From: Jaffe, Lyle D
Sent: Thursday, July 08, 2004 7:57 AM
To: Dockets, FDA
Subject: FW: Another FDA Whopper



-----Original Message-----
From: Dr. Betty Martini [mailto:Bettym19@mindspring.com]
Sent: Thursday, July 08, 2004 1:21 AM
To: Jeannie.Ertter-Prego@cfsan.fda.gov
Cc: DHATTAN-CFSAN.FDA.GOV; RXH@CFSAN.FDA.GOV; Jaffe Lyle D;
inforeply@cdc.gov; robert.brackett@fda.hhs.gov; alan.rulis@fda.hhs.gov;
janice.oliver@fda.hhs.gov
Subject: Re: Another FDA Whopper


Dear Jeannie Ertter Prego:
Do you remember the letter I just sent below pasted it?  Why do you 
continue to lie and and lie about aspartame and MSG?  There is no place in 
a government agency for a liar.  Please resign so you will not stumble 
others under Title 18, Section 1001 which makes it a crime.

Just because aspartame is masquerading as an additive does not mean it's 
not a drug.  In September, l973, Martha M. Freeman, M.D. of the FDA 
Division of Metabolic and Endocrine Drug Products addressed the adequacy of 
the information submitted by G. D. Searle in their petition to approve 
aspartame.

In her concluding remarks she said:

1.  "The administration of aspartame, as reported in these studies at high 
dosage levels for prolonged periods, constitutes clinical investigational 
use of a NEW DRUG SUBSTANCE."

2.  "The information submitted for our review is inadequate to permit a 
scientific evaluation of clinical safety."

H. J. Roberts, M.D., in Aspartame Disease: An Ignored Epidemic, 
www.sunsentpress.com or 1 800 827 7991 (a medical text on the global plague 
of aspartame disease caused by the FDA approval of a neurotoxic drug) it 
says:  "The impressive biophysiologic effects of aspartame (Section 2 and 
5) provide justification of classifying aspartame as a "drug."  Indeed, 
this chemical was first devised as a drug for treating peptic ulcer."

Under FDA Resistance and Disinformation, page 892, Dr. Roberts says:

"Donald Kennedy (l987), President of Stanford University and a former FDA 
Commissioner, expressed his increasing concern about public confusion over 
claims and counterclaims regarding scientific issues...coupled with the 
extent of scientific illiteracy.  In the case of aspartame disease such 
"illiteracy" can be attributed in part to FDA reluctance to provide any 
statement about aspartame disease.  Indeed, ninety-five (23.9 percent) of 
397 aspartame reactors who initially completed the survey questionnaire 
(Chapter XIX) had written or called the FDA...generally to no avail.  Those 
who requested information about the safety and prudent limits of aspartame 
intake received incomplete or misleading replies."

 From any note I have seen from you Ms. Ertter-Prego there has not been a 
truthful statement.  Here you say:  "Currently, there are no indications 
other than sensitivities that have been presented to the agency.  We 
continue to review all additives as part of our post market surveillance 
program. "

Talking about a whopper, how dare you make such a statement.  The FDA has 
been swamped with aspartame reactions for over 20 years.  In fact, it was 
admitted in congressional hearings the FDA was receiving so many reactions 
they started referring them to the AIDS Hotline to get rid of them. FDA's 
own report which we have on www.dorway.com lists 92 documented symptoms 
triggered by this deadly neurotoxic drug.

During 1999 when an email made world news I spoke with an employee of the 
FDA who said:  "We are flooded with complaints on aspartame constantly  and 
simply not equipped."  So you say you review all additives as part of your 
post market surveillance program.  So after review of thousands of 
complaints what did the FDA do, throw them in the circular file?   They 
certainly did not report them.  On the contrary I constantly get copies of 
the lies from the FDA when consumers report serious reactions and 
disease.  Julie Kelly reported her diabetic friend lost her life to 
aspartame.  Did the FDA even care?  No, they stuffed  a packet full of 
federal registers and a note saying not to use the safe herb sweetener, 
(after all the aspartame manufacturer's don't want consumers using safe 
products, they want them on Nutrapoison which is addictive and a cash cow) 
and one of your FDA consumer propaganda rags.  Did the death mean anything 
to the FDA?  Not at all, they just lied and said aspartame is safe.

If aspartame is safe why did the FDA want the manufacturer indicted for fraud?

If aspartame is safe why did the Board of Inquiry of the FDA say to revoke 
the petition for approval because aspartame had triggered brain tumors and 
had never been shown to be safe?

If aspartame is safe why did Jerome Bressler in the FDA audit write of 
fraud and deceit?

If aspartame is safe why have hundreds of thousands of people complained of 
reactions to not only the FDA but the CDC, the manufacturers of aspartame, 
and the manufacturers using the product in their food and consumer 
operations?

If aspartame is safe why are there probably a quarter of a million web 
sites warning people off this neurotoxic drug?

If aspartame is safe why are there aspartame support groups on line and 
physicians operating aspartame detoxification centers in the US and other 
countries?

If aspartame is safe why have lawsuits been filed against some of the 
largest companies in the world for poisoning the public with 
aspartame?  www.wnho.net

If aspartame is safe why is there an Aspartame Toxicity Center recording 
all the cases because the FDA won't report them?  www.holisticmed.com/aspartame

If aspartame is safe why have 92% of all independent, scientific peer 
reviewed research shown the problems aspartame causes, and that it is not 
safe?

If aspartame is safe why are there Mission Possible operations in every 
state and over 22 countries of the world warning consumers off the toxin 
listing research showing how deadly aspartame is, and books and medical 
texts on the symptoms and diseases that have been recorded since approval 
by world renowned physicians?

If aspartame is safe why have articles been written for over 20 years on 
the fact that it is not safe and the reactions it causes?

The FDA is nothing more than the hand-maiden of the pharmaceutical industry 
and has never cared about the fact that people are dying all over the world 
from this poison, and has covered up.  When Belcher dropped dead, an 
athlete, the FDA took Ephedra off the market, and would love to snatch all 
vitamins and herbs so the pharmaceutical companies can gouge the public 
even more.  Yet Belcher did not die from Ephedra.  It is obvious he died 
from aspartame as he was drinking diet soda all day and on other days going 
without food as one article reported.  Aspartame triggers an irregular 
heart rhythm and interacts with all cardiac medication.  It damages the 
cardiac conduction system and causes sudden death.  This is reported in 
many of the physician's articles on www.dorway.com and www.wnho.net and in 
medical books like Aspartame Disease: An Ignored Epidemic by H. J. Roberts, 
M.D., www.sunsentpress.com and in Excitotoxins: The Taste That Kills and 
Health & Nutrition Secrets to Save Your Life by neurosurgeon Russell 
Blaylock, M.D., www.russellblaylockmd.com   The FDA has snatched ephedra 
but the athletes are still dropping dead as the media continually reports.

By law an additive must be inert.  Aspartame is about as inert as 
nitroglycerin.  In Aspartame Disease there is an entire chapter about drug 
interaction.  And to make matters worse aspartame interacts with just about 
every drug used to treat the problems it causes.   So if someone has an 
aspartame seizure (4 types of seizures are listed on the FDA list of 92 
symptoms) and is sent to the ER, the physician may prescribe Dilantin 
or  like  anti-seizure medication and it interacts.  Aspartame not only can 
precipitate diabetes but simulates and aggravates diabetic retinopathy and 
neuropathy - and it interacts with insulin as discussed by Dr. Roberts who 
is a diabetic specialist and Board Certified and Recertified in Internal 
Medicine.   How many diabetics do you think take aspartame and insulin 
because the FDA approved it?  Aspartame can precipitate Parkinson's as 
discussed in the above medical books and others on www.sunsentpress.com yet 
it interacts with L-dopa.

Lots of news articles questioned why woman taking hormone replacement like 
Premarin were suffering from chronic fatigue syndrome when years ago 
Premarin did not cause this problem.  But aspartame destroys the immune 
system and causes CFS, and interacts with hormones.  Our children are 
medicated instead of educated and are even using this neurotoxic drug in 
pediatric vitamins and products.  The phenylalanine in aspartame depletes 
serotonin and triggers bi-polar or manic depression, anxiety attacks, 
behavioral and psychiatric problems, suicidal tendencies, etc.  And 
aspartame interacts with all anti-depressants.  Congress has declared that 
children in the US are poisoned and have given the National Institutes of 
Health 2.7 billion to find the culprit.  You will see my letter to them on 
www.wnho.net, click on aspartame.

