More Avandia action: Nissen secretly recorded GSK execs, FDA announces safety review

In 2007 Steve Nissen secretly recorded a meeting with 4 GlaxoSmithKline executives, according to a story by Gardiner Harris in the New York Times. Harris reports that Nissen recently “shared the contents of the recording with The Times.”

The new disclosure follows the avalanche of events precipitated by an earlier Harris story published last Friday night in which he disclosed previously unpublished reports by FDA officials and a US Senate committee that were highly critical of Avandia and its continued availability. The Senate Finance committee then released the report on Saturday.

The 2007 recording contains no substantial new information, though it does provide strong circumstantial evidence that the GSK executives were aware of the interim results of the RECORD trial, although the paper had not yet been published and the company should not at that time have had access to the results from the independent investigators.

The 2007 meeting took place immediately prior to the publication of the Nissen meta-analysis in the New England Journal of Medicine that would ignite the rosiglitzaone (Avandia) controversy. Like the RECORD analysis, the Nissen paper was confidential and the company should not have had access to the manuscript, though it is now known that a reviewer had leaked the paper to the company.

Harris explains why Nissen recorded the meeting: “Fearing he would face pressure and criticism from executives, Dr. Nissen secretly recorded the meeting — which is legal in Ohio as long as one party to the conversation is aware of the taping.”

Also on Monday afternoon, the FDA announced an ongoing review of the cardiovascular safety of Avandia, and published a safety announcement based on the RECORD trial as well as additional information for patients and healthcare professionals.

GlaxoSmithKline published “an end-of-day update” on the controversy, but we’re guessing that after the new Times story appeared their day was only getting started.

Trackbacks

  1. […] necessarily helping their case with their extreme tactics either. Monday’s Times story about Steve Nissen’s secret recording of a meeting with GSK executives is a case in point. As pointed out by Paul Raeburn, the veteran journalist who covers medical […]

  2. […] critical of rosiglitazone, the subsequent release of the Senate report, and the revelation that Steve Nissen had secretly recorded a meeting with GSK executives (though the significance of this last event is unclear), a new JAMA commentary by Steve Nissen and […]

  3. […] More Avandia action: Nissen secretly recorded GSK execs, FDA announces safety review (February 22, 2010) […]

  4. […] More Avandia action: Nissen secretly recorded GSK execs, FDA announces safety review (February 22, 2010) […]

  5. […] More Avandia action: Nissen secretly recorded GSK execs, FDA announces safety review (February 22, 2010) […]

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