(Posted 06/01/97 ... no answer to date!)
Hey... FDA!
Answer these questions on aspartame...
TRUTHFULLY!
1. Why did you give blanket approval to the neurotoxin and teratogen
aspartame in June, l996 that has been controversial since approval
because of 92 documented symptoms from seizures and blindness to coma
and death by your own report, and without public notification?
2. Why is there a warning on saccharin that it causes cancer when there
is no warning on aspartame. According to Joseph Rodicks in CALCULATED
RICKS, page 161: "Saccharin is the least potent carcinogen ever
detected in an animal study, the dose required to produce a given
lifetime incidence of tumors is greater than that of any other known
animal carcinogen."
From Sweet'ner Dearest by H. J. Roberts, M.D., page 212: (Regarding
the Wisconsin Alumni Research Foundation and Saccharin) "Urinary
bladder tumors were found in a few male rats given large amounts of
saccharin. There are two flaws. First, the validity of this rat
model has been challenged by experts. Second, other researchers
haven't been able to reproduce these findings. So you ask, "what's
the big deal?" It became a real big deal when bureaucrats pounded
on this mouse-to-man controversy by invoking the Delaney Amendment
relative to use of saccharin. The FDA mandated that products con-
taining it were to be labeled as potentially causing cancer in man.
The producers of other sweeteners clearly were not displeased."
In the case of aspartame in the Bressler Study it produced mammary
tumors, uterine tumors and ovarian tumors. It also produced brain
tumors in rats. In l985 the late Dr. Adrian Gross, honest FDA
toxicologist, told Congress that aspartame violated the Delaney
Amendment which forbids cancer causing additives being added to
food. He said:
"In view of all these indications that the cancer causing
potential of aspartame is a matter that has 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
for this food additive the Delaney Amendment to the Food, Drug
and Cosmetic Act? Is it not clear beyond any shadow of a doubt
that aspartame had caused brain tumors or brain cancer in animals,
and is this not sufficient to satisfy the provisions of that
particular section of the law?" 1985b pg 1835-40
Further, secret trade information which was not so secret was
discussed during Congressional Hearings where it was admitted
complete conversion to DKP. This is diketopiperazine, a brain
tumor agent.
3. Why do you consider yourself above the law and violate it?
Honest FDA Toxicologist, Dr. Gross continued in Congress:
"...how would the FDA justify its position that it views a certain
amount of aspartame (50 mg/kg body-weight) as constituting an ADI
(Allowable Daily Intake) or "safe" level of 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?"
4. You know the ADI was set for rats not humans. Why is this allowed?
From Sweet'ner Dearest by H. J. Roberts, M.D., chapter 34: MOUSE OR
MAN? MAYBE THE RATS WERE RIGHT?, page 211
"Fairy tales....can be dismissed as myths. On the other hand, our
licensing and regualtory agencies must not be "myth-led". Which
brings me to the FDA's arbitrary increase of aspartame's ADI to 50
milligrams (mg)/kilograms (kg) body weight. (One kilogram is 2.2
pounds.) This questionable decision qualifies as an action that
succeeds in a'canceling reality."
.The ADI represents the projection of animal studies based
on their lifetime intake. This was the testimony of Dr.
Frank Young, former FDA Commissioner, before a committee of
the U.S. Senate at a hearing on Nov 3, l987 titled, "NutraSweet"
Health and Safety Concerns."
.Market research indicates that diabetics use about 11.4 mg.
aspartame/kg daily (The Palm Beach Post) March 8, 1990, p. D-13)
.The vast majority of my patients with severe reactions attributed
to use of aspartame products got into trouble when their daily
aspartame intake ranged from 10 to 18.3 mg/kg. Once this
threshold was exceeded, they predictably suffered itching, rashes,
severe headache, mental confusion, depression, visual problems,
et cetera. (Hundreds of others experienced adverse effects
after consuming amounts far below these levels.)
