatrics, have. all been acted on I think quite rapidly. And in terms of drug development time in general for AIDS drugs, obviously there are a variety of AIDS. drugs too in terms of opportunistic infections, drugs that treat HIV, and immunomodulators, other biologics. But AZT is MILLER REPORTING CO., INC. $07 C Street, N-E. Washington, D.C. 20002 (202) 546-6666 89 certainly an example of a drug that went from test tube to approval in just over two years. So I think that while there certainly is room for improvement over all, and I think the agency has improved over the last few years in terms of backlogs of supplements and overdue applications, I think in the AIDS area our records are pretty good. | CHAIRMAN OSBORN: In view of the fact that we are running a little over, I’m going to suggest that Don DesJarlais’ question be the last, and I hope if there are other commissioners’ questions we’ll try and interact with the panel, because you have given us some very important testimony. But Don, why don’t you ask, and then we'll take an abbreviated break SO that we don’t keep our next distinguished panel waiting too much longer. COMMISSIONER DESJARLAIS: This is for both FDA and PMA. Out in the field one hears very interesting and disturbing stories about noncompliance issues with respect to AIDS drug trials, both that certain groups of patients are being pretty systematically excluded from the trials because of fears of noncompliance, and then also very interesting stories about people who do get into studies, creatively % MILLER REPORTING CO., INC. $07 C Street. N.E. Washington, D.C. 20002 (202) 546-6666 90 noncomplying, going to an outside physician to have their blood tested to find out whether they are in the experimental or the placebo group. Is there any mechanism for examining noncompliance issues in AIDS-related trials? Is either the industry or the FDA setting up some way of monitoring the extent of noncompliance and whether it--is even undermining the scientific validity of the studies being conducted? DR. COOPER: Well, I guess since the microphone is next to me I‘’ll respond briefly first. Certainly we do look, in examining data from studies and, of course, in perspectively working with sponsors in reviewing protocols and setting up the studies in the first place, look for methods of assessing compliance. And there are the traditional ones, things like pill counts, visits, that kind of thing, and then also certainly looking, when it is possible, for testing patients’ blood or urine or other body fluids for presence of either the drug under study or for other drugs likely to be used perhaps, or widely available, particularly if it is felt that they may have a Significant impact on the outcome of the study in analyzing the outcome of the study. ”) MILLER REPORTING CO., INC. 507 C Street. N.E. Washington. D.C. 20002 (202) 346-6666 91 I think it certainly is a concern, and industry and NIH I know has been looking at this problem, but in terms of results that are positive, for example, AZT, the AZT study certainly the question about mixing drug between the placebo and AZT group came up and how did that affect the outcome. Well, normally, certainly any kind of mixing of the two study groups would tend to make the differences between them be less. So the risk, of course, is that a drug that may be active or effective, you don’t detect it if there is too much mixing between the two groups. On the other hand, I think probably more of the noncompliance concerns taking drugs outside of the protocol itself, not necessarily mixing the two groups, let’s say if there are two groups that are randomized, but actually both sides taking other therapies. And that, to the extent that is similar in the two groups, actually may not have as much of an effect on the outcome as is sometimes feared, although, of course, it does depend on specifically what the drug is. And in terms of unblinding, I think the same concerns exist, that we obviously like to keep the studies blinded, that’s the most unbiased way of assessing. On the other hand, for many drugs either toxicities or drug effects MILLER REPORTING CO., INC. $07 C Street, N.E. Washington. D.C. 20002 (202) 546-6666 92 like effects, for example, AZT on the MCV do make it almost impossible to keep them blinded over a long period of time. DR. PETRICCIANI: I can’t really add very much to what Ellen has said except that there is no industry approach to the noncompliance issue, and it really has to be dealt with on a drug-by-drug clinical trial company-by-company basis. What may be appropriate for one clinical trial ina certain drug may not for another, but there is no concerted effort to try to address it. CHAIRMAN OSBORN: Let me thank you very much for very important testimony, and I think what we’ll do now is take a break until 10:25 and that will put us within 10 Minutes of schedule. And thank you so much, we may get back to you. [Brief recess. ] CHAIRMAN OSBORN: May I ask the Commissioners to come and take their seats. I want to get us started again so that we don’t hold up our guests any longer than necessary. And we very much appreciate the next panel coming from the National Institutes of Health to give us an overview. Dr. Fauci, Dr. Pizzo, Dr. Heinrick, and Tony, why don’t I let you start. 7 MILLER REPORTING CO., INC. $07 C Screer, N.E. Washington, D.C. 20002 (202) 546-6666 93 Welcome. DR. FAUCI: Thank you very much, Dr. Osborn, Dr. Rogers. It is a pleasure to be here today. What I would like to do is give you a very brief overview of the programs of the NIH, more specifically, focusing on the area of treatment, clinical trials, and accessibility to drugs. But before I do that, let me just, for those members of the Commission who have not seen these types of figures, this is a breakdown of the budget of the NIH on AIDS from 1982 when we started. off with about $3 million, increasing almost exponentially up to the current 1991 estimate of the President’s budget of about $800 million. As you can see, the rate of growth in ‘'86, ‘87, ‘88 was anywhere from 25 to 40 percent over the last couple of years. Particularly this year there has been a plateauing of the funding for AIDS relative to the rest of the NIH, namely instead of having a marked discrepancy with the increase, it is still greater that the non-AIDS component of the budget, but it isn’t as great as it has been. We have don’t have time to go into the details of this, but suffice it to say that there is the concern among the non-AIDS constituents about the disproportionate amount MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 94 of money going to AIDS. I, for one, feel that the amount of money is quite appropriate and rather than question the slicing of the pie, perhaps this would give us a reason to question whether or not we are spending a significant amount or an appropriate amount on all of biomedical research, which I think we are starting to look at more closely now, and perhaps the American public needs to make a reassessment of how much they are willing to spend on biomedical research rather than of how the pie is going to be sliced. With regard to the different institutes, the NIAID has about 47 percent of what they do is AIDS, the Cancer Institute has less, but is second, somewhere between 10 and 20 percent, and the rest of the institutes have some part of that activity, and virtually all of the NIH institutes are involved. From a functional category standpoint, this very briefly to show you the relative proportion of how the money is spent. Of the $800 million for fiscal year 1991, clearly the area of therapeutic agents -- here $326 million -- is ahead of all of the others, follow by basic biomedical research and vaccine development, which here is $86 million. We could get back to this later in the questions if would like. The research efforts I have empirically broken MILLER REPORTING CO., INC. 507 C Screet, N-E. Washington, D.C. 20002 (202) 546-6666 down into five areas, ranging the epidemiology, natural history, the etiologic agent, pathogenesis, treatment and vaccine. As I mention, we’ll focus on treatment, but as has become very clear to us, all of these others feed into treatment, as schematically diagramed here, in which our understanding of the natural history and epidemiology, as in the Multicenter AIDS Cohort Study of the NIH, gives us insight into the timing of initiation of therapy, understanding pathogenesis, and, of course, the virology and molecular biology of HIV itself, the targeted development, and finally drug development that in and of itself is geared toward the treatment of HIV and its complications. The strategy for treatment is three-fold, treating the complications of HIV, be they opportunistic infections or neoplasms, direct anti-retroviral therapy, and ultimately, if we are successful, to reconstitute the diminished immune response, which, as you could imagine, is something that is really quite complex. The drug development process is divided up into two major area -- preclinical and clinical. In the preclinical area there is screening. By that we mean testing drugs that are already developed. AZT is the prototypical screened MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 96 drug. It was developed for cancer many years ago, a poor anti-cancer drug at that, was screened because of its known anti-retroviral activity, and was found to be effective in the test tube and in clinical trials. We focus now on targeted drug development where what we know about the virus itself is translated into a directed approach towards antiviral therapy and finally both of these feed into clinical trial process, which I will describe in some detail in a moment. The targeted drug development program for the NIH has multiple components, the largest -- of which I will give you some details on in a moment -- is the National Cooperative Drug Discovery Group. The National Institute of General Medical Sciences has an extramural structural biology program. There is an intramural structural biology program at the NIH, and then there is the intramural targeted drug development program, which is substantial, of the NCI. As I mentioned, all of these ultimately feed into the clinical trial process. Getting back to the targeted development, this is a slide that many of you have seen in different formats. This is the life-cycle of HIV, showing how the virus binds to a MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 97 specific receptor, uncoats, uses an enzyme reverse transcriptase to go from RNA to DNA, integrates itself into the chromosomal material of the cell and can stay there indefinitely for the life of the cell or can activate itself, make new RNA and new virus. I show this slide because what it does is it gives us a vulnerable target point at each of these areas where one can develop a drug. For example, soluble CD4 blocks binding. Reverse transcriptase is blocked by AZT, DDI, other oligonucleoside derivatives block transcription as well as antisense, interferon alpha blocks viral assembly. You have heard in the newspapers also about how now certain genes can be mutated and reinserted to compete in a dominant fashion with a variety of these genes, both structural and functional genes; of HIV. We don’t have time to go into all of this except to say that not only can we target the life-cycle, but we can target the actual genes of HIV. Getting back to the National Cooperative Drug Discovery Program, it is a complex collaborative program involving industry, academia and government, and its purpose is to bring together a variety of interdisciplinary MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 scientists ranging from virology, molecular biology, immunology, et cetera, et cetera, in order to use the approach that I alluded to on the previous slide to target various drugs toward HIV. It has been a very successful program in bringing together the best of academia, industry and the federal government. The clinical trials program for NIH and non-NIH are divided into the following. We’ll get to the Clinical Trials Group, the largest network of any clinical trial process, AIDS or non-AIDS, the Community Program for Clinical Research, the Intramural Clinical Trials Program. You will hear some from Dr. Pizzo about the NCI’s program, also Dr. Broder and his colleagues. The NIAID has an intramural program, and then there are pediatric clinical trials involving three institutes, as listed on this slide. ° The non-NIH trials are industry sponsored clinical trials and some community research initiatives. Our AIDS Clinical Trial Group is made up of 46 trial units at about a hundred sites. They are academically based. It is a cooperative agreement mechanism with input both from the investigators and the NIH, and it serves as a multicenter network of a national resource for the evaluation MILLER REPORTING CO., INC, 507 C Sureer, N.E. Washington, D.C. 20002 (202) 346-6666 99 of drugs for HIV. This is some of the accomplishments of the AIDS Clinical Trial Group. We now have -- as I mentioned, an additional one was just funded -- 47, including 15 pediatric units, 10,000 patients have been enrolled on the trials, 52 drugs or combinations have been administered, and there are a total of 107 protocols, of which 53 are open. We have focused very extensively on early intervention in HIV, both from the prophylaxis against opportunistic infections, such as the aerosolized pentamidine and a number of other programs, comparing that with a variety of other drugs, including bactrim and dapsone, et cetera, and an area that you have heard about, namely, the treatment of HIV infected individuals who are asymptomatic or who have early symptoms. That is the 016 and 019 protocols that have recently been published. A state of the art conference was held at the NIH recommending, AZT therapy for early intervention based on those large multicentered trials, so the indications of AZT have now changed. to include individuals with T4 cells less than 500 who are totally without symptoms. Of importance is the fact that there are a number of drugs alone or in combination, usually in MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 346-6666 100 combination with AZT, as iS appropriate since that is the index drug, trying to look at less toxic regimens and regimens that can be administered early and chronically for people with HIV disease. The problem of access to experimental therapy I know has been discussed before this Commission. We look upon it: as two types of access problems, access for those who have a readily available health care delivery system, such as a middle class gay man in an area in which there is no clinical trial process, such as, for example, in certain midwestern cities, as well as access for those who do not have a readily available health care system, such as a minority individual in a city in which there is a clinical trial process but that person has been disenfranchised, over a period of time even antedating HIV, from the system, and we have to address both of those. One of the ways we. can do this -- I know you have discussed this before -- is the parallel track approach in which we try to preserve the scientific integrity of the classical clinical trial mechanism at the same time as being flexible in making available for people who cannot be on the classical clinical trial for reasons ranging from ‘e MILLER REPORTING CO., INC. $07 C Street. N.E. Washington. D.C. 20002 (202) 546-6666 101 geographical inconvenience to a total accrual of the trial to not being able to fulfill the criteria for admission, such as being too sick or having laboratory tests that preclude them from getting on to the trial. It is meant to not interfere with the scientific process but make accessibility greater. We feel very good about the NIAID Community Program for Clinical Research on AIDS which we established this year. We have 1g units now throughout the country, and the purpose is to bring the clinical trial process to the grassroots community level, to utilize the expertise different from the expertise in a secondary and tertiary medical center that a community physician can provide, and to also increase the access of people in the community, particularly IV drug users, minorities, women and children who have not been represented as much as we would like them to be in the ACTG process, but that too is improving. "Minority Participation in AIDS Research," this is a booklet that we have recently put out, our framework for action of increasing participation both by investigators and patients of minority groups. This is based on the following data: patient accrual to ACTG trials -- these are numbers you are quite familiar. You know 27 percent of AIDS cases MILLER REPORTING CO., INC. $07 C Street, NE. Washington, D.C. 20002 (202) 546-6666 102 are in black and only 11 percent of the total population are black, 16 percent are Hispanic and only 7.4 percent of the population. If one looks at the percentage in clinical trials, in 1987 we have been getting better in that 7 percent were in clinical trials in ‘87, it is now up, for the blacks 11 percent, up to 12 percent with Hispanics. But we need to do much better than this, and that is why we have outlined a program of how we can increase minority participation. We have done this by a variety of outreach programs. We have done it by direct mandating of expanding minority health professionals, as well as patients, in the clinical research project, as well as targeting strategies for information dissemination and outreach. We recently awarded a $1.2 million grant to the Association of Minority Health Profession School, AMHPS, to Support a consortium center to coordinate prevention and research activities and to help us to know how we can better get the minority community, the professionals involved, and the patients accessed on to our clinical programs. Opportunistic infections has been a problem, because there are a number of areas of difficulty. I know MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 346-6666 103 you have heard, and it is partially true, that investigators themselves are not that interested in doing OI trials. We can put some pressure on them by linking our resource allocation to the performance in this area, but there are other problems beyond their control. This is a very resource intensive activity. The patients are acutely ill. Enrollment is sometimes limited by that. They are very complex, and we have met a problem that I would hope that this Commission would address with us. Very often when you admit a patient on to a hospital ward -- which you have to do -- who has an acute opportunistic infection and you put them on a clinical trial, immediately third party payments are suspended on those individuals, in some cases because they are felt to be on a clinical trial. If the clinical trial process must assume the cost of this, you can imagine how resource intensive this would be. This is a very significant problem for the conduct of Opportunistic infection. Not withstanding that, we have been increasing our accrual. If you look at these numbers, from 7/89 until April 1990 we have had a 300 percent increase in the actual numbers of patients in OI protocols from 703 to 2,065. We still need to do better, and I’ll show you in a moment what are plans MILLER REPORTING CO., INC. 507 C Sueet, N.E. Washington, D.C. 20002 (202) 546-6666 104 are. The proportion of enrollees in OI protocols have more than doubled from 10 percent of the people in protocols . being in OI to now 22 percent of people being in OI. These are our plans for the next 12 months of new studies. Studies for drugs against HIV, the AZT/DDI type drugs, have always far been disproportionately ahead of OI studies. In the next 12 months we have five new protocols planned for HIV, but 12 additional ones for OIs, and here you see pediatrics, oncology, neurology and immune reconstitution. HIV vaccine finally -- and this is my last slide -- the past year has allowed us to gain some optimism. There have been a number of studies indicating that there is truly the possibility of a protective immune response, studies looking at the nature of antibody in mothers, which seems to be correlated with protection in children, namely a high affinity antibody against GP120. We have a number of phase one trials in humans, and there have been successful induction of protection of monkeys with whole killed SIV followed by challenge with a live virus. Now, this doesn’t mean we are going to have a > NN MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 105 vaccine soon, because these are done under optimal conditions and it will probably still be several years before you see phase two or phase three trials of vaccines in humans. So in summary then, I have outlined the broad overview of the NIH’s activities, focusing very heavily on therapy, particularly what our plans in the future will be for filling the gaps in areas that have not, in my opinion, been filed well, namely, the access of minorities, women and children. I will be happy to answer any questions. CHAIRMAN OSBORN: Thank you very much, Dr. Fauci. Maybe we can hear from all three of you first, and then we’ll have lots of questions I’m sure. DR. PIZ2Z0: Thank you very much for the opportunity to be here this morning. I have provided a rather extended outline and summary of the current clinical trials, and I’ll summarize for you this morning three basic points. the first of them is that the problem of HIV disease in the pediatric population is increasing. This first slide shows the five leading causes of death in infants and children. Young children and infants at the top, younger children at the bottom, and I think you can appreciate that agit be, s @ MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 106 over time other causes of death in the pediatric population have been stable, but AIDS is on the increase. This is true also in older children and in adolescents, and it has now made its way into the top 10 leading causes of death in children, and in some populations into the top five. We anticipate that the numbers of cases will increase significantly over the next several years. Whereas today, the proportion in the pediatric population constitutes 2 percent of all of AIDS, it is the population that is among the most rapidly growing, a 38 percent increase between 1988 to 1989, with estimates of anywhere from 6,000 to 20,000 cases in the next couple of years. The major reason for this, of course, is related to the increase in perinatal acquisition, which now represents © over 80 percent of all cases, and in the future will represent, of course, the vast majority, if not all, of these cases. An essential issue and related to most things that we think about with regard to perinatal acquisition or vertical transmission is when does it occur? And is a fundamental question that will certainly have an impact on clinical prophylactic studies. Will it follow, for example, the rubella model and be transmitted early in gestation? Will it MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 follow the hepatitis B model and be associated with intrapartum transmission? We certainly know that there are a small number of cases that can be acquired postpartum by way of breast milk. There is data on both sides of the coin at this point in time with no resolution of this issue, and yet it remains a fundamentally important research concept that will have important impact on the future research that relates to prophylaxis. In contrast to the disease in adults, at least within the United States, AIDS in children is largely one affecting minority cases. It is largely associated in urban areas, particularly in those parts of the United States where there is a high use of intravenous drug use. Now nearly 50 of the states have reported cases of HIV disease, although there is a clustering in New York City, New York, Miami and some of the larger urban areas in Texas and California. This is a disease largely of children of color. It is over 23 times the proportion in the population in black children, 13 times Hispanics, meaning that our minorities are certainly being over-represented by the impact of this disease within the pediatric population. MILLER REPORTING CO., INC. $07 C Screet, N.E. Washington, D.C. 20002 (202) 546-6666 108 I think from the point of view of pediatrics there really are two populations that one will focus on. Increasingly in the future it will infants and young children, most of whom will have acquired their disease vertically. But we also must not lose sight, of course, of the problem as it relates to teenagers and young adults. Although their routes of transmission are the same as in adults, they represent an important focal point for future transmission of this disease in the pediatric population. There are a couple of notable differences between the disease in children and adults that has an impact upon how we consider therapeutic intervention. First of all, the degree of lymphopenia associated with disease manifestations is different. Infants can become profoundly affected even before their T4 helper count has fallen below 500, so that neural encephalopathy or Pneumocystis carinii in newborns can occur when their helper counts are well above 500. Some of the opportunistic infections that have been used to guide therapy in adults are rare in children, particularly Cryptococcus and toxoplasmosis, because these infections have not yet been acquired by infants and young children. And some of the malignancies, particularly MILLER REPORTING CO., INC. 507 C Sereet, N-E. Washington. D.C. 20002 (202) 546-6666 109 Kaposi’s, rarely if ever occur in the pediatric population, although we do anticipate an increasing number of lymphomas and other malignancies in this population in the future. On the other hand, recurrent and serious bacterial infections predominant as a major cause of infection in the pediatric population, and the syndrome of lymphocytic interstitial pneumonia, which can have devastating impacts upon the pediatric population, occur in anywhere from 20 to 40 percent, hardly ever in the adult population. One of the most important symptoms that afflict young children are neurodevelopmental deficits, which occur in anywhere from 40 to 90 percent of children and can seriously affect their overall outcome. Where are we with refard to therapy? Well, there have been changes that have been taking place, but we must recognize that they are taking place in the context of our traditional approach to drug, evaluation. Certainly this is an area that has been undergoing rapid evolution in the last several years. I think we all now recognize that testing of new agents, phase one testing, really can’t wait until the completion of studies in adults. That was the traditional approach that took place in years past, and we now, I think, MILLER REPORTING CO., INC, 507 C Street, N.E. Washington. D.C. 20002 (202) 546-6666 110 largely wish to underscore the fact that phase one testing of new agents in children should begin either simultaneously or closely following the initiation of studies in the adult population. We also have to recognize that populations that have been largely excluded from the use of experimental agents need to be included, particularly young infants and newborns, and also to consider the use of prophylactic regimens that might have an impact during pregnancy and delivery. These are non-traditional approaches but certainly important ones to underscore for the future. The experimental agents that have been utilized in adults have to date already been introduced into various clinical armamentaria in children, and include the dideoxynucleosides, soluble-CD4, and some of the biological agents. There are important differences, as I have highlighted, that underscore some areas that one must address in the evaluation of clinical trials in the pediatric population. In addition to focussing on measures like surrogate markers, including the CD4 count that we have heard about this morning, we also must focus on some of the major MILLER REPORTING CO., INC. $07 C Sueet, NE. Washington. D.C. 20002 (202) 546-6666 biological abnormalities in the pediatric population, particularly the neuropsychological problems, and this may well be an important area to look at in evaluating drugs in children. We also have to keep in mind, of course, that any agent might also be organ specific, and just because an agent doesn’t work against one or more of these particular aspects doesn’t mean that it doesn’t--play a role in the overall therapeutic armamentarium. I’ll go very quickly through some of the areas that have changed and shed some light into where we might be in the future. We have had the opportunity to evaluate AZT on a number of different schedules, among the first of which was on a continuous infusion schedule designed to maintain high levels of drug above the inhibitory concentration in both plasma and CSF. And on this schedule we observed that there was rather complete improvement in children who presented with neural encephalopathy, both in terms of subjective changes, objective changes in terms of virtually complete reversals in developmental deficits and neurological abnormalities. And these were accompanied by changes in psychometric testing. On the left-hand portion is shown the IQ scores in children before they received continuous he MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 112 infusion AZT, and then six months later, a 15 point increase in the overall IQ scores, that was shown not only in those children who presented with encephalopathy, but also in children who appeared to be cognitively intact but who had AIDS, underscoring that cognitive impairment may be a significant abnormality in children early in the course of their disease manifestations. Objective changes can also occur, as is shown here. On the upper panels are the CT scan findings in a child before therapy. You can see the degree of ventricular dilatation, and then after six months of therapy a complete or virtual reversal back to baseline, accompanied by clinical improvement, underscoring that dideoxynucleosides can make a different in the pediatric population. Together with the National Institutes of Allergy and Infectious Diseases, studies have gone forward with evaluating AZT on an oral intermittent schedule, again showing benefit of this agent in the pediatric population. But as has been seen in the adult population, we recognize that AZT is not certainly going to be the cure-all and that other agents must be evaluated as well, and indeed, other studies have been proceeding. Studies with dideoxycytidine MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 113 in a pilot study, both alone and in sequential combination with AZT, have been undertaken and have shown some promising findings, as has studies with dideoxyinosine that commenced in the pediatric population in January of 1989 and that again have shown promise of this agent in the pediatric population as well. What can be concluded at this point in time with regard to agents that block reverse transcriptase, the so-called dideoxynucleosides? Well, I think that we can say that these agents do have some promise. We know that agents like AZT, DDC and DDI can lead to clinical improvement. Certainly they can to varying degrees reverse the dementia and have virally associated signs of improvement. They can also, of course, have some dependency upon the route of their delivery, and these are areas that require further study in order to maximize and optimize the schedule of therapy in the pediatric population. . We, of course, need to turn our sights toward other agents that might be used either singularly or in combination with agents that have an impact upon the life-cycle, and as Dr. Fauci has underscored, one now can begin to look at agents that block different portions of the life-cycle. CD4, MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 114 soluble CD4, is such an agent and studies are already in progress in the pediatric population, already completing studies in symptomatic patients and now getting ready to look at the role of this agent during labor and delivery, at least as one way Of being able to approach methodologies that might be able to decrease transmission of virus from mother to child. - I think that there are really four groups that we must focus on in the pediatric population. We have to focus now on the fetus and ask the question of whether we can block transmission by administering therapy, either during the intrapartum period or during the third trimester of pregnancy. Studies to begin to look at this will be initiated shortly by the merger that has taken place between the National Institutes of Allergy and Infectious Disease and the National Institute of Child Health and Human Development, and shortly we will address in a large scale multicenter study the impact of a dideoxynucleoside on preventing, or at least potentially preventing, transmission. Of course, we have to focus on the newborn as well and be able to differentiate between those who are infected versus those who simply carry antibody. We also must focus MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) $46-6666 115 on those children who have developed symptoms, and, of course, one can’t lose site of the teenager, who plays a critical role in the future generations of this disease. I think the future will, much as it has in the treatment of pedestrian cancers, be looking toward combination schedules. We have already begun in our program at the NCI combinations of dideoxynucleosides together with soluble CD4, and shortly we’ll be adding interferon to those regimens to utilize combination schedules that may block different steps in the HIV life-cycle and hopefully will have an impact on the course of this disease. However, even if we were to develop and have therapies available that might play a role, we also have to look at the impediments to their delivery, and they are of multiple factors. They include a variety of different components. Certainly, from the bureaucratic point of view, our agencies have had to come to grips with revising the formulations of how we approach drug development and approval. In the pediatric population, we need to look at this as a family disease, because certainly for every infected child there will be increasingly an infected participant, or set of parents, and often these parents will MILLER REPORTING CO., INC. 507 C Street. N.E. Washington. D.C. 20002 (202) 546-6666 116 come from areas of social disruption and will be impoverished already and face now the additional burden of having a child who is infected with this disease. Our medical systems, of course, are going to have to look at ways of trying to keep pace with this disease, not only in terms of providing care, but importantly and increasingly in training individuals who will be able to lead the research effort as well the clinical effort in the future. All of us, of course, bearing the financial burdens of treatment and research, and particularly in the pediatric population, having to face the societal issues of discrimination, which are of increasing magnitude in this population of patients. It is, in summary, a disease within the pediatric population that affects the whole repertoire from the fetus to the infant, through the various ranges of life to the adolescent who potentiates the cycle once again. Indeed, pediatrics represents an important key to the solution of AIDS, both in terms of education as well as in terms of therapy, and we hope in the future to be able to make an impact on this problem. Thank you for your attention. MILLER REPORTING CO., INC. 507 C Sueet, N.E. Washington, D.C. 29002 (202) 546-6666 117 CHAIRMAN OSBORN: Thank you very much. That is a very elegant and rich presentation. Dr. Heinrick. DR. HEINRICK: Dr. Osborn, Commissioners, I’m pleased to appear before you and share some of the activities that are going on with the fairly newly established National Center for Nursing Research.