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Thursday, September 16, 2010

Alleged Bias on FDA Rosiglitazone Panel

The Food and Drug Administration committee that decided to keep rosiglitazone (Avandia) on the market this year has been accused of loading the panel with pro-rosiglitazone members. Rosiglitazone has been linked to increasing the risks of heart attack and death in thousands of cases.

Two members of the FDA's Office of Surveillance and Epidemiology first made the accusations at the beginning of September. They claim that half the members on the July 2010 panel previously voted in favor of keeping rosiglitazone on the market at a similar panel in 2007. They blame the FDA's Center for Drug Evaluation and Research (CDER) for inviting not only current members of the panel, but all members from the 2007 meeting, even though they were not active members of the current committee. This is a move labeled "unprecedented" by the accusers.

This brought the number of members on the 2010 panel up to 32; 16 of them attended the 2007 meeting, and 15 of the 16 voted then to keep rosiglitazone on the market. The accusers claim that members voting for the first time were 4.4 times more likely to vote that the defective drug be withdrawn from the market. One said that if the previous members from the 2007 panel were not invited to the 2010 panel, ten of 17 members would have voted to pull rosiglitazone from use.

Suspected Reasoning Behind Rosiglitazone Vote

The two accusers, as well as many other researchers and doctors believe the reason rosiglitazone is still available is because the leaders at CDER and the FDA made the mistake of allowing a harmful drug on the market and then didn't do anything about it when problems came to light as early as 2003.

There are also questions about the questioning at the 2010 panel. In 2007, the question of withdrawing rosiglitazone had a straight yes/no answer. In 2010, there were five different options for members to choose from giving many involved the impression that the people in power don't want the drug pulled from the market. Due to the several options, there is a gray area on whether the members actually voted for withdrawl or severe restriction. The sponsor of the panel says the members voted to keep it on the market, but detractors believe 22 of 32 actually voted to pull rosiglitazone from the market or severely restrict its use.

This may seem conspiratorial, but the FDA has previously come under suspicion for playing politics with science, as well as looking out for the interests of those who already work there. Since the July meeting nothing has been done to look into why so many rosiglitazone patients are having cardiac events.

If you or a loved one has been injured by rosiglitazone (Avandia), please contact the experienced defective drug attorneys at the Cochran Firm for an initial case evaluation. We serve clients nationwide.


posted by Benjamin A. Irwin at 8:13 AM

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