Editorial: More Questions About Avandia

Editorial: More Questions About Avandia
Copyright by The New York Times
Published: July 4, 2010
http://www.nytimes.com/2010/07/05/opinion/05mon2.html?th&emc=th


The safety of the diabetes drug Avandia looked increasingly suspect late last month after two major studies found that it raises the risk of cardiovascular ailments. Then a third study seemed to exonerate Avandia, sowing more confusion. Expert advisers to the Food and Drug Administration will soon deliver a more definitive judgment, but at this point patients should probably be asking their doctors about alternatives.

Avandia was approved in 1999 to help diabetics control their blood sugar levels. For the past three years a debate has raged over whether it increases the risk of cardiovascular problems. The evidence has been mixed, and the F.D.A. has left it on the market while beefing up the warning labels.

Now a study in the Journal of the American Medical Association has found that elderly patients given the drug had higher risks of stroke, heart failure and death than those given Actos, another drug in the same class. This study warrants particular attention because of its huge size: it analyzed records for more than 227,000 Medicare patients who took either Avandia or Actos. A second study — in the Archives of Internal Medicine, also published by the A.M.A. — found that Avandia increased the risk of heart attack by 28 to 39 percent.

Meanwhile, a third analysis unveiled at the annual scientific sessions of the American Diabetes Association suggested that Avandia might, in fact, lower some cardiovascular risks. It is hard to know how much weight to give this new analysis because it has not yet been published in a peer-reviewed journal.

GlaxoSmithKline, the maker of Avandia, insists that several studies published in recent years show that Avandia does not increase the risk of heart attack, stroke or death. The F.D.A. will need to probe hard.

The F.D.A. has compelled Glaxo to sponsor a large randomized clinical trial, the gold standard, that will test the cardiovascular effects of both Avandia and Actos. It won’t be completed until 2015, and some critics believe it should be abandoned as too risky for the Avandia-takers.

The long struggle over Avandia has also raised serious questions over the degree of certainty that should be required before the F.D.A. removes a drug from the market as too risky. And it has raised the issue of which officials should have the power to make that decision — those who approved the drug as safe and effective in the first place and might be reluctant to reverse themselves or safety specialists focused solely on risks that emerge after the drug is in use. We side with the safety experts.