2. Article Conclusion Dr. Leibovitz opened the article by stating his conclusion as to the "safety" of aspartame: "Aspartame is made from phenylalanine, aspartic acid, and methanol--three naturally- occurring compounds; it is virtually non- toxic, and a very potent sweetening agent, as detailed elsewhere1 [Stegink 1984a]" [Emphasis added.] The reference cited for this statement is an 11-year-old book compiled by researchers for the NutraSweet industry. The book is a biased look at the NutraSweet industry's viewpoint on the "safety" of aspartame. Much of the key information in the book is out-of-date and has been proven to be incorrect in subsequent research. The truth about aspartame's toxicity is far different than what the NutraSweet Company would have your readers believe. In February of 1994, the U.S. Department of Health and Human Services released the listing of adverse reactions reported to the FDA (DHHS 1994). Aspartame accounted for more than 75% of all adverse reactions reported to the FDA's Adverse Reaction Monitoring System (ARMS). Many reactions to aspartame were very serious including seizures and death. Other reactions reported included: Headaches/Migraines Dizziness Joint Pain Nausea Numbness Muscle spasms Weight gain Rashes Depression Fatigue Irritability Tachycardia Insomnia Vision Loss Hearing Loss Heart palpitations Breathing difficulties Anxiety attacks Slurred Speech Loss of taste Tinnitus Vertigo Memory loss In an epideimological study which appeared in the Journal of Applied Nutrition (Roberts 1988), 551 persons who have reported reactions to aspartame were surveyed. What follows is a listing of the adverse health effects which were found. # of people (%) Eye - Decreased vision and/or other eye problems 140 (25%) (blurring, "bright flashes," tunnel vision) - Pain (or or both eyes) 51 (9%) - Decreased tears, trouble with contact lens, 46 (8%) or both - Blindness (one or both eyes) 14 (3%) Ear - Tinnitus ("ringing," "buzzing") 73 (13%) - Severe intolerance for noise 47 (9%) - Marked impairment of hearing 25 (5%) Neurologic - Headaches 249 (45%) - Dizziness, unsteadiness, or both 217 (39%) - Confusion, memory loss, or both 157 (29%) - Severe drowsiness and sleepiness 93 (17%) - Paresthesias ("pins and needles," "tingling") 82 (15%) or numbness of the limbs - Convulsions (grand mal epileptic attacks) 80 (15%) - Petit mal attacks and "absences" 18 (3%) - Severe slurring of speech 64 (12%) - Severe tremors 51 (9%) - Severe "hyperactivity" and "restless legs" 43 (8%) - Atypical facial pain 38 (7%) Psychologic-Psychiatric - Severe depression 139 (25%) - "Extreme irritability" 125 (23%) - "Severe anixiety attacks" 105 (19%) - "Marked personality changes" 88 (16%) - Recent "severe insomnia" 76 (14%) - "Severe aggravation of phobias" 41 (7%) Chest - Palpitations, tachycardia (rapid heart action), 88 (16%) of both - "Shortness of breath" 54 (10%) - Atypical chest pain 44 (8%) - Recent hypertension (high blood pressure) 34 (6%) Gastrointestinal - Nausea 79 (14%) - Diarrhea 70 (13%) Associated gross blood in the stools (12) - Abdominal pain 70 (13%) - Pain on swallowing 28 (5%) Skin and Allergies - Severe itching without a rash 44 (8%) - Severe lip and mouth reactions 29 (5%) - Urticaria (hives) 25 (5%) - Other eruptions 48 (9%) - Aggravation of respiratory allergies 10 (2%) Endocrine and Metabolic - Problems with diabetes: loss of control; 60 (11%) precipitation of clinical diabetes; aggravation or simulation of diabetic complications - Menstrual changes 45 (6%) Severe reduction or cessation of periods (22) - Paradoxic weight gain 34 (5%) - Marked weight loss 26 (6%) - Marked thinning or loss of the hair 32 (6%) - Aggravated hypoglycemia (low blood sugar 25 (5%) attacks) Other - Frequency of voiding (day and night), burning 69 (13%) on urination (dysuria), or both - Excessive thirst 65 (12%) - Severe joint pains 58 (11%) - "Bloat" 57 (10%) - Fluid retention and leg swelling 20 (4%) - Increased susceptibility to infection 7 (1%) According to researchers and physicians studying the adverse effects of aspartame, the following list contains a selection of chronic illnesses which may be triggered or worsened by ingesting of aspartame (Mission Possible 1994)*: Brain tumors Multiple sclerosis Epilepsy Chronic faigue syndrome Parkinson's Disease Alzheimer's Mental retardation Lymphoma Birth defects Fibromyalgia Diabetes *Note: In some cases such as MS, the severe symptoms mimic the illness or exacerbate the illness, but do not cause the disease. Both the U.S. Air Force's magazine "Flying Safety" and the