Science and Other Cultures

Issues in Philosophies of Science and Technology

Sandra Harding, Robert Figueroa

• Publisher: Routledge
• Year: 2013
• ISBN:
  9781134727391
• Edition: 1
• Topic: Philosophy
• Subtopic: Philosophy History & Theory

In this pioneering new book, Sandra Harding and Robert Figueroa bring together an important collection of original essays by leading philosophers exploring an extensive range of diversity issues for the philosophy of science and technology. The essays gathered in this volume extend current philosophical discussion of science and technology beyond the standard feminist and gender analyses that have flourished over the past two decades, by bringing a thorough and truly diverse set of cultural, racial, and ethical concerns to bear on questioning in these areas. Science and Other Cultures charts important new directions in ongoing discussions of science and technology, and makes a significant contribution to both scholarly and teaching resources available in the field.

Sciences in Cultures, Cultures in Sciences

AIDS, Crisis, and Activist Science

Robert Hood

Introduction

HIV/AIDS activists, both in the United States and internationally, have charged that existing norms of research are unresponsive to the challenges of the global HIV/AIDS crisis.¹ Activists contend that HIV/AIDS requires a response significantly different from normal medical science and that HIV/AIDS research should be considered a crisis discipline. To explore how social phenomena shape the role of values in science, I focus on a recent controversy concerning international research about HIV/AIDS in developing countries.

Crisis Science

HIV/AIDS activists argue that in light of the global HIV/AIDS crisis, normal science should be replaced by an emerging view that might be called crisis science. Crisis science exists in relation to normal science as triage medicine to standard medical practice. The magnitude of HIV/AIDS, the time-dependency of developing treatments and prevention, and the consequences of failing to act lead activists to call for a radical approach to science. Crisis science involves a number of goals, among them the attempt to achieve results as quickly as possible, the right of patients to undertake greater risks in studies than would normally be tolerated, and the right for communities to participate in the direction of research. The activist position is that in a crisis, science should take greater risks because of the urgency of the situation.

The distinction between crisis science and normal science involves normative questions of how much of a chance a researcher should be willing to take, and what standards of proof should be demanded of researchers and for what purposes. Normal science can be characterized as cautious in the sense that it tries to minimize the likelihood that inferences are drawn based on chance alone. Since medical research considers samples of populations, by chance alone a researcher risks inferential errors from studying samples instead of the whole population. Statistical theory provides estimates of the probability of committing such errors by chance alone, and, normally, medical research employs cautious standards to try to decrease the probability that errors are due to chance. This cautious attitude helps increase the confidence that a positive result can be added to scientific knowledge that is not a result of random chance. Moreover, given the potential for grave errors, and given the complexity of medical research, using cautious standards generally serves to protect patients. Were researchers to take greater chances of new information being false by chance alone, the edifice of science would be less secure. Activists point out that a secure edifice of science, however, is not the only important social value at stake.

In particular, HIV/AIDS activists argue a cautious approach is not appropriate to the urgency of the HIV/AIDS crisis. The crisis of HIV/AIDS requires desperate measures, and there is not adequate time to establish the degree of confidence normally desirable. In addition to challenging standards of evidence, activists have also argued for—and paid for—alternate models of research. HIV/AIDS activists argue for rights to participate in drug trials and by so doing, undertake risks that are greater than those normally considered tolerable.² The issues concerning activist science are complex because they involve both ethical and scientific disagreements concerning how best to discharge obligations under conditions of uncertainty, and the discussion that follows moves between normative and scientific issues. I review a controversy that emerged over research into the prevention of mother-to-child transmission of HIV in developing countries to help diagnose and clarify these issues.

Controversy over Clinical Trials

Clinical trials were initiated in 1994 to address the problem that the standard of care in industrialized countries to prevent mother-to-child transmission of HIV is not affordable to the majority of people living in developing countries—to the majority of people in the world.³ The purpose of the trial was to test a shorter, less expensive, and less intensive regimen of treatment in the hope that the short course would be safe and effective— and, most importantly, would be affordable to people in developing countries.⁴ Starting in 1994, clinical trials involving over 12,000 pregnant women in developing countries were initiated by representatives of two international groups, the World Health Organization and UNAIDS (a United Nations agency coordinating international efforts to combat AIDS), and two agencies of the United States government, the National Institute of Health and the Centers for Disease Control and Prevention. In addition to this international support, the studies also had the support of local government officials in the study locations (Bloom 1998). The research protocols involved giving $80 or less of AZT, compared to the standard treatment, known as ACTG 076, which involves about $800 of AZT. In addition, the trials administered the treatment later in pregnancy for about one month, or only a fraction of the time required by the ACTG 076 standard of care in the United States.

