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FDA petition would protect public from dangerous drugs
Date:11/14/2007

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 Vioxx, a painkiller that appeared beneficial to the heart in mouse studies, was withdrawn from the market after it was shown to be the likely cause of thousands of fatal cardiac events in people.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 Mercks HIV vaccine, which appeared safe and effective when tested in monkeys. Subsequently, a large international clinical trial was halted when Mercks new vaccine appeared to increase the risk that a human patient would contract the virus that causes AIDS.

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Contact: Jeanne McVey
jeannem@pcrm.org
202-527-7316
Physicians Committee for Responsible Medicine
Source:Eurekalert

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