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The Continuing Saga of Avandia

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The Continuing Saga of Avandia: Paid Cheerleaders for the Drug

May 2010

Annette B. Ramírez de Arellano, Dr.PH.

The diabetes drug Avandia has become increasingly linked to dubious science and conflicts of interest. The latest chapter in the saga of this drug, also known by its generic name rosiglitazone, concerns the fact that the drug appears to be viewed differently depending on whether or not the beholder has ties to industry. The latest chapter in this unsurprising but still disturbing finding is described in an article published in the British Medical Journal in March 2010.

The current controversy is the direct sequel of a debate that took place in 2007, after Steven E. Nissen and Kathy Wolski conducted a meta-analysis of studies on the drug and concluded that rosiglitazone was “associated with a significant risk of myocardial infarction (heart attack) and with an increase in the risk of death from cardiovascular causes that had borderline significance.” That conclusion, followed by a subsequent industry-sponsored large study known as the RECORD trial, prompted the publication of a number of articles, many of which were opinion pieces, which weighed in on the merits of rosiglitazone.

These articles were then examined by a team of researchers from the Mayo Clinic, whose objective was to explore a possible link between the authors’ financial conflicts of interest and their position on the association of rosiglitazone with an increased risk for heart attack. Two reviewers who did not know the authors’ ties then classified the authors’ views as being favorable, neutral or unfavorable on the risk of heart attack and on recommendations on the use of the drug. Their views were then matched with whether or not they had ties with the pharmaceutical industry.

The researchers found that disclosure rates for financial conflicts of interest were unexpectedly low, with only 53 percent of the articles having a conflict of interest statement. More important, they concluded that “there was a clear and strong link between the orientation of authors’ expressed views on the rosiglitazone controversy and their financial conflicts of interest with pharmaceutical companies.” Specifically, those who had favorable views on the safety of rosiglitazone were more than three times more likely to have a financial conflict of interest with a pharmaceutical company than were those who had unfavorable views. There was a similarly strong association between support for the use of the drug and financial conflict of interest. Conversely, authors who were unfavorable on the issue of rosiglitazone safety were largely free of identifiable conflicts of interest.

The authors of the BMJ study ended with a “call to action” to promote greater transparency among readers and writers of the scientific literature. It is a call that Public Citizen has repeatedly sounded, and which is at the core of much of what we do.