Journal of Nursing Law, Volume 12, Number 4, 2008
Drug Safety: An Argument to Ban
Animal Testing
Sheree Stachura, RN, BSN
The U.S. Food and Drug Administration (FDA) mandates that drugs under development go through
a preclinical testing phase that includes animal testing. Unfortunately, animals and humans differ
greatly biologically. Many drugs are safe for animals but not safe for humans. Therefore, when
the drugs are placed on the market and used by humans, many times those drugs harm people. In
addition, courts are reluctant to allow the admittance of animal testing as evidence, stating that the
tests are not reliable. People rely on FDA approval of drugs to their detriment. They assume that
if the FDA approved the drug, it is safe for use. In many documented incidences, this is not the
case. There are many alternative methods available other then animal testing that can make drugs
more efficient and safe for human use. Therefore, the FDA should not mandate animal testing and
should look to the alternative methods for evidence that supports drug approval.
Keywords: animal testing; drug safety; medications; Daubert standard
T
he statistics are staggering. Every year, thou- If animal testing is an accurate indicator that medi-
sands of people are hurt or killed as a result of cations are safe, why are so many drugs pulled from
using prescription drugs that were approved by the shelves once humans start taking them? There is a
the U.S. Food and Drug Administration (FDA); 5.34% much evidence that animal tests are not reliable. The
of newly approved drugs were pulled from the market results are sometimes discarded if the desired effect is
by the FDA from 1997 to 2000.1 Approximately 125,000 not achieved.6 In fact, 95% of drugs that pass the ani-
Americans have died from FDA-approved medica- mal testing stage are immediately discarded because
tions.2 Just recently, Vioxx, a medication manufactured they are useless or harmful to humans.7 Human con-
by Merck and approved by the FDA, was pulled from sumers need drugs that are proven to be safe and effec-
the market. The medication caused 25% of 239 patients tive before they are prescribed. Because animal testing
taking it to have heart attacks within 13 days of starting is unreliable and not indicative to human response, ani-
the drug.3 How does this happen? How does a drug that mal testing should be banned and alternatives utilized
goes through the process mandated by the FDA injure so that drugs are safer and useful.
or kill people as soon as it is released to the public?
Because the method by which the drugs are declared HISTORY OF ANIMAL TESTING
safe for human consumption is outdated and obviously AND ITS REGULATING LAW
detrimental to humans. The first record of animal testing can be traced back to
Animal testing is mandated by the FDA for certain early Greece. Aristotle was the first person to dissect
drugs to receive approval for distribution to the public:4 animals to reveal internal differences.8 But it was not
Scientists have to test those compounds that have shown at until the 19th century that animal testing gained wide-
least some desired effects in living animals. In animal test- spread popularity. This movement was made popular
ing, drug companies make every effort to use as few ani- by the leading scholars of that time. For example, in
mals as possible and to ensure their humane and proper
1865, the so-called father of experimental science,
care. Two or more species are typically tested because a
drug may affect one differently from another. Such tests Claude Bernard, a French physiologist, published
show whether a potential drug has toxic side effects and An Introduction to the Study of Experimental Medicine,
what its safety is at different doses.5 which in essence stated that information gleaned
Copyright 2008 Springer Publishing Company • 147
DOI: 10.1891/1073-7472.12.4.147
148 • Journal of Nursing Law • Vol. 12, No. 4
from laboratory studies far exceeded that gained in animals) of such drug adequate to justify the proposed
human clinical trials and investigation.9 He concluded, clinical testing.”20
“Experiments on animals, with deleterious substances Therefore, regardless of the rocky beginnings of
or in harmful circumstances, are very useful and such science, the government mandates that all drugs
entirely conclusive for the toxicity and hygiene of go throu