Part II
LAW, ETHICS, AND PUBLIC POLICY
The Politics of HIV Infection:
1989-1990 as Years of Change
Daniel M. Fox
A decade after AIDS emerged in the United States, most of the people who made health policy perceived it as a stage, at present the end stage, of a chronic disease that was spreading most rapidly among the disadvantaged, especially among blacks and Hispanics. This perception was the latest, and certainly not the last, chapter in a story that has changed repeatedly since 1981. As the story has changed, so has the debate about proper policy. This essay is a history of the politics of making policy for preventing the disease and caring for the majority of those who acquire it.
The Politics Of Aids To 1989
The brief history of the epidemic has been dominated by four interacting factors: fear and fascination; the identity of those who have the disease and those to whom it seems to be spreading; the endemic problems of our social policy; and the impact on policy of advances in scientific knowledge. These factors created the political context for the perception of AIDS as a chronic disease that is increasingly a burden for the disadvantaged and, therefore, for all of us.
AIDS, more accurately if ponderously called HIV infection and related diseases, has been a public issue out of proportion to its cost or mortality relative to such other contemporary afflictions as cancer, alcoholism, and automobile injuries. The standard, and probably accurate, explanation for the high public salience of the epidemic, especially
An earlier version of this essay, with the title "Chronic Disease and Disadvantage: The New Politics of HIV Infection," is reprinted with permission from Journal of Health Politics, Policy and Law 15 [Summer 1990]:341–56.
as revealed in coverage by the media, is that it evokes fascination and fear—fascination with a disease that kills celebrities and those with homosexual life-styles; fear of transmission through blood transfusion or sexual intercourse.[1]
See the essay by Timothy E. Cook and David C. Colby in this volume.
Moreover, as the incidence of the infection spread among urban blacks and Hispanics, fear of HIV intensified white people's dread of random aggression by darker-skinned males.The public salience of the epidemic was also a result of longstanding problems of social policy in the United States. Nationally and in most of the states, there is no consensus on how to educate the public about sexual behavior and what (and how much) to do about drug addiction. Our employment-based private health insurance is least comprehensive in providing outpatient and long-term care and prescription drugs, which are growing costs of treating HIV infection. Medicaid eligibility and coverage vary widely among the states; as a result, many persons who have HIV infection are left without effective entitlement to care. Moreover, states and local governments have enormous financial and political problems in serving as the health care payers of last resort.
These problems of social policy were exacerbated by both the politics of the 1980s and the epidemic of HIV infection. When the first cases of the syndrome to be called AIDS were reported in 1981, cost containment had become the priority of public policy for health financing, both for employers and for the insurance industry. A new national administration was determined to reduce federal domestic spending, including funds to assist the states in providing health care and social services to the poor. By the mid-1980s, when the Congress and many of the states took new initiatives in health policy, AIDS was already a financial burden for several states, especially New York, New Jersey, California, and Florida, and was an emerging problem in most others.[2]
Daniel M. Fox, "AIDS and the American Health Polity: The History and Prospects of a Crisis of Authority," in AIDS: The Burdens of History, ed. Daniel M. Fox and Elizabeth Fee (Berkeley: University of California Press, 1988), pp. 316-43.
Each new case represented a burden of about $100,000 in direct costs.[3]Daniel M. Fox and Emily H. Thomas, "The Cost of AIDS: Exaggeration, Entitlement and Economics," in AIDS and the American Health Care System, ed. Lawrence D. Gostin (New Haven, Conn.: Yale University Press, 1989), pp. 192-94.
As the number of cases increased among blacks and Hispanics, and as the number grew among women and children, these costs became a heavier burden on state and local government. By 1989 perhaps half the costs of caring for persons with HIV infection had been paid by state and local government, through their share of Medicaid; by insurance pools and indigent care programs; and by operating subsidies to public hospitals and clinics.[4]Dennis P. Andrulis, U. B. Weslowski, and Lawrence S. Gage, "The U.S. Hospital AIDS Survey," Journal of the American Medical Association 262 (August 11, 1989): 784-94.
The politics of HIV infection changed in 1989 for two reasons. The first reason was that infection and disease had spread rapidly among members of disadvantaged minorities. Moreover, the incidence of infection with the virus among blacks and Hispanics was growing faster as
a result of a newly observed causal relationship that linked AIDS to crack, sex, and venereal disease. This new source of infection augmented to an ominous but unmeasurable extent its diffusion by needle sharing, by intravenous drug addicts having unprotected sex, and by women with the virus having children.
The second reason for this change in the politics of HIV infection was that many health professionals and people who made policy now agreed that HIV infection must be considered a chronic disease. From 1981 to the summer of 1989, the consensual view of the epidemic employed the historical model of plagues that Elizabeth Fee and I describe in the introductory essay in this volume. Many experts argued, using the plague analogy, that AIDS required an emergency policy response because it was both an unusual and an unusually severe infliction.
The first challenge to the plague model of policy for the HIV epidemic derived from politics and policy analysis rather than from medical science and its applications. The challenge came from people who were absorbed with the problems of financing the epidemic. From the point of view of insurance executives, state Medicaid officials, and legislators addressing problems of the uninsured and hospital deficits, AIDS was similar to a chronic disease that was compressed into a period of less than two years. Like other chronic diseases, AIDS was characterized by relatively brief acute episodes, requiring hospitalization, and longer periods when patients could be cared for in nursing facilities or at home. Like persons with other chronic diseases, persons with AIDS needed considerable social support, either from friends and families or from public agencies.[5]
Daniel M. Fox, Patricia Day, and Rudolf Klein, "The Power of Professionalism: Policies for AIDS in Britain, Sweden and the United States," Daedalus 118 (Spring 1989): 93-112.
Unlike most people with expensive chronic diseases, however, most people with AIDS were not eligible for Medicare, either because they were under sixty-five or because they did not live long enough to become eligible for Social Security Disability Insurance.[6]Fox and Thomas, "Cost of AIDS."
This financially driven analogy to chronic disease was unpopular until the summer of 1989. Many advocates for persons with AIDS, especially gays, feared that defining the syndrome as a chronic infectious disease would lead to its "normalization." If AIDS became just another of the long list of killer diseases, it would cease to evoke fear and fascination and, therefore, cease to have as large a claim on public attention and funds. Some scientists attacked the chronic disease model as defeatist. A few others, notably William Haseltine of Harvard, endorsed it.[7]
William Haseltine, "Prospects for the Medical Control of the AIDS Epidemic," Daedalus 118 (Summer 1990): 23-46.
Critics insisted that a disease that was spread by sex and drugs could not be considered another chronic disease.[8]Personal communications with Allan M. Brandt and David Rothman, May 1989.
The chronic disease model became central to policy as a result of two clinical trials sponsored by the National Institutes of Health, one terminated in the spring and the other in the summer of 1989. The first trial justified the use of aerosolized pentamidine for persons who had an episode of the most common complication of HIV infection, Pneumocystis carinii pneumonia. The other validated the use of AZT to postpone the onset of symptoms of disease secondary to HIV in certain patients. Both drugs resembled cancer chemotherapy more than the romantically misnamed "magic bullets" that cured many infectious diseases of bacterial origin, or the vaccines against major infections. Like cancer chemotherapy, the anti-HIV drugs inhibited the progress of disease but did not prevent or cure it.
The new drug treatments created a new imperative and a new burden for policy. The imperative was that, for the first time since the beginning of the epidemic, persons who had engaged in risky behavior had a powerful incentive to be tested and, if infected, to receive prophylactic treatment. The burden was that treatment would be more expensive, but nobody could predict precisely how much more expensive, because it was based on new drugs. Moreover, the new drugs made the duration and course of the disease considerably more uncertain than before.
By the late summer of 1989, physicians and an increasing number of people who made health policy were describing HIV as the cause of a chronic illness with a long and lengthening course between infection and death. New diagrams that experts used to describe the disease to audiences of health and policy professionals exemplified the new perception of HIV infection. Throughout the 1980s medical scientists had drawn an iceberg, with only the tip susceptible to treatment, to depict the disease. They now offered a time-line intersected by numerous and increasing opportunities for intervention.[9]
The first time-line that I saw was on a slide presented by Deborah Cotton at a workshop sponsored by the United States Public Health Service for state legislative leaders late in August of 1989, the week following the announcement that AZT had prophylactic effects. Dr. Cotton's slide was arresting and seemed to the audience to describe a new perception of the disease. Since then I have seen similar diagrams at national and international meetings. By the spring of 1990, newspapers routinely used time-lines to update the public about HIV infection.
While this shift of perception was occurring, the incidence and prevalence of HIV infection were increasing disproportionately among the disadvantaged. HIV infection and its consequences were therefore becoming a problem of American policy and politics as they affect minorities and the poor. AIDS had been normalized, but in a somewhat different way than advocates for according it higher priority had expected. The response to the disease was now part of the normal fragmentation and frustration created by our health policy and disproportionately shared by the forty to fifty million Americans who lacked minimal health insurance coverage and by the health and policy professionals who addressed their needs.
Perceiving HIV Infection As A Problem Of The Disadvantaged
The HIV epidemic offers elegant proof of the proposition that scientific evidence, especially statistics, contributes to but does not drive public policy. In the early 1980s, when most media attention and most advocacy for policy focused on AIDS as a disease of homosexuals, hemophiliacs, and recipients of transfused blood, overwhelming statistical evidence revealed that the epidemic was a serious problem for blacks and Hispanics and that most of the people at risk of infection in these groups were of relatively low socioeconomic status. In 1982, the second year in which the federal Centers for Disease Control counted cases of AIDS, blacks and Hispanics comprised just under half of the males, almost 80 percent of the females, and almost two-thirds of the children diagnosed with the disease in the United States. In subsequent years the percentage of black and Hispanic men with AIDS ranged between 30 and 40 percent; the percentage of black and Hispanic women and children was always considerably more than half.[10]
"AIDS Cases in the United States, 1982-88," The Blue Sheet, March 22, 1989, p. 8.
More important for gauging the impact of the disease on populations, and therefore on politics and policy, the number of cases per 100,000 population was always higher among blacks and Hispanics than among whites. By 1988 the cumulative total of cases per 100,000 was almost three and a half times higher among black men and two and a half times higher among Hispanic men than among whites. The rate among females was fourteen times higher among blacks and seven times higher among Hispanics. For children the cumulative rates were four times as high among blacks and twice as high among Hispanics.[11]
"CDC AIDS Surveillance Data Omits One-Third of Current Cases," The Blue Sheet, June 22, 1989, p. 3.
There was, moreover, considerable evidence of undercounting of cases among blacks and Hispanics. In particular, intravenous drug users were reported as dying at higher rates in these years from tuberculosis and other diseases that were, most likely, secondary to HIV infection, for which they had not been tested.[12]
Ibid.
By 1988 the rate of increase in reported cases was highest in cities with large black and Hispanic populations. This increase followed the pattern that had been observed earlier in the gay communities of San Francisco and New York and in other countries. As epidemiologists writing about Latin America described this pattern, once the virus was "introduced into a population, indigenous transmission soon became established and propelled the epidemic at an alarming rate."[13]
T. C. Quinn, F. R. K. Zacarias, and R. K. St. John, "AIDS in the Americas: An Emerging Health Crisis," New England Journal of Medicine 320 (April 13, 1989): 1005-1007.
For example, in Newark, New Jersey, a predominantly black city, the rate ofcases increased from 39 per 100,000 in the twelve months ending February 1988 to 56.5 a year later, a growth of 31 percent. In San Juan, Puerto Rico, the rate of reported new cases increased by 78 percent to 66.5 per 100,000 in the same period. But in San Francisco, which has a predominantly white population, new cases increased by only 12.7 percent in the same year. Published data reveal similar, though less dramatic, contrasts across the country.[14]
Centers for Disease Control, United States Public Health Service, HIVAIDS Surveillance (Atlanta: Centers for Disease Control, July 1989).
It is easier to describe than to account for the gradualness of the realization of the political and policy problems that result from the disproportionate impact of HIV infection on the disadvantaged. Several factors seem important in explaining what happened. One factor involves the politics of epidemiological evidence; the others involve the intersection of special-interest politics with larger issues of social policy during the Reagan years.
The most important data about any epidemic, indeed about any problem, for most public officials and health professionals are the number of people clamoring for scarce resources in a particular fiscal year. For the first eight years in which cases of AIDS were counted, the largest number of cases occurred among white males. The numbers of women and children, among whom the disadvantaged were an overwhelming majority, remained relatively low for most of the 1980s; the cumulative number of cases reached only 1,000 among women in 1986, and 500 among children in 1989. Prudent political professionals logically accorded priority to financing care for white males.
The second most important data about any problem for health professionals and public officials are those that project its consequences into the practical future. The practical future for most elected officials is the year before and, sometimes, the year after the next election. For officials in the executive branch of state or local government, the practical future is the fiscal year after the one for which agencies prepared their most recent budget request. Most health professionals, especially those who treat patients or manage hospitals, have even shorter practical futures. They are trying to get through a day, a week, a few months, or a fiscal year. For both public officials and health professionals, projections of the incidence and demography of HIV infection three to five years into the future were ominous but not a problem for the practical future.
Official projections of the future number and demography of cases of AIDS had three characteristics that reduced their political salience: they were controversial; they were based on statistical reasoning rather
than on field research; and most projections were not targeted to particular jurisdictions.
Much of the controversy has been unavoidable. It is a result of ignorance about people's sexual behavior and drug habits, of congressional and White House opposition to or reluctance about asking people to describe these activities to interviewers paid with government funds, and of disputes among social scientists and biostatisticians about the accuracy of survey questions on matters about which many people are inclined to be evasive or dishonest. Moreover, strong opposition to mandatory testing for HIV or reporting the names of people who test positive has come from civil libertarians, ethicists, gay advocates, and health professionals. These people have feared that mandates would, contrary to intent, persuade many people at high risk to avoid testing from fear of punishment or discrimination.[15]
Ronald Bayer, Private Acts, Social Consequences (New York: Free Press, 1989).
As a result of this controversy, projections of future cases of HIV-related disease have been based on statistical reasoning according to competing methods. When experts disagree about the future, even when, as in projections of the number of people with HIV infection, the range of their disagreement is narrower than their area of agreement, prudent public officials are highly motivated to temporize.
An even better excuse for officials to temporize has been the lack of credible projections for specific political jurisdictions. By 1989, only the cities and states with the highest number of cases had adopted any of the competing methods of projection for local use. Moreover, both AIDS activists and their adversaries frequently challenged the accuracy of these numbers. Credible and frightening data about the impact of HIV in minority communities came mainly from New York and New Jersey, states that are not normally regarded by people in other jurisdictions as harbingers of their social problems. Most states had relatively few cases of diagnosed AIDS (half had counted 200 or fewer through the first six months of 1989) and hence no political incentive to sponsor local projections of controversial data.
The general condition of social policy and special-interest politics reinforced the willingness of public officials to interpret data in ways that made it possible for them to avoid stark confrontation with the steady increase in AIDS cases among the disadvantaged throughout the country. There was little sympathy for expanding social programs in Washington or the states during the first Reagan administration. What sympathy existed was directed mainly at poor children, at working-age adults whose health insurance lapsed when they lost their jobs or whose
employers were too marginal to purchase insurance, at people with disabilities who became ineligible for Social Security Disability Insurance as a result of new administrative procedures, and at the elderly who could not pay the catastrophic costs of illness or of long-term care. State officials were preoccupied in these years with policies to reduce the rate of increase in hospital costs in order to address competing pressures for new programs in health care, environmental regulation, welfare, and housing.
This picture of social policy is deliberately overdrawn. There were still many advocates for more health care for the disadvantaged. The people who managed health services that were traditionally aimed at black and Hispanic populations—clinics, health centers, hospitals, drug treatment programs—continued to lobby vigorously and effectively. Hospital leaders, alarmed by the growing cost of care for the poor and by the unwillingness of private insurance executives (themselves pressed by employers to reduce costs) to maintain traditional cross-subsidies, clamored for public funds to relieve their deficits. State government proposals to curtail Medicaid benefits or eligibility for coverage were strongly opposed by associations of health professionals concerned about their earnings.
Nevertheless, for the first few years of the HIV epidemic, the states with the highest number of cases, especially New York and California, assumed that they would receive little additional assistance from the federal government and that most expenditures for AIDS—especially for testing, treatment, and support services—would be made as the result of state budgetary politics. In the politics of AIDS in New York State and California in the early and middle 1980s, "doing it yourself" meant taking action mainly in response to pressures from the white gay population and the health professionals who treated them. Special-interest politics reinforced the way public officials had chosen to interpret the epidemiological data.
Two special interests were involved: gays and blacks. Gay leaders in New York City and San Francisco built effective coalitions that leveraged funds for programs to prevent HIV infection, offer anonymous testing, and provide services for people with symptoms of disease. The coalitions led by gays were not opposed to helping poor blacks and Hispanics. Many of the service programs they established (notably the Gay Men's Health Crisis in New York City) provided considerable assistance to the disadvantaged. But they had other priorities: to promote safe sex among gays and, as both a goal and a shrewd political tactic,
among white heterosexuals; and to provide better health and social services to people with the disease, the majority of whom were still white and gay. Understandably, too, they wanted to help gays who were also black and Hispanic; many of these people were not economically poor, but most of them were discriminated against by other blacks and Hispanics.
At the same time, many black leaders were unwilling to advocate that special attention or funds be given to the problem of HIV infection in their communities. Their refusal to become advocates for particular interventions to prevent the spread of infection, especially for the interventions urged by most white public health leaders, reinforced the disproportionate attention to HIV among white gays.
The reluctance of many black leaders to become special-interest lobbyists on behalf of HIV infection had complicated, overlapping causes. In a recent essay Harlan Dalton explains the political and cultural logic of reticence about AIDS among African Americans. He isolates five "overlapping factors": wariness about acknowledging "our association with AIDS so long as the larger society seems bent on blaming us as a race for its origin and initial spread"; the "suspicion and distrust many of us feel whenever whites express a sudden interest in our well-being"; the "pathology of our own homophobia"; the "uniquely problematic relationship we as a community have to the phenomenon of drug abuse"; and "difficulty transcending the deep resentment we feel at being dictated to once again."[16]
Harlan Dalton, "AIDS in Blackface," Daedalus 118 (Summer 1989): 205-28.
Some of these factors also influenced the behavior of Hispanic leaders in the early years of the epidemic. Most accounts (in the press and by other politicians) stress homophobia as the most important reason for the unwillingness of these leaders to be perceived as special-interest advocates on behalf of AIDS.
The politics of the epidemic changed quickly late in 1989, especially in the cites and states with the highest incidence of cases. The priorities in fighting a plague are learning where it came from, taking emergency action to protect endangered communities, and creating crash programs to experiment with vaccines and potential cures. The priorities in managing a chronic disease are different. These priorities are familiar to everyone who has followed the recent history of lung cancer, heart disease, stroke, or renal disease. Preventing new cases of chronic disease is a difficult and expensive process. Fear and education are effective; but there is no consensus about how much of each to use and what techniques have which effects on particular people. Treatment is expensive
and arduous. Moreover, effective treatment means incremental improvement, not cure.[17]
Daniel M. Fox, "Policy and Epidemiology: Financing Health Services for the Chronically Ill and Disabled, 1930-1990," Milbank Quarterly 67, Suppl. 2, part 2 (1989): 257-87.
Plagues are fought; chronic diseases are managed.By the end of 1989, the coalition demanding more resources for HIV infection had changed, and its membership remained in flux. Prominent blacks were becoming part of the HIV lobby, joining leadership coalitions in several cities and nationally. Dalton, for example, was appointed by Congress to the new National AIDS Commission. Advocates for spending more to prevent and treat HIV were included in the constituency for President Bush's drug abuse initiative. Black and Hispanic advocates for persons with HIV infection (and for minority physicians) were demanding new roles in the politics of research as NIH prepared to award the first contracts for community-based clinical trials. The organizers of these trials made special efforts to increase the enrollment of disadvantaged people. The increasing cost of care for people who were chronically ill with HIV infection was bringing new pressures on federal and state officials to pay for prescription drugs and increase access to outpatient and long-term-care services for members of minority communities. In addition, these new political alignments were occurring when, for the first time in almost two decades, many leaders of state government, industry, and labor were beginning to talk about rethinking our customary arrangements for financing health care, including the care of the poor.
Policies For Hiv Infection Among The Disadvantaged
The coalition on behalf of people with the chronic disease of HIV infection will probably be most effective in obtaining incremental changes in existing policies. More fanciful scenarios will be proposed, but there is little reason to expect that fundamental changes in our national health policies, or in those of the states, will be more than talk for the next several years. It is therefore useful to describe what the dominant policies are, how they affect the increasing proportion of people with HIV infection who are disadvantaged, and what incremental changes seem feasible. Four areas of policy are important: surveillance, prevention, research, and financing.
Surveillance is becoming more aggressive and less responsive to the concerns of civil libertarians and advocates for minority groups. Surveillance means both counting the number of people with infection and
at various stages of the disease and projecting those numbers into the future. Several major assumptions of surveillance policy for the epidemic had changed by the end of 1989. Before then, the incentive to be tested for individuals whose behavior placed them at risk of HIV infection was to learn whether and how to avoid infecting others or, if they were fortunate, how to protect themselves. Now that there was a prophylactic therapy, individuals who might be infected had reason to be tested not just for antibodies to the virus but also for the level of T4 cells in their immune system. Moreover, there was a better case than before for creating registries of the names of infected people, in order to offer them additional testing and treatment as new interventions became available. Such testing and treatment might be particularly beneficial for disadvantaged people who are or were addicted to drugs and for their children.
There were now new incentives to learn more about the changing levels of infection in particular populations, in order to estimate more precisely both near-term costs and the effectiveness of various techniques to prevent infection. Accuracy in counting cases remained an important goal of policy, but for more hopeful reasons than measuring the demographics of the epidemic and projecting costs. Moreover, the risks to persons from breaches of confidentiality were being weighed against the benefits of counseling people to enter treatment. Some states were considering whether to violate the rule of obtaining informed consent for testing—for instance, by routine testing of all newborns for HIV infection, similar to the testing now conducted in every state for phenylketonuria. Such testing would reveal the mother's HIV status, but it would provide a therapeutic benefit for both mothers and children who tested positive for HIV.
Similarly, prevention policy was expanding in 1989 and 1990 to include measures to delay the onset of disease symptoms as well as to reduce the number of people who acquire or transmit the virus. Preventing the onset of symptoms requires persuading people to have their T4 cells tested regularly and to receive chemotherapy. Policymakers and advocates for communities in which many poor people live faced decisions about whether to create new programs of outreach and treatment or to couple preventive treatment for HIV with existing programs of primary care and treatment for addiction.
Policies to prevent people from acquiring or transmitting the virus were also changing as a result of the perception that HIV is a chronic disease that is uncommonly prevalent among members of minority groups.
Many prominent black and Hispanic leaders who had opposed needle exchange programs, for example, continued to do so. But they were under increasing pressure from the media to assess the results of research on the effectiveness of such programs in Europe and the United States. The research provides strong evidence that programs to persuade addicts to change their needle-using behavior reinforce each other and do not discourage addicts from entering drug treatment programs.
Research policy has also been affected by the new perception that HIV infection is a chronic illness that occurs disproportionately among disadvantaged people, especially minorities. The NIH program of community-based trials, begun in 1989, is one example of change. Another, perhaps more important, change is the creation of faster-track drug approval processes by NIH and FDA. Faster tracks were a response to advocacy by leaders of gay organizations and their allies in the research community. FDA policy could change more rapidly if more black and Hispanic leaders join coalitions pressing for changes in it. Finally, the unprecedented outcry by both advocates and public officials about the pricing policies of drug companies—especially of Burroughs Wellcome, which makes AZT—may stimulate policy change or, more likely, industry accommodation, as both the cost of treating HIV infection and the public share of that cost increase.
Financing treatment for persons with HIV infection is the most difficult area of policy in which to effect changes. Treating HIV infection is expensive, and will become more so when more people are tested earlier and repeatedly and receive treatment over a longer period of time. It is too soon to conjecture whether newly approved treatments will decrease hospital cost per case, the most expensive component of care. More important is the context in which political discussion about financing HIV infection occurs. Most state officials continue to assume that the states will be the payers of last resort, even for treatment with newly approved drugs. Legislative leaders report that they are receiving increasing pressure from advocates on behalf of people with other diseases, who worry that persons with HIV infection are getting preferential treatment.[18]
Daniel M. Fox, "Financing Health Care for Persons with HIV Infection: Guidelines for State Action," American Journal of Law and Medicine 16 (Spring 1990): 223-47.
There are orphan drugs, but—politically—there are no orphan diseases.In late 1989 public health officials in several states with the highest incidence of HIV disease wanted to mobilize support for larger and broad federal subsidies, especially for prescription drugs. They argued that new drug treatments made the cost of treatment prohibitive, especially because the incidence of HIV disease was growing most rapidly
among people without private health insurance. In the summer of 1990 Congress authorized the expenditure of $2.9 billion over five years for planning and services in the cities and states with the highest incidence of HIV infection. The act was named for Ryan White, the Indiana teenager whose exclusion from school had attracted national media attention in 1985, and who had died in the spring of 1990. But naming the act for White did not disguise the fact that it provided services mainly for the disadvantaged in a tough budget year that was also an election year for the Congress. In the budget compromise of 1990, the Ryan White Act received only a token appropriation.
The most important impediment to successful political advocacy for additional federal financing of treatment for HIV disease may be that it is one among many areas of inadequacy in health care financing and organization. Only a few political leaders, even in the states with the most cases of AIDS, are willing to risk being accused of trying to solve the AIDS problem while they neglect others. Many state political leaders and representatives of health care interest groups who say that they would join a coalition to promote federal legislation to address access to care for the uninsured, the underinsured, and the poor are refusing to support legislation that is limited to HIV.[19]
Ibid.
