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OVER-THE-COUNTER CONCERNS

Linda Bagley used to get shivery with excitement when she saw a new mountain.

"I always wanted to see what's on the other side of a peak," she said.Her passion for the unknown made her the perfect wife for an explorer like Dick Bagley.

Aggressively athletic, the Murray couple spent their summers in Alaska, hiking whole mountains ranges, catching scores of salmon, tracking bear and canoeing.

Husbanding their health for those arctic excursions, the couple ate carefully and took a variety of food supplements - including the popular amino acid, L-tryptophan.

Linda Bagley's doctor had recommended the over-the-counter supplement in early 1989 to help her sleep better at night. Other U.S. doctors recommended it during the late '80s for everything from aching muscles to pre-menstrual syndrome.

The Bagleys spent the summer of 1989 in the Alaska wilds. She started certifying to fly a sea plane, planning to hop from island to island during future retreats. The couple expected to return to Alaska in the fall for their first caribou hunt.

Then L-tryptophan turned on Linda Bagley.

Along with thousands of other Americans, she had begun buying an off-brand of L-tryptophan to save money. The popularity of the amino acid and its expensive processing had driven the price of name brands to about $10 for a bottle of 30 pills - a stiff price for a supplement she and Dick took every day.

So the Bagleys began buying Albertson's store brand of the supplement in the spring of 1989. Labeled as "all natural," Linda Bagley had no way of knowing that this cheaper brand of L-tryptophan was manufactured by a Japanese company that used genetically altered bacteria to get the amino acid.

"The Albertson's brand was $2 cheaper. If it had been brand X I wouldn't have bought it. But it was Albertson's - a company I trusted," said Dick Bagley.

The Japanese company, Showa Denka, offered the supplement to U.S. retailers at a sharply reduced wholesale price. Retailers began buying it up and slapping their own store label on the drug.

Linda Bagley bought Albertson's brand of L-tryptophan, and Sandy resident Judy Sanders bought the Fred Meyer and Skaggs Alpha Beta brands of L-tryptophan - they both bought the results of Showa Denka's genetically altered bacteria.

Both women nearly died from those choices.

Showa Denka not only offered a cheaper L-tryptophan, it gave the world a new, deadly disease: Eosinophilia-myalgia Syndrome. Called EMS, the disease launched an all-out assault on the immune system of the human body, resulting in inflammation, fibrosis, spasms of all skeletal muscles and paralysis.

By November 1989, the Centers for Disease Control had an epidemic on its hands. Nearly 30 Americans had died from EMS after taking Showa Denka's L-tryptophan. More than 1,000 more were seriously ill.

Two years later, Showa Denka's L-tryptophan had struck down 500 more Americans with EMS.

And researchers can't find a cure.

Dr. Louis Sullivan, secretary for the Department of Health and Human Services, called the L-tryptophan illnesses "a major public health problem." The Centers for Disease Control called it a crisis. The FDA urged retailers to remove L-tryptophan from store shelves. Angry EMS victims showered Showa Denka and U.S. retailers with lawsuits. Congress launched an investigation.

There were times during the past two years when Linda Bagley and Sanders each thought they would die. The disease froze their muscles, leaving them clenched and hard for months.

It paralyzed the joints, twisting their hands and feet like severe arthritis would.

Often they could not walk. Sanders could not reach for food or drink from her bed. She could barely lift her head during the early months of the disease.

When EMS killed, it usually froze the muscles of the victims' chest wall, slowly squeezing the air from their lungs.

The disease attacked Bagley's vision and her mind, resulting in hallucinations.

Her weight ballooned with a speed she hadn't thought was possible. Between the disease and the side effects of the medication doctors used to control it, Bagley once gained 36 pounds in 48 hours. "I called my sister up and borrowed her maternity clothes," she said.

"I started out as a size 14 and went up to a size 26," Sanders said. The disease left her face red and puffy. "I had to wear Ed's shirts and shorts because nothing fit me. I felt so ugly!"

EMS spared no system of their bodies. "It was like rapid aging," Bagley said. "Cellulite appeared overnight. I got liver spots all over my skin. I couldn't move. I suffered memory loss. I couldn't remember what I was going to say in the middle of a sentence."

Bagley's body was so sensitive that she screamed in pain once when her newborn nephew clutched her forefinger.

Sanders' experience paralleled Bagley's. Neighbors and church members took turns caring for Sanders in three daily shifts during her months in bed. "I couldn't even roll over in bed by myself," she said.

