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Unformatted text preview: American Ethnologist n Volume 32 Number 2 May 2005 Her work raises questions about the relationship between bioethics and accountability in democratic societies and about the forms such ethics takes and to whom it is accountable. Other anthropological work on the ethics of biotechnology and new medical technologies has shifted attention away from issues of individual autonomy and has deepened the analysis of new biomedical technologies as they affect new patterns of civic, medical, and commercial organization (Biehl 2001; Cohen 1999; DelVecchio Good 2001; Dumit 2000; Franklin 1995; Lock 2001; Petryna 2002; Rapp 1999; Scheper-Hughes 2004; Strathern 1992). This work examines an important dimension of ethics beyond its universal and regulatory (or normative) frameworks. New technologies raise new contexts of decision making over doing what is right; thus, beyond defining instances of moral certainty, ethics also involves a set of tactics that can be generative of new human conditions and events (Fischer 2001, 2003; Rabinow 1996, 2003). In my ethnographic work with various professionals within the contract research organization (CRO) community (including company founders, CEOs, clinical trial managers, and health economists), the nurses and physicians with whom CROs contract, and pharmaceutical consultants and regulators in various countries, I came to see that the global dynamics of drug production play an important role in shaping contexts in which ethical norms and delineations of human subjects are changing. As violations of individual bodily integrity in human research continue to be exposed in the media, social scientists are also challenged to chart and consider how whole populations are brought into experimental orders and the ways in which available discourses and protective mechanisms are unable to assist these groups and effectively intervene. I also discovered an ethical variability at work in the globalization of trials, as one of several modes assisting pharmaceutical sponsors in mobilizing much larger populations of human subjects and in doing so much more quickly. Ethical variability refers to how international ethical guidelines (informed by principles and guidelines for research involving human subjects) are being recast as trials for global research subjects are organized.4 International standardized ethics has starkly failed to account for local contexts and lived experience (Cohen 1999; Das 1999; Kleinman 1999). In an industrial pharmaceutical context, ethical variability evolves as a tactic informing the regulation and organization of commercial clinical trials. It takes the specificities of local context and lived experience as a given and as a basis on which to consolidate a cost-effective variability in ethical standards in human research. Variability, however, is not meant to evoke the notion of ‘‘cultural relativism,’’ although variability has been interpreted in such terms (Christakis 1992). Reliance on culture to explain differences in global health practices has been a central project in the field of medical anthropology for decades. Knowledge of such cultural differences, as translated into the health care arena, tends to focus on ‘‘unbridgeable’’ moral divides between Western and non-Western groups. In the ethical imperialism versus relativism debate (Macklin 1999), anthropologists working in health care arenas and elsewhere have been faulted for an alleged blind defense of local cultural tradition, making them susceptible to the ‘‘moral and intellectual consequences that are commonly supposed to flow from relativism—subjectivism, nihilism, incoherence, Machiavellianism, ethical idiocy, esthetic blindness, and so on’’ (Geertz 2000:42). Medical anthropologists, by contrast, have recently contended that a strict focus on cultural and moral difference in health care has become dangerous to the very people and practices anthropologists have sought to understand, particularly in the contexts of massive epidemics and debates over treatment access. As Paul Farmer (1999), Jim Yong Kim et al. (2003), and others point out, culture understood as difference has been used to explain ‘‘why’’ the poor are somehow less responsible regarding treatment regimes. The alarmingly slow development of the anti-HIV drug market in Africa, for example, has been attributed to the allegedly unreliable medical and economic behaviors of that continent’s desperately poor HIV sufferers. Farmer and Kim et al. have shown the way moral assumptions in health planning can further entrench inequality, justifying some interventions while disallowing others. Other anthropologists have moved beyond emphasis on difference and have shown, via careful ethnography, how trajectories of local pandemics are influenced by the logic of international policy and choices (Biehl 2001; Cohen 1999; Das 1999). Differences in the organization of institutions authorized to deal with health problems (state bureaucracies, welfare agencies, insurance companies, medical facilities, and religious and humanitarian organizations) result in policies that not only differ in form and content but also can shape different courses of health and disease and influence the outcomes of both (Petryna and Kleinman in press). These works point to the kind of empirical precision that is required to address the moral, ethical, and cultural realities of emergent global drug markets. In this article, I explore how ethical variability works, particularly in the conjuncture of accelerated drug development and the realities of global public health crises. I specify the effects of this variability on how human-subjects research is governed across various political and economic spheres, particularly in the absence of clear legislation in the United States and of transnational regulatory policy.5 Ethical variability has become central to the development and 184 ...
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