Note to the Reader:  Dr. Fink is on the MIT Brain Tumor List
and refuses to allow aspartame information.  Keep in mind
that Dr. Richard Wurtman of MIT at one time was a critical
opponent of NutraSweet.  If you read the UPI Investigation
on www.dorway.com you will see that he was threatened by
Searle that if he did seizure studies on aspartame he no
longer would get research funds, and they were rejected.
Today MIT does get research funds and Dr. Wurtman no longer
speaks out about aspartame.  However, he left a paper trail
including the book:  Dietary Phenylalanine and Brain
Function, Edited by Richard J. Wurtman, and Eva Ritter-
Walker, Birkhauser.  Phenylalanine is 50% of aspartame and
Dr. Wurtman told Congress that as an isolate it is
neurotoxic and goes directly in the brain.  It lowers the
seizure threshold and depletes serotonin.  Aspartame breaks
down to diketopiperazine (DKP) a brain tumor agent.  There
is a river of information and government documents on
www.dorway.com   We are now taking case histories for class
action having to do with aspartame triggered brain tumors,
seizures, blindness and eye deterioration.  If you are a
victim please email me with contact information.

There was a great attempt to get information to brain tumor
victims on MIT's brain tumor list  of over 1000.  This was
blocked by Dr. Fink, and I was refused posting privileges.
Here is the debate below.   Betty Martini, Founder, Mission
Possible International (770 242-2599).

Dear Dr. Fink:

You said: "But until someone shows me scientific evidence
that aspartame causes brain tumors, long winded postings on
aspartame do not belong on this Brain tumor list, in my
opinion."

First of all, nobody could put long winded statements about
anything on this list because there is a 250 word limit.
Secondly, you want someone to show you scientific evidence
that aspartame causes brain tumors, but when I do you don't
look at the research and disregard everything I say.  You
said in one post that the information on www.dorway.com was
unscientific.  I asked you to explain how peer reviewed
research is "unscientific".  I notice you refrain from
answering such questions when you're wrong.  Peer reviewed
research is listed under the name of Dr. Ralph Walton who
showed this research on 60 Minutes in l996 when the famed
Dr. John Olney who founded the field of neuroscience called
excitotoxicity made world news on the brain tumor/aspartame
association.  Dr. Olney is probably one of the most famous
neuroscientists on the planet today.  Look at his curriculum
vitae on www.dorway.com  and you'll see its one of the most
prestigious you've ever seen.  He was the one who did the
studies on aspartic acid in l970 (40% of aspartame) and
found that it caused lesions in the brains of mice.  He told
Searle, the original manufacturer, but they did not tell the
FDA until after it was approved.

Dr. Olney update is also on this web site.  And you'll find
a journal article on brain tumors by Dr. H. J. Roberts, peer
reviewed.  When 2/3rds of the population is using a product
that breaks down to a brain tumor agent (DKP) and triggered
brain tumors in original studies, do you not think its
important enough to investigate as I asked?  Why would you
turn away from this research.

Below are three reports from the FDA toxicologist on site
having to do with aspartame studies, Dr. Adrian Gross.  The
last two letters to Senator Metzenbaum were written after he
left the FDA, although he testified in Congress and said
that aspartame violated the Delaney Amendment because
"without a shadow of a doubt" it can trigger brain tumors.
The Delaney Amendment forbid putting anything in food you
know will cause cancer.  In the second letter he lists all
the brain tumors.  Obviously, you've seen this report and
have known all along.  After all how can you say you know
what is on www.dorway.com if you've never been there?
Notice brain tumor after brain tumor, astrocytoma, meningeal
sarcoma, medulloblastoma, etc.  Dr. Gross' last words to
Congress were "And if the FDA violated its own law who is
left to protect the public?"  Quote taken directly from the
Congressional Record.  Now remember the FDA violated the law
because it approved aspartame even though without a shadow
of a doubt it triggers brain tumors.  And Dr. Gross was
there!!!!!!!!!!

And in the end the finest scientists the FDA had to offer
set up a Board of Inquiry and it was their decision that the
petition of Searle should be revoked and aspartame not
approved for two reasons, that aspartame had not been proven
safe and because it had triggered brain tumors. The
summation is on the web site and soon the entire report will
be scanned in.

I wrote you about the new medical text that goes into the
brain tumors and seizures triggered by aspartame.  Aspartame
Disease: An Ignored Epidemic, www.sunsentpress.com or 1 800
814 - 9800  I explained how important it was because there
are so many people on this list who are having seizures and
taking such drugs as Dilantin, and aspartame interacts with
Dilantin.  A physician concerned with the consumer would
want those brain tumor victims warned so they wouldn't use
this neurotoxic drug with Dilantin and like drugs.  But
instead of being concerned you simply didn't want to discuss
it.  Why would you shrug off something as important as drug
interaction when so many people on this list are using such
drugs.  Why are you not concerned about them having
reactions?

Even a former FDA Investigator wrote you about the
seriousness of this issue, and still you're not concerned.

Then you have the gall to lie about me on this list saying
about when I lectured for the World Environmental Conference
"There is evidence that she never attended the meeting, and
that the allegations she made are totally false (in a
message from the person who allegedly make the statements."
You've been on www.dorway.com so you've seen my invitation
to speak for the World Environmental Conference and my
correspondence with Dr. Gaylord who gave the keynote
address.  (www.dorway.com/nomarkle.html)   And when you
mentioned this Jay Reynolds who has tried to cover it up, I
sent you a post from Dr. Gaylord to myself admitting I was
there and lectured.   Finding out you were wrong rather than
apologize and put it on the list so they won't think your
misinformation was correct, you continue to complain about
my posting of it.  If you're wrong, be man enough to admit
it.

And you say:  "Betty Martini is not benign or sincere.  Her
entire "crusade" is based on her reported attendance at a
meeting (years ago) in which aspartame was being discussed."
Another lie.  I founded Mission Possible International
before I ever lectured for the World Environmental
Conference.  The reason it is so well known is that Nancy
Markle picked up a post I had written about it from
www.dorway.com  published it under her name, and then a
global networker put it on 450 global networks and it made
world news.  Why did she do it?  I didn't know her at the
time, but Shoshanna had just gotten a divorce because her
husband got lupus from aspartame with the usual mood swings,
and she didn't want it to happen to anyone else.  Monsanto
set up front groups on the Internet and did everything
possible to put out the fire but couldn't and sold the
NutraSweet Company.

I have received at least 10 calls about it today, and this
is the year 2002 and I lectured in l995.  Some call it a
fluke, but I know exactly why they can't put out the fire.
I mentioned so many problems triggered by aspartame that
anyone who saw it who was using it, saw their symptoms no
physician could diagnose and got off of it.  When they got
well they made 5000 more copies.  It continues to be
published in countries all over the world.  We had to set up
4 support groups just to handle the victims and today there
are 5 aspartame detoxification centers in the United States.
Even if people saw the post and didn't use aspartame they
knew many people with those symptoms.  It is a crime against
humanity to cover up such symptoms because it ties the hands
of physicians who then can't diagnose their patients.  And
aspartame interacts with just about every drug used to treat
the problems it causes as outlined in the medical text, and
the reason it was written was so that finally physicians
would have the facts instead of fantasy that looks like it
was written by little Red Riding Hood.

Neurosurgeon Russell Blaylock, M.D., author of Excitotoxins:
The Taste That Kills says about aspartame and brain tumors
on page 212 - 213:

"It is interesting to note that the first experiments done
to test the safety of aspartame before its final approval in
l981 disclosed a high incidence of brain tumors in the
animals fed NutraSweet.  In fact, this study was done by the
manufacturer of NutraSweet, G. D. Searle.  In this study 320
rats were fed aspartame and 120 rats were fed a normal diet
and used as controls.  The study lasted two years.  At the
end of the study twelve of the aspartame fed rats had
developed brain tumors (astrocytomas), while none of the
control rats had.  This represented a 3.75% incidence of
brain tumors in the rats fed aspartame, which was twenty-
five times higher than the incidence of spontaneous brain
tumors developing in rats (0.15%). "

"The study divided the rats into those exposed to low doses
of aspartame and those exposed to a high dose.  In the low
dose group five of the rats developed brain tumors for and
incidence of 3.13%.  In the high dose group, seven developed
brain tumors (4.38%).  This indicates a dose related
incidence of brain tumors.  The higher the dose of
aspartame, the more brain tumors were induced. "

"When Dr. John Olney pointed out these findings to the FDA
"Aspartame Board of Inquiry" he was told that the high
incidence of tumors was the result of spontaneous
development of brain tumors in rats.  That is, that some
rats develop brain tumors naturally, just as humans do.  Dr.
Olney is a trained neuropathologist as well as a
neuroscientist.  He reviewed the incidence of spontaneously
occurring brain tumors in rats and found that out of seven
studies using a total of 59,000 rats and only 0,08%
developed brain tumors - the aspartame fed rats had a forty-
seven fold higher incidence.  But to be fair, he even
accepted G. D. Searle's references for spontaneously
developing brain tumors in rats and arrives at a figure of
0.15%.  This was still a twenty-five fold higher incidence
in the aspartame fed rats than in the controls. "

"It was then observed that when brain tumors develop
spontaneously in rats, the rate at which they appear begins
to accelerate after two years of age, exactly when the
Searle's study ended.  Importantly, brain tumors are
extremely rare before age one and one-half in the rat.  So
in truth the incidence of spontaneously occurring brain
tumors would be even less than cited above.  Yet, the
aspartame fed rats developed two tumors by sixty weeks of
age and five tumors by seventy weeks."

