Aspartame Disease: An FDA-Approved Epidemic

[Guest guest]

http://www.mercola.com/2004/jan/7/aspartame_disease.htm

 

 

Aspartame Disease: An FDA-Approved Epidemic

 

 

 

By H. J. Roberts, M.D., F.A.C.P., F.C.C.P.

 

 

" Diet " products containing the chemical sweetener aspartame can have multiple

neurotoxic, metabolic, allergenic, fetal and carcinogenic effects. My database

of 1,200 aspartame reactors--based on logical diagnostic criteria, including

predictable recurrence on rechallenge--is reviewed.

 

 

 

The existence of aspartame disease continues to be denied by the FDA and

powerful corporate entities. Its magnitude, however, warrants removal of this

chemical as an " imminent public health threat. " The use of aspartame products by

over two-thirds of the population, and inadequate evaluation by

corporate-partial investigators underscore this opinion.

 

 

 

As said by Senator Howard Metzenbaum (1):

 

 

 

“We had better be sure that the questions that have been raised about the safety

of this product are answered. I must say at the outset, this product was

approved by the FDA in circumstances that can only be described as troubling.”

 

 

 

I have devoted more than two decades to analyzing aspartame disease, a

widespread but largely ignored disorder. Its existence continues to be

reflexively denied by the Food and Drug Administration (FDA), the American

Medical Association (AMA), and many public health/ regulatory organizations.

 

 

 

The medical profession and consumers have been assured by the Council on

Scientific Affairs of the AMA (2) and the Centers for Disease Control (CDC) that

aspartame is " completely safe. " Moreover, the impression is left that reports of

serious reactions are a " health rumor " fabrication ... notwithstanding the CDC

report in 1984 of 649 aspartame reactors with many attributed disorders (3).

 

 

An Overview of Aspartame Disease

 

 

 

As far back as 1988, seven years after the initial release of aspartame, 80

percent (!) of complaints volunteered by consumers to the FDA about supplements

involved aspartame products. By April 1995, it had received 7,232 complaints.

 

I coined the term “aspartame disease” to encompass reactions to the chemical

sweetener aspartame, commonly known as NutraSweet® and Equal®. Aspartame was

originally conceived, and an application submitted, as a drug to treat peptic

ulcer. To place its magnitude in perspective, over two-thirds of the population

now uses thousands of " diet " sodas and products--including an ever-expanding

list of new ones having greater potential for adverse effects (e.g., strips

placed on the tongue to freshen the breath).

 

 

 

This report summarizes data on the first 1,200 aspartame reactors in my

database, coupled with information of considerable clinical significance. I have

elaborated on the details in Aspartame Disease: An Ignored Epidemic (4), other

books (5-8), and numerous published articles and letters (9-12).

 

 

 

It is my belief that most physicians with active practices frequently encounter

its manifestations. But, unaware of the underlying problem, they fail to inquire

about aspartame use.

 

 

 

For orientation about the gravity of this public health dilemma, I shall mention

just a few of the published associations in aspartame reactors. They include the

initiation or aggravation of diabetes mellitus, hypoglycemia, convulsions,

headache, depression, other psychiatric states, hyperthyroidism, hypertension

and arthritis; the simulation of multiple sclerosis, Alzheimer's disease and

lupus erythematosus; increasing aspartame addiction (12); an apparent causative

role in brain tumors (10); a neurologic condition in overweight young women

known as pseudotumor cerebri; and even the carpal tunnel syndrome (11).

 

 

 

In my opinion, lack of awareness of aspartame disease has resulted in gross

miscarriage of justice. Examples include attributing the symptoms of

weight-conscious women consuming considerable amounts of aspartame to silicone

breast implants in expensive litigation (7), and imprisonment for the alleged

methanol poisoning of a deceased spouse who consumed large amounts of aspartame.

 

 

 

Having been involved in medical practice, teaching and the authorship of texts

for a half century, I do not casually make statements that might jeopardize a

longstanding reputation. As a case in point, my first book, Difficult Diagnosis:

A Guide to the Interpretation of Obscure Illness (13), was studied and used as a

reference by tens of thousands of internists and other physicians.

 

 

The following issues are also relevant:

 

 

 

My best teachers have been perceptive private patients.

All my studies were corporate-neutral, meaning without grants. I have had to

cope with the enormous hurdles of professional and editorial bias stemming from

the self-serving interests of corporate power wielded by a multi-billion dollar

industry. For example, virtually all my letters challenging the validity of

" negative scientific studies " published in peer-reviewed journals were rejected.

They were based on flawed protocols, the failure to use " real world " products

subjected to prolonged storage and elevated temperatures, and even the nature of

the test materials and placebos employed.

My repeated emphasis to colleagues, the FDA and the Congress that the

approval of aspartame for human use has spawned an imminent public health hazard

continues to fall on deaf ears.

