From: Rich Murray [rmforall@att.net] Sent: Tuesday, September 24, 2002 3:56 AM To: fdadockets@oc.fda.gov Subject: FDA Docket 02P-0317 aspartame toxicity brief review: Murray 9.23.2 rmforall FDA Docket 02P-0317 Recall Aspartame as a Neurotoxic Drug http://groups.yahoo.com/group/aspartameNM/message/871 aspartame toxicity brief review: Murray 9.23.2 rmforall Rich Murray, MA Room For All rmforall@att.net 1943 Otowi Road, Santa Fe NM 87505 USA 505-986-9103 http://groups.yahoo.com/group/aspartameNM/messages for 871 posts in a public searchable archive http://groups.yahoo.com/group/aspartameNM/message/862 long review http://groups.yahoo.com/group/aspartameNM/message/860 RTM: FDA: objections to neotame approval 8.3.2 rmforall 38 pages http://groups.yahoo.com/group/aspartameNM/message/868 Murray: submit complaints and papers to FDA Docket 02P-0317 by Jan 12 2003: Recall Aspartame as a Neurotoxic Drug 9.20.2 rmforall http://www.dorway.com/tldaddic.html 5-page review Roberts HJ Aspartame (NutraSweet) addiction. Townsend Letter 2000 Jan; HJRobertsMD@aol.com http://www.sunsentpress.com/ sunsentpress@aol.com Sunshine Sentinel Press P.O.Box 17799 West Palm Beach, FL 33416 800-814-9800 561-588-7628 561-547-8008 fax http://groups.yahoo.com/group/aspartameNM/message/669 1038-page medical text "Aspartame Disease: An Ignored Epidemic" published May 30 2001 $ 85.00 postpaid data from 1200 cases available at http://www.amazon.com over 600 references from standard medical research http://www.aspartameispoison.com/contents.html 34 chapters http://groups.yahoo.com/group/aspartameNM/message/859 RTM: Roberts: the life work of a brilliant clinician: aspartame toxicity 8.2.2 rmforall http://groups.yahoo.com/group/aspartameNM/message/790 RTM: Moseley: review Roberts "Aspartame Disease: An Ignored Epidemic" 2.7.2 rmforall http://groups.yahoo.com/group/aspartameNM/message/782 RTM: Smith, Terpening, Schmidt, Gums: full text: aspartame, MSG, fibromyalgia 1.17.2 rmforall Jerry D Smith, Chris M Terpening, Siegfried OF Schmidt, and John G Gums Relief of Fibromyalgia Symptoms Following Discontinuation of Dietary Excitotoxins. The Annals of Pharmacotherapy 2001; 35(6): 702–706. 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. Siegfried O. Schmidt, MD Asst. Clinical Prof. siggy@shands.ufl.edu Community Health and Family Medicine, U. Florida, Gainesville, FL Shands Hospital West Oak Clinic Gainesville, FL 32608-3629 352-376-5071 Debbie J. Hypes painfreeliving@aol.com 304-872-4141 (Case # 1 of 4) P.O Box 25 Lookout, WV 25868-0025 She has about 1,000 on her local mailing list, and has been a volunteer activist since 1997. Her guide first came out in 1997: http://www.Pain-Free-Living.net "The Food Plan: How To Do It" $ 5 by mail, free by email. Her sister Darlene, now 47, cured her own severe fibromyalgia in 1995 by using an elimination diet, and then Debbie also cured herself by 1997. Their doctor, Siegfried Schmidt, paying attention, tried it on two selected women, who got well, and are his third and fourth cases. http://groups.yahoo.com/group/aspartameNM/message/846 RTM: aspartame in Merck Maxalt-MLT worsens migraine, AstraZeneca Zomig, Eli Lilly Zyprexa, J&J Merck Pepcid AC (Famotidine 10mg) Chewable Tab, Pfizer Cool Mint Listerine Pocketpaks 7.16.2 rmforall Migraine MLT-Down: an unusual presentation of migraine in patients with aspartame-triggered headaches. Newman LC, Lipton RB Headache 2001 Oct; 41(9): 899-901. [Merck 10-mg Maxalt-MLT, for migraine, has 3.75 mg aspartame, while 12 oz diet soda has 200 mg.] Headache Institute, St. Lukes-Roosevelt Hospital Center, New York, NY Department of Neurology newmanache@aol.com Albert Einstein College of Medicine, Bronx, NY Innovative Medical Research RLipton@IMRInc.com