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Killing Me Sweetly Is aspartame really a safe sugar substitute? If not, why is the FDA blocking the release of a better alternative? By Bill Strubbe EVELYN BLAKE'S downhill spiral began in 1994 when she decided to lose weight: she switched to diet sodas and began using Equal as a sugar substitute. "After about four months I began feeling nervous and uneasy," Blake recalls. "My heart was beating so irregularly that I wondered if I was having a heart attack! Then one night I woke with this very strange feeling, like I was in a zombie state. I felt as if my tongue was swelling, my teeth clenched tight." Blake began to shiver, and by the time she reached her son's room her body shook uncontrollably and she couldn't talk. The frightening incident eventually subsided, and they decided against visiting the emergency room. "Not making any connection, I continued to use Equal in everything--coffee, bread, cereal, salad--and the seizures got worse." Though millions of people sip diet sodas, ingest yogurt lite, and stir the contents of those little blue packets into their coffee without noticeable side effect, Blake's ordeal is only one of thousands of alleged aspartame-poisoning complaints registered over the last two decades. By the federal Food and Drug Administration's own admission, 73 percent of all food complaints are aspartame-related--most commonly headaches, memory loss, depression, heart palpitations, and vision problems. Some contend that prolonged use of aspartame is the root cause of their permanent nerve damage, their brain lesions and tumors, and even the untimely deaths of family members. "Since many consumers may never make the connection between their maladies and aspartame intake, conceivably those complaints are only the tip of the iceberg," says Betty Martini, who heads Mission Possible International, which attempts to educate the public about the dangers of aspartame. Industry and FDA spokespersons point out that these accounts are "merely anecdotal" and "unscientific," but the sheer volume of accusations in itself should raise questions about aspartame's approval process--the independence of industry-funded research, the ethics of the revolving door relationships between FDA officials and industry--and call for the re-examination of this chemical that is now commonly found in grocery stores, on kitchen shelves, and in children's lunchboxes. Sweet Nothing: Proponants of stevia, a natural sweetener, do battle with NutraSweet. NUTRASWEET--along with Equal, Spoonful, Indulge, Equal-Measure, etc.--is a brand name for aspartame, discovered by accident in 1965 when a chemist with G. D. Searle pharmaceuticals was testing an anti-ulcer drug: he happened to lick his hand, and the rest is history. Originally approved for use in dry foods in July 1974, aspartame was put on hold several months later owing to objections filed by neuroscience researchers and consumer attorneys. When ingested, NutraSweet breaks down into aspartic acid, a chemical found in the brain; phenylalanine, an amino acid; and methanol (wood alcohol), which converts to formaldehyde, which at high levels can cause brain damage and blindness. Monsanto--the former manufacturer of NutraSweet--and the FDA argue that methanol is present in such a small amount that it poses no health risks and is harmlessly passed from the body. They also insist that except for people with the rare disease phenylketonuria, aspartame is safe. (G. D. Searle, the original makers of NutraSweet, was bought by Monsanto in the 1980s. This past year, Monsanto sold NutraSweet to J. W. Childs and divested itself of Equal, which is now a registered trademark of Merisant Co.) Dr. Russell L. Blaylock, professor of neurosurgery at the University of Mississippi's medical center, explains in his book Excitotoxins: The Taste That Kills that though aspartate (and glutamate in the chemically related substance MSG) is a neurotransmitter normally found in the brain and spinal cord, when aspartate reaches certain levels it causes the death of brain neurons. The risks to infants, children, and pregnant women are higher because the blood/brain barrier, which normally protects the brain, is not fully developed until adulthood. Dr. Blaylock and numerous other experts believe that long-term exposure to excitotoxins may play a part in diseases such as early-onset Alzheimer's, Parkinson's (Michael Fox, coincidentally the former spokesperson for Diet Pepsi, may be an example), lupus, brain lesions and tumors, epilepsy, memory loss, multiple sclerosis, and some hearing problems. Dr. John Olney, a neuroscientist at Washington University Medical Center in St. Louis, who has demonstrated the harmful effects of excitotoxins and testified before Congress, believes that both glutamate and aspartate damage areas of the brain controlling endocrine functions leading to obesity. He posits that the 30 percent increase in obesity in America in the past decade might be related to the increased use of aspartame. "While there were a few inaccuracies [in the original safety tests], there was nothing convincing to keep aspartame off the market," insists David Hattan, Ph.D., acting director of the FDA's Division of Health Effects Evaluation. "The large body of animal and clinical research carried out in a controlled environment convinces me that aspartame is safe." But a number of his colleagues have disagreed. During a congressional investigation in 1985 to scrutinize Searle's aspartame safety tests, Dr. Jacqueline Verrett, a former FDA toxicologist and FDA task force member, testified that the tests were a "disaster" and should have been "thrown out." Dr. Marvin Legator, professor of environmental toxicology at the University of Texas, characterized them as "scientifically