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Society's Choices: Social and Ethical Decision Making in Biomedicine 4 The Spectrum of Societal Responses Public moral discourse on bioethics has been fostered in a variety of ways in the United States. Some of the mechanisms described in this chapter entail the formation of a group of persons, as in grassroots organizations, while others relate to the activities of long-established social institutions, such as the legal system. Each mechanism offers distinctive capacities and limitations, and together they shed light from many perspectives on the complicated process of public deliberation of ethical issues. This chapter summarizes salient features and activities of some of the more prominent of these institutions. Past social responses to ethical quandaries in biomedicine have succeeded in a variety of ways. For example, many public commissions, at the minimum, have enlisted outstanding scholars to contribute their insights on the issue of concern. Many of the products of these commissions have been viewed as authoritative and have had a substantial impact on policy decisions, as for example occurred in the cases of defining brain death and establishing standards for human experimentation. These and other similar examples are described later in this chapter. Commissions and other deliberative bodies operate in a world where deadlines, personalities, and special interests converge. The necessity for compromise is unavoidable. Many products of these commissions have stood the test of time and continue to have a prominent role in education for health professionals and ethicists. Hospital ethics committees, for example, are often able to soften advocacy of patient interest in order to gain the willing participation of health care providers (Hoffman, 1991). While
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Society's Choices: Social and Ethical Decision Making in Biomedicine the committee does not attempt in this report to perform a comprehensive assessment of the performance of every social mechanism for deliberation of ethical issues, one of the background papers in this volume by Gray does assess some of the accomplishments, determinants of success, and views of participants in the National Commission and President's Commission. The accomplishments of other deliberative bodies described in this chapter are outlined in greater detail in Appendix A. The social and institutional context within which bioethics deliberation takes place was described in Chapter 2. In this chapter, we are concerned with the vast array of specific responses and mechanisms that facilitate the public deliberation of ethical issues in biomedicine. Whether, and to what extent, the activities of these various groups and institutions have been effective is a separate question that receives attention in Chapter 5, where criteria for evaluating the effectiveness of the work of these bodies are set forth. For organizational purposes, this chapter categorizes ethics bodies according to their source of sponsorship or authority: political and legal (e.g., federal commissions), professional and institutional (e.g., institutional review boards), or grassroots (e.g., individual and community initiatives). It will become obvious, however, that there is significant overlap in the functions served by the different mechanisms, an overlap that defies neat categorization. In some cases, there are functional similarities between mechanisms that have significant structural differences and operate in separate societal spheres. The mechanisms have been created to fulfill numerous functions-some very general, some quite specific, many interrelated-including the following: to bring to the larger public the opportunity and the responsibility (that previously belonged to elite groups) to define ethical issues; to identify ethical issues at stake in areas of societal controversy; to undertake a careful analysis of an issue; to develop and/or document areas of consensus; to expose and document areas of disagreement; to unify the expertise of authorities from a wide variety of relevant fields; to represent competing interests; to generate public awareness and debate; to be a lightning rod for public concern; to educate; to correct misunderstandings and errors in reasoning; to develop factual bases for public policy; to offer guidance for decision making; to develop recommendations for action;
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Society's Choices: Social and Ethical Decision Making in Biomedicine to recommend new legislation or changes or improvements in existing public policy; to sanction delays or recommend unpopular policies; to dignify and legitimize official action; to overcome bureaucratic obstacles; and to justify the expenditure of money. The functions served by a particular mechanism or group may be dictated by a sponsor's mandate, or, as is frequently the case, be simply incidental. For example, a group convened to recommend legislation on a controversial issue may be unable to reach agreement on a plan of legislative action but, in the course of its work, may succeed at educating members of society and perhaps even at reducing controversy by clarifying various viewpoints. Finally, experience has shown that what is ultimately achieved through public deliberation often depends more on the particular issue and on societal circumstances than on the intended outcome of the deliberation. POLITICAL AND LEGAL MECHANISMS It is not surprising-at least in democratic societies-that governments should look for means to address the ethical and social consequences of biomedical research, since research is heavily supported and encouraged by government as a means of advancing human welfare. Yet during the 20 years following the Nuremburg tribunal, neither governments nor professional bodies paid more than glancing attention to the actual or potential problems inherent in the activities and discoveries of biomedical scientists. During this period, no framework existed for judging when, how, and for what reasons the government should get involved, nor was there a means for determining which developments in the life sciences might pose significant problems. Beginning in the late 1960s, however, the first steps were taken toward sustained examination of the ethical and social effects of the processes and products of biomedical research. In 1966, for example, Surgeon General William H. Stewart promulgated rules for peer examination of the ethics of research protocols at Public Health Service grantee institutions (U.S. Public Health Service, 1966). In 1968, the Government Research Subcommittee of the Senate Committee on Government Operations held hearings on a joint resolution sponsored by Senator Walter Mondale to establish a National Advisory Commission on Health Science and Society (National Commission on Health Science and Society, 1968). After the Ad Hoc Task Force on Cardiac Replacement of the National Heart Institute acknowledged that this new technology had ethical and social implications that
