Tuesday, April 13, 2010

Articles on Avandia Influenced by Manufacturers

A new analysis of reviews and articles about Avandia has found that experts who were paid by its manufacturer have been significantly more likely than others to draw positive conclusions about the drug’s safety and efficacy. Since 2007, scientists have published hundreds of studies, reviews and opinion articles about Avandia in scientific journals and elsewhere, arriving at a range of conclusions, some sharply opposed to one another.
In 2007, The New England Journal of Medicine published a review of studies and concluded that its use was associated with a significant increase in the risk for heart attack.
After a Congressional investigation, the Food and Drug Administration imposed a “black box” safety warning on the medicine. In February, The New York Times described confidential F.D.A. reports recommending that Avandia be removed from the market.
To explore possible links between authors’ financial interests and opinions, researchers reviewed 202 articles by 180 authors who wrote about Avandia and the risk of heart attack. Then they had independent reviewers with no conflicts of interest grade each article as favorable, neutral or unfavorable, based on the authors’ positions on an association between Avandia and heart attacks and on their recommendations for continuing or ending its use. The study was published online on March 18 in the journal BMJ.
Often, authors with favorable opinions of the drug were paid both by Avandia’s maker, GlaxoSmithKline, and by its competitors. Of those who offered favorable views, 87 percent had potential conflicts with Glaxo. Among authors who had unfavorable opinions, only 20 percent had received money from Glaxo.
The BMJ study included a supplement listing all the scientists whose papers were studied.
The BMJ review found that 90 of the 202 articles were by people with potential conflicts, but only 69 of them had a statement disclosing the fact. They uncovered the 21 remaining conflicts by searching the Internet and other publications by the same authors.
The study’s authors acknowledged that their work was observational and that they were unable to assign a monetary value to any of the relationships they found.
Dr. Amy T. Wang, the lead author and a resident in internal medicine at the Mayo Clinic, emphasized that the study drew no conclusions about the safety or efficacy of Avandia.

 

Edited form an article titled “Study Sees a Slant in Articles on Drug” by NICHOLAS BAKALAR published on April 12, 2010 in the New York Times

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