"In a collective study of 41,000 rats no tumors were seen to
occur before sixty weeks and only one by seventy weeks.  The
fact that 320 aspartame fed rats developed six brain tumors
by seventy-six weeks indicates an "incredible and
unprecedented" occurrence.  Within the final twenty-eight
weeks of the study six more brain tumors occurred in the
aspartame fed group.  Dr. Olney notes that "one must assume
that many more (brain tumors) would have occurred after 104
weeks. "

"It became obvious that the G. D. Searle Company was trying
desperately to protect their potential billion dollar plus
money maker.  They claimed that more brain tumors were found
because they searched the pathological slides so diligently.
But, they searched just as diligently in the control rats
and found none.  Besides, neuropathologists examining the
slides later stated that the tumors were large enough to be
seen with the naked eye. "

"Because of the criticism submitted by Dr. Olney, the G. D.
Searle company conducted a second study which was designed
to be more comprehensive.  Instead of a two-year study, this
would span the entire lifetime of the rats, from
intrauterine life to death.  The results of this study can
only be characterized as bizarre.  This time they reported
five brain tumors in 120 control rats (an incidence of
3.13%) and four brain tumors in 120 control rats (an
incidence of 3.33%).  While this was designed to show that
aspartame was not the cause of the brain tumors, if
accepted, the study would indicate that both groups had a
brain tumor incidence thirty times higher than the known
rate of spontaneous brain tumor occurrence in rats."

"But the story gets even more interesting, Dr. Olney
hypothesized that one possible cause of the tumor induction
was a by-product of aspartame metabolism called
diketopiperazine (DKP).  When nitrosated by the gut it
produces a compound closely resembling a powerful brain
tumor causing chemical - N-nitrosourea. "

"The G. D. Searle company conducted a separate study to test
the carcinogenicity of diketopiperazine (DKP).  The results
of this study were not submitted to the FDA until after
aspartame had already been approved for general use by the
American population.  This study was not a lifetime study
but rather a 115 week study which consisted of feeding rats
their normal feed mixed with DKP.  There were 114 control
animals and 216 that supposedly ate the DKP.  (Not all of
the animals were even examined for tumors.)  There were two
brain tumors in the controls (1.62% incidence) and three
(1.52% in the DKP groups.  But strangely enough, the
incidence of brain tumors found in both groups were sixteen
times higher than would be expected from spontaneous
occurring tumors.  That did not make sense."

"So how can we explain these strange findings?  It is
instructive at this point to know that in l975 the drug
enforcement division of the Bureau of Foods investigated the
G. D. Searle company as part of an investigation of
"apparent irregularities in data collection and reporting
practices."  The director of the FDA at that time stated
that they found "sloppy" laboratory techniques and "clerical
errors, mixed-up animals, animals not getting the drugs they
were supposed to get, pathological specimens lost because of
improper handling, and a variety of other errors, (which)
even if innocent, all conspire to obscure positive findings
and produce falsely negative results."

"The drug enforcement division carried out a study under the
care of agent Jerome Bressler concerning Searle's laboratory
practices and data manipulation (known as the Bressler
Report ("Note from Martini - this FDA audit is on
www.dorway.com ")  He found that the feed used to test DKP
had been improperly mixed so that the animals would receive
only small doses of the chemical to be tested.  (I have seen
a photograph of the feed mix and can attest to the "sloppy"
method used.)  The commissioner also charged G. D. Searle
company with "failure to maintain control and experimental
animals on separate racks and failure to mark animals to
ensure against mix-ups between experiments (animals fed
aspartame and DKP) and controls."  This vital and telling
report was buried in a file cabinet, never to be acted on by
the FDA."

"Such poor techniques would explain why both control animals
and those eating aspartame had exceptionally high brain
tumor rates, since they, most likely, were both eating the
aspartame feed.  What is ironic is that the FDA would accept
studies from a company with an obvious heavy financial
interesting in having aspartame approved.  But even more
amazing is that they would depend on the same company to
provide studies that they, FDA, knew beforehand were highly
questionable and possibly fraudulent upon which they would
make such an important public safety decision."

"Thus far, no independent studies have been done to examine
this vital issue.  As a neurosurgeon I see the devastating
effects a brain tumor has, not only on its victim, but on
the victim's family as well.  To think that there is even a
reasonable doubt that aspartame can induce brain tumors in
the American population is frightening.  And to think that
the FDA has lulled them into a false sense of security is a
monumental crime."    (end of quotes from book)

I'm going to stop at this point from quoting the book
although it goes on, and even discusses the association of
primary brain lymphoma and aspartame, a particularly nasty
tumor with a high mortality rate.  He discusses Dr. Roberts
research in this issue and you can read the peer reviewed
journal article on web.

Now you can tell me I'm long winded, because I had to bring
you information on brain tumors because of your lack of
interest and constant denials.  When there is even the
suspicion that a product being used by 2/3rds of the
population triggers brain tumors, it should be your first
concern.  And after I told you about the interaction of
anti-seizure medication with aspartame and the fact that it
is documented in Dr. Roberts new medical text, did you not
feel the people on this list had the right to know?

And it doesn't stop here.  We have the secret trade
information on web as well which was volunteered during
congressional hearings.  It reads like psychomanipulation to
get aspartame approved but in the last paragraph Searle
mentions they have to consider almost complete conversion to
DKP and if they tell the FDA they are not going to get it
approved, and of course, DKP is the brain tumor agent.

And what about human studies?  Can you imagine people
signing up for a study on aspartame to see if they would
develop a brain tumor?  So Searle decided not to let them
know.  They carried out studies in six countries and
sacrificed people in poor villages that would not be missed.
They just lied to the people and told them that NutraSweet
was simply made out of papaya, a lie, and it was perfectly
safe to use.  The studies lasted 18 months and many of the
people developed all kinds of seizures and astrocytomas,
glioblastomas, etc.  Some of them died just so Searle would
know for sure!  And when they found out that aspartame is a
killer rather than publish the studies they simply sold the
company to Monsanto in l985.  Studies completed in l984.
You will find the affidavit of the translator on web, N.
Vera  But the studies showed other things like the fact
aspartame destroys the brain and the central nervous system.
And just recently in Norway a new study has shown that
aspartame destroys the brain.

The FDA never wanted aspartame approved, they wanted Searle
indicted for fraud.  Searle was even excising these brain
tumors from the rats and then putting them back in study.
When the rats died they simply resurrected them on paper.
Want it from the record?

FDA Toxicologist and Task Force member, Dr. Adrian Gross
stated (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 1984; page S5499 of Congressional
Record l985a).

And don't think that Searle didn't get caught.  When they
were found removing the brain tumors their excuse was that
the rats couldn't breathe well.  But how many brain tumors
did they remove before they were caught?  FDA toxicologist,
Dr. Adrian Gross, gave several reasons why Searle's
misconduct invalidated their experiments and one was: "It is
highly unlikely that 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."

But Searle needed help to coverup the issue so on August 4,
l976 they met with the FDA and convinced them to allow them
to hire  a private agency, University Associated for
Education in Pathology (UAREP).  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.  Why did the FDA choose to have
pathologists conduct an investigation when even some FDA
officials acknowledged at the time that UAREP had a limited
task which would only partially shed light on the validity
of Searle's testing?  The answer is not clear."

In other words, UAREP was sworn to silence, and how much did
they get to be quiet?  They received a half a million
dollars!!!

Searle was intent on getting aspartame approved.  They had
invested 19.7 million dollars in an incomplete production
facility and 9.2 million dollars in aspartame inventory.  On
Dec 8, l975, stockholders filed a class action lawsuit
alleging that G. D. Searle had concealed information from
the public regarding the nature and quality of animal
research at G. D. Searle in violation of the Securities and
Exchange Act (Farber l989, page 48).

Now Dr. Fink you do know a little about aspartame.  Because
you not only refused to take an interest in this issue, but
also tried to make it look insignificant, I'm sending a copy
of this to the list by blind copy.  How dare you say to the
group that I am insincere.  I don't get paid for warning the
world and educating them.  Mission Possible International, a
worldwide volunteer force, warning consumers off aspartame
is funded by my husband's retirement funds.  I don't sell
anything.  I'm sincere enough to care about the lives of the
people.  Because you have refused to tell them that
aspartame interacts with anti-seizure medication I've had to
write privately to each person and warn them.  I'm the one
taking case histories all day and have for years.  I'm the
one that gets the calls when a mother who didn't know
aspartame is a teratogen gives birth to a baby with a brain
tumor.  I'm the one who Kelli Motluck, a heavy user of
aspartame, called when she developed glioblastomas.  She
said I want to live, I want to live, I want to live and if I
die you tell the world Monsanto Chemical Company murdered
me.  When I lectured to the press, the regulatory people and
industry in London (filmed) I complied with Kelli's request.
Cyndi Veth cried, I'm so very young to have a brain tumor.
She drank lots of Diet Coke.

And the issue is so well documented that we are now taking
case histories for class action having to do with the brain
tumors, seizures and blindness triggered by aspartame.  A 52
week oral toxicity infant monkey study used pivotal in the
approval of aspartame, showed that out of 7 infant monkeys
fed aspartame, 5 had grand mal seizures and one died.

Today Dr. Peter Nunn in London is doing research on
aspartame and brain tumors.  Be assured that anyone who has
posted in the last year will get a copy of this note.  And
even though you owe me an apology more importantly these
people on the list have the right to know that a product
estimated to be in 9000 products and climbing and 100
countries of the world triggers brain tumors.  Now they will
know to avoid it, and they will know what went on in the
approval process and they can check out www.dorway.com And
if you consider all these government records, the damning
Center for Disease Control investigation, secret trade
information, peer reviewed research, and a river of
information from physicians unscientific, I don't think they
will.  They can even go to the Aspartame Toxicity Center,
www.holisticmed.com/aspartame and read the horror stories
that pour in from the victims.  They can also read the
archives of the Aspartame Support Groups.