U.S. Navy's magazine, "Navy Physiology" published articles warning about the many dangers of aspartame including the cumlative deliterious effects of methanol and the greater likelihood of birth defects. The articles note that the ingestion of aspartame may make pilots more susceptible to seizures and vertigo (US Air Force 1992). Recently, a hotline was set up for pilots suffering from acute reactions to aspartame ingestion. Nearly 1,000 pilots have reported symptoms including some who have reported suffering grand mal seizures in the cockpit due to aspartame (Stoddard 1995b). The danger to pilots of tunnel vision, blurred vision, seizures, vertigo and other serious adverse reactions, who may ingest large amounts of aspartame products during flight, are so great that articles and letters warning about aspartame have appeared in many aviation-related journals including The Aviation Consumer (1988), Aviation Medical Bulliten (1988), Pacific Flyer (1988), CAA General Aviation (1989), Aviation Safety Digest (1989), General Aviation News (1989), Plane & Pilot (1990), Canadian General Aviation News (1990), National Business Aircraft Association Digest (NBAA Digest 1993), International Council of Air Shows (ICAS 1995), Pacific Flyer (1995) and a paper warning about aspartame was presented at the 57th Annual Meeting of the Aerospace Medical Association (Gaffney 1986). Well over 7,000 citizens have submitted adverse reaction reports to the FDA since 1982 (DHHS 1993b, DHHS 1995). These reports detail well over 10,000 complaints of 92 different symptoms, many of them very serious. Many more people may have called the FDA to report adverse reactions only to get turned away. James Turner, Esq. had this to say about the FDA not accepting adverse reaction reports in his testimony before the U.S. Senate (Turner 1987): Mr. Turner. We have numerous instances of people calling the FDA and sayings, "We feel there is a connection. What information do you have?" and the person who answered the phone that they are speaking to telling them there is no connection between NutraSweet and side effects and not taking any further information. We have reported this to the FDA and discussed it with them, and I believe it is very important to understand--my understanding when we finished that meeting was they were going to correct that process by having all NutraSweet calls referred to an appropriate official, so that any suggestion that the number of complaints received prior to August of 1987 when we met with the FDA indicates all the calls that were received by FDA is an inaccurate presentation. Senator Metzenbaum. Can you document that statement for the Committee? Mr. Turner. We have individual statements that we can provide for the record, that is correct. Senator Metzenbaum. And has the FDA followed up? Mr. Turner. We are unclear. The Commissioner said this morning that he had undertaken steps to improve that system. However, since the August meeting there have been instances of individuals calling the FDA and then being referred to the AIDS hotline. Senator Metzenbaum. To the what? Mr. Turner. The AIDS hotline. When the AIDS hotline was answered, the individual said, "We are taking the NutraSweet calls because we don't get enough of them now to have an independent hotline for NutraSweet." Senator Metzenbaum. You have got to be kidding. Mr. Turner. I am not kidding. That is an event that occurred. We are still having communications with the FDA to straighten out the collection. The important point is that the collection system is getting a small number of the cases that occur. They are getting a small number of the cases that actually know enough to call the FDA at all. There are many other people who do not call the FDA. For example, these individuals here have not called the FDA and launched complaints. FDA officials believe that as little as 1% of the serious adverse drug reactions are reported to the FDA (Kessler 1993). Most physicians are aware of the Adverse Reaction Monitoring System (ARMS) and are required by law to report adverse drug reactions. The lay public is generally unaware of ARMS and much less likely to report adverse reactions to the FDA. In addition, most people would not know enough to link their acute reactions and chronic health problems to aspartame. In the unlikely event that they report the adverse reaction to their physician, there is no guarantee that it will be forwarded to the FDA. The reporting rate may be lower than 1% for the following reasons. a. There is no requirement that adverse reactions to food