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Dr.Roberts report was a milestone
publication, presented 15 years after the previous demonstration of high
incidence of brain tumors in rats given aspartame. Indeed, these experimental
studies were the reason that FDA scientists, consultants for the GAO, and
a Public Board of Inquiry had urged the FDA Commissioner NOT TO APPROVE
aspartame for human use. Unfortunately, a new FDA Commissioner ignored
these warnings. In subsequent letters and books by Dr.Roberts, including
a communication published in Lancet, Vol. 349, Feb 1, l997, Roberts reemphasized
the matter, and urged the FDA to declare aspartame products an imminent
public health threat for their potential carcinogenic, neurologic,psychiatric,
metabolic and fetotoxic potential based on a clinical database now exceeding
1300 aspartame reactors.
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 .." 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aspartame was withdrawn from the monkey's diets, the brain seizures ceased.
Monsanto spokesperson Dr. Robert Moser has said that aspartame does 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
blood stream. 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. How could FDA claim
a "pivotal " study in which all of the medium and high dose monkeys suffer
brain seizures, confirm Aspartame's safety for humans?
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.
The concluding testimony of Dr. Gross will never be forgotten. He 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?" (Emphasis added). Congressional
Record SID835:131 (August 1, l985)
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