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Unformatted text preview: American Ethnologist n Volume 32 Number 2 May 2005 decisions, surely they can stop inappropriate research from taking place. Much is also assumed about who is and is not the agent of abuse, most typically defined as the individual investigator him- or herself. What about instances in which risks present themselves in a more structural form? These instances tend not to find proper nouns in ethical discussions, beyond designation as ‘‘interesting’’ or ‘‘scandalous’’ cases. The fact is that certain conditions have to be met for liability to work: States themselves need to act as protectors and not abusers; transnational corporations need to respect the rights and dignity of all research subjects and recognize that different situations elicit different kinds of coercion; and international ethics codes must be enforceable in cases of clear violation. None of this occurred, unfortunately, in the following instance—a 1996 case of industry-sponsored research in Nigeria for a drug manufactured by Pfizer, Inc., called Trovan, once one of the most widely prescribed antibiotics in the United States but later taken off the market because it was found to produce serious liver side effects. In an effort to gain FDA approval for a new use of Trovan—this time using pediatric victims of bacterial meningitis who ¨ were most likely treatment naı ve—a team of Pfizer researchers traveled to the city of Kano during a bacterial meningitis outbreak (which they found out about on the Internet) and civil unrest under the Abacha military dictatorship. Doctors without Borders was already distributing a cheaper antibiotic, proven effective for treating bacterial meningitis, at a main local hospital. The trial protocol for testing a new use of Trovan was not approved by a U.S. ethics committee and received a grossly inadequate if nonexistent review in the host country. Legal documents show that informed consent forms used in Pfizer’s defense are backdated.24 The Pfizer team went to the hospital where the cheaper drug was being distributed and selected 100 children who were waiting in line to receive treatment. The Pfizer team is alleged not to have explained the experimental nature of Trovan to subjects; parents believed their children were receiving a proven treatment.25 Some of these children were given Trovan in a form never tested on humans before; others were given a lower dose of the standard of care for meningitis (ceftriaxone) that, according to the complaint filed by the New York law firm on behalf of the parents, allowed Pfizer researchers to show that Trovan was more efficacious (Lewin 2001). This low dosing, the parents claim, resulted in the deaths of 11 children. This is the first case brought by foreign subjects – citizens against a U.S.-based multinational pharmaceutical company. The plaintiffs’ lawyers suggested that a chain of complicity in making the children available for research included Nigeria’s military rulers and state officials, Ministry of Health officials, and local hospital adminis- trators; U.S. FDA regulators who authorized an unapproved drug’s export to Nigeria for ‘‘humanitarian’’ purposes; and Pfizer researchers who, from a line of children waiting for standard treatments, selected subjects for an industry-sponsored clinical trial. All were involved, lawyers claimed, in violating principles of the Nuremberg Code and other codes of human-subjects protection, referred to in plaintiffs’ court documents as ‘‘customary laws’’ that are ‘‘made up of fundamental principles of a civil society that are so widely held that they constitute binding norms on the community of nations’’ (Rabi Abdullahi, et al. v. Pfizer Inc., Case No. 01 Civ. 8118 WL 31082956 [SDNY 2002]).26 The defendant’s lawyers, by contrast, downplayed the authority of the code and stated that it and other such guidelines ‘‘are not treaties.’’ (In some domestic cases, federal judges have ruled that internationally accepted codes of human-subjects protection, in this case the Nuremberg Code and the Helsinki declaration, cannot be relied on as the basis of civil suits in U.S. courts.) The defense situated Pfizer researchers’ activities in the context of a ‘‘massive epidemic killing more than 11,000 people,’’ whose outbreak they attribute to ‘‘woefully inadequate’’ sanitary conditions. By suggesting that their experimental treatment could only do good in such a desperate context, the defense troubled the criteria by which to judge the difference between experimental and standard of care treatment. It stated that it would be ‘‘paternalistic’’ for a U.S. court to adjudicate the appropriate conduct of medical research in a country undergoing a public health crisis, and echoed the ethically relativizing stance already familiar in the African AZT case (Rabi Abdullahi, et al. v. Pfizer Inc., Case No. 01 Civ. 8118 WL 31082956 [SDNY 2002]). From this brief sketch of the legal parrying, one point is worth stressing. As much as one would like to see the Kano case as an instance of the ‘‘dubious’’ or the ‘‘para’’ (paralegal, pararegulatory, paraethical), an interlocking set of regulatory, commercial, and state interests is at play that can potentially introduce uncertainty with respect to the observability of international ethics codes in local contexts or suspend the relevance of such ethics altogether.27 In this case, a functional ethical review of U.S. industrysponsored research would have been necessary and might even have prevented this tragedy. But from the Nigerian side of things, interests were not on the side of protection but overwhelmingly on the side of making populations accessible to research. The case of Trovan is still being adjudicated, but deliberations so far suggest that knowledge of wrongdoing does not necessarily translate into the ability to regulate or prosecute wrongdoers. The case exemplifies how contextual factors (crisis and its humanitarianisms) and defenses fold into and construct new experimental scenarios and groups. Ethical positions, particularly those revealed by the AZT case, that relativize decision making over 190 ...
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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).
- Spring '10