From: Mark Gold [mgold@shelltown.

net]
Sent: Sunday, January 12, 2003 11:16 PM
To: fdadockets@oc.fda.gov
Subject: Docket # 02P-0317 Recall Aspartame as a Neurotoxic Drug: File
#8: Aspartame & Human Studies
Subject: Docket # 02P-0317
To: FDA Dockets Submittal
From: Mark D. Gold
Aspartame Toxicity Information Center
12 East Side Dr., Suite 2-18
Concord, NH 03301
603-225-2110
Date: January 12, 2002
Please find below Evidence File #8: Aspartame & Human Studies
Aspartame Testing on Humans
--------------------------Q. I have been told that there are no controlled human studies
showing that aspartame causes adverse effects. Is this true?
I ran a medical database MEDLINE search and found several
abstracts that demonstrated no problems when aspartame was
ingested in large amounts. Why is that?
Answer
-----==> I have been told that there are no controlled human studies
==> showing that aspartame causes adverse effects. Is this true?
I am afraid you have been given completely inaccurate information.
In many cases, persons who perpetuate these myths are simply
ignorant of the scientific literature. Unfortunately, some of these
persons are journalists who spread inaccurate information. In some
cases, however, blatantly false implications that aspartame has not
been shown to cause problems in controlled human studies come from
Monsanto, friends of Monsanto in certain government agencies (e.g.,
FDA), and public relations organizations that receive large sums of
money from the manufacturer (e.g., IFIC, ADA).
The following controlled human studies have shown that aspartame can
cause adverse changes or health problems: Camfield (1992), Elsas
(1988), Gulya (1992), Koehler (1988), Kulczycki (1995), Spiers
(1988), Van Den Eeden (1994), Walton (1993). Therefore, if you read
statements implying that there is no controlled research showing
problems with aspartame, you can rest assured that the writer is
completely ignorant of the scientific literature or simply relating
public relations nonsense.
==> I ran a medical database MEDLINE search and found several
==> abstracts that demonstrated no problems when aspartame was
==> ingested in large amounts. Why is that?

Before this question can be answered, it is necessary to discuss the

overall findings of the scientific community. Recently, Dr. Ralph
Walton compiled a list of all of the controlled human and animals
studies looking for the effects of aspartame (Walton 1996). Out of
90 independently-funded studies, 83 of them found one or more
problems caused by aspartame. But out of the 74 studies funded by
the aspartame industry (e.g., Monsanto, G.D. Searle, ILSI, etc.),
every single one of them claimed that no problems were found. It
is important to note that some of those few "indenpendently-funded"
studies that found no effects were funded by organizations that have
recently shown have been or were being run by persons with very close
ties to the aspartame industry.
Only the most gullible individual would believe that it is a
coincidence that all industry studies found no effects and almost all
independent studies found adverse effects. This is reminiscent of
the "safety" seen cigarette "research" during the 1950s.
For more information of abuse of the scientific method related
to Monsanto/NutraSweet research, please see the following web page:
http://www.holisticmed.com/aspartame/abuse/
References Cited
---------------Camfield, PR, et al., 1992. "Aspartame exacerbates EEG spikewave discharge in children with generalized absence
epilepsy: a double-blind controlled study." Neurology,
Volume 42, page 1000-1003.
Elsas, Louis J., James F. Trotter, 1988. "Changes in
Physiological Concentrations of Blood Phenylalanine
Produces Changes in Sensitive Parameters of Human Brain
Function," Presented at "Dietary Phenylalanine and Brain
Function." Proceedings of the First International Meeting
on Dietary Phenylalanine and Brain Function, Washington,
D.C., May 8-10, 1987. Center for Brain Sciences and
Metabolism Charitable Trust, P.O. Box 64, Kendall Square,
Cambridge, MA 02142. Reprinted in "Dietary Phenyalalnine
and Brain Function," c1988, Birkhauser, Boston, MA USA,
page 187-195.
Gulya, A. Julianna, Roy B. Sessions, Thomas R. Troost, 1992.
"Aspartame and Dizziness: Preliminary Results of a Prospective,
Nonblinded, Prevalence and Attempted Cross-Over Study," American
Journal of Otology, Volume 13, Number 5, pages 438-442.
Koehler, SM, A. Glaros, 1988. "The Effect of Aspartame on
Migraine Headache," Headache, Volume 28, page 10-14.
Kulczycki Jr., Anthony, 1995, "Aspartame-induced hives," Study
described in Letter to the Editor, Journal of Allergy &
Clinical Immunology, February 1995, page 639-640.
Spiers, P.A., Donald Schomer, LuAnn Sabounjian, Harris
Lieberman, Richard Wurtman, John Duguid, Riley McCarten,
Michele Lyden, 1988. "Aspartame and Human Behavior:
Cognitive and Behavioral Observations," Presented at

"Dietary Phenylalanine and Brain Function." Proceedings

of the First International Meeting on Dietary
Phenylalanine and Brain Function, Washington, D.C., May 810, 1987. Center for Brain Sciences and Metabolism
Charitable Trust, P.O. Box 64, Kendall Square, Cambridge,
MA 02142. Reprinted in "Dietary Phenyalalnine and Brain
Function," c1988, Birkhauser, Boston, MA USA, page 169178.
Van Den Eeden, SK, et al., 1994. "Aspartame Ingestion and
Headaches," Neurology, Volume 44, page 1787-1793.
Walton, Ralph G., et al., 1993. "Adverse Reactions to
Aspartame: Double-Blind Challenge in Patients From a
Vulnerable Population," Biological Psychiatry, Volume 34,
page 13-17. Also see followup: Volume 36, page 206-210.
Walton, Ralph G. 1996. Interview by Mike Wallace on CBS News, "60
Minutes," broadcast December 29, 1996.