Monsanto/NutraSweet's PR Statements on Aspartame/Brain Cancer Research

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Monsan.to/NutraSweet's PR Statements on Aspartame/Brain Cancer

Research

 

Quick Review of Monsanto/NutraSweet's PR Statements

 

Regarding the Aspartame / Brain Cancer Research

 

Published by Dr. John W. Olney, et al. in the Journal

 

of Neuropathology and Experimental Neurology (Nov. 1996)

 

by Mark Gold

mgo-

http://www.holisticmed.com/aspartame/

(See web page for more information and sweetener resources.)

 

Dr. Dimitrio Trichopoulos

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

According the " The Observer " of London, Dr. Trichopoulos was

approached by the manufacturer, Monsanto/NutraSweet, to write a

critique of the study for them. Therefore, his statements are

obviously not the statements of an independent scientist.

 

" This paper has a misleading title. The 'Results' section which, as

a rule, addresses the original contribution of the paper, does not

even include the word 'aspartame' that nevertheless figures

prominently in the title and the running title. "

The title of the paper is: " Increasing Brian Tumor Rates: Is There

a Link to Aspartame? " The title is clearly intended to show that the

paper examines the increasing brain tumors rates and tries to

determine if aspartame is a possible cause. It is hardly misleading.

 

The " Results " section is the results of the analysis of the rates of

various types of brain tumors. The " Discussion " section is used to

discuss whether aspartame may play a part in the increasing rates of

certain types of brain tumors.

 

Such comments are really silly and have no place in a serious

discussion of the aspartame / brain cancer link.

 

" Instead, the paper examines time trends of brain tumor incidence and

mortality in the United States, as many other authors have

previously done, with a twist that is methodologically so unsound as

to make the conclusions of the paper clearly untenable. "

Given that Dr. Trichopoulos was reviewing this study at the request

of the manufacturer, it may not surprise some that he made this

comment. However, this statement contains no discussion of why the

methodology was unsound -- it is just the opinion of someone

reviewing the study for the industry.

 

" Therefore, the arguments presented by Olney et al. fly in the face

of the ecological evidence that they invoke. The introduction and

widespread use of aspartame coincides in time with a *deceleration of

an increasing trend that has been apparent well before aspartame was

introduced. No one could seriously claim that this deceleration is

due to aspartame, but the sugestion that aspartame causes brain

cancer on the basis of these data is even more preposterous. "

A common trick of aspartame industry PR is to argue against a point

that no one (including Dr. Olney) is trying to make. The above

comment is looking at the *overall* brain cancer incidence rates over

the past 15-20 years. It is clear that brain cancer incidence rates

have been climbing rapidly since the 1970s. Dr. Trichopoulos may be

correct that *overall* brain cancer incidence rates are not

increasing quite as rapidly as they did before aspartame was

approved.

 

However, all of this seems to have little to do with Dr. Olney's

research. Dr. Olney points out that it is the rates of the extremely

deadly forms of brain cancer (e.g., glioblastoma and anaplastic

astrocytoma) in the most susceptible populations that went up

significantly not long after aspartame's approval. The rates of the

much less deadly brain cancer (i.e., astrocytoma) went down not long

after aspartame approval. It is the increase in the rate of

conversion of astrocytic tumors from a lower to higher grade (i.e.,

more deadly) that Dr. Olney, et al. focused on, not simply the change

in overall brain tumor rates.

 

" The arguments of Olney et al. implicitly require two biologically

indefensible assumptions: that a certain factor (aspartame) could

cause a solid tumor (brain cancer) with a latency period of less than

four years and that subsequent widespread exposure to this factor

would cause no further increase in the incidence of that cancer.

These assumptions are preconditions in their futile effort to

explain, in causal terms, an arbitrarily chosen and improperly

illustrated transient shift in the secular incidence of brain

tumors. "

As you can see, Dr. Trichopoulos once again seems to avoid discussing

the large shift of brain tumor rates to much more deadly forms of

brain tumors. He seems set on discussion overall brain cancer rates

despite the fact that it is only briefly discussed in Dr. Olney's

paper. Dr. Olney quite clearly expresses in the " Method " section of

the paper that he will be discussing specific tumor types in relation

to aspartame:

 

" In prior studies, the focus has been primarily on total tumor

incidence without adequate attention to individual tumor types, and

there has been a tendency to assess the magnitude of overall change

in incidence from one extreme time point to another (e.g., from the

early 1970s to the mid 1980s) without determining whether the

increases occurred episodically or on a steadily progressive basis.