5. Since there is an ADI showing there can be abuse, even though it was
set for rats, how do you dismiss consideration altogether and give
blanket approval of aspartame like it was sugar? Estimates today
are that at least 9000 products contain this deadly poison.
6. Why did you allow the drug aspartame to be marketed as an additive
when you knew it was a drug and had biologic effects? And you can't
say thats not the case since Searle actually filed a drug application
for aspartame in the 60's to treat peptic ulcers. You also know that
as an additive there would be no safety monitoring. In other words,
when deadly reactions and symptoms were reported, you could simply
dismiss them as anecdotal. And Isn't that what you have done - listed
92 documented symptoms from four different types of seizures,
coma, and blindness and dismissed them as simple anecdotes knowing
they are reactions to a deadly drug that has no safety monitoring.
7. Why have you permitted a drug that interacts with other drugs,
including monoamine oxidase inhibitors, alpha-methyl-dopa and L-
dihydroxphenylalanine to go unmonitored, when it is obvious that
in the case Parkinson's Disease, the patient could easily lose
his life.
From ASPARTAME (NUTRASWEET) IS IT SAFE? by H. J. Roberts: "Aspartame
or its components nd breakdown products (metabolites) may cause
changes in the brain comparable to those that appear to initiate or
aggravate Parkinsonism. This is especially applicable to dopamine,
a neurotransmitter whose concentration is reduced in Parkinsonism.
Shabin and Albert (l988) indicated that patients with Parkinsonism"..
appear to be more prone to aspartame's neurological adverse effects."
"A few of the changes in dopamine and serotonin concentrations within
the brain induced by aspartame, phenylalanine and aspartic acid are
listed.
* Phenylalanine is converted to tyrosine by the enzyme phenylalanine
hydroxylase. Tyronsine undergoes a change to
dihydroxyphenylalanine (levodopa, L-DOPA), which then is
transformed to dopamine.
* The chronic administration of excess phenylalanine and aspartic
acid tends to decrease serotonin and other neurotransmitter
within several regions of the brain, and may alter dopamine
receptors in certain brain cells.
* Crippling fluctuations in the motor performance of patients with
Parkinsonism who are treated with levodopa have been improved by
eliminating protein from their breakfast and lunch. Pincus et al
(l986,l987) demonstrated a close correlation between elevated
levels of the large neutral amino acids and aggravated symptoms of
Parkinsonism, notwithstanding high plasma levodopa concentrations.
These motor fluctuations improved when the amino acid levels
declined. Such antagonism of levodopa's action by protein and
amino acids probably reflects interference with its transport
across the blood-brain barrier."
From EXCITOTOXINS: THE TASTE THAT KILLS by neurosurgeon, Russell
L. Blaylock, M.D., page 106: ..persons with Parkinson's disease
should avoid all foods and drinks containing excitotoxin additives
such as MSG, hydrolyzed vegetable protein, cysteine, and aspartate
(NutraSweet)." and page 39 "Both glutamate and aspartame can cause
neurons to become extremely excited and, if given in large enough
doses, they can cause these cells to degenerate and die."
8. How do you justify adding "DEATH" as a SYMPTOM of aspartame in your
report of documented symptoms? Or do you just consider it the
"ultimate symptom"? And when a product that causes DEATH is given
blanket approval how do you justify no safety monitoring?
9. How many complaints about aspartame/NutraSweet/Equal, etc. does it
take for you to take action? In the early 80's there were 10,000
complaints and even then you were telling people you were not taking
complaints. It was even discussed in Congress that the FDA was sending
them to the Aids Hotline? In the past year countless people say you
would not take complaints and in the l996 report you say you had to
destroy hundreds because you changed your bookkeeping system.
Several organizations have existed since aspartame was approved
warning the public and each of these have had hotlines with over
10,000 complaints. Mission Possible with operations around the world
get case histories daily of those seriously ill and some even dying
on this poison. Is it a policy that you won't list over 10,000 by
not taking complaints or sending them somewhere else, or do you just
constantly change your bookkeeping system! It is now estimated that
5 out of 7 people on aspartame already have symptoms or some disease!
