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 (fwd) (and regarding epilepsy FAQ)

Betty Martini betty at noel.pd.org
Thu Jun 19 14:47:58 EST 1997


Dear Andrew:  I was so glad to see that you mentioned NutraSweet in your
FAQ in this newsgroup.  I hope it will help get a lot of people off this
neurotoxin. I would like to bring you uptodate a bit and mention one thing
you mentioned.  Also, you can understand why NutraSweet (aspartame)
triggers seizures since this happened on the original studies.  This story
is about a study that was actually pivotal and approved aspartame!!!!

Secondly, when I was on a radio program in Miami a lady called in who said
she worked for SEarle in l984 as a translator and that they replicated the
original studies in humans in South America and that she and a Dr. Ortega,
a physician, translated them.  I'll also add a press release that mentions
her.  She said that the studies were only 12 to 18 months long, in three
countries, and that the subjects (taken from poor villages) were dropping
out with astrocytomas and seizures.  I have her notarized statement.  She
was upset that aspartame was not removed from the market at the time
because the findings proved aspartame to be a deadly poison.  She said Dr.
Ortega who worked for SEarle was also upset and that Searle fired him.
Two died and she said there were some comments about the damage it does to
the brain, destroys the central nervous system and hardens the synovial
fluids.  One pregnant woman lost her baby.  Lots of neurological problems
and tremors.  

Thirdly, the reason aspartame triggers seizures is that the large amount
of phenylalanine lowers the seizure threshold of the brain.  And,
incidently, it is genetically engineered!  Dr. Roberts says on his tapes
on aspartame (1 800 -814 -9800) that you can't isolate phenylalanine from
the other amino acids in protein or it becomes neurotoxic.  In food with
other amino acids it may be like 4% and not 50% which floods the brain.

Fourth,  there have been papers on it, one is titled EFFECTS OF ASPARTAME
ON THE BRAIN, Richard J. Wurtman, M.D. and Timothy J. Maher, Department of
Brain and Cognitive Sciences, Massachusetts Institute of Technology,
Cambrige, Ma. 02139, Department of Pharmacology, Massachusetts College of
Pharmacy, 179 Longwood Avenu,e Boston, MA 02115, Running Head:  Neurologic
Effects of Aspartame, Presented at Symposium "Sweeteners:  Health Effects:
Naylor-Dana Foundation, New York, Feb 18-20, l987 (all this on front page)

On page 12 it says:  "In a similar manner, it is possible that doses of
the sweetener that cause a sufficient increase in brain phenylalanine
might increase seizure frequency among susceptible humans or might allow
seizures to occur in people who are vulnerable but had not experienced
prior episodes."  And he has several papers and goes into seizures.

Fifth, I assure you there is a big coverup on the seizure issue.  I have
an United Press International investigation by Greg Gordon from l987 and
here are some quoted remarks:  "Wurtman, who quit his job as a Searle
consultant and became a vocal NutraSweet opponent, said he has been
contacted by more than 200 persons who suspect they suffered seizures as a
result of NutraSweet use.  He said Dr. Gerald Gaull, a SEarle Vice
President, visted his laboratory in l985 and threatened to veto funding by
ILSI, the Washington based tax-exempt foundation, for his planned study
into whether NutraSweet changes brain chemistry, lowering some humans'
seizure thresholds.  Gaull said "there's no way" Searle, with one of 12
votes on the ILSI panel, could veto a grant decision, but he did not deny
making the threat.  ILSI ultimately turned away Wurtman on gorunds that
Searle already had arranged for seizure studies at Yale University and New
York's Mount Sinai Hospital, studies that have drawn criticism because
huiman volunteers were given aspartame only once or twice.  Wurtman said
he now is tapping his laboratory's budget, which is extremely limited,
slowing progress on his own studies.  'Aspartame may be a serious health
hazard,' he said.  It's critically important that high quality research
now be done to assess this hazard."  In his letter to the AMA Journal,
Pardridge said no one has fully researched the degree to which aspartame
raises phenylalanine levels in the brain and, if so, what the possible
effects are.  He said in an interview that after he raised questions about
the sweetener's effects on children, ILSI rejected his two grant proposals
in 1995."

