Tuesday, March 2, 2010

Harvard Researcher Pressured by Glaxo-Smith Kline to Withold Research Report!

Like a story pulled straight from the pages of an undercover-detective novel, the New York Times yesterday reported on the details of a private meeting that took place between Dr Nissen and GlaxoSmithKline executives just before the release of a Meta Study of the safety of its premier drug, Avandia.

Concerns about the cardiovascular safety profile of rosiglitazone (Avandia) gained widespread attention with the publication of the 2007 meta-analysis by Dr Steven Nissen and Kathy Wolski (Cleveland Clinic, OH). In that analysis of 42 trials, the use of rosiglitazone was associated with a 43% increased risk of MI and a borderline but statistically insignificant 64% increase in risk of cardiovascular death. (Note, other sources claim that over 900 diabetics Avandia patients died in the 4th Quarter of 2009 of heart attacks!)

Meeting in 2007, just a week before his meta-analysis was to be published in the New England Journal of Medicine (NEJM), Dr David Nathan (Harvard Medical School, Boston, MA, secretly recorded the meeting out of fears he would face pressure from the company. In the taped conversation, Nissen, who shared the recording with the Times, said GlaxoSmithKline wanted him not to publish his study and wait for the results of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial instead.

According to the Times article, Dr Ronald Krall, the company's chief medical officer, almost predicts the final results of that study, even though the results should not have been known at the time. At one point, he asks Nissen what he would do if, hypothetically, RECORD showed a hazard ratio of 1.12, which was very close to the 1.11 hazard ratio for hospitalizations or death from cardiovascular causes that RECORD did show.

Krall denies knowing the results of RECORD, saying he did not learn of them until later.

Equally strange, the meeting played out with GlaxoSmithKline having inappropriately seen the full results of Nissen's yet-unpublished meta-analysis, although neither party discussed the results. As reported previously, Dr Steven Haffner (University of Texas Health Science Center at San Antonio), a peer reviewer for the NEJM meta-analysis,leaked the paper to the company weeks ahead of publication.

The NYT article also notes that in the Senate report, GlaxoSmithKline is taken to task by Congress for threatening researchers critical of the drug's safety profile. For example, the company complained to the supervisors of Dr John Buse (University of North Carolina, Chapel Hill), a researcher who also gave presentations warning of rosiglitazone's risks.

GSK's reaction to the lasted study linking Avandia with death and heart trouble was to issue a Press Release saying that the study's findings were unscientific. They suggested a conclusive study, a huge, randomized study be undertaken to prove the drugs safety. However, it would not be concluded until 2020, which would give them time to pull Billions and Billions of additional profits from the suspect drug and perhaps kill thousands and thousands more.
Bill's Comments
So much for the Scientific Method! If it hurts profits, Fuggedabouit!

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