And for your information aspartame also triggered mammary,
uterine, ovarian, pancreatic, testicular and thyroid tumors
just for starters, not just brain tumors.  There were also
pituitary adenomas.  There is one lady on this list who
wrote me about her aspartame brain tumor before she got on
this list.  Her boyfriend served in the Persian Gulf where
diet sodas sat on pallets for as long as 8 weeks at a time,
and the troops drank them all day.  She was in a support
group with 70 of those vets - all with brain tumors.  If
they had only had the research on web they never would have
used the product.

I read every email on this list and many people are using
drugs that interact with aspartame.  They have the right to
know.  Now read on for Dr. Adrian Gross' letters, on-site
FDA toxicologist.  And I hope you took the note from the
former FDA Investigator very seriously.

And as to the herb situation, a man who grows them  was
visited by government officials about even growing or
selling these three herbs mentioned. However, I am grateful
for someone finding where they can be attained.  They are
getting a thank you by copy of this note.  Physicians
mentioned in this report are also getting a copy as well.
Dr. Fink, the coverup is over - period.

Betty Martini, Founder, Mission Possible International
770 242-2599
9270 River Club Parkway
Duluth, Georgia 30097

See Dr. Gross' letters below ---

Note: This is in three parts: Dr. Gross 1976 DHHS/FDA memo
to Dr. Sharp on irregular proposal Dr. Gross 1987 Oct.
Letter (reply) to Senator Metzenbaum Dr. Gross 1987 Nov.
Letter (follow-up) to Senator Metzenbaum

-------------------------------------------------------------

 (Note: This memo is on DHHS stationary) To : Mr. Carl Sharp
Date: Nov. the 4th, 1976 From : M. Adrian Gross Subject :
Draft Agreement for Validation of Searle Aspartame Studies.)

 The following are some comments which you requested on the
document under reference as well as on the cover memorandum
Wylie/Gardner dated November 1, 1976.

I must confess that I became deeply disturbed on reading
this effort - last July 14th in a telephone conversation I
had with Commissioner Schmidt during which I stated my
reservations about this entire plan, he assured me that
whatever is being contemplated in this area will be
undertaken in full knowledge of and consultation with some
of us who were intimately involved with the Searle
investigations and that whatever is finally accepted will be
of such nature as not to jeopardize or undermine all of our
previous work. Given this kind of background I suffered a
rude shock by the proposed plan in front of us at this time.

Let us put this matter in some perspective by establishing
the basic facts here. The Searle investigation which started
in the Fall of 1975 can be viewed as an investigation "for
cause" following the discovery of certain improprieties in
the conduct of animal studies during preliminary inspections
in the 1974 and in the first half of 1975. The report of the
Task Force submitted i March of 1976 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.

The Aspartame studies to which we have reference here are
nothing but an extension of the studies which were reviewed
by the Task Force. I see no essential difference between
them and any of the studies already investigated. In the
meantime this Agency as received a substantial amount of
additional funding for the express purpose of monitoring the
quality of research carried out by regulated industry in a
much expanded fashion. As part of this program, there has
been a marked degree of effort, time and money expended on
setting up sundry task forces, steering committees, training
courses for investigators, "surveillance" inspections,
regulations for good laboratory practices, compliance
programs, etc.

Yet, notwithstanding any of this, now that the Agency is
confronted with the need of completing what it started out
to do in this Searle matter, we seem to be turning to an
outside group of questionable capability in this area:- the
UAREP. I know absolutely nothing of the past experience of
this outfit to carry out investigations of this sort -
perhaps, whoever it was that selected this group to carry
out our responsibilities for us might be as kind as to
enlighten us on this point. I noted the name of Dr. Stowell
associated with this organization - I have known Dr. Stowell
for many years now from the time he was Scientific Director
of the Armed Forces Institute of Pathology and I can readily
agree that he has impeccable credentials and a remarkable
achievement in his own field of pathology; as far as
investigations of the sort that we are concerned with here,
however, I would judge him to be a complete neophyte in this
particular area. I also know nothing of the others at UAREP
to do the actual "hands-on" part of the investigation - we
need additional details here but I would doubt very much
that UAREP could come up with a number of workers who are
both experienced and competent in matters of this sort.

Speaking as a pathologist, I seriously question the wisdom
of selecting a group of pathologist to oversee the kind of
investigations that are called for here; pathology problems
do not constitute but a small part of the difficulties
involved in situations such as these. My own experience is
that, as a rule, controversial technical aspects in
pathology proper (such as whether any particular
characterization of any given lesion is a proper one or not)
are \seldom an important factor in a determination whether
any study contains serious flaws. this has been amply
demonstrated in the extensive Searle investigation as well
as in other investigations currently under way in the Bureau
of Drugs. I have great difficulties in visualizing
pathologist conducting a searching examination of a variety
of records which have nothing to do with pathology or
closely question a number of administrators, laboratory
technicians or aids, animal caretakers, etc., on their
practices, on detail of their tasks, adequacy of their
observations and so on.

 I would not like to generate the impression here that
scientific expertise in pathology or in any other scientific
field associated with studies like these could or should be
totally ignored. Far from it. However, the concept under
which we have operated ever since I can remember is that
investigations are best handled by trained and experienced
investigators. Where there is a need to address certain
scientific problems which transcend the capabilities of the
investigators, the practice has always been for the
appropriately qualified specialists from the various Bureaus
of the FDA to assist the investigators; in those few cases
where outstanding technical difficulties beyond the
capabilities of Agency scientists are required, we have not
refrained in the past from using help from outside and I
should hope we shall continue to do so in the future. But
this help provided by scientists on an ad-hoc basis and only
where it is required is an entirely different matter than
having scientists direct the actual course of the
investigation. While I believe it is entirely proper (in
fact preferable) to have scientists evaluate the scientific
impact of a set of findings, I cannot see professional
scientists do the job of professional investigators any more
than I could see members of a legal society doing the work
of detectives or policemen in investigating various aspects
of a specific crime.

It disturbs me to see from the draft we have here that the
role of what is termed the "FDA Monitor" will be reduced to
little more than having this person be present during
communications between UAREP and Searle; I find this kind of
prospect ludicrous and I do not understand the need for it.

What I understand even less is why Searle should offer or be
asked to pay the cost of this entire operation to the
investigative agent in a direct manner; why is there a
necessity for this body, UAREP, to enter into any kind of
formal contract with Searle and why are we expected to co-
sign such a contract? The fact that Searle will pay for this
cannot but give them some kind of decision-making role as is
evident from merely reading the terms of this proposed
contract. It seems to me that no-one except the FDA can have
the responsibility for undertaking this kind of work - this
is our mission and we are being paid from public funds to
carry it out.

Although, as expressed above, there is much I do not
understand about this entire plan, particularly its basic
raison d'etre, there is something here that I appreciate
fully:- this is the statement at the top of page two of
Wylie's memorandum:- "Searle understandably continues to
press for the expediting of this agreement."

I would suggest that implementation of this contract can
have only one of two predictable outcomes which are mutually
exclusive:-

 a) There are serious improprieties in the conduct of these
studies.  If this is the case, I would submit that
inexperienced outside scientists selected by an outside
agency under contract to the firm which is the object of the
investigation, will have a markedly reduced probability of
detecting such improprieties;

 b) There are no serious improprieties in the conduct of
these studies. IF this is the case, it would necessarily
follow that any report written by the "investigators" would
not signal the presence of any such improprieties. But, if
so, for exactly the same reasons as listed above, such a
report may well be interpreted as being nothing short of an
improper whitewash.

 My recommendation is simply that this entire plan be
aborted forthwith, and that we proceed with this matter in a
way we are supposed to; this is the way we have handled
things like this in the past and the way we anticipate to
operate in the future. M. Adrian Gross HFD-108 ---

(Note from Martinti:  What happened after this memo.  On
January 10, 1977 in a 33 page letter, FDA Chief Counsel
Richard Merrill recommended to U.S. Attorney Sam Skinner
that a grand jury investigate Searle for the apparent
violations of the Federal Food, Drug and Cosmetic Act 21 USC
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 USC 355 (i) and for concealing material facts and
making false statements in reports of annual studies
conducted to establish the safety of (aspartame)."  The FDA
called special attention to studies investigating the effect
of NutraSweet on monkeys and hamsters.

U.S. Attorneys Sam Skinner and William Conlon both hired on
with the defense team and the statute of limitations
expired.  No FDA Commission would allow aspartame to be on
the market for 16 years.  Then Don Rumsfeld who was working
for Searle said he would call in his markers and get
aspartame approved anyway.  He was on Reagan's Transition
Team, and the day after President Reagan took office he
appointed Dr. Arthur Hull Hayes to do the deadly deed.  A
Board of Inquiry was set by the best scientists the FDA had
who said aspartame had not been proven safe and caused brain
tumors.  Dr. Hayes over-ruled the Board of Inquiry and
approved it anyway and then went to work for the PR Agency
of the manufacturer and has refused to talk to the press
ever since.

With regard to the UAREP mentioned in this memo, Searle paid
them $500,000.  They got that money for being sworn to
silence.  From Aspartame (NutraSweet) Is It Safe? by H. J.
Roberts, M.D., Charles Press, in a chapter titled "The Myth
of 'The Most Thoroughly Tested Additive in History', under
Shortcomings:

"The failure to challenge the manufacturer's contract with
Universities Associated for Research and Education in
Pathology (UAREP), This private group was engaged to
determine the factual accuracy of prior aspartame articles -
BUT with the stipulation that UAREP "shall not express an
opinion" regarding either the design or safety significance
of these studies, nor make recommendations about the safety
of aspartame for human use!  Dr. M. Adrian Gross also
challenged the credentials of UAREF relative to its ability
to assess prior aspartame studies."

