Friday, June 01, 2007

Did NEJM and politically motivated whistleblowers conspire to upstage the FDA on Avandia?

The May 30 Heartwire report on fallout from the Avandia controversy (to which I linked earlier today) suggests so:

But new reports go one step further--suggesting that FDA whistleblowers coordinated with politicians critical of the agency and the study authors to get damaging data into the public arena before the FDA could issue a safety statement on rosiglitazone.

The Heartwire report is based on the Wall Street Journal editorial I linked here. That editorial was written by former FDA deputy commissioner Scott Gottlieb. In an earlier post I puzzled over NEJM’s decision for early open access release of the meta-analysis and related editorial. A timeline of events according to the Heartwire report, based on the WSJ editorial, suggests a reason for the decision: since the print release of the meta-analysis and editorial was not due until June 14 it was the only way to upstage the FDA safety evaluation, due out just two days later, May 23. The choice of Bruce Psaty and Curt Furberg to write the editorial would dovetail nicely with such a strategy, as these authors are well known critics of the FDA.

The question of the early open release nags. If not to discredit the FDA then why? According to the Heartwire report:

Gottlieb says the NEJM claims to have made the decision to publish quickly because of the medical importance of the research but, if that were the case, he wonders why it did not inform the FDA about its publication or the findings.

Indeed. Medically important research, maybe, but not a public health emergency. If the meta-analysis findings are to be believed the number needed to harm for rosiglitazone must be on the order of 1000, and that’s over months to years of treatment. If that’s the standard for early release it’s a new standard. Under such a standard virtually every paper in clinical epidemiology which shows a significant difference in event rates would merit early release.

No comments: