Moving Beyond Animal Research
Every day, thousands of animals are experimented on or killed to create and test drugs that will never help a sick human being. That’s because animals make for very poor predictors of a human’s reaction to a particular drug. In a petition filed November 14 with the U.S. Food and Drug Administration, PCRM and an international coalition of scientists, doctors, and animal-protection organizations asked the agency to mandate the use of validated nonanimal testing methods, when those alternatives exist, to create safer drugs for American consumers.
The Mandatory Alternatives Petition, or MAP, points to a series of recent tragedies in which pharmaceutical products that seemed safe in animal tests injured or killed consumers or participants in clinical trials. Vioxx, a painkiller that appeared beneficial to the heart in mouse studies, was withdrawn from the market after it was shown to be the likely cause of thousands of fatal cardiac events in people. Merck’s HIV vaccine appeared safe and effective when tested in monkeys. Subsequently, a large international clinical trial was halted when Merck’s new vaccine appeared to increase the risk that a human patient would contract the virus that causes AIDS.
The MAP coalition points out that more than 90 percent of drugs tested in people after successful animal tests are not approved for wider use because they don’t work or they are unsafe. Half of that small number of drugs that are approved are later withdrawn or relabeled for adverse effects not detected by animal tests. Adverse drug reactions are a leading cause of death in the United States. To reduce such risks, the MAP coalition urges wider use of human-centered research methods such as microdosing, tissue studies, and virtual drug trials.
The MAP calls on the FDA to emulate the European Union regulation that requires the use of human-centered testing methods, when available. If the FDA does not act within six months, the petitioners will consider further legal action.
The MAP is signed by more than 100 doctors, scientists, and other experts, including famed primatologist Roger Fouts, neurologist and public health expert Aysha Akhtar, M.D., M.P.H., pediatrician Roberta Gray, M.D., and economist Jeremy Rifkin. Nonprofit organization members of the MAP coalition are the Association of Veterinarians for Animal Rights, the British Union for the Abolition of Vivisection, In Defense of Animals, the New England Anti-Vivisection Society, and PCRM.