FDA Hid Research That Damned Aspartame: Fatal Studies Should Have Blocked NutraSweet Approval

[Guest guest]

FDA HID RESEARCH THAT DAMNED ASPARTAME

Fatal studies should have blocked NutraSweet approval

 

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/>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>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>http://www.wnho.net/pseudotumor_cer\

ebri.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>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>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>http://www.soundandfury.tv/page\

s/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/>http://www.holisticmed.com/aspartam\

e/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>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

<http://www.mpwhi.com/>www.mpwhi.com,

www.dorway.com and <http://www.wnho.net/>www.wnho.net

Aspartame Toxicity Center,

<http://www.holisticmed.com/aspartame>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