WARNING: Side effects may include: Seizures. Depression. Brain
damage. Memory loss. Migraine headaches. Numbness.
Blindness. (57-66)
Serious sounding repercussions. Surely the FDA would warn you if it
knew a common product might trigger reactions like these.
NOT SO. This substance, sweetly packaged, rests quietly on table tops,
in soft drinks, chewing gum, vitamins and in medicines. (37-55) The
illusion it portrays is as free of warning as a Sunday stroll in the
park. Consumers recognise it by its attractive red and white swirled
logo, and are drawn by its promise of an all-natural, low-calorie,
sweet flavour. In a country obsessed by dieting and abhorrent of the
perceived sins o f sugar, this product has gained unprecedented
popularity since it was discovered accidentally thirty years ago by a
chemist mixing chemicals in search of a medicine to relieve ulcers.
NutraSweet. Equal. Equal Measure. Spoonful. Its brand names are
ubiquitous in food and food products as it corners the market on low
calorie e sweeteners. Aspartame, as it is known generically,
skyrocketed to its position as the most popular sugar substitute in the
world shortly after it gained approval for public consumption.
World-wide, the aspartame industry's sales of the product amount to o
over $1 billion yearly. (58) In the United States, NutraSweet enjoys a
$700 million sales share, and shows no signs of retreat. (58,68)
The NutraSweet group became a part of G.D. Searle Company, a
pharmaceutical business, after one of its chemists discovered the
sweetener, and realised the sales potential of a sugar substitute.
Searle and NutraSweet are now owned by Monsanto Company. Producers of
NutraSweet maintain their platform that the safety of aspartame has
been confirmed. They cite affirmation of aspartame by a number of
agencies and organisations nation-wide, including the American Medical
Association, the World Health Organisation, the American Academy of
Paediatrics, the American Diabetes Association, the American Dietetic
Association, and the American Epilepsy Association. Yet aspartame came
amazingly close to not being approved by the Food and Drug
Administration (FDA) in the first place. What aspartame actually is,
and how it affects certain individuals, is at the heart of a continuing
controversy over its increasing distribution in food (including food
served in hospitals), medicine, candy, confections, cereal, soft
drinks, and score s of other products.
Know chemically as aspartame (C14H
18O5), NutraSweet is a compound
composed of the following chemicals by weight: methanol (10%), aspartic
ac id (40%), and phenylalanine (50%). In dry form, the composition is
stable, however, when placed in liquid it can break down into its
component parts (methanol, aspartate, and phenylalanine). Heat will
speed its breakdown. Another breakdown product is diketopiperazine
(DKP). In certain combinations these elements can results in adverse
reactions in some people e. Methanol further breaks down into
formaldehyde and formic acid, both known to cause serious side effects
in sensitive individuals. (58,64,67,69)
The RANDOM HOUSE DICTIONARY
defines methanol (also known as methyl alcohol) "as a colourless,
poisonous liquid used chiefly as a solvent, fuel l, etc." (70) Methanol
is on the Environmental Protection Agency's (EPA) Community Right to
Know List, and is reported in EPA's Toxic Substances Control Act
Inventory. Sax's Dangerous Properties of Industrial Materials states
methanol is "a human poison by ingestion." (71)
The levels of methanol are quite low in a single serving of a product
containing aspartame, provided that it has not been exposed to heat or
left for a long time on the shelf. Because these factors promote the
breakdown of aspartame into its component parts, researchers are
concerned that high consumption levels combined with aspartame 's
unstable shelf life may allow w methanol to reach toxic levels in some
cases. (21,72) Human systemic effects from methanol include changes in
circulation, cough, headache, nausea and vomiting, optic nerve
neuropathy, respiratory effects, and visual field changes. In
experiments, it has shown teratogenic (birth defects) and adverse
reproductive effects.
Genetic mutations from methanol have been
reported in human tissue. Methanol is classified as a narcotic. (71)
According to Sax, methanol's "main toxic effect is exerted upon the
nervous system, particularly the optic nerve, and possibly the retinae
which can progress to permanent blindness. Once absorbed, methanol is
only very slowly eliminated. Coma resulting from massive exposures may
last as long as 2-4 days. In the body, the products formed by its
oxidation are formaldehyde de and formic acid, both of which are toxic.