Searle sold the NutraSweet Company to Monsanto in l985 and
they have since sold it to several including Ajinomoto who
claims the UAREP were an outside independent firm.  See my
letter to Ajinomoto on www.dorway.com  and they refuse to
answer it.  Also on this site you can read the UPI
investigation documenting Rumsfeld's part in getting
aspartame approved  even though it is a deadly chemical
poison that makes brain tumors.  Aspartame Disease is now a
global plague and the 1000 page medical text, Aspartame
Disease: An Ignored Epidemic (www.aspartameispoison.com  or
www.sunsentpress.com  or 1 800 814 - 9800 lists all types of
neurodegenerative diseases, diabetes and other tumors
triggered by this neurotoxin.  It is also a baby killer, an
abortifacient and teratogen (triggers birth defects).  It
interacts with drugs and as a chemical hypersensitization
agent interacts with other toxins, additives and vaccines.)

-------------------------------------------------------------
(Note: This letter is on EPA Stationary) Senator Howard M.
Metzenbaum, (Dated 30 October, 1987) United States Senate,
140 Russell Senate Office Building, Washington, DC, 20510)

Dear Senator Metzenbaum:

 The following is in response to a request for comments
addressed to me by Mr. James C. Wagoner of your Office in
reference to the safety of the artificial sweetener
aspartame, known commercially as Nutrasweet.

As you may know, during my service with the FDA from 1964 to
1979 I participated along with others in the extensive
investigation of the quality of experimental studies carried
out by or for the G.D. Searle & Co. of Skokie, Ill. Inasmuch
as I had participated both in the "on-site" investigations
as G.D. Searle & Co., as well as in the evaluation of the
findings that emerged, my signature along with those of
others appears on the final report of that FDA
investigations (known also as the Searle Task Force Report)
which was dated March the 24th, 1976.

In early 1979 I was transferred fro duty from the FDA to the
EPA to assume a position involving a promotion for me. My
comments here ought not to be taken to imply in any way that
they represent the views of the EPA since this agency has no
regulatory concerns whatsoever in the area of food
additives; rather, such comments of mine represent strictly
my own views.

During that 1975 FDA investigation at G.D. Searle & Co. and
at a number of their contractors, a total of 25 distinct
experimental studies were intensively audited. Almost half
of those 25 studies (11, to be exact) were carried out for
aspartame with the remaining 14 studies having been
distributed amongst 6 drug products manufactured by G.D.
Searle & Co. It is worthy of note that the conduct of all
experimental studies by that firm, regardless whether they
entailed food additives or drug products, was the
responsibility of a single group in the G.D. Searle & Co.'s
organization:- the Pathology-Toxicology or Path-Tox
Department. Practices that were noted in connection with any
given such study were quite likely to have been noted also
for other studies that were audited, and this was a
situation which was in no way unexpected:- after all, the
set of all such studies executed by that firm from about
1968 to the mid 1970's were conducted in essentially the
same facilities, by virtually the same technicians,
professional workers and supervisors, and the nature of such
studies does not differ much whether a food additive or a
drug product is being tested for safety in laboratory
animals. It is in this sense, therefore, that the overall
conclusions summarized at the beginning of the Searle Task
Force Report have relevance to a all the studies audited in
1975 (whether they had reference to aspartame or to any of
the six drug products of Searle's) and, by extension, to the
totality of experimental studies carried out by that firm
around that time - 1968 to 1975.

The FDA's Task Force Report starts at the top of its page 1
with:-

"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 (case of
the) GD Searle Company, we have no basis for such reliance
now.

"Reliance on a sponsor is justified when FDA has reasonable
assurance that the sponsor will: (1) inform the agency of
all material results, observations, and conclusions of an
experiment, (2) report fully and completely all of the
conditions and circumstances under which an experiment was
conducted, and (3) submit its reports to the FDA in a timely
fashion so that measures to protect the public health and
safety can be taken promptly when warranted. Through our
efforts, we have uncovered serious deficiencies in Searle's
operations and practices which undermine the basis for
reliance on Searle's integrity in conducting high quality
animal research to accurately determine or characterize the
toxic potential of its products."

"Searle has not met the above criteria on a number of
occasions and in a number of ways. We have noted that Searle
has not submitted all of the facts of experiments to FDA,
retaining unto itself the unpermitted option of filtering,
interpreting, and not submitting information which we would
consider material to the safety evaluation of the product.
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.
Finally, we have found instances of irrelevant or
unproductive animal research where experiments have been
poorly conceived, carelessly executed, or inaccurately
analyzed or reported."

"While a single discrepancy, error, or inconsistency in any
given study may not be significant in and of itself, the
cumulative findings of problems within and across the
studies we investigated reveal a pattern of conduct which
compromises the scientific integrity of the studies. We have
attempted to analyze and characterize the problems and to
determine why they are so pervasive in the studies we
investigated."

"Unreliability in Searle's animal research does not imply,
however, that its animal studies have provided no useful
information on the safety of its products. Poorly controlled
experiments containing random error blur the differences
between treated and control animals and in- crease the
difficulty of discriminating between the two populations to
detect a product-induced effect. A positive finding of
toxicity in the test animals in a poorly controlled study
provides a reasonable lower bound on the true toxicity of
the substance. The agency must be free to conclude that the
results from such a study, while admittedly imprecise as to
incidence or severity of the untoward effect, cannot be
overlooked in arriving at a decision concerning the toxic
potential of the product."

In addition to those general comments and references to no
basis for reliance on reports generated by the GD Searle
Company, serious deficiencies in Searle's operations and
practices, Searle's integrity, Searle's selectively
reporting the results, poorly conceived, carelessly executed
and inaccurately analyzed or reported experiments at
Searle's, a pattern of conduct which compromises the
scientific integrity of the studies, pervasive problems in
the Searle studies, their unreliability, etc., which apply
across the board to all studies investigated, there are a
number of additional problems that attach specifically to
the aspartame studies. These are discussed in the FDA's
Searle Task Force Report in its page 25 - paragraph 1 - on
the identity of the material tested;

page 26 - last paragraph - on the excision of tumor masses
ante-mortem and writing the protocol after the start of a
study;

 page 31 - paragraph 2 - on Searle tactics designed to
obtain FDA approval for aspartame;

 page 32 - last paragraph - on continuity of personnel at
Searle and on the adequacy of their training and supervision
of such personnel;

page 33 - paragraph 2 - on practices which could compromise
the study;

        - paragraph 3 - on improper departure from
protocol specifications on age of the animals used;

page 34 - paragraph 2 - on deviations from protocol at
Hazleton Laboratories;

page 36 - paragraph 3 - on the lack of concern both at
Searle and at Hazleton Laboratories over the homogeneity, or
stability of the ingredient-diet mixture; subsequent
paragraphs deal with the same sort of problems at Hazleton
Laboratories and it is concluded that "there is no way in
which it can be assured that animals received the intended
dosage.";

page 39 - paragraph 1 - on the improper use of pesticides in
the areas where the studies were carried out; on the
condition of the blenders used to mix the test agent in the
diet; on the lack of records on mixing operations; on the
conditions of the labels of the mixtures; on the lack of
inventories of the test substance;

page 42 - paragraph 1 - on the records kept of the
observations made and on the numerous errors and
inconsistencies amongst observations and findings;

 page 47 - near bottom - on the impact of the errors in the
records of observations;

page 51 - paragraph 1 - on the excision of tumor masses; see
also page 52, paragraph 1 there for the impropriety of this
practice;

 page 52 - last paragraph - on the "substantial" loss in
pathology information due to autolysis, fixation "in toto",
etc.

 page 55 - top - on the impropriety of changing a
prosector's observations by others who did not participate
in examining the carcasses of the animals;

 page 57 - paragraph 2 - on the poor quality of material
prepared for microscopic examination of the tissues;

 page 60 - paragraph 3 - on observations being reported for
material that never existed; this problem was noted at both
Searle and Hazleton Laboratories;

page 62 - paragraph 2 - on the lack of training by the
"professional" scientists making observations in
teratogenicity studies;

 page 64 - paragraph 3 - on the abysmal quality of the
aspartame teratology and reproduction studies and on an
evaluation of these by a leading international British
expert in this area;

 page 66 - paragraph 3 - on the serious problems with the
Waisman study of Aspartame in monkeys;

page 80 - top - on the false values presented by Searle on
observations collected during the aspartame studies in
hamsters, with reference to blood, clinical chemistry, etc.,
and the improper filtering of results from the 115 week rat
study with aspartame.

It should be pointed out that the Task Force Report
detailing those general conclusions as well as those that
relate specifically to the aspartame studies are not merely
the views of the members of the Task Force itself. That Task
Force operated under the direction of a Steering Commit- tee
composed of a number of FDA Bureau Directors as well as
others and the Chairman of that Committee was none other
then the FDA Commissioner himself. In fact the Task Force
Report was addressed to the Commissioner in his capacity as
Chairman of the Steering Committee, and, it seems clear that
both the Committee and the Commissioner accepted that report
and transmitted it to the United States Senate as an
institutional FDA report without changing in it as much as a
semicolon. The following are quotes from pages 3 and 4 of
the record of hearings of April 8-9 and July 10, 1976, held
by Sen. Edward Kennedy, Chairman, Subcommittee on
Administrative Practice and Procedure, Committee on the
Judiciary, and Chairman, Subcommittee on Health, Committee
on Labor and Public Health:-

 page 3 of the record - Commissioner Schmidt of the FDA :-
"Today I would like to report to you the final results of
the Food and Drug Administration's (FDA) detailed
investigation of animal studies performed by Searle..."
(emphasis added);

page 4 of the record - Senator Kennedy (addressing
Commissioner Schmidt):- "Let me ask you this. These are the
conclusions of the (Task Force appointed to that ) study. Do
you agree with those conclusions?"

