Key Vioxx Research Was Written by Merck, Documents Allege

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"These allegations are not true. They're not new. A lot of these allegations showed up in litigation years ago, and our evidence successfully rebutted them," said Kent Jarrell, spokesman for Vioxx litigation on behalf of Merck. "This is an example of courtroom antics masquerading as scientific debate."

"We disagree with both articles," added Jim Fitzpatrick, an attorney with Hughes Hubbard & Reed, outside counsel for Merck. "We think the record of disclosure and transparency is really excellent."

Since Vioxx was removed from the market, there have been numerous allegations that Merck withheld and manipulated safety and efficacy data.

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The authors of the first JAMA study, who scoured litigation documents as well as the existing medical literature, say the issue is not really about Merck or about the physicians discussed in the paper, but a much larger and more troubling issue.

"We had the opportunity to examine these documents because of litigation [related to Merck and Vioxx], but this is a practice that has been rumored in the physician research world for decades," said Dr. Joseph S. Ross, lead author of the first study and an instructor in geriatrics at Mount Sinai School of Medicine in New York City. "This is about the profession and how we need to move forward to ensure that research is conducted most rigorously." Ross was a paid consultant for plaintiffs in the litigation against Merck.

This study found that, in many cases, Merck employees prepared manuscripts then, later, recruited academics with little intimate knowledge of the research to be lead or second authors. Disclosures of Merck's financial support of the research and of the author was often not included in the article.

The authors of the second study, from the University of Washington, Seattle, also reviewed legal documents and two published articles, finding that mortality information from clinical trials on cognitive impairment was downplayed. They also reported that there had been no data and safety monitoring board in place for at least one Vioxx trial.

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