…the phenylalanine in aspartame is genetically engineered. You can get this from the web page on aspartame (MIWON) http://www.ktnet.co.kr/edl/catalog/food/intro-miwon.html. Look for the manufacturing process and note how it's done, and notice the E. coli under fermentation. The phenylalanine is genetically engineered in E. coli bacteria.

(from the Foreword to "FDA Pivotal Safety Study: Aspartame Caused Brain Seizures," The Milkweed, November, 1996 from www.dorway.com.)

The manufacturer does not address the bioengineering aspect of aspartame yet it points out that phenylalanine is a natural substance, one of 22 essential amino acids found in proteins. (See 22 Carrot Nutrition for information on protein sources in food.)

Remember the ads for aspartame showing bananas and cows and the voiceover saying "Banana plants don't make NutraSweet,® neither do cows. But they might as well. If you've had bananas and milk, you've eaten what's in NutraSweet®." (Quoted in Gordon, 1987.)

What it fails to address is the health consequences when one or two particular amino acids are ingested much more than the others, and therefore out of the natural balance found in the normal eating of protein. Dr. Richard Wurtman, a neuroscientist at the Massachusetts Institute of Technology, stated that phenylalanine can serve as a barrier to 20 other amino acids that provide protein to the brain.

Medical scientists generally consider any substance that crosses the blood-brain barrier to be potentially dangerous. This is because the body specially protects the brain with a membrane that prevents most substances in the blood from entering brain tissue and potentially damaging sensitive brain mechanisms.

Dr, Wurtman stated aspartame causes abnormally high levels of phenylalanine in the brain which could increase the likelihood of epileptic seizures (Gordon, 1987). This is one of the reported consequences of consuming aspartame.


Chemical Stability. Then there is the question of the stability of aspartame. When aspartame is heated to a temperature of 86º F (an average summer day temperature) it decomposes into methanol (wood alcohol, a neurotoxin), phenylalanine and aspartic acid. This is why aspartame consumers were initially advised not to cook or bake with aspartame.

Even at lower temperatures, aspartame in solution (as in Diet Coke®, diet ice teas, etc.) undergoes the same breakdown process. This is why aspartame was initially approved in dry form only.

Added to milk products, aspartame may be even more dangerous. Robert Cohen contends that drinking a 12 oz. glass of milk buffers the pH of the human stomach from 2 to 6. At a pH of 6, Cohen states, simple proteins such as aspartame pass through undigested. Thus, they move to the blood stream intact. (Hardin, 1996)

Once in the body, phenylalanine breaks down into other substances, such as diketopiperazine (DKP), a known carcinogen. Some of the metabolites of aspartame are excreted from the body; others are stored in fat cells, leading to a cumulative effect over years.


Consumer Complaints of Ill Effects.

In recent years many reports have emerged of symptoms due to aspartame consumption. By 1987 the FDA had already received over 3,600 consumer complaints. (Gordon, 1987) The Aspartame Consumer Safety Network reported in 1996 that they had over 10,000 consumer complaints about aspartame in their files. (Stoddard, 1996)

There are 92 documented adverse effects of consuming aspartame, including:

Phenylketonuriacs are people who carry two abnormal genes for phenylketonuria (PKU) which prevent them from metabolizing phenylalanine. They must restrict their intake of phenylalanine or risk serious brain damage and death. As a result, every package of aspartame carries a warning to phenylketonuriacs that the product contains phenylalanine.

The question now arising is what about carriers of PKU, those who have only one PKU gene? They may have a limited ability to metabolize phenylalanine. Perhaps these are the people who are experiencing the majority of ill effects from consuming aspartame.


The Scientific Studies

Dr. Reuben Matalon, a pediatrician and geneticist, reported his research showed heavy use of aspartame to cause impaired attention span, memory and concentration in some people (particularly in small children). Pregnant women who are sensitive to aspartame may also face a heightened risk of birth defects in their children. Other scientists have linked aspartame to headaches, dizziness, brain damage, epileptic seizures, vision problems (including blindness) and allergic reactions.

