Medical Journal Says Merck Concealed Vioxx Data
Merck misrepresented the results of a crucial clinical trial of Vioxx to play down the drug's heart risks, The New England Journal of Medicine said today.
The Journal's allegation may play a critical role in the thousands of lawsuits that Merck faces over Vioxx, a once-popular painkiller that has been linked to heart attacks and strokes. In the three lawsuits that have reached trial so far, Merck has contended that it promptly disclosed information about Vioxx's heart risks.
But in an interview today, Dr. Gregory D. Curfman, the executive editor of The Journal, sharply criticized Merck for hiding data from the trial. The study, called Vigor, was published in The Journal in November 2000 and covered more than 8,000 patients.
"They did not disclose all they knew," Dr. Curfman said. "There were serious negative consequences for the public health as a result of that." The Journal is widely read by doctors and scientists, with a circulation of almost 200,000.
Merck said in a statement that it had acted properly and promptly disclosed the Vigor findings. But lawyers for plaintiffs said they believed that the allegation would undercut the company's defense. Shares of Merck fell sharply after the statement was made public.
In an "Expression of Concern" posted this afternoon on its Web site, The Journal said the authors of the study had deleted data on strokes and other vascular problems suffered by patients in the Vigor trial two days before it submitted the results to the publication.
The authors also underreported the number of heart attacks suffered by patients taking Vioxx, claiming that there were 17 heart attacks when there were actually 20, The Journal said. The authors have been asked to correct the study, The Journal said.
The authors of the Vigor study included both Merck scientists and independent researchers. The study's results showed that patients taking Vioxx were four times as likely to suffer heart attacks as those taking naproxen, an older painkiller. In fact, 20 patients taking Vioxx suffered heart attacks, compared with four taking naproxen, a ratio of five to one.
Merck said at the time that the difference probably resulted from the fact that naproxen protected people from heart attacks, not because Vioxx caused them. Many independent scientists disputed the company's theory.
If the authors of the study had published the data about strokes and other vascular problems, the company's theory would have been even harder to accept, Dr. Curfman said.
"The totality of the data didn't look good for Vioxx," he said.
More than 20 million Americans took Vioxx between 1999, when Merck began selling the drug, and 2004, when Merck withdrew it from the market after another clinical trial showed that it increased the risk of both heart attacks and strokes.
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