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Vioxx Settlement Puts Painkillers Back in the Spotlight


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In December 2005, the editors of the New England Journal of Medicine accused researchers and Merck of withholding key heart risk data that showed up in one of the first large trials of Vioxx; the findings from that trial were published in the journal. Specifically, the editors charged that the study published in November 2000 was submitted to the journal after information about three heart attacks among Vioxx trial participants was deleted by Merck, which funded the study.

In a statement quoted by the Associated Press, Merck said the additional heart attacks "did not materially change any of the conclusions of the article." Merck also said the additional heart attack data was not included in the study, because the heart attacks were reported after Merck's cut-off date for including study data.

Cox-2 inhibitors do work to ease pain, Topol said. "They work at least as well as NSAIDs and, in some patients, better," he said. "Unfortunately, this whole class of drugs has been hit by an outlier."

Text Continues Below



With the FDA slapping a strong "black box" warning on Celebrex's label, Topol believes the public and doctors are now well-informed about that drug, so they can make appropriate decisions about which patients should or should not receive the medicine.

"Celebrex is safe for most patients, so is Vioxx," Topol asserted. Celebrex, at higher doses, can increase the risk for blood clots, "but the risk never appeared to be as at the same level as Vioxx," he said.

Topol believes people who have heart disease might be at increased risk of heart attack from Celebrex, but there is no real proof of that, he said.

Going without cox-2s may have its downside for patients, too, experts added.

Since Vioxx and Bextra were taken off the market, rates of gastrointestinal events serious enough to require hospitalization have risen significantly, according to a presentation Thursday at the American College of Rheumatology annual meeting, in Boston.

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Copyright © 2007 ScoutNews, LLC. All rights reserved.
Last updated 11/9/2007

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SOURCES: Mark Fendrick, M.D., professor, internal medicine, University of Michigan School of Medicine and professor, health management and policy, University of Michigan School of Public Health, Ann Arbor; Eric J. Topol, M.D., director, Scripps Translational Science Institute, chief academic officer, Scripps Health, and professor of translational genomics, TSRI, senior consultant, Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, Calif.


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