Failing the Public Health — Rofecoxib, Merck, and the FDA
Posted by Clark Venable on 10/21/2004
Failing the Public Health — Rofecoxib, Merck, and the FDA
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"I believe that there should be a full Congressional review of this case. The senior executives at Merck and the leadership at the FDA share responsibility for not having taken appropriate action and not recognizing that they are accountable for the public health. Sadly, it is clear to me that Merck's commercial interest in rofecoxib sales exceeded its concern about the drug's potential cardiovascular toxicity. Had the company not valued sales over safety, a suitable trial could have been initiated rapidly at a fraction of the cost of Merck's direct-to-consumer advertising campaign. Despite the best efforts of many investigators to conduct and publish meaningful independent research concerning the cardiovascular toxicity of rofecoxib, only the FDA is given the authority to act. In my view, the FDA's passive position of waiting for data to accrue is not acceptable, given the strong signals that there was a problem and the vast number of patients who were being exposed."
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Emphasis mine.
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