Aspartame:
The Monsanto Connection

Based on an article I wrote for the Journal of the New Zealand Charter of Health Practitioners

Scientists for Sale

This is another one of those areas in which the academics line up on either side, and the arguments frequently become personal. It is interesting to note the parallels with fluoride, where much of the "expert" safety evidence was provided by the potential defendants. In the case of aspartame, however, it was not the politics of the Cold War that dictated the alleged falsification of evidence, but the politics of profit.

What is it?

Aspartame is the basis of NutraSweet, Balance, Equal, Twinsweet, and a number of other artificial sweeteners. It is also widely used in diet soft drinks, weight reduction products, "diabetic" products, and sugar free chewing gum. It was originally marketed by the pharmaceutical firm, G.D. Searle. They were bought out by the Monsanto Corporation whose prominence in the field of genetically modified food has also aroused controversy.

Aspartame aroused serious public concern when Dr John Olney, Professor of Psychiatry and Neuropathology at Washington University, St. Louis, Missouri, analysed statistics relating to brain cancer and suggested that a sufficient association existed between brain cancer and aspartame to warrant further investigation. Dr Olney’s findings were featured in a high profile TV programme, and attracted almost immediate attack.

The Best Testing Money Can Buy?

On the one hand, it has been called the most tested food additive in the world. From the other side, opponents have alleged serious flaws in the testing procedures, and accusations of deliberate fraud and bribery have also been made. One researcher, Watson, investigating mood swings, claims that he was obliged to buy his aspartame from alternative outlets when the parent company refused to supply him unless they controlled the experimental environment.

The Revolving Door

Aspartame has also been firmly linked with the longstanding tradition of senior FDA officials owning shares in the drug companies they manage, or leaving the FDA for employment in drug companies or related enterprises

Brief History

James Schlatter was researching amino acids in 1965 for the pharmaceutical firm, G.D. Searle, and specifically the combination of aspartic acid and phenylalinine. He licked his fingers to leaf through some papers and discovered an intensely sweet taste.

Some eight years later in 1973, after testing to establish the safety of aspartame, Searle applied for FDA approval of aspartame. Some of the preliminary research showed a possible link with brain tumours in laboratory animals, but the product was nevertheless approved for limited food uses.

Challenge

The decision was challenged by John Olney and James Turner. At the same time, a number of Searle’s other products began to generate serious side effects.

In 1975, a Task Force was set up to investigate Searle’s original research.

Their report stated

"We have uncovered serious deficiencies in Searle’s integrity in conducting high quality animal research to accurately determine or characterise the toxic potential of its products….

The cumulative findings of problems within and across the studies we investigated reveal a pattern of conduct which compromises the scientific integrity of the studies."

Falsification of Results

The investigation showed that Searles had cut out tumours from some animals that had been fed aspartame, neglected to report other tumours, and in other cases neglected to carry out appropriate checks for tumours. Animals that died during the study were recorded as alive.

Too hot for Senator Kennedy

In 1976, Senator Edward Kennedy, himself no stranger to spin, stated:

"The extensive nature of the almost unbelievable range of abuses discovered by the FDA on several major Searle products is profoundly disturbing."

In 1987, Dr Jacqueline Verrett testified before the Senate. She was Senior Scientist in an FDA Bureau of Foods review team set up in 1977 to review a report detailing abuses in Searle’s pre-approval testing procedures. She described the testing as a disaster, and described gagging interventions that limited comment on the tests.

The Best Lawyers Money Can Buy

Following the 1977 review of the Task Force’s report on pre-application testing abuse, Searles were to be prosecuted. The lead prosecuting attorney, Sam Skinner, was induced to switch sides, and allowed the statute of limitations to expire on the charges. The case was never brought.

If at first you don't succeed ...

In 1980, Searle once more applied for FDA approval. The FDA appointed a Public Board of Inquiry (PBOI) consisting of three qualified scientists from outside the agency.