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Society's Choices: Social and Ethical Decision Making in Biomedicine should be explored (1969), Dr. Theodore Cooper, then Director of the National Heart Institute, appointed the Artificial Heart Assessment Panel, which issued the first major government report on the ethical implications of new technologies (1973). Commissions Established by Congress When Senator Mondale initially proposed a commission, the first human-to-human heart transplants had just been performed, and his intention was for the commission to address ethical issues in biomedical developments and human subjects research. Over the next several years, further developments in human reproduction (such as in vitro fertilization), neuroscience, behavioral medicine, and control of lethal diseases underscored the need for a commission. Yet it was scandal in the research process rather than the worrisome products of research that apparently convinced the U.S. Congress to establish the first national commission on bioethics. In the wake of the revelation in 1972 of the Tuskegee Syphilis Study, the Senate Committee on Labor and Public Welfare held further hearings into research abuses in state mental facilities and prisons (Senate Committee on Labor and Public Welfare, 1973). The hearings were chaired by Senator Edward Kennedy, whose family has long been interested in issues affecting retarded persons and whose family foundation had recently established one of the first ''bioethics" centers at Georgetown University. National Commission As a result of these hearings, provisions were included in the National Research Act of 1974 (P.L. 93-348) to create the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission), as well as to require that Public Health Service (PHS) grantee institutions establish institutional review boards (IRBs) to review the ethics of research projects carried out by their employees. Although Senator Mondale's proposed examination of the ethical and social implications of medical developments was incorporated as a special study for the National Commission, the body's primary mandate was to make recommendations for the ethical conduct of research, including research that involved various vulnerable populations. The National Commission, which functioned from 1974 to 1978, was appointed by the Secretary of Health, Education, and Welfare and operated within that department (DHEW). It was made up of 11 members, all from outside the federal government: three physicians (one of whom was elected chair of the body), two psychologists, three lawyers, two professors of ethics, and one civic leader. Their work was aided by a professional and
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Society's Choices: Social and Ethical Decision Making in Biomedicine support staff of 12 and further assisted by a number of consultants from medicine, philosophy, law, and the social and natural sciences. The public was allowed access to the commission's deliberations, as well as to draft papers; the commission also held several public hearings and made site visits. During its four years, the National Commission issued ten reports: five dealt with special groups of subjects (fetuses, prisoners, children, patients undergoing psychosurgery, and the institutionalized mentally infirm); two dealt with research review (reports on IRBs and on disclosure of information under the Freedom of Information Act); one provided ethical guidelines for delivery of health services by DHEW; and one reported the results of the "special study" (the implications of research advances, the topic inherited from the Mondale bill). The best-known of the National Commission's reports was the Belmont Report (1978a), which abstracted the general principles for protection of research subjects that lay behind its other reports on particular aspects of biomedical and behavioral research. It set forth three comprehensive principles to "serve as a basic justification for the many practical ethical prescriptions and evaluation of human actions": (1) respect for persons, (2) beneficence, and (3) justice. Respect for persons requires that individuals be treated as autonomous agents, while persons with diminished autonomy are entitled to protection. Beneficence calls not only for protecting individuals from harm, but also for making efforts to secure their well-being.1 Justice relates to fairness in distribution of the benefits and burdens of research. The commission's provision of these explicit principles for the analysis of ethical issues in language that was clear and accessible to a lay audience enabled the general public to engage in informed and effective discussion of such issues, and opened up a whole new field for public discourse. The recommendations in the commission's report on fetal research were made in May 1975 and were quickly translated into proposed federal regulations. In that instance, DHEW's need for regulations was at least as important in provoking a rapid response as was the commission's statutory "action-forcing power" (i.e., the secretary had to either accept the commission's recommendations or make public the reasons for rejection). Not all of the commission's recommendations were as influential, however, and while its core points provided the basis for what are now government-wide regulations on human subjects research, several of the reports had little influence. For example, DHEW did not respond to the commission's report on the institutionalized mentally infirm (1978c). But in light of the novel nature of this enterprise, the work of the commission was impressive: 1 While the Belmont Report did not employ the term "non-maleficence" (to do no harm), the language it employed makes it clear that it encompasses this notion in the discussion of beneficence.