-: We are indeed strongly committed to stimulating research on nursing interventions to prevent HIV transmission, and on the nursing care of individuals with HIV and their families. As we have heard, there have been major strides made in therapeutic interventions to reduce symptoms and treat opportunistic infections, and we all acknowledge the fact that this is now a chronic disease. Nevertheless, HIV infection is currently incurable. Nurses have been actively involved in care of patients infected with HIV since the onset of the epidemic. Recognizing the magnitude of nursing care issues and problems, we at the National Center for Nursing Research sought guidance from a multidisciplinary expert team to establish program goals to guide our research effort. Those goals are outlined as follows: To identify health care needs MILLER REPORTING CO., INC. $07 C Screet, N.E. Washington, D.C. 20002 (202) 546-6666 118 of individuals who are infected or who practice high-risk behaviors from which appropriate nursing interventions might be derived; to develop effective nursing interventions designed to prevent HIV transmission; to develop effective nursing interventions designed to maintain optimal functioning of infected individuals and their families across the spectrum of the illness;--to test models of nursing care delivery to individuals who are infected; and to examine ethical dilemmas in providing nursing care and to establish an empirical basis for ethical decision making in nursing With that in mind, I’d like to give you some examples of some of the studies that we are currently supporting at the National Center for Nursing Research. There is a group of investigators at Hopkins in the School of Nursing, led by Dr. Judith Bagis-Smith and her colleagues, who are assessing patient care needs in a variety of settings. These include the outpatient clinical, an inpatient AIDS unit, a home health care agency and a nursing home. As you would expect, they have found a wide variation in health care needs across the spectrum of MILLER REPORTING CO., INC. $07 C Suet, N.E. Washington, D.C. 20002 (202) 546-6666 illness, increased control of adverse symptoms with new therapies, and continued practice of high-risk behaviors among many individuals who are infected but symptom free. The investigators are planning to develop nursing interventions designed to increase patient compliance with preventive behaviors. Another team at Hopkins, headed by Dr. Arlene Butz, is conducting a longitudinal study of infants born to mothers at risk for HIV infection. Again, this is an inner city group of women of color and their babies, for the most part. And the babies may be positive or they may be HIV negative. The team is unique in that they are able to collect information on the physiological variables as well as the psychosocial and environmental variables. A team, a nurse practitioner and social worker, will visit these mothers’ babies in their homes, and they are taking assessments on the infant health and growth characteristics, the maternal psychosocial health characteristics, which may include drug use, and then the biological indices. Preventing the transmission of HIV infection is critical. Certainly we have had massive public health education programs, and these are an important step in MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 120 informing the public, but we also need a better understanding of how to induce and maintain individual behavior, and this for targeted populations. One NCNR supported researcher is investigating factors associated with safe sexual behavior among college freshmen. Another investigator is testing a targeted videotape message in order to change negative or false beliefs about condoms. These study subjects are young black and white clients of both sexes attending a sexually transmitted disease clinic. Several studies are testing nursing care delivery models. Dr. Linda Aiken at the University of Pennsylvania is conducting a comparative study of the different types of organized units in the in-hospital setting. This is to really compare dedicated versus non-dedicated units for the care of people who are severely ill with AIDS. Much of the care provided to people with AIDS-related illness now takes place in the home, and people are either receiving care from relatives or friends or are practicing self-care. To help meet the demand for information for services, one center grantee is developing a computer-linked system. Dr. Brenner and her colleagues have MILLER REPORTING CO., INC. $07 C Street, NE. Washington, D.C. 20002 (202) 546-6666 121 developed a database to answer questions and provide methods to help solve nursing care problems. People in the study are provided with a computer in their home, are taught how to use this, then are able to send messages to a nurse experienced in the care of people with HIV associated illness, and they can therefore respond. Another aspect of this is that, again people can link with other people who are in their homes anonymously in providing support to one another. Another research team at Ohio State University is testing the benefits of a nurse case managed system, again in the home. Nurse case management is an administrative strategy which involves a comprehensive care plan for the delivery of appropriate services. As a relatively new research center within the National Institutes of Health, the center is responsible for a growing pool of investigators. This is also true for HIV related research. Although there is only a small pool of nurse scientists who have received directed training to conduct research in HIV infected persons, we are funding one institutional training program and we have approximately seven individual predoctoral fellows who are seeking preparation in some aspect of HIV related research. MILLER REPORTING CO., INC. 507 C Street, N-E. Washington, D.C. 20002 (202) 546-6666 122 The intramural program for HIV infection initiated this year is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, and with the NIH Clinical Center. The intramural program efforts are targeted to individuals infected with HIV, their partners, and their families, who are currently participating in studies conducted at the NIH. The general aim of our intramural program is to conduct an organized program of research that will increase our understanding of health problems that are particular prevalent and troublesome to the individual infected with HIV. The focus is really to minimize dysfunction and the suffering due to physical or psychosocial sequela of the infection, such as unintentional weight loss, decreased appetite, other nutritional disorders, diarrhea, fatigue, oral complications, pain or dementia. Other common problems such as anxiety, depression, loss and grieving, and the quality of. life may also be addressed. We know that as the infection remains incurable it is really important to direct efforts toward discovering ways to decrease morbidity in order to maximize the quality of an individual’s life. This becomes even more important because the individuals are living longer due to advances in disease MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 Nurses have played a major role in responding to the needs of individuals with infection, and improving primary care services to patients with AIDS and HIV. In providing comprehensive care, nurses face multiple decisions, along with families and individuals, and we need to support systems for these individuals. The needs and opportunities for nursing research in the care aspects of HIV infection are clear. I would be happy to answer any questions. CHAIRMAN OSBORN: Thank you very much. Thanks to all of you for some wonderful and succinct testimony. I’m sure the Commissioners have questions. David. COMMISSIONER ROGERS: Let me just second that. That was elegant and informational. Tony, in terms of your first slides where you showed the breakdown in terms of funding, are those available to us in our packet anywhere here? DR. FAUCI: I don’t think so, but we can certainly get them to you without any problem at all. MThe functional category, the breakdown, the difference between vaccines and MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 124 therapy. Yes. COMMISSIONER ROGERS: My query to you, it has been brought up by some, or at least the question is raised, is the NIH, with your powerful basic science research thrust, the appropriate spot for your ¢linical trials? Does it make sense to do your clinical drug trials out of your institute, for example? -- DR. FAUCI: Dr. Rogers, I think so, and very strongly so, for the following reason. If you are talking about the difference in having the NIH funded for medical centers and having a network that is government funded versus having industry do the trial, the purpose of the AIDS Clinical Trial Group is to determine what the best way to treat patients with HIV infection is, not to determine if a drug should be marketed or not. And that includes drugs that might not have great appeal for drug companies to develop. That might include combinations of drugs that drug companies are not too enthusiastic to do trials on. So I think that if we abandoned that, many of the important clinical questions that need to be asked and answered and then delivered to the American public in the form of the physicians who take care of patients and the a” ™, MILLER REPORTING CO., INC. $07 C Street, NE. Washington, D.C. 20002 (202) 546-6666 125 patients themselves would not get answered. We have some good examples of that. For example, we still don’t know what the optimal dosage and regimen is for AZT, and that’s why we are doing trials to try and find out what the minimum dose is, and we are going to:be faced with the same problem of combinations, whether if you use AZT at a much lower dose in combination with another drug like interferon alpha or GMCSF can you get maximum benefit out of that. I don’t believe those studies would be done as effectively if they were not done by a group that was asking that specific question, what is the best way to treat the patient, not what is the best way to get a drug licensed. COMMISSIONER ROGERS: One more question for Dr. Pizzo. I much enjoyed your presentation. Can you give us a timetable on when your studies to see if you can prevent maternal infection of children will start? . DR. PIZZO: These are studies that are just getting ready to commence. They will be beginning, hopefully, within the next couple of months. They will need to enroll a large number of mother/infant pairs. Part of the dilemma with regard to this area is that only a third, one out of three MILLER REPORTING CO., INC. $07 C Street, N.E. Washington. D.C. 20002 (202) 546-6666 126 infants born to a seropositive mother is in fact infected. And that means that a very large number of mother/infant pairs will need to be enrolled. I think almost everyone is anticipating that this first study is going to require at least one, if not two years, of time just for entrance of the 700 and so mother/infant pairs that wild need to be enrolled in this trial in order to provide that answer. COMMISSIONER ROGERS: I don’t want to prolong that, but I’m a little startled at that. If you had a highly effective drug, it seems to me about 10 mothers would settle your question for you. DR. PIZZO: Well, that may be the case. COMMISSIONER ROGERS: If it was zero infection versus 33 percent, that wouldn’t take a great many. DR. PIZZO: Yes, precisely. I think that if you had 100 percent degree of protection, then it would take a much smaller number of case entries to answer that question. I think that that is absolute gainsay. The calculations are based, of course, upon that not turning out to be the case, and I think that one of the dilemmas -- and I highlighted this for you in the presentation -- is that there really are aos, MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 127 several bases for potential failure. One of them would be that it is just not going to work no matter when you give it. The second would be that the transmission might occur before the time that the drug would be started. And that has been a topic, obviously, of some debate and concern as to when to give the therapy in a format that would provide the highest chance or activity and the least chance for toxicity. CHAIRMAN OSBORN: Don Goldman, Harlan. COMMISSIONER GOLDMAN: Thank you. Dr. Fauci, I’m concerned about some of the barriers which have pregeficluded some people from entering trials, whether or not it be what so many people have suggested, or needlessly excessive limitations in terms of SGOT levels, or whether or not it be limitations in terms of concurrent therapy such as trials that exclude people who may be taking methadone, or who have alcohol problems, or a drug addict. I mean, the kind of data that you are showing in terms of who is going to end up being in trials is clearly, if we are going talking about those kinds of issues, are going to continue to be skewed if the protocols themselves contain the kinds of limitations that naturally exclude those that might otherwise benefit from it. DR. FAUCI: Well, it is a very complex issue. I MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 346-6666 agree with you, and we are now looking at all of the protocols just with that in mind. Namely, should we be -- well, I think we should, not should be -- but how can we, without compromising the scientific integrity of the trial, be less restrictive. In other words, to make it more of a real life setting in which people are going to have some of these associated conditions and associated necessary drugs that are administered. However, there are some restrictions of trials -- you can’t talk just generically and globally about it -- that in fact would have to be maintained if you are going to ask a particular question. But I agree with you that originally, when we weren’t sure of the lay of the land, there were many, Many restrictions. But I think AIDS has created a greater degree of flexibility at all levels of the clinical trial process, and one of them is just what you are referring to. So hopefully that will loosen up a bit. Oo COMMISSIONER a : I have one more question. I’m concerned about, in looking and reviewing all the protocols that exist, there seem to be extraordinarily few available for asymptomatic HIV infected persons. Most of them seem to be related to persons who have some MILLER REPORTING CO., INC. $07 C Sureer, NE. Washington, D.C. 20002 (202) 546-6666 symptomatology, and my concern is that if we don’t start doing some of those trials very early on, if we wait until we find that a drug is effective in a person with AIDS and then begin to start looking at it in a person with symptoms, and then begin to study it, given the lag time and lead time that it takes to determine effectiveness, it is going to be an awful long time before we ever determine whether or not a drug really is likely to be effective, demonstrably so, on an early intervention basis. DR. FAUCI: Well, I would have to respond to that by saying that in part I disagree with that philosophy, and I’ll explain why. First of all, a large proportion, several thousand patients, were and still have are in a trial for asymptomatic individuals, namely 019, and the trial for people with 500 CD4 cells or greater is still going on. So you are talking about a substantial proportion of the whole pool in clinical trials are being tested with a drug that is used in the asymptomatic state. The philosophy of having a drug that has not proven to be effective in an individual who has symptomatic disease, to use that drug in a person who has no symptoms goes against all of the scientific principles of making sure you are dealing with something that works before MILLER REPORTING CO., INC. $07 C Suet, N.E. Washington, D.C. 20002 (202) 546-6666 130 you expose someone who is well to that drug. And we get recommendations from virtually every level of scientific committee that tells us that. So what we have to do is when we get a drug or a combination that shows some indication of efficacy first in someone who is symptomatic, then you would want to go to an asymptomatic individual. - CHAIRMAN OSBORN: Harlan Dalton. COMMISSIONER DALTON: I have two questions for Dr. Fauci. The first response to your testimony with respect to efforts to increase the enrollment of people of color in drug trials, I listened with interest to your testimony today. I also read previously the pamphlet that you on had on one of the slides that you recently produced. It wasn’t clear to me from either of them what carrots and what sticks you use to get people, other than admonitions, you use to get sponsors to enroll more people of color in clinical trials. Moreover, it wasn’t clear to me -- I’m now playing off of Don Goldman’s comments -- how effective trying to increase the number of public health professionals, people of color involved in clinical trials, researchers, investigators, et cetera, how effective any of those MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 131 approaches will be in the absence of dealing with some of the other more structural constraints on entry into drug treatment. So I wonder if you could respond to that. DR. FAUCI: Well, I’m not sure I understand the second question. Let me go to the first question, and that the carrot-stick situation. We have coming up now a -- first of. all, I myself have personally written and mandated to all of the principal investigators encouraging them in the strongest terms to pay very close attention to the enrollment of minorities in the clinical trial process. In the recompetition, which is coming up very soon, for the clinical trials cooperative agreements, I have made it very clear that there will be a linkage between performance and resources, and to me performance means whether you have minorities and women on your clinical trials. And if not, that will be dealt with in the situation of resources. I’m not really sure what you mean about how specifically minorities would not be involved in clinical trials based on the -- give me an example. COMMISSIONER DALTON: Well, for example, if use of intravenous drugs is an excluding factor in clinical trials, that certainly is a factor that disproportionately bears upon a : © MILLER REPORTING Co., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 132 people of color. DR. FAUCI: Well, absolutely, and that is the reason why we have instituted protocols specifically now for people who, for example, are on maintenance methadone. And there will be protocols for people -- I mean, it is very difficult to write a protocol for someone who is taking illegal IV drugs, but you can get -- well, it is difficult to get an IV drug user into a clinic, if, in fact, the person isn’t there for another reason, for example like a methadone maintenance, which is what we are aiming at. COMMISSIONER DALTON: Maybe I can put this first question a little differently. Has there been an effort to link your concern about a attracting more people of color into clinical trials and the kinds of limitations upon who can participant in clinical trials that are not on their face necessarily related to race? In other words, have you gone through the limitations on the exclusion criteria for clinical trials and -- DR. FAUCI: To see if they are minority specific more than not minority specific? COMMISSIONER DALTON: Yes. DR. FAUCI: Yes, we have. I don’t think they are MILLER REPORTING Co., INC. 507 C Sueer, N.E. Washington, D.C. 20002 (202) 546-6666 133 minority specific. What we are trying to do is try and get a situation -- for example, I don’t think that the restrictive criteria of whether your SGOT is up or whether your platelet count has to be a certain level is going to be minority specific. But what is to me more minority specific is the fact that even in cities in which we have secondary and tertiary medical centers surrounded by minority populations, that the minorities don’t get into those clinical trials because those medical centers don’t take care of minorities generally. So what we are trying to do is to link that performance with the resources of those centers, and we have established the community program to try and get community physicians, even in cities that have secondary and tertiary medical centers, to get them involved in the trial. It is not easy, but that’s what we are hoping to do. COMMISSIONER DALTON: My second question, can you help me understand, there was a flurry of news a couple of months ago about the possibility of the federal government shifting in some major way the way in which classic clinical trials are performed. I’m not interested particularly in the flap around the article, but I would like to know if there is afoot in your agency some movement in the way the classical clinical trials are conducted? DR. FAUCI: Not at all, only in the sense that I have delineated this morning, namely, the expansion of access through a variety of mechanisms. The community program is a pilot study in how one can expand clinical trials, ask questions that may not appear as sophisticated vis-a-vis technology but by their very-nature would allow larger numbers of people to come into clinical trials, to ask the real world setting questions, not whether or not you have this subset of T cell that goes up or down. That would by definition expand -- the parallel track would expand -- because it would allow access to drugs. The article that created a great deal of problem indicated that there was going to be revolutionizing of the clinical trial process where there would be 20,000 people on a given clinical trial. By its very nature, that is impossible to do with HIV infection, because of the parameters that you have to follow. If you are giving an aspirin to 20,000 people and the only parameter is whether they do or do not get a heart attack, you can do a clinical trial with 20,000 people, but when you are measuring © parameters that are very subtle it can’t be done. So that MILLER REPORTING CO., INC. $07 C Street. N.E. Washington, D.C. 20002 (202) 346-6666 MILLER REPORTING CO., INC. 507 C Street, N.E. Washington. D.C. 2¢002 (202) 546-6666 135 extreme won’t be done, but an expansion such as the community level, parallel track, et cetera, et cetera, will be done. CHAIRMAN OSBORN: Eunice Diaz. COMMISSIONER DIAZ: Just to follow up on the question that Mr. Dalton asked, it had been hoped by a number of us that the expansion of your programs into the community might generate and increase support from minority physicians, which may be the entry point for a lot of these individuals that we really need into clinical trials. I’m wondering if you have found throughout the last year that that in fact has been generated, or what plans your institute has of really going after that primary care physician who may be the focus of access for the patients? And my second question relates to the fact that nobody has been mentioned in terms of making clinical trials accessible to the incarcerated population of this country, a large number of whom are minority individuals, and I really need for some of you to highlight that, as we are concerned that this population may by virtue of the fact that they do not have access to medical care within mainstream be excluded. Is there some effort to attempt to reach the MILLER REPORTING CO., INC. $07 C Sueet, NE. Washington, D.C. 20002 (202) 546-6666 imprisoned population of this country? DR. FAUCI: Let me answer the first question first, namely, what we are.trying to do. We have, as I have outlined in our plans, a number of outreach programs to Minority physicians. We have had advisory councils devoted specifically to bringing in representatives of minority physicians and community physicians, specifically minority, to try and get ideas from them how we can best recruit them into the program. I, myself, and my staff have met both in Washington and in Los Angeles, New York. I’m going up to New York in a couple of weeks to meet with a group of minority physicians to see how we can better implement our programs at the community level there. So there is a great deal of activity, a mandated focusing on getting outreach to minority ‘physicians. So this is something that is very actively being undertaken in the group. With regard to clinical trials, true clinical trials, in incarcerated individuals, to my knowledge we don’t have any plans for that right now. If one looks at the situation of access, it would seem to me that given the indications now of AZT for people who have 500 or less clinical trials who are asymptomatic, that most of the MILLER REPORTING CC., INC. "$07 C Suet, N.E. Washington, D.C. 20002 (202) 546-6666 137 incarcerated individuals should have access to at least AZT. Now, if they are not tolerating AZT, or if they fail A2T, I would imagine that they would probably be in a situation which would not be the standard incarcerated situation. They would probably be hospitalized. If they were being advanced enough in their disease that they were failing AZT, I would think that they would have available to them any drug under a compassionate usage that wouldn't require a Clinical trial, as it were. CHAIRMAN OSBORN: Jim Allen. MR. JIM ALLEN: I have two questions, one for you, Tony, and one for you, Phil. Tony, I have heard Dan Hoeth a couple of times make reference to the ACTG protocol diet committee, and I think that maybe a few comments from you about that would help: answer the question that Harlan Dalton asked in terms of improving access to some of the trials. And Phil, I know that there are a number of impediments to enrollment of both women who are pregnant or of child-bearing age and infants into clinical trials because of the need for informed consent, ethical issues, and so on. Is there any anything, in your opinion, that the Commission could do in terms of trying to unlock or lessen in some way MILLER REPORTING CO., INC. 507 C Street, NE. Washington, D.C. 20002 (202) 546-6666 the impediments that exist? DR. FAUCI: Well, in answer to the question that you alluded to, what we are trying to do are two things. First of all, all resources are limited, and there is a limited number of resources to do clinical trials and there are many, many more drugs right now that we can test than are being tested for a variety of reasons, limitations on even patients who could fit into the trials, limitations on investigators. So we are going through all of our protocols and we are looking at protocols that now, given the events over the last year, may in fact be effete protocols, that the questions are no longer relevant. So if you eliminate a protocol you free up resources to put another protocol in. Also, we are taking a look -- when we first started a few years ago, as you would expect the case to be, there were many, many questions and data points that were collected. As we are getting more experience on clinical trials, we feel that many of those data points are not necessary. So if you pull out the collection of. a certain amount of data, again you will free up resources and allow more protocols with more access to be accomplished. That’s what we are referring to about taking a look at trimming down MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 the process. DR. PIZZO: I think there are two issue relate to Jim’s question. One of them is that the pace of research and findings that emerge from many of the adult studies have a significant impact upon those trials that are even contemplated in a pediatric population. That has happened from the very beginning. When the very first studies were starting in children, the randomized trial was already completed in adults, making it very difficult to go on and do specific controlled trials in the pediatric population. It happened last summer when 016 and 019 were announced, the results were announced, and the impact of that that was palpable on the pediatric population as well. So that provides a certain context for how the pediatric community looks at the data, coupled with the fact that the looking at data tends to be investigator and institutionally dependent. And one of the perplexities is that in terms of impediments to therapy, oftentimes there will be variation from center to center, from hospital to hospital, at what an institutional review board will view as an ethical trial as compared to one that may not be. MILLER REPORTING CO., INC. 507 C Street, NE. Washington, D.C. 20002 (202) 546-6666 And indeed, I think some recognition, some understanding of that -- and I’m not sure exactly how the committee can impact on this, but it certainly deserves consideration -- is to look at ways of providing a national credibility to an important question, so that struggles going on in an institution that may have a more limited experience with an important ethical didemma can turn to the resolution of an experience that might have taken place at some other institution, or even on a national level. And as you know, Jim, this is a topic that has been discussed by a number of fora, including