- When the G.D. Searle Co. sought FDA approval for NutraSweet
they submitted doctored, fraudulent "studies," so corrupt that
the Department of Justice appointed two prosecutors to Investigate Searle.
Searle's lawyers hired the prosecutors and the case died with
the statute of limitations.
-
- Listen in on aspartame hearings in 1976 between Senator
Ted Kennedy and FDA Commissioner Alexander Schmidt at the Senate Subcommittee
on Labor and Public Health:
-
- Commissioner Schmidt: "Today I would like to report
to you the final results of the Food and
- Drug Administration's detailed investigation of animal
studies performed by Searle."
-
- Senator Kennedy: "Is this the first time,
to your knowledge, that such a problem has been uncovered of this magnitude
by the Food and Drug Administration?"
-
- Dr. Schmidt: "It is certainly the first time that
such an extensive and detailed examination of this kind has taken place.
We have never before conducted such an examination as we did at Searle.
From time to time, we have been aware of isolated problems, but we
were not aware of the extent of the problem in one pharmaceutical house."
-
- Senator Kennedy: "The extensive nature of the almost
unbelievable range of abuses discovered by the FDA on several major
Searle products is profoundly disturbing."
-
- Yet, a year later, look what happened!
-
- The 1977 Bressler Report, even without the concealed
studies, clearly revealed fraud. Searle deleted what they didn't want FDA
to see, even excised the brain tumors from rats, and put them back in the
study. After death they resurrected them on paper.
-
-
- Chief FDA Scientist, Dr. Thomas Xavier Collins, investigated
two mice teratology (birth defects) studies. The incompetent Searle
employee who reviewed studies had but a single year of experience: worked
on rabbit populations for the Illinois Wildlife Service! The studies
were a travesty, like all Searle's studies submitted to FDA.
-
-
- When the Bressler Report was retyped, FDA omitted the
investigation of these two studies, not wanting the public to see how bad
they were. We have now restored these studies to the Bressler Report,
thanks to Dr. John Olney and Dr. Madelon Price. We also thank Jerome
Bressler for his constant persistence in motivating us to locate these
studies. He emphasized the report was not complete without them.
Dr. Thomas Xavier Collins was the Chief Scientist and FDA struck
his name from the record. Thanks also to Lane Shore, Mission Possible
Chicago who has worked tirelessly in this effort for years.
-
- H. J. Roberts, M.D., who testified before Congress and
wrote the 1000 page medical text, Aspartame Disease: An Ignored Epidemic,
- http://www.sunsentpress.com/, unsuccessfully tried to
get a copy of the deficient and misleading "studies" through
his congressman 8 years ago. Dr. Roberts explains: "These
studies are part of the reason the FDA tried to indict the manufacturer
for fraud.
-
- The results were kept under FDA seal for 3 decades. Indeed
the Bressler Report and other studies should have precluded FDA from approving
aspartame for human consumption. For instance, its unconscionable
that brain tumors were actually removed from the rats.
- I have detailed the striking rise of brain tumors that
began after aspartame approval...
- http://www.dorway.com/betty/brainc.txt
-
- "The consequences are now evidence in the explosive
rise of brain tumors nationally. The cluster of brain tumors in my
own community serves as an example. The analysis of drinking water
fails to demonstrate other chemical contaminants. My recent book, 'A
Manifesto for American Medicine' details these and other related problems
and the still ignored epidemic of aspartame disease is an unconscionable
result of which both the population and its children will have to pay.
-
- "Some of the details of these two studies left out
of the Bressler Report were scientifically objectionable and again
should have precluded the FDA approving it for human use. As
an example, one fetus showed hydrocephalus. Increased intracranial
venous pressure can lead to either pseudotumor cerebri or hydrocephalus.
I have already written a report on my clinical insights concerning
a remediable cause of pseudotumor cerebri (benign intracranial hypertension)
due to aspartame several years ago and now there are 20 cases in my
data base"
- http://www.wnho.net/pseudotumor_cerebri.htm
-
- Dr. Roberts calls attention to the issue of gender. In
his text he says the agencies responsible for approving aspartame apparently
overlooked an important gender-related detail in experimental studies.
-
- [Both concealed studies are mouse studies. One
of the investigators with initials that appear to be CLT struck through
the word "rats" on page 2 and marked it "mouse". Jerome
Bressler said they were mouse studies.]
-
- The hidden studies are returned to the Bressler Report
at the
- bottom of the report. http://www.mpwhi.com/complete_bressler_report.pdf
-
-
- Now it gets worse. Here is a 1/10/94 letter
from FDA to Barbara Alexander Mullarkey that lists "Pivotal
Studies" for aspartame approval.
-
- "Dear Mrs. Mullarkey: This is in response
to your July 26 request, for an answer from the Commissioner on the question:
-
- "Of the 112 studies, in the Index of Master File
No. 134 for Aspartame, A Nutritive Sweetener with Flavor Enhancing Properties,
which are considered pivotal for approval?"
