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from
The
Aquarian, Spring 2000
The Skeleton
in the GMO Closet
By Ingeborg Boyens IT WAS ONE OF THOSE end-of-August days that closes the door on summer indolence. In her office at the Unisys Corporation in the suburbs of Philadelphia, Dot Wilson laced up her sneakers for her lunchtime constitutional, unaware of what lay ahead for her. A brisk three-mile course was routine for Wilson. At forty-four, she was in good shape, toned by an active life and time at the health club. But on this August day in 1988, halfway through the course, she was struck by a strange sensation of extreme weariness in her legs. She dismissed it as many would disregard a sudden ache or pain. But a week later, the sensation was still there: in fact, she was feeling "strange all over." She went to see her doctor, who prescribed the normal battery of tests. When the results failed to point to an immediate diagnosis, Wilson and her mysterious symptoms were passed from one specialist to another. Her list of complaints soon grew longer: spasms, deep muscle pain, pins and needles prickling. Diagnosis, however, remained elusive. No one thought of the health food supplement, L-tryptophan, that her general practitioner had suggested that she try just three months earlier for the insomnia she suffered on her road trips. L-tryptophan was considered innocuous—after all, it had been identified as the ingredient in warm milk that brings on sleepiness. Over the fall, the change forecast by that late summer day took an ominous turn. In December, Wilson was compelled to take short-term disability leave to spend time in hospital for more comprehensive tests. Despite those tests, doctors could not come up with a sure diagnosis or a treatment plan. About one year to the day of her last lunch-time powerwalk, things turned even worse for Dot Wilson. Her legs gave out altogether one day in her bedroom; her arms turned leaden soon after. Suddenly, inexplicably, this once active career woman was rendered quadriplegic, unable to turn in her bed or manage the most basic of bodily functions. Not surprisingly, television became an essential in the limited life of the newly immobilized Wilson. In November 1989, she caught an evening news report about a puzzling new disease with symptoms just like hers. Eosinophilia myalgia syndrome (EMS) was striking Americans across the country. Some had died. The connection, it seemed, was that all of the victims had taken L-tryptophan. Within a week, all of Wilson’s specialists had called her to say they had solved her puzzle. At that time. L-tryptophan was considered a staple in health food stores in the United States. It had first become popular in the 1970s when it was heralded as a safe, nonaddictive treatment for insomnia, premenstrual syndrome and depression. Six Japanese manufacturers produced the food supplement for the U.S. market. After several months of investigation, the EMS outbreak was traced back to just one of the six producers—the Tokyo-based petrochemical giant Showa Denko K. K. The company already controlled more than half of the American market, but in 1988 and 1989, it sought to boost the efficiency of its L-tryptophan production. Showa Denko altered its normal manufacturing procedures by introducing a new, genetically engineered bacterium called Strain V. Showa Denko was not the first company to use genetic engineering in its production system. As many as one hundred other pharmaceutical and food companies had already harnessed the reproductive capabilities of genetically manipulated organisms to produce large quantities of a desired substance. Like other food supplement manufacturers, Showa Denko had routinely used a fermentation process in which large quantities of bacteria are grown in vats and the required substance is extracted and purified. In this case, Showa Denko used Strain V in the fermentation system to convert nutrients into L-tryptophan. The technique was like using a gene-spliced bacterium as a living factory. According to U.S. law, the
company was allowed to sell the L-tryptophan produced in gene-spliced bacteria
without any safety testing because it and other firms had been
selling the supplement produced in non-genetically engineered bacteria
for years without ill effects. The method of production was considered
immaterial. What was important was that the new product was "substantially
equivalent" to the L-tryptophan that had been sold for years.
The company must have considered this a routine change. However, this seemingly minor tinkering apparently produced a toxic brew. Tests showed that Showa Denko’s L-tryptophan was 99.6 percent pure, well within approved standards. But the tiny proportion of the compound that was considered "impure" contained between thirty and forty different contaminants. One of them, EBT, attracted particular attention from scientists because it was shown to cause some of the symptoms of EMS in rats. That was 1989, the early years of the biotechnology revolution. No one was eager to blacken the reputation of the new industry. Showa Denko insisted genetic engineering was not responsible for producing the unexpected and toxic contaminants. Rather, it blamed another change in its production system. The company said it had coincidentally reduced the amount of activated carbon used for purification at the same time as it introduced Strain V.
