FDA Pivotal Safety Study: Aspartame Caused Brain Seizures
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by Pete Hardin
"Despite approval by the federal Food and Drug Administration as a sweetener, Aspartame remains the focus of serious human health questions poised by a core of skeptics.
Aspartame is the generic name for "NutraSweet", which is owned by Monsanto Corp. FDA okayed Aspartame for limited food use in the early l980s. In June 1996, FDA sanctioned use of Aspartame in thousands of food products. Aspartame consists of three components: 50% phenylalanine (a chemical which transmits impulses in the human brain), 40% aspartic acid and 10% methanol (wood alcohol-a poison).
FDA's human "safety" determination for Aspartame is based upon some 112 studies submitted to FDA by the original manufacturer, Searle Pharmaceuticals. (Monsanto acquired Searle Pharmaceuticals in the mid-1980s.) Of those 112 studies, FDA designated 15 studies "pivotal".
Critics have been relooking those "pivotal" studies and come away puzzled how FDA can deduce human "safety". Take, for example, one of the 15 "pivotal" studies: "52 Week Oral Toxicity Infant Monkey Study (SC-18862)." This study orally dosed Aspartame to seven infant Rhesus monkeys for 52 weeks, in work conducted at the University of Wisconsin Medical Center at Madison, Wisconsin. The work was reported in l972.
The monkeys were divided in three groups: a low dose group (1.0 g/kg), a medium dose group (3.0 g/kg.) and a high dose group (4-6 g/kg). Aspartame was incorporated into milk formula and administered orally. The high dose group did not consume intended levels of aspartame during the study, perhaps due to the overt sweetness (200 times greater than sugar). Thus, researchers concluded, the high-dose group actually ingested approximately as much Aspartame as the medium-dose group. (Editor's note: The UW-Madison researcher, H. A. Waisman, deceased in mid-study. For that reason, the low-dose group monkeys was pulled from this study at about 200 days-prior to when brain seizures commenced for the medium and high-dose groups.)
There was no control group. That ostensible inadequacy in the research protocol was dismissed by the lack of available monkeys and "..limitations in adequately skilled laboratory personnel..."
All medium and high dose monkeys showed increased phenylalanine levels in their blood. All medium and high dose monkeys exhibited brain seizures, starting about seven months into the experiment.
The study reported "All animals in the medium and high dosage groups exhibited seizure activity. Seizures were observed for the first time following 218 days of treatment... The seizures were of the grand mal type... One monkey, m38, of the high dose group, died after 300 days of treatment. The cause of death was not determined..."
Data for the deceased monkey were lost.
The study correlates brain seizures with high amounts of phenylalanine ingested by the monkeys. The study determined: "following the end of the experiment, medium and high dose monkeys were kept under observation for three months. No further convulsions were detected during this period." In other words, once the Aspartame was withdrawn from the monkeys' diets, the brain seizures ceased.
How could FDA claim a "pivotal" study, in which all of the medium and high dose monkeys suffer brain seizures, confirms Aspartame's safety for humans?
Robert Cohen, a private citizen from Oradell, New Jersey (who has a degree in pharmakinesology - brain chemistry), recently un earthed this "pivotal" study. Cohen's personal theory: the milk-based formula in which the monkeys were served their Aspartame in this study is a key link why the brain seizures were suffered. Cohen contends that ingesting dairy products elevates the pH of the stomach. He asserts that drinking a 12 oz. glass of milk buffers the pH of the human stomach from 2 to 6. At a pH of 6, Cohen contends, simple proteins such as Aspartame pass through undigested. Thus, they move to the blood stream intact. (Editor's note: Cohen claims the same phenomenon explains why IGF-1 (insulin-like Growth Factor -- - a potent mitogen, i.e., cancer causing agent) from rbGH-derived milk survives digestion and enters the human bloodstream).
Recently, a long term Aspartame critic rolled out a new data analysis, suggesting that Aspartame was a factor in increased incidents of human brain lesions. Monsanto spokesperson Dr. Robert Moser countered that claim, saying that Aspartame was not ingested and did not enter the blood stream.
The data revealed by this "pivotal" study submitted to FDA renders false Moser's assertion that Aspartame does not enter the bloodstream. Elevated levels of phenylalanine in the blood of monkeys fed medium and high levels of Aspartame prove that the compound is absorbed into the blood stream. The brain seizures followed.
What is the significance of this issue for dairy? NutraSweet is increasingly used in dairy products. At worst, presence of dairy products increases the odds that Aspartame can be channeled through the stomach into the bloodstream, by buffering the stomach's acidity.
Word is that CBS' television's hard-hitting news program, "60 Minutes" is preparing a segment on the Aspartame controversy, tentatively due for broadcast on December 29. (was shown) (Editor's Note: We were told recently that an adhesives applications firm in Texas is working on a project to include Aspartame on the back of U.S. Postal Service stamps, to make the stamps which consumers lick "taste better") SWEET NIGHTMARES!"
Page continues: ANTI-ASPARTAME CONSUMER GROUP OFFERS INFORMATION TO PUBLIC
"A consumer group, Mission Possible, has requested that FDA withdraw Aspartame from public use, in light of the obvious negative health effects depicted in the "pivotal" study described above. The blood data shows the chemical entered the Rhesus monkeys' blood streams. All monkeys receiving medium and high doses of Aspartame suffered severe brain seizures after about seven months' treatments.
Persons wishing to receive more information about Aspartame should write Mission Possible at the following address and include 5 32 cent postage stamps to cover return postage. The address is: Mission Possible, 5950 H State Bridge Road, Suite 215, Duluth, Georgia 30155