And it only gets worse because aspartame is a chemical hypersensitization 
agent and interacts with other unsafe sweeteners the FDA has approved and 
other toxins and even vaccines.   So children don't have a chance thanks to 
the Food and Death Association!

And you dare want to regulate our safe supplements?  If the FDA can't tell 
the truth about aspartame we don't need an agency that does nothing but 
stumble the public and continue to be responsible for unsafe food and drugs.

Because aspartame is a literal chemical poison, that even liberates free 
methyl alcohol (methanol classified as a narcotic) it no doubt interacts 
with even more drugs than those listed in medical books.  So NO DRUGS ON 
THE MARKET ARE SAFE!!  That is what the FDA has caused.

Finally, its even come out in a movie, Sweet Misery:  A Poisoned 
World.  And world experts on aspartame and even James Turner, Attorney who 
tried to prevent its approval with world renowned neuroscientist, Dr. John 
Olney, expose the politics in the approval process.  Be sure to get your 
copy by either filling out the form on www.wnho.net or call toll free 1 866 
624-9710.  I doubt that listening to the horror stories of the victims will 
affect you Ms. Ertter-Prego.  Most liars who tell consumers they can safely 
consume poison don't care about those suffering from their lying 
statements, and have no remorse.

And if I'm coming down hard on you its because I've warned you before and I 
continue to get notes from those you have lied to.  If it were up to met I 
would have all those who have lied about aspartame at the FDA taken to a 
woman's prison in Troy, Virginia to see Diane Fleming who has been 
sentenced to 50 years in prison.  Her athlete husband died from aspartame 
and seeing methanol poisoning on the autopsy was indicted for murder.  He 
was a diet pop addict and the aspartame, of course, liberates free methyl 
alcohol.  It is this chronic methanol poisoning that affects the dopamine 
system of the brain and causes addiction.  And even though aspartame 
experts have written affidavits that he died from this deadly drug, she 
remains there.  She is a sweet Sunday School teacher who helped the 
homeless and bought them clothes.  She has a little girl who not only has 
lost her father but now cries for her mother.  And why is she 
there?  Because the FDA approved poison for human consumption.  You will 
hear her story in the film.

As to MSG it has a synergistic and additive effect with aspartame.  I would 
suggest you check out Jack Samuels site, www.truthinlabeling.org Thanks to 
the approval of MSG Mr. Samuels has to take his own food wherever he goes 
because if he accidently gets MSG he can go into anaphylactic shock.   When 
he filed suit against the FDA he found in the records where the glutamate 
people had been using aspartame as their placebo when they did studies on 
MSG.  They wanted to show that MSG wouldn't react any more than the 
placebo.  Glutamate and aspartate in aspartame are both excitotoxins, 
stimulate the neurons of the brain to death causing brain 
damage.  (Excitotoxins: The Taste That Kills). Since placebo's are suppose 
to be inert this is a crime. FDA even admitted when they were caught with 
their pants down this was against the law.  But the FDA had been allowing 
this and known of this for over a quarter of a century.  Not only that it 
was even used as a placebo before aspartame was approved, so they knew even 
though aspartame was reactive and a drug, and not an inert additive.  So 
what does the FDA do when industry commits a crime for a quarter of a 
century?  Absolutely nothing.  They were just caught and couldn't continue 
to lie.

The FDA has known aspartame is a neurotoxic drug from the beginning.  When 
James Bowen, M.D., wrote the FDA 18 years ago he told them aspartame was 
mass poisoning of the American public and more than 70 countries of the 
world.  The letter still remains on www.dorway.com , scroll down to experts 
and you'll see it addressed to the FDA on labeling.  How much is the FDA 
concerned about the public being poisoned?  An agent visited Dr. Bowen in 
his office and showed irritation that he had written the letter and was 
upset that Dr. Bowen insisted they take back 29 more cases of aspartame 
poisoning.

How much more evidence do you want other than FDA's own records that show 
aspartame to be a poison?  Would you like to visit cemeteries all over the 
country or the world for that matter and read the tombstones of those who 
used aspartame because the FDA said it was safe, and paid with their 
life?  Everything is a matter of public record.

If you can't answer my questions above, then you need to get a big box, 
fill it up with your personals and resign from the FDA.  The consumer 
public deserves more than lies from FDA employees.  If I were a judge, 
Diane Fleming would be free yesterday, and the prison cells would be filled 
by those who lie about aspartame and have caused disability and death the 
world over.   My last letter to you is posted below.

Dr. Betty Martini, Founder, Mission Possible International, 9270 River Club 
Parkway, Duluth, Georgia 30097  www.wnho.net and www.dorway.com  770 242-2599
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To: Jeannie.Ertter-Prego@cfsan.fda.gov
From: "Dr. Betty Martini" <Bettym19@mindspring.com>
Subject: [Filtered] Over 20 years of lies from FDA on Aspartame 
(NutraSweet/Equal,
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>Dear Jeannie:

I am addressing your recent lies and nonsense on aspartame.  That makes FDA 
guilty of Title 18, Section 1001 of knowingly misinforming the public on 
aspartame, the same law the FDA themselves used on the original 
manufacturer of aspartame, Searle, for lying and misinforming.  You say, 
"Aspartame is one of the most thoroughly tested and studied food additive 
the Food and Drug Administration (FDA or the Agency) has ever 
approved.  More than 100 toxicological and clinical studies reviewed by FDA 
confirm that aspartame is safe for the general population."  Now here's the 
real truth of the matter on those studies:

On January 10, l977 in a 33 page letter, FDA Chief counsel Richard Merrill 
recommended to U.S. Attorney Sam Skinner that a grand jury investigate 
Searle for "apparent violations of the Federal Food, Drug and Cosmetic Act, 
21 U.S.C.  331 (e), and the False Reports to the Government Act, 18, 
U.S..C. 1001, for "their willful and knowing failure to make reports to the 
Food and Drug Administration required by the Act, 21 U.S.C. 355 (i), and 
for concealing material facts and making false statements in reports of 
animal studies conducted to establish the safety of aspartame."  The FDA 
calls special attention to studies investigating the effect of NutraSweet 
on monkeys and hamsters.

Both U.S. Prosecutors Sam Skinner and William Conlon hired on with the 
defense team and the statute of limitations expired.  Who does that 
surprise?  We know the power of the pharmaceutical industry.  Don't want to 
get indicted just hire the prosecutors.  When the District Attorney goes to 
work for the godfather expect acquittal.

In August, l977 The Bressler Report (FDA audit) compiled by FDA 
investigators and headed by Jerome Bressler, was released.  The report 
found 98 of the 196 animals died during one of Searle's studies and weren't 
autopsied until later dates, in some cases over one year after they 
died.  Records for approximately 30 animals showed substantial differences 
between original observations on pathology sheets and the observations on 
pathology sheets submitted to the FDA.  There were numerous other 
inconsistencies and errors noted.  For example, a rat was reported alive, 
then dead, then alive, then dead again; a mass, a uterine polyp and ovarian 
neoplasms were found in animals but not reported or diagnosed in Searle's 
reports.  The FDA investigators found dose-related uterine polyps in 15% of 
34 animals.

And you have the audacity to say aspartame is safe?  And this is just the 
tip of the iceberg.  I personally spoke to Jerome Bressler as did Dr. H. J. 
Roberts and Dr. Russell Blaylock.  We were all told that the studies were 
so bad that when the report was retyped the FDA left out 20% of the most 
damning part.  Dr. Roberts had his congressman have the FDA release the 
other 20% omitted, as well as a cover letter and two mice studies Bressler 
mentioned but FDA refused.  Let me remind you again about Merrill's letter 
to U.S. Prosecutor Sam Skinner "FOR CONCEALING MATERIAL FACTS AND MAKING 
FALSE STATEMENTS".  That's what the FDA is doing!