Because of the slow elimination, methanol should be regarded as a
cumulative poison. Though single exposure s to fumes may cause no
harmful effect, daily exposure may result in the accumulation of
sufficient methanol in the body to cause illness. Death from ingestion
of less than 30 ml (millilitres) has been reported." (71) Phenylalanine
is an amino acid. However, in high levels it can cause brain damage.
People with phenylketonuria are at risk for brain damage if they
consume even just one litre of aspartame sweetened soda pop in a day,
because the disease inhibits the body's ability to metabolise it.
(67,72)
The FDA and the Centres for Disease Control have received
nearly 7,000 complaints, including five deaths, attributed to the use
of aspartame in food products since the FDA first permitted limited use
in 1981. (39,47,56) A number of researchers and doctors around the
country object not only to the product itself, but to the questionable
preliminary research that led FDA to approve it for use in dry products
in 1981. Aspartame was the accidental discovery of chemist Jim
Schlatter, who w as working for Searle on an anti-ulcer drug. It was
December 1965; Schlatter liked his finger and tasted the substance that
had spilled on his flask. I It's sweetness stunned him, and he
realised that tiny amounts of the chemicals he'd been mixing were
powerfully sweet. Searle began testing the chemical mixture -
aspartame - and it eventually gained FDA approval, but not without
concerns about its safety. A consumer hot line was organised in 1987
to answer questions about the sweetener and its potential deleterious
effects. (74) Doctors and researchers have protested both its us and
the research that led to its approval. A number of books have been
published denouncing and challenging its self-portrayed description as
an innocuous food additive. And victims of its side effects are listed
in doctors' case studies. (1.57-66,75,76,79)
After reviewing
scientific and medical literature on aspartame published d since 1970,
Cherry Gaffney, the Armed Forces Institute of Pathology concluded
aspartame 's ingestion may lead to blood pressure instability and
perceptual al disorders in some persons. She said that additional
studies were necessary to evaluate the impact of aspartame on
aviation.(65) Her warning was directed to pilots whose performance
could be affected by using the substance. The organisation of the
Aspartame Consumer Safety Network in 1987 was the direct result of the
founder's nightmarish encounter with aspartame.
In 1989 Mary Stoddard
related her physical and emotional decline in 1984 during g an attempt
to lose weight. She said she experienced dozens of symptoms that t
she'd never had before. She described ringing in her ears, tremors,
weakness in her limbs, muscle cramping, twitching, blocked ears, skin
lesions, depression, sinus congestion, blurred vision, joint pains, and
hearing loss. Stoddard did not have symptoms until she started using
diet products, like soft drinks, which contained aspartame. As she
continued to use more and more diet products containing aspartame, she
observed her symptoms worsened. Stoddard did not initially link
aspartame to her symptoms. She believed that a healthy diet and
regular exercise would make her feel physically better, but she
continued to have health problems that had no apparent source. She
said that she sought medical help, but received conflicting advice.
She said she eventually began to suspect the products containing
aspartame in her diet were creating her problems after she traced the
onset of the symptoms to aspartame use, and on that hunch she decided
to eliminate e NutraSweet from her diet. She began to feel better
immediately after removing the products containing aspartame from her
diet, but Stoddard said it took six months for r the symptoms to
completely recede. At one point during her recovery she inadvertently
ingested a food product containing aspartame, and had a recurrence of
the symptoms. She then had no doubt that aspartame was the root cause
of her unusual reactions. In 1987, three years after her own adverse
reactions to NutraSweet, Stoddard formed the Aspartame Consumer Safety
Network to help others afflicted with aspartame sensitivity problems.
Some specialist in food and nutrition have spoken out against aspartame
use.