The company’s claims, however, could not be corroborated. When U.S. Food and Drug Administration inspectors went to Japan to check out the production plant, they discovered Showa Denko had erased all traces of the L-tryptophan production line. Despite repeated requests, the company refused to release samples of the genetically engineered bacteria. The FDA officials reported: "The team encountered refusals to provide information, access to records and areas routinely inspected." By destroying all stocks of the modified bacteria, Showa Denko eliminated data and destroyed possible evidence that could have been useful in solving the puzzle and perhaps finding an answer for those suffering the toxic effects of L-tryptophan. Its frustrations aside, the FDA was no more eager to raise the specter of a deadly experiment in genetic engineering than was Showa Denko. The FDA had learned as early as November 1989 that the company had genetically engineered its bacteria. However, the agency neglected to reveal the fact until August 1990, when it was forced to respond to an article in Newsday. Another piece in Science magazine quoted scientists at the FDA as saying they were concerned about the "impact on industry" of a disclosure of the potential link between EMS and genetic engineering. Luck was on the biotech industry’s side. The FDA scheduled hearings into the L-tryptophan deaths, but the sessions dissolved into a debate on whether food supplements should be available for sale in health food stores. The well-financed and aggressive health food industry in the U.S. dominated the hearings, arguing that the existing regulatory system that allowed the sale of supplements should remain untouched. In 1990, the FDA opted for compromise, banning L-tryptophan, but continuing to allow the sale of other food supplements in unregulated retail operations. Canada managed to sidestep the devastating epidemic that struck just south of the border. Under Canadian law, ingestible substances are either "food" or "drugs"—there is no provision for "dietary supplements." Vitamins and herbs are unregulated, but as such are not allowed to claim therapeutic properties. (The law governing dietary supplements is currently under review.) Because of its claims of healing benefits, L-tryptophan would have been considered a drug in Canada and would have had to meet much more stringent regulations than it did in the United States. For example, the manufacturer would have been compelled to file details on its production processes and any changes it made to them. Perhaps not surprisingly, Showa Denko and the other manufacturers never bothered to apply for drug status in Canada and so L-tryptophan was not available for sale north of the U.S. boundary line. (Editor's note: In 1989 tryptophan was available by prescription in Canada from a company named ICN Canada. It still is. ICM's non-genetically-engineered product - Tryptan - has never been implicated in any cases of EMS.) The official toll in the
first year of the EMS outbreak in the United States numbered 37 dead, 1535
permanently disabled, and more than 5000 temporarily afflicted. It was
never definitively determined if the toxic assault had been caused by slipshod
production—a consequence of Showa Denko cutting back on the level of its
filtration—or on genetic engineering gone wrong. More than two hundred
scientific studies tried to determine what happened. Based on fundamental
chemical and biochemical principles, scientists deduced that the EBT contaminant
was probably generated when the concentration of L-tryptophan within the
bacteria reached such high levels that the molecules or their precursors
began to react with each other. Richard Hinds, a Washington lawyer who
represented Showa Denko, seemed to throw cold water on the notion that
inadequate filtration was to blame for the toxic brew. He told Science
magazine that the amount of powdered carbon used for filtration had varied
before, dipping as low as it had f or the virulent L-tryptophan, without
ill effect.
Dot Wilson has a diagnosis now, but she will likely never know what it was about the seemingly innocuous little pill she got from the health food store that so changed her life. In the late 1990s, she still used a wheelchair, suffered constant pain controlled only by an arsenal of drugs, and endured an ever increasing range of new problems, including heart, thyroid, and blood sugar disorders and a bout of breast cancer. She settled a lawsuit against Showa Denko in 1991, which has enabled her to live in relative financial comfort. Wilson is pleased that she has recovered some of her abilities-these days, she can prepare a cup of tea. However, one bitter irony remains: despite its advertised therapeutic benefits, L-tryptophan had never managed to coax her to sleep in an unfamiliar bed after a long day’s work, but the rigors of life with L-tryptophan-induced EMS always leave her exhausted and bone-tired at night.
