Introduction

Should scientists be allowed to pursue research on treatment of Parkinson's disease using fetal tissue from induced abortions?

Should American women be denied access to a nonsurgical abortifacient because some groups in the society feel its use is immoral?

Should the U.S. Congress make decisions about large-scale biomedical research projects that might affect the availability of funds for research in other areas?

Should scientists be the first to police and regulate their own work for potential safety risks?

Should federal reimbursement for and access to treatment be provided for victims of end-stage renal disease when other terminally ill patients are denied this entitlement?

Should patients terminally ill with acquired immune deficiency syndrome (AIDS) be allowed to take experimental drugs before their safety and effectiveness have been thoroughly assessed?



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BIOMEDICAL POLITICS Introduction Should scientists be allowed to pursue research on treatment of Parkinson's disease using fetal tissue from induced abortions? Should American women be denied access to a nonsurgical abortifacient because some groups in the society feel its use is immoral? Should the U.S. Congress make decisions about large-scale biomedical research projects that might affect the availability of funds for research in other areas? Should scientists be the first to police and regulate their own work for potential safety risks? Should federal reimbursement for and access to treatment be provided for victims of end-stage renal disease when other terminally ill patients are denied this entitlement? Should patients terminally ill with acquired immune deficiency syndrome (AIDS) be allowed to take experimental drugs before their safety and effectiveness have been thoroughly assessed?

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BIOMEDICAL POLITICS At one time it was accepted that the answers to these questions lay in the domains of science and medicine, and they would have been largely debated in those arenas. Today, biological and medical research have become a focus of public scrutiny. For each of the above questions, any public opinion poll would probably show a multitude of responses, including a healthy degree of uncertainty. Even among those questions for which a majority in the U.S. society can agree on the proper, moral response, organized vocal minorities can have considerable influence on how the debate is resolved. There are many “publics” in any debate. In biomedical research decisions, the public can take the form of voters, taxpayers, special interest groups, community organizations, and patients. In the context of this report, the public refers to any group typically outside the process of biomedical research and its medical applications—that is, laypersons. When these groups have a say in what should and should not be allowed in biomedical research and practice, deciding what should be done involves listening, negotiating, advocating, judging, and implementing. This process of weighing alternatives is the process of decision making. When it is done in public, in the light of the competing values and interests of American pluralism, it is called policymaking. How the policy process is conducted has an effect on the outcome. It is easy, with hindsight, to identify successful versus failed decisions. In the absence of outcomes, and when there is no precedent, as is often the case in biomedicine, predicting what is a correct decision becomes exceedingly difficult. Therefore, a useful strategy for examining decision making is to separate outcome from the quality of the decision process. In recent years, numerous mechanisms have been established at the federal, state, and institutional levels to define, review, and regulate the application of biomedical advances and the content of biomedical research. In addition, various quantitative methods (e.g., use of indicators, cost-benefit and cost-effectiveness analyses, surveys of need, evaluation research, policy analysis, social experimentation) have been developed to help decision makers make better decisions. Some of these analytical methods and mechanisms have worked as intended; others have failed to produce desired results, and still others require more time before their adequacy can be judged. The decision-making process is the focus of this report. Examining the way discourse proceeds among all affected parties in a policy debate may shed light on how the decision was made and could provide clues as to how similar decisions might best be debated in the future. It is not the purpose of this effort to judge whether the

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BIOMEDICAL POLITICS decisions described in the following cases were proper or improper. Rather, the goal is better understanding so that appropriate questions may be asked in the future when difficult decisions must be made. This exercise does not presume to be scientific in that it produces specific results that are reproducible or even testable. The cases in this text were chosen because they so precisely reflect the social and political mechanisms used in democracy to decide and set policy. The complexities of the decisions described bear the message of democracy: it is a difficult and sometimes uneasy way to conduct a nation's business. In 1987 the Howard Hughes Medical Institute (HHMI) awarded the Institute of Medicine (IOM) an endowment grant to develop a program of studies that would (1) identify fields of biomedical research that are candidates for accelerated development; (2) identify mechanisms that could facilitate the translation of basic biological discoveries into new health care technologies; and (3) anticipate the legal, ethical, and social issues that attend new technologies. This report is one of several IOM responses to the HHMI charge that focuses specifically on the processes by which decisions are made regarding advances in biomedical science. Early in 1989 the IOM formed the Committee to Study Biomedical Decision Making. Its membership is comprised of clinicians, researchers, industrialists, a theologian, an attorney, a historian, a sociologist, and a behavioral scientist. The historical case study was chosen as the methodology for this effort, with the cases serving as prototypes for appropriate or inappropriate strategies for decision making. Case study methodology provides a mechanism for using hindsight to identify ways to improve future performance rather than to render a verdict on any individual or group (Neustadt and May, 1986). On issues as contentious as abortion, debates over principles, morality, and rights are argued on the level of high theory, much to the confusion of practical and possible outcomes (Jonsen and Toulmin, 1988). The zealots on each side of the debate, as in other issues, tend to concentrate on universal and invariable principles, as if these principles were exhaustive and authoritative. Rules and maxims are not necessarily helpful for making decisions when the action to be taken is marginal or even ambiguous. One finds that they might apply to certain situations quite directly but to others only marginally, making decisions difficult and full of conflict. Particularly controversial actions must be considered in their context and not judged against an arbitrary set of rules. Cases, therefore, permit us to set problems in context and deal with them individually and on their own terms. Ideally, the cases sug-

