Betty Martini (fwd)
Stephan Anagnostaras
I am a real researcher, but I don't work in the area of aspartame and health
problems. However, I am somewhat familiar with the literature on this, so
I can make some comments regarding some of the claims Mark has made.
Most of the concerns about aspartame have come from the fact that it is
made from the combination of phenylalinine and aspartic acid, the latter of
which can be made highly epileptogenic (e.g., as in NMDA, methylated
aspatic acid). Thus the hypothesis that aspartame would lead to seizures
was borne since it was supposedly to be converted to NMDA or a similar
compound in some unknown reaction in the brain. There were extensive
safety studies of this sweetener prior to its use, and the FDA indeed
was extremely scrutinous of this chemical because they had failed so
miserably on examination of prior artificial sweeteners (the first ones,
introduced in the 50s caused many many cancer deaths; reports about
saccharin use unrealistic doses because of the panic over earlier
sweeteners). It was found that this sweetener was entirely safe on a
variety of scales. Moreover, the post-marketing reviews which Mark
claims support the view that aspartame causes serious concerns actually
do not. Indeed, Aspartame is commonly used as the example of how
post-marketing review of anecdotal clinical reports can actually show how
untrue they are. For most reports of aspartame-related seizures there
is no evidence to support the claim that aspartame was linked to the
seizures. Moreover, the FDA and WHO organization have set "maximum
safe consumption levels" of aspartame based on a small proportion of the
doses that are unsafe in rats. These doses are 40-50 mg/kg/d. Recent
examinations of use show that 90% of users fall below 2 mg/kg/d and
nearly all fall below 10 mg/kg/d, indicating that the actual use of
the sweetener is even safer than what is reported by the FDA, which assumes
much higher consumption levels.
You might try examining some of these reviews, e.g.:
Tollefson L; Barnard RJ.
An analysis of FDA passive surveillance reports of seizures
associated with consumption of aspartame.
Journal of the American Dietetic Association, 1992 May, 92(5):598-601.
Butchko HH; Kotsonis FN.
Acceptable daily intake vs actual intake: the aspartame example.
Journal of the American College of Nutrition, 1991 Jun, 10(3):258-66.
Butchko HH; Tschanz C; Kotsonis FN.
Postmarketing surveillance of food additives.
Regulatory Toxicology and Pharmacology, 1994 Aug, 20(1 Pt 1):105-18.
You should be especially critical of reports which come as case reports,
since most of the time, the disorder is not actually causally linked
to the problem the person reports (this is the case for most side effects
reported at less than 2-3%). Most of the studies are published in
established refereed journals, and they generally do not publish
reports by a company about their own product (although there are avenues
for this kind of report too). In any case, I would trust any double-blind
report above any case report even if it was done by the company. Finally,
the company which developed Nutrasweet (GD Searle) is an experienced
and respected pharmaceutical company, not a tobacco company, and definitely
does not have the political ties to hide something as scandalous as you
are suggesting.
Cheers
Stephan
In article <3to16j$o...@ixnews5.ix.netcom.com>, rro...@ix.netcom.com
(Robert Rogoff) wrote:
> mg...@max.tiac.net (Mark Gold) wrote:
>
>
> >Hi Todd.
>
> >I am not a "real" researcher, but I can assure you that the aspartame
> >issue has been studied by experienced neuroscientists. The "anecdotal"
> >evidence of the dangers from long-term use of aspartame has been
> >piling up for many years. I have received a large number of case
> >histories on the Net concerning serious illnesses triggered or
> >worsened by aspartame (only to have many or all of the symtpoms
> >disappear after it is removed from the diet). Of course, like many
> >substances, individual susceptibility varies considerably.
>
> >Virtual all independent studies and reviews of aspartame has shown
> >problems or serious concerns. Some of what you may see on MEDLINE
> >is written by researchers for NutraSweet (although they do not always
> >note their close ties to the industry). Just as you would probably not
> >automatically assume that studies and reviews done for the tobacco
> >industry are totally above-board (although many scientists did make this
> >assumption in the 1950s, you may find it beneficial to read NutraSweet
> >studies and reviews very critically.
>
> >I am somewhat familiar with the science of this subject and the studies.
> >I would be happy to help anyone who is really interested in finding out
> >more about the issue by discussing each specific point or by providing
> >whatever references you like.
>
> >Best regards,
>
> >- Mark
> >mg...@tiac.net
>
> Well, I am not a "real" researcher either, if by that you mean someone
> who does applied or theoretical scientific research as my primary or
> secondary occupation. However, a reason for me to read these groups
> is to learn what is actually considered to be consensus thinking among
> scientists today. If I wanted to read hyperbolic exaggerations based
> upon fringe research I can find that ad nauseum in the alt.hierarchy.
>
> Not realizing the possibility that aspartame, an FDA-approved
> non-nutritive sweetener, approved because trials indicated it was
> safer than sodium cyclamate, could cause people to "literally drop
> like flies," [see attribution below], I made some tongue-in-cheek
> comments about aspartame in the groups alt.mindcontrol and
> alt.folklore.urban. Nobody seems to have paid much attention to them
> except for a few people emailing me, but only one of the emails had
> anything to say negative about aspartame. The solitary email from
> someone claiming an aspartame-related death never responded to my
> inquiry asking if his allusion to a wasted-away sister suggested
> anorexia, and a lifestyle of drinking diet soda (perhaps also smoking
> tobacco) corrolary to that.
>
> Apparently my sophostricated expose' re aspartame was lost in the
> noise of those groups. I would hazard to speculate the heavy traffic
> and high noise ratio in those groups were what drove Watts/Martini to
> proselytize her cause in [often] serious groups such as this one.
> Another good one for propagation of this kind of urgent secret
> knowledge might be alt.conspiracy. I think Betty Martini, aka "A.R.
> Watts" is playing to the wrong crowd here if she wants attention for
> her sophostricated analyses of why aspartame is Satanic, that HGH and
> bovine somatotropin are "the same" and how her mentor(?) Dr. Whittaker
> has discovered aspartame to cause diabetic retinopathy and
> Alzheimer's.
>
> Here is a direct quote from <be...@noel.pd.org> writing under the
> alias "A.R. Watts" on 13 June 1995 in the newsgroup
> soc.culture.african.american apparently related to drinking aspartame:
> "People are literally dropping like flies." Although it is common
> consensus aspartame can lower the convulsant threshold for susceptible
> individuals, and I have heard anecdotal claims it causes more frequent
> headaches to migraine sufferers, note that a random reading of
> Watts/Martini's posts to such newsgroups as alt.support.diabetes
> indicates she is in reality not crusading =against= NutraSweet, but
> =for= the FDA to approve a competing non-nutritive sweetener she
> suggests was once used by the organic tea company Celestial Seasonings
> but subject to "seizure" by the FDA.
>
> Betty/A.R. may be on to something in the grand tradition of Kepler,
> Galileo, Tesla, and Crick--but this isn't playing to the right
> audience in bionet.neuroscience, sci.med.psychobiology, or any other
> group outside the alt. hierarchy.
>
> BTW, it does stand to reason the inventors of aspartame would
> construct the research to downplay any "anecdotal" evidence that would
> tend to negate the stringency required to get FDA approval--but it has
> been well over a decade now since its US approval. If aspartame is
> indeed all that harmful, then the one thing that's wrong with this
> picture is in the country known for frivolous lawsuits, I have never
> even heard of any out-of-court settlement stemming from aspartame
> injury or death that might prove embarrassing to Monsanto or the FDA.
>
>
> I believe there can be anecdotal evidence of almost anything however.
> I do know if I drink too much diet soda I feel symptoms I attribute to
> electrolyte imbalance. For awhile there I was hitting it really hard
> and it even caused polyuria!
--
STEPHAN ANAGNOSTARAS UCLA BEHAVIORAL NEUROSCIENCE
STE...@PSYCH.UCLA.EDU
Mark Gold
Date: Sun, 09 JUL 1995 02:51:55 -0700
From: Stephan Anagnostaras <ste...@psych.ucla.edu>
Newsgroups: bionet.neuroscience, sci.med.psychobiology
Subject: Re: Betty Martini (fwd)
: Most of the concerns about aspartame have come from the fact that it is
: made from the combination of phenylalinine and aspartic acid, the latter of
: which can be made highly epileptogenic (e.g., as in NMDA, methylated
: aspatic acid). Thus the hypothesis that aspartame would lead to seizures
: was borne since it was supposedly to be converted to NMDA or a similar
: compound in some unknown reaction in the brain.
Hi Stephan!
Where did you get this!? This has nothing to do with why it is believed
aspartame lowers the seizure threshhold. There is no hypothesis by
independent researchers that aspartic acid is converted to NMDA. Sheesh!
Ingesting aspartame (dissolved in liquid) spikes the plasma phenylalanine
to very high levels (See Metabolism, 36(5): 507-512 for example) because
it is absorbed so quickly. Aspartame contains no other Large Neutral
Amino Acids (LNAAs), therefore the plasma phenylalanine/LNAA ratio also
gets spiked to very high levels (and even to higher levels if ingested
with sugary products) (See Metabolism 31(9): 937 for example).
The high phenylalanine/LNAA ratio can affect the uptake of phenylalanine
(and possibly tyrosine) into the brain. This can not only change brain
chemistry over time, but have severe health reprecussions in some people
including lowering the seizure threshhold, affecting serotonin production,
causing behavioral and mood changes, etc.
Seizures linked to aspartame ingestion are one of the most common reports
to the FDA. When the CDC looked at seizures linked to aspartame they
attempted to dismiss all that might have had *any* other possible cause.
However, there were a number that they were unable to dismmiss. Due to
the type of work they perform and the large amount of diet beverages that
they sometimes ingest, pilots seem to be more susceptible to
aspartame-induced seizures and vertigo than the general population. Both
the Air Force's and Navy's official publications recently warned pilots
about aspartame. Other piloting magazines have published similar warnings
including the National Business Aircraft Association Digest (1993),
Aviation Medical Bulletin (1988), The Aviation Consumer (1988), Canadian
General Aviation News (1990), Pacific Flyer (1988, 1995), General Aviation
News (1989), Aviation Safety Digest (1989), Plane & Pilot (1990), CAA
General Aviation Safety Information Leaflet (1989), International Council
of Air Shows (1995), and a paper warning about aspartame was presented at
the 57th Annual Meeting of the Aerospace Medical Association (1986). Of
course seizures from aspartame are not limited to pilots.
The only *independent* study on aspartame and seizures (that I am aware
of) showed that aspartame ingestion (short-term) exacerbated EEG
spike-wave discharges in children with generalized absences epilepsy
(Neurology 1992; 42:1000-1003). The NutraSweet studies conducted to try
and disprove this independent finding were very poorly designed. I would
be happy to discuss these flaws.
: There were extensive
: safety studies of this sweetener prior to its use, and the FDA indeed
: was extremely scrutinous of this chemical because they had failed so
: miserably on examination of prior artificial sweeteners (the first ones,
: introduced in the 50s caused many many cancer deaths; reports about
: saccharin use unrealistic doses because of the panic over earlier
: sweeteners). It was found that this sweetener was entirely safe on a
: variety of scales.
You have got to be kidding! :-) The pre-approval studies of aspartame
are almost universally recognized as some of the worst in the history of the
FDA approval process. I have enclosed a short section of the history of
aspartame just so you get a sense of a) how bad it really was, and b) how
badly those reviews you are reading distort history.
