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Unformatted text preview: American Ethnologist n Volume 32 Number 2 May 2005 followed it—highlights the role of crisis in the consideration of differences in ethical standards in the area of human research; indeed, that crisis conditions legitimate variability in ethical standards. Historically, some crises have led perhaps inescapably to experimentation (Petryna 2002; Smith 1990). But one can also ask, are crises states of exception or are they the norm? To what extent does the language of crisis become instrumental, granting legitimacy to experimentation when it otherwise might not have any? The debate over the ethics of the AZT trial prompted the sixth revision of the Helsinki declaration, first issued in 1964. The declaration deals with all dimensions of human biomedical research, furnishing guidelines for conduct in research involving human subjects.18 The 2000 revision reiterated a position against placebo use when standards of treatment are known: ‘‘The benefits, risks, burdens, and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic, or therapeutic method exists’’ (World Medical Association 2000:3044).19 Although the ethics was unambiguous, the regulatory weight of the declaration was not. In this latter domain the winners and losers of the placebo debate would be named.20 Pharmaceutical companies, already eagerly expanding operations abroad and calculating the economic advantages of placebo use (placebos lower costs and, many argue, placebo trials produce more unambiguous evidence of efficacy), were scrambling to learn from regulators about the legal enforceability of the declaration and were finding ways to continue using the placebo. Haziness brought clarification of the rules of the game. Dr. Robert Temple, associate director of medical policy of the Center for Drug Evaluation of the U.S. FDA, undercut the regulatory significance of the declaration and threw his support behind placebo advocates. He stated, ‘‘We’ll have to see if the Declaration of Helsinki remains the ethical standard for the world’’ (Vastag 2000:2983). He cites the ICH (U.S. Food and Drug Administration 2001) as the alternative and more authoritative guideline on the ethics of placebo use. This guideline states, ‘‘Whether a particular placebo controlled trial of a new agent will be acceptable to subjects and investigators when there is a known effective therapy is a matter of patient, investigator, and IRB judgement, and acceptability may differ among ICH regions. Acceptability could depend on the specific trial design and population chosen’’ (Temple 2002:213, emphasis added). In other words, the ethical standard for the world was claimed to be variability. Temple’s support for the placebo trial was ostensibly guided by a concern for generating high-quality scientific data. His reaction is also indicative of how regulatory regimes can influence the definition of experimental groups. Let me briefly trace the logic of this relation. The alternative to the placebo-control is the active-control trial. Its purpose is to compare a new drug with a standard one, to show superiority of the new drug to the active control or to at least show difference. (To many patients and clinicians, this is the information of greatest relevance, namely, the comparative effectiveness of a new drug to a standard therapy.) But showing difference or superiority is not enough because ‘‘many kinds of study defects decrease the likelihood of showing a difference between treatments’’ (Temple 2002:222) and make data on difference less reliable. Study defects arise from external factors like poor patient compliance, poor diagnostic criteria, and the use of concomitant medication that can obscure effect. Other defects can include inconsistencies in the application of the definition of disease, the use of insensitive or inappropriate measures of drug effectiveness, and the chance of spontaneous recovery in a study population. These factors can be ‘‘fatal to a trial designed to show a difference’’ (Temple 2002:222; also see Pocock 2002:244 – 245). They can decrease difference or increase the chances of finding no difference, such that, in the end, in Temple’s words, ‘‘you don’t know if either of them worked’’ (Vastag 2000:2984). By contrast, a placebo-control trial is capable of showing difference, and, much more importantly, it is able to discern effective and ineffective treatments. Such ability is considered a key marker of reliable evidence of the effectiveness of a new drug. Active-control trials fail to make such a distinction and are therefore not preferable from a regulatory standpoint. A certain kind of global human subject is at stake in Temple’s description of failure of active-control trials. Most people in low-income countries, those places where many clinical trials are heading, are subject to the external factors that are said to lead to the study defects cited above. They may have medical histories that are patchy at best, thus making cross-cultural interpretation of the meaning of drug effectiveness less reliable. Their diagnoses can be inconsistent, also confusing evidence on drug effectiveness. Not only is quality of data in doubt with active-control trials but also the ‘‘quality’’ of research subjects. Researchers must standardize medical histories if they are to ensure their comparability—time-consuming, costly, and all but impossible tasks. Temple’s invalidation of the active-control trial is anthropologically and economically significant—the treat¨ ment naıve become preferable from a regulatory standpoint that emphasizes the importance of an efficient (and foolproof) global research subject. Precisely because they are often poor, without a treatment history, and without ¨ treatment, the treatment naıve are the more foolproof and valuable research subjects! 188 ...
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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