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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