A number of concerned doctors were unable to get their " anecdotal "

observations published in peer-reviewed journals, some (including the author)

having been labeled " media terrorists " disrespectful of " evidence-based "

criteria.

 

 

 

About Aspartame

 

 

 

The FDA approved aspartame as a low-nutritive sweetener for use in solid form

during 1981, and in soft drinks during 1983. It is a synthetic chemical

consisting of two amino acids, phenylalanine (50 percent) and aspartic acid (40

percent), and a methyl ester (10 percent) that promptly becomes free methyl

alcohol (methanol; wood alcohol). The latter is universally considered a severe

poison.

 

 

 

Senior FDA scientists and consultants vigorously protested approving the release

of aspartame products. Their objections related to disturbing findings in animal

studies (especially the frequency of brain tumors), seemingly flawed

experimental data, and the absence of extensive pre-marketing trials on humans

using real-world products over prolonged periods.

 

 

 

Aspartame reactions may be caused by the compound itself, its three components,

stereoisomers of the amino acids, toxic breakdown products (including

formaldehyde), or combinations thereof. They often occur in conjunction with

severe caloric restriction and excessive exercise to lose weight.

 

 

 

Various metabolic and physiologic disturbances explain the clinical

complications. Only a few are listed:

 

 

 

Damage to the retina or optic nerves is largely due to methyl alcohol

exposure. Unlike most animals, humans cannot efficiently metabolize it.

High concentrations of phenylalanine and aspartic acid occur in the brain

after aspartame intake, unlike the modest levels of amino acids following

conventional protein consumption.

Aspartame alters the function of major amino acid-derived neurotransmitters,

especially in obese persons and after carbohydrate intake.

Phenylalanine stimulates the release of insulin and growth hormone.

The ambiguous signals to the satiety center following aspartame intake may

result either in increased food consumption or severe anorexia.

Large amounts of the radioactive-carbon label from oral aspartame intake have

been detected in DNA.

 

 

The current " acceptable daily intake " (ADI) of 50 mg aspartame/kg body weight

makes no sense. It represents the projection of animal studies based on lifetime

intake! This was clearly stated by previous FDA Commissioner Dr. Frank Young

during a U.S. Senate hearing on November 3, 1987. Furthermore, it disregards the

usual 100-fold safety factor used by the FDA as a guideline for regulated food

additives. The maximum daily intake tolerated by most reactors in my series,

based on the predictable recurrence of induced symptoms and signs, ranged from

10 to 18.3 mg/kg.

 

 

 

Clinical Data Attributed to Aspartame Products

 

 

 

The clinical features attributed to aspartame products among the first 1,200

reactors in my database appear in Table 1 (reproduced from Reference 4 with

permission by the Sunshine Sentinel Press).

 

 

 

(Click to go to web page and read many, many side effects)

http://www.mercola.com/2004/jan/7/aspartame_disease.htm

 

 

 

 

 

 

 

 

Gender and Age Range

 

 

 

There was a 3:1 preponderance of females (72 percent). The various influences

that may be operative in this gender preference have been detailed previously

(4-6). The ages of persons at the onset of their reactions ranged from infancy

to 92 years. Most were in their 20s to 50s.

 

 

 

Family History

 

 

 

Two or more close relatives of 211 reactors (17.6 percent) were known to have

had reactions to aspartame products.

 

 

 

Latent Period

 

 

 

Latent periods of from several weeks to months between the initial consumption,

and increased intake of aspartame and the onset of severe symptoms were common.

On the other hand, some patients reacted almost immediately, particularly with

products conducive to oral/buccal absorption.

 

 

 

Aspartame Intake

 

 

Many reactors consumed prodigious amounts of aspartame, especially during hot

weather. Conversely, some experienced convulsions, headache, or other severe

symptoms after exposure to small amounts (e.g., chewing aspartame gum; placing

an aspartame strip on the tongue; babies while breast-feeding as the mother

drank an aspartame beverage).

 

 

 

Interval Between Cessation and Improvement

 

 

 

Nearly two-thirds of aspartame reactors experienced symptomatic improvement

within two days after avoiding aspartame. With continued abstinence, their

complaints generally disappeared.

 

 

 

Causation

 

 

 

The causative role of aspartame products has been repeatedly shown by (a) the

prompt improvement of symptoms (grand mal seizures, headache, itching, rashes,

severe gastrointestinal reactions) after stopping aspartame products, and (b)

their recurrence within minutes or hours after resuming them. The latter

included self-testing on numerous occasions, inadvertent ingestion, and formal

rechallenge.

 

 

 

Some aspartame reactors with convulsions purposefully rechallenged themselves on

one or several occasions " to be absolutely certain. " This was unique among six

pilots who had lost their licenses for unexplained seizures while consuming

aspartame products. (All had been in otherwise excellent health.) They sought to

have their licenses reinstated by such objective confirmation on rechallenge.

