Call to Decision

ASPARTAME DISEASE: AN FDA-APPROVED EPIDEMIC

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

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." 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."

"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.