Merck sued by MDs over Vioxx animal tests
In a lawsuit filed last
week, the Physicians Committee for Responsible Medicine (PCRM) alleged that
Merck & Co. wrongfully relied on tests showing Vioxx was safe in animals
while ignoring mounting evidence the drug is dangerous to humans. The
best-selling painkiller was removed from the market last fall, after the
VIGOR clinical trial showed cardiac risk to humans. This is believed to be
the first time a US 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,” said 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
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, yet failed to employ these methods.
At a news conference
held in Washington,
DC, Dallas-based cardiologist and PCRM
consultant John J. Pippin, MD, FACC, 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from an unpublished study on African green monkeys that Merck used as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,”
Pippin stated. “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. Ultimately, Merck’s reliance on scientifically flawed animal tests led
to human injury and death.”
Muhammad Mamdani,
PharmD, MA, MPH, 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, 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.
SOURCE:
Physicians Committee for Responsible Medicine, Media Advisory, July 14,
2005.