Woodrow Monte, R.D., Ph.D., director of the Arizona State
University Food Sciences and Nutrition Laboratory, is uncomfortable
with the methanol content of aspartame. In an 1986 interview, Monte
called aspartame "a crime against humanity." "Humans are 100 times more
sensitive to methanol than animals. When you ingest aspartame, it
breaks down into methanol within one hour of ingestion. Methanol forms
as soon as aspartame goes into solution and increases the longer it is
in solution." according to Monte. Because heat speeds the breakdown of
aspartame into methanol, if aspartame is added to coffee or tea at 80
degrees C (145 degrees F), one half of the amount breaks down into
methanol in 10 minutes, according to Monte. This raises serious
concern about ASPARTAME 'S 1993 approval for use in baked goods and
other heated products, like hot cocoa and tea. Although aspartame came
about as the result of a search for a drug, and its compounds were the
basis for a potential prescription medication, the petition for
approval of NutraSweet was based on the premise that it was a food
additive. The FDA followed its precedent of permitting manufacturers
to conduct their own product safety research.
Monte feels that aspartame was mislabelled from the beginning.
"aspartame is a drug, not a food additive," he said. "One
hundred million people, from little babies to the elderly, are
consuming this stuff in megadoses, more than they ever would if
it were labelled a drug."
Dr. Jacqueline Verrett, a former FDA toxicologist, and member of an FD
A task force that investigated the authenticity of research done by
Searle to establish the safety of aspartame, says she believes the
original aspartame studies were "built on a foundation of sand." (20)
She testified in front of a U.S. Senate hearing in 1987 that flawed
tests conducted by Searle - used as the basis of FDA approval - were a
"disaster" and should have been "thrown out." She said she believe d
the studies left many unanswered questions about possible birth defects
and the safety of aspartame. (20)
Verrett said the team was instructed not to be concerned with, or
comment upon, the overall validity of the study. She said a subsequent
review discarded or ignored the problems and deficiencies outlined by
her team's original report. She said, "serious departures from
acceptable toxicological protocols" that her investigative team noted
in the revaluation of these studies were also discounted.(20)
She warned that any of the improper practices would compromise and
negate a safety study of a food additive. Verrett concluded the data
in the study was worthless, and the safety of aspartame and its
breakdown products have therefore not been determined.(20) She
emphasised that aspartame exists in the marketplace without basic
toxicity information. She said there are not data to assess the
interactions with DKP, excess phenylalanine, other aspartame
metabolites, additives, drugs, or other chemicals. In her testimony,
Verrett elaborated on DKP problems, including significant increases of
uterine polyps and changes in blood cholesterol. DKP is formed when
liquids in particular are pre-sweetened with aspartame. The production
of DKP is vulnerable to increase in temperature and higher temperatures
produce increasing amounts of DKP. She reminded members of the
Congressional Committee "that is why initially, aspartame was not
intended or not planned to be used in liquids because of this
decomposition...it was decided it was too unstable to be used in hot
preparations, hot liquids, an d also in diet drinks." (20)
Senator Howard Metzenbaum (D-OH), chairman of the hearing when Verrett
testified, asked her if she disagreed with the FDA's position that
tests for aspartame safety were credible. Verrett succinctly said she
disagreed. (20 ) Dr. H. J. Roberts, a Florida internist and author,
cites cause studies of individuals adversely affected by aspartame
use.(75) In one case described by Roberts, the destruction left in the
wake of aspartame use was so debilitating that a college honour student
deteriorated from the brain damage and finally had to be
institutionalised because her mental retardation was so severe.
Roberts said he treated the 18-year-old student in 1986 because of
"profound intellectual deterioration" that followed her use of
aspartame products for weight control The young woman suffered mental
incapacitation that destroyed her academic goal when she had a drop of
20 IQ points, according to Roberts, who said prior to use of the
aspartame she had been an outstanding student at a major university, as
well as a skilled typist and pianist. Her skills had rapidly declined
according to Roberts, by the time of her first visit to his office.