As for cancer, all indenpendent groups were against the approval of
aspartame because at least one animal experiments showed a significant
increase in brain tumors (12 in test animals, 0 in controls). Several
independent FDA Investigators testified against approval because of the
brain cancer issue, the Public Board of Inquiry voted unanimously against
approval because of the brain cancer issue. (The board included the
president of the American Association of Neuropathologists.) Even the
FDA Commissioner's own appointed scientific review team was against
approval because the brain cancer figures were so worrisome. At least
one researcher has called for detailed epidemiological studies on this
issue because brain cancer incidence has increase significantly since the
mid-1980s (even when taking into account diagnostic techniques and immune
system disorders). (See Journal of Advancement in Medicine, 4(4): 231-241).
On another cancer-related issue, G.D. Searle did admit that one
pre-approval experiment showed a significant increase in uterine polyps.
: Moreover, the post-marketing reviews which Mark
: claims support the view that aspartame causes serious concerns actually
: do not. Indeed, Aspartame is commonly used as the example of how
: post-marketing review of anecdotal clinical reports can actually show how
: untrue they are.
They do not show serious concerns for the simple reason that you are not
reading the report itself. It seems that you are reading "information"
based on a CDC report conducted in 1985. The summary of the report was
not written by the authors of the report and waters it down
considerably. Then, the FDA took the watered-down summary and twisted it
to remove any negative comments about aspartame that were left. Finally,
reviews by NutraSweet will put their own spin on the FDA report to make
their product sound even "safer."
From the report:
"It was not anticipated that this investigation alone could definately
establish whether ingestion of aspartame-containing products did or did
not cause the symptoms reported."
...
"The number of instances of persons challenging themselves several times
with aspartame-containing products and reporting symptoms with each
rechallenge suggests that some individuals may be sensitive. The only
way to clearly determine this is through focused clinical studies.
Because of the number of reports, the subtlety and potential seriousness
of some of the manifestations, the concerns of some scientists, and the
possibility that one complainant has had his symtpoms of hyperactivity
verified on independent exam, it would seem that the highest priority for
any future investigations might be in the neurological/behavioral area,
focusing on such symptoms as headaches, mood alterations, and behavior
changes."
etc.
It is also important to note that aspartame did not appear in diet
beverages until 1984 and it wasn't until after 1987 that many people
started ingesting significant amounts. A large number of people are now
reporting serious problems with long-term ingestion of aspartame.
: Moreover, the FDA and WHO organization have set "maximum
: safe consumption levels" of aspartame based on a small proportion of the
: doses that are unsafe in rats. These doses are 40-50 mg/kg/d. Recent
: examinations of use show that 90% of users fall below 2 mg/kg/d and
: nearly all fall below 10 mg/kg/d, indicating that the actual use of
: the sweetener is even safer than what is reported by the FDA, which assumes
: much higher consumption levels.
You are reading those lousy NutraSweet surveys of aspartame "usage."
These surveys are laughable, at best. One survey actually has the gall
to claim that the aspartame consumption for 6-12 year olds was shown to
*decrease* significantly from 1984 (the year that aspartame appeared in
carbonated beverages) to 1989, despite the nearly tripling of sales of
aspartame from the middle of 1984 to 1989. Some of their surveys show a
higher aspartame consumption in the Winter than the hot Summer months.
Another one of their reviews claims that Canada has an aspartame
consumption rate many times what it is in the U.S. Other surveys from
NutraSweet use data from a *1977-1978* US food consumption survey to
calculate aspartame intake. These surveys also never take into account
the fact that people often forget their snacks that they ingested.
These "surveys" disagree with their own controlled studies. In a study
conducted by Searle, children who were allowed to ingest
aspartame-containing products ingested as much as 76 mg/kg/day of
aspartame. (See J. of Toxicology and Environmental Health, 2: 401-415.)
Three studies of obese individuals showed that they ingested anywhere
from 8 to 36 mg/kg/day of aspartame. (See "Aspartame: Physiology and
Biochemistry," Marcel Dekker, Inc., N.Y., page 273-286.)
It is quite common for people to drink large amount of aspartame. I have
encountered several people on the Net who ingest from 2 to 5 liters per
day plus other aspartame-containing products. Several people who are
addicted to aspartame (i.e., get withdrawl symptoms) have written to me
for help getting off of aspartame. Since about 1987, NutraSweet has been
pushing these "surveys" in order to have an excuse for testing only small
amounts of aspartame. Since their own experiments show children
ingesting way over the FDA's Acceptable Daily Intake (ADI) limit and adjust
ingesting two-thirds of that limit, all aspartame tests should be at the
absolute minimum of the FDA's ADI (if not double that value to provide a
safety cushion).
: You might try examining some of these reviews, e.g.:
:
: Tollefson L; Barnard RJ.
: An analysis of FDA passive surveillance reports of seizures
: associated with consumption of aspartame.
: Journal of the American Dietetic Association, 1992 May, 92(5):598-601.
:
: Butchko HH; Kotsonis FN.
: Acceptable daily intake vs actual intake: the aspartame example.
: Journal of the American College of Nutrition, 1991 Jun, 10(3):258-66.
:
: Butchko HH; Tschanz C; Kotsonis FN.
: Postmarketing surveillance of food additives.
: Regulatory Toxicology and Pharmacology, 1994 Aug, 20(1 Pt 1):105-18.
Two of these "reports" are written directly by NutraSweet. If you want
NutraSweet PR, filled with errors, then I strongly suggest reading these
reports. On the other hand, you may want to read *independent* reviews of
the subject. Once you do, you will see how really bad these reports are.
: You should be especially critical of reports which come as case reports,
: since most of the time, the disorder is not actually causally linked
: to the problem the person reports (this is the case for most side effects
: reported at less than 2-3%). Most of the studies are published in
: established refereed journals, and they generally do not publish
: reports by a company about their own product (although there are avenues
: for this kind of report too).
You are being naive here. Two of the reports you cited were done by
NutraSweet. A very large number of aspartame-related studies are done by
NutraSweet consultants (or former consultants) and appear in "established
refereed journals."
"Despite this system [peer review], anyone who reads journals widely and
critically is forced to realize that there are scarcely any bars to eventual
publication," wrote Drummond Rennie, professor of medicine at the
University of California at San Francisco. "There seems to be no study
too fragmented, no hypothesis to trivial, no literature too biased or too
egotistical, no design too warped, no methodology too bungled, no
presentation of results too inaccurate, too obscure and too
contradictory, no alalysis too self-serving, no argument too circular, no
conclusions too trifling or too unjustified, and no grammer and syntax
too offensive for a paper to end up in print." [Cynthia Crossen:
"Tained Truth"]
You will find all of this and more if you are open-minded enough to look
closely at the aspartame research.
: In any case, I would trust any double-blind
: report above any case report even if it was done by the company.
I believe that you are being naive here too. Just because a study is
"double-blind" doesn't mean it is designed or conducted properly. For a
simple example, I have a letter written to FASEB on an issue closely
linked to the aspartame issue where the manufacturer admits that since
1978 a reactive substance, similar to that being tested, was used in the
beverage mixture of double-blind experiments. There are quite a number
of major design flaws that can render double-blind experiments worthless.
: Finally,
: the company which developed Nutrasweet (GD Searle) is an experienced
: and respected pharmaceutical company, not a tobacco company, and definitely
: does not have the political ties to hide something as scandalous as you
: are suggesting.
Well, I'm sure the tobacco companies where "respected tobacco comapnies"
at one time. I am taking no position on G.D. Searle *today* since they are
not directly involved in aspartame any longer. (When Monsanto bought G.D.
Searle, they gave aspartame to a separate subsidery -- NutraSweet Company.)
Please don't forget to read the enclosure to find out more about the
pre-approval tests.
Best regards,
- Mark
mg...@tiac.net
P.S. -- I was simply offering to help open-minded researchers look beyond
the industry PR and look at work done by independent researchers. I can
only speak for myself and do not know (or care) what was posted to
alt.mindcontrol.
P.P.S. -- The growing number and seriousness of the problems caused or
contributed to by aspartame have led a number of patient groups to
strongly recommend against the stuff. It would be a sad sight if the
"real researchers" (who have not been involved in this issue in the past)
are the last ones to "discover" the danger.
---------------------------
BEGIN ENCLOSURE
---------------------------
History of Aspartame
--------------------
1964
----
The development of new pharmaceuticals was the focus of
research at the international pharmaceutical company, G.D.
Searle and Company (Farber 1989). The group working on an
ulcer drug was formed including Dr. Robert Mazer, James
Schlatter, Arthur Goldkemp and Imperial Chemical. In
particular, they were looking for an inhibitor of the
gastrointestinal secretory hormone gastrin (Stenik 1984,
page 3).
1965
----
In 1965, while creating a bioassay, an intermediate chemical
was synthesized -- aspartylphenylalanine-methyl-ester
(aspartame). In December of 1965, while James Schlatter was
recrystalling aspartame from ethanol, the mixture bumped
onto the outside of the flask. Some of the powder got onto
his fingers. Later, when he licked his fingers to pick up a
piece of paper, he noticed a very strong sweet taste. He
realized that the sweet taste might have been the aspartame.
So, believing that the dipeptide aspartame was not likely to
be toxic, he tasted a little bit and discovered its sweet
taste (Stegink 1984, page 4). The discovery was reported in
1966, but there was no mention of the sweetness (Furia
1972).
1969
----
The investigators first report the discovery of the
artificial sweetener in the Journal of the American Chemical
Society stating (Mazur 1969):
"We wish to report another accidental disvoery of
an organic compound with a profound sucrose (table
sugar) like taste . . . Prelminary tasting showed
this compound to have a potency of 100-200 times
sucrose depending on concentration and on what
other flavors are present and to be devoid of
unpleasant aftertaste."
---------------
G.D. Searle approached Dr. Harry Waisman (Biochemist,
Professor of Pediatrics, Director of the University of
Wisconsin's Joseph P. Kennedy Jr. Memorial Laboroatory of
Mental Retardation Research) to conduct a study of the
effects of Phenylketonuria (PKU) on primates.Seven infant
monkeys were given aspartame with milk. One died after 300
days. Five others (out of seven total) had grad mal
seizures. These results were hidden from the FDA when G.D.
Searle submitted its initial applications (Stoddard 1995,
Congrtessional Record 1985b, page S10831, US Senate 1976b,
page 373). Dr. Waisman died unexpectedly in 1971 before
completing all of his studies.
---------------
In 1969, former Commissioner of the FDA, Dr. Herbert L. Ley
was quoted as follows (Mullarkey 1992):
"The thing that bugs me is that people think the
Food and Drug Administration (FDA) is protecting
them--it isn't. What the FDA is doing and what the
public thinks it's doing are as different as night
and day."
1970
----
The discovery of aspartame is reported in the well-known
publication, Science (Cloninger 1970).
---------------
Neuroscientist and researcher John W. Olney finds that oral
intake of glutamate, aspartate and cysteine, all excitotoxic
amino acids cause brain damage in mice (Olney 1970).
---------------
An internal G.D. Searle memo lays out the strategy for
getting aspartame approved (US Senate 1976a, page 16):
At this meeting [with FDA officials], the basic
philospohy of our approach to food and drugs
should be to try to get them to say "Yes," to rank
the things that we are going to ask for so we are
putting first those questions we would like to get
a "yes" to, even if we have to throw some in that
have no significance to us, other than putting
them in a yes saying habit.
We must create affirmative atmosphere in our
dealing with them. It would help if we can get
them or get their people involved to do us any
such favors. This would also help bring them into
subconscious spirit of participation.
