by Alex Constantine

The Food and Drug Administration [FDA] refers to aspartame--the chemicalwidely known as NutraSweet--as a "food additive," not a "drug." Adverse reactions to a substance classified as a food additive need not be reported to a federal agency, nor is continued safety monitoring required by law.

Food additives are not noted to be causative agents in the development of brain lesions, headaches, mood alterations, skin polyps, blindness, brain tumors, insomnia or depression, nor are they known to erode intelligence or short-term memory. NutraSweet, according to some of the most capable scientists in the country, is. In 1991, the National Institute of Health--a branch of the Department of Health and Human Services--published Adverse Effects of Aspartame, listing the aforementioned side effects among approximately 167 reasons to avoid the substance.

Aspartame is an RDNA derivative, a combination of two amino acids. The U.S. Pentagon once listed it in an inventory of prospective biochemical-warfare weapons submitted to Congress. Instead of poisoning enemy populations, though, the formula is currently marketed as a sweetening agent in some 1,200 food products

G.D. Searle--the pharmaceutical firm that introduced NutraSweet--vigorously lobbied federal and Congressional officials to move aspartame to market, despite substantial evidence of the chemical's detrimental side effects.

According to NutraSweet's publications depiction, the origin of aspartame can be traced to a scientist developing an ulcer drug (not a "food additive") in 1966. Purportedly, the man discovered upon carelessly licking his fingers the substance under scrutiny tasted extraordinarily sweet. Thus was born the successor to saccharin, which is a coal derivative that was popular as an artificial sweetener until reports of cancer-causing properties surfaced.

Established in 1888 on the North Side of Chicago, G. D. Searle manufactures everything from prescription drugs to nuclear-imaging optical equipment. At the time of the company's acquisition by commodities colossus Monsanto Corporation in 1985, the firm's chairman was Harvard graduate William L. Searle, who was an officer in the Army Chemical Corps in the early 1950s, a time when the division was testing LSD on human subjects in concert with the CIA.

The Center for Disease Control [CDC] in Atlanta, Georgia, reports receiving stacks of letters complaining of NutraSweet's adverse effects. According to the National Soft Drink Association [NSDA]: "There have been hundreds of reports from around the country suggesting a possible relationship between consumption of NutraSweet and subsequent symptoms including headaches, aberrational behavior and slurred speech."

FDA Commissioner Arthur Hull Hayes, appointed by Ronald Reagan in April of1981, discounts such complaints as merely anecdotal. Despite what one FDA scientist described as "very serious" questions concerning pivotal braintumor tests, Hayes eagerly approved aspartame for use in dry foods in July1981. Three FDA scientists advised against such approval, citing G.D. Searle's own brain tumor tests, which contained no proof that aspartame wassafe for consumption as a food additive under its intended conditions of use.

Commissioner Hayes ignored the recommendations of the FDA's own board of inquiry, relying instead on a study conducted by Japan's Ajinomoto, Inc.--a,licensee of G.D. Searle. In so doing, Hayes based his approval of aspartame,on the Japanese test, although the testing procedures had not been reviewed by the FDA board, as is required by federal law.

Not only did Hayes approve a product based on studies that were "scientifically lacking in design and execution," according to a report issued by Science Times in February of 1985, but upon leaving the FDA, Hayestook the post of senior medical consultant for Burson-Marsteller, the public relations firm retained by G. D. Searle.

Aspartame found early opposition in consumer attorney James Turner, author of The Chemical Feast. At his own expense, Turner fought FDA approval of the sweetener for ten years, basing his argument on aspartame's potential side effects, particularly on children. Sharing Turner's concerns, Dr. John Olney, professor of neuropathology and psychiatry at the Washington School of Medicine in St. louis, Missouri, reported that clinical tests indicated that aspartame, combined with monosodium glutamate (MSG)--a common seasoning--increased the likelihood of certain forms of brain damage occurring in children.

Internally, aspartame breaks down into not only its constituent amino acids, but into methanol as well, a poisonous liquid alcohol that degrades into formaldehyde. The FDA announced in 1984 that no evidence has been found to establish that aspartame's methanol by-product reaches toxic levels, claiming that "many fruit juices contain higher levels of the natural compound." However, the Medical World News reported in 1978 that the methanol content of aspartame is 1,000 times greater than most foods under FDA control.

