This is a brilliant letter from Betty Martini of Mission Posssible to the FDA Commissioner who has just resigned! Betty puts everything in perpective of how Commisioner Henney did nothing to warn the public of the DANGERS of aspartame. Please read it and pass it on to everyone you know!
----- Original Message -----
From: "Betty Martini"
Sent: 26 January 2001 01:46
Subject: Open Letter to Jane Henney, FDA Commissioner, on her resignation
Dear Jane Henney:
According to the post below you have resigned as FDA Commissioner. During the course of your service you did nothing to warn consumers that aspartame is a deadly chemical poison in our food. And even though you are an oncologist it didn't bother you that aspartame triggered brain, uterine, ovarian, thyroid, pancreatic, testicular and mammary tumors.
You allowed information to be sent from your office saying aspartame was proven safe when, in fact, it was proven unsafe. The FDA's own audit, the Bressler Report, is on www.dorway.com for all the world to read, as well as the Board of Inquiry Report telling the FDA not to approve aspartame. "The Board has not been presented with proof of a reasonable certainty that aspartame is safe for use a food additive under its intended conditions of use. The foregoing constitutes the Board's findings of fact and conclusions of law. Therefore, it is ORDERED that: (1) Approval of the food additive petition for aspartame (FAP 3A2885) be and it is hereby withdrawn. (2) The stay of the effectiveness of the regulation for aspartame, 21 CFR 172.804, is hereby vacated and the regulation REVOKED. Obviously, Dr. Arthur Hull Hayes didn't care whether it had been proven safe or not when he over-ruled this Board.
The late FDA Toxicologist, Dr. Adrian Gross, told Congress aspartame violated the Delaney Amendment because it triggered brain tumors and in conclusion said: "And if the FDA violates its own law who is left to protect the public?" FDA Toxicologist, Dr. Jacqueline Verrett told Congress that the aspartame studies were built on a foundation and should be thrown out.
I hold in my hand a letter from your office to The Honorable W. J. Tauzin signed by Melinda K. Plaisier, Associate Commissioner for Legislation. Filled with lies it says: "Aspartame is one of the most thoroughly tested and studied food additives the FDA has ever approved. More than 100 toxicological and clinical studies reviewed by FDA confirm that aspartame is safe for the general population." Why have you permitted this lie to be told time and time again by your office to consumers and congressmen, media, etc? Dr. H. J. Roberts in Aspartame (NutraSweet) Is It Safe? (Charles Press) has an entire chapter titled: "The Myth of "The Most Thoroughly Tested Additive in History". Here are the real facts and it doesn't confirm safety of aspartame. Roberts explains that Dr. M. Adrian Gross, a respected FDA scientist, was given the task of investigating the quality of experimental studies on aspartame carried out by, or for, the G. D. Searle & Co. prior to its licensure. He submitted a summary of dozens of "serious deficiencies" pertaining to the design, execution, analysis of the manufacturer's evaluation of aspartame to Senator Metzenbaum on October 30, l987. A few are listed:
* The poor quality of material prepared for microscopic examination of tissues. * The lack of training by personnel making observations in teratogenicity (birth defects) studies. * "The false values presented". * The excision of tumor masses before death. * The "substantial" loss in pathology information due to technical errors. * Improper departure from protocol specifications. * The failure to report all tissue masses to the FDA, especially brain tumors. * The improper use of pesticides in areas where studies were conducted. * Questionable record-keeping and entries. * The substitution of some animals. * Intercurrent disease among test animals to whom drugs were administered.
Dr. Henney, where does the FDA toxicologist, Dr. Adrian Gross mention safety? Why didn't your department report the truth to the Honorable W. J. Tauzin. An internal memo from Dr. Adrian Gross to Carl Sharp dated l976 says:
"Let us put this matter in some perspective by establishing the basic facts here. The Searle investigation which started in the fall of l975 can be viewed as an investigation "for cause" following the discovery of certain improprieties in the conduct of animal studies during preliminary inspections in l972 and in the first half of l975. The report of the Task Force submitted in March l976 in essence constituted a stinging indictment of Searle and it contained various recommendations for regulatory action including referral to the Justice Department for review of possible criminal violations of the law."
