AIDS, Ethics, and Activism: Institutional Encounters in the Epidemic's First Decade

RONALD BAYER, Ph.D.

Professor, Columbia University School of Public Health

It is an extraordinary fact that no medical dimension of the epidemic of HIV infection has escaped ethical scrutiny. Among the issues that have drawn attention are: the duty of physicians to care for those who are in need,1 the limits and significance of medical confidentiality, 2 the obligation to seek informed consent before testing and commencing treatment,3 the functions of counseling infected individuals about their duties to partners4 and of assisting women who are infected as they are compelled to make reproductive decisions,5 the clash between the canons of research and the canons of care,6 the limits of acceptable underwriting by insurance companies,7 and, finally, the rights of individuals with costly medical conditions to emigrate. 8

Despite the extraordinary context of the epidemic during the past decade, what is striking about the issues that have been pressed to the fore is that they are not new. They are subjects that have drawn the attention of ethicists and humanists over the past two decades as they have considered the role of medicine in society. What is new is the intensity of the discussion, the broad participatory nature of the debate, the political forces called into play, the demands their representatives have made, and the solutions they have sought to impose.

It is that political context that has given definition to the role ethicists have sought to assume in shaping policy on AIDS; it is that political context that has fostered an unusual series of institutional efforts to engage activists in the process of establishing guidelines for AIDS policy. What was unique about these efforts was not that those who spoke on behalf of the vulner-



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Society's Choices: Social and Ethical Decision Making in Biomedicine AIDS, Ethics, and Activism: Institutional Encounters in the Epidemic's First Decade RONALD BAYER, Ph.D. Professor, Columbia University School of Public Health It is an extraordinary fact that no medical dimension of the epidemic of HIV infection has escaped ethical scrutiny. Among the issues that have drawn attention are: the duty of physicians to care for those who are in need,1 the limits and significance of medical confidentiality, 2 the obligation to seek informed consent before testing and commencing treatment,3 the functions of counseling infected individuals about their duties to partners4 and of assisting women who are infected as they are compelled to make reproductive decisions,5 the clash between the canons of research and the canons of care,6 the limits of acceptable underwriting by insurance companies,7 and, finally, the rights of individuals with costly medical conditions to emigrate. 8 Despite the extraordinary context of the epidemic during the past decade, what is striking about the issues that have been pressed to the fore is that they are not new. They are subjects that have drawn the attention of ethicists and humanists over the past two decades as they have considered the role of medicine in society. What is new is the intensity of the discussion, the broad participatory nature of the debate, the political forces called into play, the demands their representatives have made, and the solutions they have sought to impose. It is that political context that has given definition to the role ethicists have sought to assume in shaping policy on AIDS; it is that political context that has fostered an unusual series of institutional efforts to engage activists in the process of establishing guidelines for AIDS policy. What was unique about these efforts was not that those who spoke on behalf of the vulner-

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Society's Choices: Social and Ethical Decision Making in Biomedicine able were engaged at some level, but rather that representatives of vulnerable populations were sought out as collaborators. In the first years of the epidemic this process was facilitated by the existence of a politically organized, sophisticated gay community with the professional and intellectual resources that were crucial for the process of collaboration. It was the political strength and potential influence of the gay community and the widespread recognition that effective AIDS policy would require its involvement that necessitated an effort to engage it in a collaborative process. In this paper I would like to examine the role of consultation between ethicists and those at risk for HIV infection in confronting a series of critical policy questions raised by the AIDS epidemic, each of which entailed a potential clash over the interests of privacy and individual rights on the one hand and communal well-being on the other. Five such instances will be examined: the development of guidelines for the protection of the subjects of epidemiological research, 1984; the development of guidelines for HIV screening, 1986; the development of policy options on testing of pregnant women and newborns, 1990; the development of a consensus policy on clinical research, 1991; policy recommendations for the control of tuberculosis, 1992.* CREATING GUIDELINES FOR CONFIDENTIALITY IN RESEARCH ON AIDS That the debate over bathhouse closure, with its implications for restrictions on gay sexual behavior, and the relevance of the public health power of quarantine to the control of AIDS would have directly engaged gay political leaders is not surprising. More unusual was their close and watchful involvement in the conduct of public and private research into the etiology, course, and epidemiology of AIDS even before HIV was identified. Fear of being labeled, of being incarcerated, and of being deprived of access to employment and insurance marked the tension between the representatives of the gay community concerned with privacy and researchers who asserted that the public health required the conduct of epidemiological studies based upon the most intimate details about AIDS patients' lives and identities. The conflict arose early as the Centers for Disease Control sought the names of AIDS patients reported to public health authorities throughout the country. Recognizing the critical importance of longitudinal studies to a broad research program, gay leaders were nevertheless fearful that providing federal health officials with such data would *   In all but the effort to draft recommendations on the testing of pregnant women and newborns, I was a direct project participant. In the projects on epidemiological research, HIV screening, and tuberculosis, I was a project co-director. Thus this paper relies on and has all the strengths and weaknesses of a study based on participant observation.