the Secretary’s Task Force, and more recently the Committee on Women and Infants and Children. And I think it is an important issue that you can certainly offer some credence to by underscoring its importance. CHAIRMAN OSBORN: Dr. Heinrick, I wanted to thank you for your comments, particularly since the center is relatively new among agencies, and it is interesting to hear how you are getting a good start in this care. My question really relates to that newness. What are the relative abundance of investigators and projects in the context of the need of the AIDS epidemic? In particular, I notice that a number were focussed on inpatient issues, MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 141 which are important, but the thrust of the health care need increasingly is moving toward the continuity of care issues. And I know you described at least one study that was focussed on that, and I was curious as to whether you have a lot of people and insufficient resources, or how that is all matching out as you develop as a center? DR. HEINRICK: Yes; thank you for the question. We have, as I said, a growing pool of investigators. What is interesting to see is that they are forming multidisciplinary teams. They must if they are going to begin to address these very complex questions. Actually, in terms of the sites, I would say that only a couple of our currently funded studies are in hospital units. The great majority are actually in community settings. And certainly one of the things that we are finding in working with populations that are often women of color, for example, the fact that you have to essentially provide care as well as collect your data is a very important issue, which means then that the studies are more expensive. We are currently spending over a million dollars for our extramural program that is targeted to AIDS. The dollars that we have allocated that are AIDS specific are not even half that. MILLER REPORTING CO., INC. $07 C Sueet, N.E. Washington, D.C. 20002 (202) 546-6666 CHAIRMAN OSBORN: Belinda Mason. COMMISSIONER MASON: I have several questions for Dr. Fauci. The AIDS Commission has pointed out several times and bemoaned the fact that there is not a national plan for the management of the AIDS epidemic, Dr. Fauci, as you probably have heard. I wonder if the NIH has a plan for AIDS research? Is there an articulated plan that includes objectives and goals and endpoints and timetables, and is that plan documented somewhere? DR. FAUCI: The NIH has a plan that is part of the broad Public Health Service plan that is interdigitated with the plans of the other agencies of the Public Health Service, the FDA, the CDC, HRSA, Indian Health Service, et cetera, et cetera. And the answer to your question is yes, and we go through a planning process. Each year we fine tune it when we put together our budget for the following year. And every budget process is a planning, process, and besides that, we have had a number of formal planning conferences, going back from the Cool Font to the Charlottesville planning exercises that we have been through, so I’m sure that could be provided for you if you would like them. COMMISSIONER MASON: Thank you. In your written MILLER REPORTING CO., INC. $07 C Streer, N.E. Washington, D.C. 20002 (202) 546-6666 143 remarks in the bottom paragraph you alluded to the problems in translating the sophistication of science and scientific gains into state of the art health care. You alluded to some of the barriers that exist between the science and the delivery of the service to the patient. I wonder if this lag time is, in your view, a serious problem, the time between in which we find out that a therapy is effective and the time that a patient actually receives it? I wonder how much of a problem you view that and what can be done to shorten the lag time or improve the delivery? DR. FAUCI: Well, we certainly have been trying to shorten the lag time, and we have done this by initiating what -- one of the things I showed on one of the slides was a state of the art conference, because if one were to wait until a paper is published in a journal in the standard way, even with the now speeded up, process that several of the editors of the major journals have been cooperating with the biomedical research community on getting things with AIDS published more quickly, we have tried by a variety of means of dissemination of information through our Office of Communication, and particularly through the state of the art oN MILLER REPORTING CO., INC. $07 C Sueer, N.E. Washington, D.C. 20002 (202) 546-6666 144 conferences, and now we have information that is readily accessible by our AIDS Clinical Trial Information Service where people can dial an 800 number, 1-800 TRIALS-A, and get information regarding any of the clinical trials anywhere, patients, physicians, or what have you. So it still isa problem, but we are trying to circumvent it by the means that I just mentioned. -- COMMISSIONER MASON: Okay. I’d like to ask you real quickly about the controversy around DDI. I wonder if you guys have made any observations about the differences in the people in the trials and the people who were on the drug in IND compassionate use versions. It has been sort of widely repeated and mostly accepted within the community that the people who were on the so-called parallel track, which is not really the parallel track, were sicker than the other people and that in fact they died from HIV infection and maybe not from DDI. So do you have any evidence to the contrary? DR. FAUCI: No. In fact, as I have said but not been quoted, the fact is that these people who were in the expanded access were clearly much sicker than the people who were on the classic clinical trial. In fact, there a MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 145 significant number of the deaths were among people who were waiting to get their first dose of medication, and even though it was incorrectly reported that being on an expanded access was the reason why they died, that couldn’t be farther from the truth. They died because they had advanced disease. If one looked at measurable complications, like pancreatitis and pancreatic disease causing death, the relative proportion of complication to numbers of people on the trial were the same in the clinical trial as it was in the expanded access. COMMISSIONER MASON: Okay. Thank you. I just have one more quick question. I wonder if any of the trials still use death as an endpoint? DR. FAUCI: Any of the trials still use death as an endpoint? Well, death will always be an endpoint in any clinical trial, but that is not a stated endpoint in the sense of there are now predominantly surrogate markers, usually things like CD4 counts, P24 antigenemia, and in some more sophisticated Situations plasma or culturable viremia. But we don’t have a situation where the only thing we look at is whether a patient dies or not, although that data, obviously, is important data. COMMISSIONER MASON: Okay. Thank you. MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 346-6666 146 CHAIRMAN OSBORN: Don DesJarlais and then Irwin Pernick. COMMISSIONER DESJARLAIS: Earlier this morning the group from the National Academy of Sciences had some fairly strong criticisms about the lack of coordination of behavioral science research with the more traditional medical research, including the natural history studies and the Clinical Trials Group. Do you see any prospect for that improving in the future? Are there efforts across the various agencies focussing on that? I mean, clearly a lot of money is spent in the biomedical research involving subjects coming in where the additional cost of collecting some good behavioral data would be relatively small. What are the plans for sort of addressing that problem in the future? DR. FAUCI: Actually, we are looking at that very closely now in the activities that go on within the NAPO, the National AIDS Program Office, at the Assistant Secretary's Office, to try and get behavioral information from other agencies exchanged very quickly. And we meet frequently and exchange information as it comes out to try and make sure MILLER REPORTING CO., INC. $07 C Street, N.E. Washington. D.C. 20002 (202) 546-6666 147 that information on behavior that gets collected from one agency is immediately translated into the process of another agency. It is still not perfect by any means, but it certainly has been improving over the last year or so. MR. PERNICK: In its most recent report to the President, this Commission recommended the creation of a federal coordinating mechanism of some sort. I think the Commission would welcome each of your views on such a recommendation. CHAIRMAN OSBORN: I think, as you know, I’m rather sure you have seen the report, but to summarize briefly, the level of coordination that is well represented in the Interagency Task Force of the U.S. Public Health Service was part of the model for that suggestion, that multiple agencies, HHS being an agency in this context, might well serve to imitate such coordination by some mechanism or other. That was the gist the Commission's suggestion. DR. FAUCI: I think from the standpoint -- I mean, I can’t speak in the sense from each individual agency, but from the standpoint of being responsible for the conduct at the NIH of biomedical research associated with HIV infection, I think coordination among agencies in areas that would make , 5 MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 346-6666 our mission and our activities flow smoother would be a positive thing. For example, coordination among agencies, the Department of Defense and the Public Health Service and the State Department vis-a-vis the problems that we have run into, as you are well aware, concerning the meeting, et cetera, et cetera, I think that that kind of coordination is welcome. As Dr. Osborn said, within the individual agencies the levels of coordination I think are moving very nicely and smoothly, at least in the National AIDS Program Office for the Public Health Service. But I would welcome being able to have good interaction and coordination among the various full agencies. DR. PIZZ0: I agree with that totally. DR. HEINRICK: We have one good example of that kind of interagency agreement and cooperation. We recently put out a program announcement with the Agency for International Development, State Department, welcoming proposals that focus on preventions, behavioral research. CHAIRMAN OSBORN: We then thank the panel very much for your excellent testimony, and we appreciate your being willing to be here. And if we can ask you to get us perhaps MILLER REPORTING CO., INC. 507 C Street, N.E. Washington. D.C. 20002 (202) 546-6666 some copies of the slides that you showed us, Tony, that would be helpful to give us something to prod our recall. Thank you. We are going to proceed in two halves with the next group since there are in fact. six people and three chairs. And there will be a great commonality to the theme of testimony, which is community needs and perspectives. My understanding is that the first panel will be Sonia Singleton, Neil Schram and Rosa Martinez, and then we'll go on as a second panel to Jim Eigo, John Caldwell and Luis Hernandez. Let me thank you on behalf of the Commission for taking the trouble to join us today. I guess I’ll let you go forward, and please if you would, introduce yourselves as you start so that everybody knows from whence you come. MS. SINGLETON: Dr. Osborn and members of the Commission, good morning. I’m a little nervous. My name is Sonia Singleton and I’m hear today to address issues regarding women and AIDS research. I will begin by briefly qualifying. I’m 30 something years old and a recovering IVDA and crack addict. Three years ago I was tested without my MILLER REPORTING CO., INC. $07 C Sueer. N.E. Washington, D.C. 20002 (202) 546-6666 150 consent in a 28-day drug program. On the day of my post-test counseling, if that’s what you call it, I was told I was antibody positive and that I should decide if being in a drug program was really a priority. That day I called my husband to give him the news and to suggest that he also be tested. I held my breath for what seemed like an eternity. Within two weeks his test results came back. To my relief they were negative. I realized very early on that I could take responsibility for me. I came to believe that I might have to help others in order to help myself. I refused to be just another junky with AIDS. I decided I would live just to piss off the insensitive doctor who gave me a hopeless prognosis. Subsequently, I began a journey that would teach me how to be a soldier in this dreadful war. My presence here today before you indicates just that. I am inspired and appreciative of this unique Opportunity to share both my personal experiences as an HIV positive woman and my professional experiences as an AIDS intervention specialist working on the cutting edge of the AIDS crisis. The challenges I face as a recovering HIV positive MILLER REPORTING CO., INC. $07 C Sureet, N.E. Washington. D.C. 20002 (202) 546-6666 woman Causes much distress and anxiety, but the real stressers are the lack of validation for women in regard to AIDS. I was selected to present on women and AIDS research. However, due to the lack of research on women and AIDS, I can only present my personal testimony of issues that are pertinent to women. Hopefully it will enlighten you to the very need for such research initiatives, quality medical care, and treatment for women with AIDS. I have attempted to qualify for a research protocol in Miami for the last two years. Miami has taken a lead in many areas pertaining to AIDS research, but has been unable to provide a protocol that qualifies women like myself. What is available to women are perinatal prevention studies, heterosexual transmission studies, and HIV surveillance studies. In this country, women have been secondary to men with AIDS, and most recently. are secondary to babies. Therefore, research has gone from one extreme to the other. Two years ago I was unable to qualify for a study because I was of childbearing age. Now it appears I must be bearing a child in order to qualify for a research protocol. Women make up approximately 90 percent of all MILLER REPORTING CO., INC. $07 C Street, N.E. Washington. D.C. 20002 (202) 546-6666 nurses, social workers, and home health care aids. Additionally, they are wives, mothers, grandmothers, sisters, children and lovers. Today women are impacted by AIDS. Many]. women will not only be stricken with the virus, they will also become the unpaid and. underpaid primary caregivers for others who develop AIDS. The impact of AIDS--on women is compounded by other problems which affect women in our society, such as sexism, racism and poverty. AIDS is a woman’s issue. Much has been written about AIDS and prostitution with the media perpetuating misinformation that women are vectors of this disease. To my knowledge, there is no research to prove that women transmit this virus through heterosexual intercourse. What we do hear, by comparison, is the heterosexual transmission that is occurring in Africa and Haiti. However, in these countries they have only recently begun to address their still, infected blood supply and lack of health care. Homosexuality, bisexuality, situational sex and the extent of drug abuse has yet to be investigated. I personality know of several women throughout the country who like myself, without knowledge of their HIV status regularly engaged in unprotected sex with their husbands and lovers. ay By MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 153 To this day all of the men remain HIV negative. It seems to me that the only concern around women and AIDS is its relationship to female prostitutes and the fear that they may transmit this virus to the mainstream middle class married men most likely to frequent their services. There is an attitude equivalent to blatant disregard for the HIV infected woman just because she is a woman. The special needs of women remain unrecognized and invalidated. Women are disillusioned by health and service systems that are complicated, impersonal, and time consuming. Some women are fearful that their children will be taken from them during hospitalization. Others face eviction and other legal problems resulting from poverty and discrimination. It is a well known fact that women with AIDS become sicker and die faster than men. Perhaps AIDS affects women differently and the disease might be exacerbated by gender related differences. Is it possible that pregnancy weakens the immune system, making women more susceptible to infection? These are questions still unanswered 10 years into this epidemic. Many women Slip through the cracks due to MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 346-6666 154 physicians not recognizing the early signs and symptoms of AIDS. One year ago I had a gynecological problem. I sought out a physician who specialized in AIDS. Following my examination he said I looked for healthy a HIV positive individual and prescribed several antibiotics. The same problem, however, has occurred several times since then. The physician still feels that I--am asymptomatic. Recently I met a woman physician who agreed with me that I may be experiencing symptoms indigenous to women. Read my lipstick, women do not have the same symptoms as men. Women have been systematically eliminated from research protocols testing new AIDS drugs. We still don’t know how women are physiologically affected by AZT. We still don’t know. Drug studies limited to men can only apply to men. There may be very different reactions in women. AIDS treatment for women remains uninvestigated. Infected women are not given the same opportunities as men in prolonging - their lives with experimental drugs, and they certainly deserve those options. In closing, I would like to reiterate that there is a major problem that surrounds women and AIDS. These problems will continue to increase as long as women are MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 155 excluded from care, treatment, research and services that can protect them from this deadly disease. The AIDS virus does not discriminate. People do. Therefore, my recommendation to this committee is that you must make sure that the concerns women face are not pushed aside. Competition for funds should not interfere — with the research and/or services that can meet the very special needs confronting women. My hope today is that you have not only listened but heard my testimony and that you will begin to assist me and all other women faced with this tremendous challenge. I make a compassionate plea. Thank you for your attention. CHAIRMAN OSBORN: Thank you very much. We listened and we will try very hard to hear. MS. MARTINEZ: My name is Rosa Martinez, and I first would like to explain that it was difficult for me to come and do this when I was called, because my daughter died five months ago from AIDS, and the last time I was here was to bring her body back for the autopsy at NIH and to speak to Phil, to Dr. Pizzo, about that. First of all, maybe I’d like to add a face to what -- I am going to talk about the HIV clinical trials on the MILLER REPORTING CO., INC. 507 C Street. N.E. Washington, D.C. 20002 (202) 546-6666 156 children, but I would also like to just add a face to her, and just maybe pass it around so you can see who it is I’m talking about. For those of you who don’t know who I am, my daughter was the little girl that was neurologically impaired. She had received blood transfusions, and because of that she was infected with AIDS, and I adopted her when she was 11 months old. I think that she is most known for that she was -- a judge had ruled that she could go to school in a glass cage, and I appealed that case and, of course, later on she went to school. It was a three-year battle, and finally she died on November 27th of 1989, and she had attended school only 16 days. In spite of the three-year battle, I continued it because even though I knew her health was declining there were other children that I knew would benefit from this victory. After the wake of her death, what I did was I founded Eliana’s House, which will be a transitional home for children that are either abandoned or parents are not able to care for them, with the goal to find permanent home placement for them. é may MILLER REPORTING CO., INC. $07 C Street. N.E. Washington. D.C. 20002 (202) 546-6666 157 When she was infected with the AIDS virus, it was not until April of ‘85 that she was diagnosed. She started manifesting symptoms late in '84, and there weren’t any treatments that I knew of for her. I knew of Dr. Gwendolyn Scott in Miami. I had heard that they were having trials there, And I called her and went to Miami when she had told me that there were some slots available. Two weeks later when I did go there, it was a five-hour drive, and once I got there I found out that no, there were no slots, they had been taken in those two weeks. Then I found out that Duke University also had trials going on, but again, there were no slots available for Eliana. And just because of persistence and really just persevering and desperate to find something that would help my ‘daughter, I found out about NIH. I had never heard of NIH until then. And when I called there they told me that I needed her doctor to refer her to NIH, which I did, and it took about two or three months before I was finally able to get to NIH. And once there, through the help of friends, I was able to secure the money that I would need to get there and for the first day’s lodgings, and after that NIH explained that the initial expenses would be paid for by me, MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 158 but the others would be covered under the NIH budget. In August of ’87 Eliana started the AZT protocol, continuous infusions of AZT. But before that I had to wait 10 days, and that was the most nerve-wracking two weeks I had, because if she wasn't accepted into the program, there was nothing else available for my daughter, she would just be left the die. But luckily she was accepted. Our experiences at NIH for the next two years after that were excellent. Besides receiving the best medical care, NIH provided a system of care and services which included emotional support and financial support in emergency Situations. There were times when she was hospitalized at the pediatric ward there at NIH, and at other times she was hospitalized at our hometown hospital, where the NIH medical staff worked closely with the medical staff at home, so I don’t have any complaints about that. But during the months of March through December of ‘89 it was apparent that Eliana’s health was declining in spite of the AZT. Clinical trials with DDI were in progress, but there was no time for Eliana to undergo preliminary testing procedures as the protocol called for. So with the help of Dr. Pizzo, Eliana was able to receive a compassionate MILLER REPORTING CO., INC. 507 C Street, N-E. Washington, D.C. 20002 (202) $46-6666 159 release from the FDA and receive the new drug. She was on DDI for five weeks and her condition didn’t improve, because she was pretty advanced in her illness. After a lot of soul searching, I decided, on October 4th of 1989, to discontinue medication, and I opted for comfort measures only. It was a hard decision, but Phil knows, and those that know me know that my first priority with Eliana was always her quality of life and not her quantity. So at that point I just questioned whether -- who I was doing this for, was it for her or for me, and that’s why I just took her off medication. A month and a half later she did die. She was eight years old when she died. My experience with the clinical trials at NIH was positive, and just like all the other families who had children participate in the trials, I confronted daily hardships in trying to balance the requirements of my job, the needs of my sick child, and the rest of my family, which really is just my son. He kind a took a back seat in this whole situation while I took care of Eliana. And as a single parent I was the sole support at home. I wasn’t able to keep full time employment because of the monthly visits, and sometimes biweekly visits, to NIH. MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 And two and three week hospitalizations at NIH further impeded that realization. And though NIH provided other pediatric AIDS related services, those same services were completely absent at home. They were non-existent. So the only support services I had were at NIH. And this holds true for other families who are involved at NIH. I know families back home who desperately want to have their children participate in clinical trials such as the one that we had at NIH, but because the family may have other children that need the care and the presence of their parents and can’t take advantage of these trials. Therefore, their HIV infected child is denied this crucial service. And though DDI was not beneficial for Eliana, she was at least able to receive the medication through the compassionate release that Dr. Pizzo was able to ensure for her. Other children are not. as fortunate. These children have to undergo extensive testing before they can qualify to participate in clinical trials, and add to that the reality that children have a two-year wait while experimental new drugs are being tested on adults. I believe that children -- I think it has been quoted as -- the medical orphans of the MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 disease that most likely will kill them, just as it is killing the adults. I feel strongly that clinical trials on pediatric AIDS are presently extremely restrictive. The access and process to them are fatally slow. Simultaneous testing of drugs for children and adults should be implemented to give equal access to the same therapies. I believe that there should be additional institutions participating in the pediatric AIDS clinical trials, specifically in the high-risk areas. I know that Miami, Florida, has been hard hit by pediatric AIDS, but there is also no question that Hillsborough County in Tampa, Florida, is starting to face the same problem. I know personally of one family who has several children, one of whom has HIV symptomatic infection. For that family, it is an unrealistic goal to travel and participate in clinical trials either at Miami, NIH, or Duke University, just because of the other children. So presently this child receives only AZT, which I found out about two weeks ago has been having adverse reaction to his bone Marrow. Perhaps DDI or some other drug therapy would benefit him more, but I guess we are not going to know that because 162 there is no provision for significant clinical trials © _ happening where he lives. We desperately need community-based clinical trials for our HIV children in the high-risk areas that would be linked to NIH or Duke University or Miami so that these children would be able to participate. Since AIDS impacts children differently from adults, basic pediatric AIDS research and a comprehensive system of care and services should be addressed, or must be addressed and funded separately. This would ensure that Children and their families would have answers to their unique problems. There is nothing that I wouldn’t have done for Eliana, and right now there many, many parents who desperately want to do all they can for their children, but can’t. Long distance traveling is not a viable option for them, and it is for them really that I’m here speaking for and advocating for, and it is for them that I will continue to speak out for and to focus more public awareness on these issues that are being addressed until they are resolved. And I also wanted to add that not just as an American but as an Hispanic, one, my daughter and I did make a difference. The Hispanic community does care what is going @ MILLER REPORTING CO., INC. 507 C Street, NE. Washington, D.C. 20002 (202) 546-6666 MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 163 on with AIDS. We know the impact it is having on our community and there are many of us who want to be involved and fight and help in any way that we can. And unless you have any questions... CHAIRMAN OSBORN: Thank you very much for sharing that with us. We appreciate very much you taking the trouble to be here. Dr. Schram. DR. SCHRAM: Thank you. Dr. Osborn, members of the Commission, my name is Neil Schram. I am Chair of the AIDS Task Force of the American Association of Physicians for Human Rights. We are the national organization of lesbian and gay physicians, medical students, and their supporters. Unfortunately, we have more than our share of HIV infected individuals in our practices in this country, and I’m speaking on behalf of our organization. I won’t get to read my prepared remarks, because after listening this morning I realized that there is a - certain confusion, and the problem is even more enormous than I had thought about before today. And I tried to write down these thoughts while I was listening, if I might, just in terms of clinical trials, what seems to be needed. MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 164 First one has to decide if drugs are reasonably safe and effective. And for those we need studies that are done as rapidly as possible. Once we find a drug like A2T that is reasonably safe and effective, further studies are needed to find out what is the best dose for the drug. Then the question comes up, is there a difference for people of color, for women, for pregnant women, and for babies? More studies are needed. Then, how can more people of color, women, babies hemophiliacs have access to investigational drugs. And the truth is, the answer is not access to clinical trials for that to answer that question. Finally, how can people of color, women, babies, et cetera, receive adequate health care? Access to clinical trials, unfortunately, is not the answer for the majority of those individuals either. Other solutions are going to have to be found. And finally, how can information from the trials that are held be gotten to the physicians who need them as soon as the information is obtained, either as soon as they are released to the media, or as soon as they are obtained and many months before they are published in journals? New mechanisms are going to be needed. MILLER REPORTING CO., INC, 507 C Street, N.E. “Washington, D.C. (202) 546-6666 20002 165 Public health and -- the question that Dr. Fauci was not asked is what about the staff at NIH. And, as you well know, public health in this country is suffering. In 1983, NIH had over 13,000 personnel. In 1989, it has lost over a thousand people. Dr. Fauci testified in 1988 that NIH has lost 28 percent of senior research scientists. For 1989, NIH requested 492 FTEs for AIDS, yet received only 200. There are greater demands on NIH, of course, from AIDS, and they don’t include only research. “Who should be research participants? Recently our community-based organizations received funding, and gay male community clinics were almost universally excluded from those research fundings. Why? Because they were unable to get people of color into clinical trials. I think it is exceptionally important that people of color be in clinical trials, but that should not be the most important criterion for determining who gets funded. Who gets funded should be determined by who can get research subjects so that the very first step can be found, which drugs are safe and effective. The parallel track is currently being threatened. We hear about the fact -- we know that only one drug has gone MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 166 the route of the parallel track. There is an AIDS Research Advisory Committee that was set up through NIH, NIAID, that was set up in December. It will not have its first meeting until July. The purpose of that committee is to recommend additional drugs for parallel track to Dr. Fauci. Was is the delay? The delay seems to be that NIH does not have a person, at least until last week, who could get the AIDS Research Advisory Committee going. So no meetings will be held and no other drugs will be recommended. And as you well know, there are researchers who are opposed to the parallel track. I'm embarrassed to tell you at the first meeting on DDI in August a researcher came up to me after the meeting and said, "I really don’t understand why we can’t hold off on the parallel track until all of the clinical trials