CAMLAW: Complementary and Alternative Medicine Law Blog

FDA Less Trusted

With the Vioxx debacle, the FDA has lost authority and credibility as a voice for consumer protection.

Americans Growing Less Confident in FDA's Job on Safety, Poll Shows
(The Wall Street Journal, May 24, 2006) -- "Americans have become less confident in the Food and Drug Administration's ability to ensure the safety and efficacy of new prescription drugs. Fifty-eight percent of people in a new Wall Street Journal Online/Harris Interactive health-care poll said they feel the FDA does a fair or poor job in this regard, while 36% said the agency does a good or excellent job."

""The Vioxx story underscores the extent to which the FDA has come to see itself as representing the drug companies, not the public," according to Dr. Marcia Angell, senior lecturer in social medicine at Harvard Medical School, former editor in chief of The New England Journal of Medicine, and author of "The Truth About the Drug Companies: How They Deceive Us and What to Do About It." (See http://www.nybooks.com/articles/19055).

But of course if dietary supplements are involved, regulatory authorities are typically all too quick to point out the dangers of "untested" remedies, provoking criticisms of a "double standard" in judging conventional vs. alternative medicine.

Note: On April 5, 2006, a New Jersey jury found that Merck's arthritis drug Vioxx caused John McDarby, a 77-year-old retired insurance agent, to suffer the heart attack that left him debilitated in 2004. The jury also found Merck guilty of consumer fraud for not warning doctors and the public of the drug's cardiovascular risks. McDarby and his wife were awarded $4.5 million, plus another $9 million in punitive damages because the company was found to have misled the U.S. Food and Drug Administration (FDA). Merck now faces about ten thousand similar lawsuits.

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COMPLEMENTARY & ALTERNATIVE MEDICINE LAW BLOG

Michael H. Cohen, Esq.; 468 North Camden Dr. | Beverly Hills, California 90210 | 310-844-3173