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

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Chartreuse Wombat

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"False diagnostic test results can lead to significant adverse public health consequences.”
- Steve Hahn, responding to requests from public laboratories to create new coronavirus testing outside the FDA's normal processes.

"If we start using protons without rigorously testing its validity, no one can get worried whether or not proton use has adverse consequences."
- Steve Hahn, sort of.
 
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Or we could approve this South Korean test...

"Chun believes if the United States had access to Seegene's system, the country could test 1 million patients a week. But for now, the US isn't using the test on patients -- it doesn't have approval from the US Food and Drug Administration (FDA)."
 
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He's toast.

May or may not be his fault (probably not), but the lack of fore site and will to break down typical barriers in a once in a lifetime pandemic is an epic failure of the CDC/FDA. We had lead time to get testing ready and it just isn't ready.

Very smart people (Nassim Taleb et al) were sounding alarm bells back in January. We saw what Italy/Wuhan look like, yet it was bureaucracy as normal around here.

 
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Hahn has experience being a scapegoat. He was one at penn for the brachy debacle that really preceded him.
Have no idea if he has good judgment here with Coronavirus- probably not. Do feel he probably was not qualified to be fda Chief compared to previous ones with medical trial and pharm, not to
Mention fda experience.
 
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We are so trained about "Evidence based" and protocols, etc...in a stable environment, was prob fine for FDA.

When you start treating Covid-19 like the flu/H1N1 when it's not and refuse to break from protocols, you run into trouble. There's nothing evidence based about what is going on now, you just have to make tough decisions and go with it. You can't try to put it in a little checkbox. We chose wrong.

Aside - on a personal scale I have heard nothing but great things about him. Tough spot to be in. He's achieved more in a career than I ever will, but it is what it is.
 
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We are so trained about "Evidence based" and protocols, etc...in a stable environment, was prob fine for FDA.

When you start treating Covid-19 like the flu/H1N1 when it's not and refuse to break from protocols, you run into trouble. There's nothing evidence based about what is going on now, you just have to make tough decisions and go with it. You can't try to put it in a little checkbox. We chose wrong.

Aside - on a personal scale I have heard nothing but great things about him. Tough spot to be in. He's achieved more in a career than I ever will, but it is what it is.
Agree with that he is smart accomplished and very charismatic. My point is there are other highly intelligent accomplished charasmatic guys who also had benefit of careers in the fda and pharm and medical trial experience _ see prior directors

Lot of really good all star football players but how many make all nfl team.
 
I'm giving him the benefit of a doubt as I wonder how much of his passe nature in this was driven by those that he reports to above him.
 
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I'm giving him the benefit of a doubt as I wonder how much of his passe nature in this was driven by those that he reports to above him.

Agree. It'll be impossible to know.

If he gets out of this without a pink slip I'll be amazed though.
 
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I'm giving him the benefit of a doubt as I wonder how much of his passe nature in this was driven by those that he reports to above him.
I
Agree. It'll be impossible to know.

If he gets out of this without a pink slip I'll be amazed though.


Steve May need to take one for the team, but he did seek this position out in this administration.
 
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The FDA approved Roche’s test after 24 hours of review. Other private tests have been approved.

the lack of urgency in expanding testing may have come from his bosses (trump and Azar).

 
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The FDA approved Roche’s test after 24 hours of review. Other private tests have been approved.

the lack of urgency in expanding testing may have come from his bosses (trump and Azar).

Bingo. It's an election year
 
The FDA approved Roche’s test after 24 hours of review. Other private tests have been approved.

the lack of urgency in expanding testing may have come from his bosses (trump and Azar).

Arguably weeks late.

As to whether Trump Azar muscled him; Dr Hahn is the one that voluntarily lobbied for this position and knew the principals involved.

Lack of leadership-demand easing to constraints or resign.

Once again politics leads to poor public health decisions (not a partisan issue btw)
 
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Hindsight is 20/20, but it seems clear that when Wuhon looked like a disaster/war zone, FDA/CDC (if they themselves not going to be in the business of testing) should have went to LabCorp/Quest back in early Feb and said that we'll pay you to do it, but get testing ready just in case.