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Society's Choices: Social and Ethical Decision Making in Biomedicine its products met high standards of intellectual rigor, and the papers it commissioned from major scholarly figures catalyzed the study of bioethics as noted scholars became actively involved in addressing these issues. President's Commission The statute establishing the National Commission suggested that, at the conclusion of its term, a standing National Council for the Protection of Human Subjects would be established to carry its work forward. Instead, in 1978 the Congress authorized the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (President's Commission), thereby combining Senator Kennedy's interest in elevating the National Commission above the departmental level with the desire of Representative Paul Rogers and his colleagues on the House Health Subcommittee that the successor body take on topics beyond research with human subjects (P.L. 95-622). In addition to requiring biennial reports on the latter topic, Congress mandated that the President's Commission also report on the ethical and legal aspects of determining death, informed consent, confidentiality and privacy, genetic issues, and disparities in access to health care. While the National Commission had been quickly appointed, the President's Commission was not sworn in for 14 months after the passage of its authorizing statute. Like the National Commission, membership in the President's Commission was divided into several categories: three from biomedical or behavioral research (initially a professor of human genetics, a professor of psychiatry, and a molecular biologist), three from the practice of medicine (a general internist, a cardiologist, and a pediatrician), and five from other fields (a medical economist, a medical sociologist, a professor of law, a professor of ethics, and a lawyer who was appointed by the president to chair the commission). Two commissioners (the professors of ethics and law) had served on the National Commission, although one had to resign almost immediately when she was appointed to a high position in the federal government. Two other commissioners resigned later, and seven others were replaced as their terms expired, so that 21 people in total served on the President's Commission. The staff usually numbered about 20 (including 6 in support positions), but several of the professional staff (a total of 23 individuals over the life of the commission) served for only a year while on leave from academic positions. Additionally, 16 students (primarily from medicine, law, and philosophy) served as Congressional Fellows and interns. Part of the delay in appointing the original commissioners apparently resulted from political friction between the White House and Congress. The executive branch was slow to choose the commissioners, and even
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Society's Choices: Social and Ethical Decision Making in Biomedicine after they had been named in the summer of 1979, the commission could not begin its work because no funds had been requested (or appropriated) for it in the FY 1980 budget. When pressed to "reprogram" monies from other activities, the leadership of DHEW eventually complied, but only after deciding that it would end operation of its Ethics Advisory Board (EAB) on the grounds that the President's Commission made the EAB redundant (see below) and then transferred the funds originally allocated for the EAB to the President's Commission (1983d). The commission's statute included a "sunset" clause with a termination date of December 31, 1982. In 1982, Senator Kennedy proposed that the date be changed to 1984, but a provision of the December 1982 Continuing Resolution (P.L. 97-377) extended the commission only through March 31, 1983. During its 39 months, the President's Commission issued 17 volumes, consisting of 10 reports (several with one or more appendix volumes), the proceedings of a workshop on policies and procedures for responding to reports of scientific misconduct ( Whistleblowing in Biomedical Research, 1981), and a loose-leaf book (The Official IRB Guidebook). Five of the reports dealt with health care issues; four of these responded to the commission's statutory mandate: Defining Death (1981), Making Health Care Decisions (1982a), Screening and Counseling for Genetic Conditions (1983b), and Securing Access to Health Care (1983c). The fifth, Deciding to Forego Life-Sustaining Treatment (1983a), grew out of the studies on determining death, informed consent, and access to care. Four reports dealt with biomedical and behavioral research, including the subject of human genetic engineering (at the request of the president's science advisor) and compensation for research injuries (at the request of the EAB, shortly before its demise). Finally, on March 31, 1983, as it closed its doors, the commission issued a last report, entitled Summing Up, that provided an overview of its work and that addressed the one topic (privacy and confidentiality) in its original statutory mandate that had not been the subject of a separate report (1983d). Biomedical Ethics Board The third major congressionally chartered bioethics effort was less fortunate than its predecessors. Following 1982 hearings on the President's Commission report, Splicing Life (1982b), then-Representative Albert Gore, Jr., proposed the establishment of a presidential commission on genetic engineering, a proposal that was later broadened to include other bioethical issues. Because of differences in viewpoint between Senate conservatives and House liberals over what would result if another presidential bioethics panel were authorized (Cook-Deegan, 1994), Congress in 1985 chose to locate the successor within the legislative branch. A Biomedical