Dr. Schmidt:- "Yes I do."

 Senator Kennedy:- "Yes, you do. Is this the first time, to
your knowledge, that such a problem has been uncovered of
this magnitude by the Food and Drug Administration?"

 Dr. Schmidt:- "It is certainly the first time that such an
extensive and detailed examinations' of this kind has taken
place. We have never before conducted such an examination as
we did at Searle."

"From time to time, we have been aware of isolated problems,
but we were not aware of the extent of the problem in one
pharmaceutical house...

" Given those conclusions reached on the quality of Searle
experimental studies in general and of the aspartame studies
in particular, as we have seen above, by both the FDA as an
institution and its Commissioner in 1976, how is it possible
for another Commissioner in July, 1981, to reapprove the use
of aspartame being marketed in dry foods? How is it possible
for yet another Commissioner two years later, in July, 1983,
to have extended such approval for marketing aspartame also
in carbonated beverages? Such approvals were based on
largely the very same studies that were examined by the Task
Force in 1975-76.

It seems to me that no amount of additional examinations of
pathology material such as undertaken by the UAREP and
others, now additional statistical analyses carried out on
the data, and no judgmental evaluations or interpretations
of any data arising from those studies can in any way
rectify the basic problem expressed by the Task Force, i.e.,
the FDA itself: in the absence of reasonable expectation
that the experimental animals were administered the correct
dosages of the test agent, any observational data carried
out on those animals must be regarded as questionable or
flawed. This is to say nothing of all the myriad of other
problems involving the competence of those conducting such
studies, and the care they exercised in their execution.
Once a study is carried out and the test animals are
disposed of, all that remains are the number of tiny bits of
fissure preserved from their organs for microscopic
examination and the written records of observations made by
those who actually carried out that study. While the tissues
themselves can be examined by others long after the remains
of those animals no longer exist, the reliability of the
written records has already been found to be unacceptable in
a great variety of ways. Clearly, there is no way that even
the most competent scientists can make any new observations
on those animals at a time subsequent to the conduct of the
study. Once a study is compromised in its executions, it is
beyond salvation by anyone.

Even with respect to those small portions of tissue
preserved for microscopic examination for an indefinite
period of time after any study is completed there are
serious problems as presented in the 1976 FDA report with
respect to Searle studies in general and for the aspartame
studies in particular:- there is little if any assurance
that such samples of tissues as were preserved actually
originate from the specific animals said by Searle or
Hazleton to have been their source (see the discussion on
page 57 paragraph 2 et seq.) Furthermore, due to the
unacceptably high rate of post-mortem autolysis, a great
many such tissues were not collected at all from the
experimental animals. In any such study of even a few
hundred test animals, it takes no more than a dozen or so of
them to exhibit a particular lesion (such as brain tumors,
for instance) where missing no more than one or two animals
manifesting such tumors in any given exposure group may well
make the difference whether that particular lesion is or is
not significantly associated with the test agent, i.e.,
aspartame or any of its related chemicals.

Following the Senate hearing in the Spring and Summer of
1976, during the winter beginning in that year the FDA began
negotiating with GD Searle & Co. on retaining the UAREP
(Universities Associated with Research and Education in
Pathology), a private organization, on the feasibility of
investigating a number of other Searle studies with
aspartame. Whin I heard of those negotiating being in
effect, I wrote a memorandum to Mr. Carl Sharp, the chairman
of the FDA's Searle Task Force, on November the 4th, 1976. a
copy of it is given here as Attachment 1, and my
apprehensions over such plans is clearly evident there.
Basically, they amounted to the fact that the UAREP was
totally unsuited for such task since it had never before
engaged in anything like it and I also objected to the idea
that Searle was to fund that particular activity by the
UAREP. As mentioned there, the FDA had just received a
supplemental appropriation from the US Congress for the
express purpose of expanding its own activities in that very
area of investigating the conduct of such experimental
studies by the regulated industry. Under that appropriation
(which came to some $16,000.000) a great number of
additional investigators were hired and trained for this
particular task by the FDA.

 A few months prior to the UAREP beginning its
investigations in August of 1977, in April of that same
year, yet another FDA investigation of three aspartame
studies conducted at GD Searle & Co. was undertaken. The 76-
page report of that investigation (also known as the
Bressler report, after the name of the leader of the
investigative team, Mr. Jerome Bressler, a compliance
officer in the FDA's Chicago District) reveals the reference
to a single one of those studies (the 115-week experiment in
rats exposed to DKP or diketopiperazine, a breakdown product
of aspartame) the following:

 - substitutions of some of the animals in that study;

 - the presence of intercurrent disease amongst the test
animals and the administration of drugs to combat this,
neither of which were completely reported to the FDA;

- incomplete examinations of tissues from the experimental
animals;

 - excision of tissue masses likely to be tumors from live
animals during the study;

- absence of batch records for the mixing of the test
substance into the diet of the test animals;

- incomplete stability studies for the agent on test;

- absence of homoqeneity studies for the agent on test;

- deficiencies in the methods of chemical assay for the
actual DKP that was mixed into the diet of the experimental
rats;

 - problems with the dosage of the DKP that was given to
those rats;

- problems with the fixation-in-toto and autolysis;

- failure to report to the FDA all tissue masses (likely to
be tumors) which were found in the experimental rats;

 - failure to report to the FDA all internal tumors present
in the experimental rats, e.g., polyps in the uterus (animal
K9MF), ovary neoplasms (Animals H19CF, H19CF, and H7HF) as
well as other lesions (Animal D29CF);

- inconsistencies between different parts of the report on
this study submitted by GD Searle & Co. to the FDA on the
precise nature of the lesions manifested by the test rats;

- numerous transcription errors in that report.

 Interestingly and most important, the Bressler
investigating group found not only that no homogeneity test
were conducted by GD Searle & Co. on the mixture of the test
agent within the animals' diet, but they actually obtained
direct evidence that in fact the distribution of the test
agent in that diet was clearly not homogeneous due to
failure to have the test agent ground in a sufficiently fine
manner. Descriptive remarks on this issue were found by the
FDA investigators in a notebook kept by Searle personnel on
observations made during the study, as was a Polaroid photo-
graph taken by the same Searle technicians and which clearly
shows the test agent in the form of coarse particles with
the animals' diet. If follows that the experimental rats
could have consumed their feed without actually touching the
DKP and, consequently, no-one can state with any assurance
whatsoever just how much DKP (if any) those rats were
actually exposed to in the course of that study. Evidence
such as this obtained by the FDA investigators seems to me
to have been crucial to the interpretation of any findings
or observations by Searle.

On page 32 of the GAO report one can read the view of the
FDA's Center for Food Safety and Applied Nutrition (CFSAN)
on the findings of the investigators. To me these read like
a script written for Abbott and Costello in the sense of
their having their perceptions inside-out or upside-down -
"the diets may have been homogeneous because of a dose-
related increase in the incidence of uterine polyps and
decrease in blood cholesterol levels" (a clear non-sequitur,
such as one almost never encounters in real life); on the
problem with autolysis of the tissues the CFSAN felt "they
could not determine whether the results would have been
altered if these tissues had been obtained before autolysis
(an obvious instance of placing the burden of proof that a
study is unsound on the Government rather then requiring the
petitioner for approval of a food additive to demonstrate,
as the Law requires, that any study is of sound quality);
the observation by the investigators that 329 fetuses were
examined in two days by a single person (a clear
impossibility) was laid aside by the CFSAN with another non-
sequitur:- that "the Searle scientist who performed these
examinations estimated that he examined about 30 fetuses a
day..."; on the fact that an insufficient number of sections
were made out of the heart, the CFSAN observed:- "...while
there was no evidence that the study was compromised by this
issue, the practice of not making enough sections through
the organs, as specified in the protocol, did not preclude a
possible failure to observe abnormalities which may have
occurred."

Despite all these problems, at least some of which
undermined or compromised the study in an unredeeming
manner, apparently the CFSAN and the FDA Commissioner found
the quality of those three studies reported on by the
Bressler investigating group as being in fact of an
acceptable nature and GD Searle & Co. were notified to this
effect in September, 1977.

The investigation undertaken by the UAREP began in August,
1977. After reading the report of that group, it became
painfully clear to me that the misgivings which I foresaw in
November 1976 (see Attachment 1 here) were indeed justified
and my worst fears were eventually realized. If one compares
the kind of detailed and painstaking findings made by the
professional investigators from the FDA both in 1975 and in
1977 with the rather amateurish activities by the UAREP
outlined in their report, the contrast between these could
hardly have been greater. Of course, inasmuch as GD Searle
had paid for the UAREP investigation, the cost of it for the
FDA was nil; what the FDA got in return for its money, was
not worth much more than this.

Perhaps the most disappointing aspect of this entire fiasco
with the quality or reliability of the experimental studies
with aspartame was the failure of the Public Board of
Inquiry (PBOI) to consider these aspects in their
deliberations. The PBOI expressly declined to do so even
after the principal objectors to the approval of aspartame
for marketing, Mr. James Turner and Dr. John Olney, asked
for such consideration. To me it seems almost beyond belief
that a collection of scientists can sit on judgement over
the interpretations to be made on a set of results arising
from certain studies, not only failing to consider the
adequacy of the conduct of those studies but actually
refusing to do so.

