Avandia again: Nissen and JAMA editors spin RECORD round and round

Avandia is back in the news. After a month of relative silence, following the New York Times disclosure of FDA and Senate reports critical of rosiglitazone, the subsequent release of the Senate report, and the revelation that Steve Nissen had secretly recorded a meeting with GSK executives (though the significance of this last event is unclear), a new JAMA commentary by Steve Nissen and an accompanying editorial by JAMA’s editors will surely add new fuel to the Avandia bonfire.

In his Commentary, “Setting the RECORD Straight,” Nissen provides an unusually detailed personal perspective on his role in the controversy, beginning with the publication of the famous Nissen and Wolski meta-analysis that initiated the whole affair. The piece doesn’t include any major new revelations, but Nissen dissects the RECORD trial and exposes the numerous flaws and inconsistencies in its conduct and reporting.

Nissen concludes by observing that “absence of independent access to all of the data in the trial may allow physician-scientists to be manipulated by the sponsor, resulting in a manuscript that does not provide the most accurate assessment of the risks and benefits of the therapy.”

In their accompanying editorial, Katherine DeAngelis and Phil Fontanarosa start with Nissen’s idea and go quite a bit further. Similar to the “experience with clinical trial registration,” they propose that medical journals adopt “a unified approach to requirements for complete data access and independent statistical analysis in industry-sponsored studies.”

They conclude:

it is now time for all editors to require that academic researchers have full access to all trial data and that all industry-sponsored trials include independent statistical analysis and assurance. This approach would add powerful support to the fundamental principle that physicians must first do no harm.

Click here for previous CardioBrief coverage of the Avandia controversy.

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