At this point, I will stop quoting the article.  Today I do not know which
side Dr. Wurtman is on and some alledge links to the glutamate
association. Research funds play a big part unfortunately.  As an example,
NutraSweet funded a study on birth defects for Dr. Diana Dow-Edwards and
when the results were disastrous  NutraSweet withdrew their funding.  Then
neither they nor the FDA would accept the study that Dr. Dow-Edwards had
to pay for!  When Dr. Ralph Walton decided to do a study NutraSweet
refused to even sell him the aspartame.  He had to purchase analytically
certified USP grade aspartame from a distributor.  When the study was done
the frequency and severity of psychiatric, neurologic, eye and other side
effects caused the Institutional Review Board to terminate the project
prematurely.  Dr. H. J. Roberts is discussing this in an unpublished
letter to Neurology concerning epileptic seizures provoked by aspartame
products, which was published in the Townsend Letter for Doctors.  He
says: "With this revelation, corporate neutral examiners should analyze
the nature of the aspartame furnished by previous double-blind studies."

And you know the original studies were the target of an indictment for
fraud that was not carried out when two U.S. Prosecutors went to work for
Searle's law firm defending the case.  Quite a reward!  Such things as the
Bressler Report when rats reported as "dead" reappeared alive later!  

Keep in mind that Monsanto bought Searle in l985.   Senator
Metzenbaum plagued by complaints from the population wrote a bill to put a
moratorium on aspartame and a warning for pregnant women and infants, he
requested independent studies be done by NIH, and listed some of the
problems that studies should be done on, that were happening. These were
listed:

1.  The effect of the consumption of aspartame on brain chemistry;
2.  The health effects of the consumption of aspartame on pregnant women
and fetuses;
3.  Behavioral and neurological effects experienced by individuals who
have consumed aspartame, especially children who have consumed aspartame;
4.  The interaction of aspartame with drugs including monoamine oxidase
inhibitors, alpha-methyl-dopa and L-dihydroxphenylalanine; and
5.  the effect of the consumption of aspartame in increasing the
probability of SEIZURES.  

The bill never got out of committee because of heavy Monsanto lobbying.
They couldn't allow this bill to go through because they would retest
aspartame INDEPENDENTLY.  And so they sacrificed the babies, and reports
continue to flow in on birth defects, babies being born dead, with no
eyes, with no brains, neurological defects, etc.  Fetal tissue does not
tolerate wood alcohol and the phenylalanine concentrates in the placenta
and causes mental retardation if the baby lives at all.

They couldn't allow retesting of aspartame because they ALREADY KNEW what
would be found, because the studies had already been done on humans!!!!!

Now about the CDC investigation you mention:  In Nov 1984 the Center for
Disease Control reviewed 213 of 592 cases of aspartame complaints.  Ages
of the complainants ranged from four months to 77 years; 77% were between
the ages of 21 and 60 years, 75% were female and 94% were white.
Twenty-eight percent reported repeated episodes of symptoms and 26 people
experienced identical symptoms.  Some of the reported symptoms included:
aggressive behavior, disorientation, hyperactivity, extreme numbness,
excitability, memory loss, loss of depth perception, liver impairment,
cardiac arrest, SEIZURES, suicidal tendencies, severe mood swings, and
DEATH.  The CDC recommended further investigations of aspartame on the
neurological and behavioral problems and focus on symptoms such as
headaches, mood alterations and behavior changes.  Frederick L. Trowbridge
added an executive summary to the report which CONFLICTED with the
information in the report.  He stated: "Currently available information,
based on data with limitations as described in the report, indicated a
wide variety of complaints that are generally of a mild nature."......
Personally I do not consider seizures, liver impairment, cardiac arrest,
seizures and suicidal tendencies of a mild nature.

