Issues Include Publishing Of May 2007 NEJM Article And Whether To Keep Diabetic Patients On Avandia
(Posted by Tom Lamb at DrugInjuryWatch.com)
A lively discussion during a session about Avandia was the highlight of the American Diabetes Association's annual meeting in Chicago on June 25, 2007 according to news reports. During a panel discussion of this session -- which was added at the last minute in order to address Dr. Steven Nissen's "meta-analysis" of Avandia data that was published in May 2007 by The New England Journal of Medicine -- some of the 13,000 doctors and researchers in attendance heard Dr. Nissen defend his controversial Avandia study while other prominent doctors took issue with it.
According to a June 25, 2007 report from CNNMoney.com:
... Dr. Philip Home, a professor of diabetes at Newcastle University in the United Kingdom and a member of the steering committee for one of the Avandia studies included in Nissen's analysis, criticized the way Nissen conducted his analysis.
"I think this is data snooping on quite a big scale," said Dr. Home, attacking Dr. Nissen for seeking out data points in pre-existing studies rather than launching a separate study to test a hypothesis. Dr. Home also said he found conflicting results in a study conducted by Dr. Nissen's own Cleveland Clinic.
Also reporting on this Avandia session at the 2007 American Diabetes Association meeting was a June 25, 2007 article from Reuters, which included the viewpoint of Dr. John Buse, the president-elect of this diabetes group, as well as some additional comments by Dr. Home:
Nissen's analysis of the drug, known generically as rosiglitazone, sparked debate because it is based on the pooled data of 42 trials involving nearly 28,000 patients.
"If you take a study not designed to look at heart attacks, can you make a conclusion?" said John Buse, chief of endocrinology at the University of Chapel Hill, North Carolina....
The Nissen study "doesn't answer a question, it asks a question," said Home, who supported the release of Nissen's analysis but criticized the New England Journal of Medicine for not including more context and rebuttal when it was published.
Finally, a Dow Jones June 25 article by reporter Jennifer Corbett Dooren included discussion on the issue of whether Avandia should still be used by diabetic patients:
Dr. John Buse... said if a patient's blood sugar is currently being controlled well using Avandia, then he would not recommend stopping the medication....
He said doctors should be looking toward an FDA panel of outside medical experts for the next set of data involving Avandia or at least a reanalysis by the FDA of the existing studies and possibly some advice on using Avandia. That panel is set to meet July 30.
Buse and other doctors - including Barry Goldstein, the director of endocrinology, diabetes and metabolic diseases division at Jefferson Medical College in Philadelphia - however, said they wouldn't start a new patient on Avandia until more is known about the drug.
This June 25 Dow Jones article also reported that Dr. Nissen "doesn't think Avandia needs to be pulled from the U.S. market...."
No doubt, all interested parties are anxiously awaiting the July 30, 2007 meeting of an FDA advisory panel which will explore the issue of whether Avandia causes heart attacks and strokes.
P.S. For more insight on what happened at this June 25 Avandia session, see "Avandia Fights: Drs. Nissen And Home 'Battle' Over Drug" over at Pharmas Market with Mike Huckman. (6/26/07)
P.S. At the U.S. Medicine site, Stephen Spotswood posted an article on June 26, 2007 that does a nice job of re-capping the House Oversight and Government Reform Committee hearing in early June 2007 which examined whether Avandia raises the risk of heart attacks while it lowers blood sugar. Dr. Nissen and Dr. Buse testified at this Congressional hearing.
Mr. Spotwood's article, "Congress Debates Avandia's Safety, Researchers' Motives and FDA Role", concludes with this report:
Rep. Diane Watson, (D., Calif.), who suffers from type 2 diabetes ended up making one of the most jolting statements of the hearing.
"Two years after I developed [type 2 diabetes] I developed a heart problem," Rep. Watson explained. "I went to my cardiologist and he said, 'What are you taking?' I said, 'Avandia.' And he said, 'Get off it. There are other options out there.'"
(6/29/07)