VIOXX RELATED INJURY

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Tests Related To Potential Dangers Of Vioxx Not Reported To Feds

Pharmaceutical > Vioxx

July 14, 2006

Pharmaceutical

San Francisco, CA - Jurors in the first Vioxx liability case which is going to to trial in California were told Wednesday, June 28, that Merck & Co. did not inform federal authorities about two clinical trials in which users of the painkiller Vioxx were more likely to die than people given a placebo.

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Vioxx Overviews

Merck: Officials Ignored Conclusion About Death in Vioxx Trial

Merck officials in 2000 ignored the conclusion of a senior scientist that the COX-2 inhibitor Vioxx -- which the company withdrew from the market last September over safety concerns -- had probably caused the death of a patient in a clinical trial, the New York Times reports. According to several e-mail messages related to Vioxx, Alise Reicin, a vice president for clinical research at Merck, repeatedly asked Edward Scolnick, senior scientist at the company from 1985 until 2002, to revise his position about the death "so that we don't raise concerns." Merck cited the cause of death of the patient, a 73-year-old woman, as "unknown" in later reports to FDA and in a paper published in 2003. In one e-mail message, Scolnick wrote that the trial -- called Advantage -- had "put us in a terrible situation." In e-mail messages sent on April 7, 2001, to Douglas Greene, an executive vice president at Merck Research Laboratories, Scolnick raised concerns that the Advantage trial had no scientific purpose. The Merck marketing department had developed the Advantage trial as a promotional tool to introduce about 600 physicians to Vioxx, according to the Times. "This course is just stupid," Scolnick wrote, adding, "Small marketing studies which are intellectually redundant are extremely dangerous." Jeffrey Lisse, a rheumatologist at the University of Arizona who led the Advantage trial, reported in the 2003 paper that five patients who took Vioxx had experienced heart attacks during the trial, compared with one who took naproxen, a difference with no statistical significance. However, the paper did not mention the cardiac deaths of the 73-year-old woman and two other trial participants, the Times reports.

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Vioxx Recall

U.S. pharmaceutical company Merck has announced a global recall of its pain reliever drug Vioxx, after a recent study has shown there may be a greater risk of heart attacks for patients using the drug for 18 months or more.

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