Aspartame Disease: An FDA-Approved Epidemic

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Aspartame Disease: An FDA-Approved Epidemic By H. J. Roberts, M.D., F.A.C.P., F.C.C.P. "Diet" products containing the chemical sweetener aspartame can havemultiple neurotoxic, metabolic, allergenic, fetal and carcinogenic effects.My database of 1,200 aspartame reactors--based on logical diagnosticcriteria, including predictable recurrence on rechallenge--is reviewed. The existence of aspartame disease continues to be denied by the FDAand powerful corporate entities. Its magnitude, however, warrants removal ofthis chemical as an "imminent public health threat." The use of aspartameproducts by over two-thirds of the population, and inadequate evaluation bycorporate-partial investigators underscore this opinion. As said by Senator Howard Metzenbaum

(1): "We had better be sure that the questions that have been raisedabout the safety of this product are answered. I must say at the outset,this product was approved by the FDA in circumstances that can only bedescribed as troubling." I have devoted more than two decades to analyzing aspartame disease, awidespread but largely ignored disorder. Its existence continues to bereflexively denied by the Food and Drug Administration (FDA), the AmericanMedical Association (AMA), and many public health/ regulatory organizations. The medical profession and consumers have been assured by the Councilon Scientific Affairs of the AMA (2) and the Centers for Disease Control(CDC) that aspartame is "completely safe." Moreover, the impression is leftthat reports of serious reactions are a "health rumor" fabrication

....notwithstanding the CDC report in 1984 of 649 aspartame reactors with manyattributed disorders (3). An Overview of Aspartame Disease As far back as 1988, seven years after the initial release ofaspartame, 80 percent (!) of complaints volunteered by consumers to the FDAabout supplements involved aspartame products. By April 1995, it hadreceived 7,232 complaints. I coined the term "aspartame disease" to encompass reactions to thechemical sweetener aspartame, commonly known as NutraSweet® and Equal®.Aspartame was originally conceived, and an application submitted, as a drugto treat peptic ulcer. To place its magnitude in perspective, overtwo-thirds of the population now uses thousands of "diet" sodas andproducts--including an ever-expanding list of new ones having greaterpotential for adverse effects (e.g., strips

placed on the tongue to freshenthe breath). This report summarizes data on the first 1,200 aspartame reactors inmy database, coupled with information of considerable clinical significance.I have elaborated on the details in Aspartame Disease: An Ignored Epidemic(4), other books (5-8), and numerous published articles and letters (9-12). It is my belief that most physicians with active practices frequentlyencounter its manifestations. But, unaware of the underlying problem, theyfail to inquire about aspartame use. For orientation about the gravity of this public health dilemma, Ishall mention just a few of the published associations in aspartamereactors. They include the initiation or aggravation of diabetes mellitus,hypoglycemia, convulsions, headache, depression, other psychiatric states,hyperthyroidism, hypertension

and arthritis; the simulation of multiplesclerosis, Alzheimer's disease and lupus erythematosus; increasing aspartameaddiction (12); an apparent causative role in brain tumors (10); aneurologic condition in overweight young women known as pseudotumor cerebri;and even the carpal tunnel syndrome (11). In my opinion, lack of awareness of aspartame disease has resulted ingross miscarriage of justice. Examples include attributing the symptoms ofweight-conscious women consuming considerable amounts of aspartame tosilicone breast implants in expensive litigation (7), and imprisonment forthe alleged methanol poisoning of a deceased spouse who consumed largeamounts of aspartame. Having been involved in medical practice, teaching and the authorshipof texts for a half century, I do not casually make statements that mightjeopardize a longstanding reputation. As a case

in point, my first book,Difficult Diagnosis: A Guide to the Interpretation of Obscure Illness (13),was studied and used as a reference by tens of thousands of internists andother physicians. The following issues are also relevant: a.. My best teachers have been perceptive private patients. b.. All my studies were corporate-neutral, meaning without grants. Ihave had to cope with the enormous hurdles of professional and editorialbias stemming from the self-serving interests of corporate power wielded bya multi-billion dollar industry. For example, virtually all my letterschallenging the validity of "negative scientific studies" published inpeer-reviewed journals were rejected. They were based on flawed protocols,the failure to use "real world" products subjected to prolonged storage andelevated