 Given this sort of circumstance, it should not come as a
surprise to anyone that eventually the Commissioner of the
FDA finally reapproved aspartame for marketing even though
his own panel of experts were divided over the issue whether
this particular food additive had been shown in a reasonable
manner to be safe.

As mentioned in the GAO report (page 12 there) "The Federal
Food, Drug, and Cosmetic Act does not specifically define
'safety'. However, the legislative history of the Food
Additives Amendment indicates that safety means ''proof of a
reasonable certainty that no harm will result from the
proposed use of an additive'." It is intuitively clear to
anyone that no "reasonable certainty" can attach to any
results emanating from studies as profoundly flawed as the
Commissioner of the FDA had determined in 1976 and as amply
reconfirmed since then.

This concludes my remarks on the quality or reliability of
the experimental studies with aspartame carried out by the
GD Searle & Co. or by the contractors working under the
direction of that firm.

Since Mr. Wagoner of your Office has requested my comments
in a very short period of time, I am expediting this letter
to you now; however, I plan to send you in the very near
future an additional communications where two other issues
are discussed in some detail:- the problem with the brain
tumors induced by aspartame and that the FDA's having set a
very high (and, to my view, clearly dangerous) level of
Acceptable Daily Intake, or ADI, for this particular food
additive in the diet of humans.

Finally, I wish to state here that, quite aside from my
professional background as a scientist and speaking merely
as an individual citizen, I am grateful for the concern you
have had over the safety of aspartame for many years now; as
such, I wish to thank you for having given me this
opportunity of being of some service to you. With best
wishes for the future, I remain, Senator Metzenbaum,

Sincerely yours, M. Adrian Gross, Senior Science Advisor,
Benefits and Use Division, Office of Pesticide Programs
Sworn to be a true copy on 30 Oct, 1987.

------------------------------------------------------------
(Note: This letter is on EPA Stationary) Senator Howard M.
Metzenbaum, (Dated 3 November, 1987) United States Senate,
140 Russell Senate Office Building, Washington, DC, 20510)

Dear Senator Metzenbaum,

The following represents a continuation of my letter to you
of last week, October the 30th, 1987. In that letter I
discussed the many serious problems with the quality or
reliability of the experimental studies with aspartame
carried out by or for G.D. Searle & Co.; I noted there that
in 1976, the FDA Commissioner at that time, Dr. Alexander
Schmidt, speaking for the FDA as an agency, publicly stated
that he agreed with a set of conclusions, the first of which
was that the FDA had no basis for reliance on the quality of
studies generated by or for that firm.

Once such a determination is made at the highest level of
the FDA, it seems bizarre, to say the least, that
essentially the same set of studies could provide a
foundation for the subsequent decision that those studies in
fact had demonstrated the safety of aspartame with
"reasonable certainty" as required the Food Additive
Amendment of the Federal Food, Drugs, and Cosmetics Act. As
the television commercials for Weyerheauser, the "tree-
growing company", keep telling us:- "once the eagles are
gone, they are gone."

 Much the same is true also for experimental or laboratory
rats:- once they are gone, no one can bring them back for an
interview to ask them how much, if any, aspartame or DKP
they had ingested while the experimental studies in which
they had participated were in progress and, without such
essential information, examination of their preserved
tissues by even the most skillful and competent of
pathologists becomes largely a meaningless exercise which
cannot in any way resurrect in Phoenix-like fashion the
value of those studies.

 However, having said all of this, let us assume that in
fact those studies were of an acceptable quality; let us
pretend that the test animals were actually exposed
qualitatively and quantitatively to what G. D. Searle & Co.
would have us believe that they were exposed; that there was
no post-mortem autolysis of their carcasses rendering vast
numbers of their tissues to a state unsuitable for pathology
examination; that the technicians involved in the conduct of
those studies were fully trained, competent, and adequately
supervised to make observations on those animals prior to
their death; that the same was true with respect to the
observations made after their death; that in fact those
technicians actually made proper such observations; that the
proper samples of tissues with grossly observed lesions were
in fact collected for additional microscopic examination;
that the identity of such tissue specimens corresponded (as
they should) to the identity of each animal that was their
source, etc. In short, let us make believe in a spirit of
Halloween that nothing which was uncovered for the aspartame
studies by the FDA investigations of 1975 and 1977 was
actually true, i.e., that in fact we are dealing here with
studies of an absolutely perfect quality or reliability. Of
course, such assumptions belong to the domain of
Fantasyland, but, nevertheless, let us play this little game
for awhile.

Under such highly speculative hypothetical conditions, let
us now ask again whether aspartame can be viewed as being
safe with "reasonable certainty".

To answer this question, let us focus for a moment on the
pathology examinations carried out not by the pathologist
originally retained by GD Searle & Co. (those of the
Experimental Pathology Laboratories, or EPL) who examined
the tissues from the rats in the Two-Year Rat Study) but,
rather, on the examinations carried out by the expert
pathologists in the UAREP. Although in my last letter
addressed to you last week I referred to the investigative
efforts of the UAREP as being "amateurish" by comparison
with those of the professional investigators in the FDA, I
have no reason to question or criticize in any way the
competence of UAREP pathologists in their own specialty
where they had examined first-hand tissue specimens said to
gave been collected from the animals in that study.

The UAREP report (Volume 2, Chapter IV, dealing with that
particular study, reveals in Appendix IV-21 on its page 393
et seq. the animals which were found by the UAREP
pathologist to have harbored brain tumors:

- Group Sex Path.No Animal No. Type of brain tumor Weeks to
death

1 M 64-603 83-651 Astrocytoma 104

2 M 64-775 83-745 Astrocytoma 104

 3 M 64-764 83-837 Astrocytoma 76

4 M 64-707 83-919 Astrocytoma 104
   M 64-712 83-888 Oligodendroglioma 59
   M 64-713 83-892 Astrocytoma 49
   M 64-715 83-895 Astrocytoma 100

 5 M none
 Table Continued from previous page

 1 F none

 2 F 64-989 83-769 Astrocytoma 104
        65-011 83-766 Astrocytoma 69

3  F  none

4  F 64-925 83-934 Astrocytoma 85

5  F 84-881  84-010  Medulloblastoma/meningeal sarcoma 13

     64-888 84-019 Astrocytoma 67

Altogether the table just above lists a total of 12 animals
with brain tumors, 7 males and 5 females; for both sexes
there are 1 in Group1, 3, in Group 2, 1 in Group 3, 5 in
Group 4, and 2 in Group 5 for a total of 12. Note that the
GAO report which refers to those animals at the bottom of
its page 45 is in error in that it lists 4 (rather than 3)
animals with brain tumors in Group 2 (the low dosage group).
Because of this error, the GAO's Figure 4.1 on page 46 of
its report is somewhat misleading.

The GAO report also indicates under item (2) on its page
34:- "According to UAREP's president at the time of its
review"

"...the thing that impressed (UAREP) throughout the
study,... which is reflected in our final statements and
conclusions, was that the interpretations of the
experimental results by previous observers did not really
differ very significantly from ours following our review of
the material."

Yet, Appendix IV-25 beginning on page 446 of the UAREP
report repre- sents a 6-page table entitled "Significant
Discrepancies Between Histo- pathologic Diagnoses By UAREP
and EPL", the last mentioned having been, as stated above,
the "previous observers", i.e., the pathologists originally
retained by GD Searle & Co. to examine those tissues and
whose report was submitted by that firm to the FDA in
support of their petition to have aspartame approved for
marketing. In that table I have counted some 207 such
"significant discrepancies" between the diagnoses of the
UAREP and EPL and these involve some 162 animals or 37% of
all the 440 animals in that study. This was not reported by
the GAO representatives who apparently were content with
merely chatting with the UAREP president about his
reminiscences of some 10 years ago.

 Moreover, that same UAREP report reveals in that very same
Appendix IV-25 as cited above for the 12 animals with brain
tumors the characterizations or diagnoses reached by the
pathologists from the EPL:

- for animal No. 83-651 with an astrocytoma of the brain EPL
lists the brain as unremarkable;

for animal No. 83-745 with an astrocytoma of the brain EPL
lists no comparable diagnosis;

for animal No. 83-837 with an astrocytoma of the brain EPL
lists no comparable diagnosis;

for animal No. 83-919 with an astrocytoma of the brain EPL
lists no comparable diagnosis;

for animal No. 83-888 with an Oligodendroglioma of the brain
EPL lists no comparable diagnosis;

for animal No. 83-892 with an astrocytoma of the brain EPL
lists no comparable diagnosis; for animal No. 83-895 with an
astrocytoma of the brain EPL lists no comparable diagnosis;
for animal No. 83-769 with an astrocytoma of the brain EPL
lists no comparable diagnosis; for animal No. 83-766 with an
astrocytoma of the brain EPL lists no comparable diagnosis;
for animal No. 83-934 with an astrocytoma of the brain EPL
lists an ependymoma i.e., a different kind of brain tumor;

for animal No. 84-010 with a Medulloblastoma/meningeal
sarcoma of the brain, EPL lists a meningioma i.e., a tumor
of the membranes covering the brain;

 for animal No. 84-019 with an astrocytoma of the brain
there was no discrepancy in the EPL diagnosis.

In other words, for the 12 animals identified as having
brain tumors in this study by the UAREP pathologists, EPL
pathologists (i.e., the "pre- various observers" as the
president of the UAREP has it) had completely missed no less
than 9 or 75% of these. Such difference between the
diagnoses of those two groups cannot by any stretch of the
imagination be interpreted by any reasonable person as being
"not very significant" as that same president of the UAREP
is quoted by the GAO to have stated. Incidentally, the GAO
representatives themselves also failed in their report to
highlight this tremendous difference between the diagnoses
of the UAREP and EPL.

