FDA Hid Research That  Should Have Blocked NutraSweet Approval

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, 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_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.

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 into law the petition revoking aspartame. 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.

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: 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 Stuth defects, neurodegenerative diseases, drug interaction and psychiatric disease.dies 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.

Criminal malfeasance by Arthur Hull Hayes and political chicanery of Don Rumsfeld is simply genocide, for which there is no statute of limitations. 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