Every year, more than 2.7 million people pay to have one of the most powerful toxins known to man—a potential bioterrorism agent—injected into their face. The agent is botulinum toxin, but we know the commercial product as Botox®Cosmetic. It smoothes facial wrinkles, but only temporarily.
Sadly, every Botox® injection comes with a price. Animals suffer and die in the potency testing of Botox. And while Botox has important medical applications, these animals die increasingly for nothing more serious than temporarily smoothing wrinkles.
In 2007 alone, more than 2.7 million cosmetic Botox procedures were performed, according to the American Society for Aesthetic Plastic Surgery. Since 2000, Botox has been the number one cosmetic procedure performed in the United States. In 2007, Allergan netted $1.2 billion from all Botox sales, 50 percent of which were from Botox Cosmetic; that's more than $600 million for Botox Cosmetic alone. And total Botox sales are projected to increase by 13 to 17 percent in 2008.
Yet whether for therapeutic or cosmetic applications, batches of Botox must be tested before Allergan releases the product to doctors and dermatologists. To assess the potency of new batches of the toxin, Allergan uses an infamous procedure known as the LD50 (Lethal Dose 50 Percent) test. The purpose of the test is to find the dose that kills 50 percent of the animals used in the test.
You read that right: The end point of the LD50 test is death to half of the animals used.
Botox, or Botulinum Toxin Type A, comes from the waste of the bacteria Clostridium botulinum, the same toxic byproduct that causes botulism food poisoning. Botox works by paralyzing the muscles that cause wrinkles and certain medical disorders. Because Botox is produced from bacteria, each batch naturally has varying levels of potency, with some being stronger than others. To standardize the potency of its product, Allergan uses the LD50.
This test involves giving mice a single injection of the product into their abdomen and seeing if animals die within 3-4 days. The mice are first assigned to one of various dose groups; each group will receive a different concentration of the product in order to estimate which strength will kill half of the targeted group. That concentration (the LD50 value) is then considered a single "unit" of Botox; from there, Allergan packages a given number of units into a vial for human use.
During LD50 testing of Botox, animals endure differing levels of muscular paralysis and suffer from impaired vision and dry mouth. Animals in the high dose groups die 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. One could hardly imagine a more distressful test. In an April, 2008 front-page story in the Washington Post, the HSUS vice president for animal research issues, Dr. Martin Stephens, characterized the LD50 Test as "the poster child for everything that wrong with animal testing."
Animal welfare advocates have been campaigning to abolish the LD50 for more than two decades. Developed in the 1920s, it has been all but abandoned as a routine safety test. However, it is still the method of choice by the manufacturers of botulinum toxin products and the government authorities that oversee them. Encouragingly, the regulatory authorities have signaled their willingness to accept more humane alternatives when these are developed by the manufacturers.
Working with various partners, The HSUS has sought to raise the profile of this issue with manufacturers like Allergan, regulatory authorities like the Food and Drug Administration, and pro-alternative authorities such as the US Interagency Coordinating Committee on the Validation of Alternative Methods, as well as consumers. Allergan is investing resources in finding alternatives to LD50 testing of its flagship product, but the company has revealed few details of its testing practices and alternative efforts.
It’s bad enough when animals suffer and die in the name of biomedical research. It is completely unacceptable when animals are forced to die for the sake of a temporary beauty enhancer—especially at a time when leaders in the field of safety testing are predicting the end of all animal testing with the application of modern scientific approaches to the field.
What You Can Do
Contact Allergan to urge them to replace the LD50 test for Botox testing and to keep investors and consumers updated on their progress. The company especially needs to hear from Botox users and Allergan investors. Please let Allergan CEO David E.I. Pyott know that you don't think animals should die in the name of individual vanity.
Updated May 5, 2008
