Letter to Senator Hatch, Feb 25

PLEASE NOTE THE DATE!

Letter from Senator Howard Metzenbaum of the Senate Committee on Labor and Human Resources to Senator Orrin Hatch, the Chairman of the Senate Committee on Labor and Human Resources
February 25, 1986

Dear Orrin:

I am at a loss to comprehend the thrust of your recent letters on my request for hearings on the safety concerns raised in the scientific
community regarding NutraSweet.

When I sent you a 110-page report on February 6 on the failure of the U.S. Attorney to hold a grand jury investigation, you replied the same day that there were no health issues raised. You then asked that I share with you all information raising safety issues. Orrin, the report I sent you included a summary of current health concerns raised by nine different scientists. My report contained all the relevant references to medical journals and other citations.

Now you have sent me another letter, dated February 18, in which you again request evidence.

As you know, I met last Thursday with Dr. Roger Coulombe of Utah State University. You also had a conversation with Dr. Coulombe, as did your staff.

Dr. Coulombe has informed both of us that his study of NutraSweet’s effects on brain chemistry contains new and significant data.

All of the 12 mice tested showed brain chemistry changes after ingesting NutraSweet.

Four other mice received no NutraSweet and showed no brain chemistry changes. Dr. Coulombe also informed us that the issues raised in his study were not tested prior to NutraSweet’s approval. So, the FDA never reviewed this research prior to approving NutraSweet.

It is critical to note that some of the lab animals which had reactions to NutraSweet were fed doses at levels currently being consumed by
humans.

As you know, there have been many reports of seizures, headaches, mood alterations, etc., associated with NutraSweet. Dr. Coulombe’s study,
which has been accepted for publication in Toxicology and Applied Pharmacology, states:

It is therefore possible that Aspartame may produce neurobiochemical and behavioral effects in humans, particularly in children and
susceptible individuals. Based on the foregoing, there is a need for additional research on the safety of this food additive. Orrin, you have asked for new and significant scientific evidence about NutraSweet. Now you have it. Dr. Coulombe’s research as well as the other research cited in my report raises new health concerns which have not been resolved.

We need to hold hearings on NutraSweet– which is being used by over 100 million Americans. With an issue that is critical to the health of half the American population, how can you in good conscience say “no?” We cannot rely upon the tests sponsored by the manufacturer of NutraSweet, G. D. Searle, and ignore the concerns being raise by independent studies.

We don’t need the company which is making hundreds of millions of dollars on this product telling us it’s “safe,” particularly when the
credibility of that Company’s testing on NutraSweet has been severely undermined. You know that the FDA recommended a criminal investigation of possible fraud in NutraSweet tests. The FDA has never before or since made such an investigation.

Although NutraSweet was later approved, credible scientific concerns continue to be raised.

The Director of Clinical Research at M.I.T., Dr. Richard Wurtman, has recently published a letter in Lancet citing case reports suggesting a
possible association between Aspartame and seizures. According to Dr. Wurtman, the reports are compatible with evidence that high Aspartame doses may produce neurochemical changes that, in laboratory animals, are associated with depressed seizure thresholds.

Dr. William Pardridge, U.C.L.A. School of Medicine, has also cited a possible link between one of Aspartame’s principal components,
phenylalanine, and the lowering lowering of seizure thresholds in individual\individuals. He has also questioned the possible affects of
NutraSweet on fetal development.

In July, 1985, Dr. Michael Mahalik of the Philadelphia College of Osteopathic Medicine, and Dr. Ronald Gautieri of Temple University
School of Pharmacy, published a study on the potential of Aspartame to produce brain dysfunction in mouse neonates whose mothers were exposed to Aspartame in late gestation. They concluded that the possibility of brain dysfunction appears to be a viable sequela to excessive Aspartame exposure.

In June of last year, Dr. Adrian Gross, a former FDA Toxicologist, and member of the FDA Investigative Task Force which reviewed the
Aspartame studies, sent me a letter stating that depute their serious shortcomings, at least those studies established beyond a reasonable
doubt that Aspartame is capable of inducing brain tumors in experimental animals.

In February, 1985, letters were published in the Annals of Internal Medicine and the American Journal of Psychiatry, linking Aspartame to
skin lesions and to severe headaches caused by chemical interactions with an anti-depressant drug, an M.A.O. inhibitor.

In December, 1984, Dr. John Olney of Washington University published a study on excitotoxic amino acids including Aspartate, one of Aspartame’s two constituent amino acids. He concludes that excitotoxins pose a significant hazard to the developing nervous systems of young children.

Dr. Louis Elsas, at Emory University, has raised concerns about Aspartame’s other constituent amino acid, phenylalanine. He has stated
that if the mother’s blood phenylalanine is raise to high concentrations in pregnancy, her child’s brain development can be damaged. According to Dr. Elsas, it has not been determined how high the blood phenylalanine must be elevated to produce any of these effects.
However, he believes that it has not been proven that all people can take as much Aspartame without fear of ill effects as they desire.

Appearing on the news program Nightline in May of last year, Dr. Elsas warned of a whitewashed scientific review, most of which has been
supported by the industry itself, which has obvious conflict of interest.

All of these safety concerns have been raised after NutraSweet was approved for use in over 90 products. The FDA is currently considering petitions which would explain even further the dramatic increase in NutraSweet consumption. My staff has provided you with the references for all of the scientific concerns raised above. I strongly urge you to reconsider your decision and to convene oversight hearings in the Labor and Human Resources Committee as soon as possible to consider these issues.

By ignoring the safety concerns which have been raised, we are potentially jeopardizing the health and safety of over 100 million
Americans who are ingesting NutraSweet in everything from soft drinks to pudding to children’s cold remedies.

Very Sincerely Yours,

Howard M. Metzenbaum
United Stated Senator