In the November 1996 issue of the Journal of Neuropathology and Experimental Neurology, John Olney, M.D. and his colleagues Nuri Farber, M.D., Edward Spitznagel, Ph.D. and Lee Robins, Ph.D, all from Washington University in St. Louis, report that brain tumor rates have risen in the United States over the past 17 years in two distinct phases.
"The first phase occurred in the mid l970's and might be explained primarily by improved diagnostic methods. The second phase occurred abruptly in the mid l980's, resulting in a 10 per cent higher rate of brain tumors which has persisted to the present. This increase also was associated with a shift from a lower to a higher grade of malignancy."
The article raises the possibility that the artificial sweetener aspartame, which was approved for limited markets in l981 and for widespread use in foods and beverages in l983, may have contributed to this increase," Olney says. "but it is important to remind consumers that the evidence now available is not sufficient to prove that aspartame caused the brain tumor increases." Olney urges that further studies be conducted to clarify what role, if any, aspartame plays in the development of brain tumors.
"In the meantime, consumers must decide whether they are willing to expose themselves to potential risks in order to reduce their calorie intake," he says. "Fortunately, the potential risk to any individual adult appears low because the total number of people that could be affected is small."
Olney recommends, however, that pregnant women be especially cautious about consuming aspartame until new studies can assess the risk to a developing fetus.

The investigators analyzed data from the National Cancer Institute's Surveillance, Epidemiology and End Results (SEER) program, which collects and distributes data on all types of cancer. SEER data are taken from areas of the U.S. that collectively represent about 10 per cent of the national population.

Because increases in brain tumor rates that could be linked to aspartame would be expected to follow public exposure to the artificial sweetener, the group looked at increases in the incidence of each of the different types of brain tumors from l975 to l992.

The new study shows sudden 10% increase in the incidence and malignancy of brain tumors in the United States beginning about three years after aspartame was introduced. The incidence of brain tumors did not continue to rise but remained at the higher level through l992, the last year included in the study.
"Although aspartame probably has been introduced into an increasing number of foods in recent years, it is likely that the same portion of the population simply ingested greater amounts of the product," Olney explains. "If a larger proportion of the population was not exposed to aspartame, that might explain why the incidence did not continue to increase."
Olney became interested in the neurotoxic potential of aspartame in the mid 1970's, after his discovery that the widely used food additive monosodium glutamate (MSG) destroys nerve cells in the brain when fed to immature animals. This link between MSG and neural damage eventually caused the food industry to stop adding glutamate to baby foods.

Because aspartame is chemically related to glutamate, Olney later fed aspartame to immature mice and found that it also destroyed nerve cells in the brain. On the basis of this evidence, Olney protested the approval of aspartame and Food and Drug ADministration (FDA) Commissioner Alexander Schmidt granted him a hering at a Public Board of Inquiry (PBOI). The Commissioner also stayed the approval of aspartame, pending further investigation.
"To prepare for the hearing, I examined the FDA's aspartame file," Olney recalls. "I was concerned because I did not find any studies pertaining to nerve cell damage. The FDA had not required that any such studies be done."
He did, however, find two studies revealing an exceptionally high incidence of malignant brain tumors in aspartame-fed rats, and FDA Commissioner Donald Kennedy granted Olney's request that the brain tumor evidence be evaluated at the PBOI, which was held in l980.

At the PBOI, Olney and other scientists argued that further studies must be done to rule out a brain tumor risk. "We have particularly concerned that aspartame might react in the stomach with nitrites present in foods and be converted to a nitrosated molecule" he recalls. "We were aware of published studies showing that certain nitrosated molecules can enter the central nervous system and cause brain tumors in laboratory animals. These studies showed that brain tumors develop fairly rapidly following exposure of an adult animal to the nitrosated molecules or after a long delay interval if a fetus is exposed during pregnancy."

The PBOI panel of neuropathology experts appointed by the FDA to judge the brain tumor evidence unanimously concluded that aspartame should not be approved until extensive additional animal tests had ruled out the brain tumor risk. In addition, Olney says, three top FDA science advisors reviewed the brain tumor evidence and agreed with the PBOI panel of neuropathology experts.

In l981, however, a newly appointed FDA Commissioner, Arthur Hull Hayes, approved aspartame without requiring further studies. In his judgment, the available data established with reasonable certainty that aspartame does not cause brain tumors in laboratory rats.

In 1993, Swiss scientist S. E. Shephard exposed aspartame to nitrite in a test tube, causing it to undergo nitrosation as it might do when it encountered nitrite in the stomach. Shephard then demonstrated that the nitrosated aspartame molecule is able to cause mutations in cultured bacteria. This is a test commonly used to assess the cancer causing potential of chemicals.