irresponsible and disgraceful" and said, "I've never seen anything as bad as Searle's." Because of FDA budget limitations, it is standard procedure for the bulk of initial safety tests to be financed, designed, and carried out by the company with a vested interest in the product. The reliability of their results is called into question when 74 out of 74 industry-sponsored articles attested to aspartame's safety, while 84 out of 91 of the nonindustry-sponsored articles identified problems with the chemical. "I'll admit there's validity to these concerns, but it's not unusual for industry to fund studies, because they're expensive--and who else will?" counters a spokeswoman at Merisant Co. "It's a disservice to the fine scientists involved whose reputations are besmirched by aspartame detractors." AND WHAT'S to keep adverse industry test results from disappearing altogether? According to a reliable source, who chose to remain unnamed but has signed a sworn affidavit, Searle in the early 1980s conducted aspartame research in five communities in Central and South America; the groups were told they were ingesting a papaya extract. By the end of these 18-month studies, the source recalls from translating the reports from Spanish into English that many subjects experienced grand mal seizures and damage to the central nervous system, causing muscular and neural instability, hemorrhaging, brain tumors, and other maladies. "When I finished the project, I was told to destroy all my records and copies. If those studies had reached the FDA, there's no way they could have approved aspartame," the source says. "Imagine my surprise when I found out soon after that aspartame is being consumed en masse! I urged my family and everyone I knew not to use anything containing aspartame because, as I said, 'it would make their brains into mush.' " The late Dr. M. Adrian Gross, former senior FDA toxicologist, stated in his testimony before Congress, "Beyond a shadow of a doubt, aspartame triggers brain tumors," and "therefore by allowing aspartame to be placed on the market, the FDA has violated the Delaney Amendment," which makes it illegal to allow any residues of cancer-causing chemicals in foods. His last words to Congress were: "And if the FDA itself elects to violate the law, who is left to protect the health of the public?" The cancer-causing agent referred to above is diketopiperazine, or DKP. So concerned was Searle about toxic DKP that it's mentioned several times in an early 1970 internal memo distributed by Herbert Helling: "My prime concern at this time is with the production of DKP and our lack of complete toxicological data on DKP if [aspartame's chemical code broke down] completely to DKP. We then must consider how much DKP could be formed from the time the system is converted to a wet system to the time of consumption allowing for maximum likely abuse." "SOUNDS LIKE the tobacco fraud all over again. But this time it's the drug industry, and it's big," says former U.S. Department of Justice attorney Ed Johnson, who for the last 10 years has served as president and CEO of a large law firm in San Antonio. Several years ago, he was diagnosed with a pituitary adenoma and underwent two life-threatening surgeries to remove the tumor, which he believes was caused by his heavy ingestion of Diet Coke and NutraSweet. "When the class actions [lawsuits] hit, and they will, I predict that they'll rival the tobacco litigation we have seen in the past few years." Aspartame tests in the United States continued until July 18, 1981 when FDA Commissioner Dr. Arthur Hull Hayes Jr. disregarded the Food Drug and Cosmetic Act, which states that a food additive should not be approved if tests are inconclusive, overruling six of the nine scientists on two agency review panels who thought the studies of brain tumors in rats had been inadequate. Applying an "acceptable daily intake" measure, the FDA approved the chemical for use in dry products and then raised the ADI in 1983 to enable the introduction of aspartame into beverages. In subsequent years, $30 million to $40 million annually was pumped into advertising by NutraSweet Co. alone, and ads--featuring the likes of Bill Cosby, Raquel Welch, Joe Montana, and Geraldine Ferraro--by diet soft-drink manufacturers and other companies employing the chemical pushed that figure past $100 million a year, quickly making NutraSweet a household word. Soon after, complaints to the FDA began rolling in: headaches, dizziness, anxiety, depression, memory loss, joint pain, vomiting, heart palpitations, slurred speech, seizures, brain tumors, comas, and even deaths attributed to aspartame. The FDA took "some of these early reports quite seriously," and Monsanto performed follow-up studies. But, according to the principles of science, "if test results cannot be reproduced in a controlled setting, then you cannot preclude other factors that might have caused seizure expressions," explains Hattan at the FDA, who declares that he consumes copious amounts of aspartame with no ill effects. "I think that many of the symptoms attributed to aspartame are actually caused by something else in the individual's environment." EVELYN BLAKE'S seizures got worse, racking her body on a regular basis, sometimes twice a day. She recalls entering into a "zombie stare . . . looking but not seeing," and feeling as if her body "were attached to an electrical current," her heart racing. More EKGs, EEGs, and blood tests followed, but the doctor could determine only low blood pressure and a slight thyroid problem. Meanwhile, she says, her hair started falling out by "the handful." Temporary relief finally arrived when she visited her brother in Georgia and she skipped her "diet," which included the use of Equal. For three weeks, she began to