WASHINGTON—In a lawsuit filed this week, the Physicians Committee for Responsible Medicine (PCRM) alleges that Merck & Co. wrongfully relied on tests showing Vioxx was safe in animals while ignoring mounting evidence that the drug is dangerous to humans. Vioxx, a best-selling painkiller, was pulled off the market last fall, after the VIGOR clinical trial showed cardiac risk to humans. This is believed to be the first time a U.S. pharmaceutical company has been sued specifically for relying on animal tests.
“Merck endangered public health by relying on inapplicable animal tests rather than relevant and available human data,” says Dan Kinburn, PCRM associate general counsel. The injured plaintiff, Nancy Tufford, a PCRM member from Minnesota, is seeking $1 million in damages because she developed congestive heart failure while taking Vioxx.
The lawsuit charges that Merck was well aware of the limitations of animal testing—that animal studies are often inconsistent, species-dependent, and not useful in predicting drug safety or efficacy in humans. At least nine of 11 mice and rat studies, for example, showed Vioxx to be beneficial for animal hearts. The suit accuses Merck of using these and other inapplicable animal data to justify keeping Vioxx on the market. It also states that Merck knew of more effective safety assessment methods, such as postmarket surveillance of patient reactions, in vitro tests using human cells and tissues, and computer modeling, but failed to employ these methods.
At a news conference held in Washington, D.C., today, Dallas-based cardiologist and PCRM consultant John J. Pippin, M.D., F.A.C.C., shared the results of his research into the Vioxx tragedy, including a new “smoking gun. Dr. Pippin presented data from an unpublished study on African green monkeys that Merck used as additional evidence of Vioxx’s supposed safety.
“Animal tests clearly show Vioxx to be safe, but these tests simply do not apply to humans,” Dr. Pippin said. “Merck was wrong to rely on data from mice, rats, and African green monkeys when faced with compelling evidence that human patients are at risk,” says Dr. Pippin. “Ultimately, Merck’s reliance on scientifically flawed animal tests led to human injury and death.”
Muhammad Mamdani, PharmD, M.A., M.P.H., senior scientist and leader of the Drug Research Group at the Institute for Clinical Evaluative Sciences in Toronto, Ontario, also participated in the news conference. Dr. Mamdani, the lead author of a recent human-based study in The Lancet that links Vioxx to congestive heart failure, has stated that studies with mice and monkeys are not always predictive of a drug’s effect in human patients.
Founded in 1985, the Physicians Committee for Responsible Medicine is a nonprofit health organization that promotes preventive medicine, especially good nutrition. PCRM also conducts clinical research studies, opposes unethical human experimentation, and promotes alternatives to animal research.