The PBOI reviewed available data, and in 1980 stated that "the evidence suggested that aspartame might induce brain tumours" in laboratory rats, and concluded that approval for marketing be suspended until further animal testing was conducted to resolve the brain tumour issue.

...review the findings

A five member Commissioner’s team of scientists was then formed to look at these conclusions. It became obvious that the decision was going to be 3-2 against aspartame. Inexplicably, a sixth scientist was appointed who voted in favour, to deadlock the vote. Dr Goyan, the FDA Commissioner, however, decided not to approve aspartame this time either.

Political Appointment

Later, in 1981, a new FDA Commissioner, Dr Arthur Hull Hayes, Jr., was appointed. Searle reapplied for approval of aspartame. Dr Hayes reinterpreted the data and reversed the FDA decision without any further evidence being presented. Aspartame was approved for use in dry foods. In 1983, he approved aspartame for use in soft drinks.

Well, well, well!

One month later, he left the FDA to take up an appointment with Searle’s advertising agency, Burton Marsteller.

Uncompromisingly damned

Aspartame had reached the market with no more scientific guarantees of safety than it had in 1980, and these had been uncompromisingly damned.

In 1985, Searle was bought out by Monsanto and an aggressive marketing campaign followed.

Guilt by Association

As with fluoride research, much of the evidence pointing to problems is statistical. That is, researchers have shown a link between aspartame and various problems, without demonstrating the precise nature of the relationship.

For example, many soldiers in the Gulf War reported a disturbing set of symptoms which became known as Gulf War syndrome. Many of them subsequently had babies with birth defects.

These personnel had all been exposed to Diet soft drinks which had been sitting outside on pallets in extremely high desert temperatures before being finally chilled and drunk. (At high temperatures, aspartame breaks down and the resulting drink has much more available methanol than usual.)

Soldiers on combat rations drinking water only reported no such symptoms.

Much of the research, too, is on laboratory animals. This is the sort of scene that enables Colgate Palmolive to claim somewhat speciously that "from the vast quantities of clinical and research material, there is no scientific evidence that fluoridation has toxic, carcinogenic, mutagenic, or allergic effects on humans."

The underlining is mine. (Even so, I believe they are wrong. There is much research indicating damage to humans.)

With any research of this kind, caution is certainly indicated until replicating studies and other corroboratory evidence begins to stack up. Do we have this build up of evidence with aspartame? I think so.

Next, the case for aspartame’s safety should be, like Caesar’s wife, beyond suspicion. Evidence or research sponsored or funded or controlled by the manufacturers is not satisfactory, though the FDA routinely accepts research of this nature. There are too many levers, direct or implicit .

And Searle was certainly implicated in scandals involving falsification of tests and selective provision of data, even when it employed "independent" researchers.

Public Relations.

Keep an eye out for any suggestion of PR or spin doctoring. Nobody hires PR experts to tell you the whole story. Ask your average prime minister.

Take, for example, the aspartame story as related by the International Food Information Council Foundation (IFIC) in 1992. (This organisation, by the way, along with the American Dietetics Association, has been described as a "PR firm for junk food manufacturers".)

"Is aspartame safe for people with epilepsy?

Yes. The Epilepsy Institute, an organisation devoted to people suffering from seizure-related problems, has concluded that aspartame is not related to seizures among epileptic patients."

The review note accompanying this little gem states: "The Epilepsy Institute is not the Epilepsy Foundation, but a Monsanto-funded epilepsy centre in New York. There have been no properly conducted tests on aspartame and seizures. All independent research has shown problems with aspartame. (Camfield 1992, Elsas 1988, Walton 1986, Walton 1988)

Seizures are one of the most common adverse reactions linked to aspartame usage."

(The American Diabetes Association gets a good deal of its funding from Monsanto. Its assurances to diabetics about the safety of aspartame are similarly compromised.)

Further on, like Colgate, IFIC baldly state:

"There is no scientific evidence that aspartame is linked to adverse reaction in people."

