FDA Safety Signals and Data Analysis

Here's the sheet.

These are the adverse events that they were showing a safety

signal for using the new method. Bell's palsy,

sinus rhythm,

cardiac failure, chronic, acute left ventricular

failure,

agonal rhythm, which is severe arrhythmia generally occurred

at the end of life, pulmonary infarction,

cerebral artery occlusion, aortic

stenosis, sudden cardiac death,

hypertensive emergency,

basal ganglia stroke.

Now, these aren't minor. Remember, we're always told, you know,

adverse events are rare and minor.

These are not minor

adverse events. And these safety signals were showing

and they were

strong, but they were being hidden because FDA officials

refused to acknowledge that the current system they were using

was invalidated.

And they had to look at the new system that unmasked these things.

Our report goes on to detail how federal officials refused to acknowledge these

revelations or take action to warn the public.

Instead, senior FDA officials repeatedly

tried to stop Dr. Sharfman from continuing her work or

communicating her findings outside of FDA.

In September 2021, Dr. Marks

informed Dr. Patricia Cavazzoni, the then director of

CDER, that Dr. Sharfman, who was a CDER employee,

quote, has been asked to cease and desist conducting

her data analysis. Dr. Marks complained that Dr.

Sharfman's work had become, quote, a major distraction,

that her efforts could create erroneous conflicts that feed

to anti-vaccination rhetoric.