Avandia May Be Removed From Market
Many Georgians have taken the drug Avandia which was heavily promoted as a treatment option for diabetes by its manufacturer, GlaxoSmithKline. Yesterday, a federal medical advisory panel recommended that Avandia should either be withdrawn from the market or have sales severely restricted because it increases the risks of heart attacks.
First approved for sale in 1999, Avandia helps control blood sugar in diabetics by making patients more sensitive to their own insulin. It is one of a class of three drugs, the first of which, Rezulin, was withdrawn because it caused liver damage. The other drug in the class, Actos, made by Takeda, has appeared safe.
Avandia was once the biggest-selling diabetes medicine in the world. However, sales declined in 2007 after a study by Dr. Steven Nissen of the highly regarded Cleveland Clinic found that it increased the risk of heart attacks. An advisory committee in 2007 decided that Avandia did increase heart risks but voted to keep it on the market.
The panel voted to take this action after two days of intensive scientific hearings during which GlaxoSmithKline insisted that Avandia is safe and necessary for the treatment of diabetes.
The scientific panel members expressed concerns about the trustworthiness of GlaxoSmithKline after questions were raised about its clinical trials. Internal company documents showed that the company for years kept crucial safety information about Avandia from the public.
The panel consisted of 33 members. Twelve voted that Avandia should be withdrawn from the market; ten voted that its sales should be restricted and the warnings on its label enhanced; seven voted only to support enhanced warnings on the drug’s label; and three voted that the drug should continue to be sold with its present warnings unchanged. One member abstained, and no one voted for a final option, to weaken the label’s present heart warnings.
The Food and Drug Administration will have the final decision regarding the future of Avandia sales, as the panel serves in only an advisory role. The F.D.A. often takes the advice of its advisory panels, but experts say they cannot predict its action in this case due to the split nature of the vote.
Many of the same experts who decided to keep the drug on the market in 2007 voted Wednesday that it should be withdrawn or restricted. Those restrictions could mean that patients would have to apply for special permission to use the drug.
Dr. Nissen of the Cleveland Clinic commented that the committee’s vote was the best he could hope for. “Effectively, this drug is gone,” he said.
GlaxoSmithKline said it was in the midst of a clinical trial that would test definitively if Avandia caused heart attacks. Several panel members said the trial came too late.
In the 1990s, GlaxoSmithKline decided against just such a study because it feared that the results might hurt sales, according to recently revealed internal company documents.