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Society's Choices: Social and Ethical Decision Making in Biomedicine create the circumstances for the deprivation of the civil rights of gay men, intravenous drug users, and undocumented aliens. For them, the technical requirements of research had to be viewed within a broad political and ethical context. How much did federal researchers need to know? Could codes be substituted for names? Were codes inviolable? Could the CDC's professional scientists be trusted to protect the confidentiality of their data? What were the links between public health researchers and public health enforcers? These were the questions that proved so troublesome. Doubts about the capacity or willingness of federal researchers to protect the privacy interests of AIDS patients came from many sources. The commissioner of health in the District of Columbia thus stated: I wouldn't trust the CDC one moment not to give up to the FBI, the CIA, or the Social Security Administration. The CDC is a federal agency. You and I both know that federal agencies do exchange information, and they will always do that on what they understand to be an appropriate need-to know basis. And they will not consider that a breach of confidentiality. 9 Virginia Apuzzo, executive director of the National Gay Task Force, underscored the social context of the confidentiality debate: In this country we [gays] are illegal in half of the states. We can't serve in the armed forces, we can't raise our own kids in many states, and we sure as hell can't teach other people's kids. When you tell us you're interested in our social security numbers, when we know we are not permitted to have security clearance, we would . . . be naive, at best, not to ask "What will you do with the information? Can we trust you enough?"10 The dilemma posed for gay leaders was pinpointed by Jeff Levi of the National Gay Task Force: "We could not be more interested in the gathering of accurate information about AIDS, but we also firmly believe that reporting mechanisms must guarantee confidentiality." 11 While some believed that no tension existed between the imposition of ironclad protections and the conduct of epidemiological research, others felt it imperative to note that, while it was possible to strike a compromise position, all such efforts involved trade-offs in the speed and ease with which data could be gathered and subjected to analysis. The New York Native, a gay newspaper, soberly observed: Confidentiality and epidemiology may not be as mutually compatible as some gay leaders would have us think. Confidentiality and epidemiology are matters of tense negotiation, not marriage. We are in a gray area in which abuses on both sides could occur. On the one hand, someone could illegally obtain a list of people with AIDS and try to create havoc. On the other hand, some well-intentioned gay leaders who think that AIDS is primarily a civil liberties issue may be "endangering" research.12

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Society's Choices: Social and Ethical Decision Making in Biomedicine In a remarkable and quite unusual process, all the more striking since it occurred during the conservative Reagan years, representatives of gay organizations entered into a complex set of negotiations over the nature of the confidentiality protections that were to be afforded to AIDS research subjects. Out of this process of negotiation and confrontation, compromises were fashioned for the protection of confidentiality. While some have asserted that the interests of public health were sacrificed, others acknowledged that the volatile setting of AIDS research required such adjustments. A refusal to yield would have produced inadequate or inaccurate reporting. James Allen of the CDC thus noted, ''It clearly is a compromise position, which will make it more difficult to do our work. But if we are not getting reports, we can't do it either."13 It was within this context that the first institutional response to AIDS on the part of those professionally involved with bioethics occurred. In 1982, Daniel Callahan, the director of the Hastings Center, was called by Dr. Mathilde Krim (a member of the Center's board of directors and among the researchers first concerned about the emerging epidemic) to ask him to send a representative to a meeting at the New York City Department of Health that was to discuss the issue of confidentiality and epidemiological research. More specifically, the meeting was to discuss the question of the reporting of AIDS cases by name to the Centers for Disease Control. It was as a result of attendance at that session that Carol Levine, editor of the Hastings Center Report and managing editor of IRB: A Review of Human Subjects Research, became engaged in the complex set of questions being posed by the new disease. Issues of confidentiality and the ethics of research were not new to the Hastings Center, and so it seemed only a natural extension of its institutional mission to confront these questions. Through the efforts of Dr. Krim, the Center was able to receive a small grant from the Charles A. Dana Foundation to undertake its work. This was the first private foundation grant to support work on AIDS in the United States. From its very inception, the project on confidentiality, which lasted for approximately one year (1983-1984), was marked by the unique sensitivities that were to characterize work on ethical issues raised by the AIDS epidemic. In addition to experts on the ethics and law of human subjects research, public health representatives, and specialists on civil liberties, the group created to examine the question of confidentiality and research included representatives of the gay community. A physician who was among the first to seek a cure for those with AIDS, a patient of his who had early emerged as a spokesperson for people with AIDS, representatives from the Lambda Legal Defense and Education Fund, and the National Gay Task Force were all involved. Additionally, since Haitians were at that

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Society's Choices: Social and Ethical Decision Making in Biomedicine time thought to be at increased risk, efforts were made to engage representatives of that community. Over the period of several months when the group met, discussions were often spirited, revealing the depths of suspicion on the part of those who were at risk for both the new disease and breaches of confidentiality, as well as the impatience that could sometimes characterize those committed to the efficient conduct of research. By design the discussions sought to underscore the points of consensus as well as to make manifest the points of disagreement. As a matter of principle, it appeared critical to the project's directors to avoid language that would mask the differences with well-meaning banalities. The guidelines, broadly agreed to by the group and endorsed by much larger constituencies of experts on ethics as well as by representatives of the gay community, were published at the end of 1984. Any investigation involving a possibly communicable disease poses a tension between an individual's desire to control personal information and the desire of others to have access to that information. Although this tension is not unique to AIDS, it is particularly sharply drawn in this case because those groups that have been identified as at high risk are also highly vulnerable socially, economically, and politically. Because in the early 1980s so much was unknown about AIDS, researchers believed they had to explore many intimate aspects of an individual's medical, social, and behavioral history and had to keep these data for an extended period. Investigators had to seek information that revealed, for example, that a subject had engaged in homosexual or other sexual practices that are illegal in many states and are subject to social stigma; had injected drugs obtained illegally; had engaged in criminal activities, such as prostitution; or had entered the country illegally. The guidelines thus argued: Furthermore, disclosure of a diagnosis of AIDS-or perhaps even involvement in AIDS research-carries a stigma that can adversely affect a person's interests socially, politically, and economically. Potential subjects, either individually or through organizations representing their interests, have sought recognition of these risks and assurances that appropriate measures will be taken to protect their privacy. For these reasons we believe that special guidelines are necessary for AIDS research. 14 Clearly the guidelines embraced the concerns of the vulnerable. Despite a remarkable degree of consensus on the need to embrace confidentiality protections, to prevent the misuse of research data, and to employ personal identifiers only when critical to the task of linking research records in longitudinal studies, disagreement persisted on the topic of whether social security numbers should be used in AIDS research. For the advocates of such identifiers, they presented the greatest potential for matching

