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Journalistic Malpractice
Dr. Scott Gottlieb, Wall Street Journal, 5-29-07

Gottlieb criticizes the New England Journal of Medicine for rushing a study on Avandia into print even as the FDA was engaged in a more thorough review of the same data.

As medical information is exploding and becoming more accessible, all of us, particularly physicians, need objective sources to interpret data and present a balanced view. Unfortunately, major medical journals that should be filling this role often put more weight on pushing political agendas. Their editorial prejudice has left a troubling void for rigorous and unbiased arbiters of medical evidence who can guide sound medical practice decisions.

The behavior of the New England Journal of Medicine (NEJM) is a case in point, when it 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 journal seemed bent on beating the FDA to the punch. The goal? Painting the FDA as impotent, in order to argue for legislation winding through Congress that would increase regulatory hurdles for drug approvals. The journal's motives were made bare by its own editorial on the matter.

While there are "questions" whether Avandia is associated with certain heart risks—so far unsupported by more rigorous, randomized studies and extensive review by the FDA and other authorities around the world—the NEJM study doesn't add much new insight into those issues because of its own limitations. But you wouldn't know that from the way the Journal hyped its analysis to the media or opined about the study's significance. These facts weren't lost on clinicians and even NEJMs competitors. The Lancet, NEJM's British sister–publication, said of the study, "Alarmist headlines and confident declarations help nobody." A top American medical researcher told WebMD, "I can't help but wonder if the NEJM is functioning more like the mainstream press than a scientific journal at this point."

Project FDA.
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