Inspiration of The Heart

Editor's note: This was sent to the Aspartame Victims Support Group by a member,
Betty Martini, probably the world's most active aspartame activist, and the real
author of the famous "Nancy Markle E-mail". The Ecologist is a very respected
journal, and articles are sent their to be reviewed by people knowledgeable in
the themes the journal deals with, and it is expected that these articles will
stand scrutiny, under normal circumstances. We believe that this article will
stand scrutiny from all fair observers, and we hope that this will open some eyes
and help save a lot of people from needless suffering.

Subject:
       [Aspartame Support Group] Sweet Talking, The Ecologist, Vol 30, No 4 June 2000
       (Aspartame)
   Date:
       Wed, 28 Jun 2000 19:08:57 -0400
From:
       Betty Martini <[email protected]>
    To:
       Activist Mailing List <[email protected]>

Health Matters: In a recent survey of 166 studies on the effects of the
sweetener aspartame on human health, 74 had industry-related funding and 92
were independently funded. Of the industry sponsored articles, 100 per
cent attested to aspartame's safety. Of the non-industry sponsored
articles, 92 per cent demonstrated some type of adverse reaction. Ed
Metcalfe investigates whether the industry's assurances about aspartame are
any more than sweeteners themselves.

Aspartame is a sugar substitute added to literally thousands of products,
most notably diet soft drinks, and known best to the world of diet
conscious consumers as NutraSweet. While NutraSweet maintains that its
product is entirely safe, independent researchers continue to present
evidence of the chemical's neurotoxicity, linking its ingestion with the
onset of numerous adverse symptoms including - in particular - headaches
seizures (convulsions) and mood disorders. In fact, aspartame had been the
focus of controversey long before it was approved for public consumption in
l981. Several key tests conducted in the early l970s to establish the
safety of the product were heavily critcised by US Food and Drug
Administration (FDA) scientists; while a Public Board of Inquiry set up by
the FDA to address the question of aspartame's safety actually recommended
that aspartame should not be approved until further tests had been done to
discount a possible link between aspartame and brain cancer. In spite of
these objections, the FDA Commissioner approved aspartame. It is only now,
18 years later, that those further tests on brain tumors are being
conducted, not by NutraSweet (not surprisingly), but by independent
researchers at King's College London.

APPROVAL WITHHELD
Aspartame was discovered by accident in l965 by James Schlatter, a chemist
working for US pharmaceutical company G D Searle. Following Schlatter's
discovery, Searle conducted tests on the safety of aspartame, and in l97
petitioned the FDA for permission to market the chemical as a sweetening
agent. In July l974 the FDA gave its approval, only to withdraw it again
in December that year.

The retraction was caused by controversy within the FDA as to the safety of
aspartame and the validity of Searle's tests. In August l974, before
aspartame had made it onto the market, consumer interest attorney James
Turner and neuroscientist Dr. John Olney of Washington University filed a
formal objection to the FDA's approval, stating they believed aspartame
could cause brain damage. They cited research carried out by Olney which
found that aspartate (one of the constituents of aspartame) destroyed nerve
cells in the brains of mice. Furthermore, FDA toxicologist Dr. Adrian
Gross had come upon some irregularities in the submitted tests of another
Searle product, Flagyl. Searle's unsatisfactory responses to queries
concerning Flagyl raised suspicions over the validity of Searle's tests in
general.

With approval now withheld, Gross and others were appointed to a task force
to investigate Searle's studies on a number of products including
aspartame. The task force, which reported in March l976, noted that
'Searle has not submitted all the facts of experiments to the FDA,
retaining unto itself the unpermitted option of filtering, interpreting,
and not submitting information which we would consider material to the
safety of the product'. It concluded:

   'At the heart of the FDA's regulatory process is its ability to rely
upon the integrity of
   the basic safety data submitted by sponsors of regulated products. Our
investigation
   clearly demonstrates that, (in the case of) the GD Searle Company, we
have no basis
   for such reliance now.'

