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FDA Advisor Who Voted in Favor of Avandia Had Ties to Glaxo

Jul 20, 2010 | Parker Waichman LLP One of the members of a government advisory panel who voted to back Avandia last week was on GlaxoSmithKline’s payroll. According to The Wall Street Journal, Endocrinologist David Capuzzi of Philadelphia is a paid speaker for the drug maker.

A Food & Drug Administration (FDA) advisory panel took up Avandia last week. Since 2007, Avandia has borne a black box label – the FDA’s most urgent safety warning – regarding its heart attack risks. An FDA advisory panel met last week to consider further restrictions on the controversial diabetes drug.

According to an earlier report in The New York Times, 12 of the panel’s 33 members voted that Avandia should be withdrawn; 10 voted that its sales should be restricted and the warnings on its label enhanced; 7 voted only to support enhanced warnings on the drug’s label; and 3 voted that the drug should continue to be sold with its present warnings unchanged.

The FDA is not required to follow the recommendations of such panels, but does so in most cases. However, the lack of unity among panel members in the case of Avandia makes it hard to predict what the agency will do, The Times said.

According to The Wall Street Journal, Dr. Capuzzi defended Avandia during the two-day meeting, and was among the three members who voted to allow the drug to stay on the market with no additional warnings or restrictions.

Glaxo’s website shows that he received $3,750 from the company as a speaker between April 2009 and March 2010. A spokesperson for the company also told the Journal that he was paid $8,000 in speaking fees from the company before that period and an additional $3,000 in the second quarter of this year. No one else on the panel received any money from Glaxo during that same time frame.

According to the Journal, Dr. Capuzzi has confirmed his relationship with Avandia’s maker. While he said he has given talks on another Glaxo drug called Lovaza, Dr. Capuzzi said he has never spoken on Avandia.

Dr. Capuzzi also said he told the FDA about his payments from Glaxo. But apparently, this was not made known to other members of the advisory panel. One panel member, Cardiologist Arthur Moss of the University of Rochester Medical Center in New York, told the Journal he would have liked to have known about it, and was “surprised” the panel wasn’t told. Dr. Moss also voted with Dr. Capuzzi to allow Avandia to stay on the market without further warnings or restrictions.

According to the Journal, the FDA is looking into whether there was disclosure to the agency and, if so, why it wasn’t conveyed to the committee.

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