Because increases attributable to aspartame would be expected to have

a unique temporal pattern corresponding to the pattern of public

exposure to this agent, and might be limited to increases in only

specific tumor types, we plotted the incidence rate for each year and

each tumor type from 1975 to 1992.... "

 

Dr. Olney points out that " it is currently believed that multiple

separate mutations involving several types of proteins must occur to

cause normal cells to become carcinogenic. Thus, in human adult or

aging populations the accumulation of spontaneous mutations may be

sufficient to set the stage for an environmental agent to provide a

single critical factor required to trigger carcinogenesis. "

Therefore, in the population group that is, by far, the most

susceptible to glioblastomas and anaplastic astrocytomas -- the late

middle aged and elderly -- it would certainly be possible for brain

tumors to progress after 4-5 years that aspartame was on the market.

It is the less susceptible populations that would likely see a longer

time period (on average) before the tumor develops.

 

Dr. Paul Levy

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

Dr. Levy has cowritten with Monsanto/NutraSweet a defense of

aspartame (Neurology 45:1631). That, by itself, doesn't prove that

Dr. Levy's statements are inaccurate, but it does show that Dr. Levy

was not an independent researcher who happened to write comments

about this study.

 

" ...this statistical and epidemiological treatment of the SEER data

is seriously flawed and furnishes no evidence to justify the

conclusion of an association between aspartame use and increased

brain tumor incidence rates. "

Again, nothing but opinion. It is interesting that Monsanto/NutraSweet

would approach their friends in the scientific community to comment

on the study, but would quite often quote statements such as that

above that have no facts or reasonining associated with them. We

will just have to wait until the responses are published in the

Journal of Neuropathology and Experimental Neurology before we see

what (if anything) they are basing these statements on.

 

" When the same analysis is performed separately in age groups 0-19

years, 20-39 years, 40-64 years, and 65 plus years, the only

significant increase with time is in the 65 plus age group which can

be explained, at least in part, by the increased access to health

care including diagnostic procedures among the elderly. "

Once again, it appears that Dr. Levy is now discussing *overall*

brain tumor rates. Dr. Olney shows that the much more deadly types

of brain cancer (glioblastoma and anaplastic astrocytoma) increased

substantially in the 45-69 age group and the 70+ age group. As Dr.

Olney stated, " the earlier onset of the highly malignant tumors in

the older age groups could relate to the fact that they have had more

years to accumulate spontaneous mutations for the proposed

aspartame-linked mutations to interact with. " If exposure of in

utero fetuses to aspartame can cause brain tumors on a delayed basis,

tumors induced by this mechanism may not become evident for another

20 or 30 years. "

 

Dr. Olney also discusses the effect of the changes in diagnostic

procedures on cancer incidence rates. Here is an excerpt from Dr.

Olney's paper that should help put to rest Dr. Levy's unsubstantiated

statement about diagnostic precedures:

 

" It is reasonable to question whether the steady increase in these

tumors occuring in phase 2 [1985-1992] could be explained in terms of

MRI (introduced circa 1983) being able to detect additional tumors

not detectable by CT [technology]. We consider this unlikely for the

following reasons: Sophisticated detection methods are not used for

general screening, but rather for diagnosis of conditions that are

producing clinical symptoms. Most if not all of these tumors are

malignant enough so that when they begin to produce symptoms they are

already large enough (or soon will be) to be detected by either MRI

or CT. Certain occult, benign, very slow growing tumors (e.g.,

gangliogliomas) can be detected earlier and more effectively by MRI

than CT, but the tumors in question would effectively be detected in

a relatively short time by either technology. "

 

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

 

Dr. Adalbert Koestner

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

Dr. Koestner wrote a chapter about aspartame and brain tumors for the

manufacturer's aspartame book in 1984. Once again, this shows that

Dr. Koestner just didn't happen to read the study and respond as

might an independent researcher.

 

" Dr. Olney states, 'The most striking fiding was that the 320

aspartame-fed rats developed 12 malignant brain tumors and 120

concurrent controls had not brain tumors.' This statement is a

misrepresentation of the facts. "

It amazes me that Dr. Koestner could question Dr. Olney's statements

on this fact since Dr. Olney was an active participant in the

pre-approval hearings when the number of tumors was discussed. It is

clear that Dr. Koestner inappropriately received his tumor figures

from UAREP, an organization that was reportedly paid $500,000 to

" review " studies for the manufacturer. (See the footnote at the

bottom of the second page of Dr. Koestner's article in " Aspartame:

Physiology and Biochemistry " published by Marcel Dekker, page 447.)

