Tuesday, August 25, 2020

Straight Talk on the FDA's Decision to Use Conavalescent Plasma in Covid-19 Treatment

Environmental & Science Education, STEM, Health, Medicine, Society

Ed Hessler

For all of my life the U. S. Food and Drug administration has been free of political influence, in other words a trusted and trustworthy agency. Independent.

As you probably know on Sunday night, weekends are favorite nights for announcements, President Trump with FDA Commissioner Stephen Hahn, held a "news conference to announce the decision"granting the "emergency use authorization of convalescent plasma to treat patients with Covid-19. Trump characterized the decision as a major breakthrough." Hahn, there to provide professional backup, failed right out of the gate. He claimed "that giving plasma would help 35 out of 100 people treated."

STAT senior writers, Matt Herper and Adam Feurerstein, sat down "to gather their thoughts." Their spirited conversation is available here

In response to Herper's characterization of Commissioner Hahn's statement, i.e., that he misspoke, Feurerstein responded: "Misspoke is being kind. Hahn grossly mischaracterized the benefit of convalescent plasma on Sunday night. I’ll just quote him here: “A 35% improvement in survival is a pretty substantial clinical benefit. What that means is — and if the data continue to pan out — 100 people who are sick with Covid-19, 35 would have been saved because of the administration of plasma.”

Feurestein's closing sentence is one I like, of course, one all of us should, because it is based in the reality of numbers. "The data don't show that." Herper then continues the conversation about what the reported numbers should be.

Decisions about medicines and vaccines must be made under circumstances of scientific independence IF an agency is to be trusted and IF the scientists, doctors and technicians who work there know this. This undermines that AND as Herper points out, "This country has a serious problem with vaccine hesitancy. Even the whiff of politics into the FDA review process for Covid-19 vaccines could be disastrous." (my emphasis)

The conversation is too lively and informed for me to pick a few quotes here and there, so do yourself a favor and read it.

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