Vioxx Tragedy Spotlights Failure of Animal Research
 PCRM
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 dkinburn@pcrm.org. |
PCRM Online,
March 2005
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