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Unformatted text preview: ADRIANA PETRYNA New School University Ethical variability:
Drug development and globalizing clinical trials ABSTRACT
The rapid growth of pharmaceutical markets has led to increased demands for human subjects for drug research, particularly in low-income countries. For regulatory, economic, and even biological reasons, new populations are being pursued as human subjects for pharmaceutical trials. In this article I consider the evolution of commercialized clinical trials and ethical and regulatory environments as they contribute to a dramatic growth of humansubjects involvement in research. I focus on the operations of U.S.-based contract research organizations (CROs), which make up a specialized global industry focusing on human-subjects recruitment and research and the on ways in which they expedite drug testing to low-income contexts. Specifically, I analyze how these transstate actors interact with regulatory authorities in the United States and how they recast international ethical guidelines as they organize trials for research subjects abroad. [global pharmaceuticals, bioethics, clinical trials, human subjects, research ethics, governance, biological citizenship] ince the early 1990s, growth in the number of people participating in and required for pharmaceutical clinical trials has been massive. The number of clinical trial investigators conducting multinational drug research in low-income settings increased 16-fold in the past decade (Office of Inspector General, Department of Health and Human Services 2001), and the average annual growth rate of privately funded U.S. clinical trials recruiting subjects is projected to double by 2007.1 Many of these new trials are being performed in geographical areas of political and economic instability and unprecedented health care crises and where subjects are readily accessible. 2 Drug companies’ apparent ease of accessibility to such areas raises questions about the unequal social contexts in which research is being performed and about how conditions of inequality are at present facilitating a global proliferation of pharmaceutical drug trials. Practical issues have overwhelmed ethics in terms of who governs international guidelines for ethical research and their capacity to protect the rights, interests, and well-being of human subjects globally (Benatar 2001; Benatar and Singer 2000; Farmer 2002; Lurie and Wolfe 2001; Office of Inspector General, Department of Health and Human Services 2001; Rothman 2000; Schuklenk and Ashcroft 2000). Social scientists have critiqued bioethicists for focusing discussions of new global experimental orders almost exclusively on procedural questions of informed consent and clinical conduct, narrowing the view of the complexity of emergent ethical dilemmas in the arena of global human-subjects research. Such a focus has led to a profound disconnect between bioethics—an abstract philosophical discourse grounding a set of codified norms for medical practice and research—and empirical reality.3 Arthur Kleinman (1999), for example, points to a ‘‘dangerous break’’ between bioethics and the realities of local moral worlds. Along this fault line of the moral and the ethical persons and their bodily integrity can be further damaged. Veena Das (1999) links international immunization programs and the manner of their implementation with the reemergence of local epidemics in India. S AMERICAN ETHNOLOGIST, Vol. 32, No. 2, pp. 183 – 197, ISSN 0094-0496, electronic ISSN 1548-1425. A 2005 by the American Anthropological Association. All rights reserved. Please direct all requests for permission to photocopy or reproduce article content through the University of California Press’s Rights and Permissions website, www.ucpress.edu/journals/ rights.htm. ...
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This note was uploaded on 10/10/2010 for the course ENG 000121 taught by Professor Mcgrand during the Spring '10 term at Cornell.
- Spring '10