We got 11 million pages. The FDA, CDC was not cooperating with us or Kennedy. Kennedy finally said no. Give him this data dump. So 11 million pages. We discovered that Peter Marks, the head of cber, was warned by Dr. Anna Sharsman that their algorithm is going to hide in mass safety signals. mass safety signals. 26 days later, they developed a new algorithm and they showed Dr. Marks and senior FDA officials 25 safety signals on things like sudden cardiac death, pulmonary infarction, Bell's palsy, different types of strokes. (06:25–06:43)
CLAIM
Asserts that Peter Marks was warned about algorithm issues hiding safety signals.
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