Mmmm.... Aspatame. Thanks Don. Timeline December 1965– While working on an ulcer drug, James Schlatter, a chemist at G.D. Searle, accidentally discovers aspartame, a substance that is 180 times sweeter than sugar yet has no calories. Spring 1967– Searle begins the safety tests on aspartame that are necessary for applying for FDA approval of food additives. Fall 1967– Dr. Harold Waisman, a biochemist at the University of Wisconsin, conducts aspartame safety tests on infant monkeys on behalf of the Searle Company. Of the seven monkeys that were being fed aspartame mixed with milk, one dies and five others have grand mal seizures. November 1970– Cyclamate, the reigning low-calorie artificial sweetener — is pulled off the market after some scientists associate it with cancer. Questions are also raised about safety of saccharin, the only other artificial sweetener on the market, leaving the field wide open for aspartame. December 18, 1970– Searle Company executives lay out a “Food and Drug Sweetener Strategy’ that they feel will put the FDA into a positive frame of mind about aspartame. An internal policy memo describes psychological tactics the company should use to bring the FDA into a subconscious spirit of participation” with them on aspartame and get FDA regulators into the “habit of saying, “Yes”.” Spring 1971– Neuroscientist Dr. John Olney (whose pioneering work with monosodium glutamate was responsible for having it removed from baby foods) informs Searle that his studies show that aspartic acid (one of the ingredients of aspartame) caused holes in the brains of infant mice. One of Searle’s own researchers confirmed Dr. Olney’s findings in a similar study. February 1973– After spending tens of millions of dollars conducting safety tests, the G.D. Searle Company applies for FDA approval and submits over 100 studies they claim support aspartame’s safety. March 5, 1973– One of the first FDA scientists to review the aspartame safety data states that “the information provided (by Searle) is inadequate to permit an evaluation of the potential toxicity of aspartame”. She says in her report that in order to be certain that aspartame is safe, further clinical tests are needed. May 1974– Attorney, Jim Turner (consumer advocate who was instrumental in getting cyclamate taken off the market) meets with Searle representatives to discuss Dr. Olney’s 1971 study which showed that aspartic acid caused holes in the brains of infant mice. July 26, 1974– The FDA grants aspartame its first approval for restricted use in dry foods. August 1974– Jim Turner and Dr. John Olney file the first objections against aspartame’s approval. March 24, 1976– Turner and Olney’s petition triggers an FDA investigation of the laboratory practices of aspartame’s manufacturer, G.D. Searle. The investigation finds Searle’s testing procedures shoddy, full of inaccuracies and “manipulated” test data. The investigators report they “had never seen anything as bad as Searle’s testing.” January 10, 1977– The FDA formally requests the U.S. Attorney’s office to begin grand jury proceedings to investigate whether indictments should be filed against Searle for knowingly misrepresenting findings and “concealing material facts and making false statements” in aspartame safety tests. This is the first time in the FDA’s history that they request a criminal investigation of a manufacturer. January 26, 1977– While the grand jury probe is underway, Sidley & Austin, the law firm representing Searle, begins job negotiations with the U.S. Attorney in charge of the investigation, Samuel Skinner. March 8, 1977– G. D. Searle hires prominent Washington insider Donald Rumsfeld as the new CEO to try to turn the beleaguered company around. A former Member of Congress and Secretary of Defense in the Ford Administration, Rumsfeld brings in several of his Washington cronies as top management.
Posted on: Sun, 30 Mar 2014 19:43:31 +0000
Trending Topics
Recently Viewed Topics
© 2015