According to the Washington University researchers, three types of evidence are usually gathered to asses a substance's cancer causing potential:

(1) Can the substance cause mutations?
(2) Is there an abnormally high incidence of specific types of cancer in animals that are exposed chronically to the agent?
(3) Is there an increased incidence of the same kind of cancer in human populations exposed chronically to the agent?
"While it looks as if our new study and the prior evidence answer all three questions in the affirmative," Olney emphasized that further studies are needed. "A major problem is that early animal feeding studies showing an apparent brain tumor risk are contradictory and difficult to interpret. More reliable animal feeding studies are needed. In addition, studies are needed to clarify the significance of the mutation causing potential of aspartame. The chemical reactions that aspartame can undergo in the body and the effects of the resulting products on the brain need to be determined."

"Studies of brain tumor rates before and after the introduction of aspartame in other countries also are needed" Olney says. "Upward trends in deaths from brain tumors have been detected in the United Kingdom, France, Germany and Italy. These trends must be carefully analyzed in relation to aspartame consumption."
Other factors that have been studies in relation to increased brain tumor rates include ionizing radiation, electromagnetic fields, smoke inhalation, pesticides and various industrial chemicals. "The evidence linking aspartame to the recent brain tumor increases is stronger than for any of these other factors," Olney says. "However, the evidence presently available is not adequate to establish whether aspartame does or does not cause brain tumors. Therefore, new studies properly designed to answer this question are urgently needed."

Why has world renowned Dr. John Olney asked for further studies? Could it be because the original studies were a disaster and the manufacturers of aspartame have resisted any more testing? Senator Howard Metzenbaum who investigated the aspartame issue and the problems arising in the population wrote a bill that would have required independent testing by the National Institute of Health and put a moratorium on aspartame. It would have required studies to investigate some of neurological problems then being complained about back in l985 when aspartame was only in a few hundred products not 9000 and climbing with an expired patent. Heavy lobbying by Monsanto prevented the bill from getting out of committee.

Dr. H. J. Roberts in his letter in Lancet in February went a little further than requesting new studies being accomplished. He said: "I have documented other severe neuropsychiatric reactions to aspartame products - most notably headache, seizures, confusion and depression, and the probable acceleration of Alzheimer's disease by aspartame products. I believe that our society faces a preventable medical disaster if aspartame products are not promptly removed from public use." Dr. Roberts has written on the brain tumor issue for years and has authored books on the dangers of aspartame.

There have been independent studies on aspartame over the years, not funded by the manufacturer. Dr. Ralph Walton on 60 Minutes on Dec 29 said that out of 90 independent studies 83 showed a problem with aspartame.

During Congressional Hearings on aspartame a document was discussed titled CONFIDENTIAL TRADE SECRET INFORMATION, Food and Drug Sweetener Strategy, 12/28/70. In the concluding paragraph it says: "we have no way of estimating maximum likely abuse and hence need to utilize data based on almost complete conversion to DKP. If we include this .. we stand a good chance of ending up with nothing.."

Diketopiperazine (DKP) is a BRAIN TUMOR AGENT.

With regard to the studies, Dr. Jacqueline Verrett, a former FDA toxicologist and member of an FDA task force that investigated the authenticity of research done by Searle to establish the safety of aspartame, said she believes the original aspartame studies were "built on a foundation of sand". (Testimony of Dr. Jacqueline Verrett, FDA toxicologist, before the US Senate Committee on Labor and Human Resources, regarding "NutraSweet Health and Safety Concerns, 11/3/87)

Dr. Verrett testified that flawed tests conducted by SEarle - used as the basis of FDA approval - were a "disaster" and should have been "thrown out". She said she believed the studies left many unanswered questions about possible birth defects and the safety of aspartame. Verrett said the team was instructed not to be concerned with, or comment upon, the overall validity of the study. She said a subsequent review discarded or ignored the problems and deficiencies outlined by her team's original report. She said, "serious departures from acceptable toxicological protocols" that her investigative team noted in the reevaluation of these studies were also discounted. Verrett concluded the data in the study was worthless, and the safety of aspartame and its breakdown products have therefore not been determined.

She emphasized that aspartame exists in the market place without basic toxicity information. She said there are no data to assess the interactions with DKP, excess phenylalanine, other aspartame metabolites, additives, drugs, or other chemicals. She elaborated on DKP problems, including significant increases of uterine polyps and changes in blood cholesterol. DKP is formed when liquids in particular are pre-sweetened with aspartame. The production of DKP is vulnerable to increase in temperature, and higher temperatures produce increasing amounts of DKP. She reminded members of Congress "that is why initially, aspartame was not intended or not planned to be used in liquids because of this decomposition... it was decided it was too unstable to be used in hot preparations, hot liquids, and also in diet drinks."

