PCRM Calls on FDA to Speed the Transition to Nonanimal Tests
Every day, thousands of animals are experimented on or killed to create and test drugs that will never help a sick human being. In some cases, animal tests suggest that a new drug is dangerous when in fact it would be quite safe for humans; yet the drug is abandoned. In other cases, drugs appear safe in animal tests when in fact they are dangerous to humans. In both cases, a drug’s effect in animals makes for a very inexact predictor of its effect on people.
The push for nonanimal testing methods comes from scientists concerned about both the humane aspects of animal testing and the need for better testing methods. Unfortunately, the fact that new and accurate nonanimal test methods have been developed does not mean they will be used. The pharmaceutical industry is often shy about using methods that break from tradition.
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 Vioxx, a painkiller that appeared beneficial to the heart in mouse studies, was withdrawn from the market after it was shown to be the likely cause of thousands of fatal cardiac events in people.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 make humans more susceptible to HIV infection.
The MAP coalition points out that more than 90 percent of drugs tested in people after seemingly successful animal tests are not approved for wider use because they don’t work or they are unsafe. Half of the remainder are later withdrawn or relabeled with new warnings of adverse effects not detected by animal tests. Adverse drug reactions are a leading cause of death in the United States. To improve the testing process and reduce drug risks, the MAP coalition urges wider use of human-centered research methods such as microdosing, tissue studies, and virtual drug trials, all of which are highly effective and entail essentially no risk.
Ethically conducted, human-centered research spares the lives of countless monkeys, dogs, cats, rabbits, rodents, and other animals each year. Animals in laboratories suffer when forced to ingest toxic substances or undergo painful procedures, but they also experience profound stress just from routine laboratory procedures, like handling and blood draws.
The MAP calls on the FDA to emulate the European Union regulation that requires the use of nonanimal and other alternate testing methods, when available. If the FDA does not act within six months, the petitioners will consider further legal action.
“One of the reasons that dangerous drugs have been left on the market is that regulators have allowed drug companies to use misleading animal tests,” says PCRM senior medical adviser John J. Pippin, M.D., F.A.C.C. “The Food and Drug Administration could avert these tragedies by focusing on more accurate methods.”
To learn more about the MAP, visit www.alternatives-petition.org.
The Food and Drug Administration needs to hear from you! More than 15,000 PCRM members have already signed petitions that are being sent to the FDA. Please write to the FDA commissioner and politely urge the organization to mandate the use of validated alternatives to animal tests:
Andrew C. von Eschenbach, M.D., Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857