recover. Upon returning home--and back to her use of Equal--the nightmare revved up again. "I thought it might be stress from the house remodeling and other duties," she says. "My memory was getting so bad I couldn't remember where I was going when I got into my car. My eyesight suddenly got worse. I was afraid of being alone, never knowing when the next seizure would hit! The doctors could find nothing wrong with me." WITHIN SEVERAL years of aspartame's appearance on the market, a number of FDA and government officials left their posts and took jobs closely linked to the food, beverage, and NutraSweet industries. Shortly after pushing aspartame's approval, Dr. Arthur Hull Hayes left the FDA under a shadow of improprieties and became a consultant--at $1,000 a day--with Burston-Marsteller, Searle's public relations firm. Wayne Pines, Hayes' former top spokesman, previously had joined the firm. In July 1986, Anthony Brunetti, an FDA consumer product officer who drafted the 1983 notice approving NutraSweet's use in soft drinks, joined the Soft Drink Association as a science adviser. In the late 1970s, Samuel Skinner and William Conlon, two senior Justice Department prosecutors investigating criminal allegations against G. D. Searle & Co. for falsifying NutraSweet safety-test results, later joined the law firm of Sidley & Austin, which represented Searle during the lengthy investigation. Skinner, who knew of the statute-of-limitations deadline, delayed pursuing prosecution, thus placing Searle out of reach. He subsequently defected to Sidley & Austin in July 1977. "The aspartame manufacturer has a lot of political influence, and when the FDA director refused to allow aspartame on the market, he was replaced by one who would, and did," says attorney Ed Johnson, former assistant U.S. attorney under William S. Sessions (who went on to become the head of the FBI). "Though it's against ethics laws for an FDA official to sit in on any action regarding a firm with which they had any prior relationship," explains former FDA investigator Arthur Evangelista, "there is nothing to stop federal officials from being influenced with promises of a position in a firm they are meant to be regulating." Evangelista believes that influence-peddling is rife throughout the FDA, both directly and indirectly, via government PAC monies influencing politicians, who in turn use their influence on regulatory agencies. And the revolving door continues to spin. In 1999, Dr. Virginia Weldon, vice president for public policy at Monsanto (the former parent corporation of NutraSweet), was considered for the FDA's commissioner post. On June 14, 1999, retiring FDA Commissioner Michael Friedman became the senior vice president for clinical affairs at Searle's drug unit. How can the FDA effectively safeguard the public's health while being influenced by the corporations it is meant to regulate? For two decades the aspartame controversy has continued to simmer, leaving respectable organizations with opposing verdicts. The American Diabetes Association, the American Academy of Pediatrics, the American Medical Association, and the Epilepsy Institute endorse aspartame as safe (though it is a matter of record that several of these organizations have received donations from NutraSweet). But hundreds of airline pilots reporting adverse effects from aspartame, including grand mal seizures while in the cockpit, led a dozen aviation publications, including Navy Physiology, Planes & Pilot, Canadian General Aviation News, and Flying Safety, to warn pilots not to consume aspartame before or while flying. "I am not denying these people's symptoms," says Hattan at the FDA, "but it is entirely possible that when patients stopped using aspartame they might also coincidentally have had remission of their symptoms." Both the FDA's and NutraSweet's categorical dismissal of the thousands of aspartame consumer complaints as coincidental, anecdotal, or unscientific has not diminished the convictions of thousands of unpaid volunteers at Aspartame Victims and Their Friends; the Aspartame Detoxification Center in Atlanta; and chapters in dozens of countries of Mission Possible International that compile aspartame-related articles and personal accounts. As of 1987, the last year that NutraSweet publicized records, Americans consumed about 17.l million pounds of aspartame, and the number is now estimated to top 25 million pounds. Since the chemical additive is now sold in dozens of other countries, aspartame-poisoning complaints now are fielded from around the world. Those who suspect that they have any symptoms of aspartame poisoning, nutritionists say, should take the aspartame test: For one month stop using aspartame-containing products and see if your symptoms subside. Evelyn Blake decided to try eliminating, one by one, everything she was eating, but the seizures continued. "When I finally eliminated Equal, I never had any more attacks or seizures! Since I stopped Equal on Sept. 13, 1997, my health has slowly improved: my eyesight and memory returned, my hair quit falling out, my blood pressure is good. My heart continues with an irregular beat, which my cardiologist says only a pacemaker can correct," Blake says. "Because of Equal, my life for four years was one living hell. Can't someone do something about this unregulated chemically engineered drug called Equal/aspartame that has affected thousands?" Blacklist BEWARE of any food product that contains the words "lite," "diet," "low-calorie," or "no calorie." Among these are: diet iced teas diet soft drinks Crystal Light yogurt lite Diet Jell-O some cereals some children's vitamins. Bill Strubbe is a California-based freelance writer who confesses to having once been addicted to SweetTarts. [ Sonoma County | MetroActive Central | Archives ]