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Society's Choices: Social and Ethical Decision Making in Biomedicine Ethics Board (BEB) was authorized through September 30, 1988, to be composed of six Senators and six Representatives (equally divided between the two major parties) (P.L. 99-158). The BEB was responsible for appointing a 14-member Biomedical Ethics Advisory Committee (BEAC) made up of experts from law, medicine, research, and ethics, as well as members of the general public. The BEAC was instructed to begin its work by studying three topics: human genetic engineering, fetal research, and food and fluids for dying patients (see Appendix A for a further description of the BEAC). From the outset, politics-especially the sharp division in Congress over the abortion issue-complicated the operation of the BEB and the BEAC. It took nearly a year to choose the 12-member BEB and another 30 months of internal wrangling before BEB members could agree on 14 people for the BEAC; one of the 14 died before the BEAC could even hold its first meeting. Congress passed a two-year extension and an appropriation for FY 1989, but withheld authority to meet or to expend funds until the BEB agreed upon a new chair (which with the start of the 101st Congress had shifted from the House back to the Senate) and named a replacement for the BEAC member who had died. The BEB was unable to do so, and the BEAC had no further sessions after its second meeting in February 1989. It issued no reports, its staff departed by the end of FY 1989, and its mandate expired on September 30, 1990. Ethics Bodies in the Executive Branch Ethics Advisory Board, DHEW Among the recommendations of the National Commission was the establishment of a group within DHEW to provide ethical advice regarding proposals that involved particularly sensitive types of research. This recommendation became a part of the department's regulations (45 C.F.R. 46), and in September 1977 Secretary Joseph Califano appointed a 14-member Ethics Advisory Board to review problematic protocols that required special scrutiny under the human subjects regulations (e.g., problematic protocols having to do with more than minimal risk for nonconsenting subjects). The group had a distinguished interdisciplinary membership (see Appendix A for further description of the EAB). Between 1978 and 1980, the EAB's principal work was to produce a major report on Research Involving Human In Vitro Fertilization and Embryo Transfer (May 4, 1979), which came in response to an approved application for NIH support of research that would have used in vitro fertilization (IVF) in basic research. The EAB also conducted two inquiries in response to requests from NIH and the Centers for Disease Control for legislative recommendations that would provide for limited exemptions from the
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Society's Choices: Social and Ethical Decision Making in Biomedicine Freedom of Information Act. At the time it was disbanded in 1980, it had also embarked on a study of another policy topic-compensation for research injuries-that had previously been examined by a DHEW task force (U.S. Department of Health, Education, and Welfare, 1977). The EAB did creditable work, but for several reasons it remains at best a footnote in the history of public bioethics. First, its report on IVF was delivered to Dr. Califano's successor, Patricia Harris, who had little interest in the field. Neither she nor any of her successors have officially accepted or rejected the EAB's recommendations. Second, although the department's regulations continue to provide for the existence of an EAB, Secretary Harris disbanded the existing body due to what was perceived as duplication with the President's Commission, even though the EAB focused on intra-agency issues and the commission on broad, national issues. Finally, the lack of an EAB allowed the Reagan and Bush administrations to avoid approving any research with human embryos or tissues between 1981 and 1992, during some of which time explicit moratoria on such research were written into various congressional bills. Recombinant DNA Advisory Committee, NIH In 1975, the Director of NIH established a Recombinant DNA Advisory Committee (RAC). This committee and its implementing regulations were a response to the conclusions reached at a meeting held at the Asilomar Conference Center in California under the sponsorship of the National Academy of Sciences. The meeting addressed the concerns that had led several leading molecular biologists to call for an international moratorium on certain classes of laboratory research using newly developed methods of cutting and splicing DNA. As a result of the meeting, the scientists in attendance voted to lift the moratorium and adopted certain procedures for their research, including developing means to carry it out more safely. Since some members of Congress seemed to believe that these methods of self-regulation by scientists might be too self-interested, NIH Director Donald Fredrickson broadened the membership of the RAC to include nonscientists. The primary concern of the RAC in its first years was laboratory safety; thereafter, it began to confront issues involved with commercial development of recombinant techniques and release of altered organisms into the environment. While ethical issues were inherent in such deliberations, the major focus was on technical concerns about the relative riskiness of particular microorganisms, with or without genetic alteration. In response to the 1982 report of the President's Commission, Splicing Life, the RAC decided to address ethical issues more intensely by appointing a task force on human gene therapy, subsequently modified into a standing Subcommit-
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Society's Choices: Social and Ethical Decision Making in Biomedicine tee on Human Gene Therapy. This body eventually established the benchmarks for review and approval of protocols to apply the techniques of gene transfer to human beings in a set of "Points to Consider," which was first issued in 1988 and subsequently modified on a number of occasions. For several years, protocols were reviewed first by the subcommittee and then by the RAC; by 1992, it was decided that, since the RAC was devoting most of its own time to human gene protocols, the subcommittee's work was redundant and all proposals would come directly to RAC. On all matters, the RAC is advisory to the Director of NIH, who publishes the committee's recommendations in the course of announcing which studies have been approved for NIH funding or sponsorship. The RAC is a multidisciplinary committee, a majority of whose members are physicians and scientists who work in some aspect of molecular biology or genetics. The committee also includes lawyers, social scientists, ethicists, and members of the general public with an interest in genetic disease. Although traditionally chaired by one of its scientific members, the current chair is an ethicist with long involvement in genetic engineering issues. As a federal advisory committee, its