Legal Information and Resources

Further to my June 24 blog and as reported in the The Boston Globe, Harvard Medical School has joined the ranks of medical educational facilities that have enacted new, tough conflict-of –interest rules affecting the payment of educators and others by Big Pharma and Medical Device manufacturers. (more…)

The good news keeps coming for Glaxo, the pharma giant that makes the diabetes drug Avandia. Yesterday the FDA ordered Glaxo to stop patient enrollment in a study that compared Avandia to a competing drug Actos, and to warn all patients already enrolled that Avandia may increase the risk of heart attacks.

Dr. Steven Nissen, whose 2007 study sounded the alarm about Avandia, was quoted in the New York Times today as saying he believed that the Panel’s findings about Avandia would eventually lead to suspension and abandonment of the study altogether. Nissen noted: “There was really no other action they [FDA] could take. Now the challenge is, if that trial is unethical, how can Avandia stay on the market?”

Stay tuned.
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As a follow-up to my blog post of July 16, 1010, the Wall Street Journal today reports that an FDA panelist who voted to leave Glaxo’s diabetes drug Avandia on the US market with no additional restrictions received—wait for it folks—money from the drug maker for being a member of its “speakers bureau.” Philadelphia based endocrinologist David Capuzzi, M.D. told the WSJ that since he never gave talks “promoting” Avandia, he didn’t see any conflict of interest. Dr. Capuzzi was only one of three members of the 33 member panel who voted to leave Avandia on the market without further restrictions. (more…)

After 2 days of intensive hearings, the FDA Advisory Panel charged with oversight of the Glaxo-SmithKline diabetes drug Avandia (Rosiglitazone) recommend to FDA that the drug be either withdrawn or otherwise its use should be severely restricted. The ruling came as a result of analyses done of GSK studies and others which show that users of Avandia suffer a clearly increased risk of heart attack when using the drug. Some panel members also questioned the truthfulness of GSK in light of the questions raised by internal company documents that revealed Glaxo’s efforts to hide critical safety data. (more…)