Lawyers on many sides are preparing for court cases associated with the effects of Vioxx. It is an arthritis drug made by Merck that went off the market several years ago.
Now, report published in the Journal of the American Medical Association is making new claims about alleged life-threatening dangers that the new report alleges were not made public by the drug company.
The claims come from legal documents reviewed by Dr. Bruce Psaty and his colleagues at the University of Washington.
They are documents from ongoing litigation involving Merck and Vioxx.
In the late 90's, Merck tested Vioxx in patients with Alzheimer's disease. The questions was whether the drug could prevent cognitive decline in these patients.
According to the JAMA report, some death risks from the study were documented, but weren't reported to the FDA or to the public.
"The company found a three-fold increase risk in mortality and failed to see a safety signal," Dr. Psaty said. "By scientific standards, this is a major safety issue."
In a published report in 2004, Merck reported that Vioxx is "generally well-tolerated by the elderly patients in our study."
But the researchers point to an internal company document, which they say tells a different story. They say that, in 2001, Merck knew about the life-threatening dangers in the Vioxx study.
"Merck did not provide this analysis to the FDA or to the public," Dr. Psaty said. "When the FDA asked the company about these analysis, the company dismissed the mortality finding and did not see any possible concern."
Merck told us they had not been given an opportunity to respond to what they label as "misleading claims" in the articles. They say their own analysis of the data, show "no pattern in the actual causes of death suggesting any connection to Vioxx."
Psaty says more oversight of clinical trials is necessary.
"Large clinical trials like these clearly need independent data and safety monitoring committees to protect the patients," Dr. Psaty said.
It is also worth nothing that one of the two authors of this report was paid by plaintiff attorneys as an expert witness regarding the lind between Vioxx and heart attacks. Dr. Psaty, the lead author, had not been involved in any Vioxx-related lawsuits.
