Cardiologist to testify at FDA hearing: Animal tests implicated in Vioxx tragedy

Main Category: Cardiovascular / Cardiology
Article Date: 16 Feb 2005 - 14:00 PDT

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Numerous mouse experiments showed heart-protective effects for COX-2 inhibitors allowing killer painkillers on market

On February 17, John J. Pippin, M.D., FA.C.C., will testify before Food and Drug Administration (FDA) officials and present a new report detailing how experiments on mice, dogs, and other animals misled scientists and ultimately contributed to a tragic outcome for human patients exposed to Vioxx and other drugs. Dr. Pippin will represent the nonprofit Physicians Committee for Responsible Medicine (PCRM).

PCRM's report reveals that Vioxx and other COX-2 drugs actually had a heart-protective effect in mice and other animals, exactly opposite of how the drugs later performed in humans. The report also reveals that once clinical trials started showing that the drugs caused heart problems in humans, the pharmaceutical companies ignored this information and instead pointed to the animal tests as "evidence" that the drugs were safe. As Dr. Pippin illustrates in the report, the Vioxx animal testing debacle is not unique. Over the years, millions of patients have been exposed to harmful drugs, such as Rezulin and Baycol, that seemed safe in tests on mice, dogs, rats, monkeys, horses, and other animals.

"Reliance on animal tests enabled the FDA to approve Vioxx," says Dr. Pippin. "It is time to turn to newer, more reliable human-based methods such as studying drug metabolism using human liver subcellular fractions." Liver toxicity is the major reason for drug re-labeling and withdrawal, and it often does not show up in dogs and other animals.

WHO: Cardiologist, John J. Pippin, M.D., F.A.C.C., representing PCRM
WHAT: Testimony at FDA hearing on Vioxx and related drugs.
WHEN: Thursday February 17, 2005 between 1 and 3 p.m.
WHERE: The Ballrooms at the Hilton DC North, 620 Perry Pkwy., Gaithersburg, MD.

For an interview with Dr. Pippin call Jeanne S. McVey, on-site cell phone, (415) 509-1833.

Founded in 1985, the Physicians Committee for Responsible Medicine is a nonprofit health organization that promotes preventive medicine, especially good nutrition. PCRM also conducts clinical research studies, opposes unethical human experimentation, and promotes alternatives to animal research.

Contact: Jeanne Stuart McVey
jeannem@pcrm.org
Physicians Committee for Responsible Medicine