http://www.mpwhi.com/aspartame_sidebars.pdf
Aspartame was discovered in 1965 by a scientist working for pharmaceutical behemoth G.D. Searle and
Company. Recognizing a potential cash, G.D. Searle and Co set about gaining FDA approval for their
entry into the lucrative artificial sweetener market. In a 1970 internal memo, company officials laid out a
strategy of “bringing the FDA into a subconscious spirit of participation.” Our approach …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,
other than putting them in a yes saying habit.
The first scientists who conducted clinical studies on aspartame, biochemist Dr. Harry Waisman and
neuroscientist Dr. John W. Olney, gave it thumbs down. Searle’s only reaction to their findings was to use
their own scientists — or those of their favorite contractor — throughout the rest of approval process.
Waisman’s results, when reported to the FDA, were falsified, while Olney’s were hidden from sight,
techniques the company would continue to use in all their dealings with the FDA and other government
and consumer agencies concerning aspartame.
Searle’s slight of hand was noted early on by a number of FDA scientists and officials, but in July of 1974,
the director of the FDA approved aspartame for limited use. Before it could go on the market, however,
Dr. Olney and James Turner Esq. filed a formal objection, stating they believed that aspartame had the
potential to cause brain damage, and that they were particularly concerned about its effects on children.
Searle’s nonresponse
to the subsequent questions about their methodology set off a controversy within
the FDA, and a special inhouse
Task Force was convened to examine the key studies done on
aspartame and a number of pharmaceuticals.
The task force’s preliminary findings caused the FDA to put a hold on aspartame’s approval. Further
obfuscation by Searle led FDA Chief Counsel Richard Merrill to recommend a grand jury be convened to
investigate Searle — a recommendation that ran into a brick wall when presiding U.S. Attorney Sam
Skinner left his job to work for Sidley & Austin, G.D. Searle’s law firm. Following Skinner’s departure,
Assistant U.S. Attorney William Conlon convened a grand jury, but let the statue of limitations run out on
the complaint. Fifteen months later he, too, went to work for Sidley & Austin.
In 1977, amidst continued rumblings about the company’s fraudulent research, Searle brought out the Big
Gun. Donald Rumsfeld, former Chief of Staff in the Ford administration — and current Secretary of
Defense — was hired as president of the company. Though it took nearly four years, Rumsfeld eventually
proved to be worth his weight in artificial sweetener. The day after Ronald Reagan took office in 1980,
G.D. Searle reapplied for FDA approval of aspartame. At that time, according to a former Searle
employee, Rumsfeld told his sales force that, “he would call in all his markers and that no matter what, he
would see to it that aspartame would be approved that year.” Six months later, it was approved (for use in
dry foods only) by the new, Reaganappointed
Commissioner of the FDA.
Soon after, an amendment was attached to the Orphan Drug Act which extended Searle’s patent on
aspartame by 5 years, 10 months and 17 days. The bill passed, speeded along by Utah Senator Orrin
Hatch, who later received $2,500 from the soft drink political action committee, and $1,000 each from
William and Daniel Searle and a Searle brotherinlaw
and William Searle. Since then, Hatch has been an
outspoken advocate for the sweetener, possibly due to his holdings in Twin Lab, a health supplement
company that uses aspartame in a number of their products. Between 1979 and 1982, four FDA officials
who assisted in the aspartame approval process landed jobs in artificial sweetener industry.
In 1983, aspartame was approved for use in carbonated beverages. Shortly after, the Commissioner of
the FDA, Arthur Hayes, left the FDA under charges of impropriety, and was hired as a consultant with
Searle’s public relations firm, Burson Marsteller [at $1,000 a day]. That same year, James Turner, Esq.
filed a petition with the FDA on behalf of himself and Community Nutrition Institute objecting to the
approval of aspartame. Three months later, the FDA denied the request “because public interest did not
require it.”
In May of 1985, the U.S. Senate heard testimony relating to an amendment put forth by Senator Howard
Metzenbaum requiring the quantity of aspartame used in products to be labeled. Senator Orrin Hatch led
the fight against the labeling amendment, which was defeated. Three months later, Metzenbaum
introduced the Aspartame Safety Act of 1985, another attempt at labeling, that also mandated a
moratorium on new uses of aspartame until independent research could be conducted by the National
Institutes of Health. The bill died in the Senate.
Also in 1985, G.D. Searle sold the NutraSweet Company (the subsidiary formed by Searle to market
aspartame) to the Monsanto Company, over the objections of Monsanto’s stockholders, who were leery
of the legal liabilities associated with the product.
In November, 1987, a hearing was held in a U.S. Senate Committee to address aspartame safety and
proposed labeling. Senator Orrin Hatch once again blocked the proceedings.
The patent for aspartame expired in December of 1992, opening up the market to other companies, such
as the Holland Sweetener Company.
In 1996, the FDA approved aspartame for “general use,” allowing it to be used in baking and cooking.
