Imagine that you are one of the animals unfortunate enough to be used in assessing the potency of new batches of Botox® Cosmetic. A popular anti-wrinkle treatment, Botox Cosmetic's active ingredient—Botulinum toxin—is one of the most poisonous of known substances.
First, the toxic substance or the full product is injected into your stomach. Then, as it courses through your bloodstream, the toxin causes nausea and then brings on a wave of muscle paralysis that spreads throughout your body. Finally, over the course of the three-to-four day test, you suffocate to death.
Welcome to the ugly world of testing the most common cosmetic procedure in the United States—testing that uses a method known as "LD50" which leaves at least 50% of its animal subjects—mice—dead. A recent development in HSUS's campaign to end Botox testing on animals has the potential to change the look of that world, and to help protect mice from this gruesome death.
A Wrinkle in Deadly Testing
The Humane Society of the United States has been working to end the inhumane practice of LD50 testing of Botox Cosmetic (and similar Botulinum toxin-based products) since October 2004. Both the manufacturer of Botox—Allergan, Incorporated—and the agency that regulates this product—the U.S. Food and Drug Administration (FDA)—have ignored HSUS calls to put a stop to this testing on animals.
But in January 2006, The HSUS made a breakthrough. In 2005, The HSUS submitted a proposal to the U.S. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), urging the agency to pursue alternative methods for the testing of these products. The agency is responsible for developing and validating new testing methods.
In January, ICCVAM responded by essentially adopting HSUS's proposal.
In a Federal Register notice issued January 27, ICCVAM announced that, as a first step in investigating potential alternatives to LD50 testing of Botox-type products, the agency will coordinate an expert workshop on the subject as a high priority. Then ICCVAM requested feedback from interested parties on it plans, asking: Is an expert workshop an appropriate first step in the process and, if so, should this action be a high priority?
The HSUS took the opportunity to encourage all caring people to respond to ICCVAM, and urged them to move forward with the workshop as a high priority, and as the most efficient way to identify the most promising alternative methods. Close to three thousand concerned people responded to this call, and wrote to ICCVAM in support of the workshop by the March 13, 2006 deadline. You can view these letters and other comments on the ICCVAM web site.
Allergan: The Key to Alternatives?
This announcement opened the door for Allergan to play a large role in the new initiative. Allergan was in a unique position to provide the technical information that ICCVAM was soliciting on the performance of the LD50 test and any potential alternatives relevant to Botox-type product testing.
As the only producer of Botox Cosmetic and the leading producer of all Botulinum toxin "type A" products, Allergan has access to years of LD50 testing data that would be invaluable to ICCVAM's assessment of the status quo.
Moreover, in response to The HSUS campaign, Allergan announced (without providing details) that the company has spent millions of dollars on alternatives to the LD50. If true, the company should have just the kind of data on potential alternative methods that ICCVAM is seeking.
The HSUS has urged Allergan to cooperate with ICCVAM by sharing its data on the performance of the LD50 test and the alternatives that the company claims it has been pursuing. "ICCVAM's announced plans provide an excellent opportunity for Allergan to contribute openly toward developing and validating alternative methods for assessing the potency of Botox-type products," said Dr. Marin Stephens, vice president for The HSUS's Animal Research Issues.
For their part, ICCVAM officials contacted Allergan in advance of the workshop as part of their review process.
The Price of Beauty
Though Botox does have several therapeutic uses, its most common use is cosmetic—namely, as a wrinkle reducer. Allergan netted over $830 million dollars in 2005 from its sale of Botox. Of that amount, 43% percent, or $357 million, was from the cosmetic use. This percentage has 
increased steadily since 2002, when the FDA approved Botox to treat frown lines, and shows no signs of stopping. Botox Cosmetic's effect lasts only about 3 months, so as more people begin using this vanity product, more are also likely to seek additional treatments to maintain their wrinkle-free look.
"The HSUS acknowledges that Botox has several medical uses that are beneficial to humans, and those uses should continue," said Stephens, "But nearly half of the drug use, and the animal suffering, are for beauty enhancement. An ICCVAM workshop using Allergan's data has a good chance of leading to the use of alternatives for assessing all Botox-type products, no matter what the application."
LD50 testing of Botox-type products represents a remnant use of a procedure that had been the quintessential safety test for decades. In this test, large numbers of animals are exposed to a substance, usually through forced-feeding, in order to statistically estimate the dose that kills 50% of the animals; hence the name LD50 or "Lethal Dose 50%." The lower the estimated LD50 value is, the higher the toxicity or, in the case of Botox-type products, the higher the potency.
In recent decades, the LD50 Test has been widely criticized on scientific and humane grounds, and consequently, its use has been in decline. In 2002, for example, the Organisation for Economic Cooperation and Development (a trade organization that issues internationally accepted testing guidelines for industrial chemicals) deleted the LD50 Test from its guidelines.
The use of the LD50 Test in assessing the potency of Botox Cosmetic was publicly exposed in 2003. The following year The HSUS launched its campaign to end the use of this application of the test. The recent ICCVAM announcement is clearly a welcome breakthrough in this campaign, and The HSUS believes that a workshop is indeed a wise first step in the effort to identify and refine alternatives to the deadly LD50 test.
Mice, admittedly, are not the most popular animals. But as British philosopher Jeremy Bentham once famously said about the treatment of animals, "...the question is not, Can they reason? nor, Can they talk? but, Can they suffer?" In this case, there is no doubt that mice are indeed suffering.
What You Can Do
Thousands of you responded to our call for action and wrote to ICCVAM and Allergan, letting them know that a workshop was in order and that Allergan should help by sharing its testing data. Thank you for taking action. Your enthusiastic responses will have made a difference.
For an up-to-date list of "cruelty-free" cosmetics and personal care products and manufacturers, visit The Coalition for Consumer Information of Cosmetics.
