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Vioxx Tragedy Spotlights Failure of Animal Research

VioxxPCRM consultant John J. Pippin, M.D., F.A.C.C., flew to Washington, D.C., last month on an unusual mission. The longtime cardiologist—most recently head of cardiology at Dallas’s Cooper Clinic—had just written a 23-page report detailing how animal experiments misled scientists in the development of Vioxx and the other COX-2 inhibitors. Dr. Pippin presented his findings at a highly publicized FDA hearing on February 17.

Dr. Pippin’s report reveals that Vioxx and other COX-2 inhibitors actually had a heart-protective effect in mice and other animals—exactly the opposite of how the drugs later performed in humans. The report also reveals that once clinical trials started showing that the drugs caused heart problems in humans, the pharmaceutical companies ignored this information and instead pointed to the animal tests as evidence that the drugs were safe.

As Dr. Pippin details in his report, the Vioxx animal testing debacle is not unique. Over the years, millions of patients have been exposed to harmful drugs, such as Rezulin and Baycol, that seemed safe in tests on mice, dogs, rats, monkeys, horses, and other animals. Physiological differences between humans and other animals are at the root of the problem, notes Dr. Pippin. His report includes information about new, ethical, and more reliable human-based methods for studying drug metabolism.

Are You or Any of Your Family Members, Friends, or Patients Concerned about Potential Injuries from Taking Vioxx?

Like all prescription medications, Vioxx went through an approval process that included significant reliance on animal testing, resulting in pain, suffering, and death to animals. However, animal testing often gives results that do not predict effects in humans.

In the case of Vioxx, our scientists believe that its manufacturer, Merck, improperly relied, in part, on animal test results to convince the Food and Drug Administration that Vioxx was safe and effective when clinical data from human trials showed the opposite. Had Merck relied on human data, which are far more relevant than animal data, injuries would have been averted and lives saved.

PCRM aims to go to court to force Merck to disclose information about the animal studies it conducted and its reliance on them. We would use information produced by this suit to alert the public to the human health risks inherent in reliance on animal testing. To bring suit, we need to identify someone who took Vioxx for a period of time. The ideal person would have taken Vioxx for a number of months, with preexisting heart or circulatory problems or a history of stroke, atherosclerosis, diabetes, or significant obesity.

If you or someone you know fits this description and is interested in helping, please contact PCRM senior counsel Dan Kinburn at 202-686-2210, ext. 308, or



PCRM Online, March 2005

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