10. Since the FDA does not mandate the reporting of aspartame side effects
by health professionals, how many does the 10,386 (9,737-April 20,
1995 + 649 - early l980s) complaints represent?
11. How can the FDA justify the remarks of their spokesperson on the 700
Club TV show (February l994) who said: "further aspartame complaints
by consumers would not make a difference in their deliberations." Do
these remarks indicate a bias?
After two 700 club TV shows in January and February 1995, over
100,000 people sent for a fact sheet on aspartame and MSG!
12. Why does the FDA dismiss the rat' uterine polyps, mammary and ovarian
tumors, marked atrophy of the testis, prostate, seminal vesicles, etc.
in the FDA's 1977 Bressler Report, an investigation of lab practices
of aspartame's manufacturer, G. D. SEarle & Co. in Skokie, Illinois?
13. Why does the FDA dismiss the aspartame findings of:
Jeffrey Bada, Ph.D. Woodrow Monte, Ph.D. H. J. Roberts, M.D.
Russell Blaylock,M.D. John Olney, M.D. Ralph Walton, M.D.
Roger Columbe, Ph.D. Diana Dow-Edwards, Ph.D.
Is it the policy of the FDA to accept only the findings of the
manufacturer that say its safe because of loyalty and dismiss
the negative findings of world renowned physicians and researchers?
A good example of the way the game appears to be played is the way
Dr. Dow-Edwards was treated. NutraSweet funded this study on birth
defects but when Dr. Dow-Edwards got diastrous results, rather than
recall aspartame the NutraSweet Company withdrew their funding and Dr.
Dow-Edwards had to pay for the study herself. Then neither NutraSweet
or the FDA would accept this study. Isn't the message clear? "If
you won't say its safe we won't accept it, and neither will our loyal
friends, the FDA."
14. Why do you allow the manufacturer to test its own product and accept
their data without "independent" replications? Why weren't the
original aspartame studies replicated and why do you stand behind
Monsanto who wants to prevent this? Especially in the face of the
original studies being a target for an indictment for fraud that was
not carried out because two U.S. prosecutors decided to work for the
law firm defending the case instead of doing their job. Quite a
reward, wouldn't you say?
15. Why do you tell the public that aspartame was proven safe when what
it proved is serious medical problems and cancer? FDA toxicologist
Dr. Adrian Gross said in l976 in a memo:
"The report of the Task force submitted in March l976 in essence
constituted a stinging indictment of Searle and it contained various
recommendations for regulatory action including referral to the
Justice Department for review of possible criminal violations of the
law."
On Jan 10, l977 in a 33 page letter, FDA Chief Counsel Richard Merrill
recommended to U.S. Attorney Sam Skinner, a grand jury investigate
Searle for "apparent violations of the Federal Food, Drug and Cosmetic
Act 21 U.S.C. 355 and for concealing material facts and making false
statements in reports of animal studies conducted to establish the
safety of aspartame."
Since these studies were never replicated explain why the public
should accept them as showing safety in light of the above statements?
Especially explain how rats reported dead in the Bressler Report were
listed as alive later in the document. Maybe the manufacturer can
tell us how to work this trick on those who have perished from this
poison!
16. Why did you approve aspartame in liquid based on the data of it in
dry form? Why did the FDA officials tell the 3 member Board of
Inquiry not to concern themselves with the liquid form?
17. Why do you mislead the public with an IFIC brochure on aspartame
with false information? These false statements are answered in
an attachment with the facts.
As an example: "Aspartic acid and phenylalanine are building blocks
of protein and are found naturally in all protein-containing foods,
including meats, grains and dairy products. Methanol is found
naturally in the body and in many foods such as fruit and vegetable
juices."