In one study considered "pivotal" by the FDA, fifty-two (52) discrepancies were found regarding the toxicity test of a phenylalanine metabolite, DKP, alone. (Millstone, 1994)

The task force report reviewing the safety and toxicity studies on aspartame, the Bressler Report, stated "Observation records indicated that animal A23LM was alive at week 88, dead from week 92 through week 104, alive at week 108 and dead at week 112." (Quoted in Millstone, 1994)

These are some of the studies on which the manufacturer of aspartame laid its laurels.


The growth of neurological illnesses, many of unknown origin.

The U.S. Air Force has been reported to have formally warned all pilots to refrain from drinking aspartame-containing drinks due to their link with seizures, vertigo, heart disease and suicidal depression. (Colbin, 1996)

The Neurotransmitter Connection. Ms Colbin also reports that aspartame inhibits the production of the neurotransmitter serotonin, which helps regulate mood and sleep patterns. She writes," Isn't it really interesting that sales of the anti-depressant Prozac®, which encourages the production of serotonin, have gone through the roof?"

Betty Martini states aspartame changes dopamine (another neurotransmitter) levels in the brain. Lack of dopamine in the substantia nigra region of the brain causes Parkinson's disease.


The pervasiveness of aspartame in food.

Mark Gold has written:

At this time aspartame can be found in: instant breakfasts, breath mints, cereals, sugar-free chewing gum, cocoa mixes, coffee beverages, frozen desserts, gelatin desserts, juice beverages, laxatives, multivitamins, milk drinks, pharmaceuticals and supplements, shake mixes, soft drinks, tabletop sweeteners, tea beverages, instant teas and coffees, topping mixes, wine coolers, and yogurt.

I have been told that aspartame has been found in products where it is not listed on the label. One must be particular careful of pharmaceuticals and supplements. I have been informed that even some supplements made by well-known supplement manufacturers such as Twinlabs contain aspartame.

Don't be beguiled by the manufacturer's claims of safety. If its product is so safe, why did Monsanto fob it off onto another company last year as the truth of its danger is emerging?


Recovery, or partial recovery after removing aspartame from the diet.

The most compelling evidence that aspartame is responsible for many of the symptoms listed above is that symptoms disappear or lessen after aspartame is removed from the diet.

Try the 60-day "No Aspartame Test." If you feel better, you know what to do.

Just say "NO" to aspartame. Allow your inner knowing to guide you to safe foods. Choose natural sweeteners, such as honey, raisin syrup, fruit juice concentrate and stevia.

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The 60 Day No Aspartame Test

by Betty Martini, edited by Billii Roberti

Take the 60 Day "No Aspartame Self Test" Now!

If you feel pain or symptoms that your doctors can't seem to cure, and you use aspartame (now in over 6,000 products), take the 60 day "No-aspartame self-test" at-home and see what happens.

1. Round up all products containing aspartame and place them in a box, and then seal it for the duration of the test (or until you are certain of the results of this self-test).
   
   
2. Create a log. Enter all your current problems/symptoms along with the types and quantities of medication you are using to treat those problems/symptoms. Include observations concerning both your physical and mental health for the next 60 days, or until you are convinced that aspartame is (or is not) the cause of one or all of your problems.
   
   During this test period read all product labels. If any says "sugar free" or "no-calorie" you might consider not consuming it—just to be sure. Someone has reported that aspartame may be teamed with sugar (!!!), as well as saccharin, acesulfame-k, and who knows what else.
   
   
3. When you have completed as much of the "No-aspartame test" as you feel necessary (at least three weeks) do another inventory of your problems and symptoms, as well as the current levels of your medications and their types. Remember to consider mood, vision, perceptions, everything. If some or all of your symptoms are gone, then you know what to do. Never eat anything containing aspartame again.
   
   
4. If you are convinced aspartame was a significant reason for one or more of your health problems, it is time to return all the aspartame-containing products to the original point of sale. Request a full refund, even (and especially) on opened/partly consumed products, to make your point to the retailers, distributors and manufacturers.
   
