Thread by @DonnaYoungDC

.@SteveFDA: I personally could have done a better job & could have done a better job at that press conference.
He insists there's promising efficacy & safety data per @MayoClinic.
Data totally support EUA for #ConvalescentPlasma
He says #FDA scientists made decision.
#COVID19

.@SteveFDA: @MayoClinic data/identified a group #ConvalescentPlasma benefited most. Asked for additional validation data which supported; comparing those high concentrations of antibody vs low. When look at those data, survival benefit between 2 groups has relative benefit of 35%

.@SteveFDA: Timing #convalescentplasma EUA was totally based on when we got the data.
Had back & forth with NIH & internally about what data needed.
@MayoClinic expanded access timed to end this week.
Wanted to maintain availability.
Those are the facts.

#FDA #COVID19

Q: #COVID19 Reinfection?
.@SteveFDA: We've been learning a lot a
Continue to believe the immunity one has is long-lasting but those data aren't in
Still have to follow patients to figure out how long immunity lasts

Jury is still out.

[He's all over the place here]

#FDA

Q: Relationship with Trump?
.@SteveFDA: I feel like I enjoy a very good relationship with the president.

#FDA #convalescentplasma #vaccines #COVID19

.@CBSThisMorning video @SteveFDA
#ConvalescentPlasma #COVID19 #FDA

More @CBSThisMorning video w/ @SteveFDA
#ConvalescentPlasma #COVID19 #FDA

Meanwhile, on @IDSAInfo, .@ShohamTxID says biggest impact w/ #convalescentplasma will be when it's given early at a time of lower viral load & lower infection.
But need to find answers as to how effective it is early on.
Sooner get the answers to these questions the better.

.@IDSAInfo .@ShohamTxID: What everybody agrees on is the gaps in knowledge that could be best addressed by randomized control trials.

#ConvalescentPlasma #FDA #COVID19

Liise-anne Pirofski: There's been signals of efficacy of #convalescentplasma in this pandemic & going back over 100 years.
There appears to be a dose-response.
More antibody appears to be more effective.
Large number of case reports that demonstrate positive signals when used.

.@IDSAInfo Liise-anne Pirofski: Available data is very promising #convalescentplasma.
Can't think of one shred of data that would suggest harm.
Science/data need to be focused on rather than decision
Don't think anybody knows what drove #FDA decision other than people in room.

.@IDSAInfo .@ShohamTxID: Really important for patients/families/doctors to have information on what the data shows & what the data doesn't show so they can make best decisions.
Must talk about gaps in knowledge.

#ConvalescentPlasma #FDA #COVID19

.@IDSAInfo Liise-anne Pirofski: Need people to donate their plasma.

#ConvalescentPlasma #FDA #COVID19

Q: Is it widely known under HIPAA clarification can contact patients/ask donate plasma?
.@IDSAInfo Pirofski I think it's know but could probably be better known.
Majority of plasma collected from patients w/ moderate disease didn't require hospitalization.

#convalescentplasma

ICYMI Plasma action sparks White House bullying accusations; US FDA chief muddles data spglobal.com/marketintellig… #ConvalescentPlasma #FDA #vaccines #COVID19

I've still not seen an official retraction from #FDA on @SteveFDA's wrong information from Sunday, Aug. 23.

I've asked, no response still. Hahn was on @CBSThisMorning today trying to smooth out his muddled mess from Sunday.

It took him more than 24 hours to tweet last night.

.@SteveFDA appears to blame the media for the criticism he's received on his muddled mess on #convalescentplasma EUA & that "35%" flub up.
It was broadly the scientific community that was criticizing him.
#FDA

.@IDSAInfo Pirofski: What happened w/ #convalescentplasma EA reflects desperation having critically ill patients & absence of available therapies.
Rapid expansion really reflects that.
I believe program change the way we do clinical research in future/science in a pandemic.

.@IDSAInfo .@ShohamTxID: Vast majority of people w/ #COVID19 don't want to be in a trial. They just want to have COVID & get it over with.
Will need to look at major lessons learned as to how we can improve

#convalescentplasma #vaccines

.@IDSAInfo Pirofski: Don't know if lower antibody titer can work
.@ShohamTxID: There's a lot we don't know about what is in plasma.
High titer to something we looked for.
But things we haven't looked for.
Lots of basic research work needs to be done.
#convalescentplasma

.@IDSAInfo .@ShohamTxID: #ConvalescentPlasma is a weigh station toward learning more about what part of immune system helps/how to do clinical trials in #COVID19 population, so that the next level monoclonal antibodies/other technologies that use biologics can move forward.

Today @CBSThisMorning after @SteveFDA's late-night tweets acknowledging his huge mistake, though not correcting/apologizing for it, he said more #convalescentplasma info would be forthcoming.

#FDA spox: We'll flag any additional info when it's available.

So, that transparency?

Here's the full @CBSThisMorning interview w/ @SteveFDA cbsnews.com/video/fda-comm… #ConvalescentPlasma #Vaccines #FDA #COVID19

Again anybody know why @SteveFDA is in Colorado today?

He totally misleads the public. 24+ hours later acknowledges, somewhat, his huge mistake in late-night tweets. Next day on CBS doesn't really correct/apologize.

Escapes to the mountains leaving turmoil he created behind?

.@SenWarren @EdMarkey want copies of all communications between #FDA & White House officials about EUA for #convalescentplasma to treat #COVID19 patients
warren.senate.gov/imo/media/doc/…