Moreover, few states are likely to legislate comprehensive solutions to the problems of financing treatment for HIV infection. Not surprisingly, in the epidemic to date, state financing policies have been a result of past and present health politics, particularly the politics of Medicaid, rather than of the number of cases of disease. In the HIV epidemic, as for most other illnesses, equality of access to health care is not yet an attainable entitlement. For Americans of working age and their children, where they live and for whom they work continue to be the major determinants of what care they can have and how it will be financed.
There have been three stages in state responses to the epidemic, each stage a result of the interaction of politics and the incidence of disease. In the first stage, a state relied on its existing policies for financing health care and regulating the institutions that provide it. Toward the end of the first stage, states earmarked appropriations to pay for care of persons with AIDS. New York was the first to earmark funds. By 1986 states that earmarked funds included, among others, California, New Jersey, New Mexico, and Ohio.
In the second stage, states made deliberate decisions about how to adapt their Medicaid policies and regulations and often initiated state-only
programs to address some of the problems of financing and organizing care for persons with HIV-related diseases. The most frequently implemented policies concerned "waivers," a ruling by the Health Care Financing Administration (HCFA) that a state may make a particular mix of Medicaid services available to some but not all beneficiaries on the condition that the proposed services will not add to federal costs. By the end of 1988, HCFA had granted waivers to six states to reimburse care for persons with AIDS in homes or community facilities as a substitute for acute hospital care. Other states obtained waivers in 1989 and 1990. Several states—Illinois and North Carolina, for example—financed treatment for persons with AIDS as part of a broader grant of waiver authority (for the aged and disabled) from HCFA.
Other states decided not to seek a waiver. Several did not apply, either because they wanted to avoid potential costs or because officials believed that the problem of financing care for HIV-related disease was not yet pressing. In other states—New York and Michigan, for example—the decision not to seek a waiver had other sources. In New York officials decided that Medicaid was already covering "almost everything that was waiverable." In Michigan officials also believed that they were already providing a "rich service package," and, in any case, they regarded waivers as difficult to administer.[20]
Ibid.
By 1989 twenty-seven states routinely appropriated funds for patient care for persons with HIV-related diseases in addition to their Medicaid programs. Eighteen of these states also made appropriations for support services. Most of these funds subsidized inpatient care for people with low incomes, but they were also used for hospices, outpatient clinics, and case management services, and, in ten states, to purchase and administer AZT.
In the third stage—reached by 1990 in California, New York, and to a lesser extent Michigan and New Jersey—states, in collaboration with other payers and institutions, adopted policies for organizing and financing care so that populations other than those eligible for Medicaid services could be helped. In New York, for example, the AIDS Treatment Center program, begun in 1986, mandated enhanced reimbursement to hospitals from all payers for inpatient care and for case management of ambulatory and long-term care. New York also provided enhanced reimbursement rates in long-term-care facilities. In California the Department of Health Services funded twenty-six pilot projects to provide home health and attendant care; subsidized hospice services; and established a new institutional category, a "licensed health care
facility for persons with AIDS." Late in 1989 New Jersey established a new program, apparently the first in the country, of "assessment centers," to encourage early detection of infection, regular testing for the level of T4 cells, and the use of AZT to retard the onset of symptoms. The state provided the start-up costs for this program; Medicaid and private insurers covered most of the ongoing costs.[21]
Ibid.
By 1990 three states had addressed the problem of financing care for persons with HIV infection as part of the larger problem of access for the uninsured and the underinsured. A 1989 Michigan law required the Department of Social Services to "identify potential Medicaid recipients who test HIV positive and pay their insurance premiums so that they can maintain their health insurance policies." The state of Washington implemented a similar HIV/AIDS insurance continuation program. California had a continuation program, but only for persons who were already eligible for Medicaid. Officials in all three states acknowledge that these programs are pilots for addressing other chronic diseases that lead to financial impoverishment and have high public costs.[22]
Ibid.
Efforts to legislate a similar program in New York failed in 1990, mainly as a result of opposition from an aroused insurance industry that was eager to avoid what would be certain losses.Because it is new, spreads so rapidly, and is expensive to treat, HIV infection reveals—more clearly than most diseases do—the flaws in the collection of laws and customs we call health policy. But recognizing flaws creates both problems and opportunities. There is no lack of clever solutions to the problems of health policy in the United States. There is, however, no politically effective coalition at the present time, either nationally or in any of the states, that is willing to pay the price of legislating any of the more fundamental solutions.
The Future Of Policy For Hiv
Four uncertainties will have a profound influence on the politics of the HIV epidemic. One, discussed above, is how the states and the federal government will address the general problems of paying for the care of people with chronic diseases and of providing access to care for the uninsured and the underinsured. The price of the epidemic of HIV infection will surely increase, whether new strategies to finance treatment are specific to this epidemic or address the fundamental problems of health policy in the United States. What is uncertain, however, is the total price and the politics of paying it.
The other three uncertainties arise at the intersection of politics and policy with biology and human behavior. The first is uncertainty about the natural history of the virus—whether it will mutate and, if so, how it will mutate, and how it will respond to efforts by scientists to produce vaccines to inhibit its infectivity and drugs to reduce or prevent its effects.
The second is uncertainty about the number and distribution of the sexual behaviors that transmit infection with HIV and about the effectiveness of various policies to persuade people to modify these behaviors. There is little evidence about the number, distribution, race, ethnicity, and socioeconomic class of homosexuals, of bisexuals, and of heterosexual people who practice unprotected anal intercourse. Moreover, there is little research-based knowledge about the relative effectiveness of various methods of inducing fear and prudence and thereby changing people's sexual behaviors.
The third area of uncertainty concerns the number of people who use addictive drugs and the effectiveness of measures to change their behavior. Estimates of the number of people who use intravenous drugs are mainly conjectures based on extrapolation from the number of people who seek treatment. Moreover, little is known about the linkage of crack, heightened sexual activity, venereal disease, and HIV infection. There is impressionistic evidence that drug-using behavior among more affluent people is linked to HIV infection in areas as diverse as the suburbs of New York and rural Georgia.[23]
Emily H. Thomas and Daniel M. Fox, "AIDS on Long Island: The Regional History of an Epidemic," Long Island Historical Journal 1 (Fall 1989): 92-112. For rural Georgia, personal communication from Charles Konigsberg, Jr., member, National Commission on AIDS.
Evidence about the effectiveness of programs to persuade drug users to change their needle-using and sexual practices has, to date, been more persuasive to advocates than to political leaders.These uncertainties, taken together, make impossible any predictions, or even very many recommendations, about future policies. Numerous alternative scenarios were being debated in late 1990, when this essay was revised for publication in this book. The authors of most of these scenarios assumed that the epidemic would become increasingly expensive to treat, as a result of advances in therapeutics, and that it would continue to have a disproportionate impact on blacks and Hispanics. Thus, most scenarios assumed that the epidemic would make increasing claims on scarce public funds but that it was unlikely that a powerful coalition of political leaders who have white, relatively affluent constituencies would be eager to grant these claims. At the end of 1990, most political leaders seemed to agree that the public attitude
(and that of most of their colleagues) toward HIV infection had become "massive apathy," as one powerful state legislator said.[24]
The legislator was David C. Hollister, who chairs the health appropriations subcommittee in the Michigan House of Representatives. Lest anyone mistake his position, I must emphasize that Hollister made this comment in order to emphasize the importance of overcoming this apathy and to underline the difficulty of doing so in difficult economic times. The comment was made at a planning meeting for a USPHS workshop on AIDS.
Scenarios are inevitably extrapolated from current events. As recently as 1987, for example, a few serious scenarists were conjecturing a rapid spread of HIV infection among affluent white heterosexuals. By 1989 such a scenario was regarded as alarmist. In 1986 and 1987 most scenarios assumed that AIDS was a disease with a relatively swift and terrible course that would, for the near future, not be treatable. By 1989 most health professionals talked about AIDS as the end stage of a chronic disease of uncertain course that could be modified by chemical therapies. Any scenario is likely to be wrong.
For almost a decade, however, HIV infection has dramatized the dilemmas of health policy in the United States. HIV disease is an expensive disease to manage, but our policies distribute most of the resources for managing expensive diseases through Medicare and Medicaid payments for long-term care for the elderly. Prevention is the most cost-effective intervention, but we know very little about the effectiveness of different strategies and have no routine way to pay for implementing them. We spend an unusually large proportion of our national income on health care, but increasing numbers of people are dependent on the inadequate care that is provided by state and local government as payers of last resort. We generously finance biomedical science, but the results of that effort do not translate quickly into measures that reduce the incidence and pain of disease.
In sum, the epidemic of HIV infection continues to reveal what many people already know about health policy in the United States. By doing so, the epidemic clarifies the difference between knowledge and power, and between concern, even compassion, and effective political will.
The AIDS Litigation Project:
A National Review of Court and Human Rights Commission Decisions on Discrimination
Larry Gostin
Every major government, medical, public health, and legal organization to issue a report on the HIV epidemic has condemned discrimination because it violates basic tenets of individual justice and is detrimental to the public health.[1]
Government reports: Presidential Commission on the Human Immunodeficiency Virus Epidemic, Report (Washington, D.C.: U.S. Government Print-Office, 1988); Centers for Disease Control, Recommended Additional Guidelines for HIV Antibody Counseling and Testing in the Prevention of HIV Infection (Washington, D.C.: Public Health Service, 1987). Medical reports: Institute of Medicine and National Academy of Sciences, Confronting AIDS: Directions for Public Health Care and Research (Washington, D.C.: National Academy Press, 1986; 1988 update); American Medical Association Board of Trustees, "Prevention and Control of Acquired Immunodeficiency Syndrome: An Interim Report," Journal of the American Medical Association 258 (1987): 2097-2103. Public health report: Association of State and Territorial Health Officials, Guide to Public Health Practice: AIDS Confidentiality and Antidiscrimination Principles: Interim Report (Washington, D.C.: ASTHO, 1987). Legal reports: American Bar Association, AIDS Coordinating Committee, AIDS: The Legal Issues (Washington D.C.: ABA, 1988); American Bar Association, Policy on AIDS (Washington, D.C.: ABA, August 1989).
Discrimination based on an infectious condition is just as inequitable as discrimination based on race, gender, or disability. In each case people are treated inequitably, not because they lack inherent ability but solely because of a status over which they have no control. Complex and often pernicious mythologies develop about the nature, cause, and transmission of disease. As the Supreme Court has recognized: "Society's accumulated myths and fears about disability and disease are just as handicapping as are the physical limitations that flow from actual impairment. Few aspects of handicap give rise to the same level of public fear and misapprehension as contagiousness."[2]School Board of Nassau County v. Arline, 107 S. Ct. 1123 (1987).
Persons infected with HIV must endure not only the archaic assumption that they present a health menace but also moral disapproval of their behavior. The public association of the disease with traditionally disfavored groups—gays, intravenous drug users, and prostitutes—only compounds the bigotry.
The Presidential Commission on the HIV epidemic concluded that "discrimination is impairing this nation's ability to limit the spread of the epidemic." The absence of adequate safeguards against discrimination undercuts the Public Health Service's strategy of early identification of persons infected with HIV.[3]
Centers for Disease Control, "Guidelines for Prophylaxis against Pneumocystis Carinii Pneumonia for Persons Infected with HIV," Morbidity and Mortality Weekly Report 38, no. S-5 (1989): 1-9.
Case identification (testing, reporting, and partner notification) is of growing importance as the benefitsThis article was originally published as the second part in a two-part series in the Journal of the American Medical Association 263 (1990): 2086–93, © 1990, American Medical Association, and is reprinted with permission. The AIDS Litigation Project was supported under a contract from the National AIDS Program Office (NAPO), U.S. Public Health Service. I would like to thank Lane Porter, J.D., M.P.H. (American Bar Association); and Hazel Sandomire, J.D. (Columbia Law School); James Allen, M.D., and Iris Gelberg of NAPO; and Richard Riseberg, J.D., Chief Counsel, U.S. Public Health Service.
of early intervention become clearer. Fears that there will be a breach of confidentiality and subsequent discrimination may discourage individuals from cooperating with vital public health programs.
No studies have yet revealed the scope and kinds of discrimination that have occurred since the beginning of the HIV epidemic. In this essay I review 149 cases of discrimination described in complaints, legal briefs, settlements, and decisions by courts and human rights commissions. (The cases cited are listed at the end of this essay; numbers in brackets in the text refer to these cases.) I also review major reports from federal[4]
Federal Office of Civil Rights, Department of Health and Human Services, AIDS (Washington, D.C.: DHHS, 1987).
and municipal[5]San Francisco AIDS Referral Panel, Annual Report (San Francisco: AIDS Referral Panel, 1989); San Francisco Human Rights Commission, Report on Sexual Orientation and AIDS (San Francisco: Human Rights Commission, 1987-88); AIDS Discrimination Cases Handled by the Office of the City Attorney, Los Angeles. Personal communication from David Schulman, January 27, 1989; New York City Commission on Human Rights, Reports on Discrimination against People with Aids (New York: Commission on Human Rights, 1983-1987; updates, 1988, 1989).
antidiscrimination agencies, as well as independent policy analysts.[6]R. J. Steele et al., Identification and Assessment of State and Local Strategies to Prevent Discrimination (Silver Spring, Md.: Birch and Davis Associates, 1989); B. Bridgham and M. Rowe, AIDS Discrimination: A Review of State Laws That Affect HIV Infection, 1983-1988 (Washington, D.C.: Intergovernmental Health Policy Project, 1989).
Together these data provide a comprehensive picture of past, current, and potential future patterns of discrimination.Americans With Disabilities Act
In 1990 the U.S. Congress enacted the Americans with Disabilities Act (ADA), the most sweeping civil rights measure since the Civil Rights Act of 1964 with respect to people with disabilities. For the first time, federal legislation will comprehensively extend antidiscrimination protection for people with disabilities, including HIV infection, to the private as well as the public sector, in employment, public services, public transportation, public accommodations, and telecommunications.
The ADA proscribes discrimination against a qualified individual because of his or her disability. "Disability" is construed very widely to include a broad range of physical and mental disabilities "which substantially limit one or more of the major life activities of that individual; a record of such impairment; or being regarded as having such an impairment." The courts have consistently found that all stages of HIV disease—including AIDS, AIDS-related complex (ARC), and asymptomatic infection—are handicaps under the federal Rehabilitation Act of 1973 [15, 84]. That act continues in force and includes an almost identical definition of "handicap" as in the ADA.
Congressional debates demonstrate conclusively that HIV/AIDS comes within the purview of the ADA. The act would make AIDS discrimination unlawful unless the person poses a "direct threat" to fellow workers. "Direct threat" means a "significant risk to the health or safety of others that cannot be eliminated by reasonable accommodation." Par ticularly controversial was the applicability of the act to food handlers infected with HIV. The ADA instructs the secretary of health to publish
a list of infectious or communicable diseases that are transmitted through handling of the food supply. Even though the risk of HIV transmission gave impetus to this amendment, it is unlikely—given the extant epidemiological data—that HIV will appear on the secretary's list.
A disabled person must be "qualified," which means that he or she is capable of meeting all performance criteria of the particular position, service, or benefit. There is, moreover, an affirmative obligation to provide reasonable accommodation if it would enable the person to meet the performance criteria. Accommodation is not reasonable if it involves "undue hardship," which is an action requiring significant difficulty or expense.
The ADA does not cover federal employees, who continue to be protected by the Rehabilitation Act of 1973. Nor does the ADA cover housing. The Federal Fair Housing Amendment of 1989 prohibits private and public discrimination in the sale or rental of accommodation.
All states also have handicap statutes, all but four of which prohibit discrimination in the private as well as the public sector. In more than half the states, courts, human rights commissions, or attorneys general have formally or informally declared that handicap laws apply to AIDS or HIV infection.[7]
National Gay Rights Advocates, Protection against Discrimination under State Handicap Laws: A Fifty State Analysis (San Francisco: NGRA, 1989).
Courts have reasoned that state handicap statutes closely follow the federal civil rights approach, and should cover HIV as a protected disability [16, 18]. To reinforce the importance of safeguarding persons infected with HIV from discrimination, many states and municipalities have enacted AIDS-specific antidiscrimination statutes.[8]L. Gostin, "Public Health Strategies for Confronting AIDS: Legislative and Regulatory Policy in the United States," Journal of the American Medical Association 261 (1989): 1621-30.
Discrimination based on an immutable condition such as infection should be so repugnant in our society that it should not be left to the inconsistencies and vagaries of the current legal system; states where people infected with HIV need greatest protection may afford the least.
This essay will review the major areas of discrimination currently being litigated: education, employment, housing, insurance, and health care.
Education
From the earliest times of the HIV epidemic, exclusion of schoolchildren infected with HIV was an issue debated with great emotion. Parents of children infected with HIV sued school boards for denying children state education [13], giving homebound instruction [3, 12], or
making the child wait for inordinate periods while the board developed a policy [9]. In other cases HIV-infected children were permitted to attend school, but they were clearly singled out as different: placed alone in a separate "modular" classroom [4]; required to use a separate bathroom and to be accompanied by an adult on all field trips [14]; or even isolated inside a glass booth [1].
Some school board policies, perhaps reasonably, required disclosure of the child's identity to the school district, faculty, and staff [3]. Others revealed the child's identity throughout the school or even publicly announced to the entire community that the infected child had been admitted to the school [2].
Parents challenging decisions to exclude their children from education at school relied on the Rehabilitation Act, which applies to most schools because of their receipt of federal funding [3], and on the federal Education for All Handicapped Children Act,[9]
20 U.S.C. sections 1400 et seq.
which gives all school-age handicapped children the right to a free public education in the least restrictive environment appropriate to the case [1, 6].The courts have not tolerated decisions to exclude HIV-infected children from ordinary schools [3–5, 7, 9]. The courts even found it unlawful to exclude a kindergartner who bit another child and was labeled "aggressive" by the school psychologist [8].
Courts that have safeguarded the right of HIV-infected children not to be discriminated against in their school placement have, nonetheless, required the school, parents, and child to comply with specified safeguards [3, 7, 8], including stringent compliance with CDC guidelines;[10]
Centers for Disease Control, "Education and Foster Care of Children Infected with Human T-Lymphotropic Virus Type III/Lymphadenopathy-Associated Virus," Morbidity and Mortality Weekly Report 34 (1985): 517-21.
covering of all sores and lesions; maintenance of elevated standards of personal hygiene; denial of participation in curricular or extracurricular contact sports; and frequent medical examinations by both a private and a school physician. Some courts have gone further and required sexual and drug education for students, parents, and even the entire school system [7, 13].In cases where the school board believed there was some behavioral or medical reason not to integrate the child fully, some courts have delineated a fair procedure for deciding the case, including parental and medical participation [13].
Most courts have required full integration without any visible barrier between the child and his or her classmates. To do otherwise, the courts reasoned, would cause irreparable emotional and psychological harm to the child [3, 4, 7]. However, a federal district court mandated a "safeguard" that stigmatized the child perhaps more than exclusion from
school [1]. The court ordered the school board to construct a cubicle in the classroom with a large picture window to allow sound from the outer area to be heard. The cubicle, to be sure, allowed the child to be in the classroom and avoided the already remote risk of transmission. However, it provided a visible symbol of separation of the child from the rest of her class. The Eleventh Circuit Court of Appeals subsequently vacated the district court's decision, holding that the child must be placed in the least restrictive environment that would allow her to attend school.
The most difficult cases involved decisions to exclude students from educational settings where they may be inherently more likely to cut themselves and expose others to their blood.[11]
Association of American Medical Colleges, The HIV Epidemic and Medical Education (Washington, D.C.: AAMC, 1989).
Illustrative cases involve a dental student excluded because the course of study required performing invasive procedures, such as tooth extractions [122], and a student excluded from a medical assistant program [116].Employment
The complaints reviewed by courts and human rights commissions provide insight into the kinds of employment disputes that have occurred since the start of the epidemic: dismissal without medical evidence [51, 55], notice [28], or a hearing [16, 18]; demotion to positions of lower experience and skill—for instance, an experienced teacher to an administrator [15], a fire fighter to a janitor [32], and a finance manager to a car salesman [49]; denial of insurance benefits to pay for AIDS-related expenses [36, 49]; reduction in salary [31]; harassment [39]; and a dishonorable discharge from the National Guard after the serviceman refused a reduction in rank solely because he was infected with HIV [52].
Cases were clustered in three areas, which account for the majority of employment disputes: health care workers [47, 48, 117, 118]; workers who provide human services for children—for example, teachers [15, 35, 58, 59], foster parents, and day care workers [34, 50]; and food handlers [21, 27, 37, 41].
Adverse employment decisions did not appear to be based on an assessment of the person's ability to do the job. Subtle abilities to do complicated or safety-oriented tasks were rarely an issue. Indeed, some adverse employment decisions were based merely on rumor [27, 54] or innuendo [37] that the person was infected with HIV; other such decisions were made because the employee appeared to have lost weight or
was absent from work for short intervals as a result of pneumonia [44], or refused to be tested for HIV [53], or refused to disclose the results of a test taken at an anonymous site [34]. Employees were dismissed despite the fact that they had received regular salary increases based on merit [30], had been honored for "outstanding" work [56], or had "exemplary" work records [52].
Employers have given many reasons for their decisions. They have contended, for instance, that their establishment was being picketed [45]; that there was a threat of violence to the infected worker [22]; that they received adverse publicity when an employee appeared on television as an AIDS advocate [48]; or that they had to protect their business interests [43] and were facing a significant increase in insurance premiums because an employee was known to have AIDS [29].
Virtually all courts have held that a positive HIV test result or a diagnosis of an HIV-related disease does not provide a sufficient basis for unfair treatment by employers [15, 16, 18] or their agents [21]. If a person infected with HIV is capable of doing the job with reasonable accommodations, then discrimination is prohibited. The employers' decisions, moreover, must be based on reasonable medical judgments [18].
Housing And Property
People infected with HIV have been denied equal opportunity in the purchase or lease of housing because of an erroneous belief that they pose a health risk, and because they make nondisabled people uncomfortable [63]. The factual pattern of complaints brought under this legislation by persons infected with HIV are varied: evictions from housing [68]; rescission of a contract to buy because the previous owner had AIDS [65]; locking out an infected tenant; and harassment or assault [73].
Numerous cases before human rights commissions involved evictions from premises because a person with AIDS missed monthly rent payments. One court refused to "add to the tenant's misery and suffering" by allowing the eviction [68]. Other cases involved tenants with HIV disease whose health was being affected by landlords' refusal to repair broken plumbing, heating, or other basic services in the building [72, 74].
Where courts or human rights commissions have applied handicap law to housing discrimination, they usually afford relief [65, 68, 73]. Courts have extended this protection to those who were evicted because
they were perceived to be infected with HIV, although they actually were not—for instance, a mother and sister of a person with AIDS [71] and a healthy homosexual man [72]. It is reasoned that to discriminate against persons on the basis of a fear that they are infected is contrary to the purpose of civil rights law [64].
Still, serious questions remain about the adequacy of existing law to protect HIV-infected persons from housing discrimination. A particularly important consideration is whether a "life partner" can be protected against discrimination [66, 67]. Where a person with AIDS has in every manner possible made his life partner a member of his immediate family, that partner should be afforded the same rights in law as a spouse [67].
More troubling is the tendency of some courts to rely on contract rather than handicap law. Where contract law is used, courts focus on the failure to disclose a person's serological status, thus voiding the housing contract [109]. Other courts have suggested that if housing contracts were clearer in requiring disclosure of a person's medical condition, the property might not have to be sold to a person with AIDS [65]. The Federal Fair Housing Act may provide a solution by proscribing contract provisions that require disclosure of a person's HIV status.[12]
Op. Tex. Att. Gen., No. JM-1093; AIDS Lit. Rptr., Oct 13, 1989, p. 3467.
Nursing Homes
The federal Office of Civil Rights, in the Department of Health and Human Services, investigating admissions to residential health care facilities, found a general reluctance to provide services for persons infected with HIV. Hospital discharge planners experienced so many admission denials of AIDS patients that many stopped their attempts to place them in skilled nursing facilities.
State human rights commissions have reported the same difficulty in obtaining admissions to skilled nursing facilities. Illustrative cases included a city's refusal to issue a zoning permit for a hospice for terminally ill AIDS patients [63] and a refusal to rent premises for a group home for people with AIDS [69]. Some nursing homes have a fixed policy not to take patients with AIDS, and patients have died before hearings to challenge these rules could be held [100].
Premises For Health Care Professionals
Professionals who provide health care or social services for persons with HIV disease sometimes have found themselves the objects of housing
discrimination. Examples include the eviction of a dentist who listed his name with the Gay Men's Health Crisis to provide services for AIDS patients [101]; refusal to sell property to a social service group that would be serving clients with AIDS [112]; or refusal to allow physicians to move into an apartment because they would be treating persons with AIDS [110].
The courts have protected health care professionals who are not themselves handicapped but are trying to provide vital services for those who are [70, 111]. When the courts balance the equities of such cases, they consider the "enormous public interests involved," because discriminatory practices "injure society as a whole." If professionals were prevented from serving persons with AIDS, "arguably the group most in need of medical treatment would suffer" [110]. Health care professionals who sought to make their services available to "a needy and discriminated against class and who are thwarted in their efforts" would be protected [111].
Public Accommodations
The right of persons infected with HIV to receive equal treatment in public accommodations has been an ongoing concern of human rights commissions. Complaints of discrimination in physicians' private offices have predominated and are discussed below, in the section on "Health Care Providers' Duty to Treat." Other discrimination complaints in this area concern refusals to provide personal services at a nail salon [75, 77, 82, 83], an airline [81], a television studio [79], and a spiritual retreat [78]. Funeral home owners have refused to embalm the body or to allow an open-casket service [80], or they have charged inflated fees [76]. Courts and human rights commissions have ruled that the protection afforded by handicap legislation persists after death [76].
