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Tryptophan trips up.

In November 1989, Gerald Gleich of the Mayo Clinic placed a call to the Centers for Disease Control in Atlanta. He reported that three women in New Mexico and one person in Minnesota were suffering from the same puzzling symptoms.

All had been taking tryptophan, an amino acid the body uses to build protein.

The Disease

The new disease was called EMS, or Eosinophilia-Myalgia Syndrome, because patients have high levels of white blood cells called eosinophils and muscle pain (myalgia). What does it feel like?

"Imagine a painful cramp in the foot multiplied a hundredfold," said Paul L. Houts, an EMS victim who testified at a Congressional hearing last July.

"The spasms hit every part of the body--no muscle is inviolate. Furthermore, the spasms are liable to hit simultaneously, leaving the victim howling in pain or writhing on the nearest flat surface."

And it doesn't go away. "Problems which persist include fatigue, muscle weakness, aches and cramping, joint pains, scarred tight skin, and nerve, heart and lung damage," Esther Sternberg, a researcher at the National Institutes of Health, told Congress.

Of the more than 1,500 victims reported so far, 31 have died because of irregular heartbeats and lung faiure. So far, there is no treatment.

The Regulations

In 1973, the FDA took tryptophan and all other amino acids off the GRAS (Generally Recognized As Safe) list. It wasn't that they had a clue about EMS. "Our main concern was that too much of one amino acid could cause an imbalance of others, not acute toxicity," says the FDA's Douglas Archer.

But in 1977, the FDA fumbled. It published a GRAS list that, by mistake, included tryptophan, and it took six months to correct the error. So when the FDA seized tryptophan tablets in 1977, the manufacturer sued and won, arguing that tryptophan had been on the GRAS list at the time it was being sold.

Despite this defeat, says Philip Derfler of the FDA's General Counsel's office, "we believe that tryptophan's marketing was unlawful under the [Food, Drug and Cosmetic] Act since 1973." But the FDA didn't act, because of the court case . . . and a new law.


In 1973, the FDA tried to rein in all supplements, perhaps too tightly. Any supplement containing high doses, said the FDA, would be classified as a drug.

Within three years, Congress passed the Proxmire Amendment, which specifically prohibited the agency from calling a supplement a drug just because the dose was high.

"It seemed to signal Congessional intent that supplement-type products not be regulated without indications of real danger to health," Archer told Congress.

That explains why, for almost two decades, tryptophan was--and other amino acids still are--sold in the U.S. even though the FDA considered their sale unlawful.

The Cause

Like millions of others, Norma Hart, a former New York City school teacher, had no clue that the FDA considered tryptophan illegal. "I've always had trouble sleeping and wanted to avoid the side effects of habit-forming drugs," she told a recent FDA hearing on supplements, breathing rapidly to counter EMS's damage to her lungs.

Tryptophan is supposed to promote sleep because the body converts it to serotonin, a chemical that passes messages from one nerve cell to another.

"I was told that tryptophan was a natural substance that occurred in milk and turkey. With my two masters and a doctorate in education, I thought it was made from boiled down milk and turkey," says Hart.

In fact, tryptophan is made by bacteria. But, as the supplement industry is eager to point out, tryptophan is made by bacteria. But, as the supplement industry is eager to point out, tryptophan was taken safely for 25 years before anyone got EMS. The tryptophan that caused EMS was made by one Japanese company, Showa Denko.

Between the fall of 1988 and the summer of 1989, Showa Denko made two changes in the way it produced its tryptophan:

* it introduced a new strain of bacterium that was genetically engineered to produce higher levels of tryptophan, and

* it cut back on the filtering process used to purify the tryptophan.

Because of one--or both--of these changes, Showa Denko's tryptophan contained a compound not found in any other company's tryptophan. Referred to as Peak 97 (after the spike it forms on a graph of its components), it consists largely of two tryptophans chemically stuck together.

Researchers are eagerly awaiting the results of Sternberg's most recent study, which should show whether Peak 97 causes all the key symptoms of EMS in animals. If it doesn't, it's back to the drawing board.

The Catch

It will take some time before the FDA solves the EMS mystery. But regardless of what caused the disease and how it can be treated, one troubling fact remains: Showa Denko's tryptophan was "pure" enough to be sold as drug. So it's hard to know how EMS could have been avoided.

"This was a new disease with a new, unknown cause, and no one could have anticipated it," says Archer. "Can we be sure another strange disease syndrome won't crop up? No."
COPYRIGHT 1991 Center for Science in the Public Interest
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1991, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

Article Details
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Title Annotation:dietary supplements
Author:Liebman, Bonnie
Publication:Nutrition Action Healthletter
Article Type:Cover Story
Date:Oct 1, 1991
Previous Article:Taking supplements seriously.
Next Article:Stripped-juice tease.

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