http://groups.yahoo.com/group/aspartameNM/message/855 RTM: Blumenthall & Vance: aspartame chewing gum headaches Nov 1997 7.28.2 rmforall Harvey J. Blumenthal, MD, Dwight A Vance, RPh Chewing Gum Headaches. Headache 1997 Nov-Dec; 37(10): 665-6. Department of Neurology, University of Oklahoma College of Medicine, Tulsa, USA. neurotulsa@aol.com Aspartame, a popular dietetic sweetener, may provoke headache in some susceptible individuals. Herein, we describe three cases of young women with migraine who reported their headaches could be provoked by chewing gum sweetened with aspartame. [6-8 mg aspartame per stick chewing gum] http://ww.presidiotex.com/barcelona/index.html Trocho C, Pardo R, Rafecas I, Virgili J, Remesar X, Fernandez-Lopez JA, Alemany M ["Trok-ho"] Formaldehyde derived from dietary aspartame binds to tissue components in vivo. Life Sci 1998 Jun 26; 63(5): 337-49. Departament de Bioquimica i Biologia Molecular, Facultat de Biologia, Universitat de Barcelona, Spain. http://www.presidiotex.com/barcelona/index.html Maria Alemany, PhD (male) alemany@porthos.bio.ub.es http://groups.yahoo.com/group/aspartameNM/message/864 Murray: Butchko, Tephly, McMartin: Alemany: aspartame formaldehyde adducts in rats 9.8.2 rmforall Prof. Alemany vigorously affirms the validity of the Trocho study against criticism: Butchko, HH et al [24 authors], Aspartame: review of safety. Regul. Toxicol. Pharmacol. 2002 April 1; 35 (2 Pt 2): S1-93, review available for $35, [an industry paid organ]. Butchko: "When all the research on aspartame, including evaluations in both the premarketing and postmarketing periods, is examined as a whole, it is clear that aspartame is safe, and there are no unresolved questions regarding its safety under conditions of intended use." http://groups.yahoo.com/group/aspartameNM/message/867 Murray: Thatcher: simple tests for immune system reactions due to formaldehyde from the 11% methanol in aspartame: Tholen 9.17.2 rmforall http://groups.yahoo.com/group/aspartameNM/message/628 Rich Murray: Professional House Doctors: Singer: EPA: CPSC: formaldehyde toxicity 6.10.1 rmforall http://groups.yahoo.com/group/aspartameNM/message/863 Murray: Wilson: CIIN: EPA: Gold: Thrasher & Kilburn: Shaham: formaldehyde toxicity 8.22.2 rmforall http://groups.yahoo.com/group/aspartameNM/message/645 Rich Murray: 18 recent formaldehyde toxicity [Comet assay] abstracts 6.25.1 rmforall http://groups.yahoo.com/group/aspartameNM/message/622 Rich Murray: Gold: Koehler: Walton: Van Den Eeden: Leon: aspartame toxicity 6.4.1 rmforall http://groups.yahoo.com/group/aspartameNM/message/623 Rich Murray: Simmons: Gold: Schiffman: Spiers: aspartame toxicity 6.4.1 rmforall http://groups.yahoo.com/group/aspartameNM/message/870 Aspartame: Methanol and the Public Interest 1984: Monte: Murray 9.23.2 rmforall Dr. Woodrow C. Monte Aspartame: methanol, and the public health. Journal of Applied Nutrition 1984; 36 (1): 42-54. (62 references) Professsor of Food Science Director of the Food Science and Nutrition Laboratory Arizona State University, Tempe, Arizona 85287 6411 South River Drive #61 Tempe, Arizona 85283-3337 602-965-6938 woody.monte@asu.edu The methanol from 2 L of diet soda, 5.6 12-oz cans, 20 mg/can, is 112 mg, 10% of the aspartame. The EPA limit for water is 7.8 mg daily for methanol (wood alcohol), a deadly cumulative poison. Many users drink 1-2 L daily. The reported symptoms are entirely consistent with chronic methanol toxicity. (Fresh orange juice has 34 mg/L, but, like all juices, has 16 times more ethanol, which strongly protects against methanol.) "Fruit and vegetables contain pectin with variable methyl ester content. However, the human has no digestive enzymes for pectin (6, 25) particularly the pectin esterase