Insurance
There is an irresolvable conflict between standard insurance underwriting and nondiscrimination principles. Health and life insurance policies are written after an assessment of the applicant's risk. The industry's objective is to discriminate against those with higher risk by charging higher premiums, placing a cap on expenses covered [147], or refusing to write the policy [137]. If the actuarial principles of the insurance industry are fully accepted, it follows that persons infected with HIV will be treated differently because of the undoubtedly higher risk they
incur. The increased risk of HIV infection is greater than the risk associated with smoking, high blood pressure, or other conditions that are taken into account by insurers. The industry therefore regards persons infected with HIV as uninsurable,[13]
Health Insurance Association of America and American Council of Life Insurance, Survey of Health and Life Insurance Companies Concerning AIDS (Washington, D.C.: HIAA and ACLI, 1986).
and it does not believe that such a position reflects unlawful discrimination [131].Insurance underwriting, however, is not merely a business, particularly when it provides health coverage. Public policy favors the provision of decent health care for all persons suffering from serious illness. The consequence of systematic refusal to insure persons infected with HIV is that the financial burden shifts to public hospitals that must care for patients without compensation. Many hospitals that serve large numbers of low-income persons with AIDS have encountered moderate to severe financial shortfalls because of their patients' lack of private health insurance coverage.[14]
D. P. Andrulis, V. B. Weslowski, and L. S. Gage, "The 1987 U.S. Hospital AIDS Survey," Journal of the American Medical Association 262 (1989): 784-94.
The most advantageous policy would share the health costs equitably among the government, private insurers, and employers.Several states have sought to regulate the insurance industry by limiting the use of HIV testing in making decisions about insurability. The intention is to ensure that the industry assumes its fair share of the burden of health care costs. The courts, however, have been highly suspicious of such regulation. The Massachusetts Supreme Judicial Court held that the insurance commissioner had no statutory authority to prohibit insurers from using HIV tests in making underwriting decisions regarding health insurance. The court reasoned that the commissioner cannot interfere with an insurer's ability to assess risk [135]. A New York court also limited the regulatory power to require insurers to offer insurance without regard to proven actuarial factors [136].
A federal district court did uphold a District of Columbia statute that proscribed the use of any HIV test for the purposes of issuing insurance or adjusting rates or premiums [131]. The court, however, suggested that the law may well be "inequitable" or "unwise." It also based its decision largely on the unreliability of HIV antibody tests, an argument that may not be valid today.
Health Care
The HIV epidemic has transformed perceptions about the hazards involved in the practice of medicine, nursing, and associated fields.[15]
L. Gostin, "Hospitals, Health Care Professionals and AIDS: The 'Right to Know' the Health Status of Professionals and Patients," Maryland Law Review 48 (1989): 12-54.
Documented cases of occupational transmission of HIV have demonstrated that health care professionals can contract their patients' lethalinfections.[16]
Centers for Disease Control, "Recommendations for Prevention of HIV Transmission in Health-Care Settings," Morbidity and Mortality Weekly Report 36 (1987): S2-S18.
AIDS, therefore, is increasingly being viewed as an occupational disease for health care professionals, despite the evidence that HIV is exceedingly hard to transmit in health care settings. The litigation reviewed in this section examines the duty to treat patients with HIV disease, access to experimental treatments, and the rights and responsibilities of HIV-infected health care professionals.Health Care Providers' Duty To Treat
Health care professionals have an ethical duty to provide treatment for persons infected with HIV.[17]
A. Jonsen, "The Duty to Treat Patients with AIDS and HIV Infection," in AIDS and the Health Care System, ed. L. Gostin (New Haven, Conn.: Yale University Press, 1990); Council on Ethical and Judicial Affairs, American Medical Association, "Ethical Issues Involved in the Growing AIDS Crisis," Journal of the American Medical Association 259 (1988): 1360-61.
The training, licensure, and professional purpose of health care professionals require that decisions be based on a good-faith clinical assessment of benefit and harm to the patient, and not on the patient's handicap. The risks to health care professionals who take rigorous precautions against contracting infection, moreover, are remote and do not justify deviation from this professional obligation not to discriminate. Certainly, the vast majority of health care professionals provide dedicated and equal treatment for all their patients.[18]P. M. Arnow et al., "Orthopedic Surgeons' Attitudes and Practices Concerning Treatment of Patients with HIV Infection," Public Health Review 104 (1989): 121-29.
In the instances where treatment has been withheld from patients infected with HIV, the courts have enforced the professional obligation to treat HIV-infected patients [84, 88, 89].The litigation illustrates the harm that can result from treatment refusals. In one case a clinically depressed woman was left unattended in a room where she could lock the door and take an overdose of pills [94]. In other cases medical personnel refused to perform a routine hernia operation;[19]
Doe v. Shasta General Hospital, Shasta City, Cal. Super. Ct. No. 92336 (1988).
intentionally dropped a gurney after hearing that the person was infected with HIV [97]; or were so late in responding to an emergency call that the patient suffered an aggravated brain injury [100]. In some cases patients allege that excessive force was used [94].Discriminatory practices may not always cause physical harm but show a lack of respect, empathy, and care that is inexcusable. Patients should not be placed in isolation except in rare circumstances when their medical condition requires it [94, 103, 104]. There is no adequate public health justification for refusing to administer medicine or alter a chest drain [104]; for leaving food trays outside the door [104]; or for excluding the patient from patient activities, including use of the telephone or other hospital amenities [103].
While few health care professionals would condone blatant treatment refusals that cause harm or result in insensitive treatment of patients, some practices are far more subtle; so it is often difficult to distinguish
between the valid exercise of clinical judgment and a disguised form of prejudice. Physicians are defending their decisions not to treat, or to refer, HIV-infected patients by arguing that they are exercising clinical judgment and are not practicing discrimination, and that to restrict the physician's right to decide whom to treat or when to refer is to dictate the practice of medicine [102].
It is true that the physician-patient relationship is not easy to regulate by law, and that courts must grant due deference to the good-faith judgments of responsible health professionals [87]. Still, the physician's exercise of clinical judgment cannot render all treatment refusals or referrals immune from review if there is evidence to show they were motivated by prejudice [88]. Consider, for example, physicians' claims in court that they have insufficient expertise to treat any person with AIDS [87, 127]. Certainly, there are some manifestations of HIV disease that require specialized knowledge. However, all physicians are held by law to have a level of expertise commensurate with the standard prevailing in their specialty. As HIV disease becomes more prevalent, primary practitioners such as internists [87] or dentists [88] must be trained in the diagnosis and treatment of HIV disease, with referral where indicated. Specialists such as surgeons, nephrologists [93], and allergists [92] also need to be able to provide services for persons infected with HIV. Failure to maintain basic skills in relation to one disease may be grounds for revocation of a physician's license. A decision not to treat any patient infected with HIV [96, 98] or a refusal even to make a referral is likely to be viewed by the courts as medically unjustified and based on irrational fear or prejudice [102].
Another reason given for refusing to treat patients infected with HIV is a concern about occupational hazards. Legal and ethical obligations of health care professionals require them to endure reasonable risks, for example, where treatment is necessary to save or prolong life [93]. But some health care professionals take a different view when the treatment is elective [92, 98] or cosmetic [107]. The question then becomes whether patient X should receive different treatment from patient Y , not because of clinical differences but because of a perceived occupational risk to the physician. Professionals sometimes refuse to provide treatment because of inadequate equipment, education, or training for infection control [101, 107]. In particular, they claim that the federal Occupational Safety and Health Rules permit employees to refuse to perform assigned tasks because of a reasonable apprehension of serious injury [89].
All patients have a right to expect appropriate treatment. They also have a right to expect that professionals will have available, and will utilize, adequate infection control. Where the necessary equipment or training is not available, the proper response is to seek redress from the health care facility and not to turn the patient away [89].
Comprehensive settlements to disputes in this area supervised by the courts [106] and the federal Office of Civil Rights [150] provide models of good practice. Inter alia , they require health care facilities to develop policies for nondiscriminatory admission of patients with HIV disease; to protect patient confidentiality; and to comply with CDC guidelines by providing education, training, and necessary equipment for rigorous infection control.
The courts have found that persons infected with HIV, even if asymptomatic, cannot be discriminated against in the receipt of health care services [84]. Most courts have decided that private medical or dental offices as well as clinics, hospitals, and dispensaries are "public accommodations" and that the medical field is not exempt from the requirement not to discriminate on the basis of handicap [88, 98]. However, one court held that a physician's private office is "unique in character" and should not be regulated as a public accommodation [87].
It is conceivable that courts may be more likely to uphold discriminatory practices in the future where there is the potential for significant exposure to blood. Pending cases that raise this question involve dialysis units [93, 124].
The professional obligation to treat patients who can clearly benefit must extend to all health professionals, whether in private offices or where there may be exposure to blood. To exempt certain professionals from the obligation to provide nondiscriminatory treatment to patients infected with HIV would jeopardize the health of those most in need of medical attention. It would also unfairly shift the burden from physicians who choose to opt out to those dedicated to providing care without prejudice.
Access To Innovative Treatments
The HIV epidemic has revitalized a perennial debate about whether there is legal right of access to experimental or innovative treatments for hopelessly ill patients.[20]
B. Freedman, "Licensing of New Drugs: The Balance between FDA Regulation and the Hopes of the Terminally Ill," Hastings Center Report 19 (1989): 14-20.
Traditionally, the law will not provide an enforceable entitlement to particular medical services unless they arenecessary in an emergency.[21]
T. Brennan, "Ensuring Adequate Health Care for the Sick: The Challenge of the Acquired Immunodeficiency Syndrome as an Occupational Disease," Duke Law Journal (1988): 29-78.
The health care provider may not discriminate on the basis of a patient's serological status. But what if the refusal to treat does not involve discrimination but is based on a valid clinical, research, or financial consideration?Persons with AIDS claim the right to unimpeded access to innovative pharmaceuticals approved by the federal Food and Drug Administration, including the right to adequate financing. AIDS patients have successfully sued both the state [85] and hospitals [86] for rationing their access to AZT and aerosolized pentamidine on the grounds of inadequate resources rather than for clinical reasons. The state of Missouri limited medical coverage for AZT to recipients who have a history of cytologically confirmed Pneumocystis carinii pneumonia (PCP) or an absolute T4/helper/inducer lymphocyte count of less than 200, in accordance with the FDA approval statement. A federal court ordered that Medicaid coverage for the drug must be determined by the physician's decision that the drug is medically necessary [85]. A federal district court in Texas prohibited a hospital AIDS clinic from using a waiting list to control access to AZT and pentamidine, because it violated state public policy that no person be denied medical treatment for fiscal reasons [86].
In the treatment of HIV disease, often the most promising pharmaceuticals are as yet unapproved. The only realistic access to such innovative treatments for hopelessly ill patients may be through participation in a clinical trial. There is no established legal right to experimental therapy. Yet patients have bitterly disputed decisions to exclude them from clinical investigations. In some cases the exclusion appeared almost arbitrary. One subject, for instance, was prevented from continuing experimental medication after arriving forty-five minutes late for a clinical trial appointment [95]. Patients have even contested the discontinuation of a clinical investigation because the preliminary results indicated the drug was ineffective. In one such case the patient contended that the drug had stabilized his condition [91].
This search for a promising therapeutic intervention vividly illustrates the human anguish of AIDS patients. The potential conflict between patients' rights of access to unproven pharmaceuticals and valid research goals is powerful. If patients succeed in achieving an ethical or even a legal entitlement to unimpeded access to experimental drugs, the ability of researchers to conduct scientifically sound research could be compromised by a lack of subjects willing to participate in controlled clinical trials.
Hiv-Infected Health Care Professionals: Testing And Limitations On The Right To Practice
A strong ethical argument can be made that health care professionals who are infected with HIV should be permitted to continue their normal practice, provided they are capable of doing so.[22]
L. Gostin, "HIV-Infected Physicians and the Practice of Seriously Invasive Procedures," Hastings Center Report 19 (1989): 32-39.
The potential harm to patients is negligible if rigorous infection control procedures are used. The risk of transmission of HIV from health care professional to patient is estimated to be exceedingly low, with no documented case of transmission.[23]J. R. Allen, "Health Care Workers and the Risk of HIV Transmission," Hastings Center Report 18 (1988): S2-S5.
The burden on health care professionals if they are denied the right to practice, on the other hand, is considerable.[24]L. M. Peterson, "AIDS: The Ethical Dilemma for Surgeons," Law, Medicine and Health Care 17 (1989): 139-44.
The professional can lose his or her livelihood, and disclosure of information to colleagues and patients can be psychologically harmful.This relatively straightforward ethical analysis, however, is not reflected in the professional literature or judicial case law. The American Medical Association's ethical position is that a "physician who knows he or she is seropositive should not engage in any activity that creates a risk of transmission of the disease to others." If professionals are infected with HIV, they should consult their physician and employer to determine whether it is safe to continue to practice.
The AMA position, which opposes any risk to patients, is exceedingly harsh. That standard could well require hospitals to place some limits on the right of an HIV-infected professional to practice. The guideline to consult the professional's physician and employer begs the question, for it does not specify the circumstances that might warrant limitations on the right to practice. One rational standard, for example, would be to allow the professional to practice normally (with supervision and careful infection control), but to avoid the performance of invasive procedures where blood exchange is possible.
The problem with the AMA's ethical position that any risk must be avoided is that it could be used by the courts to set an enforceable legal standard of care. Failure of hospitals or health care professionals to comply with that standard could result in liability. In fact, in a growing number of cases hospitals, clinics, and group practices are summarily excluding health care professionals infected with HIV, purporting to respond to ethical guidelines [122]. More worrisome is the argument that, since it is ethically wrong for infected professionals to treat patients, there is a correlative duty to screen workers. The courts, moreover, have been inconsistent in resolving disputes between health care facilities and their HIV-infected employees.
The contrasting decisions of the federal courts in Glover [113] and Leckelt [114] illustrate the dilemma. In Glover the Eighth Circuit Court of Appeals found that a decision of a facility for mentally retarded persons to screen its staff who are in direct contact with patients is unconstitutional. The basis for the policy was the hospital's concern about clients who bite or scratch staff and become exposed to their blood. The appellate court upheld the district court's view that the risk to patients was low, "approaching zero." Courts [125] and human rights agencies [128] have also held that a hospital's repeated refusals to allow an HIV-infected nurse to return to work constitute unlawful discrimination. In one case the hospital even refused the nurse's offer to be transferred to working in the supply room [128].
The federal district court in Leckelt took a very different view of a clinic's decision to dismiss a nurse after he refused to disclose the results of an HIV test conducted at an anonymous test site. The nurse had been previously treated for syphilis and was a chronic carrier of hepatitis B virus. The court held that the nurse was not discriminated against, because disclosure of the test result was the necessary first step in safeguarding the security of patients.
Health care facilities support their decisions to dismiss, or limit the practice of, infected health care professionals on public health, ethical, and economic grounds. They suggest that the prospect of transmission of HIV during a professional career of performing invasive procedures is a real risk: "gloves cannot prevent penetrating injuries by needles or other sharp instruments," such injuries are common, and the consequences of infection of patients are severe [122]. They also argue that there is an ethical obligation not to permit any known risk of transmitting HIV infection to patients [122]. Some hospitals stress the economic hardship they would suffer if they knowingly continued to employ a professional infected with HIV; the perception is that the public would refuse to be treated in a facility known to have infected professionals on its staff [121].
The impact of hospital policies on HIV-infected health care professionals has been significant. A nurse was subjected to "full isolation procedures," with his colleagues "fully masked, gowned and gloved" while in his presence [119, 126]; a director of anesthesiology was denied contact with patients and was then disciplined when he personally assisted a patient who had vomited and was in immediate danger of aspirating [120]; a gynecologist was forced out of a lucrative medical partnership despite his offer to do no "hands-on" work [123]. Even health care professionals who contracted HIV from occupational exposure
have been dismissed or penalized by the hospital where the exposure took place [124, 125].
Thoughtful resolutions of the rights and duties of HIV-infected health care professionals have been ironed out in court-approved settlements. These settlements have characteristically permitted health care professionals to continue to practice but to be limited in the performance of seriously invasive procedures. The settlements also required health care professionals to use rigorous infection control procedures at all times and to submit to regular medical examinations and supervision by their physician and the hospital [125]. Settlements have also required the health care facility to provide special training for the infected professional [116] and education for all personnel [117].
Changes And Trends In The Pattern Of Discrimination
Human rights commissions report that, early in the HIV epidemic, employment discrimination was "systemic," meaning that the problem was "company or industry wide, that a tacit or written policy existed which would adversely affect any person with AIDS who came into contact with the policy" [150]. However, complaints of discrimination and cruel behavior have been significantly reduced when employers have introduced AIDS education programs in the workplace.
The same changing pattern of discrimination is apparent in education, housing, and public accommodations. Traditional forms of discrimination—such as exclusion of children from school, refusal to rent or sell property, or refusal to provide personal services—are declining.
Complaints about discrimination in health care, nursing, and social services have predominated in recent years, and this trend is likely to continue. Major issues to be faced in the coming years will involve admissions of HIV-infected students to medical and dental schools; employment of HIV-infected health care workers, particularly those performing invasive procedures; and access of HIV-infected patients to nursing homes, hospitals, private medical and dental offices, and other health care facilities.
There are many reasons for the changing complexion of discrimination since the beginning of the HIV epidemic. Most important, public opinion surveys show that the overwhelming majority of respondents understand the primary modes of transmission of HIV.[25]
D. A. Dawson, AIDS Knowledge and Attitudes for January-March 1989: Provisional Data from the National Health Interview Survey; Advance Data from Vital and Health Statistics 176 (August 15, 1989): 1-12.
Attitudes toward persons at high risk of HIV, while initially hostile,[26]R. J. Blendon and K. Donelan, "Discrimination against People with AIDS: The Public's Perspective," New England Journal of Medicine 319 (1988): 1022-26.
are softening. Educationalprograms designed to promote greater acceptance and tolerance of persons infected with HIV have achieved a measure of success.[27]
P. D. Cleary, "Education and the Prevention of AIDS," Law, Medicine and Health Care 16 (1988): 267-73.
The shifting pattern of discrimination is further explained by the rapid ethnographic changes in the HIV epidemic.[28]
S. R. Friedman, J. L. Sotheran, and A. Abdul-Quader, "The AIDS Epidemic among Blacks and Hispanics," Milbank Quarterly 65, Suppl. 2 (1987): 455-99.
As the epidemic moves from the gay community to intravenous drug users, there is a greater likelihood that persons with HIV disease will have impeded access to services. Intravenous drug users have traditionally been underserved in the health care systems because of their socioeconomic class and because of the lack of expertise and willingness among many health care professionals to treat drug abuse.Often the reason for discriminatory practice is not pure prejudice or even ignorance or irrational fear. Rather, exclusion of HIV-infected persons is intended to eliminate all risk of infection through exposure to blood. That is why health care and emergency services have become the new focal points for discrimination. These service providers should recognize that they cannot expect to eliminate all risk. As long as strict infection control procedures are used, however, occupational risks should remain within acceptable limits.
Discrimination is also fueled by financial concerns. Persons with HIV disease can increase costs by driving up insurance premiums or deterring potential customers. But the very purpose of civil rights law is to get beyond the inequities of a market economy and to set standards of equal opportunity that cannot be compromised.[29]
United States v. Pelzer Realty Co., 484 F.2d 438, 443 (5th Cr. 1973), cert. denied, 416 U.S. 936 (1974).
Nondiscrimination for persons infected with HIV is consistent with the prevailing sense of justice in America. With continued AIDS education, rigorous enforcement of handicap law, and increased tolerance of gays and IV drug users, discrimination can be reduced and, with it, the public health advanced.
Compilation Of Cases
Many of the cases in the compilation are from primary source material and are not reported elsewhere. Primary sources include the Lambda Legal Defense Fund (a lesbian and gay rights advocacy organization), the Columbia Law School AIDS Clinic, the American Civil Liberties Union, and others. Readers who want a more detailed understanding of the methodology of how the cases were collected and reported and an expanded citation form are directed to L. Gostin, L. Porter, and H. Sandomire, The AIDS Litigation Project . 2 vols. (Washington, D.C.: U.S. Government Printing Office, 1990).
Education
1. Martinez v. School Board of Hillsborough County, Fla. , 861 F. 2d 1502 (11th Cir. 1989), reversing , 711 F. Supp. 1293 (M.D. Fla. 1988).
2. Child v. School Board of Fairfax County , 875 F. 2d 314 (4th Cir. 1989).
3. Doe v. Dolton Elementary School District No. 148 , 694 F. Supp. 440 (N.D. Ill. 1988).
4. Robertson v. Granite City Community Unit School District No. 9 , 684 F. Supp. 1002 (S.D. Ill. 1988).
5. Doe v. Belleville School District No. 118 , 672 F. Supp. 342 (S.D. Ill. 1987).
6. Parents of Child v. Coker, 676 F. Supp. 1072 (E.D. Okla. 1987).
7. Ray v. School District of DeSoto County , 666 F. Supp. 1524 (M.D. Fla. 1987).
8. Thomas v. Atascadero Unified School District , 662 F. Supp. 376 (C.D. Cal. 1986).
9. Phipps v. Saddleback Valley Unified School District , 251 Cal. Rptr. 720 Cal. App. 4th 1988).
10. District 27 Community School Board v. Board of Education , 502 N.Y.S. 325 (Sup. Ct., Queens County 1986).
11. Bogard v. White , Clinton Cir. Ct. No. 86-144, Ind.; ACLU.
12. Moore v. School Board of Manatee County , U.S. Dist. Ct., M.D. Fla.; AIDS Lit. Rptr., Jan. 27, 1989, and Dec. 23, 1988.
13. New York v. Dow , U.S. Dist. Ct., Conn.; AIDS Lit. Rptr., June 10, 1988.
14. Child, by Parent v. Spillane and the School Board of Fairfax County, Va. , U.S. Ct. of Appeals (4th Cir.); Lambda, Apr. 29, 1989.
Discrimination: Employment
15. Chalk v. U.S. District Court, C.D. Cal. , 840 F. 2d 701 (9th Cir. 1988).
16. Shuttleworth v. Broward County , 639 F. Supp. 654, 649 F. Supp. 35 (S.D. Fla. 1986).
17. Evans v. Kornfeld , Pa. Ct. Common Pleas, Luzerne County, No. 3468-C of 1988; ACLU.
18. Raytheon v. Fair Employment and Housing Commission, Estate of Chadbourne , 261 Cal. Rptr. 197 (Cal. App. 2d 1989).
19. M.A.E., Estate of J.J.E. v. Doe and Roe , 586 A. 2d 285 (Sup. Ct. N.J., 1989).
20. Doe v. 315 232 Street Corp. , No. 17150-1988, N.Y. Sup. Ct., Bronx County, 1988; Colum. AIDS Law Clinic.
21. Chapoton v. Majestic Caterers and Karageorge , Cir. Ct., City of Roanoke, Va.; Lambda, Mar. 21, 1988.
22. Cronan v. New England Telephone , 41 F.E.P. 1273 (Mass. 1986).
23. T. v. A Financial Service Company , N.Y. Sup. Ct., 1988; Colum. AIDS Law Clinic.
24. Brunner v. al Attar , Dist. Ct., Harris County, Tex., 295th Jud. Dist. No. 86-42628; ACLU.
25. Nieto v. Clark, Thomas, Winters and Newton , Tex. Dist. Ct., Travis County; AIDS Lit. Rptr., Aug. 12, 1988, and Mar. 10, 1989.
26. Illinois Department of Human Rights v. Fossett Corp. , Cir. Ct., Cook County, Ill.; AIDS Lit. Rptr., Feb. 26, 1988.
27. Wolfe v. Tidewater Pizza , Va. Sup. Ct., Jan. 1988.
28. Trueman v. Camden , Mich. Cir. Ct., Wayne County, May 16, 1984.
29. Garner v. Rainbow Lodge , U.S. Dist. Ct., S.D. Tex., Houston Div. H-88-1705 (1989); Lambda.
30. Cain v. Hyatt , 1989, West Law 17511 (E.D. Pa. 1989).
31. Crowley v. Idelman Telemarketing , U.S. Dist. Ct., E.D. Va.; AIDS Lit. Rptr., Feb. 12, 1988.
32. Severino v. North Fort Myers Fire Control District , U.S. Dist. Ct., M.D. Fla.; AIDS Lit. Rptr., Nov. 11, 1988.
33. Houseknecht v. White , U.S. Dist. Ct., E.D. Pa., Civ. Act No. 88-9586; ACLU, Dec. 16, 1988.
34. Chinchilla v. Social Service Agency of Orange County , U.S. Dist. Ct., C.D. Cal., Case No. 8704811, FFF(Kx); ACLU, July 16, 1987.
35. Rice v. Bloomer , U.S. Dist. Ct., E.D. Va., No. 87-162-A; ACLU, Feb. 18, 1987.
36. McCormick v. Hechnier , U.S. Dist. Ct., Md.; Lambda.
37. Little v. Bryce and Randall's Food Market , 733 S.W. 2d 937 (Tex. App. 1987).
38. Doe v. Sinicola and Sons Excavating , Oakland County Cir. Ct., Mich., No. 86-320825NZ; ACLU, Apr. 8, 1987.
39. Griffin v. Tri-Met , Ore. Cir. Ct., Multnomah County; AIDS Lit. Rptr., Mar. 10, 1989.
40. Foulks v. Sup. Provision , Mich. Cir. Ct., Wayne Country, Nov. 17, 1988.
41. Farris v. Marriott Corp. , Cal. Sup. Ct., Riverside County; AIDS Lit. Rptr., Feb. 12, 1988.
42. Burgess v. Your House of Raleigh , 380 S.E. 2d 769 (N.C. 1989).
43. Shawn v. Legs Co. Partnership , Sup. Ct. N.Y.; AIDS Lit. Rptr., Mar. 10, 1989.
44. Doe v. Independent Office Machines , Ct. of Common Pleas, Montgomery County, Pa.; AIDS Lit. Rptr., Nov. 29, 1988.
45. Mosby v. Joe's Westlake Restaurant , Cal. Sup. Ct., San Francisco County, No. 865045; ACLU.
46. Herrera v. Eastman Kodak , Cal. Sup. Ct., Los Angeles County; ACLU.
47. Doe v. Dept. of Health and Human Services , Admin. complaint of employment discrimination filed with DHSS in Ala. June 9, 1986; ACLU.