So why didn't your office tell the truth about the original studies, and that in January, l977 in a 33 page letter FDA Chief Counsel Richard Merrill recommended to U.S. Attorney Sam Skinner that a grand jury investigate Searle for "apparent violations of the Federal Food, Drug and Cosmetic Act 21 USC 331 (e), and the False Reports to the Government Act 18USC 1001, for "their willful and knowing failure to make reports to the Food and Drug Administration required by the Act 21 USC 355 (i) and for concealing material facts and making false statements in reports of animal studies conducted to establish the safety of (aspartame)." The FDA called special attention to studies investigating the effect of NutraSweet on monkeys and hamsters."
I don't see anything like that in this letter to Congressman Tauzin. And neither in any of the records did I find anything about studies showing aspartame to be safe. What I found was the FDA's Board of Inquiry telling the FDA not to approve aspartame because it hadn't been proven safe.
And as I read this letter from the FDA I see more lies: "Some websites on the Internet and other publications have attempted to link aspartame consumption to various health conditions such as systemic lupus, multiple sclerosis, vision problems, headaches, fatigue and even Alzheimer's disease. The Agency has not been presented with any credible scientific evidence to support any of these claims, nor is it aware of any evidence presented in peer reviewed scientific journals that support these claims."
First of all, studies in third world countries by Searle showed aspartame destroyed the central nervous system and the brain and people died in those studies. Why weren't they in peer reviewed journals? Because those studies showed aspartame to be the killer it is, they didn't publish them. See notarized affidavit from the translator on www.dorway.com Neurosurgeon Russell Blaylock, M.D. (author of Excitotoxins: The Taste That Kills, on aspartame and MSG) , in a letter to the Minneapolis Neuropathy Association on www.dorway.com/nomarkle.html speaks about a l997 study which found that macrophages exposed to aspartame produces a threefold rise in leukotriene (B4, C4 and 15 hydroxyeicosatetraenoic acid) and arachidonic acid metabolites. He says this would be detrimental to patients having autoimmune disorders such as lupus, multiple sclerosis and rheumatoid arthritis. Clinically, there is some evidence for worsening of two of the these conditions (MS and Lupus) by aspartame users. (Hardcastle JE, Bruch RT, Effect of L-aspartyl-L-phenylalanine methyl ester on leukotriene biosynthesis in macrophage cells. Prostagland Leukot Essen Fatty Acids 57:331-333, l997. On this same page - www.dorway.com/nomarkle.html you will also see Dr. H. J. Roberts position paper Multiple Sclerosis or Aspartame Disease? While this was not published in a journal it is based on the 20 year study on aspartame using the public as guinea pigs. The FDA has for years received these case histories of consumers being misdiagnosed as having MS, getting off aspartame and the symptoms disappearing.
In the case of lupus what do you expect with aspartame being an adjuvant, forming antigenic tissue, triggering immunologic attack. As Dr. James Bowen said in his report Aspartame Murders Infants, "The ability of methyl alcohol/formaldehyde to create antigenicity, especially as combined in aspartame molecules is so great as to cause severe autoimmune reactors to the tissues deformed by formaldehyde polemerization, adduct formation. The Immune system turns against the victim's tissues: Lupus."
