(2010-02-23) Avandia Drug Safety Study Games

Dr. Steven Nissen recently shared the tape he secretly made of a meeting between he and Glaxo Smith Kline (PharmCo) executives in 2007 about their Avandia diabetes drug. During the meeting with Dr Nissen, the four executives spoke as if they did not know the results of Dr. Nissen’s still-unpublished study. And Dr. Nissen did not mention that he had already sent it to the journal, the recording shows. But a week before the meeting, the Congressional investigators said, Glaxo Smith Kline had been secretly and inappropriately faxed a copy of Dr. Nissen’s manuscript by a journal reviewer who also worked as a consultant to Glaxo Smith Kline.

Jul10 update: A lengthy memo by Thomas Marciniak, a medical team leader in the Division of Cardiovascular and Renal Products, is part of a 765-page briefing document prepared by FDA scientists in advance of next week's advisory committee meeting on Avandia's fate... Next Tuesday and Wednesday's advisory committee meeting will be the second in three years to review Avandia's risk/benefit profile... In February of this year, an investigation by the Senate Finance Committee concluded that maker Glaxo Smith Kline, or GSK, knew of possible Avandia heart risks for several years before publication of Nissen's study... To definitively answer whether Avandia increases cardiovascular risk, the FDA asked GSK to conduct the TIDE trial. The trial, which aims to study 16,000 patients in countries around the world, began enrolling participants in May. It is designed to compare the risk of heart attacks, stroke and cardiovascular death in diabetes patients randomly assigned to take either Avandia or Actos... (David Graham) called the TIDE trial unethical because "it's treating humans as if they are laboratory rats. Why on Earth would anyone want to be randomized to Avandia in a clinical trial the purpose of which is to prove with absolute certainty that Avandia increases risk?"... Graham and colleague Kate Gelperin?s critique of both the TIDE and RECORD trials is among the briefing documents for the advisory committee.

Jul15: In* a surprising turn of events, an expert panel convened by the Food and Drug Administration voted yesterday to keep the diabetes drug Avandia on the market... Only 12 of the 33 members voted to withdraw Avandia, while an additional 10 voted to allow the drug to be prescribed only with severe limitations such as requiring physicians and patients to be educated about its risks. The panel, like the FDA itself, was largely divided over what to make of Avandia's potential health risks. (FDA commissioner Margaret Hamburg will ultimately decide Avandia's fate.)*

Aug19: James Dougherty gives a history of the confusing data and framing of the studies/questions.