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@SteveFDA You need to correct the 35 lives saved per 100 sick with covid-19 so people understand that was absolutely wrong, Steve. That there is no evidence to support that. That there is no evidence at this juncture to support *any* survival benefit. That we need RCTs.
@SteveFDA 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
@SteveFDA Awaiting your response, Steve. This is important and the matter is not going to go away without a forthright explanation and clarification to the public.
nytimes.com/2020/08/24/hea…
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Eric Topol
@EricTopol
@ScottGottliebMD It's not whether the announcement today met EUA criteria, Scott. It's about claiming it is a breakthrough, 35% improved survival, with no hard data. I know you would never have pulled a stunt like this; you were an extraordinary leader at FDA
@ScottGottliebMD In this statement, @SteveFDA claims 35 per 100 people treated with plasma would be saved. The Mayo observational data indicates that would be 3 people saved at 7 days, or 5 at 30 days. And that was via exploratory analyses. Not only blatantly wrong; an egregious public statement.
@ScottGottliebMD @SteveFDA The @US_FDA tweeting this subgroup of a subgroup of a subgroup analysis just adds to this disgraceful claim of 35% survival improvement.
Read 5 tweets
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Eric Topol
@EricTopol
Today's "breakthrough" announcement is unlikely to be any breakthrough.
1. Convalescent plasma has no randomized trials. It contains many antibodies that have no neutralizing effect. If it has efficacy, it will be be relatively modest, at best.
2. There are no new, large-scale randomized trials that have been completed with repurposed drugs; the combination of JAK inhibitor (Baricitinib) and Remdesivir may have results but it only has 400 patients and no replication
investor.lilly.com/news-releases/…
3. Type 1 interferon (intranasal) early, preventive therapy has considerable promise (reviewed w/ @VirusesImmunity and this🧵; there are many trials but they are in progress

Read 8 tweets
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Eric Topol
@EricTopol
To better understand the #COVID19 immune response, we just did a podcast w/ @VirusesImmunity, an extraordinary immunobiologist @YaleMed @YaleIBIO @HHMINEWS
link here:
medscape.com/viewarticle/93…
w/ @cuttingforstone @Medscape
We covered a lot of ground, here's a thread summary👇
1. Interferon, part of our innate immunity 1st line of defense, is deficient in some people. Giving recombinant type I IFN early and the right dose may turn out to be preventive, and there are some clinical trial data to support Image
2. The antibody response waning in the first 2-3 months is expected, not a concern. Memory B cells and a T-cell immune response are on standby. Image
Read 15 tweets

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