Letter from Senator Howard Metzenbaum of the Senate Committe 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