11_Ethical Variability - Petryna

11_Ethical Variability - Petryna - Globalizing clinical...

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Unformatted text preview: Globalizing clinical trials n American Ethnologist may ultimately provide the basis for a critique of marketdriven human research. Notes Acknowledgments. I thank Harry Marks, Arthur Kleinman, Iris Young, Rayna Rapp, Paul Rabinow, Noam Zohar, Nicole LuceRizzo, Margaret Lock, Joseph Harrington, Richard Cone, Veena ˜ Das, and Joao Biehl for their discussions, commentaries, and insights. This work was supported by the Crichton Fund (Department of Anthropology of Harvard University) and the National Endowment for the Humanities. The article was revised while I was a member of the School of Social Science of the Institute for Advanced Study at Princeton, and I am grateful for the support of the school’s faculty, fellows, and staff as well as the suggestions of Virginia Dominguez and the anonymous reviewers of American Ethnologist. 1. Source: Business Communication Co., Inc. 2003. This figure is derived from industry surveys, the U.S. General Accounting Office, and the annual reports of seven major philanthropic organizations. 2. According to the Office of Inspector General, Department of Health and Human Services, ‘‘Among the countries that have experienced the largest growth in clinical investigators [for U.S. commercially sponsored trials] are Russia and countries in Eastern Europe and Latin America’’ (2001:i). 3. For earlier warnings on the dangers of ethics becoming disassociated from the empirical realities it claims to know, see Jonas 1969 and Toulmin 1987. Histories of bioethics and medical humanities approaches speak of the loss of intimacy in medical care as codes and norms (related to informed consent, e.g.) transform the patient – doctor relationship so that it is ‘‘no longer the intimate affair that it once was’’ (Rothman 1991:4). Such intimacy, as anthropologists and historians of colonial and postcolonial settings suggest, is rarely a part of medicine in these settings. It is the control of populations, rather than of individuals, that becomes the focal point of medicine in such settings (see Anderson 2003; Arnold 1993; Biehl 2005; Briggs and MantiniBriggs 2003; Comaroff and Comaroff 1992; Lindenbaum 1978; Misra 2000; Prakash 1999; Scheper-Hughes 1992; Vaughan 1992; among others). 4. Rules and regulations for conducting human-subjects research have been evolving since the establishment of the 1947 Nuremberg Code. The World Medical Association’s Declaration of Helsinki states ethical principles that should guide investigators and participants in medical research. The U.S. Food and Drug Administration (FDA) and other government and professional organizations also issue guidelines. The Office of Human Research Protection of the Department of Health and Human Services (DHHS) and the Declaration of Helsinki follow the ethical principles outlined in the Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1974). Yet these guidelines only apply to companies and institutions receiving DHHS funding. In the United States as well as in other countries, clinical trials are monitored by institutional review boards (IRBs). The number of commercial IRBs is growing. 5. By ‘‘government’’ of human-subjects research I mean its ethical codes, the mechanisms of its growth, and its regulation. One goal of my research is to understand how wider ethnographic contexts inform the design and operation of clinical trials. Harry Marks’s (1997) work is particularly illuminating in showing how ethics was incorporated into the design of the controlled, randomized trial in the United States in the interwar period. Else- where (Petryna n.d.), I address the many forms and functions that human-subjects research assumes at local and national levels and how the terms of commercialized human-subjects research are being challenged so as to redirect economic, moral, and scientific investments in particular contexts. 6. Estimates for the current number of clinical trials differ dramatically. For example, according to CenterWatch (2002), an information services company monitoring clinical research, 80,000 clinical trials were underway in the United States alone in 2002 (this number is routinely quoted in industry literature). One industry contact, however, believes that number is too high. He noted that estimating the number of clinical trials worldwide is next to impossible because there is no central repository. Instead, this individual suggests ‘‘that there are between 25,000 – 40,000 clinical trials conducted in the U.S. alone’’ and that ‘‘other sources indicate 80,000 for the U.S.—but others believe that the 80,000 represents the number of clinical trials globally.’’ Such ambiguity in numerical estimates suggests a global field of experimental activity whose true scope is largely unknown and prone to guesswork and that requires ethnographic attention (Petryna n.d.). Estimating the number of clinical trials is an inexact science, to say the least. Dickersin and Rennie suggest major barriers to a comprehensive repository of clinical trials, including ‘‘industry resistance, the lack of a funding appropriation for a serious and sustained effort, lack of a mechanism for enforcement of policies, and lack of awareness of the importance of the problem’’ (2003:516). I thank Nicole Luce-Rizzo for her insights and generous research assistance here and elsewhere. 7. I interviewed this individual in June 2003. 8. The full name of this initiative is the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 9. Testing requirements are typically established by national regulatory agencies, and they can differ from country to country; duplicate testing threatened to delay foreign market access and affect the global trade in pharmaceuticals. Japan, perceived to be a potential and large consumer market for U.S. pharmaceuticals, is famous for its intransigent regulatory system. See Applbaum in press. 10. Drug development is broken down into four phases (preclinical, clinical, marketing, and postmarketing). Forty billion of the estimated $55 billion that is being invested in drug research and development goes to development. According to the CEO of one major contract research organization that I interviewed, ‘‘Probably 60 percent of that $40 billion is spent on phase two and three trials. So big money is there.’’ Hundreds of CROs operate worldwide and employ a labor force of nearly 100,000 professionals (Rettig 2000). The move toward outsourcing increased dramatically in the 1990s. By 2004, nearly 42 percent of all pharmaceutical drug development expenditures had been committed to outsourcing; that compared with only four percent in the early 1990s. The pharmaceutical industry is outsourcing an increasing number of operations, ranging from discovery research to clinical trials operations to manufacturing, final packaging, and distribution as well as sales and marketing activities. 11. For an assessment of the commercialization of ethical review boards, see Lemmens and Freedman 2000. 12. See Jonathan Moreno’s (2004) analysis of the ethics of human experiments for national security purposes. The focus on standards of consent in a time of international crisis can be read as a means through which a ‘‘postwar national security state protect[s] itself from critics of expanded governmental power’’ (Moreno 2004:198). 13. Post-Soviet scientists were new to the randomization aspect of modern controlled clinical trials. 193 ...
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