48. Shannon v. Charter Real Hospital , Admin. complaint, Dallas, Apr. 28, 1986; ACLU.
49. Doe v. Beaverton Nissan , Equal Employment Opportunity Commission and Ore. Civil Rights Case No. ST-EM-HP-870108-1353.
50. Rohloff v. New York State Division for Youth , N.Y.S. Division of Human Rights; Colum. AIDS Law Clinic, 1988.
51. Iacono v. Town of Huntington Security Division , N.Y.S. Div. of Human Rights; Colum. AIDS Law Clinic, 1989.
52. Doe v. New York National Guard , N.Y.S. Div. of Human Rights, Mar. 9, 1989; AIDS Lit. Rptr., Mar. 24, 1989.
53. Butler v. Southland Corp., 7–11 Stores , Cir. Ct., Baltimore, Md., Sup. Ct., Jan. 27, 1989.
54. Isbell v. Poor Richard's , W. Va. Human Rights Commission; AIDS Lit. Rptr., Sept. 23, 1988.
55. Bernabei v. Del Cars , Ill. Human Rights Commission; ACLU.
56. Sweetland v. Telecheck , Kan. Commission on Civil Rights; AIDS Lit. Rptr., Dec. 23, 1988.
57. Bowers v. Baker & McKenzie , N.Y.S. Human Rights Commission 1B-E-D-86-115824; National Law Journal, Sept. 14, 1987.
58. Racine Education Association v. Racine Unified School District , 385 N.W. 2d 510 (Wis. 1988).
59. Scott Eckholdt v. Perkins School for the Blind , Mass. Committee against Discrimination, Case No. 87-BEM-1194, filed Nov. 11, 1987; ACLU.
60. B. v. A Construction Co. , N.Y.C. Commission on Human Rights; Colum. AIDS Law Clinic, 1988.
61. N. v. A Restaurant , N.Y.C. Commission on Human Rights; Colum. AIDS Law Clinic, 1989.
62. Note: Employment Discrimination Cases Handled by the San Francisco AIDS Legal Referral Panel , Annual Rpts. 1987, 1988.
Discrimination: Housing And Property
63. Baxter v. Belleville , U.S. Dist. Ct., S.D. Ill., Lexis 10298 (1989).
64. Poff v. Caro , 549 A. 2d 900 (N.J. Super. 1987).
65. Kleinfeld v. McNally Real Estate , N.Y. County Sup. Ct.; Lambda, July 15, 1988.
66. Braschi v. Stahl Associates , 543 N.E. 2d 49 (N.Y. Ct. App. 1989).
67. Marbru and Berkeley Association v. Berg , Civ. Ct. N.Y. County; Lambda.
68. Clover Court Realty v. Lombardi , N.Y. County Civ. Ct., May 9, 1988.
69. Whitman Walker Clinic and Thomas v. Sibay , Cir. Ct. Arlington County, Va.; Lambda.
70. People v. 49 West 12 Tenants Corp. , Sup. Ct. N.Y. County, No. 43604/83, Aug. 1984; NGRA.
71. West 22nd St. Association v. Thomas and Thomas , 144 Misc. 2d 292 (N.Y. Sup. Ct. 1989).
72. C. v. A Landlord , N.Y.S. Division of Human Rights; Colum. AIDS Law Clinic, 1988.
73. Weingarten v. Gruenberg , N.Y.C. Commission on Human Rights; AIDS Lit. Rptr., July 15, 1988.
74. Note: Housing Discrimination Cases Handled by the San Francisco AIDS Legal Referral Panel , Annual Rpts. 1987, 1988.
Discrimination: Public Accommodations And Commercial Establishments
75. Jasperson v. Jessica's Nail Clinic , 1989 WL 154205 (Cal. App. 2d).
76. Dimicelli & Sons Funeral Homes v. New York City Commission on Human Rights , N.Y. County Sup. Ct., Jan. 9, 1987.
77. People v. Vartoughian , Beverly Hills Municipal Ct.; AIDS Lit. Rptr., Apr. 14, 1989.
78. Gittleson v. Jacumba Foundation , Cal. Super. Ct., Los Angeles County, Mar. 8, 1989; AIDS Lit. Rptr., Mar. 24, 1989.
79. Townsend v. Post-Newsweek Station , Mich. Cir. Ct., Wayne County. Oct. 4, 1985.
80. Doe v. Lacarenza Funeral Home , Conn. Sup. Ct., Stamford, No. CV87-0090916S; ACLU Nov. 9, 1987.
81. Cooper, Commissioner v. Northwest Airlines , Human Rights Dept., Minn.; NGRA, Sept. 16, 1987.
82. Tema S. Luft v. Nail Gallery ; Md. Commission on Human Rights.
83. Tama S. Luft v. All That Glitters ; Md. Commission on Human Rights.
Discrimination: Health Care
Failure to Treat HIV-Infected Patients
84. Doe v. Centinela Hospital , 57 U.S.L.W. 2034 (C.D. Cal. 1988).
85. Weaver v. Reagen , 886 F. 2d 194 (8th Cir. 1989), affirming , 701 F. Supp. 717 (W.D. Mo. 1988).
86. Dallas Gay Alliance v. Dallas County Hospital District , 719 F. Supp. 1380 (N.D. Tex. 1989).
87. Elstein v. State Division of Human Rights , Sup. Ct., Onondaga County (N.Y.); AIDS Lit. Rptr., Sept. 9, 1988.
88. Hurwitz v. New York City Commission on Human Rights , 142 Misc. 2d 214 (N.Y. Sup. Ct. 1988).
89. Stepp v. Review Board of the Indiana Employment Security Division , 521 N.E. 2d 350 (Ind. App. 4th 1988).
90. Mair v. Barton , 705 F. Supp. 520 (D. Kan. 1987).
91. DeVito v. H.E.M. , 705 F. Supp. 1076 (M.D. Pa. 1988).
92. Doe v. Lankenau Hospital , U.S. Dist. Ct., E.D. Pa.; AIDS Lit. Rptr., Nov. 29, 1988.
93. Roe v. Cumberland County Hospital System , U.S. Dist. Ct., E.D.N.C., Case No. 88-62-CIV-3, June 10, 1988; ACLU.
94. Doe v. Howard University Hospital , complaint filed.
95. Bleyenberg v. Gustafson and Miller , Dist. Ct., Harris County, Tex.; AIDS Lit. Rptr., Apr. 29, 1988.
96. Beardon v. Sutter Place Dental Group , Cal. Super. Ct., San Francisco; AIDS Lit. Rptr., Dec. 9, 1988, and Feb. 24, 1989.
97. Johnson v. District of Columbia , D.C. Super. Ct., Civ. Div.; AIDS Lit. Rptr., Apr. 29, 1989.
98. Walsh v. Cicmanec , Cal. Super. Ct., San Diego, Jan. 31, 1989; AIDS Lit. Rptr., Mar. 10, 1989.
99. Brogan v. Kimberly Services , Cal. Super. Ct., San Francisco; AIDS Lit. Rptr., Sept. 23, 1988.
100. McKenany v. Four Seasons Nursing Center , Dist. Ct., Travis County, Tex., Dec. 2, 1986; ACLU.
101. Vermont v. Lunt , Dept. of Health; AIDS Lit. Rptr., Mar. 25, 1988.
102. G.S. v. Karim Baksh, D.D.S. , Ill. Human Rights Commission, No. 1987CPO113, Sept. 26, 1988; NGRA.
103. Frazier v. Marcus Garvey Nursing Home , N.Y.S. Division of Human Rights, No. 9K-B-D-88-132002; Colum. AIDS Law Clinic, 1988.
104. Doe v. St. Francis Hospital , N.Y.S. Division of Human Rights, No. 3-P-D-87-123301; Colum. AIDS Law Clinic, 1987.
105. B. v. A Dentist , N.Y.C. Commission on Human Rights; Colum. AIDS Law Clinic, 1989.
106. Levert v. SSEU Local 371 , N.Y.C. Commission on Human Rights, No. 10286460-PA, Apr. 27, 1988; N.Y.C. Dept. of Health.
107. Whittacre v. Northern Dispensary , N.Y.C. Commission on Human Rights, Nos. AU-00015021387, GA-0023030687-DN; ACLU, Feb. 1988.
108. F.R. v. M.G.H. , Mass. Commission on Human Rights, Doc. No. 007-85-SO, Sept. 28, 1987.
Refusal to Provide Premises to Health Care Professionals
109. Whitman Walker Clinic v. C. J. Coakley , Cir. Ct. Arlington County, Va.; Lambda; AIDS Lit. Rptr., Jan. 12, 1989.
110. Seitzman v. Hudson River Association , 513 N.Y.S. 2d 148 (App. Div. 1987).
111. Barton v. New York City Commission on Human Rights , 531 N.Y.S. 2d 979 (Sup. Ct. 1988), affirmed , 542 N.Y.S. 2d 176 (1989).
112. Action AIDS v. Dirot Del and U.S. Realty , Philadelphia Commission on Human Relations; AIDS Lit. Rptr., Sept. 23, 1988.
HIV-Infected Health Care Professionals
113. Glover v. Eastern Nebraska Office of Retardation , 867 F. 2d 461 (8th Cir. 1989), cert. denied , 110 S. Ct. 321 (1989).
114. Leckelt v. Board of Commissioners of Hospital District 1 , 714 F. Supp. 1377 (E.D. La. 1989).
115. Doe, M.D. v. Cook County , U.S. Dist. Ct., N.D. Ill., Mar. 11, 1988.
116. Doe v. National Education Center and Strayer , U.S. Dist. Ct., E.D. Pa.; AIDS Lit. Rptr., Nov. 29, 1988, and Apr. 29, 1989.
117. Galiher v. Los Angeles County , U.S. Dist. Ct., C.D. Cal.; AIDS Lit. Rptr., Jan 13, 1989.
118. Doe v. U.S. Attorney General , 723 F. Supp. 452 (N.D. Cal. 1989).
119. Rhodes v. Charter Hospital , U.S. Dist. Ct., S.D. Miss.; AIDS Lit. Rptr., Mar. 10, 1989.
120. Mark Bible v. Mother Francis Hospital , U.S. Dist. Ct., E.D. Tex.; ACLU, 1987.
121. Laredo v. Southwest Community Health Services , U.S. Dist. Ct., N.M., Aug. 1987; Lambda.
122. Doe v. Washington University Dental School , Mo. Cir. Ct., St. Louis County; AIDS Lit. Rptr., Dec. 23, 1988, and Feb. 10, 1989.
123. Gordon v. Blanchard , Cal. Sup. Ct., Los Angeles County; AIDS Lit. Rptr., May 13, 1988.
124. Hartford Hospital Nurses v. Hartford Hospital , Conn. Sup. Ct., Hartford, June 19, 1987; ACLU.
125. Dept. of Health and Human Services v. Charlotte Memorial Hospital , DHHS No. 04-84-3096, Aug. 5, 1986, Charlotte, N.C.; ACLU.
126. J. v. A Medical Center , N.Y.S. Division of Human Rights; Colum. AIDS Law Clinic, 1988.
127. Doe, R.N., v. New York Hospital , N.Y.C. Commission on Human Rights; AIDS Lit. Rptr., Oct. 28, 1988.
128. Dade County Fair Housing and Employment Appeals Board , No. E-1097; ACLU, Aug. 1987.
129. Note: Health Care Discrimination Cases Handled by the San Francisco AIDS Legal Referral Panel , Annual Rpts. 1987, 1988.
Discrimination: Insurance
130. Kentucky Central Life Insurance v. Webster , 651 F. Supp. 935 (N.D. Ala. 1986), 841 F. 2d 397 (11th Cir. 1988).
131. American Council of Life Insurance v. District of Columbia , 645 F. Supp. 84 (D.D.C. 1986).
132. Lilley v. Protective Life Insurance , 1989 West Law 8831 (E.D. La. 1989).
133. Zachary Trading v. Northwest Mutual Life Insurance , 668 F. Supp. 343 (S.D.N.Y. 1987).
134. Cheney v. Bell National Life Insurance , 527 A. 2d 331 (1987).
135. Life Insurance Association of Massachusetts v. Commissioner of Insurance , 403 Mass. 410 (1988).
136. Health Insurance Association of America v. Corcoran , 140 Misc. 2d 255 (N.Y. Sup. Ct. 1988).
137. People v. Health America , Cal. Sup. Ct., San Francisco; AIDS Lit. Rptr., Nov. 29, 1988.
138. Horner v. Great Republic Insurance , Cal. Sup. Ct., San Francisco, No. 852522, Jan. 31, 1985; ACLU.
139. Northwest Mutual Life Insurance v. Barth , U.S. Dist. Ct., S.D.N.Y., 85 Civ. 8360, GLG; ACLU.
140. Frantz v. Coastal Insurance , Cal. Sup. Ct., San Francisco; AIDS Lit. Rptr., Jan. 13, 1989.
141. National Gay Rights Advocates and David Hurlibert v. Great Republic Insurance , Cal. Sup. Ct., San Francisco; AIDS Lit. Rptr., Oct. 18, 1988.
142. Charon v. First Columbia Life Insurance , Ill. Cir. Ct., Cook County, Chancery Div., June 7, 1988; ACLU.
143. Murphy v. State Farm Insurance , Cal. Sup. Ct., Alameda County; AIDS Lit. Rptr., June 10, 1988.
144. Kraemer v. Time Insurance , Ill. Cir. Ct., Cook County, Ch. 87CHO7208, July 23, 1987; ACLU.
145. Pinney v. Aetna Life Insurance , Sup. Ct., N.Y. County, No. 2828, Mar. 1986; ACLU.
146. Doe v. Connecticut Mutual Life Insurance , Mass. Sup. Ct., Suffolk County, No. 88-6453-C; Lambda.
147. Starkey v. Arvida Corp. , Fla. Commission on Human Rights; AIDS Lit. Rptr., Mar. 11, 1988.
148. National Gay Rights Advocates v. Health America , Cal. Dept. of Corporations, Nov. 7, 1986.
149. Note: Insurance Discrimination Cases Handled by the San Francisco AIDS Legal Referral Panel , Annual Rpts. 1987, 1988.
150. Discrimination: Cases from four civil rights agencies Federal Office of Civil Rights, Department of Health and Human Services San Francisco Human Rights Commission Los Angeles Office of the City Attorney New York City Human Rights Commission
The History of Transfusion AIDS:
Practice and Policy Alternatives
Harvey M. Sapolsky
Stephen L. Boswell
The relatively small threat of contracting AIDS through blood transfusions in the United States has led to significant improvements in the overall quality of American blood services, nearly all of which could have been achieved without the existence of this new health menace. Nonautologous exposures to blood are always hazardous. Transfusions save lives, but they can also transmit life-threatening diseases. Transfusion recipients are not alone in being endangered. Health care personnel are placed at risk through accidental blood spills and needlesticks. However, as blood-banking service expanded in the 1960s and 1970s, the handling and use of blood became incautious. Convenience rather than safety often guided behavior. But fear of AIDS is now so great that attention has focused on efforts to reduce risk, forcing long-needed changes in medical practice.
The number of transfusions, previously increasing in the United States, has leveled off in recent years as greater care is being taken in prescribing blood. New tests for rare as well as common hazards are being applied to blood. Autologous donations, the safest kind, are up sharply. Research on blood substitutes has expanded. The handling of blood is more carefully audited. Appropriately, health care personnel worry about their exposures to blood. Witness the increased use of gloves and masks whenever contact with blood is possible.[1]
The precautions needed to limit exposures go beyond gloves and masks and are described in Centers for Disease Control, "Recommendations for Prevention of HIV Transmission in Health-Care Settings," Morbidity and Mortality Weekly Report 36, Suppl. 2S (August 21, 1987).
These and other precautions have reduced the risk of disease transmission, including the transmission of AIDS, but they have not eliminated it. The tests are not perfect; medical mistakes and accidents still
An earlier version of this essay, with the title "AIDS, Blood Banking and the Bonds of Community" by Harvey M. Sapolsky, appeared in Daedalus 118 (Spring 1989) and in Stephen R. Graubard, Living with AIDS (Cambridge: MIT Press, 1990), 297–308, and is reprinted with permission.
happen. The risk of contracting AIDS through transfusion may grow if the disease spreads, as some still predict, from the current high-risk groups to the general population, further contaminating the pool of available blood donors.
Irrespective of the actual risk, the search for increased safety caused by the fear of AIDS alone may be sufficient to alter drastically the structure of blood banking. In the United States, and nearly everywhere else, the provision of blood for transfusions is largely a community responsibility. Voluntary donors give blood for those in need without personal knowledge of the recipient and without direct monetary reward. But several of the remaining ways in which the safety of transfusions can be enhanced would require the breaking of these bonds of community, improving chances for some recipients while perhaps harming those for others. Individual gain at the potential expense of the community is not uncommon in society. In this instance, however, the gains and losses are measured in lives.
Aids In The Blood Supply: Differing Perceptions Of Risk
The first case of immune deficiency linked to blood products was reported in a Florida hemophiliac in January 1982.[2]
Randy Shilts, And the Band Played On: Politics, People, and the AIDS Epidemic (New York: St. Martin's Press, 1987).
Although the man's death precluded the elimination of other possible causes of his immune deficiency, and made his exclusion from known risk groups problematic, it nonetheless generated great concern, especially among the epidemiologists at the Centers for Disease Control (CDC). By July two more cases had been documented: the first in a Denver hemophiliac; the second in a hemophiliac living in Ohio.[3]Ibid.
That same month the Morbidity and Mortality Weekly Report , a weekly publication of the CDC, reported the case histories of these three hemophiliacs.[4]Morbidity and Mortality Weekly Report 31 (December 10, 1982): 644-46.
What until that time had been viewed as a problem of sexually active gay and bisexual men, intravenous drug users, and Haitians had suddenly also become an important problem for those who received blood products.It was not long thereafter that the first transfusion-related AIDS case was reported in an infant. The infant was transfused at the University of California at San Francisco for Rh incompatibility at two weeks of age and had died of profound immune suppression at twenty months. One of the units of blood that the child received was from a donor who at the time of his donation was well but who died of AIDS eighteen months later. A second transfusion case was discovered three days after
the announcement of the first.[5]
Shilts, And the Band Played On.
The donor, a man with a history of intravenous drug use, had given blood during a blood drive conducted by the New York Blood Center.What was becoming clear by the end of 1982 was that AIDS was caused by a transmissible agent that behaved very similarly to hepatitis B. It could be sexually transmitted, and it was endemic in many of the same groups as was the hepatitis virus, especially gay men and intravenous drug users. As with hepatitis B, the agent appeared to have a carrier state in which individuals were unaware of their infection or the potential danger their donation represented to others. Individuals so infected appeared well, and thus were able to donate blood and plasma without remonstration. In fact, because bacteria and protozoa can be easily separated from blood products during their preparation, it seemed increasingly likely that the cause of AIDS was a virus, the only organism small enough to pass through the filters used in preparing many blood products, as hepatitis viruses had already clearly demonstrated.
Weighing this evidence, the CDC epidemiologists began warning representatives of the several blood-banking organizations that the blood supply was possibly being contaminated with AIDS. These discussions culminated in a meeting in Atlanta in early January 1983, at which proposals were presented to screen out from the blood donor pool members of high-risk groups. Since the AIDS antibody test was then not available, members of high-risk groups would have to self-identify through questionnaires and/or interviews.[6]
William A. Clark, "Preventing AIDS Transmission: Should Blood Donors Be Screened?" Journal of the American Medical Association 249, no. 5 (February 4, 1983): 567-70; Andrea Rock, "Inside the Billion-Dollar Business of Blood," Money, March 1986, pp. 140-51; Shilts, And the Band Played On; Ross D. Eckert, "AIDS and the Blood Bankers," Regulation, September-October 1986, pp. 15-24, 54.
Blood banking in the United States is divided into two distinct sectors, and so too was the response to the screening proposals. The plasma sector, which is controlled by a handful of large pharmaceutical firms and which pays its blood donors, indicated its intention to adopt screening protocols that included direct questioning of potential donors about sexual preferences, AIDS symptoms, and contact with individuals diagnosed with AIDS.[7]
Clark, "Preventing AIDS Transmission," p. 569; "ABRA Releases Recommendation on AIDS and Plasma Donors," CCBC Newsletter, February 4, 1983, p. 1.
In fact, Alpha Therapeutics Corporation, a major plasma collector, had already stopped procuring plasma in Los Angeles, New York, and San Francisco—major epicenters of the AIDS epidemic—in late 1982; and two weeks before the meeting, it had begun interrogating donors at all other collection sites about their membership in high-risk groups.[8]Alpha Therapeutics Corporation, "Press Information: Alpha Therapeutics Acts to Protect Hemophiliacs from AIDS Epidemic," January 12, 1983; D. J. Gury, "AIDS and the Paid Donor," Lancet 2 (1983): 575.
One of the main uses of plasma is for the production of fractions, which are vital in the treatment of hemophilia. The American Hemophilia Association, which was also represented at the meeting, had already declared its desire that protective measures be implemented immediately. Well that it did, because hemophiliacs weresoon devastated by the AIDS virus. Clotting factors for hemophiliacs are made from pooled plasma lots composed of as many as 5,000 donations and can be contaminated by a single AIDS virus carrier. Nearly half of the 15,000 hemophiliacs in the United States are now infected. Among those with the most severe form of hemophilia, who necessarily have the greatest exposure to the clotting factor, the infection rate is estimated to be 70 to 90 percent.[9]
Gina Kolata, "Hemophilia and AIDS: Silent Suffering," New York Times, May 16, 1988, p. 1.
The effects of the contamination are worldwide, because the United States has been the major international supplier of plasma products.[10]The international plasma business is discussed in Piet J. Hagen, ed., Blood: Gift or Merchandise (New York: Alan R. Liss, 1982).
With the recognition that AIDS is caused by a virus, it has been possible to protect the hemophiliac population from further risk by the use of a heat treatment to kill the virus in the processing of plasma fractions.[11]Centers for Disease Control, "Safety of Therapeutic Products Used for Hemophilia Patients," Morbidity and Mortality Weekly Report 37 (July 29, 1988): 441-44; Margaret W. Hlgartner, "AIDS and Hemophilia," New England Journal of Medicine 317, no. 18 (October 29, 1987): 1153-54.
The other blood-banking sector collects and processes whole-blood donations for transfusions and is almost entirely composed of nonprofit regional blood centers and local hospital blood banks that do not pay donors. Nationally, this sector is represented by three organizations with somewhat overlapping memberships: the American Red Cross (ARC), the American Association of Blood Banks (AABB), and the Council of Community Blood Centers (CCBC).[12]
Alvin Drake, Stan Finkelstein, and Harvey M. Sapolsky, The American Blood Supply (Cambridge, Mass.: MIT Press, 1982), especially chap. 4.
Their representatives opposed the screening proposal at the January 1983 meeting, arguing that evidence was not sufficient to exclude gay men from the donor lists or to implement the use of surrogate tests such as the test for hepatitis B core antibody, which had also been proposed. The words one representative used are often cited to show the concern expressed about disrupting established routines: "We are contemplating all these wide-ranging measures because one baby got AIDS after a transfusion from a person who later came down with AIDS and there may be a few other cases."[13]Clark, "Preventing AIDS Transmission," p. 568.
The whole-blood collectors feared that a linkage between AIDS and the blood supply would significantly reduce both blood donations and blood transfusions. Moreover, they were annoyed by the intrusion of risk-averse epidemiologists into their professional domain. The opposition of the whole-blood collectors delayed governmental action intended to reduce the risks of AIDS transmission through transfusions. It was not until March 1983 that the Centers for Disease Control made public the recommendations for widespread screening.[14]Office of Biologics, U.S. Food and Drug Administration, Recommendations to Decrease the Risk of Transmitting Acquired Immune Deficiency Syndrome (AIDS) from Blood Donors (Washington, D.C.: FDA, March 24, 1983); Centers for Disease Control, "Prevention of Acquired Immune Deficiency Syndrome (AIDS) Report of Inter-Agency Recommendations," Morbidity and Mortality Weekly Report 32 (March 4, 1983): 101-3.
This public announcement forced the banks to begin excluding high-risk donors.Structural differences help explain the inconsistent responses to AIDS within blood banking. The whole-blood sector relies on voluntary donors. Women and minorities give less frequently than do young white males. In several cities the gay community provided a readily accessible,
often organized population of young white males to solicit for donations. Through repeated campaigns the blood banks had built good relations with the gay community and found it to be a convenient source of donations. Many gays regarded the call for screening as scapegoating and saw in it a threat to their recently won civil liberty gains.[15]
Clark, "Preventing AIDS Transmission," p. 569. See also Shilts, And the Band Played On.
Sensitive to the concerns of the gay community, some influential blood bankers were reluctant to force the exclusion of gays and doubted the effectiveness of direct questioning of donors to achieve that exclusion. In contrast, plasma collectors pay their donors. If one group of donors were excluded, another would be found quickly to maintain the supply. Their relationship with donors was simply a financial one, with no attempt to build long-term trust or mutual support.The plasma sector is also highly competitive; its products are interchangeable among manufacturers and are marketed internationally. The buyers of these products are knowledgeable about quality differences, some being government medical agencies and other individuals who must be in constant contact with medical specialists because of their illness. The firm with a demonstrably safer product would rapidly gain business.[16]
Reuben A. Kessel, "Transfused Blood, Serum Hepatitis, and the Coase Theorem," Journal of Law and Economics 17, no. 2 (October 1974): 265-89.
