2 Senior FDA Officials Quit

[mohoosier]

https://www.thedailybeast.com/fda-o...-frustrations-with-biden-admin-covid-response

Key line: “Gruber and Krause were frustrated that the CDC was making decisions that should be made by the FDA. The final straw was reportedly the Biden administration’s announcement that COVID booster shots would be made available—before the FDA had finished evaluating data on the need for a third jab.”

What decisions? Not finished evaluating the data?

And...

“The officials’ departure threatens to further destabilize an agency plagued by a lack of a fixed leader.”

Further destabilize the Agency??

But don’t question the experts you damn anti-vaxers!!!

 

[Marvin the Martian]

Which line implies a complaint about the approval of the three vaccines to begin with?

 

[Bulk VanderHuge]

So, does the "final straw" imply a whole bunch of straws for a long period of time?

 

[NPT]

Which line implies a complaint about the approval of the three vaccines to begin with?

Maybe I didn't read correctly but I don't think he said anything about the 3 vaccines..... just about the third jab.

On edit: I would assume that the decision is an FDA decision but I'm not sure. However, we can't wait around for months for them to decide.

 

[Marvin the Martian]

Maybe I didn't read correctly but I don't think he said anything about the 3 vaccines..... just about the third jab.

On edit: I would assume that the decision is an FDA decision but I'm not sure. However, we can't wait around for months for them to decide.

His line "But don’t question the experts you damn anti-vaxers!!!" sure implies more than the booster. There hasn't been a lot of debate on shot 3, so antivaxxers haven't been called out on it yet.

 

[mcmurtry66]

His line "But don’t question the experts you damn anti-vaxers!!!" sure implies more than the booster. There hasn't been a lot of debate on shot 3, so antivaxxers haven't been called out on it yet.

you're my resident expert on all this shit marv so is shot 3 a third shot or is it a booster (implying something different - what i don't know - espresso shot vs coffee or something)

 

[NPT]

His line "But don’t question the experts you damn anti-vaxers!!!" sure implies more than the booster. There hasn't been a lot of debate on shot 3, so antivaxxers haven't been called out on it yet.

I thought you were talking about the 3 vaccines and not 3 shots.

 

[Spartans9312]

you're my resident expert on all this shit marv so is shot 3 a third shot or is it a booster (implying something different - what i don't know - espresso shot vs coffee or something)

Shot 3 is available now for immunocompromised.
Booster will be 8 months after 2nd shot.

Both are the same jab

 

[Marvin the Martian]

I thought you were talking about the 3 vaccines and not 3 shots.

His complaint about being called an antivaxxer is regarding complaining about the 3 vaccinations now available (Moderna, Pfizer, J&J). That is where people claiming to know more because they read a website from someone who took 1 biology class, in high school, and got a C, have been called antivaxxers. Not over the potential for a third booster shot of the Pfizer or Moderna vaccines.

And the booster shot is the exact same formula as in the first two. So all 3 Pfizer's are identical. That 8s why some think people should get the other brand as a booster. But there aren't studies on that.

 

[MyTeamIsOnTheFloor]

you're my resident expert on all this shit marv so is shot 3 a third shot or is it a booster (implying something different - what i don't know - espresso shot vs coffee or something)

That same confusion exists on the CDC page discussing “third shot” versus “booster”

I gave up and just went to Walgreens and got a third Moderna - I’m hoping it won’t eat my organs.

Words matter and the CDC/Fauci/lab nerd crowd have created clear mud from the beginning, and never use 10 words when they can use 500. Like lawyers who don’t know what they really need to say, they just babble - substituting quantity for meaning.

 

[mcmurtry66]

That same confusion exists on the CDC page discussing “third shot” versus “booster”

I gave up and just went to Walgreens and got a third Moderna - I’m hoping it won’t eat my organs.

Words matter and the CDC/Fauci/lab nerd crowd have created clear mud from the beginning, and never use 10 words when they can use 500. Like lawyers who don’t know what they really need to say, they just babble - substituting quantity for meaning.

Ohhhhhh this feels heavy. Has to be a disputed fact in there somewhere....

 

[NPT]

His complaint about being called an antivaxxer is regarding complaining about the 3 vaccinations now available (Moderna, Pfizer, J&J). That is where people claiming to know more because they read a website from someone who took 1 biology class, in high school, and got a C, have been called antivaxxers. Not over the potential for a third booster shot of the Pfizer or Moderna vaccines.