The *original* record clearly shows 12 brain tumors in the test

animals and zero in the controls as stated by Dr. Olney:

 

" There were other problematic aspects of the brain

tumor data. In the pre-1975 records that I

reviewed, it was clear that several competent

pathologists had carefully examined the original

microscopic slides from the first study and agreed

that there were 12 brain tumors in the NutraSweet-

fed rats and zero brain tumors in the controls.

When the FDA conducted a task force investigation

of these laboratories in 1975, they singled out

these studies for further investigation and

ordered that all laboratory records, including

microscopic slides etc. be impounded under FDA

seal. Several years later when a group of

pathologists (UAREP) was sent to authenticate

these studies, they could not find the microscopic

slides. The UAREP pathologists were finally taken

to a laboratory where the slides were not supposed

to be and there they found some but not all of the

original slides. Clearly they had not been kept

under FDA seal and by mysterious coincidence the

slides that were finally presented to the UAREP

pathologists contained evidence for 11 brain

tumors in Nutrasweet-fed rats and 1 tumor in

contols. It is important to recognize that if

there are zero tumors in the controls, it is very

difficult to argue that the tumor incidence in the

control and Nutrasweet-fed rats is the same. But

if there is 1 tumor in the control group, it is

possible with statistical acrobatics to reach the

conclusion that the incidence is the same. And,

indeed, this is exactly the argument that the

manufacturer and the FDA Bureau of Foods pressed

at the Public Board of Inquiry. They accepted the

finding of 1 brain tumor among the controls even

though the authentic record showed zero brain

tumors in the controls, then they proceeded to

break down the animals into smaller and smaller

sub groups according to sex, dose level etc. and

finally the 1 brain tumor in one sub group of

control animals appeared to be not significantly

different from 2 or 3 tumors in each of the

experimental sub groups. I seriously doubt whether

this method of data analysis would stand the

scrutiny of competent disinterested statisticians.

Even more seriously I wonder why FDA allows

microscopic slides to disappear (while supposedly

impounded) and why they do not question the de

novo emergence of a brain tumor among the controls

when the slides reappear. "

 

" Since aspartame in the two Searle-Hazelton studies did not fulfill

any of the criteria established for neurocarcinogenic agents and

since the incidence of brain tumors was well within the range of

spontaneous brain tumors in 2-year-old Sprague Dawley rats, there can

be no causal link between aspartame and brain tumors observed in the

Searle-Hazelton studies. "

Dr. Koestner is arbitrarily stating that aspartame does not meet the

criteria established for neurocarcinogenic agents. He goes into

detail in the chapter from the book mentioned above. His arguments

in that chapter are badly flawed as I discuss in detail in the draft

scientific/history review of aspartame ( " Aspartylphenylalanine

Diketopiperazine (DKP) " chapter) on my web page:

< http://www.holisticmed.com/aspartame/ >

 

Twelve brain tumors in the aspartame-fed rats was well outside the

spontaneous brain tumor rates for 2-year-old Sprague Dawley rats. He

is just making up statements out of the blue now. The Public Board

of Inquiry which included the President of the American Association

of Neuropathologists (and which unanimously voted *against* aspartame

approval because of the brain tumors) found that the spontaneous

brain tumor rate would be somewhere around 0.7% -- many times below

the brain tumor rate of 3.75% found in one pre-approval study and over

3% in another pre-approval study. The FDA Commissioners own

scientists were against approval and worried because of this brain

tumor rate.

 

The FDA Commissioner used a study that *did not* discuss methodoloy

at all to guess that the spontaneous brain tumor rate was 2.2% (still

below what was found in the pre-approval experiments). But he

apparently felt it was close enough and decided to approve aspartame.

And as is well-known, he became a high-paid consultant for the

manufacturer's PR firm shortly thereafter.

 

 

Dr. Gary Flamm

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

 

" The paper misstates critical facts and totally ignores important

facts such as the third carcinogenicity study conducted on aspartame

in rats which confirmed earlier findings that aspartame is not

carcinogenic. "

As is discussed in the draft review on my web page, Dr. Olney

points out that 1) this study was not used in the determination for

aspartame approval (as admitted to by the FDA Commissioner), 2) it

appeared in a poor quality journal, 3) the report was sketchy (i.e.,

not detailed), and 4) the type of rats used was different than in

the pre-approval studies.

 

I further point out that the study was conducted by a close business

partner of the manufactuer, Ajinomoto (who is now producing

aspartame). Ajinomoto was a major part of the International Glutamate

Technical Committee (IGTC). During that period of time, the IGTC

funding " research " that including hiding aspartame in the drink mix

of MSG experiments, using a brain protective substance on animals

before giving the animals the test substances (including aspartame

and MSG), and recropping a picture from an old experiment to show " no

damage " in a newer experiment. One has to be unbelievably gullible

to accept any sketchy study from Ajinomoto during this period of

time.

