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Aspartame Dangers – Part 2

aspartame products
In part 2 of Aspartame Dangers, we will look at the Bressler Report and then the shady attempts to get aspartame approved.  As we know these duplicitous tactics have worked and now aspartame is consumed by billions of people worldwide.  How many, I wonder, are suffering because of their instake of this chemical, not realising what’s making them sick.  Here is Part 1 and Part 3 

Yet another report

In 1977, over a period of 5 months, another report known as “The Bressler Report” was instigated to investigate procedures of Searle research because of inconsistencies found by the FDA.  The report was damning with 40 different parts of the research found to be lacking in areas of:

  1. Design & Conduct of Study
  2. Stability and Homogeneity of Diet Mixture
  3. Dosage, Body Weight and Food Consumption
  4. Gross and Microscopic Pathology
  5. Organ Weights
  6. Survival
  7. Clinical Laboratory Procedures
Affected animals excluded from study results
rat tumour
Before and after a tumour excision

For instance under Gross and Microscopic Pathology:  “Animal F6HF, a high dose female,was found dead at 787 days of treatment and the gross pathology sheet reported a tissue mass measuring 5.0 x 4.5 x 2.5 cm.  The submission to FDA reported no tissue mass and the animal was excluded from the study due to marked autolysis.” (postmortem changes after death).  A total of 20 animals were excluded from the study due to excessive autolysis.  Of these, 17 had been fixed in toto and autopsied at a later date.

Animals dying twice!

Under Design & Conduct of Study: “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.”

Under Clinical Laboratory Procedures: “Some of the data sheets for urinalysis had erroneously labeled the phenylketones test values as “phenylalanine.” 

This is just an example of the sloppiness of the research done by GD Searle.  In the opinion of many critics, this was more to do with fraud.

Obvious attempts to massage results

The above comes from The complete Bressler Report and is worth looking at.  It is a little difficult to read in places because of the copying but you can see what’s going on here and how Searle attempted to ‘massage’ the research they did on aspartame, with these three different studies, one of rats and two others on mice.  These went missing for 3 decades.

Rumsfeld appointed President of Searle

In 1977 Donald Rumsfeld was appointed President of GD Searle.  Attorney James Turner Esq., alledged that this position given to Rumsfeld, was Searle’s attempt  to get aspartame approved through political means rather than scientific.  Rumsfeld was also on the Board of Directors of the Chicago Tribune.  The newspaper had recently written a glowing article on the Nutrasweet Company.

Grand jury investigation of Searle recommended

On January 10th 1977, a letter from FDA Chief Counsel Richard Merrill recommended to US Attorney Sam Skinner that a grand jury investigate Searle for “apparent violations of the Federal Food, Drug and Cosmetic Act, 21 USC 331 (e) and the False Reports to the Government Act, 18 USC 1001 for their willful and knowing failure to make reports to the FDA required by the act, 21 USC 355 (i) and for concealing material facts and making false statements in reports of animals studies conducted to establish the safety of aspartame.”

StatuteStatute of Limitations runs out

In July 1977 US Attorney Samuel Skinner who was supposed to instigate the grand jury investigation, was recruited by GD Searle’s law firm Sidley & Austin.   US Attorney William Conlon convened a grand jury but he let the statute of limitation lapse for the aspartame charges, thus the investigation was dropped.

5 person Task Force to review Bressler Report

After the Bressler Report, HR Roberts, Director of the FDA’s Bureau of Foods created a 5 person task force to review the report.  He would later leave the FDA to become vice president of the National Soft Drink Assn. in 1978.  Jacqueline Verrett was appointed the Senior Scientist for the review.  She later openly discussed the review and testified before the US Senate.  In one of her statements she said “It would appear that the safety of aspartame and its breakdown products has still not been satisfactorly determined, since many of the flaws cited in these three studies were also present in all of the other studies submitted by Searle.”

Searle pays $500,000 to validate research

Incidiously as time went by, reviews of Searle’s research started to tone down.  In December of 1978 UAREP ( Universities Associated for Research and Education in Pathology), stated that “no discrepancies in any of the sponsor’s reports that were of sufficient magnitude or nature that would compromise that data originally submitted.”     FDA toxicologist Adrian Gross stated that the UAREP review “may well be interpreted as nothing short of a whitewash”.  It is worth noting that Searle paid $500,000 for outside validation of their studies and it beggars belief that the FDA would allow such an action or take notice of the report results.

