In 2002 the U.S. Food and Drug Administration (FDA) approved the use of Botox® Cosmetic to reduce the appearance of frown lines. Since then use of this product has skyrocketed, with more than $200 million in sales during 2003. But consumers aren't the only ones paying a price.
The maker of Botox—California-based Allergan, Inc.—acknowledges that it uses the Lethal Dose 50 Percent (LD50) test for each new batch. In this procedure laboratory staff give animals different doses of a product to test its toxicity by seeing how much is needed to kill half of them.
Botox's active ingredient is the paralyzing nerve toxin produced by Clostridium botulinum bacteria, which also causes food poisoning. Mice injected with Botox become paralyzed during the three- to four-day test. In most cases those given a high enough dose slowly suffocate as their respiratory muscles become paralyzed—undoubtedly after considerable suffering.
The LD50 test is now widely considered inhumane, outdated, and unreliable. Leading toxicologists criticize the test's scientific value because of the huge variability in results. And alternative tests are available. In fact, European authorities recently identified several that—once validated—might be substituted in Allergan's testing.
Last fall we asked the company to commit to a plan to replace its use of animals in Botox Cosmetic testing. Allergan officials claimed to devote "significant" resources to develop other methods but so far haven't provided any specifics on a development program for alternatives or on current animal testing programs.
Company officials also insist that the FDA requires the LD50 test to assess Botox's potency. While the agency hasn't confirmed this, we're calling on the FDA to work with Allergan to end the use of animal testing for Botox Cosmetic within three years and to stop requiring the LD50 test for any other product.
Animals shouldn't have to suffer so someone's facial wrinkles will be less noticeable for a few months. Patients using Botox for medical treatment may not have other options, but consumers who simply want to look younger should think twice, as long as the LD50 tests continue. And while our focus is on Botox Cosmetic rather than on Botox used for therapeutic purposes, any nonanimal alternative tests developed for cosmetic applications are also likely to apply to medical uses.
We'll continue offering Allergan help in developing alternatives to the LD50 test. We'll continue keeping pressure on the FDA to encourage sound—and humane—science. We'll keep working to ensure that mice bred for and used in research gain long-needed protections they don't currently receive under the federal Animal Welfare Act. And we'll keep you informed about our progress.
For more on Botox Cosmetic and what you can do to help us stop the use of the LD50 test, visit the links below. And for an up-to-date list of "cruelty-free" cosmetics and personal care products and manufacturers, visit www.leapingbunny.org.