In the light of these findings the FDA singled out three key studies
submitted by Searle on the safety of aspartame. It set up a new task
force, headed by Jerome Bressler, to investigate these studies and
determine whether or not they had been properly conducted. In August l977
the Bressler Report (as it became known) was released. Investigators found
significant deviations from acceptable procedures for conducting
non-clinical laboratory studies. They discovered, for instance, that a
significant proportion of animal tissues from one of the studies had been
allowed to decompose before post-mortem examinations could be performed.
Original animal pathology sheets and the pathology sheets submitted to the
FDA showed marked differences. Animals were recorded as dead and then
subsequent records would indicate that the same animal was still alive -
almost certain evidence of a mix-up - which tallied with evidence that
animals had not been correctly tagged. In one of the studies examining the
possible carcinogenicity in rats of a breakdown product of aspartame called
diketopiperazine (DKP), investigators could not ascertain what dosage of
DKP had been fed to the rats. There was also evidence that the feed in the
DKP test had been improperly mixed, allowing the animals to avoid the DKP
while eating.

In l987 Dr. Jacqueline Verrett, a toxicologist and member of the Bressler
Task Force, testified before a US Senate hearing. She described the
discrepancies found in the Searle tests of aspartame as, 'serious
departures from acceptable toxicological protocols'.

'It is unthinkable', she said, 'that any reputable toxicologist giving a
complete objective evaluation of this data resulting from such a study
could conclude anything other than that the study was uninterpretable and
worthless and should be repeated'.

On the crucial question itself: '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'.

SWITCHING SIDES
Even before the Bressler Report had been released the FDA's Chief Counsel,
Richard Merrill, considered there to be enough evidence to bring fraud
indictments against Searle. In January l977 Merrill wrote to US Federal
Attorney Samuel Skinner requesting that he'convene a Grand Jury
investigation into Searle and three of its officers, for their wilful and
knowing failure to make reports to the FDA and for concealing material
facts and making false statements in reports of animal studies conducted to
establish the safety of the food additive aspartame'.

Since the studies in question were conducted in the early l970s, it was
important that Skinner act quickly to avoid the five year deadline imposed
on criminal prosecutions by the US Statute of Limitations. In what can
only be described as an interesting twist, Skinner was approached by
Searle's lawyers, Sidley and Austin and invited to join their
firm. Skinner accepted, leaving the decision on a Grand Jury investigation
to await the appointment of his successor. By December l977, despite
repeated warnings from Richard Merrill at the FDA, the Statute of
Limitations had expired on the aspartame case.

TUMOUR RUMOURS
In l978, while examining FA files on aspartame animal studies, Dr. John
Olney found two studies that revealed an unexpectedly high incidence of
malignant brain tumours in aspartame-fed rats. In response to Dr. Olney's
concerns, the FDA decided to set up a Public Board of Inquiry (PBOI) to
evaluate this brain tumour evidence and reach a final conclusion on the
safety of aspartame an issue that had now been dragging on since l974.

The study causing most concern was called E33/34. This was a two year
study in which 320 rats were fed aspartame and 119 rats were fed a normal
diet and used as controls. At the end of the study 12 of the aspartame-fed
rats had developed brain tumours while none of the control rats had. This
represented a 3.75 per cent incidence of brain tumors in the rats fed
aspartame. In order to determine whether or not these were simply
naturally occurring brain tumours the PBOI had to ascertain the spontaneous
brain tumour rate in laboratory rats. After examining the literature they
concluded that the spontaneous brain tumour rate was considerably les -
approximately 0.7 per cent. it was clear, therefore, that
E33/34 exhibited a worryingly high tumour incidence that could not be
discounted.

Accordingly, in October l980, the PBOI unanimously recommended that
aspartame should not be approved until additional studies were performed to
establish whether or not a relationship existed between the ingestion of
aspartame and brain tumours. For FDA toxicologist, Dr. Adrian Gross,
E33/334 was unambiguous in its significance. In l985, in his testimony
before the US Senate, he stated; 'at least one of those studies (E33/34)
has established beyond any reasonable doubt that aspartame is capable of
inducing brain tumours in experimental animals.' Arthur Hull Hayes,
however, the new FDA Commissioner on whom the final approval decision
rested, did not share this view. he overruled the PBOI and without any
further tests being conducted approved aspartame for use in dry foods in
l981 and in beverages in l983.