---------------
The FDA bans the sweetener cyclamate. Robert Scheuplein, who
was the acting Director of FDA's Toxicological Services
Center for Food Safety and Applied Nutrition was quoted as
saying "the decision was more a matter of politics than
science." (Stoddard 1995)
1971
----
Ann Reynolds, a researcher who was hired by G.D. Searle and
who has done research for the Glutamate (MSG) Association,
confirmed aspartame's neurotoxicity in infant mice (Reynolds 1971).
---------------
Dr. John W. Olney informs G.D. Searle that aspartic acid
caused holes in the brains of mice. G.D. Searle did not
inform the FDA of this study until after aspartame's
approval. None of the tests submitted by G.D. Searle to the
FDA contradicted these findings (Stoddard 1995).
1972
----
FDA Toxicologist Dr. Adrian Gross came upon some
irregularities in the submitted tests of the G.D. Searle
drug Flagyl. G.D. Searle did not respond for another two
years. Their response raised serious questions about the
validity of their tests.
1973
----
On March 5, 1973, G.D. Searle's petition to the FDA for
approval to market aspartame as a sweetening agent with
published in the Federal Register (1973).
---------------
On March 21, 1973 the MBR report was submitted to G.D. Searle.
Background
----------
In August of 1970, G.D. Searle conducted two 78-
week toxicity studies on rats for what was to
become a best-selling heart medication, Aldactone.
One study was conducted at G.D. Searle and one at
Hazelton Laboratories. In March 1972, the rats for
autopsied and the pathology slides were analyzed.
For confirmation of the results, G.D. Searle sent
the slides to Biological Research, Ltd. where
board certified pathologist, Dr. Jacqueline Mauro
examined the data. She discovered that the drug
appeared to induce tumors in the liver, testes,
and thyroid of the rats. The report submitted to
G.D. Searle by Dr. Mauro was known as the MBR
Report.
These statistically significant findings were confirmed
by G.D. Searle's Mathematics-Statistics Departement.
Instead of submitting these alarming findings to the
FDA, G.D. Searle contracted with another pathologist,
Dr. Donald A. Willigan. He was given 1,000 slides to
examine. The Willigan Report was more to G.D. Searle's
liking because it revealed a statistically significant
increase in thyroid and testes tumors, but not in liver
tumors. Liver tumors are of much more concern to the
FDA. The Willigan Report was immediately submitted to
the FDA. G.D. Searle did not disclose the MBR Report to
the FDA until July 1975, 27 months after it had been
given to G.D. Searle.
---------------
The FDA Commissioner from 1972 to 1976, Alexander Schmidt,
M.D. felt that "Superficially, it seemed like, if there
would ever be a safe kind of product, that would be it. The
idea that two naturally-occuring amino acids could harm
someone in relatively small amounts...." (Mullarkey 1992)
---------------
In an FDA memorandum dated August 20, 1973, Martha M.
Freeman, M.D. of the FDA Division of Metabolic and Endocrine
Drug Products addressed the adequecy of the information
submited by G.D. Searle in their petition to approve
aspartame (US Senate 1987, page 326-336):
"Although it was stated that studies were also
performed with diketopiperazine [DKP] an impurity
which results from acid hydrolysis of Aspartame,
no data are provided on this product."
Commenting on one particular single dose study:
"It is not feasible to extrapolate results of such
single dose testing to the likely condition of use
of Aspartame as an artificial sweetener."
It is important to note that Dr. Freeman pointed out the
inadequency of single-dose tests of aspartame as early as
1973. Since then, the NutraSweet Company has flooded the
scientific community with single-dose studies.
"Chemistry - No information is provided other than
formulae for Aspartame and its diketo-piperazine."
"Pharmacology - Reference is made to 2 year rat
studies, but no data are provided on acute or
chronic toxicity."
"Clinical - No protocols nor curriculum vitae
information are provided for the 10 completed
clinical studies. Results are reported in
narrative summary form, and tabulations of mean
average values only. No information is given as to
the identity of the reporting labs, methodology
(except rarely), or normal values. (Reported units
for several parameters cannot be verified at this
time.)
"No pharmacokinetic data are provided on
absorption, excretion, metabolism, half-life; nor
bioaviliability of capsule vs. food-additive
administration."
Dr. Freeman concludes:
"1.The administration of Aspartame, as reported
in these studies at high dosage levels for
prolonged periods, constitutes clinical
investigational use of a new drug substance."
"2.The information submitted for our review is
inadequate to permit a scientific evaluation
of clinical safety."
She went on to recommend that marketing of aspartame be
contingent upon proven clinical safety of aspartame. The FDA
Bureau of Foods rejected Dr. Freeman's recommendation
(Graves 1984).
---------------
Construction of a large aspartame manufacturing plant in
Augusta, Georgia was halted. It was thought that aspartame's
uncertain regulatory future was the main reason for the
stopping of construction (Farber 1989). In the 1973 G.D.
Searle Annual Report, an executive stated that "commercial
quanities of the sweetener will be supplied from the
enlarged facility of Ajinomoto." Ajinomoto is the inventor
and main producer of the food additive MSG.
1974
----
Ninety of the 113 studies which were submitted by G.D.
Searle to the FDA were conducted in the early to mid-1970's.
All of the tests that were described by the FDA as "pivotal"
were conducted during this time. Eighty percent of these
tests were conducted by G.D. Searle or by their major
contractor, Hazleton Laboratories, Inc. (Graves 1984).
---------------
Dr. J. Richard Crout, the acting director of the FDA Bureau
of Drugs stated that "The information submitted for our
review was limited to narrative clinical summaries and
tabulated mean values of laboratory studies. No protocols,
manufacturing controls infromation or preclinical data were
provided. Such deficiencies in each area of required
infromation precluded a scientific evaluation of the clinica
safety of this pr
oduct...." (Mullarkey 1992, page 23)
---------------
Dr. John Olney and Consumer Interest attorney, James Turner,
Esq. met with G.D. Searle to discuss the results of Olney's
experiments. G.D. Searle representatives claim that Olney's
data raises no health concerns (Stoddard 1995, Farber 1989).
---------------
The FDA approved aspartame for limited use on July 26, 1974.
The allowable uses included free-flowing sugar substitute,
tablets for sweetening hot beverages, cereals, gum, and dry
bases (Farber 1989). It was not approved for baking goods,
cooking, or carbonated beverages. This approval came despite
the fact that FDA scientists found serious deficiencies in
all of the 13 tests related to genetic damage which were
submitted by G.D. Searle.
---------------
In August 1974, before aspartame could go on the market, Dr.
John Olney, James Turner, and Label Inc. (Legal Action for
Buyers' Education and Labeling) filed a formal objection
stating that they believe aspartame could cause brain
damage. They were particularly worried about aspartame's
effects on children (Graves 1984).
---------------
G.D. Searle's responses to queries about the testing of
their drug Flagyl, serious and unexpected side effect from
other drugs they developed, and information from Dr. John
Olney's studies started a controversy within the FDA as to
the quality and validity of G.D. Searle's test of aspartame
and pharmaceuticals (Graves 1984, Stoddard 1995).
1975
----
In July 1975, the FDA Commissioner, Dr. Alexander Schmidt
appointed a special Task Force to look at 25 key studies for
the drugs Flagyl, Aldactone, Norpace, and the food additive
aspartame. Eleven of the pivotal studies examined involved
aspartame. All of the studies whether conducted at G.D.
Searle or Hazleton were the responsibility of the Pathology-
Toxicology Department at G.D. Searle. (US Senate 1987, page
430). The special Task Force was headed by Philip Brodsky,
FDA's Lead Investigator and assisted by FDA Toxicologist,
Dr. Adrian Gross. The Task Force was especially interested
in "pivotal" tests as described in an article from Common
Cause Magazine by Florence Graves (1984) reprinted in the
Congressional Record (1985a, page S5499):
"Before the tast force had completed its
investigation in 1976, Searle had submitted the
vast majority of the more than 100 tests it
ultimately gave the FDA in an effort to get
aspartame approved. These included all test ever
described as 'pivotal' by the FDA. About half the
pivotal tests were done at Searle; about one-third
were done at Hazleton Laboratories. 'Pivotal'
tests include long-term (two-year) tests such as
those done to determine whether aspartame might
cause cancer. Former FDA commissioner Alexander
Schmidt said in a recent interview that if a
pivotal test is found to be unreliable, it must be
repeated 'Some studies are more important than
others, and they have to be done impeccably,'
Schmidt said."
---------------
G.D. Searle executives admit to "payments to employees of
certain foreign governments to obtain sales of their
products." (Searle 1975)
---------------
The Investigative Task Force discovers that G.D. Searle
withheld information from the FDA, including the 1969 study
by Dr. Harry Waisman showing that aspartame caused seizures
in infant primates. G.D. Searle responds that Dr. Waisman
was an independent researcher and therefore his tests were
not valid (Stoddard 1995).
---------------
On July 10, 1975, Senator Edward Kennedy chairs a heaing on
drug-related research before the Senate Subcommittee on
Health of the Committee on Labor and Public Welfare (US
Senate 1975). Preliminary reports of discrepancies
discovered about G.D. Searle were discussed. The findings of
the FDA Task Force were later presented at further hearings
on January 20, 1976 (US Senate 1976a) and April 8, 1976 (US
Senate 1976b).
---------------
On December 5, 1975, Dr. John Olney and James Turner waive
their right to a hearing at the suggestion of the FDA
General Counsel after the FDA and G.D. Searle agreed to hold
a Public Board Of Inquiry (PBOI) (Federal Register 1981,
page 286, Mullarkey 1994b).
---------------
On December 5, 1975, the FDA puts a hold on the approval of
aspartame due to the preliminary findings of the FDA Task
Force. The Public Board of Inquiry is also put on hold
(Mullarkey 1994b, Federal Register 1975).
---------------
G.D. Searle had invested 19.7 million dollars in an
incomplete production facility and 9.2. million dollars in
aspartame inventory. On December 8, 1975, stockholders filed
a class action lawsuit alledging 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 1989).
1976
----
On January 7, 1976, G.D. Searle submits to the FDA their
proposal for the adoption of "Good Laboratory Practices" (US
Senate 1976a, page 185). G.D. Searle's input was used in
FDA's adoption of Good Laboratory Practices.
---------------
In March 1976, the Task Force submits a 500-page report with
15,000 pages of exhibits (80-page summary) to the FDA after
completing their investigation.
---------------
A preliminary statement about the breadth of the
investigation from FDA Toxicologist and Task Force team
member, Dr. Andrian Gross before the US Senate (1987, page
430-431).
"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 tehnicians,
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 conclusion
summarized at the beginning of the Searle Task
Force Report have relevance to all the studies
audited in 1975 (whether they had references 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."
A few of the conclusions of the FDA Task Force:
"At the heart of 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."
"We have noted that Searle has not submitted all
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 . . . Finally, we have
found instances of irrelevant or unproductive
animal research where experiments have been poorly
conceived, carelessly executed, or inaccurately
analyzed or reported."
"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 allay the concerns of
questions of an FDA reviewer."
"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 errors blur the differences
between treated and control animals and increase
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."
A few of the relevant findings summarized from various
documents describing the FDA Task Force Report:
a. "Excising masses (tumors) from live animals,
in some cases without histologic examination
of the masses, in others without reporting
them to the FDA." (US Senate 1976b, page 4)
Searle's representatives, when caught and
questioned on these irregularities, stated
that "these masses were in the head and neck
areas and prevented the animals from feeding."
