What's up with Avandia?
Published: Tuesday, July 2, 2013 at 6:01 a.m.
Last Modified: Monday, July 1, 2013 at 2:29 p.m.
Q: I have type 2 diabetes, and three years ago I stopped taking Avandia because the Food and Drug Administration labeled it a heart-attack risk. Now it's OK'd by an FDA panel. Is it safe?
— Jolene P., Atlanta
A: After the drug rosiglitazone (Avandia) was approved for sale in the U.S. in 1999 there were questions about its safety. So the manufacturer asked Duke researchers to conduct the RECORD study. Unfortunately, it turned out that results of this study, made public in 2009, seemed to have been altered or misreported, so that the medication appeared safer than it was. Lawsuits followed. The FDA then had the pharma company arrange with Duke Clinical Research Institute to re-examine that data.
But in the meantime, back in 2007, our esteemed colleague Dr. Steve Nissen, chair of cardiovascular medicine at the Cleveland Clinic, published a study in the New England Journal of Medicine that raised an alarm. Using the pharma company's own data, he found that Avandia raised the risk of death from heart attack by 43 percent. And a Senate committee found internal pharma company emails back to 2000 that were downplaying the drug's risks. Because of the public outcry, in 2010 the FDA decided that only specific doctors could prescribe Avandia. In 2012, the pharma company agreed to pay a $3 billion settlement for not providing the FDA with safety data and improperly marketing the drug. The medication that once had been prescribed to 117,000 people a year, now is only used by 3,400 Americans and banned completely in Europe.
Now back to the Duke re-evaluation of the RECORD study: That's what's making all the news now. On June 6, 20 of 26 panelists on the FDA advisory committee, after getting the results of the new Duke review of the same old study, recommended removing or modifying restrictions on Avandia.
As Dr. Nissen pointed out after this announcement, the idea of reanalyzing an old trial is ridiculous. And it's highly unlikely that this new review will convince doctors that they can prescribe rosiglitazone safely to most patients. Currently there are safer and more effective treatments.
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