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Society's Choices: Social and Ethical Decision Making in Biomedicine data sets; for those who opposed their use, they posed the greatest threat to confidentiality. Recognizing the prospect of an ever-expanding series of questions posed by research into AIDS, the guidelines proposed the creation of a national board that would consider such matters. Although never acted upon, this recommendation reflected the emerging commitment to a broad consultative model, which would include representatives of the communities most at risk for AIDS, for conducting work on the ethical issues posed by the AIDS epidemic. It was this model of collaboration that was to inform the next major undertaking of the Hastings Center as it confronted the question of the tension between public health and civil liberties in the context of the AIDS epidemic. With support from the recently organized AIDS Medical Foundation (later to be called the American Foundation for AIDS Research) and a number of small liberal foundations, a much larger and more ambitious project commenced in 1985. It took as its agenda the exploration of the fundamentals of public health in light of contemporary ethical and constitutional standards for the limitation of the powers of the state. Reflecting of its broader scope, the project brought together leaders from the national gay community, health officials from the epidemic's epicenters (New York, San Francisco), and experts on ethics, law, and history. For the project's organizers the involvement of representatives of the gay community was critical not only because they believed it necessary to hear their opinions. As important, it was necessary to learn from those who could uniquely convey the insights, fears, and needs of those most at risk for AIDS. Not long after it began its discussions the Hastings group elected to focus its work on the ethical challenges posed by the prospect of serological screening for HIV infection. Here, too, the Center was able to bring its long-time concern with the ethics of population screening to bear on the special problems posed by AIDS. THE ETHICS OF SCREENING FOR HIV From the outset the test developed to detect antibody to the AIDS virus-and first used on a broad scale in blood banking-was mired in controversy. Uncertainty about the significance of the test's findings and about its quality and accuracy provided the technical substrate of disputes that inevitably took on a political character, since issues of privacy, communal health, social and economic discrimination, coercion, and liberty were always involved. For those who feared that public anxiety about AIDS would turn individuals identified as infected with the AIDS virus into targets of irrational social policy and practice, the antibody test became emblematic of the most threatening prospect in the community's response to

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Society's Choices: Social and Ethical Decision Making in Biomedicine AIDS. Vigorous encouragement of testing would ineluctably lead to mandatory approaches as the impatient appealed to the authoritarian history of public health. Since confidentiality would not be preserved, the consequences would be stigmatization and deprivation of the right to work, go to school, and obtain insurance. Most ominously, the identification of the infected could threaten freedom itself. No marginal advance of the public health, those who argued against wide-scale testing asserted, could warrant such a catastrophic array of personal burdens. "Don't take the test" became the rallying cry of the leaders of the gay community. In an editorial, the New York Native wrote: "No gay or bisexual man should allow his blood to be tested..... The meaning of the test remains completely unknown. Scientists and physicians agree that a positive test result cannot be used to diagnose anything." What was far from uncertain, however, was the personal anxiety and socioeconomic oppression that [would] result from the existence of a record of a blood test result .... Will test results be used to identify the sexual orientation of millions of Americans? Will a list of names be made? How can such information be kept confidential? Who will be able to keep this list out of the hands of insurance companies, employers, landlords, and the government itself? What was critical was for gay and bisexual men to modify their behaviors in order to protect their own health and that of their sexual partners. For those purposes, what role could such an ambiguous and potentially dangerous test play? "If you test positive, will you act with any more wisdom or concern than if you test negative? Will you be less or more conscious of following safe and health sexual guidelines?" 15 Those who believed that the identification of the infected or potentially infected provided an opportunity for strategically targeted measures designed to modify risky behavior saw in the test a great opportunity. Some advocates of testing, opposed to the use of coercion and attentive to matters of privacy so forcefully articulated by gay groups, stressed the importance of preserving the right of each individual to determine whether to be tested, protecting the confidentiality of tests results, and guaranteeing the social and economic rights of those whose test results revealed infection with HIV. Their was a posture that sought to demonstrate the compatibility of an aggressive defense of the public health with a commitment to the privacy and social interests of the infected and those at risk of infection. The stress on voluntariness was reflected in the early policy statements of the national organization of state public health officials, the Association of State and Territorial Health Officials (ASTHO). In August 1985, ASTHO convened a national consensus conference devoted to the antibody test. On this occasion, earlier doubts about the