This wasn't done.

Link behind a paywall, but I've seen this posted:

Remember: “The CDC, a U.S. federal agency, opted to develop its own test kit rather than use the existing one recommended by the World Health Organization; it is not yet clear why.” —Why US coronavirus testing lags so far behind other countries'
 
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without getting political, President Trump refused to use the WHO testing and refused to pursue testing too much at all because he did not want the US case numbers to appear high.

Clearly based on yesterday's press conference, he is going to try to blame lots of people, but not himself. same thing for the getting rid of the Pandemic Global Security department for which he literally said yesterday 'I take no responsibility'
 
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without getting political, President Trump refused to use the WHO testing and refused to pursue testing too much at all because he did not want the US case numbers to appear high.

Clearly based on yesterday's press conference, he is going to try to blame lots of people, but not himself. same thing for the getting rid of the Pandemic Global Security department for which he literally said yesterday 'I take no responsibility'

I think this is probably the case.

However, how do we know that Trump and not the CDC (?FDA?) refused the WHO test. I guess the buck stops with him, but is that a call the President makes? Seems like the agencies would make that call.

Obviously, we'll probably never know the full/real story.
 
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Hopefully he is allowing him more free reign to speak.
It is instructive to look at the careers of others in health policy medical leadership like Dr. Fauci and prior fda directors. Experience probably helps in times of crisis and their careers don’t seem to reflect an urgency of ambition.
Steve May be very smart and commanding, but with zero experience in public or regulatory health , he is not in much of position to raise an alarm or say wtf if testing became a political issue in dec or Jan.
I remember reading on a thread that he made a large contribution to trump election campaign- can anyone confirm that?
 
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It is instructive to look at the careers of others in health policy medical leadership like Dr. Fauci and prior fda directors. Experience probably helps in times of crisis and their careers don’t seem to reflect an urgency of ambition.
Steve May be very smart and commanding, but with zero experience in public or regulatory health , he is not in much of position to raise an alarm or say wtf if testing became a political issue in dec or Jan.
I remember reading on a thread that he made a large contribution to trump election campaign- can anyone confirm that?
Yesterday morning there were 75,000 tests available in the USA! Disgusting. Epic failure. Affront to common sense. Han owns this as he is in charge of approving testing: Hahn needs to go even if he bears the least responsibility. He could have spoken up or sounded the alarm. Again My guess is he didn’t because he is new to all of this. There is an element of negligence when you put yourself in a position that demands expertise that you don’t have and then the sht hits the fan. It’s his job to approve testing and if he is overruled from above, he needs to sound the alarm and resign. Period.
Prior fda director had recommended his deputy for job. Very likely the guy had a lot more experience than Hahn and could moved things faster within the agency and better able to work with other agencies not to mention a lifetime of experience in regulatory health. Expeience counts. We object when dermatologist give radiation! It’s why we train for 5 years. We will never know if the other guy would have performed better, but he sure had the background to do so and obviously this will cost lives. Will more Americans die becuase Hahn was appointed head of fda vs other guy and the lack of testing slowed containment and ability to flatten the curve? (Goal is to spread out all the cases so health system not overwhelmed and patients die from not having access to vents etc) Would this have happened with a more vocal or effective fda commissioner who has years of experience in the agency and working with other gov agencies?

Luckily for Hahn, Low death rate here, otherwise....

 
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Behind a paywall but this story demonstrates how rules designed to protect health and patients can backfire


“The Association of Public Health Laboratories made what it called an “extraordinary and rare request” of Dr. Stephen Hahn, the commissioner of the F.D.A., asking him to use his discretion to allow state and local public health laboratories to create their own tests for the virus. “

“Dr. Hahn responded two days later, saying in a letter that “false diagnostic test results can lead to significant adverse public health consequences” and that the laboratories were welcome to submit their own tests for emergency authorization.”
 
