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Society's Choices: Social and Ethical Decision Making in Biomedicine 2 The Social Context of Bioethical THE AMERICAN CHARACTER The distinctive history and culture of our society shapes the range, character, and form of social and ethical responses to developments in biomedical technology. U.S. history is replete with examples of stirring moral debates that have mobilized the entire country; current debates over developments in biomedicine are shaped by some of the same forces that molded the great controversies of the past. Our nation was born in rebellion against tyranny to preserve individual liberty; tension between the powers of the state and the rights of the individual has persisted, and it colors the public debate and resolution of major moral issues. In addition, our culture is suffused with an optimistic expectation of progress and change for the better, best exemplified in an unwavering belief in the myth of upward social mobility. Ambivalence about the proper role of government, together with a fervent belief in the power and ultimate triumph of individual efforts, is manifested in a pluralistic approach to political, social, and ethical issues, involving the active participation of numerous and diverse groups and individuals in public discourse. The religious commitments of many of this country's early inhabitants both fostered skepticism about the range of governmental authority and favored governmental sanctions on morality. While moral issues in public policy are often settled at the national level, intense debate may occur at both local and state levels and within scientific, religious, and other communities long before the national debate takes definite shape.
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Society's Choices: Social and Ethical Decision Making in Biomedicine Cases illustrative of this multifaceted approach are found in the history of child labor laws, women's suffrage, prohibition, and the abolition of slavery. For example, in the latter case, citizens engaged in heated debates and formed antislavery societies, newspapers editorialized, churches issued proclamations, and local political bodies took stands, all of which led up to the Civil War and culminated in a national solution. Thus, intense debate at the local and state levels contributed to the formation and acceptance of a central governmental response. The capacities for public debate of ethical issues in our society have expanded and matured within the past few decades. Discussed in this chapter is the overall social and institutional context in which ethical quandaries arise, get debated, and, sometimes, get resolved. We see, for example, that government performs a dual role: on the one hand it formulates policy responses to nationally debated moral quandaries; on the other, it fuels these quandaries through its funding of the research that produces problematic developments. Over time, and in many contexts, Americans have managed to maintain a tenuous balance between the celebration of the individual and responsibility for the community, between market striving and civic sharing, between the private sphere and the public good. Populist political mobilizations have offered one mode for restoring the balance; religious movements have proved to be another potent mechanism for doing the same. The structure, function, and dominant ideologies of the political and religious spheres have been central in shaping public discourse on important moral issues-both spheres reflect key aspects of the American character. The struggle between pluralistic diversity and universal standards has been vivid in both secular and religious American thought. In the political realm, the early colonists demanded to participate in governing their society. The chaos of early participatory politics would echo throughout U.S. history as future generations fought new battles over their place in the political realm. Along with demands for participation came sharp limits to the legitimacy of central authority. A very similar dynamic could be seen in the religious sphere. In contrast to the fixed religious establishments of the old world, Americans witnessed an extraordinary sectarianism, driven by the waves of populist revivalism. Generations of American fundamentalists have, ironically, only added to the multiplicity of sects (Butler, 1990). Ambivalence About Government Given that public power has long been viewed as a threat to individual liberty, the state occupies an unusually ambiguous place in U.S. society. As a result, political discourse has been preoccupied with limiting state authority (Morone, 1990). Even as the modern administrative state began to
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Society's Choices: Social and Ethical Decision Making in Biomedicine take its contemporary form, somewhere between the two Roosevelt administrations, ambivalence remained. For example, Americans developed their social insurance programs far more reluctantly and obliquely than did their European counterparts (Skocpol, 1992). Throughout the twentieth century, new social welfare proposals were greeted with state bashing, threats of looming socialism, and concerns about the erosion of the work ethic. Hartz (1955), in a classic formulation of this ideology, described the result as ''American exceptionalism": ... opposition to the state that weakens every move toward government programs, let alone a class-based politics. New forms of government authority evoke the charge that an overreaching state threatens the people's liberty. Observers of U.S. health care are familiar with this theme. Ambivalence about government has been offered as an explanation for why Americans refused national health insurance long after the rest of the industrialized world had secured it. While this inconsistent reaction to government runs deep in U.S. politics, however, it is often overstated. Other legacies in U.S. political history have offered now familiar visions of a radically different nature-a strong and active state. American distrust of government matters, but it is only part of the story. The Political Process Caution around centralized government is built into U.S. political institutions and celebrated as "checks and balances." Political programs must often pass through the executive branch, both houses of Congress, and