According to independent tests, aspartame intake is shown by animal studies to alter brain chemicals affecting behavior. Aspartame's effects on the brain led Massachusetts Institute of Technology [MIT] neuroscientist Richard Wurtman to discover that the sweetener defeats its purpose as a diet aid, since high doses of aspartame apparently instill a craving for calorie-laden carbohydrates. In addition, Wurtman's pilot studies found that the NutraSweet/carbohydrate combination increases the sweetener's effect on brain composition.

Searle officials denigrated Wurtman's findings, but the American Cancer Society has since confirmed--after tracking weight fluctuations in 80,000 women for six years--that "among women who gained weight, artificial-sweetener users gained more than those who didn't use the products."

According to findings by Dr. Paul Spiers, a neuropsychologist at Boston's Beth Israel Hospital, aspartame can depress intelligence. In clinical tests, Spiers analyzed subjects with a history of consuming NutraSweet, who were unaware that they might be suffering ill effects from the sweetener.

The subjects were given NutraSweet in capsules containing the FDA's allowable daily limit. Spiers was alarmed to discover that the test subjects developed cognitive deficits. One of Spiers's tests required mental recall of pattern arrangements and alphabetical sequences. The quiz is challenging, but most people improve as they learn how it is done. Aspartame users, discovered Spiers, did not improve.

"Some showed a reverse pattern," states Spiers. "I have received a letter recently from a person who is well known to me, whose word is impeccable, as far as I am concerned," testified Senator Russell Long, (D-Louisiana) at the May 1985 FDA hearings instigated by Senator Howard Metzenbaum (D-Ohio) to require stricter labeling of NutraSweet in food products. "This person told me that, while dieting, she had been using soft drinks containing NutraSweet. She said she found her memory slipping. She could not recall a good bit of that which was going on about her, to the extent that she was afraid she was losing her mind. In due course, someone suggested that the problem might be due to NutraSweet; so she stopped using it, and her memory came back and her mind was restored."

"There have been hundreds of incidences of people who have suffered loss of memory, headaches, dizziness and other neurological symptoms, which they feel are related to aspartame," noted etzenbaum, siting Long's concern.

As far back as March 1976, an FDA task force brought into question all of G.D. Searle's aspartame-testing procedures conducted between 1967 and 1975. The final FDA report noted faulty and fraudulent product testing, knowingly misrepresented findings and instances of irrelevant or unproductive animal research where experiments had been poorly conceived, carelessly executed or inaccurately analyzed.

The FDA's chief counsel, Richard Merrill, petitioned Samuel K. Skinner, U.S. Attorney for the northern district of Illinois, for a grand jury investigation of Searle's willful and knowing failure to submit required test reports, the concealment of material facts and the company's false statements in reports on aspartame submitted to the agency.

Searle company officials turned to longtime Washington politico Donald Rumsfeld, a former Nixon and Ford Administration operative, electing him the chairman of the Searle organization. Industry analysts, interviewed by the Wall Street Journal six months after Rumsfeld's appointment as chairman, noted a rapid turnabout in Searle's fortunes as a result of Rumsfeld's direction.

Reported the Wall Street Journal in 1977, Rumsfeld "has been mending fences with the FDA by ersonally asking top agency officials what Searle should do to straighten out its reputation (regarding falsifying and withholding aspartame test data].'

In January of 1977, the FDA formally requested that U.S. Attorney Samuel Skinner be hired to investigate G.D. Searle's aspartame-testing procedures. A month later, Skinner met with attorneys rom Searle's Chicago law firm, Sidley & Austin. When newly elected President Jimmy Carter announced that same year that Skinner would not be asked to remain in office, Skinner informed reporters that he would be hired by Sidley & Austin.

Skinner recused himself from the Searle prosecution. Senior Assistant U.S. Attorney William Conlon inherited the case. Conlon eased off the investigation, citing caseload pressures, and gave a deaf ear to complaints of delays from the Justice Department, which urged that a grand jury be convened to prosecute Searle for falsifying NutraSweet test data. In January 1979, Conlon too joined Searle's law firm, Sidley & Austin.

In its bid to obtain FDA approval of aspartame in 1975, G.D. Searle submitted a battery of ancer-test results, titled the Willigan Report, which contained a statistical table that wrongly excluded four alignant,aspartame-related mammary tumors detected by Dr. Willigan and incorporated in his initial data.

Somehow, the malignancies were made to appear benign. Searle dismissed the misrepresentation as a computer error, claiming that the unfavorable mammary malignancy data were innocently omitted from the summary table four separate times by three different individuals.

