AARP Public Policy Institute INSIGHT on the Issues Comparative Effectiveness: What’s at Stake for Consumers? The Public Policy Institute and Consumers Union, with support from Divided We Fail, sponsored a Solutions Forum on October 9, 2008, to look at comparative effectiveness from a consumer perspective. AARP’s president, Jennie Chin Hansen, and Consumers Union’s chief executive officer, Jim Guest, spoke on the importance of comparative effectiveness as a foundation for evidence on what services work best in health care. Gail Shearer, director of Health Policy Analysis, amplified the Consumers Union perspective and moderated a panel of experts, who spoke to different consumer perspectives on the issue—from consumers as citizens, representatives at the decision-making table, members of different communities, and patients. Comparative Effectiveness—Why comparisons on what therapies work It Is Important for Health Care best for patients with a given health Reform problem. Estimates vary widely on the proportion of medical care in the United Health policy experts point to States that is actually supported by investment in comparative effectiveness, evidence. Some place that figure at well the study of what works best in health below half. The lack of investment in care, as a critical component of a comparative effectiveness is stunning. reformed health care delivery system. The Institute of Medicine has pointed Jennie Chin Hansen started the forum by out that, of the nation’s more than $2 discussing AARP’s key objectives—to trillion annual expenditure on health achieve health and financial security for care, less than 0.1 percent is invested in everyone. AARP members, like most assessing comparative effectiveness of Americans, look at health care from two prescription medications, healthy perspectives—as a pocketbook issue behaviors, and treatment interventions. because affordability is critical, and as a safety and quality issue. They are Promising efforts are under way to build demanding solutions to the upward the evidence base, but these efforts are spiral in health care cost, which they not enough. They include the evidence- correctly see as a threat to their financial based practice centers at the federal security. Agency for Healthcare Research and Quality and state-level efforts such as Many policy analysts have noted the Oregon’s Drug Effectiveness Review lack of a scientific knowledge base to Project. Private initiatives such as ECRI support many of the health care Institute and the Blue Cross Technology decisions that patients and clinicians Evaluation Center also make important now make. There is a good deal of contributions. Many are calling for an consensus on the need for more research, independent entity to oversee the including comparative effectiveness conduct of comparative effectiveness research that performs head-to-head research. A key issue is governance. The Comparative Effectiveness: What’s at Stake for Consumers? entity should be independent and free health care. Consumers Union also from economic and political influences offers a drug reference guide and a while being transparent in its operations. program called Consumers Reports Best The participation of all stakeholders, Buy Drugs. This program takes including consumers and patients, will information from the Drug Effectiveness be important. Review Project and adds price information. Best Buy Drugs can save What Consumers Union Has Done people thousands of dollars, depending to Help People Understand What on their medical situation. And the Works Consumer Reports Health Ratings Center is a new initiative to give Jim Guest of Consumers Union echoed consumers objective sources of the importance of investing in information around health care and comparative effectiveness research. He related matters. reminded the audience that since 1936, when Consumers Union was formed, Consumers Union’s focus groups and comparative effectiveness and evidence- research reveal that people think their based information has been a key focus doctors are already using comparative of the organization, whether for buying a effectiveness information. The car, a toaster, a DVD, or a digital organization is trying to let people know camera—giving subscribers and the that they can expect more from their public the information to make choices. physicians, that they should not assume Consumers Union also evaluates and that all the health care they receive has rates drugs, using an unbiased scientific been clinically proven, and that they approach, and rates treatments. In a should expect to ask questions and not project with the British Medical Journal, be brushed off. Ideally, patients will get Consumers Union takes the information answers to their questions, improve the that the Journal provides to doctors and dialogue, and create a demand among turns it into plain English for consumers. both medical providers and patients for This helps consumers understand which more comparative effectiveness treatments for back pain, for example, information. are proven to be potentially effective, which ones have been proven to be What Does Comparative ineffective, and which are in between. Effectiveness Mean? Consumers Union has also rated natural medicines, health maintenance Gail Shearer of Consumers Union organizations, hospitals, nursing homes, provided a framework concerning what and a variety of other elements of the comparative effectiveness really means health care system. for consumers. Comparative effectiveness research tends to go hand Consumers are looking for useful in hand with the term “evidence-based information. Consumers Union makes it medicine.” But the average consumer available through its magazine; there are does not know what evidence-based more than 8 million subscribers to the medicine really means. To most different print products, and about 20 consumers, it sounds like rationing. million people get the magazine from AARP and Consumers Union are someone else. A Consumers Union combining their efforts to educate health newsletter has been growing at consumers about what comparative double-digit rates for the last few years, effectiveness research really means. which demonstrates that people are Shannon Brownlee, the author, has a looking for information they can trust on definition that is very helpful: the ability 2 Comparative Effectiveness: What’s at Stake for Consumers? to compare different kinds of treatments Consumers Union is translating to find out which one works best for evidence-based medicine for consumers, which patient. an