This brings us to the Trocho Study which demonstrated that following aspartame ingestion, significant amounts of formaldehyde accumulate in the tissues. Formaldehyde is known to bind strongly to proteins and nucleic acids, forming adducts that are extremely difficult to eliminate through normal metabolic pathways. (Trocho C, Pardo R, et al. Formaldehyde derived from dietary aspartame binds to tissue components in vivo. Life Sciences 63:337-349, l998. )
As to headaches, which is #1 on your FDA report, here is the whole file on that research from Mark Gold of the Aspartame Toxicity Center including the flaws of industry research attempting to defend their chemical poison. (firstname.lastname@example.org www.holisticmed.com/aspartame)
Migraine/Headache Research Related to Aspartame
Summary of Aspartame-Caused Migraine/Headache Issue Meaningless Industry Research Other Migraine/Headache Aspartame Research References
Summary of Aspartame and Migraine/Headache Issue Headaches comprise 28.7% of the aspartame toxicity reactions reported to the U.S. Food and Drug Administration Adverse Reaction Monitoring System (DHHS 1997). In a survey of 551 aspartame toxicity cases, 45% (249) reported headaches or migraines from aspartame use (Roberts 1988). In a survey of 190 patients seen at the Montefiore Headache Unit in New York, Lipton (1989) found that 8.2% of the patients reported aspartame as a definite headache precipitant. Johns (1986) reported a case of aspartame causing migraine in a young woman. Migraines decreased and ceased upon elimination of aspartame. Rechallenge with aspartame in liquid led to a reoccurrence of migraines. Watts (1991) reported headache, shaking chills, lethargy, confusion, and myalgia from aspartame use. Blumenthal (1997) reported three cases of headaches in women chewing aspartame-containing gum. Headaches reported refer to migraines, cluster headaches, and other headaches.
In addition, aspartame-caused headaches are often part of many symptoms linked to aspartame use: "A 68-y-old female respondent developed nausea, vomiting and diarrhea after using 15 mL (one tablespoon) of a popular aspartame-flavored powdered laxative twice daily for several months. There was concomitant decreased vision and pain in both eyes, impaired hearing, marked sensitivity to noise in both ears, severe headaches, dizziness and unsteadiness (at times requiring assistance while walking), intense drowsiness, tremors, depression and itching. Her symptoms disappeared several weeks after she stopped using this and other aspartame products, and had not recurred when she completed the questionnaire." (Roberts 1988) "A 39-year-old white female complained of depression, memory loss, lethargy, irritability, dizziness, and headaches. The complainant's first use of aspartame-containing products was in March 1983, when she began using approximately 8 packs on Equal per day. During the symptomatic interval, the complainant added other aspartame-containing products to he diet, including Diet Coke and Kool Aid. The symptoms started in mid-April and increased in number and intensity in subsequent months. the first symptom to occur was lethargy. Over the ensuing months, irritability, dizziness, depression, and memory loss occurred. She states that when she stopped using aspartame-containing products in mid-September following a news report, the symptoms improved within 1 day and ceased within 1 week. The complainant subsequently re challenged herself approximately 2 months later with Equal, consuming 4 packets per day for approximately 3 days.
She stated that she became dizzy on the third day and that the episode was "very frightening." After these symptoms appeared she stated that she stopped consuming Equal, and approximately 24 hours later the symptoms subsided." (CDC 1984) Koehler (1988) conducted a double-blind study of patients who had a medical diagnosis of migraines, who were not on medications (other than analgesics) and who suspected that aspartame had a negative effect on their migraine headaches. Following a baseline period where the subjects tracked their headaches and their diets, the subjects were given 300 mg of aspartame or placebo, 4 times daily, for four weeks. The placebo group had no increase in headaches over the baseline levels. Approximately half of the subjects who took aspartame had a large increase in headaches. The most likely causes for migraines/headaches from aspartame use is the combination of the excitotoxin, aspartic acid, and the formaldehyde metabolites of aspartame as discussed in the Methanol/Formaldehyde document in this section. Ingestion of aspartame leads to a significant and sudden influx of free-form excitotoxic amino acid (Stegink 1987) and methanol (Davoli 1986). The methanol metabolizes into the highly toxic formaldehyde once in the body (DHHS 1993, Liesivuori 1991). Since the aspartic acid is in free form, it is absorbed very quickly, rather than the very slow influx of aspartic acid from the break down of proteins during the digestion of food (Stegink 1987). As will be discussed in the aspartic acid section, the amount of aspartic acid absorbed suddenly is many times the baseline level of plasma aspartic acid. In 1990, it was hypothesized that migraines and spreading depression were caused by excess excitatory amino acids in the Central Nervous System (CNS) (Welch 1990).
