Cardiologist Will Drop Bombshell Testimony at Vioxx Hearing

[paineinthearse]

Cardiologist Will Drop Bombshell Testimony at Vioxx Hearing: Animal Tests Implicated in Tragic Outcomes for Human Patients

2/15/2005 2:25:00 PM

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To: Assignment Desk, Daybook Editor, Medical and Health Reporter

Contact: Jeanne Stuart McVey of the Physicians Committee for Responsible Medicine, 202-686-2210, ext. 316 or 415-509-1833 (cell), [e-mail]

News Advisory:

On Feb. 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, Feb. 17, 2005 between 1 and 3 p.m.

WHERE: The Ballrooms at the Hilton D.C. North, 620 Perry Pkwy., Gaithersburg, MD.

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

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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.

http://www.usnewswire.com/

[Warpy]

1. THIS is why a lot of side effects, even deadly ones,

aren't known for certain until a large enough human population takes the drugs for a long enough time.

The problem with the COX2 inhibitors is that once the problems in humans became known, the pharmaceutical companies were loath to issue a black box warning and affect their profits. People were injured and killed because of it.

This is why the revolving door between the FDA and the pharmaceutical companies needs to be nailed shut, with at least a five year period between the time one can work for one and go to the other.

It's the same revolving door that needs to be nailed shut between all regulatory agencies and the industries they regulate. The same door between Congress and lobbying firms.

[bmbmd]

2. The Physicians Committee for Responsible Medicine

is not a legitimate scientific or accrediting body. It has strong ties to PETA, and primarily espouses vegan lifestyles. I bet you that this testimony is more about animal experimentation than cox-induced endotheliitis.