Aspartame is a low-calorie sweetener which is produced by G D Searle a company owned by Monsanto. It is approximately 200 times sweeter than sucrose. According to the official website the benefits include:

  • Aspartame Tastes Like Sugar
  • Aspartame Enhances and Extends Flavors
  • Aspartame Does Not Promote Tooth Decay
  • Aspartame is Helpful for Individuals with Diabetes
  • Scientific Studies Show Aspartame is Beneficial in Weight Control
  • Aspartame Can Be Part of a Healthful Diet (1).

The Food Standards Agency (FSA) takes the view that aspartame is perfectly OK as shown by this extract from the website:

Aspartame was first approved in the UK in 1982 following the review of its safety by the UK’s Committee on Toxicity, Consumer Products and the Environment (COT), a committee of independent experts that advises the Government on the safety of food chemicals. This was reaffirmed in 1988 by the European Commission’s former Scientific Committee on Food (SCF).

Following the publication of a number of anecdotal reports, which cast doubt on the safety of this sweetener, the SCF reviewed more than 500 papers published in the scientific literature between 1988 and 2001 on the safety of aspartame, including studies supporting the safety of aspartame and others pointing to potential adverse effects, which concluded, in 2002, that there was no evidence to suggest a need to revise the outcome of their earlier risk assessment or the Acceptable Daily Intake (ADI) previously established for aspartame of 40 milligrams per kilogram of body weight per day (40 mg/kg bw/day).

A study published by the Ramazzini Foundation in Bologna, Italy, in July 2005 claimed to have shown that rats given dosages of aspartame equivalent to the Acceptable Daily Intake (ADI) may develop tumours. EFSA assessed the study and raised a number of concerns regarding it. They concluded, that ‘there is no need to further review the safety of aspartame nor to revise the previously established ADI’.

The FSA supported the conclusions of EFSA’s review but reiterated that all approvals of food additives should be kept under review as and when new scientific information becomes available. Indeed, as part of its systematic re-evaluation of all food additives, EFSA has re-evaluated the safety of aspartame ………As a result, it concluded in December 2013 that ‘aspartame and its breakdown products are safe for human consumption at current levels of exposure’ ” (2).

However not everyone would agree with this position. In particular, Devra Davis has delved into the background and she would certainly dispute the rather complacent line taken by the FSA (3). Devra  has impeccable credentials. She is an epidemiologist who spent 10 years employed by the National Academy of Sciences. During her time as Senior Advisor to the Assistant Secretary for Health in the Department of Health and Human Services, she advised leading officials in the United States, United Nations, European Environment Agency, Pan American Health Organization, World Health Organization, and World Bank. Between 1983 and 1986 she served as a member of the Board of Scientific Counsellors of the U.S. National Toxicology Program. She founded the Center for Environmental Oncology of the University of Pittsburgh Cancer Institute where she was director from 2004 to 2010.

In an interview in the late 1990s, the author discovered some interesting history about aspartame from James Olney, a research neurologist and psychiatrist at Washington University in St Louis. In 1969 a study conducted by researcher Harry Waisman with 7 infant monkeys found that after drinking milk flavoured with aspartame for a year, one was dead and 5 had suffered epileptic seizures. In 1971 Waisman died and the work was never completed. However Olney’s own studies showed that aspartame paired with MSG to produce brain tumours in rats. Two years later, FDA scientist Martha Freeman decided the information submitted by the manufacturers on safety was inadequate.

In July 1976, the FDA decided to investigate the 15 key aspartame studies submitted by G D Searle and set up a Task Force under the chairmanship of Jerome Bressler. The sequence of events following the publication of the report is described in a document prepared by the Aspartame Toxicity Information Center (4). This provides a mine of information which should be consulted by anyone who is interested in the background to the approval of aspartame by the FDA. The references have been removed but many relate to official US Government documents. In August 1977, the Bressler report was released and it contained major criticisms of the procedures relating to the material presented by Searle, namely:

  • “In one study, 98 of the 196 animals died but were not autopsied until as much as one year later. Because of the delay, much of the animal tissue could not be used and at least 20 animals had to be excluded from postmortem examinations
  • The original pathology sheets and the pathology sheets submitted to the FDA showed differences for 30 animals
  • One animal was reported alive at week 88, dead from week 92 through week 104, alive at week 108, and finally dead at week 112
  • An outbreak of an infectious disease was not reported to the FDA
  • Tissue from some animals were noted to be unavailable for analysis on the pathology sheets, yet results from an analysis of this “unavailable” tissue was submitted to the FDA
  • There was evidence that the diet mix was not homogeneous allowing the animals to eat around the test substance. This evidence included a picture and statements by a lab technician
  • Fifteen foetuses from animals in one experiment were missing
  • Sections from the animals were too thick for examination
  • There was no documentation on the age or source of the test animals
  • There was no protocol until one of the studies was well underway
  • Animals were not permanently tagged to prevent mix ups
  • Some laboratory methods were changed during the study, but not documented.”

A G.D. Searle pathologist referring one of the studies was quoted by investigators as saying:

You should have seen things when this study was run — there were five studies being run at one time — things were a mess!”

Bressler himself commented:

The question you have got to ask yourself is: Because of the importance of this study, why wasn’t greater care taken? The study is highly questionable because of our findings. Why didn’t Searle, with their scientists, closely evaluate this, knowing fully well that the whole society, from the youngest to the elderly, from the sick to the unsick . . . will have access to this product.”

At this point it should be noted that Donald Rumsfeld who had just left office as Defense Secretary had been appointed as the CEO of Searle. It was evident that he had been hired early in 1977 because of his connections with government and with the Republican Party, although at that time the Democrat Jimmy Carter was president.

In September 1997, the Director of the FDA’s Bureau of Foods received a report from another Task Force which claimed that the Searle studies appeared to be authentic (meaning that they hadactually been conducted).

For each of the major discrepancies found by the Bressler-led Task Force — those listed above and many others – there was a comment in the FDA Bureau of Foods Report minimizing the problem. It seemed that no matter how serious the mistakes were, the FDA Bureau of Foods was determined toaccept the studies by G.D. Searle.

The experimental errors as described above were so bad that it proved difficult to minimize all of the major errors in these key studies. In some cases, the best that they could do was to say that “The Task Force could find no evidence that this was a deliberate attempt to influence the study.” or “It could not be determined if the results would have been altered….”

In other words it was evident that moves were being made to downplay the serious criticisms in order to pave the way for approval. This was confirmed by Jacqueline Verrett, a senior investigator at the FDA, who earlier had conducted an examination of the procedures and protocols which applied to the Searle studies. After she left the Agency, she was interviewed by a journalist who reported as follows:

Jacqueline Verrett, the senior scientist on the review team, said members were barred from stating opinions about the research quality. ‘It seemed pretty obvious that somewhere along that line they(bureau officials) were working up to a  whitewash,’ she said. ‘I seriously thought of just walking off of that task force.’ Verrett, now a private consultant, said that she and other members wanted to ‘just come out and say that this whole experiment was a disaster and should be disregarded.”

In her testimony before the U.S. Senate during 1987, Dr. Verrett stated the following:

This authentication was hence intended to verify that the submitted data had not been altered;that it reflected the actual outcome of the study and that it did not change substantially, particularly in a statistical sense, the various parameters from which the conclusion of safety had been derived.Our analysis of the data in this manner reveal that in these three studies, there were really no substantial changes that resulted, although in numerous instances, a definitive answer could not be arrived at because of the basic inadequacies and improper procedures used in the execution of these studies.

I would like to emphasize the point that we were specifically instructed not to be concerned with, or to comment upon, the overall validity of the study. This was to be done in a subsequent review, carried out at a higher level.

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 inall of the other studies submitted by Searle.

 Well, they told us in no uncertain terms that we were not to comment on the validity of it. And I hoped, although having been there at that point for 19 years, I should have known better, that there really would be an objective evaluation o this beyond the evaluation that we did. I do not feel that that was done, based on what I have read in the GAO report that I have looked at and so forth. They definitely did not objectively evaluate these studies, and I really think it should have been thrown out from day one.”

 “We were looking at a lot of little details and easy parameters in this study, when the foundationof the study, the diet and all of these other things, were worthless. We were talking about the jockey when we should have been talking about the horse, that he had weak legs. It is built on foundation of sand.”

