4. An outbreak of an infectious disease was not included in the report to the FDA.
5. Tissue from some animals was noted to be unavailable for analysis on the pathology sheets. However, the results from an analysis of this "unavailable" tissue were submitted to the FDA.
6. There was evidence that the diet mix was not homogeneous (allowing the animals to eat around the test substance). This evidence included a picture as well as statements by a lab technician.
7. Fifteen fetuses from animals involved in one experiment were missing.
8. Some sections from the animals were too thick for examination.
9. There was no documentation about the age or source of the animals.
10. For one study, there was no protocol until it was well underway.
11. Animals were not adequately tagged to prevent mistakes.
12. Some laboratory methods were changed during the study but this was not documented.
>>>>
Curiously, in March of 1979, the FDA was able to conclude that G.D. Searle's aspartame studies were acceptable. They decided to convene the Public Board of Inquiry (PBOI). This had been agreed to by Dr. John Olney and Attorney James Turner over four years earlier.
In April of 1979, the FDA outlined the specific questions that were going to be addressed by the PBOI. The scope of investigation was limited to:
a. Whether the ingestion of aspartame (alone or together with glutamate) poses a risk of contributing to mental retardation, brain damage, or undesired effects on neuroendocrine regulatory systems.
b. Whether the ingestion of aspartame may induce brain neoplasms (tumors) in rats.
Based on the answers to the above queries:
a. Should aspartame be allowed for use in foods or should the approval of aspartame be withdrawn?
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