Unformatted text preview: Globalizing clinical trials n American Ethnologist Ethics as a workable document
In responding to the Helsinki declaration revision, U.S. regulators conveyed the value of research efficiency to industrial clinical researchers. And the murky ethics of the placebo could be bypassed by providing for what is known as ‘‘equivalent medication’’—not necessarily the best or standard treatment, but whatever is available as the best local equivalent. ‘‘Do I give them a sugar pill or vitamin C?’’ as one researcher cynically asked me. In the meantime, the study will be ethical, the data will have in¨ tegrity, and sadly, the patients will remain treatment naıve. Another researcher echoed the reality of this shift from concerns about redistribution to efficiency-based standards in global research when he told me that ethics came to be seen as a ‘‘workable document.’’ ‘‘Equivalent medication in Eastern Europe is not the same as equivalent medication in Western Europe, so you could work the Helsinki declaration,’’ he said. In the name of efficiency, pharmaceutical companies and CROs intensified their ¨ search for treatment-naıve populations worldwide. In tracing the relation between regulation and the making of ethics in human research, Marks notes, ‘‘It is as if ethical discourse and the regulations governing research exist in two parallel universes which share some common elements but do not connect’’ (2000:14). The main point of this Helsinki genealogy is to show how connected those universes are. Regulatory response in the context of debates over the Helsinki declaration’s revision (which itself was a response to controversial uses of human subjects) is itself instantiating new populations of ¨ human subjects—the treatment naıve. The story told here is about how regulatory decision making at the transnational level encourages the evolution of ‘‘local’’ experimental terrains whose ethics are workable and whose subjects can be (justifiably) variably protected under current international ethical codes such as the Helsinki declaration. I say ‘‘variably’’ because some national governments faced with a sudden growth of humansubjects research, indeed, have minimal bureaucracies to cope with, and some may know little about, structures of liability in cases of adverse or catastrophic events.21 Neither might they have the bargaining power or be interested in pressing for fairer procedures and access to drugs during and after the trial. Thus, a distinction is to be made between ethical codes (in which the definition of what constitutes biomedical harm is fairly unambiguous) and ethical regulation (in which deliberation of those definitions is balanced against economic, scientific, and regulatory constraints and demands). Ethical regulation entails minimally enforceable procedures governing human research as inscribed in public policy and law. It is also a realm of contingent practice, and the allocation of protection for human-subjects research is far from settled here. The ethical arrangements that have grown up around populations and their diseases are made visible by examining the spatial and temporal complexities associated with global pharmaceutical development and by analyzing the practices of CROs, for example, that fill this demand. Starting in the early 1990s, just four years before the controversial AZT trials, the FDA began to actively promote the globalization of clinical trials, declaring ‘‘that the search for sites and sources of data are part of its mandate to determine the safety and efficacy’’ (Office of Inspector General, Department of Health and Human Services 2001:42) through the establishment of the ICH. Participation in U.S.-sponsored research began to swell among clinical investigators in countries that had voluntarily agreed to harmonizing standards in the field of commercial drug testing: Argentina, Brazil, Hungary, Mexico, Poland, Russia, and Thailand, among others. As a result, the number of international human subjects involved in clinical trials grew dramatically between 1995 and 1999 (in 1995, 4,000; in 1999, 400,000; these are only partial estimates; see Office of Inspector General, Department of Health and Human Services 2001).22 This global growth of research brought with it a new set of unknowns related to the circumstances of research and concerns about possible exploitation of foreign subjects, and currently, no U.S. legislation or transnational regulatory policy is aimed at controlling or monitoring the conduct of globalizing clinical trials. Many proposals have been made for improving the system of monitoring. In 1999, the Office of Inspector General (OIG), a body that carries out periodic reviews of the FDA, told that agency after careful review that, ‘‘in spite of its active promotion of the search for sites and subjects elsewhere,’’ the FDA is not able to protect human subjects in research elsewhere.23 The inspector general’s office recommended that the FDA support and in some cases help to construct local ethical review boards. The regulatory preference for the expansion of the IRB model was reflected in a recent National Bioethics Advisory Commission (2000) report recommending that studies submitted to the FDA receive ethical committee review both in the United States and in the country in which research is being carried out (as opposed to the present situation, in which only foreign ethical review and approval is mandated). The report supported the idea of dual review but stated that, if host countries have working ethical review committees, then only approval of those committees is required. These approaches involve monitoring, data collection, and more local ethics committees and lean heavily toward what Iris Young (2004) calls the ‘‘liability model’’ of accountability: Let regulators name the responsible local parties (in some cases, set them up first) and surely those parties can gather information and make the right 189 ...
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- Spring '10
- Business Ethics, Helsinki, placebo, Helsinki declaration