PCRM Cardiologist Testifies at FDA Hearing:
Reliance on Animal Experiments Partly to Blame for Vioxx Tragedy
PCRM consultant John J. Pippin, M.D., F.A.C.C., dropped a bombshell
at a highly publicized Food and Drug Administration hearing on February
17. The cardiologist presented a report detailing how experiments
on mice, dogs, and other animals misled scientists and ultimately
contributed to the problems with Vioxx and other COX-2 inhibitors.
The report reveals that Vioxx and other COX-2 drugs 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 pointed out, 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. The
report also includes information about new, ethical, and more reliable
human-based methods for studying drug metabolism. Download
a copy of the report, or contact 202-686-2210, ext. 306.
Dr. Pippin’s op-ed on Vioxx appeared in the Winter
issue of Good
Medicine.
|
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 are not predictive
of 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 intends 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 and not have had preexisting
heart or circulatory problems or a history of stoke, 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. |
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