For 16 years FDA themselves refused to allow aspartame on the market.  In 
l974 Dr. J. Richard Crout, the acting director of the FDA Bureau of Drugs 
stated that "The information submitted for our review was limited to 
narrative clinical summaries and tabulated mean values of laboratory 
studies.  No protocols, manufacturing controls information or pre-clinical 
data were provided.  Such deficiencies in each area of required information 
precluded a scientific evaluation of the clinical safety of this 
product....." (Mullarkey 1992, page 23)

March 24, l976 The FDA task force reports, "At the heart of the FDA's 
regulatory process is its ability to rely upon the integrity of the basic 
safety data submitted by sponsors of regulated products.  Our investigation 
clearly demonstrates that, in the G. D. Searle Company, we have no basis 
for such reliance now."  The task force further says, "Some of our findings 
suggest an attitude of disregard for FDA's mission of protection of the 
public health by selectively reporting the results of studies in a manner 
which allays the concerns of questions of an FDA reviewer."  (FDA Searle 
Investigation Task Force Chaired by Carlton Sharp. "Final Report of 
Investigation of G. D. Searle Company." 3/24/76)

Tell me Jeannie Ertter-Prego, when did aspartame become safe?  Everything 
in the records shows aspartame was never proven safe.  Do you want to hear 
some of the findings summarized from various documents describing the FDA 
Task Force Report?

a.  "Excising masses (tumors from live animals, in some cases without 
histologic examination of the masses, in other without reporting them to 
the FDA."  (Schmidt 1976c, page 4 of US Senate l976b).  Searle's 
representatives, when caught and questioned about these actions, stated 
that "these masses were in the head and neck areas and prevented the 
animals from feeding."  (Buzzard l976a)

"Failure to report to the FDA all internal tumors present in the 
experimental rats, e.g.., polyps in the uterine, ovary neoplasms as well as 
other lesions."  (Gross l987a, page8)

b.  G. D. Searle "stored animal tissues in formaldehyde for so long that 
they deteriorated."  (Gordon l987, page 496 of US Senate l987; US Schmidt 
l976c, page 25, 27 of US Senate l976b

c.  "Instead of performing autopsies on rhesus monkeys that suffered 
seizures after being fed aspartame, the company had financed a new monkey 
seizure study with a different methodology that showed no 
problems."  (Gordon l987, page 496 of US Senate l987)

d.  "Reporting animals as unavailable for necropsy when, in fact, records 
indicate that the animals were available but Searle choose not to purchase 
them."  (Schmidt l976c, page 5 of US Senate l976b)

e.  Animals which had died were sometimes recorded as being alive and vice 
cersa.  "These include approximately 20 instances of animals reported as 
dead and then reported as having vital signs normal gain at subsequent 
observation periods."  (Gross l985, page S10835)

f.  "Selecting statistical procedures which used a total number of animals 
as the denominator when only a portion of the animals were examined, thus 
reducing the significance of adverse effects."  (Schmidt l976c, page 4 of 
US Senate l976b)

g.  G. D. Searle told the FDA that 12 lots of DKP were manufactured and 
tested in one study, yet only seven batches were actually made (Gross l985, 
page S10835).  (DKP is the brain tumor agent that gave rats brain tumors in 
original studies)

h.  "Significant deviations from the protocols of several studies were 
noted which may have compromised the value of these studies ..."

In at last one study, the aspartame 52 weeks monkey study, the protocol was 
written after the study had been initiated."  (Gross l985, page S10835)

i.  "In each study investigated, poor practices, inaccuracies, and 
discrepancies were noted in the antemortem phases which could compromise 
the study."  (Gross l985, page S10836 of Congressional Record l985b)

j.  In the aspartame (DKP) 115 week rat study the written observations of 
the pathology report was changed by the supervising pathologist, Dr. 
Rudolph Stejskal even though he was not physically present during the 
autopsies and could not have verified the observations of the pathologist 
who did perform the autopsies.  The pathologist who did perform some of the 
autopsies had no formal training for such procedures.  (Gross l985, page 
S10837 of congressional Record l985b)

The FDA toxicologist who was on site was the late Dr. Adrian Gross, and he 
was a Task Force member.  Here's what he said:  (Wilson l985):

"They (G. D. Searle) lied and they didn't submit the real nature of their 
observations because had they done that it is more than likely that a great 
number of these studies would have been rejected simply for adequacy.  what 
Searle did, they took great pains to camouflage these shortcomings of the 
study.  as I say filter and just present to the FDA what they wished the 
FDA to know and they did other terrible things for instance animals would 
develop tumors while they were under study.  well they would remove these 
tumors from the animals."

FDA Lead Investigator and Task Force Team Leader, Phillip Brodsky described 
the l975 FDA Task Force members as some of the most experienced drug 
investigators.  He went on to state that he had never seen anything as bad 
as G. D. Searle's studies (Graves l984; page S5499 of congressional Record 
l985a)

FDA Commissioner at the time, Alexander Schmidt stated (Graves l984, page 
S5497 of Congressional Record l985a):

Dr. Marvin Legator, professor and director of environmental toxicology at 
the University of Texas and the pioneer of mutagenicity testing at the FDA 
from l962 to l972 was asked by Common Cause Magazine to review the FDA 
investigation results of G. D. Searle's tests ( Graves l984, page S5498 of 
Congressional Record l985a)

"All tests were scientifically irresponsible and disgraceful.  I'm just 
shocked that the kind of sloppy work would even be sent to FDA, and that 
the FDA administrators accepted it.  There no reason why these tests 
couldn't have been carried out correctly.  It's not that we are talking 
about some great scientific breakthrough in methodology."

So Dr. Gross said because of their deliberate misconduct and "lies" it 
invalidated their experiments for the following reasons:

1.  Many of the problems with the studies included horrendous experimental 
designs, questions regarding dosage given, loss of animal tissue and data, 
etc., etc. which invalidates entire experiments and causes what they claim 
to be 4 million observations and calculations per study (average) to become 
irrelevant.

2.  Only the key aspartame studies were looked at.  It is almost a 
certainty that the non-key aspartame studies were equally 
flawed.  Therefore, this would invalidate the "hundreds of millions" of 
observations and calculations made during these studies.

3.  The difference between a study showing no statistical difference and a 
significant statistical difference is often only a few observations or 
calculations.  Therefore, had the myriad of other serious experimental 
errors not occurred , the observation and calculation mistakes in each 
periment investigated would, by themselves, invalidate most of the key studies.

4.  It is highly unlikely the FDA Investigative teams found all of the 
problems with G. D. Searle's studies.  G. D. Searle seemed so intent on 
covering up their misconduct, that it is quite likely that they were able 
to hide many of the problems from the FDA.

Now tell me again Jeannie Ertter-Prego how you can say more than 100 
toxicological and clinical studies reviewed by FDA confirm that aspartame 
is safe for the general population.  According to the actual records the 
FDA invalidated them.  This goes along with what FDA toxicologist, Dr. 
Jacqueline Verrett, also a member of the investigation task force, told 
Congress on Nov 3, l987, and that was all studies were built on a 
foundation of sand and should be thrown out.  In watching some of the tapes 
of the congressional hearings she also said in l987 that the study having 
to do with the allowable daily intake (ADI) had no validity and if 
aspartame is on the market based on the studies that were done, it is a 
disaster.  She said at this point aspartame has still not been shown to be 
safe.

So what was the problem in showing safety?  Aspartame is a neurotoxic drug 
and chemical poison.  You can't do studies on a poison and make it show 
safety.  It can't be done.  This is why on August 4, l976 G. D. Searle 
representative met with the FDA and convinced them to allow Searle to hire 
a private agency, University Associated for Education in Pathology (UAREP) 
to "validate"  some studies (Gordon l987 page 498 of US Senate l987).  This 
is one of the more outrageous things Searle did because they "swore them to 
silence".  And for this they were paid $500,000.  As described by Florence 
Graves (l984, page S5500 of Congressional Record l985a) "The pathologists 
were specifically told that they were not to make a judgment about 
aspartame's safety or to look at the designs of the tests."

So let's just skip down to the FDA's final word on aspartame and 
safety.  It was June 1, l979 when the FDA established a Public Board of 
Inquiry of the finest scientists they had to offer to rule on safety issues 
surround NutraSweet.  On January 15, l980 the Board of Inquiry held 
hearings on objections to aspartame approval.  On Sept 30, l980 the PBOI 
concluded NutraSweet should not be approved because of the brain tumor 
issue and because the Board "has not been presented with proof of 
reasonable certainty that aspartame is safe for use as a food 
additive."  They said to revoke the petition for approval.

So for 16 years no FDA Commissioner would allow aspartame on the market and 
all comments were that aspartame had never been proven safe.  At the time 
Don Rumsfeld was CEO of Searle and he didn't care that aspartame could not 
be proven safe.  As discussed in the United Press International 
investigation of aspartame and the congressional record, Rumsfeld said he 
would call in his markers and get it approved anyway.  He was on Reagan's 
transition team and the day after Reagan took office he appointed an FDA 
Commissioner who would approve it, Arthur Hull Hayes.  Hayes over-ruled the 
Board of Inquiry on July 15, l981 and allowed it to be marketed.  Then he 
went to work for the PR Agency of the manufacturer at what some say was 
$1000.00 a day, and has refused to talk to the press ever since. So safety 
had nothing to do with the approval of aspartame, just a political ploy by 
Don Rumsfeld,and he got a lot of money for doing it.

