mothers




The opinion of Louis J. Elsas, II, M.D., Director, Division of Medical Genetics, Professor of Pediatrics, as stated to the Labor and Human Resources Committee, U.S. Senate

EMORY UNIVERSITY SCHOOL OF MEDICINE
DEPARTMENT OF PEDIATRICS
2040 Ridgewood Drive, NE
Atlanta, Georgia 30322
Division of Medical Genetics

Statement for the Labor and Human Resources Committee, U.S. Senate

I have considerable concern for the increased dissemination and consumption of the sweetener, aspartame (1-methyl N-Laspartyl-L- phenylalanine) in our world food supply. This artificial dipeptide is hydrolyzd by the intestinal tract to product L-phenylalanine which in excess is a known neurotoxin. Normal humans do not metabolize phenylalanie as efficiently as do lower species such as rodents, and thus most of the previous studies in Aspartame effects on rats are irrelevant to the question, "does phenylalanine excess occur with Aspartame ingestion?" and if so "will it adversely affect human brain function?"

Preliminary studies in my laboratory provide tentative positive answers to both questions. Many studies of both acute and chronic ingestion of 34 mg Aspartame/kg/day have demonstrated a two to five fold increase in semi-fasting blood phenylalanine concentrations (from approximately 50 5o 250 pM) without concomitant increases in tyrosine or other amino acids. The degree of increase by normal humans depends on several variables including the efficiency of gut transport, liver utilization, and growth rates. It was thought by many scientists and clinicians that this degree of blood phenylalanine increases would not affect brain function. However, currently available information indicates that this is not true.

1) In the developing fetus such a rise in maternal blood phenylalanine could be magnified four to six fold by the concentrative efforts of the placenta and fetal blood brain barrier. Thus a maternal phenylalanine of 150 pM could reach 900 pM in the developing fetal brain cell and this concentration kills such cells in tissue culture. The effect of such an increased fetal brain concentrations in vivo would probably be much more subtle and expressed as mental retardation, microcephaly, or potential certain birth defects.

2) In the rapidly growing post-natal brain (children of 9-12 months) irreversible brain damage could occur by the same mechanism.

3) In the adult we have found that changes in blood phenylalanine in these concentration ranges are associated with slowing of the electroencephalogram, and prolongation of cognitive function tests. Fortunately, these effects on the mature brain are reversible but provide clear evidence for a negative effect on sensitive parameters of brain function. In view of these new (and confirmation of old) research findings, I suggest the following:

1) Immediate quantitative labeling of all aspartame-containing foods, so the consumer will know how much phenylalanine he/she is ingesting.

2) Declare an immediate moratorium on addition of aspartame to more foods, and remove it from all low-protein beverages, foods, and children's medications.

3) Provide funds not controlled by industry to:

a) Allow active surveillance for potential side-effects of aspartame on newborns whose mothers dieted with NutraSweet (aspartame)-containing foods.

b) Allow active evaluation of other users whose complaints cannot be adequately studied at present.

c) Clarify the dose relationship and mechanisms by which L- phenylalanine affects human brain function..

Respectfully submitted,

Louis J. Elsas, II, M.D.

Director, Division of Medical Genetics, Professor of Pediatrics

H. J. Roberts, M.D. - 1995 statement concerning pregnant women, infants and children

H.J. ROBERTS, M.D., F.A.C.P., F.C.C.P.
6708 Pamela Lane
West Palm Beach, FL 33405
FAX 561-547-8008

Diplomate, American Board of FAX (407)832-2400 Internal Medicine (Recertified)

PROFESSIONAL OPINION OF H. J. ROBERTS, M.D., F.A.C.P., F.C.C.P. CONCERNING THE USE OF PRODUCTS CONTAINING ASPARTAME (NUTRASWEET) BY PREGNANT WOMEN, INFANTS AND CHILDREN

It is my firm opinion that pregnant women, infants and children should avoid ALL products containing aspartame - including vitamins, drugs and supplements.

This corporate-neutral summary statement has been prepared as general information in response to numerous requests from concerned patients, parents and consumers. There is no bias or malice intended against any company, distributor, researcher or individuals who may hold a contrary view.

The statement is based on considerable observation, research and correspondence published in more than a score of articles and these two books:

* ASPARTAME (NUTRASWEET): IS IT SAFE? (Philadelphia, The Charles Press)

* SWEET'NER DEAREST: BITTERSWEET VIGNETTES ABOUT ASPARTAME (NUTRASWEET) (West Palm Beach, Sunshine Sentinel Press, P.O. Box 17799, 1-800-814-9800)

This subject is also reviewed in an updated two-cassette talk: IS ASPARTAME (NUTRASWEET) SAFE? A MEDICAL, PUBLIC HEALTH AND LEGAL OVERVIEW -- 1995 (Sunshine Sentinel Press).

AN OVERVIEW OF ASPARTAME

Each of the three components of aspartame - phenylalnine; aspartic acid; the methyl ester, which promptly becomes methyl alcohol or methanol -- and their multiple breakdown products after exposure to heat or during prolonged storage is potentially toxic, especially to the developing brain.

Such toxicity and other serious physiologic derangements are evidenced by the serious reactions suffered by thousands of persons who used these products. The neurotoxic and metabolic complications are likely to affect the fetus and young children even more severely.

In my publications, and testimony to Congress and an FDA advisory group, I have expressed the belief that the current wholesale ingestion of aspartame products by over half the adult population constitutes a probably "imminent public health hazard." My concern is intensified by (1) evidence that these products may play a causative or aggravating role in many medical disorders (including headaches, dizziness, confusion, impaired vision, convulsions, and probably brain tumors), (2) the flawed nature of most "scientific" studies being used to "prove" the alleged safety of these products, and (3) reports of serious reactions volunteered to the FDA by over 7,300 irate consumers.

PREGNANT WOMEN AND NURSING MOTHERS

I urge ALL pregnant women and mothers who breast-fee to avoid aspartame products...without exception! This message also has been given to obstetricians.

The medical and scientific grounds for such advice include:

* Exposure of the fetus to considerable phenylalanine and methylalcohol

* Maternal malnutrition associated with nausea, vomiting, diarrhea and reduced calories

* Transmission of aspartame and its byproducts via the mother's milk

* Increasing the "allergic load"...thereby risking future hypersensitivity diseases

INFANTS AND CHILDREN

I have reported many adverse effects of aspartame products experienced by young persons. They include severe headaches, convulsions, rashes, asthma, gastrointestinal problems, and weight loss or gain. The neuropsychiatric features encompass irritability, hyperactivity, depression, antisocial behavior, deterioration of intelligence, and poor school performance.

These complications tend to be magnified in children with unrecognized hypothyroidism (underactive thyroid), hypoglycemia (low blood sugar reactions), diabetes, and phenylketonuria or PKU. Persons with PKU lack the enzyme needed for handling phenylalanine, which can cause severe neurological and other damage if dietary precautions aimed at preventing excessive levels are not instituted.

BIRTH DEFECTS

The issue of aspartame-related birth defects has not been resolved by epidemiologic studies. I remain concerned about this possibility, however, because of histories of reports given me about severe problems in the fetus or infant of parents (including fathers) who consumed much aspartame at the time of conception and/or during pregnancy. Several animal studies support such concern.

1995 H. J. Roberts, M.D.

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