additives be reported. b. The reporting rate cited above applies to serious adverse reactions. The FDA has stated that, "What should be reported are those cases in which the physician suspects that an FDA-regulated product was associated with a serious outcome -- death, a life-threatening condition, initial or prolonged hospitalization, disability, or congenital anomaly, or when intervention was required to prevent permenent impairment or damage." (Kessler 1993) Therefore, the reporting rate for all adverse reactions to aspartame is much likely lower than 1%. c. Many physicians do not take such reports seriously having been told that aspartame is "safe" by the FDA and AMA. d. It is often very difficult for a comsumer to link advese reactions to aspartame because many of the adverse effects are either delayed and/or gradual damage from prolonged use. Immediate reactions such as headaches and asthma are more easily linked to the culprit. Using the FDA's own calculations on actual as opposed to reported reactions, well over 700,000 persons are likely to have experienced adverse reactions from aspartame since 1982. Of course, some unknown percentage of these adverse reactions may have been actually caused by something other than aspartame. However, anyone who has taken the time to read the countless chilling first- and second-hand accounts of severe acute and chronic health problems caused by aspartame poisoning will be hard-pressed to dismiss these reactions, "out-of-hand" as is done by the FDA. I have personally received several first-hand accounts via electronic mail of aspartame poisoning. The FDA and NutraSweet claim that the number of reported adverse reactions have declined substantially since the mid- 1980s (Pauli 1995, Butchko 1994). Adverse reaction figures provided by the FDA are suspect as you will see in the "FDA Response" chapter. The Aspartame Consumer Safety Network (ACSN) has received over 7,000 adverse reaction reports since July 1987 (Stoddard 1995b). The ACSN does not place advertisements asking people to report adverse reactions. People hear about the ACSN by word-of-mouth or from news reports. According to the ACSN, adverse reaction reports to their organization have been increasing every year since 1987. The president of the ASCN, Mary Nash Stoddard states that, increasingly, the callers reporting health problems due to aspartame ingestion say that they know that the FDA does not care about the health problems caused by aspartame and would therefore not bother calling them to report their adverse reactions. The ACSN and other persons taking adverse reaction reports generally do not encourage people to waste their time by calling the FDA, but instead, encourage others to warn their friends and family about the dangers of aspartame. Over the years, the public has, to a large extent, lost faith in the FDA and that is why adverse reaction reports to them have decreased. Many of these accounts are accessable to the public in various books, articles available from the Aspartame Consumer Safety Network, P.O. Box 780634, Dallas, Texas 75378, (214/352-4268). A few selections follows: a. One of the many accounts from "Aspartame (NutraSweet): Is It Safe?" by H.J. Roberts, M.D. (Roberts 1990a). "A 59-Year-old forester had his initial seizure during March 1984. He was consuming three packets of an aspartame tabletop sweetener and up to eight glasses of an aspartame soft drink daily. He then suffered two convulsions in July 1984 after unknowingly ingesting aspartame. Severe convulsions recurred in March 1985-- again after taking aspartame in an unrecognized form. His wife described their ordeal when he went on a business trip during July 1985 to evaluate timber. 'It was a hot day and a tiring trip, so he bought two cans of a soft drink which he did not realize had changed to aspartame from saccharin that week. He drank them, and later on the way home stopped and drank two glasses of punch which we later found out was made from aspartame. When he got home at 7 p.m., he wouldn't eat any dinner and was cranky and tired, and went right to bed. At about 5:30 a.m., I was awakened by this roaring sound. He was having another violent convulsion . . . he dislocated his shoulder and was in lots of physical pain. I asked the doctor if this didn't prove that it was the aspartame causing his convulsions. He said "Maybe," I said, "Shouldn't someone write the aspartame company and tell them what had happened?" All he said was, "Yeah, you do it." We asked to see a neurologist. He was even less interested in aspartame . . . A