other points in the federal bureaucracy; then they must negotiate the various layers of federalism-regions, states, substrate bodies, counties, municipalities-each with its own government, each itself fragmented in a number of ways. Legal matters must also be addressed at nearly every stage. To pass through this gauntlet, proposed programs are typically oversold by their supporters, who promise all kinds of benefits to all kinds of constituencies at the same time that they heavily compromise their propositions. The combination, while often succeeding in finding common ground among many competing interests, is also a well-tested recipe for disappointment. This tangled system of checks and balances is rooted in the Constitution and has been further complicated by succeeding generations of reform. In the vain hope of getting beyond politics, wave after wave of American reformers have organized new agencies designed to be independent, expert, apolitical. Each new "apolitical" reform is quickly bogged down in precisely the politics it was designed to avoid (McConnell, 1966;
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Society's Choices: Social and Ethical Decision Making in Biomedicine Morone, 1992). The result is a political framework that is geared toward narrow incremental changes and best negotiated by individual agencies with narrow jurisdictions and parochial interests. The system is especially resistant to broad policy changes that require coordination from the political center. In this institutional context, U.S. politics is characterized by broad and persistent participation at every point in the political process. Political scientists once celebrated the resulting play of interest groups as a bulwark for democratic participation. Today, they call it "hyperpluralism" and, generally, lament the resulting stalemate. In sum, an activist interest group culture operates within a sprawling, fragmented state that is always vulnerable to challenges of illegitimacy (Greenstone, 1975; Morone, 1992). One result is that organized interests can influence policies at multiple points in the political process. The broader consequence is that ideology, institutional design, and the politics of both interests and groups all reinforce the same biases in U.S. politics. Change is difficult to introduce, and the broader the change, the more difficult the task. The overwhelming bias is toward incremental adjustments in the status quo. How, then, do Americans change their politics and their society? One answer lies in the recurring impulse to organize great democratic movements-a populist urge to remake government, organize direct participation, foster a renewed sense of community. This "democratic wish" has been pursued in a wide variety of contexts across the generations: Anti-Federalists resisting the Constitution, Jacksonians remaking the federal government, abolitionists redefining citizenship, New Left students seeking a more democratic society, and African American activists demanding civil rights. Broad participatory movements have had a powerful influence throughout U.S. history. It may be difficult to dent the political status quo, but great gusts of democratic sentiment regularly break the impasse. Popular mobilizations create new coalitions, new political rules, new institutions, an entirely new status quo. Precisely when U.S. politics grows most contentious, Americans look beyond their adversary pluralism for direct participation in a shared communal fate. The Religious Sphere Religious values permeate U.S. culture. This is the case even for those who are little involved with religious practice, for the substance of religious thought is spread throughout arts, literature, popular culture, and all of the media. Indeed, one can speak of a "civil religion" that throughout the centuries of U.S. history has held the nation together and helped define its character (Bellah, 1985). The question is how this rich fund of human
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Society's Choices: Social and Ethical Decision Making in Biomedicine thought and experience can appropriately contribute to public debate and decision making in a democratic society, in which religion is neither to be favored nor curtailed. The separation of church and state has worked to prevent the dominance of any sectarian theology or religious ideology within U.S. society. As both secularism and religious pluralism have grown with great rapidity during recent decades, some religious groups that had rarely been politically active in former times have developed coalitions that have become a political factor. Some of these groups have mastered the use of the mass media (radio and television, advertising, mass mailings, and political action committees). They have been enlisted by politicians and political parties to further general, national programs, and they have themselves enrolled politicians in their own causes. This public activity by some religious groups has, on the whole, contributed positively to the clarification of issues in the field of biomedicine (Bishop and Coutts, 1994). Religious zeal can, however, lead politically active groups to insist that their religiously derived norms must be accepted by the society at large. Out of such religious zeal, some individuals have resorted to violence against their opponents. Naturally enough, virtually all religious groups have given major attention to fundamental moral questions raised in the fields of medical science and medical technology. Some of these issues divide the religious communities sharply; issues related to the inception and end of life are particularly divisive. This division is not unique to religious communities, nor is the division merely between the more conservative and the more liberal portions of the religious community, as the issue of abortion makes clear. Persons committed to a traditional or conservative theology may nevertheless be forceful advocates of a more liberal social, economic, and political agenda (see background paper by Swezey in this volume). At the same time, much religious thought and activity has been directed toward more effective ways of presenting commonly held religious values, such as respect for the views of others, honesty in individual, group, and public life, and the overcoming of racial, ethnic, and sexual biases. Representatives of many religions, including Islam, Buddhism, Hinduism, Judaism, and Christianity often have joined in this effort. Note, for example, the effort by the World Parliament of Religions to articulate a set of common moral commitments and understandings. Religious organizations are not the only groups that have actively debated and responded to major moral issues, including those brought on by developments in biomedical technology; many other groups are notable for their participation in such debates. Moreover, in addition to the response of diverse social groups, institutions (e.g., the scientific research community and biotechnology industry) also react to and change in accordance with developments in biomedicine. Both specific actors (e.g., mi-