While Hayes left the FDA shortly afterwards to become a paid consultant
with Searle's public relations firm Burson-Marsteller, Professor Olney has
kept the spotlight on the brain tumour issue, reiterating the PBOI's call
for further testing. In l996 a study conducted by Olney and his colleagues
from Washington University alleged a link between the widespread use of
aspartame and a 10 per cent increase in the incidence of brain tumours in
the early l980s in the US. The language used in the paper is cautious,
however. The researchers stress the importance of reminding consumers that
the evidence presently available is not sufficient to prove that aspartame
caused the brain tumour increases. Therefore new studies properly designed
to answer this question are urgently needed.

SPONSORING SAFETY
A new three year study, begun in October l999 at King's College London,
should go some way towards resolving this issue. The research team headed
by neurochemist Dr. Peter Nunn, will examine whether aspartame could be
linked to primary brain tumours as Olney and others have been suggesting.

In l985 Searle was bought by US food and chemical giant Monsanto and the
NutraSweet Company was made in a separate subsidiary. In response to news
of the King's College study, NutraSweet stated: 'There is already an
overwhelming amount of scientific evidence which confirms the safety of
aspartame'. The brain tumour issue they attribute to
'scare-mongers'. This is typical of the industry's stance since the l970s
and mirrors the FDA's frequently repeated description of aspartame as 'the
most thoroughly tested additive in history'. Since its approval, however,
reports of toxic reactions to aspartame have steadily mounted prompting, in
November l987, a US Senate Hearing at which Senator Howard Metzenbaum
testified that the FDA had already received close to 4,000 complaints
ranging from seizures and headaches to mood alterations. today, US
campaigners on aspartame claim that figure represents barely a fraction of
those who have suffered from the effects of aspartame toxicity. At present
the Internet is awash with accounts of individuals who claim the onset of
problems when aspartame is ingested, and their improvement upon the
avoidance of aspartame. In the face of this growing pressure both Monsanto
and the FDA remain defiant in their defence of aspartame. They dismiss the
accusations as anecdotal, not scientifically proven, and fuelled by
misinformation posted on the Internet. The response of both NutraSweet and
the FDA is to point to an extensive volume of literature attesting to
aspartame's safety.

The integrity of this literature, however, is not above
suspicion. Professor Ralph Walton of Northeastern Ohio University's
College of Medicine recently conducted a survey of aspartame studies in
peer-reviewed medical literature. Of 166 studies felt to have relevance
for questions of human safety, 74 had NutraSweet industry related funding
and 92 were independently funded. Of the industry-sponsored articles,
74/74 (100 per cent) attested to aspartame's safety; of the
non-industry-sponsored articles, 84/92 (92 per cent) demonstrated some type
of adverse reaction. As Walton says, 'the clear split in the literature,
with outcome correlated so closely to funding source, is deeply trouble
(raising questions) about aspartame's safety and the appropriatedness of
industry sponsorship of medical research'.

Perhaps the new research currently being conducted will shed further light
on the ingredient. One thing seems certain: we do not know everything yet
that there is to know about aspartame.

For further information on aspartame, and international campaigns against
it, see www.dorway.com and www.holisticmed.com/aspartame. Freelance
journalist Ed Metcalfe thanks the websites' coordinators Betty Martini and
Mark Gold for their invaluable contributions to this article.

Further reading
1. Olney, JW, 'Brain damage in infant mice following oral intake of
glutamate,aspartate or cysteine', nature l970, 227, pp.609-610.
2. Olney, JW. et al., 'Increasing Brain Tumour Rates: Is there a Link to
Aspartame? Journal of Neuropathology and Experimental Neurology, l996 55
(11) pp. 1115-1123.
3. Walton, RG., 'Survey of Aspartame Studies: Correlation of Outcome and
Funding Sources' Unpublished study compiled for US TV program 60 Minutes
and provided to Ed Metcalfe by the author.
4. Wurtman, RJ.,'Neurological changes following high-dose aspartame with
dietary carbohydrates, New Eng J Med, l983, 309 (7), pp. 429-430.
5. Walton, RG, 'Seizure and mania after high intake of aspartame',
Psychosomatics, l986, 27, pp218-220.
6. Walton, RG, 'Possible Role of Aspartame in Seizure Induction',
In: Wurtman, Walker (eds) Dietary Phenylalanine and Brain
Function. Boston: Birkhauser, chp 18.
7. Olney, JW, Excitotix Food Additive', Neurobehav Toxicol Terratol l984,
6, 445-562, Progress in Brain Research, l988, 73, 283-294.
8. Monte,W, 'Aspartame: Methanol and Public Health, J. Appl. Nutr l984,
6:42 -54.
9. Trocho, C., et. al, Formaldehyde derived from dietary aspartame binds
to tissue components in vivo', Life Sciences l998, 63 (5): 337 - 49