week later, we went out to dinner at a local restaurant with friends. While we had a cocktail from the bar, he ordered a regular soft drink. They evidently used the nozzle with the brand's aspartame drink . . . We came home and went to bed. About 2:30 a.m., he went into the first of seven consecutive convulsions.'" [Note: There have been hundreds of reported cases of seizure linked to aspartame and probably many times more unreported and undiagnosed cases.] b. One account of a case of extremely high phenylalanine levels caused by aspartame was recently published the the "Wednesday Journal" in an article entitled "An Aspartame Nightmare." John Cook began drinking 6 to 8 diet drinks every day. His symptoms started out as memory loss and frequent headaches. He began to crave more aspartame-sweetened drinks. His condition deteriorated so much that he experienced wide mood swings and violent rages. Even though he did not suffer from PKU, a blood test revealed a phenylalanine level of 80 mg/dl. (Normal fasting phenylalanine levels are usually below 3 mg/dl.) He also showed abnormal brain function and brain damage. After he kicked his aspartame habit, his symptoms improved dramatically (Mullarkey 1994b). c. From Letters to the Editor in local Atlanta publication (EHSA 1994): "My 3 year old daughter had a seizure while drinking soda sweetened with NutraSweet. Now we find out NutraSweet has a reputation of causing seizures and brain tumors. "In the "Journal of Advancement in Medicine, Vol. 4 #4, 1991, Dr. H.J. Roberts reports high incidence of brain tumors in rats after the experimental administration of aspartame. He warns there is an unacceptably large number of aspartame-related seizures reported to the FDA and to him, this warrents an 'imminent public health hazard.' "Where is the FDA warnings of fatal diseases caused by consuming NutraSweet? Searle and Monsanto who market and make the venom are selling an unlabeled poison that can kill our babies." . . . . --------------- "Aspartame killed my wife. No words can express the agony and horror sweet Joyce endured. This poison destroyed her brain, ravaged all her organs and blinded her. She died at age 46 in 1991. "When we filed suit we were harassed and threatened. Our gung-ho attorneys with a medically documented case suddenly seemed scared away. The case had to be dropped. Joyce deteriorated so quickly she would not have been able to participate in the legal proceedings anyway. "Don't listen to the paid Judas-goats and TV celebrities who say its safe. Save your life and those you love, and avoid the grief I endured. The makers of this poison considered her death an acceptable cost of business. I'm a man without a wife because the NutraSweet Company is a business without a conscience. April is Anti-Aspartame month. Take dead serious the warnings you will hear. The life you save may be your own." d. In a statement concerning the use of products containing aspartame by persons with diabetes and hypoglycemia, Dr. Roberts states (Roberts 1994): "Unfortunately, many patients in my practice, and others seen in consultation, developed serious metabolic, neurologic and other complications that could be specifically attributed to using aspartame products. This was evidenced by: "The loss of diabetic control, the intensification of hypoglycemia, the occurrence of presumed 'insulin reactions' (including convulsions) that proved to be aspartame reactions, and the precipitation, aggravation or simulation of diabetic complications (especially impaired vision and neuropathy) while using these products." "Dramatic improvement of such features after avoiding aspartame, and the prompt predictable recurrence of these problems when the patient resumed aspartame products, knowingly or inadvertently." "I regret the failure of other physicians and the American Diabetes Association (ADA) to sound appropriate warnings to patients and consumers based on these repeated findings which have been described in my corporate-neutral studies and publications." There are countless other accounts of both minor and serious health effects from aspartame available for persons who are seriously interested in investigating the issue. Many of these people rechallenged themselves as many as ten times before finally believing that aspartame was causing their problem (Roberts 1990a, page 73).The fortunate individuals are those who react badly to aspartame and then avoid all products that contain it. The unfortunate individuals are those who either a) have health problems which they do not realize are caused or