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Society's Choices: Social and Ethical Decision Making in Biomedicine test, its use, and what recommendations should be made to those who tested positive had all but gone. ASTHO's published report declared: "With less than six months' experience, it is clear that [the tests] are more than simply measures to screen donated blood. Their high sensitivity, specificity, and in higher prevalence groups, their predictive powers for exposure to HTLV-III will substantially assist the disease prevention effort. When properly used, test information may also enhance the education efforts which remain for now the principal intervention to prevent HTLV-III transmission."16 But an increased reliance on voluntary testing was predicated on the capacity to protect the confidentiality of test results. Acknowledging the skepticism of the gay community-indeed, at least one representative of the gay community was involved in the process of drafting the ASTHO report-the document stressed the importance of convincing those at risk that all measures would be taken to preclude the unwarranted disclosure of test findings."17 The defense of confidentiality was not antithetical to the protection of public health; it provided the condition for the required interventions. There were, of course, those who rejected the emphasis on voluntariness. Some argued for "routine screening." Others asserted that the defense of the public health required coercion and limitations on the liberty of the infected. For them screening on a compulsory basis was both necessary and inevitable. Assertions that the public health would not require such efforts merely masked, they argued, the willingness to sacrifice the communal welfare to private interests. The specter of such coercion haunted the discussion of all public health efforts, even the apparently voluntary attempts to facilitate identification of the infected. Ultimately, the debate over testing and other public health measures designed to identify the infected would force a confrontation over which proposed interventions could most effectively contribute to the transformation of the private behaviors linked to the spread of HIV infection and the development of a public culture that would encourage and reinforce such changes. Bold moves might advance the cause of public health in the face of the AIDS epidemic, or they might subvert that very cause. Caution might represent wisdom or a failure to grasp the opportunity to affect the pattern of HIV transmission. Appeals to the history of public health would inform the perspectives of those who encountered each other as antagonists; so too would profound differences over the weight to be given to communal well-being and personal liberty. Empirical considerations, historical perspectives, and philosophical commitments each thus helped to shape the fractious struggles that characterized the politics of identification. Given the profound gulf that separated those who believed that HIV testing was crucial to the strategy of preventing the spread of a lethal

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Society's Choices: Social and Ethical Decision Making in Biomedicine infection and those who saw in such testing not only a misdirection of public efforts but a potentially dangerous approach to the epidemic, it would have been futile in 1986 to seek a common ground on the question of the place of testing in the campaign against AIDS. What was possible, however, was to provide the ethical foundations for an approach that rejected mandatory screening. Relying on the principles first enunciated in The Belmont Report, as well as on constitutional principles, limiting the exercise of state power in the name of the public health and welfare, it was possible for the directors of the Hastings project to provide a clear enunciation of the case for voluntary HIV testing. More specifically the guidelines, published in the Journal of the American Medical Association, provided a response to the concerns voiced by gay leaders. Arguments for the protection of confidentiality and against discrimination were clearly asserted. So too was the necessity of informed consent with pretest counseling-requirements that were to become the platform of those committed to liberal AIDS policies. The Hastings Center authors were unencumbered by a commitment to produce a consensus report. Nevertheless, they worked to elicit broad support for the guidelines from their working group. Drafts were repeatedly circulated. Comments and criticisms were considered carefully. It was, however, the relative independence of the guidelines' authors that made it possible for them to take a rather striking position in favor of wide scale voluntary testing and against the moral right of those who had been tested not to know their status. "We conclude," stated the guidelines, "that given the disastrous consequences of HIV infection and the imperative of the harm principle, those who are infected have an obligation to know their antibody status, to inform their sexual partners, and to modify their behavior."18 As a consequence those who had elected to undergo testing had no moral claim to shield themselves from those results. But that posture, in defense of what was perceived to be a public health imperative, was for the Hastings group intimately linked to the defense of the liberal values that inspired the voluntarist strategy for dealing with AIDS. Thus the guidelines concluded: We believe that the greatest hope for stopping the spread of HIV infection lies in the voluntary cooperation of those at higher risk-their willingness to undergo testing and to alter their personal behavior and goals in the interests of the community. But we can expect this voluntary cooperation-in some cases, sacrifice-only if the legitimate interests of these groups and individuals in being protected from discrimination are heeded by legislators, professionals, and the public. Yet voluntary testing is not enough. We must proceed with vigorous research and educational efforts to eliminate both the scourge of AIDS and the social havoc that has accompanied it.

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Society's Choices: Social and Ethical Decision Making in Biomedicine TESTING PREGNANT WOMEN AND NEWBORNS The approach to consultation with those at risk adopted by the Working Group on HIV Testing of Pregnant Women and Newborns, organized under the aegis of the Johns Hopkins University School of Public Health, was more conventional than that which had been adopted by the Hastings Center. Described by its chair, Dr. Ruth Faden, as a "self-appointed group," it included a range of experts in public health, law, ethics, and policy drawn from the Hopkins community, the Georgetown Law Center, and the Kennedy Institute of Ethics.19 Funded by the American Foundation for AIDS Research, the group undertook, through a series of meetings in the late 1980s, an examination of a range of complex screening issues involving women and newborns. Given the epidemiology of HIV infection in women, this was a project that had to confront a set of questions with enormous implications for women of color. Like the Hastings Center group, the Working Group on HIV Testing of Pregnant Women and Newborns demonstrated a singular commitment to the privacy rights of those who might be the target of screening and efforts at prevention. Most critically, the group sought to underscore its commitment to the reproductive rights of those with HIV: ". . we reject the implementation of counseling and screening, policies that interfere with women's reproductive freedom or that result in the unfair stigmatization of vulnerable social groups."20 Incorporating the well-established ethical principles that inform genetic counseling, the Working Group explicitly rejected efforts to discourage pregnancy on the part of HIV-infected women. In so doing the Working Group had adopted a position long advocated by feminists but one that stood in sharp contrast to the formal policy of the Centers for Disease Control and many state health departments which urged HIV-infected women to consider the postponement of pregnancy. Even more striking was the position adopted by the Working Group on the question of whether information and screening resources should be targeted to those communities at greatest risk for HIV infection-poor inner-city communities of color. Here the Working Group was initially divided, with some favoring such targeting as the rational application of public health principles and others believing that programs that targeted poor black and Latina women would be stigmatizing. On this topic the group was ultimately strongly influenced by its one-time consultation with representatives of a number of organizations representing the interests of African American and Latina women. It was this encounter, which occurred as part of a day long session with representatives of communities at risk as well as public health officials, that led the Working Group to define as "unjust" any program that either implicitly or explicitly targeted women of color and to state that, "to add

