Sweet Delusion - How Safe is Your Artificial Sweetener?

Sweet Delusion - How Safe is Your Artificial Sweetener?

Part One: The Hidden History of Aspartame

by Barbara Alexander Mullarkey with Adell V. Newman

INFORMED CONSENT - The Magazine of Health, Prevention, and

Environmental News - May/June 1994, Volume 1, Issue 4

WARNING:

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 recognize it by its

attractive red and white swirled logo, and are drawn by its promise of an allnatural,

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 realized 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 organizations nation-wide, including the American

Medical Association, the World Health Organization, the American Academy of

Side effects may include: Seizures. Depression. Brain damage.

Pediatrics, 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.

Known chemically as aspartame (C

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

retina which can progress to permanent blindness. Once absorbed, methanol is

only very slowly eliminated. Coma resulting from massive exposures may last as

14H 18O5), NutraSweet is a compound

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 (milliliters) 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 liter

of aspartame sweetened soda pop in a day, because the disease inhibits the body's

ability to metabolize 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 realized 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

organization 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 specialists 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 mislabeled 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 mega doses, more than they ever

would if it were labeled 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

institutionalized 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 behavior

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 sugarsweetened

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 days. 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 favorable 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, "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. ]

http://eagle.westnet.gr/~aesclep/ic1.htm