---------- From: Rich Murray <[EMAIL PROTECTED]> Newsgroups: alt.health,alt.health.diabetes,alt.support.depression Date: Fri, 23 Jun 2000 19:59:37 -0600 To: [EMAIL PROTECTED], [EMAIL PROTECTED], Alan Raetz <[EMAIL PROTECTED]>, [EMAIL PROTECTED], [EMAIL PROTECTED], [EMAIL PROTECTED] Subject: Murray: Gold: Schiffman: Spiers: aspartame toxicity 2.18.00 Murray: Gold: Schiffman: Spiers: aspartame toxicity 2.18.00 N Engl J Med 1987 Nov 5;317(19):1181-5 Aspartame and susceptibility to headache. Schiffman SS, Buckley CE 3d, Sampson HA, Massey EW, Baraniuk JN, Follett JV, Warwick ZS Department of Psychiatry, Duke University, Durham, N.C. 27710. Dr. Susan S. Schiffman Dept. of Psychiatry Duke University www.duke edu [EMAIL PROTECTED] 919-684-3303, 660-5657. She has over 100 obviously competent experimental studies and reviews since 1971 in PubMed. Her major field is the deterioration of smell and taste in seniors and AIDS patients from exposure to drugs, chemicals, and pollutants-- one wonders if she ever considered the effects of aspartame, since smell and tase impairment are known to result from exposure to aspartame or formaldehyde. "Loss of taste" is one of 90 symptoms from many case reports of aspartame toxicity, summarized in: Department of Health and Human Services. "Report on All Adverse Reactions in the Adverse Reaction Monitoring System." (February 25 and 28, 1994). Abstract (Schiffman et al, 1987): We performed a double-blind crossover trial of challenges with 30 mg of aspartame per kilogram of body weight or placebo in 40 subjects who reported having headaches repeatedly after consuming products containing aspartame. The incidence rate of headache after aspartame (35 percent) was not significantly different from that after placebo (45 percent) (P less than 0.50). No serious reactions were observed, and the incidence of symptoms other than headache following aspartame was also equivalent to that after placebo. No treatment-related effects were detected in vital signs, blood pressure, or plasma concentrations of cortisol, insulin, glucagon, histamine, epinephrine, or norepinephrine. Most of the subjects were well educated and overweight and had a family or personal history of allergic reactions. The subjects who had headaches had lower plasma concentrations of norepinephrine (P less than 0.0002) and epinephrine (P less than 0.02) just before the development of headache. We conclude that in this population, aspartame is no more likely to produce headache than placebo. PMID: 3657889, UI: 88014077 Aspartame Toxicity Information Center Mark D. Gold www.HolisticMed.com/aspartame 603-225-2100 "Scientific Abuse in Aspartame Research" http://www.holisticmed.com/aspartame/abuse/methanol.html [EMAIL PROTECTED] 12 East Side Drive #2-18 Concord, NH 03301 http://www.holisticmed.com/aspartame/abuse/migraine.html : "Scientific Abuse in Migraine/Headache Research Related to Aspartame": "Other industry researchers have cited this study as evidence that aspartame does not induce headaches (Butchko 1994, Leon 1989, Moser 1994). In addition, Yost (1989) claimed that aspartame is not more likely to cause headache than placebo. Tollefson (1992) of the FDA cited this Schiffman study as evidence that aspartame does not cause headaches. (The Tollefson review was discussed in detail in the Seizure Research Abuse section). "What these researchers fail to mention is that the Schiffman (1987) research is useless because of major design flaws. It is also particularly troubling that none of the above-mentioned authors cited the Koehler (1988) double-blind study! "Before we discuss the major flaws of the Schiffman study, I will present some background information. The study was partially funded by Monsanto/NutraSweet and conducted at the Searle Center at Duke University. (G.D. Searle is owned by Monsanto.) Susan Schiffman performed her research at the "Searle Center" at Duke University. The Searle Center is under the guidance of William Anlyan, a former G.D. Searle director. Schiffman is a former General Foods and G.D. Searle consultant. The FDA helped design the study protocol. [Gordon 1987, page 500 of US Senate 1987; Shapiro 1987, page 403 of US Senate 1987].) "Schiffman (1987) major flaws: 1.The aspartame was given for only one day. 2.The aspartame was given in encapsulated form which would lower the toxicity by eliminating the sudden absorption of the excitotoxic amino acid and methanol (Stegink 1987). The absorption of the excitotoxin is gradual, somewhat closer to what happens when ingesting food. The methanol is absorbed more slowly and that may significantly reduce toxicity as happens when food in the stomach slows methanol absorption (Posner 1975). 