May 5, 2008 -- A representative of The Humane Society of the United States will present a shareholder resolution at Allergan, Inc.'s annual meeting tomorrow calling for greater transparency about the company's efforts to develop alternatives to the use of lethal animal testing in manufacturing Botox and Botox Cosmetic.
Allergan uses the Lethal Dose 50 Percent (LD50) test to assess the potency of batches of Botox and Botox Cosmetic. The shareholder resolution requests annual updates on Allergan's efforts to replace this controversial animal test with a non-animal alternative. The resolution was also filed by the Calvert Asset Management Company, inc., investment advisor for the Calvert Family of Funds. Calvert is a socially responsible investment firm and has $15 billion in total assets under management.
The LD50 test seeks to find the amount of a substance that will kill 50 percent of a test group of animals. Botox's active ingredient is a nerve toxin produced by Clostridium botulinum bacteria, which also causes food poisoning. When injected into test animals, this substance can cause paralysis and prolonged suffering before death.
Although Botox has important medical applications, 50 percent of net sales are for the cosmetic application. Animal use for cosmetic applications is being phased out internationally, due in part to consumer pressure and legislative mandates. Allergan, based in Irvine, Calif., is the only company licensed to sell Botox for cosmetic purposes in the U.S.
"Allergan must join the twenty-first century and phase out the killing of animals in the testing of Botox," said Martin Stephens, The HSUS' vice president for animal research issues. "Consumers demand good corporate stewardship and transparency when it comes to animal welfare."
Facts:
* The LD50 test used for Botox involves giving mice a single injection of the product, then seeing if animals die within three to four days. Each group of animals receives a different strength of the product to estimate the strength that kills half of the animals.
* There is a thriving international effort to develop alternatives to animal-based methods of safety testing. This effort has virtually replaced the use of the 80-year-old LD50 test for safety testing. The continued use of LD50 in standardizing batches of botulinum toxin products is an exception to the trend of phasing out this test.
* Animals who die from the Botox LD50 test do so from suffocation, after their diaphragms become paralyzed and they can no longer breathe. Those who don't die immediately may languish with varying degrees of paralysis before being euthanized at the end of the three- to four-day test.
Website: www.humanesociety.org
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