FDA acquiesces

In March 1979, the FDA seemed to change their tune and concludes that Searle’s aspartame studies were in fact acceptable!  Under pressure, they did decide however, to summon a Public Board of Inquiry (PBOI) which Dr John Olney and Attorney James Turner suggested 4 years earlier.

Public Board of Inquiry (PBOI)

Dr Olney, Searle and the FDA’s Bureau of Foods were to nominate scientists for the 3 person PBOI.  Note that the scope of the review was very limited and did not encompass all the various adverse reactions reported to the FDA.  Validity discussions were not allowed as the FDA had already accepted that the experiments had been validated.  Also consideration was to be for aspartame in dry goods only.

Dr Olney objects to Dr Young
Dr Young
Dr Vernon Young
Dr Olney
Dr John Olney

Dr John Olney objected to the panelists (Dr Vernon Young) because of a conflict of interest and lack of qualifications.  Dr Young had written articles working with Searle scientists.  Also that a neuropathologist was necessary to question aspartic acid’s neurotoxicity and Dr Young was unqualified in this field.  Dr Olney’s objections were overruled and Dr Young was assigned to study aspartic acid toxicity!

One of the three, Dr Nauta, stated that he would definately have considered other tests and research should be done if he had known that aspartame was planned for soft drinks usage.

PBOI rejects the use of aspartame

In 1980, the PBOI unanimously rejected the use of aspartame until additonal studies on aspartame’s potential to trigger brain tumors was done.  One experiment E33/34 of 320 rats receiving aspartame and the consequential high incidence of tumors, was of great concern.  As was the E70 experiment where 80 rats received aspartame but both the aspartame group and the control group had an unusually high number of tumors, leading to suspicions that both groups were actually given aspartame.

Although the PBOI did not consider that aspartic acid was a neurotoxic hazard, Dr Olney pointed out that “[Dr Young had a] lack of qualification” and that he “based his decision on a consideration of [aspartic acid] alone without regard to the real issue, ie. is it safe to add [aspartic acid] to the large amount of [glutamic acid/MSG] that were already adulterating the food supply?”  Also Dr Young used a conservative safety plasma level of aspartic acid that was the level at which half the rats developed brain damage.  Dr Young’s errors put the question of safety of aspartic acid into doubt.

ReaganRumsfeldSearle reapplies the day after Reagan takes office

On 20th January 1981, Ronald Reagan takes office as US President.  The day after, with Rumsfeld in charge, Searle reapplied for the approval of aspartame.  Rumsfeld’s connections with the Republican party was considered to be the reasoning behind this ‘political’ move.

Rumsfeld will “call in all his markers”ReaganRumsfeld

According to a former GD Searle salesperson, Patty Wood-Allott, GD 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.”

5 member panel set up to review PBOI

In March 1981, Jere Goyan the FDA Commissioner set up a 5 member panel of scientists to review the issues raised by the PBOI.   In April 1981 Arthur Hull Hayes Jr. was appointed FDA Commissioner by Ronald Reagan.

3 panel members appose approval
FDA Commissioner
Commissioner Jere Goyan FDA

A letter was sent on 18th May 1981 by three of the scientists on this panel, Dr Satva Dubey (FDA Chief of Statistical Evaluation Branch), Douglas Park (Staff Science Advisor) and Robert Condon (Veterinary Medicine) to the panel lawyer Joseph Levitt.  One of the panelists Dr Satva Dubey said that the brain tumor data for the aspartame research was so worrisome that he could not recommend approval of aspartame.  In another study, Dubey said that key data appeared to have been altered.

5 members change to 6!

These three of the five scientists on the team opposed approval so it was decided to bring in a toxicologist for his opinion.  Reagan replaces Goyan with Arthur Hull Hayes.  Goyan said he would not have increased the team if the decision was up to him.  So now there was a 3-3 split.  Arthur Hull Hayes had the last word and made the split 3:4 in favour of approving aspartame.