In 1999, Brand Week magazine named NutraSweet one of the top 100 brands of the century. NutraSweet
brand aspartame is sold in more than 100 countries and used in approximately 5,000 products by 250
million people on a regular basis.
In May 2000 The J.W. Childs company purchased the NutraSweet Company from Monsanto for $440
million in cash. The sale includes the sweetener business, the NutraSweet brand name and rights to the
company’s new sweetener, neotame.
“The NutraSweet Company revolutionized the sweetener industry in 1981 with the introduction of
aspartame," says Nick Rosa, the new president and CEO of the NutraSweet Company, "and we intend to
do it again with neotame when we receive approval from various regulatory agencies around the world.” •
OTHER NONCALORIC
SWEETENERS
In the United States, the Food and Drug Administration (FDA) permits six lowcalorie
sweeteners to be
used as food additives: Saccharin, aspartame (known around the world as NutraSweet, Equal, Spoonfuls,
Canderel, Bienvia, NatraSweet and Miwon), acesulfame K, (sold under the brand name Sunett),
sucralose (marketed as Splenda), trehalose and tagatose.
Saccharin
Discovered in 1879, saccharin was initially used as an antiseptic and a food preservative. Its use as a
sweetener developed slowly until World Wars I and II, when sugar rationing caused its popularity to
boom. The FDA has allowed the makers of saccharin to make a selfdetermined
Generally Recognized
As Safe (GRAS) declaration, claiming exemption from the premarket or food additive approval
requirements, although the FDA also lists it as an "anticipated" human carcinogen. All saccharinsweetened
products must bear a label stating: "Use of this product may be hazardous to your health. This
product contains saccharin which has been determined to cause cancer in laboratory animals."
AcesulfameK
(Sunette)
AcesulfameK
(5,6dimethyl1,2,3oxathiazine4(
3H)one2,2dioxide)
is approximately 200 times sweeter
than sucrose. It has been approved by the FDA in 1988 for use in baked goods, refrigerated and frozen
desserts, alcoholic beverages, yogurt, dry dessert mixes, confections, hard and soft candies, tabletop
sweeteners, bulk sweeteners, chewing gum, dry dairy analog bases, syrups, sweet sauces and toppings.
Acesulfame K, produced by Hoechst Food Ingredients in Germany, is often used in combination with
other artificial sweeteners, such as aspartame and saccharin. The Center for Science in the Public
Interest, a food watchdog agency, has repeatedly expressed concern that acesulfame K is a potential
carcinogen, and that the FDA has failed to require the manufacturer to conduct highquality
tests of the
artificial sweetener.
According to CSPI, testing done on acesulfame K “ followed inadequate protocols, which are greatly at
variance with current standards for test design, execution and reporting required for the National
Toxicology Program's bioassays.”
Sucralose (Splenda)
Sucralose (trichlorogalactosucrose) was approved by the FDA in 1988 as a tabletop sweetener and for
use in a number of desserts, confections, and nonalcoholic beverages. Sucralose is produced by
chlorinating sucrose (sugar); three chlorine atoms are substituted for three three hydroxyl groups.
According to Consumers Research Magazine , some concern was initially raised about sucralose being a
chlorinated molecule, as chlorinated molecules also serve as the basis for pesticides such as D.D.T., and
accumulate in body fat. However, the manufacturer, Johnson & Johnson emphasized that “sucralose
passes through the body unabsorbed."
Research animals fed sucralose exhibited the following symptoms: Shrunken thymus glands (up to 40%
shrinkage), enlarged liver and kidneys, atrophy of lymph follicles in the spleen and thymus, reduced
growth rate, decreased red blood cell count, hyperplasia of the pelvis, extension of the pregnancy period ,
aborted pregnancy, decreased fetal body weights and placental weights and chronic diarrhea.
In the wake of the continued controversy over aspartame, many pharmaceutical and health food
manufacturers — including Pro Lab, Twin Lab and Ross Products, makers of Pedialyte) — have switched
over to sucralose.
Tagatose & Trehalose
Like saccharin, both of these sweeteners have slipped through the FDA with a Generally Recognized As
Safe (GRAS) status.
The Calorie Control Council — which enthusiastically endorses the use of all artificial sweeteners —
describes tagatose as “a naturally occurring reducedcalorie
sweetener that can be found in some dairy
products” and “commercially produced via a patented process.” Less sweet than sugar, tagatose also
“browns” more readily than sucrose in baked goods, and has been shown to cause diarrhea and gas.
Nonetheless, manufacturers plan to use tagatose in chocolate, caramel, chewing gum, ice cream, soft
drinks, cereals and meal replacements.
Trehalose is almost half as sweet as table sugar, and is said to occur naturally in honey, mushrooms,
lobster, shrimp and foods produced using baker's and brewer's yeast. It is approved for use in beverages,
including fruit juices, purees, fillings, nutrition bars, dehydrated fruits and vegetables and white chocolate
for cookies or chips. though because of its low sweetness rating, trehalose is most often used as a
preservative.
