Policy/Biz

FDA Panel Votes to Loosen Restrictions on Controversial Diabetes Drug Avandia

FDA Panel Votes to Loosen Restrictions on Controversial Diabetes Drug Avandia
The FDA and a panel of health experts voted to loosen restrictions on the controversial diabetes drug based on a study by the drug's maker GlaxoSmithKline. Wikimedia Commons (Benjism89)

After two days of discussions, the Food and Drug Administration (FDA) and a panel of health experts voted to relax restrictions on the use of the GlaxoSmithKline diabetes drug, Avandia.

The group of health experts had to decide whether the controversial drug, which is supposed to help cells become more responsive to insulin, should be used with less restrictions after a 2007 analysis of other studies, by Dr. Steven Nissen of the Cleveland Clinic, found that Avandia raised the risk of heart attack by 43 percent. His report became the subject of controversy as experts tried to weigh the benefits against the risks. Since diabetics are already predisposed to heart attacks, it wasn't clear if Avandia was the cause. Since then, the drug has been restricted heavily, used in the US only on those patients who didn't respond to other treatments first, while in Europe it was taken off the market, according to NBC News.

Of the panel that voted earlier today, 13 members favored modification of the restrictions on Avandia, while seven others voted to remove the restrictions altogether. Five members voted to keep current safeguards in place and one voted to withdraw the drug from the market altogether, Reuters reported.

The members based their decisions on a study conducted by researchers at Duke University, and funded by GlaxoSmithKline, which was called RECORD. It followed 4,400 patients and tracked rates of heart attack, hospitalization, and death for six years. They concluded that Avandia is as safe as any other diabetes drug.

In a memo posted on Monday, three senior FDA drug officials wrote about its safety, USA Today reported.

"After re-adjudication, we do not find a cardiovascular signal of concern in RECORD. The mortality data are, in fact, reassuring."

Panel member Rebecca Killion, representing Bowie, Md., also argued for keeping the drug available.

"What we fear overpowers what we know," she told NBC. "One of the things that we can't know is the harm to patients that might not have access to a therapy that is best suited to them."

Avandia is controversial not only for Dr. Nissen's study, but also because GlaxoSmithKline financed and provided all of the documentation to the Duke researchers for the study that the FDA and panelists based this vote on, according to The New York Times.

Dr. Nissen was denied time for a formal presentation on the risks of Avandia.

"I don't see how patients could possibly benefit from lifting these regulatory restrictions," he said.

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