Also here is the Bressler Report on the same issue: .mpwhi.com/complete_bressler_report.pdf
On Jan 10, 1977 in a 33 page letter, FDA Chief Counsel Richard Merrill recommended to U.S. Attorney Sam Skinner that a grand jury investigate Searle for "apparent violations of the Federal, Food, Drug and Cosmetic Act, 21 U.S.C. 331 (e), and the False Reports to the Government Act, 18 U.S.C. 1001, for 'their willful and knowing failure to make reports to the Food and Drug Administration required by the Act, 21 U.S.C. 355 (i), and for concealing material facts and making false statements in reports of animal studies conducted to establish the safety of aspartame.'" The FDA called special attention to studies investigating the effect of NutraSweet on monkeys and hamsters.
Aspartame being marketed for human consumption after its forced FDA approval resulted from the political chicanery and lethal skullduggery of Don Rumsfeld. It was never proven safe.
The FDA Board of Inquiry revoked the petition for approval (and the original petition is on my web site, www.mpwhi.com, because aspartame could not be proven safe and because of the clear statistical record that it caused brain tumors.
G. D. Searle filed suit to prevent this revocation. Probably as a favor to Donald Rumsfeld (who was CEO at that time of G.D. Searle and who had so much to gain financially from a forced FDA approval), President Ronald Reagan wrote an executive order to prevent the FDA from signing the revocation into law and then fired Dr. Jere Goyan who was the FDA Commissioner. According to Mrs. Goyan, someone from Reagan's transition team called at 3:00 AM with the news that Dr. Goyan was fired.
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A superb meticulous day-to-day historical analysis of these processes at the FDA was prepared and published by the Organic Consumers Association:
In August 1977, the Bressler Report involving three key aspartame studies (E5, E77/78 and E89) was released. Some of the findings from these three studies reviewed by the Bressler-led FDA Task Force included:1. In one study, 98 of the 196 animals participating died but were not autopsied until as much as one year later. Because of this delay, most of the animal tissue could not be used. At least 20 animals had to be excluded from postmortem examinations.
2. There was a discrepancy between the original pathology sheets and the pathology sheets submitted to the FDA. There were differences shown for 30 animals.
3. One animal was actually reported alive at week 88, dead between weeks 92 and 104, and then alive again at week 108, and finally permanently dead at week 112.
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