-
- The following studies were considered pivotal.
-
- Entry No. FAMF 134 Title
- E-5 An
Evaluation of Embryotoxic and Teratogenic Potential
- in
the Rat (SC-18862)
-
- E-11 Two
Generation Reproduction Study in Rats (SC-18862)
-
- E-28 106
Week Oral Toxicity Dog Study (SC-18862)
-
- E-32 52-WEEK
ORAL TOXICITY IN THE INFANT MONKEY (SC-18862)
-
- E-33 Appendix:
Two Year Toxicity Study in the Rat (SC-18862)
-
- E-34 Two
Year Toxicity Study in the Rat (SC-18862)
-
- E-70 Lifetime
Toxicity Study in the Rat (SC-18862)
-
- E-75 104-Week
Toxicity in the Mouse (SC-18862)
-
- E-76 110-Week
Toxicity Study in the Mouse (SC-19192)
-
- E-77 & 78 115-Week Oral Tumorigenicity
Study in the Rat (SC-19192)
-
- E-86 A
Supplemental Study of Dog Brains from a 106-Week Oral
- Toxicity
Study (SC-18862)
-
- E-87 A
Supplemental Study of Rat Brains from Two
- Tumorigenicity
Studies (SC-18862)
-
- E-89 An
Evaluation of Embryotoxic and Teratogenic Potential
- in
the Mouse (SC-18862)
-
- E-90 An
Evaluation of Embryotoxic and Teratogenic Potential
- in
the Rabbit (SC-18862)
-
- "We also note there were other studies of interest
in considering the
- safety review for aspartame approval.
-
- Sincerely yours,
- Rudolph Harris, Ph.D., Branch Chief
- Novel Ingredients Branch, HFS-207
- Center for Food Safety and Applied Nutrition"
-
- So thus, we arrive at the plain admission by the FDA
that they used E-5 and E89, the concealed faulty studies, to approve aspartame;
Jerome Bressler said these were the worst ones. " Pivotal"
means studies from which data will be used to make significant claims;
of vital or crucial importance.
-
- It doesn't stop there. Notice E-32 is a 52-week
oral toxicity infant monkey study. In this study 5 of 7 infant monkeys
had grand mal seizures and 1 died. http://www.dorway.com/raoreport.txt
-
- E-32 is FDA ADMISSION that aspartame triggers seizures.
Yet they used it to approve the poison. FDA's report
of 92 aspartame symptoms from coma to death lists 4 types of seizures.
In 1986 Atty Jim Turner and the Community Nutrition Institute filed
a Citizens Petition to ban aspartame because of seizures and blinding.
FDA refused, even though they knew it for years.
-
- Turner, who tried to stop approval said today: "Any
rational interpretation of pivotal studies would have caused any reasonable
individual to deny approval of aspartame. Every scientist that looked
at the pivotal studies said they don't support safety of NutraSweet and
did not support its approval."
-
- Aspartame was approved through the political chicanery
of Don Rumsfeld who was CEO of G. D. Searle and a member of President Reagan's
transition team (one of the ugliest, darkest chapters in the checkered
history of the FDA). Reagan appointed Arthur Hayes as FDA Commissioner
and fired FDA Commissioner Jere Goyan who was going to sign the petition
revoking aspartame into law. Reagan wrote an Executive Order making
FDA powerless to sign that petition until Hayes arrived to kill it. Obviously
Hayes didn't care what the pivotal studies showed. In the movie,
"Sweet Misery: A Poisoned World", Atty Turner explains
what happened.
-
- http://www.soundandfury.tv/pages/rumsfeld2.html
-
- This criminal malfeasance by FDA precipitated what Dr.
James Bowen said twenty years ago is "mass poisoning of the
US and over 70 countries of the world".
-
- Food Standards in New Zealand in 2007 admitted they never
did studies on aspartame and relied on FDA. In England a business
proposition was used to approve it. Parliament had a blowout
and the story was published in the Guardian. No studies were done
in the UK. By now 100 nations have rubberstamped G. D. Searle' fraudulent
and corrupt data with FDA's blessing so Don Rumsfeld's aspartame disease
has become a plague upon all mankind. .
-
- Dr. Ralph Walton today said: "Aspartame should never
have been approved and furthermore, the FDA scientists at the time did
not want it approved but they were over-ruled by the FDA Commissioner,
Arthur Hull Hayes. It was a unilateral decision, a political decision
and not one based on medical and scientific data."
-
- Our lives and health are sacrificed to an addictive,
excitoneurotoxic, genetically engineered, carcinogenic drug that damages
the mitochondria and even interacts with drugs and vaccines. It is
used in the US by half of the population, creating an incredible
epidemic of diseases described in Aspartame Disease: An Ignored Epidemic
by H. J. Roberts, M.D. and Excitotoxins: The Taste That Kills by neurosurgeon
Russell Blaylock, M.D, for starters.