Jeannie, then you say:  "Some websites on the Internet and other 
publications such as Dr. Russell Blaylock's book have attempted to link 
aspartame consumption to various health conditions such as systemic lupus, 
multiple sclerosis, vision problems, headaches, fatigue and even 
Alzheimer's disease.  The Agency has not been presented with any credible 
scientific evidence to support any of these claims, nor is it aware of any 
evidence presented in peer-reviewed scientific journals that support these 
claims."   First of all, its not "some" it more like a quarter of a 
million, at least.  They say where there is smoke there is fire, this is a 
blazing conflagration.  There is also an Aspartame Toxicity Center to 
record the cases of the victims which never stop and aspartame 
detoxification centers where physicians treat the victims.  And Mission 
Possible International is just one of the operations that alerts the public 
that aspartame is a deadly neurotoxic drug  and is in 50 states and more 
than 22 countries of the world.  Dr. Blaylock's book is just one of them 
getting the facts out so physicians and consumers can be educated on the 
damaging effect of this neurotoxin.  How else would physicians correlate 
the symptoms and diseases with the culprit with the FDA, industry and 
professional organizations funded by industry lying.  And you have the 
audacity to say the agency has not been presented with any credible 
scientific evidence to support any of these claims.  You do not think that 
after having a deadly chemical poison on the market for over 20 years we 
wouldn't know what it causes?  How long did it take for people to 
understand why thalidomide was doing?  And yes, scientific studies were 
done but you don't think we're stupid enough to believe the manufacturer 
would publish the studies that showed what the toxin does, do you?  First 
of all, in l983/84 Searle did studies on humans in South America that 
showed that aspartame destroys the central nervous system (mimics MS) and 
the brain.  They sacrificed people in poor villages to grow brain tumors 
and brain tumors is what they suffered from as well as seizures.  These 
studies also showed aspartame hardens the synovial fluids and causes 
agonizing joint pain.  Some of the people in the study died and a pregnant 
woman lost her baby and then disappeared!  A notarized affidavit from the 
translator N. Vera is on www.dorway.com Not only do aspartame manufacturers 
not publish the damaging studies but they threaten physicians not to do 
them.  Read the UPI investigation on this same web site that shows Searle 
actually threatened Dr. Wurtman if he did studies on aspartame and seizures 
his research funds would be rejected and they were.  And where do they get 
their research funds?  From ILSE, Life Sciences, made up of aspartame 
manufactures, and manufacturers like Coke who use the toxin.  Dr. Wurtman 
is at MIT and today they get research funds and Dr. Wurtman no longer 
speaks out about aspartame.  That's the way its done and you know 
it.  Doctors and professional organizations are paid to say this toxin is safe.

And its the FDA themselves who have supported the manufacturer knowing 
aspartame is not safe, and resisted proposals from government scientists 
for comprehensive studies.  Gregory Gordon when he was working for the Star 
Tribune in l996 wrote about this on November 22nd.  He said:

"FDA officials have for years resisted proposals from government scientists 
for comprehensive studies of the safety of the artificial sweetener 
aspartame, which 100 million Americans consume as NutraSweet.  Between the 
early l980's and l994 scientists at the National Institutes of 
Environmental Health Sciences (NIEHS) proposed at least four times that the 
government's leading program for toxicology research fund such studies, the 
Star Tribune has learned.  The government scientists said they wanted the 
National Toxicology Program to conduct animal studies to resolve questions 
about the sweetener's cancer risks.  After each of these "nominations" 
NIEHS officials elected not to pursue the research at the urging of FDA 
officials who said they were satisfied with industry-sponsored research 
that found no health risks." .....

So the FDA while out of one side of their mouth says they would have to see 
scientific studies, have prevented these scientific studies from being done 
and replicating the ones that were invalided years ago.  You don't have any 
defense.  The FDA would lie if the truth would do.

Multiple Sclerosis is epidemic.  When I lectured for the World 
Environmental Conference, Dr. Gaylord of the EPA said:  "We have an 
epidemic of MS and lupus and cannot identify the toxin."  I answered I was 
there to lecture on MS and lupus and identify the toxin as NutraSweet.  Not 
only were scientific studies done by Searle in South America and not 
published which is a crime, but a good deal of the population using 
aspartame long time complain of MS symptoms which are listed on your own 
FDA report of 92 documented symptoms triggered by this 
neurotoxin.  Dizziness is so prevalent is #2  and the numbness and tingling 
they experience is #17.  They slur their words from the methanol toxicity 
and speech impairment is also on the list as well as the other neurological 
symptoms.  If its not too late all we have to do is get them off aspartame 
and their symptoms disappear.  Not only has Dr. Blaylock written about it 
but Dr. H. J. Roberts as well, and his position paper Multiple Sclerosis or 
Aspartame Disease? is on www.dorway.com/nomarkle.html along with my letter 
to the MS Society quoting Dr. Roberts medical text, Aspartame Disease: An 
Ignored Epidemic, on the chapter on aspartame and MS, including the 
mechanism.  Cori Brackett is one of those aspartame victims who was 
diagnosed by the Mayo Clinic with MS, and had a huge lesion.  She got off 
aspartame, walked out of her wheelchair and made a movie to tell the story 
called Sweet Misery:  A Poisoned World.  You can even get a copy from her 
at Cori@soundandfuryproductions.com  Today off aspartame even the large 
lesion has disappeared.  Ermelle Martinez is another one who started using 
aspartame and was diagnosed as having MS in medical school.  She never got 
to finish thanks to FDA's approval of this neurotoxin.  She was ready for a 
wheelchair when she found out about aspartame and got off of it.  Today she 
is just fine and her large lesion has also disappeared.  Alicia Morris was 
diagnosed by two physicians as having MS, got off her three Diet Coke's a 
day, and all symptoms disappeared.  Her story was in First for Women.  And 
its not just the methanol toxicity but the whole chemical mess.  There are 
so many of these cases they are stacked up for me to answer.  Joyce Wilson 
was also misdiagnosed as having MS but it was too late.  I still have her 
pitiful last letter to Senator Metzenbaum where she said:  "It's too late 
for me, please warn others."  And then she died.  That's what FDA did when 
they approved a chemical poison for human consumption.  And I notice death 
is on your report of 92 symptoms as well.  I guess you would call that the 
"ultimate symptom"!
Additives by law are suppose to be inert or non-reactive.  When something 
causes over 92 symptoms by your own record, enough diseases to fill up a 
1038 page medical, interacts with drugs, vaccines and your other approved 
toxins like Splenda (sucralose), asculfame potassium, MSG, and even causes 
death its no additive.  It is not only against the law to approve a deadly 
drug as an additive but especially one that liberates free methyl alcohol.

Dr. John Olney, one of the most renowned neuroscientists on the planet 
today did the studies on aspartic acid in l970 and found it causes lesions 
in the brains of mice.  He founded the field of neuroscience called 
excitotoxicity.  Neurosurgeon Russell Blaylock, M.D., wrote the excellent 
book you mentioned, Excitotoxins: The Taste That Kills.  And they do 
kill.  An excitotoxin is a product that literally stimulates the neurons of 
the brain to death causing brain damage.  When you think of MS also 
remember that an excitotoxin unlike a neurotoxin that goes directly into 
the brain does not cross the blood brain barrier but is secreted into the 
cerebral spinal fluid by the choroid plexus located in the ventricles of 
the brain.  And there in the brain's lower area and upper terminus of the 
spinal cord is where Lou Gehrigs, Parkinson's Disease and Multiple 
Sclerosis damage is most prominent.  These critical locations are bathed in 
the toxin as it removes from the blood.  From the third to fourth ventricle 
there is a narrow canal called sylvian aqueduct which fills with this 
secretion and washes the roof of the hypothalamus.  And this accounts for 
aspartame damage to the hypothalamus which produces serious and diverse 
problems including sexual dysfunction.  This also is discussed in 
Excitotoxins and Dr. James Bowen has also discussed it at length.

