FDA Chief (RadOnc) the ScapeGoat for Lack of Covid-19 testing?

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Chartreuse Wombat said:
www.nytimes.com

F.D.A. ‘Grossly Misrepresented’ Blood Plasma Data, Scientists Say (Published 2020)

Many experts — including a scientist who worked on the Mayo Clinic study — were bewildered about where a key statistic came from.
www.nytimes.com www.nytimes.com

Ugh
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No matter what else he is doing/does, this is now part of his legacy. This is adding to what he will be best known for- putting out falsehoods in the middle of an international crisis- and the news cycle narrative and Wikipedia will ensure this. I’ve never seen someone aggravate so many smart people/physicians so fast.

Already on wiki:

"In April 2020, Hahn instructed Federal Emergency Management Administrator Peter Gaynor "to distribute hydroxychloroquine to pharmacies nationwide, even though [an Emergency Use Authorization issued by the FDA] did not provide for outpatient use of the drug," according to a whistleblower complaint filed by HHS infectious disease expert Rick Bright.[19] Hydroxychloroquine was later linked to multiple deaths of COVID-19 patients.[20]

On July 5, 2020, Hahn refused to dispute the claim by Donald Trump that 99% of coronavirus cases are "totally harmless," – contradicting contemporary understandings of the disease from both the US Centers for Disease Control and Prevention and the World Health Organization. [21]"
 
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I don't have ny times, but saw that someone on the mayo study is upset with the way in which it was interpreted. Are they really blameless here? They published a submitted study on the web that showed a benefit to giving plasma before as opposed to after an arbitrary cutpoint. Iow, nothing. Given the way data is totally misused in the present environment, they should bear some responsibility. I can't believe everyone on that study thought it's helpful or useful. Maybe I'm missing something.
 
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Ray D. Ayshun said:
I don't have ny times, but saw that someone on the mayo study is upset with the way in which it was interpreted. Are they really blameless here? They published a submitted study on the web that showed a benefit to giving plasma before as opposed to after an arbitrary cutpoint. Iow, nothing. Given the way data is totally misused in the present environment, they should bear some responsibility. I can't believe everyone on that study thought it's helpful or useful. Maybe I'm missing something.
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A taste for the proper koolaid, i prefer grape over orange, personally
 
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Radonc90 said:
ASTRO should disown Hahn...
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Again, Hahn has moved beyond needing to care what ASTRO thinks. Oooo no, he might never get an offer to staff an academic satellite again!

Furthermore, why would a radiation oncology society comment about the chair of the FDA discussing an infectious disease?
 
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Not only did Hahn have no experience, he apparently surrounded himself with staff who had even less. Wouldnt be surprised if he was just reciting talking points prepared by one of his inexperienced staff. experience counts for many jobs!

"According to interviews with current and former agency officials, the challenge has been especially complicated because more than any recent commissioner, Hahn has surrounded himself with an insular cadre of advisers, none of whom has significant experience in FDA leadership .... Hahn, moreover, doesn’t have relationships with the small group of former FDA commissioners who often support one another with policy and other advice: The three most recent FDA commissioners told STAT that they have had only passing conversations with Hahn since he was confirmed. "


www.statnews.com

As Covid-19 pressures mount, political newcomer Stephen Hahn struggles to protect an FDA under siege

With almost no institutional knowledge behind him, FDA experts worry Hahn is flying blind, leaving the agency flailing despite its vital role in the effort to control the spread of Covid-19.
www.statnews.com www.statnews.com
 
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Throw back in time, Dec. 2019 screenshot of Tweet...
Wonder what those people are saying now...
Do you guys miss the good oldeeeee days...lol?


FDA.png
 
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Can someone explain to me what convoluted reasoning right wing nut jobs are going to use to rationalize this type of behavior? If anyone thinks this was an honest mistake and not an attempt to intentionally mislead, they haven't been paying attention for the last 4 years.
 
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Who could have ever guessed it would be Steve brought to gut the FDA of credibility. Same thing happening over at CDC now too. Steve needs to stand up and walk out why the he*l does he want to play politics like this, he’s a novice that is being used
 
MegaVoltagePhoton said:
I think a lot people are bending over backwards here to defend Steve Hahn. “His replacement would be even worse!l is not really a defense. Following orders is not an excuse. Steve Hahn is doing whatever a trump puppet would do, so how exactly would the replacement be worse anyway? Maybe Jared Kushner is behaving this way because his replacement would be worse. Maybe no one should have argued against kavanaugh being appointed to the sc because there are worse judges out there.

My comment about what he has done was facetious. He has “led” UPenn and MD Anderson but does that make him so great that so many people are doing mental gymnastics to defend him now?
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i agree. Pretty ridiculous to constantly hear this argument that he is staying in trying to prevent a worst individual. At the beginning of this thread, i said he would ruin any reputation he had and he did. This is an absolute stooge folks! He is retreating back to his rad onc roots of being a yes man like most “academics”.
 