Conflict emerged over the trial design—in particular, on the appropriate comparison group. Mothers in the trials in developing countries were given either the short course of AZT or a placebo—that is, the women and infants in the control group received no AZT. The fact that women from developing countries in the control group would get a placebo rather than the standard clinical treatment struck some as a straightforward ethical violation. Researchers stopped using placebo-controls in these particular studies a year after they began, when results emerged from a study in Thailand that showed the use of AZT in only the last four weeks of pregnancy could cut transmission rates by 50 percent (Marc Llemant and Vithayasai 1995; Strolberg 1998).

The majority of the literature on this controversy has focused on ethical issues, such as whether the there should be a single international standard for research subjects or whether global inequities in the allocation of health care resources justify placebo-controlled trials when an effective treatment exists but is unavailable in the host country (Schüklenk 1988; Angell 1997; Lurie and Wolfe 1997; Bloom 1998; Crouch and Arras 1998; del Rio 1998; Grady 1998; Lie 1998; Resnik 1998; Luna 1999; Schüklenk and Ashcroft 2000; Benatar 2001). In contrast, my focus is on how differing views of what is required under crisis conditions shape the practice of science. The two sides to the debate over international placebo trials reflect the distinction made above concerning crisis science: those in favor of placebo trials argued the placebo trials were necessary in order to show the degree to which the short course would be effective, whereas those opposed to the placebo trials seemed willing to forgo seeking additional evidence and argued that the dynamics of the HIV/AIDS crisis made this a special case on both scientific and ethical grounds.

Critics argued that placebo research in developing countries was not justified. For example, Public Citizens Health Research Group attacked these clinical trials on the grounds that randomized placebo-controls should not have been used when there was already an established standard of care for minimizing the transmission of HIV from mother to infant in industrialized countries, namely, the ACTG 076 protocol (Lurie and Wolfe 1997). The debate was heated, with one editorial claiming that the placebo trials are morally equivalent to the Tuskegee experiments (Angell 1997). The critics contend that as soon as the research community has good evidence that a treatment is more effective than a placebo, then researchers have an ethical obligation to discontinue use of placebos. They believe such evidence exists concerning ACTG 076 and, moreover, believe that research in industrialized countries concerning mother-to-infant HIV transmission applies in developing countries. Critics contend that studies that use placebos when effective treatment is available subordinate the welfare of human subjects to questionable research goals. Instead of placebo trials, they advocate comparative studies where subjects would get either the short-course treatment or the standard ACTG 076 protocol—that is, they advocate that the research in developing countries be conducted as it would be in industrialized countries.

Critics interpret international agreements governing conduct of clinical research as clearly proscribing placebo trials. The Helsinki Declaration, for example, grants subjects the right to receive “best proven diagnostic and therapeutic method” (World Medical Association 2001).⁵ The International Ethical Guidelines for Biomedical Research Involving Human Subjects states that “researchers working in developing countries have an ethical responsibility to provide treatment that conforms to the standard of care in the sponsoring country, wherever possible” (Council for International Organizations of Medical Sciences 1993; see also Weijer and Anderson 2001). In addition, it is well established that for a trial to be ethical, a state of genuine uncertainty (“clinical equipoise”) as to the comparative merits of the treatments under study must exist within the expert clinical community (Freedman 1987). Critics contended that there was not genuine uncertainty in this case and argued that they knew of no reason why study results could not be generalized across populations and across variations of HIV.

Critics also pointed out that for a trial to be ethical there must be a strong likelihood its results will be made available to the population in the host country. Since the per capita health expenditure in the region in question is often less than $10, critics charge that those conducting clinical trials knew the treatment would only in the most unlikely circumstances be made available to subjects in developing countries and so were unethical from the start, a point that has been discussed extensively (e.g., Grady 1998).