These researchers showed a high level of the excitotoxic amino acid, glutamate in the platelets during headaches and during migraines with aura. Brain magnesium (Mg++) was reduced approximately 19% in the brains during a migraine attack (based on NMR spectroscopy measurements). D'Andrea (1991) found increased levels of platelet aspartate and glutamate during migraines with aura. Castillo (1995) found increased levels of plasma glutamate and glutamate in the cerebrospinal fluid (CSF) in patients with headache during the acute phase of cerebrovascular ischemic disease. Cananzi (1995) found increased levels of glutamate in platelets (but not plasma) in patients experiencing migraines with aura. In a study of migraine and children, D'Eufemia (1997) found that aspartate was significantly increased in the erythrocytes (red blood cells) of children suffering from migraine (both with and without aura). The plasma glutamate and aspartate levels were reduced as compared to controls. The excitotoxins were increased in the erythrocytes and decreased in the plasma during migraine in children.
The authors conclude: "These results seem to suggest the presence of a higher activity of the erythrocytes' glutamate/aspartate transport system that could reflect a similar alteration at the neuronal/glial cell level in the CNS. Our study suggests an imbalance of the excitatory amino acid turnover in the pathogenesis of migraine in children." As pointed out in the Methanol/Formaldehyde document in this section, the formaldehyde/formic acid metabolite of aspartame will likely increase the excitotoxic effects of the free-form aspartic acid absorbed from aspartame. Meaningless Industry Research In 1987, Schiffman (1987) published a double-blind, cross-over study of 40 subjects claiming to have headaches from aspartame ingestion. No increase in headaches were seen in the aspartame group. The authors conclude: "In this population, aspartame is no more likely to produce headache than placebo." 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! Other Migraine/Headache Aspartame Research In 1994, Van Den Eeden (1994) published a double-blind, cross-over study related to aspartame and headaches. The aspartame was given for 7 days at a dose of 30 mg/kg/day (300 mg capsules) in three separate doses at mealtimes. The subjects who were "very certain" that aspartame caused their headaches showed a significant increase in headaches. Subjects who were either not certain or somewhat certain that aspartame caused their headaches showed no increase during the aspartame treatment period. In this independent study, we see an increase in headaches. The increase was not as dramatic as in the Koehler (1988) study, but this study was only 1/4 the length. In addition, one of the capsule ingestions during the Koehler study was at bedtime. The capsule administration in both studies significantly slows the influx of methanol, aspartic acid, phenylalanine and other aspartame breakdown products. Ingesting food at the same time as the capsules might be expected to further slow the absorption of these breakdown products.
One capsule ingestion period in the Koehler study was possibly on an empty stomach (at bedtime). Some may raise the issue that there are more factors to quality double-blind studies than just length and capsule administration. That is true. However, clinical experience has shown that the length of aspartame use is a major factor in the development of toxicity symptoms (CDC 1984, Roberts 1988) and an understanding of the toxicity of aspartame metabolites (methanol/formaldehyde, aspartic acid, etc.) leads one to the conclusion that capsule administration would significantly reduce toxicity (so that it would take a much higher dose and/or longer use to produce symptoms). Roberts (1995) made the unusual, but understandable point that Van Den Eeden (1994) should be wary of obtaining aspartame and capsules from the manufacturer (Monsanto/NutraSweet). While this may seem strange, it is important to note that some independent researchers no longer trust aspartame manufacturer involvement in studies. Roberts points out that since 1978, aspartame was hidden in the drink mixes given to controls in experiments studying the adverse effects of the excitotoxin MSG and where the study was funded by the MSG industry (Ebert 1991).
