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G. D. Searle conducted animal experiments on the safety of DKP. The FDA found numerous experimental errors occurred, including “clerical errors, mixed-up animals, animals not getting drugs they were supposed to get, pathological specimens lost because of improper handling" and many other errors." These sloppy laboratory procedures may explain why both the test and control animals had 16 times more brain tumours than would be expected in experiments of this length. In an ironic twist, shortly after these experimental errors were discovered, the FDA used guidelines recommended by G. D. Searle to develop the industry-wide FDA standards for Good Laboratory Practices." DKP has also been implicated as a cause of uterine polyps and changes in blood cholesterol by FDA toxicologist Dr Jacqueline Verrett in her testimony before the US Senate."* testified before the US Congress that aspartame was capable of producing brain tumours. This made it illegal for the FDA to set an allowable daily intake at any level. He stated in his testimony that Searle's studies were "to a large extent unreliable" and that "at least one of those studies has established beyond any reasonable doubt that aspartame is capable of inducing brain tumours in experimental animals..." He concluded his testimony by asking, "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 and Cosmetic Act?... And if the FDA itself elects to violate the law, who is left to protect the health of the public?" gue D as also been implicated as a cause of uterine polyps and —_ Footnotes: changes in blood cholesterol by FDA toxicologist Dr Jacqueline —_1. Department of Health and Human Services, "Report on All Adverse Verrett in her testimony before the US Senate.” Reactions in the Adverse Reaetion Monitoring System", 25 and 28 February 1994. 2. Compiled by researchers, physicians, and artificial sweetener experts for AILMENTS RESULTING FROM ASPARTAME Mission Possible, a group dedicated t warning The components of aspartame can lead to a wide variety of ailments. Some of these problems occur gradu- ally; others are immediate, acute researcher, was funded by reactions. Monsanto to study possible birth ff 223-889-2124, Task Order No. 8. There is an enormous population . * 5. FDA Adverse Reaction Monitoring of people who are suffering from defects caused by the ingestion of System. i - 6. Wurtm: id Walker, "Di Fhegneb a pemated by aspartame. Altered tame, yet they have no idea why y . herbs or drugs are not helping relieve After preliminary data showed Proceedings of the First International their problems. ‘There are other users ; . ‘ b Meeting on Dictary Phenylalanine and Brain - y Function, Washington, D.C., USA, 8 Ma: of aspartame who appear not to be damaging information about 1987. “i 7 suffering immediate reactions to aspartame, funding for the study 7. Hearing Before the Committee on Labor consumers about aspartame. Mi b k, R MD. i ins: Dr Diana Dow Edwards, ay >," Ril M. Bm 4. Life Sciences Research Office, Safety of Amino Acids, FASEB, FDA Contract No. aspartame. But even these individu- 2 and Human Resources, First Session on pps susceptible to the long-term was cut off. Examining the Health and Safety Concerns of damage caused by excitatory amino ——— (aspartame), United States acids, phenylalanine, methanol and , 8. Account of John Cook as published in: Mullarkey, Barbara, "How Safe Is DKP. A few of the many disorders that are of particular concern —_Your Artificial Sweetener?", Informed Consent magazine, September/October to me include the following: 1994. 9. Monte, Woodrow C., Ph.D., R.D., "Aspartame: Methanol and the Public Birth Defects Health", Journal of Applied Nutrition, 36(1):42-53. * > 10. US Court of Appeals for the District of Columbia Circuit, No. 84-1153, Dr Diana Dow Edwards, a researcher, was funded by Monsanto Community Nutrition Institute and Dr Woodrow Monte v. Dr Mark Novitch, to study possible birth defects caused by the ingestion of aspar- Acting Commissioner, US FDA, 24 September 1985. tame. After preliminary data showed damaging information about 1], Mullarkey, Barbara, "Aspartame Time Line”, Informed Consent, May/June aspartame, funding for the study was cut off. A genetic paediatri- 1994. cian at Emory University has testified that aspartame is causing 12. FDA Searle Investigation Task Force, “Final Report of Investigation of G. birth defects.’ D. Searle Company", 24 March 1976. . ee . 13. Testimony of Dr Jacqueline Verrett, FDA toxicologist, before the US Senate In the book, While Waiting: A Prenatal Guidebook, by George Committee ialier and Human Resources, 3 November 1987. R. Verrilli, M.D. and Anne Marie Mueser, it is stated that aspar- 4. Internal FDA memorandum. tame is suspected of causing brain damage in sensitive individuals. 5. Analysis prepared by Dr John Olney as a statement before the Aspartame A foetus may be at risk for these effects. Some researchers have _ Board of Inquiry of the FDA. Also, Blaylock, Russell, M.D., Excitotoxins: The suggested that high doses of aspartame may be associated with Taste That Kills. problems ranging from dizziness and subtle brain changes to men- _!6- Congressional Record SID835:131, 1 August 1985. tal retardation. Continued in the next issue of NEXUS... Cancer (Brain Cancer) In 1981, Satya Dubey, an FDA statistician, stated that the brain tumour data on aspartame was so “worrisome” that he could not FIND OUT HOW POLLUTION IS AFFECTING WEATHER, ECOSYSTEMS AND YOU. SUBSCRIBE TO: recommend approval of NutraSweet." In a two-year study con- — Blazing Tattles — ducted by the manufacturer of aspartame, 12 of the 320 rats fed a Extend your subscription, or subscribe at the low rate of normal diet and aspartame developed brain tumours, while none of USD$25.00 a year for 12 issues (USD$35.00 outside the control rats had tumours. Five of the 12 tumours were in rats USA/Canada/Mexico). Ask about special rates for students, given a low dose of aspartame." pensioners, unemployed, etc. The approval of aspartame was a violation of the Delaney PO Box 1073, Half Moon Bay, CA 94019, USA Amendment which was supposed to prevent cancer-causing sub- Phone: +1 (415) 712 0772, Fax: +1 (415) 712 8547 stances such as methanol (formaldehye) and DKP from entering E-mail: blazing@crl.com our food supply. The late Dr Adrian Gross, an FDA toxicologist, Birth Defects Dr Diana Dow Edwards, a researcher, was funded by Monsanto to study possible birth defects caused by the ingestion of aspar- tame. After preliminary data showed damaging information about aspartame, funding for the study was cut off. A genetic paediatri- cian at Emory University has testified that aspartame is causing birth defects.’ In the book, While Waiting: A Prenatal Guidebook, by George R. Verrilli, M.D. and Anne Marie Mueser, it is stated that aspar- tame is suspected of causing brain damage in sensitive individuals. A foetus may be at risk for these effects. Some researchers have suggested that high doses of aspartame may be associated with problems ranging from dizziness and subtle brain changes to men- tal retardation. Cancer (Brain Cancer) In 1981, Satya Dubey, an FDA statistician, stated that the brain tumour data on aspartame was so "worrisome" that he could not recommend approval of NutraSweet."* In a two-year study con- ducted by the manufacturer of aspartame, 12 of the 320 rats fed a normal diet and aspartame developed brain tumours, while none of the control rats had tumours. Five of the 12 tumours were in rats given a low dose of aspartame.'® The approval of aspartame was a violation of the Delaney Amendment which was supposed to prevent cancer-causing sub- stances such as methanol (formaldehye) and DKP from entering our food supply. The late Dr Adrian Gross, an FDA toxicologist, 28 * NEXUS OCTOBER - NOVEMBER 1995