“The Association of Public Health Laboratories made what it called an “extraordinary and rare request” of Dr. Stephen Hahn, the commissioner of the F.D.A., asking him to use his discretion to allow state and local public health laboratories to create their own tests for the virus. “

“Dr. Hahn responded two days later, saying in a letter that “false diagnostic test results can lead to significant adverse public health consequences” and that the laboratories were welcome to submit their own tests for emergency authorization.”

I guess Steve was under the impression that much better alternatives abound? The sentiment on this board is “to hang” the dermatologist who gives superficial xrt for high grade skin skin cancer with Lvi. Should we give a pass to Steve? In fairness to dermatologists, they have far more extensive background in skin cancer than Steve does in public or regulatory health/ managing huge government agencies and conflicts with other agencies. It not an exaggeration to say that Steve may end up costing some Americans their lives vs a better qualified commissioner.(Btw, if I performed brain surgery and the patient died, I would feel a twinge of guilt, why - Because there would be a lot of other people like neurosurgeons who could perform a better job. Even if it were not my fault that the patient died, there would still be moral
Negligence.
 
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100% slow testing was Bc of trump; entirely an economic reason, unfortunately for the stable genius he didn’t realize that he can’t lie his way though this one. Hope you all hedged your positions 3 weeks ago Bc this has been a historic short opportunity that we as physicians could see coming from a mile away
 
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100% slow testing was Bc of trump; entirely an economic reason, unfortunately for the stable genius he didn’t realize that he can’t lie his way though this one. Hope you all hedged your positions 3 weeks ago Bc this has been a historic short opportunity that we as physicians could see coming from a mile away
I would like to think that if trump ordered me not to test for Coronavirus I would have the backbone to object, be vocal, and resign. (Even from pure self interest standpoint-anyone with a brain would know that wouldn’t end well and would want to be on right side of news, and when you leave you will have choice of university presidencies ) Leadership does not equal charisma. It involves some backbone. Steve doesn’t work for trump he works for the public.
 
But look at how many of these directors, lawyers, politicians, etc fold under him to do what’s best for him and not the country. He has shown he will reward loyalty by placing incompetent figure heads in powerful positions just as long as they keep his best interests over the country. Hahn was just another and the latest example.
 
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But look at how many of these directors, lawyers, politicians, etc fold under him to do what’s best for him and not the country. He has shown he will reward loyalty by placing incompetent figure heads in powerful positions just as long as they keep his best interests over the country. Hahn was just another and the latest example.
I'm sure there was pressure to delay testing straight from the top. Make the numbers look better
 
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Hopefully not too late
 
Perhaps he's doing OK. Was at yesterday's presser. Have heard Hahn, in addition to FDA duties, is in charge of UV radiation to Prez's face; thus not likely to be let go?

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i hear medgator fell for the scam and bought a bunch of chloroquine 'just in case'?

you hate to see it
 
Hahn has been in controversy anywhere he has been, he is a known GOP donor and big Trump donor. I said it back then and ill say it again that he would ruin whatever “reputation” he had by being involved with this administration.
 
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Hahn has been in controversy anywhere he has been, he is a known GOP doner and big Trump doner. I said it back then and ill say it again that he would ruin whatever “reputation” he had by being involved with this administration.

donor
 
FDA should probably relinquish emergency ID testing to CLIA after this.
 
Really instructive how fda commissioner with long experience in public health communicates frankly and intelligently about the virus.

 
Read this guys tweets and it will be obvious we likely not be in this situation in terms of testing if he had stayed on and didn’t retire.
 
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NYT weighs in


Dr. Stephen Hahn, 60, the commissioner of the Food and Drug Administration, enforced regulations that paradoxically made it tougher for hospitals, private clinics and companies to deploy diagnostic tests in an emergency.
 
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"Guys. Seriously. It was like my first day."
 
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“Instead, under his leadership, the F.D.A. became a significant roadblock, according to current and former officials as well as researchers and doctors at laboratories around the country.”
 
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Now pulling one of the most commonly prescribed/bought OOC medications >6 months after they learned it contained a known carcinogen.

Swift work.
 
Yes. Zantac. When did we learn it contained a known carcinogen? July, 2019? It is now April, 2020. 9 months to yank it off the shelves. WTF is this organization doing?
 
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