have been fully personed." She actually could not understand the inhumanity of that question. . Another problem with clinical trials and they are currently done is that if the community standard of care changes, it takes too long to get the changes of benefit into clinical trials. For example, when it was found out that pneumocystis prophylaxis was useful for people with fewer MILLER REPORTING CO., INC. 507 C Suet, N.E. Washington, D.C. 20002 (202) 546-6666 167 than 200 T-cells, it took many months before that could be included into 016 and 019, so that some of those people suffered from pneumocystis when it could have been prevented. I just want to stress that in my opinion the solution to access of health care for people of color and for others in this country who are not getting it is not access to clinical trials. The solution is for the United States to accept its responsibility to provide health care to everybody in this country. To get back to the community the information that needs to be gotten, NIH has great difficulty communicating its information to physicians. Most new information is now communicated via the media. What is needed and what NIH does not have the staff to do is to contact physician groups around the country, ask them to find out which of their members need research information rapidly, and provide the information to those groups and let those groups then transmit the information to their physician members . NIH recognizes the need to do this, but it so far does not have a single person, or half a person, to fulfill this simple task, so that people with HIV infection are better informed about later medical advances than are the MILLER REPORTING CO., INC. $07 C Sureet, N.E. Washington, D.C. 20002 (202) 546-6666 168 physicians who are supposed to be responsible for their health care. Another problem with research information getting to physicians is the regulation that prepublicity before medical journal information is published can prevent publication of an article. The New England Journal of Medicine has done an excellent job of saying that if it is life threatening information for a disease like AIDS they will make an exception. Other journals have not made that concession, and in fact have been quoted in the newspaper as saying that they will not. As a result, there is many months delay in the time that there is research information that can save lives until it is published. I think that is unconscionable and I think this Commission should contact the editors of medical journals around the country and get them to agree that for life threatening diseases, especially including AIDS, that there is no harm in getting information released and that that should not harm the researcher's ability to get publication. Dr. Fauci talked about the state of the art conference on AZT and was very proud of it. I happened to be one of the participants in it. What he didn’t tell you was MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 169 that we started talking about that in August of last year when 016 and 019 went public, when the results of them went public. The state of the art conference was not held until March of this year, and the basic reason for the delay is that the researchers were unwilling to have their data presented at the conference and recommendations come out until they are assured that publication would not be interfered with. And that’s why there was a seven-month delay from the time that 016 and 019 were stopped because of the important finding and the state of the art conference got full detailed information to physicians. I don’t have to be the only one to repeat that a master plan for NIH is sorely needed. And finally, there is a lot of talk today about the Opportunistic infections and whether we should be spending research funds on opportunistic infections ox we should be spending research money on drugs to treat the virus. That is an impossible choice to make. It is clearly necessary that both be done. It is not and must not be allowed to be one or the other. I’m basically through with my remarks except to say, first of all, that the recommendations that this MILLER REPORTING co., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 170 Commission has made to this point have been wonderful, remarkable, and greatly appreciated: But I must Say, this epidemic has been studied to death. It is time to get the leadership and the money that are necessary to make your recommendations and those of the former Surgeon General and those of the National Institutes of Health and those of the National Academy of Sciences and the Institutes of Medicine and the previous Presidential AIDS Commission to start happening. Too many words and too little action. Thank you. CHAIRMAN OSBORN: Thank you very much, Neil. I think that we will probably best do is, if it is all right, and I think at least several of you have some schedule constraints, perhaps we can take questions for this group and then proceed, knowing that the next three witnesses will be dealing with similar topics. But perhaps there are questions for these people now. Eunice Diaz. COMMISSIONER DIAZ: Dr. Schram, you have been ‘involved in California extensively, and across the nation in the education of physicians about the use of not only the drug protocols, but also about their involvement in screening MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 171 for at-risk individuals. And I know of your work, but I wish that you would share with the Commission some of the road blocks that you have found not only in communities, educating professionals in the communities of color, but among the rank and file physicians as to their reluctance to really get behind risk assessment. I can think of the efforts that you did in so many other things, trying to mobilize a large cadre] of people to really be able to assess more individuals that need to be looked at in terms of their risks. DR. SCHRAM: Thank you for that questions. Physicians don’t like AIDS. I don’t like AIDS. The world doesn’t like AIDS. Unfortunately, as a physician I feel I have to respond to it. To many physicians have chosen to sit out the epidemic of the century. The reasons are many. This is sexophobia. Physicians don’t to talk about sex. There is homophobia, they don’t want to deal with homosexuals. There is IV drug use-aphobia, they, don’t want to have to deal with Iv drug users. There is a feeling of inadequacy, which is genuine. There is a feeling of fear of infection, which in rare instances is correct, but in far to many instances is incorrect. There is having to deal with dying, having to deal with facing their own mortality. MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 172 This is a very difficult disease, but it is no excuse. Physicians have got to assume their responsibility. And actually, the California Medical Association is having a meeting this Friday, which I think is the first of its kind in the country, which is really dealing with the fundamental question of how do you change physician behavior, how do you get physicians to do risk assessment? Because, if you don’t have that as the first step, so many of the medical advances will be denied to the people who would benefit from them. And in my opinion we are actually reaching the point in our country where anybody who learns of an HIV infection by getting sick represents a failure of our medical system. CHAIRMAN OSBORN: David Rogers, and then Howard. COMMISSIONER ROGERS: First I just want to indicate how moved I was with some of the testimony. Thank you very much for being here. Dr. Schram, you gave us some figures on the sort of down slope on NIH which I had not heard before in terms of personnel. Are those readily available to us? DR. SCHRAM: I got them from NIH. COMMISSIONER ROGERS: Thank you. We didn’t hear them from NIH, but I think we should. Thank you. MILLER REPORTING CO., INC. $07 C Street, NE. Washington, D.C. 20002 (202) 546-6666 DR. SCHRAM: I think you will also find, incidentally, that the FDA has had a similar type of decrease, and it is equally tragic in the midst of all of this. CHAIRMAN OSBORN: Harlan Dalton. COMMISSIONER DALTON: My question is also for Dr. Schram, but let me first say to Ms. Singleton, you seem to have gotten over your nervousness in a hurry, which I appreciate. And it is really terrific to have you here for me, because the issues that you talk about are ones that, as you quite correctly point out, are systematically sort of underplayed, ignored, not seen. And you have articulated them brilliantly in a short period of time, put ina lot of information. I appreciate that. It is also nice to see, I must Say, a woman of AIDS who looks like you, which is to say, as do most. Belinda Mason, who is sitting to my right, never tires of pointing out that she often is put on platforms to speak for and about women and nobody can ever. seem to find you, except, obviously, you are available, and I’m glad you are here today. MS. SINGLETON: She is a role model for me. MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 COMMISSIONER DALTON: Ms. Martinez, I’m also delighted that you are here. Eliana is a beautiful daughter and it was good of you to bring her face and her personality to us, which shows in every one of those pictures. It is also good to see your face, and I have sort of known about you and it is nice to sort of see who you are up close and personal. And people like you just carry a lot of the burden for the society in terms of dealing with this disease. I don’t know of a way that we can thank you collectively, but thank you. Dr. Schram, I guess the question I want to ask you has to do with your comments regarding gay organizations that, as you characterized them, were not allowed to participate in -- as I understood your comments -- in drug trials because they had not been successful in incorporating into the trials people of color. And it seemed to me you spoke with some passion about that. And as I understood your solution to the problem, at least in your written testimony, it is to, quote, "provide access to quality health care for all Americans," rather than engaging in politics, I believe was the way you characterized the attempt by NIH to mandate inclusion of people of color in drug trials. MILLER REPORTING CO., INC. 907 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 I guess I find that sort of unsatisfactory on several levels. One, it implies that gay men are only white. That is one question I would ask, is why is it that gay organizations have not been able to find black gay men to bring them into clinical trials? Number two, yes, I would love to have quality health care for all Americans, but there are some short term realities of the quite crappy health care system that we have at the moment, both in terms of financing and delivery. I shouldn’t say "quite crappy," quite inadequate, and disproportionately inadequate for people of color. Given the world in which you live in 1990, it seems to me that there were some very real hard questions about who gets to take advantage of the limited resources of clinical trials, and it seems to me that pointing to that sort of halcyon day, to point to the millennia when in fact health care will be available for everyone is well and good, but it doesn’t answer the hard question of who gets to participate in clinical trials. And to characterize that as politics in a negative kind of way, that is, "that" meaning the creation of incentives, shall we say, to get people of color into clinical trials, I think is really kind of unfortunate. MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C: 20002 (202) 546-6666 176 Which leads me to my third problem and overarching problems, which is that you know as well as I do that there is a real risk of us all being set one against another in terms of this disease. And I know that, other than for this particular comment that I’m picking up on, I mean, I know your work and your writing, you struggle as hard as the rest of us to keep from being divided and conquered, or indeed, from dividing ourselves. But I do worry about the particular form of your presentation today just contributing to the division between the various populations that are particularly affected by this epidemic. DR. SCHRAM: I think that all can be answered under the global answer of in my view the political problem of access to clinical care for people of color in this country should not be allowed to interfere with the speed of clinical trials, and that is my concern. I don’t care what color people are who go into clinical trials. My patients are black, they are white, they are Latino, they are men, they are women. Not a single one of them cares whether a drug was tested on people of color, people who are white, gay men, or anybody else. All they want are drugs that work. And what I’m suggesting is that the political process slowed down the MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 177 answers. If it didn’t, if it was time neutral, then there is no problem with that as a political goal. COMMISSIONER DALTON: I guess what bothers me is your characterization of the desire of people of color to be involved in clinical trials as a political problem or a political desire when in fact the reason that people of color want to be involved in clinical trials is because they want access to drugs for treatment, basically. That is to say, if clinical trials are one of the ways in which people in this country can get access to treatment early on, then the question is who gets to have that treatment. And so people want to improve their life prospects. DR. SCHRAM: What you have heard today though is why the system doesn’t work. And you have to address that fact. I mean, here is a woman who had to go 500 miles to get into a clinical trial. How many babies are in clinical trials around the country? Two-hundred, 300, 500? How many thousands of babies are infected? Twenty-thousand? ‘The solution for those 20,000 babies is not 10 babies of color getting into clinical trials. There are a million people infected in this country.: Half of them are probably people of color. Getting 200 or 300 of those people MILLER REPORTING CO., INC. $07 C Street, NE. Washington, D.C. 20002 (202) 546-6666 178 into clinical trials doesn’t solve the problem, and it takes away from the problem. The purpose of clinical trials is to prove if drugs work or don’t work. COMMISSIONER DALTON: But the reality is that for many people they also provide treatment, and surely in different context you would be agreeing with me about that. DR. SCHRAM: JI don’t disagree at all. All I am saying is that -- and that is what I said in my remarks today -- the purpose of the parallel track is to provide these drugs to people outside of the clinical trials. And that’s the key. The key is wider distribution of the drugs. COMMISSIONER DALTON: Well, the purpose of the parallel track will be, but we are talking about a historical phenomenon in which there is no parallel track available. DR. SCHRAM: And what I’m saying is that that, in my opinion, is the way to go. The way is not to use a lot of political power to get a few, hundred people into clinical trials. It is. It became a big political issue, and that’s what people are complaining about today, is that hemophiliacs aren’t getting into clinical trials, women aren't getting into clinical trials, the problem isn’t the clinical trials. Everybody is really saying, I want to be able to get the MILLER REPORTING CO., INC. 507 C Sueet, N.E. Washington, D.C. 20002 (202) 546-6666 179 drug, and that’s what we should be focussing on, getting people the drug. CHAIRMAN OSBORN: Thank you very much, again. These are difficult issues, as is quite clear, and this will not be our last chance to discuss them, and we look forward to reading more of what you write, Neil. You are a very important voice in the epidemic and we appreciate it. Ms. Martinez, Ms. Singleton, thank you so much for sharing with us your powerful thoughts and feelings. I speak for myself in saying that you have fueled me to keep trying harder, and I really appreciate your coming to join us. Our next group of witnesses will include Jim Eigo, John Caldwell and Luis Hernandez. MR. HERNANDEZ: My name is Luis Hernandez, and I came to the United States in 1980, and in 1986 I was tested positive for HIV and I was guided to a program for drug and alcohol rehabilitation. As part of my recovery I took my health seriously, and then as a result of searching I joined a Clinical trial at the Community Research Initiative. I thought that that option was comfortable for many reasons. I didn’t need insurance to participate, my participation was free, no one made any moral judgment about who I was or how I MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 180 got infected. They also didn’t ask me any questions about immigration status or anything like that. The people there answered all my questions and treated me like they really cared. Being in a clinical trial gave me a sense of hope and I felt very well taken care of and my health improved. I wanted to work CRI because I wanted to help other people like me. My qualifications were that I was a Spanish speaking recovering addict who participated in clinical trials. I also had experienced a support group with other gay men who were recovering from drug addiction. CRI agreed to hire me to help recruit people of color and women into clinical trials and to create outreach and educational material in Spanish. I have learned many things since I began work at CRI. Many people who are eligible to participate in clinical trials don’t know they exist. Information about them is usually too complicated for most people to understand and it takes a lot of time to explain things on a one on one basis. I have learned that a lot of doctors don’t care about people with AIDS, or taking the effort to explain to people basic facts about their health. MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 181 These doctors, as well as doctors who have a large number of patients with AIDS, don’t take time to explain and discuss experimental drug trials. For many people in New York City a clinic visit consists of a five minute visit. A prescription for AZT, the doctors do not explain the side effects of AZT, if it works, how it works. They don’t explain anything else either, and let alone experimental treatments being tested. For many patients just getting to their clinic visit is very difficult. And the people who have addiction problems, or carry the responsibility of taking care of a family or other sick family members need additional support and counseling to participate in clinical trials. Poverty, alienation and denial also prevent people from obtaining needed services. Daily survival is a more pressing need than an experimental treatment being offered at clinical trials. I was hesitant about coming here today to testify because aS an immigrant with a temporary resident status, I must be tested for HIV if I want to receive a permanent resident status. There are many people who do not seek treatment for HIV infection or join clinical trials out of fear of being discovered as illegal aliens. The privilege of MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 182 being able to testify before you and, in so, helping the many people who desperately need it, out weighs the concern I have about my personal immigration status. I thank you for giving me the opportunity to speak before you today. I think emphasis is put on prevention, and it is not that much on treatment and hope. What it seems to me is that we are saying you have to prevent for getting the virus, to don’t do anything that will make you get it, but if you have it and if we will tell you that, we will help you to get treatment or give you hope, that means you can do that. And I think it is sort of like a moral issue in the whole thing, because everywhere I have seen it is a lot of prevention, but with the prevention also should be the thing about treatment and about hope, and there are various things available. And I think there is more things. The thing, have never used AZT or have never used DDI or any other kind of thing for the last five, six, seven years and I have kept myself healthy, and the opposite, there are people that have seen taking those drugs and die. I mean, there is a lot of questions, why there is only these two drugs or three drugs when there is a way you can also stay alive. And these MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 183 things are not being studied. I mean, I have done lots things and I have stayed healthy, and a lot of people I know who have done things outside of AZT and DDI and stuff like that are healthy, and a lot of people who took these drugs get sick, and I see it all the time. That’s my opinion and. my personal experience that I have see. Thank you. CHAIRMAN OSBORN: Thank you very much. John Caldwell. MR. CALDWELL: My name is John Caldwell. Thanks for the opportunity to be here today. I bring a personal greeting from Martin Delaney to all members of the Commission, and particularly you, Dr. Osborn. He is sorry that he couldn’t be here himself. Project Inform is an HIV treatment advocacy group dating from 1985. From the beginning we spread a message of early intervention that has now become the standard of care. We have also emphasized an active doctor-patient partnership in which the physician is enlightened by the patient as well as vice versa. We see this model of cooperation extending to intersection between patient advocates and the medical and the research regulatory establishments, and it is in this spirit that we address the Commission today. MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 184 We are known for our work with the Food and Drug Administration that led to expanded access for promising experimental treatments and to the licensing of community-based trials. In this testimony, however, we would like to focus on problems and possibilities in the search establishment headed by the National Institute for Allergy and Infectious Diseases. We recognize the unprecedented nature of the goals set for the NIAID AIDS program and we grant that-in certain areas it has achieved reasonable success. We are deeply concerned, however, that research efforts have been hampered by problems in two areas that can be broadly classified as administration and research philosophy. NIAID and the AIDS Clinical Trial Group are plagued, often by their own admission, by administrative inefficiencies. Scientists shouldn’t be asked to be the top administrators of these agencies. People with production oriented managerial skills could free scientists for creative thinking, at the same time establish and expectation framework for getting things done. As currently managed, NIAID lacks functional authority over the ACTG. Instead of research being directed MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 by a central scheme, the interest of a few individual researchers dictates project selection and funding on a piecemeal basis. Furthermore, there needs to be an ongoing review system that holds the ACTG accountable for its failures and delays, removing funding where appropriate. There also must be room for initiative and creativity. A fixed percentage of NIAID funds should be used for investigator initiated studies. These might originate in private industry, community groups, individual practices or the NIAID itself. An independent community trials was responsible for the FDA approval of aerosolized pentamidine, and after this same trial was denied funding by the NIAID, now that such funding is available through NIAID’s Community Program for Clinical Research, the community groups are hamstrung by the application of overly rigid federal contracting rules to the money that they get. The research philosophy of NIAID and the ACTG suffers from an unbalanced focus on single-agent anti-retroviral drug development. AZT, which was also first developed in non-NIAID studies, now consumes a huge share of the research budget with analogues such as DDI and DDC taking most of the rest. Key committee posts should be staffed by MILLER REPORTING CO., INC. 507 C Street, NE. Washington. D.C. 20002 (202) 546-6666 186 oncologists, infectious disease specialists, and immunologists, as well as virologists, to give a broader perspective. Moreover, long term economic factors must be considered when establishing priorities for research. It makes little sense to put all our efforts behind drugs which may ultimately prove too expensive for widespread use. Manufacturers should assume more of the responsibility for taking a drug through the stages of testing once its usefulness has been recognized, rather than turning the ACTG into a virtual drug licensing factory. The resources of the ACTG should be directed at rapid Phase I-II testing of an array of promising drugs directed at opportunistic infections and immunomodulation as well as HIV itself. There should be a far greater flexibility to test drugs in combination even before they are licensed for use as Single agents. This system has worked well in cancer research for years. . Thinking needs to be reoriented toward a therapeutic model which addresses patient survival, not just the licensing of drugs for sale. Create task force groups with responsibility for addressing the most devastating Opportunistic infections. No one, for instance, is now MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 187 responsible for MAI research or toxoplasmosis research. These groups must have access to all available investigational agents and be permitted to work with minimal regulatory and administrative overhead. Their charge should be to push the envelope of existing therapy with acceptance of increased risks. At this moment I too feel compelled to deviate from my prepared remarks in response to some of the things I heard Dr. Fauci say. One of the areas that we feel the NIAID has been reasonably successful is in getting the process opened up to input from treatment advocacy groups like Project Inform, and it seems almost as though Dr. Fauci has incorporated our message into his remarks today in terms of sensitivity, but we haven’t seen our recommendations translated into real changes at the agency. Particularly I was impressed by the fact that he thought to put up a graph that showed the increase in spending for opportunistic infections, but I would point out that the graph was relating only to an increase in spending and not to where the money is actually going. If you looked and where money is actually being spent, you would find it is overwhelming directed at the anti-retroviral agents like DDI, MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 188 DDC, AZT. Furthermore, it should be pointed out that AZT is a tremendously profitable drug which has gained a constituency because of the money that is being spent to promote trials, to study it, that is being given to researchers to do the studies. We feel it should be the role of the NIH to direct resources toward rapid Phase I-II testing of all promising agents so we know what works, and then turn what works over to drug companies who can pursue what works on a profit oriented basis. Furthermore, on the issue of OIs, he seemed to suggest that it was too expensive, OIsS were tremendously complicated, funding wasn’t available, where could this resource be directed? I think that the kind of task force groups that we are talking about can work with small numbers of patients. These patients should have their health care paid for by the government, and I think very important answers would come out of work with these groups. This work is already going on, but it is happening in private practices and it is largely funded by patients’ health insurance or patients’ own dollars if the health insurance is refusing to cover the application of drugs. Practices all over San Francisco and New York have committed MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 189 physicians who are doing exactly this kind of work with the treatment of OIs, and all of the information is coming out of the communities and out of the clinical practices, it is not coming from the government. And I think it is incredibly irresponsible that this information has to come from the bottom up instead of being organized and come from the government down. Dr. Fauci also sort of picked up our theme about, you know, the diversity of the NIH’s role, in response to a question I believe that was asked, that the NIH’s role should be in testing a wide array of diverse agents rather than concentrating on a few big drugs. This has been the Project Inform message all along, and we hope that the Commission can see a way to implement it. Back to my text. Both the administrative and scientific posts must be populated by talented people who are motivated by a crisis atmosphere and who actually believe that AIDS can be cured. Leadership from the highest level of government is needed to set the tone. After ten years isn’t it time that someone was placed in charge of the overall AIDS research effort? The will to take this obvious step is still sadly lacking. MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 190 We ask the Commission to step back momentarily from the details of the epidemic and imagine AIDS from the historical perspective of a future vantage point. AIDS could be the catalyst for sweeping and necessary reforms in the drug approval and health care delivery systems. It might be seen as the vehicle for a golden age of immunologic research. AIDS could even be understood as the foundation for a new era of social cohesion. The reality of this vision depends on bold action now. We challenge the Commission to: design and provoke a vital response. Thank you very much. CHAIRMAN OSBORN: Thank you very much. Jim Eigo. MR. EIGO: I’m Jim Eigo, I work with ACT UP, the AIDS Coalition to Unleash Power. We are the country’s oldest and largest AIDS activist organization. My written address to the Commission is about 12 pages long. I hope you got a copy because there was a FAX error the other day with a missing page. I hope you have gotten it. At first I thought I might try and condense that to five minutes by giving highlights in each of the areas that I wanted to talk on, but I was afraid I would sound as idiotic as the nightly news with a series of sound bytes. So what I MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 191 would rather do is deal extensively with two of the areas I want to deal with and hope that you read the test of it. I also will leave to the written part of it the personal message that I usually like to begin things with, because many of you have heard it before, and it is there in writing. The two things I want to deal with are, first, a status report on the AIDS Clinical Trials Group, and secondly, why I think AIDS trials are accruing so slowly, therefore why it is taking so incredibly long to get answers, given the patient pool that we have got. A word of introduction about this first one, the status report on the ACTG. I heard Drs. Broder and Shavner of the National Cancer Institute speak on January 2, 1989, and one of the interesting things Dr. Sam Broder said was, of course the measure of the success of any AIDS clinical trials program is its results. That is, the drugs it gets us and the amount of information it, gets us. And it was almost as if scales fell from my eyes when I heard Dr. Broder say that and I had a new marker -by which to measure the government AIDS effort. So I’m going to read you the latest version of what has been an ongoing effort of mine about the last ten months MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 192 to keep abreast with what the ACTG has actually given us. The AIDS Clinical Trials Group, or the ACTG, of the National Institute of Allergy and Infectious Diseases is the government sponsored network for testing potential AIDS related therapies in people. It is, by the estimation of its leader, the most generously endowed clinical trials system ever. The ACTG, previously known as the ATEU, has been in existence almost four years now. And as of February lst, the ACTG had opened about 102 trials; 54 were still open as of that date, 37 had been closed to accrual but not completed, nine had been completed, and two had been temporarily closed, and I’m not quite sure what that means. The one FDA approved drug for AIDS, AZT, highly toxic and marginally effective for a limited amount of time, was developed outside the ACTG. The ACTG has yet to