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An open letter from a Physician to the Director of US FDA


An open letter to FDA Janet Woodcock - Request Immediate EUA for LERONLIMAB

An open letter to FDA commissioner Dr. Janet Woodcock.

By John Bream, MD, FACEP

April 27, 2021

Dr. Woodcock,

While most of this happened under the prior administration and Dr. Hahn’s leadership, it is worth noting the FDA’s record on Emergency Use Authorization.

Therapeutics that have received EUA:

1) remdesivir - ACTT-1, the trial sponsored by Gilead and the NIAID, changed its endpoint essentially from ordinal scale improvement to time to discharge. This trial remains the only trial that showed any benefit for remdesivir. In fact, the WHO has gone so far as to recommend against its use, which is the correct decision based on the literature.

This is based on studies out of Hubei (which were available at the time EUA was given in pre-print) and the SOLIDARITY trials. The Chinese study nor SOLIDARITY found any benefit to using remdesivir. SIMPLE - severe trial showed no benefit from 5 days of remdesivir versus 10.

Clearly, the studies are all negative except the one backed by the Gilead and the NIAID with a changed, clinically insignificant endpoint. Not to mention, remdesivir’s relatively high rate of adverse effects.

Why are we still using remdesivir when the data is clear it doesn’t work? What has happened to first do no harm?

2) baricitinib - ACTT-2 expounded upon ACTT-1’s non-patient-oriented outcome by showing a decreased time to discharge by 1 additional day with baricitinib.

Two wrongs don’t make a right.

3) hydroxychloroquine- the data here was so poor that the FDA rescinded the EUA. This is not surprising as the study used for this EUA was of very poor quality and ultimately was retracted, I believe, as it arrived at its conclusion that HCQ is beneficial only by excluding the 6 deaths in the HCQ group. If I read the study and knew this, how does it get by the FDA?

4) convalescent plasma - admittedly, I supported this EUA on “safe and may be effective” grounds. Further study showed that plasma isn’t useful. However, it should be noted that even the initial evidence was shaky as there was not even one placebo-controlled trial for comparison.

5) bamlanivimab - BLAZE-1 earned an EUA for for this drug based on a phase 2 interim analysis showing decreased viral load at only one dose (2800mg) and a reported decrease in ER visits/hospitalizations. Turns out, none of those conclusions were found to hold merit in the phase 3 trial - except in the polyclonal antibody cocktail - which wasn’t even in the original phase 2 portion of BLAZE-1 (or at least not that I could find). Now, it’s rarely used - even recommended against in some states - due to variants.

I reviewed this study and saw this coming in November (see Bream Medical FB Live in November the Battle of the MABs: leronlimab v bamlanivimab). If I could see this, how did the FDA not?

6) polyclonal antibodies - the only EUA that actually looks legitimate and is backed by solid data (especially Regeneron’s cocktail).

So, what we have are a litany of failures - that were largely predictable - based on poor studies for medications that are geared only toward mild-moderate illness - all of which are backed by “Big Pharma.” Why hasn’t the FDA emergency use authorized a single therapeutic for severe-critical?

What is certain is that the data behind leronlimab, tocilizumab, aviptadil, and lenzilumab, while imperfect, is eons better in quality than the data backing up any of the EUAs provided for therapeutics excepting polyclonal antibodies. As proven above, most of the drugs that received an EUA were based on highly flawed studies that any medical student would recognize, but somehow this all escapes the FDA? And why has severe-critical remained completely neglected when multiple drugs meet the “safe but may be effective” criteria?

If leronlimab, tocilizumab, aviptadil, or lenzilumab were made by Gilead, Pfizer, Lily, or other “Big Pharma,” are we having this discussion?

Dr. Woodcock, I think you owe the public an explanation.

As of today, 573,000+ Americans have died without access to a therapeutic targeting severe/critical COVID-19 while a myriad of EUAs were given out based on shaky data for mild-moderate illness in drugs that failed to provide benefit in severe/critical populations. That’s 573,000+ patients and families who had no hope - a handful of whom I cared for in their final days as these patients poured into Emergency Departments.

Dr. Woodcock, my final request is simple. I ask you to watch this video:

I was the doctor for this family. This was one of 3 patients I cared for on shift that day - April 13th 2020 - who died and made this the shift I’ll never forget. Maybe a novel therapeutic could have saved his life. Or any of those patients’ lives.

Due to the inaction of FDA, we’ll never know.

And the really sad part is that these patients could have come in on April 13th, 2021 and nothing would have been any different. A whole year has been wasted while promising therapeutics with statistically significant outcomes for the critically ill remain shelved.

No one understands why.

I beg of you, please take action for patients, for families, and for the world, who are all desperate for a COVID therapeutic that works in severe/critical.

We know they exist. But, you have to make them available.

I beg of you - just do the right thing.

Best regards,

John Bream, MD,

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