By CiajDiann Harris

OHIO – While the country braces for terrorism waged by the enemy; some Americans are fighting the effects of biochemical warfare that they’ve unknowingly unleashed upon themselves.

At the age of 33, a lady who does not wish to be identified, so she’ll be called, "Dora," was an active, energetic young woman working as a therapist. She states that she was working full-time, taking 23 credit hours a semester working toward her Ph.D. in psychology and doing community theater. Because her time was so valuable, she said, "when I went to bed I needed to go to sleep right away, not toss and turn." Dora began taking L-tryptophan, an amino acid. "L-t produces serotonin in the brain like turkey and warm milk do to make you sleepy," she explained. She didn’t want to take any chemical medicines so she trusted what she thought was a natural product and a healthier way to achieve a restful nights sleep. Today, Dora spends her nights and most of her days in bed taking an abundance of chemical medicines for the pain and other symptoms of EMS while she, as she plainly states, waits to die.

There are 1,000 documented cases of Eosinophilia Myalgia Syndrome (EMS) in the U.S. and according to the National EMS Network (NEMSN); the third largest cluster of victims (50) resides in Ohio. EMS is a painful, debilitating, terminal illness and one of its causes has been directly linked to taking contaminated L-tryptophan. The problem was not the L-t itself, but rather the method used to manufacture it. FDA regulation of dietary supplements that are bought and consumed in mass quantities in the U.S., has proven to be, at least in these cases, inadequate to protect the health and safety of the American consumer.

"They found if they put the bacteria under high-powered lights that it sped up the process for making the L-tryptophan and the demand was great for amino acids among health-conscious consumers. The bacteria they used was bug feces," said Stephen Sheller, Esq., a Philadelphia attorney who represented Dora and over a hundred other individual claims against Showa Denko K.K., the Japanese company that manufactured the contaminated L-t. [Note: "K.K. denotes Showa Denko’s corporate status in Japan; it is the equivalent of Inc. or Ltd."].

A never ending supply of bottles, positioned shoulder-to-shoulder on the shelves of homestyle health food stores and the larger nutrition store chains are like soldiers prepared to assail whatever ails us. They are like a beacon of light to the growing population who is looking for healthy alternatives to chemical medicines. However, many consumers would probably be surprised to know the following. The U.S. General Accounting Office (GAO), the investigative arm of Congress, in its report regarding dietary supplements titled: "Food Safety: Improvements Needed in Overseeing the Safety of Dietary Supplements and ‘Functional Foods,’" stated: "FDA’s efforts and federal laws provide limited assurances of the safety of functional foods and dietary supplements."

Jeffrey Harwood, M.D., a New London physician and the Huron County Coroner said that while he is not a leading authority on EMS, he has treated the disease. "I’m not for big government," Harwood said "but I think it’s odd that you have this whole industry that is virtually unregulated. From a scientific point of view, health care professionals have a problem with that."

If it was thought that the Showa Denko outrage was an isolated incident and if consumers believed that something like that could never happen here again, obviously they were wrong. While it has been several years since the first cases of EMS linked to a contaminated dietary supplement were diagnosed and L-t was taken off store shelves; according to Sharron Lobaugh, president of the NEMSN in Juneau, Alaska, "We have people who received (what she called) a valid prescription for it since that time and they also have contracted EMS."

A more recent case is Renee Kleemeier of Cincinnati, however, Renee didn’t have a prescription, she purchased an over-the-counter sleep aid called 5HTP and now she has EMS. 5HTP was sold as an aid for insomnia, depression, and obesity and for children with Attention Deficit Disorder (ADD).

Renee Kleemeier wasn’t aware of any connection between L-tryptophan and 5HTP and disease and death. She was a 35 year old new mother of twin baby boys who was experiencing some difficulty sleeping again after her sons, Ben and Sam were about one-year old. "After they started sleeping through the night, my insomnia came back," Renee says. "I didn’t want to deep sleep with the babies and I also had a lot of concern about prescription sleep aids."

