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This is a set of timelines for references use in Aspartame controversy. Discuss in Talk:Aspartame controversy.

Approval in the US

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  • 1965 discovered by James M. Schlatter, chemist at G.D. Searle & Company, while working on anti-ulcer drug candidate. Licked finger in lab (bad idea!).[1]
  • ??? to ??? Searle conducts 178 or 168 or 170 safety studies
  • 1974 approved for use in dry foods; ADI set at 20mg/kg, since 2000 mg/kg was deemed the highest "no effect" level for animals. harold m schmeck (26 July 1974). "FDA to approve a new sweetener". p. 66. {{cite news}}: Unknown parameter |publication= ignored (help)
  • August, 1974 Olney and Turner request hearing, agree to PBOI hearing .[2]: 38 [3][4]
  • 1974 - 1975 -- FDA investigators determined Searle had submitted fraudulent or incomplete data on Flagyl and Aldacone.[5] The Commissioner directed a task force to review 25 animal studies for 7 products (6 drugs and aspartame).[2]: 28 
  • 1975 July "preliminary reports of discrepencies in preclinical testing [of Flagyl] conducted by and for Searle were partially responsible for hearings on drug-related research held before the Senate Subcommittee on Health of the Committee on Labor and Public Welfare and theSubcommittee on Administrative Practices and Procedures of the Committee on the Judiciary both chaired by Senator Edward Kennedy"[6]
  • 1975 December -- preliminary report from task force -- stay on aspartame approval.[2]
  • 1976 March 24 -- Task force said "“the results were so serious in some studies as to make it difficult, if not impossible, to draw conclusions regarding the full toxic potential of the products from the data.”[2]: 30  GAO87 says "uncovered “serious deficiencies in Searle’s operations and practices which undermine the basis for reliance on Searle’s integrity in conducting high quality animal research to accurately determine or characterize the toxic potential of its products.” and reccommended evaluating specific studies to see if they could be used.[2]: 83 
  • 1976 January and 1976 April 8' "Subsequent testimony updating hte investigation and the positions of the FDA and Searle were taken before the joint [US Senate] subcommittees.[6]
  • 1976 April -- FDA requested Federal Grand Jury investigation for Flagyl[7] US attorney Sam Skinner assigns several assisstant US attorneys to investigate.[8]
  • 1976 NovemberM. Adrian Gross (4 November 1976), Memorandum to Carl Sharp: Draft Agreement for Validation of Searle Aspartame Studies FDA pathologist Dr. Adrian Gross gives opinion on the plan to Validate Searle Aspartame studies 1)UAREP, being headed by a pathologist, is unsuited to the task of investigating whether the Searle data is valid 2)terms of contract with UAREP give Searle too large a decision-making role in investigation 3)These problems will create the appearance of conflict of interest, even if the UAREP does a good job.
  • 1976 NovemberRichard D. Lyons (17 November 1976). "FDA Broadens Inquiry on Testing of New Drugs". New York Times. p. 24. -- Adrian Gross of FDA noted discrepency between Mario Rustia Study on Flagyl and Searle's studies -- goes to allegations of Searle fraud not directly related to aspartame.
  • 1977 January -- FDA requests Skinner to convene a grand jury in Searle case for unresolved discrepencies in Flagyl, failure to submit safety information for Aldactone, and concealing material facts and making false statements in studies submitted in support of searle's food additive petition for aspartame[9] [6]
  • 1977 Feb -- Incoming Carter fires Skinner
  • 1977 March 8 -- Skinner (to be fired by Carter) recuses himself from Searle case (accepting job w/Searles lawyers)
  • April 1977 CFSAN authenticated 3 studies, to determine if Searle's supporting data matched its submiitted reports to the FDA -- concluded those 3 studies were OK to use.[2]
  • August 1977 to 1978 , UAREP 12 studies -- concluded those 12 studies were OK to use.[2] UAREP concluded: Although UAREP noted “a substantial number of minor and inconsequential discrepancies” during its review, it found “few, if any, discrepancies which would produce a change of greater than five percent in the final numerical data being compared.” In addition, it did not find evidence that, “given the experiment design, there was any indication that animals in any one group had been treated deliberately to produce biased results.” The discrepancies it observed “appeared randomly distributed between treated and control groups.” [2]: 89  N.B. -- no mention of suspected fraud in GAO87 report on approval of aspartame.

Post-approval Controversy and the Metzenbaum Investigations

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  • 1987 December John W. Olney (8 December 1987), Letter from John Olney to Senator Metzenbaum concerning neurotoxicology issues presented to 1980 PBOI on aspartame, p. 9 John Olney's objections are 1)PBOI did not consider the effects of Asp and Glu as co-additives in food 2)FDA did not consider the effect of phenylalanine on unborn babies with undiagnosed PKU or PKU-like disorders when the pregnant mother consumes aspartame 3) One of Searle's aspartame/brain tumor studies was severely flawed -- it appeared that control and experimental animals were fed each other's chow, resulting in a high rate of brain tumors in both groups 4)In another rate aspartame/brain tumor study, improper statistical analysis was used to claim no significant effect (11 tumors in treated group, 1 tumor in control group), and the unusually large size of the tumors in the treated group were ignored 5) In the DKP studies, photographic was ignored that rats were able to eat their powdered chow while avoiding the "large chunks" of DKP mixed in with it 6) The Ajinimoto rat study was poor quality, and sketchily described in a journal of poor quality.