important role. On the Consumer Reports Health Web site, viewers can Improving the information base about find research on translating evidence- what services work will improve based medicine about medical quality, safety, and costs. The Drug treatments. Consumers Union plans to Effectiveness Review Project is a great expand its work on doctors and success story: For example, most of the hospitals. Consumer Reports’ Best Buy states that are members of the project did Drugs is based on data from the Drug not put Vioxx on their preferred drug Effectiveness Review Project, which list. This decision probably saved about 14 states now use to select drugs thousands of lives and certainly for their Medicaid programs. thousands, if not millions, of dollars in medical expense. Another example can Consumers as Citizens be seen in the October issue of Health Services Research, which shows the Marge Ginsburg, executive director of potential savings. Researchers at the Sacramento Healthcare Decisions, talked University of Pittsburgh and about the role of citizens in contrast to Massachusetts General Hospital looked the role of consumers. The role of at the Best Buy Drug Program. They citizens is to help define the underlying found potential savings of about $2.7 principles or values for how our society billion if people who are taking a drug in is going to provide health care, allocate one of four categories switched to a best- shared health care resources, and buy drug. That is about 8 percent of influence providers and consumers. This spending in those drug categories. Many citizen role, however, is not one that this individuals who are taking drugs in those country has fostered. If comparative categories can save between $1,000 and effectiveness involves a value $2,000 a year by switching from what is determination (finding the acceptable probably a highly advertised drug to a balance between the benefit of medical best-buy drug that is equally effective, intervention and its cost), then it must but costs much less. incorporate citizens’ views on the use of communal resources. Virtually all Some of the pressing policy issues to be insurance products are based on the decided include how to engage concept of shared risk and shared stakeholders and ensure the long-term dollars. sustainability of a new entity that does comparative effectiveness research. The Priorities change depending on which entity needs to be structured so it does hat we wear, citizen or patient. The work not fail, stakeholders should be engaged, Sacramento Healthcare Decisions has and the system should not build in done suggests that citizens, given conflicts of interest that would accurate, unbiased information, welcome undermine the value of the research. the chance to weigh in on decisions Another key issue for policymakers is about societal health care priorities. The how to structure a new entity so the big question is whether we as patients research does not increase health care are willing to live with the limits that we disparities, but actually embarks on a establish prospectively as citizens. It will path to reduce them. require greater openness about the reality of finite resources and consensus 3 Comparative Effectiveness: What’s at Stake for Consumers? on the obligations and limits of health Committee. This and other experiences care as a social good. have taught him that representation of citizen-consumer public interest is Sacramento Healthcare Decisions has critical in all levels of health policy engaged citizens in a variety of projects discussion and decision making. But it to explore priority setting in the face of has to be meaningful representation, finite resources. The intent of this work preferably more than one consumer, is to help policymakers understand how because there are lots of other people at people make trade-offs and to convey the table in groups representing special the importance of citizen participation in interests. these larger value-based questions. Two of its projects centered on comparative Citizens and consumers should be effectiveness and incorporated the selected as representatives on the basis concept of cost-effectiveness for making of objective criteria, including an clinical or coverage decisions. While absolute prohibition of any material most of the project findings are conflict of interest or inappropriate bias qualitative, at the conclusion of the latest such as cooption by industry. It is not project, Sacramento Healthcare easy to be a consumer representative, Decisions used a post-discussion written especially in open public settings. survey to ask participants if cost- Audiences can be very large and media effectiveness should be considered when coverage can be extensive. Many experts the government makes decisions about know each other by first name or by insurance coverage. Eighty percent reputation, and do not know the responded that it should be used in some consumer representative. It can take or most situations. Fifteen percent courage and passion to be a single responded that it should never be used, consumer representative and to buck the and 7 percent had some other response. trend set by other participants. Levin cast the only vote against Vioxx in the If the public is going to accept changes Drug Safety and Risk Management in health care policy and practice, then Advisory Committee; the chair of the inclusiveness of their input and advisory panel afterward said he told his transparency of the process must be friends that the only one who got it right hallmarks of getting to a system we want was the consumer representative. So it is and can afford. possible for consumer representatives to play a meaningful and important role in Consumers as Stakeholders this process, even if the vote goes against them. Art Levin, director of the Center for Medical Consumers, addressed how Another ground rule for effective consumers can be effective at the consumer participation is for consumer decision-making table. He supports the representatives to be thoroughly right and need for citizen experts to be committed, including being present at fully enfranchised—not only to be at the every meeting. They must do the health policy decision-making table, but homework and go to meetings well when appropriate, to lead the discussion. prepared. And they must be willing, to Levin’s most relevant experience is as the degree permitted by the rules of the the consumer representative on the Food game—and it is important to follow the and Drug Administration’s (FDA) Drug rules of the game—to talk to other