The story on the news cycle this week is convalescent plasma (which I shall abbreviate CP). CP is the plasma of an infected person who has recovered from an infectious illness. The idea is that if you administer the plasma of that person to a currently infected patient, the patient would fare better. Presumably, because there are antibodies to the infecting agent in the CP that helps fight it. It has been tried before and found useful. In the original SARS epidemic there are a few trials that show benefit and even during the MERS (Middle Eastern Respiratory Syndrome) in roughly 2015 CP showed some use. Both of these were coronaviruses. I remember during that whole Ebola virus thing, there were two Americans (one doctor– Kent Brantley) that got Ebola from Africa and were transferred to Atlanta, GA. They recovered and donated their plasma.

The Mayo Clinic is heading up the first round of studies with CP. What they did was study 35,000 patients and gave them all different titers of CP but no placebo group. They showed that the mortality in the high titer group was around 13%. The lowest titer group was about 7.5%. With that, the FDA said there was a 35% reduction in mortality and issued an Emergency Use Authorization( EUA). On their website they site many other studies and emphasize the safety component quite effectively.

The news honed in on the political angle. The FDA commissioner had overstated the effects and later apologized. He conveyed there was a 35% reduction in mortality. Considering that there was no placebo group, that patients were also on steroids and remedesvir, thus leading to confounding variables, that was an optimistic conclusion not supported statistically. Honorably, he owned up and retracted his statement. It was insinuated that he was coerced by the Government to do it. It doesn’t help that the FDA website glorifies the accomplishments of the current administration as one would expect of Chairman Mao. So everyone piled on.

But if you look at it, the FDA has a reasonable argument. First, there is no currently approved therapy for SARS-COVID2 and this would be the first. Second, the safety data consistently shows the risks of blood clot formation or heart failure as possible but not common. The sub analysis shows this best benefits patients less than 80 years old and not intubated. So it has to be used early. It enters into the realm of “might help, won’t hurt” category. Hey, this is a global pandemic. The twixt we’ve never seen. Maybe that bar is high enough right now. Wouldn’t pass muster in normal times. (I used to think that was “pass mustard”). The FDA is a bureaucratic institution and there ought to be a mechanism to break through it in times of crisis to get treatment available to the public. I support the Government’s action.

However, Dr. Tony Fauci cautioned the other day, that we ought not treat vaccines in a similar manner. I understand his concern. There is already skepticism enough in the population about even getting a vaccine if it’s available. The last thing we need is a vaccine that is rushed out with the EUA. If the vaccine does have safety issues that have not been discovered, then it will implode the entire effort. If it is barely passes the bar into the “might help, won’t hurt” category, we’re in for it. People won’t keep getting injected with the latest vaccine purported to be effective when the last one was proven in rigorous randomized placebo controlled trials to be ineffective. So each vaccine we come out with has to work (at least at 60%). Sorry, fellas, that’s gonna take time and let’s put that EUA back into our pockets.

Personal note: As a father of school aged children, I know that all of us are going through a lot right now with figuring out how to get our children educated safely as the school year starts. I just want to send my good vibes out to you that you are able to achieve what you want.