Other information in article on components listed as:

CHEMICAL REACTIONS
In seeking to get at the truth of aspartame's safety the interested
consumer's beset approach is to listen to the views of independent
scientists and researchers. Aspartame is made up of three
chemical: phenylalanine, aspartic acid and methanol. Independent
researchers have found all three chemicals to have toxic potential linked
to adverse clinical events.

PHENYLALANINE
Phenylalanine is an amino acid normally found in the brain. Ingesting
aspartame can significantly increase brain phenylalanine and tyrosine
levels and can suppress the usual increase in tryptophan that follows a
carbohydrate rich meal. Such neurochemical changes have been postulated as
the cause of numerous adverse neurologic and behavioural symptoms including
seizures (convulsions), mood disorders and headaches.

Reports of aspartame's role in seizure induction are anecdotal though
highly persuasive. Walton published an anecdotal case of particular
interest in l986. The case involved a 54 year old woman with no known
medical difficulties other than a history of depression. without warning
she experienced a grand mal seizure followed by a profound behavioural
change categorised as symptomatic of mania. It was discovered that it was
her custom to drink up to a gallon per day of iced tea. In the past she
had sweetened the tea with sugar, but during the weeks prior to her seizure
she had used aspartame instead. She was taken off all medication and
aspartame was eliminated from her diet. Within four days all evidence of
manic activity had subsided. She continued to ingest large amounts of iced
tea, sweetened with sugar, and experienced no relapse. Walton
concludes: This patient's clinical course suggests that high intake of
aspartame may have triggered a seizure and subsequent manic episode.

In l988 Walton published a further eight cases of seizures linked to
aspartame.

ASPARTIC ACID (ASPARTATE)
As early as l970 Olney presented evidence of aspartate's neurotoxicity; it
was on these grounds that he objected to aspartame's approval in
l974. Aspartate, like glutamate (MSG), is an amino acid that acts as a
neurotransmitter in the brain. it is primarily Olney who is responsible
for demonstrating that neurons (brain cells) exposed to excessive amounts
of aspartate and glutamate become overstimulated and die.

In a series of experiments since the l970s Olney has conclusively
demonstrated that glutamate and aspartate administered orally to mice cause
cell death in certain areas of the brain. The circumventricular organs,
which lack the protection of the blood brain barrier, show the worst
evidence of neuronal destruction, even at low doses of glutamate and aspartate.

The resulting disruption of the hormone flow meant the infant mice
displayed sexual disfunction, obesity and stunted growth.

METHANOL
Aspartame also contains methanol, which upon ingestion is broken down to
formaldehyde and then formic acid. Formaldehyde is a highly toxic known
carcinogen that causes retinal damage and acts to alter DNA. NutraSweet
and the FDA seek to allay the fears of consumers by arguing that there are
other foodstuffs that supply as much or even more methanol, such as citrus
fruits and juices. The argument is virtually an insult to the independent
scientists and campaigners who are concerned about aspartame. As the FDA
and NutraSweet know full well, ripe fruits always contain the natural
antidote, ethanol, which protects from methanol poisoning by preventing the
conversion to formaldehyde and formate. An important recent study confirms
that far from being carried out of the body, the formaldehyde from
aspartame accumulates in body tissues.

