Dang

[DrHoops]

LOL. Deflecting? I directly answered your accusation...with multiple sources. You're embarrassing yourself...again.

Trump tried to override the FDA's approval process. If it wasn't for threats of mass resignations, and the FDA deciding the only way to stop Trump from acting was by putting their criteria on their web site despite what Trump wanted. Clearly you didn't read any of the articles...I know you're kinda thick, but...

Hydroxychloroquine is a prime example of Trump pressuring the FDA, as I linked in my post.

The FDA’s recent record on EUAs is not encouraging. The agency issued an EUA for use of the antimalarial drug hydroxychloroquine in COVID-19 cases on March 28, almost certainly in response to Trump’s relentless public championing of the drug and despite the lack of solid scientific evidence that it was useful.​

​

Over 100 Americans died after taking hydroxychloroquine for COVID-19

In the first six months of 293 people died after taking hydroxychloroquine, according to the Milwaukee Journal Sentinel's review of FDA data. More than half took it to treat coronavirus.

www.dailymail.co.uk

Seriously, you're better off in a thread with Lucy and VPM. You have nothing of substance to say around here except "bothsiderisms".



Poor guy.

 

[DrHoops]

lol

No...no you didn't. You dumped rhetoric thus deflecting/

If nothing else you are predictable

Your hands are shaking...Take the next few plays off before you hurt someone

sheesh

Whoops...didn't finish my post before I hit reply. Again, you're way wrong. You don't even know what deflecting means...and that's a shame.

LOL. Deflecting? I directly answered your accusation...with multiple sources. You're embarrassing yourself...again. Not surprising.

Trump tried to override the FDA's approval process of a potential vaccine's safety so he could get it out on November 1st. If it wasn't for threats of mass resignations, and the FDA deciding the only way to stop Trump from acting was by putting their criteria on their web site despite what Trump wanted. Clearly you didn't read any of the articles...I know you're kinda thick, but...

Hydroxychloroquine is a prime example of Trump pressuring the FDA into doing something that killed many people and sickened many more, as I linked in my post. But since you're impervious to evidence, it went right over your head, as usual.

The FDA’s recent record on EUAs is not encouraging. The agency issued an EUA for use of the antimalarial drug hydroxychloroquine in COVID-19 cases on March 28, almost certainly in response to Trump’s relentless public championing of the drug and despite the lack of solid scientific evidence that it was useful.​

Over 100 Americans died after taking hydroxychloroquine for COVID-19

In the first six months of 293 people died after taking hydroxychloroquine, according to the Milwaukee Journal Sentinel's review of FDA data. More than half took it to treat coronavirus.

www.dailymail.co.uk

Seriously, you're better off in a thread with Lucy and VPM. You have nothing of substance to say around here except "bothsiderisms".

 

[Courtsensetwo]

Whoops...didn't finish my post before I hit reply. Again, you're way wrong. You don't even know what deflecting means...and that's a shame.

LOL. Deflecting? I directly answered your accusation...with multiple sources. You're embarrassing yourself...again.

Trump tried to override the FDA's approval process. If it wasn't for threats of mass resignations, and the FDA deciding the only way to stop Trump from acting was by putting their criteria on their web site despite what Trump wanted. Clearly you didn't read any of the articles...I know you're kinda thick, but...

Hydroxychloroquine is a prime example of Trump pressuring the FDA into doing something that killed many people and sickened many more, as I linked in my post.

The FDA’s recent record on EUAs is not encouraging. The agency issued an EUA for use of the antimalarial drug hydroxychloroquine in COVID-19 cases on March 28, almost certainly in response to Trump’s relentless public championing of the drug and despite the lack of solid scientific evidence that it was useful.

Over 100 Americans died after taking hydroxychloroquine for COVID-19

In the first six months of 293 people died after taking hydroxychloroquine, according to the Milwaukee Journal Sentinel's review of FDA data. More than half took it to treat coronavirus.

www.dailymail.co.uk

Seriously, you're better off in a thread with Lucy and VPM. You have nothing of substance to say around here except "bothsiderisms".

Thanks...anything that relates to the original discussion? I will wait.

I understand and actually am pleased that you don't like my posts. Far right nutjobs don't like me either.

Shows I am getting it right.

Oh....and....after inauguration day...I am going to hold Biden Harris to the same standards I have held Trump Pence. You are REALLY going to hate me then.

 

[DrHoops]

Thanks...anything that relates to the original discussion? I will wait.

I understand and actually am pleased that you don't like my posts. Far right nutjobs don't like me either.

Shows I am getting it right.

Oh....and....after inauguration day...I am going to hold Biden Harris to the same standards I have held Trump Pence. You are REALLY going to hate me then.

Courtnonsensetwo said: "My response was to DrHoops who made the ridiculous implication with zero evidence that somehow the standards for safety and efficacy were being lowered."

