Unformatted text preview: Globalizing clinical trials n American Ethnologist ‘‘who gets those patients, who I can sign up to be in my alliance so that when I do attract a sponsor, I can say ‘I can line up 500 cancer patients for you tomorrow morning.’ You are seeing that happening a lot because recruitment is one of the most time-consuming and expensive portions of the plan.’’ Eastern Europe and Latin America are particularly attractive because of the extent of so¨´ called treatment naıvete—or the widespread absence of treatment for common and uncommon diseases—and ¨ treatment-naıve populations are considered ‘‘incredibly valuable’’ because they do not have any background medication (i.e., medications in a patient’s body at the time of a trial), or any medication, for that matter, that might confuse the results of the trial. CROs make them¨ selves competitive by locating the treatment naı ve. As one researcher told me, these populations ‘‘offer a more likely prospect of minimizing the number of variables affecting results and a better chance of showing drug effectiveness.’’15 On the one hand, pharmaceutical markets are growing. On the other hand, drug developers are now focusing on the biology of populations experiencing acute health care crises—populations whose life expectancies increased and whose incidence of infectious disease and mortality rates decreased under the demographic health transition but whose lives are now shorter, more chronically diseased, and less socially protected.16 The public health of demarcating disease to prevent disease (involving epidemiology, prevention, and medical access) is now used to carve out new catchment areas of human subjects who ¨´ are targeted precisely because of their treatment naıvete. This move may appear exploitative in itself, but the pharmaceutical industry argues that it is positive because in these regions clinical trials have become social goods in themselves. And they may well be, providing health care where there is none (Reynolds Whyte et al. in press) and medical relief for participants’ specific ailments for the duration of the trial. Although industry and U.S. regulators would not dare codify such justifications for promoting clinical trials in poor areas, in many ways such justifications have already become an industry norm. Yet the question of precisely what made the move of the human-subjects research enterprise to resource-poor settings both ethical and opportune remains unaddressed. In the next section, I consider some key moments in the recent ethical and regulatory discussion of globalizing research in contexts of crisis, which have implications for how experimental groups are being defined and pursued globally today. Ethical variability: Constructing global subjects
The controversy over placebo use in Africa in 1994 during trials of short-course AZT treatment to halt perinatal transmission of HIV was a watershed in the debate over ethical standards in global clinical research (Angell 1988, 1997, 2000; Bayer 1998; Botbol-Baum 2000; Crouch and Arras 1998; de Zulueta 2001; Lurie and Wolfe 1998, 2000). Here I consider it as a watershed of another kind: for understanding how a cost-effective consolidation of variability in ethical standards overtook efforts to make a universal ethics (as codified in key ethical guidelines for human-subjects research) applicable and enforceable worldwide. Underpinning this process is a more general anthropological problematic of how new subject populations are forged at the intersection of regulatory deliberation, corporate interests, and crises (upon crises) of health. My specific inquiry here centers on how the ability of the ¨ pharmaceutical industry to recruit global treatment-naıve subjects was solidified. In this well-known case, some U.S. researchers argued that giving less than standard care to those on the placebo arm of the study was ethically responsible, even if in the United States the standard of care medication was already known.17 A placebo is an inactive treatment made to appear like real treatment; it amounts to no treatment. Critics viewed the use of a placebo arm in this case as highly unethical. They charged that research carried out in developing countries could be held to a standard that differs from requirements in developed countries. Marcia Angell (2000), for example, noted patterns of conduct reminiscent of the Tuskegee experiment, in which lowincome communities provide standing reserves of exploitable research subjects. Harold Varmus of the U.S. National Institutes of Health and David Satcher of the U.S. Centers for Disease Control, which, among other government institutions, authorized and funded the trial, claimed the trial was ethically sound (Varmus and Satcher 1996). They cited local cultural variables and deteriorated health infrastructures as making the delivery of the best standard of care infeasible. It would be a paternalistic imposition, they argued, for critics in the United States to determine the appropriate design of medical research in a region undergoing a massive health crisis and that deciding the appropriate conduct of research and treatment distribution was within the jurisdiction of local and national authorities. Ethical imperialism or ethical relativism? The debate, as it stands, is unresolved. Yet these catch phrases represent current responses to the ethics of the trial. The first position builds on well-known cases of marginalized communities acting as human subjects, and those cases, as medical historian Harry Marks (2002) suggests, may obscure more than they reveal about the contexts of experimental communities today. The second position relativizes ethical decision making as a matter of sound science, but it fails to consider the uptake of this relativizing move in corporate research contexts. For me, the fact of the African trial—and of the ethical debates that 187 ...
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- Spring '10
- Ethics , Clinical trial