[BostonCard]

https://www.washingtonpost.com/health/20...d-vaccine/

The Trump administration threatened to fire Hahn if he didn't approve the Pfizer vaccine today.  By all indications, the FDA was poised to approve the vaccine imminently, possibly as early as tomorrow, but the Trump administration's move threatens the independence of the agency.  This is G-d damned stupid.  It establishes a horrible precedent for the future, undermines confidence in the vaccine approval process, and maybe buys you a couple of days of getting the vaccine approved earlier (which in any case is supply constrained).

It's easy for me, but if I were Steve Hahn I would resign and tell the CBER to ignore pressure from the White House and approve it at their original schedule.  Hahn is going to be replaced anyways in 6 weeks, so you might as well get an extra long Christmas break and resign with a shred of dignity than go down as the yes man that allowed the FDA's independence to be subverted.

By the looks of it, the vaccine will be approved tonight instead of tomorrow, which has no effect on ending the pandemic but an effect of unusual size on the Agency's scientific integrity.

BC

[BostonCard]

https://www.washingtonpost.com/health/20...d-vaccine/

The Trump administration threatened to fire Hahn if he didn't approve the Pfizer vaccine today.  By all indications, the FDA was poised to approve the vaccine imminently, possibly as early as tomorrow, but the Trump administration's move threatens the independence of the agency.  This is G-d damned stupid.  It establishes a horrible precedent for the future, undermines confidence in the vaccine approval process, and maybe buys you a couple of days of getting the vaccine approved earlier (which in any case is supply constrained).

It's easy for me, but if I were Steve Hahn I would resign and tell the CBER to ignore pressure from the White House and approve it at their original schedule.  Hahn is going to be replaced anyways in 6 weeks, so you might as well get an extra long Christmas break and resign with a shred of dignity than go down as the yes man that allowed the FDA's independence to be subverted.

By the looks of it, the vaccine will be approved tonight instead of tomorrow, which has no effect on ending the pandemic but an effect of unusual size on the Agency's scientific integrity.

BC

[dabigv13]

I disagree about him resigning- I think it would draw even more attention to this and make vaccine skeptics even more worried.

Obviously terrible that Trump is publicly pressuring the FDA on a vaccine where lots of people have legitimate fears about political pressure and a rushed process, but he has never cared about anything but himself so no surprise.

[dabigv13]

I disagree about him resigning- I think it would draw even more attention to this and make vaccine skeptics even more worried.

Obviously terrible that Trump is publicly pressuring the FDA on a vaccine where lots of people have legitimate fears about political pressure and a rushed process, but he has never cared about anything but himself so no surprise.

[OutsiderFan]

While I concur the Turd behavior is as reprehensible as usual, I'm under no illusions that the vaccine wouldn't be approved in very short order.  I have to believe that if the reviews weren't sound, the vaccine would have been rejected, firing threats included.

So I guess what I'm saying is the threats really don't matter if you ignore who is making them and nobody will hurt people by doing what happens might appear be in line with acquiescing to the threat.

It would be a real bad look for the POTUS to fire a department head with less than 40 days left in office, and firing the FDA head at this time would cause a very potent shitstorm.

[OutsiderFan]

While I concur the Turd behavior is as reprehensible as usual, I'm under no illusions that the vaccine wouldn't be approved in very short order.  I have to believe that if the reviews weren't sound, the vaccine would have been rejected, firing threats included.

So I guess what I'm saying is the threats really don't matter if you ignore who is making them and nobody will hurt people by doing what happens might appear be in line with acquiescing to the threat.

It would be a real bad look for the POTUS to fire a department head with less than 40 days left in office, and firing the FDA head at this time would cause a very potent shitstorm.

[Goose]

The threat should simply be ignored and Hahn should proceed as if it had never happened. I am frustrated when there is any "extra" delay in the approval process of any treatment, but like it or not the FDA is a process driven organization. This fact protects us (almost perfectly) from errors due to a rushed approval process, but it also means you have to let the FDA do things it's way. Sometimes that leads to the FDA to being arrogant, inefficient, and slow. It is a balance that constantly needs to be addressed. Threats from the POTUS obviously do not facilitate such a balance and are inadmissible, period.