(Stoddard 1995, page 8)
"Failure to report to the FDA all internal
tumors present in the experimental rats, e.g.,
polyps in the uterus, ovary neoplasms as well
as other lesions." US Senate 1987, page 437).
b. G.D. Searle "stored animal tissues in
formaldehyde for so long that they
deteriorated." (Gordon 1987)
c. "Instead of performing autopsies on rhesus
monkeys that suffered seizures after being fed
aspartame, the company had financed a new
monkey seizure study with a different
methodology that showed no problems." (Gordon
1987)
d. "Reporting animals as unavailable for necropsy
when, in fact, records indicate that the
animals were available but Searle choose not
to purchase them."
(US Senate 1976b, page 5)
e. Animals which had died were sometimes recorded
as being alive and vica versa. "These include
approximately 20 instances of animals reported
as dead and then reported as having vital
signs normal again at subsequent observation
periods."
(Congressional Record 1985b, page S10836)
f. "Selecting statistical procedures which used a
total number of animals as the denominator
when only a portion of the animals were
examined, thus reducing the significance of
adverse effects."
(US Senate 1976b, page 4)
g. G.D. Searle told the FDA that 12 lots of DKP
were manufacturered and tested in one study,
yet only seven batches were actually made.
(Congressional Record 1985b, page S10835)
h. "Significant deviations from the protocols of
several studies were noted which may have
compromised the value of these studies . . .
In at least one study, the Aspartame 52 weeks
monkey study, the protocol was written after
the study had been initiated."
(Congressional Record 1985b, page S10835)
i. "It is significant to note that the Searle
employee responsible for reviewing most of the
reproduction studies had only one year of
prior experience, working on population
dynamics of cotton tail rabbits while employed
by Illinois Wildlife Service. In order to
prepare him for this title of 'Senior Research
Assistant in Teratology' (fetal damage) Searle
bought him books to read on the subject and
also sent him to a meeting of the Teratology
Society. This qualified him to submit 18 of
the initial tests to the FDA, in addition to
training an assistant and 2 technicians. He
certainly must have kept them busy because
Searle claimed that 329 teratology
examinations were conducted in just 2 days. He
estimated that he himself examined about 30
fetuses a day, but officials for the Center
for Food and Applied Nutrition could never
determine how that was possible."
(Stoddard 1995, page 9, Congressional Record
1985a, page S5500)
j. "In each study investigated, poor practices,
inaccuracies, and discrepancies were noted in
the antemortem phases which could compromise
the study."
(Congressional Record 1985b, page S10836)
k. "Presenting information to FDA in a manner
likely to obscure problems, such as editing
the report of a consulting pathologist . . .
Reporting one pathology report while failing
to submit, or make reference to another
usually more adverse pathology report on the
same slide."
(US Senate 1976b, page 4-5)
l. Animals were not removed from the room during
the twice per month exterminator sprayings.
(Congressional Record 1985b, page S10836)
m. Often the substance being tested which was
given to the animals was not analyzed or
tested for homogeneity. "No records were found
to indicate that any treatment mixtures used
in the studies were ever tested or assayed for
pesticide content . . . Running inventory
records for either treatment mixtures or the
test compounds used in treatment mixtures are
not maintained."
(Congressional Record 1985b, page S10836)
n. In the Aspartame (DKP) 115 week rat study the
written observations of the pathology report
was changed by the supervising pathologist,
Dr. Rudolph Stejskal even though he was not
physically present during the autopsies and
could not have verified the observations of
the pathologist who did perform the autopsies.
The pathologist who did perform some of the
autopsies had no formal training for such
procedures.
(Congressional Record 1985b, page S10837)
o. "Contrary to protocol, slides were not
prepared of this [unusual lesions from the
Aspartame (DKP) study) tissue for microscopic
examinstions . . . ."
(Congressional Record 1985b, page S10837)
p. "In the Aspartame 46 weeks hamster study,
blood samples reported in the submission to
FDA as 26 week values (for certain specified
animals) were found by our investigators as
being, in fact, values for different animals
which were bled at the 38th week. Many of the
animals for which these values were reported
(to the FDA) were dead at the 38th week."
"It is appraent from the report, that the
Appendix portion contains all the individual
(animal) values of clinical lab data available from
the raw data file. A selected portion of these
values appears to have been used in computing group
means (which were reported to the FDA). It is not
clear what criteria may have been used for
selecting a portion of the data or for deleting the
others in computing the means (reported to the
FDA)."
(Congressional Record 1985b, page S10838)
q. "Searle technical personnel failed to adhere
to protocols, make accurate observations, sign
and date records, and accurately administer
the product under test and proper lab
procedures."
(Farber 1989)
FDA Toxicologist and Task Force member, Dr. Andrian Gross as
quoted in the Congressional Record (1985b, page S10826):
"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 1975 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).
The report quotes a letter written to G.D. Searle on July
15, 1975 from its consultant in reproduction and teratology,
Dr. Gregory Palmer, in regards to a review of some of G.D.
Searle's repreductive studies submitted to the FDA
(Congresssional Record 1985b, page S10838):
"Even following the track you did, it seems to me
you have only confounded the issue by a series of
studies most of which have severe design
deficiencies or obvious lack of expertise in
animal management. Because of these twin factors,
all the careful and detailed examination of
fetuses, all the writing, summarization and
resummarization is of little avail because of the
shaky foundation."
The FDA Commissioner at the time, Alexander Schmidt stated
(Graves 1984):
"[Searle's studies were] incredibly sloppy
science. What we discovered was reprehensible."
Dr. Marvin Legator, professor and director of environmental
toxicology at the University of Texas and the pioneer of
mutagenicity testing at the FDA from 1962 to 1972 was asked
by Common Cause Magazine to review the FDA investigation
results of G.D. Searle's tests (Graves 1984):
"[All tests were] scientifically irresponsible
[and] disgraceful. I'm just shocked that that kind
of sloppy [work] would even be sent to FDA, and
that the FDA administrators accepted it. There is
no reason why these tests couldn't have been
carried out correctly. It's not that we are
talking about some great scientific breakthrough
in methodology."
Senator Edward Kennedy at the April 8, 1976 hearings before
the Senate Subcommittee on Labor and Public Welfare stated
(US Senate 1976b, page 1):
"The extensive nature of the almost unbelievable
range of abuses discovered by the FDA on several
major Searle products is profoundly disturbing."
---------------
A series of poorly conceived, flawed studies funded by G.D.
Searle are published in volume 2 (1976) of the Journal of
Toxicology and Environmental Health. The Associate Editor of
this scientific journal was Robert G. McConnell, the
Director of G.D. Searle's Department of Pathology and
Toxicology (the department responsible for monitoring the
quality of G.D. Searle's pre-approval tests investigated by
the 1975 FDA Task Force). Mr. McConnell's story continues
later in 1977. Another G.D. Searle employee, Carl R.
Mackerer was an editor of the journal. Another editor of the
journal was Thomas R. Tephyl, the person responsible for
conducting the blood methanol measurements in the NutraSweet-
funded, flawed study by Leon (1989) discussed earlier.
---------------
In July 1976, the FDA decides to investigate 15 key studies
submited by G.D. Searle in which the 1975 FDA Task Force
discovered problems. Three (3) of the studies were
investigator at the FDA by a 5-member Task Force headed by
FDA veteran Inspector, Jerome Bressler.
---------------
On August 4, 1976, G.D. Searle representatives met with the
FDA and convinced them to allow G.D. Searle to hire a
private agency, University Associated for Education in
Pathology (UAREP), and pay them $500,000 to "validate" the
other 12 studies (Gordon 1987)
According the FDA Commissioner during the early 1980s,
Arthur Hull Hayes, the UAREP investigation was to "make sure
that the studies were actually conducted."
As described by Florence Graves (1984):
"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.
"Dr. Kenneth Endicott, Director of UAREP, said in
an interview that the FDA had 'reasons to suspect'
that Searle's tests 'were not entirely honest.'
Because the FDA 'had doubts about [Searle's]
veracity,' Edicott said, officials wanted UAREP
'to determine whether the reports were accurate.'
"FDA scientist Dr. Adrian Gross, in a letter to an
FDA official, said, 'speaking as a pathologist, it
seemed questionable that the group could do the
kind of comprehensive investigation that was
required. He pointed in particular to a variety of
issues that needed to be investigated. He said
some of these would involved closely questioning
administrators and lab technicians about their
practices. Since many important issues that should
be investigated 'have nothing to do with
pathology,' he said, only trained FDA
investigators were qualified to do a comprehensive
evaluation of the testing. . . .
"Meanwhile, an interview with Endicott indicates
that Adrian Gross was right: the pathologists
couldn't--and didn't--carry out a comprehensive
review. . . . As former FDA Commissioner Alexander
Schmidt put it in a recent interview, UAREP looked
at the slides to determine whether they had been
misrepresented, but didn't look at the conduct of
the experiments in depth. The 1975 [FDA] task
force investigation looked at the conduct of the
experiments in depth, but did not look at the
slides. . . . Endicott agreed . . . 'We could only
look at what was there--the tissues.'
The findings of this investigation where released in the
Bessler Report in August 1977 (see below).
1977
----
Donald Rumsfeld, who was a former member of the U.S.
Congress and the Chief of Staff in the Gerald Ford
Administration, is hired as G.D. Searle's President.
Attorney James Turner alledged that G.D. Searle hired
Rumsfeld to handle the aspartame approval difficulties as a
"legal problem rather than a scientific problem." (Gordon
1987).
As layed out by Mary Nash Stoddard (Stoddard 1995), Rumsfeld
hired:
John Robson as Executive Vice President. He was a
former lawyer with Sidley and Austin, Searle's Law
Firm and also served as chairman of the Civil
Aeronautics Board, which was then connect to the
Department of Transportation.
Robert Shapiro as General Counsel. He is now head
of Searle's NutraSweet Division. He had been
Robson's Special Assistant at the Department of
Transportation.
William Greener, Jr., as Chief Spokesman. He was a
former spokesman in the Ford White House.
---------------
On January 10, 1977, FDA Chief Counsel Richard Merrill
recommends to U.S. Attorney Sam Skinner in a 33-page letter
detailing violations of the law that a grand jury be set up
to investigate G.D. Searle. In the letter, Merrill stated
(Congressional Record 1985b, page S10827):
"We request that your office convene a Grand Jury
investigation into apparent violations of the
Federal Food, Drug, and Cosmetic Act, 21 U.S..C.
331(e), and the False Reports to the Government
Act, 18 U.S.C. 1001, by G.D. Searle and Company
and three of its responsible officers for their
willful and knowing failure to make reports to the
Food and Drug Administration required by the Act,
21 U.S.C. 355(i), and for conceailing material
facts and making false statements in reports of
animal studies conducted to establish the safety
of the drug Aldactone and the food additive
Aspartame."
All of the G.D. Searle studies were abyssmal as discussed
above. However, there were two studies where the violation
of the law were especially flagrant. The two studies cited
by Merrill were the 52-week toxicity study on infant monkeys
performed by Dr. Waisman which G.D. Searle withheld from the
FDA and the 46-week toxicity study in the hamster where G.D.
Searle had taken blood from healthy animals at the 38th week
and claimed 1) that the blood tests were performed on
different animals -- ones that were dead at the 38th week --
and 2) that the tests had actually been performed at the
26th week.
---------------
On January 26, 1977, G.D. Searle's law firm Sidley & Austin
requests a meeting with U.S. Attorney Samuel Skinner before
a grand jury is convened (Gordon 1987, Mullarkey 1994b).
---------------
On March 8, 1977, in a confidential memo to aides, U.S.
Attorney Samuel Skinner states that he had begun preliminary
employment discussions with G.D. Searle's law firm Sidley &
Austin (Gordon 1987, Mullarkey 1994b).