These products were listed as may contain aspartame - check label first.
Chewing gums                                                 Tea beverages
Dry mixes for gelatins, puddings,                    Refrigerated gelatins
beverages and dairy toppings                          Yogurts
Ready to eat cereals                                         Frozen desserts
Carbonated soft drinks                                      Biscuit fillings
Chewable vitamins                                             Fruit drinks
Refrigerated juice based drinks                        Fruit spreads
Frozen
novelties                                                 Refrigerated puddings
Breath mints                                                        Hard
boiled sweets

______End of article

For more information on aspartame:
www.dorway.com
www.holisticmed.com/aspartame
www.aspartamekills.com
www.sunsentpress.com
www.presidiotex.com/aspartame   and asparspan (Spanish)
www.aspartame-survivors.org

S. Hrg. 100-567 "NUTRASWEET" - HEALTH AND SAFETY CONCERNS HEARING before the COMMITTEE ON LABOR AND HUMAN RESOURCES UNITED STATES SENATE ON HUNDREDTH CONGRESS FIRST SESSION ON EXAMINING THE HEALTH AND SAFETY CONCERNS OF NUTRASWEET (ASPARTAME) NOVEMBER 3, 1987 STATEMENT BY DR. LOUIS J. ELSAS, II, M.D. DIRECTOR, DIVISION OF MEDICAL GENETICS PROFESSOR OF PEDIATRICS (pages 360 through 369 of S. Hrg. 100-567) Senator Metzenbaum. Dr. Elsas, since Senator Hatch saw fit to go into the funding question, I will ask you, are your studies funded by industry? Dr. Elsas. No, sir. I had a research grant three years ago, for three years, from the March of Dimes, to study the effects of phenylalanine on human brain function. When the political issue got to aspartame, the society decided not to refund that. So all of the funding that is going on now - and the reason it is so slow has been through my own division’s efforts, personal funds, and university-based fund. Senator Metzenbaum. What do you think of our present system for funding scientific research? Dr. Elsas. I think the NIH is superb, I think there is a lot of concern about how industry and the FDA interact, where industry is made responsible for developing the data to support its own contentions. There is not a broad enough scientific base, such as an RFA, as we can it at NIH - research funds available - requesting input from the whole scientific community, stating that funds are in an unbiased approach - what the questions are which we need to ask? That is the problem here today. The questions about phenylalanine effects on human brain function have not been asked. So we have spent millions of dollars through our current system on mostly irrelevant experiments without approaching those particular questions. Senator Metzenbaum. What about the advertising campaign that NutraSweet puts on, and are you concerned about that? Dr. Elsas. Yes, sir. Senator Metzenbaum. In what way? Dr. Elsas. I am mostly concerned that it gives the false impression that NutraSweet is good for you, that it is nature’s best, and that it might even be good for children to take. A lot of the ads recently have shown children with the little ying and yang NutraSweet thing on it, making it sound like you should go with your mommy to the grocery store and look for that, and be sure that you buy that because it is real sweet and good. Senator Metzenbaum. Can you tell the Committee about your own experiences with the International Life Sciences Institute? Dr. Elsas. Yes, sir. It was not good. Senator Metzenbaum. Who is that group, can you tell us? Dr. Elsas. Well, Dr. Dews is right here; he can probably give you more personal information about it, because I have never gotten any feedback from them. But I was asked after issuing concerns both privately and then publicly on "Nightline" to give them a specific protocol for how I would approach these concerns. I did this. I wrote it up completely in a research grant format; submitted it through ILSI for their review, and basically, got a few phone calls from Dr. Dews over a prolonged period of time, stating that they had problems, but without ever a written peer review of criticism. So I basically never got funded; that is the bottom line. And the ideas are now reappearing three years later in other places funded by industry. Senator Metzenbaum. ILSI is pretty much the coordinating group for funding in the food and beverage industry, including pops, carbonated drinks, NutraSweet itself; is that correct? Dr. Elsas. As far as I know, that is correct, sir. I am not an expert on ILSI; I have repressed that experience. Senator Metzenbaum. It is my understanding that Dr. Pardridge has to catch a plane, so I am going to pass on to him. But I appreciate your testimony, Dr. Elsas, and I am only sorry Senator Hatch was not here to hear you comment on the fact that - at least, the inference; it is not a fact -that if the information or the research is not going to be supportive of their position, that sometimes one does not get supported by organizations such as ILSI, NutraSweet and others. Do you think that general conclusion of mine might be inappropriate, or