NEWS: @US_FDA is in the final stages of issuing an EUA for convalescent plasma treatments.

Will this change everything? No.
Will it be helpful? Probably.
Is there contraversy? Of course.

Follow if interested. Posting shortly.

Convalescent plasma treatment involves giving donated plasma with antibodies from patients who have recovered from COVID.

It is being done in many places without FDA approval under something called an “expanded access program.”

Mayo has treated over 60k patients.

Mayo did an observational study— they just looked at what was different in about 30,000 patients who took CP.

They didn’t randomize patients or compare them to a similar group of patients without it. Or use other protocols like blinding the doc/patient to the treatment.

But they apparently saw a reduction in the death rate if CP treatment is given within a few days of diagnosis. No benefit apparently if given later.

As much as a 20-50% reduction.

Good news right? So why aren’t people ecstatic?

I’ve talked to several scientists & government officials who have reviewed the study. They have a lot of questions & concerns about the study. About how it was structured.

Here is what I hear:

Data cherry picked
A lot of variables like how much antibody in each sample
May not be as strong a finding
Data is weaker than people hoped

All sound like very legitamite concerns. And the NIH people like well designed trials. But...

There are no reports that CP isn’t safe.
Sometimes you look for one thing (w broad benefit) & find another (a narrow benefit— say with early patients only). Why ignore that benefit?
It makes sense to keep hunting but in the meantime should the FDA approve this under EUA?

Complicated question for the FDA.

They are sensitive by a hit to their reputation from hydroxy where they bowed to political pressure in issuing the EUA.
The NIH is making clear they have concerns
There is some political pressure here as well

But disappointment over the perhaps less exciting results shouldn’t prevent them from moving forward with things that may have a benefit in an emergency AS LONG AS THEY ARE VERY CLEAR ABOUT THEIR CONCERNS in this analysis.

In my view the most important thing the @US_FDA can do is make it a step towards reestablishing confidence in their analysis, transparency & independence when issuing an EUA.

As they anticipate making recommendations on early vaccine candidates in particular.

2 final points:
-If you’ve had COVID, please donate your plasma. It is very hard to maintain enough for this treatment & if approved, expect shortages.
-CP puts us one step closer to monoclonal antibodies— the most promising therapy you hear of.

Will know more next week.