WE WILL PROBABLY never know if genetic engineering was to blame for EMS. In much the same way, we may not know definitively if the gene-spliced foods on the supermarket shelves are safe. Unless there are new stringent requirements for human testing of all genetically engineered foods, there are no assurances that history will not repeat itself. It is worth noting that Canadian and American regulators do not even talk about "food safety"; they talk about "acceptable risk." It seems there are no guarantees that what we put in our mouths today will be as good for us as the apple a day once prescribed by the family dentist and doctor. The biotechnology industry insists there is virtually no risk in transgenic foods. It claims the changes it is making to food are miniscule, so there is no more cause for concern than there would be for naturally produced foods. Those who dare to question this logic are dismissed as cranks or fear mongers. Corporate biotechnology likes to hold up government regulators as the ultimate police force patrolling safe food. Indeed, American and Canadian governments have a commendable record ensuring the safety of the essential nutritional staple of life. However, in this case, government regulators have adopted a passive role in the assessment of health risks. Genetic engineering alters foods so they contain proteins and other compounds that have never been part of the human diet. The only way to tell if those new foods might be allergenic or toxic is to test them vigorously. Yet Canadian and American government agencies do not require such testing, nor are labels mandated. There are no pre-market human tests required of "novel" foods in Canada as there would be for the introduction of a new drug. For example, the federal government determined that New Leaf potatoes, with their built-in pesticide, were safe to eat on the basis of lab tests in which mice, rats, and quails were fed the potatoes or protein extracts from them. "Treatment related effects were not observed," says the decision document release by the Food Production and Inspection Branch. In North America, both Canadian and American governments have largely delegated the responsibility for test-tube food safety to the very corporations bringing those foods forward. According to a 1996 editorial in the New England Journal of Medicine, the FDA’s role "would appear to favor industry over consumer protection." And as one Canadian critic wryly remarked, Health Canada essentially says to the developers of new test-tube foods, "if your novel food kills people, let us know." Even full-scale safety testing cannot guarantee one hundred percent certainty that a genetically engineered food is safe. For example, testing on volunteer human subjects for three years might not reveal longer-term effects. But at least this much caution seems the bare minimum of responsible science. The final years of this century could be characterized as a period of food scares. hamburger disease, chicken virus, mad cow disease—they are enough to make one yearn for the simplicity of the apple-a-day era. It is puzzling that Canadian and U.S. governments have, in essence, given the biotechnology industry carte blanche. The industry is using its regulatory freedom to roll out transgenic foods in what has to be seen as a giant nutritional experiment. Are the health risks so remote as to warrant these remarkably lax regulations? The story of L-tryptophan illustrates that even minor genetic alterations can be risky. Dot Wilson has no confidence in the ability of government or industry to regulate a genetically engineered future. She shudders at the thought of her supermarket shelves swelling with products manipulated for profit, and without any labeling to let her avoid them. These days, Wilson is struggling to find some meaning in her experience. She is an activist prepared to speak out against test-tube foods. She works on the executive of the National EMS Network, a nonprofit group that still remembers the L-tryptophan assault on health. About one thousand Americans belong to the group, a number that is shrinking every month as more victims finally succumb to the disease. Wilson is convinced there will be more victims of illnesses created by genetic engineering, but fears her words of caution fall on deaf ears. "There just are not enough of us. People think we are a bunch of fanatics." For now, it seems North American governments are prepared to place corporate biotechnology, with its promise of jobs and economic wealth, ahead of the Dot Wilsons of the world.
Award-winning Canadian journalist Ingeborg Boyens first became suspicious of biotechnological agribusiness while working as a producer for CBC's "Country Canada." She lives in Winnipeg with her husband. |
"Unless there are new stringent requirements for human testing of all genetically engineered foods, there are no assurances that history will not repeat itself."
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