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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers Women in Clinical Studies: A Feminist View Susan Sherwin In this brief discussion, I shall appeal to certain feminist assumptions about the distribution of power and privilege in the world. Specifically, I shall simply assume agreement (and not argue for the position) that there is overwhelming evidence that women are systematically oppressed in society on the basis of their gender, and that, in many cases, gender oppression is complicated and exacerbated by other forms of oppression based on such features as race, class, ethnicity, age, religion, disabilities, or sexual orientation.1 I also take it as well-established that the institutions responsible for the identification and delivery of health care services are implicated in the existing patterns of oppression; they play a role in the power structures of society and have, in many distinct ways, contributed to the multiple forms of oppression, and, more positively, they can play a role in dismantling oppressive systems.2 I wish to make clear that I am not attributing malice or deliberate intent to everyone who participates in oppressive practices. I understand oppression to be systemic and endemic in society and believe that it takes conscious and persistent effort to resist complicity in its patterns. I will also take it for granted that oppression is a moral and political wrong. Hence, I will be appealing to Iris Marion Young's conception of social justice, which recognizes oppression as a form of injustice. Like Young, I find most conventional standards of justice to be too narrow in their tendency to reduce justice to the question of fair distributions of identified benefits and burdens. Purely distributive approaches to justice obscure important questions of social organization and distort our understanding of the social nature of persons
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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers by identifying them as atomistic, interchangeable beings. Indeed, distributive theories of justice treat as irrelevant such politically significant features of persons as their gender, race, and class. In contrast, Young's social justice conception recognizes the importance of attending to these kinds of considerations in order to correct the effects of oppressive practices that arise from the biases inherent in sexism, racism, classism, and so on. Treating people as if they are equally situated with respect to power and privilege when they are not is a way of maintaining existing power structures. Understanding justice as social justice, defined as including concern for matters of domination and oppression, invites us to respond to the crippling biases and differing access to power that underlie systematic patterns of oppression. Even when our focus is purely distributive, it is important to raise questions about the social context in which distributions are carried out. Thus, when we are trying to decide on a matter of social policy with respect to an oppressed group, this conception of social justice requires us to investigate how the proposed practice is likely to affect current patterns of domination and oppression in society: i.e., is it likely to worsen or improve the existing levels of oppression in society?3 Among other ethical questions, we need to ask of each practice or policy reviewed, whose interests does it serve and whose does it harm? In the current context, where the task is to decide about policy regarding the inclusion of women in clinical studies, the ethical questions raised should include questions about how the proposed policy will affect the oppressed status of all women and, more specifically, how it will affect the status of women who are multiply oppressed by virtue of the intersection of gender with their race, class, age, and so on. By this measure, we can identify several specific areas of feminist concern, including: (1) some or all women may be unjustly excluded from some studies and suffer as a result; (2) women may be unjustly enrolled in studies that expose them to risk without offering appropriate benefits; (3) the research agenda may be unresponsive to the interests of oppressed groups; and (4) most generally, the process by which research decisions are made and carried out may maintain and promote oppressive practices. I will expand on each of these concerns in turn. The exclusion of women from important clinical studies is the best known of the problems of injustice identified as falling within the scope of the topic of women's role in clinical studies. Historically, many studies of diseases that are common to both sexes have systematically excluded women from participation, so the necessary data for guiding treatment decisions for women are unavailable.4 Women's health care must often be based on untested inferences from data collected about men, but because there are important physiological differences between women and men, such inferences cannot always be presumed to be reliable; and, even when some data are collected about women's responses to the treatment in question, we may lack information about how a proposed treatment will affect specific groups of women (e.g., those who
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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers are disabled, elderly, or poor). Even according to traditional distributive conceptions of justice, it is clear that this sort of discrimination is unjust and bound to result in less effective health care for (some) women than for comparable men because the knowledge base which guides health care practices is unfairly skewed; if we accept the view that well-designed clinical studies are beneficial for a population, then the systematic exclusion of women from such studies must be seen as disadvantaging them unfairly. A social justice approach that is sensitive to matters of oppression helps us to recognize that this disadvantage is not random or accidental, but is a result and further dimension of women's generally oppressed status in society. According to the distributive models of justice, women ought to be represented proportionately to their health risk in any clinical studies likely to be of benefit to subject populations. The social justice model I am proposing allows us to argue the stronger claim that in order to counteract the disadvantage from which they begin, those who are currently oppressed in