Sunday, August 23, 2020

Global USA Very bad and disgraceful day for FDA and Steve Hahn and Alex Azar – They caved to pressure from Trump to issue EUA for Convalescent Plasma (CP). Francis Cliff and I among others a few days ago looked at the data and since there was no control and the analysis was post hoc with end points that were NOT predetermined, we could not say that there was any effect. When they tortured the data, they came up with a 35% decrease in deaths among people 3 days from dx, .80 years old and not on ventilator. Very narrow group. We had agreed to wait for further data from the same Mayo Clinic study to do a predetermined end point analysis to see if it strengthened the original data. The new data was collected, but before we could see it, Mark Meadows decided to “break the log jam” and got Steve Hahn and Alex to cave in and issue the EUA tonight, the night before the beginning of the GOP convention tomorrow night. I am afraid that this will happen with the upcoming vaccine trials. PRESS: New York Times and Washington Post coverage of old statements by me and Francis and Cliff about our skepticism of the EUA data