meetings are announced in the Federal Register and are open to the public; when important new scientific projects are before the committee for review, media attention is often intense and the group's recommendations are given extensive coverage. At the present time, the protocols that come before the RAC usually involve the transfer of genes to serve as markers on cells being administered in experimental therapies or to enhance the effectiveness of various immunological methods of fighting diseases like cancer and AIDS; in addition, some studies involving gene transfer to treat single-gene diseases have been approved. Beyond such somatic cell gene therapy, the "Points to Consider" state that the RAC will not now entertain proposals for gene transfers that would affect germ-line cells. In light of developments in molecular genetics, it may soon become necessary to consider when (if ever), under what conditions, and for what reasons it would be appropriate to broaden gene therapy to germ-line cells, or for purposes of genetic enhancement. No attention has been given to such issues because RAC meetings for several years have been absorbed with protocols under the existing guidelines. At its September 1993 meeting, however, the RAC placed these issues on its agenda for the coming year (see Appendix for further description of the RAC). Ethical, Legal, and Social Implications (ELSI) Working Group, NCHGR and DOE The Ethical, Legal, and Social Implications (ELSI) Working Group was founded in 1988 at the National Center for Human Genome Research
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Society's Choices: Social and Ethical Decision Making in Biomedicine (NCHGR) of NIH. The U.S. Department of Energy (DOE) joined in support of the ELSI Working Group in 1989. Having recognized that the capabilities arising out of the Human Genome Initiative are likely to have a profound impact on individuals and society, NIH created the ELSI Working Group to explore such issues as fairness in the use of genetic information with respect to insurance, employment, and the criminal justice system; privacy of genetic information; and the influence of genetic information on reproductive decisions (see Appendix A and the background paper by Hanna in this volume for further descriptions of the ELSI Working Group). Today, a sizable portion of the budgets for both NCHGR and DOE (from 3 to 5 percent) is formally designated to support studies on the identification and examination of these broader impacts of genetic science. This seems to be the first instance in which a portion of a science budget has been devoted specifically to the study of the ethical, legal, and social impacts of science. In all other instances, we have allowed the technology to develop and to be applied, and the resulting ethical, legal, and social dilemmas to arise, and then attempted to resolve them largely in retrospect. The impact of the ELSI program is not yet clear. Arguments that it is overly academic and not adequately representative of society merit consideration (see Hanna, this volume). At the same time, however, many observers and even some critics seem to agree that the ELSI program is indeed stimulating effective ethical inquiries into genetic technologies and encouraging the molecular biology community to design their technological studies accordingly. Such an effect would be of great benefit to the genome project, and the success of this earmarked ELSI funding program could serve as a very useful model for other areas of science. Human Fetal Tissue Transplantation Research Panel, DHHS The NIH Human Fetal Tissue Transplantation Research Panel was convened in 1988 at the request of Assistant Secretary for Health Robert Windom. Following discussions with NIH Director James Wyngaarden about proposed research that involved the transplantation of human fetal neural tissue into patients with Parkinson's disease, Dr. Windom requested that a panel be formed to investigate the issue and formulated ten questions the panel was to address. Wyngaarden believed that the research was extremely important, but that it also had the potential to stir controversy and perhaps even to send a message to the public that NIH encouraged abortions (Childress, 1991). Windom responded to Wyngaarden's concerns by issuing a moratorium on the use of fetal tissue in federally funded transplantation research until NIH could convene a panel to deliberate the issue and offer recommendations.
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Society's Choices: Social and Ethical Decision Making in Biomedicine only because of weak governmental support for such research but also because of the willingness of NRLC and other antiabortion groups to engage in public protests and threaten boycotts if they do proceed with such research. The history of the development and distribution of RU486 in France confirms that these fears of reprisal are well founded. Because many drug companies are unwilling to become the target of controversial protests, they will avoid areas of research that may provoke such action. In the case of RU-486, and in the development of contraceptive technology in general, the grassroots antiabortion movement thus far has been largely successful in its goal (Charo, 1991). Community Prevention Sometimes entire communities (whether geographic, ethnic, or cultural) respond to the changes brought about by technological advances. The response of communities has been variable: weaker for general health initiatives, but often stronger for specific initiatives such as screening for genetic disease. Success in the latter enterprise has also varied widely depending on the particular community and the strategies of the agencies that initiate and organize the screening. In general, however, large-scale community-based health education and intervention programs-in such areas as heart disease, nutrition, smoking, and drugs-have either not worked or worked only within certain limited class, educational, cultural, and racially or ethnically distinct community segments. Few have succeeded in effecting lasting changes in health behavior (Mechanic, 1990, 1992). Their failure is increasingly recognized as a function of treating health behavior as an individual rather than a social and cultural phenomenon (Mechanic, 1990; Syme and Alcalay, 1982). One notable exception is the recent series of efforts to curb smoking by stepping up public education and by banning smoking in public places; these initiatives seem to have reduced smoking behavior in many sectors of society. A growing body of research shows that cultural factors are critical to understanding and modifying health-related behavior, including preventive action (Cruickshank and Beevers, 1989; Graham, 1984; Mascie-Taylor, 1993; Strauss, 1991; Helman, 1990; Biersecker et al., 1987; Armstrong, 1989). Assessing Genetic Risks Cultural issues are particularly salient in understanding responses to new genetic knowledge and screening possibilities, in part because genetic disorders, to a greater extent than other health problems, coincide with "risk populations" that are ethnically and racially demarcated. Thus, each disorder may exist in a different cultural context: Americans of African
