A Troubled History
According to the FDA, 92 percent of drugs tested safe and effective
in animals fail during human trials, and over half of the 8 percent
gaining approval are later withdrawn or relabeled due to severe
side effects. Among the drugs that were safe in animal tests but
later banned for human use are the following.
 Vioxx: The FDA’s Dr. David Graham called this cox-2
inhibitor (anti-inflammatory drug) “the single greatest drug-safety
catastrophe in the history of the world.” During four and
a half years on the market (until September 2004), it is estimated
to have caused 140,000-160,000 serious cardiovascular events and
60,000-70,000 deaths in the U.S. alone. The worldwide estimates
are 320,000 cardiovascular events and 140,000 deaths. Vioxx was
not only safe but sometimes protective for cardiovascular risk
in at least eight studies in six animal species.
Baycol: A cholesterol-lowering drug approved in 1997, it
was withdrawn in 2001 after causing over 100 deaths from rhabdomyolysis
(muscle destruction). This adverse effect was not seen in preclinical
tests in five animal species. After the drug was withdrawn, comparative
studies showed that rat muscle cells were 200 times more resistant
to the damaging effects of Baycol than human muscle cells.
Propulsid: A heartburn drug often prescribed for GI reflux,
Propulsid caused over 300 deaths between 1993 and its withdrawal
in 2000. Many of the deaths were among infants and children. Along
with the withdrawn allergy drugs Seldane (1992) and Hismanal (1999),
Propulsid caused fatal heart rhythm abnormalities.
Rezulin: This drug for diabetes mellitus showed heart toxicities
but no liver toxicities in animal studies. Approved in 1997 after
clinical trials showed no human heart toxicities, Rezulin was immediately
linked to severe liver damage. It was relabelled four times before
its withdrawal in 2000, after being linked to nearly 400 deaths
and many more cases of liver failure. Animal tests were thus false
negative for liver disease and false positive for heart disease.
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