Commissioner, you have failed the American people. There are no randomized controlled clinical trial data supporting this EUA. You caved to political pressure from @realDonaldTrump. You have proven yourself unworthy to be @FDACommissioner. Resign.https://twitter.com/SteveFDA/status/1297642147945025536 …
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David Gorski, MD, PhD Retweeted Dr. Stephen M. Hahn
This is utter nonsense. By making convalescent plasma available so widely, you’ve almost certainly guaranteed that these clinical trials will never accrue enough patients to answer the question of whether antibody therapy works against
#COVID19.https://twitter.com/SteveFDA/status/1297642151199809537 …David Gorski, MD, PhD added,
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Replying to @gorskon
Can I ask, it looks like this 35% number came from this statement: "Those who received transfusions within three days of diagnosis had a seven-day death rate of 8.7%, while patients who got plasma after four or more days had a mortality rate of 11.9%."
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Replying to @kunstderfuge1 @gorskon
Dr. Hahn said that if "100 people are sick with COVID-19, 35 would be saved". Isn't it more accurately something like "if 100 people who died after being treated with plasma after 4 or more days had instead been treated within 3 days, 35 wouldn't have died."?
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Replying to @kunstderfuge1
He said that? What utter BS! Going from 11.9% to 8.7% mortality is a 3.2% absolute benefit. If this study is correct (and it's not a randomized controlled study, making it relatively unlikely to be correct), that means that with treatment you're 3.2%, not 35%, less likely to die.
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Replying to @gorskon @kunstderfuge1
I would look at this the way we look at survival in oncology trials. Untreated patients had an 88.1% survival, while treated patients had a 91.3% survival. Sounds a lot less impressive that way, doesn't it? And it should, because it isn't impressive.
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Replying to @gorskon @kunstderfuge1
The 3.1% survival benefit is so small that I really don't believe it in a retrospective, uncontrolled study.
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Replying to @gorskon @kunstderfuge1
Also, using relative survival benefit numbers rather than absolute numbers is always a red flag for me. If you quote a number for a relative survival benefit, you really do have to quote the absolute survival benefit too, to put it in perspective.
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Replying to @gorskon @kunstderfuge1
Think of it this way and use
@SteveFDA's number of 35%, as incorrect as it is. A decrease in mortality by a treatment of 35% means a much different thing when mortality of the untreated patient is 10% than when untreated mortality is 50%.1 reply 0 retweets 1 like
If untreated mortality is 10%, then a 35% decrease in mortality is 3.5% on an absolute basis. For a 50% untreated mortality, it's a 17.5% absolute decline.
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