Since the aspartame manufacturer had the patent on aspartame, they must have given aspartame to the MSG industry to use in these drink mixes (before it was approved for human use!) and should have known that giving an excitotoxin to the control group in an excitotoxin experiment amounted to scientific fraud. Secondly, Roberts points out that Monsanto/NutraSweet refused to sell aspartame to an independent researcher for a study on aspartame and depression (Walton 1993). Roberts suggests that aspartame should be obtained from independent chemical suppliers and analyzed by corporate-neutral individuals.
Blumenthal, H.J., D.A. Vance, 1997, "Chewing Gum Headaches," Headache, Volume 37, Number 10, pages 665-666.
Butchko, Harriet, Frank Kotsonis, 1994. "Postmarketing Surveillance in the Food Industry: The Aspartame Case Study,"
Nutritional Toxicology, edited by Frank Kotsonis, Maureen Mackey, and Jerry Hjelle, Raven Press, Ltd., New York, pages 235-249.
Cananzi, A.R., G. D'Andrea, F. Perini, F. Zamberlan, K.M.A. Welch, 1995. "Platelet and Plasma Levels of Glutamate and Glutamine in Migraine With and Without Aura," Cephalalgia, Volume 15, pages 132-135.
Castillo, J., et al., 1995. "Amino Acid Transmitters in Patients With Headache During the Acute Phase of Cerebrovascular Ischemic Disease," Stroke, Volume 26, pages 2035-2039. CDC 1984.
"Evaluation of Consumer Complaints Related to Aspartame Use," Division of Nutrition, Center for Health Promotion and Education, Centers for Disease Control, Atlanta, GA 30333, November 1984. D'Andrea, G., et al., 1991. "Platelet Glycine,
Glutamate and Aspartate in Primary Headache," Cephalalgia, Volume 11, pages 197-200.
Davoli, E., et al., 1986. "Serum Methanol Concentrations in Rats and in Men After a Single Dose of Aspartame," Food and Chemical Toxicology, Volume 24, No. 3, page 187-189. DHHS 1993.
"Methanol Toxicity," American Family Physician, Volume 71(1):163-171, January 1993. Adapted from Case Studies in Environmental Medicine published by the Agency For Toxic Substances and Disease Registry, U.S. Department of Heath and Human Services. DHHS 1997.
"Summary of Adverse Reactions Attributed to Aspartame [1980-1996]," Memorandum From DHHS Technical Information Specialist (HFS-728) to Health Hazard Evaluation Board on June 26, 1997. Ebert, Andrew G., 1991.
Letter to Sue Ann Anderson, R.D., Ph.D., Senior Staff Scientist, Life Sciences Research Office, Federation of American Societies for Experimental Biology (FASEB), March 22, 1991.
FDA Docket No. 90N-0379 (Item CR2). Gordon, Gregory, 1987. "NutraSweet: Questions Swirl," UPI Investigative Report, 10/12/87. Reprinted in US Senate (1987, page 483-510). Hertelendy, Zsolt, et al., 1993.
"Biochemical and Clinical Effects of Aspartame in Patients with Chronic, Stable Alcoholic Liver Disease," The American Journal of Gastroenterology, Volume 88, No. 5, 1993.
Johns, Donald R., "Migraine Provoked by Aspartame," New England Journal of Medicine, Volume 314, August 14, 1986, page 456.
Koehler, SM, A. Glaros, 1988. "The Effect of Aspartame on Migraine Headache," Headache, Volume 28, page 10-14.
Leon, Arthur S., et al., 1989. "Safety of Long-Term Large Doses of Aspartame," Archives of Internal Medicine, Volume 149, page 2318-2324.
Liesivuori, Jyrki, Heikki Savolainen, 1991. "Methanol and Formic Acid Toxicity: Biochemical Mechanisms," Pharmacology & Toxicology, Volume 69, page 157-163.
