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Panelist Who Backed Avandia Gets Fees From Glaxo

The drug companies just keep doing it — buying positive reviews and reports. The latest evidence of that is detailed in a Wall Street Journal article about GlaxoSmithKline and it’s diabetes drug Avandia. Here are excerpts:

One of the panelists who voted in favor of the diabetes drug Avandia at a Food and Drug Administration advisory meeting last week is a paid speaker for the drug’s maker, GlaxoSmithKline PLC, according to the company and its records.

The panel voted 20-12 to keep Avandia on the market, though most of the members wanted stronger warnings.

Endocrinologist David Capuzzi of Philadelphia confirmed that he has been on Glaxo’s speakers bureau for several years and said he doesn’t see the relationship as a conflict.

“I have not given any talks [to doctors’ groups] promoting Avandia,” he said in an interview. He said he spoke on behalf of another Glaxo drug called Lovaza, which can help lower triglycerides in the bloodstream that often lead to heart attacks.

Avandia, approved in 1999 as a medicine to lower blood sugar in diabetics, has been under fire because of a series of studies linking it to an increased risk of heart attacks. The two-day FDA meeting last week was closely watched by Wall Street and the industry because of its implications both for Glaxo and the agency’s stance on broader drug-safety issues.

Though the panel voted to keep Avandia on the market, 17 of the panelists in favor wanted either tighter prescribing restrictions or more warnings about cardiovascular risks. Dr. Capuzzi defended the drug during the meeting. He was one of only three experts who wanted 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 Glaxo spokesman said Dr. Capuzzi also received about $8,000 in speaking fees from the company before that period and an additional $3,000 in the second quarter of this year, making the total payments about $14,750. The company has said Avandia is safe and should stay on the market.

“In the middle of a firestorm over a drug, all connections to the company involved should be disclosed,” said medical ethicist Arthur Caplan of the University of Pennsylvania. Otherwise experts leave themselves “open to post-facto criticism and second-guessing,” he said.

One of the panelists who voted to keep Avandia on the market, cardiologist Arthur Moss of the University of Rochester Medical Center in New York, said he wished the FDA disclosed that Dr. Capuzzi spoke for Glaxo. “I’m surprised we weren’t told,” Dr. Moss said.

Bob Kraft

I am a Dallas, Texas lawyer who has had the privilege of helping thousands of clients since 1971 in the areas of Personal Injury law and Social Security Disability.

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