[Goose]

The threat should simply be ignored and Hahn should proceed as if it had never happened. I am frustrated when there is any "extra" delay in the approval process of any treatment, but like it or not the FDA is a process driven organization. This fact protects us (almost perfectly) from errors due to a rushed approval process, but it also means you have to let the FDA do things it's way. Sometimes that leads to the FDA to being arrogant, inefficient, and slow. It is a balance that constantly needs to be addressed. Threats from the POTUS obviously do not facilitate such a balance and are inadmissible, period.

[Farm93]

The threat should simply be ignored and Hahn should proceed as if it had never happened. I am frustrated when there is any "extra" delay in the approval process of any treatment, but like it or not the FDA is a process driven organization. This fact protects us (almost perfectly) from errors due to a rushed approval process, but it also means you have to let the FDA do things it's way. Sometimes that leads to the FDA to being arrogant, inefficient, and slow. It is a balance that constantly needs to be addressed. Threats from the POTUS obviously do not facilitate such a balance and are inadmissible, period.

We are talking about 24 hours, and a weekend 24 hours at that.

We already have too many Americans worried about the efficacy of a EUA vaccine, so it does not help our nation to have it appear as though the vaccine release was influenced by Mr. "Take it" rather than a sound process.

All of that anti-vaxx concern that will last for months just to get ~24 hours of hype and credit?!!

Though given the SCOTUS embarrassment was certain and pending this afternoon maybe POTUS suspected he needed an alternate headline ASAP.

[Farm93]

The threat should simply be ignored and Hahn should proceed as if it had never happened. I am frustrated when there is any "extra" delay in the approval process of any treatment, but like it or not the FDA is a process driven organization. This fact protects us (almost perfectly) from errors due to a rushed approval process, but it also means you have to let the FDA do things it's way. Sometimes that leads to the FDA to being arrogant, inefficient, and slow. It is a balance that constantly needs to be addressed. Threats from the POTUS obviously do not facilitate such a balance and are inadmissible, period.

We are talking about 24 hours, and a weekend 24 hours at that.

We already have too many Americans worried about the efficacy of a EUA vaccine, so it does not help our nation to have it appear as though the vaccine release was influenced by Mr. "Take it" rather than a sound process.

All of that anti-vaxx concern that will last for months just to get ~24 hours of hype and credit?!!

Though given the SCOTUS embarrassment was certain and pending this afternoon maybe POTUS suspected he needed an alternate headline ASAP.

[Goose]

The threat should simply be ignored and Hahn should proceed as if it had never happened. I am frustrated when there is any "extra" delay in the approval process of any treatment, but like it or not the FDA is a process driven organization. This fact protects us (almost perfectly) from errors due to a rushed approval process, but it also means you have to let the FDA do things it's way. Sometimes that leads to the FDA to being arrogant, inefficient, and slow. It is a balance that constantly needs to be addressed. Threats from the POTUS obviously do not facilitate such a balance and are inadmissible, period.

We are talking about 24 hours, and a weekend 24 hours at that.

We already have too many Americans worried about the efficacy of a EUA vaccine, so it does not help our nation to have it appear as though the vaccine release was influenced by Mr. "Take it" rather than a sound process.

All of that anti-vaxx concern that will last for months just to get ~24 hours of hype and credit?!!

Though given the SCOTUS embarrassment was certain and pending this afternoon maybe POTUS suspected he needed an alternate headline ASAP.

It is really ugly that Trump is threatening the FDA, but I still believe the best course of action is for the FDA to proceed normally as if it hadn't happened. Resigning won't help anything. It will just look like Trump got what he wanted anyway. The threat alone makes anything the FDA does now subject to the idea that it was influenced by the threat. That bell can't be un-rung. This is why the POTUS can never, ever make a public statement pressuring the FDA. Whatever happens subsequently becomes questionable, especially in the minds of those that already don't trust the system. If the FDA follows their stated processes, at least they have a credible defense for their actions. Anything else admits Trump influence of some kind.

[Goose]

The threat should simply be ignored and Hahn should proceed as if it had never happened. I am frustrated when there is any "extra" delay in the approval process of any treatment, but like it or not the FDA is a process driven organization. This fact protects us (almost perfectly) from errors due to a rushed approval process, but it also means you have to let the FDA do things it's way. Sometimes that leads to the FDA to being arrogant, inefficient, and slow. It is a balance that constantly needs to be addressed. Threats from the POTUS obviously do not facilitate such a balance and are inadmissible, period.

We are talking about 24 hours, and a weekend 24 hours at that.

