A former deputy commissioner of the U.S. FDA has an op-ed piece in today's Wall Street Journal. In Journalistic Malpractice, Scott Gottlieb says major medical journals are pushing political agendas. Case in point, he says NEJM "rushed onto its Web site a limited and flawed analysis of safety concerns around the diabetes drug Avandia. The publication was timed to get ahead of the Food and Drug Administration's more careful evaluation of the same issues.... The goal? Painting the FDA as impotent, in order to argue for legislation winding through Congress that would increase regulatory hurdles for drug approvals."
Gottlieb says that "NEJM editors have long favored more drug regulation" and that "There have now been too many instances where one of the major medical journals has used editorial decisions about publication and placement of bottom-line medical information as a tool to primarily influence political discourse, rather than informing medical practice." The editorial also questioned how NEJM kept only some folks in the loop, saying that "NEJM said it rushed to post the study on the Web because of its medical importance, but the FDA, which would need to act on any safety issues, wasn't even given a heads up about the study's publication or its findings. Rep. Henry Waxman (D., Calif.), however, seems to have known in advance that it was coming because he issued a substantive press release immediately after the study was posted online.... Mr. Waxman is trying to add new restrictions to the FDA's drug approvals."
The article ends by saying that journals are important public health tools, but "When they use shortcuts and shoddy analysis to fabricate criticism and doubt of drug regulation, they're no better than some politicians they increasingly comport with." Ouch.
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