Ghostwriting fuels foes of FDA rule change

Last week, we reported on Big Pharma's march on the capital in support of new off-label marketing rules. Now, opponents of those rules are drawing on another of last week's news events for support: the Vioxx ghostwriting story.

You'll recall that last week's Journal of the American Medical Association included an article showing that Merck used ghostwriters to produce journal articles supporting the now-withdrawn painkiller Vioxx. You'll also recall that the proposed FDA rules would allow drugmakers to distribute journal articles supporting off-label uses of their products.

Critics of the proposal say that if the credibility of journal articles can't be guaranteed--and in fact might have been skewed by the drugmakers--then why should they be exempt from off-label marketing prohibitions? Even before the Vioxx story broke, Blue Cross Blue Shield had written the FDA to question the marketing proposal, citing the possibility that ghostwritten articles could be used to bolster off-label uses, the New York Times reports. And New York State's health commissioner weighed in with similar concerns, referring to Pfizer's use of journal articles to promote off-label use of Neurontin; Pfizer later paid $430 million to settle off-label marketing claims. (Funny, there was a Neurontin story last week, too.)

"We just have so many concerns," Commissioner Dr. Richard F. Daines told the NYT. "You don't know the publication's true peer-review standards and transparency."

- read the NYT story

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