NEJM –What ails the FDA?
The following letter by yours truly was published in the June 16th issue of the New England Journal of Medicine.
To the Editor: Okie’s article could lead the reader to the conclusion that an independent drug-safety agency would protect patients better. But Okie omits certain events surrounding the withdrawal of rofecoxib from the market that illustrate the potential downside of separating the FDA’s drug-approval function from post-marketing safety surveillance. In particular, she does not mention the fact that experts in drug safety and the relevant therapeutic field who gathered at an FDA advisory committee meeting in February to discuss the safety of cyclooxygenase-2 (COX-2) inhibitors and nonsteroidal antiinflammatory drugs (NSAIDs) voted 17 to 15 that rofecoxib ought to be allowed to be marketed. Nor did Okie mention that David Graham, the FDA epidemiologist who has heartily criticized the agency’s handling of the rofecoxib review, is rather more certain in his views of the benefit–risk equation for the drug; he has said that “there really doesn’t appear to be a need for COX-2 selective NSAIDs.” The point is that drug-safety experts tend to downplay therapeutic benefits, and clinical practitioners tend to downplay risks. What is needed at the FDA is an unrestrained voice for experts on both sides of the equation.