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BIOMEDICAL POLITICS TABLE 1 Criteria for Case Selection Category Criteria Factors of contention Ethical/religious concerns Equity and allocation Risk or perceived risk Fear of social control Conflicting world view Decision maker Public or citizen groups Legislators Regulators Scientists/universities Third party payers Clinicians Industry Funding agency Commission Courts Church Stage of diffusion Research and development Trial and approval Dissemination Use and acceptance Reimbursement Evaluation Dualities Consults and tribunes Expertise and ignorance Outcome Successful Uncertain Failure Yet to come gest, at the margin, how the public's biomedical business might be better done in the future. Case study excuses us from addressing issues on the level of high theory and general principles by injecting a large measure of pragmatism. Indeed, democracy in America seems to preclude the development of fixed universal laws and immutable principles, and attempts to set policy on such assumptions tend to create irresoluble debate. The tales told in the following pages demonstrate that, as much as some would like to believe it so, there is little in modern life that is eternal and invariable. The IOM committee was immediately faced with the logistics of conducting this project and with two tasks in particular: first, to develop a taxonomy for case selection that would meet the needs of

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BIOMEDICAL POLITICS the project's mission; and second, to develop a morphology for case construction. The cases were selected based on a set of criteria (Table 1) that constitute characteristic facets of a biomedical policy problem. The committee spent considerable time developing a framework from which to choose the cases to ensure that the complexities of decision making were comprehensively illustrated. The committee agreed that the cases should be considered in the aggregate and that no case, standing alone, could possibly fulfill all of the criteria. Thus, the reader is encouraged to read all of the cases because as a set they illustrate the texture of decision making in the field of health sciences research. To ensure that the six cases collectively encompassed the selection criteria, a matrix was developed to score candidate cases, and the six that best filled the cells of the matrix were chosen for the project. Many additional cases were considered and might have served equally well. They included the use of animals in biomedical research, deinstitutionalization of the mentally ill, vaccine development, and the use of maternal serum alpha-fetoprotein test kits. There are, and have been, numerous contentious issues in biomedical research. The cases described in this text are by no means exhaustively inclusive of the many issues raised by advancing technology. The committee organized the criteria in five categories. The basis of the disagreement, or factors of contention. Was the problem a problem because of ethical or religious differences, inequities or misallocations, risk or perceived risk, fear of social control, or conflicting philosophical or world views? Decisions might be made differently and by different mechanisms depending on the nature of the contention. None of these factors are mutually exclusive—just convenient ways of dissecting the problem. The decision maker. Presumably the process and outcome of decision making will differ depending on the stature, authority, and power of the person or persons making the decision. The point in the diffusion process at which the innovation entered the policy arena. For example, innovations in the research and development stage are subject to different sets of decisions and decision makers than innovations that have entered the realm of treatment, reimbursement, and evaluation. Is the type of advance predictive of public involvement? For instance, is the public more likely to get involved if the advance is a therapeutic drug (because there is greater potential for immediate benefit) than if the advance is a medical procedure (because the medical model entrusts those decisions to the practitioner)? At what point in the process of diffusion were critical decisions made? Banta 's (1984) diffusion-adoption

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BIOMEDICAL POLITICS continuum indicates that the factors influencing adoption of a new practice may be different at each stage. Dualities in terms of expertise and ignorance. Who was consulted, who provided advice, and how was that advice received and used by those with the authority to act? The perceptions of the decision or decisions after the fact. Was the decision considered to be an effective one in that intentions were met? Were goals not met? Is the outcome uncertain? Is it too early to tell? The group of case writers chosen to prepare the stories of these decisions counted among their ranks an ethicist, an attorney, a policy analyst, an activist, a scientist/public official, and a political scientist (biographies can be found in Appendix B). Each author provided a unique viewpoint, coming to his or her specific issue with different working knowledge and experiences. The task set by the committee for the case writers, however, was the same: to identify and expose the underlying values held by all those described in their decisions and to determine if and how the moral response to the problem or issues changed under pressure. (Pressure could be created by time, special interest groups, perceived risk, administrative duties or obligations, economics, or the law.) The writers were also asked to describe the process by which decisions were made and identify all known constituencies and the extent to which they were involved in the decision. The writers were to consider whether the implications of the decision were well thought out or discussed during deliberations. In a sense, the writers were asked to serve as reporters, documenting what happened and what led up to the decision that was made. In the first case, activist Jeffrey Levi reports on the activities that led to the 1989 Food and Drug Administration decision to approve the use of dideoxyinosine (ddI), an as yet unproven AIDS therapy, in a parallel track protocol. The case illustrates an extraordinary confluence of action on the part of diverse groups—scientists, regulators, and activists—directed toward the possibility of providing relief and saving lives. In the second case, attorney R. Alta Charo provides an overview of action and inaction in the heated debate over the inavailability of RU-486 (the “French abortion pill”) in the United States. The case highlights the sometimes paralyzing influence of special interest groups on a decision that involves not only moral but economic values. Thus, it is really a case about delayed or postponed decision making, only the first chapter from an ongoing and as yet unresolved debate. In the third case, Robert Cook-Deegan, a physician-turned-policy