Lipton, Richard B., et al., 1989. "Aspartame as a Dietary Trigger of Headache," Headache, Volume 29, pages 90-92.
Moser, Robert H., 1994. "Aspartame and Memory Loss," Journal of the American Medical Association, Volume 272, No. 19, page 1543.
Posner, Herbert S., 1975. "Biohazards of Methanol in Proposed New Uses," Journal of Toxicology and Environmental Helath, Volume 1, page 153-171.
Roberts, H.J., 1988. "Reactions Attributed to Aspartame-Containing Products: 551 Cases," Journal of Applied Nutrition, Volume 40, page 85-94.
Roberts, H.J., 1995. "Aspartame and Headache," Letter to the Editor. Neurology, Volume 45, page 1631.
Rowen, A. James, Bennett A. Shaywitz, et al., 1995. "Aspartame and Seizure Susceptibility: Results of a Clinical Study in Reportedly Sensitive Individuals," Epilepsia, Volume 36, No. 3, page 270-275.
Schiffman, Susan S., et al., "Aspartame and Susceptibility to Headache," New England Journal of Medicine, Volume 317, No. 19, pages 1181-1185.
Shapiro, Robert, 1987. Statement of Robert Shapiro, Chief Executive Officer, NutraSweet Company, before the U.S. Senate Committee on Labor and Human Resources, November 3, 1987 regarding "NutraSweet Health and Safety Concerns." Document # Y 4.L 11/4:S.HR6.100, page 400-427.
Shaywitz, B.A., et al., 1994a, "Aspartame Has No Effect on Seizures or Epileptiform Discharges in Epileptic Children," Annuls of Neurology, Volume 35, page 98-103.
Spiers, Paul A., L. Sabounjian, Al Reiner, D. Myers, J. Wurtman, D. Schomer, 1998. "Aspartame: Neuropsychologic and Neurophysiologic Evaluation of Acute and Chronic Effects," American Journal of Clinical Nutrition, Volume 68, pages 531-537.
Stegink, Lewis D., et al. 1987. "Plasma Amino Acid Concentrations in Normal Adults Administered Aspartame in Capsules or Solution: Lack of Bioequivalence," Metabolism, Volume 36, No. 5, page 507-512.
Tollefson, Linda, Robert J. Barnard,1992. "An Analysis of FDA Passive Surveillance Reports of Seizures Associated With Consumption of Aspartame," Journal of the American Dietetic Association, Volume 92, No. 5, page 598-601.
Trefz, Friedrich, Leo de Sonneville, Peter Matthis, Christian Benninger, Brigitte Lanz-Englert, Horst Bickel, 1994. "Neuropsychological and Biochemical Investigations in Heterozygotes for Phenylketonuria During Ingestion of High Dose Aspartame (A Sweetener Containing Phenylalanine)," Human Genetics, Volume 93, page 369-374.
US Senate 1987. U.S. Senate Committee on Labor and Human Resources, November 3, 1987 regarding "NutraSweet Health and Safety Concerns." Document # Y 4.L 11/4:S.HR6.100.
Van Den Eeden, S.K., et al., 1994. "Aspartame Ingestion and Headaches: A Randomized Crossover Trial," Neurology, Volume 44, pages 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.
Watts, Richard S., 1991. "Aspartame, Headaches and Beta Blockers" (Letter to the Editor), Headache, March, 1991, Page 181-182.
Welch, K.M.A., et al., 1990. "The Concept of Migraine as a State of Central Neuronal Hyperexcitability," Headache, Volume 8, No. 4, pages 817-828.
Yost, David A., 1989. "Clinical Safety of Aspartame," American Family Physician, Volume 39, Number 2, pages 201-206, 1989.