   
5. Please share the information in this issue of Journal of Healing with others. Write letters to the newspaper and the local health department and share your story. Ask the media why they are silent on this subject. When we continually focus attention on this issue the tide will turn and we will be successful in removing aspartame from our food. There are still almost 200 million people who are unaware of the risks of eating foods made with this substance. Help wake them up.
   
   
6. Most importantly, report your experience to the FDA! If you or someone you know stops consuming all aspartame products and gets better, be sure to get a copy of the Aspartame Reaction Report Form at http://www.dorway.com/reprtfrm.html. Send it via certified mail to the FDA, and send a copy to Betty Martini (her address is on the form).

For information on FDA's MedWatch visit http://www.fda.gov/medwatch/report/consumer
/consumer.htm.

You can also notify the FDA by downloading the Adverse Event Reporting Form 3500 (Voluntary) or using the MedWatch Online Voluntary Submission Form 3500 at http://www.accessdata.fda.gov/scripts
/medwatch/.

You can also call MedWatch at (800) 332-1088 or fax them at (800) 332-0178 to get a postage-paid MedWatch form that can be sent by mail or fax.

A Brief History of Aspartame:
A Case Study of U.S. FDA’s Incestuous Relationship With
The Pharmaceutical Industry

Compiled by Billii Roberti from various sources (see References)

The U.S. Food and Drug Administration (FDA) is responsible for ensuring the safety of the nation’s food supply and pharmaceuticals. Any synthetic substance added to food must be tested for safety and approved for use by the FDA before it can be used in food.

This is the history of one synthetic substance, aspartame, developed by G.D. Searle & Co. and trademarked under the name NutraSweet®. (FYI, Searle, bought by Monsanto in 1985, became a subsidiary of Pharmacia in the 1999 Monsanto-Pharmacia & Upjohn merger.)

1965

Aspartame was synthesized by a research scientist at G.D. Searle & Co. He combined two amino acids, aspartic acid and phenylalanine, to form L-aspartyl-L-phenylalanyl-methyl-ester. He was looking for a peptic ulcer cure, but when he licked his finger to pick up a piece of paper and tasted a sweet flavor, he realized he had discovered something much more valuable: a sugar substitute.¹

1969

Dr. Harry Waisman was a physician and biochemist, Professor of Pediatrics - University of Wisconsin, Director of the University’s Waisman Center on Mental Retardation and Human Development. He was an expert on phenylketonuria (PKU, a genetic disorder resulting in brain damage if undetected). Dr. Waisman was approached by Searle in 1969 to conduct a study on the PKU effects of aspartame, using primates.

The results of Dr. Waisman’s study: Of the seven infant monkeys being fed aspartame mixed with milk, one died after 300 days and 5 others had grand mal seizures.
Searle deleted the negative finding before they submitted Dr. Waisman’s study to the FDA as evidence of aspartame’s safety.

1971

Dr. John Olney is a research psychiatrist at the Departments of Psychiatry and Pathology and Immunology of the Washington University School of Medicine. Dr. Olney found that young mice fed aspartame had nerve cell damage in their brains. Ann Reynolds, a researcher hired by Searle, confirmed Dr. Olney’s findings in a similar study.

Searle had submitted 13 studies on aspartame’s safety. FDA scientists who reviewed the research found serious deficiencies in all of them. FDA officials decided the studies could be relied on.

1975

A large task force was formed to determine whether studies on the safety and toxicity of aspartame had been properly conducted and reported. Here are excerpts from the summary of the "Bressler Report," which was released in 1977:

• 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 that compromises the scientific integrity of the studies.
  
  
• Many of the test animals fed aspartame developed large tumors. These tumors had 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.
  

The U.S. Justice Department 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.

The FDA still uses guidelines recommended by Searle in the industry-wide FDA standards for Good Laboratory Practices.

