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Graham Blows The Lid on Toxic COX-2 Drugs

I had been anticipating this week's FDA meeting -- probing the safety of Vioxx and its related painkillers Celebrex and Bextra -- for some time, and very much looking forward to today's testimony by Dr. David Graham, my newest hero. And I wasn't disappointed by his testimony concerning Vioxx and Celebrex.

Various studies showed a range of increased heart attack risk ranging from 400 to as many as some 11,000 additional heart attacks in men ages 65-74 at low doses of Vioxx, Graham said.

Why the range? Patients who participate in clinical trials are typically healthier than those "in the real world," which could have much to do with underestimating Vioxx's lethal impact, Graham says. The average user of a COX-2 inhibitor like Vioxx or Celebrex is a patient in their 60s with other health issues and already at a 2 percent risk of a heart attack. Graham also believes there are also risks in taking Celebrex at high doses, but does not have enough information on Bextra to make a call.

Perhaps, even more damning evidence: Yesterday's testimony from Dr. Ned S. Braunstein, senior director of Merck Research Laboratories, who believes the problem Graham and others have identified affects the entire class of COX-2 inhibitors.

Also of great interest was the testimony of Dr. Garret A. FitzGerald of the University of Pennsylvania who has worked for years to uncover how COX-2 drugs affected body chemicals that determine the "stickiness" of blood and, thus, the likelihood that someone taking them might experience a heart attack, stroke or similar problem.

Moreover, simply reducing the doses of Celebrex or Bextra would not be effective in eliminating the risks of the drugs, FitzGerald said.

Just more incentive to try more sensible, natural and healthier approaches to treating pain:

Yahoo News February 17, 2005

New York Times February 17, 2005

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