Furthermore, Appendix IV-20 on page 391 of that same UAREP
report reveals in the first row of the table on that
specific page that GD Searle & Co. or their agents had
provided to the subcontracting EPL pathologists, i.e., to
those whose report that firm had originally submitted to the
FDA:

a) only 8 (or only 10%) of the brain sections for the 80
   animals in group 2;
b) only 7 (or only less then 9%) of the brain sections for
   the 80 animals in Group 3;
c) only 5 (or only less than 7%) of the brain sections for
   the 80 animals in Group 4;

and the UAREP were proved with the brain sections of 2 fewer
animals than were provided to the EPL. Again, this is
another little wrinkle not high- lighted in the GAO report.

This, quite by itself, is sufficiently eloquent on just how
G.D. Searle & Co. saw fit to discharge their
responsibilities in reporting fully and completely their
results of the Two Year Rat Study with aspartame to the FDA;
it is just as eloquent on precisely how thoroughly the
Bureau of Foods of the FDA (the predecessor of the CFSAN)
had reviewed the data emanating from that study prior to its
initial approval in 1974 for the marketing of that food
additive.

I note at the bottom of page 54 in the GAO report that CFSAN
had objected to the medulloblastoma that was noted in a
female rat at the top exposure level on the grounds that "it
was unlikely aspartame caused this tumor". Such statement
would imply that aspartame had caused all the other tumors
(the nine astrocytomas and the solitary oligodendroglioma
noted in animals exposed to it) which is vastly more than
enough to lead to a conclusion that, because of this, it
cannot be regarded as being a safe food additive. The reason
for such conclusion by the CFSAN appear in the first
paragraph of page 46 of the GAO report. As is also true for
many of the other arguments advanced by the CFSAN and by
G.D. Searle & Co., those reasons are largely speculative and
without much merit. Still, to accom- modate the CFSAN's
views regardless of their validity, I am willing to ignore
the occurrence of that particular tumor in a female animal
at the top exposure level.

 If we are to analyze the distribution of the rest of those
brain tumors, we ought ignore also the response of any
animals at the top level of exposure (Group 5) on the
grounds that completing toxicity may well have inhibited the
expression of brain tumors in the animals of that group.

Accordingly we have for the male animals with brain tumors:

in Group 1 i.e., at 0 mcm/kgm body-weight 1/59 = 1.69% positive rats;

in Group 2 i.e., at 1,000 mcm/kgm body-weight 1/36 = 2.78% positive rats;

in Group 3 i.e., at 2,000 mcm/kgm body-weight 1/40 = 2.50% positive rats;

in Group 4 i.e., at 4,000 mcm/kgm body-weight 4/40 = 10.00% positive rats;

This particular distribution yields a dose-response slope as
high as 0.000,019,865 with standard error of only
0.000,009,729,2 leading to a chi square with one degree of
freedom for slope as high as 4.118, whose one-sided
probability is as low as p = 0.021,217; in other words, the
dose-dependent increase in frequency of brain tumors for the
male rats in that study was highly significant and,
therefore, attributable to aspartame, the agent on test.

 That particular slope of the dose-response function yields
the following expected incidences of brain tumors amongst
male animals:

- at 0 mcm/kgm body-weight - 0.867%

 at 1,000 mcm/kgm body-weight - 2.854%

at 2,000 mcm/kgm body-weight - 4.840%

at 4,000 mcm/kgm body-weight - 8.813%

 Note that the four expected values given just above are
fairly close to their respective observed values listed near
the bottom of the preceding page, which indicates a close
fit of the observations to the dose-response or regression
function.

 If we have reference to the animals of both sexes with
brain tumors, we have:-

in Group 1 i.e., at 0 mcm/kgm body-weight 1/118 = 0.847% positive rats;
in Group 2 i.e., at 1,000 mcm/kgm body-weight 3/ 76 = 3.948% positive rats;
in Group 3 i.e., at 2,000 mcm/kgm body-weight 1/ 80 = 1.250% positive rats;
in Group 4 i.e., at 4,000 mcm/kgm body-weight 5/ 80 = 6.250% positive rats;

 This particular distribution yields a dose-response slope
as high as 0.000,011,578 with a standard error of only
0.000,005,831,8 leading to a chi square with one degree of
freedom for slope almost as high as the one for merely the
male animals, 3.920, with one-sided probability almost as
low as that for merely the male animals, p = 0.023,860. The
conclusion that follows is identical with that reached above
for merely the male animals.

The expected incidences for both sexes are:-

 at 0 mcm/kgm body-weight - 1.006%
 at 1,000 mcm/kgm body-weight - 2.164%
 at 2,000 mcm/kgm body-weight - 3.322%
 at 4,000 mcm/kgm body-weight - 5.638%

 or, again, fairly close agreement to the observed values
given just above.

Note that in the analyses outlined above I have not combined
the response noted at two or more experimental groups, as
was done by the PBOI and as objected to by the CFSAN.

 If we now analyze the data in the same "uncombined"
fashion, while still excluding from consideration the
medulloblastoma manifested by a female in the top exposure
level group, and even if we do consider the poor response of
the animals in the top exposure level group (which, as
noted, may have been due to competing toxicity interfering
with the expression of brain tumors), but consider the so-
called "historical control" incidence of brain tumors
(49/59,812 cited by Dr. Olney in his table 2 on page 2 of
Part III of his written statement presented to the PBOI as
well as the rate of 4/115 positive control animals noted by
both the UAREP and EPL for the Lifetime Toxicity study of
aspartame in the rat - see UAREP report, Chapter V, page
559) along with the contemporaneous (local) control rate of
1.118 positive animals of both sexes noted in the Two-Year
aspartame study in the rat, we end up with a total of
54/60,045 = 0.090% for the control inci- dence for both
sexes. The weighted averages of the exposure level in Group
5 animals was 7,420 mgm/kgm body-weight. Accordingly we
would have:

at 0 mcm/kgm body-weight - 54/60,045 = 0.090% rats with brain tumors;
at 1,000 mcm/kgm body-weight - 3/ 76 = 3.947% rats with brain tumors;
at 2,000 mcm/kgm body-weight - 1/ 80 = 1.250% rats with brain tumors;
at 4,000 mcm/kgm body-weight - 5/ 80 = 6.250% rats with brain tumors;
at 7,420 mcm/kgm body-weight - 1/ 77 = 1.299% rats with brain tumors;

This distribution yields a slope of dose-response function
as high as 0.000,005,297 with a standard error of only
0.000,000,423,4, leading to a chi square with one degree of
freedom for slope as high as 156 whose one- sided
probability is as low as 4.031E-36, i.e., 4 with 35 zeros
ahead of it and to the right of the decimal point. This is
nothing short of astronomically high significance.

 Alternatively, if one considers merely the contemporaneous
or local control value in the two-year rat study with
aspartame, 1/118 = 0.85% animals positive for brain tumors,
the response at the lowest level of exposure, 1000 mgm/kgm
body-weight, 3/76 = 3.95% animals similarly positive for
brain tumors, is elevated by comparison with that control
rate more than 4.5 times which is borderline significance at
p = 0.058,674. The response at the next to the highest level
of exposure of 4,000 mgm/kgm body-weight, 5/80 = 6.25%
animals with brain tumors, is elevated more than 7.3 times
over that same control rate of 0.85%, and this is highly
significant at the p = 0.009,975 probability level.

Finally in this entire consideration of significance for the
brain tumors, one could set up yet another sort of contrast
by making believe that all animals exposed to aspartame were
in fact exposed to the highest level tried, 7,420 mgm/kgm
body-weight. This would extend a great deal of the benefit
of doubt to aspartame. that particular contrast of 0.090%
the control rate versus 10/313 = 3.195% for all exposed
animals (still excluding the medulloblastoma objected to by
the CFSAN), leads to a chi square adjusted for continuity
and with one degree of freedom as high as 254 which is,
again, of almost astronomical significance.

In other words, even if one is willing to give aspartame a
very generous benefit of doubt on the quality or reliability
of the two-year study in rats as well as several other
considerable benefits of the doubt involved in the test of
significance, it still emerges that the rate of brain tumors
amongst the animals exposed to it vastly exceeds that for
animals not exposed to it and such excess is very highly
significant. What this says is that there cannot be any
reasonable, or even shadow of a doubt that aspartame had
caused such an increase in the incidence of brain tumors.

It follows, therefore, that the conclusion of the PBOI and
of several members of the FDA Commissioner's panel of
experts is the right conclusion, and that reached by the
CFSAN and by the FDA Commissioner who overturned the PBOI
view in this respect is the wrong conclusion.

As a result of all the considerations above, I would add my
full endorsement to the conclusion of the unidentified
statistician mentioned in paragraph 3 on page 56 of the GAO
report who apparently reached the same conclusion as I did
in an independent manner.

I would also support the views of the similarly unidentified
carcinogenicity specialist mentioned in paragraph 2. of that
same page in the GAO report who felt that the relatively
high exposure rates in the two- year rat study with
aspartame were a necessary compensation for the relatively
low power of this study to detect as significant increases
as high as 5% in the brain tumor rate for humans exposed to
aspartame, which would constitute a downright catastrophe.

The Acceptable daily Intake (ADI) of aspartame.

Still under the hypothetical assumption that these
experimental studies were of an impeccable quality, let us
now turn to a different aspect of the interpretation of
results arising from them.

Near the bottom of page 60 of the GAO report it is disclosed
that the Acceptable Daily Intake (ADI) of aspartame was
raised from 20 mgm/kgm body- weight to 50 mgm/kgm body-
weight after aspartame was approved for use in carbonated
beverages and after it became evident to the FDA that very
young children could potentially consume almost 50 mgm/kgm
body-weight of it per day.

