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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
The statistics are staggering. Every year, thousands of people are hurt or killed as a result of using prescription drugs that were approved by the U.S. Food and Drug Administration (FDA); 5.34% of newly approved drugs were pulled from the market by the FDA from 1997 to 2000. 1 Approximately 125,000 Americans have died from FDA-approved medications. 2 Just recently, Vioxx, a medication manufactured by Merck and approved by the FDA, was pulled from the market. The medication caused 25% of 239 patients taking it to have heart attacks within 13 days of starting the drug. 3 How does this happen? How does a drug that goes through the process mandated by the FDA injure or kill people as soon as it is released to the public? Because the method by which the drugs are declared safe for human consumption is outdated and obviously detrimental to humans.
Animal testing is mandated by the FDA for certain drugs to receive approval for distribution to the public: 4
Scientists have to test those compounds that have shown at least some desired effects in living animals. In animal testing, drug companies make every effort to use as few animals as possible and to ensure their humane and proper care. Two or more species are...