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American%20Ethnologist%202005%20Petryna - ADRIANA PETRYNA...

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A B S T R A C T 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 human- subjects 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 ] S ince the early 1990s, growth in the number of people participating in and required for pharmaceutical clinical trials has been mas- sive. The number of clinical trial investigators conducting multi- national 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 geo- graphical 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 cri- tiqued 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.
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