In addition to these ethical arguments, critics also contested the scientific merits of the trials. First, they argued that the performance of AZT in pregnant mothers is well understood (based on trials and clinical practice in industrialized countries). Those in developing countries are not, in their view, significantly different from those in industrialized countries. Furthermore, they contend that the use of placebo trials was unnecessary, for two reasons. First, an analysis of subgroup data from previous studies demonstrated that a short course was safe and effective (Lurie and Wolfe 1997). Second, they noted that a previous study in Thailand had already shown a shorter AZT regime to be safe and effective compared with the 076 protocol, and that, consequently, additional testing was unnecessary—especially when those getting placebos would not be getting any treatment. The Thailand study showed it was possible to reduce amounts of AZT while still achieving the efficacy of the ACGT 076 protocol. Notably, the Thailand study’s directors refused to include a placebo group in the research because they thought using placebos would be unethical. Even without using placebos, the Thailand study showed the short-course AZT treatment resulted in a 50 percent reduction in mother-to-infant transmission (Marc Llemant and Vithayasai 1995; Lurie and Wolfe 1997). In sum, based on their analysis of the 076 subgroup data, and on the Thailand study, the critics concluded that sufficient evidence existed indicating the placebo trials were unnecessary.

Those defending the study also saw themselves as seeking the best possible scientific results as a foundation for making policy recommendations. In their view, placebo trials are the gold standard of clinical research and are most likely to yield the clearest results. Defenders respond to the moral arguments that, consistent with the general lack of health care in the developing countries of the study, the vast majority of the women in the study would not have received any medical treatment outside the study by arguing that participation in the placebo-controlled study did not deny them treatment they otherwise would have received, nor did it increase their risk of transmitting HIV to their infants. As Grady notes, “By participating in the study the women are not being denied treatment in the interests of science” (Grady 1998). Thus, the study did not deny access to anything because it did not otherwise exist. The justification for this turns on several distinctions, between clinical treatment and research on the one hand, and between misfortune and injustice on the other. Although it is unfortunate that people in developing countries cannot afford treatment, people who cannot afford treatment are not in this position because they were wronged; thus they have no right to health care (Crouch and Arras 1998).

Second, those defending the placebo study argue that placebo trials are necessary for scientific proof because the subject populations in developing countries are sufficiently different from people studied in the 076 protocol. Harold Varmus and David Satcher, for example, justified the trials on the grounds that the subject population of pregnant women in developing countries has a higher incidence of anemia, malnutrition, and various diseases, and “we do not have reliable data about safety and efficacy in populations from developing countries” (Varmus and Satcher 1997). The defenders do not address the concern that some patients in industrialized countries are also anemic and have multiple disorders. To the extent there is uncertainty about subjects in developing countries, then it is not clear why there wouldn’t be uncertainty about similar patients in industrialized countries. Be that as it may, defenders point to other uncertainties—for example, the clades of the HIV virus in Europe and North America are different from those on the African continent and then again different from those in Asia. These differences in the virus could yield differences in drug behavior. Significantly, defenders of the trials were concerned that a short course of treatment might cause drug-resistant strains of HIV.

One defender of the placebo study, David Resnik, claims that placebo trials are necessary for science, arguing that “once scientists chose to tackle this research problem, empirical and methodological considerations support the case for using placebo-controls to meet the demands of scientific rigor” (Resnik 1998). Resnik and other defenders of placebo trials raise the concern that although comparative studies might have shown that the short-course treatment was less effective than ACTG 076, it would not have shown how much less effective or the degree to which it would still be worth implementing (Grady 1998). That is, a comparative study might not have had sufficient difference between results to show that a result was not due to chance. In general, if the difference between the two groups being compared is small, then it will take larger numbers of research subjects and could potentially take longer to show significant results. Thus, another reason defenders argue for placebo trials is because they will provide the clearest results faster than other study designs, particularly when the difference between groups is small. Interestingly, this attempt to answer the urgent need for results is consistent with what AIDS activists have asked for— namely, that science move quickly due to the urgen...

Table of contents

• Cover
• Half Title
• Title Page
• Copyright Page
• Table of Contents
• Acknowledgments
• Introduction
• Part I: Sciences in Cultures, Cultures in Sciences
• Part II: Classifying People: Science and Technology at Our Service
• Part III: Tradition and Modernity: Issues in Philosophies of Technological Change
• Contributors
• Index