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Society's Choices: Social and Ethical Decision Making in Biomedicine descent are at greater risk for sickle cell anemia; Americans of European descent are at greater risk for cystic fibrosis; Americans of Ashkenazi Jewish descent are at greater risk for Tay-Sachs disease; Americans of Southern Italian descent are at greater risk for beta-thalassemia (McKusick, 1988). Because genetic disorders are typically located in subsets of populations at greater risk due to ethnic and racial endogamy, because transmission is limited to offspring, and because there are no cures for any of these genetic disorders, the question of who screens whom and for what purpose is potentially charged and culturally loaded. Genetic disorders are experienced not only by individuals and their families, but also simultaneously by risk populations that are culturally distinct, and these populations will have highly variable responses to "their disease." The variability will be linked to their social attributes, including the meaning of a genetic disorder in their respective cultural, racial, or ethnic groups. In the past, many community health interventions have not worked because they have not been articulated with the cultural meanings and constructions which are at the center of people's everyday life priorities (Syme and Alcalay, 1982). For example, important elements of genetic knowledge do penetrate into the popular culture, and people do use genetic explanations to account for maladies and odd traits in their families, but in most cases they do not use genetic information (through testing, screening, counseling) to guide their health-related behaviors. The exceptions to this pattern occur when the larger social context of a genetic disorder becomes either highly politicized, as with sickle cell anemia in the late 1960s, or when a community "takes over and possesses its own genetic disorder," as with Tay-Sachs disease during the early 1970s. With respect to the latter, a community-based carrier screening program was initiated in the greater Baltimore/Washington area in the early 1970s. The program had the support of leading rabbis, and worked with a committee of committed lay people. Brochures from supportive physicians blanketed the Jewish community. Mass mailings and television and radio announcements were also used, all in support of a community-ratified voluntary screening program. Before the program, 98 percent of the Jews in the area that were surveyed had never heard of Tay-Sachs. Within a year, not only were 95 percent of those surveyed aware of the disorder, but thousands volunteered for screening (Stine, 1977). In the first year of the program, 7,000 adults, approximately 10 percent of the total eligible population, were screened (NAS, 1975). One of the key architects of this program, Michael Kaback, perhaps the world's leading specialist on the topic, had this to say about the issue of voluntary versus mandatory screening: An alternative approach, mandatory (or legislated) screening, although easier to implement perhaps, was regarded as unwarranted, unnecessary and ethically unacceptable (Kaback et al., 1974).
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Society's Choices: Social and Ethical Decision Making in Biomedicine The estimated cost of the program was $65,000 to provide equipment, supplies, and personnel. All those screened were asked to contribute $5, and most did so. At-risk couples received counseling, and reports indicate that it was direct, careful, and sensitive (Stine, 1977). The success of the initial Baltimore/Washington project was such that scores of Jewish communities around the United States followed suit and were later joined by Jewish communities in five other countries. By the early 1980s, over 310,000 Jews around the world had been screened voluntarily, leading to the identification of 268 couples in which both partners were carriers. In New York city, Hasidic Jews developed a program, the Chevra Dor Yeshorim program, to deter the marriage of partners who were both carriers of the Tay- Sachs gene (Merz, 1987). The history of screening for sickle cell was very different. Perhaps most significantly, many of the screening programs were developed without adequate consultation and education of the affected communities (IOM, 1994). Little could be offered to high-risk couples once they were identified and safe prenatal diagnosis of sickle cell disease was not possible at the time (as it was for Tay-Sachs). The failure of the Black Panthers (who were among the first to start and favor sickle cell screening) as well as the politically motivated whites, to recognize the technological limitations made the experience of sickle cell screening a very negative one for the African American community. Some have also suggested that, while many of those who were managing or recruiting for these screening programs were doing so for health and medical reasons, a sizeable proportion came from community-based organizations that had a political agenda, including urban poverty programs and methadone clinics (Duster, 1990). Rationalizing Health Care Priorities One of the side effects of advances in biomedicine has been skyrocketing health care costs, particularly of the elderly, premature infants, and those with rare disorders. In contrast, preventive medicine has sometimes gotten short shrift, despite the demonstrable cost savings to society. This situation has led to several attempts around the nation to ''rationalize" the allocation of health care. The most famous case has been the work of the Oregon Health Services Commission, which expanded the notion of community responses to include well-organized, focused, volunteer-led group discussion of vital health care issues. The higher-level initiative brought together citizens from different geographical, socioeconomic, and cultural communities. In the mid-1980s, Oregon was faced with a series of very difficult decisions about the provision of transplants for poor children. The cost for one liver transplant was so high that the same amount of money could
