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Questions Over Avandia Disclosures Prompt FDA Probe

Aug 13, 2010 | Parker Waichman LLP

Avandia may be about to cause more trouble for GlaxoSmithKline. According to a report in TIME Magazine, the US Food & Drug Administration (FDA) is trying to determine if Glaxo broke the law when it didn’t disclose data on the controversial diabetes drug’s heart risks.

Since November 2007, Avandia’s label has included a black box warning – the FDA’s strongest safety alert – detailing its association with myocardial ischemia. The black box was added after the Cleveland Clinic published a meta- analysis of 42 clinical trails that showed patients taking Avandia had a 43-percent higher risk of having a heart attack. Since the addition of the black box, evidence linking Avandia to an increased risk of heart attacks has continued to accumulate.

Earlier this summer, an FDA advisory panel voted 20-12 to recommend that Avandia be allowed to stay on the market. However, 10 panel members voted that its sales should be restricted and that warnings on its label regarding heart risks be strengthened.

According to the TIME Magazine report, prior to its approval, Glaxo defended Avandia to the FDA, even as a debate over its heart risks raged within the company. After the drug came on the market in 1999, two analysis produced by Glaxo in 2005 and 2006 found an 29 percent and 31 percent increase in heart side effects among patients taking the drug. The company did not provided the FDA with the results of those analysis until May 2006. The agency did not make them public.

The TIME report goes on:

“It was seven years after the drug was approved, and the dangers of Avandia had still not been made sufficiently clear to the public. The FDA was sitting on the new analyses, and GSK (Glaxo), the FDA discovered during an investigation by its inspections unit in the fall of 2007, had failed to report clinical data and other material from 15 tests of Avandia by the end of 2006, according to a March 25, 2008, warning letter to the company. With the company and the FDA maintaining tight control over the full database of information on Avandia’s effectiveness and safety, there was little independent scientists could do to assuage their growing concerns about the drug.”

Deputy FDA commissioner Dr. Joshua Sharfstein told TIME that the agency is trying to if Glaxo’s failure to fully inform the agency of Avandia’s heart risks broke the law.

However, the report doesn’t hold the FDA blameless in the Avandia debacle. After all, it withheld the 2005 and 2006 Glaxo Avandia studies from the public. The TIME report suggests that the FDA is too cozy with the industry it regulates, something that allowed Glaxo “to perpetuate the uncertainty about (Avandia’s) safety rather than clarify it.”


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