Animal Rights Groups Petition FDA To Require Human Testing

In a petition filed today with the U.S. Food and Drug Administration, an
international coalition of scientists and doctors, including the

Physicians Committee for Responsible Medicine, Association of

Veterinarians for Animal Rights and In Defense of Animals, is seeking

to compel the FDA to mandate the use of human-centered rather than

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mouse studies, was withdrawn from the market after it was shown to be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that are approved are later withdrawn or relabeled for adverse effects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.