Researchers charge Merck misrepresented Vioxx data

By Julie Steenhuysen

CHICAGO (Reuters) - Merck & Co Inc suppressed evidence that its withdrawn arthritis pill Vioxx could harm patients, U.S. researchers charged on Tuesday.

An analysis of court documents suggests Merck knew about the problems years before it acted, the researchers report in the Journal of the American Medical Association.

They charge that Merck failed to disclose an internal analysis that found Alzheimer's patients taking Vioxx had a three times greater risk of death than patients taking a placebo.

"This is a major, serious safety signal," said Dr. Bruce Psaty of the University of Washington in Seattle, whose study compared internal Merck documents with data submitted to the U.S. Food and Drug Administration and published research.

"If these findings had been reported publicly in April of 2001, it is likely that many fewer patients would have chosen to use Vioxx and probably many fewer would have been injured," Psaty said in a telephone interview.

A separate analysis suggests Merck recruited academic researchers to lend their names and credibility to company-written studies used to give evidence of the drug's safety and effectiveness.

"Generally, these allegations, we believe, are not true," said Kent Jarrell, a crisis management expert and spokesman for the law firm representing Merck in litigation over Vioxx, which Merck withdrew in 2004 after studies showed it doubled heart attack and stroke risks.

The studies, published along with a commentary by the journal's editors, call for sweeping changes that would curtail drugmakers' ability to influence medical research.

MEANT TO BE SAFER

Vioxx is a type of drug known as a COX-2 inhibitor. These drugs were designed to be safer alternatives to aspirin, ibuprofen and other pain relievers that can cause often deadly stomach bleeding.

Merck is in the midst of a $4.85 billion deal with plaintiffs attorneys to settle thousands of Vioxx claims and the company has also been hit by declining sales from its jointly marketed cholesterol pill Vytorin.

More than 20 million people in the United States took Vioxx before it was withdrawn.

Psaty said patients were harmed because of Merck's hesitation.

"In April 2001, Merck conducted high-quality analyses that identified a three-fold increase in the risk of death for patients taking Vioxx compared to placebo," Psaty said, noting that Merck did not disclose this data to the FDA until 2003.

Merck denied this.