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Society's Choices: Social and Ethical Decision Making in Biomedicine provide prenatal care for poor women in the state for almost a year. As a result, Oregon ended funding for soft-tissue transplants. The rationale was simple enough: that it would be more cost-effective to transfer a projected $1.1 million per year from the transplants to prenatal care (Daniels, 1991). This action initiated fierce debate, but the debate itself provided neither the criteria for ranking health care procedures nor the process that would establish such criteria. It was not clear whether such a project should be entrusted to a group of medical experts, elected officials, the general public, or some combination thereof. The solution was a major, statewide grassroots effort. Oregon Health Decisions, a private, nonprofit community educational group, sponsored citizen meetings throughout the state, encouraging serious thought about the proper allocation of Medicaid dollars through carefully led group discussions centering on specific difficult medical cases (Crawshaw et al., 1985; Garland, 1992; OTA, 1992b). The values under girding a desirable health care system were enumerated by citizens, and included equity, quality of life, cost, functional independence, and community compassion (Garland and Hasnain, 1990). A summary document set forth these and other principles, one of which was that the poor should be guaranteed access to basic health care services, even if it meant that the range of services available to that same group had to be restricted. Thus, citizens favored the breadth of service provision (minimal services to many) over the depth of service provision (extensive services to a few). Because these fundamental principles were arrived at through an open and democratic process, they achieved a certain legitimacy that might not have been earned by alternative approaches (Welch and Dixon, 1991). The information provided by these discussions and the results of a parliamentary debate and vote taken by citizens chosen from these statewide discussion groups was part of the information used by the 11-member Oregon Health Services Commission to guide the ranking of health care services (Klevit et al., 1991). In early May of 1990, the commission published a list of health care services, with each assigned a different level of priority; coverage would be restricted to those conditions assigned a high priority (Hadorn, 1991). The Oregon experience has generated considerable debate and controversy, in part because of particular rankings but primarily because it highlights the essential and enduring conflict between individual and collective interests. As health care is increasingly viewed as an issue in the public domain, this conflict-between expensive procedures to save the lives of a few and inexpensive preventive measures to save the lives (or improve the quality of life) of the many-will increase. Another set of issues raised by citizen-sponsored health forums in Oregon and other states and regions (e.g., California's Orange County, Hawaii, Maine, Washington, Idaho) is that of participatory democracy and its role in the allocation of scarce
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Society's Choices: Social and Ethical Decision Making in Biomedicine health resources, including the use and/or restriction of biomedical technologies (Jennings, 1988). While political scientists have long argued that apathy pervades the democratic political arena (at least in the United States), this indifference has not been evident in the citizen-sponsored health forums (Jennings, 1993). On the contrary, citizens have been energized and active in these efforts, with minimal outside encouragement and no apparent rewards for their involvement other than the intrinsic satisfaction of participation. There was much variation among the states in their approach to these forums, but their successes had several critical elements in common: building a base of community support by utilizing existing community groups and recognized leaders; holding forums carefully structured to allow open discussion of competing views; relying on motivated, trained volunteers; and channeling the enthusiasm surrounding the discussions into constructive action (Jennings, 1988). The success of these efforts suggests that true participatory democracy may play a unique and vibrant role in health care reform and practice. Not only does the process itself provide satisfaction to participants, it also confers legitimacy upon the decisions reached. Moreover, because biomedical advances are an integral part of the discussions concerning the allocation of health care, these forums set the stage for greater citizen monitoring of and influence in the development and use of biomedical technologies. It is critical to note that these citizen efforts, while fruitful, are not without their limitations. Those who participated in these community discussions were more likely to be white, affluent, and better-educated than most Oregon residents. In some instances more than 50 percent of participants were health professionals. Only 9.4 percent of participants were persons without insurance. Given that the uninsured constitute 16 percent of Oregon's population, it is clear that this group was underrepresented. Medicaid recipients, too, were seriously underrepresented (Daniels, 1991). Thus, those least likely to attend these meetings-the poor, underemployed, elderly, minorities, and Medicaid recipients-were those most likely to be seriously affected by any rationing plan developed as part of health care reform. Without the input of these groups, the ultimate validity of such citizen proposals is seriously undermined. Nearly every public issue requires moral judgment in its resolution. For some issues, however, consideration of moral ideas such as dignity, freedom, rights, justice, respect, and equality are especially critical to resolution. Scientific and social changes stemming from developments in biomedicine have raised such issues. These changes have exerted particular
