Biotech Alarm

The possibility that genetic engineering might be responsible for the deadly EMS epidemic posed quite a threat to the young biotech industry. If consumers linked the new science with the horrid symptoms of the disease, the industry might have to spend years or decades to win back public confidence. At the very least, new regulations might force them to submit products for costly safety testing, something they had thus far been able to avoid.

But the word started to spread. On July 11,1990, the Journal of the American Medical Association (JAMA) published a study mentioning for the first time that Showa Denko's bacteria had been genetically engineered. In fact, the company had introduced a new GM bacterium called Strain V in December 1988, a few months before the epidemic hit.

On August 14, Newsday ran a story entitled "Genetic Engineering Flaw Blamed for Toxic Deaths." The article quoted Michael Osterholm, an epidemiologist at the Minnesota Health Department and coauthor of a study on EMS published that month in the New England Journal of Medicine. He said, "Strain V was cranked up to make more L-tryptophan and something went wrong. This obviously leads to that whole debate about genetic engineering."10 The Newsday article inspired a slew of other papers also to report the EMS story as a genetic engineering problem.

To stem the tide of anti-biotech sentiment, the industry relied on a spokesman it would later count on year after year—the FDA In an article in Science magazine in late August, Sam Page, chief of the natural products and instrumentation branch at the FDA, "blasted Osterholm for 'propagating hysteria.' The whole question: Is there any relation to genetic engineering? is premature—especially given the impact on the industry."11

Osterholm countered: "Anyone who looks at the data comes to the same conclusion. ... I think FDA doesn't want it to be so because of the implications for the agency."

According to the article, the FDA knew for months that the contaminated L-tryptophan was created by GM bacteria, but withheld the information from the public "apparendy hoping to keep the recombinant link quiet until they could determine whether it in fact did play a role in the outbreak."11

In spite of any damage Osterholm's remark may have had on the biotech industry, the study he helped coauthor inadvertently gave GMO proponents an alternative explanation for the epidemic that they continue to use to this day. Shortly after Strain V was introduced, Showa Denko made another change in its L-tryptophan production process. The company reduced the amount of carbon powder in its filters from twenty to ten kilograms per batch.

Carbon filters are used to remove contaminants that are created during the fermentation process. Showa Denko officials claimed that the ten kilos of carbon continued to produce a product that was within the specifications required by U.S. pharmaceutical standards: purity of 98.5 percent or better. Nonetheless, it was possible that the change in the filter could have allowed deadly trace contaminants to get through. Hence the new argument: the culprit was not genetic engineering but a change in the filtration.

This alternative hypothesis appears to have saved the reputation of the biotech industry, allowing GM food and supplements to continue to be sold without safety testing. Let's analyze this alternative hypothesis to see if it justifies the FDA's hands-off approach.

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