Document Type

Article

Publication Date

2005

Abstract

Controversy over recent revelations concerning the adverse cardiovascular effects of selective cyclooxygenase- 2 (COX-2) inhibitors has generally been framed as a story of regulatory failure, in which the Food and Drug Administration (FDA) has failed in its mission to protect the public from unsafe products. But this simplistic understanding of the mission of the FDA seems to make failure all but inevitable, if the reliable observation of the risks and benefits of a drug requires rigorous long-term studies. Perhaps in an earlier era the goal of drug regulation was simply to protect the public from poisons. Today, drug regulation guides the development of information that turns poisons, used advisedly, into drugs. From this perspective, the growing knowledge of the complex effects of COX-2 inhibitors might be retold as a story of regulatory success.


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