Animals Die For Drug Company Lie

andrew.voneschenbach(at)fda.hhs.gov

Andrew C. von Eschenbach, M.D., Acting Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane, Parklawn Bldg.; Rockville, Maryland 20857
web feedback form: http://www.fda.gov/comments/webform.html
website: http://www.fda.gov/

Dear Commissioner Von Eschenbach,

I respectfully ask you to direct the FDA to uphold the ICCVAM Authorization Act, established to validate non-animal research modes and eliminate animal studies whenever possible. Please retire present regulations stipulating every drug marketed in the U.S. be tested on animals.

I urge the FDA to keep pace with international standards for drug testing. Non-animal research is widely embraced throughout Europe, due to its superior relevance to human health.

U.S. Secretary of Health and Human Services Mike Leavitt has said nine of ten experimental drugs fail in clinical studies because "we cannot accurately predict how they will behave in people based on animal studies." Indeed, it's difficult to stay current with the escalating list of banned or restricted drugs -- each deemed "safe" for human use in animal studies.

Science derived from distressed animals does not result in accurate extrapolation to humans. Lab variables such as pain, injury, confinement, loneliness and repeated handling generate misleading data. Findings published in Contemporary Topics in Laboratory Animal Science show researchers are unable to separate the effects of stress hormones from the drug or disease under analysis.

Animal-to-human imprecision is behind the rise in ADRs (adverse drug reactions), the fourth leading cause of death in the U.S. According to the Journal of the American Medical Association, 52% of drugs are recalled or relabeled due to adverse effects not detected prior to approval. In fact, animal testing is so non-predictive it flaunts a 92% failure rate. As reported in The Scientist, just 8% of (animal-tested) drugs that enter Phase 1 and 2 trials reach the marketplace and half fail in the late stage Phase 3 trials.

Nonetheless, millions of animals annually undergo invasive procedures, isolation and death to demonstrate redundant information with no bearing on human health. Profit-driven research laboratories are routinely cited for falsification of data and cruelty to animals. Nearly all stock animals in barren environments with little regard for standards outlined in the U.S. Animal Welfare Act.

For example, the USDA recently inspected and fined Covance Laboratories in response to substantiated allegations of taunting, slapping and choking "uncooperative" primates at its Virginia facility. Some animals suffered intestinal protrusions through their rectums from unremitting stress and diarrhea. Others were denied painkillers or even euthanasia during agonizing drug tests. Sadly, Covance is hardly the exception. It is the norm among animal experimentation facilities.

Growing recognition of the physiological, cellular, genetic and psychological disparities between species has prompted some researchers to utilize expedient non-animal systems. Options range from in vitro cell and tissue culture models and genetic/protein analysis to epidemiology, videos and mathematical modeling, virtual organs and 3-D models, autopsy/biopsy studies, advanced MRI imaging, and a multitude of other human-focused tools.

Yet as long as U.S. law mandates animal testing for every saleable drug, researchers will waste time, money and lives on old-fashioned animal experiments. I encourage the FDA to advocate progressive animal-free research methods that are not only more humane, but also more applicable to humans.

Sincerely,