ASPARTAME DISEASE: AN FDA APPROVED EPIDEMIC

[Guest guest]

ASPARTAME DISEASE:

AN FDA-APPROVED EPIDEMIC

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

E-Mail: HJrobertsmd

©2004 by H. J. Roberts, M.D.

 

 

 

 

 

 

 

" 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 Metzenbaum1:

 

 

" 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 AMA2 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 disorders3.

 

An Overview of Aspartame Disease

 

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

aspartame, 80 percent1 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 at:

http://www.amazon.com/exec/obidos/ASIN/1884243177/optimalwellnessc4,

other books5-8 and numerous published articles and letters9-12.

 

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 addiction12; an apparent

causative role in brain tumors10; a neurologic condition in

overweight young women known as pseudotumor cerebri; and even the

carpal tunnel syndrome11.

 

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 litigation7, 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 Illness13, 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).

 

 

 

 

 

 

 

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 previously4-6. 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.

 

 

References

 

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

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

Council on Scientific Affairs. Aspartame: Review of safety issues.

JAMA 1985; 254:400-402.

Centers for Disease Control. Evaluation of consumer complaints

related to aspartame use. Morbidity and Mortality Weekly Report 1984;

November 2:605-607.

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

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

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

Charles Press, 1989.

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

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

(www.sunsentpress.com)

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

Suppressed Opinion About a Perceived Medicolegal Travesty West Palm

Beach, Sunshine Sentinel Press, 1999. (http://www.sunsentpress.com)

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)

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

Appl Nutr 1988; 40:86-94.

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

4 (Winter):231-241.

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

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

Roberts HJ. Aspartame (NutraSweet) addiction. Townsend Letter for

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

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

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