temperatures, and even the nature of the test materials andplacebos employed. c.. My repeated emphasis to colleagues, the FDA and the Congressthat the approval of aspartame for human use has spawned an imminent publichealth hazard continues to fall on deaf ears. d.. A number of concerned doctors were unable to get their"anecdotal" observations published in peer-reviewed journals, some(including the author) having been labeled "media terrorists" disrespectfulof "evidence-based" criteria. About Aspartame The FDA approved aspartame as a low-nutritive sweetener for use insolid form during 1981, and in soft drinks during 1983. It is a syntheticchemical consisting of two amino acids, phenylalanine (50 percent) andaspartic acid (40 percent), and a methyl ester (10 percent) that

promptlybecomes free methyl alcohol (methanol; wood alcohol). The latter isuniversally considered a severe poison. Senior FDA scientists and consultants vigorously protested approvingthe release of aspartame products. Their objections related to disturbingfindings in animal studies (especially the frequency of brain tumors),seemingly flawed experimental data, and the absence of extensivepre-marketing trials on humans using real-world products over prolongedperiods. Aspartame reactions may be caused by the compound itself, its threecomponents, stereoisomers of the amino acids, toxic breakdown products(including formaldehyde), or combinations thereof. They often occur inconjunction with severe caloric restriction and excessive exercise to loseweight. Various metabolic and physiologic disturbances explain the

clinicalcomplications. Only a few are listed: a.. Damage to the retina or optic nerves is largely due to methylalcohol exposure. Unlike most animals, humans cannot efficiently metabolizeit. b.. High concentrations of phenylalanine and aspartic acid occur inthe brain after aspartame intake, unlike the modest levels of amino acidsfollowing conventional protein consumption. c.. Aspartame alters the function of major amino acid-derivedneurotransmitters, especially in obese persons and after carbohydrateintake. d.. Phenylalanine stimulates the release of insulin and growthhormone. e.. The ambiguous signals to the satiety center following aspartameintake may result either in increased food consumption or severe

anorexia. f.. Large amounts of the radioactive-carbon label from oralaspartame intake have been detected in DNA. The current "acceptable daily intake" (ADI) of 50 mg aspartame/kg bodyweight makes no sense. It represents the projection of animal studies basedon lifetime intake! This was clearly stated by previous FDA Commissioner Dr.Frank Young during a U.S. Senate hearing on November 3, 1987. Furthermore,it disregards the usual 100-fold safety factor used by the FDA as aguideline for regulated food additives. The maximum daily intake toleratedby most reactors in my series, based on the predictable recurrence ofinduced symptoms and signs, ranged from 10 to 18.3 mg/kg. Clinical Data Attributed to Aspartame Products The clinical features attributed to aspartame products among the

first1,200 reactors in my database appear in Table 1 (reproduced from Reference 4with permission by the Sunshine Sentinel Press). Gender and Age Range There was a 3:1 preponderance of females (72 percent). The variousinfluences that may be operative in this gender preference have beendetailed previously (4-6). The ages of persons at the onset of theirreactions ranged from infancy to 92 years. Most were in their 20s to 50s. Family History Two or more close relatives of 211 reactors (17.6 percent) were knownto have had reactions to aspartame products. Latent Period Latent periods of from several weeks to months between the initialconsumption, and increased intake of aspartame and the

onset of severesymptoms were common. On the other hand, some patients reacted almostimmediately, particularly with products conducive to oral/buccal absorption. Aspartame Intake Many reactors consumed prodigious amounts of aspartame, especiallyduring hot weather. Conversely, some experienced convulsions, headache, orother severe symptoms after exposure to small amounts (e.g., chewingaspartame gum; placing an aspartame strip on the tongue; babies whilebreast-feeding as the mother drank an aspartame beverage). Interval Between Cessation and Improvement Nearly two-thirds of aspartame reactors experienced symptomaticimprovement within two days after avoiding aspartame. With continuedabstinence, their complaints generally disappeared.

Causation The causative role of aspartame products has been repeatedly shown by(a) the prompt improvement of symptoms (grand mal seizures, headache,itching, rashes, severe gastrointestinal reactions) after stopping aspartameproducts, and (b) their recurrence within minutes or hours after resumingthem. The latter included self-testing on numerous occasions, inadvertentingestion, and formal rechallenge. Some aspartame reactors with convulsions purposefully rechallengedthemselves on one or several occasions "to be absolutely certain." This wasunique among six pilots who had lost their licenses for unexplained seizureswhile consuming aspartame products. (All had been in otherwise excellenthealth.) They sought to have their licenses reinstated by such objectiveconfirmation on rechallenge. High-Risk