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Society's Choices: Social and Ethical Decision Making in Biomedicine norities, women) and arenas (government, industry, hospitals) shape public ethical discourse on biomedical developments. ACTORS SHAPING THE SOCIAL CONTEXT FOR BIOETHICS Advances in biomedicine do not occur in a vacuum-they are applied within a rich and varied cultural context, with different impacts on diverse social groups. Over the past three decades, the empowerment of certain groups within U.S. society, from minorities to women, from gays and lesbians to health care consumers and patients, has contributed new and distinct voices to the debate surrounding advances in medicine and health policy. While the emergence of these groups occurred roughly contemporaneously and in a somewhat interrelated fashion, each group is treated separately below in order to highlight its own unique perspective. Minorities: A History of Distrust The civil rights movement born in the 1960s brought institutional racism and entrenched social inequalities to the forefront of national attention. From the 1959 bus boycotts to the March on Washington in 1963, from the Freedom Riders to the Black Panthers, the movement chipped away at discrimination and instilled a collective consciousness and pride that coalesced African Americans into a powerful interest group (Branch, 1988; Garrow, 1989). While health care was not at the top of the movement's agenda, issues of distributive justice were; the 1963 March on Washington was not only about race discrimination, but also about poverty and economic opportunity. The movement provided impetus for President Johnson's "war on poverty," declared in 1964, which led to passage of Medicaid and other antipoverty programs; data show that after passage of Medicaid, utilization of medical services by the poor increased sharply (Starr, 1983). Two events in the early 1970s highlighted the racism endemic to the U.S. health establishment and further entrenched the African American community's distrust of medicine: the Tuskegee Syphilis Study (see Chapter 1) and the African American community's experience with sickle cell anemia screening programs. The Tuskegee Syphilis Study has become the most potent symbol to African Americans and other minorities of racist exploitation by the public health community (Jones, 1993). Public outrage over the study was enormous and provided the impetus for the eventual crafting of federal regulations protecting human subjects. However, the study left another legacy that can still be felt today: a profound suspicion and distrust by the minority community of the motives of the U.S. medical
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Society's Choices: Social and Ethical Decision Making in Biomedicine establishment (Jones, 1992; Lex and Norris, 1994). Writes Jones (1992) about the exposure of the study in 1972, Confronted with the experiment's moral bankruptcy, many blacks lost faith in the government and no longer believed health officials who spoke on matters of public concern. Ironically, the desire to respond to the historical neglect of the minority community led to another defining event that only reaffirmed this distrust: racial discrimination and stigmatization resulting from sickle cell anemia screening programs. These programs were spurred in the early 1970s by a perception that the disease, more prevalent in African Americans than in others, had been neglected, and by a desire to remedy the racial inequities brought to light by the civil rights movement. However, screening programs were undertaken with little public education, little counseling for those identified as carriers, and insufficient attention to clarification of the distinction between sickle cell traits and sickle cell disease (Fost and Kaback, 1972). Many of the 12 states that passed sickle cell screening laws required mandatory screening of infants and children, even though at the time the only valid scientific objective of the screening was to provide carriers with information concerning whether or not to have a child, since no treatment was available. Fears that these laws would result in racial discrimination were borne out, with disastrous results for some in the African American community. Children with the disease were stigmatized; insurance carriers raised insurance premiums for sickle cell carriers; some corporations initiated screening programs; and most major airlines grounded or fired employees with sickle cell trait (Bowman and Murray, 1981; Duster, 1990). Indeed, the U.S. Air Force Academy decided to exclude candidates with sickle cell trait from 1973 until 1979 (when the policy was ended after a lawsuit), based on a National Research Council report that characterized its own evidence as inadequate (Duster, 1990). Such reactions to sickle cell disease tended to reinforce both racial discrimination and the suspicions of minorities that medical advances would be used to their detriment. The legacy of distrust left by Tuskegee and sickle cell screening continues to shape the attitudes of minorities toward organized medicine. Fears of medical exploitation and racial discrimination have led some in the African American community to charge that AIDS was engineered as a program of genocide (Jones, 1993). Suspicions in the minority community have made it difficult to enroll minorities in AIDS and other clinical trials, despite a high level of infection among those populations (El-Sadr, 1992). Concerns remain that any racial differences found in the course of AIDS and other diseases will be used to justify discrimination against minority groups (King, 1992).
