When the G.D. Searle Co. sought FDA approval for NutraSweet they submitted doctored, fraudulent “studies,” so corrupt that the Department of Justice appointed two prosecutors to Investigate Searle. Searle's lawyers hired the prosecutors and the case died with the statute of limitations.
Listen in on aspartame hearings in 1976 between Senator Ted Kennedy and FDA Commissioner Alexander Schmidt at the Senate Subcommittee on Labor and Public Health:
Commissioner Schmidt: ”Today I would like to report to you the final results of the Food and Drug Administration's detailed investigation of animal studies performed by Searle.”
Senator Kennedy: “Is this the first time, to your knowledge, that such a problem has been uncovered of this magnitude by the Food and Drug Administration?”
Dr. Schmidt: “It is certainly the first time that such an extensive and detailed examination of this kind has taken place. We have never before conducted such an examination as we did at Searle. From time to time, we have been aware of isolated problems, but we were not aware of the extent of the problem in one pharmaceutical house.”
Senator Kennedy : “The extensive nature of the almost unbelievable range of abuses discovered by the FDA on several major Searle products is profoundly disturbing.”
Yet a year later look what happened!
The 1977 Bressler Report, even without the concealed studies, clearly revealed fraud. Searle deleted what they didn't want FDA to see, even excised the brain tumors from rats, and put them back in the study. After death they resurrected them on paper.
Chief FDA Scientist, Dr. Thomas Xavier Collins, investigated two mice teratology (birth defects) studies. The incompetent Searle employee who reviewed studies had but a single year of experience: worked on rabbit populations for the Illinois Wildlife Service! The studies were a travesty, like all Searle's studies submitted to FDA . ...
1 comment:
I and most Americans fail to understand why some people are so stuck in the past that they still attack a decision made to approve aspartame some twenty years later. Not only does aspartame have an excellent history of safety since approval, it is one of the most studied substances in history. It has been declared safe by virtually all Western regulatory agencies. Today there are no viable scientific papers questioning the safety this substance and thus no basis for any questions about the safety of this GRAS (generally recognized as safe) listed substance. However, it is fact that folic acid is crucial to the metabolism of this and many other natural and unnatural substances. And in the 1980’s, when this controversy arose, there were many people deficient in folic acid and there still are way too many people deficient in this vitamin. That vitamin deficiency and related health issues, not aspartame, can explain virtually all sensitivities to aspartame, not to speak of some 90+ health issues critics attribute to aspartame, but which are really innate folate-deficiency and related problems. Consider breast cancer, for example. One breast cancer study “suggest[s] that moderate folate deficiency has a stronger effect on chromosomal instability than BRCA1 or BRCA2 mutations found in breast cancer families”, see http://www.ncbi.nlm.nih.gov/pubmed/16162645?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum.
John E. Garst, Ph.D. (Medicinal Chemistry, Pharmacology, Toxicology, and Nutrition)
(FYI, the author has absolutely no financial or biasing connection with the aspartame, the soft drink or their related industries. The author has a Ph.D. in Medicinal Chemistry (Pharmacy) from the University of Iowa, postdoctoral experience at Yale University (Molecular Biophysics & Biochemistry) and at Vanderbilt University and taught nutritional toxicology at the University of Illinois (Champaign-Urbana) besides having conducted federally funded research at Vanderbilt, UIUC, and at several other universities before recently entering into retirement.)
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