3.There was no baseline frequency of headaches determined before administering aspartame or placebo. "It is very important to note the main distinction between the Koehler (1988) study and the Schiffman (1987) study. While both studies used capsules, which would be expected to significantly reduce aspartame toxicity, and both studies used subjects who claimed to have headaches from aspartame, the Koehler (1988) study administered aspartame for four weeks, while the Schiffman (1987) study administered the aspartame for only one day! "When one examines the double-blind studies funded by the aspartame industry, a pattern develops. Industry-supported research on subjects who have reported serious reactions to aspartame is almost always one day long and the aspartame is administered in capsules (e.g., Hertelendy 1993, Rowen 1995, Schiffman 1987). Industry-supported research that lasts several weeks is usually performed on individuals that might be expected to experience adverse reactions after at least several months of aspartame use (e.g., Shaywitz 1994) or on individuals even less susceptible to short-term aspartame toxicity, but where more sensitive neurological tests were conducted (e.g., Spiers 1998). The longer (but still relatively short) industry-supported research (3-6 months) usually uses healthy subjects who would likely only experience serious adverse reactions after many months or several years of aspartame use (e.g., Leon 1989, Trefz 1994). While the length of the study is not the only flaw in these industry-sponsored studies, there appears to be an obvious pattern of exceptionally short studies used on more susceptible subjects. It would appear that the manufacturer funds research with protocol designs virtually guaranteed to find no adverse reactions!" [end of Gold quote] Am J Clin Nutr 1998 Sep; 68(3): 531-7 Aspartame: neuropsychologic and neurophysiologic evaluation of acute and chronic effects. Spiers PA, Sabounjian L, Reiner A, Myers DK, Schomer DL Clinical Research Center, Massachusetts Institute of Technology, Cambridge 02139, USA. Paul A. Spiers [EMAIL PROTECTED] 617-253-6797 and 978-887-6220 Neurological Associates Donald L. Schomer, M.D., Assc. Prof. Neurology, Beth Israel Deaconess Medical Center, Harvard Medical Sch., [EMAIL PROTECTED], 617-667-3999 This study, done on or before 1993, was described in an abstract in 1993: then Richard J. Wurtman, Ph.D., Director of the CRC, was listed as an author, but not in 1998. It was paid for by NutraSweet Co. It used 48 healthy college students, half male and half female in each group of 24, high-dose and low-dose aspartame, also tested with placebo and sucrose, who took 20 days each of daily aspartame, sucrose, or placebo, and were tested clinically on the morning of the 20th day, before the last dose. The study is summarized by Schomer, Spiers, and Sabounjian on pages 225-31 in "The Clinical Evaluation of a Food Additive: Assessment of Aspartame," 1996, CRC Press, 308 pages, Ed. by Tschanz C, Butchko H, Stargel WW, Kotsonis FN, all employees of Monsanto/NutraSweet. High-dose, 45, and low-dose, 15 mg/kg daily, groups had 24 subjects each. The results showed that the total number of headaches was about the same for low dose, sucrose, and placebo, at 11,14, and 11, but only 4 headaches for the 24 high-dose subjects in 20 days. The probability of this is not given. The numbers for fatigue were 3, 4, 2, and 1, for nausea 1, 3, 4, and 1, for acne 1, 4, 3, and 2. For these 4 symptoms, the most common reported, the high-dose group is far less than sucrose or placebo. This indicates that some sort of confounding processes were indeed operating, and that the study is therefore meaningless, unless we are to start proclaiming aspartame as the newest aspirin. Wouldn't a few students simply stop taking pills, if they thought it caused headache, and wouldn't they also start taking regular aspirin? Wouldn't a few students continue their favored diet drinks and foods? Wouldn't exposure to MSG, claimed by many researchers to have similar toxic biochemistry and symptoms, also confound the results? Only a few malfunctions like this suffice to eliminate statistical significance in a group of only 24. "Complaints of adverse experiences were recorded in blinded fashion." It is not clear whether a symptom log was kept on a daily basis, or if symptoms were discussed only at day 10 and 20. The scientific community should have access to the actual raw data for daily symptoms for each subject. "We were clearly able to distinguish the subjects in the high-dose aspartame group when they received the aspartame treatment because they had significantly elevated fasting plasma phenylalanine concentrations (Figures 3 and 4)..." This was about a 30% higher value at 85 minutes after the 3 PM dose on day 10, compared to placebo or sucrose. Is this kind of rise seen from consumption of phenylalanine in ordinary foods? Since aspartame and its products, methanol, formaldehyde, and aspartic acid are cumulative toxins, we would expect symptoms to increase over the 20 days, and to continue afterwards when the subjects were given sucrose and placebo. Since vulnerability varies greatly, we would expect a few subjects to be providing most of the symptoms. It might be illuminating to have the raw data on each of the subjects. Moreover, when aspartame is given in capsules and at meals, then it is released gradually into the body, along with foods that mitigate its effects, while diet soda, the main source of aspartame, allows aspartame to be absorbed quickly, often with little food. In many cases, symptoms may not develop until after months and years of daily exposure, as in the case of tobacco. Finally, the sample of 24 in the high-dose group allows us to infer, at best, even if the study had inpecably consistent results, that the incidence of harm within 3 weeks in healthy college students is perhaps less than 5 or 10% at the 95% confidence level. *********************************************************************** Rich Murray Room For All [EMAIL PROTECTED] 1943 Otowi Drive Santa Fe, NM 87505 505-986-9103 505-920-6130 ***********************************************************************