FDA HID RESEARCH THAT DAMNED ASPARTAME: Fatal studies should have blocked NutraSweet approval

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.

.... When the Bressler Report was retyped, FDA omitted the investigation of these two studies, not wanting the public to see how bad they were. We have now restored these studies to the Bressler Report, thanks to Dr. John Olney and Dr. Madelon Price. We also thank Jerome Bressler for his constant persistence in motivating us to locate these studies. He emphasized the report was not complete without them. Dr. Thomas Xavier Collins was the Chief Scientist and FDA struck his name from the record. Thanks also to Lane Shore, Mission Possible Chicago who has worked tirelessly in this effort for years.

H. J. Roberts, M.D., who testified before Congress and wrote the 1000 page medical text, Aspartame Disease: An Ignored Epidemic, www.sunsentpress.com, unsuccessfully tried to get a copy of the deficient and misleading “studies” through his congressman 8 years ago. Dr. Roberts explains: “These studies are part of the reason the FDA tried to indict the manufacturer for fraud.

The results were kept under FDA seal for 3 decades. Indeed the Bressler Report and other studies should have precluded FDA from approving aspartame for human consumption. For instance, its unconscionable that brain tumors were actually removed from the rats.
I have detailed the striking rise of brain tumors that began after aspartame approval...
http://www.dorway.com/betty/brainc.txt

“The consequences are now evidence in the explosive rise of brain tumors nationally.The cluster of brain tumors in my own community serves as an example. The analysis of drinking water fails to demonstrate other chemical contaminants. My recent book, 'A Manifesto for American Medicine' details these and other related problems and the still ignored epidemic of aspartame disease is an unconscionable result of which both the population and its children will have to pay.

”Some of the details of these two studies left out of the Bressler Report were scientifically objectionable and again should have precluded the FDA approving it for human use. As an example, one fetus showed hydrocephalus. Increased intracranial venous pressure can lead to either pseudotumor cerebri or hydrocephalus. I have already written a report on my clinical insights concerning a remediable cause of pseudotumor cerebri (benign intracranial hypertension) due to aspartame several years ago and now there are 20 cases in my data base”
http://www.wnho.net/pseudotumor_cerebri.htm

Dr. Roberts calls attention to the issue of gender. In his text he says the agencies responsible for approving aspartame apparently overlooked an important gender-related detail in experimental studies.

[Both concealed studies are mouse studies. One of the investigators with initials that appear to be CLT struck through the word “rats” on page 2 and marked it “mouse”. Jerome Bressler said they were mouse studies.]

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