folks, Safety and Risk Management other advocates, and other citizens about 4 Comparative Effectiveness: What’s at Stake for Consumers? the topic of the meeting. Another critical able to call up other resources if they concern is that consumer representatives have questions about the integrity of a not define themselves narrowly. statement that is made, for example, Consumer representatives often bring about a study. For citizen-consumer medical and scientific expertise to the participation to be meaningful, we have table as well as their advocacy to remove the barriers. And the barriers experience. include securing financing, accessing financing, and training and resourcing Those who doubt the utility of having those people so they can be maximally citizens, consumers, or patients involved effective in their role. (FDA, in the case in these deliberative processes about of advisory committee meetings, does health care policy usually express two provide all panel members with a modest concerns. One is that the decisions to be compensation for meeting time, along made are too complex for the laity to with travel, lodging, and other per diem understand. The second is that only expenses.) those with impressive credentials, postgraduate education, professional Consumers as Parts of Diverse education, and years of experience in Communities scientific method, research, evidence synthesis, and clinical practice—a skill Perry Payne, a professor of health policy set far beyond that of many consumer at George Washington University, representatives—can participate conducts research on health disparities meaningfully in the process. That simply and on genetic information. He stated is not true. For example, the HIV/AIDS that communities should have input into community became extremely well the research process. Most researchers organized and outspoken when it never have a chance to sit in front of the became clear that the health care system, community that they are studying and the research, and the treatment meet with the types of people they are community were being terribly thinking about treating or for whom they unresponsive to this epidemic. Many are developing some kind of remedy. advocates and patients quickly They should hear from those people. developed a startling degree of scientific This is more important than having a knowledge about the virus. consumer sit on a panel. Researchers should stand up in front of 100 people An important part of any comparative who have the disease they are studying effectiveness bill might be to fund or whose family members have that training for consumer and patient disease and talk about their research. advocacy and compensate Researchers and pharmaceutical representatives for their time. This companies should hear from the would address part of the unlevel families; they should hear whether the playing field. Special interests are work makes sense and whether the involved with their way already paid, but research is being done appropriately. consumer representatives often They could ask what is missing, whether participate on their own time. Industry they are characterizing the community representatives have huge support for appropriately, and whether a better line their participation in the meeting and of research is needed. These dialogues deliberative processes. Consumers don’t. will provide strong community Consumers not only should be engagement from beginning to end. compensated for the meeting time, meals, and travel, but also need to be 5 Comparative Effectiveness: What’s at Stake for Consumers? At the beginning of the research process, drug that is 20 percent more effective someone has to establish priorities. That than another and the costs are the same, is where community input should start, a payer will decide to cover only the including what diseases to study, what more effective drug. The problem is populations to include, and in what part human variation—for some people the of the country to conduct the research. other drug might be more effective. For This process will lead to more buy-in example, some people were doing fine and in the end be more useful to with Vioxx. Perhaps providers can use consumers. These consumers are more genetic tests to identify the populations likely to respond positively. that can benefit more from certain drugs. Communities should be involved with priorities and funding at the outset. Another challenge is how to personalize this complex information for consumers. Communities include those that For example, how do you come up with experience health disparities, which exist some scale for the average consumer that throughout the nation. We will never get simplifies the choices? Communication rid of health disparities, but we should strategies may vary with communities, move from disparities between healthy types of people, levels of education, and people and unhealthy people to people in different age-groups. disparities among healthy people. A Language diversity is another challenge. diverse health care workforce can think more about the various types of Comparative effectiveness is one part of communities and about how the results the solution to address health disparities. from comparative effectiveness research But environmental issues, including how will play out in the delivery system. we have organized society, have an Some of the existing datasets used for important role in health disparities. comparative effectiveness research do Comparative effectiveness can chip not include diverse groups of people. away at disparities, but it is not the Those datasets should be bolstered as we solution to everything. move forward. Consumers as Patients Researchers should think about how they characterize themselves genetically, Jack Fowler, president of the Foundation physiologically, and environmentally so for Informed Decision Making, that comparative effectiveness addressed the importance of informed information can be useful for many types medical decision making that takes of people. This will allow them to use individual preferences into account. The evidence in as personalized a way as foundation is committed to making possible. That does not mean that every patients as informed and involved as type of person should be included in possible in the decisions that affect their every study. But it does mean that health and well-being. The foundation is researchers should think about how to focused on collecting information, characterize people in a way that helps making it available, and getting it to clinicians and