From: Mark Gold [mgold@shelltown.net] Sent: Sunday, January 12, 2003 11:18 PM To: fdadockets@oc.fda.gov Subject: Docket # 02P-0317 Recall Aspartame as a Neurotoxic Drug: File #9: Recent Independent Aspartame Research 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 #9: Recent Independent Aspartame Research Recent Independent Aspartame Research Results (1998 - 2002) The results of recent independent research continue the trend of research not funded by the manufacturer finding serious problems with aspartame ingestion. Details about other independent research demonstrating the hazards of aspartame ingestion can be found in the Aspartame FAQs and Aspartame Scientific Abuse web pages. Table of Contents Aspartame Ingestion Causes Formaldehyde Accumulation in the Body Aspartame and MSG Cause to Painful Fibromyalgia Symptoms Aspartame and Brain Tumors (Swedish Study) Aspartame Causes Memory Loss -------------------------------------------------------------------------------- -------------------------------------------------------------------------------- Aspartame Ingestion Causes Formaldehyde Accumulation in the Body Excerpt from: Trocho, C., et al., 1998. "Formaldehyde Derived From Dietary Aspartame Vinds to Tissue Components in vivo," Life Sciences, Vol. 63, No. 5, pp. 337+, 1998 "These are indeed extremely high levels for adducts of formaldehyde, a substance responsible for chronic deleterious effects that has also been considered carcinogenic. .... "It is concluded that aspartame consumption may constitute a hazard because of its contribution to the formation of formaldehyde adducts." "It was a very interesting paper, that demonstrates that formaldehyde formation from aspartame ingestion is very common and does indeed accumulate within the cell, reacting with cellular proteins (mostly enzymes) and DNA (both mitochondrial and nuclear). The fact that it accumulates with each dose, indicates grave consequences among those who consume diet drinks and foodstuffs on a daily basis." (Neuroscientist Russell Blaylock, MD) -------------------------------------------------------------------------------- -------------------------------------------------------------------------------- Aspartame and MSG Cause to Painful Fibromyalgia Symptoms Ann Pharmacother 2001 Jun;35(6):702-6 Relief of fibromyalgia symptoms following discontinuation of dietary excitotoxins. Smith JD, Terpening CM, Schmidt SO, Gums JG. Malcolm Randall Veterans Affairs Medical Center, Gainesville, FL, USA. BACKGROUND: Fibromyalgia is a common rheumatologic disorder that is often difficult to treat effectively. CASE SUMMARY: Four patients diagnosed with fibromyalgia syndrome for two to 17 years are described. All had undergone multiple treatment modalities with limited success. All had complete, or nearly complete, resolution of their symptoms within months after eliminating monosodium glutamate (MSG) or MSG plus aspartame from their diet. All patients were women with multiple comorbidities prior to elimination of MSG. All have had recurrence of symptoms whenever MSG is ingested. DISCUSSION: Excitotoxins are molecules, such as MSG and aspartate, that act as excitatory neurotransmitters, and can lead to neurotoxicity when used in excess. We propose that these four patients may represent a subset of fibromyalgia syndrome that is induced or exacerbated by excitotoxins or, alternatively, may comprise an excitotoxin syndrome that is similar to fibromyalgia. We suggest that identification of similar patients and research with larger numbers of patients must be performed before definitive conclusions can be made. CONCLUSIONS: The elimination of MSG and other excitotoxins from the diets of patients with fibromyalgia offers a benign treatment option that has the potential for dramatic results in a subset of patients. PMID: 11408989 -------------------------------------------------------------------------------- -------------------------------------------------------------------------------- Aspartame and Brain Tumors A published study in Sweden that looked at various possible causes of brain tumors (e.g., cell phones, aspartame) found a link between use of diet drinks and certain types of large brain tumors in middle-aged and elderly population groups. http://www.medscape.com/MedGenMed/braintumors -------------------------------------------------------------------------------- -------------------------------------------------------------------------------- Aspartame Causes Memory Loss Title: DANGEROUS DIET DRINKS. Subject(s): ASPARTAME -- Physiological effect; NONNUTRITIVE sweeteners Side effects; MEMORY Source: Psychology Today, Mar/Apr 2001, Vol. 34 Issue 2, p20, 2/5p Section: [Nutrition] Facts&Findings MIND DANGEROUS DIET DRINKS CAN'T REMEMBER WHAT YOU HAD FOR LUNCH? WHAT YOU ATE OR DRANK MIGHT BE THE REASON. New research suggests that the artificial sweetener aspartame may actually go to your head. By Peter Rebhahn Anecdotal evidence that aspartame disrupts memory has been growing since the sugar substitute was approved in the early 1980s, though attempts to prove the claim have so far been equivocal. Previous studies have tested memory by asking aspartame users to remember lists of words or numbers-- tests of short-term memory. But according to Timothy M. Barth, Ph.D., a psychology professor at Texas Christian University, those studies focused on the wrong type of memory. In his study of 90 students, Barth found that participants who regularly drank diet sodas containing aspartame performed as well as nonusers on laboratory tests. However, aspartame users were more likely to report long-term memory lapses like forgetting details of personal routines or whether or not a task had been completed. "These people aren't crazy," says Barth. Instead, "the type of memory problems they report are not the type of memories that have been assessed in the typical laboratory study." After reporting his findings at a recent Society for Neuroscience meeting, Barth cautioned that he thinks it's premature to condemn aspartame. But he does worry about the largely untested effects of long-term use. Already, he has made some converts. "Several of my graduate students who drank diet soda no longer do."