contributed to by aspartame, or b) do not have immediate reactions to aspartame and then continue ingesting it -- not realizing the silent long-term damage that it may be causing. I suggest starting by reading the selection of accounts in the book, "Aspartame (NutraSweet): Is It Safe?" by H.J. Roberts, M.D. Dr. Roberts does an excellent job presenting an overview of the science of aspartame and case histories from his epidemiological study. One critic (Rolla 1990) tries to attack the book by comparing it to a journal article, which it is not. It is a book for a general audience and scientists alike. Rolla also suggests that the data be presented to a scientific journal first. Roberts (1988) did publish the epidemiological study two years before the book was published. The information collected by Dr. Roberts from persons who have had health problems from aspartame is similiar to the FDA or any researcher collecting data on case histories. This should be encouraged. Presenting this data to the general public was a great service as the FDA did not release this type of data, so the general public was being kept in the dark about the health problems linked to aspartame. Now that the FDA is no longer interested in recording adverse effects from aspartame (Food 1995), information such as that kept by Dr. Roberts becomes even more important. Two legitamate questions are often brought up about adverse reactions to aspartame: a. "Aspartame doesn't cause problems for me/my friends even after several years of ingestion. Therefore it is not dangerous for me. Right?" Wrong! Reactions to aspartame or to the individual breakdown products of aspartame have been shown to vary considerably from person to person. I have seen many people tolerate cigarettes for many years, or many years of a poor diet (i.e., high fat, junk food, etc.) or a poor lifestyle even though they are silently doing damage to the body. But the negative effects will catch up with most of these people. The same is true for aspartame. Some people experienced severe reactions soon after they began ingesting it. For many others, serious reactions began with a few years of use, still more people are experiencing serious health problems from 5 to 10 years of use. Not unlike the cigarette and lung cancer connection, once the damage is done from years or decades of ingesting aspartame, there may be little that can be done to reverse the damage. The damage is often slow and silent. For example, regular use of aspartame use has changed the brain chemistry in some people. This can be a causitive or contribuatory factor in many serious chronic illnesses. It is my understanding that coal miners used to use canaries in the mines to check the air quality before deciding whether to go in. If the canary died, it was an early warning signal that the air quality was dangerous. The people who are experiencing serious health problems from aspartame after only a relatively short period of use (i.e., 5 to 10 years of use compared to a lifetime of use) are our canaries giving us a warning that something is seriously amiss. Since aspartame has only been used for a very short period of time in significant quantities (i.e., since ~1987), I strongly suggest that those who would consider a lifetime of use of this neurotoxin to please carefully weigh these early warning signals. b. "I use aspartame and don't have disease xyz, therefore aspartame doesn't cause disease xyz." A corollary is, "I had disease xyz before I began using aspartame, therefore it doesn't cause disease xyz." Diseases and especially syndromes can often have multiple causes or contribuatory factors. Persons with diabetes, for example, can suffer eye damage from retinopathy. They can also suffer eye damage from long-term aspartame use or from some combination of these two (or more) contribuatory factors. (Examples will be given later.) Due to the complex nature of what causes many diseases and due to the fact that patients and physicians are nearly force-fed innaccurate NutraSweet PR, the overwhelming majority of people will not connect their illness to the medium- to long-term damage from aspartame unless they permanently get it out of their diet. They may incorrectly assume that their illness is "fate" or that their worsening symptoms are part of the "normal" progression of their illness. Even in the cases where aspartame is not one of the major causitive factors of an illness, it is absolutely crucial to remove it from the diet -- at least for those people who have any concern for their health now and in the future.