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BIOMEDICAL POLITICS analyst, chronicles the events of 1986-1990 leading to congressional action on the human genome project. The case describes the events surrounding decisions made by executive agencies, scientific constituencies, science spokespersons, and Congress to fund a large-scale project to map and sequence the entire human genetic complement. It spotlights science policy formation and implementation and will surprise readers who believe that the process is rational. The fourth case, prepared by Richard Rettig, a political scientist, analyzes the events leading to the passage of Section 299I of the Social Security Amendments of 1972, which produced an entitlement program for victims of end-stage renal disease. This entitlement remains the only one of its kind, and the decision remains controversial today. The case exemplifies the way law making about life-threatening illness is affected by politics, chance, spending assumptions, and human foibles or capabilities. It also provides a realistic view of how the U.S. Congress operates. In case five, bioethicist James Childress describes the deliberations of the Human Fetal Tissue Transplantation Research panel in its efforts to provide advice to the Department of Health and Human Services on the morality of using fetal tissue obtained from induced abortions for therapeutic transplantation. The case offers insight on how experts can disagree, as well as agree to disagree, and yet arrive at a consensus on whether a particular research effort should continue. In the last case, former National Institutes of Health Director Donald Fredrickson takes us back to the 1970s and describes the events that led to and included the Asilomar conference on recombinant deoxyribonucleic acid (DNA). In this case we are treated to an inside look at how the scientific community came to terms with their own uncertainty about the safety of a new biotechnique and how they negotiated a moratorium. Some of the decisions described in the cases have been well documented; for example, numerous articles have been written about the events at Asilomar that led to the moratorium on certain types of recombinant DNA research, and audio transcripts of the meetings are available. Written transcripts are on record for the Human Fetal Tissue Transplantation Research panel meetings. Hearing records exist that document the congressional debate on entitlement for end-stage renal disease and funding for the human genome project. In other cases a variety of communications, both public and personal, provide the bases for the author's documentation. In some cases, such as the ones on ddI and the human genome project, the author was a participant in the process and can rely on the authority of experience as well as secondary references. The case of RU-486 has

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BIOMEDICAL POLITICS not yet been played out, and the primary documents available to the author were those provided to the press by the actors involved and media accounts of the events as they unfolded. Because the case study approach is inherently a subjective process, the writers were urged to use all available sources of reference for their work and describe the process by which they investigated the case study. Endnotes and references can be found at the conclusion of each case. Also following each case are two commentaries, written and signed by individual members of the IOM committee, all of whom have their own rich experiences on which to draw. They present different aspects and viewpoints on the decisions—their unique perspectives as opposed to the conclusions of the full committee. The last chapter summarizes the committee conclusions and suggests areas for continued research. In Appendix A, committee member Stanley Reiser provides a historical perspective on the public and the expert in biomedical policy controversies. These cases illustrate the complexity and evolution of decision making related to the diffusion and adoption of advances in biomedicine. The committee did not judge whether the cases were resolved adequately; in fact, in many of these cases the debate is still in process. What makes this collection different from other “technology transfer” reports is the deliberate intent to include the impact of values and the role of the public in the discussion. The cases do not merely present a historical, descriptive documentation of the diffusion process. Integral to the final analyses is a discussion of the myriad moral, religious, political, legal, psychological, and economic forces that influence how and when certain decisions are made. REFERENCES Banta, H. D. 1984. Embracing or rejecting innovations: Clinical diffusion of health care technology. In The Machine at the Bedside, S. T. Reiser and M. Anbar, eds. Cambridge: Cambridge University Press. Jonsen, A. R., and S. Toulmin. 1988. The Abuse of Casuistry: A History of Moral Reasoning. Berkeley, California: University of California Press. Neustadt, R. E., and E. R. May. 1986. Thinking in Time: The Uses of History for Decision Makers. New York: The Free Press.