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FDA petition would protect public from dangerous drugs

November 15, 2007

Mandatory alternatives petition being filed today would compel fda to modernize testing requirements for drugs, vaccines and other pharmaceuticals

WASHINGTON---In a petition filed today with the U.S. Food and Drug Administration, an international coalition of scientists and doctors seeks to compel the agency to stem the flood of dangerous drugs reaching American consumers by mandating the use of scientifically superior non-animal testing methods when those alternatives exist.

Petition signatories include a plaintiff in a Vioxx lawsuit who refuses to accept the recently proposed settlement with Merck because she is concerned that misleading animal drug testing will continue to put consumers at risk. After taking Vioxx to cope with pain from a shoulder injury, Nancy Tufford was diagnosed with congestive heart failure. Vioxx, a painkiller that appeared beneficial to the heart in mouse studies, was withdrawn from the market after it was shown to be the likely cause of thousands of fatal cardiac events in people.

Noting a series of similar tragedies in which pharmaceutical products that seemed safe in animal tests injured or killed consumers or participants in clinical trials, the coalition calls on the FDA to emulate a European Union regulation that requires the use of human-centered testing methods, when available. The Mandatory Alternatives Petition, or MAP, lays the groundwork for legal action. If the FDA does not act within six months, the petitioners will consider further action.

"Dangerous drugs are killing American consumers because regulators allow drug companies to use misleading animal tests," says coalition spokesman John J. Pippin, M.D., F.A.C.C. "The Food and Drug Administration could avert these tragedies by focusing on human-centered methods."

Recent pharmaceutical product testing failures include Merck's HIV vaccine, which 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.

Coalition members point 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 Half the drugs that are approved are later withdrawn or relabeled for adverse effects not detected by animal tests.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. Greater use of alternatives would also have a humane benefit because it would reduce the use of monkeys, dogs, cats, mice, and other animals. In Europe, the use of scientifically satisfactory alternatives, where those alternatives are available, is mandated under European Union Directive 86/609/EEC.

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 the Physicians Committee for Responsible Medicine.

Physicians Committee for Responsible Medicine