David Graham's latest black helicopter theory about the fact that an FDA advisory committee recommended keeping Avandia on the market (with additional warnings) with editorial comments from Steve Nissen:
Silver Spring, MD - Accusations of bias among the FDA advisory committee that voted on the fate of rosiglitazone (Avandia, GlaxoSmithKline) earlier this summer have been made by two members of the FDA's Office of Surveillance and Epidemiology [1].
In a letter to BMJ published online September 7, 2010, Drs David Graham and Kate Gelperin point out that half the members of the July 2010 advisory panel had previously voted in favor of allowing rosiglitazone to stay on the market at an earlier FDA advisory committee in 2007. They write: "In an unprecedented move, the FDA's Center for Drug Evaluation and Research (CDER), which originally approved rosiglitazone and has defended its continued marketing, invited not only the current members of these committees [the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee] but also all members from the 2007 meeting, even though they were no longer active members of either committee. Of the 32 advisers who voted at the 2010 meeting, 16 (50%) attended the 2007 meeting, and 15 of them had voted that rosiglitazone remain on the market (one attendee was a temporary nonvoting invitee)."
Graham and Gelperin say this biased the vote at the 2010 meeting. They calculate that members voting for the first time were 4.4 times more likely to vote that rosiglitazone be withdrawn from the market than were members who had voted previously to keep it on the market. "Had these former members not been included, the vote would have been 10 out of 17 (59%) in favor of rosiglitazone withdrawal, with an additional three in favor of severely restricted distribution," they add.
Panel "loaded"?
Commenting on this for heartwire, Dr Steve Nissen (Cleveland Clinic, OH), the coauthor of the meta-analysis at the center of the rosiglitazone safety concerns, who has been leading the campaign to get rosiglitazone withdrawn, said it was obvious that the 2010 panel was "loaded."
They have rigorously defended rosiglitazone again and again, and obviously they feel they cannot be seen to have made such an error.
He added: "The outcome of FDA advisory panels is significantly influenced by who is on the panel. When I saw the roster, I knew it was going to be an uphill struggle. I was very surprised that they had invited back people who had already voted to keep the drug on the market in 2007. Once you have opined publicly, it is very difficult to turn around and admit you made a mistake." Nissen said it would have been the leadership at the CDER that decided who to invite to this panel meeting, and this is another demonstration they do not want to act against this drug. "They should have acted much earlier on, when the first negative data were reported. But they have rigorously defended rosiglitazone again and again, and obviously they feel they cannot be seen to have made such an error."
Here are my questions:
Why does BMJ feel compelled to help Graham and Nissen peddle their fearmongering? And where is the opportunity to provide an opposing (and more balanced) view?
Why are the two launching an attack on FDA's integrity now? Does it have anything to do with yet another campaign to pressure the agency to overturn the Ad Comm decision?
Does Nissen actually believe that the composition of the Ad Comm is part of a CDER coverup? That is a very serious accusation. Did St. Steven the Pure wear a wire when talking to CDER officials?
www.theheart.org/article/1121701.do
Oh, and one more question: What about the recent observational study showing no difference in heart risks between Avandia and Actos. No comment or BMJ editorial yet from Nissen or Graham, a study that, uniike Graham's did not use data dredging to squeeze out an 18 percent additional risk of heart problems associated with Avandia compared to Actos..
circoutcomes.ahajournals.org/cgi/content/short/3/5/538