yield a new anti-AIDS drug. The majority of AIDS related opportunistic infections have no relatively safe FDA approved treatments. Fluconozole was recently approved to treat some AIDS related fungal infections, and part of the data for supporting that drug’s effectiveness came from the ACTG. But none of the data for the approval of any other AIDS related opportunistic MILLER REPORTING CO., INC. $07 C Sureet, N-E. Washington, D.C. 20002 (202) 546-6666 infection drug has come from the ACTG. Of AIDS related opportunistic infections, only pneumocystis carinii pneumonia has approved prophylaxis, that is, a preventive drug, and that was developed outside the ACTG. The ACTG has yet to yield a new drug to prophylax against any opportunistic infection. Because their immune systems are partially destroyed, people with AIDS will need therapies that in addition to fighting the virus rebuild the immune system. The ACTG has yet to yield a drug to boost the immune system. In fact, the ACTG has recently shut down the research committee that was supposed to be developing immune boosting therapies and turned those duties over to a subcommittee of one of its resource committees. None of the ACTG’s current high priority trials tests a drug that attacks AIDS in a way significantly different from AZT. That is, they are all nucleoside analogues, the priority trials. None of the ACTG’s current high priority trials tests a drug for new treatment or prophylaxis against an AIDS related opportunistic infection. None of the ACTG’s current high priority trials tests a drug to boost the immune system. Results from the few high MILLER REPORTING CO., INC. 507 C Sueet, N.E. Washington, D.C. 20002 (202) 546-6666 194 priority trials that have been completed on the dosage of AZT and on the use of AZT in wider populations leave us with many questions about treatment in the real world. For example, what is a minimal effective dose of AZT? And should kids really be getting AZT at a significantly higher does than adults are? None of the data from ACTG trials have been swiftly translated, either into FDA approval or change in FDA labeling or guidelines for clinical practice, or even into changes in other protocols for ACTG trials. All of the ACTG’s long term large efficacy trials for new agents have either already closed and yielded all the data they likely ever will or failed. All of the newly opened high priority trials are for drugs like AZT and are recruiting trial participants nearly as slowly as previous trials. Because Of an ongoing shift in the ACTG’s system of data management -- and that is from RTI in North Carolina to SDAC up in Harvard -- all of the new large efficacy trials recently slated to open have either been delayed or been turned into pilot projects or been turning into non-routine protocols. and I should note that is a change from my original testimony. I say non-standard protocols. I meant MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 195 non-routine. Non-standard protocol is something else entirely. Non-routine protocols, that is, protocols where the investigational new drug application is held by the drug company, and the data managed by the drug company, and arrangement universally loathed within the ACTG from the nomenclatura who sit on the executive committee and feel that the trials are getting out of their control down to the grunts in the field who collect the data and have to serve two masters. And after a recent review of all pending ACTG trials or concept sheets for trials, the executive committee of the ACTG has decided to reverse itself and disapprove 24 and to defer another 21. So that in the foreseeable future we cannot hope for results from any major ACTG trials, whether they be ongoing, new, or prospective, and in the foreseeable future the ACTG will deliver no new ways of fighting AIDS, no new drugs to fight AIDS in the established way, or to fight or prevent its related infections, and little new information about the old drugs we have. With a past and present this bleak and a prospect not much brighter, it should be obvious that at the ACTG there need to be some changes. I believe that before the MILLER REPORTING CO., INC. 507 C Street, NE. Washington, D.C. 20002 (202) 546-6666 196 ACTG begins to be effective, it will have to lay down some general comprehensive, scientific, ethical and practical parameters for itself, and will have to come to grips with some very particular features of the AIDS epidemic that complicate AIDS clinical trials. The second section I want to go into is why clinical trials take so slowly to accrue. I believe that is a major reason delaying the answers that we all want. People with symptomatic HIV disease don’t have the time to wait several years until large efficacy trials are completed. And for every person with AIDS there are several infected, and the number is increasing, people in whom we can prevent the disease if only we come up with the therapies fast enough. Yet, despite the need for swift answers, AIDS clinical trials enroll very slowly. As of February 1, 1990 121,645 AIDS cases had been diagnosed and reported in the United States, and many more people have ARC, or AIDS Related Complex. yet, as of that same date, the ACTG had accrued 6,300 people with AIDS or ARC into clinical trials, about 3,000 more asymptomatic people, a howling disparity considering how inadequate available AIDS treatments are and the number of people who are desperate for MILLER REPORTING CO., INC. 507 C Sueet, N.E. Washington, D.C. 20002 (202) 546-6666 197 treatments. I believe that there are two major reasons for this disparity between epidemic and trial enrollment, that these two reasons dwarf all other reasons in importance, and that these two reasons distinguish AIDS clinical trials from other clinical trials. I also believe that the AIDS bureaucracy has barely begun to address them, and until they do recruitment into AIDS clinical trials will remain sluggish. Briefly, the first is that most people with AIDS are ineligible for AIDS trials, which are designed for them, the second is that special populations that have been or are increasingly associated with the epidemic have been under-enrolled in AIDS clinical trials, and I'll look at each of these two very briefly. First, most people with advanced HIV are very sick in many ways. Investigators have traditionally had to deal with people who were sick in, a Single way. They prefer their sick people well. This has not been a capricious preference. It makes it easy to measure response to a study drug when people only have one condition and only need to take one drug. But it is an unreasonable preference to hold in the face of the facts of AIDS, and it has made a shambles of the MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 198 efforts to enroll AIDS clinical trials. Most AIDS clinical trials eliminate people who do not have certain baseline values as measured by a battery of laboratory markers. For this reason, few people with AIDS are eligible for clinical trials for AIDS drugs, and also, most AIDS clinical trials eliminate people who are on certain prescribed medication, yet most people with AIDS are on lost of medication, and need to be, and may need to be on more in the near future and are not about to go off medication to enter a clinical trial, nor should they have to. The trials will have to be designed with the people in mind. We have to relax our clinical trials entry standards if we ever hope to get the information we seek. Given the rough bundle of infections and malignancies that constitute AIDS, the notion that we can test AIDS drugs in a homogeneous population has always been an eee fiction, and is more so now than ever as people with AIDS live longer, individual medical histories more and more diverge, and they are all taking a range of -different drugs to treat and prevent infections. Because most people with HIV are ineligible for most HIV trials, these trials take indefensibly long to enroll and complete. MILLER REPORTING CO., INC. 907 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 199 But even successfully completed trials, because they exclude so many types of people with AIDS, tell sadly little about drug toxicity and interdrug relations in the real world, and sadly little about optimal does of drugs in different subpopulations. Efficacy trials for AIDS drugs will have sometimes to be bigger, exclude fewer and to stratify more extensively to generate lots of real world data in a short period of time. The status quo is untenable. It is utter absurdity to design trials for AIDS drugs that routinely exclude the vast majority of people with AIDS. Who, after all, do we think will be using these drugs? And I will mention that in my written testimony I give very concrete specific examples of trials that have been scotched pretty much because they have been unable to enroll people. The second major reason for the slow enrollment into AIDS clinical trials is; the under-enrollment of special populations in AIDS clinical trials. Some of these populations have been associated with the epidemic from the beginning, such as intravenous drug users, or black and Latino men, or people with hemophilia, When other special populations, like women and children, and especially women MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 200 and children of color, their original small percentages of the epidemic are now growing at alarming rates. These special populations are all slightly to grossly under-enrolled in the government sponsored system of AIDS clinical trials, but I will focus on one, the worst. For example, as of February lst, blacks compromised 27 percent of the epidemic in the United States. Yet only 10.2 percent of the people enrolled in ACTG trials. And in New York State it was, believe it or not, worse. In New York State where blacks compromised 35 percent of the reported population with AIDS, blacks compromised only 9.6 percent of the people enrolled in ACTG trials. This means that blacks in general are more severely under-enrolled in ACTG trials than are intravenous drug users, for whom there is at least a shred of a scientific reason for low enrollment. As this epidemic moves more and more into these populations, their under representation becomes more and more severe, as does the imperative that the ACTG do something to address this disparity. I believe, and have always believed, that equity demands it, but so does practicality now. Unless the ACTG reaches out to these populations, there is no hope that it will ever complete their large efficacy trials MILLER REPORTING CO., INC. 307 C Sureet, N.E. Washington, D.C. 20002 (202) 546-6666 203 I wanted to back track a minute on aerosolized pentamidine and point out that it was widely known and widely used in the community. The collection of data by the community consortium was an after thought to get the data needed to have it approved by the FDA. Believe me, the treatments for AIDS are coming up through the community and it is the government that has to be told in a big way, get these things done, rather than us being helped by the government. The specific problem that I am referring to is the fact that this money that is being given out by the CIPCRA, as it is commonly called, or by the NIH to CIPCRA, is the fact that it is money given out on a federal contracting basis, and there are some very specific rules that apply to how this money can be used, how it is accounted for, how it is spent. And the complaint that I have heard from Donald Abrams, who I think you will, be hearing from tomorrow, and you might ask him about this, even though I don’t believe he is including it in his written statement or prepared testimony, is that the degree of accountability that this federal contracting system imposes on the community trials prevents the work from actually going forward. MILLER REPORTING CO., INC. 507 C Sureer, N.E. Washington, D.C. 20002 (202) 546-6666 204 Furthermore, I would point out that at lot of people have talked about prophylaxis studies. There has been an idea for a very specific study on toxoplasmosis kicking around for a long time to test two agents that are used in the treatment of the infection now as prophylaxis in individuals who have a positive tighter for toxo but who are not yet ill with it. And it has been thoughtfully designed with the input of the community, but implementation of the protocol is currently being delayed somewhere back at the NIH. And you might want to ask Donald Abrams a little bit more about that tomorrow, if the federal contracting rules have anything to do with that delay. I’m not sure. COMMISSIONER MASON: Just kind of a follow-up maybe comment. I believe it is true that the ACTG has received the same amount of funding regardless of how many patients they enroll, and then the community-based -- what is it, CIPCRA or something like that, that funding is tied very specifically to numbers of patients; is that true? MR. CALDWELL: I’m not intimately familiar with it. It is my understanding that the CIPCRA units got grants of fixed amounts of money, and one of our complaints about the way the ACTG functions is that funding isn’t taken away when MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 205 things don’t get done, when the trials don’t accrue. CHAIRMAN OSBORN: David Rogers. COMMISSIONER ROGERS: Thank you all for some elegant testimony. I didn’t quite understand your comment, Mr. Caldwell, in response to Belinda about the level of accountability interfered with getting the trial done. Could you give me an example there so I understand what you mean? MR. CALDWELL: I can’t. Before I came here today I asked one of the people who is directing the community consortium to be specific with me and he was unable. I would encourage you to question Donald Abrams on that tomorrow. He is the head of the community consortium in San Francisco. The suggestion of problems of the federal contracting approach I believe came from him and I think he could be very specific with you on how it functionally impedes him. CHAIRMAN OSBORN: i mean, clearly you would want your community group accountable, but -- MR. CALDWELL: Obviously. COMMISSIONER ROGERS: But something is inhibiting in terms of the level? MR. CALDWELL: We are suggesting that there are MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 207 AFTERNOON SESSION 2:20 p.m. CHAIRMAN OSBORN: Why don’t we try and get started. I think almost everybody is here. While everybody is taking their seats, I have an apology to make. As your official photographer for the visit to Georgia, the pictures are wonderful, but they are also in Ann Arbor because I forgot yesterday. So I promise to bring them on the next possible occasion, and during the summer one of my goals is to make packets of pictures for people, so it will all come after awhile. But I have an absolutely wonderful one of Congressman Rowland and me and that cop in front of his Harley Davidson, and it is even turned so that it says "Albany Georgia Police" right there. I think in fact we should thank Roy Rowland very specifically for the wonderful experience we had and the wonderful hospitality that we experienced. And the onions. This afternoon we want to go with the flow to a certain extent, and under the agenda that is put out, that it is a proposed agenda really, but those are items that we should touch on. In terms of Commission goals and strategies, I MILLER REPORTING CO., INC, $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 208 thought we might want to start out by hearing any more things that you folks wanted to contribute, particularly from the discussion that I was unable to participate in at our last hearing because of the sudden news of Jonathan Mann’s resignation. I think I was away for a lot of that and David was chairing it, and maybe you want to just take over again briefly and finish that off, or are there things that needed to be pursued further? COMMISSIONER ROGERS: Well, I think I would sort of open it up to suggestions, comments, that anyone would like to make about how are we proceeding? Are we proceeding to the satisfaction of one and all? Are there other things we should be doing? Are there ways in which we should be doing things that we are not? Are people feeling they are having adequate input to what is coming out? Are you pleased with the shorty reports rather than the long one? I would think Just, some general comments on process and how we are proceeding would be helpful. Larry. COMMISSIONER KESSLER: I have been getting a lot of positive feedback, actually, about the reports from a lot of levels and people asking for them. This is a procedural or tactical question, I suppose, and that is whether or not it MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 209 would be worth putting those two reports in a very inexpensive pamphlet form for people to have at their fingertips. JI have been supplying Xerox copies of the report. COMMISSIONER ROGERS: I like that idea. I don’t know how the rest of you feel, but I have too, because I keep | running out and then I’m asked for reports. And I think the beauty of it is it is short enough that people really want it because they actually read it, because it is five pages, not 50. Would that be possible, Maureen? MS. BYRNES: It seems to me if the Surgeon General can do it, so can the National Commission on AIDS. I think it is a great idea. I think we should look into trying to get that done right away. COMMISSIONER ROGERS: Well, while on that topic, I would be interested in the feedback that others have been having. I have had very positive feedback from all kinds of groups about the report, and we heard a little bit about it this morning. COMMISSIONER KESSLER: I guess the only caveat I would add, I just thought of it, looking at Eunice reminded me that we probably ought to-do it, if we afford it or can MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 210 get it translated, in Spanish as well, and that would be helpful I think. Let’s not make the same mistake that we all have made in the past. COMMISSIONER ROGERS: Very good. CHAIRMAN OSBORN: I had an interesting comment from somebody at Ann Arbor during the graduation ceremonies. They said, is your Commission beginning to wind up it’s work? And I said, goodness no, we have only been going eight months out of two years. And they said, well, we wondered, because we are hearing so much from the Commission that it sounded as if it was finishing its work. I said, well just wait, you are going to hear a lot more. But that’s an interesting interpretation that the fact. that we are in there pitching made some people think that we were finishing. COMMISSIONER ROGERS: Other comments? Dianne. COMMISSIONER AHRENS: Yes. I do have some concerns. I think there are a number of things, as I look back, that we have done very, very well. I think this Commission has demonstrated and been tested on its ability and willingness to spend the time and work hard and real commitment here. I think we have been a kind of reactive MILLER REPORTING CO., INC. 507 C Suet, N.E. Washington, D.C. 20002 (202) 546-6666 211 Commission, appropriately reactive, to issues as they have come up and we have been able to address them, maybe really make some changes, at least help things move in a direction we think they should move in. I think we have been effective there. I think we have been very effective with the reports in informing the public, and I hope that sort of thing will continue. I think our site visits have been absolutely marvelous and have helped us to visualize what it is we are really about. But I think there are some major areas that for me are unaddressed, and in that sense I feel a lack of direction. If I’m ruining on parallel tracks that don’t coincide with the rest of you, I hope you will step forward and say so, but that’s the sense I get. The sense of where we are going, I’m really somewhat unclear on that. Not somewhat, but I think I’m really quite unclear about that, and even less clear about how we are going to get there, and in terms of what sort of a time frame. In terms of the where we are going to go, I think we did spend some time on that last time we met here in defining the kinds of issues and areas that we felt should be MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 212 covered, and we all participated in that and I think we came out with a good list. And staff then took that back and helped to flesh that out and they sent us all copies. I guess we didn’t participate at all in that fleshing out. I think it might be useful if we did spend a little time on that, because I think we would all like to participate a bit on how we do that. COMMISSIONER ROGERS: If we took what we had done before and moved it farther? COMMISSIONER AHRENS: Yes, I guess that is what I’m suggesting. It takes a real roundtable to do that, and I think in a setting that is less than this. But just as importantly, and something which I don’t think we spent any time on, not as a group, is the process to get there. I mean, how are we going to deal with this subject matter? And we are 14 months to go, nine months into our two-year termination, and I don’t think we have a lot of time. As I count the formal meetings of this Commission, we only have about seven left, and how we utilize the total Commission time vis-a-vis subgroups or working groups or whatever we want to call them, I’m not clear about that. And I don’t know, some of the issues that we have not even begun MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 to cover here, which deal with service delivery and financing, those are enormous substantive issues that I think will require time, either subcommittee and total Commission time, or total Commission time however we decide to organize it. But those are just two of the list of about 12 or maybe 14 issues that I think we had listed at our last meeting. So those things bother me, and I simply want to express them and say I’m open to challenge. If some of you think that you do have a sense of vision and you do know where you are going, then by all means come convince me. COMMISSIONER ROGERS: Well, let me make a suggestion, which, at least, if I’m hearing you correctly, that we that might take from that potpourri, that sort of wish list that we put together -- well, let me make a comment first. My reaction is we ought to be sure where we want to go before we decide the process by how we get there. If we are going to Cleveland, it might be a somewhat different process than if we are going to Puerto Rico. But would it make sense for the group to take that list sometime and in essence say here are the big five, or here are the big six, or here are the big three that we really want to be sure we cover, and then plan the process? MILLER REPORTING CO., INC. $07 C Sureet, N.E. Washington, D.C. 20002 (202) 546-6666 Would that make sense in some way? COMMISSIONER AHRENS: Yes, I think one has to precede the other. But it seems to me that we have got to get on with knowing how we are going to get there soon. COMMISSIONER ROGERS: But we better decide where we are going. COMMISSIONER AHRENS: That’s right. COMMISSIONER ROGERS: Other comments on this? Dianne and I talked a bit. She felt insecure about did we have a clear road map in terms of where wanted to go and how we would get there. Yes Don. COMMISSIONER GOLDMAN: I share some of the unease that Dianne feels, although I’m not sure that it is necessary. I think if we look at the range of areas that we need to be concerned with, it is probably too large an area that we could possibly encompass.in our two-year lifespan with the staffing and budget, and Manpower that we have, and we could never hope to do it. And I think wisely we have looked at that list opportunistically in the sense of seeing what items on this list, based upon sometimes external factors that are beyond our control, might we make an important contribution in one ares or another. And if it MILLER REPORTING CO., INC. 507 C Screet, N.E. Washington, D.C. 20002 (202) 546-6666 215 turns out that it is item.number 37 this week that we can actually do something effectively about, then we ought not hesitate to do so. And while that may appear on one level to be disorganized, on the other hand I think that at the same token it takes full advantage of the limited resources that we have and takes full opportunity. And so while I share Dianne’s discomfort in a certain sense with a clear road map, I think by necessity we have to do it. Another area, however, one of the questions that I have though is the question to me of where we ought to be going and either, A, how we have done, and B, what we have left undone seems to me to a large extent is a question that ought to be answered by Congressman Rowland and by Jim Allen and others in the governmental sector that we are supposed to be providing counsel to, and have we been doing it appropriately and in what areas and arenas does either the executive or the legislative branch feel that we ought to be doing more work in and in what areas might our assistance be of some use. COMMISSIONER ROGER: Roy, may I just collect a few more inputs and then get both you and Jim to respond. Chuck. MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 216 COMMISSIONER KONIGSBERG: Let me support Dianne’s comments, although I don’t agree with Don either. I think that the group does need a little bit clearer focus. I think we have identified some critical issues, but to me it has been unclear as to the priority setting process and how the. group itself helps determine that process. I mean, we were given a fairly broad general charge by Congress that we have all read. It has some specifics in it, but within there are many particular critical issues. I agree with Don that, to phrase it a little differently though, we do need some flexibility. We shouldn’t be so bound to some sort of priory setting process that if, for example, the care act comes along and we are working on something else, that we don’t stop and try to take care of some very important business. And I am sure that everybody would agree with that. But I really would. -- my recommendation would be that this group consider -- and I don’t know what the correct format would be -- to set some goals and some priorities as a group process, because we’re collectively responsible as well as individually responsible, and see where that takes us. And I don’t think it is too late. I think we have done some MILLER REPORTING CO., INC. 507 C Screec, N.E. Washington, D.C. 20002 (202) 546-6666 217 very good work and in effect have identified some critical issues. But it is the need for focus, that we seem to be kind of all over the waterfront, and I have heard several people comment that we have been on the reactive side. And again, some of that is appropriate and should be, but we have got to also kind of get out front on some things. COMMISSIONER ROGERS: Thank you, Charlie. Other comments on that particular bit? June? CHAIRMAN OSBORN: Just one comment. As one starts to look at how to cover what is a very long list of potential things, one line of thinking that I have had, which I think I have said before, but which I think is useful in trying to plot out 14 months or whatever we are looking at in terms of time, is that given the breadth of background represented by the Commissioners as a whole, in choosing topics that have a great deal of expertise that can be brought to bear on a given subject -- and financing comes quickly to mind -- where there are a lot of people who could help us and who are very much more expert than any of us can be, that the small working group, or even better yet, the expert advisory committee almost entirely drawn from outside can accelerate us a great deal. So that a report from such a group could MILLER REPORTING CO., INC. 507 C Street, NE. Washington, D.C. 20002 (202) 546-6666 collapse some of what looks like formidable agenda. And that is a strategy that we haven’t used quite as such yet but which we can readily do. So when one goes down the list of things, there is a mix of things on that list, and some of them are issues that I think are very | appropriate to the Commission as a whole that are broad cross-cutting issues that require input from all the likes of us and lots of other people besides in a hearing setting, and that serve the public well by being aired publicly. There are others where learning the fine detail of this versus that financing mechanism serves nobody’s interest particularly well to do it in detail in public and yet is important to the outcome. So I think we can help to cut down the length of that seemingly formidable list that way, and I think in the second year of the Commission budget we’ll be in a position to do that a little bit better using the consultancy roll as a much more active mechanism than we have thus far. COMMISSIONER ROGERS: Thank you. Other comments on COMMISSIONER KONIGSBERG: I think that gets back to the question of the how do we get there. But I still believe MILLER-REPORTING CO., INC. $07 C Suet, N.E. Washington, D.C. 20002 (202) 546-6666 219 that the Commission collectively has got to decide ina democratic fashion what the focus is and what the critical issues are. The how to will vary, and I would agree there are many areas of which we are not expert in, but we are still, I think, responsible for focussing in on. For example, I’m sure everybody would agree that health care financing is one. And we would have to have outside expertise. COMMISSIONER ROGERS: Let me try this out on you. We did go through that process of at least trying to develop a quick and dirty in terms of a list without any prioritizing, and I sense everyone is saying now let’s, where the rubber hits the road, let’s decide on the four or five, or the six or eight, or the two or three that we think are most important. I think at the outset that we decided that we were going to be a rifle, not a shotgun, that we were going to try and pick a few major areas. Would it be worthwhile for that list to be recirculated to this group to then have that group process that Charlie’s is suggesting where we tried to agree that there were these four -- with the caveat of some flexibility, some opportunistic kinds of approaches that Don is suggesting MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 220 -- and then and only then decide how to get there. Some of it might be, that’s where we need a special committee from the outside, here is one that we could deal with ourselves, here is a rough timetable in terms of how we do it. Would that make sense to the group? Larry and Scott. COMMISSIONER KESSLER: David, I think we do have some thoughts and feelings, and we have got the ingredients for a strategic plan here. But with due respect to my fellow Commissioners and myself, none of us I think have a lot of experience in very tight strategic planning, long range planning. I do think we need some outside help to accomplish that 14-month goal and to work backwards from there to here. There is one person that comes to mind that I have used three times now on a national level who is from New York City, from Columbia, and also Mary Knoll Institute, who is an expert at strategic planning in terms of helping groups get to their goals and objectives. But we need someone like that to help us do it collectively and help us see the plan so that we buy into it collectively and guide it. It is relatively simple, and I’m getting there after going through it three times with her, but I still don’t have the skills yet that she has in terms of MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 221 communicating it. And she does it in such a way that it is so clear and succinct that I think we could probably do it in a four or five hour session. COMMISSIONER ROGER: Larry, where do you introduce that? Should the group first decide here are the five things we would like to do, and then introduce her? COMMISSIONER KESSLER: You probably do it with her. You could give her what we have to date, but it is important to do it with someone like that, if that’s the person you chose, because of the buy-in. I've seen this person actually flick lights switches in people’s heads. COMMISSIONER ROGER: What does your head look light when your switch is flipped? [Laughter. ] COMMISSIONER KESSLER: Well, in terms of understanding the process. And I think that’s what we are talking about, is the process. How do we get from there to here, not from her to there. We have to work backwards figuring out what it is we want to do at the end of that 14-month period