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Society's Choices: Social and Ethical Decision Making in Biomedicine This persistent distrust of public health officials could thwart efforts to reverse the current decline in the health of minority groups. Indeed, the documented disparity between the health status of Americans based on race and class reinforces the view that current health policies are not responsive to the specific needs of these groups. These and other health inequalities likely reflect differences in access to and quality of health care services for minority and poor populations. While recent initiatives have been established to improve the health of minority groups (National Institutes of Health, 1991), the sad history of medical racism and the suspicion it engendered remains to be addressed. Women: A Struggle for Control The women's movement began to take shape in the late 1950s and early 1960s, on the heels of early successes in the civil rights movement. The first mainstream women's organization, the National Organization for Women (NOW), was organized in 1966 to focus on attainment of women's legal rights; other groups followed with a less traditional agenda. By the early 1970s, the "women's liberation movement" emerged full force, composed of both the more traditional groups and a younger, more radical, cohort. A slogan of the movement, "the personal is political," highlighted its concern not only with discriminatory legal barriers to women, but also with more subtle, pervasive cultural sexism (McGlen and O'Connor, 1983; Rosenberg, 1992). The women's movement was unique in its concern, from the outset, with health-related issues-namely, the need for women to control their reproductive lives as a prerequisite for individual autonomy. Reproductive politics surrounding both abortion and contraception engaged feminists early on. Women exerted enormous pressure toward the repeal of restrictive abortion laws from 1968 to 1973. Women's groups were also instrumental in facilitating access to illegal abortions; one group in Chicago organized an underground abortion clinic where abortions were performed by self-trained women (Petchesky, 1990). Access to contraception, previously the purview of the population control movement, arose as another leading demand of the women's movement, centering on theories of self-determination, sexual discovery, or "sexual liberation" (Gordon, 1976). These reproductive issues became the catalyst for the formation of a distinct women's health movement in the early 1970s. As restrictions on reproductive freedom came to be seen as an issue of male domination over women's sexuality and autonomy, the movement expanded to encompass a broader challenge to the male-dominated medical profession's authority to dictate women's health in many other areas. With the first publication of Our Bodies, Ourselves by the Boston Women's Health Book Collective in
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Society's Choices: Social and Ethical Decision Making in Biomedicine 1973, the women's health movement expanded throughout the country as a campaign by women to re appropriate control over their own medical experience, particularly by means of medical self-help and self-awareness training groups and women's medical clinics. The movement focused on issues such as demedicalizing women's routine health care and childbirth practices, sterilization and surgical abuses, and self-help gynecology (Ruzek, 1978). In addition to its objections to and concerns with traditional medical practice, the women's health movement also grew distrustful of the drug and device industry over what it perceived to be inadequate drug and device safety measures for drugs marketed to women. Women became concerned over the dangers of the birth control pill, which frequently were not relayed to them by physicians; a book on this subject geared toward the lay reader set off a series of events that finally led the Food and Drug Administration (FDA) to require warning labels for oral contraceptives (Seaman, 1969). Women's suspicion of the drug industry was heightened further by revelations that diethylstilbestrol (DES), a synthetic estrogen prescribed to millions of women between 1945 and 1970 to prevent early miscarriages, caused vaginal cancer in some of their daughters. When concerns were raised about the health complications of IUDs, women's health advocates were instrumental in pressuring the FDA to recall Copper-7 IUDs and halt the manufacture of the Dalkon Shield; further protests eventually led to the regulation of such devices by the FDA (Ruzek, 1978). More recent developments illustrate women's continued concern with the safety of drugs and devices prescribed for them, and a perceived lack of responsiveness to women's unique health needs by the medical establishment. The recent scandal over the safety of silicone breast implants sparked outcries by some feminists that women's health was being exploited for profit (Wolf, 1992). Allegations that there has been a historical lack of research attention to breast cancer, as well as cardiovascular disease and AIDS in women, has also sparked a wealth of efforts by a wide range of women's organizations to ensure that these areas of investigation are adequately addressed. Despite increasing numbers of women entering careers in medicine, women continue to be underrepresented in the medical profession, and some within it have observed an entrenched bias against women (Komaromy et al., 1993). Women's health advocates were also instrumental in calling for the review and revision of existing NIH and FDA policies that routinely excluded women of childbearing age from research trials. This had led to revised policies at both agencies, reflected in the NIH Revitalization Act of 1993 (P.L. 103-43), which requires promulgation of guidelines to ensure that women and minorities are included in NIH funded research.
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Society's Choices: Social and Ethical Decision Making in Biomedicine A myriad of pressing issues continues to confront women in health care, including a renewed battle over abortion rights and access to RU-486 (Charo, 1991), disparate treatment of women in medical management of illness (Steingart et al., 1991), violence against women as a public health threat (American Medical Association, 1992), the growing population of women infected with HIV (United Nations Development Programme, 1993), and complex questions surrounding the maternal-fetal relationship, fetal diagnosis, and the control of pregnant women (Rothman, 1987; Mattingly, 1992). Despite these continuing concerns and problems, however, there is no doubt that women have become a viable, forceful interest group, challenging sexism in medical practice and research and calling attention to medical problems unique to women. Gays and Lesbians: A New Activism Gay rights, like minority and women's rights, have long been a part of U.S. political debate, but gays and lesbians emerged as a powerful, distinct interest group in the 1970s. The Stonewall riots in New York City in 1969, following a police raid on a gay bar in Greenwich Village, led to a decade of organizing, fundraising, and consciousness-raising among gays and lesbians throughout the country, modeled on the civil rights and feminist