required for its hydrolysis to methanol (26). Fermentation in the gut may cause disappearance of pectin (6) but the production of free methanol is not guaranteed by fermentation (3). In fact, bacteria in the colon probably reduce methanol directly to formic acid or carbon dioxide (6) (aspartame is completely absorbed before reaching the colon). Heating of pectins has been shown to cause virtually no demethoxylation; even temperatures of 120 deg C produced only traces of methanol (3). Methanol evolved during cooking of high pectin foods (7) has been accounted for in the volatile fraction during boiling and is quickly lost to the atmosphere (49). Entrapment of these volatiles probably accounts for the elevation in methanol levels of certain fruit and vegetable products during canning (31, 33)." Recent research [see links at end of post] supports his focus on the methanol to formaldehyde toxic process: "The United States Environmental Protection Agency in their Multimedia Environmental Goals for Environmental Assessment recommends a minimum acute toxicity concentration of methanol in drinking water at 3.9 parts per million, with a recommended limit of consumption below 7.8 mg/day (8). This report clearly indicates that methanol: "is considered a cumulative poison due to the low rate of excretion once it is absorbed. In the body, methanol is oxidized to formaldehyde and formic acid; both of these metabolites are toxic." (8).... Recently the toxic role of formaldehyde (in methanol toxicity) has been questioned (34). No skeptic can overlook the fact that, metabolically, formaldehyde must be formed as an intermediate to formic acid production (54). Formaldehyde has a high reactivity which may be why it has not been found in humans or other primates during methanol poisioning (59).... If formaldehyde is produced from methanol and does have a reasonable half life within certain cells in the poisoned organism the chronic toxicological ramifications could be grave. Formaldehyde is a known carcinogen (57) producing squamous-cell carcinomas by inhalation exposure in experimental animals (22). The available epidemiological studies do not provide adequate data for assessing the carcinogenicity of formaldehyde in man (22, 24, 57). However, reaction of formaldehyde with deoxyribonucleic acid (DNA) has resulted in irreversible denaturation that could interfere with DNA replication and result in mutation (37)...." http://www.dorway.com/barua.html Dr. J. Barua (ophthalmic surgeon), Dr. Arun Bal (surgeon) Emerging facts about aspartame. Journal Of The Diabetic Association Of India 1995; 35 (4): (79 references) barua@giasbm01.vsnl.net.in "...the total amount of methanol absorbed will be approximately 10% of aspartame ingested. An EPA assessment of methanol states that methanol, 'is considered a cumulative poison due to the low rate of excretion once it is absorbed. The absorbed methanol is then slowly converted to formaldehyde...'" "Reaction of formaldehyde with DNA has been observed, by spectrophotometry and electron microscopy, to result in irreversible denaturation." "DKP has been implicated in the occurence of brain tumors." http://groups.yahoo.com/group/aspartameNM/message/804 RTM: Hetle & Eltervaag: 2001 thesis abstract: aspartame brain damage in mice: Sonnewald 1995 study full text 2.17.2 rmforall http://groups.yahoo.com/group/aspartameNM/message/346 WebMD: Barclay: Barth: survey shows aspartame hurts memory in students 11.9.00 http://www.psy.tcu.edu/psy/barth.htm Timothy M. Barth Department of Psychology t.barth@tcu.edu Texas Christian University TCU Box 298920 Fort Worth, TX 76129 Chairman, Physiological Psychology 817-921-7410 http://groups.yahoo.com/group/aspartameNM/message/760 Kovatsi L, Tsouggas M