Once donor screening was suggested as a possibility for reducing the risk of transmitting AIDS, plasma collectors had no choice but to adopt it on the fear that one of them would.The whole-blood sector lacks many of these characteristics. It is dominated by nonprofit blood-collecting agencies that are local monopolists, supplying all or nearly all of the blood transfused within a given region. Blood quality in transfusions is more the responsibility of the supplier than it is of the purchasing hospitals. Nationally, the Red Cross, the AABB, and the CCBC coordinate policies, effectively cartelizing the whole-blood sector by refraining from competing with one another. A hospital seeking an alternative to its local blood center would have difficulty obtaining services from an extraregional supplier. Although hospitals can be licensed to draw their own supply, there have been economic and professional obstacles that limit this option for most hospitals.
The structure of blood banking in the United States was altered in the early 1970s, when—at the urging of the nonprofit collectors—the federal government adopted policies favoring voluntary blood donations in collections for transfusions.[17]
For a more detailed analysis of the structure and performance of blood banking in the United States, see Drake et al., American Blood Supply.
Richard Titmuss, the English sociologist, had just published a widely praised comparative analysis of the American and British blood-banking systems, which helped focus public attention on the risks of transfusion-related hepatitis.[18]Richard M. Titmuss, The Gift Relationship: From Human Blood to Social Policy (New York: Pantheon Books, 1971).
In a devastating critique of the American system, Titmuss argued that paymentfor donations significantly increased the hepatitis hazard for transfusion recipients. In Britain, where the most a donor could get for his donation was a cup of tea or a glass of stout, hepatitis was not a problem; but in the United States, where payment was permitted, the gift of life was often something else, he claimed. The nonprofit collectors, under pressure to improve the safety of transfusions, promoted this view, inaccurate though it was; they sought the elimination of commercial collectors, as well as the elimination of payment for donors from the whole-blood sector.
The critique was quite misleading, because transfusion hepatitis rates do not correlate well with donor payment. Sweden pays all its donors but has a low hepatitis rate. Japan switched in the 1960s from a largely paid donor system to an exclusively voluntary one without greatly altering its high hepatitis rate. The low rate that Titmuss observed in Britain probably had more to do with the fact that British blood is transfused there than the fact that British donors are unpaid. Incredibly, Titmuss failed to mention the extra precautions that the British transfusion service took to keep the hepatitis rates down. It has avoided collections in areas with large concentrations of immigrants from Third World countries, where hepatitis is endemic. It also has labeled blood donations by race and did not transfuse the blood donated by Pakistani, African, and other immigrants. In addition, Titmuss ignored the fact that some of the leading medical institutions in the United States, the Mayo Clinic and the Massachusetts General Hospital among them, paid donors but had low hepatitis transfusion rates as a result of careful donor-screening practices.[19]
Harvey M. Sapolsky and Stan Finkelstein, "Blood Policy Revisited," Public Interest 46 (Winter 1977): 15-27; Comptroller General of the United States, Hepatitis from Blood Transfusions: Evaluation of Methods to Reduce the Problem (Washington, D.C.: General Accounting Office, February 13, 1976).
Ironically, paid donations were not a major factor in American blood collections by the early 1970s because the commercial collectors, which did most of the paying, had already shifted their attention to the plasma market, which was rapidly growing due to the discovery of important plasma products. Plasma donations are more demanding in terms of donor time, and usually require compensation. Federal policies encouraging voluntary donations for transfusion merely assured the nonprofits that competition from commercial collectors would remain limited. The nonprofits attempted to consolidate their position further through a co-operative program of regionalization that certified dominant collectors as monopoly suppliers in designated areas.[20]
"As GAO Investigates, Blood Commission Seeks Regionalization," American Medical News, April 14, 1978, p. 1.
Not surprisingly, these actions had little effect on the national hepatitis rate. Like AIDS, hepatitis is a complex scientific problem that has eluded a quick solution.[21]
Harold M. Schmeck, Jr., "Scientists Seek Ways to Limit Lasting Harm of Hepatitis Infection," New York Times, May 19, 1988, p. B15; Janice Hopkins Tanne, "The Other Plague," New York Magazine, July 11, 1988; pp. 34-40.
Research on control techniques continuedduring the 1970s, but the nonprofits devoted much energy to reducing their responsibility for the continuing presence of hepatitis in the blood supply. They persuaded the federal government and some state governments to require the labeling of blood by donor source, either paid or volunteer, with the implication that the transfusion of paid donor blood held a special legal liability for the transfusing agent. At the same time, they obtained legislation in nearly all states designating blood a service rather than a product, thus exempting themselves from liability other than for negligence when hepatitis or any other disease is transmitted via transfusion. Because they set their own practice standards, through professional organizations with relatively little governmental supervision, negligence itself becomes difficult to prove.[22]
Gilbert M. Clark, ed., Legal Issues in Transfusion Medicine (Arlington, Va.: American Association of Blood Banks, 1986); Lynn Shodahl, "Liability for Transfusion-Transmitted Disease," William Mitchell Law Review 14 (1988): 141-67; David A. Roling, "Transfusion-Associated Acquired Immunodeficiency Syndrome (AIDS): Blood Bank Liability?" Baltimore Law Review 16 (1986): 81-116; Stan N. Finkelstein and Harvey M. Sapolsky, "Controlling Post-Transfusion Hepatitis: A Proposal to Publicize Hepatitis Rates of Transfusion Facilities," American Journal of Law and Medicine 5, no. 1 (Spring 1979): 1-9; "Blood Bank Is Cleared in Colorado AIDS Case," New York Times, June 5, 1988, p. 29; Beth Rabkin and Michael Scott Rabkin, "Individual and Institutional Liability for Transfusion-Acquired Diseases," Journal of the American Medical Association 256, no. 16 (October 24, 1986): 2242-43; Patti J. Miller et al., "Potential Liability for Transfusion-Associated AIDS," Journal of the American Medical Association 253, no. 23 (June 21, 1985): 3419-24. On recent developments see Stuart Wasserman, "Nation's Blood Supply on Trial," Boston Globe, January 3, 1989, p. 1.
The nonprofit blood banks hold a unique position in American medicine. They are protected from commercial competition, exempt from most consumer suits, and free to divide geographical markets among themselves. As economists often remind us, monopolists prefer the quiet life free from public scrutiny. When the AIDS crisis appeared, the blood bankers' inclination was essentially to deny that it was a major threat to blood safety. A week after the Atlanta meeting, the ARC, the AABB, and the CCBC issued a joint statement arguing that the evidence regarding the transmissibility of AIDS via transfusions was "inconclusive" and "incomplete."[23]
American Association of Blood Banks, American Red Cross, and Council of Community Blood Centers, Joint Statement on Acquired Immune Deficiency Syndrome (AIDS) Related to Transfusion, January 13, 1983.
The only screening they advocated was much less intense than that employed by the plasma sector. Specifically, potential donors would be given brochures describing AIDS symptoms and would be asked to sign forms indicating that people with AIDS or in contact with AIDS victims should not donate, but they would not be directly questioned about their sexual preferences. And when the AIDS antibody test was developed in 1985, the associations jointly proclaimed it to be entirely sufficient to protect the blood supply. There was no longer a need to worry about getting AIDS through transfusions, they implied. Unlike many in the society who have sought to exploit public fears about AIDS, the nonprofit blood bankers have continually offered reassurance that all was safe despite AIDS.[24]Harvey M. Sapolsky, "AIDS and the Blood Supply: Is Honesty the Best Policy?" in AIDS: Public Policy Dimensions (New York: United Hospital Fund, 1987), pp. 107-14.
The Search For Safer Transfusions
Despite the reassurance offered by the national associations, some professionals recognized that the blood supply would be increasingly contaminated unless immediate action was taken. The screening of donors alone would not protect transfusion recipients. A screening test for
blood was needed. Until a direct test for the AIDS virus was developed, a surrogate test was required. Dr. E. Engleman, medical director of the Staford University Blood Bank, was the first to try such a test. A research hematologist whose interest focused on a type of blood cell known as a lymphocyte, Engleman stood apart from the pathologists-turned-administrators who were usually in charge of blood banks in the United States. He noted that people with AIDS and many individuals in high-risk groups who appeared well had abnormalities in their T cells, a subset of lymphocytes. Aware of the growing evidence of a long incubation for AIDS, Engleman proposed using a T-cell test to screen donations for AIDS-infected units. His attempts to gain support for the T-cell test among fellow blood bankers were frustrated, the argument being that the benefits of costly surrogate testing could not be proven—as indeed they could not be until an actual test for the virus was developed.
Engleman nevertheless instituted the test at Stanford. In one dramatic incident the Stanford bank discarded a unit from a person who had donated thirteen times in the San Francisco Bay area before being diagnosed as having AIDS. The T-cell test had rejected the unit given at Stanford, but the other dozen units were transfused elsewhere. When the AIDS antibody test finally became available, it was learned that 5 percent of blood discarded at Stanford was HIV positive, whereas only 0.01 percent of blood donated by individuals with normal T cells was positive. Thus, HIV-positive donors were 500 times more frequent in the group with T-cell abnormalities than in those with no abnormalities.[25]
E. Engleman, "AIDS and the Blood Supply: A Report to the Presidential Commission on the Human Immunoceficiency Virus Epidemic," May 9, 1988.
Admittedly, the T-cell test was difficult to administer and relatively expensive. Other surrogate tests were also suggested for use in screening the blood supply to prevent transfusion-related AIDS. Unlike the T-cell test, which discriminated among units of blood on the basis of abnormalities closely associated with AIDS or the preclinical stages of the disease, these tests sought evidence of past infections, which occurred frequently in those at risk for AIDS. Chief among them was the hepatitis B core antibody test, which utilized equipment already available at most blood banks and was not especially costly.
The Food and Drug Administration's Blood Products Advisory Committee studied the issues pertaining to screening the blood supply in early 1984, concluding that surrogate testing, and most specifically the hepatitis B core antibody test, was not appropriate as a means of identifying those at high risk for developing AIDS because it screened out too much of the blood supply. The incidence of hepatitis in the United
States was much higher than the perceived incidence of HIV infection (AIDS) in 1984. To exclude large numbers of individuals because these individuals are at higher risk of transmitting AIDS, it was argued, would add significantly to the cost of blood and blood products. The blood banks not only would incur the cost of this testing but also would be faced with the added cost of recruiting more donors and processing additional blood to replace the discarded units. Irwin Memorial Blood Bank in San Francisco estimated that the use of the test for antibodies to the hepatitis B core antigen would result in a 5 to 7 percent increase in deferrals.[26]
E. J. Power, AIDS and the San Francisco Blood Supply, contract No. 433-4520.0 (Washington, D.C.: U.S. Congress, Office of Technology Assessment, April 1984).
The committee did recommend that small-scale experiments be conducted with another test, beta-2 microglobulin, a cell surface glycoprotein present on certain human immune cells and found in elevated concentration among patients with AIDS. This test, it concluded, seemed to be more specific for blood that might transmit AIDS. Very much aware of costs, the committee sought a test that would incorrectly exclude as few units of blood as possible. Less attention was given to the issue of test sensitivity—the ability to identify as many of the infectious units as possible.
The flaw in this thinking is that high-risk, asymptomatic individuals who would later develop AIDS could still donate blood. It was known at the time that beta-2 microglobulin seemed to be elevated with increased frequency in those with AIDS. However, little was known about the test's behavior in those who were asymptomatic but at high risk. If, as many suspected, there is a long latent period before the onset of symptoms, and if beta-2 microglobulin is elevated only in the later stages of AIDS, then large numbers of potentially infectious individuals might be missed. The committee seemed to be arguing that in the tradeoff between sensitivity and specificity, which always occurs when screening tests are employed, test specificity is of greater importance. Put another way, if surrogate tests were going to be employed, the committee desired that the added costs of those tests be borne by those who receive the blood rather than those who process it. These added costs would be measured in lives lost rather than in dollars spent.
In spite of the committee's recommendations, some nonprofit blood banks and several plasma companies began to employ surrogate tests for AIDS. In large part these decisions were made because of growing public pressure on the blood industry to take aggressive steps to protect the blood supply, but other factors also played a role in these decisions. The concern over the growing threat of lawsuits arising from transfusion-associated
AIDS contributed greatly to the increase in surrogate testing. As was pointed out earlier, competition among the various companies in the plasma sector also added to the use of surrogate tests. In fact, in at least one case, competition among nonprofit blood banks may have contributed to the wider adoption of surrogate testing. San Francisco's Irwin Memorial Blood Bank adopted the hepatitis B core antibody test, in part, because of perceived differences in quality between the blood in its possession and blood from nearby Stanford University Blood Bank, where the T-cell test was being used.[27]
Ibid.
The pressure to employ surrogate testing was largely mitigated when the Department of Health and Human Services announced on April 23, 1984, that the cause of AIDS had been identified. With the identification of the offending agent, a virus, came a promise that a blood test would be "widely available within about six months," which should "identify AIDS victims with essentially 100 percent certainty."[28]
M. Heckler, Secretary, U.S. Department of Health and Human Services, Statement announcing the discovery of the possible etiological agent for AIDS, Washington, D.C., April 23, 1984.
One year later, in March 1985, the Food and Drug Administration licensed antibody kits that were able to identify those exposed to the AIDS virus with 93 to 99 percent certainty.Surrogate testing was not the only issue around which controversy centered. Early in the epidemic calls for directed donation were often heard. The calls emanated from patients and their families, and in some locations led to the development of "blood clubs."[29]
"As AIDS Scare Hits Nation's Blood Supply," U.S. News and World Report, July 25, 1983, p. 72.
"Directed donation" means that the potential recipient of blood designates those who will be allowed to donate on his or her behalf. By its very nature, directed donation cannot be employed in every situation where a transfusion is necessary. For example, virtually all situations where the need for blood cannot be anticipated are not amenable to this kind of donation. However, with proper planning many transfusions could be accomplished within the framework of directed donations.Many nonprofit blood bankers opposed the widespread use of directed donations. In opposing it, they cited four points. First, they argued that there was no reason to expect that directed donation was any safer than the traditional anonymous system. But this contention was incorrect, and the blood bankers knew it. Many obvious criteria could be used to decrease one's risk of being transfused with HIV-positive blood. One obvious criterion, for example, might be to select women as donors, since women were far less likely to have been exposed to HIV than were men. Further, at the time the argument that directed donations were no safer than regular donations was being made, a prominent East Coast blood banker had on the wall of his office a map
displaying the relative risk of various blood-transmitted diseases by zip code of the donor's residence. There were wide and predictable variations based on this criterion. Clearly, there were ways to affect one's risk of receiving HIV-tainted blood, and most of them were readily available to those who wished to utilize a directed donor program.
Second, those who opposed directed donations argued that patients would place great pressure on those they selected to donate on their behalf, and that this pressure would cause donors to be untruthful about their ability to meet donor requirements. What the blood bankers did not acknowledge was that this problem already existed in the anonymous system. Many of the techniques developed by blood bankers a decade earlier to increase the supply of blood facilitated this kind of pressure. Blood drives at schools, work, and other social gatherings were far more successful because of the peer pressure created within these social contexts. In fact, many blood bankers had already recognized the adverse effect such peer pressure might have on donor behavior and in early 1984 began to establish twenty-four-hour telephone lines so that donors who deemed themselves at higher risk of HIV infection and later regretted having donated could confidentially ask that their blood not be used for transfusion.[30]
"Blood Bank Opens AIDS-Risk Hotline," Santa Ana Register, January 10, 1984.
Further, most blood banks that employed directed donation did not allow the recipient of the donation to know whose blood was actually used. Thus, the patient would never know that a high-risk individual whom he had solicited as a directed donor had excluded his blood from human use.Third, the blood bankers argued that directed donation would be more costly than the anonymous system already in place. Costs, however, depend on one's perspective. The costs of concern to the blood banker are not the costs perceived by society as a whole or by the individual who receives a unit of HIV-positive blood. Even when viewed from the perspective of the blood banker, however, a system of directed donation would not necessarily be more costly. In 1984 an article published in the New England Journal of Medicine cast doubt on the blood bankers' assertion when Thomas Jefferson University's blood bank analyzed its nascent directed donor program—a program initiated largely at the insistence of cardiac surgeons who feared the migration of patients if directed donation were not available. Contrary to the arguments put forth in the communiqué from the AABB, the ARC, and the CCBC, the researchers who analyzed the program found that it "resulted in savings to the institution of $4,142 in four months. The annual figure is $12,426—a substantial reduction in operating expenditures."[31]
S. K. Ballas et al., "Designated Blood Donations," New England Journal of Medicine 310 (1984): 124.
These savings, in part a result of decreased recruitment costs, run counter to the argument put forth by the nonprofit blood bankers and suggest that, in addition to improving the quality of the blood supply, directed donation might decrease its costs as well.
Fourth, the blood bankers contended that directed donation would result in de facto discrimination against those who are socially isolated. In particular, they argued that the poor and the elderly would be adversely affected in a two-tiered blood supply. That is, the use of directed donors would undermine the ability of blood banks to find anonymous donors, and the resulting burdens would fall disproportionately on those who found it difficult to locate directed donors. This contention assumes that directed donation will adversely affect the anonymous donor pool, which is not necessarily the case. Although it is undoubtedly true that some participants in a directed donor program would have previously been anonymous donors, it is incorrect to assume that all directed donors would have previously donated. To the extent that directed donors have not participated in the anonymous pool, the blood they donate represents additional blood that would not have been available without a directed donor program. And to the extent that the blood donated in this fashion is safer than anonymously donated blood, the overall quality of the blood supply improves. There are three possible scenarios.
The first scenario is one in which the individual who donates in a directed donor program has never been an anonymous donor. The overall effect of this individual's donation will be to increase the availability of blood within the anonymous system. In the second, the donor has previously been an anonymous donor and the directed donation withdraws blood from the anonymous pool temporarily. In this situation the donation would have no net impact on the overall supply of blood. However, the additional blood donated by those who were not previously blood donors would increase the available blood within the anonymous pool. In the final scenario the donor has previously been an anonymous donor but, in order to remain eligible to give blood should an emergency arise for a friend or family member, he or she elects to refrain from anonymous donation permanently. The extent to which this is a realistic concern is uncertain. In order for it to have an adverse effect on overall blood availability, however, the loss of blood as a consequence of this phenomenon would have to outweigh the amount of blood gained from those who did not previously participate in the anonymous donor system.
Regardless of the comparative safety of blood obtained by directed donation vis-à-vis blood that is anonymously donated, a strong directed donation program would not a priori result in additional costs to the blood banker, as the Thomas Jefferson University's blood bank was quick to realize. Further, the actual risk of contracting AIDS from a blood transfusion may be only one factor in the patient's well-being. Los Angeles' Cedars-Sinai Hospital concluded that "we function with a philosophy that incorporates a concern for the patient's psychological responses to illness, as well as his need for blood. … [B]y providing these very frightened patients with knowledge that the blood to be received is from their chosen donors … we enhance their general well-being and eventual recovery."[32]
L. Pura et al., "Directed Donor Program: A Three-Fold Benefit," paper presented at the 36th annual meeting of the American Association of Blood Banks, New York, November 1983.
As time has passed, pressure in favor of directed donation has grown. Legislators in several states—Florida and Georgia were two early examples—have introduced bills requiring blood banks to accept the practice. Irwin Memorial Blood Bank, located in San Francisco, one of the metropolitan areas hardest hit by the AIDS epidemic, adopted such a program in June 1984.[33]
"Irwin Initiates Directed Donation Program," AABB News Briefs, July 1984, p. 4.
Its variation reflected the disdain the blood bank harbored for the concept. Irwin advised patients "that blood from directed (family and friend) donors is at best no safer than blood from other volunteer donors [and] there is actually a danger that direct donations may be less safe."[34]Blood Policy and Technology, OTA-H-260 (Washington, D.C.: U.S. Congress, Office of Technology Assessment, January 1985).
Patients desiring directed donation were required to have their physicians place the request for blood at least one week prior to the anticipated transfusion. An additional charge of $15 was assessed against each directed donor. The actual donation had to occur on a second visit, thus making it more inconvenient for the directed donor.In contrast to the controversy surrounding directed donation, one source of blood was recognized as inarguably safer than blood obtained from other individuals—either through directed donation or anonymous donation. A rarity prior to AIDS, autologous transfusions—achieved through either the predeposit of blood or its intraoperative salvage—now account for as much as 2 percent of blood usage and are growing in popularity.[35]
D. M. Surgenor, "The Patient's Blood Is the Safest Blood," New England Journal of Medicine 316, no. 9 (1987): 542-44; Pearl T. C. Y. Toy et al., "Predeposited Autologous Blood for Elective Surgery," New England Journal of Medicine 316, no 9 (1987): 517-20; Johanna Pindyck et al., "Blood Donations by the Elderly," Journal of the American Medical Association 257, no. 9 (1987): 1186-88; Lawrence K. Altman, "The Safest Blood: One's Own," New York Times, December 2, 1986, p. C1; B. U. Anderson and P. A. Tomasulo, "Current Autologous Transfusion Practices: Implications for the Future," Transfusion 28, no. 4 (1988): 394-96; "Autologous Blood Transfusions: Principles, Policies and Practices," Forum Focus (Spring 1988): entire issue. Note also "Contact Lasers Reduce Pain, Blood Loss in Mastectomies," Modern Healthcare, November 1988, p. 90.
Blood banks had not encouraged the practice, despite the safety advantages offered patients who can anticipate their need for blood and who are healthy enough to provide the donation. Autologous collections cause inventory complications for blood banks and contradict their donor recruitment message that blood is a community responsibility. But the fear of AIDS among patients and surgeonshas left the banks with little choice other than to advocate the maximum possible use of autologous donations.
Risks Remain
About 3 percent of the AIDS cases recorded in the United States are attributed to the therapeutic exchange of blood. The AIDS toll is certain to grow, but not likely the transfusion-related share of that toll. The AIDS antibody test provides an important, although imperfect, defense against the spread of the disease through blood services. So, too, do improvements in medical practice.
The number of units of whole blood and red cells transfused annually in the United States, which peaked at approximately 12 million units in 1986 after years of steady growth, is now declining.[36]
D. M. Surgenor et al., "Collection and Transfusion of Blood in the United States, 1982-1988," New England Journal of Medicine 322 (1990): 1646-51.
In the absence of a national blood data system, precise figures are not available; but estimates are that in 1987, the most recent year for which there are complete data, the rate of red cell transfusion was 15 percent lower than could have been expected if the historic growth in transfusion rates had been sustained.[37]The figure for the Massachusetts General Hospital is a 25 percent reduction. See "AIDS: Out of Tragedy Comes Good," MGH News 46, no. 8 (November 1987): 2.
The growing tendency in many medical centers is to avoid transfusion unless defined need criteria are met. It is becoming less common for a physician to order a unit of blood to put the blush back into the cheeks of a patient about to be discharged from a hospital. And physicians and patients think harder than they once did about the risks of transfusions when considering surgery.Ultimately, it is the AIDS test that guards transfusions. Not all uses of blood can be avoided, nor can all recipients provide for themselves. When someone else's blood is to be transfused, safety depends on the effectiveness of the screen. In AIDS testing, as in testing for many other diseases, the screen is less than perfect. Some infected units will get through.[38]
Don Dagani, "The Problem of Diagnostic Tests," Chemical and Engineering News, November 23, 1987, pp. 35-40; Deborah M. Barnes, "Keeping the AIDS Virus Out of the Blood Supply," Science 233 (August 1, 1986): 514-15; Philip P. Mortimer, "Serological Tests," in Blood, Blood Products and AIDS, ed. R. Madhok, D. D. Forbes, and B. L. Evatt (Baltimore: Johns Hopkins University Press, 1987), pp. 125-42.
The most commonly used screening test for AIDS is the enzyme-linked immunosorbent assay (ELISA). Blood bank procedures require each donated unit to be screened by the ELISA test immediately after collection. Positive units are often rescreened. If the rescreening test is also positive, the unit is usually considered unusable and not transfused. (Many, but not all, blood centers discard initially reactive units, even though this status is not predictive of the disease.) A confirming test, usually the Western blot, is performed before the donor is notified of a positive status. Most ELISA positives turn out to be false positives.[39]
Thomas F. Zuck, "Human T-Cell Lymphotropic Virus, Type III, Antibody Testing in the United States: Experience of the First Year," in AIDS: The Safety of Blood and Blood Products, ed. J. C. Petricciani et al. (New York: Wiley, 1987), p. 221.
The ELISAscreen is purposely set low so as to eliminate as many dangerous units as possible. The intent of this process, however, is that some blood pass the screen in order that there will be blood for transfusions. A perfect screen for a low-incidence population, such as blood donors under current conditions, would mean substantially reduced blood availability. As it is, nearly 1 percent of donated blood is discarded on the chance that it might be HIV infected.[40]
Personal communication with Michael Barry, 1989.
For the potential recipient the issue is not how many units are discarded but how many infected units are passed into inventory and transfused. As a result of technican error, faulty test batches, or mishandled units, some HIV-infected units will get through. More significantly, the AIDS screen as an antibody test has inherent limitations. One problem is that infected individuals do not immediately produce antibodies to HIV. Several weeks will pass before antibodies begin appearing in the blood of a virus carrier. Those in the terminal stage of the disease may also be antibody free. There are also reports of a few victims who do not produce detectable antibodies in the middle stages of the disease.[41]
H. A. Kessler et al., "Diagnosis of Human Immunodeficient Virus Infection in Seronegative Homosexuals Presenting with an Acute Viral Syndrome," Journal of the American Medical Association 258 (September 4, 1987): 1196-99.