movements. The late 1970s saw renewed efforts in reaction to a backlash that resulted in the repeal of gay rights ordinances in Dade County, Florida, and other cities. In 1978, riots broke out in San Francisco after Dan White, the killer of gay supervisor Harvey Milk and mayor George Moscone, received a sentence of only seven years in prison (D'Emilio, 1983; Cruikshank, 1992). As with minorities and women, the history of the gay community's relation with the U.S. medical establishment is characterized by suspicion and distrust (see background paper by Bayer). A decade before the AIDS epidemic, gay men began to form their own health clinics in response to perceived discriminatory treatment for sexually transmitted diseases. The American Psychiatric Association classified homosexuality as a mental illness until 1976; but even until 1990, the Public Health Service was responsible for enforcing a ban on immigration by homosexuals based on that mental classification (Levi, 1991). But as with other rights movements, the gay liberation movement focused its initial energies not on health issues, but on legal and social stigmatization and discrimination in housing, jobs, and other areas. In the early 1980s, the general public's erroneous perception that AIDS was a disease affecting only gay men lent momentum to gay activism. The labeling of AIDS as a "gay" disease transformed what should have been a mass mobilization of public health resources to combat a critical health
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Society's Choices: Social and Ethical Decision Making in Biomedicine problem into the politicization of public health agencies. Former Surgeon General C. Everett Koop notes in his 1991 autobiography that "the Reagan revolution brought into positions of power and influence Americans whose politics and personal beliefs predisposed them to antipathy toward the homosexual community." Conservative politics, Koop adds, both slowed the understanding of AIDS and thwarted his attempts to educate the public about the disease. In the face of an establishment that failed to rise to the challenge of the AIDS epidemic, gays began to organize their own community health clinics and treatment networks, seeking to redefine the notion of AIDS as a disease rather than divine retribution (Shilts, 1987; Padgug and Oppenheimer, 1992). Gay health advocates introduced a new level of activism and self-help to the previous endeavors of health interest groups. For example, in response to what was perceived as a sluggish federal drug approval process, gays organized an "AIDS underground," a network of illegal drug buyer clubs. In 1987, the AIDS Coalition to Unleash Power (ACT-UP) was organized in New York City as a more activist alternative to existing gay health groups. ACT-UP repeatedly caught the attention of federal and state policymakers by relying on dramatic modes of civil protest and disobedience borrowed from the civil rights movement (Arno and Feiden, 1992). The development of a parallel track policy at the FDA, arising from the introduction of dideoxyinosine (ddI) as a potential AIDS therapy, exemplifies an unprecedented involvement by gays and other consumer groups in federal health policy-making, even though the outcome of this policy has yet to be evaluated. Extending the basic tenets of the patients' rights movement concerning participation in treatment decisions, gay activists succeeded in negotiating with federal officials and drug manufacturers to speed the availability of unapproved but possibly effective treatments for AIDS (Levi, 1991). The activism of gays in response to the AIDS epidemic marks a significant turning point in the history of health interest organizations and their relations with the medical and research establishments. This activism may well inform the future efforts of other groups as well, perhaps changing the power dynamics between the medical community and patient groups. HEALTH CARE AND SCIENCE: SHAPING THE SOCIAL CONTEXT FOR BIOETHICS Patients, Employers, and Insurance Companies: Health Care Consumers Substantial changes in the delivery of health care have transformed patients from trusting, relatively passive recipients of health care to a more
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Society's Choices: Social and Ethical Decision Making in Biomedicine bated as a desirable alternative. Thereafter, medical domination of hospitals began to yield to professional administrators (Starr, 1983). Increasingly, physicians offer the hospital professional skills, technology, and income; but in many hospitals their dominance was diminished with the increased control gained by administrators. Along with the change in control came a greater focus on the financial aspects of running a hospital. Between 1850 and 1920, the American hospital was transformed from an asylum for the indigent-noisy, dirty, and in disarray-to a scientifically oriented institution for medical management and nursing care. The dramatic change was prompted largely by a combination of industrialization, urbanization, and immigration, as well as by advances in sanitation and medical treatment (Rosenberg, 1987). Not only did the hospital become clean and efficient, it became increasingly technological and interventionist (Stevens, 1989). It also assumed a dominant role in the training of physicians, shaping their interests, attitudes, behavior, values, and practice. In the process, it also became increasingly sensitive to political and societal pressures, cultural rewards, and economic incentives and disincentives, changing its scope, priorities, and structure as it accommodated to these influences. In this evolutionary process, the physician became less of a healer than an expert who provided access to the necessary technology; often, the nurse was charged with ministering to the patient's care and well-being. For most of the nineteenth and early twentieth century, the health care system centered around the hospital and its inpatient activities. Surgery became its mainstay. More and more, its success and visibility depended on its ability to deliver up-to-date acute and specialized care. As the hospital's primary role as a charitable institution faded, however, it began to assume a more corporate mentality, and low occupancy became a major detriment to economic viability. In the 1960s and 1970s, with the advent of Medicare and employer-sponsored health insurance programs, admissions to hospitals rose; in the 1990s, due to AIDS and the rise in chronic diseases, they are increasing again. At the same time, a growing emphasis on specialty medicine led to a decline of primary care medicine. Along with greater reliance on science and technological sophistication, specialists assumed a central role in the business of medicine. Some showed entrepreneurial instincts that verged on conflicts of interest. Physicians also became targets for those with products to sell (e.g., drugs) and for malpractice suits by those with failed expectations. All of these factors contributed to the rising cost of practicing medicine and of running hospitals. The term "hospital" refers today to short-term, acute care, general hospitals that include both medicine and surgery. Most are voluntary, not-for-profit organizations; these provide 70 percent of short-term beds in the United States.
