Dear Steve: I find it hard to believe that you would say that Searle
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: betty at pd.org
UUCP: ...!emory!pd.org!betty
On Sun, 9 Jul 1995, Stephan Anagnostaras wrote:
> Hi,
>> 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$ojg at ixnews5.ix.netcom.com>, rrogoff at ix.netcom.com> (Robert Rogoff) wrote:
>> > mgold at 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
> > >mgold at 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 <betty at 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
>STEPHAN at PSYCH.UCLA.EDU>>