When painkillers failed to ease Sanders' agony, her doctor sent her to the LDS Hospital's Pain Clinic, where specialists taught her to live with chronic pain.

Although the women don't know each other and lead very different lives, their disease followed a similar path. In the early months, the women and their doctors had no idea what was wrong. Until Showa Denka created L-tryptophan, American medicine had never seen anything like EMS.

Sanders suffered seizures, loss of consciousness and abrupt memory loss. "When I'm tired, I often can't remember the names of objects," she said.

Like most EMS victims, Bagley and Sanders didn't suspect L-tryptophan. During the early months of confusion, while their doctors tested, speculated and consulted, the two continued taking the supplement. Twisted with pain, they often increased their dosage in a bid for elusive sleep.

Sanders' husband heard of the disease on television and brought it to her doctor's attention. Linda Bagley learned of the connection with L-tryptophan when a doctor called from the LDS Hospital in the middle of the night to ask if she was using it.

He had just read a New York Times article on the disease and recognized Bagley's symptoms. Yes, she told him. She used the supplement. She had taken some before going to bed that night.

Discovering the cause of the disease offered a bit of peace - but no hope. Experience with the disease to date suggests the women may never recover.

The doctors offer no assurances. They keep telling the women they tread an untrodden path. No specialist knows what lies around the bend, they say.

According to a national EMS support group, EMS victims across the nation are depressed and frightened. Serious secondary symptoms, including eye and brain dysfunctions, are only now surfacing in EMS victims who thought they were getting better.

Health experts gathered in Los Alamos, N.M., in June 1990 to compare their findings on the disease. The conclusion: most EMS victims have been permanently damaged by the disease. "They will never recover," stated a publication by the EMS support group.

Sanders and Bagley's doctors can't allay the horror of those stark words.

Both women battle anger and depression. "I got real angry at God and quit talking to him totally," Sanders said. "I did a lot of screaming and crying."

Dick Bagley will never forgive Showa Denka or Albertson's. "The bottle said, `all natural,' but what could be less natural than genetically altered bacteria," he said.

Sanders and Linda Bagley are still seriously ill. Each is on a variety of medications, including powerful cortisones, while Sanders takes anti-seizure drugs. The drugs' side effects are only slightly less frightening than the disease itself. Neither can walk without taking vast quantities of cortisone, yet the drug can also be permanently disabling.

When Bagley isn't fearing the disease, she fears the side effects of her medication. The woman who once loved the mystery of an unclimbed mountain now shudders at the future's uncertainty.

"It's hell to be a medical pioneer," she said.

*****

(Additional story #1)

Showa Denka showered with suits

Approximately 100 Americans stricken with EMS have filed lawsuits against Showa Denka claiming more than $810 million in damages. So many suits have been filed that a federal court in South Carolina is managing the discovery phase of the cases. More suits are expected, including suits from other Utahns.

Showa Denka, which reported revenues of $5 billion in 1990, reorganized its biotechnology division after the FDA blamed the company for the EMS outbreak. The company transferred 23 production managers out of the division in the months following the outbreak of the disease.

Showa Denka, which once manufactured nearly 80 percent of the world's supply of L-tryptophan, also recalled all shipments of the diet supplement. The company funded an EMS hotline and promised to fund research seeking a cure for EMS. But it has also assembled a team of lawyers to battle suits against the company and failed to finance a promised EMS Humanitarian Aid Program to help EMS patients pay for medical treatment.

Showa Denka has settled a few of the L-tryptophan suits against the company for undisclosed amounts. The settlements include Showa Denka's denial of any blame or liability in the EMS tragedy.

*****

(Additional information)

FDA blames Japanese company

The FDA has traced all contaminated batches of L-tryptophan to Showa Denko, Japan's third-largest petrochemical manufacturer.

The company manufactured the contaminated diet supplement from January to May of 1989, sending all shipments to the United States. Large wholesale health food job lotters assembled the supplement under various brand names and shipped it to stores across the country.

According to the FDA, Showa Denka apparently manufactured the supplement with genetically engineered bacteria called Strain V. After splicing the genes that created the bacteria, the company biochemically enhanced the gene to increase the bacteria's production of L-tryptophan. At the same time, Showa Denka dropped several purification steps from the manufacture of L-tryptophan.

The FDA and Centers for Disease Control blame the supplement's contamination on either the genetic splicing and biochemical enhancement of the bacteria or the poor purification process.