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Public Citizen Wants Avandia Study Halted

Public Health Advocate Wants Avandia Study Halted

From Associated Press (April 28, 2010)

WASHINGTON -- A leading public health advocate pressed his case Wednesday to halt a trial of GlaxoSmithKline’s diabetes drug Avandia, telling a House subcommittee the pill needlessly increases patients’ heart attack risk.

Public Citizen’s Dr. Sidney Wolfe told House lawmakers the Food and Drug Administration should stop a study comparing patients taking Avandia with those on a similar diabetes drug called Actos.

The 16,000-patient study of Avandia is designed to give a definitive picture of heart risks associated with it; they’re not fully understood even though the drug has been on the market since 1999.

Wolfe argued that evidence already shows Avandia is a riskier drug than its main competitor.

"Thousands of high-risk patients with diabetes are being needlessly exposed to a drug with an unfavorable safety profile and no clinical advantage," Wolfe told a House appropriations subcommittee that oversees FDA funding.

Subcommittee Chairwoman Rosa DeLauro, D-Conn., called the hearing to discuss a Senate report that raises new questions about what Glaxo and the FDA knew -- and when -- about Avandia’s risks. The report, issued in February, criticized FDA for overruling two safety specialists who recommended pulling it from the market.

Wolfe reiterated that the FDA should pull Avandia off the market -- a position Public Citizen has advocated since 2008.

FDA Commissioner Margaret Hamburg said in a letter last month that FDA backed the Avandia-Actos study because "it represents the most rigorous approach to evaluating the comparative safety of the two drugs."

The agency plans a July hearing to examine the latest data on Avandia’s safety and air internal disagreement among its scientists over what should be done.

The results of the Avandia safety study aren’t expected until 2015, 16 years after FDA approved it.

"We should not take so long to study a drug about which such serious safety issues have been raised," DeLauro said in her opening remarks.

Avandia has been under public scrutiny since May 2007, when a medical journal article suggested it could increase the risk of heart attack 43 percent compared with other diabetes drugs. The FDA now requires that the drug carry a warning label about those risks.

Avandia was London-based Glaxo’s third best-selling drug in 2006 with revenue of $2.2 billion. The safety concerns disclosed the following year slashed revenue to $1.2 billion by 2008.

In 2007, an FDA panel of outside experts voted 22-1 to keep Avandia on the market.


Posted: April 2010