Do you really think after over 20 years of post marketing reports 
and  physicians  treating aspartame victims in the trenches of medical 
practice all this wouldn't be known?  And as to lupus, what is it that you 
don't understand about aspartame being an adjuvant that forms antigenic 
tissue, triggering immunologic attack.   Dr. Blaylock also wrote on 
aspartame toxicity for Lancet's Discussion Group where he mentioned 
lupus.  He was discussing the Trocho Study when he wrote about a study 
using radiolabeled aspartame that indicated attachment of the formaldehyde 
breakdown product to DNA and that the formaldehyde was cumulative with each 
dose.  He said "this should be a cause of concern especially so in relation 
to oncogene activation and in disorders associated with elevated rats of 
DNA damage, such as lupus and the neurodegenerative disorders.  He said 
Shephard, et al found that aspartame was nitrosated in the GI tract and 
that in this form was significantly mutagenic.  Such nitrosation, according 
to their findings could also occur in endothelial cells and stimulated 
macrophages.  This would raise concern not only of carcinogenic potential 
but also the stimulation of free radical generation in blood vessels 
associated with atherosclerosis.  Related to this finding is another report 
by Hardcastle and Bruch, in which they found that macrophages treated with 
aspartame produced an excess of leukotrienes and other arachidonic acid 
metabolites.  Yamada, et all found that aspartic acid inhibited melatonin 
secretion from the pineal gland.  It has been shown that aspartame 
consumption does increase aspartic acid blood levels, especially when 
consumed with MSG."

Dr. Blaylock ended his report by saying: "With the complexity of the 
central nervous system it would be irresponsible for the FDA to allow the 
widespread selling of aspartame without further independent study of the 
neurophysiological, neurobehavioral and neurochemical effects of high 
intakes of this drug at all ages using chronic studies.  I think it is 
foolish to ignore the complaints of millions of individuals reporting 
difficulties with this substance."

But, of course, the FDA doesn't want these studies done as Gregory Gordon 
pointed out. The FDA knows how deadly aspartame is, and once its documented 
there is no way to explain the marketing of a deadly drug that has caused a 
global plague.  As Dr. James Bowen told FDA years ago (on www.dorway.com) 
"....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. Bowen has also written about lupus and said the ability of methyl 
alcohol/formaldehyde to create antigenicity, especially as combined in 
aspartame molecules is so great as to cause severe autoimmune reactions to 
the tissues deformed by formaldehyde polemerization, adduct formation.  The 
immune system turns against the victim's tissues:  Lupus.  So why write as 
if it wasn't so when it is so easy to understand.  Dr. Roberts likewise has 
written about it in his medical text and says it mimics and can trigger lupus.

Visions problems likewise are on your FDA report and are so common they are 
#6 of 92 symptoms and include blindness.  But what would you expect when 
you approve a product with methanol that converts to formaldehyde and 
formic acid even in the retina of the eye and destroys the optic nerve.
The seizures and blindness are so common with aspartame use that in l986 
the Community Nutrition Institute in Washington, D.C. petitioned FDA to ban 
it on this basis.  So don't act like this is something FDA doesn't know, 
they documented it themselves and then refused to ban aspartame as 
blindness became epidemic.  And don't use words like "attempted to link" as 
FDA knows fully well what aspartame causes.  In fact, so well that it was 
disclosed in congressional hearings FDA was getting so many complaints they 
were referring them to the AIDS Hotline to get rid of them.  You say"When 
controlled scientific studies have been conducted to attempt to replicate 
these anecdotally reported adverse effects or uncover a mechanistic bases 
for their causation by aspartame"...  FDA attempts to prevent these 
controlled scientific studies from being accomplished while at the same 
time asking to be provided with credible scientific proof.  And you act 
like you don't know they exist when FDA wrote the report of the symptoms.

Furthermore, when scientific studies are done or peer reviewed reports 
rather than be accepted by FDA it rebuts them like Dr. Olney's study on the 
association of aspartame and brain tumors.

You say, "To date, the results of independent studies carried out in 
government, academic, and private laboratories consistently have been 
reassuring about the safety of aspartame.  FDA is aware of no reports of 
well-controlled clinical studies that would question the safety of 
aspartame under normal use conditions."  What a lie.  Ralph Walton, M.D. 
did a research paper for 60 Minutes showing that 92% of independent 
scientific peer reviewed studies show the problems aspartame causes.  This 
is on www.dorway.com And if you eliminate one pro-industry summation and 6 
studies that the FDA had something to do with, 100% of independent, 
scientific peer reviewed studies show the problems aspartame triggers.  I 
can understand why Dr. Walton said that since while the FDA should be 
independent, it is nothing more than the handmaiden of the pharmaceutical 
and chemical industry.  Only studies funded and controlled by the 
manufacturer have ever said aspartame was safe, and the manufacturers are 
pros at fixing studies as the FDA proved themselves.  Take the Rowan Study 
funded by Monsanto on aspartame and seizures.  They used 18 subjects for a 
one day study with one capsule of aspartame, and forgot to mention they 
gave anti-seizure medication to 16 of them. It's tantamount to smelling the 
bottle.  Then they get it peer reviewed with their power  with medical 
journals and claim they did a scientific peer reviewed study and aspartame 
doesn't cause seizures.  I was just reading today an article titled Why You 
Can't Trust Medical Journals Anymore by The Washington Monthly, April 1, 
2004 (Doctors Without Borders).  It talks about researchers with financial 
ties to drug and biotech companies.  It ends by saying "What are we to do 
with the knowledge that much of what passes as science in medicine is 
little more than gussied-up marketing?"
There is no way to trust industry or the FDA.  Dr. Ralph Walton himself did 
a study on aspartame and Monsanto refused to sell him the aspartame because 
they could not control it.  They obviously knew what would happen.  One man 
had a retinal detachment, another was bleeding from the eyes, conjunctival 
bleeding, and some said they were being poisoned.  The institution had to 
stop the study.

So you say:  "FDA is aware of no reports of well-controlled clinical 
studies that would question the safety of aspartame under normal use 
conditions."  Read Dr. Walton's report of all these independent studies 
that have shown that aspartame is not safe, and tell me why you lied when, 
in fact, FDA has seen them all.  No wonder a friend wears a button about 
the FDA that simply says:  "They lie and deny."

Then you want somebody to read your FDA Consumer Magazine with the well 
known reputation of being a propaganda rag supporting industry.  Shame on 
you Jeannine Ertter-Prego.

Physicians like Doctors Blaylock, Roberts, Olney, Walton and Bowen are 
giants as aspartame experts.  They don't lie like the FDA does, like you 
have in your note on aspartame.  If it wasn't for them putting out truthful 
information hundreds of thousands more would be dead.  You have proven my 
point in your note.  You put down any book that tells the facts on 
aspartame because you want to stumble the public and have them believe FDA 
lies.  We're not going to allow it to happen, that's why millions of 
anti-aspartame activists work free to get the truth all over the world.

I read the article in the New York Times about your coverup of the 
anti-depressants and suicidal tendencies.  Aspartame which depletes 
serotonin triggering manic depression, mood swings, SUICIDAL TENDENCIES, 
etc. is used by 70 per cent of the population and 40% of our kids.  And 
according to Dr. H. J. Roberts medical text, Aspartame Disease: An Ignored 
Epidemic, aspartame interacts with ALL antidepressants.  FDA couldn't let 
people know that.  When you tell one lie you keep on telling more to 
coverup the first ones.

Then FDA took ephedra off the market in violation of the Dietary Supplement 
Act to coverup the fact  aspartame damages the cardiac conduction system 
and causes sudden death.  And now that it's off the market and athletes are 
still dropping dead, what's your excuse!  Defibrillators are becoming as 
common as fire extinguishers!  Lots of information on www.wnho.net, just 
click on aspartame. Be sure you read the Diane Fleming story and her 
petition.  Charles Fleming played basketball four times a week while he was 
addicted to diet pop and other aspartame products for years.  It took his 
life. The police saw the methanol poisoning on autopsy and thought she 
poisoned him even though there was no evidence and she passed a lie 
detector test.  In fact, she was even the one who called the police.  She 
remains in a Troy, Virginia prison even though the FDA has been notified he 
died of aspartame and has done nothing.  It's this chronic methanol 
poisoning that affects the dopamine system of the brain and causes 
addiction.  And remember that methanol is classified as a narcotic and FDA 
allows it even in pediatric products.

What does it take for the FDA to stop serving above the law?  I filed a 
petition for recall almost two years ago and the law states that the FDA 
has 180 days to answer.  Obviously, they don't know how to answer it since 
I told the FDA its not based on safety because we know its not safe, its 
based on the fact that I have the FDA records showing it to be a chemical 
poison and the FDA continues to lie to the public.  I also stated I will 
not accept a packet of Federal Registers and a propaganda rag (FDA 
Consumer) as an answer as the FDA sends out when they can't answer questions.

