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Vital Vioxx Details 'Manipulated'

JAMA Editors Call for Clinical Trial Reforms, Alleging Vioxx Withheld Data on Deaths
By
WebMD Health News
Reviewed by Louise Chang, MD

April 15, 2008 -- Two studies appearing in Tuesday's Journal of the American Medical Association have prompted the journal's editors to call for "drastic action" to prevent drug companies from misrepresenting data from clinical trials.

The two investigations involve the pain medication Vioxx, which was taken off the market in 2004 after being linked to an increased risk of heart attacks and strokes among long-term users. The revelations are the latest to come to light from lawsuits brought by people who claimed they'd been harmed by Vioxx.

Researchers charged that the drug's manufacturer, Merck, withheld key data from Vioxx trials from federal regulators and misrepresented the Vioxx research. The JAMA editors agreed, but they added that the problems are pervasive within the industry and not confined to Merck.

"The (two studies) document how one company, Merck & Co. Inc., apparently manipulated dozens of publications to promote one of its products," the journal's editor in chief and executive deputy editor write. "But make no mistake -- the manipulation of study results, authors, editors, and reviews is not the sole purview of one company."

Merck Responds to Criticism

In one of the JAMA articles, researchers charge that data from clinical trials showing a threefold increase in deaths among Vioxx users were withheld from the FDA for more than two years.

In their review of the data and internal company documents made public during civil litigation against Vioxx, the two researchers from the University of Washington, Seattle say the company appears to have misrepresented Vioxx's safety profile in studies involving Alzheimer's patients. One of those researchers, Richard A. Kronmal, PhD, was retained as an expert witness by plaintiffs' attorneys in Vioxx litigation.

In a separate analysis of the court documents, another group of researchers concluded that Merck misled federal regulators and the public about its role in the Vioxx studies by naming outside investigators who had little to do with those studies as principal investigators. All of these researchers served as paid consultants to plantiffs in Vioxx litigation.

A spokesman for the company tells WebMD that both charges are unfounded and that the company plans to formally respond to the JAMA editorial.

"All of Merck's disclosures to the FDA and the medical community were proper and appropriate," Merck legal spokesman Kent Jarrell says.

"We heard the points presented in these articles during the litigation and we rebutted them with evidence," Jarrell says. "It was a case of trial lawyer's antic masquerading as scientific substance."

JAMA Calls for Reforms

The JAMA editorial notes that the "manipulation of studies and misrepresentation of study results could not have occurred without the cooperation (active and tacit) of clinical researchers, other authors, journal editors, peer reviewer, and the FDA."

It further noted that the public's trust in clinical research is in great jeopardy because the extent of the problem is not known.

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