and then create a time line with goals and objectives. It would be very helpful if the process was for the Commissioners with the staff observing so they could be MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 222 supportive, because they are going to have to support the infrastructure here and help us do it. But I think it can be done. And we ought to do it soon, because the antsiness or unease that I think Dianne has described, and Don and Charles, probably we all have it to a certain degree, but yet we are powerless I think to change the direction without some skilled help. COMMISSIONER ROGERS: All right. That’s an interesting thought. Now let’s hear from Roy and from Jim. Excuse me Scott, you are next, and then I’m going to ask Roy and Jim to comment. COMMISSIONER ALLEN: All I wanted to say is that some of what we have done in the working group is a lot of that processing that has been extremely helpful to us, and not only a place there, as we’ll talk about later, of what we have gone through and open it up to you all, but how even this working group fits into the larger picture I think would be helpful, as Larry was saying, just to figure back on what Larry is saying, we need something that will process, that will blend all the different perspectives and the main issues into something that is cohesive. And so I think what we have i MILLER REPORTING CO., INC, 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 223 done here is look at the goals and so forth and go down the list, and sometime later we are going to look at that. But where that fits into the broader picture, what is the broad picture of the financing and so forth and how we are going to all meet at the end of the trail if we are going to be working into working groups, is very important. And so that's basically what I wanted to say. COMMISSIONER ROGERS: Roy, give us your Congressional wisdom now. CONGRESSMAN ROWLAND: ri say something Congressional, but I don’t know if it will be wise. COMMISSIONER ROGERS: Your Georgia wisdom. We have a lot of Kentucky wisdom today, now we are going to get a little Georgia wisdom. CONGRESSMAN ROWLAND: Well, I think that on tactical matters that the Commission has done extremely well. I am very pleased with what has taken place there, the recommendation for impact to support that impact of financing in districts, areas that are hard hit, including AIDS and ADA. Dealing with the immigration issue too, all of those are tactical things, and I think it has been largely MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 224 reactive though, things that the has reacted to. One thing that I think the Commission has done that has been very good is recommended to the President that there be a coordinator of all of the agencies. I think that is the strategic goal. That is a long term goal. But it seems to me, just my idea | about what is going on is that we really haven't selected a goal, whatever that goal is, and tried to seek that goal. We have just sort of been wandering around in the wilderness here for -- was it 40 days? COMMISSIONER DIAZ: Forty years. | CONGRESSMAN ROWLAND: Forty years. Okay. And going on for eight months now. VOICE: It was 40 days under water. [Laughter. ] CONGRESSMAN ROWLAND: You scholars of the Bible know more about that than I do. But it seems to me, David, that to make a determination about what some strategic goals should be, and I think you. talked about this in the very beginning, that we should not select an array of things that we ought to deal with, but may be two or three or four things that we really needed to deal with that was so important to addressing the MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 225 epidemic. And I don’t think -- I don’t have the feeling myself that we have really done that strategically, that we have reacted real good to some things that needed to be addressed tactically, but strategically it seems to me that we hadn’t really moved. And maybe we needed to have this time to kind of let things simmer some and find out exactly where we are, but we may be at the point now that we need to look at that. COMMISSIONER ROGERS: Okay. Jim, do you want to comment? I don’t know whether he wants to comment or not. MR. JIM ALLEN: Well, I think Harlan has got the right attitude there. Part of the difficulty, I think, that has surrounded what has happened in the last eight months -- is that right, is that how long you have been -- six or seven, whatever it is -- I think that not only are you struggling to identify the issues and the agenda, but I think you are also struggling a little bit to identify the right audience to whom to address the information. And while your two reports and the accompanying letters have gone to the President, he in many ways is only one of the target audiences, and some ways is not really the best. MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 226 Many of the recommendations, of course, come to Health and Human Services, and they have been heard with mixed reactions. The issue on housing, perhaps, has not been heard at all yet by those that do. It clearly is not an HHS issue. Your invitation to Housing and Urban Development was not responded to at the time that it was issued, and I don’t know whether the message has been heard any further. I mean, it has gone into sort of a black hole there. And I guess what I’m trying to say is I think identifying exactly the audiences and how to reach them is important. Another potential audience is obviously Congress, and I think that again among the members of Congress there have been some members that have been very open, very receptive, have sought out your advise and counsel, have heard the recommendations and are acting on them vigorously. There are others, including those with whom June spars on the pages of the newspapers, that are probably somewhat less enthusiastic with your message. Another potential audience, obviously, is the much broader one of the American populace and the various industries that are impacted, or should be impacted. And here again, I think that the message has been heard with MILLER REPORTING CO., INC. 507 C Screer, N.E. Washington, D.C. 20002 (202) 546-6666 227 mixed reactions. I think that in general the visibility, the continuing flow of information from the Commission has been extremely helpful in terms of keeping the issues on the front pages. You are not just having hearings that are then reported in the press over a year or two-year period of time, you are making pronouncements, you are giving information, recommendations, messages, and I think that distinction between simply having reporting of what goes on at the hearings as opposed to coming out with things is very important. I hope that that will continue, and it may be quite a bit broader in some ways than the few major messages that you choose to give your primary emphasis to. I think you have done a very good job at getting a lot of information out. You know, I sit here as at a session today and, of course, know a lot of what each of the speakers is going to say. On the other hand, there are new things that come out each time, there are different ways of looking at it, and even among the activist community, to look at the difference of opinion between Neil Schram’s position and that of Jim Eigo, you know. Now, what does the Commission need to do with this information? Probably not much today with the research information, but to assure that it gets out and that MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 228 it gets heard so that others can pick it up and act on it. In this instance, the National Academy of Sciences is already addressing to a great extent what the NIH is doing. I have picked up a lot of information. There are things that we are not going to sit around and wait for the Commission necessarily to get all the information on. But it is. very helpful to hear it. .. I think there are a number of public health issues. I think the issue of how do we do about in our country establishing a milieu in which prevention is a very important message is going to be one that the Commission is going to need to tackle, because I don’t think those of us working in Our own agencies and departments are going to be able to do a lot. So I think that the next couple of months will help you define very much what are those issues where you uniquely can make an important difference, and I think you will be identifying the right target audiences and moving forward. COMMISSIONER ROGERS: Let me try this Out on the group. It seems to me we are saying we must through a group process set some goals and that appropriately, if I’m hearing Roy, that they would be limited, that it wouldn’t be 50, it MILLER REPORTING CO., INC. $07 C Street. N.E. Washington. D.C. 20002 (202) 546-6666 229 might be five, or it might be four, with the recognition they might shift, or that we might react to a particularly pressing issue at an appropriate time, as we have done in the past. But that they are proactive as well as reactive, that we set a real series of objectives and goals. That we also in that decide the audience. I think Jim just made -- or a series,.of audiences, but who do we really want to hit. And then the process by which we get there, which might include outside groups as well as sessions as well as visits and what have you. Let me get a reaction to -- excuse me, Irwin. MR. PERNICK: Even though I missed the first session, I thought it was plenty clear to me this morning what the objectives of this Commission should be, at least one of the major objectives, considering all the tension that existed up there, even though the various parties were not sitting together. I think some of them probably if they were at the same table would have come to blows, and that’s fine. I mean, that really clarifies in my mind what some of the problems are. I know there is a lot of interest in AIDS, I know there is a lot of money in AIDS, I know there is a lot of MILLER REPORTING CO., INC. 507 C Street, N.E. Washington. D.C. 20002 (202) 546-6666 230 research in AIDS. And yet, I’m part of this Commission and I’m wondering what is going on. Your recommendation, which I had some doubts about in the last report, this thing firmed up to me. You can see the drug industry fighting with the FDA fighting with the AIDS activists, who are also fighting with NIH and all the other, and Jim and his other colleagues, who in turn are fighting with other physicians who are Claiming that the government is a little too uptight about the whole thing. Coordination is necessary. Now, I asked a very polite question, but I knew what the answer would be. Nobody up there said, "No, hell no, we don’t want to a Bill Bennett drug czar type for an AIDS czar." And maybe that’s what we need. What’s her name -- I’m sorry, I’ve forgotten the name. I think it is Alzheimer’s. COMMISSIONER ROGERS: No, her name was not Alzheimer. . MR. PERNICK: The lady from the National Institute for Nursing Research said, oh, yes, we have got a cooperative project with the State Department, or AID, or something like that. That’s not what we are talking about, and that MILLER REPORTING CO., INC. $07 C Sueet, NE. Washington, D.C. 20002 (202) 546-6666 231 really exemplifies what should be at least one of the major tasks of this Commission, pushing for some coordinated | action. I am the last person around here who knows anything about medical care delivery. I’m really ignorant. I marvel that everybody is involved and knows what is going on. We talk about the National Academy of Science, National Science Foundation, National Institutes of Health, and Jim's outfits. Who is going what? And then, of course, the VA complains -- the VA -- we complain if in talking about medical care the VA isn’t mentioned. y know we are doing something, but I’m not sure what anybody is doing. And how does everybody get to know about it? Then, I was very happy to hear Dr. Schram say how unhappy his group is when something like JAMA, or the professional magazines, except for the New England Journal, refuse to allow prepublication of their key issues. They should be jailed if it is a matter of life or death in those cases. And maybe that’s another issue this kind of Commission should take up. June is laughing because she has been in medicine all her life, and so have most of the rest of you. This is MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 232 new to me. And I thought doctors were not politicians or bureaucrats, but you are. [Laughter. } MR. PERNICK: But as a bureaucrat, it is all right. | You see, that’s why I was a little surprised to hear Dianne say -- you know, it was sounding a little forlorn. There’s plenty to do, plenty in terms. of a few key things that we could probably sink our teeth into. COMMISSIONER ROGERS: And if we accomplished even that one in terms of some overall coordinative mechanism that cut the red tape and speeded things, that would be quite a contribution. MR. PERNICK: Now, at this point I would have to step back and represent my agency and say we would have to look into that one. {Laugher. } COMMISSIONER ROGERS : Thank you very much. MR. PERNICK: And really, we put Jim on the spot because he, in a very importance office in his agency, still has all of these other outfits that are somehow attached to HHS that are really going to complain about that. COMMISSIONER ROGERS: How would you feel about all MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 looking at that list? How do you feel about Larry’s suggestion as regards the process? | COMMISSIONER DIAZ: It seems like that would be the first step, because this lady could really help us in the development of even lumping some of those priorities together. That’s their skill, and so, you know, if we already have a lot of that done and then say to the person, enter at this point in the process, it is not as helpful. We are not getting as much bang for our buck. COMMISSIONER ROGERS: You feel, Larry, it enter COMMISSIONER KESSLER: I think we are about ripe. I think we needed to get to know the landscape and to know each other, but now seems about the time that you would enter this kind of a process so that you would get more mileage in the last 12 months than we got in the first 12. But there is no short cut here. I think everything we have done is right, but now we are looking for real quality time and a high quality product. COMMISSIONER ROGERS: All right. Well, I sense fair unanimity on this. Chuck. COMMISSIONER KONIGSBERG: Real quick. I agree with MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 COMMISSIONER ROGERS: Okay. COMMISSIONER GOLDMAN: Real quick. I agree with Larry in principle, my only question is -- COMMISSIONER ROGERS: There is the lawyer coming COMMISSIONER GOLDMAN: My only question is if we wait for the next Commission meeting in July to begin that process, I’m just concerned about the time frame and whether or not there might be some ways -- and not that I disagree with it -- but there might be some ways to shorten up the process in some way. And I don’t know what kind of time frame people might be talking about, but maybe what we could do between staff and between perhaps a few members of the Commission, put together something a little bit better, ask members of the Commission to send lists in and perhaps expand upon it, maybe do some of the work in preparatory for that kind of meeting ahead of time so that when we get to that point we aren’t starting from scratch and putting up ideas on the blackboard for the first time. COMMISSIONER ROGERS: My antennae tell me that that ain’t where the group is, that it is saying as a group we MILLER REPORTING CO., INC. 907 C Street. N.E. Washington. D.C. 20002 (202) 546-6666 235 should do this. I don’t think it would be that complicated frankly. I mean, we have already gone through the exercise. My suggestion would be all of you take a look at that list, that we go ahead and plan. I would think a day would do it, or a half a day would do it. COMMISSIONER KESSLER: I think there is a way that, if. we decided to use this particular person, that she could get the input from individuals in writing and on the phone, but I’d rather she asked the questions rather than us assuming the path, and that would save time for everybody. But at least then she would have a framework and we would be using her framework to suit our needs. COMMISSIONER ROGERS: Eunice. COMMISSIONER DIAZ: Just a quick question. Are you talking more retreat type format, and could a day do it, or will we need to have follow-ups? COMMISSIONER KESSLER: I think a day could do it. I have gone through it several times with her with other national groups that I am a part of, and she has done twice in one day and once in a day and a half. COMMISSIONER DIAZ: Do you need retreat setting or that type of thing? MILLER REPORTING CO., INC. 507 C Street, N.E. Washington. D.C. 20002 (202) 546-6666 236 COMMISSIONER KESSLER: It could be a setting very much like this. It doesn’t have to be a retreat center or anything. It is a work process. COMMISSIONER ROGERS: Yes, I think a number of us have tried this and it works very successfully. Are you comfortable with a day? Dianne, are you comfortable with a day? COMMISSIONER AHRENS: If Larry says so. COMMISSIONER ROGERS: Larry, if it works we’ll take the credit; you know who is going to get the blame if it doesn’t work. MS. BYRNES: I officially want to ask Don Goldman's assistance in helping me figure out how we do this if it doesn’t fit within our consultant fee statutorily. I’m convinced there is a way to do it, but I’m alerting you to the fact that I have some constraints on how we hire someone to facilitate such a process. I’m convinced it can happen. I’m saying it won’t be easy if it goes beyond our consulting fee. COMMISSIONER KESSLER: One way to do it, I think, I think this is legal, would be that we spread her fee out over five days worth of consulting or something, but she would MILLER REPORTING CO., INC. $07 C Street, N.E. Washington. D.C. 20002 (202) 546-6666 really be with us one day. MS. BYRNES: We’ll figure it out. I’m just mentioning it in passing. COMMISSIONER ROGERS: Does the idea have appeal to everyone? Why don’t we ask the staff to proceed to do it. June, does that make sense to you? COMMISSIONER DIAZ:.. When are we going to discuss possible times? I’m feeling a little pressured now in view of the additional meetings. CHAIRMAN OSBORN: We’1ll get to the schedule ina minute, and then probably at the end should come back to be sure this fits. But I think this clearly has got a priority that we'll want to work into whatever schedule agreements we come to about other things. COMMISSIONER ROGERS: Well, I sense my part of this is over. Is everyone satisfied with the way -- well, Don isn’t satisfied, but he is going to put it in principle. COMMISSIONER GOLDMAN: I’m satisfied, and it is fine. I just hope we can do it soon. And I would also hope that -- and I will do my best to do so -- but I would also hope that we not fail to think about it on our own in terms of organizing our own ideas between the time that we do MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 238 choose to come together. And it is something we really have to take seriously. COMMISSIONER ROGERS: And I think we should all take those lists again and in your own heart and your own home decide if I had three things that I really wanted to put before the nation or the Congress or what have you, what would they be, so that we come to that session -- well, we are not coming uninformed as it is. And I agree with you, Larry, I’m really very proud of what has happened to date, and I think the kind of input that we are getting about the Commission has exceeded my fondest expectations of it when we started. And I think what we have done so far was a necessary preamble. I don’t feel we could have done what we are about to do until we got to about this stage. Roy? CONGRESSMAN ROWLAND: David answered my question. My question was, what are going to be the goals that you set, what are going to be the issues that you are going to address, how are you going to arrive at that, how are you going to make that decision? I guess what you are saying is that everybody looks at two or three or four things and decides that’s the thing MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 239 that they -- COMMISSIONER ROGERS: And that’s what we would do in that session. We would put that together and prioritize it and then decide what mechanisms we could used. I like June’s thought, I think there are some areas where an expert panel could put together something for us that we would buy into or not, that could extend the work of the Commission but without us all having to meet. CHAIRMAN OSBORN: The reason that I threw that comment in when it seemed a little out of sync with the discussion wasn’t to be out of sync, but rather because I think as you look at the list and try and decide how ambitious is it reasonable to be, if you don’t have that mechanism in mind, then we pull in our ambitions. And I don’t want us to do that. So that’s why I suggested that as you are looking at that -- and financing keeps being a very good example -- you look at that and say well no, we can’t spend days and days of Commission hearings when we have only got so many days. So on the one hand, if you didn’t have that mechanism in mind you would be inclined to walk away from it, saying there is the Pepper Commission, there are other people that are paying attention to that, we’ll leave MILLER REPORTING CO., INC. $07 C Sereet, N.E. Washington, D.C. 20002 (202) 546-6666 I don’t think we have to do that when we have more resources than we now have, but we expect that we might soon, or with the new budget year. We will be able to be ambitious in ways like that this Commission as we have been working couldn't, and that is why I tossed it in when I did. And so as. you go through the thinking process, I wouldn’t be very surprised if we came out with a remarkable consensus not coincidentally but because we have gone through several months worth of very impressive experiences together, and I think that we may be -- that’s another sense in which this may be very good timing, and that’s another sense in which I don’t feel terribly hurried. Let me point out that between now and the next Commission meeting is the international meeting, and that’s going to have its own set of events and experiences and new insights and lack of new insights, and I’m afraid a lot of national dynamics that we will be involved in to one extent Or another, so that that may not be at all a bad time right after that to sit down and say, okay, we have got roughly one “more year here, we have an interim report in August that can either be very large or a reasonably modest supplement to MILLER REPORTING CO., INC. $07 C Sueet, N.E. Washington, D.C. 20002 (202) 546-6666 241 what has been written already, we have some choices there. So I would say the timing of the next scheduled hearings is a rather good time to do what Larry is describing, and I like the sound of it. I think it is better than having any one of us try to move everybody around, since we have all been coequal partners in the experiences that will be shaping our consensus as we go. -- Now, this is a strategic thing, and I’m changing gears. We have all decided that one urgency, one sort of episodic thing that we got behind was the disaster relief approach to the immediate circumstance, and, among other things, the Kennedy-Hatch bill which has now had very strong support. There is a hazard that that could get to be a victim of internal planning an mechanisms, and rather than getting into wording here, I was going to see if you felt it was all right for David and me to write a letter reiterating the fact that that whole thing was conceived as relief of a disaster and the disaster is now and that we continue to feel some urgency about it, and aim that kind of a message from the Commission. It would be a simply worded reinforcement of things that I think we have already said, but the timing is such *) MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 . 242 that it might get very badly stalled out, and it certainly runs the risk of not being dealt with as disaster relief legislation. CONGRESSMAN ROWLAND: I wanted to report to you on that. We passed this AIDS legislation out of the Health and Environment Subcommittee this past week. Are you aware of that? | -- CHAIRMAN OSBORN: Yes, I knew about that. The Senate side is the one I’m worried about, because that’s about to go on stall. It was already scheduled and absolutely was going to happen at the beginning of last week and went on stall, and I think that a simple letter from us is warranted, if you agree, and we write something that is very straightforward and basically reinforces prior Commission statements but points out that this is a disaster -and that you don’t want to go business as usual, or in this instance, worse. It basically, as I understand it, is at some risk of getting caught in the campaign reform debate which is estimated to take somewhere between four and six weeks. And that may happen. But we feel that there is at least a little window where we could still write a letter MILLER REPORTING CO., INC. 507 C Street, NE. Washington, D.C. 20002 (202) 546-6666 243 rather urgently saying that this was conceived as disaster relief, it is a disaster, none of that has changed, please deal with it that way. “CONGRESSMAN ROWLAND: Do you know where the hold up is in the Senate? Do you know what person the hold up is in the Senate? There is usually one person that is holding things up. CHAIRMAN OSBORN: Well, I know one person. Maybe Carlton knows more than one. MR. LEE: When the bill was about to come up a couple of weeks ago there were three holds on the bill, Senator Wallop, Senator Helms, and Senator Armstrong. Armstrong and Wallop I think by most people’s assessment have gone away, they are not going to push this. They tend to have holds on any AIDS bill that might come up so something isn’t done while they are out of town and that kind of thing. So Helms, to my understanding, is still concerned about going to the Floor. He has not expressed what his concerns are, and Senators Hatch and Kennedy and others are talking with him, so that is the hold up. CONGRESSMAN ROWLAND: The same story. MR. LEE: The same story, different bill. MILLER REPORTING CO., INC. $07 C Street, NE. Washington. D.C. 20002 (202) 546-6666 CHAIRMAN OSBORN: But I think it is felt by informal communication from the leadership to the effect that this is one time when the Commission could be helpful by reiterating the urgency of it. And I think we can do that in a way -- when we took our last step it was already bipartisan. By now it had 60 cosponsors as it started to go to. the Floor, which included not only Senator Hatch and Senator Hatfield, but senator Dole, as well as the Democratic leadership and so forth, so that by now it is about as massively bipartisan -- and it came out of committee with unanimous endorsement, so we are no longer in the uneasy spot of worrying about bipartisanship. This is a very broadly supported bill as it gets started and suddenly runs into a glitch. And I would hope we could do something about it. COMMISSIONER ALLEN: To whom would this be addressed, the letter? CHAIRMAN OSBORN: Presumably the Senate leadership. COMMISSIONER ALLEN: The leadership. Okay. CHAIRMAN OSBORN: Not Senator Helms. I don’t think Senator Helms wants to hear from us. MR. LEE: Mitchell and Dole. COMMISSIONER KESSLER: June, I would make a motion, MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 245 it that is helpful, that we do that, and especially stressing the emergency disaster component. Otherwise we may end up waiting until ‘92 for this thing to get through, and that will make the disaster even more disastrous, greater proportions. 