And the booster shot is the exact same formula as in the first two. So all 3 Pfizer's are identical. That 8s why some think people should get the other brand as a booster. But there aren't studies on that.

I think the original poster was just taking a jab at the "experts" because you'll have to admit that they say one thing one day and something different. Fauci said originally we didn't did masks and I saw him in an interview after they decided we did and he was asked "Why did you tell us we didn't need mask?" and his answer was "Because we didn't know.". If he didn't know then tell us that they don't know. It's not a crime to admit that they don't know something.

 

[twenty02]

I think the original poster was just taking a jab at the "experts" because you'll have to admit that they say one thing one day and something different. Fauci said originally we didn't did masks and I saw him in an interview after they decided we did and he was asked "Why did you tell us we didn't need mask?" and his answer was "Because we didn't know.". If he didn't know then tell us that they don't know. It's not a crime to admit that they don't know something.

The OP is an anti-vax shit for brains.

 

[Marvin the Martian]

I think the original poster was just taking a jab at the "experts" because you'll have to admit that they say one thing one day and something different. Fauci said originally we didn't did masks and I saw him in an interview after they decided we did and he was asked "Why did you tell us we didn't need mask?" and his answer was "Because we didn't know.". If he didn't know then tell us that they don't know. It's not a crime to admit that they don't know something.

America doesn't allow "I don't know" as an answer. We just don't. We want an answer, and one can never "flip flop" on that answer no matter what new data arrives. That's how Americans roll.

There was not evidence to support wearing masks since there weren't any studies. There was evidence we didn't have near enough N95 masks. So yes, they could have said "masks may help so you might want to wear them but don't go buy the one mask we know works" but we all know everyone would have flocked to the stores to buy up all the N95 masks (one cart filled with them, the other with toilet paper).

 

[MyTeamIsOnTheFloor]

Ohhhhhh this feels heavy. Has to be a disputed fact in there somewhere....

Long story - I met an eastern Kentucky plaintiffs lawyer years ago when I was a pup lawyer. He took a shine to me because I wore a sweater to a deposition instead of a suit and tie. (Small town 200 miles away - screw the bosses! Also my deposition in the harassment suit got him a later divorce client!) He used to recommend me to local businesses there after that. Never sent me a dull case. He eventually got rich, and got put on a bank board. He hired me for the bank after another lawyer filed a 68 page summary judgment motion and lost. I knew zero about bank law, but I filed a 12 page motion, won, and the judge signed my tendered order with zero changes. Upheld on appeal too. One of my best performances!

That was my “pills, diamonds and prison” case. Great stories. I oughta write a book.

 

[Bulk VanderHuge]

Long story - I met an eastern Kentucky plaintiffs lawyer years ago when I was a pup lawyer. He took a shine to me because I wore a sweater to a deposition instead of a suit and tie. (Small town 200 miles away - screw the bosses! Also my deposition in the harassment suit got him a later divorce client!) He used to recommend me to local businesses there after that. Never sent me a dull case. He eventually got rich, and got put on a bank board. He hired me for the bank after another lawyer filed a 68 page summary judgment motion and lost. I knew zero about bank law, but I filed a 12 page motion, won, and the judge signed my tendered order with zero changes. Upheld on appeal too. One of my best performances!

That was my “pills, diamonds and prison” case. Great stories. I oughta write a book.

Sorry you peaked at such a young age.

(That was just a joke. I know you have had a long and distinguished career.)

 

[NPT]

The OP is an anti-vax shit for brains.

That may be but it has nothing to do with the FDA and CDC talking out of both sides of their mouth and giving mixed messages.

 

[NPT]

Sorry you peaked at such a young age.

(That was just a joke. I know you have had a long and distinguished career.)

It was downhill from there.... but it's easier to go downhill.
Or should we say he was over the hill?

 

[MyTeamIsOnTheFloor]

Sorry you peaked at such a young age.

(That was just a joke. I know you have had a long and distinguished career.)

Well, long-ish. You were half right (which is better than your average.






Joke)

 

[mcmurtry66]

Long story - I met an eastern Kentucky plaintiffs lawyer years ago when I was a pup lawyer. He took a shine to me because I wore a sweater to a deposition instead of a suit and tie. (Small town 200 miles away - screw the bosses! Also my deposition in the harassment suit got him a later divorce client!) He used to recommend me to local businesses there after that. Never sent me a dull case. He eventually got rich, and got put on a bank board. He hired me for the bank after another lawyer filed a 68 page summary judgment motion and lost. I knew zero about bank law, but I filed a 12 page motion, won, and the judge signed my tendered order with zero changes. Upheld on appeal too. One of my best performances!