And On the Horizon…
Alitame,
Discovered by Pfizer, Inc., alitame (brand name Aclame) is 2,000 times sweeter than sugar. Like
aspartame, it is made from amino acids, including aspartic acid, Dalanine
and a novel amine.
Alitame has the potential to be used in almost all areas where sweeteners are presently used —e.g.,
baked goods and baking mixes, hot and cold beverages, dry beverage mixes, milk products, frozen
desserts and mixes, fruit preparations, chewing gums and candies, tabletop sweeteners, toiletries and
pharmaceuticals.
Pfizer applied for FDA approval of alitame in 1986, but it has yet to be granted. It is, however, available in
other countries, including Australia, New Zealand and the People’s Republic of China.
Neotame
Neotame contains all the dangerous elements of aspartame and more: the amino acids Laspartic
acid
and Lphenylalanine,
and two organic functional groups: one known as a methyl ester group and the
other as a neohexyl group. These components are joined together to form an incredibly sweet (8,000
times sweeter than sugar) and potentially dangerous compound.
The FDA was petitioned in 1997 to approve neotame for use as a tabletop sweetener. Approval is still
pending. The NutraSweet Company, which owns the right to neotame, plans to use the sweetener in
chewing gum, carbonated soft drinks, refrigerated and nonrefrigerated
readytodrink
beverages, frozen
desserts and novelties, puddings and fillings, yogurttype
products, baked goods and candies.
Cyclamate
Cyclamate was first introduced as a sweetener in the early 1950s, and dominate the artificial sweetener
market though much of the ‘60s. In the late 60s, however, concerns arose over cyclamate’s potential to
cause genetic damage, testicular atrophy and cancer, and in 1970, the FDA imposed a total ban on its
use. Under pressure from the sweetener industry, the FDA is said to be considering reapproval of
cyclamate, which is still in use in 50 other countries. In many products made overseas and shipped to the
United States, cyclamate, AcesulfameK
and aspartame are blended together to create a “super
sweetener.” •
"IN A WORLD OF UNIVERSAL DECEIT, TELLING THE TRUTH IA A REVOLUTIONARY ACT."
-george orwell
-george orwell
Thursday, April 23, 2009
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1 comment:
The information reported here about aspartame is quite outdated. All aspartame research prior to 2009 is fatally flawed, because it was all done in a scientifically unacceptable manner. That was established by preliminary work presented at the Society of Toxicology (Seattle) and the American Chemical Society (New Orleans) national meetings in early 2008 and is currently being preparing for regular publication. There it was demonstrated that inappropriate controls were used in all aspartame research starting with the original Searle work and extending through the Soffritti et al work published over the past several years (and even other work thereafter). The standard control-versus-treated animal experiments are simply invalid for aspartame, because aspartame is hydrolyzed to methanol. Methanol has long been known to deplete a vitamin, namely folic acid. No properly done experiment can deplete a vitamin, but all experiments to date have done just that! Hence, both controlled and treated groups of animals must be provided either appropriate supplemental folic acid to counter methanol-induced loss OR both controlled and treated groups of animals must be provided the same intake of methanol, one directly and the other from aspartame. However, direct provision of methanol (given evaporation and other difficulties) is an experimentally more challenging option. No experiments to date have done these experiments correctly; hence all aspartame research is seriously and fatally flawed.
Strong associations are clear between all aspartame animal work and the many consequences of folate deficiency, which include the leukemia/lymphomas and mammary tumors claims reported by Soffritti et al in all their work. The consequences of that poorly controlled work and the folate deficiency that results only for the aspartame treated group is the accrual of homocysteine, because of insufficient methylation of methionine. There is no data suggesting any adverse effect, including those cited here cannot simply and completely be explained by the folate deficiency/homocysteine paradigm. This new information only suggests aspartame is even safer, now that what I have reported above is known to all the regulatory authorities.
John E. Garst, Ph.D. (Medicinal Chemistry, Pharmacology, Toxicology, and Nutrition)
(FYI, the author has absolutely no financial or biasing connection with the aspartame, the soft drink or their related industries and has made not one penny from my opposition, unlike many antiaspartame critics. The author has an undergraduate degree in chemistry (with emphasis in organic and biological chemistry) from the University of Kansas, a Ph.D. in Medicinal Chemistry (Pharmacy) from the University of Iowa, postdoctoral experience at Yale University (Molecular Biophysics & Biochemistry) and two postdoctoral fellowships at Vanderbilt University (physiology-pharmacology (mentor moved), then nutritional toxicology) and taught nutritional toxicology at the University of Illinois (Champaign-Urbana, UIUC) besides having conducted federally funded research at Vanderbilt, UIUC, and at several other universities before recently entering into semi-retirement.)
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