Her physical complaints included headaches decreasing vision in one
eye, dizziness, intense drowsiness, tremors, insomnia, suicidal
depression, itching, burning on urination, personality change,
abdominal pain, recurrent nausea, loss of menstrual cycle, and an
ironic 15-pound weight gain. Roberts said extensive neuro-physical
tests were conducted on the woman, and no consistent patterns were
found for a primary disorder or schizophrenia. When he noted the woman
experienced drowsiness after ingesting aspartame drinks and dozed while
driving, he advised her to avoid aspartame, and to follow an
anti-hypoglycemic diet with medication. Avoidance of aspartame
relieved her symptoms, but the apparent brain damage remained,
requiring her placement in a facility for the mentally retarded.(75)
In a recent study investigating the consequences of aspartame on people
with mood disorders, Ralph Walton, M.D., Robert Hudak, Ph.D., and Ruth
J. Green-Waite concluded "individuals with mood disorders are
particularly sensitive to this artificial sweetener (aspartame) and its
use in this population should be discouraged." (60) Walton said their
study was terminated after only 20 days by the Institutional Review
Board of Western Reserve Care System, Youngstown, Ohio because the
reactions (including a detached retina and conjunctival haemorrhage)
among the patients with a history of depression were so severe they
could not "ethically continue the study."(60) The study included a
total of 13 subjects. Eight of the subjects were patients, ranging in
age from 24 to 60 years. All suffered from recurrent major depression.
Five healthy hospital employees, including the hospital administrator,
volunteered as a control group for the study. Each participant was
asked to monitor his or her own symptoms for a checklist of headache,
nervousness, dizziness, memory problems, binge eating, lower back pain,
nausea, upset stomach, depression, insomnia, uncontrollable temper
outburst, or other symptoms. The hospital's pharmacy prepared 300 mg
capsules of aspartame for some participants, and sugar placebos for
others. (NutraSweet Company denied the request from the researchers to
purchase the aspartame for the study, so capsules were provided by
Schwiezerhall, Inc., of New Jersey.) A 154-pound person ingested seven
of the prepared capsules daily - the approximate aspartame equivalent
would be 10 to 12 cans of diet soda.
Although the study was
abbreviated because of the severity of the subjects' symptoms, the
researchers did find the incidence of headaches in participants taking
aspartame increased and that persons with a history of depression
demonstrated significant adverse reactions while taking aspartame.
They also reported adverse symptoms for the group taking aspartame
increased significantly. (60) Walton, then chief of psychiatry at New
York's Jamestown Hospital an d Chautauque County mental health
commissioner, reported a case study of a patient who reacted adversely
to aspartame. His 54-year-old female patient "suddenly experience a
grand mal seizure followed by profound behaviour changes." Some of the
personality changes included euphoria, flight of ideas, increased motor
activity and insomnia. A history of the woman's eating habits revealed
she had been accustomed to drinking about a gallon of sugar-sweetened
iced tea daily. In the weeks before her seizure, she had switched from
sugar-sweetened tea to an iced tea product containing aspartame. After
reviewing her case, Walton advised her to eliminate the aspartame
product, upon which she returned to normal and the symptoms
subsided.(66) Walton questions the reliability and validity of studies
for the safety of aspartame funded by the NutraSweet Company. "I'm
absolutely convinced," he says. "I know it causes seizures. I'm
convinced also that it definitely causes behavioural changes. I'm very
angry that this substance is on the market. I personally question the
reliability and validity of any studies funded by the NutraSweet
Company." In the 1987 proceedings of the First International Meeting on
Dietary Phenylalanine and Brain Function, he also presented either
other seizures cases, along with case studies of mania, panic attacks
and weight gain induced by aspartame use.
In NO-NONSENSE NUTRITION FOR KIDS Annette Natow and Jo Ann Heslin write
"animal and human studies have shown that aspartame cause chemical
change s in the brain. More research is needed to determine if
aspartame is a health hazard."(76) The questions about the validity of
the Searle research and tests of aspartame date back to 1976 when FDA
was uncertain about the animal test data provided by Searle. The FDA
administrators asked Sam Skinner, former U.S. attorney in the Northern
District of Illinois, to convene a grand jury to investigate
discrepancies in the animal test data provided by Searle.(15) On
January 10, 1977, RDA chief counsel, Richard Merril, sent a 33-page
letter to Skinner repeating the request for the grand jury
investigation "into apparent violations of the Federal Food, Drug, and
Cosmetic Act...and False Reports to the Government Act...by G. D.
