September 7th, 2010
BMJ Papers Increase Pressure on Avandia
Larry Husten, PHD
A trio of papers in BMJ are turning up the heat on rosiglitazone (Avandia), prompting the editor-in-chief of the journal, Fiona Godlee, to say that she believes rosiglitazone “should not have been licensed and should now be withdrawn.”
The detailed investigative report by BMJ features editor Deborah Cohen reviews the long and troubled history of rosiglitazone, with a focus on the deficiencies of the European and British regulatory process. Cohen writes that “we still have no clear picture of why, after initial rejection in October 1999, the [European Medicines Agency] gave market authorisation to rosiglitazone in July 2000 in the absence of new evidence.” She also reports for the first time that in July of this year the U.K.’s Commission on Human Medicines unanimously recommended that the Medicines and Healthcare products Regulatory Agency (MHRA) withdraw rosiglitazone from the market, but “a ‘dear doctor’ letter sent to UK doctors in July advised doctors to ‘consider alternative treatments where appropriate’.”
In an accompanying editorial, Richard Lehman, John Yudkin, and Harlan Krumholz (editor-in-chief of CardioExchange) shift some of the blame for the Avandia crisis to clinicians, noting that “we had lost sight of the main reason for treating this complex and progressive disease, which is not to reduce glycaemia but to prevent complications.” The important lesson to be learned before allowing new drugs to enter the market is that “surrogate end points are not enough, robust evidence of benefits and harms is needed.”
In an accompanying commentary, Nick Freemantle points out that to avoid problems like rosiglitazone in the future, it will be essential for regulatory agencies to require companies to provide much better data from clinical trials.
In a related development, GSK has posted the audio recording of a May 10, 2007 meeting between Steven Nissen and GSK officials. The existence of the tape, which was recorded surreptitiously by Nissen, was disclosed in February by the New York Times.
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