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 spike- wave 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 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 169- 178. 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.