Absent the use of a test for the HIV viral antigen, which is under consideration, there will always be some false negatives as long as infected individuals donate blood. And some potentially infected individuals will continue to donate, if only because blood banks unintentionally provide a convenient and confidential way to discover one's antibody status. The question then becomes: How many infected units pass into the blood supply and cause AIDS?Several factors complicate the calculation of the blood-related AIDS transmission rate. Not all collected blood is transfused; upward of 10 percent of the units are discarded because they are outdated. Transfusion recipients are often severely ill; as many as half die immediately or shortly after the transfusion because of their underlying condition. Not every infection necessarily will produce a defined AIDS case; AIDS-related complex, milder infirmity, or no disease may result. And the incubation period for AIDS may be longer than ten years; consequently, not all cases contracted since the antibody screen was implemented have yet been identified.
Blood bankers, concerned about the impact that fear of AIDS was having on public confidence in the safety of the blood supply, were over-enthusiastic about the effectiveness of the antibody test and proclaimed its arrival as ensuring the total elimination of HIV infection risk from blood use.[42]
Lawrence K. Altman, "Blood Supply Called Free of AIDS," New York Times, August 1, 1985, p. 1.
Since then they have had to acknowledge the test's inherent limitations and to revise their estimates of the continuing AIDS risk intransfusions. At first the rate was cited as 1 in a million. Then it was 1 in 300,000. Still later it was 1 in 100,000.[43]
Gerald H. Friedland and Robert S. Klein, "Transmission of the Human Immunodeficiency Virus," New England Journal of Medicine 317, no. 18 (October 29, 1987): 1126.
Currently it is listed as between 1 in 10,000 and 1 in 100,000, although some researchers claim it is as high as 1 in 5,000.[44]"AIDS Risk Cited in Donated Blood," Boston Globe, August 25, 1988, p. 8; J. R. Bove, "Transfusion-Associated Hepatitis and AIDS: What Is the Risk?" New England Journal of Medicine 317 (1987): 242-45; Philip M. Boffey, "Federal Panel Calls for Improved AIDS Test," New York Times, July 16, 1986, p. A20; Gina Kolata, "New Blood Test Raises Thorny Issues," Science 233 (July 11, 1986): 149-50.
Given approximately three and a half million transfusions, that means there are between 35 and 700 new cases each year still being transmitted through the blood supply.AIDS, of course, is not the only hazard of transfusions. Several thousand transfusion hepatitis cases, most of the elusive type C, are transmitted each year, with a significant fatality rate. HIV-2, a virus related to the AIDS agent, has been detected in blood, although not yet in great frequency. The human T-cell leukemia/lymphoma virus, HTLV-1, has also been found in the United States blood supply, with a transmission rate that is much greater than that of HIV-2. A screening test for HTLV-1 was instituted in early 1989. A test for hepatitis C became available in 1990. Other screening tests are in development, but their efficaciousness has not been determined.[45]
"Testing for HTLV-1 Infection Should Begin among Blood Donors, Yale Researcher Tells NHLBI Panel," The Blue Sheet 30, no. 44 (November 4, 1987): 2; "Red Cross Plans Blood Test for Cancer Virus in Donors," New York Times, April 29, 1988, p. A1.
Not surprisingly, there is still much public fear about the safety of the blood supply, a fear that affects potential donors even though they are not at all threatened directly by these transfusion dangers.[46]"AABB Public Opinion Poll Reveals Surprising Views," AABB News Briefs 11, no. 6 (July 1988): 1; see also "AIDS: A Multicountry Assessment," Public Opinion 11 (May-June 1988): 36-39.
Donations are down by about 6 percent, and in some regions a supply crisis has been averted only because usage has also declined.Science can make transfusions safer. Better tests and the development of vaccines will help, but the significant gains will be in the introduction of blood substitutes, artificially produced substances that can duplicate the life-sustaining traits of blood components. Helpful, too, will be the use of recombinant human growth factors to stimulate the endogenous production of various blood cell lines.[47]
J. E. Groopman, J. M. Molina, and D. T. Scaddem, "Hematopoietic Growth Factors: Biology and Clinical Applications," New England Journal of Medicine 321 (November 23, 1989): 1449.
Chief among these new hormones is erythropoietin, which can stimulate the production of red blood cells in certain individuals.[48]J. W. Ischbach et al., "Recombinant Human Erythropoietin in Anemic Patients with End-Stage Renal Disease: Results of a Phase III Multicenter Clinical Trial," Annals of Internal Medicine 111 (1989): 992-1000.
Much work along these lines is under way, enhanced by the accumulating progress being recorded in biotechnology. When they occur, the advances may alter the structure of blood banking and eliminate the need for recruiting and screening blood donors. Given its emphasis on research, Genentech or some other biotechnology firm is more likely to be the supplier of the substitutes than are the American Red Cross and the other traditional blood collectors.Seeking Greater Safety
Even without a breakthrough in synthetic blood research, the structure of blood banking seems certain to change. The fear of AIDS, disproportional
though it may be to the actual risk, is sufficient among transfusion recipients and medical staffs to force a continuing search for alternatives to the random draw from the community blood donor pool. Provision of autologous donations, however, is likely to satisfy no more than 10 percent of the demand for blood, because of the unpredictability of individual need and because of the frailty of many recipients. The search then will be for safer homologous sources. At least three exist, each of which threatens blood banking as it is currently structured.
One is directed donations, in which donors provide blood to designated recipients, usually friends or relatives, who actively solicit their contributions. As was mentioned, blood bankers have generally opposed this form of donation because it undermines the basic ideology of the blood system: that blood banks serve the community rather than individuals, operating like a community charity rather than a bank with individual accounts. But—as demonstrated in insurance, schools, and other social systems—individuals and groups often have much to gain by withdrawing from community pools. This should be especially true for achieving isolation from a disease focused in defined groups that are separated from most of the rest of the population.[49]
The insurance analogy is discussed in two articles by Harvey M. Sapolsky: "Prospective Payment in Perspective," in Health Policy in Transition, ed. Laurence Brown (Durham, N.C.: Duke University Press, 1987); and "An Evaluation of the New Jersey DRG Hospital Payment System," New Jersey Medicine 85 (January 1988): 32-37.
A second alternative is to obtain blood for transfusions from locations that have a very low AIDS incidence. This already occurs to some extent in the United States, because high-donating rural areas subsidize low-donating urban areas in most regions. It is also the unintended by-product of a little-publicized program that imports red cells from Switzerland and Germany to New York City, where a chronic blood shortage exists because of inadequate donor recruitment. The Swiss and German Red Crosses overbleed their populations to obtain sufficient supplies of plasma for domestic processing. As a result, they produce a surplus of several hundred thousand red cell units, which they ship to the New York Blood Center in exchange for blood-processing equipment, deftly avoiding the embarrassment that a transfer of cash would involve.[50]
See Drake et al., American Blood Supply, chap. 7, for a discussion of the "Euroblood" program. There is currently discussion of extending the program to Atlanta, which is said also to experience chronic supply problems. According to the American Blood Commission, overall blood imports are up, accounting for perhaps as much as 5 percent of the 12 million units used in the United States each year.
Further extension of such programs would increase the safety of the blood supply in many American cities but would require recognition that the concept of community responsibility for blood is inadequate or at least requires substantial expansion.A third alternative is to expand donor exclusion so that other high-risk groups will be prevented from contributing to the blood supply. Such an expansion of donor exclusion criteria was recently proposed by the Food and Drug Administration when it suggested that Haitians
be banned from donating blood. The reasons for the FDA's proposal were straightforward. First, the Haitian community has a much higher prevalence of HIV infection than the United States population as a whole.[51]
"FDA Defends Plan as Based on HIV Data but Might Re-examine," American Medical News, June 15, 1990, p. 3.
The FDA argues that, since the blood test for HIV is not 100 percent accurate, a disproportionate fraction of HIV-infected Haitian blood will enter the blood supply. Second, the FDA argues that adequate screening of Haitian donors is not possible, because heterosexual intercourse is believed to be the primary mode of transmission among Haitians.[52]Collaborative Study Group of AIDS in Haitian-Americans, "Risk Factors for AIDS Among Haitians Residing in the United States: Evidence of Heterosexual Transmission," Journal of the American Medical Association 257 (February 6, 1987): 635-39.
Fearing the loss of large numbers of potentially safe donors, blood banks do not currently screen people who have multiple heterosexual partners.The proposal to eliminate Haitian blood donors created great controversy and led to numerous protests around the country, including a march by more than 100,000 people in New York City. Although the Haitian donor ban may decrease the risk of transfusion AIDS in the United States, the decrease comes with a price. The price of such a plan is borne disproportionately by the communities affected. There is, of course, a precedent. The gay community, one of the first groups recognized to be at increased risk of HIV infection, is largely excluded as well. The net effect of expanding the donor exclusion criteria is to further diminish the notion of community responsibility for blood.
Paying donors is yet another option that is likely to be considered in order to reduce the risk of AIDS transmission in transfusions. The use of direct financial incentives, of course, would reverse federal policies favoring voluntary—that is, noncash—donations established in the 1970s and strongly supported by the nonprofit collectors. But, as was previously mentioned, several of the nation's leading medical institutions once used cash payments to create panels of frequently tested and monitored blood donors to protect against transfusion hepatitis. Today the same procedures could be used to recruit more women, middle-aged donors, or other donors who are less likely to harbor HIV or to engage in high-risk behavior.
Paying blood donors is an anathema to nonprofit collectors, who argue that money is a corrupting force in blood banking, tempting both the collector and the donor to conceal the truth about the quality of the blood they supply. Ignored is the fact that some voluntary donors currently receive substantial cash-equivalent rewards in the form of extra vacation days and time off from work and that blood banks sell blood and other products to hospitals for cash. Confusing blood bankers' arguments against payments, directed donations, and increased imports
are their concerns about the future of blood banking. Each of the reform proposals holds potential for increased competition from hospitals and commercial blood collectors, which are likely to be responsive to the real or imagined fears of transfusion recipients and medical staffs about the safety of blood. But there is a more compelling public policy question: How will attempts to reduce the risks of transfusions affect those who may not be able to take advantage of the additional protections made possible by implementing the proposals and who therefore must rely on the community supply of blood?
Titmuss claimed that blood-banking systems are symbolic of the relationships favored within a society. Voluntary systems, he believed, encourage altruism and strengthen the bonds of community, because these systems are based on the giving by one stranger to save another. Payment systems, he thought, destroy community by creating a market in the gift of life. Timuss did not discuss directed donations, but he would undoubtedly view them as divisive and dangerous, replacing trust among strangers with tribal and family-defined selfishness.
However, the problem we face today is that disease can spread by either altruistic or selfish acts. Not every carrier is aware of his or her exposure to the virus. Tests provide no guarantee that the uncompensated gift from a stranger is safer than the compensated gift from a stranger. The random draw from the community blood pool can be quite hazardous, depending on the pool's composition. Titmuss was mistaken in believing that voluntary donations would eliminate the hepatitis problem. We have no assurance that voluntary blood donations will protect absolutely against AIDS.
Frightened people will seek to protect themselves. Better public understanding of AIDS will surely reduce fears, but it will not eliminate them. Small risks as well as large risks encourage avoidance. Physicians, entrepreneurs, and policy analysts are certain to inform us how that avoidance can be achieved. The reality is that neither the fear nor the risk of transfusion-transmitted AIDS will disappear.
Some cannot fend for themselves when fending is required. The elderly, the poor, and the friendless are most vulnerable in systems that permit payment and directed donations. But donor payments may actually decrease blood collection costs by reducing recruitment expenditures and blood wastage. Much, although not all, blood use is financed through insurance and public benefit programs. Increased costs, if there are any, can be absorbed by adjusting reimbursement levels or through charity drives. More difficult, if this blood collection method becomes common, is the identification of directed donors for those in society
who are alone or in high-risk groups. Here churches, fraternal orders, clubs, and other voluntary organizations may be willing to provide donors for those in need. It is not clear that altruism disappears when alternative donation systems exist. Those who donate for friends and relatives may be quite ready to step forward for others as well.
The more people withdraw from the community pool by making private arrangements to protect themselves, the more likely it is that the shrinking pool will become increasingly disadvantageous for those who must continue to use it. This is the result in too many institutions, urban public schools being but the most dramatic example. A cartel of nonprofit organizations is not sufficient to manage this problem, because they tend to deny the risks and fears that drive people from the community-based arrangement. Blood banking needs to be made more responsive to the public's concerns if it is to retain broad support.
One possibility would be to remove the exemption from strict liability standards that blood banks have obtained in most jurisdictions. The purveyors of nearly all other products in the United States are held strictly liable for faults that cause illness or death independent of any negligent acts in product preparation or distribution. With the burden of liability shifted back to the blood banks, they would soon adopt one or more of the methods previously described that would reduce the hazards of transfusions. Protections that are certain to be available for some could be made available for all.
Another possibility would be for the federal government to encourage interregional and international transfers of blood. In a focused epidemic some areas suffer more than others. The task then is to even the risks of transfusion transmissions among locations. Surgical candidates in New York, Newark, or San Francisco need not suffer greater risks of contracting AIDS simply because New York, Newark, and San Francisco are especially burdened by AIDS. Like other disaster victims, they should expect government-directed assistance from those who are spared or at least less threatened.
The measure of community is not the sharing of risks but the effective management of hazards that may or may not be evenly distributed within a population. There are opportunities to reduce anxiety and risk for all, but we cannot realize these opportunities by denying the existence of dangers or ignoring the possibility of risk avoidance. Instead, to seize these opportunities we must acknowledge and use the many motivations that guide behavior in society, altruism being only one of them.
The justification in the United States for favoring community responsibility for blood has been that it was safer. But that is not the case in
at least some locations. What is necessary is to make blood use safer for all, for the friend as well as for the stranger. Protecting organizations that hold small empires and convenient ideologies does not reduce the risks of transfusions or build community. Finding ways to give reassurance to those who must be transfused is the more responsive and more responsible course to serve the community.
Scientific Rigor and Medical Realities:
Placebo Trials in Cancer and AIDS Research
David J. Rothman
Harold Edgar
In the recent debates on the ethics of placebo-based trials in the evaluation of new drugs to combat AIDS, a sharp line is often drawn between the need to satisfy the principles of "sound science" and the readiness to satisfy "humanitarian impulses." The proponents of sound science contend that the only procedure that will demonstrate the efficacy of a new agent is a placebo trial in a population that is randomly selected; in such a trial both the subjects and the investigators must be ignorant, or blinded, as to who is receiving the active agent and who the inert substance. Although half the subjects will receive an inactive ingredient, proponents believe that the long-term good of establishing knowledge outweighs all other considerations. Those opposed to placebo trials contend that, although the new substance is of unknown efficacy, it may work, and therefore may give persons with AIDS an opportunity, both psychological and pharmacological, to extend their lives. But an evaluation of the ethics of placebo trials in the AIDS era does not require us to pursue an either/or approach, a rigid opposition of scientific progress and compassion, with no ground between these two extremes. In fact, the choices are not so stark, mostly because the principles of sound science are not so rigid and immutable as many of its advocates insist. The placebo-based random clinical trial does not have the hegemony in drug development that its proponents suggest—and the departures from the standard have not come at the price of ignorance or malfeasance. The evidence for this proposition comes most powerfully from cancer research. The way cancer researchers have pursued drug
The authors would like to acknowledge research support from the American Foundation for AIDS Research.
development casts a very different light on the AIDS controversies and deserves sustained analysis.
Long before the AIDS crisis, the issue of scientific rigor and patient needs was confronted in the cancer research field, surfacing most notably in the disputes that marked the relationship of the National Cancer Institute (NCI) and the federal Food and Drug Administration (FDA). The NCI, a government-funded research organization, actively develops and tests new drugs. In formal terms it has the same relationship to the FDA that any other drug manufacturer has; that is, the drugs it develops must be licensed by the FDA before distribution. But in reality the FDA-NCI relationship is far more complicated, and the NCI generally follows special procedures that depart from FDA requirements. Probably the most important difference between the two organizations is on the matter of demonstrating drug efficacy, in effect, on the kinds of clinical trials appropriate to demonstrating efficacy.
A 1982 congressional hearing clarified these differences. The hearings were occasioned by a series of articles in the Washington Post , describing protocols in which cancer patients were ostensibly used as guinea pigs in research. These patients, the article contended, were receiving drugs that investigators knew were too toxic, or ineffective, and the FDA was failing to supervise or regulate their work. (Even as late as 1981, the predominant fear among outsiders was not that patients were unable to enroll in protocols but that patients would be misused by researchers.) The cancer investigators, for their part, insisted that the patients were fully informed about the risks and benefits, that drugs ineffective against one type of tumor might be effective against another type, and that high drug toxicity was unavoidable in light of the present state of knowledge. But what emerged most vividly in the course of the hearings was the shared commitment among cancer researchers to doing something, anything, for the terminally ill cancer patient. When death was the alternative, they were ready to try new and admittedly dangerous drugs on patients who wanted a shot, even a long shot, at a remission or cure, and if this commitment brought them into conflict with the FDA, or with the gold standard of random clinical trials (RCTs), so be it. The first loyalty was to the patient.
Vincent DeVita, director of the NCI, explicated this position fully. "The most serious toxicity of all," he declared in his testimony, "is the unnecessary death from cancer. … Any system of drug distribution we develop that denies any cancer patient access to these resources is wrong."[1]
National Cancer Institute's Therapy Program, Joint Hearing before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce (House of Representatives) and the Subcommittee on Investigations and Oversight of the Committee on Science and Technology, 97th Cong., 1st sess., October 27, 1981 (Washington, D.C.: U.S. Government Printing Office, 1981) p. 154.
The NCI arrangements aimed to maximize distribution withoutsacrificing oversight. New cancer drugs (all cytoxic—that is, by definition injurious to normal cells) were designated A, B, or C, with a rough but not complete analogue to Phase I, II, III categories. Drugs in category A were tested first on patients with advanced disease by oncologists in ten designated institutions; should any of the drugs appear promising (by evidence of tumor shrinkage or improved quality of life), they moved to category B, to be tested by a larger group of selected clinical investigators on a wider range of patients. The drugs that demonstrated effectiveness were then promoted to category C, to be distributed to a still wider network of designated practicing physicians (those sponsored by NCI grants or contracts). This distribution was akin to the FDA's "compassionate use" procedure but was much more extensive and systematic.
Several aspects of this system made clear the extent to which cancer drug development was treatment oriented. First, this considerable distribution of drugs took place before the FDA actually licensed them. Second, drugs were moved into category A without extensive animal tests (since they were known to be toxic). Again and again cancer researchers made the point that the true toxicity was cancer. As Dr. James Holland of New York City's Mt. Sinai Hospital put it: "Can it be more ethical to deny the possible good effects to most, by avoiding all toxicity in order to do no harm to one? The unmitigated disease must be calculated as a toxic cost of cancer. Underdosing, in an attempt to avoid toxicity, is far more deadly."[2]
Ibid., p. 256.
Third, no one at NCI disputed that "leakage" occurred; that is, physicians who received drugs in A or B category and did not exhaust their supply sent the remainder on to still other physicians for use with their patients. DeVita was not very apologetic about the leakage, insisting that "sometimes patients benefit."[3]Ibid., p. 218.
Finally, and perhaps most important, and we will return to explore this point in more detail later, the trials with cytoxic drugs against advanced cancers were almost always single armed—that is, not controlled and not placebo based.The cancer investigators in their testimony made no secret of their disdain for the FDA regulatory apparatus. "Innovation and regulation are constantly in conflict," argued Dr. Emil Freireich, of the University of Texas System Cancer Center, and formerly at the NCI. "In our country we have gone extremely to the side of regulation, much to the detriment of innovative creative science. … It is truly ironic that the mechanisms designed for protection create serious harm to thousands of individuals with cancer without any potential for benefit. … Speaking
as a physician-scientist … there is continuous frustration resulting from excessive regulation. … It is clear that any new knowledge requires additional risk."[4]
Ibid., pp. 261, 264, 265, 268.
Indeed, these researchers were impatient not only with the FDA but with the idea of government paternalism, and if some of this attitude may have been the product of professionals wanting to maintain ample discretion, it also reflected a deep concern for the desperately ill patient. When Dr. John Ultmann, director of the Cancer Research Center at the University of Chicago, was asked whether in category A or Phase I studies the researchers might be sacrificing patient welfare for scientific knowledge, he insisted that "throughout this process, above all else we are doctors."[5]Ibid., p. 272.
And when California congressman Henry Waxman invoked the need for the government "to protect the public from drugs that are going to kill them, poison them, maim them," Dr. Holland reminded him that with cancer drugs the injunction to "do no harm" was meaningless, for "all the patients who would have benefitted will be undertreated."[6]Ibid., pp. 279, 283.
In the immediate aftermath of the 1981 hearing, the NCI and the FDA established a joint task force. Its report, aptly titled Anticancer Drugs: The NCI's Development and the FDA's Regulation , spelled out further differences between the more patient-centered risk-taking procedures at the NCI and the more paternalistic and "sound science" oversight at the FDA.[7]
Joint Task Force, National Cancer Institute and U.S. Food and Drug Administration, Anticancer Drugs: The NCI's Development and the FDA's Regulation (Washington, D.C.: U.S. Department of Health and Human Services, January 28, 1982).
For one, the cancer researchers were so committed to patient care that they were unwilling to continue to test a new drug against all types of tumors when the drug had shown little efficacy in its initial tumor screens. Conceding that some drugs had proven effective only against one or two types of tumors (and if the screening had not been complete, this efficacy would have been missed), the researchers were nevertheless "reluctant to enroll patients with a given tumor in a study of a drug already shown ineffective in several other tumors; they prefer, instead, to try a drug with which there is little prior experience."[8]Ibid., p. 33.
For another, the FDA required that, before any drug could be licensed to be used in combination therapies (together with other drugs), its own individual efficacy had to be established. By the gold standard, drug X should not be added to drugs Y and Z unless drug X had independently demonstrated its efficacy. The cancer researchers took a contrary position; they were ready to go with what worked, regardless of testing requirements. Thus, in Phase III studies the NCI focused on the patient and the disease, not on the drug. "Most research oncologists are convinced that they will obtain the best therapeutic results with drug
combinations, so that the design at this stage that will clearly illustrate the value of a drug may appear unethical." The FDA staff accused the NCI of being unwilling to do proper testing; the NCI responded that over the past decade, as a result of its testing methods, a number of drugs had found "secure places in the practice of clinical oncology and … overall survival of cancer patients has improved."[9]
Ibid., p. 36.
The task force also had to address the issue that the Washington Post had raised about the appropriateness of using cancer patients in Phase I, or NCI category A, tests for toxicity. Here, too, it concluded that patients should be permitted to make their own determinations of risk and that the FDA should not decide what risks were or were not allowable. "While the Task Force recognized that people do not have an absolute right to harm themselves consciously, neither should they be absolutely precluded from seeking treatment which holds out hope of benefit." Even an overall response rate of 9.5 percent (the average response rate to Phase I drugs) was reason enough to let the patient make the choice.[10]
Ibid., p. 69.
The task force then confronted two especially controversial aspects of NCI procedures. First was the NCI's unwillingness, and the general unwillingness of cancer researchers, to adhere to the placebo trials. Although it acknowledged the widespread perception that "NCI protocols are not scientifically adequate; they are biostatistically flawed," the task force unapologetically defended the NCI procedures in language that is well worth scrutinizing: "There are difficulties in creating ethical controlled trials in a uniformly fatal disease, and there are restrictions on the number of patients to be studied because of the known drug toxicity. Ideal experimental design must be compromised to achieve the best possible patient care . As a result, many Phase II studies have used historical controls, and Phase III studies [have used] combination therapies. Thus they may not be compared with experiments that can be performed in other kinds of illnesses."[11]
Ibid., pp. 90-91 (italics added).
In other words, the need to treat desperately ill patients ruled out the use of placebos or the testing for efficacy of the individual drugs that went into combination therapies.This same rationale supported the distribution of the drugs in group C testing. Although the efficacy of these drugs had not been proved by FDA standards, and although the drugs were being distributed to hundreds of physicians, the task force defended the procedure. First, it noted that the drugs were distributed only to a selected group of qualified physicians; second: "The Task Force believes that Group C status
is an appropriate method for bringing important medications to patients who need them."[12]
Ibid., pp. 101-2.
Once again the needs of patients took first priority.The task force's endorsement of the practice of distributing cytoxic drugs whose efficacy had not been established in placebo-based clinical trials was only the latest entry in a decade-long debate on the standards that should be satisfied before drugs were made available. This same controversy erupted, with even more heat, around the release of AIDS drugs. Were the new agents to undergo placebo trials? Should the active agent be given to all subjects, and its efficacy measured against past knowledge of the course of the disease?
The FDA, in fact, does not insist on placebo-controlled studies or rule out the use of historical controls. Its 1985 regulations defining "adequate and well-controlled studies" (section 314.126) open with the statement: "The purpose of conducting clinical investigations of a drug is to distinguish the effect of a drug from other influences, such as spontaneous change in the course of the disease, placebo effect, or biased observation." It then lists five types of controls that are "recognized." The first is placebo concurrent control; the others include a "no treatment concurrent control," or control through comparison with another active agent. Fifth—and by no coincidence last on the list—is the historical control: "The results of treatment with the test drug are compared with experience historically derived from the adequately documented natural history of the disease … in comparable patients or populations. Because historical control populations usually cannot be as well assessed with respect to pertinent variables … historical control designs are usually reserved for special circumstances. Examples include studies of diseases with high and predictable mortality (for example, certain malignancies) " (italics added). Hence, the FDA does accept historical controls as a type of control in clinical trials, in contradistinction to the reliance on "isolated case reports" or "random experience."