The review note proceeds to quote seven double blind trials linking adverse reactions in humans to aspartame intake.

One of the researchers quoted, Kulczicki, walked off an industry-funded aspartame study because, he said, the researchers were clearly not interested in conducting the research properly.

Finally: "It’s the most tested product in history."

Comment: "In a 60 Minutes programme, 164 tests on aspartame were reported. 74 studies funded by NutraSweet found it was ‘as healthy as rain’. 83 of 90 studies by neutral laboratories reported dangers." Six of the seven favourable independent studies were carried out by officials of the FDA.

Short term studies

Industry-conducted studies are almost without exception short term studies. One can understand the need for private capital to seek its returns as swiftly as possible, but this is a bit like evaluating the effects of smoking using short term studies. The essence of the case against aspartame is in the effects of long term use.

It is these industry-conducted studies, by the way, that tend to be presented along with appropriate PR to various official groups around the world, such as the United Nations FAO and WHO. These groups are then quoted as approving aspartame.

The American Medical Association approved aspartame in 1985. Their statement is pretty much a rehash of FDA Commissioner Hayes’ statement approving aspartame against the advice of his own scientists. NutraSweet even helps the American Dietetic Association write their fact sheets.

Symptoms

Reported symptoms associated with aspartame cover an enormous range, from hair loss to convulsions, from headaches and blindness to impotence, arthritis and brain damage. One report lists approximately 40 possible symptoms. Another lists around 60 and yet another lists 92.

The alleged effects of aspartame mimic or exaggerate the symptoms of fibromyalgia, chronic fatigue syndrome, arthritis, epilepsy, multiple sclerosis, systemic lupus, diabetes, Alzheimer’s, Lyme disease, attention deficit disorder (ADD), panic attacks, depression and so on.

Around 80% of all complaints to the US Federal authorities since 1985 relate to aspartame. That’s 20% for everything else, on the market or prescribed.

It is extremely difficult to demonstrate conclusively that aspartame is the villain in any given case, and it is certainly possible that at least some of the complaints may not be well-founded – there is a fairly fickle fashion in public enemies as there is in many other social phenomena.

However, companies such as Monsanto have a long record of obfuscation. The present reluctance to label food containing genetically modified ingredients or derivatives of these is a case in point. The possibility of obtaining a control group who have not eaten GE food is just about nil. Remember that with smoking, even with control groups much more readily available and identifiable, it still took more than thirty years to sheet home responsibility for lung cancer.

Remember the statement by Phil Angell, Monsanto's director of corporate communications: ''Monsanto should not have to vouchsafe the safety of biotech food. Our interest is in selling as much of it as possible. Assuring its safety is the FDA's job,''

The Ultimate Test

Certainly, you should consult your health professional in the first instance, in respect of any alarming symptoms. Most GP's are not yet geared to suspect aspartame, but it is still important to check symptoms against knowledge they do have.

But, the ultimate test is this. If you are suffering symptoms which do not respond to conventional medical advice or prescription, and if you are consuming aspartame regularly, as sugar substitute, diet foods, soft-drinks or sweets, cut it out of your diet totally for at least sixty days and monitor the symptoms.

If the symptoms disappear or diminish, you still haven’t proved scientifically that aspartame is to blame, but you may be a lot healthier anyway . Thousands of people already are.

Symptoms

• hair loss
• convulsions
• headaches
• blindness
• impotence
• arthritis
• brain damage
• etc

Effects mimic

• fibromyalgia
• chronic fatigue syndrome
• systemic lupus
• diabetes
• Alzheimers
• Lyme disease
• attention deficit disorder (ADD)
• panic attacks
• depression
• etc

Diet Coke

Diet Pepsi

Diet Tonic and other soft drinks and mixers

"Diabetic" Foods

Weight watchers and slimmers products

Equal

Nutrasweet

Balance

Twinsweet