Individuals These groups include pregnant and lactating women, young children,older persons, those at risk for phenylketonuria (PKU), the relatives ofaspartame reactors (see above), and patients with liver disease,iron-deficiency anemia, kidney impairment, migraine, diabetes, hypoglycemia,and hypothyroidism. Clinical Implications Physicians must question patients who present with the aforementionedconditions about aspartame use, particularly when they fail to respond toconventional therapy. If it is being consumed, a brief trial of abstinenceshould be recommended before initiating expensive tests, consultations andhospitalization. The following caveats derive from clinical experience: a.. Every patient with unresolved neurologic,

psychologic, allergic,dermatologic, gastrointestinal and metabolic/endocrine problems should bequeried about aspartame intake. b.. The diagnosis of multiple sclerosis should be deferred pendingat least several months observation in the case of persons consumingaspartame. c.. A pregnant woman should not risk the health of her fetus byconsuming aspartame products. d.. Visual, neurologic or bowel problems in diabetics should not beascribed to a presumed underlying retinopathy or neuropathy until evaluating theresponse to aspartame abstinence. e.. Cataract surgery ought to be deferred in heavy aspartame usersto evaluate for spontaneous improvement after abstinence. f.. Patients

presenting with seizures, headache, atypical facial oreye pain, the Meniere syndrome, depression, the carpal tunnel syndrome,normal-pressure hydrocephalus, and a host of other unexplainedneuropsychiatric problems, or who fail to respond to conventional treatment,must be queried about aspartame use . especially if invasive studies areplanned. g.. Young adults who express concern about "possibly having earlyAlzheimer's disease," based on recent confusion and memory loss, ought to beobserved at least one month after stopping aspartame before this diagnosisis pursued. h.. Gynecologic surgical procedures to evaluate gross menstrualchanges should be deferred pending the response to abstinence. ©2004 H. J. Roberts, M.D. Published with permission from the author. Dr. Roberts is

director of the Palm Beach Institute for MedicalResearch, and an emeritus member of the medical staffs of the Good SamaritanHospital and St. Mary's Hospital in West Palm Beach, and prestigiousmedical/scientific organizations. These include the American College ofPhysicians, the Endocrine Society, the American Academy of Neurology, andthe American Federation for Clinical Research. He has authored 18 texts andhas had more than 240 original articles and letters published, most dealwith challenging diagnostic, metabolic and neurological problems. Dr.Roberts has been knighted by the Order of St. George for his professionaland humanitarian efforts, and was chosen by the editors of a nationalmedical journal as "The Best Doctor in the U.S."-------- References 1. Metzenbaum H.

Discussion of S.1557 (Aspartame Safety Act).Congressional Record-Senate August 1, 1985, p.S 10820. 2. Council on Scientific Affairs. Aspartame: Review of safetyissues. JAMA 1985; 254:400-402. 3. Centers for Disease Control. Evaluation of consumer complaintsrelated to aspartame use. Morbidity and Mortality Weekly Report 1984;November 2:605-607. 4. Roberts HJ. Aspartame Disease: An Ignored Epidemic West PalmBeach, Sunshine Sentinel Press, 2001. (www.sunsentpress.com) 5. Roberts HJ. Aspartame (Nutrasweet): Is It Safe? Philadelphia, TheCharles Press, 1989. 6. Roberts HJ. Sweet'ner Dearest: Bittersweet

Vignettes aboutAspartame (NutraSweet) West Palm Beach, Sunshine Sentinel Press, 1992.(www.sunsentpress.com) 7. Roberts HJ. Breast Implants or Aspartame (NutraSweet) Disease?The Suppressed Opinion About a Perceived Medicolegal Travesty West PalmBeach, Sunshine Sentinel Press, 1999. (www.sunsentpress.com) 8. Roberts HJ. Useful Insights for Diagnosis, Treatment and PublicHealth West Palm Beach, Palm Beach Institute for Medical Research, 2002.(www.pb-medical-research.com) 9. Roberts HJ. Reactions attributed to aspartame products: 551cases. J Appl Nutr 1988; 40:86-94. 10. Roberts HJ. Does aspartame cause human brain cancer? J Advanc M1991; 4 (Winter):231-241. 11. Roberts HJ. Carpal tunnel syndrome due to aspartame disease.Townsend Letter for Doctors & Patients 2000; 198 (November):82-84. 12. Roberts HJ. Aspartame (NutraSweet) addiction. Townsend Letterfor Doctors & Patients 2000; 198 (January):52-57. 13. Roberts HJ. Difficult Diagnosis: A Guide to the Interpretationof Obscure Illness Philadelphia, W.B. Saunders Company, 1958.

 

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