Next, Alzheimers: H. J. Roberts, M.D. has already written Defense Against Alzheimers Disease and explains that aspartame is escalating it. Really Dr. Henney, memory loss is #11 on your own FDA report of 92 symptoms triggered by aspartame its so prevalent and only a few weeks ago a new study on memory loss was reported on WEBMD. It was presented at a conference and no doubt will soon be published.
In the case of vision problems, has the FDA forgotten that in l986 so many hundreds of people were going blind on aspartame, many of them diagnosed by the late Dr. Morgan Raiford (specialist in methanol toxicity) that the Community Nutrition Institute petitioned the FDA to ban aspartame? And that petition also included seizures, documented on a pivotal study that approved aspartame (SC-18862) with 5 out of 7 monkeys having grand mal seizures, one died.
Also in this letter to Mr. Tauzin she says: "The Agency has analyzed a very large number of medical reports for these alleged adverse reactions as part of ARMS. These data do not provide credible scientific evidence of a causal relationship between consumption of aspartame and any of the alleged adverse effects." Jane Henney, let me enlighten you and your office. When 1000 people have the same reaction to a product it is no longer called an anecdote - its called a study. Example, Dr. Baret of the Dominican Republic gave 360 children juice laced with aspartame. All the children suffered restlessness, behavioral problems, etc. Four days after taking the children off aspartame, all the 360 children returned to normal. We do the same thing, when consumers complain of symptoms we know to be triggered by aspartame and on your own FDA report, we tell them to try the 60 Day No Aspartame Test. And they get to see their symptoms disappear, that is if it isn't too late.
The FDA has for years tried various means not to report all the aspartame complaints. Even in Congress it was discussed how the FDA was actually sending consumers with complaints to the AIDS Hotline. Then in l996 when Dr. David Kessler wanted to show a decrease in complaints so he could grant blanket approval to this poison, it was noted that the FDA had changed their bookkeeping system requiring they destroy hundreds of aspartame complaints. No reports from Mission Possible were counted and callers were told the FDA was no longer taking complaints.
This next paragraph gets the prize for the biggest whopper of the year. Plaisier says: "In addition, the Agency has reviewed scientific studies in both animals and human subjects to determine if there is any discernible basis for the reported adverse reactions. To date, the results of INDEPENDENT studies carried out in government, academic, and private laboratories consistently have been reassuring about the safety of aspartame. FDA is aware of no reports of well-controlled clinical studies that would question the safety of aspartame under normal use conditions." Has your office no shame to tell such a lie?
In front of God and the world, Dr. Ralph Walton, pointed out on 60 Minutes on Dec 29, l996, that he had done peer reviewed research showing 90 INDEPENDENT studies on aspartame. 83 out of 90 or 92% identified a problem. The seven (7) non-industry studies attesting to aspartame's safety were six (6) studies from the FDA and one (1) literature review reflecting almost exclusively the industry sponsored research. Dr. Walton pointed out in his research, "As the role of the FDA in the question of aspartame safety, has been controversial and allegations were made of a conflict of interest on the part of the FDA Commissioner at the time of aspartame's approval, one could argue that the FDA studies should not be considered truly "independent". If these studies are excluded, along with the literature review focusing only on NutraSweet industry funded research, then 100% of the truly independently funded research demonstrated some type of adverse reaction to NutraSweet. " You can be sure that I will mail to Congressman Tauzin a copy of that research proving the FDA continually lies on the aspartame issue.
Plaisier goes on to say "Should the need arise, the Agency will take the appropriate action to protect public health." I ask, Jane Henney, what shows a need? Since aspartame was first approved there have been operations warning consumers off aspartame because the symptoms are predictable and there is a pattern. The exact reason, H. J. Roberts, M.D., says aspartame is a disease. He has now declared it a world plague.
