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FDA at Work

C. Norman Shealy, M.D., Ph.D.

I will just list some facts and let you come to the conclusion.

In the 1960’s the FDA invited me to be on an Advisory Committee to evaluate Chymopapain, a purified meat tenderizer being promoted to cure ruptured discs. The advisory committee of 20 physicians reviewed 2000 “research” cases and came to the recommendation that the research team had not followed the protocol, so we recommended they start over and do the project according to protocol. The FDA abolished the Advisory Committee and approved the drug! It had, among other problems, a 1.5% rate of anaphylaxis (SHOCK) with potential for death. There had been one death and several other serious complications. The drug was withdrawn from the market eventually by the manufacturer because of the complications.
On March 22, 1990, the FDA BANNED the sale of L-Tryptophan because one of 7 companies manufacturing Tryptophan had a contaminant that may have caused Eosinophilic-Myalgia-Syndrome. FOUR DAYS LATER, on March 26, 1990, TIME magazine featured a lead article on the virtues of Prozac. I need not enumerate the suicide rate and other complications of Prozac.

On at least two occasions in the past, Tylenol  was recalled for a few days when it was found to have a contaminant of arsenic! It was never banned and is still a leading cause of liver failure.

Cranial Electrical Stimulators have been on the market since at least 1975. I personally have use the best of these, the Liss CES in over 30,000 patients with great success in treating depression, with no complications. CES units have been selling at the rate of 100,000 units a year and no significant problems have been reported. Now the FDA has issued an advisory that they may ban all Cranial Electrical Stimulators as of November 12, unless someone comes up with an argument acceptable to the FDA ($100 million).

Of course, CES units require a prescription. In every other country in the world, all TENS and CES units are sold over the counter.


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