Now that Trump got his fanfare boost, FDA chief coward Stephen Hahn is walking back his press statement.
On Sunday night at a press conference with President Donald Trump, FDA Commissioner Stephen Hahn said that blood plasma from Covid-19 survivors given to new patients could save huge numbers of lives.
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Hahn’s remarks followed similar comments by Trump, who said that the therapy is “proven to reduce mortality by 35%,” and by Health and Human Services Secretary Alex Azar.
On Monday night, Hahn reversed himself.
“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified,” Hahn said in a tweet. He went on CBS on Tuesday morning to continue walking back the claim, telling the network that “I could have done a better job of explaining that at the press conference.”
Bloomberg
Cowardly piece of shit.
“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,” Hahn said [at the press conference].
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Hahn had spent much of Monday taking heat from health experts, including two former FDA commissioners, for his remarks.
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The 35% statistic about blood plasma’s effectiveness has several fatal flaws. Since everyone in the program received blood plasma, it’s not known what would have happened compared with patients who didn’t get the therapy.
Flaws? That's no study at all, ffs.
And scores of variables, like how sick the patients were and when they were treated -- that could have skewed the results.
You think? JFC.
What the data do show is that a higher dose of blood plasma is better than a lower one. And while there are promising signals that it will lead to a real benefit when compared to a placebo, that’s not known yet.
“Until we have a randomized controlled trial, we don’t know definitively,” [Arturo Casadevall, chair of the department of molecular microbiology and immunology at the Johns Hopkins School of Public Health] said. Trump has said he expects one to be ready in time for his potential re-election, and on Saturday accused unnamed members of the “deep state” at the FDA of slowing work to hurt him politically.
Which is when Hahn and Azar disgraced themselves publicly and put lives at risk to placate the orange beast.
There is no evidence this is happening at the FDA.
Obviously what's happening at the FDA is just the opposite.
Azar and Hahn both have extensive experience with drugs and therapies. Azar is a former pharmaceutical executive, and Hahn has spent several decades treating patients and researching cancer. Before joining the FDA, he was the chief medical executive of the University of Texas MD Anderson Cancer Center, a leading oncology treatment and research hospital.
And now he has destroyed his reputation. What on earth was he thinking?
In a tweet posted earlier Monday, Hahn said that the agency will “reevaluate our emergency use authorization (EUA) based upon new incoming data that we receive.”
He emphasized that the decision to allow emergency use of the therapy had been made based on science alone.
More obvious bullshit. Another lie negates his attempt to reclaim some respect.
The FDA analysis was pulled from a subset of data in the trial -- typically a no-no for credible studies. And despite a day of criticism online from doctors and researchers, Hahn’s correction wasn’t enough for some.
It shouldn't be enough for anyone. Not to mention the bullshitting he muddled it with.
Doctors and patients rely on the FDA to put out authoritative information about the safety and efficacy of drugs, vaccines, medical devices and other products, guiding their use not just in the U.S. but around the world. The agency has historically carefully guarded its reputation and scientific independence.
And Hahn just blew that up.
“When we overstate findings it erodes confidence in science and undermines public trust in regulatory decisions. The right message was this ‘may’ provide a benefit, it could be meaningful for some patients, but we need more evidence to prove it, [Hahn’s predecessor Scott Gottlieb, who served as FDA commissioner under Trump from 2017 to 2019] said in a tweet.
“The way the public part was handled will erode precious public confidence,” he said. “You earn public confidence in small drops and you loose it in buckets.”
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Hahn’s comments about 35 out of 100 people being saved were still posted to the FDA’s official twitter account as of Monday afternoon.
Shame.
Alyssa Farah, a White House spokeswoman made a similarly misleading tweet, saying that the therapy cuts mortality by 30% to 50%. And Michael Caputo, Azar’s chief spokesman at HHS, echoed the claim: “If you’re one of the 35 people out of a hundred who survive severe COVID symptoms because of convalescent plasma, you’re damn right this is a BREAKTHROUGH.”
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Caputo deferred comment to the FDA, though his tweet with the incorrect information was still up as of Tuesday morning in New York.
These goddamned despicable people.
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