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Society's Choices: Social and Ethical Decision Making in Biomedicine Voluntary hospitals handled the financial pressures by becoming more aggressive, competitive, expansionary, profit-oriented, and income-maximizing. Access to health care became increasingly dependent on ability to pay. Some hospitals, faced with prospects of financial doom, merged with others; others fled to the suburbs where the payer mix was more favorable. This contributed to the growing problem of limited access to health care for the uninsured: the poor, the part-time worker without benefits, and the unemployed. Currently, the voluntary hospital is a central part of the changing scene in health care delivery. The idea of "managed competition" is driving hospitals into health care networks. The tempo of competition among urban hospitals has become fierce as they strive to set up networks for managed competition. Insurance companies are prominently engaged in the struggle for a piece of the pie. Drug companies are resorting to novel strategies in order to maintain prized relationships with physicians and hospitals while the restructuring is under way. A variety of influences is diminishing our society's traditional reliance on hospitals as independent entities: increased dissatisfaction of the public and of major political figures with the high cost of health care and the major role played by hospitals and their administrative costs in the genesis of this difficult burden; growing ability of and financial incentive for outpatient care to substitute for in-hospital care due to advances in medical management and technology (e.g., cardiac catheterization, renal dialysis); less need for hospitalization because of the development of noninvasive technologies for diagnosis and treatment (e.g., CAT scanning, MRI, or ultrasound); restructuring of health care (e.g., through HMOs, which discourage referrals to hospital-based specialists, and greater strictures on reimbursement by third-party payers); development of new effective therapeutic agents (e.g., antibiotics for cystic fibrosis); expanded use of living wills advance directives, which may limit interventions and expenditures for terminal disease; and greater effectiveness of preventive measures (e.g., education for AIDS, vaccines). As the United States prepares itself for health care reform, it is important to recognize that in addition to unmet needs (e.g., preventive medicine), the aging of the population will introduce additional needs and related ethical questions. For example, disability from dementia, including Alzheimer's disease and stroke, will require research into etiology, medications, devices, and suitable treatment environments. The major
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Society's Choices: Social and Ethical Decision Making in Biomedicine causes of death have shifted from acute infectious diseases (e.g., influenza) to chronic diseases (e.g., heart disease and cancer), and death by these causes occurs later in life, after a period that includes limited functional capacity and impaired quality of life. In the course of a patient's dying, hospitals often provide a variety of expensive life-prolonging measures, even though the effect on survival time and quality of life is often small. Decisions have to be made concerning the availability of such measures. The Health Care Industry Health care is a big business with several components that are germane to our considerations of social and ethical issues: primary among them are health care services and the research, development, and use of drugs and devices. Health care costs include the money paid to physicians in managed care or private practice, to hospitals, laboratories, and other health care workers. Costs also include the money spent on the products of pharmaceutical and biotechnology companies as well as the money spent on health-related research to develop and produce these drugs and technologies. Some basic statistics illustrate the size and scope of this business and, hence, the stakes involved in changing any aspect through public policy. In 1991, according to Letsch and colleagues (1992), the United States spent a total of $751.8 billion for health care, or $2,868 per person. Approximately 88 percent of the health care expenditures paid for medical services or products such as hospital services, physician services, drugs, and nursing home care. Inpatient and outpatient hospital care comprised 43.7 percent of the total personal health care expenditures, but only 3.4 percent of this was paid directly by the patient, while private health insurance paid for 35.2 percent and public health insurance paid for 56.3 percent of the charges. Another $23.1 billion was spent on biomedical research and development, about half of it in federal funds. Biomedical Research: The Federal Government and Private Industry Since the end of World War II, a growing function of government has been sponsorship of biomedical research, primarily through the National Institutes of Health and the National Science Foundation (NSF). The idea that public investments in biomedical science should play a major role in improving the economic status of the country has become a recurrent theme and is prominently featured in the Clinton economic policy. A frequently cited analysis estimated 28 percent rate of return to society from funds invested in academic research (Mansfield, 1991). Beginning in 1980, a series of laws and regulations have sought to benefit the economy through the commercial development of government funded science. These laws have fundamentally altered the role of re-
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Society's Choices: Social and Ethical Decision Making in Biomedicine search scientists in relation to their discoveries. The Stevenson-Wydler Act (P.L. 96-480) of 1980 required that 0.5 percent of the R&D budgets of federal agencies be used for technology transfer activities. The Bayh-Dole Patent and Trademark Laws Amendment Act of 1980 (P.L. 96-517) assigned intellectual property rights to the institutions carrying out the government-funded research, allowing grantee institutions to patent and license their developments and collect and retain royalties. Also in 1980, the Small Business Patent Procedure Act (P.L. 96-517) reversed the federal policy of nonexclusive licensing by assigning patent rights to small businesses, universities, and some nonprofit organizations that were involved with government contracts. The Federal Technology Transfer Act of 1986 (P.L. 99-502), authorized government-operated laboratories to establish Cooperative Research and Development Agreements (CRADAs) with other federal agencies, state or local governments, and industrial and nonprofit organizations for the licensing of government-owned inventions, with inventors and their laboratories keeping part of the