society should have a privileged place in studies that are likely to be of specific benefit to members of the group investigated. It is important, however, not to translate this call for greater research attention toward women and other oppressed groups into a wholesale endorsement of the use of members of oppressed groups as research subjects in all studies without qualification. Clinical trials often expose subjects to significant risk, discomfort, or inconvenience without offering any special benefits to either the subjects or the groups from which they are recruited; in many trials, other, more privileged subjects would have served equally well except for the fact that the well-being of such people is more highly valued by society. Many shameful events in the history of clinical research testify to the ease with which researchers exploit the vulnerability of oppressed or devalued members of society for the ultimate benefit of others; far from demonstrating an interest in providing effective care for the group in question, in these cases the choice of subjects reflects the perceived expandability of members of the subject group.5 Various approaches have been pursued to guard against the exploitative abuse of research subjects. Ethical guidelines recommend getting informed, voluntary consent from subjects and taking special precautions with groups that are recognized as being especially vulnerable to exploitation, such as children, people who are very ill or infirm, prisoners, those with severe mental handicaps, and those who are living in institutions. The guidelines usually restrict the use of subjects from groups recognized as being most readily exploited to studies that are of explicit benefit to that group. These restrictions should be extended to encompass oppressed groups: they also constitute a group that is at particular risk of exploitation, since society values them less than other groups and so is more inclined to expose them to risk. It is important to ensure that oppressed people are not included in research studies merely on the basis of the unjust belief that risks or inconvenience are less significant when they occur to devalued individuals. Clinical studies which propose to recruit women or members of other
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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers oppressed groups should be required to demonstrate that the results produced will be of specific benefit to the individuals or to the group in question.6 Feminists raise several ethical questions about the content of research agendas and the process for setting them: (3a) Although the research agenda regarding women's health needs has historically neglected many important questions, there has been a substantial body of research directed at gaining control over women's reproduction. In fact, this is the one area of study where women have received a disproportionately large share of research attention. For example, almost all contraceptive research has explored means of controlling women's fertility.7 Similarly, efforts to relieve infertility have focused on procedures that can be done to women—even when the infertility is associated with such male conditions as low sperm count.8 As a result, a disproportionate share of the burden, risks, expenses, and responsibility for managing fertility now belongs to women, because that is where the knowledge base is. Again, this imbalance in available knowledge can be recognized as unjust by traditional distributive justice measures, but a richer social justice perspective provides further indications of injustice in light of the fact that women's oppressed status is inseparable from their traditionally assigned roles in the spheres of sexuality and reproduction. The concentration of medical attention on women's reproductive role not only assumes the conventional view that women are, by nature, to be responsible and available for reproductive activities; it also legitimizes, reinforces, and further entrenches such views and the attitudes that accompany them. Moreover, the knowledge obtained through these studies is sometimes used by those with more power in society to regulate and control women's fertility, e.g., through population control programs and those that sterilize women who are deemed to be unsuitable mothers.9 Clearly, not all women are affected equally by the knowledge produced by studies into women's reproduction. Women who are multiply oppressed, i.e., those who are poor, belong to racial minorities, suffer from mental illness, or live in a Third World country, are at far higher risk of imposed contraception or sterilization than are privileged white women; at the same time, new reproductive technologies aimed at facilitating conception are usually made available only to the most affluent and advantaged women in society. (3b) Studies into the control of women's reproduction also raise another area of feminist concern, namely, the absence of clear guidelines to distinguish between therapy, innovative practice, and research. Historically and currently many women have paid very high prices when unsafe treatments are provided as means of obtaining control over some aspect of their reproductive lives. From contraceptives (Dalkon Shield, early doses of birth control pills), through drugs prescribed in pregnancy (DES, thalidomide), to the ever-expanding practices in the area of new reproductive technologies, treatments have been developed and offered to women as therapy without adequate prior clinical studies to establish their safety and effectiveness. Clinical studies are governed by regulations
