4_Ethical Variability - Petryna - American Ethnologist n...

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Unformatted text preview: American Ethnologist n Volume 32 Number 2 May 2005 of clinical trials, and they are paid to know the constraints and opportunities afforded by country-by-country and regional regulations related to drug testing.10 CROs are rapidly expanding into the Third World and the former Second World of Eastern Europe, statistically and innovatively carving out new populations for larger and more complicated trials to assess the drug safety and efficacy demanded by U.S. regulators and consumers. In selecting a CRO, pharmaceutical sponsors weigh the cost of a study, its quality, and its timeliness. CROs claim to recruit patients quickly and more cheaply than academic medical centers. Most firms are involved in locating research sites, recruiting patients, and in some cases, drawing up the study design and performing analyses. Elements considered in cost-effective trial siting include local levels of unemployment, population disease profiles, morbidity and mortality rates, per-patient trial costs, and potential for future marketing of the approved drug. CROs investigate the host country’s regulatory environment. They ask whether universal access to health is in place. They assess regulatory priorities and capacities of host countries (e.g., efficacy of local ethical review boards and outlooks and regulations on placebo use). In managing clinical trial sites, CROs sometimes work with site management organizations, which may include primary health care facilities, general practitioner networks, hospitals, or consortia of specialists focusing on a particular therapeutic area. U.S.-based CROs have alliances with site management organizations in countries in Eastern Europe, Latin America, and the Middle East, for example. Some even have their own centralized IRBs for single-investigator trials or for multicenter trials that can involve studies of up to 10,000 people in 10 – 20 countries.11 IRBs are, ideally, independent boards that are composed of scientific and nonscientific members whose duty is to ensure the safety of patients in a trial. Their purpose is to review and approve the trial protocol and methods to be used in obtaining and documenting the informed consent of trial subjects. The ethics committee model for monitoring the conduct of research, as sociologists and anthropologists of bioethics have noted, turns the ethical universe in which researchers operate into an essentially procedural one (Bosk 1999, 2002, 2005; Bosk and de Vries 2004; de Vries 2004; Guillemin 1998) and deflects attention from structural circumstances that can contribute to increased risk and injustice (Chambliss 1996; Marshall and Koenig 2004). Do clinical researchers have the patient’s informed consent? Does the local investigator agree to accept all responsibility in case of an adverse reaction or death? In the international context of drug development, the IRB model avoids the challenge of variability across distinct political and economic contexts. At stake is the construction of an airtight documentary environment ensuring the portability of clinical data from anywhere in the world to U.S. regulatory settings of drug approval, even if those data were derived in the middle of an epidemic or in a war zone.12 Treatment naıvete ¨´ This work evolved out of my prior research and writing on the Chernobyl nuclear disaster in the former Soviet Union (Petryna 2002). Working in government-operated research clinics and hospitals in the mid- to late 1990s, I observed a rapid growth of pharmaceutical and clinical trial markets in Ukraine and its neighboring countries. Physicians who tended to Chernobyl sufferers routinely expressed eagerness to learn how to conduct clinical trials and to attract clinical trial contracts from multinational pharmaceutical sponsors because of the abundance of various untreated diseases.13 They were also eager because the scientific infrastructures on which they were dependent were quickly deteriorating without state funding. The combination of local public health crises and commercial and scientific interest led to the sudden revaluing of patients who themselves had lost state protection in the form of guaranteed health care. It was not quite the dream ‘‘of Neel, Chagnon, and their gold-rush, tourist-hunting allies ‘to turn the Yanomami’s homeland into the world’s largest private reserve,’ a six-thousandsquare-mile research station and ‘biosphere’ administered by themselves’’ (Geertz 2001:21).14 But scientists’ rush to reconceptualize their object of study ‘‘not as a people but as a population’’ (Geertz 2001:21) to be brokered as valued research subjects on the pharmaceutical world scene was certainly there. Currently a turf war is raging among pharmaceutical sponsors for human subjects. The competition is not only about the numbers of subjects a given company can recruit but also about recruiting subjects quickly. As one veteran recruiter told me, ‘‘It’s really a problem. I don’t know anybody who has really cracked the code. Sometimes you get lucky and you fill the study quickly, but for the most part, patients are really difficult to find, and they are difficult to find because everybody is looking for them.’’ CROs see Eastern Europe as a particularly good recruitment site. Given the collapse of basic health care there, patient enrollment in clinical trials is said to be quick. Postsocialist health care systems are conducive to running efficient trials because they remain centralized. High literacy rates in this region mean that subjects offer more ‘‘meaningful’’ informed consent, thus, smoothing potential regulatory problems in the future. Large Latin ˜ American cities such as Lima and Sao Paulo are also considered premium because, as one CRO-based recruiter told me, ‘‘Populations are massive. It’s a question of how many patients I can get within a limited area, which reduces travel cost.’’ According to him, CROs battle over 186 ...
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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 University (Engineering School).

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