It appears that the justification for such sudden and
considerable increase of 150% in the ADI for aspartame was
provided by the results of five clinical studies as well as
five other studies published in the literature; however, it
is unclear from the GAO report whether any of those studies
were of a long duration (such as a major part of the life-
span) - clearly, such studies conducted with humans could
not possibly have been of this nature.

 To examine whether an ADI of 50 mgm/kgm body-weight can be
justifiably regarded as "safe", let us return to the issue
of the brain tumors and conduct for these a formal Risk
Assessment. Although it has been established here that the
incidence of brain tumors in rats was highly significantly
related to the dosage of aspartame in the two-year rat study
(and, therefore, that aspartame had cause that increase in
incidence of brain tumors amongst exposed animals by
reference to the rate noted in comparable unexposed ones)
such determination of high significance is in fact not a
necessary requirement for a formal risk assessment.

I have carried out such risk assessment by utilizing two
separate procedures which are widely accepted for this
purpose:- the Mantel-Bryan approach (also known as the log-
probit method) and the Hone Hit method of extrapolation.

To extend again the benefit of doubt to aspartame, I have
had reference in such assessment to the control rate of
brain tumors noted merely in the local or contemporaneous
control animals (1/118 = 0.847%) rather then to the almost
ten times lower rate of the "expanded" control group
discussed in the previous section here (54/60.045 = 0.090%);
also, I have assumed all non-control rats to have been
exposed at the top levels of exposure (7,420 mgm/kgm body-
weight) rather then to a series of levels starting at merely
1,000 mgm/kgm body-weight; I have also excluded from
consideration the medulloblastoma observed for Animal No.
84-010, but have not excluded the response of any other
animal in that study. Each of these features, as mentioned,
provides the benefit of doubt to aspartame, i.e., to its
"producers" as distinct from its "consumers".

With such additional assumptions, we may tabulate the
estimated "virtually safe" levels of aspartame in the
mgm/kgm body-weight/day for a variety of upper limits on the
risk indicated in the column at the extreme left of the
table that follows here .

 Note that for each of the two methods of extrapolation, two
estimates are given in the table opposite each upper limit
on the risk:- on for rats and one for humans. The estimate
for the humans is related to the corresponding one for rats
by being 5.23 time smaller then it. This is the factor
necessary for "translation" from rats to humans by
correcting for the body-area of the two species:- due to its
larger size, the human has a body-area per unit mass smaller
than does the rat:-

An average male rat in the study considered here weighed 506
Gms., and an average female rat 331 Gms., for a mean weight
of 418.5 for the two sexes. This a human of average weight
of 60 Kgms., say, is "worth" on a mass or weight basis
60,000/418.5 = 143.37 rats of average weight. But that same
human weighing 60 Kgms is worth on a body-area basis only
the two-thirds power of 143.37 i.e., only 27 .39 such rats.
Thus, to have equivalence for doses expressed in mgm/kgms
body-weight rats and humans, the dosage for the rats must be
divided by the one-third power of 143.37, i.e., by 5.23.
Hence the factor used in the table that follows.

RESULTS EMANATING FROM THE FORMAL RISK ASSESSMENT INVOLVING
BRAIN TUMORS

"virtually safe" level of aspartame in mgm/kgm bw/day Log
probit method ----------------------One Hit method

Upper limit on risk    for rats    for humans   for rats      for humans

1/100,000,000         0.700        0.134        0.001,278     0.000,244

5/100,000,000         1.349        0.258        0.006,392     0.001,22

1/ 10,000,000         1.809        0.346        0.012,78      0.002,44

5/ 10,000,000         3.674        0.702        0.063,92      0.012,2

1/ 1,000,000          5.050        0.966        0.127,8       0.024,,4

5/ 1,000,000         10.95         2.09         0.639,2       0.122,

1/ 100,000            15.55         2.97         1.278         0.244

5/ 100,000            36.81         7.04         6.392         1.22

1/ 10,000              54.63        10.45        12.78          2.44

5/ 10,000             146.5         28.01        63.93          12.2

1/ 1,000               232.3         44.42       127.9           24.5

5/ 1,000               759.1        145.2        640.8          123.0

It turns out from the entries in the table just above that
an ADI of 50 mgm/kgm body-weight for humans is associated by
both methods of extrapo- lation with an upper limit on the
risk as high as between 1/1,000 and 5/1,000 population
exposed to aspartame to develop brain tumors as a result of
exposure to that food additive. For this to actually become
evident, it would take many years since such tumors have a
very long latent period, i.e., it takes a long time for them
to become manifest. Thus, it seems to me that we are dealing
here with a huge time bomb.

 There is hardly any need for me to emphasize here that this
represents an unacceptably high risk or hazard posed by
aspartame.

SUMMARY AND CONCLUSIONS.

From what has been discussed in my letter addressed to you
last week as well as from what has been presented in the
previous pages of this communication, I can conclude the
following:-

1. It is impossible for anyone to appreciate just how a
determination by the FDA that the G.D. Searle & Co.
experimental studies with aspartame were of an unacceptable
quality in 1976 can be metamorphosed several years later
into a view by that same Agency that essentially the same
studies were sufficiently reliable for anyone to assess that
this food additive is "reasonably certain" to be safe for
consumption by humans.

2. Even if, contrary to the FDA's view in 1976, the quality
of the conduct of those studies could be relied upon by the
same agency to even begin making such a determination, at
least one of those studies had reveled a highly
significantly dose-related increase in the incidence of
brain tumors as a result of exposure to aspartame.

The full incidence of those brain tumors was not disclosed
by G.D. Searle & Co. to the FDA prior to the initial
approval for the marketing of aspartame in 1974; moreover,
the review of that study in the FDA was so flawed that the
Agency apparently did not even realize tat that time that
only a portion of the observations on brain tumors had in
fact been submit- ted by G.D. Searle & Co. in their petition
for that approval.

3. Quite aside from the remarkable significance of the
increased incidence with dose of those brain tumors, the ADI
of 50 mgm/kgm body- weight recently set by the FDA for the
human consumption of aspartame is alarmingly dangerous in
that it involves an extremely high and, therefore, a totally
unacceptable upper limit on the risk for those consuming
aspartame: between 1/1,000 and 5/1,000 population to develop
brain tumors as a result of such exposure. 4. Although in
their report the GAO express the view that the FDA "followed
its required process in approving aspartame (for marketing)"
I would sharply disagree with such evaluation. Although the
FDA may have gone through the motions or it may have given
the appearance of such a process being in place here, the
people of this country expect and require a great deal more
from that agency charged with protecting their public
health:- in addition to mere facade or window-dressing on
the part of the FDA, they require a thorough and
scientifically based evaluation by the Agency on the safety
of the products it regulates.

Unfortunately this has clearly not been the case here. And
without this kind of assurance, any such "process: or dance
represents no more than a farce and a mockery of what is
truly required.

 Sincerely yours

 M. Adrian Gross, Senior Science Advisor, Benefits and Use
Division, Office of Pesticide Programs Sworn to be a true
copy on 3 November, 1987.

(Martini Note)  There have been three congressional
hearings.  By this time NutraSweet was owned by Monsanto who
paid Senators like Orrin Hatch.  One of his press releases
said:  Hatch says no to congressional hearings on aspartame.
So they didn't even happen until l985.  Senator Metzenbaum
wrote a bill listed as dead bill on www.dorway.com to have
independent studies done on the problems being seen in the
population.  But Monsanto could not allow that to happen.
Gregory Gordon who wrote the UPI 8 month investigation on
aspartame wrote an article in the Star Tribune on Nov 22,
1996 titled FDA Resisted Proposals To Test Aspartame.  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."

The FDA who tried for years to prevent the approval of
aspartame had now given it's loyalty to industry instead of
the consumer public.  As I told Acting FDA Commissioner
Michael Friedman who was hired by Monsanto in l999:  "The
FDA no longer needs a revolving door - why not build a
bridge to take care of the traffic?"  Obviously, this was
his reward for defending Monsanto on 60 Minutes in l996.

Never forget the words of FDA toxicologist Dr. Adrian Gross
who was a hero of the FDA in his last words to Congress.  He
said at least one of Searle's studies "has established
beyond any reasonable doubt that aspartame is capable of
inducing brain tumors in experimental animals and that this
predisposition of it is of extremely high significance ....
In view of these indications that the cancer causing
potential of aspartame is a matter that had been established
way beyond any reasonable doubt, one can ask:  What is the
reason for the apparent refusal by the FDA to invoke for
this food additive the so-called Delaney Amendment to the
Food, Drug and Cosmetic Act?" ..."Given the cancer causing
potential of aspartame how would the FDA justify its
position that it views a certain amount of aspartame as
constituting an allowable daily intake or 'safe' level of
it?  Is that position in effect not equivalent to setting a
'tolerance' for this food additive and thus a violation of
that law?  And if the FDA itself elects to violate the law,
who is left to protect the health of the public?"

The Delaney Amendment made it illegal to allow any residues
of cancer causing chemicals in foods.  Today it has been
repealed.  Dr. Adrian Gross has passed on but we will never
forget him and his efforts as well as Dr. Jacqueline
Verrett, another FDA toxicologist who told Congress that all
studies from Searle were built on a foundation of sand and
should be thrown out.  Aspartame, a deadly chemical poison,
that among other things makes brain tumors and kills babies,
was marketed for human consumption only because the FDA
violated the law.  And so operations of Mission Possible
International exist the world over, an unpaid volunteer
force warning all consumers off aspartame.  Take it
seriously and save your life.

Betty Martini, Founder, Mission Possible International
bettym19@mindspring.com
9270 River Club Parkway
Duluth, Georgia 30097
770 242-2599