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Society's Choices: Social and Ethical Decision Making in Biomedicine the stigma of AIDS contagion to poor women of color is to further harm a group of persons who are already unfairly disadvantaged."21 In considering the unique impact that the one-time consultation had played, the Working Group chair, Dr. Faden, has lamented the fact that limited resources had not permitted a more systematic and ongoing involvement of those at risk-the poor women themselves as well as the advocacy groups that spoke on their behalf. Nevertheless, even the modest consultation that did occur represented more than had been undertaken in the past. Was it AIDS itself that had pressed Faden and her group in a new direction? "Probably," she has said. But as important was the commitment to developing a consensus, one that was "in tune" with the communities of color affected by the threat of AIDS. Going beyond the consultative efforts of both the Hastings and the Hopkins groups were there those which were undertaken in response to the challenge posed by AIDS to the process of new drug development in the United States. Here the search for a new consensus necessitated a level of collaboration that was unprecedented. THE ETHICS OF DRUG TRIALS In the mid-1970s, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued The Belmont Report, which codified a set of ethical principles that sought to inform the work of researchers. Those norms provided the foundations for regulations subsequently enacted by the Department of Health and Human Services and the Food and Drug Administration. At the core of those guidelines was the radical distinction between research designed to produce socially necessary, generalizable knowledge and therapy designed to benefit individuals. Against the former, The Belmont Report held, individual especially those who are socially vulnerable-need protection against conscription. AIDS has forced a reconsideration of this formulation. There had been challenges to federal protections in the past, for example, when prisoners at Jackson State Prison in Michigan demanded that they be permitted to serve as research subjects because participation provided them with social advantages. But the HIV epidemic has provided the circumstances for the emergence of a broad and potent political movement that has sought to reshape radically the conditions under which research is undertaken. The role of the randomized clinical trial, the importance of placebo controls, the centrality of academic research institutions, the dominance of scientists over subjects, the sharp distinction between research and therapy, and the protectionist ethos of The Belmont Report have all been brought into question.

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Society's Choices: Social and Ethical Decision Making in Biomedicine Although scholars concerned with the methodological demands of sound research and ethicists committed to the protection of research subjects have played a crucial role in the ensuing discussions, both as defenders of the received wisdom and as critics, the debate has been driven by the articulate demands of those most threatened by AIDS. Most prominent have been groups such as the People with AIDS Coalition and ACT-UP, organizations made up primarily of white, gay men. But advocates of women's, children's, and prisoners' rights have also made their voices heard. What has been so stunning, disconcerting to some, and exciting to others has been the rhythm of challenge and response. Rather than the careful exchange of academic arguments, there has been the mobilization of disruptive and effective political protest. The threat of death has hovered over the process. As Carol Levine has noted, "the shortage of proven therapeutic alternatives for AIDS and the belief that trials are, in and of themselves, beneficial have led to the claim that people have a right to be research subjects. This is the exact opposite of the tradition started with Nuremberg-that people have a right not to be research subjects."22 That striking reversal has resulted in a rejection of the model of research conducted at remote academic centers, with restrictive (protective) standards of access, and strict adherence to the "gold standard" of the randomized clinical trial. Blurring the distinction between research and treatment-''A Drug Trial Is Health Care Too"-those insistent on radical reform have sought to open wide the points of entry to new "therapeutic" agents both within and outside of clinical trials; they have demanded that the paternalistic ethical warrant for the protection of the vulnerable from research be replaced by an ethical regime informed by respect for the autonomous choice of potential subjects who could weigh, for themselves, the potential risks and benefits of new treatments for HIV infection. Moreover, the revisionists have demanded a basic reconceptualization of the relationship between researchers and subjects. In place of protocols imposed from above, they have proposed a more egalitarian and democratic model in which negotiation would replace a scientific authority. The reformulation of the ethics of research that has begun under the brutal impact of AIDS has implications that go far beyond the epidemic of HIV disease because the emerging new conceptions and standards could govern the conduct of the entire research enterprise. Furthermore, the role of the carefully controlled clinical trial as providing protection against the wide-scale use of drugs whose safety and efficacy have not yet been proven no longer commands unquestioned respect. Protagonists who have been locked in often acrimonious debate foretell very different consequences of the changing social standards of research. Proponents of a revised ethos hold out the prospect of a new

