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Researchers Claim Merck Cooked Vioxx Data

Study finds 'very serious transgression'

April 16, 2008

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Two independent reviews of Merck & Co. internal documents have raised questions about how the drug maker marketed its arthritis drug Vioxx in the years before it was forced to withdraw it from the market.

The documents were made public during the flurry of litigation that ensued after Merck withdrew Vioxx in 2004 when clinical trials exposed a fatal weakness – taking the drug increased the chances of having a heart attack or stroke.

The two studies, appearing in the Journal of the American Medical Association, suggest Merck might not have been all that surprised by Vioxx's link to heart risk.

Researchers from the University of Washington say they found that the pharmaceutical giant had not fully disclosed the death rates in previous trials, when Vioxx was tested as a means to slow the progression of Alzheimer's disease.

While Merck reported that its drug was "well tolerated" among the Alzheimer's patients who were taking it in the trial, the researchers cite internal documents showing subjects taking Vioxx in one trial had been four times more likely to die as those getting a placebo.

The link was less pronounced in a second trial, but still significant, researchers found. In that second test, taking Vioxx increased your risk of dying by two and a half times. In the two trials, 34 out of 1,000 people taking Vioxx died while the number of deaths of subjects taking placebo was only 12.

The problem, the authors say, is what happened next. Or more precisely, what didn't happen.

"These mortality analyses were neither provided to the U.S. Food and Drug Administration nor made public in a timely fashion," the researchers concluded. "There was a threefold increase in the risk of death for these patients. Our study raises questions about the wisdom of allowing drug study sponsors like Merck to control the data and analyses."

Similar conclusion

A study by researchers at Mount Sinai School of Medicine in New York reached a similar conclusion. It looked about more than 200 Merck documents and found that academics were recruited to support Vioxx – a practice lead author Dr. Joseph Ross of Mount Sinai called "a very serious transgression."

JAMA appears to agree, throwing its editorial weight behind the two studies and calling for "drastic action" to prevent drug companies from manipulation and misrepresenting scientific data in the marketing of their products.

For its part, Merck accuses the researchers and the journal of misrepresenting the data themselves. Peter Kim, head of research at Merck, categorically denied the allegation that his firm misrepresented the mortality data in the Alzheimer's trials.

A lawyer for Merck said the allegations are nothing new, and were, in fact, delivered in court by plaintiff's lawyers who were suing the drug company.

After insisting it would contest each of the thousands of product liability lawsuits over Vioxx, Merck agreed in November 2007 to settle claims over the withdrawn painkiller for $4.85 billion.

The cases were filed in connection with Vioxx's removal from the market, with plaintiffs charging the company should have acted sooner. More than 27,000 consumers or their family members filed suit against Merck as a result.

In the last three years, only a handful of the cases had gone to trial.

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