FDA "PIVOTAL" SAFETY STUDY (SC-18862):
ASPARTAME CAUSED BRAIN SEIZURES, published in THE MILKWEED,
Nov. l996
PERMISSION TO REPRINT GIVEN BY EDITOR
PETE HARDIN, THE MILKWEED, P. O. BOX 10, BROOKLYN,
WISCONSIN , 53521
This information is of particular interest to those
concerned with the bovine growth hormone. The only
point it doesn't go into is that the phenylalanine in
aspartame is genetically engineered. You can get this
from the web page on aspartame (MIWON- website no loger
exists). Look for the manufacturing process and note
how its done, and notice the E. coli under
fermentation. The phenylalanine is genetically
engineered in E. coli bacteria.
Here is the article and Pete Hardin, owner of the
Milkweed asks that it be reprinted as a warning to the
world.
FDA PIVOTAL SAFETY STUDY: ASPARTAME CAUSED BRAIN
SEIZURES 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.
WEBMASTERS NOTE: Please read Dr. Moser's statement to Jennifer
Cohen regarding this pivotal "RAO" report on seizures!
(NOTE: The RAO report is now on DORway as a text file
without grapichs, or complete as an Adobe PDF file).
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: Mrs. Betty
Martini, Mission Possible International, 9270 River
Club Parkway, Duluth, Georgia 30097 Email:
bettym19@mindspring.com"
END OF MILKWEED ARTICLE
Betty Martini, Founder Mission Possible Worldwide
We ask that this be distributed as a press release,
reprinted and put on web to counteract misinformation
put out by the NutraSweet Company. On Dave Rietz
DORway WEB site there are over 200 pages on aspartame
with the IFIC brochure
debunked by a well-referenced commentary by Mark Gold.
Mark Gold has a large web page with many well-
referenced articles on aspartame at: http://www
.holisticmed.com/aspartame
The DORway WEB site links to
many other web sites on the dangers of aspartame,
including Dr. H. J. Roberts web page on
publications, or you can call 1-800-814-9800. Doctors
writing request a "doctor's packet" with $3.00 priority
postage and studies, FDA report, etc. will be sent free
of charge. It will include Dr. Roberts position papers
which can be distributed to patients on aspartame
effects on the central nervous system (mimicking MS),
the eyes, diabetes, the heart, etc. Please also put
this information in other newsgroups.
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