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Society's Choices: Social and Ethical Decision Making in Biomedicine regime that is both respectful of individual rights and the requirements of good science. Martin Delaney of Project Inform in San Francisco, for example, has stated: Regulatory practices contribute to the failure of science, demean the public good, and tread heavily on our civil liberties.... Scientist and patient alike would be better served by a system that permits life-threatened patients some form of access to the most promising experimental therapies, peacefully coexisting alongside a program of unencumbered clinical research.23 Those who are less sanguine have spoken in a different voice. George Annas has warned that the blurring of the distinction between research and treatment can only harm the desperate: "It is not compassionate to hold out false hope to terminally ill patients so that they spend their last dollars on unproven remedies that they might live longer." 24 Jerome Groopman of New England Deaconess Hospital in Boston has gone further, viewing liberalization as a threat to the research enterprise itself: "If the philosophy is that anyone can decide at any point what drugs he or she wants to take, then you will not be able to do a clinical."25 Here was an issue that raised questions somewhat different from those involved in the confrontation between public health and privacy. Nevertheless, it was an issue that entailed a clash between differing conceptions of the demands of the common good and of the priority that ought to be accorded to those demands. For the American Foundation for AIDS Research (AmFAR), which had been instrumental in funding virtually every effort on AIDS and ethics, the debate over drug trials was of central importance. That Mathilde Krim, AmFAR's founding co-chair, was an early and persistent critic of the research orthodoxies was, of course, a critical contributing factor. But most important, the challenge to the research establishment by AIDS activists made the question of the conduct of research trials a topic that no one concerned about AIDS could ignore. It was the existence of such activism that would fundamentally shape the design of the project funded by AmFAR to examine the issues at hand. The project directors, Carol Levine, Robert Levine, and Nancy Dubler, had long and distinguished records for examining issues involving human experimentation. But for a project that was charged with the responsibility of forging a new consensus on research ethics, one that would "entail a reappraisal of the ethical balance between protecting the rights and welfare of subjects and expanding their options for possibly beneficial but still unproven drugs,"26 it would have been unthinkable to approach the questions without fully involving those who had forced the issue onto the national agenda. And indeed the task force constituted represented the most serious effort to date to develop a fully collaborative relationship between

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Society's Choices: Social and Ethical Decision Making in Biomedicine activists and ethicists. Community-based researchers, members of ACT-UP, representatives of minority communities, as well as lawyers, ethicists, and policymakers, were recruited. That collaboration was especially crucial since the project goal was to develop a consensus document that would serve as a platform for reforming drug trials in the United States. The degree to which the task force was successful in achieving its goal of consensus was in no small part a function of the care and skill of its directors in selecting the participants. "We could have had a total standoff on any issue if there had been non compromisers in the group," said Carol Levine. "We [sought out] people who could hear other points of view and who could accept something less than the full incorporation of their own views and values in a final document." 27 In the process of seeking a "negotiated settlement," it was crucial to lay the foundations for the broad points of agreement, thus moving those questions upon which consensus could not be reached to the margins, no matter how important they were. When finally published in IRB: A Review of Human Subjects Research in 1991, the report, "Building a New Consensus: Ethical Principles and Policies for Clinical Research on HIV/AIDS," reflected agreement on the need to replace the overly protective and paternalistic ethos that had informed the regulation of research and to open wide access to therapeutic trials to those who had previously been excluded or who had faced severe restrictions-women, prisoners, drug users, members of minority groups. Reflecting the political demands of AIDS activists, the consensus not only stressed the critical importance of community consultation but argued that such consultation should not be viewed as a way to obtain acceptance of an already agreed-upon protocol; the task of shaping the protocol itself "must be a partnership." Thus did the process of arriving at a consensus on research through the joint efforts of ethicists and activists produce a recommendation for partnership in the enterprise of investigating new drugs. Despite the spirit of cooperation that animated the process of consensus building, there was one issue that remained intractable: the question of whether research participants were morally obligated to be truthful with investigators on matters of compliance and criteria for inclusion in trials. At stake, in a fundamental way, was the extent to which participants in research trials had obligations to others that could constrain their behavior. Failure to reach consensus thus represented in an acute way the profound tension between a perspective driven by a commitment to the survival interests of individuals with HIV and that which while sympathetic to those interests did not view them as trumping all other concerns. Rather than disguise the clash of perspectives, the consensus statements openly acknowledge them. Those who held that participants had a duty to candor believed that a failure to adhere to such a norm represented a violation of

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Society's Choices: Social and Ethical Decision Making in Biomedicine the trust of the researchers that could "harm the interests of current and future patients because the trial may result in scientifically invalid data and have a negative effect on their care." To others the legacy of injustice in research and the health care system made it difficult to demand compliance from those who viewed access to a drug trial as providing the only access to a potentially lifesaving drug. In the face of this irresolvable conflict the consensus document retreated from the task of making normative statements and instead underscored the prospect for improving candor and compliance if a number of meliorative measures were taken. The experience of preparing the report on drug trials thus revealed both the strengths and limitations of efforts at consensus building between ethicists and activists. Those who believed that consensus was always possible simply did not understand the extent to which unbridgeable ideological differences might surface in the course of joint effort. It was these limitations that would be revealed in 1992 when a task force was constituted to examine the ethical challenges posed by the resurgence of tuberculosis in the face of the AIDS epidemic. PUBLIC HEALTH AND TUBERCULOSIS CONTROL From the mid-1980s on, the century-long decline in the incidence of tuberculosis came to an end. Fueled by a rise in poverty, homelessness, untreated drug addiction, and the crowding of prisons, this stark shift was fundamentally linked to the HIV epidemic. Those who are dually infected with HIV and microbacterium tuberculosis are at sharply increased risk for developing tuberculosis disease. Complicating the epidemiological picture was the dramatic increase in multiple-drug-resistant tuberculosis, the treatment of which involves toxic drugs and is costly, long and often ineffective. The rise in drug-resistant tuberculosis has been attributed to the failure of those who commence treatment to complete the course of therapy. In New York City, only slightly more than half of those who are diagnosed with tuberculosis complete treatment. In that city 20 percent of diagnosed cases are resistant to two or more drugs. Tuberculosis is, of course, not AIDS. It is airborne and can be transmitted through casual contact. It is these factors that provide the biological foundations for the strategy of TB control which is compulsory at its core, standing in marked contrast to the voluntaristic strategy for dealing with HIV. To those whose first extended engagement with the public health challenges posed by a communicable disease was the AIDS epidemic, the resurgence of tuberculosis provoked profound concerns. Given the epidemiology of the tuberculosis epidemic, its relationship to HIV infection, and the fact that it is the most socially marginalized individuals who are typically sick or at risk, there was a danger that the

