(Adds comment from Merck, FDA, Congress paragraphs 14-17, 21-23)
CHICAGO, April 15 Merck & Co Inc (MRK.N) suppressed evidence that its withdrawn arthritis pill Vioxx could harm patients, U.S. researchers charged on Tuesday.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More than 20 million people in the United States took Vioxx before it was withdrawn.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.
"The allegation that Merck misrepresented mortality data from our Alzheimer's studies is just plain wrong," said Dr. Peter S. Kim, president of Merck Research Laboratories, in a statement.
The company said it provided complete mortality data from the Alzheimer's studies to the FDA.
An FDA spokeswoman said the agency did not have any specific comment but said it would evaluate the issues raised by the journal on Vioxx.
A second study in the medical journal, by Dr. Joseph Ross of Mount Sinai School of Medicine in New York, suggested that one of the central studies of Vioxx was designed and conducted in large part by scientists at Merck, but primary authorship was attributed to three academic researchers in addition to eight Merck scientists.
One of the researchers, Steve Ferris of New York University, denied this. "I think that JAMA got it wrong in using this as a particular example of guest authorship," Ferris said in a telephone interview.
But in a telephone interview, Ross said, "We don't think it is limited to Merck. We think this is a widespread problem."
Iowa Sen. Chuck Grassley, a Republican who chaired Senate Finance Committee hearings on Vioxx deaths, said he was asking Merck to explain what it knew and when.
"These reports reveal just how far a drug maker might go to market its product and try to bury information that might hurt sales even when that information directly affected the health and safety of the people taking their medicine," Grassley said in a statement.
"Revealing this kind of activity is very important in building pressure on the Food and Drug Administration to regulate, not accommodate drug makers."