Many investigators object to this position, insisting that historical controls are never an adequate base for measuring the efficacy of a drug. One of the most persistent critics has been Thomas Chalmers, who was dismayed to report, on the basis of a survey of abstracts presented to the 1971 meeting of the American Association for Cancer Research, that only 21 percent of the protocols had used clinical trials. He found it "surprising that this crucial concept has not caught on to a greater extent" and marshaled arguments for its use. Noting that "many clinical
investigators believe that they cannot deprive their patients of the opportunity to receive a new drug," he countered that "the experience with every new cancer drug, when it is introduced into man, is such that either the risk of drug toxicity and mortality is greatest during its early use, or impotent doses are used at first to avoid unknown toxic effects. In either case little benefit to the first patients treated with the new agent can be anticipated." Moreover, Chalmers continued, if a drug shows some signs of early efficacy, investigators will then not undertake randomized trials but will accept the pilot test results as definitive. From Chalmers's perspective, the only way to avoid the predicament is to randomize from the first patient; otherwise, a state of ignorance is certain to prevail.[13]
Thomas C. Chalmers, Jerome Block, and Stephanie Lee, "Controlled Studies in Clinical Cancer Research," New England Journal of Medicine 287 (July 13, 1972): 75-78.
Franz Ingelfinger, then editor of the New England Journal of Medicine , ran an accompanying editorial to the Chalmers article, supporting his insistence on the randomized clinical trial. Noting the "ethical and emotional" objections to the trials, Ingelfinger declared: "It is an investigator of strong moral and intellectual fiber who would resist the urge to 'do something' for a fatally sick patient … who would use 'cold science' when the pressures are all on the side of warm hope." But researchers must rise to the challenge: "Ethical, as well as scientific, considerations require that medicine depend on the most reliable and best controlled data available—the kind of data that is sought by the randomized clinical trial."[14]
Franz Ingelfinger, "The Randomized Clinical Trial," New England Journal of Medicine 287 (July 13, 1972): 100-101.
The types of arguments that Chalmers and Ingelfinger raised in defense of the RCT are familiar and have been often repeated. What is more needed is a full explication of the counterposition, one that goes beyond "warm hope" for the subject or the weak fiber of the researcher-clinician. At its core is the proposition, conceded by the FDA but ignored by Chalmers and the others, that placebo-based trials are ethically inappropriate in the case of a "uniformly fatal disease." In the standard medical text on cancer, a chapter on the design of clinical trials declares: "To determine whether a new treatment cures any patients with a disease that is uniformly and rapidly fatal, history is a satisfactory control. … Are randomized trials necessary for identifying major advances in treatment? No. There are many examples of therapeutic breakthroughs that were recognized without randomized trials. For the most part, however, these occurred in diseases where the prognosis was 100% predictable before the advent of the new therapy, and hence there was no possibility of bias with regard to patient selection."[15]
Richard Simon, "Design and Conduct of Clinical Trials," in Cancer: Principles and Practice of Oncology, 2nd ed., ed. V. DeVita, S. Hellman, and S. Rosenberg (New York: Lippincon, 1985), pp. 332-33.
This position was also advanced by David Byar, of the NCI's Clinical and Diagnostic Trials Section, in an essay on the "Necessity and Justification of Randomized Clinical Trials." Byer listed six difficulties with historical controls (from missing data to failure to convince others of the results), presented another six arguments in favor of randomized trials (bias is avoided, time trends are no problem, fewer patients need to be treated to get a convincing answer), and comfortably declared that the ethical dilemmas in RCTs were resolved because "there is always some cost in learning something." But Byar was also prepared to support nonrandomized studies "when a new treatment appears that is markedly effective for a disease which before that time was virtually incurable." Those situations, he cautioned, might be rare, but when they arose, "it would be difficult or impossible to justify a randomized study … from an ethical point of view."[16]
David Byar, "The Necessity and Justification of Randomized Clinical Trials," in Controversies in Cancer, ed. H. Tagnon and M. Staquet (New York: Masson Publishing, 1979), chap. 10
Some cancer researchers were even prepared to go further in undercutting an exclusive reliance on RCTs. Drs. Edmund Gehan and Emil Freireich, of the M. D. Anderson Hospital and Tumor Institute, writing in 1974, insisted: "A clinical investigator has an ethical responsibility for his patients when they are involved in a clinical trial … to administer … the treatment that gives him the highest probability of a successful outcome. … If preliminary clinical studies suggest that a new treatment is significantly more effective than a standard … the physician would not be fulfilling his ethical responsibility if he planned a randomized comparative trial." Hence, the authors concluded: "In clinical trials it is unwise to assign patients to treatments by any single method. In the field of cancer chemotherapy, effective new therapies have been detected, confirmed, and applied widely in practice as a result of prospective and quantitative clinical trials that have not used random allocation of patients. … The widespread acceptance of the randomized comparative trial seems based … more on the intuitive attractiveness of the technique than on any objective scientific evaluation of the methodology."[17]
Edmund A. Gehan and Emil J. Freireich, "Non-randomized Controls in Clinical Trials," New England Journal of Medicine 290 (January 24, 1974): 198-203 (quotations from pp. 202-3).
Thus, for a number of reasons, the placebo-based RCT is not the gold standard in cancer research, not in principle and not in fact, when the disease is uniformly fatal or virtually incurable. Cancer researchers have openly made the case against the monopoly of RCTs in trial design and in practice have prepared to avoid them, even at the risk of not satisfying FDA procedures. As Dr. Robert Wittes of the NCI concluded: "The placebo or no-treatment control has always had a very limited role in the evaluation of cytoxic therapy in advanced cancer. … Clinical
oncologists in the United States have been generally unwilling to randomize a patient with advanced progressive cancer to placebo or observation alone." Instead, "the clearest demonstration of a beneficial effect on survival might only come from a comparison with a carefully selected and characterized historical control group.[18]
Robert E. Wittes, "Antineoplastic Agents and FDA Regulations: Square Pegs for Round Holes?" Cancer Treatment Reports 71 (1987): 795-806, at pp. 799, 804.
And by 1989 at least, the FDA was on the whole ready to accept the position. In a "Talk Paper" on "Approval of New Cancer Drugs," issued March 3, 1989, as part of a series of papers "to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest," the FDA declared that in decisions to approve new drugs "neither safety nor effectiveness is absolute, but must be weighed in particular cases" and that "although randomized clinical trials … are the preferable means of evaluation, other study designs may be acceptable, especially for refractory diseases (those malignancies which do not respond to standard therapy), where a clear response may be apparent even without a randomized control."With the cancer research model to mind, let us now examine the controversies around research design and AIDS drugs, focusing first on the AIDS Drug Development hearings conducted in July 1986 by Congressman Ted Weiss, and then on the ethical dimensions of the decision to make the first large-scale AZT trial placebo based.
The Weiss hearings confronted directly the issue of placebo-based trials, and the testimony split along the lines that we have been tracing. Proponents of the classic-style RCT came predominantly from the realms of infectious diseases, the FDA, and the drug companies (whose products, after all, must pass FDA review). Their model was not the cancer model; the research in AIDS was not to follow on the designs for research in cancer. "We have learned," declared Harvard professor of medicine and infectious disease specialist Martin Hirsch, "in clinical trials of antiviral agents against other fatal diseases … that placebo controls are mandatory until an effective agent is found. The same procedures must be followed in HIV infections, or we will pay the price in unnecessary delays and unwarranted deaths. … Until you have some evidence of efficacy of a drug you are still justified in doing placebo-controlled trials even in a fatal condition, such as AIDS, because you may do harm with any of these drugs."[19]
AIDS Drug Development and Related Issues, Hearing before a Subcommittee of the Committee on Government Operations (House of Representatives), 99th Cong., 2d Sess., July 1, 1986 (Washington, D.C.: U.S. Government Printing Office, 1986), pp. 52, 69.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, and Dr. Harry Meyer from the FDA both tried to differentiate AIDS from intractable cancer. "Although one can project
that within a five-year period most of the patients will succumb to disease," argued Fauci, "in fact, to those of us who see AIDS patients every day, it becomes very clear that the natural history is quite variable. One of the great problems that we could create for ourselves would result from using a control that is not an adequate control and feeling that an agent was helpful when it really was not."[20]
Ibid., p. 104.
This position was also defended by Dr. David Barry, vice-president of research, Burroughs Wellcome (the manufacturer of AZT): Stating unequivocally that AIDS was unlike cancer, he argued that "because of the waxing and waning of some of the clinical manifestations of AIDS, we could not do an uncontrolled study."[21]Ibid., pp. 115-16.
Dr. Mathilde Krim, herself a cancer researcher before she established the American Foundation for AIDS Research, most explicitly made the case for having AIDS research follow on the cancer model. (Surprisingly, she remains one of the very few commentators in this debate to do so—the "plague-like" quality of AIDS apparently made the cancer model seem as irrelevant in the laboratory as in the design of the delivery of care.) Her arguments drew on the traditions in cancer research. Noting that "ethically and scientifically satisfying alternatives to placebo-controlled trials have been devised for the study of experimental drugs in cancer patients," she asked why they were not being used in AIDS. Observing, as well, that experimental (group C) drugs were made available to cancer patients before FDA licensing, she wondered why AIDS patients were not coming under the same policy. After all, "AIDS is presently more surely lethal, within a shorter time, than most cancers. There is no known accepted treatment."[22]
Ibid., pp. 23, 38-39.
The differences that emerged at the Weiss hearing were anything but academic. At that very moment, the first large-scale trial on the new drug AZT was being conducted, and the trial was placebo based. AZT had been first tested on 19 patients with AIDS and ARC; and the highly promising findings from this six-week trial, in which all patients received the drug, were published in March 1986 in Lancet . To review some of the highlights: the patients generally tolerated the drug well, 15 of the 19 had increases in helper T cells, 13 patients had a weight gain of 2 kilograms or more, and 6 patients noted cessation of fever or night sweats and an improvement in their sense of well-being. The published report of the study concluded that the trial did not demonstrate whether immunological improvements would be sustained, whether AZT could be tolerated over a long time, whether viral drug resistance would develop,
or whether AZT would affect disease progression or survival. "These are issues which can be resolved only by appropriately controlled long-term studies."[23]
Robert Yarchoan et al., "Administration of [AZT] to Patients with AIDS or AIDS-Related Complex," Lancet 1 (March 15, 1986): 575-80.
On the basis of these findings, a multicenter, placebo-based trial was undertaken in 282 patients; 145 subjects received AZT, and 137 received placebo. Of the patients with AIDS, all had experienced a first episode of Pneumocystis carinii pneumonia (PCP) within 120 days; patients with ARC had notable weight loss or other symptoms, such as herpes zoster or lymphadenopathy. The multicenter study was terminated after twenty-four weeks because the first results demonstrated the efficacy of the drug: over this period, 19 subjects in the placebo group but only 1 in the AZT group died. More generally, in 1986, patients with AIDS and PCP had a median survival of twelve and a half months, and after twenty-two months three-quarters of these patients were dead.
Was the design of this trial ethically proper? Should 137 patients have received placebo? This question was actually the subtext of the testimony at the Weiss hearing. Dr. Krim, in effect, said no, asking why "any AIDS patient should be forced to accept cornstarch pills. … This practice has long been abandoned in the experimental treatment of patients with advanced cancer."[24]
Ibid., p. 39.
From her perspective, a median survival of twelve and a half months made AIDS an intractable and uniformly fatal disease, and historical controls would have been sufficient to establish efficacy. On the other side, the remarks by Drs. Fauci and Meyer about the standards for research and the variability of the disease patterns in AIDS were clearly intended to defend the protocol's design.Whatever the nature of the dispute, it is apparent that were AZT an anticancer drug, the trial would not have been placebo based. Had 19 patients with advanced cancer and no known therapeutic agent done as well as the first 19 patients on AZT, the next trials would have given the drug to all subjects. The goals of treatment would have taken first precedence. Put another way, that the AZT trials were placebo based testifies to the fact that the treatment of AIDS was based not on the cancer model but on a more generalized medicine model, really an infectious disease model.
This formulation has several implications that merit notice. First, in light of the initial definitions of what constituted the AIDS crisis, it is not surprising that the research design followed an infectious disease model. AIDS was a plague, an infection, the result of a viral agent, not a chronic illness of cellular origin. And those working in infectious diseases,
unlike those in cancer research, generally had considerably less day-to-day contact, and less intense contact, with terminally ill patients than their counterparts in oncology. Most of the research in infectious diseases, although certainly not all, did not involve desperately ill patients willing to take high risks for the slimmest possibility of a gain. Inevitably, in the realm of infectious diseases, the commitment to placebo-based random trials did not have to come up against agonizing questions.
By the same token, the FDA staff, driven for a variety of reasons to maximize safety and minimize risk, were also committed to rigorous RCTs; and the group that stood out against this orientation, the cancer researchers, had over the years been able to insulate their operations, through the NCI, from systematic FDA oversight.[25]
For an overview of the tension between FDA regulation and AIDS activism, see our article: "New Rules for New Drugs: The Challenge of AIDS to the Regulatory Process," Milbank Quarterly, 68, Suppl. 1 (1990): 111-42.
Hence, it was the infectious disease—FDA model, not the cancer model, that structured the design of the AZT tests.A recognition of this process has a direct relevance to deliberations on the ethics of clinical trials, for it makes apparent that science comes in a variety of models, and the process by which one or another subsumes a particular area of medicine is determined not by immutable canons of research but by historical and social contingencies, or, if you will, by metaphors. Since the first designation of AIDS was of a plague, not a chronic disease, the models of infectious disease, not cancer, took hold. Put another way, a committee charged to analyze the ethics of trials is confronting a choice not between science and compassion but between which model of science is most appropriate to AIDS.
Entering the Second Decade:
The Politics of Prevention, the Politics of Neglect
Ronald Bayer
In 1991 the AIDS epidemic in the United States entered its second decade. More than 200,000 people have been diagnosed with AIDS; 140,000 are dead. It is a time of great promise but also of great risk. Remarkable advances have been made in the biomedical realm, and public policies have been designed to limit the spread of HIV infection and protect the rights of those who are infected or at risk of infection. These are singular accomplishments—all the more so since they have come as a consequence of intense political conflict, spurred by the demands of those who have borne the burden of disease and their allies. But these achievements also set the stage for new controversies in public health. The central political and ethical question of privacy, which was debated in the epidemic's first phase, has now been joined, although not displaced, by the question of equity. How America responds to the new issues concerning access to potentially life-prolonging therapies will have a profound impact on the shape and course of the epidemic in the next years. The situation will be far different in the Third World, where, because of the international maldistribution of professional and economic resources, access to new therapeutic regimes will be all but beyond reach. A single virus may thus create two very different epidemic patterns: one that permits increasingly effective clinical responses; another where men, women, and children continue to succumb, with an enormous toll in human suffering and social dislocation.
Inevitably, public policy will be affected by changing perceptions of the dimensions of the epidemic. Estimates of the number of infected
Reprinted with permission from Private Acts, Social Consequences: AIDS and the Politics of Public Health (New Brunswick, N.J.: Rutgers University Press, 1991).
individuals made in 1986 were, it is now clear, too high. Indeed, figures presented in late 1989 suggest that no more and perhaps fewer Americans were infected at that time than were assumed to be infected three years earlier.[1]
Centers for Disease Control, "CDC Fstimates of HIV Prevalence and Projected AIDS Cases: Summary of a Workshop, Oct 31-Nov 1, 1989," Morbidity and Mortality Weekly Report 39 (February 23, 1990): 110-19.
Equally important, epidemiological trends first noticed in the last years of the 1980s made it clear that, although heterosexual transmission of HIV continues to occur, the spread of infection has remained largely confined to those groups first identified as being at increased risk. The prospect of a rapid spread of HIV among the general population, which served as a specter haunting public policy and which fueled public anxieties, is not currently considered likely. Gay and bisexual men, intravenous drug users, their typically female sexual partners, and their offspring will continue to bear the epidemic's greatest burden of disease, suffering, and death. Sexual orientation and the lines of social cleavage that tend to limit sexual contact between the poor, urban underclass and the broader society have served thus far to contain the epidemic.Because the epidemic of HIV infection appeared less threatening than was previously thought, many people feared that only limited resources would be allocated to it—at a time when major infusions of funds for care would be needed. It is in that light that Michael Fumento's Myth of Heterosexual AIDS must be read; its polemical thrust is directed at those who appealed for resources to meet the challenge of AIDS.[2]
Michael Fumento, The Myth of Heterosexual AIDS (New York: Basic Books, 1990).
The angry reaction from gay groups such as the Gay Men's Health Crisis and especially ACT UP, in the summer of 1988, when the New York City Health Department revised downward by 50 percent the estimated number of infected New Yorkers, must also be understood in that light.[3]Expert Panel on HIV Seroprevalence Fstimates and AIDS Cases Projection Methodologies, Report (New York: City Health Department, February 15, 1989); Richard Dunne, letter to Stephen Joseph, August 18, 1988.
At the same time, the increasing association of AIDS with the underclass may fundamentally weaken the political alliance that underlay the voluntarist consensus which dominated public discourse about prevention policies in the epidemic's first decade.Even more critical to an understanding of the evolving political debates about AIDS and the public health are recent clinical developments. The therapeutic impotence of the early years of the epidemic has begun to give way to a sober yet more optimistic perspective. Progress has been made not only in meeting the challenge posed by opportunistic infections but also in slowing the progression of disease in those who are infected but still asymptomatic. Although it is still too soon to speak of AIDS itself as a chronic disease, HIV infection will increasingly require the kind of long-term clinical management associated with such conditions. As a consequence, public health officials are no longer intent
solely on preventing the further spread of infection; rather, they face the task of creating the necessary medical infrastructure to ensure that the million or more infected Americans are provided with appropriate clinical supervision. It is within this changed context that screening, reporting, and partner notification—issues that figured prominently in the early days of AIDS prevention—have taken on new significance and have provoked fresh debates about the appropriate role of the state. The traditional approaches of public health officials to epidemic disease, approaches that were vigorously challenged in the early and mid-1980s, have found new support from those who had previously found them inadequate or ethically unacceptable.
No issue has consumed more attention in the debates over public policy and AIDS than the use of the antibody test to identify those infected with HIV. In the period following the test's development, controversy centered on the role of testing in supporting the radical modifications of behavior that were universally deemed critical to altering the epidemic's course. Out of these debates emerged a broad consensus, often codified in state statutes, that testing should be conducted only with the informed voluntary and specific consent of individuals. Despite that standard, and the carefully defined, though always contested, exceptions to its scope, many clinicians and hospitals undertook surreptitious testing of patients, justifying their practices by the belief that the protection of health care workers and sound diagnostic work required such screening.[4]
New York Times, February 17, 1990, p. 1.
In Illinois organized medicine went further, successfully pressing the governor and legislature, despite opposition from the state's chief health official, to permit testing at the discretion of the clinician.[5]Windy City Times, September 8, 1988, p. 1.
In New York State four medical societies, including the New York Medical Society, unsuccessfully brought the commissioner of health to court because of his failure to designate AIDS a sexually transmitted disease, a determination that would have permitted testing without consent.[6]New York State Society of Surgeons, New York State Society of Orthopaedic Surgeons, New York State Society of Obstetricians and Gynecologists, and the Medical Society of New York v. David Axelrod, New York State Court of Appeals, May 2, 1991.
With the announcement in mid-1989 that clinical trials had revealed the efficacy of early therapeutic intervention in slowing the course of illness in asymptomatic but infected persons and in preventing the occurrence of Pneumocystis carinii pneumonia, the political debate about testing underwent a fundamental change. Gay groups such as Project Inform in San Francisco and the Gay Men's Health Crisis in New York, which had formerly opposed testing, now began to encourage people in high-risk groups to determine whether or not they were infected.[7]
PI Perspective, April 1988, p. 7; New York Times, August 16, 1989, p. 1.
Physicians pressed more vigorously for the "return of AIDS to the medicalmainstream," so that testing might be routinely done under conditions of presumed consent.[8]
Frank S. Rhame and Dennis A. Maki, "The Case for Wider Use of Testing for HIV Infection," New England Journal of Medicine 320 (May 11, 1989): 1248-54.
Public health officials—most notably in New York and New Jersey, which had borne much of the burden of AIDS—launched aggressive testing campaigns.Although physicians and public health officials have typically avoided the language of compulsion, stressing instead routine testing, the threat of coercion loomed before gay activists, their liberal political allies, and proponents of civil liberties. So, too, did the risk of increased stigmatization and discrimination.
With the promise of early therapeutic intervention came the unraveling of the alliances that had been forged in the first phase of the epidemic. A powerful movement emerged, supported by obstetricians and pediatricians, for the routine screening of pregnant women who could transmit HIV to their offspring and the mandatory screening of infants at high risk for infection. The public health practice of testing for syphilis and hepatitis B served as a model for the testing of pregnant women; the widescale and broadly accepted tradition of screening for congenital conditions such as phenylketonuria (PKU) served as the standard for the screening of infants. The promise—with little evidentiary base—that early intervention might protect the fetus or at least enhance the life prospects of babies at risk for HIV infection had begun to override ethical concerns about the coercive identification of infected women, most of whom were black or Hispanic, as well as about the potential burdens of exclusion from housing, social services, and health care itself that might be imposed on those so identified.
The erosion of the alliance that had resisted the application of traditional public health practices could be seen also in the shifting trends on the issue of reporting the names of those infected with HIV to confidential public health department registries. Such reporting requirements had been fiercely resisted by gay groups and their allies because of concerns about privacy and confidentiality. The requirements also had been opposed by public health officials in areas with large numbers of AIDS cases because of the potential impact on the willingness of individuals voluntarily to seek HIV testing and counseling. As a consequence, the reporting requirements had become policy in only a handful of states. It was thus a great setback for those who opposed reporting that the Presidential Commission on the Human Immunodeficiency Epidemic—appointed by President Reagan and skillfully chaired by Admiral James D. Watkins—urged in its mid-1988 final report the universal adoption of a policy first chosen by Colorado three years earlier.[9]
Presidential Commission on the Human Immunodeficiency Virus Epidemic, Report (Washington, D.C.: U.S. Government Printing Office, 1988), p. 76.
That decision was all the more distressing since much of the commission's final report contained proposals broadly applauded by liberal critics of the Reagan administration's failure to commit either sufficient resources or political leadership to the struggle against AIDS.
Ultimately more significant were the fissures that had begun to appear in the alliance opposing named reporting in those states where the prevalence of HIV infection was high and where gay communities were well organized. In New York, for example, the same suit brought by the medical societies that sought to compel the commissioner of health to declare AIDS a sexually transmitted disease demanded that HIV infection be made a reportable condition.[10]
Society of Surgeons et al. v. Axelrod.
What made the (ultimately unsuccessful) suit so remarkable was the posture of the opposing sides. Historically, clinicians had resisted efforts by public health officials to require the reporting by name of individuals with infectious diseases, arguing that such policies represented an intrusion upon the doctor-patient relationship. In this instance the representatives of clinical medicine were asserting that reporting was critical to the public health while the state's chief health official resisted such a perspective. That apparent paradox can be explained only by the unique political alliances that had been created early in the epidemic between gay organizations, civil liberties groups, and public health officials.But by June 1989, even that feature of the political landscape of public health had begun to change. In an address that was met with cries of protest, Stephen Joseph, commissioner of health in New York City, told the Fifth International Conference on AIDS that the prospect of early clinical intervention necessitated a "shift toward a disease control approach to HIV infection along the lines of classic tuberculosis practices."[11]
Stephen C. Joseph, "Remarks at the Fifth International Conference on AIDS," Montreal, June 5, 1989, mimeo.
A central feature of such an approach would be the "reporting of seropositives" to ensure effective clinical follow-up and the initiation of "more aggressive contact tracing." Joseph's proposals opened a debate that was only temporarily settled by the defeat of New York's mayor, Edward Koch, in his bid for reelection. When the newly elected mayor, David Dinkins, selected Woodrow Myers, formerly commissioner of health in Indiana, to replace Joseph, his appointment was almost aborted, in part because he had supported named reporting.[12]New York Times, January 19, 1990, p. B1.
The festering debate was ended only by a political decision on the part of the mayor, who had drawn heavily on support within the gay community, to stand by his appointment while promising that there would be no named reporting in New York.In New Jersey, which shared with New York a relatively high level
of HIV infection, the commissioner of health also supported named reporting, but in that case the politics surrounding the issue were very different. There both houses of the state legislature endorsed without dissent a confidentiality statute that included named reporting of cases of HIV infection.[13]
Newark Star Ledger, January 5, 1990.
New Jersey simply exemplified a national trend. For, although only nine states at the end of 1989 required named reporting without any provision for anonymity, states increasingly were adopting policies that required reporting in at least some circumstances.[14]Intergovernmental Health Policy Project, "HIV Reporting in the States," Intergovernmental AIDS Reports, November-December 1989.
Finally, in late 1990 the House of Delegates of the American Medical Association went on record as supporting named reporting. So, too, did the CDC, if in a somewhat circumspect fashion.[15]CDC, "Update: Public Health Suveillance for HIV Infection—United States, 1989 and 1990," Morbidity and Mortality Weekly Report 39 (1990): 860.
And always the arguments were the same. New therapeutic possibilities provided the warrant for reestablishing a standard of traditional public health practice.Ironically, pressure to extend the provision of Medicaid coverage for early treatment and to expand government-funded clinics to treat those with HIV infection will inevitably result in the creation of records on growing numbers of infected individuals regardless of whether states adopt mandatory reporting requirements. The move toward early clinical intervention is, then, incompatible with the preservation of anonymity. As a result, creating and enforcing regimes to protect the rights of infected persons from acts of discrimination will assume greater importance than in the epidemic's first years. In this context state-level protections for individuals with HIV infection will be crucial. But even more important will be the enforcement of the Americans with Disabilities Act by the Congress, legislation that provides those with HIV infection rights extended to those with other impairments.
The move toward reporting was linked only in part to the argument that state health departments needed the names of individuals to ensure adequate clinical follow-up. Also important was the assertion from public health officials that effective contact tracing, now more critical than ever because of the need for early clinical intervention, could be undertaken only if those with HIV infection, but not yet diagnosed as having AIDS, could be interviewed. Despite its central and well-established role in venereal disease control, the notification of the sexual and needle-sharing partners in the context of AIDS had been a source of ongoing conflict between gay groups and civil liberties organizations, on the one hand, and public health officials who had proposed such a strategy in the early years of the epidemic, on the other. This standard disease control measure had always been predicated on the willingness of those
with sexually transmitted diseases to provide public health workers with the names of their partners in exchange for a promise of anonymity. AIDS activists had viewed contact tracing as a threat to confidentiality and as a potentially coercive intervention. Indeed, opponents of contact tracing typically denounced it as "mandatory."