-
- Dr. Roberts is a diabetic specialist and says aspartame
can not only precipitate diabetes but also simulates and aggravates
diabetic retinopathy and neuropathy, destroys the optic nerve, causes diabetics
to go into convulsions and even interacts with insulin. So we have
epidemics of diabetes, obesity, MS, lupus, autism, ALS and other horrors
because of the malfeasance of Arthur Hull Hayes and the political
chicanery of Don Rumsfeld. Lives have been destroyed across the planet
while FDA continues to lie on its safety with full knowledge of toxicity.
-
- Dr. Ken Stoller, pediatrician, who has the New Mexico
Aspartame Detox Center also looked over the investigation of the concealed
studies. He said, "These are scientifically offensive "studies".
The manufacturer did everything it could to whitewash aspartame as
was done in other studies investigated in the Bressler Report where it
was found Searle excised brain tumors from rats, added them back
to the study and resurrected them on paper when they died. Who persuaded
FDA to delete Dr. Collins investigation of these teratology studies that
should have been on public record? They even removed his name from
the report. Aspartame is a teratogen, triggers birth defects and
mental retardation, yet there is no warning to pregnant women. With
the CDC now saying autism is 1% of the children and still a supposed "mystery"
allowing known neurotoxins into the food chain is insanity."
-
- One thing about the aspartame industry they know how
to use influence and power and money, and they know how to do flawed
studies. Monsanto bought Searle in 1985 and later sold NutraSweet.
Here's how they abused science:
-
- http://www.holisticmed.com/aspartame/abuse/
-
-
- The aspartame industry says 200 studies proved aspartame
safety. These objectionable, inferior and worthless studies
prove nothing but fraud and cover-up, and the FDA's own toxicologist,
Dr. Jacqueline Verrett said they were built on a foundation of sand.
Dr. Verrett testified to the U.S. Senate in 1987 and stated that flawed
tests conducted by Searle used as the basis of FDA approval were a disaster
and should have been thrown out. She said she believed the studies
left many unanswered questions about possible birth defects and the
safety of aspartame.
-
- FDA also knew aspartame caused cancer. An adenocarcinoma
found in 1972 animal study, pp 6, 67, 70 of Bressler Report. FDA
toxicologist and scientist, Dr. Adrian Gross, admitted to the Senate, aspartame
caused cancer on 8/1/85 and said:
-
-
- "In view of these indications that the cancer causing
potential of aspartame is a matter that had been established way beyond
any reasonable doubt, one can ask: What is the reason for the apparent
refusal by the FDA to invoke for this food additive the so-called Delaney
Amendment to the Food, Drug and Cosmetic Act?" He was talking
about brain cancer.
-
- The Delaney Amendment makes it illegal to allow any residues
of cancer causing chemicals in foods. In his concluding testimony
Gross asked, "Given the cancer causing potential of aspartame how
would the FDA justify its position that it views a certain amount of aspartame
as constituting an allowable daily intake or safe level of it? Is
that position in effect not equivalent to setting a tolerance for
this food additive and thus a violation of that law? And if the FDA
itself elects to violate the law, who is left to protect the health of
the public?" So here is the admission by FDA's own toxicologist
that aspartame is on the market because FDA violated the law.
-
- In 2005 and 2007 the impeccable Ramazzini Studies in
Italy peer reviewed by 7 world experts proved aspartame to be a multipotential
carcinogen. No surprise to the FDA since they knew about the cancer all
along. As usual they just lied and denied it when the Ramazzini Studies
were published. The medical text, Aspartame Disease: An Ignored Epidemic
has a 1000 pages of why aspartame should not have been approved from adulteration
and seizures to birth defects, neurodegenerative diseases, drug interaction
and psychiatric disease.
-
- Criminal Malfeasance by Arthur Hull Hayes and political
chicanery of Don Rumsfeld is simply genocide, for which there is no statute
of limitations. http://www.rense.com/general/asp.htm
-
-
- It can't be said any better than Dr. James Bowen told
the FDA over two decades ago: "The only responsible action would
be to immediately take aspartame off the market, fully disclose its toxicities,
offer full compensation to the injured, public and criminally prosecute
anyone who participated in the fraudulent placement of aspartame on the
marketplace. That includes those who work so diligently to keep it on the
market as well."
-
- Dr. Betty Martini, D.Hum, Founder
- Mission Possible International
- 9270 River Club Parkway
- Duluth, Georgia 30097
- 770 242-2599
- www.mpwhi.com, www.dorway.com and www.wnho.net
- Aspartame Toxicity Center, www.holisticmed.com/aspartame
-
- Board of Inquiry Report revoking the petition for approval
of aspartame:
- <http://www.mpwhi.com/fda_petition1.doc>http://www.mpwhi.com/fda_petition1.doc
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