Newly appointed  FDA Commissioner approves aspartame
Hill Hayes
Arthur Hull Hayes

On 18th July 1981, aspartame was approved for use with dry foods by the new FDA Commissioner Arthur Hull Hayes Jr.  This despite the PBOI and ignoring the law of the Food Drug and Cosmetic Act (21 U.S.C. 348).  This states that a food additive should not be approved if tests are inconclusive.

Searle applies for additional aspartame approval

On 15th October 1982, Searle applied to the FDA for approval to use aspartame in soft drinks and children’s vitamins.

Mark Novitch
Mark Novitch

In 1983, Mark Novitch, acting FDA Commissioner, approved aspartame for use in carbonated beverages and carbonated beverage syrup basis.  Although FDA Commissioner Arthur Hull Hayes was out of town, he worked closely with Mark Novitch and ignoring the FDA’s own safety standards, they more than doubled the ADI (acceptable daily intake) of aspartame from 20mg/kg to 50mg/kg.

Arthur Hull Hayes left the FDA shortly after FDA approval for aspartame in carbonated beverages, under a cloud of improprieties.  He became Dean of New York Medical College and was hired as a consultant at $1,000 per Ches Powerday by Searle’s public relations firm, Burston Marsteller.

Part 3 of this extensive post will be explaining exactly what happens to your body when you ingest aspartame.

  1. Life-span exposure to low doses of aspartame beginning during prenatal life increases cancer effects in rats. Soffritti M1, Belpoggi F, Tibaldi E, Esposti DD, Lauriola M.  Environ Health Perspect. 2007 Sep;115(9):1293-7

Aspartame Dangers – this will shock you!

aspartame sodasAspartame Dangers will shock you!

Do you drink a diet coke or other diet sodas?  How many  sugar free yoghurts do you eat?   Read Aspartame Dangers and be shocked. What about aspartame flavoured cereal, chewing gum, puddings, cakes, juices or one of the other 6,000 products that contain aspartame?  Aspartame Dangers will go into how this chemical affects your body.  If you have time, take a look at this video:  (See Part 2 and Part 3 of this trilogy).

NutraSweet and others

Aspartame is commonly known as NutraSweet, Equal, Spoonful, Equal Measure etc.  You will be shocked at how this poison was passed initially by the FDA (Food and Drug Administration).  Now it is consumed by millions but will you keep using it after reading gumthis post?

But first, I want to relay to you how aspartame was passed as safe by the FDA. This was without proper research, with fraudulent and misleading studies by the then aspartame producing company G D Searle. As well as this, political misdemeanours abounded by Donald Rumsfeld, the CEO of Searle at the time of FDA approval.

How it started

The story starts way back in 1965, when a sweet substance was discovered, quite by accident, by James M. Schlatter, a chemist working for G D Searle & Company.  He was working on an anti ulcer drug. After some of the powder was spilt he licked his fingers to pick up a piece of paper and noticed a very strong sweet taste…

A long story

The story of aspartame is a long one, too long to cover in this article so I will try and give you the salient points. This will allow you to make an informed decision as to whether you wish to continue consuming it.

Dr John OlneyA good place to start

In the spring of 1971 a neuroscientist Dr John Olney was studying MSG (monosodium glutamate). He informed Searle that his studies had revealed that aspartic acid, one of the ingredients of aspartame, caused holes in the brains of infant mice.  (Dr Olney was responsible for having msg removed from baby foods).  One of Searle’s researchers, Ann Reynolds, confirms Olney’s findings in a similar study.

Controversial studies

In November 1971, Searle started a 115 week study (No. E-77/78) to test aspartame with 360 weanling albino rats, 190 of each sex.  They also did 2 other studies using mice and it was these particular studies that caused much controversy.

FDA approved aspartame

The FDA approved aspartame in July 1974 for limited use as a sugar substitute for sweetening hot beverages, cereals, gum and dry bases. It was not approved for baking goods, cooking or carbonated beverages.  FDA scientists found serious flaws in 13 tests related to genetic damage which was submitted by Searle.  So why did they give their approval?