With time and a better understanding of how contact tracing functions in the context of sexually transmitted diseases, some of the most vocal opponents of tracing yielded their principled opposition, at least in private meetings and discussions, and instead centered their concerns on the cost of so labor-intensive an intervention. Support for voluntary contact tracing was ultimately to come from the Institute of Medicine and the National Academy of Sciences, the Presidential Commission on the HIV Epidemic, the American Bar Association, and the American Medical Association.[16]
Institute of Medicine and National Academy of Sciences, Confronting AIDS: Update 1988 (Washington, D.C.: National Academy Press, 1988), p. 82; Presidential Commission, Report, p. 76; American Bar Association, AIDS Coordinating Committee, Policy on AIDS (Washington, D.C.: American Bar Association, 1989); American Medical News, July 8-15, 1988, p. 4.
Indeed, it was the AMA's support for tracing—justified by its executive director, James Sammons, as having "the potential in the heterosexual society to substantially reduce the proliferation and spread of AIDS"—that provided the grounds for the group's support for mandatory HIV reporting.[17]American Medical News, July 8-15, 1988, p. 4.
Most important in pressing for the adoption of contact-tracing programs at the state level, where all such programs are organized and funded, has been the Centers for Disease Control.[18]
Kathleen Toomey and Willard Cates, "Partner Notification for the Prevention of HIV Infection," AIDS, 39, Suppl. 1 (1989): 557-62.
Critically involved in the training of workers in SDS clinics and in the funding of local venereal disease programs, the CDC had from the outset urged the adoption of this standard public health approach to AIDS and HIV infection. In February of 1988 the federal agency took on a more aggressive posture, making the adoption of partner notification by the states a condition for the receipt of funds from its HIV Prevention Program.[19]Federal Register 53, no. 24 (February 1988): 3554.
Despite such pressure the response on the part of the states was variable. Those most heavily burdened by AIDS continued to favor programs that encouraged infected individuals to notify their own partners. Of the states that stressed the role of professional public health workers—the "provider referral" model—most tended to have relatively modest AIDS case counts.[20]Kathleen Toomey, "Parener Notification for HIV Prevention: Current State Programs and Policies in the United States," paper presented at the Fifth International AIDS Conference, Montreal, June 7, 1989.
Thus, local epidemiological factors as well as political forces continued to influence the course of public health policy. But the trend was unmistakable, and in 1991 a New York City Health Department panel was constituted to examine the issue of partner notification. The panel—which included representatives of community-based organizations such as the Gay Men's Health Crisis, as well as experts in medical ethics—gave its support, in principle, to an expanded program of partner notification.In part, both the early and the lingering resistance to partner notification can be explained by the conflation of the standard public health approach to sexually transmitted disease control with policies and practices that are rooted in a very different tradition, entailing a "duty to warn" or protect those who might be threatened by individuals with communicable conditions. In the early part of this century, courts and legislatures adopted legal norms that imposed on those with infectious diseases a duty to inform those whom they might place at risk through contact. Physicians who knew that their patients could place family members or neighbors in danger could be held civilly liable for failure to warn those at risk.[21]
Donald H. J. Hernann, "AIDS: Malpractice and Transmission Liability," University of Colorado Law Review 58 (1986-87): 63-107.
With the decline of infectious disease as a social threat, this legal tradition fell into disuse. It was given new life, however, with the 1976 case of Tarasoff v. Regents of California , in which the court held that psychotherapists have a duty to protect the identifiable potential victims of their patients' violent acts. While some state courts have rejected Tarasoff , others have handed down rulings that placed limits on the principle of the inviolability of physician-patient communications, holding that clinicians have a duty to protect or warn identifiable individuals who might be harmed by those under their treatment.[22]Vanessa Merton, "Confidentiality and the 'Dangerous' Patient: Implications of Tarasoff for Psychiatrists and Lawyers," Emory Law Journal 31 (Spring 1982): 263-343.
That line of cases set the stage for the debate over whether physicians could be held liable for failing to warn the partners of those who, though infected with HIV, planned to act in a way that posed a risk of viral transmission.The early and strict confidentiality rules surrounding HIV screening and medical records all but precluded physicians from assuming their Tarasoff -like duties, especially in New York and California. In recent years the recognition that such limitations placed physicians in a position that sometimes violated professional ethical norms, the realization that some patients could pose a grave threat to unsuspecting partners, and the increasing importance of early therapeutic intervention have led to modifications of early confidentiality restrictions. Such modifications are often opposed on principled grounds by those who believe that physician-patient communications should never be violated and by those who argue that such breaches of confidentiality would have the counterproductive consequence of reducing patient candor, thus limiting the capacity of clinicians to effectively counsel and persuade individuals who might harm their partners. At the same time, the modifications in the standard of strict confidentiality have been given strong support in a number of state legislatures, and by the American Medical Association and the Association of State and Territorial Health Officials.[23]
Board of Trustees, American Medical Association, December 1989; Association of State and Territorial Health Officials, National Association of County Health Officials, and U.S. Conference of Local Health Officers, Guide to Public Health Practice: HIV Partner Notification Strategies (Washington, D.C.: Public Health Foundation, 1988).
As of 1990 no state had imposed on physicians a duty to warn unsuspecting partners. But about a dozen had adopted legislation granting physicians a "privilege to warn or inform," thus freeing physicians from liability for either warning or not warning those at risk.[24]
Intergovernmental Health Policy Project, "1989 Legislative Overview," Intergovernmental AIDS Reports 2 (January 1990): 1-3.
Reflecting profound concerns about the centrality of confidentiality to the struggle against AIDS, New York's 1989 confidentiality statute went further and, borrowing from the tradition of contact tracing, stipulated that the identity of the threatening party not be revealed to those being warned.[25]New York State, Public Health Law, Article 27-F.
To those—the American Bar Association, for example[26]American Bar Association, House of Delegates, Report No. 124 (Washington, D.C.: American Bar Association, February 12-13, 1990).
—who believed that adequate warnings require the identification of the infected party to the individuals placed at risk, such compromises represented an undue limitation imposed by a mistaken interpretation of the ethics of confidentiality.The question of how to respond to individuals whose behavior represents a threat to unknowing partners inevitably provoked continued discussion of the public health tradition of imposing restrictions on liberty in the name of communal welfare. The specter of quarantine has haunted all such discussions, not because there was any serious consideration in the United States of the Cuban approach to AIDS—which mandates the isolation of all persons infected with HIV[27]
Ronald Bayer and Cheryl Healton, "Controlling AIDS in Cuba," New England Journal of Medicine 320 (April 13, 1985): 1022-24.
—but because of fears that even a more limited recognition of the authority to quarantine would lead to egregious intrusions on privacy and invidiously imposed deprivations of freedom.In spite of fierce opposition to all such efforts, between 1987 and 1990 more than a dozen states had brought AIDS within the scope of their quarantine statutes. At the same time, many of these states modernized their disease control laws to reflect contemporary constitutional standards detailing procedural guarantees, and to require that restrictions on freedom represent the "least restrictive alternative" available to achieve a "compelling state interest."[28]
This conclusion is based on a review of all AIDS-related legislation in the files of the Intergovernmental Health Policy Project, Washington, D.C.
Soon after he resigned as commissioner of health in New York City at the end of 1989, Stephen Joseph bluntly made the case for the careful exercise of the power of quarantine. He did so on the occasion of the continuing uproar surrounding the appointment of Woodrow Myers as his successor. Gay and civil liberties groups opposed Myers, in part, because he had supported quarantine legislation in Indiana and had reportedly exercised the authority then granted him under state law. They demanded that such policies never be pursued in New York. No such pledge could or should be made, stated Joseph in an editorial written for the New York Times .[29]
New York Times, February 10, 1990, p. 25.
Among his last formal acts had been thesigning of a detention order for a woman with infectious tuberculosis because of her repeated unwillingness to take the medication that would render her noninfectious. "It is virtually certain that at some point, a New York City Health Commissioner will be faced with an analogous situation concerning the transmission of the AIDS virus. When all lesser remedies have failed, can anyone doubt what would be the proper course of action for the Commissioner to take, faced with … an infected individual who knowingly and repeatedly sold his blood for transfusion?" When and if a treatment became available that would render HIV-infected persons less infectious, "would there not then be a clear obligation to take all reasonable measures to ensure that the infected take their medication, thus protecting others?" In characteristically vigorous form—but in language emboldened by the freedom to speak without the constraints of office—Joseph reasserted the traditional claims of public health. His boldness was reinforced by his belief that with advances in therapy AIDS and its control would follow the model established by earlier infectious diseases.
With the exception of the few notable cases that have received press attention, there is no well-documented review of the extent to which newly revised quarantine statutes have been applied to the AIDS epidemic. There are, however, data to suggest that the power vested in public health officials by such laws has been used more often to warn those whose behavior has posed a risk of HIV transmission than to incarcerate. But in any case the numbers have been small. It is clear, therefore, that the enactment of revised quarantine laws has been responsive to political pressures and the belief in the efficacy of symbolic bulwarks.
The enactment of statutes criminalizing behaviors linked to the spread of AIDS has paralleled the political receptivity to laws extending the authority of public health officials to control individuals whose behavior poses a risk of HIV transmission. Such use of the criminal law, broadly endorsed by the Presidential Commission on the HIV Epidemic, called upon a tradition of state enactments that made the knowing transmission of venereal disease a crime.[30]
Presidential Commission, Report, pp. 130-31.
Though they almost never were enforced, the existence of these older laws served as a rationale for new legislative initiatives. Between 1987 and 1989 twenty states enacted such statutes, the vast majority of which defined the proscribed acts as felonies despite the fact that older statutes typically treated knowing transmission as a misdemeanor.[31]This information is derived from a review of all AIDS-related legislation in the files of the Intergovernmental Health Policy Project, Washington, D.C. See, generally, Martha A. Field and Kathleen M. Sullivan, "AIDS and the Criminal Law," Law, Medicine and Health Care 15 (Summer 1987): 46-60.
Moreover, aggressive prosecutors have relied on laws defining assaultive behavior and attempted murder to bring indictments even in the absence of AIDS-specific legislation.Any effort to determine the extent to which prosecutions for HIV-related acts have occurred must confront the difficulty of monitoring the activity of local courts when there is neither a guilty verdict nor an appeal to a higher state tribunal. One survey, relying on newspaper accounts as well as official court reports, estimated that between fifty and one hundred prosecutions had been initiated involving acts as diverse as spitting, biting, blood splattering, blood donation, and sexual intercourse with an unsuspecting partner.[32]
Lawrence O. Gostin, "The AIDS Litigation Project: A National Review of Court and Human Rights Commission Decisions, Part 1: The Social Impact of AIDS," Journal of the American Medical Association 263 (April 11, 1990): 1963.
Though small in number, these cases have drawn great attention. In the vast majority either the defendant was acquitted or the prosecution was dropped. In the small number of cases that produced guilty verdicts, however, there have been some unusually harsh sentences. In Nevada, where prostitution is both legal and regulated, a woman was sentenced to twenty years' imprisonment in 1989 under a statute that made solicitation by those who tested positive for HIV a felony. In the same year, an Indiana appeals court upheld a conviction for attempted murder against an individual who had splattered blood on emergency workers seeking to prevent him from committing suicide.[33]Larry Gostin, "The Politics of AIDS: Compulsory State Powers, Public Health, Civil Liberties," Ohio State Law Journal 49 (1989): 1041.
Whatever the allure of such measures and of the rediscovery of traditional public health approaches in the effort to combat the spread of HIV infection, it has remained clear that the AIDS epidemic will be stemmed only when radical voluntary changes in behavior are made and sustained. Educational campaigns and counseling programs, most effectively undertaken by groups linked to the populations at risk, have remained the centerpiece of that preventive effort. Such efforts are still limited by moralistic trends in American society, and especially by those reflecting the abhorrence of homosexuality. The most striking failure in the preventive realm, however, is rooted in the unwillingness to commit the resources necessary for the provision of drug abuse treatment.
The dimensions of that failure were underscored in the 1988 preliminary report of the Presidential Commission on the HIV Epidemic.[34]
New York Times, February 25, 1988, p. 1.
A vast expansion in government efforts was needed. One and a half billion dollars a year would be necessary for drug abuse treatment and education. Only such an investment could make possible the provision of immediate treatment to all drug users who might seek such help. For the Reagan administration, which had placed its emphasis on a moral appeal to abstinence and which had entertained the idea of a return to harsh street-level enforcement of drug use and possession statutes, the call for the massive funding of drug abuse treatment programs must have seemed the siren call of a discredited liberalism. For those whowere all too familiar with the inadequacy of available services, and the difficulties that would follow even if there were a commitment of resources, the commission's declaration provided some reason for hope.
The call for greater attention to the problem of drug abuse in the light of the AIDS epidemic was repeated by the Institute of Medicine and the National Academy of Sciences. In the 1988 update to its earlier report, Confronting AIDS , the IOM-NAS painted a bleak picture linking intravenous drug use, heterosexual transmission, and the birth of infants with HIV infection. "The Committee believes that the gross inadequacy of federal efforts to reduce HIV transmission among IV drug users, when considered in relation to the scope and implications of such transmission, is now the most serious deficiency in current efforts to control HIV infection in the United States."[35]
Institute of Medicine and National Academy of Sciences, Confronting AIDS: Update 1988, p. 84.
Relying on the report of the Presidential Commission, the IOM-NAS also called for an annual expenditure of $1.5 billion. But despite these appeals, little has been done. In its first report to President George Bush, issued in December 1989, the National Commission on Acquired Immune Deficiency Syndrome lamented the failure of the White House National Drug Control Strategy to give appropriate attention to AIDS. Like its predecessor, the National Commission—chaired by June Osborn, a well-known critic of federal AIDS policy, and vice-chaired by David Rogers, a persistent voice for increased federal support to the cities most severely affected by the epidemic—called for the availability of treatment "on request" for all drug users.[36]National Commission on Acquired Immune Deficiency Syndrome, Report Number One (Washington, D.C.: U.S. Government Printing Office, December 5, 1989), mimeo.
Concern about budgetary deficits, ten years of ideological opposition to welfare state—like programs by conservative national administrations, and the absence of a strong political constituency capable of effectively clamoring for the needs of the underclass have resulted in the politics of neglect. This context helps to explain why black and Hispanic community leaders are opposed to the halfway measures of needle exchange and education about the use of bleach to cleanse drug injection equipment.[37]
Harlan Dalton, "AIDS in Blackface," Daedalus 118 (Summer 1989): 205-28.
In the absence of a strong commitment to treatment, such measures appear to write off the needs of the poor. Thus, there has emerged the tragic alliance of the moralistic right and those who speak in the name of the dispossessed. It was the first black commissioner of health in New York City, acting at the behest of the city's first black mayor, who terminated a small and politically hobbled needle exchange program soon after assuming office.[38]New York Times, February 14, 1990, p. B1.
More stunning, the commissioner sought to cancel a municipal contract that funded a community-basedgroup to provide drug users with bleach and education about how to sterilize injection equipment.[39]
AMA News, May 25, 1990, p. 5.
The failure to fund drug abuse services was but a portion of a much deeper problem: the failure of the federal government to plan for and assist those localities that were compelled to bear the burden of providing care for large numbers of patients with AIDS. And such patients were but a fraction of those who would increasingly be defined as in need of care. In mid-1989 the Public Health Service announced that chemoprophylaxis could dramatically affect the likelihood of developing Pneumocystis carinii pneumonia.[40]
Public Health Service, "Guidelines for Prophylaxis against Pneumocystis Carinii Pneumonia for Persons Infected with Human Immunodeficiency Virus," Morbidity and Mortality Weekly Report, Suppl. 5, June 16, 1989.
Soon thereafter, clinical investigators announced that the use of AZT could retard the onset of disease in asymptomatic individuals whose immune systems had already begun to show the impact of HIV infection.[41]Paul Volberding et al., "Zidovudine in Asymptomatic Human Immunodeficiency Virus Infection: A Controlled Trial in Persons with Fewer Than 500 CDR-Positive Cells per Cubic Millileter," New England Journal of Medicine 332 (April 5, 1990): 941-49.
Writing in the Journal of the American Medical Association , researchers predicted that "rather than a fulminant disease treated primarily inside the hospital, the disease will become a largely chronic condition requiring years of outpatient monitoring and pharmacologic intervention."[42]Peter S. Arno et al., "Economic and Policy Implications of Early Intervention in HIV Disease," Journal of the American Medical Association 264 (September 15, 1990): 1494.
To meet the challenge of chronic HIV infection, it would be necessary to create and fund an infrastructure capable of providing ongoing clinical services to more than half of those with HIV infection. Some predicted that such care soon would be necessary for a million individuals.Here, then, was a paradox not new to the American health care system. Extraordinary advances in medicine must inevitably confront the social reality of the most inequitable system of medical care among advanced democratic societies. Thirty to forty million Americans have no health insurance at all. Of those who are insured, many are inadequately protected. Virtually the whole cost of prescription drugs must be borne by those for whom they are prescribed. Could such a health care system meet the challenge of providing between five hundred thousand and one million persons, many of whom are impoverished, with the outpatient clinical services they would need and with the expensive drugs they would require? Would it be possible for a health care system so fundamentally unjust to fashion a just response to those infected with HIV? Before these questions the earlier important debates about discrimination by private medical insurers paled.
Emergency federal programs to assist the states in paying the cost of AZT for those without insurance, Medicaid reimbursement policies, and a host of patchwork programs in the states provided some relief but were clearly inadequate.[43]
Intergovernmental Health Policy Project, "AZT: Who Will Pay?" Intergovernmental AIDS Reports 2 (May-June 1989): 4-5; Intergovernmental Health Policy Project, "State Financing for AIDS: Options and Trends," Intergovernmental AIDS Reports 3 (March-April 1990): 1-8, 12.
In its December 1989 report to the president,the National Commission on Acquired Immune Deficiency Syndrome warned that medical breakthroughs would "mean little unless the health care system can incorporate them and make them accessible to people in need."[44]
National Commission, Report Number One.
The existence of a medically disenfranchised class meant that, for many, access to care was almost solely through the "emergency room door of one of the few hospitals in the community that treats people with HIV infection and AIDS." Hardly the foundation for the kind of care HIV infection would require in the 1990s.These were the conditions under which ACT UP, which had rejected conventional political styles of protest for the methods of direct action reminiscent of the 1960s, turned its attention to the shape of the American health care system, going beyond its earlier bold challenge to the bureaucratic structure of new drug development. It was the context in which President George Bush's first address on AIDS, in the spring of 1990, was greeted as hollow by many AIDS activists. No longer was it enough to declare that those who are ill have a right to be treated with "dignity, compassion, care and confidentiality and without discrimination."[45]
New York Newsday, March 30 1990, p. 1.
Federal exclusionary policies in the military, the Foreign Service, and the Job Corps, as well as restrictions on the rights of foreign travelers with HIV infection, made such a declaration seem less than honest. But equally as important was the failure to guarantee that those with HIV infection would have access to the full range of needed clinical and social services.The situation that prevailed in New York, the epicenter of the American AIDS epidemic, was extreme because of the existence of a number of concurrent sociomedical and economic crises, including drug abuse, homelessness, and dire fiscal conditions. Nevertheless, it revealed that a failure to commit sufficient resources, itself a consequence of federal default, could have catastrophic results—not only for those with HIV-related disorders and the poor, who are dependent on publicly provided medical services, but for the system of health care more generally.
As early as the spring of 1988, investigators writing in the Bulletin of the New York Academy of Medicine could assert that "to ignore the possibilities inherent in the empirical evidence available is to create a social calamity even greater than the one already perceived. … One can imagine bitter competition for hospital beds. … The AIDS epidemic threatens not only individual lives but the city's health care, education and research environment as well. The time is short, the need is great, and is likely to grow rapidly."[46]
Michael Alderman et al., "Predicting the Future of the AIDS Epidemic and Its Consequences for the Health Care System of New York City," Bulletin of the New York Academy of Medicine 64 (March 1988): 181.
Within a year three separatereports by public- or voluntary-sector groups detailed how far New York was from being able to meet the demands of the epidemic.[47]
New York City AIDS Task Force, Report (New York: AIDS Task Force, July 1989); Citizens Commission on AIDS, The Crisis in AIDS Care (New York: Citizens Commission, March 1989); Mayor's Task Force on AIDS, Assuring Care for New York City's AIDS Population (New York: Mayor's Task Force, March 1989).
Community-based organizations, typically within the gay community, had provided an extraordinary range of services to those with HIV infection and AIDS. They could not, however, meet the needs that public bodies and large private-sector agencies were responsible for meeting. Volunteerism was no substitute for the institutional response that was demanded. Three to five hundred new acute care hospital beds would be needed each year for five years in order to meet requirements of those who became ill. In addition, hundreds of nursing home beds and special housing units would be needed for those requiring less intensive medical care. The capital costs alone for meeting these demands would be over $700 million. And if only half of those who could benefit from ambulatory care for HIV infection were to seek it, the city's already overburdened clinic system would have to absorb an additional 800,000 visits a year. Commenting on the care and attention to detail revealed in each of the report projections, Kenneth Raske, president of the Greater New York Hospital Association, said, "This is the biggest amount of planning for an epidemic with the least amount of action to go along with it."[48]New York Times, April 23, 1989, p. E24.
It was not too soon to start thinking of worst-case scenarios.[49]
United Hospital Fund, "Presidents Letter," February 1990.
Middle-class patients together with their physicians might increasingly flee the city in search of medical care in the suburbs. If they remained, and were able to protect their own interests by insulating themselves from the critical shortage of hospital beds, those institutions forced to bear the burden of caring for the poor would be compelled to restrict even further access to inpatient care for "elective" procedures. While middle-class patients would continue to receive increasingly effective outpatient care from their overworked physicians, the poor would face growing delays and waiting lists as they sought out the benefits of early therapeutic intervention. Many, discouraged, would simply not seek care at all.Shortages would impose the need for rationing, and in the political economy of a city such as New York competition among the desperate would ensue. In what Bruce Vladek, president of the United Hospital Fund, termed the "calculus of misery," it would become increasingly necessary to choose between AIDS cases and the frail elderly for admission to nursing homes; between single adults with AIDS and homeless families with young children for access to newly renovated apartments;
between children and homeless persons dying of AIDS for access to transitional shelter; between HIV-infected pregnant women and women not yet infected for admission to drug abuse treatment programs.
The looming crisis in health care for those with HIV disease set the stage for congressional action that could scarcely have been imagined a short time earlier. Such action was the fruit of dogged efforts on the part of AIDS activists, their allies, and some political leaders from the cities and states that had borne the disproportionate share of AIDS cases. In the winter of 1990 Senator Edward Kennedy, the exemplar of Democratic party liberalism, and Senator Orrin Hatch, a Republican whose stance on abortion often cast him in the role of a conservative, jointly sponsored legislation—the Comprehensive AIDS Resource Emergency Act of 1990—that would provide a major infusion of federal assistance to those localities most severely burdened by AIDS. As the government had responded to natural disasters, the Kennedy-Hatch Bill asked it to respond to the medical disaster of AIDS. "The Human Immunodeficiency Virus constitutes a crisis as devastating as an earthquake, flood or drought. Indeed, the death toll of the unfolding AIDS tragedy is already a hundredfold greater than any natural disaster to strike our nation in this century."[50]
Senator Edward Kennedy Letter, February 1990, mimeo.
As remarkable as the joint sponsorship of this legislation, which promised to provide $2.9 billion over five years in a complex political formula to the cities and states most severely struck by AIDS, was the overwhelming support the legislation received in the Senate, where the vote was 95–4.[51]
New York Times, May 12, 1990, p. B10.
When similar legislation, with even greater resource commitments, was voted on by the House of Representatives, the vote was 408–14.[52]New York Times, June 12, 1990, p. B9.
However late in coming, this legislation repreented on both symbolic and practical levels an important act of national solidarity. But the hopes of early summer were dashed by the fall, when the Congress, confronted with a severe budgetary crisis, slashed funds for the now-renamed Ryan White Act. What allocations will be made in successive years cannot be foretold. It is certain, however, that such an emergency act cannot be a substitute for fundamental changes in the organization and financing of health care—changes that will be required by the chronic management of the medical and social needs of all HIV-infected persons at a moment when many other medical needs of the nation's poor remain unmet.
With the rapid development of therapies for HIV-related disease, the link between the provision of care and the strategy of prevention has
assumed critical importance.[53]
Donald Francis et al., "Targetting AIDS Prevention and Treatment toward HIV-Infected Persons: The Concept of Early Intervention," Journal of the American Medical Association 262 (November 10, 1989): 2572-76.
Public health officials have used the occasion of new therapeutic prospects as a justification for rethinking policies adopted in the epidemic's first years. But the prospect of new therapies is not enough. If lives are to be prolonged, and if the public health goal of preventing the further spread of HIV infection is to be achieved, these therapies must be available to those who need them. If those with HIV infection can receive ongoing clinical care, behavioral changes can be encouraged, supported, and sustained. A failure to provide care and counseling—especially to the poor, among whom intravenous drug use plays a critical role in HIV transmission—will entail not only a sentence of needlessly foreshortened life but a lost opportunity to intervene in the epidemic's epidemiological course.New therapeutic possibilities made possible by scientific advances create the conditions for establishing a moral standard against which to judge the responses of the American policy to AIDS in the second decade. Unlike the Third World, where absolute scarcity imposes limits on what can be done to meet the challenge of HIV infection, in the United States restrictions on governmental efforts will be the consequence of social decisions. History will judge us by the choices we make at this moment, when the possibilities are greater than at any point since HIV first made its appearance.