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RESEARCH ETHICS By Kristie Stoick, M.P.H., and John J. Pippin, M.D., F.A.C.C.
ALTERNATIVES TO ANIMAL RESEARCH
EPA and NIH Aim to Move Away from Animal Tests
Government regulators are taking a huge step away from animal testing. As we reported in the autumn 2007 issue of Good Medicine, the future of toxicity testing is in the test tube. In the latest issue of the journal Science, the Environmental Protection Agency and the National Institutes of Health announced a collaborative research program that lays the foundation for achieving this vision.
The agreement will bring together research conducted as part of three government programs: the National Toxicology Program’s Biomolecular Screening Program, the EPA’s ToxCast Program, and the NIH’s National Center for Computation Genomics. Research is already under way in all three of these initiatives using thousands of chemicals to optimize nonanimal test-tube assays. The sets of assays can be used together to screen hundreds or thousands of chemicals or products in a few days or weeks—something that is not possible with animal-based tests. The agreement will help the three programs across two agencies share data and methods, allowing faster, better-coordinated work.
Although it is not clear whether the programs will have a stable funding source, this announcement is a major step forward for the replacement of animals in toxicity testing. “This won’t mean that animal testing will disappear overnight, but it signals the beginning of the end,” says NIH director Elias Zerhouni.
Collins FS, Gray GM, Bucher JR. Toxicology. Transforming environmental health protection. Science. Feb. 15, 2008;319(5865):906-907, Weise, E: Three US agencies aim to end animal testing. USA Today. Feb. 14, 2008.
The End of the Lethal Dose 50?
Scientists from 18 major pharmaceutical companies have concluded that a notoriously cruel and extremely common animal test does not produce useful data and should not be used to safety-test pharmaceuticals. The report, which was published in the journal Regulatory Toxicology and Pharmacology, questions the need for the Lethal Dose 50, or LD50, test. The LD50, conducted for all pharmaceuticals and most chemicals, determines the dose of a chemical that kills 50 percent of the animals in the study. It is considered a crude way to measure toxicity.
The industry scientists analyzed 74 compounds and determined that data from the LD50 had never stopped the development of a drug or provided information for further animal or human studies, and that other tests, including cellular methods, were more useful. While animal protection scientists have been promoting the use of test-tube assays as a replacement for the LD50 for years, this prominent publication has already attracted attention from pharmaceutical regulators and is a huge step toward ending the use of one of the cruelest toxicity tests.
Robinson S, et al. A European pharmaceutical initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development. Reg Tox Pharm. (2007), doi:10.1016/j.yrtph.2007.11.009.
President Bush Signs “Chimp Haven Is Home Act”
On December 26, President Bush signed the “Chimp Haven Is Home Act,” which prevents the chimpanzees at Chimp Haven, a sanctuary in Louisiana, from being returned to research laboratories. Chimp Haven provides lifetime care for chimpanzees who have been retired from medical research or the entertainment industry, or who are no longer wanted as companion animals.
NUTRITION By Susan Levin, M.S., R.D.
Younger Women Dying of Heart Disease
Young and middle-age women are dying of heart disease at increasing rates. Among those ages 35 to 54, heart disease deaths have climbed 1.3 percent each year since 2002. Among older men and women, death rates have fallen, probably due to increased use of cholesterol-lowering medications. The troubling trend among younger adults could be attributed to worsening diets that, in turn, aggravate risk factors such as obesity, diabetes, hypertension, and metabolic syndrome.
Ford ES, Capewell S. Coronary heart disease mortality among young adults in the U.S. from 1980 through 2002: concealed leveling of mortality rates. J Am Coll Cardiol. 2007;50:2182-2132.
Chubby Kids Are Headed for Heart Attacks
Overweight children are headed for serious heart risks in adulthood, according to a new study from Denmark. The study followed 276,835 children, ages 7 to 13, into adulthood, finding that heavier children were much more likely to develop coronary heart disease as adults. According to the Centers for Disease Control and Prevention, 19 percent of children ages 6 to 11 years are overweight. For many, hypertension, cholesterol problems, high blood sugar, and blood vessel abnormalities are already present.
Baker JL, Olsen LW, Sørensen TIA. Childhood body-mass index and the risk of coronary heart disease in adulthood. N Engl J Med. 2007;357:2329-2337.
FDA Approves Milk and Meat from Cloned Animals
Despite consumer concerns, the Food and Drug Administration has declared that meat and dairy products from cloned cattle, pigs, and goats can be sold to consumers. About two-thirds of American consumers are uncomfortable with the idea of cloning animals for food, citing ethical, religious, and food-safety concerns. Animal clones are more likely to have severe birth defects, compared with animals born as a result of sexual reproduction, according to data collected by the FDA. Milk and meat from cloned animals and their offspring will likely be sold without special labeling.
US Food and Drug Administration. Guidance for industry use of animal clones and clone progeny for human food and animal feed. Rockville, MD: Center for Veterinary Medicine, US Department of Health and Human Services; January 15, 2008. Guideline No. 179.