1976

There was a U.S. Senate Subcommittee on Labor and Public Welfare meeting on April 8, 1976. Senator Edward Kennedy stated that the extensive nature of almost unbelievable range of abuses discovered by the FDA on several major Searle products was profoundly disturbing.

1977

In January, the FDA formally requested the U.S. Attorney, Samuel Skinner, to conduct a grand jury fraud investigation of the tests on two Searle products: NutraSweet® and Aldactone®. Skinner removed himself from the case two months later because of anticipated employment with the law firm of Sidley & Austin (now Sidley, Austin, Brown & Wood) who, at the time, was defending Searle in the investigation.

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 statute of limitations for a grand jury investigation expired. One year later, Conlon also took a position with Sidley & Austin.

Donald Rumsfeld, former member of Congress and Secretary of Defense in the Ford Administration, was hired as Searle’s Chairman and CEO. Although he had no direct connection to the FDA, his political connections as a recently departed major player in government provided Searle with powerful influence.

1978

Howard Roberts, Acting Director of the FDA’s Bureau of Foods, became Vice President of the National Soft Drink Association.

The Department of Psychology, Northeastern Illinois University, studied aspartame and found:

1. Reproductive dysfunction in male and female animals
2. Endocrine dysfunction (pituitary, thyroid, ovaries, testes)
3. Increase in weight
4. Decrease in locomotor function

1979

Dr. Daniel Azarnoff, head of Searle’s Research and Development, stated that rats eating the required amount of DKP (an aspartame breakdown product) had a statistically significant number of tumors in their wombs.

1980

A Public Board of Inquiry was impaneled as a result of a protest of the pending approval of aspartame by Dr. John Olney. The Board voted unanimously to recommend further testing before approving aspartame for human consumption.

A five member Commissioner’s Team of Scientists was impaneled because of the negative findings of the Public Board of Inquiry. Dr. Olney pointed out that no studies had been done to rule out brain damage by aspartame and urged these studies be done. The three members looking at the malignant 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 that it was pretty obvious that somewhere along the line the bureau officials were working up to a whitewash and that many questions of safety remained unanswered.

1981

Satya Dubey, Senior FDA statistician, stated in a memo, that the brain tumor data was so worrisome he could not recommend approval of NutraSweet®
.
Dr. Arthur Hull Hayes, Jr. was appointed the new FDA Commissioner in April of 1981. In July, Dr. Hayes overruled the Public Board of Inquiry’s recommendation that aspartame should not be approved for marketing until further animal testing was conducted to resolve the brain tumor issue.
The FDA approved NutraSweet® as a food additive in dry foods.

The FDA approval of NutraSweet® as a food additive (not a drug) made it exempt from continued safety monitoring, and therefore G.D. Searle was not obligated to monitor adverse reactions associated with NutraSweet® or submit reports to the FDA of such 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 Gardner -- FDA’s 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 -- Associate Director of the Bureau of Foods for Toxicology.

1982

The Patent for NutraSweet® was extended by an amendment to the Orphan Drug Act.

1983

The FDA approved NutraSweet® for use in carbonated drinks and water-based syrups.

Commissioner Hayes of the FDA approved NutraSweet® for soft drinks two months before he left office. Dr. Hayes resigned while the Department of Health and Human Services was investigating his acceptance of gratuities, including free rides aboard a General Foods jet. Dr. Hayes accepted a position as senior medical advisor to a Searle public relations firm, Burson Marsteller, which represented NutraSweet® and several major users. Hayes was paid $1,000 per day as a consultant.
Anthony Brunetti, the FDA Consumer Product Officer who drafted the notice approving NutraSweet® in soft drinks, later accepted a position with the Soft Drink Association as a science advisor.

The FDA disregarded Section 170.22 of Title 21 of the Code of Federal Regulations, which would have limited the safe daily intake of diet drinks to only 2 cans per day. They raised the acceptable maximum daily intake of aspartame to the equivalent of 17 cans of diet drink for a 150-pound person.