 

 

 

High-Risk Individuals

 

 

 

These groups include pregnant and lactating women, young children, older

persons, those at risk for phenylketonuria (PKU), the relatives of aspartame

reactors (see above), and patients with liver disease, iron-deficiency anemia,

kidney impairment, migraine, diabetes, hypoglycemia, and hypothyroidism.

 

Clinical Implications

 

 

 

Physicians must question patients who present with the aforementioned conditions

about aspartame use, particularly when they fail to respond to conventional

therapy. If it is being consumed, a brief trial of abstinence should be

recommended before initiating expensive tests, consultations and

hospitalization.

 

 

 

The following caveats derive from clinical experience:

 

 

 

Every patient with unresolved neurologic, psychologic, allergic,

dermatologic, gastrointestinal and metabolic/endocrine problems should be

queried about aspartame intake.

The diagnosis of multiple sclerosis should be deferred pending at least

several months observation in the case of persons consuming aspartame.

A pregnant woman should not risk the health of her fetus by consuming

aspartame products.

Visual, neurologic or bowel problems in diabetics should not be ascribed to a

presumed underlying retinopathy or neuropathy until evaluating the response to

aspartame abstinence.

Cataract surgery ought to be deferred in heavy aspartame users to evaluate

for spontaneous improvement after abstinence.

Patients presenting with seizures, headache, atypical facial or eye pain, the

Meniere syndrome, depression, the carpal tunnel syndrome, normal-pressure

hydrocephalus, and a host of other unexplained neuropsychiatric problems, or who

fail to respond to conventional treatment, must be queried about aspartame use …

especially if invasive studies are planned.

Young adults who express concern about " possibly having early Alzheimer's

disease, " based on recent confusion and memory loss, ought to be observed at

least one month after stopping aspartame before this diagnosis is pursued.

Gynecologic surgical procedures to evaluate gross menstrual changes should be

deferred pending the response to abstinence.

 

 

 

©2004 H. J. Roberts, M.D. Published with permission from the author.

 

Dr. Roberts is director of the Palm Beach Institute for Medical Research, and an

emeritus member of the medical staffs of the Good Samaritan Hospital and St.

Mary's Hospital in West Palm Beach, and prestigious medical/scientific

organizations. These include the American College of Physicians, the Endocrine

Society, the American Academy of Neurology, and the American Federation for

Clinical Research. He has authored 18 texts and has had more than 240 original

articles and letters published, most deal with challenging diagnostic, metabolic

and neurological problems. Dr. Roberts has been knighted by the Order of St.

George for his professional and humanitarian efforts, and was chosen by the

editors of a national medical journal as " The Best Doctor in the U.S. "

 

 

 

References

 

 

 

1. Metzenbaum H. Discussion of S.1557 (Aspartame Safety Act). Congressional

Record-Senate August 1, 1985, p.S 10820.

 

2. Council on Scientific Affairs. Aspartame: Review of safety issues. JAMA 1985;

254:400-402.

 

3. Centers for Disease Control. Evaluation of consumer complaints related to

aspartame use. Morbidity and Mortality Weekly Report 1984; November 2:605-607.

 

4. Roberts HJ. Aspartame Disease: An Ignored Epidemic West Palm Beach, Sunshine

Sentinel Press, 2001. (www.sunsentpress.com)

 

5. Roberts HJ. Aspartame (Nutrasweet): Is It Safe? Philadelphia, The Charles

Press, 1989.

 

6. Roberts HJ. Sweet'ner Dearest: Bittersweet Vignettes about Aspartame

(NutraSweet) West Palm Beach, Sunshine Sentinel Press, 1992.

(www.sunsentpress.com)

 

7. Roberts HJ. Breast Implants or Aspartame (NutraSweet) Disease? The Suppressed

Opinion About a Perceived Medicolegal Travesty West Palm Beach, Sunshine

Sentinel Press, 1999. (www.sunsentpress.com)

 

8. Roberts HJ. Useful Insights for Diagnosis, Treatment and Public Health West

Palm Beach, Palm Beach Institute for Medical Research, 2002.

(www.pb-medical-research.com)

 

9. Roberts HJ. Reactions attributed to aspartame products: 551 cases. J Appl

Nutr 1988; 40:86-94.

 

10. Roberts HJ. Does aspartame cause human brain cancer? J Advanc M 1991; 4

(Winter):231-241.

 

11. Roberts HJ. Carpal tunnel syndrome due to aspartame disease. Townsend Letter

for Doctors & Patients 2000; 198 (November):82-84.

 

12. Roberts HJ. Aspartame (NutraSweet) addiction. Townsend Letter for Doctors &

Patients 2000; 198 (January):52-57.

 

13. Roberts HJ. Difficult Diagnosis: A Guide to the Interpretation of Obscure

Illness Philadelphia, W.B. Saunders Company, 1958.

 

 

 

 

 

Hotjobs: Enter the " Signing Bonus " Sweepstakes