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Glaxo Under Fire for Avandia Memo

Aug 20, 2010 | Parker Waichman LLP

The New York Times is reporting that the credibility of an Avandia memo from GlaxoSmithKline detailing last month’s advisory panel meeting on the controversial diabetes drug is being attacked. A federal official and some members of that same advisory panel have criticized the memo as being misleading, and claim it could even put patients at risk.

As we’ve reported previously, that 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.

Since November 2007, Avandia’s label has included a black box warning – the Food & Drug Administration’s (FDA) 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.

According to the Times, Glaxo sent the memo, dated July 29, at the behest of the FDA. It discussed the TIDE trial, an Avandia study funded by the drug maker. After the advisory panel meeting, the FDA ordered Glaxo to stop enrolling patients in TIDE to give the agency time to study new evidence of Avandia’s risks. Glaxo was also ordered to update physicians and ethics oversight boards involved in the trial regarding all new safety information about the drug, thus the July 29 memo.

TIDE compared the safety of Avandia to another drug, Actos, which has not been associated with as many safety concerns as Glaxo’s drug. As we’ve reported previously, scientists inside and outside the FDA have opposed TIDE, saying it is unethical to compare Avandia, with its known cardiac risks, with a seemingly safer alternative.

According to The New York Times, none of the arguments presented at last month’s advisory panel meeting were included in the memo. Dr. David Graham, an FDA medical who argued against the study during that meeting told the Times that Glaxo’s memo is “biased, misleading and not truthful.”

Several members of the advisory committee also complained that the company’s letter was biased, the Times said.

Dr. Steven Nissen, a Cleveland Clinic cardiologist who made a presentation before the committee arguing for Avandia’s withdrawal, said that GlaxoSmithKline’s letter failed to mention that the committee concluded that Avandia carries a higher risk of heart attack than Actos.

“Since the TIDE trial compares these two alternative therapies, this omission does not meet any reasonable ethical standards,” Dr. Nissen told the Times.

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