We already have too many Americans worried about the efficacy of a EUA vaccine, so it does not help our nation to have it appear as though the vaccine release was influenced by Mr. "Take it" rather than a sound process.

All of that anti-vaxx concern that will last for months just to get ~24 hours of hype and credit?!!

Though given the SCOTUS embarrassment was certain and pending this afternoon maybe POTUS suspected he needed an alternate headline ASAP.

It is really ugly that Trump is threatening the FDA, but I still believe the best course of action is for the FDA to proceed normally as if it hadn't happened. Resigning won't help anything. It will just look like Trump got what he wanted anyway. The threat alone makes anything the FDA does now subject to the idea that it was influenced by the threat. That bell can't be un-rung. This is why the POTUS can never, ever make a public statement pressuring the FDA. Whatever happens subsequently becomes questionable, especially in the minds of those that already don't trust the system. If the FDA follows their stated processes, at least they have a credible defense for their actions. Anything else admits Trump influence of some kind.

[M T]

On the other hand, maybe the President knew that Hahn & the FDA would not return a result today even under the threat.   If they approve it after the President's deadline, does it give the appearance that the FDA stood up to the politics and managed the process as they felt should be done?   I believe that will be the appearance.

[M T]

On the other hand, maybe the President knew that Hahn & the FDA would not return a result today even under the threat.   If they approve it after the President's deadline, does it give the appearance that the FDA stood up to the politics and managed the process as they felt should be done?   I believe that will be the appearance.

[BostonCard]

https://www.nytimes.com/2020/12/11/healt...d=tw-share

Well, the FDA gave the EUA.

The action followed an extraordinary sequence of events on Friday morning when the White House chief of staff, Mark Meadows, told the F.D.A. commissioner, Dr. Stephen Hahn, to consider looking for his next job if he didn’t get the emergency approval done on Friday, according to a senior administration official who spoke on condition of anonymity because he was not authorized to discuss the matter. Dr. Hahn then ordered vaccine regulators at the agency to do it by the end of the day.

I think this is pretty pathetic by Hahn.  Imagine that an FDA reviewer, looking through the batch records, finds unacceptable levels of a contaminant in one of the batches that is authorized for release or that examining the stability logs they figure out that degradation is faster than reported and as a result the first few million doses are lower than expected and produce a sub-efficacious response and consequently are wasted.

People talk about why can't the FDA just move faster given that the efficacy is clear and the safety is acceptable, but the answer is that there are thousands of details in the documentation furnished to the Agency that reviewers pore over, everything from the assays of the raw materials, to the factory GMP certifications, to the qualifications of the people running the clinical trials.  And now what you have created is an atmosphere where you are telling people that none of that matters because the President wants his EUA.  I think we would all be horrified if 6 months from now it is discovered that one of the batches has a carcinogen, or was not sterile, or any one of a thousand different things that could go wrong.  The last thing you want is a 737 MAX situation to happen with a vaccine; it would destroy the credibility of the agency for decades.

BC

[BostonCard]

https://www.nytimes.com/2020/12/11/healt...d=tw-share

Well, the FDA gave the EUA.

The action followed an extraordinary sequence of events on Friday morning when the White House chief of staff, Mark Meadows, told the F.D.A. commissioner, Dr. Stephen Hahn, to consider looking for his next job if he didn’t get the emergency approval done on Friday, according to a senior administration official who spoke on condition of anonymity because he was not authorized to discuss the matter. Dr. Hahn then ordered vaccine regulators at the agency to do it by the end of the day.

I think this is pretty pathetic by Hahn.  Imagine that an FDA reviewer, looking through the batch records, finds unacceptable levels of a contaminant in one of the batches that is authorized for release or that examining the stability logs they figure out that degradation is faster than reported and as a result the first few million doses are lower than expected and produce a sub-efficacious response and consequently are wasted.

People talk about why can't the FDA just move faster given that the efficacy is clear and the safety is acceptable, but the answer is that there are thousands of details in the documentation furnished to the Agency that reviewers pore over, everything from the assays of the raw materials, to the factory GMP certifications, to the qualifications of the people running the clinical trials.  And now what you have created is an atmosphere where you are telling people that none of that matters because the President wants his EUA.  I think we would all be horrified if 6 months from now it is discovered that one of the batches has a carcinogen, or was not sterile, or any one of a thousand different things that could go wrong.  The last thing you want is a 737 MAX situation to happen with a vaccine; it would destroy the credibility of the agency for decades.

