Questions For Dr. Philip Krause About Peter Marks' Tainted Legacy At FDA
Yes, you heard that right.
Dr. Philip Krause is coming back on the podcast!
He does not have any interest in media attention (my first podcast with him was his first!) but he sees this as a public service in the pursuit of creating transparency and awareness about what has happened at the world’s premier drug approval agency.
I asked Dr. Krause to come back on to discuss Peter Marks’ controversial departure and his views on various bizarre, unprincipled, unscientific decisions Marks made at the FDA.
Krause can speak on this as he was directly involved in reviewing the applications for Pfizer and Moderna’s Covid shots as the Deputy Director at the Office of Vaccines Research and Review.
Do you have questions for Dr. Krause about the old FDA?
Leave it in the comments below.
This is for paid members only — in part because I will only have 1 hour with Krause this time and I won’t be able to ask more than a handful of really interesting, high-quality questions from readers (assuming that happens which I’m sure it will!).
Secondly, this is my small way of encouraging paid memberships in a time where your support is much-needed! Consider becoming a paid or founding member to receive exclusive articles, early-access episodes, and ask questions for future episodes. Or support The Illusion of Consensus with a one-time donation.
Paid members can also message me and join member-only chats:
Catch up on my first podcast with Dr. Krause here:
Full Interview: Former FDA Official Dr. Philip Krause Reveals Biden Admin Pressure On FDA To Approve Pfizer Vaccine
Link: https://rumble.com/v6raq68-former-fda-official-dr.-philip-krause-on-white-house-pressure-to-approve-co.htmlThe Illusion of Consensus is a reader-supported podcast and publication. To receive new posts and support my work, consider becoming a paid subscriber:
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!
I'd like to extend a thank you in advance to Dr. Krause.
The FDA has the Emergency Use Authorization pathway to get life-saving drugs onto the market quickly. Why doesn't the FDA grant EUA approvals to other drugs that have demonstrated efficacy against fatal diseases? For example, babies with severe LAD-I can survive for at most two years. There's a drug in development, Kresladi, that has shown good efficacy and safety in these patients. The FDA has not given Kresladi approval, even long after the PDUFA date. Should the FDA give Kresladi an EUA?
About 160 million people received mRNA COVID-19 vaccines before those products received full approval from the FDA. Essentially, the FDA said it’s okay with Americans receiving drugs that hadn’t been fully evaluated by the FDA. If that is true, why does any drug ever need to be fully evaluated by the FDA? Why can’t all approvals be simpler EUA-type approvals?