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Key Vioxx Research Was Written by Merck, Documents Allege
Reports say academics were paid to lend their names to ghost-written studies that exaggerated painkiller's safety
By Amanda Gardner HealthDay Reporter
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TUESDAY, April 15 (HealthDay News) -- Industry documents reveal that pharmaceutical giant Merck & Co. paid academics to put their names on Vioxx research published in top medical journals while company employees often ghost-wrote the studies on the controversial cox-2 painkiller.
The company apparently also exaggerated the safety of the medication in published clinical trials, and the academics frequently did not disclose industry financial support, the documents allege.
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Two articles detailing these findings, the latest episode in the Byzantine tangle surrounding the former best-selling pain reliever, appear in the April 16 issue of the Journal of the American Medical Association.
The scope of the analysis was significant. The researchers combed through 250 documents that included 24 clinical trials, 72 review articles and numerous editorials to come to their conclusions. The Vioxx articles appeared in more than a dozen medical journals, including the New England Journal of Medicine and JAMA.
"These are extraordinary manuscripts, and they reveal the inner workings of the promotion of a drug that ultimately turned out to be a hazard," said Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic.
Nissen, who first warned that Vioxx caused heart problems in 2001, was not involved in either paper but said that he agreed with an editorial in the same issue of the journal that "the only people that need to change to stop this are physicians."
Vioxx was pulled from the market in 2004, after a study showed the drug increased users' risks of heart attack and stroke. And last November, Merck agreed to pay $4.85 billion to settle 27,000 lawsuits from plaintiffs who said they or family members were injured or died after taking Vioxx.
Since the findings of both new studies derive largely from documents associated with the litigation surrounding Vioxx, Merck representatives disputed the assertions.
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Copyright © 2008 ScoutNews, LLC. All rights reserved.
Last updated 4/15/2008
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SOURCES: Joseph S. Ross, M.D., instructor, department of geriatrics, Mount Sinai School of Medicine, New York City; Steven Nissen, M.D., chairman, department of cardiovascular medicine, Cleveland Clinic Foundation; Kent Jarrell, outside spokesman, Merck & Co.; Jim Fitzpatrick, attorney, Hughes Hubbard & Reed, New York City; April 16, 2008, Journal of the American Medical Association; April 14, 2008, statement, Merck & Co.
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