I'm still waiting for the FDA to answer one of my letters, since its known 
for making allegations and never able to back them up.  I'm waiting for you 
to show me how you can say aspartame is safe when I have copies of your 
original records showing it not to be safe.

You people don't even have the decency to put a warning for pregnant women 
knowing full well that aspartame is a teratogen as discussed by Louis 
Elsas, M.D., Pediatric Professor, genetics. , below.  How many millions of 
babies have been murdered in their mother's womb because of your eyes.  You 
will notice also below Dr. Blaylock's excellent letter to the Miami Herald 
in answer to them publishing a letter from NutraSweet's front group, the 
Calorie Control Council.  Take a lesson in integrity from this outstanding 
physician.

You will also see below a press release on aspartame lawsuits, and this is 
only the beginning.  I leave you with the words of your own late FDA 
toxicologist, Dr. Adrian Gross, when he testified before Congress.  He said 
aspartame without a shadow of a doubt can trigger brain tumors and brain 
cancer, and violated the Delaney Amendment which forbid putting anything in 
food you know will cause cancer.  "And if the FDA violates its own laws who 
is left to protect the public?"  Obviously, the public has no protector 
because of the existence of your government agency pushing unsafe food and 
drugs while trying to snatch safe supplement for industry.

Dr. Betty Martini, Founder, Mission Possible International, 9270 River Club 
Parkway, Duluth, Georgia 30097  770 242-2599 www.dorway.com and 
www.wnho.net   See below for more reports