I gave you multiple links about how Trump was doing just that. He had already done that once with hydroxychloroquine and the FDA felt pressured to approve it for emergency use. That killed people. And as the multiple links I provided (that you obviously didn't read) stated, Trump was trying to do the same thing with a vaccine so he could announce it before the election.

Why are you having so much trouble?

 

[DrHoops]

Thanks...anything that relates to the original discussion? I will wait.

I understand and actually am pleased that you don't like my posts. Far right nutjobs don't like me either.

Shows I am getting it right.

Oh....and....after inauguration day...I am going to hold Biden Harris to the same standards I have held Trump Pence. You are REALLY going to hate me then.

Yes, all of the links I provided you. Your inability to grasp them is out of my hands.

 

[Courtsensetwo]

Yes, all of the links I provided you. Your inability to grasp them is out of my hands.

Oh, I grasp them quite well thank you. The only thing they add from my initial posts is that there are things i would actually not want Biden to do from a pressure standpoint.

Not that any of those have been successful in lowering development standards for safety and efficacy (the original point)...they are just foolish.

Throwing a whole lot of trash and smoke out there is a loser's tactic and doesn't change the facts...it just makes you (like Trump) look foolish.

Take a nap...seriously

 

[DrHoops]

Oh, I grasp them quite well thank you. The only thing they add from my initial posts is that there are things i would actually not want Biden to do from a pressure standpoint.

Not that any of those have been successful in lowering development standards for safety and efficacy (the original point)...they are just foolish.

Throwing a whole lot of trash and smoke out there is a loser's tactic and doesn't change the facts...it just makes you (like Trump) look foolish.

Take a nap...seriously

Yes, you go with your gut...and I go with facts by actual journalists and data. It's called an education.

Again, I'm sorry you're having trouble with all this. I really am. Unfortunately I can't post coloring books for you.

 

[UncleMark]

Not that any of those have been successful in lowering development standards for safety and efficacy (the original point)...they are just foolish.

Are you choosing to just ignore what went on with hydroxy?

 

[Courtsensetwo]

Yes, you go with your gut...and I go with facts by actual journalists and data. It's called an education.

Again, I'm sorry you're having trouble with all this. I really am. Unfortunately I can't post coloring books for you.

lol...you are still here sobbing and wringing your hands like a child?

Go home and lick your wounds.

Better yet shut your mouth, open your mind and listen to those who have the capacity to see the bigger picture....you might learn something.

Why do those that know the least always know it the loudest??

sheesh

 

[Courtsensetwo]

Are you choosing to just ignore what went on with hydroxy?

No. That was covered in #46

 

[UncleMark]

No. That was covered in #46

No, it wasn't.

"Not that any of those have been successful in lowering development standards for safety and efficacy (the original point)...they are just foolish."​

That's exactly what did occur.

That's why people are rightfully concerned that the Trump political appointees might be tempted to push the envelope and announce a vaccine before election day without it having been fully vetted. They've done it before -- given an unproven therapeutic an EUA under pressure from Trump, and were then forced to backtrack.

 

[Courtsensetwo]

No, it wasn't.

"Not that any of those have been successful in lowering development standards for safety and efficacy (the original point)...they are just foolish."​

That's exactly what did occur.

That's why people are rightfully concerned that the Trump political appointees might be tempted to push the envelope and announce a vaccine before election day without it having been fully vetted. They've done it before -- given an unproven therapeutic an EUA under pressure from Trump, and were then forced to backtrack.

No.

Plaquinil was already on the market. I covered this in #46 where I clarified one previous statement about wanting Biden to what Trump had done. I clearly was talking about vaccine development. Your loudmouth closed-minded pal dragged all the rest of the smoke in to somehow twist the discussion to meet his lost debate and whatever maddow told him to think this morning. He apparently succeeded in confusing you...

You mark? You?

 

[UncleMark]

No.

Plaquinil was already on the market. I covered this in #46 where I clarified one previous statement about wanting Biden to what Trump had done. I clearly was talking about vaccine development. Your loudmouth closed-minded pal dragged all the rest of the smoke in to somehow twist the discussion to meet his lost debate and whatever maddow told him to think this morning. He apparently succeeded in confusing you...

You mark? You?

So you're claiming that Trump wouldn't apply the same kind of pressure to approve a vaccine that he did for approving the unproven use of hydroxy? Have I got the nuance right? That always confuses me.

 

[DrHoops]

lol...you are still here sobbing and wringing your hands like a child?

Go home and lick your wounds.

Better yet shut your mouth, open your mind and listen to those who have the capacity to see the bigger picture....you might learn something.

Why do those that know the least always know it the loudest??

sheesh

Cuckoo!!!

 

[outside shooter]

We need to keep in mind that this was the first of many Lilly trials and was the use of one antibody on hospitalized patients, so they already had roaring dsease.

