LD-50 Tests are Horror and Useless!

robert.bronaugh@fda.hhs.gov, richard.mcfarland@fda.hhs.gov, devaraya.jagannath@fda.hhs.gov, ying.huang@fda.hhs.gov, cecilia.aguila@fda.hhs.gov, abigail.jacobs@fda.hhs.gov, melvin.stratmeyer@fda.hhs.gov, paul.brown@fda.hhs.gov, polanda@mail.nih.gov, kevin.howcroft@nih.hhs.gov, tice@niehs.nih.gov, chhabrar@niehs.nih.gov, heindelj@niehs.nih.gov, snyderm@od.nih.gov, paul.nicolaysen@cdc.hhs.gov, kmurali.rao@cdc.hhs.gov, goshorj@nlm.nih.gov, ahir.surender@dol.gov, jodie.a.kulpa-eddy@aphis.usda.gov, betty.j.goldentyer@usda.gov

Dr. William Stokes, ICCVAM Executive Director & NICEATM Director
Interagency Coordinating Committee on the Validation of Alternative Methods
NIEHS, EC-17, P.O. Box 12233
Research Triangle Park, NC, 27709

Marilyn L. Wind, Ph.D., Chair, ICCVAM
Deputy Associate Executive Director
Directorate for Health Sciences
U.S. Consumer Product Safety Commission
4330 East West Highway, Rm. 600
Bethesda, Maryland  20814


Dear Representative, Senators, and ICCVAM Committee:

The Lethal Dose 50 Percent (LD-50) test measures the dose of a substance needed to kill half a group of laboratory animals. For up to two years, animals ingest chemicals via stomach tube, inhalation, spray and injection. They vomit, convulse, become paralyzed and bleed from eyes, nose and mouth.

LD-50 tests are not as accurate as combined human cell tests. Still, pharmaceutical, chemical and consumer firms are required to poison animals. Companies that conduct animal-free experiments in-house must ultimately kill animals to meet regulatory qualifications.

I respectfully ask government regulators to accelerate validation of non-animal research tools. I also ask my elected officials to advocate legislation mandating the use of animal-free tests.

Since the ICCVAM Authorization Act established the Interagency Coordinating Committee on the Validation of Alternative Methods as a permanent committee in 2000 -- ICCVAM's panel has approved just four non-animal tests (among 185 reviews). Comparatively, the European Center for the Evaluation of Alternative Methods (ECVAM) has 34 human-focused methods in place, with 170 more under active evaluation. In 1986 the European Commission stipulated use of animal-free tests whenever feasible and later began a phase-out of animal experiments for cosmetics.

U.S. lawmakers must allocate funds to ICCVAM so informed scientists can develop non-animal models as their European counterpart does. ICCVAM's current committee clings to customary, but old-fashioned animal experiments that haven't undergone thorough scientific analysis.

Toxicity testing in animals is "expensive, time-consuming, uses animals in large numbers...and it doesn't always work," says Francis Collins, director of NIH's National Human Genome Research Institute. A National Academy of Sciences report, "Toxicity Testing in the 21st Century," calls for non-animal methodology. According to the National Research Council, in vitro strategy "would generate more-relevant data to evaluate risks people face."

It is indisputably cruel to pour toxins into the clipped-open eyes of rabbits (Draize eye irritancy) or smear corrosives over an animal's shaved skin (skin absorption tests). Human safety data should not come from poisoning animals (LD-50) or overdosing them with drugs while locked in metal restraints (pyrogenicity tests).

Please capitalize on strides in biology and computer automation that let researchers gauge toxicity more reliably. I urge ICCVAM to do its job. I urge Congress to enact funding so ICCVAM can do its job.

Yours sincerely,