Dora had taken amino acids off and on for several years before she hit what she calls the "bad batch." Renee Kleemeier took what was essentially less than one bottle, only about 20 pills of the 5HTP, the "safe version" of L-tryptophan before she became ill. From that point there were three different hospitalizations with no diagnosis before she found herself in the hospital with congestive heart failure. Renee’s husband, Ken, a computer specialist said, "My sadness and depression over my wife’s EMS has partly been turned into anger…I can’t believe this drug was still on the market."

Herein lies the problem. L-t, 5HTP and everything found and bought off the shelves of health food and nutrition stores are not drugs. They are dietary supplements and as such are not required to have FDA, carte blanche approval in order to be sold to an unaware public. "The laws governing the safety of functional foods and dietary supplements, as well as FDA’s implementation of these laws, may allow products of questionable safety to reach the market." according the U.S. General Accounting Office report.

"…I awakened at 2:30 shivering as if I were in zero degrees but my face was flame red and burning. I was able to make my way out of my room, through the cabin to where "B" (her husband), was. I sat in my chair at the computer and told him I was having ‘one of those attacks’," Dora wrote this in an email to the friends that she’s met around the world via computer. "…I hate when this stupid disease makes those around me helpless…I put my loved ones through hell as there’s nothing to be done but wait it out" she continued.

Death might be welcomed like a conquering hero to some who have suffered long and hard like Dora but it brings its own pain to those who are left behind. That was the case with another Ohio woman whose husband, Mr. P., refused to talk about her death. A spokesperson for Mr. P would only confirm that Mrs. P’s death was attributed to taking the contaminated amino acid (L-t) and he had received some monetary compensation, after her death through the ensuing litigation.

"I can no longer hike the mountains with my family and enjoy skiing or other sports," said Sharron Lobaugh, speaking from her home in Alaska. "The pain is neuropathic and increases gradually to involve my whole lower body relentlessly aching and burning. Many different medications have been tried without much success."

EMS is not unlike many other diseases in that some suffer intense physical pain for years and some perhaps can be helped more by medication - while others die; but the physical, mental and emotional pain of some victims is compounded by their knowledge that it didn’t have to happen.

"My wife is stable but she is on so many drugs," Ken Kleemeier wrote in a letter to NEMSN seeking "any advise or words of wisdom." In an interview Ken said, "This has negatively impacted not only Renee’s health but all aspects of our lives not least of all, our decision not to have any more children." Renee recalled that her heart hurt nearly as much when she returned home from the hospital after suffering congestive heart failure because "I couldn’t lift or hold my kids and that really hurt." She continued by saying that during the most difficult time in their lives "Dr. Rothenberg has made a major difference and has been very supportive to my family. Not only is he an expert, he is a very compassionate doctor."

Marc E. Rothenberg, M.D., Ph.D., Section Chief, Allergy and Clinical Immunology; Pulmonary Medicine, Allergy, Clinical Immunology at Children’s Hospital Medical Center in Cincinnati stated that "Other things may cause the disease (EMS) but it is certain that the contaminated 5HTP was the cause in her (Renee) case." Dr. Rothenberg also said that some of the symptoms of EMS "overlap" with other diseases and it is possible that some people have been misdiagnosed and are being treated for other diseases when they actually have EMS. He agreed that inadequate regulation of the multi-million dollar dietary supplement industry is a "definite problem." Rothenberg is currently conducting a FDA study to, as he explained in lay terms, "figure out why some people’s cells are susceptible (to the disease) and other people’s are not."

The label that appears on all dietary supplements that says, "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease," possibly has many people thinking that maybe it won’t help them, but it can’t hurt them. Most American consumers probably believe that all products sold in the U.S. have passed rigorous scrutiny and testing and the occasional slip up is quickly snatched from the shelves. Those who contracted EMS from contaminated L-tryptophan would strongly disagree and the FDA has also said that’s not so.

The FDA in its response to the U.S. General Accounting Office citing "lack of resources" stated, that "FDA, among other activities, conducts plant inspections about once every 5 years, on average…only three staff are available part-time to investigate reports of health problems associated with dietary supplements…FDA becomes aware of health problems potentially associated with these products only when consumers, health professionals, or others contact FDA to alert the agency." In the case of functional foods, "foods enhanced with extra ingredients (herbs and supplements) deemed to be beneficial to health;" these products need only meet the "generally recognized as safe (GRAS) standard …and companies do not have to notify FDA before selling the product to consumers."