---------------
On April 13, 1977, a U.S. Justice Department memo urges U.S.
Attorney Samuel Skinner to proceed with grand jury
investigations of G.D. Searle. The memo points out that the
Statute of limitations on prosecution would run out shortly
(October 10, 1977 for the monkey study and December 8, 1977
for the hamster study) (Mullarkey 1994b).
---------------
Samual Skinner withdraws from the G.D. Searle case and
Assistant U.S. Attorney William Conlon was then assigned to
the case (Stoddard 1995).
---------------
On July 1, 1977, U.S. Attorney Samuel Skinner leaves his job
to work for the G.D. Searle law firm Sidley & Austin. Thomas
Sullivan was appointed as Samuel Skinner's successor (Gordon
1987, Stoddard 1995).
---------------
Assistant U.S. Attorney William Conlon convenes a grand
jury, but lets the Statute of Limitations run out on the
aspartame charges (Gordon 1987). A year later, Conlon
accepts a job with the law firm representing G.D. Searle,
Sidley & Austin (Stoddard 1995).
---------------
Robert McConnell was the Director of G.D. Searle's
Department of Pathology and Toxicology which oversaw most of
the aspartame research. Mr. McConnell was named in Richard
Merrill's letter to U.S. Attorney Samuel Skinner. According
to McConnell's attorney, his client was awarded a $15,000
bonus and asked to take a 3-year sabbatical (for which he
received $60,000/year) because he was a "political
liability." (Gordon 1987)
---------------
Philip Brodsky, the Lead Investigator for the orginal FDA
Task Force looking into G.D. Searles studies retires. He
states that his reason for retiring was the disclosure of
the 1975 FDA Task Force findings before the U.S. Congress
(Sen Kennedy hearings in 1976) had become "politicized." As
Gregory Gordon put it in the UPI Investigative article:
"He said the main witnesses, Searle executives and
top FDA officials uninvolved in the investigation
gave 'the wrong answers to the wrong questions . .
. They didn't even let the experts answer the
questions.'"
---------------
In August 1977, the Bressler Report is released. Some of the
findings from the three studies reviewed by the Bressler-led
FDA Task Force include (Mullarkey 1994b, Farber 1989, US Senate
1987, page 385):
a. In one study, 98 of the 196 animals died but were not
autopsied until as much as one year later. Because of
the delay, much of the animal tissue could not be used
and at least 20 animals had to be excluded from
postmortem examinations.
b. The original pathology sheets and the pathology sheets
submitted to the FDA showed differences for 30 animals.
c. One animal was reported alive at week 88, dead from week
92 through week 104, alive at week 108, and finally dead
at week 112.
d. An outbreak of an infectious disease was not reported to
the FDA.
e. Tissue from some animals were noted to be unavailable
for analysis on the pathology sheets, yet results from
an analysis of this "unavailable" tissue was submitted
to the FDA.
f. There was evidence that the diet mix was not homogeneous
allowing the animals to eat around the test substance.
This evidence included a picture and statements by a lab
technician.
g. Fifteen fetuses from animals in one experiment were
missing.
h. Sections from the animals were too thick for
examination.
i. There was no documentation on the age or source of the
test animals.
j. There was no protocol until one of the studies was well
underway.
k. Animals were not permanently tagged to prevent mixups.
l. Some laboratory methods were changed during the study,
but not documented.
A G.D. Searle pathologist referring to the DKP study was
quoted by investigators as saying (Graves 1984):
"You should have seen things when this study was
run -- there were five studies being run at one
time -- things were a mess!"
The leader of the Task Force, Jerome Bressler, was quoted as
saying (Gordon 1987):
"The question you have got to ask yourself is:
Because of the importance of this study, why
wasn't greater care taken? The study is highly
questionable because of our findings. Why didn't
Searle, with their scientists, closely evaluate
this, knowing fully well that the whole society,
from the youngest to the elderly, from the sick to
the unsick . . . will have access to this
product."
---------------
Immediately after the Bressler Report was released, H.R.
Roberts, Director of the FDA's Bureau of Foods creates a 5-
person task force to review the Bressler Report. (H.R.
Roberts would leave the FDA to become the a vice president of the
National Soft Drink Association in 1978.) FDA Toxicologist,
Jacqueline Verrett was appointed the Senior Scientist of the
Bureau of Foods Task Force.
On September 28, 1977, H.R. Roberts, Director of the FDA's
Bureau of Foods received a report from a Bureau of Foods
Task Force which claimed that G.D. Searle's studies they
reviewed appeared to be authentic (meaning that they were
actually conducted) (Mullarkey 1994b).
For each of the major discrpancies found by the Bressler-led
Task Force -- those listed above and many others -- there
was a comment in the FDA Bureau of Foods Report minimizing
the problem. It seemed that no matter how serious the
mistakes were the FDA Bureau of Foods was determined to
accept the studies by G.D. Searle.
The Senior Scientist of the FDA Bureau of Foods Task Force,
Jacqueline Verrett had left the FDA when she openly
discussed the Task Force with UPI Investigative Reporter,
Gregory Gordon (Gordon 1987):
"Jacqueline Verrett, the senior scientist on the
review team, said members were barred from stating
opinions about the research quality. 'It seemed
pretty obvious that somewhere along that line they
(bureau officials) were working up to a
whitewash,' she said. 'I seriously thought of just
walking off of that task force.' Verrett, now a
private consultant, said that she and other
members wanted to 'just come out and say that this
whole experiment was a disaster and should be
disregarded.'
In her testimony before the U.S. Senate, Dr. Verrett stated
the following (US Senate 1987, page 383-390):
"This authentication was hence intended to verify
that the submitted data had not been altered;
that it reflected the actual outcome of the study,
and that it did not change substantially,
particularly in a statistical sense, the various
parameters from which the conclusion of safety had
been derived.
"Our analysis of the data in this manner revealed
that in these three studies, there were really no
substantial changes that resulted, although in
numerous instances, a definitive answer could not
be arrived at because of the basic inadequacies
and improper precedures used in the execution of
these studies.
"I would like to emphasize the point that we were
specifically instructed not to be concerned with,
or to comment upon, the overall validity of the
study. This was to be done in a subsequent review,
carried out at a higher level.
. . . .
"It would appear that the safety of aspartame and
its breakdown products has still not been
satisfactorily determined, since many of the flaws
cited in these three studies were also present in
all of the other studies submitted by Searle.
. . . .
"Well, they told us in no uncertain terms that we
were not to comment on the validity of it. And I
hoped, although having been there at that point
for 19 years, I should have known better, that
there really would be an objective evaluation of
this beyond the evaluation that we did.
"I do not feel that that was done, based on what I
have read in the GAO report that I have looked at
and so forth. They definately did not objectively
evaluate these studies, and I really think it
should have been thrown out from day one.
"We were looking at a lot of little details and
easy parameters in this study, when the foundation
of the study, the diet and all of these other
things, were worthless. We were talking about the
jockey when we should have been talking about the
horse, that he had weak legs. It is built on a
foundation of sand."
1978
----
On December 13, 1978, UAREP submits its results of their
analysis on 12 of G.D. Searle's aspartame studies. UAREP
stated in their report that "no discrepancies in any of the
sponsor's reports that were of sufficient magnitude or
nature that would compromise that data originally
submitted." (Farber 1989) Remember, the Director of UAREP
pointed out in an interview that their pathologists did not
conduct a comprehensive review of the studies, they only
looked at the animal tissues (Graves 1984).
As it turns out, UAREP pathologists who examined the test
results were discovered to have withheld negative findings
from the FDA. In some cases, they completely missed
cancerous brain tumors when analyzing the slides. For
example, in one study, twelve animals actually had cancerous
brain tumors, yet UAREP reported to the FDA that only three
animals had such tumors (US Senate 1987, page 445-446). In
addition, some of the slides that were to be examined by
UAREP pathologists were missing even though they where
supposed to have been kept under "FDA seal." (US Senate
1987, page 473-474)
1979
----
In March of 1979, the FDA concludes that G.D. Searle's
aspartame studies could be accepted. They decide to convene
the Public Board of Inquiry (PBOI) which was agreed to by
Dr. John Olney and Attorney James Turner more than four
years earlier.
---------------
In April of 1979, the FDA outlined the specific questions
which were to be addressed by the PBOI. The FDA limited the
scope of the PBOI to (Federal Register 1981):
a. Whether the ingestion of aspartame either
alone or together with glutamate poses a risk
of contributing to mental retardation, brain
damage, or undesireable effects on
neuroendocrine regulatory systems.
b. Whether the ingestion of aspartame may induce
brain neoplasms (tumors) in the rat.
c. Based on answer to the above questions.
(i) Should aspartame be allowed for use in
foods, or, instead should approval of
aspartame be withdrawn?
(ii) If aspartame is allowed for use in
foods, i.e., if its approval is not
withdrawn, what conditions of use and
labeling and label statements should be
required, if any?
Dr. John Olney and G.D. Searle were allowed to nominate
scientists for the 3-person PBOI panel (Farber 1989).
It is important to note that the scope of the review was very
limited in light of all of the adverse reactions reported to
the FDA. The PBOI also disallowed any discussion of the validity
of the pre-approval experiments because it accepted the word
of certain FDA officials that these experiments had been
"validated." Finally, the PBOI was told not to consider aspartame
in beverages, only in dry goods.
One of the PBOI members, Dr. Walle Nauta stated:
"It was a shocking story we were told [about Searle's animal
testing] but, there was no way we could go after it. We
had absolutely no way of knowing who was right. We had to
take the FDA's word." (Graves 1984)
---------------
In June of 1979, the acting FDA Commissioner, Sherwin
Gardner selects the 3-person Public Board of Inquiry. The
panelists were Peter J. Lampert, M.D., Professor and
Chairman, Department of Pathology, University of California
(San Diego), Vernon R. Young, Ph.D., University of
Nutritional Biochemistry, M.I.T., and Walle Nauta, M.D.,
Ph.D., Institute Professor, Department of Psychology and
Brain Science, M.I.T.
Dr. John Olney strongly objected to the Commissioner's
selection of one of the panelists on grounds of conflict of
interest and lack of qualifications. His objections were
overruled and the panelists who he objected to was assigned
to study the issue of aspartic acid toxicity (US Senate
1987, page 470) .
1980
----
The Public Board on Inquiry voted unanimously to reject the
of aspartame until studies on brain tumors could be done.
1981
----
On January 21, 1981, the day after Ronald Reagan takes
office as U.S. President, G.D. Searle reapplies for the
approval of aspartame. It was believed that Reagan would
certainly replace Jere Goyan, the FDA Comissioner. G.D.
Searle president, Donald Rumsfeld's connections to the
Republican party were also thought to play a part in
Searle's decision to reapply for aspartame's approval on the
day after Ronald Reagan was inaugurated (Gordon 1987).
---------------
According to a former G.D. Searle salesperson, Patty Wood-
Allott, G.D. Searle president, Donald Rumsfeld told his
salesforce that, if necessary, "he would call in all his
markers and that no matter what, he would see to it that
aspartame would be approved that year." (Gordon 1987)
---------------
In March of 1981, a 5-member panel of scientists is
established bythe FDA Commissioner Jere Goyan to review the
issues raised by the PBOI (Mullarkey 1994a).
---------------
In April 1981, Arthur Hull Hayes, Jr. was appointed FDA
Commissioner by Ronald Reagan.
