A federal medical advisory panel recommended last month that the diabetes drug, Avandia, should either be withdrawn from the market or have sales severely restricted because it increases the risk of heart attacks. The panel listened to two days of intensive scientific discussions before its members took a vote. GlaxoSmithKline, which makes Avandia, claims that the drug is a safe and a needed option in treating diabetes. But there have been serious safety concerns by a tremendous number of medical professionals.
Panel members voiced great skepticism about the company’s trustworthiness after questions were raised about its clinical trials. Internal company documents reveal that GlaxoSmithKline kept crucial safety information about Avandia from the public for years. On the critical vote, which was on what the FDA should do, ten members voted that the drug’s sales should be restricted and the warnings on its label enhanced. Twelve voted that Avandia should be withdrawn, but seven voted only to support enhanced warnings on the drug’s label.
Approved in 1999, Avandia helps control blood sugar levels 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 It is one of a class of three drugs, the first of which, Rezulin, was withdrawn because it caused liver damage.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 relatively safe. The sales of Avandia, which was once the biggest-selling diabetes medicine in the world, abruptly declined in 2007. That came after a study by Dr. Steven Nissen, a noted Cleveland Clinic cardiologist, found that Avandia 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.
Many of the same experts who decided to keep the drug on the market in 2007 voted that it should be withdrawn or restricted. Those restrictions could mean that patients would have to apply for special permission to use the drug. Reactions to the panel’s vote have been as mixed as the vote itself. The FDA generally undertakes programs to restrict a drug’s sales only when a drug offers a unique benefit, something not one study has shown about Avandia. A majority of the committee found that Avandia increased the risk of heart attacks, but a majority also said that studies had failed to prove it increased the risk of death.
A majority decided that if Avandia were to continue to be sold, the company should complete a clinical trial to prove it was safe. But several members said that the vote probably made a trial impossible because patients would not want to risk taking Avandia. You might now wonder how in the world the committee, which should put a drug’s safety at the top of its priority list, could have come up with so many different conclusions. If so, I share your concern.
It’s quite obvious that the manufacturer of Avandia has not been honest with the FDA. Marketing seems to have been the driving force when critical decisions were made by the company. It was said during the panel’s hearings that studies were not completed because the company feared that the results might hurt sales. This information came from internal company documents.
Sources: New York Times and USA Today
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