In November 2001, Sens. Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) introduced an amendment to an existing agriculture Bill directing 1 million dollars to be used for "accurate product labeling and truthful, substantiated claims." It was reported that this came on the heels of the International Olympic Committee warning athletes to "avoid dietary supplements because of what is called ‘lax quality control and labeling.’"

Ken Kleemeier feels that being concerned about labels on products whose safety and purification is questionable is a little like "shutting the barn door after the horse is gone." However, he says, "it is one step closer to getting to that goal and maybe with some lobbying on our part, we can get our representatives to back this Bill and add to it the things we would like to see."

Designer foods, those created by modifying foods through genetic-engineering, hybrid breeding or by feeding livestock special diets and functional foods, fortified foods, enriched foods and nutraceuticals which are dietary supplements containing vitamins, minerals, amino acids or botanicals, according to Arthritis Today magazine, are "the generally accepted terms for the new foods."

The careful consumer needs to be aware of the possibility of overdoses, particularly among children eating and drinking enhanced snacks and beverages several times a day and the danger of herb-drug interactions among people with chronic ailments who take medications. However, it’s possible that the potential dangers won’t be at the forefront of the minds of American consumers who have always felt they could trust what they buy in stores as long as the expiration date says it’s still good.

As recently as this month (February 2003), with the war looming in Iraq, the United States made the decision not to sue the European Union over its ban on genetically modified food and U.S. refusal to label these foods, according to a New York Times article. It seems the U.S. is choosing which battle is more important and would prefer to have European support in the event of war. The article also made it quite clear that after the deaths attributed to Mad Cow disease, "Europeans are wary of any food not clearly labeled and easily traced."

"I really try not to blame her," said Renee Kleemeier when talking about her former physician. "When I told her I was having trouble sleeping she told me what another patient had said was helping her sleep, 5HTP. The doctor didn’t recommend it, she just passed along some information."

Robert S. Perhala, M.D., F.A.C.R. a Board Certified Rheumatologist in Elyria states "Most physicians know very little about herbal medicine and supplements. We would have to go to school all over again to be able to advise patients in that area." Perhala said that he has often heard people who sell supplements extolling the virtues of their products and "sounding like doctors. When we (physicians) object or question in anyway to the validity of their claims, they say we’re jealous." "It has nothing to do with jealousy," he continued. "There are legitimate concerns and money has nothing to do with it. Most of us (physicians) got into this business because we care, we’re here because we want to help people."

Whenever she is able, Dora is at her desk or in bed with her laptop computer keeping in touch with members of the national EMS Network where she is a former board member or with new friends around the world. Other times she continues to work on a book about her life. When she is able to get out in the Village with a cane or a walker to shop and she runs into old friends "I know it’s time to make my excuses and head for home when my legs begin to shake and my brow becomes hot and damp," she said. "But the charmed part of my life, " she continues "is when I say goodbye…not knowing if they will ever see me again…they hug and kiss me goodbye…I always try to leave them with a laugh and a smile.

The laughter in Renee Kleemeier’s voice when she talks about once again being able to take care of her two preschoolers on her own belies the devastation that she has experienced. She says, "It has affected me emotionally and psychologically. Even though I seem to be all right physically, the possibility that one day I may have to have a heart transplant still haunts me. I’m in therapy now to help me deal with those issues."

Kleemeier’s warning is "I just want consumers to be aware that the products they buy, everything from products that claim to make their lungs work better to products for losing weight, may not contain what they think they contain and they might be dangerous. There needs to be an agency or something in place to protect consumers, but until there is, or because there isn’t one, we need to police ourselves. People just aren’t aware of the dangers."

Dora ends her email messages by saying, "Be very careful what you put into your body. It’s the only one you’re sure to have. I love you all, ‘Dora’."

Author's email is  CiajDiann Harris