Article: Santa Fe Pediatrician Ken Stoller Asks FDA to Rescind Aspartame's Approval

Over the years many independent studies have been done. It's of interest that the manufacturer of aspartame will always say there are 200 studies that show safety. If these studies were done before approval then these are the studies that the FDA complained about and tried to have Searle indicted over it. If these studies were done after approval they were fudged studies, such as the aspartame seizure studies by Monsanto, who bought Searle in l985.[11]

Why did they bother to do fraudulant studies? First of all, seizures are listed 5 times on the FDA report of 92 symptoms from male sexual dysfunction to Death.[12] If you look over these seizure studies above you'll see investigators were so worried somebody would have a seizure that in the Rowan study they actually gave 16 people anti-seizure medication. They used one capsule of aspartame for a one day study, sort of tantamount to smelling the bottle. Then they got it peer reviewed by exercising the power only a member of Big Pharma can do. So when consumers complain of seizures they say "we did studies and aspartame doesn't cause seizures".

Today there are full-time front groups like Calorie Control Council, which do most of the dirty work making sure manufacturers can keep pushing this poison.[13]

When 60 Minutes did a story about aspartame and brain tumors, again the manufacturer was saying they had all these studies showing safety. So Dr. Ralph Walton, who was on the show, decided to do some research, having to do with scientific peer reviewed research and funding.[14]

Note that just as expected 92% of independent scientific peer reviewed studies show that there are problems with aspartame, while only those funded or controlled by industry ever said it was safe. In fact, if you eliminate 6 studies the FDA had something to do with (after the FDA became loyal to Commissioner Hayes decision to approve aspartame), and one pro-aspartame summary, 100% of the independent scientific peer reviewed studies show aspartame's toxic and carcinogenic problems.

According to the Ecologist Magazine, aspartame was even listed with the pentagon in an inventory of prospective biochemical warfare weapons submitted to Congress.[15]

Soffritti, lead researcher on three long-term aspartame studies, was recently honored at New York's Mt Sinai School of Medicine with the Irving J Selikoff Award for his outstanding contributions to the identification of environmental and industrial carcinogens and his promotion of independent scientific research. Dr. Soffritti explains:

The first ERF study (2005) was conducted on 1800 Sprague-Dawley rats

(100-150/per sex/per group). In order to simulate daily human intake, aspartame was added to the standard rat diet in quantities of 5000, 2500, 100, 500, 20, 4, and 0 mg/Kg of body weight. Treatment of the animals began at 8 weeks of age and continued until spontaneous death. The results show that APM causes a statistically significant, dose-related increase of lymphomas/leukemias and malignant tumors of the renal pelvis in females and malignant tumors of peripheral nerves in males. These results demonstrate for the first time that APM is a carcinogenic agent, capable of inducing malignancies at various dose levels, including those lower than the current acceptable daily intake (ADI) for humans (50 mg/kg of body weight in the US, 40 mg/kg of body weight in the EU).

The second ERF study (2007) was conducted on 400 Sprague-Dawley rats (70-95/per sex/per group). In order to simulate daily human intake, aspartame was added to the standard rat diet in quantities of 100, 20, and 0 mg/Kg of body weight. Treatment of the animals began on the 12th day of fetal life until natural death. The results of the second study show an increased incidence of lymphomas/leukemias in female rats with respect to the first study. Moreover, the study shows that when lifespan exposure to APM begins during fetal life, the age at which lymphomas/leukemias develop in females is anticipated. For the first time, a statistically significant increase in mammary cancers in females was also observed in the second study. The results of this

transplacental carcinogenicity bioassay not only confirm, but also reinforce the first experimental demonstration of APMs multipotential carcinogenicity.

On August 1, l985 the FDA's own toxicologist, Dr. Adrian Gross, told

Congress16 at least one of Searle's studies "has established beyond ANY

REASONABLE DOUBT that aspartame is capable of inducing brain tumors in experimental animals and that this predisposition of it is of extremely high significance. ... 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?"

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?"[16]

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