One pivotal safety study involved fetal damage. The FDA task force found that the medical researcher in charge at Searle was inexperienced in conducting studies of this nature. The esearcher's sole credential was a field study of the cottontail rabbit for the Illinois Wildlife Service; yet at Searle he'd been assigned to laboratory training and supervision. When asked about his curriculum vitae in fetal research, the researcher replied that he'd once attended a seminar on the subject, and the Searle company had provided him with a library of reference works.

The Willigan report was prepared by Searle Labs. Although two members of the 1975 federal task force considered the mishandled Willigan tests to be fraudulent, FDA Commissioner Hayes and Searle representatives declared the results valid.

Dr. Gross, the chief scientist on the FDA task force investigating Searle told the CBS Nightly News staff in January of 1984 that Searle company officials made "deliberate decisions" to cloak Aspartame's toxic effects.

"Searle took great pains to camouflage the shortcomings of the study," claimed Gross. "And they did other terrible things. For instance, animals would develop tumors while they were under study. Well, Searle would remove these tumors from the animals [surgically masking possible cancerous effects of aspartame]."

In November of 1984, the CDC announced that no "serious, widespread" side effects of aspartame had been found. It was "unlikely," said CDC officials, that "complainers" could establish a link between NutraSweet and their maladies. The reported side effects of aspartame fell into two distinct categories: central nervous system (65%) and gastrointestinal disorders (24%). Yet the CDC claimed erroneously that no consistent reaction pattern had been found.

Based on the assurances of the November 1984 CDC report, soft drink colossus PepsiCo announced that it was dropping saccharin and adopting aspartame as the sweetener in all its diet drinks. When soda bottlers petitioned the FDA in 1983 for a delay in approval of NutraSweet for soft drinks until further evaluation verified its safety, the move was interpreted by market analysts as a ploy to drive down the price of the sweetener. The cola companies soon abandoned the effort to block approval and seemingly dropped all health concerns they might have had as well.

Senator Metzenbaum berated Searle's apparently flawed aspartame tests at Senate hearings on August 1, 1985.

"The FDA," said Metzenbaum, "is content to have the manufacturer of aspartame, G.D. Searle, conduct [all necessary safety] studies of the substance. That's absurd."

The Journal of the American Medical Association recently reported--with significant disclaimers--that the consumption of aspartame poses no health risk for most people. However, the report is based on FDA findings relying solely on the tests conducted by G.D. Searle.

Executives of G.D. Searle argue that the use of aspartame as an artificial sweetener has been officially approved not only by the FDA but by foreign regulatory agencies and the World Health Organization. Reviewing the foreign studies on aspartame safety, however, Dr. H.J. Roberts, an internal medicine specialist in West Palm Beach, Florida, found that the approval of the majority of foreign agencies was based on contestable Searle-sponsored aspartame research, not independently conducted tests.

In. August of 1987, the University of Illinois, a recipient of funding from Monsanto (Searle's parent corporation), issued a study exonerating aspartame of causing seizures in laboratory animals.

FDA safety regulator Dave Hattan believes that the study only confirmed the need for testing on humans. In independent tests, insists Hattan, aspartame provoked seizures in laboratory animals.

In 1985, a coalition of consumer groups were handed a ruling by the Federal Circuit Court of appeals for the District of Columbia stating that, in the opinion of the Court, the FDA had followed proper procedures inapproving aspartame for use in foods and soft drinks. A year later, the Washington Post reported that the Supreme Court refused to consider arguments the contrary "despite critics' arguments that the product, sold under the brand name NutraSweet, may cause brain damage."

Recently denied publication of his short brief Aspartame-Associated Confusion and Memory Loss: A Possible Human Model for Early Alzheimer's Disease in a peer-review medical journal, Dr. H.J. Roberts wonders at the cause of the rejection.

"For a report on this issue to be refused publication seems peculiar," says Roberts, author of Aspartame (NutraSweet): Is It Safe? (Charles Press, Philadelphia. 1990). "considering the increasing magnitude of the problems of Alzheimer's disease and the relevance of my observations to newer biochemical findings and avenues of research."

According to Roberts, researchers seeking to publish articles concerning problematic, health-related reactions to products containing NutraSweet are generally limited to burying their findings in small-circulation journals such as the bulletins of county medical societies, reporting their research results in the form of a letter to a magazine or newspaper, or, most often, they must simply discard the project.

Should a researcher's findings happen to favor the benign characteristics of aspartame, however, professional prospects may be brighter. Reportedly, Monsanto granted one such NutraSweet research facility a $1.3-million honorarium.

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