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Society's Choices: Social and Ethical Decision Making in Biomedicine pressure on deep-rooted moral ideas acquired through experiences with one's family, church, and country, and have thus presented society with complex social and ethical quandaries. As we have seen in this chapter, debate about these quandaries is occurring in many places and in many ways throughout our society. Some of the debate has been conducted in an undisciplined fashion, in which the interests of particular interests groups have dominated. More constructively, however, the debate has involved open, informed, and impartial discussion, mutual respect, and rational moral deliberation. Given the impending changes in health care and the promise of continued scientific development, it will be important to ensure that there are places where this sort of deliberation can continue to take place so that the storm of debate can be picked up, channeled, made comprehensible, and perhaps even brought to bear on long-term solutions like the restructuring of institutions and laws. REFERENCES Abram, M.B., and Wolf, S.M. 1984. Public involvement in medical ethics: A model for government action. New England Journal of Medicine 310:627-632. Altman, L.K. 1993. Fatal drug trial raises questions about "informed consent." New York Times (Oct. 5):C3. American College of Obstetricians and Gynecologists (ACOG). 1990. Ethical Issues in Surrogate Motherhood Committee on Ethics Opinion Number 88. Washington, D.C.: ACOG. ACOG. 1991. News Release: New Board to Monitor Preembryo and Fetal Tissue Research Announced (4 September). Washington, D.C.: ACOG. ACOG. 1992. List of Committee Opinions (December). Washington, D.C.: ACOG Resource Center. American College of Physicians (ACP). 1992. American College of Physicians Ethics Manual, Third Edition. Annals of Internal Medicine 117:947-960. American Medical Association (AMA). 1981. Guidelines for the determination of death: Report of Medical Consultants on the diagnosis death to the President's Commission. Journal of the American Medical Association 246(19):2184-2186. AMA. 1992a. Code of Medical Ethics: Annotated Current Opinions. Chicago, IL: AMA. AMA. 1992b. Code of Medical Ethics: Reports of the Ethical and Judicial Affairs of the American Medical Association. Vol. 3, No. 1 (January). Chicago, IL: AMA. American Thoracic Society (ATS). 1991. Withholding and withdrawing life sustaining therapy. American Review of Respiratory Diseases 144:726-731. Appelbaum, P.S., Roth, L.H., Lidz, C.W., Benson, P., and Winslade, W. 1987. False hopes and best data: Consent to research and the therapeutic misconception. Hastings Center Report 17:20-24. Armstrong, D. 1989. An Outline of Sociology As Applied to Medicine. Third Edition. London: Wright. Bellah, R.N., Madsen, R., Sullivan, W.M., Swidler, A., and Tipton, S.M. 1991. The Good Society. New York: Alfred A. Knopf. Biersecker, et al. 1987. Strategies in genetic counseling: Religious, cultural, and ethnic influences on the counseling process. March of Dimes Original article series, March of Dimes Birth Defects: Vol. 23, No. 6.
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Society's Choices: Social and Ethical Decision Making in Biomedicine OTA. 1984a. Human Gene Therapy: A Background Paper. Washington, D.C.: U.S. Government Printing Office. OTA. 1984b. Impacts of Neuroscience. Washington, D.C.: U.S. Government Printing Office. OTA. 1985a. Reproductive Health Hazards in the Workplace. Washington, D.C.: U.S. Government Printing Office. OTA. 1985b. Technology and Aging in America Washington, D.C.: U.S. Government Printing Office. OTA. 1986. Alternatives to Animal Use in Research, Testing, and Education. Washington, D.C.: U.S. Government Printing Office. OTA. 1987a. Life-Sustaining Technologies and the Elderly. Washington, D.C.: U.S. Government Printing Office. OTA. 1987b. New Developments in Biotechnology, 1. Ownership of Human Tissues and Cells-Special Report. Washington, D.C.: U.S. Government Printing Office. OTA. 1987c. New Developments in Biotechnology, 2. Public Perceptions of Biotechnology-Background Paper. Washington, D.C.: U.S. Government Printing Office . OTA. 1988a. Infertility: Medical and Social Choices. Washington, D.C.: U.S. Government Printing Office. OTA. 1988b. Mapping Our Genes-Genome Projects: How Big? How Fast? Washington, D.C.: U.S. Government Printing Office. OTA. 1988c. New Developments in Biotechnology, 4. U.S. Investment in Biotechnology. Washington, D.C.: U.S. Government Printing Office. OTA. 1989. New Developments in Biotechnology, 5. Patenting Life. Washington, D.C.: U.S. Government Printing Office. OTA. 1990. Neural Grafting: Repairing the Brain and Spinal Cord. Washington, D.C.: U.S. Government Printing Office. OTA. 1992a. Cystic Fibrosis and DNA Tests: Implications of Carrier Screening. Washington, D.C.: U.S. Government Printing Office. OTA. 1992b. Summary: Evaluation of the Oregon Medicaid Proposal Washington, D.C.: U.S. Government Printing Office. OTA. 1993. Biomedical Ethics in U.S. Public Policy. Washington, D.C.: U.S. Government Printing Office. Pan American Health Organization (PAHO). 1992. Progress Report on the Establishment of the Pan American Institute of Bioethics in Chile. SPP19/5, 9 November. Washington, D.C.: PAHO. Presbyterian Church, U.S.A. 1988. Life Abundant: Values, Choices, and Health Care. The Responsibility and Role of the Presbyterian Church. Louisville, KY: Presbyterian Church, (USA) President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (President's Commission). 1981a. Defining Death. Washington, D.C.: U.S. Government Printing Office. President's Commission. 1981b. Whistleblowing in Biomedical Research. Washington, D.C.: U.S. Government Printing Office. President's Commission. 1982a. Making Health Care Decisions. Washington, D.C.: U.S. Government Printing Office. President's Commission. 1982b. Splicing Life. Washington, D.C.: U.S. Government Printing Office. President's Commission. 1983a. Deciding to Forego Life-Sustaining Treatment. Washington, D.C.: U.S. Government Printing Office. President's Commission. 1983b. Screening and Counseling for Genetic Conditions. Washington, D.C.: U.S. Government Printing Office. President's Commission. 1983c. Securing Access to Health Care. Washington, D.C.: U.S. Government Printing Office.
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Representative terms from entire chapter: