Discussion about this post

User's avatar
Stephanie de Garay's avatar

First, thank you Dr. Krause for being wiiiing to speak in this oodcast.

How do well do you feel Peter Marks did with handling concerns brought to FDA’s attention with respect to adverse reactions during the vaccine clinical trials and after the covid vaccines received EUA approval?

With respect to that question, what would happen if a clinical trial participant was misdiagnosed by doctors during a covid vaccine trial? Would it be re-evaluated for causation and how is causation determined? Did this happen at all during the covid vaccine clinical trials?

If there were any serious adverse reactions during the covid vaccine clinical trials does the FDA review the case and medical records or rely solely on the opinion of the PI and pharmaceutical company? If it is the latter, does the FDA have a way to confirm the data they provide the FDA for the participants adverse reaction, diagnosis and causality is accurate?

Thank you!

Expand full comment
Arne's avatar

What options does Krause think the government needs to develop for disciplining and potentially firing officials like Marks who create conflicts of interest and override agency procedures?

Expand full comment
6 more comments...

No posts