In U.S., Few Alternatives To Testing On Animals
Saturday, April 12, 2008
Each year, American doctors inject more than 3 million doses of Botox to temporarily smooth their patients' wrinkles and frown lines. But before each batch is shipped, the manufacturer puts it through one of the oldest and most controversial animal tests available.
To check the potency of its product under federal safety rules, Allergan Inc. injects mice with Botox until it finds a dose at which half of the animals die -- a rough gauge of potential harm to humans.
Animal protection groups consider "lethal dose 50," as the test is known, to be "the poster child for everything that's wrong with animal testing," said Martin Stephens, vice president for animal research issues at the Humane Society of the United States. "It's as bad as it gets, poisoning animals to death."
Allergan officials say they have no choice. Without a federally approved safety test that does not use animals, a company spokeswoman says, lethal dose 50 "is by default the required test."
The controversy over the Botox test highlights the slow pace of government efforts to replace or reduce the large numbers of animals used by pharmaceutical companies, chemical manufacturers and consumer firms to ensure that their products are safe for people. A decade after Congress created a panel to spur the development of non-animal tests, only four such tests have been approved out of 185 reviews, according to the panel's records.
Several of the panel's original backers now consider the system broken. As a result, critics say, hundreds of thousands of mice, rabbits, hamsters and dogs continue to suffer and die unnecessarily in tests for pesticides, household cleaners, sunscreens and other products.
"We were thrilled when the legislation was passed," said Sara Amundson, a former official with the Doris Day Animal League who was involved in creating the panel. "It's shocking to look back and see how little we have accomplished."
The federal panel is known as the Interagency Coordinating Committee on the Validation of Alternative Methods, or ICCVAM. Representatives of 15 federal agencies make up the committee.
Instead of acting as an advocate for companies and nonprofits proposing non-animal tests, the panel has become an obstacle, animal welfare groups say. They point to Europe, where a similar panel has approved 34 alternatives to animal tests and has another 170 in its pipeline. Critics say the U.S. panel is slow and favors older animal tests that have never gone through the same rigorous scientific review.
The executive director of the U.S. panel, William S. Stokes, said in a statement that his group "has successfully reviewed over 185 test methods" and that the four alternatives it has endorsed "have significantly reduced the number of animals required for safety assessments, and provided for improved welfare of animals used in safety evaluations." One alternative has saved "at least 36,000 animals annually," Stokes said.
Members of the panel also contend that it is unfair to compare Europe and the United States because the laws, rules and expectations are different. Europe has legislation mandating the use of non-animal tests. The United States only recommends their use.
Nevertheless, some U.S. company officials and scientists said they have delayed or abandoned their proposals for non-animal tests because panel reviews are protracted and expensive. Others consider panel members biased in favor of animal tests that in some cases date back to the 1920s.