Lawsuit: Drug-Maker Knew About Risks of Vioxx
Posted April 15, 2008 3:12 p.m. EDT
Updated April 15, 2008 11:39 p.m. EDT
Vioxx, the anti-inflammatory drug, was pulled from the market four years ago over safety concerns. Since then, material revealed during litigation indicates the drug's maker, Merck, knew about life-threatening risks that were never made public.
In the late 1990s, Merck tested whether Vioxx could prevent cognitive decline in patients with Alzheimer's disease. Testers discovered an increased risk of death that was never reported to the Food and Drug Administration or the public.
“The company found a three-fold increase risk in mortality and failed to see a safety signal. By scientific standards, this is a major safety issue,” said Dr. Bruce Psaty with the University of Washington.
Researchers reviewed legal documents from lawsuits involving Merck and Vioxx. In 2004, the company reported the drug was "generally well tolerated by the elderly patients in our study."
However, an internal company document revealed Merck knew about an increased risk of death and heart attacks as early as 2001. Psaty says Vioxx should have been removed from the market then, rather than three years later.
“Fewer people would have been harmed,” he said.
Despite knowing the risk, Merck extended one of the clinical trials and enrolled new patients in 2003. During that time, eight deaths were associated with the use of Vioxx.
“Large clinical trials like these clearly need independent data and safety monitoring committees to protect the patients,” Psaty said.
Psaty's review appeared in the Journal of the American Medical Association. He says stricter regulations are necessary to avoid selective reporting of results and to help restore the public trust.
Some new safeguards are already in place. The FDA Amendments Act went into effect last fall, and it requires companies to make all clinical trial findings available to the public instead of just those results that may appear favorable.