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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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But the FDA defended its decision to review the Duke re-analysis of the original trial.

"Given the public interest in Avandia, the extensive history of the product and the continued uncertainty of risk, the FDA is holding the advisory committee meeting to have a transparent, public discussion of the results of the RECORD readjudication," FDA spokesperson Morgan Liscinsky said.

Avandia quickly became a blockbuster diabetes drug following its release in 1999, with sales topping $3 billion in 2006.

But in 2007, Nissen published a study showing that Avandia raised the risk of heart attack by more than 40 percent. The outcry that followed led to Senate hearings in which the FDA's drug approval process came under intense scrutiny.

An FDA analysis of more than 50 studies of Avandia found that the drug was linked to an increased risk of heart problems. One study tied Avandia use to more than 47,000 cases of heart attack, stroke or heart failure during a 10-year period, even though the company-funded RECORD trial had not found an increased risk of cardiovascular trouble.

The FDA ended up pulling Avandia from pharmacy shelves in November of 2011, placing severe restrictions on the drug that limited its use to extremely ill diabetics. Patients wanting to take the medication now must enroll in a special program to qualify for its use.

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]."

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