There is a cache of newspaper clippings at aspartame~1985 scribd:Congressional Record FDA toxicologist, Dr. Adrian Gross. It does not contain the congresssional record pages with Dr. Gross' testimony. The cache may be in violation of copyright, since NYT and the Chicago Tribune sell access to many of these clippings on its website. So that URL is no good for references for the article, even though it is a good way to find sources that document the controversy.

In Congressional Record. 131 (106) (part II ed.): S1097. 1 August 1985. {{cite journal}}: Missing or empty |title= (help), available at http://www.mpwhi.com/congressional_record_1985.pdf, several newspaper articles have been read into the record, in addition to the letter from the FDA to Samuel Skinner.

Reported adverse effects

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References for Ramazzinni section

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  • November 2005 Online publication of Soffritti "First Experimental Demonstration of the Multipotential Carcinogenic Effects of Aspartame Administered in the Feed to Sprague-Dawley Rats"[10]"The results of this mega-experiment indicate that [aspartame] is a multipotential carcinogenic agent, even at a daily dose of 20 mg/kg body weight, much less than the current acceptable daily intake." -- 1800 rats from 8 weeks of age until natural death.
  • March 2006 Print version of "First Experimental Demonstration..." [10]
  • May 2006 European Food Safety Authority discounts "First". The full version of the report looks like an excellent reference for the "reported effects" portion of the article -- they did all the WP:SYNTH.[11]
  • May 2006 Story in Guardian notes head of EFSA says panel was fully impartial.[12]
  • September 2006 "Results of long-term carcinogenicity bioassay on Sprague-Dawley rats exposed to aspartame administered in feed." published in special volume of annals of the NY Academy of Science "Living in a Chemical World" [13]
  • April 2007 FDA discounts "Results of Long-term"... [14]
  • June 2007 Online Publication of "Life-Span Exposure to Low Doses of Aspartame Beginning during Prenatal Life Increases Cancer Effects in Rats" [15]
  • June 2007 NZFSA discounts "Results of Long-term..."[16]
  • July 2007 News Item in Science notes CSPI letter to FDA[17]
  • September 2007 Magnuson and Burdock in Critical Reviews[18]
  • September 2007 Print version of "Life-Span Exposure..."
  • October 2007 Huff and La Dou publish "Aspartame bioassay findings portend human cancer hazards." in Int J Occup Environ Health. ,[19]
  • October 2007 Huff, Davis, et all publish CSPI letter to FDA in Int J Occup Environ Health[20]
  • May 2008 Magnuson et. al criticize "Life-Span Exposure..." in Env. Health Perspectives.[21]
  • May 2008 Soffritti responds to Magnuson's letter[21]
  • June 2008 Huff and Davis Deride 2-year Toxicology studies in rats in "The Limits of Two-Year Bioassay Exposure Regimens for Identifying Chemical Carcinogens"[22]
  • November 2008 "The Limits of Two-Year Bioassay" appears in print