>>>Posted: 24 Apr 2004
>>>
>>>
>>>Miami Herald
>>>02 February 2004
>>>
>>>Dear Editor,
>>>
>>>It has come to my attention that the Calorie Control Council, a front group
>>>for the NutraSweet Company, recently suggested that aspartame was safe for
>>>women to use during pregnancy, as well as by those with serious liver
>>>disease and phenylketonurics. This is the most serious breech of public
>>>trust in the history of this nation. There is not one long-term study of
>>>aspartame safety ever conducted on the offspring of pregnant women
>>>consuming aspartame. Yet, there are numerous studies indicating aspartame
>>>could pose a serious danger to both mother and infant.
>>>
>>>For example, according to the National Collaborative Study for Maternal
>>>PKU, blood levels of phenylalanine, a major component of aspartame and a
>>>developmental brain toxin, should not exceed 6mg./dl. In a study of
>>>pregnant women it was found that aspartame consumption at commonly consumed
>>>amounts reached these levels in 42% of normal women and 100% of PKU
>>>carriers. One in fifty people are PKU carriers and do not know it. This
>>>same group concluded that levels of 10mg/dl held a serious risk of infant
>>>brain impairment. In this same study 15% of pregnant women reached this
>>>toxic level of phenylalanine and 36% of PKU carriers.
>>>
>>>This means that fully a third of all babies born to PKU carrier mothers
>>>consuming aspartame foods and drinks risk varying degrees of brain damage.
>>>It is also known that the amount of toxic phenylalanine reaching the baby
>>>is twice as high as that in the mother's blood because the placenta
>>>concentrates the toxin. In addition, numerous metabolic breakdown products
>>>of aspartame are known to damage the developing infant's brain, including
>>>methanol, formaldehyde, formic acid, diketopiperizine and phenylacetate.
>>>Aspartame has been shown by several studies to damage DNA, which can lead
>>>to cancer and degenerative brain disorders later in life. The risk of
>>>increased brain tumors in such a child would be enormous. Similar
>>>mechanisms of damage would be expected in those with liver disease. Studies
>>>on aspartame safety have shown that the product increases tumors throughout
>>>numerous organs, especially the brain. It was shown that brain tumor
>>>incidence increased over 47X in animals exposed to aspartame.
>>>
>>>With the public concern over childhood obesity and diabetes, few are being
>>>told of the overwhelming evidence that early exposure to excitotoxins (as
>>>found in aspartame) consistently produce gross obesity and insulin
>>>resistant diabetes, just as we are seeing in our youth.
>>>
>>>The promoters of aspartame use have been lying from the beginning and
>>>continue to use their money and political clout to cover up the real and
>>>present dangers of this toxic product.
>>>
>>>Russell L. Blaylock, M.D.
>>>Neurosurgeon
>>>Ridgeland, MS 39157
>>
>>                   EMORY UNIVERSITY SCHOOL OF MEDICINE
>>                         DEPARTMENT OF PEDIATRICS
>>              2040 Ridgewood Drive, N.E.  Atlanta, Georgia 30322
>>
>>Division of
>>MEDICAL GENETICS                                 (404) 727-5840
>>
>>Statement for the Labor and Human Resources Committee, U.S. Senate
>>
>>     I have considerable concern for the increased dissemination and
>>consumption of the sweetener, aspartame, (1-methyl N-L-a-aspartyl-L-
>>phenylalanine) in our world food supply.  This artificial dipeptide is
>>hydrolyzed by the intestinal tract to produce L-phenylalanine which in
>>excess is a known neurotoxin.  Normal humans do not metabolize phenylalanine
>>as efficiently as do lower species such as rodents and thus most of the
>>previous studies in Aspartame effects on rats are irrelevant to the
>>question, "does phenylalanine excess occur with Aspartame ingestion?".
>>
>>     Preliminary studies in my laboratory provide tentative positive answers
>>to both questions.  Many studies of both acute and chronic ingestion of 34mg
>>Aspartame/kg/day have demonstrated a two to five fold increase in semi-
>>fasting blood phenylalanine concentrations (from approximately 50 to 250 M)
>>without concomitant increases in tyrosine or other aminoacids.  The degree
>>of increase by normal humans depends on several variables including the
>>efficiency of tut transport, liver utilization, and growth rates.  It was
>>thought by many scientists and clinicians that this degree of phenylalanine
>>increase would not affect brain function.  However, currently available
>>information indicates that this is not true.
>>
>>    1.  In the developing fetus such a rise in material blood
>>        phenylalanine could be magnified four to six fold by
>>        the concentrative efforts of the placenta and fetal
>>        blood brain barrier.  Thus a maternal phenylalanine of
>>        150 M could reach 900 M in the developing fetal brain]
>>        cell and this concentration kills such cells in tissue
>>        culture.  The effect of such an increased fetal brain
>>        concentrations in vivo would probably be much more
>>        subtle and expressed as mental retardation,
>>        microcephaly, or potential certain birth defects.
>>
>>    2.  In the rapidly growing post-natal bran (children of 0-
>>        12 months) irreversible brain damage could occur by the
>>        same mechanism.
>>
>>    3.  In the adult we have found that changes in blood
>>        phenylalanine in these concentration ranges are
>>        associated with slowing of the electroencephalogram,
>>        and prolongation of cognitive function tests.
>>        Fortunately, these effects on the mature brain are
>>        reversible but provide clear evidence for negative
>>        effect on sensitive parameters of brain function.
>>
>>    In view of these new (and confirmation of old) research
>>findings I suggest the following:
>>
>>    1)  Immediate labeling of all aspartame-containing foods,
>>        so the consumer will know how much phenylalanine
>>        he/she is ingesting.
>>
>>    2)  Declare an immediate moratorium on addition of
>>        aspartame to more foods and remove it from all low-
>>        protein beverages, foods, and children's medications.
>>
>>    3) Provide funds not controlled by industry to:
>>
>>      a.  Allow active surveillance for potential side-effects
>>          of aspartame on newborns whose mothers dieted with
>>          Nutrasweet (aspartame) -containing foods.
>>
>>      b.  Allow active evaluation of other users whose
>>          complaints cannot be adequately studied at present.
>>
>>      c.  Clarify the dose relationship and mechanisms by
>>          which L-phenylalanine affects human brain function.
>>
>>     Respectfully submitted
>>
>>     Louis J. Elsas, II, M.D.
>>     Director, Division of Medical Genetics
>>     Professor of Pediatrics
>>
>>******************
>>
>>    The above statement was before the Committee of Labor and Human Resources
>>on the subject "Nutrasweet: Health and safety concerns", and dated  November
>>3, 1987.
>S. Hrg. 100-567
>"NUTRASWEET" - HEALTH AND SAFETY CONCERNS
>HEARING before the COMMITTEE ON LABOR AND HUMAN RESOURCES
>UNITED STATES SENATE
>ON HUNDREDTH CONGRESS
>FIRST SESSION ON EXAMINING THE HEALTH AND SAFETY CONCERNS OF NUTRASWEET
>(ASPARTAME)
>NOVEMBER 3, 1987
>STATEMENT BY DR. LOUIS J. ELSAS, II, M.D.
>DIRECTOR, DIVISION OF MEDICAL GENETICS
>PROFESSOR OF PEDIATRICS
>(pages 360 through 369 of S. Hrg. 100-567)
>       Senator Metzenbaum.  Dr. Elsas, since Senator Hatch saw fit to go into
>the funding question, I will ask you, are your studies funded by industry?
>       Dr. Elsas.  No, sir.  I had a research grant three years ago, for three
>years, from the March of Dimes, to study the effects of phenylalanine on
>human brain function. When the political issue got to aspartame, the society
>decided not to refund that. So all of the funding that is going on now - and
>the reason it is so slow has been through my own division's efforts,
>personal funds, and university-based fund.
>       Senator Metzenbaum.  What do you think of our present system for
>funding scientific
>research?
>       Dr. Elsas.  I think the NIH is superb, I think there is a lot of
>concern about how industry and the FDA interact, where industry is made
>responsible for developing the data to support its own contentions. There is
>not a broad enough scientific base, such as an RFA, as we can it at NIH -
>research funds available - requesting input from the whole scientific
>community, stating that funds are in an unbiased approach - what the
>questions are which we need to ask?  That is the problem here today.  The
>questions about phenylalanine effects on human brain function have not been
>asked.  So we have spent millions of dollars through our current system on
>mostly irrelevant experiments without approaching those particular
>questions.
>       Senator Metzenbaum.  What about the advertising campaign that
>NutraSweet puts on, and are you concerned about that?
>       Dr. Elsas.  Yes, sir.
>       Senator Metzenbaum.  In what way?
>       Dr. Elsas.  I am mostly concerned that it gives the false impression
>that NutraSweet is good for you, that it is nature's best, and that it might
>even be good for children to take.  A lot of the ads recently have shown
>children with the little ying and yang NutraSweet thing on it, making it
>sound like you should go with your mommy to the grocery store and look for
>that, and be sure that you buy that because it is real sweet and good.
>       Senator Metzenbaum.  Can you tell the Committee about your own
>experiences with the International Life Sciences Institute?
>       Dr. Elsas.  Yes, sir.  It was not good.
>       Senator Metzenbaum.  Who is that group, can you tell us?
>       Dr. Elsas.  Well, Dr. Dews is right here; he can probably give you more
>personal information about it, because I have never gotten any feedback from
>them.  But I was asked after issuing concerns both privately and then
>publicly on "Nightline" to give them a specific protocol for how I would
>approach these concerns.  I did this.  I wrote it up completely in a
>research grant format; submitted it through ILSI for their review, and
>basically, got a few phone calls from Dr. Dews over a prolonged period of
>time, stating that they had problems, but without ever a written peer review
>of criticism.
>       So I basically never got funded; that is the bottom line.  And the
>ideas are now reappearing three years later in other places funded by
>industry.
>       Senator Metzenbaum.  ILSI is pretty much the coordinating group for
>funding in the food and beverage industry, including pops, carbonated
>drinks, NutraSweet itself; is that correct?
>       Dr. Elsas.  As far as I know, that is correct, sir.  I am not an expert
>on ILSI; I have repressed that experience.
>       Senator Metzenbaum.  It is my understanding that Dr. Pardridge has to
>catch a plane, so I am going to pass on to him.  But I appreciate your
>testimony, Dr. Elsas, and I am only sorry Senator Hatch was not here to hear
>you comment on the fact that - at least, the inference; it is not a fact -
>that if the information
>or the research is not going to be supportive of their position, that
>sometimes one does not get supported by organizations such as ILSI,
>NutraSweet and others.
>       Do you think that general conclusion of mine might be inappropriate, or
>appropriate?
>       Dr. Elsas.  Sir, I think that is  very cogent and appropriate.
>       Senator Metzenbaum. Thank you very much.  Would you agree with that,
>Dr. Wurtman? Dr. Wurtman.  Yes, sir.
>       Senator Metzenbaum.  Thank you.
>       Dr. Pardridge, we are happy to hear from you, sir.
>       Dr. Pardridge.  Thank you, Senator, and thank you for having me.
>       I am a Professor of Medicine at the University of California, a
>practicing endocrinologist, and I have been doing neuroscience research on
>the blood-brain barrier transport of phenylalanine and other substances
>since 1970.
>       I believe in the discussion this morning, there are three key
>scientific food policy questions that have really not been  properly
>illuminated.
>      The first question is the dosage problem.  We are led to believe by the
>FDA this morning that the typical consumer will have 2 to 4 milligrams per
>kilogram of aspartame per day; that the 99th percentile intake is 34
>milligrams per kilograms per day; and that the advisable daily intake or ADI
>is 50 milligrams per kilogram per day.
>       Now, the layperson sitting in the audience is really in no position to
>analyze these esoteric numbers.  But if we put it in a different context and
>recognize that 50 milligrams per kilogram per day is equal to 5 servings of
>NutraSweet per 50-pound body weight, we are at great risk for
>overconsumption of NutraSweet.
>       All one has to do in this room is look up at that chart and ask
>yourself if a 50-pound or 60-pound 7 year-old is going to consumer 5 or 6
>servings of that per day.  If they are, then they have consumer 50
>milligrams per kilogram per day, of the advisable daily intake.
>       Now, an 11-year study in the literature has already shown this, that
>the average 7-to-12-year old, when made freely available to products like
>that, consumes 5 servings per 50-pound body weight per day , and up to 77
>milligrams per day.
>       Senator Metzenbaum.  That is the average?
>       Dr. Pardridge.  The average in children is the ADI - 5 servings per 50-
>pound body weight.  Ask yourself:  Would an average child have 5 servings? I
>think the answer is yes.
>       Another study by Porikos in obese subjects showed that the average
>intake was 20 milligrams per kilogram per day, or 2 servings per 50-pound
>body weight, and that obese adults consume up to 36 milligrams per kilogram
>per day, even in the face of that high body weight.
>       Now, if you accept the premise of the first question, that some
>individuals and in fact many children consume near the advisable daily
>intake of 50 milligrams per kilogram per day, then you must ask yourself
>what level of increase in blood phenylalanine will be concomitant with that
>ingestion of NutraSweet.  And the answer is that your blood phenylalanine
>will rise three-to four-fold.  That is not 10 percent or 20 percent.  That
>is 300 to 400 percent.  And this study has been done by Drs. Stenink and
>Filer, which was funded by the industry.
>       If you now accept that many individuals, particularly children, consume
>50 milligrams per kilogram per day, or 5 servings per 50-pound body weight
>per day, and that they enjoy or a four-fold increase in their blood
>phenylalanine, the third question that must now be addressed is, are there
>any untoward effects on the human brain, that are associated with a four-
>fold increase in phenylalanine, bearing in mind that this molecule is a
>known neurotoxin?
>       And three studies come to mind.  One study shows that when blood
>phenylalanine in pregnant mothers is increased five-fold, there is a 10-
>point drop in the I.Q. of the baby born of that mother.
>       Senator Metzenbaum.  Of I.Q.  All right.
>       Dr. Pardridge.  A second study shows that if you measure choice
>reaction time, a test of higher cognitive function in humans, that when
>their bloom phenylalanine is increased six-fold, there is a 10 percent shift
>in your ability to make a key decision before a video screen.
>       And a more recent study by Dr. Elsas has shown that there are
>quantitative changes in the human electroencephalogram when the blood
>phenylalanine is raised three-fold - something that clearly will happen in
>children who consume near 5 servings per 50-pound body weight.
>       So if I may summarize, phenylalanine, is a known neurotoxin, and the
>food industry added nearly 8,000 tons of aspartame to the food supply in
>1986, which amounts to approximately 8 million pounds of phenylalanine added
>to our food supply in a single year.
>       The consumption of aspartame has increased exponentially since its
>introduction in 1981.  The 1986 consumption of aspartame in the United
>States was equal to nearly 22 percent of the 1986 consumption of refined
>sugar when one allows for a 200-fold increase in sweetener potency of
>aspartame relative to sugar.
>       With the enormous selective infusion of phenylalanine into the food
>supply, the key questions before the United States Congress and other
>scientific and medical organizations are whether selective increases in the
>blood phenylalanine level on the order of 200 micromolar or four- fold above
>normal, are to be expected with liberal intake of aspartame, and whether
>blood phenylalanine increases of this magnitude have untoward effects on the
>human brain.
>       Thank you.
>       (The prepared statement of Dr. Pardridge follows:)  Page 369
>
>
>Aspartame Lawsuits Filed Against Some of World's Largest Companies For 
>Poisoning Consumers
>
>Leading Fortune 500 Companies, Coke, Pepsi, Walmart, Kraft General Foods, 
>etc. filed against for knowingly poisoning the public with aspartame
>
>SACRAMENTO, CA (PRWEB) April 24, 2004--ASPARTAME LAWSUITS ACCUSE MANY 
>COMPANIES OF POISONING THE PUBLIC. Defendants in the lawsuits include 
>Coca-cola, PepsiCo, Bayer Corp., the Dannon Company, William Wrigley Jr. 
>Company, Walmart, ConAgra Foods, Wyeth, Inc., The NutraSweet Company, and 
>Altria Corp. (parent company of Kraft Foods and Philip Morris).
>
>Lawsuits were filed in three separate California courts against twelve 
>companies who either produce or use the artificial sweetener aspartame as 
>a sugar substitute in their products. The suits were filed in Shasta, 
>Sonoma and Butte County, California.
>
>The suits allege that the food companies committed fraud and breach of 
>warranty by marketing products to the public such as diet Coke, diet 
>Pepsi, sugar free gum, Flintstone's vitamins, yogurt and children's 
>aspirin with the full knowledge that aspartame, the sweetener in them, is 
>neurotoxic.
>
>Aspartame is a drug masquerading as an additive. It interacts with other 
>drugs, has a synergistic and additive effect with MSG, and is a chemical 
>hyper-sensitization agent. As far back as 1970, Dr. John Olney founded the 
>field of neuroscience called excitotoxicity when he did studies on 
>aspartic acid, which makes up 40% of aspartame, and found it caused 
>lesions in the brains of mice. He made world news on the aspartame/brain 
>tumor connection in l996. Dr. Ralph Walton, Professor and Chairman of the 
>Department of Psychiatry, Northeastern Ohio Universities College of 
>Medicine has written of the behavioral and psychiatric problems triggered 
>by aspartame-caused depletion of serotonin.
>
>Aspartame causes headache, memory loss, seizures, vision loss, coma and 
>cancer. It worsens or mimics the symptoms of such diseases and conditions 
>as fibromyalgia, MS, lupus, ADD, diabetes, Alzheimer's, chronic fatigue 
>and depression.
>
>Aspartame liberates free methyl alcohol. The resulting chronic methanol 
>poisoning affects the dopamine system of the brain causing addiction. 
>Methanol, or wood alcohol, constitutes one-third of the aspartame molecule 
>and is classified as a severe metabolic poison and narcotic.
>
>Recent news is full of reports of world-class athletes and other healthy 
>consumers of aspartame suddenly dropping dead. Sudden death can occur from 
>aspartame use because it damages the cardiac conduction system.
>
>Dr. Woodrow Monte in the peer reviewed journal, Aspartame: Methanol and 
>the Public Health, wrote: "When diet sodas and soft drinks, sweetened with 
>aspartame, are used to replace fluid loss during exercise and physical 
>exertion in hot climates, the intake of methanol can exceed 250 mg/day or 
>32 times the Environmental Protection Agency's recommended limit of 
>consumption for this cumulative poison."
>
>The effects of aspartame are documented by the FDA's own data. In 1995 the 
>agency was forced, under the Freedom Of Information Act, to release a list 
>of ninety-two aspartame symptoms reported by thousands of victims. This is 
>only the tip of the iceberg. H. J. Roberts, MD, published the medical text 
>"Aspartame Disease: An Ignored Epidemic" -- 1,000 pages of symptoms and 
>diseases triggered by this neurotoxin including the sordid history of its 
>approval.
>
>Since its discovery in 1965, controversy has raged over the health risks 
>associated with the sugar substitute. From laboratory testing of the 
>chemical on rats, researchers have discovered that the drug induces brain 
>tumors. On Sept 30, l980 the Board of Inquiry of the FDA concurred and 
>denied the petition for approval. In l981, the newly appointed FDA 
>Commissioner, Arthur Hull Hayes, ignored the negative ruling and approved 
>aspartame for dry goods. As recorded in the Congressional Record of 1985, 
>then CEO of Searle Laboratories Donald Rumsfeld said that he would call in 
>his markers to get aspartame approved. Rumsfeld was on President Reagan's 
>transition team and a day after taking office appointed Hayes. No FDA 
>Commissioner in the previous sixteen years had allowed Aspartame on the market.
>
>In 1983, aspartame was approved for use in carbonated beverages. Today it 
>is found in over 5000 foods, drinks and medicines.
>
>Neurosurgeon Russell Blaylock, MD, author of "Excitotoxins: The Taste That 
>Kills" (http://www.russellblaylockmd.com) wrote about the relationship 
>between aspartame and macular degeneration, diabetic blindness and 
>glaucoma (all known to result from excitotoxin accumulation in the retina).
>
>All of these neurodegenerative diseases are worsened by aspartame. In 
>addition, we now have evidence that excitotoxins play a major role in 
>exacerbation of MS and other demyelinating disorders including trigeminal 
>neuraliga. Blaylock says that new studies show excitotoxins trigger 
>significant elevation of free radicals in the lining (endothelial cells) 
>of arteries, which means that aspartame will increase the incidence of 
>heart attacks and strokes (atherosclerosis).
>
>In original studies, aspartame has triggered brain, mammary, uterine, 
>ovarian, testicular, thyroid and pancreatic tumors.
>
>Plaintiffs have asked for an injunction to stop companies from producing, 
>manufacturing, processing, selling or using aspartame.
>
>Plaintiffs in all three cases are seeking a jury trial.
>
>If you would like to schedule someone from the National Justice League for 
>an interview, please call or fax us at 208-246-1171.
>
>Roberta Bellon, Public Relations
>
>NATIONAL JUSTICE LEAGUE
>http://www.nationaljusticeleague.com
>2205 Hilltop Dr. Ste. 2022
>Redding, Ca 96002
>Phone: 208-246-1171
>California: 530-248-3483
>Cell Phone: 208-890-0034
>E-mail: info@nationaljusticeleague.com
>
>FOR INFORMATION ON ASPARTAME:
>http://www.dorway.com
>http://www.wnho.net
>
>You can also contact Dr. Betty Martini, Founder, Mission Possible Intl, 
>9270 River Club Parkway, Duluth, Georgia 30097 USA 770-242-2599
>
>This release is issued by courtesy of:WORLD NATURAL HEALTH ORGANIZATION 
>(for further information on this Breaking News and History of 
>Aspartame)     http://www.wnho.net
>
>
>
>Contact Information
>
>Betty Martini
>MISSION POSSIBLE INTERNATIONAL
><http://www.wnho.net, www.dorway.com>http://www.wnho.net,