patients understand who consumers. this comparative effectiveness information really applies to. From an ethical perspective, patients should know the risks and benefits of How should comparative effectiveness treatments or tests that are proposed for information be communicated to payers, them, and the alternatives, and should public and private? Some people are understand what each does for them worried that if researchers say that one compared with one another and 6 Comparative Effectiveness: What’s at Stake for Consumers? compared with doing nothing at all. This If doctors get the patient’s input, they knowledge should be a standard part of can make better decisions. Delegating expectations before a patient accepts the whole decision to the doctor is not medical treatment. And it would be hard the way to get the best decision. The to argue for ignorance, though current doctor and the patient both play a role in practice is testimony that ignorance is getting it right. One of the disappointing well tolerated. realities is that decisions currently are not made in a way that is conducive to A safety argument can be made for giving patients a say in what is done. informed decision making. Let’s say that Doctors are still the main source of patient A is the person with the bad information for people, and they do not knee, but patient B has the operation. routinely provide information on When this happens, we call it a medical alternatives. Doctors rarely ask patients error. A medical error also occurs if what they want. Too often, decision people have a type of surgery that they making is one-sided, that is, would not want if they were informed paternalistic, doctor-driven, not shared, and really understood what they were and not informed. getting into. In both cases, we operated on the wrong patient. Studies show that people exposed to decision aids are better informed than Consider what would happen if the those receiving usual care. Informed informed consent form for a surgical consumers make decisions that are more procedure were presented that said (after consistent with their reported needs and the list of the usual things), “I understand concerns, and more consistent with the that my risk of a heart attack, stroke, or things they care about, than people death will be no better after this stent is receiving usual care. More often than placed in my artery than if I simply not, when patients are informed, they manage my heart condition with also end up choosing the intervention— medicine. And, in fact, I might get a whether it is an operation, a test, or little symptom relief, but in two or three something else —less often than people years, my symptoms will be just about in usual care. the same as if I had taken medicine alone.” Although no informed consent In conclusion, informed decision making forms actually read like this, isn’t that is ethical; it is the right thing to do. how they should read? Second, there are safety issues about exposing people to risks and treatments Patients can make better medical that they would not choose if they had decisions if they have input and are more information. Third, better medical informed and involved. The evidence decisions result from the input of patient alone does not tell you what the decision values and concerns. When patients are ought to be. Consumers should apply informed and involved, they are more their own set of values and weights to likely to receive the treatment that best determine what care will best serve their serves their interests. Finally, when interests. The doctor’s job is to present patients are given an informed say in the array of reasonable options. The their care, less intervention might result. costs and benefits, learned from And that could be a good thing for all of comparative effectiveness studies, us. should factor into the equation. Patients can then add what they care about, their values, and their views of possible complications and side effects. 7 Comparative Effectiveness: What’s at Stake for Consumers? How Can We Build Support for high-quality medicine at an affordable Comparative Effectiveness among price. Changing the relationships and the Public? how medicine is delivered is important as well. Mr. Fowler said that the argument that less care might be better than more is a Additional information on the panelists’ INSIGHT on the Issues hard one for people to grasp. A strength organizations can be found at the of the argument that patients should be addresses below: informed and involved and have a big say in the care they receive is that having Consumers Union patients make their own decisions is a www.consumersunion.org more politically palatable approach to AARP reducing intervention than having others www.aarp.org impose limitations on them. Mr. Levin pointed out that people are wary of a Sacramento Health Decisions message that could be interpreted as www.sachealthdecisions.org insurance companies trying to cut back on care. Any entity that conducts Center for Medical Consumers comparative effectiveness research has www.medicalconsumers.org to be organized in a way that convinces the public that this is operating for their Foundation for Informed Decision interest. It should be a trusted source and Making resource. Making the case for www.informedmedicaldecisions.org comparative effectiveness is a huge job of social engineering, because in this Insight on the Issues 17, November, 2008 country, all the effort is spent on getting people to consume more. The drug ads, Written by Sarah Thomas the device ads, the marketing to AARP Public Policy Institute, physicians all say that more is better. We 601 E Street, NW, Washington, DC 20049 portray the willingness to absorb www.aarp.org/ppi unnecessary, harmful, late-stage 202-434-3890, ppi@aarp.org treatment as heroic. So we have to think © 2008, AARP. about all of those subtle and not-so- Reprinting with permission only. subtle ways that we engineer people to think that more is always better. Ms. Ginsburg agreed that the public is bombarded with every possible message to consume more health care, devices, and drugs, and to use the hospital more often. If a group starts telling people that more is not better, are they going to believe it? When consumers look to people they trust, the first person they look to is their own physician. But this may not be the best source. We should get rid of fee-for-service medicine, ensure that all systems of delivery have the same motivations, and ensure that they are on the same wavelength and aiming toward the same goal, which is 8