7 CHAIRMAN OSBORN: Harlan? COMMISSIONER DALTON: I’m obviously in favor of that. I was just trying to glance at the letter from Congressman Waxman. CHAIRMAN OSBORN: We are going to get to that later. Quite specifically now I’m talking about the Senate hangup. COMMISSIONER DALTON: I understand that, but what I was going to ask is whether or not there was also a hold on the pieces of legislation that are not simply the House analogue to the Kennedy bill. That is to say, there is a Waxman bill for which there is a Senate analogue, and I just wanted to know whether it was in the same situation. CHAIRMAN OSBORN: No, it is the Kennedy-Hatch bill, the so-called care bill is the one that is caught right now and has a chance to be broken loose quickly or to get badly stalled, which is why we are being so -- MILLER REPORTING CO., INC. 507 C Sueet. N.E. Washington. D.C. 20002 (202) 546-6666 246 MR. LEE: The Waxman bill was just marked up in subcommittee and was reported out this past week. COMMISSIONER KONIGSBERG: I would like to second the motion before we have any further discussion. CHAIRMAN OSBORN: if I could ask, I think the motion was to support the idea that David and I write a letter on behalf of the Commission. I think in terms of doing it very quickly, that is probably the way to do it. If you are agreeable, we’ll make that the motion and then ask if all those in favor would please say aye. [A chorus of ayes. ] CHAIRMAN OSBORN: Opposed? Abstaining? It is unanimous. Good. We’ll try and do that, and in fact we'll try and do it this afternoon, because I think there is still a little window for Wednesday, and so we might still be able to get something to move, if we are effective. COMMISSIONER ALLEN: Are we going to be moving toward the legislative now? I have one more question about the process issue. When we were talking about pulling in the woman to do that, does that mean that the personnel issues for the next meeting and the public health meeting issues, is MILLER REPORTING CO., INC. $07 C Street, N.E. Washington. D.C. 20002 (202) 546-6666 247 all that put on hold, the working group issues? CHAIRMAN OSBORN: Scott, we haven’t even gotten there yet. COMMISSIONER ALLEN: I am just wondering about the process, because it sounded like we were going to stop and take stock, and I was wondering if we were moving into legislative and moving away from the process. CHAIRMAN OSBORN: I see what your concern is. The way this agenda is written it looks like that is the end, I agree with you, but no, I was thinking what we should -- MS. BYRNES: Scott, my understanding is that we are going to try to find a time and a place, with everyone's agreement, to do that, but that we are still doing manpower for July and we are still doing public health for September, and to some degree the strategy planning will identify where does that fit into where we are going. COMMISSIONER ALLEN: Okay. JI was just curious. Because of the working group issues as we get down to it, I’m just wondering if we need to put all of this on hold until -- Okay. Just a point of clarification. COMMISSIONER AHRENS: Madam Chairman, I know that we only have 45 minutes before we are supposed to adjourn. MILLER REPORTING CO., INC. $07 C Sueet. N-E. Washington, D.C. 20002 (202) 546-6666 Are we going to get to the scheduling of things today? CHAIRMAN OSBORN: Yes, definitely. Let me just make an inquiry. I think we had a 4:00 o’clock adjournment time as a convenient time. Does anybody have constraints that make 4:30 unreasonable, or 5:00? I mean, I thought that was just a way of showing that we were going to have an ordinary working day but we are starting at 8:00. So I don’t think that was intended to be a short cutoff, unless I -- COMMISSIONER AHRENS: So we will get to scheduling CHAIRMAN OSBORN: Yes. Our hope was to get through this agenda. CHAIRMAN OSBORN: Carlton, I’m sorry to steal your thunder, but not too sorry. MR. LEE: That’s fine. CHAIRMAN OSBORN: Anyway, would you proceed then. MR. LEE: Just a few other items. There is on your desk a copy of a summary of the Waxman bill that was marked up this week, H.R. 4470. Attached is also a summary of H.R. 4080, which is the Medicaid, AIDS, and HIV Amendments Act of 1990. And those are on your desk, as well as a blue packet with some materials in it, much of which you have seen before MILLER REPORTING CCO., INC. $07 C Sueet. NE. Washington, D.C. 20002 (202) 346-6666 249 on the Kennedy-Hatch bill, with some editorials at the back on the bill. The Commission is mentioned a number of times in those editorials, and a copy of the committee report on the Kennedy-Hatch bill on top. Just briefly, the bill that was marked up in Waxman’s committee this week, the AIDS Prevention Act, was marked up. I guess that was.on Wednesday. And that is the bill that authorizes $500 million a year from FY91 to FY95 for early intervention services, including testing, counseling and outpatient diagnostics, as well as drugs and prescription drugs. That includes the $300 million for emergency relief for the 13 cities hardest bit by the epidemic as well, and during the markup there were a number of amendments offered by Mr. Dannemeyer and several other members of the committee, which were defeated, that related to HIV. Those included efforts to require mandatory. testing in prisons, hospitals, and for major licenses in high incidence areas. There were also amendments to omit the sections of the bill requiring pretest counseling and informed consent, as well as to require name reporting. All of those were defeated by margins of about two to one, for the most part. That bill I MILLER REPORTING CO., INC. $07 C Srreet, N.E. Washington, D.C. 20002 (202) 546-6666 250 would suspect may be full committee marked up in the next week or so. The other bill I wanted to touch on was the Americans with Disabilities Act, which was marked up this week in the House Judiciary Committee. This was the last committee of jurisdiction to consider the bill. There were four in all. The next step is Floor consideration, which should happen sometime later this month. During this markup there were also efforts made regarding HIV to eliminate coverage for people with all contagious diseases, to limit the association provision of those who associate with people who have disabilities, to limit that to just blood relatives, and also an amendment to allow food industries to transfer employees with HIV to address public concerns, so transferring those employees to non-food positions, food handling positions. My guess is the bill could come up, they say the week of the 14th. That’s just a guess. I would hope though before Labor Day. The President hopes to sign the bill, he has stated, prior to Labor Day. COMMISSIONER GOLDMAN: Carlton, I assume those were all defeated, the ones that you mentioned? MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 346-6666 MR. LEE: Yes, all those were defeated. The only other bill I wanted to touch on is, of course, Congressman Rowland’s bill, H.R. 4506, which is the immigration related bill that I believe Cathy informs me the hearing might happen in the next several weeks. It is still up in the air I believe. The HIV record that. is on your desk also has a quote mentioned in there by one of the deputy White House press secretaries as saying it is possible, or likely, that the bill passes the Congress the President would sign it. So I think that is news. I haven’t seen that before. I don’t think Congressman Rowland has seen that before either. So that was a good sign. And as far as other bills, there is a markup this week of .the AIDS Housing Opportunities Act by Congressman McDermott, which we touched on at the last hearing. And there is on Wednesday a bill, to be introduced by Senator Kennedy called the Homelessness Prevention Act, which will include $100 million for housing for homeless people, elderly and PWAsS, so that is good news. And that’s about all I had today. MS. BYRNES: Do you want to raise the issue of MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 Congressman Waxman’s request to the Commission? MR. LEE: Yes. Congressman Waxman has indicated that he would like to have an indication of support for the principles and objectives of his legislation, again, the two bills that you have outlines of, H.R. 4470 and H.R. 4080, the Medicaid bill. COMMISSIONER ROGERS: One of them is the match for the Kennedy-Hatch, is that right? MR. LEE: Yes, the Waxman H.R. 4470 includes the Title I of the Kennedy-Hatch bill, which is the impact aid for the 13 cities, $300 million. He also has in there some different pieces, the testing counseling, early intervention provisions. MS. BYRNES: The other one is the changing of Medicaid eligibility to include asymptomatics and additional reimbursement to disproportionately impacted hospitals. MR. LEE: Right, hospitals, exactly. And I think perhaps we could open that up for some discussion about a similar statement as we made on the care act upon its introduction back on March 6th. CHAIRMAN OSBORN: I would welcome comments. Harlan. MILLER REPORTING CO., INC. 507 C Sureer, N.E. Washington, D.C. 20002 (202) 546-6666 253 COMMISSIONER DALTON: Yes. I wanted to speak about the Medicaid Amendments Act of 1990. My mind is still going back to our Los Angeles visit and that woman whose son had died two days earlier because of screwups in the Medicaid system. This doesn’t necessarily speak to her concerns, but it seems to me insofar as we can make -- and I am also thinking about Congressman Waxman’s testimony before us about the kind of Catch 22 within Medicaid, if you are not sick enough you can’t get reimbursed. And it seems to me that we ought to support this bill, since we have all expressed our concern about allocation and issues with respect to HIV treatment. It seems to me that if there is any bill that has to do with sort of class, essentially, in AIDS, this is it. CHAIRMAN OSBORN: So for slightly different sets of reasons you would suggest supporting both of them. COMMISSIONER DALTON: Yes. CONGRESSMAN ROWLAND: I just wanted to make a comment about the Medicaid amendments bill, and that portion that would require states to pay a higher rate of Medicaid reimbursements to hospitals that care for a large number of AIDS patients. I have always got a concern about mandating states do thus and so under the Medicaid program, regardless MILLER REPORTING CO., INC. $07 C Street, NE. Washington, D.C. 20002 (202) 546-6666 254 of what it might be. We always run into a lot of resistance from the governors. I can tell you that there are some states that are having a very difficult time now with meeting some of the mandates under the Medicaid program, and so I’m somewhat uneasy about that aspect of this particular piece of legislation. If you are going to shift it from some other area, shift the funds from some other area to do that, it would be different than talking about new money. But even shifting money. from some other area might -- well, I don’t know whether it is appropriate or not. I’m just throwing this out for discussion. This says it requires states to make a higher rate of Medicaid reimbursement to hospitals, require states to do that. COMMISSIONER DESJARLAIS: {Mike off. ] CONGRESSMAN ROWLAND: I’m sorry, Don. This letter that I have got here before me from -- MR. LEE: Your summary, states would be required. COMMISSIONER DESJARLAIS: Yes, but the top paragraph says optional -- CONGRESSMAN ROWLAND: Some parts of it are optional. MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 255 MR. LEE: There are four parts to the bill. The first paragraph is part one, then part three, part four. Each is different, but the part two is the only one where there is a requirement. COMMISSIONER DESJARLAIS: Okay. The optional then doesn’t apply to the bottom. Okay. CHAIRMAN OSBORN: JDon Goldman. COMMISSIONER GOLDMAN: I think as a Commission we would be well advised to avoid endorsing specific language in specific bills. I think we talked before about the Kennedy-Hatch bill in terms of its disaster relief program. I do not take that as an explicit endorsement of every dot, of every "t", of every "i" and of every comma in the entire bill. In many ways, for example, personally, I think some of the changes that have been provided by your subcommittee, Congressman Rowland, substantially improve the Kennedy-Hatch bill, and if I were given a choice personally between voting for one or the other, I would vote for the one that came out of your subcommittee. So I think what we are talking about in supporting this legislation in terms of the Medicaid area, I think what we are saying -- or what I would like to suggest that we say if it is not clear -- is that the kinds of MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 256 Medicaid improvements that are expounded, at least in terms of principle in the Medicaid AIDS and HIV Amendments Act of 1990 ought to be approved by the Commission. Whether or not in one case it ought to be optional or mandatory, and what the definition of a high volume of persons with AIDS and how that should be worked out, I’m not terribly concerned with and I don’t think this Commission should get itself involved in necessarily. | CONGRESSMAN ROWLAND: Don makes a good point in that respect. CHAIRMAN OSBORN: Carlton, I wonder if we would create some language that in essence mimics the kind of endorsement in principle that we did in the first round, avoiding that double entendre that endorsing in principle has some slightly.negative effect. We don’t want to do that, but rather to move away from the points that a closer reading might bring up, and still be in a position to support the direction of motion that the bills represent. MR. LEE: Okay. COMMISSIONER ROGERS: And I hope would build in the sort of thing that I think Harlan was alluding to. I mean, it is very much philosophically with what this Commission MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 257 would wish, and these long delays are what we are trying to avoid. I like Don’s thought of just endorsing it in principle. Excuse me, clearly we want that changed so that HIV positive people get on to the lists swiftly and appropriately. - MR. LEE: Okay. That was it. CHAIRMAN OSBORN: Does that give you enough to go on? Let me ask for a show of support from the Commission. All those in favor of such a statement? [Show of hands. ] CHAIRMAN OSBORN: Opposed? CONGRESSMAN ROWLAND: I would like to see the statement before I agree. Listen, maybe I’m attuned to the politics of this too closely, but we want to be sure that -- CHAIRMAN OSBORN: Well, I think we would definitely want to be working with you no matter what in the wording in order to be sure that it waS appropriate to the sentiment, and you have had a chance to hear the sentiment, so that that might be the operational way we could proceed, if that is okay with the rest of the Commission. We would certainly not do that without your having seen it, even if you were fully MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 enthused, just to make sure we did it right. Okay. That’s it. Thank you. Thank you especially Carlton. I know you have got family in town and we appreciate your being with us anyway. MR. LEE: Thank you. COMMISSIONER KONIGSBERG: I just wanted to ask a question, and maybe Carlton knows, and maybe Congressman Rowland knows, what is the status of your bill, Congressman Rowland, in terms of the Judiciary Committee referral and that aspect of it? MR. LEE: There is no plan at this point to move ahead of the Subcommittee on Health by the Judiciary members. CHAIRMAN OSBORN: Okay. The Presidential Commission recommendations are the next item on the agenda. Shall we go on to that. MS. BYRNES: This can be fairly brief, but we did indicate to you that we would be making a report on the implementation update on the Presidential Commission recommendations. The report is as follows: There is none. I would express some real concern over the difficulty we have been having in getting some concrete response and reaction from many of the agencies that we are MILLER REPORTING CO., INC. 507 C Street, NE. Washington, D.C. 20002 (202) 346-6666 259 looking for updates and implementations from. The National AIDS Program Office I think has been doing the best the office can. I don’t want to fault any individual or any particular office. They are the entity that has asked the different agencies and departments to provide the information. But Carlton and Karen have met on a number of occasions with the staff from the National AIDS Program Office to put together a mechanism by which information would come back that would be useful to us, recategorizing, if you will, the categories that those recommendations have gone into -- what does "ongoing" mean, what does "under consideration” mean, what does "completed" mean in some cases. And I think we had some fairly good activity at that level. There was then an understanding that we would identify some key recommendations that we thought the Commission was particularly interested in getting information on, and that information was to be provided to us with the new categories by the lst of May with the understanding that I think it was every six months, or once a year even -- we were still negotiating on how often ~~ we would get MILLER REPORTING CO., INC. © $07 C Street. N.E. Washington, D.C. 20002 (202) 546-6666 260 information about the rest of the recommendations. So we were going to identify just short of 200 recommendations out of the 597 to get some information to you by the lst of May, with then an update on the other recommendations as to what those recommendations’ status was. NAPO has missed the deadline. The information was not provided to us, as we expected, by the lst of May. That means the agencies missed their deadline. The excuse is that they are very busy with budget documentation and have had a difficult time putting that information on paper. I believe that. I have certainly worked with the agencies long enough to know this is a fairly busy time for them in terms of putting the numbers together. I would also share with you that there has been a lot of notice about how long we have been expecting this information, and I feel at this point in time there is no mechanism for us to be able to respond to one of the statutorily required activities, which is to monitor the implementation of those recommendations. The end of this story is that we will continue to work with Jim Allen's office and the people in there, who are continuing to work with the agency within the PHS in MILLER REPORTING CO., INC. $07 C Suet, NUE. Washington, D.C. 20002 (202) 546-6666 261 particular for getting to the other departments. I mean, this is a perfect example of why a coordinating mechanism at the federal level would be most helpful. I think this in fact highlights how difficult it is for HHS to even get information outside the PHS. I mean, for HHS to get information beyond the Public Health Service -- for NAPO I should say, not HHS -- for NAPO to get it beyond the Public Health Service is incredible. And that’s within the same department, much less looking for information from the Housing or the State or the Justice Department. That’s the report. We will try to get that to you as quickly as possible. I’m not sure if you need something else from us in terms of what you think the next step should be. But my report to you is that we are having a real difficult time learning about the implication of those recommendations. CHAIRMAN OSBORN: Eunice. COMMISSIONER DIAZ: JI can accept your explanation, and can believe that there are difficulties in the National AIDS Program Office eliciting this information. But I would hope that we would not be complacent about having to do an interim report in August and not meet something that was in f-~ 7 MILLER REPORTING CO., INC. 507 C Streer, N.E. Washington, D.C. 20002 (202) 546-6666 262 that statute that created us. I, for one, from the first day that I came here have been saying that that was kind of our first mandate. And sure enough we said it is a Commission that died a year ago, or a year and a half ago, but still there were some excellent recommendations. I’m glad to hear it is narrowed down to 200, and if need be, one of the recommendations that I would give is within those 200, those that are ongoing and are for the world and we can't tag, let's at least take the 50 that still have a major priority and do the same type of fleshing out we are stalking about doing among ourselves here and just go for it so that we can say something in August. MS. BYRNES: The issues is even getting the information back for us to narrow it down from 200 to 50. And I share your perception. That’s why the May Ist deadline was set. That would give us enough time to put something together substantive to report on for the interim report. So I don’t think we would have any concerns in consultation with the rest of the Commissioners in narrowing it down. But we don’t have anything. COMMISSIONER DIAZ: Is there any hope, Jim, because that is disquieting. MILLER REPORTING CO., INC. $07 C Street. N.E. Washington, D.C. 20002 (202) 546-6666 CHAIRMAN OSBORN: Jim Allen, and then Harlan. MR. JIM ALLEN: You know, one can always go into a lot of reasons which vary between being actual reasons and being excuses. It is a long process. It always astounds me how long it takes to get things done, what the turn around time is. This has been a very busy spring for us. In part it. is exacerbated in my personal office in that we are going through a reorganization that we are trying to do along with everything else. And right now I have got -- I don’t think I have got any full time desk officers to relate to the agency’s right now. They have either been promoted to supervisory positions or they are in the process of leaving. So we are building our staff, and this has exacerbated it. We have got a major report that is due to Congress, it was due to Congress a couple of months ago, that got dumped on us right at the last minute. There was another office that was supposed to have taken responsibility, and. we pulled together literally what amounts to about a four to five inch report in a period of two months, and that cut back on the time. It is in the process, it is coming. We had our budget presentation period significantly abbreviated this last time. We were struggling to pull the budget out, present it to the assistant secretary last week, but it is -- they are coming in, we will get them done, and we’ll get them to you. Let me go back and check tonight and see if I can give you an answer tomorrow as to when we’ll have them ready. But Maureen has put her finger on another part of that problem, and that is for any of the none-Public Health Service agencies, we don’t have any direct line authority. And I don’t know what to say except that -- you have been in touch directly with them, or are you going through us on all of that? I’m not sure, with NIH of the other HHS -- MS. BYRNES: We primarily have been going through NAPO, because the ones we narrowed down to below 200 primarily fall within the Public Health Service or HCFA, and your office has been working with us on HCFA. MR. JIM ALLEN: Okay. Well, let me double check with my staff tonight and see where we stand and I will try to get back to you tomorrow. CHAIRMAN OSBORN: Harlan. COMMISSIONER DALTON: This is sort of embarrassingly simple. With respect to HHS agencies, I mean © Health and Human Services agencies other than PHS, couldn’t MILLER REPORTING Co., INC. $07 C Street, NE. Washington, D.C. 20002 (202) 546-6666 MILLER REPORTING CO., INC. 507 C Sureet, N.E. Washington, D.C. 20002 (202) 546-6666 265 we Call upon our fellow Commissioner, Dr. Sullivan, to sort of send the word down, particularly given that this is a Congressionally mandated piece of our report? Would that be inappropriate? MR. JIM ALLEN: Let me put it this way, it would be difficult to do. The easiest way to get through to Dr. Sullivan is to have June or David pick up the phone and call him. COMMISSIONER ROGERS: I think that is a good thought. Jim can’t do it, but we can. MR. JIM ALLEN: He and Jim Mason are both in Geneva this week at the World Health Assembly meetings, although he will be back in town the end of the week. MS. BYRNES: And not to say to Jim Allen do your job to the heads of each of the agencies that are supposed -- COMMISSIONER DALTON: That is precisely what I meant, and I did mean for it, to come from June, not from you, but I just thought you were thinking that it wasn’t a good. idea for June to do it. CHAIRMAN OSBORN: I think we can do that. I think one of the things that we need to be thoughtful about is the number of times we pick up the phone and call Low and about MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 266 what, and that’s the only question I would have about this, is that we have used that mechanism intermittently, and it works, but the question is what do we get for having done that. If it is a report that goes no further than that much compliance, is it worth it? “So that is not the issue. I think at the point at which it becomes clearly a road block for a major Commission goal,. including certainly by the time it is due in a report that is commissioned by Congress, if that’s what is needed, that can be done. Scott, and then Don. COMMISSIONER ALLEN: Along that thought. Go for COMMISSIONER GOLDMAN: The only thing I was going to say is it seems to me if we are not getting responses from other agencies, that while I have no problem in relying upon the NAPO office, I think that we will run into a problem if ultimately we can’t get any information, and you can be assured that those agencies will say that we never heard from the Commission, and even if it is a CYA pro forma thing, I think we ought to be making direct requests of those other agencies for their responses to those items and indicate perhaps that they can report back through NAPO if they wish MILLER REPORTING CO., INC. 507 C Street, N.E. Washington. D.C. 20002 (202) 546-6666 267 to do so, but I think we ought to formally request of it of Justice and of State and all those other departments to go on record and in writing and do so. CHAIRMAN OSBORN: Scott. COMMISSIONER ALLEN: I’m just curious about the recommendations on the drug treatment and the drug issues. Who have you been in contact. with? HHS, but what about Bennett’s folks? MS. BYRNES: We have been working through the NAPO office, who essentially is getting in touch with ADAMHA, who essentially gets in touch with NIDA, who essentially gets in touch with -- COMMISSIONER ALLEN: I was wondering what the channels were and what we could report on the monitoring of this drug effort that is apparently happening, if that is being incorporated into our -- MS. BYRNES: We have not specifically approached that entity, or any other. I think that does follow on what Don just said, Scott. That’s a good suggestion. Perhaps we feed to identify the department of the agency as well as the recommendations and write our own letters saying we are anxious to get this information back by whatever soon date we 268 set, and work with the NAPO office about us being the ones sort of giving them the push to get it in. That may well be one of those agencies. COMMISSIONER ROGERS: I like that idea. It seems to me a good tough letter signed by you that says come on ante up, we have got this mandate and you are not delivering. CHAIRMAN OSBORN: Okay. I think that brings us up to date to whatever extent with the Presidential Commission recommendations. And probably, if I can say under my breath, I just keep being so glad that David instituted the short report idea back aways, because we are were springing ourselves loose from this punishment even as we go, which is nice. Okay. Next we have a couple of things that might be taken up together, the prison site visit and the meeting schedules, because we are running into a variety of issues and concerns about the initial round of efforts to schedule meetings, which isn’t too surprising, but at least we have got some dates to talk about. Maureen, why don’t you take over. MS. BYRNES: We had tentatively -- and I have not © run this by more than two or three Commissioners if I MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 ry MILLER REPORTING CO., INC. 507 C Sureet, N.E. Washington. D.C. 20002 (202) 546-6666 269 happened to be on the telephone with you -- penciled in the 25th and 26th of June as the date for a prison site visit. Karen Porter and Jeff Striker will be the key people on that visit. They are exploring now where to go, what the focus of the hearings would be. The feedback I’m getting even initially is that for many of you that date may not be workable. So let me go through where I think we are for the rest of the summer and the fall and get your input as to how we best should schedule a prison site visit, either the 25th or 26th of June, or at some other time. That was the tentative time that we had identified where a couple of people could be available, but it is clear that that is problematic for others. COMMISSIONER DIAZ: In view of our earlier discussion to date, might we not start with trying to get consensus on that date, and then back up from there, because being that that is so urgent, and then follow with -- MS. BYRNES: Sure. Then I would say the floor is open for recommendations for a date. COMMISSIONER KESSLER: Would it be possible -- I didn't hear your whole statement. I think you were talking about the 18th and 19th of July? or, Ne oe MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 270 COMMISSIONER DIAZ: No, I am talking about dealing with the suggestion of the professional facilitator for that meeting to occur. COMMISSIONER KESSLER: Well, we are meeting here the 18th and 19th, right, in July. And one possibility to see whether she was available the 17th or the 20th. Then we don’t incur any extra flying. expense and only one more night in a hotel. COMMISSIONER ALLEN: I would like for it to be on the front side of that. COMMISSIONER KESSLER: She does this thing internationally, so I have no idea whether she is available, but we could shoot for that. The 17th is okay, the 20th is second choice. CHAIRMAN OSBORN: Either is fine. COMMISSIONER DESJARLAIS: Wait a minute. If we want to do it on the front end, let’s not do it on the 20th, let’s do it on the 18th and have the 19th and the 20th for the regular. COMMISSIONER ROGERS: I see, okay. Let’s get at her while we are fresh. CHAIRMAN OSBORN: So we would do a three-day MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 271 instead of a two-day thing, the first day of which would be her, and it would be either the 17th, 18th, 19th, or the 18th, 19th and 20th. But in either instance, the first day would be the planning activity. I don’t have that written down quite right. 7 COMMISSIONER DIAZ: So right now we should hold both open. CHAIRMAN OSBORN: And then the hearing topics on July 17th, 18th -- MS. BYRNES: Manpower. CHAIRMAN OSBORN: Manpower. COMMISSIONER ROGERS: People power. MS. BYRNES: I'm pretty generic on that stuff. It is the important things I care about, like money. Titles don’t bother me. Prison site visit in June. COMMISSIONER KESSLER: I think it has occurred to us that since is the international goes to the 24th, and after five or six intense days there that getting back east, which is probably the site of the prison visit, the 25th is difficult. We will already have been away from our workplaces for a week. MILLER REPORTING CO., INC. $07 C Street, NE. Washington, D.C. 20002 (202) 546-6666 272 I looked at June’s book, with her permission. It looks like July 1 and 2, the Monday and Tuesday of the week of the 4th of July -- or is it July 2 and 3 -- 2 and 3 looks clear for her. I know it is clear for me, but I don’t know how it is for anybody else. 7 didn’t see your books. CHAIRMAN OSBORN: Harlan is shaking his head sadly. COMMISSIONER DALTON: Well, I have some trouble with the 4th of July. Those of us who have families. MS. BYRNES: Another possibility is to -- we have not spoken about what our plans for the month of August are. My recommendation, given many of the Commissioners commitments in the month of August, some budgetary concerns I have about getting at the end of the fiscal year, I was prepared to recommend that we schedule the Puerto Rico visit for October or November. We could potentially delay the -prison site visit until August, but that would put it off a couple of months. But that’s an option. That would leave us without a meeting or a site visit in the month of June, a full Commission meeting in July, with some working group meetings, my understanding is, and then a prison site visit at some point in August. COMMISSIONER ROGERS: August is a good powerful MILLER REPORTING CO., INC. $07 C Street, N.E. Washington,.D.C. 20002 (202) 546-6666 273 time to see prisons. It will be hotter than hell. That’s a good time. I’m serious. COMMISSIONER DIAZ: That’s probably not the best time for Puerto Rico. CHAIRMAN OSBORN: We had been talking about August 2nd and 3rd, or else 7th and 8th for the Puerto Rican trip, if. that were to have occurred. So those dates, at least on my calendar, I have been holding, which could then go to the prison visit, although I will be in Puerto Rico on the 6th, so that limits me a little bit. MS. BYRNES: No good on the 7th and 8th, is that what you are saying? How about the 2nd and 3rd. No good. COMMISSIONER GOLDMAN: Are we going to do anything in terms of our Commission’s one-year anniversary? Are we going to do a report? CHAIRMAN OSBORN: I would suggest that that be part of our planning process, because the shape of that report will make quite a difference as to what the staff can do besides the report. And I think we may want to decide where we want to get to by the end of the two years, how much impact we have seen that we have had with the short reports, whether a third short report plus the other two plus some MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 274 staff background that is relatively succinct might serve. We are only required to write an interim report at that time and that is not defined. And my only thinking is that if we have got a very activist agenda coming up, that basically takes the staff out from the end of the July meeting until the end of August, if we do a big report. COMMISSIONER GOLDMAN: My questions have related to meetings, not related to the report, and that is that if we do do such a report, even an interim report, ought we at least on a contingency basis tentatively determine a date upon which we are going to make such a report, and if we are going to do it in fanfare, and if so, at least hold a date that those of us can know about, if we wish to do it that way? - CHAIRMAN OSBORN: Yes. I was kind of commenting on that, because I was suggesting that an alternative is to really not make a big deal about that report per se, have that be sort of logged in as the response to the statutory requirement, but take as little time as possible. If we wanted to have a report about something, to do what we have been going, and let that one just sort of go into the files, in an orderly way, I don’t mean to minimize it, but not to MILLER REPORTING CO., INC. $07 C Sereet, NE. Washington, D.C. 20002 (202) 546-6666 275 maximize it either. Because I am arguing out of the chair a little bit here and I shouldn’t, but my sense is if we make much of that report people will think we are done. And I would be rather inclined to stay off the anniversary and to pull together some of the recent things that we might want to make recommendations about and do a third report in a continuing series over the two-year life of the Commission and let the statutorily required report enter the files however. That’s what I was saying. COMMISSIONER GOLDMAN: All I was saying is that if we come along on the 17th, 18th and 19th and decide, based upon that meeting, that it is, for example, of strategic importance to have a -- and we want to announce the plan that we have set up for the following year, that we then on July 18th and 19th will never be able to pick a date upon which we were going to do that if we want to do that for the anniversary of our report that the members of the Commission have held aside. I was just thinking in terms of purely a Matter of contingency planning, and if you think that likelihood is so low that it is not worth contingency planning for, that’s fine. CHAIRMAN OSBORN: Well, I hadn’t heard anybody say MILLER REPORTING CO., INC. 507 C Sueer. N.E. Washington, D.C. 20002 (202) 346-6666 276 anything wrong with the 16th and.17th of August yet, and that is pretty close to the lst anniversary of our first -- I think that may have been the time when we appointed Maureen, for instance. And we could do that about anywhere. In fact, it wouldn't hurt at all to do from a prison. Do you want to hold the 16th and 17th for whatever prison site visits? The 17th of August. COMMISSIONER ROGERS: Do they have any prisons in Alaska? Sing-Sing is great in August. CHAIRMAN OSBORN: Okay. MS. BYRNES: Should I go through the rest of the CHAIRMAN OSBORN: Right. MS. BYRNES: No formal meeting in June. Save the 17th to the 20th of July, the 16th and 17th of August for the prison site visit, and whatever we strategically