royalties received from these licenses. As a result of all of these actions, biomedical scientists began to benefit financially from their ideas by forming relationships with industry and by starting small biotechnology companies of their own. The development of recombinant DNA technology, in combination with the change in government policies with respect to technology transfer, underlay the biotechnology industry that was created de novo during the 1980s. The number of new biotechnology companies soared during the 1980s, making the United States a world leader in the commercialization of biotechnology products. A June 1993 fact sheet from the Biotechnology Industry Organization (BIO) reports that there are 1,231 biotechnology companies in the United States, an 11 percent increase since 1991. Thirty-eight percent of U.S. biotechnology companies are involved in product development in therapeutic agents, while 28 percent are producing human diagnostics. Other companies are involved in agricultural, chemical, environmental, or service areas. The industry presently employs 79,000 individuals (BIO, 1993). By 1993, 21 approved drugs or vaccines and over 600 diagnostic agents had reached the market; another 16 agents are awaiting FDA approval, and 132 agents are in clinical trials. The biotechnology industry is predicted to grow to a $50 billion industry by the year 2000 (President's Council on Competitiveness, 1991). As was the case in the past decade, new technologies that alter existing practices and challenge traditional values and beliefs promise to accompany this growth. Another site of biomedical innovation from which ethical and social quandaries are likely to arise is the pharmaceutical industry. The vast majority of new drugs have been developed by this industry, which has doubled its investment in R&D every 5 years since 1970. In 1993, the industry was expected to invest $12.6 billion in R&D-a 13.5 percent in-
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Society's Choices: Social and Ethical Decision Making in Biomedicine crease over 1992. This investment amounts to 16.7 percent of the industry's expected sales in 1993, four times the average of R&D investment for all U.S. industries that conduct research (Beary, 1993). Since 1988, the member companies of the Pharmaceutical Manufacturers Association (PMA) have supported more R&D than the NIH, with industry spending totaling $9.2 billion in 1991 (PMA, 1991). Although it is difficult to accurately estimate the costs of developing any single drug, DiMasi et al. (1991) estimated that the average cost of developing a single drug was $231 million. A more recent report by the OTA (1993) estimates that the average cost to a company for moving a single new medicine from laboratory to practice is presently $359 million. The high cost of drug development is partly a result of the rigorous testing process that a new drug undergoes. It takes an average of 12 years for a new drug to reach the market, and for every 5,000 compounds that are evaluated, only 5 enter clinical trials in humans and only 1 is approved (Wierenga and Eaton, 1993). In spite of the huge investments of time and money required to produce a single drug, the pharmaceutical industry has been highly productive, commercially successful, and highly profitable to its investors. Kaitin et al. (1993) studied 196 new chemical entities that had been approved by the FDA between 1981 and 1990, and found that 181 drugs (92.4 percent) were developed by the pharmaceutical industry, 7 by academia, 2 by the government, and 2 by individuals. As the biotechnology and pharmaceutical industries play an increasing role in the economic competitiveness of our society, industry needs new resources from various sectors of society. From the regulatory agencies, it needs clear guidance on what is expected in terms of safety and efficacy regarding the testing process, as well as an efficient approval process. The success of industry also depends on basic biomedical research in academic and government laboratories, a vital academic research enterprise that generates new scientific insights. Industry also looks to the academic research community for new skills and techniques, specific assays and reagents, personnel to conduct clinical trials, consultants and collaborators, individuals to provide expertise to regulatory agencies, and highly skilled scientists and technicians to work in industry. To facilitate cooperation between academia and industry, value questions related to ownership of intellectual property rights and conflicts of interest must be resolved. A 1990 National Academy of Sciences (NAS) report on industrial perspectives on innovation and interactions with universities concluded that, in the early stages of large scientific breakthroughs, industry needs interaction with university scientists, who are at the forefront of scientific knowledge. As a breakthrough matures, however, incremental improvements (product- and process-oriented technical changes that are related to competitiveness) occur most often within industry only. Thus, primary roles
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Society's Choices: Social and Ethical Decision Making in Biomedicine for universities in academic-industry partnerships lie not in product development but in providing in-depth education about new and emerging concepts. A cautious analyst of "technology transfer" from the university or the national laboratories to industry is John A. Armstrong, retired vice president for science and technology at IBM (1993). He holds industry responsible for poor management decisions, lack of attention to quality and cost in manufacturing, past high interest rates, and poorly trained workers. "The most effective technology transfer from universities in the short term is well-trained technical and scientific workers at many levels of sophistication and knowledge," he concludes. If universities become focused on technology transfer and economic competitiveness, he anticipates a variety of problems, including a shift in the amount and priorities of available funding, a distortion of the role of universities, and an increase in ethical issues such as potential conflicts of interest of research faculty. Universities could improve the rate of return on society's investment in basic research through the following actions: improve the training of scientists and engineers to make them more effective and enthusiastic participants in R&D exploitation with heightened interest in the challenges of manufacturing; make innovations in how universities and industry interact; rationalize university policy with respect to intellectual property rights; reexamine university conflicts of interest policies. Harold Shapiro, president of Princeton University, echoes these concerns (Shapiro, 1992). He notes that technologic progress depends not only on new science and technology but also on cultural and social factors such as political stability, life expectancy, nutrition, attitudes toward risk, natural resources, property rights, religious values, demographics, and openness to change. The critical contributions from the university sector are education and advanced training, quasi-independent scientific agendas, and exploration of the human condition, through a broad set of historical, cultural, political, and value questions. In the final analysis, "[i]t is a society that is full of hope rather than fear, full of trust rather than alienation, full of knowledge rather than ignorance, full of honesty rather than cynicism, full of confidence rather than helplessness that will survive and progress." Funding of Scientific Research Since 1950, the federal government has been the main source of financing for scientific research and a principal shaper of the research
