Subject: Aspartame/Brain Tumors - Original Studies, Part 2 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 "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. The brochure touting the safety of aspartame and its components is on Dave Rietz web page, email address below, and it has been answered by Mark Gold. Mission Possible reports are http://www.dorway.com/possible.html See part 3, for further aspartame information, and the FDA report of symptoms attributable to this neurotoxin.