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FDA Panel Votes to Change Restrictions on Avandia

Controversial decision comes after a second look at major data review focused on heart risks
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Critics called this week's meetings a waste of taxpayer dollars, arguing that so many concerns have been raised about Avandia's safety that a green light now from the FDA would be meaningless.

"It's not an issue of any importance to the medical community," Nissen said. "It's all about the FDA. If the FDA is allowed to whitewash the Avandia affair, it makes it less likely the right thing will be done when issues like this come up in the future," he added.

"Unfortunately, the public is caught in the crossfire," he continued. "The last thing we want to do is promote the use of an agent that is not helpful and is almost certainly harmful in the majority of the people who take it."

Nissen and other critics noted that the Duke review was funded by GlaxoSmithKline and have questioned the independence of the follow-up research.

A panel of FDA officials had vouched for the Duke report, however, and argue that its findings deserve scrutiny in a public forum.

"The FDA strongly believes that regulatory decisions should be based on strong scientific evidence. If such evidence becomes available to revisit previous regulatory decisions, it is important for the FDA to consider this evidence in a transparent process," Liscinsky said. "The FDA is critically evaluating the RECORD readjudication. Once the advisory committee meeting has been held and review is complete, the FDA will determine if the results of the readjudication in the context of all the pertinent available data affect the agency's assessment of the risk-benefit information for rosiglitazone [Avandia]."

Dr. George King, director of research for the Joslin Diabetes Center and a professor of medicine at Harvard Medical School, said Avandia use needs to be restricted but has no problem with the FDA taking a look at the new evidence.

"A reanalysis is always good," King said. "Why spend all that money to do the study if you're not going to consider the data, right?"

King noted that Avandia and other drugs in its class, called thiazolidinediones, occupy a unique place in diabetes treatment. They decrease insulin resistance in the body by binding to receptors in fat cells and making those cells more responsive to insulin.

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