Dr. Bream posted this critique of the FDA on his Bream Medical Facebook page yesterday.
All of these countries look to the FDA for guidance for therapeutics. Our FDA has let them down.
I’ll say it again....the FDA’s cozy relationship with Big Pharma, whose drugs have all been failures in really sick COVID patients (sans Roche’s tocilizumab), has cost millions of lives worldwide.
Because all the Big Pharma companies failed, the FDA basically did nothing. Dr. Woodcock herself admitted all of the trials on actually sick patients were underpowered (the FDA signs off on trial design) when she participated in a forum with AMA President, Susan Bailey. As such, none of them were powered to hit a primary endpoint. So, basically, the therapeutic trials were a waste - UNLESS the FDA actually starts following the “safe and may be effective” criteria for an EUA. Then, other countries, who are struggling BADLY right now, can get medications like leronlimab, aviptadil, abs tocilizumab (although they have manufacturing shortfall). The FDA could also do an Operation Warp Speed for therapeutics as well!
How many people have to die for a p-value, Dr. Woodock?
So, let’s analyze the FDA’s record on COVID:
HCQ - failed EUA that was granted despite the data suggesting its failure
Plasma - failed EUA granted without any significant study showing benefit; only that if plasma is given sooner it any be more beneficial. But, at no time was a placebo-controlled trial done for its EUA. Those trials failed.
Remdesivir - failed EUA despite studies in China showing no benefit. Association with NIAID and Gilead got the goal posts moved on its study. It showed no benefit in severely ill patients and its 4 day reduction in hospitalization length didn’t hold up in larger trials.
Regeneron/Lily MABs - I told this page’s followers back in November these drugs would fail due to mutations in my talk about why leronlimab was better than bamlanivimab. And, guess what? States are now not using those drugs because the mutations rendered them useless. This will be another pretty much failed EUA. While these drugs had initial promise, much like with the vaccines, EUA without logistics made them hard to obtain. This would compounded by the need for an infusion in an overwhelmed healthcare system (which was another colossal US healthcare failure).
Baricitinib? (laughing emoji here)
As a physician, and as a human who has had a friend to die and a close friend lose his dad, what the FDA has done is indefensible, unethical, and a violation of the Hipppcratic Oath. When promising drugs have shown they’re safe, not allowing them to be used by the FDA is a violation of “first do no harm.”
It’s past time we demand better from our government. We have let the world down!
USFDA