A formal objectionJames Turner

in August 1974, a formal objection was filed.  Dr John Olney, James Turner and Label Inc. (legal action for buyers’ education and labeling) expressed serious concerns  They stated that they believed that aspartame could cause brain damage.  Aspartame’s effects on children was of particular concern to them.

Concerns over other drug studies

We’re only talking about aspartame here. But in July 1975 the FDA commissioner Dr Alexander Schmidt appointed a Task Force to look into 25 studies for the drugs Flagyl, Aldactone, Norpace and Aspartame.  This was because of concerns of Searle’s responses to queries about the testing of their drug Flagyl. Also there were serious and unexpected side effects from other drugs Searle developed.   The Olney studies and information, started controversy within the FDA as to the validity of Searle’s research of aspartame and other drugs.  All of the studies were either by Searle or done for Searle, ie. Hazleton Laboratories.  Eleven of the studies involved aspartame.


Approval
 put on hold

In December 1975 there was a hold of approval by the FDA for aspartame, due to findings of the Task Force.  The evidence of the aspartame pivotal studies were protected under FDA seal on December 3rd 1975.

Searle building an aspartame facility

Meanwhile, Searle was building a production facility for aspartame and had so far spent 19.7 million dollars.   On 8th December 1975, stockholders filed a class action lawsuit against Searle. They accused them of concealing information regarding the quality of research at Searle. This being in violation of the Securities and Exchange Act.

500 page report completed.

In March 1976 a 500 page report by the FDA Task Force was completed.  Here are some of the conclusions from this report. Searle’s research practices have been taken from Mark D. Gold’s FDA Dockets Submittal which has all relevant references therein.

“We have 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 evalution of the product….Finally we have found instance of irrelevant or unproductive animal research where experiments have been poorly conceived, carelessly executed, or inaccurately analyzed or reported.”

and

“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.”

Worrying research practices

“Excising masses (tumors) from live animals, in some cases without histologic examination of the masses, in others without reporting them to the FDA.”  When Searle’s representatives were questioned they stated “these masses were in the head and neck areas and prevented the animals from feeding.”

“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.”

“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 methology that showed no problems.”

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.

“Never seen anything as bad as Searle’s studies!”
“even with some fraud thrown in, it didn’t work”.

Phillip Brodsky described the 1975 FDA Task Force members as some of the most experienced drug investigators.  Brodsky was the lead investigator. He went on to state that he had never seen anything as bad as Searle’s studies.

The FDA Commissioner at the time, Alexander Schmidt stated “[Searle’s studies were] incredibly sloppy science.  What we discovered was reprehensible.”

Senator Kennedy says “profoundly disturbing.”

Senator Edward Kennedy at the April 1976 hearings, before the Senate subcommittee on Labor and Public Welfare stated: “The extensive nature of the almost unbelievable range of abuses discovered by the FDA on several major Searle products is profoundly disturbing.

research into aspartameAn independent study

To finish Part One of this post, take a look at this research. This was done by an independent researcher who just wanted to know the truth. Victoria Inness-Brown started the study because of concerns for her family who drank many diet sodas.

Victoria came across ‘The Bressler Report’ which we will discuss in Part 2. Hence, she decided to do her own experiment so she could see for herself if aspartame did actually produce tumours.  She used rats for the study, 108 of them that she raised herself.  Victoria had a control group as well as an experimental group.

NutraSweet used in study

male rat tumour aspartameShe could not obtain the pure form of aspartame because she wasn’t a food manufacturer consquently she used NutraSweet which she put into the rats’ water.  The rats were given the acceptable daily limit or acceptable daily intake (ADI). This is set by the FDA which is 50mg per kilogram.  The research took 2.5 years, ie. 30 months to complete.  Also, she had no help with finance but stated that it wasn’t too expensive to do the study, just time consuming.  She did all the care for the animals and was meticulous with recording her research.

As you can see by the images here, the results of the study are quite horrendous.  If you wish to look at more information regarding this study you can go to her page at  www.AspartameExperiment.com. or check out the narrative of her special interview with Victoria Inness-Brown and Dr Mercola.

Ches PowerIn Part 2 of this article, the Bressler Report is instigated by the FDA and Donald Rumsfeld joins G D Searle. President Ronald Reagan comes to power in 1981. Approval of aspartame comes soon after.