Reference List

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  1. ^ Magnuson BA, Burdock GA, Doull J; et al. (2007). "Aspartame: a safety evaluation based on current use levels, regulations, and toxicological and epidemiological studies". Crit. Rev. Toxicol. 37 (8): 629–727. doi:10.1080/10408440701516184. PMID 17828671. {{cite journal}}: Explicit use of et al. in: |author= (help)CS1 maint: multiple names: authors list (link) Citing: Mazur, R.H. (1984). Discovery of aspartame. In Aspartame: Physiology and Biochemistry (L. D. Stegink and L. J. Filer Jr., Eds.). Marcel Dekker, New York, pp. 3–9.
  2. ^ a b c d e f g h GAO 1987. "Food Additive Approval Process Followed for Aspartame" United States General Accounting Office, GAO/HRD-87-46, June 18, 1987
  3. ^ "FDA Hearing Set to Resolve Dispute over a Sweetener". New York Times. 24 September 1974. p. 26.
  4. ^ "FDA Chief is Criticized Over a Sugar Substitute". 22 October 1974. p. 19.-- US Senator Proxmire criticizes Schmidt over lack of public hearing, following charges from Olney
  5. ^ "FDA Bars Sales of Sweetener". New York Times. 5 December 1975. Senator Kennedy: concerned 2 other... products... Flagyl & Aldactone... {{cite news}}: Unknown parameter |pg= ignored (help)
  6. ^ a b c Letter from Department of Health, Education, and Welfare to Hon. Samuel K. Skinner, US Attorney, Northern district of Illinois, 10 January 1977 as read (with names of some Searle employees deleted) into Congressional Record. 131 (106) (part II ed.): S1097. 1 August 1985. {{cite journal}}: Missing or empty |title= (help)
  7. ^ "FDA urges Grand Jury Study of GD Searle's Drug Reports". New York Times. 8 April 1976. p. 27.
  8. ^ "DEPARTMENT OF TRANSPORTATION", Congressional Record, 101st Congress 1st session, 135: s832ff, 31 January 1989
  9. ^ "Probe asked in charge that Searle rigged test". Chicago Tribune. 27 January 1977. p. B9. {{cite news}}: Cite has empty unknown parameter: |1= (help)
  10. ^ a b Soffritti M, Belpoggi F, Degli Esposti D, Lambertini L, Tibaldi E, Rigano A (2006). "First experimental demonstration of the multipotential carcinogenic effects of aspartame administered in the feed to Sprague-Dawley rats". Environ. Health Perspect. 114 (3): 379–85. doi:10.1289/ehp.8711. PMC 1392232. PMID 16507461. {{cite journal}}: Unknown parameter |month= ignored (help)CS1 maint: multiple names: authors list (link) published online November 2005
  11. ^ European Food Safety Authority (2006-05-03). "Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) related to a new long-term carcinogenicity study on aspartame". Retrieved 2009-02-28.
  12. ^ Felicity Lawrence (2006=05-15). "Food safety authority says aspartame not linked to cancer". Guardian Unlimited. Retrieved 2006-12-31. {{cite web}}: Check date values in: |date= (help); Unknown parameter |month= ignored (help)CS1 maint: date and year (link)
  13. ^ Soffritti; et al. (2006-09-01). "Results of long-term carcinogenicity bioassay on Sprague-Dawley rats exposed to aspartame administered in feed". Annals of the New York Academy of Sciences. 1076: 559–577. doi:10.1196/annals.1371.080. PMID 17119233. {{cite journal}}: Explicit use of et al. in: |author= (help)
  14. ^ "US FDA/CFSAN - FDA Statement on European Aspartame Study". 2007-04-20. Retrieved 2009-02-28.
  15. ^ Soffritti M, Belpoggi F, Tibaldi E, Esposti DD, Lauriola M (2007). "Life-span exposure to low doses of aspartame beginning during prenatal life increases cancer effects in rats". Environ. Health Perspect. 115 (9): 1293–7. doi:10.1289/ehp.10271. PMC 1964906. PMID 17805418. {{cite journal}}: Unknown parameter |month= ignored (help)CS1 maint: multiple names: authors list (link) published online June 2007
  16. ^ NZFSA (2007-08-03). "Food Safety Authority challenges activists' views on aspartame". Retrieved 2009-02-28.
  17. ^ Couzin J (2007). "Souring on Fake Sugar". Science. doi:10.1126/science.317.5834.29c. News Item
  18. ^ Magnuson BA, Burdock GA, Doull J; et al. (2007-09-01). "Aspartame: a safety evaluation based on current use levels, regulations, and toxicological and epidemiological studies". Crit. Rev. Toxicol. 37 (8): 629–727. doi:10.1080/10408440701516184. PMID 17828671. {{cite journal}}: Explicit use of et al. in: |author= (help); Unknown parameter |month= ignored (help)CS1 maint: date and year (link) CS1 maint: multiple names: authors list (link)
  19. ^ Huff J, LaDou J (2007). "Aspartame bioassay findings portend human cancer hazards". Int J Occup Environ Health. 13 (4): 446–8. PMID 18085058. {{cite journal}}: Unknown parameter |Month= ignored (help) Commentary
  20. ^ Abdo KM, Camargo CA, Davis D; et al. (2007). "Letter to U.S. FDA commissioner. Questions about the safety of the artificial sweetener aspartame" (PDF). Int J Occup Environ Health. 13 (4): 449–50. PMID 18085059. {{cite journal}}: Explicit use of et al. in: |author= (help); Unknown parameter |month= ignored (help)CS1 maint: multiple names: authors list (link) Letter
  21. ^ a b Bernadene Magnuson, Gary M. Williams (2008). "Carcinogenicity of Aspartame in Rats Not Proven". Environ Health Perspect. 116 (6): A239–A240. PMID 18560494. {{cite journal}}: Unknown parameter |month= ignored (help) published online 27 May 2008 in Correspondence, with Soffritti's response
  22. ^ James Huff, Michael F. Jacobson, and Devra Lee Davis (2008-11). "The Limits of Two-Year Bioassay Exposure Regimens for Identifying Chemical Carcinogens". Environmental Health Perspectives. 116. doi:10.1289/ehp.10716. PMID 19057693. {{cite journal}}: Check date values in: |date= (help); Unknown parameter |Number= ignored (|number= suggested) (help)CS1 maint: multiple names: authors list (link) published online 30 June 2008 in Commentary
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