Why would the CDC do such a dispicable thing as to misinform the public?
CDC is part of the Department of Health and Human Services, the FDA.  They
are extremely loyal to Searle/Monsanto.  In fact, on the bovine growth
hormone issue the GAO did an investigation titled THE INCESTUOUS
RELATIONSHIP OF MONSANTO AND THE FDA.  And how did they get out of that?
Marian Burris of the New York Times had the goods on them.  She was
visited by Monsanto attorneys.  The next thing that happened is that she
wrote a lukewarm story that must have pleased Monsanto.  Then her son gets
a big job at the GAO over this investigation and it was sqelched.  

If you call the CDC and ask for this investigation all they will send you
is the summary.  You must file Freedom of Information to get it, and they
sure tried to keep it from me until I told them I had already read the
report and I had the right to it under the law.  Reluctantly, they sent it
and it is one of the most damning reports you will ever read on aspartame.
I encourage you to get it and read it for yourself.  

Aspartame is  a SEIZURE TRIGGERING DRUG.  It is not an additive and in the
l960's they made an application for it to be used as a drug to treat
peptic ulcers.  They withdrew it when they realized it was sweet.
According to Alex Constantine in NutraPoison it was listed with the
pentagon in an inventory of prospective biochemical warfare weapons
submitted to Congress.  They also knew it was a poison.  And it has been
rumored that one of the 3 scientists who developed aspartame worked off
the job because he told them aspartame was a deadly poison and they said
they were going to market it anyway.  We have been looking for that
scientist.  Interestingly, one lady who gave an affidavit said she ran
into the scientist many years ago who keep muttering:  "Warn everyone you
know that NutraSweet is a poison.  I told them it was a killer and it will
kill over and over again."  Don't we know it as the deaths are reported.

Death is also listed on the FDA report of 92 documented symptoms and it
includes FOUR DIFFERENT TYPES OF SEIZURES, while they continue to tell
people it doesn't cause seizures and that they are not taking complaints.

Only today I received a letter from a doctor admitting that when William
Reed who was having 6 or 8 seizures a day got off NutraSweet they stopped
in two days and have never returned.  That was 2 years ago, about a week
before the doctor told the family to make funeral arrangements.  We told
someone in the family to get him off because aspartame was causing all his
medical problems and seizures.  She said as she left our home:  "If we
hadn't stopped in Atlanta William would now be dead."  

At the Conference of the American College of Physicians in Atlanta in l985
which I attended with Dr. H. J. Roberts, the first thing said in Neurology
workshops was: "Somebody tell us where all the seizures are coming from?"

WE continue to get people off aspartame and seizures continue to stop -
the ones that are warned in time.  Mission Possible operations are now
opening up all over the world warning all consumers off this deadly,
deadly, seizure triggering drug.

Regards,
Betty Martini, Founder
Mission Possible Worldwide

Please checkout the Dorway web page below my signature and Mark Gold's web
page, and he lists a few lines from the thousands of case histories that
come in through the Internet system.  Notice all the seizures and
neurological problems, etc.  Studies are now being replicated on the
people in 100 countries of the world, as the FDA gave blanket approval in
June l996.  Welcome to the International Association of Guinea Pigs and
Lab Rats!!  WE have demanded the recall from the worldwide market based on
the pivotal study you see below.  NutraSweet says aspartame doesn't cause
seizures.  I would like them to explain then what these monkeys
experienced!   
*****************************************************************************
For more information on aspartame email:  betty at pd.org
    TYPE:    sendme help        on the Subject Line
                          1. Take the 60-day No Aspartame Test and
  Mission Possible                send us your case history.
5950-H State Bridge Rd.   2. Tell your doctor and all of your friends!
     Suite 215            3. Return Asparcidal food to the store. Anything
 Duluth, GA 30155  USA       with Monsanto's NutraSweet/Equal/Spoonful
                                  or Benevia or NatraTaste
VISIT  http://www.dorway.com/possible.html  Get links to 29 other sites.
       http://www.tiac.net/users/mgold/aspartame/  FAQs/Toxicity Reports
  
    Disability and Death are not acceptable costs of business!

---------- Forwarded message ----------
Date: Tue, 25 Mar 1997 09:13:43 -0500 (EST)
From: Betty Martini <betty at noel.pd.org>
To: Betty Martini <betty at noel.pd.org>
Subject: 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 (fwd)


Subject: 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 at 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.






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