decide during the July meeting. I then went through the calendars that I received. I also need to mention, I did not get everyone’s calendar, so there may be some concerns with these dates. But I used what I had received by our agreed upon deadline. MILLER REPORTING CO., INC. 507 C Sueer. N.E. Washington, D.C. 20002 (202) 546-6666 For September 17th and 18th, for the manpower hearing -- I’m sorry, public health. And then I went ahead and scheduled two days every month. If we have a site visit every meeting, we can just block those dates off. tentatively the 10th -- I’m sorry. The 17th and 18th of September, the 10th and 1lith of. October, the 26th and 27th of November, and the 17th and | 18th of December. Now, what I do want to mention is that Dianne has a standing conflict with Tuesdays, and a number of these are scheduled for Tuesdays because in order to accommodate the majority of the calendars those were the dates that were available. If for some reason -- I mention that in passing that, if we look at these dates data for the site visits, if there is some flexibility, I do have some concerns that these wound up mostly being Mondays and Tuesdays, but those were the days that were available. for the bulk of the calendars that I received. I have only done it through December. I didn’t have complete calendars from everyone else. I will try to finish for the rest of the year and get that back out in the mail as quickly as possible. But if you could block those dates off, that gets us a few months ahead.. MILLER REPORTING CO., INC. 507 C Sueet, N.E. Washington, D.C. 20002 (202) 546-6666 278 MR. JIM ALLEN: The October and December meetings will both be site visits and the September and November meetings will be Commission hearings, is that -- CHAIRMAN OSBORN: Well, one of the ideas we had was that the November 26-27 might then be a Puerto Rico hearing instead of a site visit. In other words, the one time that we. would hold hearings away next year. COMMISSIONER DIAZ: October -- CHAIRMAN OSBORN: Well, October would be a site COMMISSIONER KESSLER: If I understand you, doing a hearing in Puerto Rico and only do it for two days without site visits I think is a problem in the sense of we could get clobbered for rushing in and rushing out without doing anything there other than holding a hearing. CHAIRMAN OSBORN: Well, I’m not objecting to the idea of doing more. I was just simply proposing that we have the hearing format there in Puerto Rico, as we did in California last year. In other words, one hearing outside of Washington. Congress I think was out of session at that time, which makes it a little easier, and I am perfectly glad to have more than two days. MILLER REPORTING CO., INC. 507 C Streer, N.E. Washington, D.C. 20002 (202) 546-6666 279 COMMISSIONER KESSLER: Well, that’s why I think we ought to schedule -- if that’s what we are thinking of, why don’t we schedule three at that point? CHAIRMAN OSBORN: Well, I could we could schedule three. What I was thinking, however, was that we could mix the format a little bit, do hearing business, but also perhaps when we are doing this sort of thing in the afternoons here, we could be doing site visits there, as we did with our first sit-down hearing here. We went and spent part of our time visiting around. So we can do some of each. When I talk about hearing, I mean holding off some of the time for formal Commission business and not being strictly on a site visit mode. But I think any time we are away from here we should be learning what we can about where we are, so that is important. MS. BYRNES: And if we are going to add a third day, that will require my going back to see whether or not that can accommodate October or November. I mean, your calendars are very tight. CHAIRMAN OSBORN: I can tell you right now, October won’t do. I can’t get three days at any point in October. COMMISSIONER ROGERS: Well, won’t we be evolving MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 280 part of this with our magic woman in July? I mean, as to how we decide this strategic planning. COMMISSIONER DIAZ: No. COMMISSIONER KESSLER: I was thinking more along the time lines of losing so much for travel and also being culturally sensitive. If we rush in and rush out of Puerto Rico I think we open up a Pandora’s Box. COMMISSIONER DIAZ: I just came back from Puerto Rico this past week, I was a speaker there at the National Association of Community Health Centers, and they are very excited about the possibility. The Puerto Rican people would appreciate a hearing, so I’m very sensitive to the fact that you are saying there may be a hearing in November versus what we are calling a site visit in October. They would appreciate the formality of the place, saying let’s go with the hearing. I would rather be sensitive to their needs. CHAIRMAN OSBORN: Z really regret the fact -- I really regret the fact that my October calendar is literally full now. And so beyond two days I can’t do it, and November at the moment is fine. So particularly with that in mind, and Larry’s comments I think are well taken, I have nothing against spending more time. MILLER REPORTING CO., INC. 307 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 281 COMMISSIONER DIAZ: The main thing they would like is just a letter saying what days we are promising them, and that’s the main thing they are waiting for. MS. BYRNES: Am I hearing that we are going to save that for November? CHAIRMAN OSBORN: Yes. COMMISSIONER AHRENS: Maureen, could I just ask the members of the Commission, I know that we have all sent in our calendars through 1991. I also know that sometimes we may check things off that we think may be a problem and they turn out not to be a problem. And I guess I’m a little late in asking this, but if any of you have sort of traditionally indicated that you have a problem with days that you think you may not have a problem with, it would really be helpful -- I think Maureen is struggling with trying to put all our schedules together, and by what has been worked out here it looks like there are three of the five dates that we have selected that I can’t be at least for Tuesdays. I do have a problem with Tuesdays, and I can’t do anything about that. So if some of you have a little more flexibility toward the end of the week and you think you might be able to adjust things, especially I’m thinking of 1991 as we move into that, I think it would be helpful to me and perhaps maybe loosen it a little bit up for Maureen as well. COMMISSIONER DIAZ: Are you saying with the dates that you have given now you have a problem with three of the dates up there? - COMMISSIONER AHRENS: Yes. That’s what I’m saying. MS. BYRNES: Three, of them are Monday-Tuesday combinations, and Dianne has a regular problem with Tuesdays. COMMISSIONER DIAZ: So are you asking us if we could look now? CHAIRMAN OSBORN: No. The idea would be that we try and balance it off after the first of the year if at all possible, to avoid Tuesdays. I think that is probably the most functional outcome, because I know I, at least through November, don’t have any flexibility left. But beyond November I do, and I think that would be the best way we could try and redress what is distinctly and unfair kind of thing for Dianne, if we can just try very hard to make sure that we loosen up things other than the Monday-Tuesday combination. COMMISSIONER DIAZ: Should we look at December as a © possible change? MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 * ) MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 283 MS. BYRNES: Eunice, I have looked at all the schedules that have been submitted to me. COMMISSIONER DIAZ: She is saying have we looked at the possibility of -- COMMISSIONER ROGERS : Madam Chairman, I would suggest we could spend the rest of the afternoon on this and it. is going to profitless. We have given Maureen our calendars, we understand Dianne’s problem. Maureen, work it out the best you can. CHAIRMAN OSBORN: I think the problem with the December thing is if you move it to the end of that week, all of a sudden you are into Christmas. I think that perhaps the way to do it is to try and pay special attention on avoiding Tuesdays after the first of the year, with still four hearings to set up, so that we can make sure that it comes out better. Okay. Thank you. _i’m sorry that those things are always awkward, but they always are. Now, it is 4:00 o’clock. We have got a working group report, and shall we go for it, or should we take a 10 Minute break before we go for it? Nobody needs to take a 10 minute break? Okay. Why don’t you go for it. MILLER REPORTING CO., INC. 507 C Sueer, N.E. Washington, D.C. 20002 (202) 546-6666 284 COMMISSIONER ALLEN: Jason, do you want to pass it out. I think all the working group members have the document. You all have this document before you. You can read it, but I may need to read it into the minutes, at least for that purpose, of looking at what we have designed as a mission statement and three goals, and then going through the goals for an objective for each goal. And a point to clearing up, and then we have the calendar at the end of what we are trying to accomplish and by when to get this done and get it over with. The mission statement is, the mission of the Working Group on Social and Human Issues is to examine the range of human and social needs for persons affected by the HIV AIDS epidemic, identify the gaps in the structure and services, and make recommendations. And as you see, there are three goals. One, establish the range of human and social needs and define each one; two, examine the availability and accessibility of human and social services and identify barriers to the provision of these services; three, identify the partnerships and resources needed to provide the range of integrated human and MILLER REPORTING CO., INC. $07 C Sureer. N.E. Washington, D.C. 20002 (202) 546-6666 social services. Those are the three goals that we have. And as you look through, these are obviously not exhaustive in the listing, but it is the point of departure. And the list of the human and social needs, I don’t think I need to read through all that, unless folks feel it is necessary. I am comfortable either way. What. do you think, Maureen? MS. BYRNES: I think that’s fine if everybody has it in front of them and can raise questions as they come up. COMMISSIONER ALLEN: Yes, just look through it and then to examine -- I think looking at closer detail to goal two, because goal one is pretty self-explanatory as we are looking at what are the social issues and the structures out in the community, not necessarily tied to the medical model but so the social model, of what is that range of services that a person living with this disease needs in order to keep them out of the hospital, , keep them functioning in society, and to. address their needs. So this is just the beginning of the range, and then you go into the examine the availability and accessibility of the human services in goal two. And then to get into more detail, you may want to have a little more MILLER REPORTING CO., INC. 507 C Sureet, N.E. Washington, D.C. 20002 (202) 546-6666 dialogue about. And if any of the Commissioners have something to say that are on the working group, go ahead and jump in. But examining the impact of the following factors, geographical variation, cultural, racial, ethnic, sexual and language differences, concomitant health and social indicators, poverty, mobility, chemical dependency, homelessness, hemophilia, et cetera. Then to identify the role and responsibility of federal, state and local governments in planning to meet this range of services in partnership with the private sector. And I think that’s something that if you want to talk about that a little further, we are open to it. And then saying the impact of the following on the provision of the human services, such, such, such. And identify other barriers. And then goal three is to -- the objectives in goal three is to examine the various partnerships, consortiums, linkages, affiliations, joint grants, cooperative arrangements, coalitions, task force, and identify what sustains them; B, identify common themes in the partnerships; C, identify a linkage at the federal level, HRSA, CDC, NIDA, MILLER REPORTING CO., INC. $07 C Sueer, N-E. Washington, D.C. 20002 (202) 546-6666 287 with the local efforts, and state efforts, I might add. And then define the role of the private sector in the partnerships, foundations being one example of that type of partnership. And then when you look at the schedule of events, you may see on here, there are a lot of events. Let me just point out the ones that -- let me point out then the meetings. We had talked about having two hearings and sites, kind of combination site hearings, and one being in Dallas on 9 and 10 of July, and then the 30th and 3lst in Seattle. In Dallas we are going to hopefully concentrate on how public health and the nonprofit organizations in the private sector move in relationship to deal with this epidemic. And Charlie, you may want to mention something to that effect of that kind of relationship. COMMISSIONER KONIGSBERG: Well, it was my understanding the meeting was originally planned to be held in Atlanta, but it seemed to me that Atlanta would be an appropriate site for the day in September for the public health session, since that is where CDC is, and beyond that, there wasn’t anything special about Atlanta in relation to these goals. And I think with Scott being chair of the MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 working group and the things that he has told us about Dallas, the fact that there is probably a number of us that are trying to find some excuse, seriously, to get to Texas -- for business only -- also there is a place where I can buy shoes there, that is another motivation. CHAIRMAN OSBORN: I think the reason that I had just automatically written down Washington for September hearings is because of the Congress being in, and this is a short Congressional year because of the elections. COMMISSIONER KONIGSBERG: Oh, I don’t have & problem with that. CHAIRMAN OSBORN: Okay, because that would be the only time that we could meet here when Congress was in session before the elections. COMMISSIONER KONIGSBERG: I think the major point was the reason why Dallas as opposed to where the public health session. I don’t have a problem with that at all. COMMISSIONER ALLEN: It is not just going to be Dallas. We are going to be bringing in folks from around the country. And it is not going to be just, well, let’s look and see what is happening here. But there is some benefit to Dallas, in that the beginning of the efforts in the MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 289 community-based organizations really evolved in that partnership with public health and has evolved in something very substantial, very meaningful out of AIDS Arms and out of the Robert Wood Johnson Foundation. And we also have the dynamic of the state not being sensitive to the issues, and then the federal issues of the HRSA money and so forth. But it.needs to be much broader than that of public health folks. Perhaps Nashville is a good model to bring in, and so forth. CHAIRMAN OSBORN: Scott, that brings up a question that I might not ordinarily ask. But given the last thing you mentioned, the relative insensitivity of the state, would it be helpful to you if other Commissioners could come if possible? COMMISSIONER ALLEN: Come on down. CHAIRMAN OSBORN: I mean, I don’t want to disturb the dynamic of the small working group, and I am asking it rather hesitantly, because I; have sort of purposefully stayed away from the other ones because of wanting that to work as a small working group. But if you are going to in fact have a national meeting in an area as uneasy as Dallas has been, I wonder if we should -- COMMISSIONER ALLEN: I think it would be beneficial MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 290 for all the members to experience Texas and Dallas and it would be very helpful. CHAIRMAN OSBORN: Okay. Helpfulness is I think the key there, because we don’t want to overpower. COMMISSIONER ALLEN: It would never be overburdening to have you all experience what we are up to, and also having that kind of, input and dialogue. I think we also have the dynamic in Dallas that is very serious, and that is the issue of the homophobia. As we have seen, the judge's statements about giving two people a lesser sentence because they killed homosexuals, and other issues. The hate crimes that we have had in Dallas are enormous, and that dynamic plays very heavily in how we respond as a community. And there are some very courageous things going on and very helpful things going on in the private sector, but there is also the resistance element, which is very sad. CHAIRMAN OSBORN: Well, that’s why I raised the question really, because our feedback from Georgia has been that by the fact that the Commission showed up in almost complete numbers there was I think part of the reason that we got several informal and somewhat formal feedbacks that we were helpful in Georgia just by being there. And from what i MILLER REPORTING CO., INC. 507 C Street. NE. Washington, D.C. 20002 (202) 546-6666 291 you have told me, and others I’m sure, I wondered about that in Dallas as well. It is harder to say nasty things to 12 or 15 people than it is two. COMMISSIONER ALLEN: Well, not necessarily, if you have ever been to Texas. It is not that hard, numbers don’t matter. But still, it is something that needs to be dealt with, and we need to deal with this. There are some very wonderful things going on in Texas, but again, we as a working group are very sensitive that this is not just come to Texas and we are going to deal with Texas. We are going to be bringing people from around the country, and we may have some brief site situation going on, but this is definitely dealing with care systems and there is more than one model and we want to broaden that. So it is not going to be let’s just go to Texas and deal with that. So I want to emphasize that, if you want to come, that would be wonderful, but. it is not going to be let’s parade ourselves through Dallas. COMMISSIONER AHRENS: I do have a concern in terms of Dallas and maybe some other cities in the midwest, but when we have done our site visits, LA was a meeting, but it was also a good site visit as well, and Georgia, and then New MILLER REPORTING CO., INC. $07 C Street, N.E. Washington. D.C. 20002 (202) 546-6666 292 York. But I do think that we need to get into middle America where there are substantial problems and show ourselves and be visible there and be helpful if we can to those communities that are struggling with this kind of thing. And Maybe we ought to take a look at going back to Dallas sometime next year in terms of one of our site visits. CHAIRMAN OSBORN: Well, we actually have I think two very formal invitations from Chicago, and we have at least one very formal invitation from Detroit. And so there are -- and Kansas has indicated some interest on occasion. I obviously share your sensitivity to the issue of the middle west, and that’s something that as we layout -- what I have tried to do with the hearing dates is to make sure that when Congress is in session we are here, because one of our most important and voting members otherwise ends up in a very bad conflict. The site visiting, which is more optional for people, we haven't tried to pay attention to that. But I think that probably in the second half of next year we would certainly want to have at least one hearing scheduled in a major middle western area, and I am inclined to suggest Chicago because it has got the worst problem of an awful lot of the cities outside of Texas of the middle MILLER REPORTING CO., INC. $07 C Street. NE. Washington, D.C. 20002 (202) 546-6666 western cities. COMMISSIONER ALLEN: Let me get back to -- one thing Larry suggested for the Dallas visit would be to have some kind of site visit, like Sunday for those that would like to be a part of that. But I really want the hearings to be expanded beyond Dallas. And there are some good things going on there. You are morg. than welcome. I can work on that and set that up. But that’s an idea that is informal. If you want to come, fine. If not, depending on what schedules are like, and it may be too much. But it was something Larry asked me. Sure, I can drive him around. I drive a big old Chevy van, I can put this baby in there and drive him around and show him what’s happening. But if there is more, if you want it to be more formality to it, that would be fine.. But again, I would like for the hearings to be much broader, so if there is a site, we can do that in another arena. ; COMMISSIONER ROGERS: I just wanted to build on that point. This is moderately philosophical, but I think the Commission should not underestimate how enabling we are to people that are doing good hard things to do in the areas in which we go. I mean, I really did feel that after Georgia MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 346-6666 294 and some of my input there, is that the people who were doing wonderful things really got a little pat on the back and it made it more legitimate for them to continue to do those things. I think that would very much apply in Dallas. I mean, there are some lonely people down there who simply the fact that this distinguished group listened and applauded would give them a lot more clout. I really think it is not only the input to us, but just the fact that we are there and saying we hear you and we are applauding this. I think that | can do really quite a bit more than we would guess. COMMISSIONER ALLEN: I can just say, I have been a part of the work in Dallas since '85 and have seen some tremendously courageous people and efforts, and a would be more than happy for you to meet these folks, because I’m very proud to be a part of that effort. So that would be wonderful. But again, I am very hesitant just to localize it. Because I am very excited about the things that are doing on there. There are some very good things in the midst of adverse circumstances. But again, the service delivery systems, as we see in our goals, is to look at the geographical differences, and I think we are going to need to pull those in as well to the hearing aspects. MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 COMMISSIONER KONIGSBERG: Just a couple of comments. I really very strongly agree that we need to take a look at middle America. I’m not sure how one defines the midwest. I’m still learning what that is, but I’m fairly satisfied that Chicago and Wichita are probably fairly different. And I think we could probably have some discussions about a Kansas visit. I would not recommend rural Kansas. I don’t think there is much to find there. The other thing, which I have brought up before, is there are a couple of unique situations in South Florida. And I know that Miami has been beat to death in a lot of ways, but it is impossible to do enough of Belle Glade, and particularly with the international connection in the Caribbean is particularly unique, and then Key West has been totally ignored by virtually every national and even state groups, if we can avoid criticisms as to why we are going to Key West. You go there in the winter too, by the way. MS. BYRNES: I was just going to say, we don’t have anything scheduled for our December site visit. One suggestion, Larry, if you don’t mind my raising it, Larry just passed a note indicating that the NAN conference is in Chicago October llth to the 14th. One MILLER REPORTING CO., INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 296 thought would be to schedule a site visit in Chicago on the 10th and lith, which was our October dates, and have those go back to back and still hold off the possibility of a full Commission meeting in Wichita or some place else at a later date. CHAIRMAN OSBORN: My informal information is if we want to see a public hospital. on the brink of collapse, we cannot do better than Cook County. So maybe we should just deal with that as an idea. COMMISSIONER KESSLER: The reason that I was suggesting that is that, other than inviting CBO leaders and so on to various hearings and testimony, I think it would send an incredibly strong signal to the gathering of 800 or so CBO types to do something in the same city simultaneously and at least attend their reception, which last year we sort of botched, because we went out to that wonderful Xerox place instead. ; But, you know, everybody keeps crediting -- I told her she would never forgot that, or we wouldn’t let her forget it. But that would be the same dates, except that we would be back to back with them. And I think it would be perceived positively. And then those who wanted to stay for AT oN MILLER REPORTING CO., INC. $07 C Street, NE. Washington, D.C. 20002 (202) 546-6666 297 the conference could do so. It is an incredibly valuable conference in terms of technical assistance. COMMISSIONER ALLEN: Getting back to this, we are also looking at the geographical differences and issues as we meet July 30th and 31st in Seattle, and then looking at how the -- we are going to see in Dallas some adversity in the relationship of federal, state, and local issues, and private sector, and some wonderful coalitions in Seattle, from what I understand, although I have not been there. And then we are going to have a report for the folks in September, our September full Commission, about the goals and what we have accomplished, with the mission statement and then the goals. And that’s our time line and so forth. CHAIRMAN OSBORN: Well, I thank you very much, because that’s obviously an enormous amount of work that has gone into that stage of planning, and it is rather exciting to have you taking on the huge, but I think it sounds like a manageable, assignment. We very much appreciate that. COMMISSIONER ALLEN: In the final report, I neglected to say, we are going to combine the Boston meeting, Dallas and Seattle to put together, and looking at all the issues in that range of services, and hopefully an assessment MILLER REPORTING CO., INC. 507 C Street. NUE. Washington. D.C. 20002 (202) 546-6666 298 of how those services are being met, or not being met, and which is very crucial if we are talking about HRSA and the CDC and so forth and how they are. MR. JIM ALLEN: Scott, are you planning to invite people from each of those agencies also at the appropriate time to be part of the discussion? COMMISSIONER ALLENs- Most definitely. We had talked about that in the planning, and then we are going to work on having people at both meetings, hopefully, but more specifically when we get to that point of seeing where the gaps are, of having some testimony, some interaction, and I think we are also going to have interaction in the midst of writing the report, some dialogue between the agencies at that point, and putting it together. MR. JIM ALLEN: Let us know if we can help you in identifying the right people or getting that set up. CHAIRMAN OSBORN: Okay. The last item on the agenda is the interim report, but we have up here been whispering that in view of the strategy that we have put forward for July, that that may be best put into that discussion as to how that will weave its way into the sort of second push that the Commission gives, is it better to sort MILLER REPORTING CO., INC. 507 C Sueer, NE. Washington, D.C. 20002 (202) 546-6666 299 are deep six it the way I was suggesting, is it a good idea to have a first anniversary report with a big loud fanfare for the second year, or what. So perhaps that’s a very important or very reasonable way to deal with that in July, which still gives us some time -- I think the chief thing that would do would be to send the signal to the Commission staff that we are not expecting a big dog and pony kind of a thing at the first year benchmark. And I would strongly urge that we not ask them to do that. We are not required to do it. There is nothing defines that interim report. And given the effective strategy of intermittent reports, I think we could conceivably decide not to do much of anything about it except a stapler. So somewhere between the stapler and a small bit of consolidation, and then how to play it could be part of a I July 17th or 18th discussion with the facilitator that Larry was talking about. That fits with what you were thinking, doesn’t it, Larry? Harlan, did you have a comment? COMMISSIONER DALTON: I absolutely agree with you, June. I was just going to say not only is it staff time that MILLER REPORTING CO., INC. 507 C Street, N-E. Washington, D.C. 20002 (202) 546-6666 300 would be taken up if we were going to do the other extreme, but our time as well, because, of course, we would be having input, approving, et cetera, et cetera. COMMISSIONER DIAZ: In view of the previous suggestion that Larry made about this little bound book, would we wait until that interim report to bind it? CHAIRMAN OSBORN: No, I think we can do that. We can always keep doing it. COMMISSIONER DIAZ: In other words, at this point just bind the first and second? MS. BYRNES: Separately, so that we like two separate -- CHAIRMAN OSBORN: Let me tell you, the World Health Organization has been doing this now for some years, and what they end up with is a very skinny thing that people are not intimidated by but has a distinct title that, in their case, is thematic and comes out of. topic specific consultation. But I think we could easily do it with First Report of the National Commission on AIDS, Second Report of the National commission on AIDS, whatever. COMMISSIONER GOLDMAN: Do we have an agenda for tomorrow afternoon? MILLER REPORTING CO., INC. $07 C Sureet. NE. Washington, D.C. 20002 (202) 546-6666 301 COMMISSIONER ROGERS: I just wanted to weigh in with June on this. I think doing the unexpected, as we have done with these two, has really given us a lot of brownie points. I view an interim report as a pro forma kind of thing, and if we are going to do one, let’s do another arresting report on something we really care about, and then package all three. I mean, that simply is fulfilling an assignment, and I don’t think that gets much mileage and I wouldn’t like to see the staff spending a lot of time doing that. That’s busy work. We have done a lot better than busy work so far. COMMISSIONER KESSLER: I only have one suggestion, and I’ll send the staff a sample of a format, but I think we ought to do this one in red, white and blue to say that compassion and response to AIDS is patriotic. MS. BYRNES: Being one of the most uncreative people in Washington, I would love it if you would help us do that. COMMISSIONER KESSLER: We did something similar on discrimination and we used the same sort of format to make sure that people understood that discrimination was unpatriotic. MILLER REPORTING CO., INC. $07 C Street, N.E. Washington, D.C. 20002 (202) 546-6666 302 COMMISSIONER ALLEN: I have one question before we leave this meeting here. You mentioned a site visit possibly. Are we talking about briefly a site visit in Dallas with the working group for Sunday? How many people want to do that? If this is something that we want to do, I need to work on it. If not -- I mean, I'm not invested, but I need your input. That was.-just briefly mentioned. Anybody in the working group, outside of the working group, or in the working group, that wants to look at that, I need to know to some degree. Or we can talk about that tomorrow, it would be fresher, but I just wanted to -- CHAIRMAN OSBORN: We don’t have anything specific on the schedule right now for tomorrow, but we have got time tomorrow. Now, my guess is by the time we get done we may want to talk a little bit to digest what we have heard today, and perhaps that is something we could think about. I think even with early planes we have Still got enough time that we could do a little of that. And in fact, I think that’s why we have got the schedule as relatively relaxed as it is, because we have all been missing that kind of debriefing time together. And so maybe we can just have that as part of tomorrow’s agenda. > ~~ 2 MILLER REPORTING CO., INC. 507 C Street, N-E. Washington, D.C. 20002 (202) 346-6666 COMMISSIONER ALLEN: Okay. That’s good. CHAIRMAN OSBORN: And that way we'll try and give you an idea of what David and I fire off to the Hill and that kind of stuff too. MS. BYRNES: We'll recess this until tomorrow morning at 8:00 o’clock. [Whereupon, at 4:30 p.m., the hearing was recessed to reconvene the following day at 8:00 a.m. ]