BC

[Goose]

People talk about why can't the FDA just move faster given that the efficacy is clear and the safety is acceptable, but the answer is that there are thousands of details in the documentation furnished to the Agency that reviewers pore over, everything from the assays of the raw materials, to the factory GMP certifications, to the qualifications of the people running the clinical trials.  And now what you have created is an atmosphere where you are telling people that none of that matters because the President wants his EUA.  I think we would all be horrified if 6 months from now it is discovered that one of the batches has a carcinogen, or was not sterile, or any one of a thousand different things that could go wrong.  The last thing you want is a 737 MAX situation to happen with a vaccine; it would destroy the credibility of the agency for decades.


BC

Amen! Let the FDA do their job. It may not be pretty but it is usually through and effective. If they are going to approve something that later turns out to have issues (which inevitably does happen), let it be with their process, not some rush job. Both the congress and previous POTUS have prodded the FDA to eliminate unnecessary delays, and this is proper and reasonable. Threatening somebodies job if a certain result is not not delivered by a certain date is totally inappropriate.

[Goose]

People talk about why can't the FDA just move faster given that the efficacy is clear and the safety is acceptable, but the answer is that there are thousands of details in the documentation furnished to the Agency that reviewers pore over, everything from the assays of the raw materials, to the factory GMP certifications, to the qualifications of the people running the clinical trials.  And now what you have created is an atmosphere where you are telling people that none of that matters because the President wants his EUA.  I think we would all be horrified if 6 months from now it is discovered that one of the batches has a carcinogen, or was not sterile, or any one of a thousand different things that could go wrong.  The last thing you want is a 737 MAX situation to happen with a vaccine; it would destroy the credibility of the agency for decades.


BC

Amen! Let the FDA do their job. It may not be pretty but it is usually through and effective. If they are going to approve something that later turns out to have issues (which inevitably does happen), let it be with their process, not some rush job. Both the congress and previous POTUS have prodded the FDA to eliminate unnecessary delays, and this is proper and reasonable. Threatening somebodies job if a certain result is not not delivered by a certain date is totally inappropriate.

[old spanish trail]

[quote="BostonCard" pid='300748' dateline='1607740162']
People talk about why can't the FDA just move faster given that the efficacy is clear and the safety is acceptable, but the answer is that there are thousands of details in the documentation furnished to the Agency that reviewers pore over, everything from the assays of the raw materials, to the factory GMP certifications, to the qualifications of the people running the clinical trials.  And now what you have created is an atmosphere where you are telling people that none of that matters because the President wants his EUA.  I think we would all be horrified if 6 months from now it is discovered that one of the batches has a carcinogen, or was not sterile, or any one of a thousand different things that could go wrong.  The last thing you want is a 737 MAX situation to happen with a vaccine; it would destroy the credibility of the agency for decades.


BC

Amen! Let the FDA do their job. It may not be pretty but it is usually through and effective. If they are going to approve something that later turns out to have issues (which inevitably does happen), let it be with their process, not some rush job. Both the congress and previous POTUS have prodded the FDA to eliminate unnecessary delays, and this is proper and reasonable. Threatening somebodies job if a certain result is not not delivered by a certain date is totally inappropriate.

_______________________________________
He is an absolutely terrible person.

[old spanish trail]

[quote="BostonCard" pid='300748' dateline='1607740162']
People talk about why can't the FDA just move faster given that the efficacy is clear and the safety is acceptable, but the answer is that there are thousands of details in the documentation furnished to the Agency that reviewers pore over, everything from the assays of the raw materials, to the factory GMP certifications, to the qualifications of the people running the clinical trials.  And now what you have created is an atmosphere where you are telling people that none of that matters because the President wants his EUA.  I think we would all be horrified if 6 months from now it is discovered that one of the batches has a carcinogen, or was not sterile, or any one of a thousand different things that could go wrong.  The last thing you want is a 737 MAX situation to happen with a vaccine; it would destroy the credibility of the agency for decades.


BC

Amen! Let the FDA do their job. It may not be pretty but it is usually through and effective. If they are going to approve something that later turns out to have issues (which inevitably does happen), let it be with their process, not some rush job. Both the congress and previous POTUS have prodded the FDA to eliminate unnecessary delays, and this is proper and reasonable. Threatening somebodies job if a certain result is not not delivered by a certain date is totally inappropriate.

_______________________________________
He is an absolutely terrible person.