Searle Company"(12) The letter also charged that Searle concealed
material facts and made false statements in reports of animal studies
conducted to establish the safety of the food additive aspartame. The
studies cities for investigation had been conducted in 1972, and
five-year statutes of limitation for criminal prosecution were due to
expire on October 10, and December 8, 1977. (7) The statutes of
limitation ran out before any criminal charges were ever filed. in
1977 Skinner was offered and accepted a job with Sidley and Austin, the
law firm that represented Searle. While still U.S. district attorney,
Skinner did eventually excuse himself from the Searle investigation.
The next U.S. attorney, Tom Sullivan, then dropped NutraSweet from the
grand jury investigation.(7) In 1988 Senator Metzenbaum challenged
Skinner's nomination for appointment as U.S. secretary of
transportation. Metzenbaum issued a press release that said Skinner
"failed to launch a grand jury probe of G.D. Searle, the manufacturer
of NutraSweet, which was requested by the Food and Drug Administration.
A year after the FDA brought Skinner allegations of fraudulent safety
tests by Searle, Skinner took a job with the law firm that defended
Searle in the case."(7) Although Metzenbaum did later say he would not
object to the nomination to the position of secretary of
transportation, he said that Skinner told him that "he may have made
mistakes in his handling the NutraSweet investigation." The studies
under scrutiny were the purview of Dr. Harry Waisman, a researcher at
the University of Wisconsin's Regional Primate Center. He was asked to
compare toxicity effects from aspartame (particularly seizures and
learning defects from brain damage) with those from phenylalanine, a
primary ingredient in aspartame. Waisman's 52-week toxicity study on
seven infant Rhesus monkeys fed a diet containing aspartame did not
include a control group for comparison. The results of the study,
submitted to Searle in 1972, showed the death of one monkey after 300
days, the administration of aspartame halted on two monkeys after 200
days, and four monkeys who received aspartame for 365 day s. The FDA,
in a report on the tests, said that no behavioural or learning tests
were undertaken on the monkeys. Former FDA Commissioner Alexander
Schmidt, now deceased, said the tests were "shoddy" and "far less than
perfect "(79)
A second study initiated by Searle was to have been a
104-week toxicity study on the effects of aspartame on hamsters. The
study was halted prematurely after 46 weeks because of the unexpectedly
high mortality rate in both control and treated animals following and
outbreak of diarrhea among t he test animals. Other inconsistencies in
the tests were noted upon review by the FDA, including submission of
false information, and reports that were written to convey impressions
more favourable than underlying data would support.(7,16) The FDA
researchers also said that their agency needed more adequate and better
controlled studies. They said the FDA must base its recommendations on
sound data because the substance could be part of the daily diet of
ever y American.(25) Schmidt commented that "if you're approving a food
additive that will be taken by children around the world, you will
accept absolutely no risk, particularly if it's a non-nutritive
sweetener."(7)
The FDA task force observed laboratory methods at Searle from April 25
to August 4, 1977. The Bressler Report (named for team leader Jerome
Bressler) identified major discrepancies, including "substantial
differences between gross observation on pathology sheets when compared
with those submitted to the FDA" in a rat toxicology test of
aspartame.(16) According to the Bressler Report, one rat even appeared
resurrected. It stated, "Observed records indicated that animal A23LM
was alive at week 88, dead from week 92 to week 104, alive at week 108,
and dead at week 112." (16) The actual meal fed to the rats was also in
question. Raymond Schroeder, a former Searle employee, said in an FDA
interview on July 13, 1977 that "the particles of DKP were large enough
to allow the rats to discriminate between the DKP and the basal diet."
In 1982, representatives of the carbonated beverage industry asked
Monte to evaluate the scientific data for aspartame. Monte said "I was
stunned by the poor quality research and recommended against
aspartame's use in carbonated beverages. I understood that the
industry was going to abide by my evaluation but something turned them
around."
