Toxic L-tryptophan: Shedding Light on a Mysterious Epidemic—Unanswered Letters to Government Officials

Toxic L-tryptophan: Shedding Light on a Mysterious Epidemic—Unanswered Letters to Government Officials

by William E. Crist

This section includes three letters sent to government regulatory authorities and researchers concerning:
(1) key information and/or data that appears to have been concealed from the public regarding L-tryptophan and the EMS epidemic, and
(2) discrepancies in the interpretation of research data and in the procurement of samples of Showa Denko’s (SDK) genetically engineered strains of bacteria.
After several months, and now years, no one from either the National Centers for Disease Control or the Food and Drug Administration has answered several key, material questions.

  1. Dr. Rossanne Philen, at the National Centers for Disease Control (CDC) in Atlanta, did not reply to either a letter or to two follow-up phone messages. At issue is an obvious missing correlation in the CDC epidemiological data, between the known dates of onset of 97 pre-epidemic EMS cases (Swygert, JAMA, 1990) and the reported levels of EBT contaminant in “case-associated” production lots dating back to August 19, 1986 (Philen,American Journal of Epidemiology, 1993). This is more than two years before the manufacturer’s product allegedly became contaminated, according to the agency’s reports.
  2. James Maryanski, PhD, Biotechnology Coordinator at FDA, and Joseph A. Levitt, Director of the Center for Food Safety and Applied Nutrition at FDA, did not reply to a letter that raised several key discrepancies concerning the agency’s interpretation of research data used in FDA’s Position Statement on L-Tryptophan Dec. 17, 1997. Copies of my letter were sent to both FDA officials by Certified Mail.

    In question is the validity of the arguments used by FDA in its position on L-tryptophan to exonerate the GE strains used by Showa Denko and to implicate L-tryptophan itself as a possible cause of EMS. The latter suggested that consuming any manufacturer’s L-tryptophan can cause EMS and led to FDA’s banning L-tryptophan as an over-the-counter food supplement. However, on close inspection, this view is not substantiated either by leading EMS researchers (non-FDA), including CDC’s (Kilbourne, Philen, et al,J. Rheumatology Suppl, 1996), or from the information available on pre-epidemic EMS cases, which also appear to be unambiguously linked to Showa Denko product made from earlier GE strains.

  3. Dr. Sam Page, Scientific Director, Center for Food Safety and Applied Nutrition at FDA, returned one call and left a phone message after receiving a letter, but a few days later he was assigned to WHO in Geneva, Switzerland, for two years. Via email correspondence, he said that he had forwarded the letter to someone else at FDA. No one ever responded. A follow-up email to Dr. Page asked him for the name of the person at FDA that he forwarded the letter to. Dr. Page never replied.

    The key discrepancy here is that FDA claims that Showa Denko never provided them with samples of the bacteria/GE strains, while an attorney representing the company claims that the FDA never followed up on the manufacturer’s offer to provide them with samples.

In addition, several Freedom of Information (FOI) requests were sent to the FDA and CDC, one series in 1998 and another in 2001. In 1998, responses were received from FDA and CDC, but none of the specific documents and/or information requested were supplied. In 2001, FDA FOI staff said that the information requested either “was lost” or “could not be found,” and that the people who were involved at that time (1989-90) had all left FDA. I mentioned that Dr. Sam Page is still at FDA and that Dr. Rossanne Philen, Dr. Henry Falk, and Dr. Edwin Kilbourne are all still at CDC, to which the requests related among others, but the FDA FOI staff person repeated that the people involved had left.

This lack of response to key questions is perplexing. Why wouldn’t representatives of FDA and CDC have the common courtesy to answer some pretty simple questions? Are they trying to hide something, hoping that the questions will go just away by ignoring them? Their failure to respond suggests that the questions may, in fact, be on target. For more than a decade the whole question of whether Showa Denko’s genetically engineered bacteria were a causal factor in EMS has been downplayed or denied outright by these agencies. Now, it appears that both agencies knew critical information about the GE strains, including their link to pre-epidemic cases, but concealed it to protect the US biotech industry. If they did not intentionally hide information, then it would suggest serious blundering in these agencies.

Next section: Conclusion — Who’s Responsible?>>

© Copyright 2005 William E. Crist. All Rights Reserved