WASHINGTON (AFP) — Merck played down the risk of death linked to the US pharmaceutical giant's anti-inflammatory drug Vioxx in trial studies the company made public, according to a study released Tuesday.
The report, appearing in the April 18 issue of the Journal of the American Medical Association (JAMA), compares Merck's internal data from 2001 with the results of clinical tests made public in 2004 and 2005.
Merck voluntarily withdrew Vioxx from sale in September 2004 after a company internal study in 2001 showed the drug doubled the risks of heart attack in patients who took it for 18 months or longer.
"Sponsors have a marketing interest to represent their products in the best light. This approach conflicts with scientific standards that require the symmetric and comparable reporting of safety and efficacy data," wrote doctors Bruce Psaty and Richard Kronmal with the University of Washington, Seattle, the study co-authors.
The analysis was based on clinical tests carried out on 3,000 Alzheimer patients in 2000 and 2001.
"The mortality findings and the Alzheimer disease findings would, in our judgment, have prompted a (safety review board) ... to stop the trial early," the researchers wrote.
Merck's internal analyses dating from April 2001 of pooled data from the two trials "identified a significant three-fold increase in total mortality."
But, the new study said, "These mortality analyses were neither provided to the FDA nor made public in a timely fashion."
Merck said in a statement it was not given a chance to respond to the article prior to publication.
"The allegation that Merck misrepresented mortality data from our Alzheimer's studies is just plain wrong," Merck Research Laboratories president Peter Kim said in a statement.
The drug company "provided complete mortality data from the Alzheimer's studies to the US Food and Drug Administration, as well as the mortality data from its other studies," Merck said.
According to Merck, "a full, unbiased evaluation of the Merck documents shows significant errors in the conclusions put forward by the authors of the JAMA articles."
The study marks the latest blow for Vioxx, which last year was the focus of a 4.85-billion-dollar legal settlement.
The November deal, which allowed Merck to settle more than 95 percent of lawsuits over the drug, marked a major reversal of course for the company, which had earlier said it would fight more than 27,000 lawsuits.
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