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Society's Choices: Social and Ethical Decision Making in Biomedicine agenda. One reason for growing public interest in scientific expenditures is the sheer size of the government-funded program of biomedical research. The NIH budget alone grew from $26 million in 1945 to over $10 billion in 1993, and the Clinton administration's budget request for FY 1994 is $10.668 billion. Almost 90 percent of the funding goes to extramural research. Additional matching funds are applied to the construction of biomedical research facilities. For its part, NSF has a FY 1994 budget request of $3.182 billion to fulfill its scientific mission. The establishment and success of these premier scientific research agencies resulted partly from the early insights of Vannevar Bush, head of the wartime Office of Scientific Research and Development, who pointed out in his book, Science-The Endless Frontier, the importance of the uninterrupted flow of new scientific knowledge for both health and defense. To accomplish these purposes, Bush proposed a permanent governmental structure receiving funds from Congress to support basic research in the colleges, universities, and research institutes, as well as scholarships and fellowships for training. Bush specified that this proposed agency should recognize the importance of freedom of inquiry on the part of the individual scientist. Today, it is precisely this unfettered freedom of the individual scientist to determine research priorities that is being questioned. Yet, who should be setting the priorities for science? Congress must respond to a variety of pressures from constituents, resulting in academic earmarks to fund "pork barrel," non-peer-reviewed science at levels that have grown from about $10 million in 1980 to almost $800 million in 1993 ( Washington Fax, 1993). Congress also responds to the voices of special interest groups by specifying funding levels for specific diseases. Scientists as a group have not developed a way to effectively establish research priorities across the various fields of scientific endeavor. Unfortunately, Congress also seems to lack a mechanism for obtaining objective data to help to weigh scientific priorities across the spectrum of important diseases. At the same time that the public demands greater accountability in the funding of biomedical science, it is generally optimistic about the ultimate outcome of its investments. A 1990 survey by the National Science Board showed that most Americans trust the motives of scientists; 80 percent of respondents agreed that most scientists want to make life better for the average person (National Science Board, 1991). The survey also showed that between 1979 and 1990, decreasing proportions of respondents agreed with the statement that "Science makes our way of life change too fast." Most respondents indicated that they believe that the benefits of scientific research had outweighed the harmful results; a majority perceived a strong link between advances in science and technology and improvements in their own daily lives.
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Society's Choices: Social and Ethical Decision Making in Biomedicine How the public responds to developments in biomedicine is often influenced by the way such developments are presented in the media. In general, the media provide a valuable service by informing the public of developments in health-related research and biotechnology, not only the scientific advances but also the social, legal, or ethical impacts of these advances on the lives of all Americans. However, as the media strive to create a newsworthy story, the value of this service can be diminished. The 30-second sound bite conveys partial information but ignores crucial details. The limited success of an animal experiment can be reported in a manner that suggests an imminent breakthrough in human therapy; when the expected results do not immediately materialize, such stories can lead to public disillusionment. These tendencies in the media compound the problems caused when politicians or scientists over promise about expected breakthroughs. A salient example was the so-called "War Against Cancer" during the 1950s and 1960s (IOM, 1973). The funds that were expended under that program have contributed to advances in the diagnosis and treatment of cancer (and to the understanding of HIV disease), but the idea that cancer would be defeated by this program caused unfounded expectations on the part of the public, and resulting disappointment. Research on the human genome is an area in which the media's influence has been more positive, however. There has been a concerted effort to deal with ethical, social, and legal issues related to the uses of new genetic technologies (see background paper by Hanna). Nobel laureate James Watson has been a central figure in expanding our understanding of the molecular structure of DNA and of the relationship between viruses and cancer. As head of the NIH Office of Genome Research (now the National Center for Human Genome Research), he responded to public and congressional concern by proposing to use part of the money allocated to the Human Genome Project to study the ethical, social, and legal issues that are raised by the information this research generates. Media coverage highlighted this effort and was partially responsible for encouraging public support for this initiative. REFERENCES American Medical Association (AMA), Council on Ethical and Judicial Affairs. 1992. Violence against women: Relevance for medical practitioners. Journal of the American Medical Association 263(3):3184-3189. Armstrong, J.A. 1993. Research and competitiveness: Problems of a new rationale. The Bridge 23(1):3-10. Arno, P., and Feiden, K. 1992. Against the Odds: The Story of AIDS Drug Development, Politics and Profits. New York: Harper Collins. Beary ,J.F. 1993. New Medicines: The Best Hope for Older Americans. In: In Development: New
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