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Unformatted text preview: Globalizing clinical trials n American Ethnologist appropriate conduct of research to local context inform a legal defense strategy to make acts of experimentation— particularly those enacted in public health crises—either reachable or unreachable by international ethics codes.28 What appears as scandalous activity with respect to global human-subjects research may, in fact, be seen as legitimate under evolving ethical and legal notions of fair play. This ‘‘expedient’’ experimentality first caught my attention in the context of the scientific management of the Chernobyl nuclear crisis. Here, too, the language of crisis became instrumental, granting legitimacy to experimentation when it otherwise might have had none. A public health disaster combined with the state’s incapacity to protect the life of citizens; this combination, in turn, justified a commercially sponsored clinical trial that would have been impossible to conduct elsewhere at the time. Human research whose exploitativeness might have been hard to judge was justified under the rubric of humanitarianism; and this process in itself may lie outside the bounds of what ethical discourse about human-subjects research and even legal codes can capture.29 Occurring at a time when research priorities in the world of international science were shifting toward biotechnology, Chernobyl afforded a venue for biotechnological research.30 The Soviet state’s response to the crisis is widely documented as having been grossly negligent, particularly in the first days after the disaster.31 Under strong pressure to restore the credibility lost by the state’s initial inadequate response to the disaster, then – general secretary Gorbachev agreed to cooperate in an unprecedented Soviet – U.S. scientific venture. He personally invited a team of U.S. oncologists and radiation scientists to conduct experimental bone marrow transplants on workers from the ‘‘Zone’’ (an area 30 kilometers in diameter circumscribing the destroyed nuclear reactor site) whose exposures were beyond the lethal limit and for whom no treatment was available. In exchange for the credibility garnered from this move, Soviet medical authorities gave in to the U.S. research team’s demands to conduct human testing of a genetically engineered hematopoetic growth factor molecule (rhGM-CSF, thought to regenerate stem cell growth and to be useful for treating leukemia). Some animal testing had been underway in the United States, using highly irradiated chimpanzees and dogs, but human testing of the molecule had not been approved by the FDA. The humanitarian ethics to treat in a crisis where there was no treatment legitimated the transfer and use of unapproved experimental drugs. The lead scientist on this trial told me that he had no clinical trial protocol but that he had acted consistently ‘‘with what was legal.’’32 He did not know the exact number of individuals on whom the molecule was tested (he guessed it was over 400). During our 1996 interview, he described his interests in the Chernobyl cohort as short term. In his view, the accident offered his team a readymade set of experimental conditions: ‘‘The Chernobyl accident for the firemen at the power plant was exactly what we do at the clinic every day. Potentially, there were patients with [leukemic] cancer exposed to acute whole body irradiation.’’ This scientist, who had gained fame and admiration for his humanitarianism, spoke to me about these unregulated trials in a surprisingly confident fashion, suggesting that political arrangements gave him adequate refuge from ethical sanctions. ‘‘No one was going to believe what Gorbachev had to say about Chernobyl. I convinced them of that [in my negotiations]. They had no credibility.’’ This scientist’s confidence points to a political, regulatory, legal, and ethical milieu that lay beyond a procedural one governing relations between researchers and their human subjects. Disaster reframed as humanitarian crisis presented a unique scientific and political opportunity. Politically, normal rules of conduct were suspended. Scientifically, the disaster offered a set of negative health circumstances that, because of codes of ethics prohibiting human experimentation, would have been impossible to simulate in normal clinical trial circumstances in the United States. In other words, the crisis provided a regulatory, environmental, and technical ready-made scenario for bioscientific research. As such, it gave researchers liberal access to a pool of highly endangered people. This pool became attractive precisely when a nonhuman model showing the effects of a particular molecule was lacking. Although the results of this trial were deemed largely unsuccessful, both sides gained significantly from their short-term arrangement. The U.S. scientist’s team and its major pharmaceutical backer got a valuable jump start on the emerging biotechnological market in growth-factor molecules. Soviet officials got a rare opportunity to shore up the state’s credibility locally and internationally. Biological citizenship
As in both the Trovan and Chernobyl cases, a humanitarian crisis creates a space that appears to be ‘‘ethics free’’ precisely because it is disastrous, beyond the reach of regulation. With the sudden suspension of normalcy, whole groups of people actually or potentially become experimental subjects.33 Both cases also demonstrate to a greater or lesser extent a breakdown in consent processes and in citizens’ trust and reliance on state systems of public health and protection. Ethics is used variably and tactically by all actors in a chain of interests involved in human-subjects research. Such chains now function in states where lives of citizens are not adequately protected via traditional health or welfare systems. The biological 191 ...
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- Spring '10