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Friday, December 3, 2004

Thalidomide, Vioxx, Ortho Evra patch, Morning After Pills, RU-486...

"Which of those 5 drugs doesn't belong?"

They all do, in my opinion: "Safety of American Drugs Questioned" (also found here on MSNBC).

Associated Press reports
In a sharp pivot, many medical authorities are questioning the fundamental safety guarantees for American drugs, threatening to dull the national appetite that has demanded and devoured pharmaceuticals at a faster clip for nearly a generation.

In a challenge unthinkable even two months ago, Dr. Catherine DeAngelis, [M.D.,] editor of the Journal of the American Medical Association, now compares the drug safety system to a dangerous building: "This building is on very shaky ground. Would I condemn it? No, but I would tell people, 'You go in at your own risk.'"
Dr. Jerry Avorn, Harvard Medical School expert: "...says recent revelations about the FDA suggest 'a culture of denial' about dangerous side effects, especially once a drug is on the market."

Dr. David Graham, a senior safety scientist at FDA: "The system itself is completely broken. The system is incapable of preventing another Vioxx." The article states that "Graham has put forth his own list of five marketed drugs to re-evaluate.

[An AP story from Dec. 9, 2002 reported that "the Bush administration is ordering 10 prescription drugs to be detained at the U.S. border if patients buy them abroad instead of through their doctors, calling the medications too risky for unsupervised use. Included in the FDA directive: the dangerous abortion drug mifepristone (otherwise known as RU 486 or mifiprex). All of the drugs...can cause serious side effects and are allowed to sell in the United States only under severe restrictions... The Clinton administration [in September 2000] hurriedly approved the abortion drug, then known as RU 486."

Dr. Sidney Wolfe, director of the nonprofit Public Citizen Health Research Group: "...says there are better, safer alternatives to more than 180 drugs." [Their email address is]

Dr. Marcia Angell, a former editor of the New England Journal of Medicine: "The [drug] industry has now captured the agency that is supposed to be regulating it."

I also didn't know there are "100,000 annual [legal, prescription] drug deaths" in this country.

So. The editor of the prestigious JAMA is quoted saying the FDA isn't doing a good enough job keeping us safe. And Harvard, FDA and NEJM physician/researchers are also saying it.

So, it isn't just us saying it anymore. Hmmmm.

Sure, the article doesn't say those doctors are including the Ortho Evra patch, Morning After Pills and RU-486 on their list of drugs to be re-reviewed for safety. But they should be, if they're not already.

I'd love to see that list of drugs Dr. DeAngelis and Dr. Graham have in mind, though. Mayhap we should consider writing Dr. DeAngelis, Dr. Graham, and the head of the FDA's doctor-in-charge of such things, asking them to make sure those drugs are on that list:
Dr. Janet Woodcock
Director of U.S. FDA
Center for Drug Evaluation and Research
Food and Drug Administration
Building PKLN, Room 1061 or 1471
Mailstop HF-2
5630 Fishers Lane
Rockville, MD 20857

Or submit online comments here, or send her an
e-mail here.

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