appropriate? Dr. Elsas. Sir, I think that is very cogent and appropriate. Senator Metzenbaum. Thank you very much. Would you agree with that, Dr. Wurtman? Dr. Wurtman. Yes, sir. Senator Metzenbaum. Thank you. Dr. Pardridge, we are happy to hear from you, sir. Dr. Pardridge. Thank you, Senator, and thank you for having me. I am a Professor of Medicine at the University of California, a practicing endocrinologist, and I have been doing neuroscience research on the blood-brain barrier transport of phenylalanine and other substances since 1970. I believe in the discussion this morning, there are three key scientific food policy questions that have really not been properly illuminated. The first question is the dosage problem. We are led to believe by the FDA this morning that the typical consumer will have 2 to 4 milligrams per kilogram of aspartame per day; that the 99th percentile intake is 34 milligrams per kilograms per day; and that the advisable daily intake or ADI is 50 milligrams per kilogram per day. Now, the layperson sitting in the audience is really in no position to analyze these esoteric numbers. But if we put it in a different context and recognize that 50 milligrams per kilogram per day is equal to 5 servings of NutraSweet per 50-pound body weight, we are at great risk for overconsumption of NutraSweet. All one has to do in this room is look up at that chart and ask yourself if a 50-pound or 60-pound 7 year-old is going to consumer 5 or 6 servings of that per day. If they are, then they have consumer 50 milligrams per kilogram per day, of the advisable daily intake. Now, an 11-year study in the literature has already shown this, that the average 7-to-12-year old, when made freely available to products like that, consumes 5 servings per 50-pound body weight per day , and up to 77 milligrams per day. Senator Metzenbaum. That is the average? Dr. Pardridge. The average in children is the ADI - 5 servings per 50-pound body weight. Ask yourself: Would an average child have 5 servings? I think the answer is yes. Another study by Porikos in obese subjects showed that the average intake was 20 milligrams per kilogram per day, or 2 servings per 50-pound body weight, and that obese adults consume up to 36 milligrams per kilogram per day, even in the face of that high body weight. Now, if you accept the premise of the first question, that some individuals and in fact many children consume near the advisable daily intake of 50 milligrams per kilogram per day, then you must ask yourself what level of increase in blood phenylalanine will be concomitant with that ingestion of NutraSweet. And the answer is that your blood phenylalanine will rise three-to four-fold. That is not 10 percent or 20 percent. That is 300 to 400 percent. And this study has been done by Drs. Stenink and Filer, which was funded by the industry. If you now accept that many individuals, particularly children, consume 50 milligrams per kilogram per day, or 5 servings per 50-pound body weight per day, and that they enjoy or a four-fold increase in their blood phenylalanine, the third question that must now be addressed is, are there any untoward effects on the human brain, that are associated with a four-fold increase in phenylalanine, bearing in mind that this molecule is a known neurotoxin? And three studies come to mind. One study shows that when blood phenylalanine in pregnant mothers is increased five-fold, there is a 10- point drop in the I.Q. of the baby born of that mother. Senator Metzenbaum. Of I.Q. All right. Dr. Pardridge. A second study shows that if you measure choice reaction time, a test of higher cognitive function in humans, that when their bloom phenylalanine is increased six-fold, there is a 10 percent shift in your ability to make a key decision before a video screen. And a more recent study by Dr. Elsas has shown that there are quantitative changes in the human electroencephalogram when the blood phenylalanine is raised three-fold - something that clearly will happen in children who consume near 5 servings per 50-pound body weight. So if I may summarize, phenylalanine, is a known neurotoxin, and the food industry added nearly 8,000 tons of aspartame to the food supply in 1986, which amounts to approximately 8 million pounds of phenylalanine added to our food supply in a single year. The consumption of aspartame has increased exponentially since its introduction in 1981. The 1986 consumption of aspartame in the United States was equal to nearly 22 percent of the 1986 consumption of refined sugar when one allows for a 200-fold increase in sweetener potency of aspartame relative to sugar. With the enormous selective infusion of phenylalanine into the food supply, the key questions before the United States Congress and other scientific and medical organizations are whether selective increases in the blood phenylalanine level on the order of 200 micromolar or four- fold above normal, are to be expected with liberal intake of aspartame, and whether blood phenylalanine increases of this magnitude have untoward effects on the human brain. Thank you. (The prepared statement of Dr. Pardridge follows:) Page 369