---------------
On May 18, 1981, three of the scientists in the 5-member
panel sent a letter to the panel lawyer, Joseph Levitt
discussing their concerns about aspartame. Those three
scientists were Satva Dubey (FDA Chief of Statistical
Evaluation Branch), Douglas Park (Staff Science Advisor),
and Robert Condon (Veterinary Medicine). Dubey thought that
the brain tumor data was so "worrisome" in one study that he
could not recommend approval of aspartame (Stoddard 1995).
In another study, Dubey said that key data appeared to have
been altered (Gordon 1987).
In his UPI Investigation, Gregory Gordon goes on to describe
the unusual events that followed (Gordon 1987):
"[Douglas] Park said that [panel lawyer Joseph]
Levitt hurried the panel to decide the issue.
'They wanted to have the results yesterday,' he
said. 'We really didn't have the time to do the in-
depth review we wanted to do.'
"Part said Levitt met frequently with Hayes and
'was obviously getting the pressure to get a
resolution and a decision made.'
"With three of five scientists on the
commissioner's team opposing approval, it was
decided to bring in a toxicologist for his opinion
on isolated issues [Barry N. Rosloff]. Goyan said
if the decision were his, he never would have
enlarged the team. While the panel did not vote,
it ended up split 3-3.
"Levitt, who normally would have been expected to
draft an options paper spelling out scientific
evidence on key issues, took an unusual tack. He
circulated an approval recommendation and only
backed of when Dubey, Park, and Condon objected,
team members said. Levitt said he was not directed
to draft the approval memo, but did so as a
'tactical' step to break the team's weeks-long
impasse by forcing each scientist to state his
views. 'It worked, didn't it?' said Levitt, who
later was promoted to a post as an executive
assistant to the FDA Commissioner."
---------------
On July 18, 1981 aspartame was approved for use dry foods by
FDA Commissioner Arthur Hull Hayes, Jr. overruling the
Public Board of Inquiry and ignoring the law which says that
a food additive should not be approved if tests are
inconclusive (Federal Register 1981, Stoddard 1995). In an
article in Common Cause Magazine, Florence Graves states
that two FDA offices said that Arthur Hull Hayes, Jr. wanted
to push aspartame approval through in order to signal
reforms of the Reagan Administration.
1982
-----
On October 1, 1982 an amendment was attached to the Orphan
Drug Act (an act which encourages the development of drugs
for rare diseases) which modified the U.S. Patent law
(Congressional Record 1982). The amendment extended the
patent on only one product -- aspartame --by 5 years, 10
months and 17 days (Gordon 1987). The amendment did not
mention aspartame or G.D. Searle by name and there was no
debate or discussion on the amendment.
The amendment was proposed by Senator Howell Heflin, brought
up for a vote by Senator Robert Byrd, and pushed through by
Representative Henry Waxman and Orrin Hatch. G.D. Searle
asked Senator Heflin to sponsor the amendment. Heflin
received $9,000 in campaign donations shortly after this
amendment was approved from G.D. Searle company executives
and their wives. Senator Byrd had received a $1,000 campaign
contribution from the CEO of G.D. Searle before the
amendment was proposed. Representative Waxman received a
$1,500 campaign contribution from the soft drink political
action committee including $500 before the amendment was
proposed. Senator Hatch received $2,500 from the soft drink
political action committee (Gordon 1987). Senator Hatch
repeatedly blocked hearings looking into the safety of
aspartame (Gordon 1987).
It could be argued that the amendment to extend G.D.
Searle's patent of aspartame rectified the lost marketing
time caused by the FDA investigations. However, it was G.D.
Searle's horrendous pre-approval studies which led to the
FDA investigations and the delays. Had they performed the
studies with any competance, aspartame could have been
approved quickly like any other FDA-approved food additive.
(Actually, had the studies been done right, it is likely
that aspartame would never been approved due to serious
adverse reactions.) In addition, the amendment was
applicable to one product and cannot be used similarly for
other products.
[snip]
References
Cloninger, M.R., R.E. Balwin 1970. "Aspartylphenylalanine
methyl ester: a low calorie sweetener," Science, Volume
170, page 81.
Congressional Record 1985a. "Saccharin Study and Labeling
Act Amendments of 1985," Congressional Record, Volume
131, No. 58, May 7, 1985, page S5489-S5519.
Congressional Record 1985b. "Aspartame Safety Act,"
Congressional Record, Volume 131, No. 106, August 1,
1985, page S10820-10847.
Farber, Steven A. 1989. "Aspartame and the Regulation of
Food Additives: A Study of FDA Decision-Making and a
Proposal for Change," Master of Science in Technology and
Public Policy Thesis at Massachusetts Institute of
Technology, Cambridge, MA 02139.
Federal Register 1973. Notice of Filing of Food Additive
Petition, G.D.Searle & Company. Federal Register, Volume
38, page 5,921.
Federal Register 1975. Volume 40, page 56907, December 5,
1975.
Federal Register 1981. "Aspartame: Commissioner's Final
Decision," Federal Register, Volume 46, page 285.
Gordon, Gregory, 1987. "NutraSweet: Questions Swirl," UPI
Investigative Report, 10/12/87. Reprinted in US Senate
(1987, page 483-510).
Graves, Florence, 1984. "How Safe is Your Diet Soft Drink,"
Common Cause Magazine, July/August 1984. Reprinted in
Congressional Record (1985a, pages S5497-S5506)
Leon, Arthur S., et al., 1989. "Safety of Long-Term Large
Doses of Aspartame," Archives of Internal Medicine,
Volume 149, page 2318-2324.
Mazur, Robert, James Schlatter, Arthur Goldkemp 1969. "The
Structure-Taste Relationship of Some Dipeptides," Journal
of the Americna Chemical Society, Volume 91, No. 2, page
684.
Mullarkey, Barbara 1992. "Bittersweet Aspartame: A Diet
Delusion" by Barbara Alexander Mullarkey, NutriVoice,
P.O. Box 946, Oak Park, Illinois 60303, Avaialbe from the
Aspartame Consumer Safety Network -- See Stoddard (1995).
Mullarkey, Barbara 1994b. "How Safe Is Your Artificial
Sweetner" by Barbara Mullarkey, May/June 1994. Available
from Informed Consent Magazine, P.O. Box 935, Williston,
ND 58802-0935, 701/859-3002.
Olney, John W., et al., 1970. "Brain damage in infant mice
following oral intake of glutamate, aspartate or
cysteine," Nature, Volume 227, page 609-610.
Reynolds, W. Ann, N. Lemkey-Johnston, L.J. Filer, Jr., R.M.
Pitkin, 1971. "Monosodium Glutamate: Absence of
Hypothalamic Lesions After Ingestion by Newborn
Primates," Science, Volume 172, page 1342-1344.
Searle 1975. "G.D. Searle Annual Report," 1975.
Stoddard, Mary Nash 1995. "The Deadly Deception" Compiled by
the Aspartame Consumer Safety Network for volumes of
available published information, ACSN, P.O. Box 780634,
Dallas, Texas 75378, (800) 969-6050.
US Senate 1975. U.S. Senate Joint Hearings before the
Subcommittee on Health of the Committee on Labor and
Public Welfare and the Subcommittee on Administrative
Practice and Procedure of the Committee on the Judiciary,
"Preclinical and Clinical Testing by the Pharmaceutical
Industry, 1975, Part 1," No. Y4.L11/2:P49/2/975, CIS#
S541-16.
US Senate 1976a. U.S. Senate Joint Hearings before the
Subcommittee on Health of the Committee on Labor and
Public Welfare and the Subcommittee on Administrative
Practice and Procedure of the Committee on the Judiciary,
"Preclinical and Clinical Testing by the Pharmaceutical
Industry, 1976, Part 2," No. Y4.L11/2:P49/2/976/pt2, CIS#
S541-82.
US Senate 1976b. U.S. Senate Joint Hearings before the
Subcommittee on Health of the Committee on Labor and
Public Welfare and the Subcommittee on Administrative
Practice and Procedure of the Committee on the Judiciary,
"Preclinical and Clinical Testing by the Pharmaceutical
Industry, 1976, Part 3," No. Y4.L11/2:P49/2/976/pt.3,
CIS# S541-12.
US Senate 1987. U.S. Senate Committee on Labor and Human
Resources, November 3, 1987 regarding "NutraSweet Health
and Safety Concerns." Document # Y 4.L 11/4:S.HR6.100.
Betty Martini
THE DEPT OF HEALTH AND HUMAN SERVICES ON
"SYMPTOMS ATTRIBUTED TO ASPARTAME IN COMPLAINTS SUBMITTED TO FDA*"
*Some cnsumers described more than one symptom attriuted
Headache 1,847
Dizziness/poor equilibrium 735
Change in Mood 656
Vomiting or Nausea 647
Abdominal Pain & Cramps 453
Change in Vision 362
Diarrhea 330
Siezures and Convulsions 290
Memory Loss 255
Fatigue, weakness 242 (Chronic Fatigue Syndrome?)
Other Neurological 230
Rash 226
Sleep Problems 201
Hives 191
Change in Heart Rate 185
Itching 175
Grand Mal 174 (add to siezures, above)
Numbness, Tingling 172
Local swelling 114
Change in activity level 113 (see Fatigue, above)
Difficulty Breathing 112
Oral sensory changes 108
Change inmenstraul pattern 107
Symptoms reported by less
than 100 complaints 1,812 GRAND TOTAL: 9,737!
This catalogue of misery represents more than 75% of the complaints the
FDA has received on any food additive. Now they've closed the reporting
window, according to a report I received last week; they're not accepting
additional complaints. When you smell smoke do you wait till the house is
ablaze before investigating for yourself?
January 10, 1977 in a 33 page letter FDA Chief Counsel Richard Merrill
recommended to US Attorney Sam Skinner that a grand jury investigate
Searl for concealing material facts and making false statements in reports
calling attention to studies on the effect of NSweet on monkeys & hamsters.
February 2, 1977 Skinner is offered a job with Sidley & Austin, Searl's
law firm and the case was dropped.
After overruling the findings of a public board of inquiry on 7/15/81
to approve NutraSweet for dry products Dr. Arthur Hull Hayes, Jr, FDA
Commissioner hired on with Burson-Marsteller, Searl/NutraSweet's\
public relations firm as "Senior scientific consultant." Scientific
Consultant for a PR firm: to understand that just think of an Art Director
for a Pig Farm.
FDA = FATAL DRUGS ALLOWED!
Betty Martini
Domain: be...@pd.org
UUCP: ...!emory!pd.org!betty
Betty Martini
sent button before I could correct. Commissioner Hayes of the FDA
resigned in September 1983 not 1981. He then went to work for
Burson-Marsteller Searle's public relations firm. Hayes is then
unavailable to the press for the next ten years. This happened after the
approval of carbonated beverages. The Congressional Record on the point
of carbonated beverages (Protest of the National Soft Drink Assn) said
they used the wrong test when the right one was available, did not pick
up aspartic acid, used the wrong solution (a buffered solution instead of
beverage matrix), didn't test for breakdown products (a witches brew of
formaldehyde, formic acid (ant sting poison) and DKP (a brain tumor agent),
and didn't test for temperature elevation. At 86 degrees aspartame
liberates methanol in the can.