That was my “pills, diamonds and prison” case. Great stories. I oughta write a book.

love it!

 

[Bulk VanderHuge]

Well, long-ish. You were half right (which is better than your average.






Joke)

I thought it was better than my average joke, too.

 

[bawlmer]

https://www.thedailybeast.com/fda-o...-frustrations-with-biden-admin-covid-response

Key line: “Gruber and Krause were frustrated that the CDC was making decisions that should be made by the FDA. The final straw was reportedly the Biden administration’s announcement that COVID booster shots would be made available—before the FDA had finished evaluating data on the need for a third jab.”

What decisions? Not finished evaluating the data?

And...

“The officials’ departure threatens to further destabilize an agency plagued by a lack of a fixed leader.”

Further destabilize the Agency??

But don’t question the experts you damn anti-vaxers!!!

It is remarkable that in the middle of the pandemic there is not even a nominee to lead the FDA. Starting to wonder if Biden needs to have a hard look at his Chief of Staff, Ron Klain. Things haven't exactly been running smoothly.

 

[UncleMark]

It is remarkable that in the middle of the pandemic there is not even a nominee to lead the FDA. Starting to wonder if Biden needs to have a hard look at his Chief of Staff, Ron Klain. Things haven't exactly been running smoothly.

Not surprising to me that there isn't a line of highly qualified people wanting the job, given the current circumstances and climate.

 

[MyTeamIsOnTheFloor]

Not surprising to me that there isn't a line of highly qualified people wanting the job, given the current circumstances and climate.

The Borkian Cancel Culture has unintended consequences too.

Plus, the GOP has long claimed the Democrats can’t actually RUN a government - they can merely criticize one.

 

[bawlmer]

Not surprising to me that there isn't a line of highly qualified people wanting the job, given the current circumstances and climate.

That's part of it, for sure. But there usually isn't a shortage of egos willing to take the challenge.

I haven't seen anything suggesting the agency is not getting its job done, but the lack of a political head contributes to the perception that it is being influenced by outside forces.

 

[Noodle]

Long story - I met an eastern Kentucky plaintiffs lawyer years ago when I was a pup lawyer. He took a shine to me because I wore a sweater to a deposition instead of a suit and tie. (Small town 200 miles away - screw the bosses! Also my deposition in the harassment suit got him a later divorce client!) He used to recommend me to local businesses there after that. Never sent me a dull case. He eventually got rich, and got put on a bank board. He hired me for the bank after another lawyer filed a 68 page summary judgment motion and lost. I knew zero about bank law, but I filed a 12 page motion, won, and the judge signed my tendered order with zero changes. Upheld on appeal too. One of my best performances!

That was my “pills, diamonds and prison” case. Great stories. I oughta write a book.

Love stories like this. I always tell young attorneys that sometimes your best referral sources can be opposing counsel. Don't be a dick, get to know opposing counsel if they will let you, and protect your reputation all the time. And if you're up against a dick, being extra polite and ignoring their antics whenever possible will usually drive them crazy. (OK, that last line reads a bit off-color.)

 

[outside shooter]

America doesn't allow "I don't know" as an answer.

I would say that America doesn't allow "I don't know" as a RECOMMENDATION.

Fauci was asked to recommend a course of action based upon what he knew at the time. not to opine on where he felt the scientific evidence weighed 51-49, 80-20, or 99-1.

As to the issue in this thread, it is the FDA and not the CDC that is solely reponsible for approving drugs and for approving changes in treatment regimines. They have every right to be ticked off.

 

[IU_Hickory]

https://www.thedailybeast.com/fda-o...-frustrations-with-biden-admin-covid-response

Key line: “Gruber and Krause were frustrated that the CDC was making decisions that should be made by the FDA. The final straw was reportedly the Biden administration’s announcement that COVID booster shots would be made available—before the FDA had finished evaluating data on the need for a third jab.”

What decisions? Not finished evaluating the data?

And...

“The officials’ departure threatens to further destabilize an agency plagued by a lack of a fixed leader.”

Further destabilize the Agency??

But don’t question the experts you damn anti-vaxers!!!

Further destabilize doesn't say that anything was wrong with the approval process. Just because a couple people think 1 agency was overstepping their bounds is a far step from saying the experts were wrong.