1984

The FDA approved aspartame for use in children’s chewable and multivitamins.

1986

According to Food Chemical News, the Community Nutrition Institute petitioned the FDA to ban the use of aspartame, presenting many cases of seizures and visual problems. The petition was denied.

1987

According to the UPI news service, the International Life Sciences Institute stated that the Aspartame Technical Committee has been accused of discriminated against NutraSweet® critics in the granting of research funding awards. The Aspartame Technical Committee consists of NutraSweet Co., Ajinomoto Co. (Searle’s Japanese licensee), Coca-Cola Co., PepsiCo, Inc., Royal Crown Cola Co., Seven-Up, General Foods and many other manufacturers and users of aspartame.

Dr. Verrett, a member of the 1980 Public Board of Inquiry, testified before the U.S. Senate that the safety research on aspartame conducted by Searle was a "disaster." She said her team was instructed not to comment on the validity of the studies, and further stated that many questions brought up at the inquiry are still unanswered.

1992

The FDA approved aspartame for use in malt beverages (beer), breakfast cereals, refrigerated puddings, pie fillings and similar foods.

1993

The FDA approved aspartame for use in hard and soft candy, fruit juice cocktails, baked goods, tea beverages and other foods.

1996

The FDA approved the use of aspartame as a "general purpose sweetener." This means that aspartame can now be used as a sweetener in all foods and beverages².

2000

Monsanto sold NutraSweet® to J. W. Childs and divested itself of Equal, which is now a registered trademark of Merisant Co.³

****************************************

References:

Colbin, Annemarie, CHES, "Aspartame, the Real Story,"Free Spirit Magazine, October & November, 1996.

"Fraud, Collusion and Coverup with Searle Products" Leading Edge Research, 1996, http://www.trufax.org/research/f29.html

Gold, Mark, http://www.holisticmed.com/aspartame

Gordon, Gregory "Part 1: Did Searle Ignore Early Warning Signs?" UPI Investigative Report, 1987, on http://www.dorway.com/upipart1.txt

Gordon, Gregory "Part 2: Nutrasweet Approval Marred By Controversy," UPI Investigative Report, 1987, on http://www.dorway.com/upipart2.txt

Gordon, Gregory "Part 3: Sweet Corporate Victories," UPI Investigative Report, 1987, on http://www.dorway.com/upipart3.txt

"History of Aspartame," http://users.westnet.gr/~cgian/asphistory.htm

Martini, Betty of Mission Possible www.dorway.com

Martini, Betty, Foreword to "FDA Pivotal Safety Study: Aspartame Caused Brain Seizures," The Milkweed, November, 1996 (from www.dorway.com)

Millstone, Erik P., Ph.D., "Sweet and Sour: The Unanswered Questions About Aspartame," The Ecologist, Vol. 24, No. 2, March/April 1994, pp. 71-4, reprinted in the newsgroup sci.med, 10/04/1995, http://groups.google.com/groups?q=Aspartame%2Bsafety&hl=en&safe
=off&mum=8&selm=44u55h%24iiu%40infa.central.susx.ac.uk

Official aspartame site, http://www.aspartame.net/media/history.html and http://www.aspartame.net/media/history/approved.html

Stoddard, Mary Nash, Deadly Deception: Story of Aspartame: Shocking Expose of the World's Most Controversial Sweetener, 1995, compiled by the Aspartame Consumer Safety Network for volumes of available published information, ACSN, P.O. Box 780634, Dallas, Texas 75378, (800) 969-6050.

Stoddard, Mary (founder of Aspartame Consumer Safety Network, ACSN) "Before You Reach for That Sweetener!" misc.healthdiabetes newsgroup, 11/06/96.

Strubbe, Bill, "Killing Me Sweetly," Sonoma County Independent, September 28, 2000, http://www.metroactive.com/papers/sonoma/09.28.00/aspartame-0039.html.



Recommended reading:

Blaylock, Russell, M.D. Excitotoxins: The Taste That Kills, Health Press, 1996.