>  www.dorway.com
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At 08:35 PM 6/29/2004,


>Hi Betty,
>
>This message was sent to the FDA by a longtime
>listener...the response he received is typically
>disgusting.
>
>Best wishes,
>Jeff
>
>PS -  More and more foods...even in 'health food' stores...
>are showing up with a new ingredient on their package
>labels:  'Natural Flavors'.
>
>
>
>-----Original Message-----
>
>From: Name Protected
>Sent: Friday, June 25, 2004 5:01 PM
>To: Ertter-Prego, Jeannie (FDA)
>Subject: Comment submitted via CFSAN QA-ASK
>
>Personal Information
>Name: xxxx xxxxx
>Email: xxxxxxxx
>
>Comment:
>The drugs aspartame & MSG in foods are as often as not not even indicated as
>being contained in food products [link below]. Fact of the matter is,
>neither should even be on the market.
>
>When is FDA going to do something about this?
>
>http://www.rense.com/general35/hidd.htm
>
>Sincerely,
>
>
>
>
>From: "Ertter-Prego, Jeannie" <Jeannie.Ertter-Prego@cfsan.fda.gov>
>To: "'miclevy@aol.com'" <miclevy@aol.com>
>Subject: RE: Comment submitted via CFSAN QA-ASK
>Date: Tue, 29 Jun 2004 08:47:20 -0400
>
>Mr. xxxx:  Both of these are approved food additives, not drugs.  Currently,
>there are no indications other than sensitivities that have been presented
>to the agency.  We continue to review all additives as part of our post
>market surveillance program.