FDA Commissioner Stephen Hahn walked back his statement claiming a “35 percent improvement in survival” from plasma therapy to treat COVID-19 in a tweet last night during the RNC:
I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.
— Dr. Stephen M. Hahn (@SteveFDA) August 25, 2020
Here’s what he said at the White House on Sunday:
"A 35 percent improvement in survival is a pretty substantial clinical benefit," FDA Commissioner @SteveFDA said in relation to the convalescent plasma emergency use authorization issued today. pic.twitter.com/Dd97vLSZeL
— U.S. FDA (@US_FDA) August 23, 2020
It’s actually a pretty big walk back:
Hahn’s statement that if “100 people were sick, 35 would be saved by plasma” is shockingly wrong. The risk reduction between early plasma and late plasma is relative, not absolute. In this trial, if 100 people were treated, 3.2 fewer would die. https://t.co/Fgz4MVVqNp
— Jonathan Reiner (@JReinerMD) August 23, 2020
Yep:
The President will not be happy about this, I suspect. https://t.co/BBaT0s7c7k
— Jeff Greenfield (@greenfield64) August 25, 2020
And Dr. Hahn was called out for it on Sunday as soon as he made the claim:
This "35% mortality reduction" is a very misleading figure.
The study compared early vs late plasma therapy; not a Randomized Controlled Trial (RCT) of plasma vs placebo.
AND, the absolute difference in mortality was ONLY 11.9% – 8.7% = 3.2%, NOT 35%.https://t.co/7P5ivnZvva https://t.co/v8bjKD8Hhm pic.twitter.com/KKZHHzSpm2
— Dr. Safa Mote (@SafaMote) August 24, 2020
And he said that it was “really important” to correct the record:
Spoke briefly with Hahn tonight, who insisted that no one put him up to these tweets, that he thought it was “really important” to correct the record and that the plasma EUA could always be withdrawn if more evidence emerges. https://t.co/PvgFrn2Bog
— Dan Diamond (@ddiamond) August 25, 2020
But blue-checks aren’t happy:
with all due respect, one job of the nation's top drug regulator is to be able to explain things clearly and accurately to the American public in a time of unprecedented crisis. Absolute v relative risk shouldn't be that hard https://t.co/Ev4xhvk1AQ
— Joanne Kenen (@JoanneKenen) August 25, 2020
Some are calling for a whole new press conference to address it:
Steve,
Millions of people watched your presser w/ @realDonaldTrump & @SecAzar
Serious mistakes undermine your credibility and @US_FDA
Sorry, your?doesn't cut it
When will you have a press conference to fully correct this? And fix FDA's website?
To restore public trust. Please pic.twitter.com/3kZo9whlap— Eric Topol (@EricTopol) August 25, 2020
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