Why don't you tell the public that aspartic acid and phenylalanine
are NEUROTOXIC when isolated from the other amino acids in protein
and go past the blood brain barrier and deteriorate the neurons of
the brain causing brain damage of varying degrees. In food
phenylalanine may be 4% not 50% like in aspartame flooding the
brain. And why don't you tell them that the phenylalanine in
aspartame is genetically engineered in E. coli bacteria and breaks
down into DKP or diketopiperazine, a brain tumor agent. In food
unisolated from the other amino acids in protein it does not break
down into a tumor agent!!!! And why don't you tell them the
phenylalanine can concentrate the placenta and cause mental retarda-
tion, if the baby lives at all!
And why don't you tell the public that methanol is a cumulative
poison that breaks down into formaldehyde and formic acid (ant sting
poison) and causes metabolic acidosis? And why don't you admit
when methanol is in fruit or vegetables it is always accompanied
by ethanol which is the antidote to methanol toxicity and takes it
safely out of the body? And why don't you tell the public you don't
slur your words when you eat an orange, go blind or die from methanol
toxicity like Patricia Craine and Joyce Wilson did from aspartame?
From: Journal of Applied Nutrition, Volume 36, Number 1, l984,
ASPARTAME: METHANOL AND THE PUBLIC HEALTH by Dr. Woodrow Monte
"Ethanol, the classic antidote for methanol toxicity, is found in
natural food sources of methanol at concentrations 5 to 500,000
times that of the toxin. Ethanol inhibits metabolism of methanol
and allows the body time for clearance of the toxin through the
lungs and kidneys."
18. How do you consider one of the pivotal studies that approved
aspartame, SC 18862, showing 6 out of 7 monkeys fed
aspartame having grand mal seizures (1 died) as proving safety.
Then you tell the public aspartame doesn't cause seizures! Wurtman's
reports (MIT) on phenylalanine clearly explain how it lowers the
seizure threshold of the brain! And you last 4 different types of
seizures on your report of 92 documented symptoms!
19. Why when faced with the fact that you have approved a seizure
triggering drug for the public you have done nothing to alert
the FAA. As pilots continue to have grand mal seizures in the
cockpits of commercial airliners how do you justify turning a blind
eye and deaf ear when this is such a great hazard to aviation.
Both the U. S. Air Force and the Navy warned all pilots off
aspartame in their publications.
In the Air Force journal, FLYING SAFETY, May 1992 it says:
"In pregnancy the effects of aspartame can be passed directly on
to the fetus, even in very small doses. Some people have suffered
aspartame related disorders with doses as small as that carried
in a single stick of chewing gum. This could mean a pilot who
drinks diet sodas is more susceptible to flicker vertigo, or to
flicker induced epileptic activity. It also means that all pilots
are potential victims of sudden memory loss, dizziness during
instrument flight and gradual loss of vision."
Instead of telling the FAA to alert all pilots you open the floodgates
pouring more of this poison into the marketplace with blanket approval.
I can't help but wonder how you can muster the audacity to continue
your farce telling the public this deadly neurotoxin has been
proven safe. Why don't you just put Monsanto's address on your
stationery so the people know where you stand? On Hardcopy on
12/31/96 Continental pilot Haynes Dunn explained how he had a
seizure losing his health and occupation. Another pilot admitted
he completely blacked out. Nothing like having pilots having grand
mal seizures and blacking out on commerial airliners flying a plane
with hundreds of passengers! And what about the pilots lives or
do you care? I guess to ask the question is to answer it. An
American Airline pilot petitioned them to remove Equal but American
kept their Monsanto account. And then pilot Virgil Culp died from
it!