On January 10, l977, FDA chief counsel, Richard Merrill, sent a 33 page letter to U.S. Attorney Skinner repeating the request for the grand jury investigation "into apparent violations of the Federal Food, Drug and Cosmetic Act and False Reports to the Government Act ... by G. D. Searle".

The letter charged that SEarle concealed material facts and made false statements in reports of animal studies conducted to establish the safety of aspartame. Studies cited for investigation had been conducted in l972 and five year statues of limitation for criminal prosecution were due to expire on 10/10 and 12/8/77. U. S. Attorney Sam Skinner went to work for Searle's law firm, Sidley and Austin, and the statue of limitations ran out.

The FDA task force observed laboratory methods at Searle from April 25 to August 4, l977. The Bressler Report (named for team leader Jerome Bressler) identified major discrepancies including "substantial differences between gross observation on pathology sheets when compared with those submitted to the FDA" in a rat toxicology test of aspartame. (FDA, Bressler Report, Investigation of Searle Laboratories, 8/7/77)

According to the Bressler Report, one rat even appeared resurrected. It stated: "Observed records indicated that animal A23LM was alive at week 88, dead from week 92 to week 104, alive at week 108, and dead at week 112."

The actual meal fed to the rats was also in question. Raymond Schroeder, a former SEarle employee, said in an FDA interview on July 13, l977 that "the particles of DKP were large enough to allow the rats to discriminate between the DKP and the basal diet."

Dr. John Olney, psychiatrist, neuropathologist and professor at Washington University in St. Louis, found 12 brain tumors in 320 dosed rats and none in 120 control rats when he examined FDA files on aspartame animal studies in l978. Olney advised that the high number of brain tumors was unusual. Olney voiced another concern based on his research. He showed that when glutamate and aspartic acid are ingested together each agent augments the neurotoxic effects of the other.

Olney, along with consumer activist attorney James Turner, initiated court action over aspartame. In a l986 interview Turner said he had spent 15 years battling approval of aspartame because "its hurting people".

The late Dr. M. Adrian Gross, an FDA toxicologist, spoke out against aspartame in the August 1, l985 Congressional Record. Gross, who took part in on site investigations at Searle laboratories, said the studies carried out by Searle to show the safety of aspartame were "to a large extent unreliable." He said "at least one of those studies has established beyond any reasonable doubt that aspartame is capable of inducing brain tumors in experimental animals and that this .. is of extremely high significance." (Congressional Record SID835:131 Aug 1, l985)

Gross also testified that because aspartame was capable of producing brain tumors and brain cancer, FDA should not have been able to set an allowable daily intake of the substance at any level.

He said at least one of Searle's studies:
"has established beyond any reasonable doubt that aspartame is capable of inducing brain tumors in experimental animals and that this predisposition of it is of extremely high significance... In view of these indications that the cancer causing potential of aspartame is a matter that has been established way beyond any reasonable doubt, one can ask: What is the reason for the apparent refusal by the FDA to invoke for this food additive the so-called Delaney Amendment to the Food, Drug an Cosmetic Act?"
The Delaney Amendment makes it illegal to allow any residues of cancer causing chemicals in foods. In his concluding testimony Gross asked:
"Given the (cancer causing potential of aspartame) how would the FDA justify its position that it views a certain amount of aspartame as constituting an allowable daily intake or 'safe' level of it? Is that position in effect not equivalent to setting a 'tolerance' for this food additive and thus a violation of that law? And if the FDA itself elects to violate the law, who is left to protect the health of the public?"
H.R. 3200 just repealed the Delaney Amendment and in June the FDA at the request of the NutraSweet Co. (Monsanto) gave blanket approval to this neurotoxin without public notification. Dr. Kessler of the FDA who approved it then recently resigned and left office. Aspartame was approved in l981 by Dr. Arthur Hull Hayes when he over-ruled a Board of inquiry and went to work for Searle's PR firm. He refused to talk to the press for over 10 years and refused recently to be interviewed by 60 Minutes.

When the NutraSweet Company tells you aspartame has been proven safe, remember that these are the studies that approved it. This is the myth of the most tested additive in history. Monsanto funds the trade organizations, the AMA and Congress. Petitions to ban aspartame have failed in the past. Monsanto has great power and the FDA has great loyalty to them. When Dr. Olney's report made world news the NutraSweet Co. attempted to defend their product and the FDA went to their defense.