Here are some comments about the approval process by the FDA:

  • “In March of 1979, the FDA somehow concluded that G.D.Searle’s aspartame studies could be accepted. They decide to convene the Public Board of Inquiry (PBOI).”
  • “The PBOI voted unanimously to reject the use of aspartame until additional studies on aspartame’s potential to cause brain tumours could be done. The PBOI was particularly concerned about experiment E33/34 where 320 rats received aspartame and a much higher percentage of animals in the aspartame group developed tumours than in the control group (Brannigan 1983, page 196). In addition, the PBOI was concerned about experiment E70 where 80 rats received aspartame. Both the aspartame group and the control group had an unusually high number of tumours, leading one to suspect that both groups were actually given aspartame.”
  • “On January 21, 1981, the day after Ronald Reagan takes office as U.S. President, G.D. Searle reapplied for the approval of aspartame. G.D. Searle submits several new studies along with their application. It was believed that Reagan would certainly replace Jere Goyan, the FDA Comissioner. G.D. Searle president, Donald Rumsfeld’s connections to the Republican party were also thought to play a part in Searle’s decision to reapply for aspartame’s approval on the day after Ronald Reagan was inaugurated.”
  • “In March of 1981, a 5-member panel of scientists was established by the FDA Commissioner Jere Goyan to review the issues raised by the PBOI.”
  • “In April 1981, Arthur Hull Hayes, Jr. was appointed FDA Commissioner by Ronald Reagan.”
  • “On July 18, 1981 aspartame was approved for use in dry foods by FDA Commissioner Arthur Hull Hayes, Jr. overruling the Public Board of Inquiry and ignoring the law, Section 409(c)(3) of the Food Drug and Cosmetic Act (21 U.S.C. 348), which says that a food additive should not be approved if tests are inconclusive (Federal Register 1981, Farber 1989,page 38). In an article in Common Cause Magazine, Florence Graves states that two FDA officials said that Arthur Hull Hayes, Jr. wanted to push aspartame approval through in order to signal reforms of the Reagan Administration.”
  • “On October 1, 1982 an amendment was attached to the Orphan Drug Act (an act which encourages the development of drugs for rare diseases) which modified the U.S. Patent law.
    The amendment extended the patent on only one product — aspartame — by 5 years, 10 months and 17 days.”
  • “On October 15, 1982, G.D. Searle petitioned the FDA for approval to use aspartame in soft drinks and children’s vitamins.”
  • “In 1983 acting FDA Commissioner, Mark Novitch approved aspartame for use in carbonated beverages and carbonated beverage syrupbases . FDA Commissioner, Arthur Hull Hayes was out of town the day that the approval was signed, but he worked closely with Mark Novitch on this issue. Ignoring the FDA’s own safety standards, they more than doubled the Acceptable Daily Intake (ADI) of aspartame from 20 mg/kg to 50 mg/kg.”
  • “Shortly after the FDA approval for aspartame in carbonated beverages, FDA Commissioner, Arthur Hull Hayes left the FDA under charges of improprieties, took a position as the Dean of New York Medical College and was hired as an a consultant ($1,000 per day) with G.D. Searle’s public relations firm, Burston Marsteller.”

CONCLUSION

There really is no need for much comment. The information speaks for itself. There is a lot more for anyone who wishes to follow the link to reference (4). The case for approving aspartame is built on a foundation of sand. With this background it is difficult to understand how and why the FSA and other regulatory bodies appear to be so complacent. One wonders if they have even bothered to review the information presented here. No doubt further testing has been done but how much can this be trusted in view of the appalling record of the company? If this information could be disseminated widely, then consumers could make up their own minds. As aspartame is extensively used in low calorie products, those especially at risk will be people who are attempting the follow the official dietary guidelines.

REFERENCES

  1. http://www.aspartame.org/
  2. http://www.food.gov.uk/science/additives/aspartame
  3. Devra Davis (2009) “The Secret History of the War on Cancer” pp 419-426. Basic Books New York ISBN 978-0-465-01568-9
  4. http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012203/02P-0317_emc-000202.txt