The Avandia Controversy Continues - A Conspiracy?

The controversy continues surrounding last week's New England Journal of Medicine report that patients taking Avandia (rosiglitazone) for diabetes may be at increased risk for cardiovascular complications. (Read about this report here.)

In yesterday's Wall Street Journal, Scott Gottlieb (a former FDA deputy commissioner) wrote that the study's authors, the editors of the New England Journal, and certain politicians may have rushed this article into print in a somewhat irregular manner to preempt (and presumably embarrass) the FDA, which had been working on its own safety evaluation of Avandia.

Dr. Nissen (the primary author) submitted the article on May 1, and it was published - along with a lengthy editorial by two authors (selected by the Journal) with a history of being critical of FDA - on May 21. This submission-to-publication time is extraordinarily rapid for the New England Journal, where a lag period of several months is more typical. Furthermore, according to Gottlieb, neither FDA nor GlaxoSmithKline (makers of Avandia) were alerted that the article was in press, a practice that is typically done. Both FDA and the drug maker consequently were left scrambling to make coherent responses.

In fact, both FDA and GlaxoSmithKline had been in the process of evaluating potential safety concerns with Avandia. The ongoing RECORD trial, for instance, was expected to provide definitive data on the cardiac safety of the drug. Ironically, now that the Nissen article has been published, many patients enrolled in the RECORD trial are apparently unwilling to continue (as reported in the New York Times on May 26), leaving completion of the trial in jeopardy.

To patients taking Avandia and their doctors, the imputations of conspiracy may be interesting, but not particularly helpful as they decide whether or not to continue the drug. DrRich himself finds these latest allegations troubling, but has not changed his original assessment of what patients ought to make of the potential risks with Avandia, while waiting for the scientists (and now, the politicians and journalists) to fight it out.