It’s like a Hollywood movie. There’s the poor boy and the poor girl who everyone knows belong together. Each can see the beauty in the other that somehow no one else in the movie can see. And by the end of the movie they hook up. A match made in heaven.

And, maybe, so is the collaboration announced today between the makers of prasugrel (Effient, Lilly and Daiichi Sankyo), and Accumetrics, the company that markets VerifyNow, a platelet function test. Both sides have had trouble finding love. Prasugrel, famously, had a hard time getting through the FDA and now has had a hard time gaining acceptance in the marketplace. Platelet function tests seem like a good idea but no one can agree when or if they should be used. (The recent ACC/AHA clinical alert concluded that “the evidence base is insufficient to recommend either routine genetic or platelet function testing at the present time. There is no information that routine testing improves outcome in large subgroups of patients.”
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Avandia critics have focused on the dearth of evidence suggesting any advantage for rosiglitazone when compared to pioglitazone. They argue that there is no good reason for anyone to take rosiglitazone instead of pioglitazone. This view receives some support from the systematic review of controlled epidemiologic studies of cardiovascular risk in patients treated with rosiglitazone or pioglitazone by Kate Gelperin, Esther Zhou and David J. Graham from the Office of Surveillance and Epidemiology. (See our previous posts here and here for additional coverage of the briefing material.)

Here are the authors’ conclusions and 3 key Forest plots (click to enlarge):
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The FDA has posted the briefing documents for next week’s rosiglitazone (Avandia) advisory panel meeting. CardioBrief will be updating this page periodically with information gleaned from the documents. (See bottom of page for links to individual documents.)
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Prior to publication of key papers on rosiglitazone (Avandia) and ezetimibe (Vytorin) in the New England Journal of Medicine, the editors of the journal were not aware that trial sponsors had “manipulated” the Data and Safety Monitoring Boards (DSMBs) of the trials, according to information contained in an editorial in NEJM by its editor, Jeffrey Drazen, and Alastair JJ Wood.

In response to the incidents , Drazen and Wood ”propose fundamental changes in the way DSMBs are constituted, are funded, and report,” and say that DSMBs “should be chosen and convened under the aegis of an independent public body.”

The editorialists write that the problem represented by these two episodes “puts the integrity of the whole clinical-trial enterprise at risk.”
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