In November 1984 The Center for Disease Control reviewed 213 of 592 cases
of aspartame complaints. Ages of the complainants ranged from four months
to 77 years; 77% were between the ages of 21 and 60 years, 75% were
female, and 94% were white. Twenty-eight percent reported repeated
episodes of symptoms and 26 people experienced identical symptoms. Some
of the reported symptoms included: aggressive behavior, disorientation,
hyperactivity, extreme numbness, excitability, memory loss, loss of depth
perception, liver impairment, cardiac arrest, seizures, suicidal
tendencies, severe mood swings and death. The CDC recommended future
investigations of aspartame investigate the neurological and behavioral
problems and focus on symptoms as headaches, mood alterations and
behavior changes. Frederick L. Trowbridge adds an executive summary to
the report which conflicts with the information in the report. He
states, "Currently available information, based on data with limitations
as described in the report, indicated a wide variety of complaints that
are generally of a mild nature. Although it may be that certain
individuals have an unusual sensitivity to the product, these data do not
provide evidence for the existence of serious, widespread, adverse health
consequences to the use of aspartame." (Center for Disease Control,
Division of Nutrition, Center for Health Promotion and Education.
"Evaluation of Consumer Complaints Related to Aspartame Use." (November,
1984".
On December 21, 1988 Senator Metzenbaum issues a press release saying
senators should not approve the appointment of Sam Skinner as Department
of Transportation secretary without an inquiry concerning Skinner's
failure, as U. S. district attorney in the Northern Illinois District to
pursue allegations about fradulent testing of NutraSweet. Metzenbaum
raises the issue of Skinner accepting a position with Searle's law firm,
Sidley and Austin, during the time the FDA asked Skinner to review
allegations of fradulent safety tests by Searle and urges the Senate to
convene a grand jury to investigate the charges. (Sen. Howard Metzenbaum
press release of December 21, 1988) The district attorney goes to work
for the godfather?!
On January 25, 1989 Senator Metzenbaum issues a press release saying that
Skinner acknowledged he may have made mistakes in the NutraSweet
investigation, but Metzenbaum says he supports Skinner's nomination as
secretary of the Department of Transportation. Could this be the reason
that the FAA does not supply assistance in warning pilots of the many
grand mal seizures that are on record from pilots who had grand mal
seizures in the cockpit of commercial airliners from consuming NutraSweet?
On February 28, 1994 The Department of Health and Human Services report
on adverse reactions attributed to aspartame and lists 6,888 complaints
including 649 reported by the Centers for Disease Control and 1,305
reported by the FDA. Aspartame accounts for the majority (75.7%) of all
the complaints in the Adverse Reaction Monitoring System.
The report of April, l995 and list over 10,000 complaints. In June of
this year the FDA announced that they would no longer compile complaints
on aspartame. Most people don't even report complaints to the FDA, they
just stop using the product when they have a reaction. However,
complaints continue to come in by the thousands and are recorded by the
ASPARTAME CONSUMER SAFETY NETWORK, WORLDWIDE PILOT HOTLINE and MISSION
POSSIBLE. Sleeping are federal regulators who turn a blind eye and deaf
ear to complaints!
Betty Martini
Domain: be...@pd.org
UUCP: ...!emory!pd.org!betty
Betty Martini
can read it above. But I want to respond to this Martini/Watts first.
Alan Watts has nothing to do with me. His name was just accidently
placed on the pd.org with mine I guess because we are on the same pd.org
and he helped set me up.
Second, the reason I have posted in this news group is because the
majority of all symptoms from NutraSweet are neurological and if you will
read the posting above you will note that the NutraSweet-Alzheimer link
is the subject of a new book by a researcher of Alzheimers for 30 years.
Third, Dr. Whitaker is not my mentor and has nothing to do with Alzheimers.
I have mentioned Dr. Whitaker in the diabetic newsgroup because he has
written a book called REVERSING DIABETES. I am familiar with his work
and have seen diabetics following his advice eliminate many diabetic
problems. I do admire the man because he combines allopathic medicine
with alternative medicine, relying many times on natural products that
will eliminate dangerous drugs. For instance, if you look in the PDR you
will notice under Micronase, a diabetic drug, it admits a side effects of
heart mortality. He has recommended Stevia instead of aspartame because
Stevia is a food and helps metabolize sugar in diabetics so would assist
them rather than poison them like aspartame.
Also, I attended the American College of Physicians conference here in
March in Atlanta and I can tell you the endocrinologists do not know
there is methyl alcohol in aspartame and what they are recommending for
diabetics is what is keeping them out of control. Much of what they
think is diabetic retinopathy is in fact vision disturbance from
aspartame because the methanol converts to formaldehyde in the retina.
One of the professors there was Dr. Jonathan B. Jaspan, F.R.C.P. (UK),
F.A.C.P., Tulis-Tulane Alumni Professor, Chief, Diabetes Program,
Director, Endocrine Fellowship Training Program. I sent him the
documents he requested and on April 20, 1995 he sent me this letter:
"Dear Mrs. Martini:
Thanks for your letter which I read with great interest. This whole area
is obviously very complex, and extremely important. I unfortunately have
little knowledge on this subject, but it is clear to me from the
information you provide that a lot more controlled research in this area
is necessary. I am certainly chastened by what yu have told me and I
think it is vital to inform the consumer public of the potential dangaers
inherent in unrestricted aspartame use."
Dr. Jaspan is probably the most eradite speaker I've ever heard. I was
told he was one of the leading endocrinologists in this country and has a
very high reputation.
It is interesting that the most brilliant minds are the ones open and the
ones who want to look at the evidence.
Many physicians at the conference in endocrinology were horified when
they saw the reports I had with him on aspartame. Two physicians said:
"How could the American Diabetic Assn do this to us." In other words,
how could they recommend this for diabetics when it is a neurotoxin and has
methyl alcohol in it which is lethal for diabetics. I lamented that they
are funded by Monsanto who owns Searle.
The methanol in aspartame converts to formaldehyde and then formic acid
and causes metabolic acidosis. The phenylalaline in aspartame breaks
down the seizure threshold of the brain and depletes serotonin production.
Researchers attribute low brain serotonin levels to depression, rage and
paranoia. This is what we are seeing.
Why would the FDA over-rule a Board of Inquiry that told them not to
approve aspartame because it caused brain tumors and seizures in lab
animals, and outlaw a safe substitute like Stevia? The April report from
the FDA lists over 10,000 complaints which makes up almost 80% of all
complaints on food additives. What are they going to do about it. They
said in the Food Chemical News they were no longer going to compile reports.
The FDA complaint report which I had to get by filing with Freedom of
Information (even though it was in the public domain) lists almost 500
cases of seizure and 362 vision problems, 255 cases of memory loss, 230
other neurological problems they don't list and 656 complaints having to
do with change in mood. There were 736 complaints of dizziness and poor
equilibrium and 1847 complaints of headaches. Normally when you complain
of headaches to the FDA they tell you they are not taking headache
complaints. Sometimes they just turn you away when you try to complain.
Since these postings are read around the world there are a lot of people
getting off of aspartame, and I can tell you my mail is piled high on my
desk, and messages come in by the hundreds. Those who are listening and
taking the "no aspartame" test are getting well and their symptoms are
disappearing.
Even physicians have been kept in the dark because Monsanto funds
organizations, Congress, etc. At the Conference of the American College
of Physicians one neurosurgeon (professor) said in a workshop: "Please
somebody tell us why are so many people having seizures. I don't care
how absurd it may sound - we have to find out where they are coming from."
Obviously, we know. When a Worldwide Pilot Hotline has to be set up to
do nothing but warn pilots and take complaints its quite serious. Their
number iss 214 352-4268. Over 600 pilots have already called, many of
them because of grand mal seizures in the cockpits of commercial airliners.
While the FDA calls these complaints anecdotes and turns away MISSION
POSSIBLE has packets flown around the world to air traffic controls to
warn pilots and keep the planes in the sky.
According to Mary Nash Stoddard, founder of the Worldwide Pilot Hotline,
the U.S. Air Force and U.S. Navy closed down for 48 hours because of
unexplained accidents and then warned all pilots off this neurotoxin. OUR
flyer quotes a paragraph from the U.S. Air Force Journal at that time,
FLYING SAFETY, May 1992: "Some people have suffered aspartame related
disorders with doses as small as that carried in a single stick of
chewing gum. This could mean a pilot who drinks diet sodas is more
susceptible to flicker vertigo, or to flicker induced epileptic
activity. It also means that all pilots are potential victims of sudden
memory loss, dizziness during instrument flight and gradual loss of vision."
Remember that the American Airliner that fell out of the sky in December
was reported as pilot error - tunnel vision.
If you want a copy of this warning flyer we distribute worldwide simply
email me to email you instructions on getting this from an auto-responder.
You can also access case histories of real people, and see multiple sclerosis
reversed because in reality it was methanol toxicity from aspartame. It
causes horrible equilibrium problems.
And if you are asking about death from NutraSweet let me quote a case
history that was printed in a local newspaper in Atlanta in April, 1994:
"Aspartame killed my wife. No words can express the agony and horror
sweet Joyce endured. This poison destroyed her brain, ravaged all her
organs and blinded her. She died at age 46 in 1991.
When we filed suit we were harassed and threatened. Our gung-ho
attorneys with a medically documented case suddenly seemed scared away.
The case had to be dropped. Joyce deteriorated so quickly she would not
have been able to participate in the legal proceedings anyway.
Don't listen to the paid Judas-goats and TV celebrities who say its
safe. Save your life and those you love, and avoid the grief I endured.
The makers of this poison considered her death an acceptable cost of
business. I'm a man without a wife because the NutraSweet Company is a
business without a conscience. April is Anti-aspartame month. Take dead
serious the warnings you will hear. The life you save may be your own."
Richard Wilson, Stockbridge, Georgia.
Before Joyce died she testified before Congress. Her case was listed
when the Community Nutrition Institute filed a petition to remove
aspartame from the marketplace because of its link to blindness. When
she died she was just like an Alzheimer patient with no memory. I'm
telling the symptoms are neurological!
In late September Joyce's son married. On her empty chair was a long
stem rose. On October 1 MISSION POSSIBLE exposed the American Diabetic
Assn. in Atlanta at their walk-a-thon (sponsored by NutraSweet, of
course) for taking megabucks from Monsanto and endorsing this poison with
full knowledge of its disastrous affects on diabetics. The day was
dedicated to Joyce Wilson. Press packs were given out with black lace
for mourning and garnished with a long stem yellow rose.
Diabetics continually called because they were given flyers at the
walk-a-thon and a paper by a physician telling how deadly aspartame is
for diabetics. Most of them said: "I can't believe it - since I've been
off aspartame, my vision is returning, my blood sugar is under control,
my headaches and depression are gone - and I feel my life has been returned."
It was reported in a local newspaper. A former FDA investigator wrote:
"In my opinion, NutraSweet is a poisonous neurotoxin."
You can access this article by emailing me for instructions to the
auto-responder.
Take it seriously, like Richard Wilson said: The life you save just may
be your own! We are a volunteer force - we are not physicians - but we
are working at our expense to warn you the public that NutraSweet is a
chemical poison and can take your life just like it took the life of
Joyce Wilson. Patricia Craine also lost her life to NutraSweet.
Christine Onassis' (a diet coke addict) autopsy report was identical to
that of Patricia Craine as reported on CBN about a year ago.
Sometimes the FDA lists deaths under symptoms - other! I guess you would
call it the ultimate symptom.
I don't have to convince anyone reading this posting who may be on
NutraSweet and having neurological problems. Take the "No aspartame
test" and see the difference in your condition in about six weeks.
w
Betty Martini
would not be involved in anything political. Here are the facts:
When a task force was formed, headed by FDA lead Investigator, Philip
Brodsky in 1975 here is a quote from the conclusions of their summary:
"We have uncovered serious deficiencies in Searle's integrity in
conducting high quality animal research to accurately determine or
characterize the toxic potential of its products."
"We have found instances of irrelevant or unproductive animal research
where experiments have been poorly conceived, carelessly executed or
inaccurately analyzed or reported." 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."
