Vioxx Studies: Ghostwriters And Merck Sponsorship

Posted April 15th, 2008 by admin_huliq

While you thought that those Vioxx studies in medical journals were independent, hands-off affairs that may not have been necessarily true. An examination of medical journal articles about Vioxx and court documents from Vioxx lawsuits found that Merck employees or ghostwriters were frequently involved in various articles, but the primary authors were often academics who actually had little to do with the studies or didn’t always disclose financial ties to Merck.

That’s the finding of an article in the latest issue of the Journal of the American Medical Association by four academics who acknowledged they have served as expert witnesses for plaintiffs’ attorneys that have filed lawsuits against Merck. Among 96 relevant published articles, they found that 22 of 24 clinical trial articles published a disclosure of Merck’s financial support, but only 36 of 72 of review articles published either a disclosure of Merck sponsorship or a disclosure of whether the author had received any financial compensation from the drug maker.

The article is likely to renew the controversy over ghostwriting and undisclosed financial ties between authors and drug makers. “It almost calls into question all legitimate research that’s been conducted by the pharmaceutical industry with the academic physician,” James Ross of Mt. Sinai School of Medicine and one of the authors, tells The New York Times.

“By having no outside researchers look at data or be in control of a study allowed Merck to manipulate the trials,” David Egilman, a clinical associate professor in community health at Brown University and another of the study authors, tells Pharmalot. “They were able to use spin to create the impression that the drug didn’t kill people, which it did. They’d be less able to do this if independent academic researchers were evaluating data, writing drafts and were involved in final papers. Instead, they get to repackage their own data without any serious external review, publish in prestigious journals with prestigious authors and use it to market off-label by dropping papers that appear to be legt in doctors’ offices.”

In an editorial, JAMA’s editors write that “public trust for clinical research is in great jeopardy especially when the extent of how widespread such practices have become is unknown.” And they called for nearly a dozen immediate changes, including full disclosure of all financial ties and all study authors must fulfill certain authorship criteria.

Source: By buypharmacy.livejournal.com blogger.

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