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Society's Choices: Social and Ethical Decision Making in Biomedicine demands by the public for increased health protections would create a climate within which the rights and interests of those with tuberculosis and HIV would be disregarded. Additionally, there was the potential that the policies created during the first decade of the AIDS epidemic that promoted and protected individual choice and confidentiality and that sought to prevent unwarranted acts of discrimination could be subverted in the name of tuberculosis control.28 Finally, the resurgence of tuberculosis necessitated an examination of the compatibility of the voluntaristic strategy for dealing with HIV and the compulsory tradition of dealing with tuberculosis. These concerns inspired two ethicists (Ronald Bayer and Nancy Dubler) and a physician (Sheldon Landesman) long associated with work on the AIDS epidemic to constitute a working group under the auspices of the United Hospital Fund in New York City, with additional funding by AmFAR. Emboldened by the experience of past working groups that had successfully achieved broad consensus on critical policy issues posed by the HIV epidemic, the three project directors constituted a panel that was built on the model of the first Hastings Center working group on AIDS. It included clinicians, lawyers, philosophers, public health officials and representatives of the gay community. Although an explicit decision was made not to develop a consensus report, every effort was to be made to achieve consensus on all critical issues. When the report Tuberculosis in the 1990s: Ethical, Legal and Policy Issues in Screening, Treatment and the Protection of Those in Congregate Facilities was issued at the end of 1992, it did, in fact, reflect the successful attainment of agreement on a number of issues that the working group had struggled with over time: there was no need to initiate mandatory HIV testing in order to effectively conduct compulsory or routine TB screening; resources should be made available to provide the social and support services necessary to enhance the capacity of the poor, the homeless, the mentally ill, and the drug addicted to comply with their TB treatment; those with HIV infection should not be excluded from work settings where they might be exposed to tuberculosis. Where consensus eluded the group was when it confronted the question of a mandatory system of directly observed therapy for all tuberculosis patients in the postacute phase of treatment. Here the chasm between those whose perspective was informed by a primary commitment to the preventive values became clear. Despite repeated efforts the gap was unbridgeable. In the end two working group members-representatives of the Gay Men's Health Crisis and the Lesbian and Gay Rights Project of the American Civil Liberties Union-refused to sign the report. In summarizing this controversy the authors of the report wrote:

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Society's Choices: Social and Ethical Decision Making in Biomedicine Some have argued that requiring all patients to submit to directly observed therapy is an unacceptable intrusion on privacy and liberty. 29 Why should those who have no prior record of failure to adhere to treatment be subjected to a regime that is appropriate only for those who cannot be trusted to take their medication? Wouldn't such a requirement be overbroad? Wouldn't it represent a violation of the constitutional principle that for each individual the least restrictive alternative should be relied on in pursuing the goals of public health? Opponents of such a requirement also argue that the cost of directly observed therapy in all instances represents a misallocation of scarce public health resources. We recognize that a requirement that all patients undergo directly observed therapy will entail impossible supervision on some patients who might otherwise complete the course of treatment without such oversight. Nevertheless, we believe that the marginal intrusions on privacy and restrictions on autonomy represented by supervised therapy are justified, on balance, by the public health benefits that could be achieved. Given the social costs of noncompliance, the expenditure of resources on mandated directly observed therapy, at least during the initial phase of treatment, clearly would represent a cost-effective approach to tuberculosis control.30 CONCLUSIONS As ethicists have sought to make an impact on the shaping of public health policy in the context of the AIDS epidemic-an undertaking that has perforce required an extension of the principles first developed in the context of the challenges posed by the clinical encounter-they have tended to develop positions most compatible with the political perspectives of those most at risk. In part the ideological content of the work of ethicists during the first decade of the AIDS epidemic reflected their own political identification as American liberals; in part it reflected the extension of the concern for the subordinate party in the clinical encounter that so shaped the development of medical ethics since the late 1960s. Finally, the preeminent place of the values of liberal individualism in contemporary bioethics was critical in forging an identification between those whose professional work centered on bioethics and those most at risk for HIV infection who for historical reasons harbored deep suspicions about the role of the state and its agencies. But the challenges of public health were not completely analogous to those of the clinical setting. After all, the public health authority could be deployed to protect vulnerable communities in a way that was fundamentally different from the paternalistic exercise of physician authority over a non consenting competent adult. It was the concern over the protection of the community-whether involving the advocacy of voluntary HIV testing at a time when gay organi-