The effect of oral aspartame administration on the balance of magnesium in the rat. Magnes Res 2001 Sep;14(3): 189-94. Laboratory of Forensic Medicine & Toxicology, Faculty of Medicine Aristotle University of Thessaloniki, Greece kovatsi@med.auth.gr http://groups.yahoo.com/group/aspartameNM/message/689 Karikas GA, Schulpis KH, Reclos GJ, Kokotos G Measurement of molecular interaction of aspartame and its metabolites with DNA. Clin Biochem 1998 Jul; 31(5): 405-7. Dept. of Chemistry, University of Athens, Greece http://www.chem.uoa.gr gkokotos@atlas.uoa.gr http://www.medscape.com/MedGenMed/braintumors Lennart Hardell, M.D., PhD, in 1999 reported in Sweden that both cell phone use and heavy aspartame use correlate with increased brain cancers lennart.hardell@orebroll.se +46 19 602 15 46 http://groups.yahoo.com/group/aspartameNM/message/31 Murray: Wurtman: aspartame & seizures 11.9.85 10.30.99 Wurtman RJ Aspartame: possible effect on seizure susceptibility. Lancet 1985 Nov 9; 2(8463): 1060. Richard J. Wurtman, Ph.D. dick@mit.edu 617-253-3091 Professor of Neuroscience Prof. of Health Sciences and Technology Massachusetts Institute of Technlogy Cambridge, Mass. 02139 http://groups.yahoo.com/group/aspartameNM/message/32 Murray: Drake: aspartame & panic attacks 9.13.86 10.30.99 rmforall Miles E. Drake, MD Panic attacks and excessive aspartame ingestion. Lancet 1986 Sep 13; 2(8507): 631. Department of Neurology and Psychiatry, Ohio State University Medical Center, Columbus, Ohio 43210, USA http://www.dorway.com/blayenn.html Russell L. Blaylock, MD dodd@netdoor.com Excitotoxins, neurodegeneration and neurodevelopment. The Medical Sentinel Journal 1999 Fall; (95 references) russell@misnet.com 601-982-1175 http://www.truthinlabeling.org/ Truth in Labeling Campaign [MSG] Adrienne Samuels, PhD The toxicity/safety of processed free glutamic acid (MSG): a study in suppression of information. Accountability in Research 1999; 6: 259-310. 52-page review P.O. Box 2532 Darien, Illinois 60561 858-481-9333 adandjack@aol.com http://groups.yahoo.com/group/aspartameNM/message/841 RTM: Merisant Co., MSD Capital, Dell Computer Corp., NutraSweet Co., JW Childs Assc.: aspartame-neotame toxicity 7.10.2 rmforall http://groups.yahoo.com/group/aspartameNM/message/857 RTM: www.dorway.com: original documents and long reviews of flaws in aspartame toxicity research 7.31.2 rmforall http://www.dorway.com David O. Rietz over 12,000 print pages Mission-Possible-USA Betty Martini 770-242-2599 Bettym19@mindspring.com dorietz@awod.com http://www.dorway.com/asprlink.html many links http://www.dorway.com/nslawsuit.txt Jeff Martin, Attorney http://www.dorway.com/upipart1.txt UPI reporter Gregory Gordon: 96K 3-part expose Oct 1987 http://www.dorway.com/doctors.txt What many informed doctors are saying/have said about aspartame http://www.HolisticMed.com/aspartame 603-225-2100 Aspartame Toxicity Information Center Mark D. Gold mgold@shelltown.net 12 East Side Drive #2-18 Concord, NH 03301 http://www.holisticmed.com/aspartame/abuse/methanol.html "Scientific Abuse in Aspartame Research" Aspartame Consumer Safety Network and Pilot Hotline [1987-2001] Mary Nash Stoddard, Founder & President P.O. Box 780634 Dallas, TX 75378 . 