Many of the test animals fed aspartame developed large tumors. These
tumors had then been cut out and the animals returned to the study. In
several cases, animals that were reported as dead, were later reported as
alive again. (Bressler Report)
1976: Senate Subcommittee on Labor and Public Welfare meeting on April
8, 1976: Senator Edward Kennedy stated that "the extensive nature of the
almost unbelievable range of abuses discovered by the FDA on several
major Searle products is profoundly disturbing."
1977 In January the FDA formally requested the U.S. Attorney, Samuel
Skinner to conduct a Grand Jury investigation of the tests on two Searle
products: NutraSweet and Aldactone. Samuel Skinner removed himself from
the case two months later, because of anticipated employment with the law
firm of Sidley and Austin, who, at the time, were defending Searle in the
investigation.
In l975, the Justice Department had instituted proceedings against Searle
based on findings in animal studies for two drug products, Flagyl and
Aldactone (two Searle drugs). This was another case in which there were
problems with false and inaccurate reporting of tumor findings.
FDA used guidelines recommended by Searle in developing the Industry-wide
FDA standards for Good Laboratory Practices.
1977 Mr. William Conlon, Senior Assistant U.S. Attorney was assigned to
the Searle case but took no action. Conlon finally "reduced or ended"
his involvement in the investigation and the five year statue of
limitations for a grand jury investigation expired. One year later
Conlon took a position with Sidley and Austin, the law firm representing
Searle.
In 1979 Dr. Daniel Azarnoff, Head of Searle's Research and Development
Division, stated that rats eating the required amounts of SKP (Aspartame
breakdown product) had a statistically significant number of tumors in
their wombs.
1980 The Public Board of Inquiry is impaneled. The Board voted
unanimously to recommend banning aspartame for human consumption.
This time, a five member Commissioner's Team of Scientists was impaneled
because of the negative findings of the Public Board of Inquiry. The
three members looking at the brain tumor studies expressed serious
concern because the data showed that Aspartame ingestion caused them.
The two others expressed satisfaction that Aspartame did not seem to
cause any brain damage. For some unexplained reason, a sixth member
was appointed to the Team, apparently to make it look like a deadlock.
The end result was that three members pronounced Aspartame safe and three
concluded that Aspartame was dangerous.
The deadlocked report carried great weight in getting Aspartame approved
by the FDA. Jacqueline Verrett, Ph.D., Toxicologist and a senior member
of the review team, was extremely critical of the way the review was
done. She stated, "It was pretty obvious that somewhere along the line,
the bureau officials were working up to a whitewash."
On February 27, and February 28, 1995 an NBC affiliate in Miami, Channel 4,
exposed the whole FDA approval process and the dangers of NutraSweet.
Again Dr. Verrett testified.
In 1981 Senior FDA statistician (Satya Dubey) stated in a memo, that the
brain tumor data was so "worrisome" he could not recommend approval of
NutraSweet.
1981 Dr. Arthur Hull Hayes, Jr. was appointed the new FDA Commissioner
(April).
In July, Dr. Arthur Hull Hayes, Jr. overruled the Public Board of Inquiry
recommendation that "Aspartame should not be approved for marketing until
further animal testing was conducted to resolve the brain tumor issue."
The FDA approval of NutraSweet as a "food additive" makes it exempt from
continued safety monitoring and therefore G. D. Searle is not obligated
to monitor adverse reactions. Between 1979 and 1982 four more FDA
officials who participated in the approval of NutraSweet took jobs linked
to the NutraSweet industry.
S. M. Pape - Health and Human Services, Associate Chief Counsel for foods
from October 1976 to March 1979 and Special Assistant to the FDA
Commissioner from March to December 1979.
Sherwin Garder - FDA Deputy Commissioner between October 1973 and December
1979, and Acting Commissioner at various times.
Mike Taylor - Attorney involved with the Public Board of Inquiry.
Albert Kolbye - Was Associate Director of the Bureau of Foods for Toxicology.
It is interesting that the GAO recently investigated Mike Taylor. This
had to do with the bovine growth hormone, and the incestulous
relationship of Monsanto and the FDA. Monsanto bought Searle in l985.
I could go on. In fact, U.S. Sam Skinner eventually became Secretary of
Transportation squelching any help we could have gotten from the FAA over
the problem of pilots having grand mal seizures. He then became Chief of
Staff under Bush, the second most powerful man in the nation.
Interestingly, the Epileptic Foundation, made Sam Skinner man of the year
in 1993. How about an endorsement for a seizure triggering drug,
aspartame, for those with seizures! Insanity!
Jean-Martin Charcot, a famous neurologist, once said: "Such was the case
for so many other ideas which are today universally accepted because they
are based on demonstrable evidence, but which met for so long only
skepticism and often sarcasm - it is only a matter of time."
The handwriting is on the wall. Flyers with symptoms and diseases
triggered by NutraSweet are distributed worldwide. Other countries are
requesting information who also are having problems with this neurotoxin.
Coke has withdrawn NutraSweet from Diet Coke in Toronto and is testing a
new sweetener.
One day this will be considered one of the greatest scandals in U.S. History.
People are taking the "no aspartame" test and their neurological symptoms
are disappearing. They too join our volunteer force to warn others!
We will keep on passing this torch of knowledge until one day we can hold
up this torch to the world and say MISSION ACCOMPLISHED!
For those who want to know more email me for instructions for the
auto-responder which will give you a copy of the flyer. In about 2 weeks
we will have scientific reports added. The books on the back of the
flyer give the information I have just quoted and much much more.
If NutraSweet was so safe why would three organizations be warning the
entire world that this is a deadly chemical poison.
These are MISSION POSSIBLE, THE ASPARTAME CONSUMER SAFETY NETWORK AND
WORLDWIDE PILOT HOTLINE, SET UP FOR THE SOLE PURPOSE OF WARNING THE WORLD.
The number of the Aspartame Consumer Safety Network is 214 - 352--4268.
This is no joke! Senator Metzenbaum in one book is quoted as saying:
"People should be dropping like flies, but they aren't" Yes, they are
they just have not associated their neurological problems with aspartame
until the flyers started being distributed. Now the jig is up. MISSION
POSSIBLE has nothing to sell, is made up of volunteers, and gives away the
truth. Simple logic would tell you: Investigate. If you must err, err
on the side of caution.
Betty Martini
Domain: be...@pd.org
UUCP: ...!emory!pd.org!betty
Betty Martini
finally supporting Sam Skinner for Secretary of Transportation, it didn't
have anything to do with the FAA not assisting in warning pilots. I
meant that when Sam Skinner became Secretary of Transportation he was
over the FAA. Here is a man who was asked to do a grand jury
investigation to indite Searle for fradulent tests, and instead he goes
to work for Searle's siamese twin, Sidley & Austin, their law firm
defending the case. So his loyalty is to Searle; he's not going to aid
in alerting pilots their product will cause seizures!
When a district attorney goes to work for those who allegedly committed
the crime isn't it like the district attorney going to work for the
godfather?
There is no doubt that NutraSweet causes seizures. It produced grand mal
seizures in lab animals as it does in the public. Researchers at Mass
Institute of Technology surveyed 80 people who suffered brain seizures
after eating or drinking products with Aspartame. Said the Community
Nutrition Institute: "These 80 cases meets the FDA's own definition of an
imminent hazard to the public health, which requires the FDA to
expeditiously remove a product from the market."
I'm going to forward to you our instructions to get information on
NutraSweet from the auto-responder. One of the case histories is on
Gweene Allen who had seizures for 8 years until she read Dr. H. J.
Roberts' book ASPARTAME (NUTRASWEET) IS IT SAFE? She stopped aspartame
and within a month her seizures stopped, her vision improved and the rest
of the symptoms she had suffered for 8 years completely disappeared. She
is one of the fortunate ones. We faxed this case history to an NBC
affiliate, Channel 4, in Miami and they used her to film an expose on
NutraSweet on February 27 and February 28. In fact, they used her story
like a commercial or teaser all weekend long and it jammed their lines
with people who realized their problems too were from NutraSweet. They
referred these calls to the Aspartame Consumer Safety Network and the
answering service couldn't hardly take the calls - said at least 5 or 6
people were holding at any given time.
The called the expose SWEET SICKNESS. They even mentioned that people
using aspartame because of the phenylalaine in warm climates were more
prone to deadly melanomas. Did an incredible job and completely exposed
the entire FDA approval process.
I was given a Diet Coke by accident and almost lost control of the car as
my body trembled. In Dr. Roberts new book DAAD; DEFENSE AGAINST
ALZHEIMERS DISEASE, he explains how these single amino acids without the
other amino acids in protein can pass the blood brain barrier and
deteriorate the neurons of the brain - which is the cause of Alzheimers.
There are other neurotoxic substances that also trigger Alzheimers, a
20th century disease, now the 4th leading cause of death in adults in
this country, but NutraSweet has accelerated the disease according to Dr.
Roberts. Even the baby-boomers are getting it. 4 million in this
country have it and 250,000 each year get it, with 100,000 dying; 50% of
those in nursing homes according to Dr. Roberts have Alzheimers.
We've got to get this substance off the market. I've been on Internet
about 4 weeks and we keep telling people to take the "no aspartame test"
and see if their medical problems aren't caused by daily dosing of a
chemical poison. You would be surprised how many people have posted back
with me to private email that their symptoms are disappearing, their
headaches are gone, their vertigo is gone and even their vision is improving.
(The methanol converts to formaldehyde in the retina).
I don't kow what state you're in but Dr. Roberts is giving a seminar here
at the Doubletree Hotel on July 29 and he will go into the connection
between Alzheimers and NutraSweet. I know that when some people die from
NutraSweet they are like an Alzheimer patient without memory. That's how
Joyce Wilson was when she died. Her husband, Richard, wrote: "Aspartame
killed my wife. No words can express the agony and horror sweet Joyce
endured. This poison destroyed her brain, ravaged all her organs and
blinded her. She died at age 46 in l991." .........
Joyce testified before Congress and did everything she could to warn
others, but finally she could no longer remember anybody and then she died.
As to sending the protest of the National Soft Drink Association to our
representatives, or that part of the congressional record - what
difference would it make? They heard it! They heard Joyce Wilson. They
heard Dr. Roberts. They heard Dr. Elsas say it caused mental
retardation. And they heard the late Dr. Adrian Gross, FDA toxicologist say:
(talking about NutraSweet violating the Delaney Amendment because it
causes cancer)
"Is it not clear beyond any shadow of a doubt that aspartame had caused
brain tumors or brain cancer in animals, and is this not sufficient to
satisfy the provisions of that particular section of the law? Given that
this is so (and I cannot see any kind of tenable argument opposing
theview that aspartame causes cancer) how would the FDA justify its
position that it views certain amount of aspartame as constituting an ADI
(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?"
When I hear the hospitals talk about all these youngster with brain
tumors I could weep. The FDA says they are going to no longer even
compile complaints. The FDA is the last person that is going to help.
They converted this substance that was discovered by a Searle chemist
while testing an ulcer drug , into a food additive (must have had a magic
wand). This means they don't have to monitor it for safety, and since it
was the FDA who over-ruled the Board of Inquiry who said not to approve
it, they are not going to admit they were wrong.
This is why people all over the world are distributing our warning
flyer. Three worldwide organizations are warning the world - MISSION
POSSIBLE, THE ASPARTAME CONSUMER SAFETY NETWORK AND WORLDWIDE PILOT HOTLINE.
As case histories pour in the FDA looks the other way and tells people
this is a safe substance. Thats why I said FDA means Fatal Drugs Allowed!