DEBATE
  SCIENCE
    Question
    Data
    Equivalency


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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