In 1984, Florence Graves, vice president of COMMON CAUSE wrote
"NutraSweet has been touted as the most tested food additive in
history, but our investigation reveals such serious flaws in the
government's approval of NutraSweet that Congress should begin its own
investigation immediately." (38) A 1987 report released by the General
Accounting Office, "FDA Food Additive Approval Process Followed for
Aspartame," included information t hat waved red flags of potential
calamity.
Some of the findings in the report:(11)
*The rat DKP Study showed a significant incidence of uterine polyps in
rats fed at the two highest dose levels as compared to rats not fed
DKP. Review teams later said the polyps were not cancerous,
precancerous, or potentially cancerous.
*The Center for Safety and Nutrition advised Searle
that because it had not submitted studies for evaluating
long-term effects of DKP, aspartame was no t approved for
products that could have an appreciable breakdown to DKP.
* An investigative team report showed that examination of rat
fetuses and t he reporting of the results in two teratology
studies were inadequate.
*Dr. John Olney, psychiatrist,
neuro-pathologist, and professor at Washington University in
St. Louis found 12 brain tumors in 320 dosed rats and none in
120 control rats when he examined FDA files on aspartame animal
studies in 1978.
* Olney advised that the high number of brain tumors was
unusual.
* Olney voiced another concern based on his research. He showed
that when glutamate and aspartic acid are ingested together each
agent augments the neurotoxic effects of the other.
In a 1981 interview at Washington University Olney said,
"Chemicals marketed as food additives are consumed without
supervision by hundreds of millions, most of whom do not know
they are ingesting the additive, do not derive health benefits
from it and have no understanding of its adverse effects."
Olney, along with consumer activist attorney James Turner,
initiated court action over aspartame. In a 1986 interview
Turner said he had spent 15 years battling approval of aspartame
because "it's hurting people." Monte also called the scientific
data supplied on aspartame as "poor quality research" and said
he recommended against aspartame's use in carbonated beverages.
Dr. Jeffrey Bada, a chemistry professor at the University of
California at San Diego, warned against heating aspartame and
the resultant internal rearrangement of its chemical structure.
The late Dr. M. Adrian Gross, an FDA toxicologist, spoke out
against aspartame in the August 1, 1985 Congressional Record.
Gross, who took part in on-site investigations at Searle
laboratories, said the studies carried out by Searle to show the
safety of aspartame were "to a large extent unreliable." He said
"at least one of those studies has established beyond any
reasonable doubt that aspartame is capable of inducing brain
tumors in experimental animals and that this...is of extremely
high significance."( 42) Gross also testified that because
aspartame was capable of producing brain tumors and brain
cancer, FDA should not have been able to set an allowable daily
intake of the substance at any level. He said at least one of
Searle's studies "has established beyond any responsible doubt
that aspartame is capable of inducing brain tumors in
experiments animals and that this predisposition of it is of
extremely high significance...
In view of these indications that the cancer causing potential
of aspartame is a matter that had been established way beyond
any reasonable doubt, one can ask: What is the reason for the
apparent refusal by the FDA to invoke for this food additive the
so-called Delaney Amendment to the Food, Drug and Cosmetic Act?"
The Delaney Amendment makes it illegal to allow any residues of
cancer causing chemicals in foods. In his concluding testimony
Gross asked, "Given the [cancer causing potential of aspartame]
how would the FDA justify its position that it views a certain
amount of aspartame as constituting an allowable daily intake or
91safe'level of it? Is that position in effect not equivalent
to setting a 91tolerance' for this food additive and thus a
violation of that law? And it the FDA itself elects to violate
the law, who is left to protect the health of the public?"
For more information contact:
* NutriVoice, Inc.
* PO Box 946
* Oak Park, IL 60303
* Published BITTERSWEET ASPARTAME: A DIET DELUSION
by Barbara Alexander - Mullarkey
* Aspartame Consumer Safety Network
* PO Box 780634
* Dallas, TX 75378
* (214) 352-4268
[Editor's Note: Barbara Alexander Mullarkey is an investigative
columnist who has been researching aspartame for 12 years.
Part Two of this two-part series on aspartame will take a closer
look at the medical literature, including what levels of intake
are considered dangerous. ]