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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers ensuring patients receive detailed information and careful monitoring; further protection is provided by the demands for peer review before the initiation of a study. No such control exists in untested therapies that may be offered as innovative treatment, or, sometimes, as conventional treatment. Because oppression involves a society's devaluing of the interests of those who are oppressed, there is significant danger that victims of oppression may face higher risks of harm when they are singled out for new, unproven treatments. When dealing with treatments offered solely to members of an oppressed group, it is especially important, then, to ensure that patients' interests are protected. Regulations demanding testing and monitoring before therapies are mass marketed to some specific oppressed group may be necessary to improve safety standards. (3c) A justice model that concerns itself with oppression also provides grounds for objecting to the fact that almost the entire health research budget is absorbed by clinical studies directed at conditions that threaten those who are most privileged in society. Moreover, the bulk of the health research agenda is defined around a model of crisis intervention, rather than prevention. Thus, even though the links between poverty and illness are well known, efforts are concentrated in developing ways of responding to illness rather than avoiding it in the first place. Other specific health concerns of those who are most marginalized in society tend to be virtually ignored: e.g., there is little research into lupus, a disease found three times as often in black women as in the general population;10 and despite the flurry of research attention provoked by AIDS, the investigation of AIDS in women has also been neglected, perhaps because it is believed that few white women are at risk of contracting AIDS, though African American women face a risk 12 times higher.11 In addition, too many clinical studies explore expensive, highly technological solutions which, even if successful, will be accessible to only a small proportion of the population within developed countries—they are virtually useless in a global perspective of health needs. In general, research agendas reflect the interests, power, and privilege of the elites who set them; they are seldom defined by the health needs or interests of those who are most marginalized in society. It is no surprise, then, that clinical studies tend to produce knowledge that strengthens the health and opportunity of those who are already well placed in society while ignoring the needs of the disadvantaged, leaving them in ever weaker relative positions. If we want to recognize and respond to existing patterns of oppression we must go beyond the questions of who to include or exclude in research studies and investigate which studies are conducted and which are not pursued. Therefore, if we are serious about eradicating oppression, we must begin by challenging the process by which research agendas are set and research programs are carried out. Some feminists have argued that we need to rethink current views of research as an objective, technical activity in which investigators belong to an elite group of knowledgeable scientists and subjects are regarded
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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers as their passive research tools; they propose alternate conceptions of research as a collegial activity in which subjects and investigators negotiate the terms of participation to achieve a shared commitment to the success of the activity.12 Research is not separate from other practices of society, and it is certainly not automatically immune from the poisonous effects of bias. If clinical research is to respond fully to the demands of justice, investigators will need to develop ways to be more inclusive and less elitist in all stages of their studies. They might, for example, adapt models of participatory democracy, in which those who have a stake in the research help to formulate priorities. In order to begin to counteract the disadvantage that oppression creates for its victims, members of oppressed groups should, whenever possible, be included, not only as subjects, but also as investigators and active participants in the deliberations. NOTES 1. I shall not provide any evidence for this belief since the literature is filled with detailed analysis of the systematic ways in which women are disadvantaged economically, socially, legally, politically, physically, and culturally. The account of oppression underlying my interpretation of the empirical data about women's disadvantaged status and choices as constituting oppression has been provided by Iris Marion Young, Justice and the Politics of Difference (Princeton: Princeton University Press, 1990). Young identifies five conditions as characterizing oppression, whether they appear singly or in combination: exploitation, marginalization, powerlessness, cultural imperialism, and violence. 2. See, for example, Barbara Ehrenreich and Deirdre English, For Her Own Good: 150 Years of the Experts' Advice to Women (Garden City, N.Y.: Anchor Books, 1979); Elizabeth Fee, ed., Women and Health: The Politics of Sex in Medicine (Farmindgale, N.Y.: Bayood, 1983); Sue Fisher, In the Patient's Best Interest: Women and the Politics of Medical Decisions (New Brunswick, N.J.: Rutgers University Press, 1986); Cesar A. Periles and Lauren S. Young, eds., Too Little, Too Late: Dealing with the Health Needs of Women in Poverty (New York: Harrington Park Press, 1988); Alexandra Dundas Todd, Intimate Adversaries: Cultural Conflict Between Doctors and Women Patients (Philadelphia: University of Pennsylvania Press, 1989); Evelyn C. White, ed., The Black Women's Health Book: Speaking for Ourselves (Seattle: Seal Press, 1990). 3. This argument is spelled out in greater detail in Susan Sherwin, No Longer Patient: Feminist Ethics and Health Care (Philadelphia: Temple University Press, 1992). 4. Several examples of such exclusions are provided by Rebecca Dresser, ''Wanted: Single, White Male for Medical Research,'' Hastings Center Report 22(1):24–29, 1992. 5. Nazi studies on concentration camp prisoners and the Tuskegee Syphilis Study are two of the most notorious examples in this category. 6. See Sherwin, No Longer Patient, pp. 159–165. 7. Gena Corea, The Hidden Malpractice: How American Medicine Mistreats Women, updated edition (New York: Harper Colophon Books, 1985), pp. 130–188.
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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers 8. Renate D. Klein, Infertility: Women Speak Out About Their Experiences of Reproductive Medicine (London: Pandora Press, 1989). 9. Kathleen McDonnell, ed., Adverse Effects: Women and the Pharmaceutical Industry (Toronto: The Women's Press, 1986). 10. Vida Labrie Jones, "Lupus and Black Women: Managing a Complex Chronic Disability," in White, ed., The Black Women's Health Book. 11. In Angela Y. Davis, "Sick and Tired of Being Sick and Tired: The Politics of Black Women's Health," in White, ed., The Black Woman's Health Book. 12. See, for example, Sandra Harding, Whose Science? Whose Knowledge? (Ithaca: Cornell University Press, 1991).
Representative terms from entire chapter: