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Vioxx Court Documents Show Minimized Mortality Risk

Academic investigators often used as first study authors despite use of company ghostwriters

TUESDAY, April 15 (HealthDay News) -- Court documents related to Vioxx (rofecoxib) litigation and published clinical trials have shown that Merck minimized mortality risk and often recruited academically affiliated investigators as first authors even though the manuscripts were written by Merck employees, according to two studies published in the April 16 issue of the Journal of the American Medical Association.

In the first study, Bruce M. Psaty, M.D., Ph.D., and Richard A. Kronmal, Ph.D., from the University of Washington in Seattle, reviewed Merck documents from the rofecoxib litigation and two clinical trials published in 2004 and 2005. They found that the published trials concluded that the drug was "well tolerated," despite a lack of analysis of the mortality data. In contrast, the company's internal analysis in 2001 showed a significant increase in mortality, but the data was not made available to the public or the U.S. Food and Drug Administration in a timely fashion.

In the second study, Joseph S. Ross, M.D., from Mount Sinai School of Medicine in New York City, and colleagues reviewed about 250 court documents and published articles pertaining to rofecoxib to determine the extent and types of ghost authorship. They found that clinical trial manuscripts were written by Merck employees and review articles written by unacknowledged authors, but both often gave first authorship to external, academically affiliated investigators.

"When integrity in medical science or practice is impugned or threatened -- such as by the influence of industry -- patients, clinicians and researchers are all at risk for harm, and public trust in research is jeopardized," Catherine D. DeAngelis, M.D., and Phil B. Fontanarosa, M.D., of JAMA write in an accompanying editorial. "Ensuring, maintaining and strengthening the integrity of medical science must be a priority for everyone."

Psaty notes that he testified at a Senate Finance Committee hearing entitled "FDA, Merck and Vioxx: Putting Patients First" in 2004. Kronmal notes that he was retained as an expert witness by the plaintiffs in litigation on Vioxx and cardiovascular events from 2005-2007. The authors of the second study note that they have been compensated for their work as consultants/expert witnesses for the plantiffs in litigation against Merck.

Abstract - Psaty
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Abstract - Ross
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