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From NYT
BREAKING NEWS
Two P.R. advisers at the F.D.A. were ousted from their positions after the agency's chief acknowledged exaggerating plasma's benefits for Covid-19.
Friday, August 28, 2020 12:14 PM EST
The F.D.A. commissioner, Dr. Stephen Hahn, removed Emily Miller as the agency’s chief spokeswoman. The White House had installed her in the post just 11 days earlier. Ms. Miller had previously worked in communications for the re-election campaign of Senator Ted Cruz and as a journalist for the conservative cable network One America News.
Ms. Miller’s termination comes one day after the F.D.A.’s parent agency, the Department of Health and Human Services, terminated the contract of another public relations consultant, Wayne Pines, who had advised Dr. Hahn to apologize for misleading comments about the benefits of blood plasma for Covid-19.
 
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Chartreuse Wombat said:
From NYT
BREAKING NEWS
Two P.R. advisers at the F.D.A. were ousted from their positions after the agency's chief acknowledged exaggerating plasma's benefits for Covid-19.
Friday, August 28, 2020 12:14 PM EST
The F.D.A. commissioner, Dr. Stephen Hahn, removed Emily Miller as the agency’s chief spokeswoman. The White House had installed her in the post just 11 days earlier. Ms. Miller had previously worked in communications for the re-election campaign of Senator Ted Cruz and as a journalist for the conservative cable network One America News.
Ms. Miller’s termination comes one day after the F.D.A.’s parent agency, the Department of Health and Human Services, terminated the contract of another public relations consultant, Wayne Pines, who had advised Dr. Hahn to apologize for misleading comments about the benefits of blood plasma for Covid-19.
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I suppose the agencies chief spokesMan, who made the comments, is keeping his position...
 
hey can you guys summarize, is plasma OK or not if you're admitted with COVID
 
seper said:
hey can you guys summarize, is plasma OK or not if you're admitted with COVID
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The original randomize trial has of several hundred patients trended Strongly towards significance without reaching it. Very likely it had a small benefit.
 
if afflicted & at risk of harm, would accept 'high titer' plasma ([contains most anti-covid antibodies] which had better effect over lower titer plasma, which confirmed obvious past scientific inferences, such as 1+1 = 2 ... for real though, why obfuscate the name of a placebo or 'everyone knowledgeable knows it should be less effective' treatment, how is that ethical?).
 
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Today he is back in the news saying he’d approve AstraZeneca Covid vaccine without Phase III data. Thoughts?
 
seper said:
Today he is back in the news saying he’d approve AstraZeneca Covid vaccine without Phase III data. Thoughts?
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Well he did build Penn and MD Anderson on the back of an unproven technology (protons) so it shouldn't surprise us. I must say I am not an anti-vaxxer but not sure I would agree to a vaccine in absence of Phase III. These decisions will only worsen the skepticism surrounding public health decisions.
 
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Given the unprecedented times, and our experience with vaccines wrt safety, it seems reasonable to me to start administering the vaccine should it generate a good antibody response. Even in the absence of phase III data. I leave to the experts to say what a good antibody response is.
 
It's a deadly disease, so one would have to figure to risk of "ADE" before getting a vaccine

Ray D. Ayshun said:
Given the unprecedented times, and our experience with vaccines wrt safety, it seems reasonable to me to start administering the vaccine should it generate a good antibody response. Even in the absence of phase III data. I leave to the experts to say what a good antibody response is.
Click to expand...
 
seper said:
It's a deadly disease, so one would have to figure to risk of "ADE" before getting a vaccine
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Certainly. But when we're losing 500-1000 daily and have only documented infection of 2% of the population, the expected value equations for rushing vs not rushing a vaccine to market gets a little trickier.
 
Yes I would trust nothing that the FDA passes while Trump is president and Hahn leads it. I don't give a **** what Hahn did as a radiation oncologist. Untrustworthy, shameful, unethical, total lack of confidence...no surprise that our field has gone to **** with fools like this in power. Open letter to Hahn and Hahn friends and Hahn supporters and Hahn-like leaders, resign and fix our ****ing job market and stop publishing worthless **** and approving crap treatments (or lack thereof).
 
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hbosch said:
Yes I would trust nothing that the FDA passes while Trump is president and Hahn leads it. I don't give a **** what Hahn did as a radiation oncologist. Untrustworthy, shameful, unethical, total lack of confidence...no surprise that our field has gone to **** with fools like this in power. Open letter to Hahn and Hahn friends and Hahn supporters and Hahn-like leaders, resign and fix our ****ing job market and stop publishing worthless **** and approving crap treatments (or lack thereof).
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In a lot of ways, he’s just a classic rad onc. Treat the referring rather than the patient.
 
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