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Society's Choices: Social and Ethical Decision Making in Biomedicine zations saw in the test a terrible threat, the protection of the research enterprise from subversion by those who failed to comply with protocols, or the recommendation for universal directly observed therapy for tuberculosis-that the gap between the ideological perspective of bioethicists drawn to the issue of AIDS and the most articulate proponents of the rights of those groups most at risk was manifest. Nevertheless, the lessons of the past decade have made clear that to the extent that bioethics seeks to enter the policy arena there are considerable advantages to open collaborative relationships with activists. In some instances it is only through such collaboration that bioethicists can learn about the complexity of the issues to which they will bring their analytical tools, and can fully appreciate the contextual forces that shape the lives of the individuals who will be affected by particular policy choices. Most important, such collaboration will be enhanced if those selected for various working parties are committed to the possibility and value of compromise. But on some matters it may not be possible to identify such individuals. There are occasions when compromise will be viewed as an unacceptable capitulation to expedience rather than as a virtue. (Needless to say, the unyielding adherence to principle or position may characterize ethicists or activists.) Under such circumstances fruitful collaboration may not be possible. At best it may be possible only to agree to disagree. Fortunately, that was not, for the most part, the case during the first decade of the AIDS epidemic. At a time when national administrations were indifferent, even hostile, to the concerns of those with HIV it was vital for ethicists and activists to find common ground in shaping perspectives that were both humane and effective. That they did so was a singular achievement. NOTES 1.   Zuger, A., and S.H. Miles. 1987. Physicians, AIDS and occupational risk: Historic traditions and ethical obligations. JAMA 258:1924-1928. 2.   Dickens, B. 1989. Confidentiality and the duty to warn. In L. Gostin, ed., AIDS and the Health Care System. New Haven: Yale University Press. 3.   Bayer, R., C. Levine, and S. Wolf. 1986. HIV antibody screening: An ethical framework for evaluating proposed programs. JAMA 256:1768-1774. 4.   Shoeman, F. 1991. AIDS and privacy. In F. Reamer, ed., AIDS and Ethics. New York: Columbia University Press. 5.   Bayer, R. 1991. AIDS and the future of reproductive freedom. In D. Wilkin, D. Nelkin, and S. Paris, eds., A Disease of Society: Cultural and Institutional Responses to AIDS. New York: Cambridge University Press. 6.   Levine, C., N.N. Dubler, and RJ. Levine. 1991. Building a new consensus: Ethical principles and policies for clinical research on HIV/AIDS. IRB: 4 Review of Human Subjects Research 13:1-17. 7.   Oppenheimer, G.M., and R.A. Padgug. 1991. AIDS and the crisis of health insurance. In F. Reamer, ed., AIDS and Ethics. New York: Columbia University Press.

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Society's Choices: Social and Ethical Decision Making in Biomedicine 8.   Gostin, L., P. Cleary, K. Mayer, et al. 1990. Screening immigrants and international travelers for the human immunodeficiency virus. New England Journal of Medicine 322:1743- 1746. 9.   The Washington Post, July 18, 1983, p. 4. 10.   The Washington Post, July 18, 1983. 11.   "'Confidentiality' Issue May Cloud Epidemiologic Studies of AIDS," JAMA, Oct. 21, 1983, p. 1945. 12.   New York Native, Nov. 7-20, 1983. 13.   The Washington Post, July 18, 1983. 14.   IRB: A Review of Human Subjects Research, 1984, 6(6). 15.   New York Native, October 8-21, 1984, 5. 16.   Association of State and Territorial Health Officials, ASTHO Guide to Public Health Practice: HTLVII Antibody Testing and Community Approaches. Washington, D.C.: Public Health Foundation, 1985, 16. 17.   Ibid. 18.   Bayer, R., C. Levine, and S.M. Wolf. 1986. HIV antibody screening: an ethical framework for evaluating proposed programs. JAMA 256:1768-1774. 19.   Interview with Ruth Faden. 20.   Working Group in HIV Testing of Pregnant Women and Newborns. 1990. "HIV Infection, Pregnant Women, and Newborns: A Policy Proposal for Information and Testing." JAMA 264(18). 21.   Working Group on HIV Testing of Pregnant Women and Newborns. 1990. HIV infection, pregnant women, and newborns: a policy proposal for information and testing. JAMA 264:2416-2420. 22.   Levine, C. 1988. Has AIDS changed the ethics of human subjects research. Law, Medicine and Health Care 16:167-173. 23.   Parallel track system defended. 1989. CDC AIDS Weekly. December 11, 3. 24.   Annas, GJ. 1989. Faith, healing, hope and charity at the FDA: The politics of AIDS drug trials. Villanova Law Review 34:771-797. 25.   Parallel track system defended. 1989. CDC AIDS Weekly December 11, 3. 26.   IRB: A Review of Human Subjects Research, 1991, 13(1-2). 27.   Interview with Carol Levine. 28.   Bayer, R. 1991. Private Acts, Social Consequences: AIDS and the Politics of Public Health. New Brunswick, NJ: Rutgers University Press. 29.   Gostin, L. 1993. Controlling the re-emergent tuberculosis epidemic: A fifty-state survey of TB statutes and proposals for reform. JAMA 269:255-261. 30.   Bayer, R., N.N. Dubler and S. Landesman. 1993. The dual epidemics of tuberculosis and AIDS: Ethical and policy issues in screening and treatment. American Journal of Public Health 83:649-654.