 

" I also deeply resent the insinuation that the FDA Commissioner

approved aspartame on the basis of his judgment alone with no support

from experts in carcinogenesis. This charge is clearly contradicted

by the written record.... "

As Dr. Olney points out:

 

" Also highly relevant is the fact that in the 1980 FDA convened a

Public Board of Inquiry (PBOI) where a panel of scientists, including

prominent neuroscientists (Walle J.H. Nauta and Peter W. Lampert),

were asked to evaluate evidence from two animal studies potentially

linking aspartame to malignant astrocytic brain tumors. The PBOI

panel concluded that evidence from one study was 'bizarre' and

totally unreliable, and evidence from the other study appeared to

show that 'aspartame may contribute to the development of brain

tumors.' .... The FDA Commissioner who received the PBOI report

referred it to additional expert FDA consultants who concurred with

the PBOI panel's recommendations. "

 

Please note that Dr. Peter W. Lampert was, at that time, the

President of the American Association of Neuropathologists and, by

far, the most qualified member of the PBOI to judge whether aspartame

had the potential to cause brain tumors. He never waivered from his

position that more studies were needed before approval should be

allowed.

 

From the FDA Commissioner's statement approving aspartame in 1981

(Federal Register, Vol. 46, No 142., 7/24/81) one can see that he

relied only on his own judgement (or lack thereof) and a review

performed by the FDA Bureau of Foods. It is surprising to say the

least that the FDA Commissioner would ignore the PBOI suggestions,

the suggestion of the FDA Commissioner's review team and instead

accept a report from the FDA Bureau of Foods.

 

" While nitrosation of aspartame or DKP is theoretically possible as

discussed in the paper cited by Shephard et al., the product would

not be nitrosourea as was incorrectly stated by the authors. The

formation of nitrosamides would, if it occurred, proceed through

nitrosation of the peptide bond. The quantity of nitrosated product

produced with aspartame would be minuscule compared to that which

would form with dietary protein and peptides. Reaction of peptide

bonds proceed very slowly and are not considered to be a public

health problem. "

As Olney pointed out, the Shephard paper showed that " if aspartame is

nitrosated in vitro to simulate the nitrosation that is believed to

occur in the stomach, the nitrosated product has substantial

mutagenic activity. " That is what Shephard et al. found. If Dr.

Flamm believes that the conversion of DKP to other chemicals does not

create a mutagenic compound, then he should push for completely

independent research to address this issue (as should have been done

many years ago before approval was granted). Dr. Olney points to this

as a possibility as to how aspartame may contribute to brain cancer.

 

As I point out in my draft review, one cannot discount the effects of

other breakdown products of aspartame contributing to the increase in

the deadlier forms of brain cancer without adequate research.

 

" In conclusion, I am in deep despair over the damage the subject

paper may do to the credibility of science and to the FDA. The paper

has replaced proper scientific analysis of all relevant data with a

selective picking of just that which might support their groundless

speculation. "

The manufacturer of aspartame, Monsanto/NutraSweet has long since

begun the destruction of the scientific process by conducting

experiments on aspartame that can generously be described as

" deceptive. " The fact that several officials at the FDA obtained key

positions in the aspartame industry and that since that time the FDA

has done everything possible (including banning safe sweeteners) to

help the manufacturer push aspartame on the public only serves to dig

a deeper hole for the FDA. If the FDA reputation is irrepairbly

damaged, the FDA officials need only look in the mirror to discover

the cause of the problem. Then they should look at the large and

growing number of serious toxicity reactions caused by aspartame.

(See samples on my web page.)

 

In conclusion, Dr. Olney is correct in his call for independent

studies to look at the aspartame and brain cancer issue. He points

out that aspartame meets the three main criteria usually invoked in

evaluating the potential of an environmental agent to behave as a

human carcinogen.

 

a. Aspartame has been shown to have in vitro mutagenic potential.

 

b. There was an increased in incidence of specific types of cancer

when animals were exposed to aspartame.

 

c. Humans have shown an increase (especially susceptible

populations) in the same types of cancer since not long after

aspartame has been approved.

 

Dr. Olney is not asserting that he proved that aspartame causes brain

cancer. However, he is calling for indenpendent research to settle

the matter before it is too late.

 

Obviously, there are many reasons why one would not choose to slowly

poison onself with chronic, long-term aspartame use, even if

aspartame didn't cause brain cancer. See the web page address below

for more information.

 

- Mark Gold

mgo-

http://www.holisticmed.com/

http://www.holisticmed.com/aspartame/

 

http://www.rawfoodinfo.com/home/home_a.html

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