GENTECH archive 8.96-97

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FDA "PIVOTAL" SAFETY STUDY: 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)
http://www.ktnet.co.kr/edl/catalog/food/intro-miwon.html  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.  

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"

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 Reitz web page of 117 pages on aspartame he has the brochure put out
with the misinformation, answered by Mark Gold.  Mark Gold has the largest
web page on aspartame which is http://www.tiac.net/users/mgold.health.html
Dave Rietz site now links to 29 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.


*****************************************************************************
To get more information on aspartame, email betty@pd.org as follows:
Subject: sendme help   
The subject line must be typed exactly like the above line.
Betty Martini             1.  Take the 60-day No-Aspartame test
Mission Possible                 and send us your case history.
5950-H State Bridge Rd    2.  Tell your doctor and your friends.
Suite 215                 3.  Return Aspar-Poisoned foods to the store. 
Duluth GA  30155  USA     (Nutrasweet(tm), Equal(tm), Spoonful(tm), etc)

Visit http://www.dorway.com with links to more than 25 other Web Sites

We are dedicated to the proposition that we will not be satisfied until death 
and disability are no longer considered an acceptable cost of business.