There are now five aspartame detoxification centers. Mission Possible operations warning consumers aspartame is a neurotoxin exist in most states and over 20 countries of the world. Newton Laboratories has made an anecdote to try and remove some of the formaldehyde. There are now four support groups for victims of aspartame on line. There have been 3 congressional hearings because of the outrage of the public on being poisoned. There is an Aspartame Toxicity Center recording the cases of the sick and dying. Articles on aspartame's toxicity and sordid past are constantly in the news. Aspartame is constantly discussed on radio and TV. Books continue to be published by eminent physicians warning consumers.
When will the FDA decide there is a "need" to protect the public? How many thousands more have to die before FDA tells the truth and tells industry to recall it. How many thousands of babies are murdered in their mother's womb by this deadly poison or maimed for life with birth defects. This spring, H. J. Roberts, M.D., will be publishing a 900 page medical text on the world plague of aspartame so that physicians can accurately diagnose their patients. With the cockamamie propaganda put out by industry and the professional organizations they fund, and your department, the medical community has no way of knowing aspartame is actually a drug masquerading as an additive and deadly. Nor do they associate the problems on the FDA report with aspartame since you only sent that report under Freedom of Information or through a congressman.
When a Congressman asks the FDA for answers the FDA is suppose to tell the truth, not continually lie and deny, lie and deny. When Newt Gingrich was Speaker of the House he asked the FDA to answer 26 questions I posed on aspartame and which remain on www.dorway.com It has now been over 5 years and the FDA has not complied. The last word given to Gingrich's aide was "We have to ask our attorney what we can answer." Did he tell the FDA if the questions were answered honestly aspartame would have to be recalled? Is that the holdup all these years?
And doing nothing about aspartame mass poisoning the consumer public in 100 countries of the world is not the only legacy you will leave behind. It's hard to believe that an oncologist would grant approval of Tamoxifen for healthy women, with full knowledge that the World Health Organization has declared it a carcinogen, and that a Duke Study has shown it backfires and gives you cancer. Even I talked to the researcher, Dr. Trudy Bush, who said she tried her best to tell industry that Tamoxifen is not an anti-estrogen but a pro-estrogen. Even Dr. Fisher had to step down when it was found they didn't tell women in studies that it could target the endometrium and kill with endometrial cancer. And people died. How could you, Jane Henney, approve for this for healthy women? How many will die because you did?
And then RBGH, recombinant bovine growth hormone. Robert Cohen had the goods on that issue, and you walked away from the table and did nothing. So our children are drinking milk from cows injected with the bovine growth hormone which increases the insulin growth factor, the regulator of cancer.
Thank God you never approved Neotame, an even more potent aspartame. I believe any FDA Commissioner that approves it with the history of aspartame should be indicted for malfeasance. However, the public knows what the FDA people do in many cases before they leave office. In the case of U.S. Prosecutor Sam Skinner, instead of indicting Searle, he went to work for their defense team, but he didn't work for the FDA. David Kessler before he left for Yale granted blanket approval of this poison. Before Dr. Arthur Hull Hayes left the FDA after over-ruling a Board of Inquiry, he granted approval to aspartame in dry form and in carbonated beverages. Even the Board of Inquiry didn't realize he would even consider approving aspartame in beverages. Then he went to work for the PR Agency of the manufacturer. After FDA Acting Commissioner Mike Friedman got on 60 Minutes and defended Monsanto he got employed by Searle, owned by Monsanto. And you know I could go on and on. Where will you go? You have certainly pleased industry, especially Monsanto, with your non-feasance! There is a new book out you should read, Trust Us, We're Experts! by John Stauber and Sheldon Rampton - How industry manipulates science and gambles with your future. These are the outstanding authors of Toxic Sludge is Good For You.
This is your legacy and more. In the entire term of your office you have never answered one of my letters. You disregard those who are suffering from this neurotoxin. Think about it. You can demand industry recall aspartame and those others that should not be on the market, and know you have done something to preserve life . Or you can turn out the lights and know disability and death from deadly drugs you allowed to stay on the market, will always be your legacy.
Mrs. Betty Martini, Mission Possible International,
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