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The Scientific Debate.
While ethical considerations lay
at the heart of the controversy over placebos, their use was criticized, and
justified, on scientific grounds as well.
Essentially, the position of critics
of the clinical trials was summed up by Marcia Angell who, in an October 28,
1997 op-ed piece in the Wall Street Journal, entitled "Tuskegee Revisited,"
wrote that "there is no scientific necessity to compare [shorter regimens of
AZT] with placebos."
The position of supporters of the
trials, on the other hand, was articulated by Drs. Harold Varmus and David Satcher--directors,
respectively, of NIH and CDC--who wrote, in the October
2, 1997 issue of The New England Journal of Medicine, that placebo-controlled
studies provided "definitive answers to questions about the safety and value
of an intervention in the setting in which the study is performed, and these
answers are the point of the research."
Within this overall debate over
the appropriateness of the study design, a number of issues became the focus
of discussion: the nature of the research
question that justified use of placebos, the uses of observational and historical
data, and the appropriateness of equivalency
trials.
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