Too quick to jump to conclusions.

 

[mcmurtry66]

Love stories like this. I always tell young attorneys that sometimes your best referral sources can be opposing counsel. Don't be a dick, get to know opposing counsel if they will let you, and protect your reputation all the time. And if you're up against a dick, being extra polite and ignoring their antics whenever possible will usually drive them crazy. (OK, that last line reads a bit off-color.)

i could count on one hand the number of lawyers i genuinely thought were aholes. judges too. loved 99% of the lawyers and judges.

 

[ButHerEmails]

Shot 3 is available now for immunocompromised.
Booster will be 8 months after 2nd shot.

Both are the same jab

I read somewhere that moderna will be 8 months and Pfizer will be 6 months. Looked like antibody levels from the Pfizer vaccine we’re declining slightly faster than moderna.

 

[ButHerEmails]

Further destabilize doesn't say that anything was wrong with the approval process. Just because a couple people think 1 agency was overstepping their bounds is a far step from saying the experts were wrong.

Too quick to jump to conclusions.

It read more like a dick measuring contest. And the people retiring are so upset, they aren’t retiring for another couple months.

That’s our decision to make!!!
No, it’s our decision to make!!!

 

[jet812]

That's part of it, for sure. But there usually isn't a shortage of egos willing to take the challenge.

I haven't seen anything suggesting the agency is not getting its job done, but the lack of a political head contributes to the perception that it is being influenced by outside forces.

Of course it is influenced by outside forces, as is the FDA. There is a reason big pharma laps the field in bribery political contributions. Many of the folks here believe they are beyond reproach & approvals, data, recommendations, etc. are given based on humanitarian considerations & not a P&L statement, which boggles the mind given the track record of settlements & litigation…

 

[Marvin the Martian]

Of course it is influenced by outside forces, as is the FDA. There is a reason big pharma laps the field in bribery political contributions. Many of the folks here believe they are beyond reproach & approvals, data, recommendations, etc. are given based on humanitarian considerations & not a P&L statement, which boggles the mind given the track record of settlements & litigation…

It is funny how similar this sounds to Bernie and his hard-core supporters. The far left and the far right meet up on the circle.

 

[Sope Creek]

Further destabilize the Agency??

LOL!! You don't know, do you?

I'll give you a clue: from Michael Lewis' The Fifth Risk, p. 17 (it's the first page of the paperback version of the book):

Chris Christie noticed a piece in the New York Times - that's how it all started. The New Jersey governor had dropped out of the presidential race in February 2016 and thrown what support he had behind Donald Trump. In late April he saw the article. It described meetings between representatives of the remaining candidates still in the race - Trump, John Kasich, Ted Cruz, Hillary Clinton, and Bernie Sanders - and the Obama White House. Anyone who still had any kind of a shot at becoming president of the United States apparently needed to start preparing to run the federal government. They guy Trump sent to the meeting was, in Christie's estimation, comically qualified. Christie called up Trump's campaign manager, Corey Lewandowski, to ask why the critical job hasn't been handed to someone who actually knew something about government. "We don't have anyone," said Lewandowski.

It's a helluva read . . . and answers your question above definitively.

 

[jet812]

It is funny how similar this sounds to Bernie and his hard-core supporters. The far left and the far right meet up on the circle.

I support Bernie on many issues.

 

[Bulk VanderHuge]

i could count on one hand the number of lawyers i genuinely thought were aholes. judges too. loved 99% of the lawyers and judges.

I always suspected you were a 1%er.

(jk)

 

[UncleMark]

i could count on one hand the number of lawyers i genuinely thought were aholes. judges too. loved 99% of the lawyers and judges.

But the clients...

 

[UncleMark]

I haven't seen anything suggesting the agency is not getting its job done, but the lack of a political head contributes to the perception that it is being influenced by outside forces.

Or maybe it's not? No outside political forces?

 

[Sope Creek]

But the clients...

I had a senior partner who once said that the law was a perfect way to make a living . . . except for the clients.

He ended up on a bench. Perfect for him.

 

[Sope Creek]

Many of the folks here believe they are beyond reproach

Who here believes that? I don't know of anybody who believes that . . . but there are those who recognize that for all its faults the pharma industry is the best solution for specific health issues . . .

. . . and TV advertising $$. I think pharma has taken over for the car companies in supporting national TV . . . and local plaintiffs lawyers have taken over supporting local TV news . . . .