- Betty Martini's debate with Dr. R. Fink on Brain Tumor
List:
-
- Scientific Evidence For Aspartame (NutraSweet/Equal,
Canderel, etc.)
- Triggering Brain Tumors
-
- FDA Toxicologist, Dr. Adrian Gross' Letters To Senator
Howard Metzenbaum
-
- Note to the Reader: Dr. Fink is on the MIT Brain Tumor
List and refuses to allow aspartame information to be posted on the list.
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 into diketopiperazine (DKP) - a known 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 www.dorway.com,
- 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
- United States Senate
- 140 Russell Senate Office Building
- Washington, DC, 20510
-
- (Dated 30 October, 1987)
-
- 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."
-
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