214-352-4268 marystod@airmail.net http://web2.airmail.net/marystod/index.html http://web2.airmail.net/marystod/espanol.htm Toxicology Sourcebook: "Deadly Deception: Story of Aspartame" http://groups.yahoo.com/group/aspartameNM/message/858 RTM: Samuels: Strong: Roberts: Gold: flaws in double-blind studies re aspartame and MSG toxicity 8.1.2 rmforall "Survey of aspartame studies: correlation of outcome and funding sources," 1998, unpublished: http://www.dorway.com/peerrev.html Walton found 166 separate published studies in the peer reviewed medical literature, which had relevance for questions of human safety. The 74 studies funded by industry all (100%) attested to aspartame's safety, whereas of the 92 non-industry funded studies, 84 (91%) identified a problem. Six of the seven non-industry funded studies that were favorable to aspartame safety were from the FDA, which has a public record that shows a strong pro-industry bias. Ralph G. Walton, MD, Prof. of Clinical Psychology, Northeastern Ohio Universities, College of Medicine, Dept. of Psychiatry, Youngstown, OH 44501, Chairman, The Center for Behavioral Medicine, Northside Medical Center, 500 Gypsy Lane, P.O. Box 240 Youngstown, OH 44501 330-740-3621 rwalton193@aol.com http://www.neoucom.edu/DEPTS/Psychiatry/walton.htm http://google.com gives 105,000 websites for "aspartame" , while http://groups.google.com/ finds on 700 MB of posts from 20-years of Usenet groups, 72,300 posts, and http://www.AllTheWeb.com gives 177,012, the top four being leading and very well informed volunteer anti-aspartame sites. http://www.ncbi.nlm.nih.gov/PubMed/ lists 712 aspartame items. http://www.readthelabel.org.uk/ Additives Survivors' Network (UK) geoffbrewer@eurobell.co.uk http://www.aspartame.ca/ John T. Linnell admin@aspartame.ca http://www.aspartame.ca/page_a10.html Canadian Class Action Law Suit http://groups.yahoo.com/group/aspartameNM/message/802 RTM: 700.club.com: CBN: Totheroh & Robertson: aspartame expose 2.13.2 rmforall http://groups.yahoo.com/group/aspartameNM/message/805 RTM: Ive: UK Daily Mirror Magazine: aspartame toxicity 2.18.2 rmforall http://groups.yahoo.com/group/aspartameNM/message/813 [also on http://www.rense.com/general20/bushaspertameAL.htm Contact Jeff Rense ] RTM: (corrected) danger to President Bush from aspartame toxicity 2.24.2 rmforall http://www.vegsource.com extensive vegan information http://www.vegsource.com/articles/kradjian_milk.htm Robert Kradjian MD Discusses Milk ********************************************************** Serious symptom syndrome summary: Aspartame (NutraSweet, Equal, Canderel, Benevia) is reported by scientific studies and case histories to be toxic: * headaches * many body and joint pains (or burning, tingling, tremors, twitching, spasms, cramps, or numbness) * fever, fatigue * "mind fog", "feel unreal", poor memory, confusion, anxiety, irritability, depression, mania, insomnia, dizziness, slurred speech, ringing in ears, sexual problems, poor vision, hearing, or taste * red face, itching, rashes, burning eyes or throat, dry mouth or eyes, mouth sores * hair loss * obesity, bloating, edema, anorexia, poor or excessive hunger or thirst * breathing problems * nausea, diarrhea or constipation * coldness * sweating * racing heart, high blood pressure, erratic blood sugar levels * seizures * birth defects * brain cancers * addiction * aggrivates diabetes, autism, ADHD, allergies, and interstitial cystitis (bladder pain) ********************************************************** http://members.tripod.com/~mission_possible/scotland_branch.html http://www.aspartame.ca/ Canada http://www.geocities.com/HotSprings/4578/ Canada http://www.cybernaute.com/earthconcert2000/AspartaMalcache.htm http://www.reseauproteus.net/therapies/nutritio/aspartame.htm http://ww2.grn.es/avalls/aspa1.htm Spain http://www.geocities.com/HotSprings/Falls/8669/ Brazil http://www.phd.com.br/aspartame.htm http://hem.passagen.se/mission.possible.sweden/ http://home.online.no/~dusan/foods/aspartame.html Norway http://www.aspartaam.nl/info/product.html Holland, in Dutch http://www.laleva.org/ Italy http://www.laleva.org/alimenti/dorwayaspartame.html http://users.westnet.gr/~cgian/aspartame.htm Greece **********************************************************