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'Journal' suggests Vioxx risk may appear earlier

Jun 27, 2006 | USA Today

Pharmaceutical giant Merck's contention that its Vioxx painkiller raised the risk of heart attack or stroke only after 18 months' usage was contradicted Monday by the New England Journal of Medicine.

Correcting the results of a Merck-sponsored study it previously published, the Journal suggested the increased health risk started earlier for Vioxx patients, but didn't specify a time frame.

The correction escalated the debate about Vioxx, the drug Merck pulled off the market in September 2004 after the study found the elevated health danger. The company faces more than 11,500 lawsuits over the drug, and has won half of the six cases in the court trials completed so far.

The Journal reported that the original article about the study used a faulty statistical analysis, which Merck itself disclosed earlier this year. But while company experts contended the mistake didn't affect conclusions about when the danger risk begins, the Journal disagreed.

"Therefore, statements regarding an increase in risk after 18 months should be removed," from the article that reported the study results, the Journal said.

Lawyers suing Merck on behalf of Vioxx patients or their survivors argued that the Journal correction significantly undercut Merck's legal contentions.

"I think that judges are almost required now to grant new trials in the cases where Merck has won, because the linchpin of Merck's defense has always been the 18-month argument," said a Texas attorney who won a $253 million Vioxx verdict against the firm last year. "It turns out that 18 months is bogus, and it's bogus because of Merck's own internal mistakes."

A New York attorney who last year lost a Vioxx case in which shorter-term usage of the drug was an issue, said he plans to add the Journal correction to his legal arguments seeking a new trial.

"This removes a major hurdle to getting verdicts against Merck," Seeger said.

But Dr. Peter Kim, president of Merck Research Laboratories, said the Journal correction "centered on the description of a single statistical method" and did not change the data in the Vioxx study "or its results."

He reiterated that "the increased relative risk was observed beginning after 18 months."

The Journal also released letters from two doctors critical of that claim. In counterpoint, two of the Vioxx study authors wrote that an analysis of the long-term experience of Vioxx users tested in the study is now underway.

Merck general counsel Kenneth Frazier said the debate "in no way changes our commitment to defending the Vioxx litigation on a case-by-case basis."


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