The FAA says they can't warn pilots off of aspartame as long as you
say its safe. Here you are with a pivotal study in hand, SC 18862,
that shows 6 out of 7 monkeys had grand mal seizures from using
aspartame (7th died), and KNOW WITHOUT A SHADOW OF A DOUBT IT CAUSES
SEIZURES and you REFUSE to tell the FAA to warn pilots. What kind
of people are you anyway - this TREMENDOUS hazard to aviation which
has already caused pilots to have seizures with a planeload of
passengers and you do nothing but approve more of this poison. Your
own report of symptoms list 4 different kinds of seizures in the
population and Dr. Wurtman of MIT has mentioned these seizures from
aspartame many times. So while U. S. Air Force and the U.S. Navy has
already warned their pilots off the FDA simply shows more
loyalty to Monsanto by dumping more of this seizure triggering drug
on the public. And it doesn't take a rocket scientist to know if
aspartame has 50% of phenylalanine in it, its going to lower the
seizure threshold of the brain. Plus wood alcohol and the altitude
make pilots particularly prone to problems.
You also know that wood alcohol (methanol) blinds, and have already
had one petition to ban aspartame on this basis as people started
losing their sight. You know this toxin causes people to have
vertigo, and lose their equilibrium, on the FDA report as well.
Yet, with full knowledge that pilots are flying planes with 300 and
400 passengers and can have seizures, lose their vision and
equilibrium (and do), you continue to standby and do nothing. Do
you not consider this irresponsible behavior by a Government
agency that is suppose to protect the people from these kinds of
poisons?
20. In October l986 the Community Nutrition Institute in Washington, D.C.
wrote a petition to ban aspartame because people were going blind.
Why didn't you do it? In the l980's Dr. James Bowen who also became
deathly ill on aspartame told you it was mass poisoning of the
American public and more than 70 countries of the world. Why did
again you turn a deaf ear? In his last paragraph he said: "In
light of the above 4 points, I highly recommend that you deny in
every way possible any subterfuge of respectability that the
aspartame people have enshrouded themselves and their product in
hopes of quickly denying its access to the worldwide marketplace.
I write this, not believing that it will do the slightest bit of
good in the sense of affecting the labeling issue per se, but that
instead it might reach some honest, concerned, conscientious
individuals in the process." It looks like more and more people
know exactly what to expect from the FDA! Do you know how many
people would still be alive if you had banned aspartame when you
were petitioned?
21. When rats developed brain tumors in the original studies why did you
not demand these studies be replicated?
22. Pate of the National Yogurt Assoc. petitioned that aspartame not have
to be labeled in yogurt. What have you done about this? This would
be against the labeling law that requires a PKU warning. But then
Pate knows this since he was head of the National Soft Drink Assoc.
who wrote a 30 page protest against aspartame being allowed in
carbonated beverages. Then the NSDA switched sides and lobbied for
NutraSweet! Do you know the reason why?
23. Why are companies like Coke allowed to have products like Fresca that
contain aspartame in a machine that bears no PKU warning?
24. Why are drug companies not required to have aspartame labeled on the
outer container with a PKU warning. In the case of Cherry Alka
Seltzer, for example, it is not on the box and only on the insert.
Therefore, people who have to read the labels to avoid this toxin
would not realize until they opened the package it had aspartame
in the product, and therefore have to take it back. And how many
people would read the insert not seeing it on the box? And how
many people carry magnifying glasses for this purpose?
25. What about other unpublished studies showing dangerous findings?
26. After refusing to approve NutraSweet for 16 years because of the
brain tumor issue, knowing rats developed astrocytomas, why did
you side with Monsanto instead of the people when Dr. John Olney
brought this to the attention of the world as the population
of heavy aspartame users begin to develop the very same rare
brain tumor as the rats? Didn't you expect it?
Betty Martini, Founder
Mission Possible
As WEBMASTER of "DORway to Discovery", http://www.dorway.com I would like to know why, as highly-paid PUBLIC SERVANTS, you are too busy to respond to anyone on the subject of aspartame. You only sent Senator Strom Thurmond your standard "canned" package of disinformation... the very same that the aspartame industry provides. None of YOUR "answers" were factual or satisfactory... in any manner. If the FDA wants to resolve this growing HEALTH problem, it is time to recognize that the time is NOW... not later, to submit to the truth! Answering the above twenty-six questions would be a good start, if answered completely, and truthfully, using ALL facts and common sense! David Rietz WebMaster and Victim |