They are still trying it on early stage disease, where it ought to work better, though who knows, and one version which is a combination of two different antibodies and thus ought to be more resilient vs. mutant strains, when used early.

They are also trying it prophylactically (preventative), though that is a harder way to go, since antibodies are so expensive and approving antibodies used on non-infected people is a way more expensive row to hoe than using a vaccine on non-infected people.

 

[Courtsensetwo]

Cuckoo!!!

That is what we thought.

 

[Courtsensetwo]

So you're claiming that Trump wouldn't apply the same kind of pressure to approve a vaccine that he did for approving the unproven use of hydroxy? Have I got the nuance right? That always confuses me.

I won't speculate on what Trump would do. Will leave that to the partisans.

 

[Spartans9312]

We should be cognizant that the fastest an effective, widespread vaccine has ever been developed is 4 years. Even having a vaccine 18-24 months would be extraordinary. I believe it will happen, but these hiccups are to be expected in this uncharted territory.

The company I work for is shipping freezers to all locations that don't currently have one. It's in anticipation of a frozen vaccine. This may mean absolutely nothing.

 

[Spartans9312]

It's crazy how fast it is growing. @Zizkov

These European Countries Are Seeing Worse Coronavirus Spikes

Many countries in Europe are recording more daily COVID-19 cases than the first wave in the spring

time.com

Are Sweden's numbers exploding as well?

 

[JamieDimonsBalls]

Are Sweden's numbers exploding as well?

Yes, but not as exponentially as many EU countries

COVID-19 Data Explorer

Research and data to make progress against the world’s largest problems

ourworldindata.org

 

[DrHoops]

That is what we thought.

Cool story!

 

[JamieDimonsBalls]

So you're claiming that Trump wouldn't apply the same kind of pressure to approve a vaccine that he did for approving the unproven use of hydroxy? Have I got the nuance right? That always confuses me.

The problem with him is that he refuses to acknowledge that other people know far more than he ever could about these issues, on top of denial and adoption of science-lacking standpoints.

That being said, I missed this piece on the EU's desperation for a vaccine, which is causing it to be less stringent than the FDA.

European Union Would Apply Lower Threshold in Assessing Covid-19 Vaccine

The EU’s drug regulator is willing to approve a vaccine even if it were effective in less than half of people taking it, a lower threshold than the FDA is likely to apply.

www.wsj.com

The European Union’s chief drug regulator would approve a vaccine against Covid-19 even if trials showed that it was effective in less than half the people who take it, lower than the threshold the U.S. Food and Drug Administration is likely to apply in assessing vaccine candidates for the U.S. population.

I'm concerned this could ignite a race to the bottom.

 

[Aloha Hoosier]

The Lilly antibodies are, someone should point out, not a vaccine at all, but a therapeutic antibody.

The compromise being made for vaccine approval, it seems, is the accelerated review of phase 3 data based upon 2 or (preferably) 3 months of patient use, in tens of thousands of diverse patients.

Normally the FDA will rely on 9-18 months of assessment following treatment, but meta analysis of historical vaccine trial data sets show that an early endpoint only slightly increases the risk of missing long term toxicities, at least with respect to vaccines, which tend to have the lowest incidence of toxicity of any drug class. Plus, with a vaccine it is a one time or two time injection, and biomarkers should emerge in that shorter timespan.

Proof of efficacy may not be as clear in that timespan, but these approvals would seem to be driven more by safety endpoints and clear sign of efficacy based upon biomarkers (antibody levels, B cell and T cell activation, etc), but not necessarily proof of disease prevention at Earth-shattering levels.

So a conditional approval based upon a shorter timespan is a managed risk. It's like the added risk to the public raising a speed limit from 55 to 60. It's not like raising a speed limit from 55 to 120. The antivaxxers want you to think it's like raising the speed limit in a school zone from 20 mph to 120 mph.

I believe you said you were a Doctor. I played golf with a surgeon three weeks back and he said he's been hearing through the medical grapevine (my words) that medical personnel would possibly, he thought it likely, start being vaccinated in January or February. He said he'd have no problem being vaccinated because he trusts that it will be safe. Are you hearing anything like that timeline your medical circle? I assume health care providers would be first in line when it's available.

 

[mcmurtry66]

The problem with him is that he refuses to acknowledge that other people know far more than he ever could about these issues, on top of denial and adoption of science-lacking standpoints.

That being said, I missed this piece on the EU's desperation for a vaccine, which is causing it to be less stringent than the FDA.

European Union Would Apply Lower Threshold in Assessing Covid-19 Vaccine

The EU’s drug regulator is willing to approve a vaccine even if it were effective in less than half of people taking it, a lower threshold than the FDA is likely to apply.

www.wsj.com

The European Union’s chief drug regulator would approve a vaccine against Covid-19 even if trials showed that it was effective in less than half the people who take it, lower than the threshold the U.S. Food and Drug Administration is likely to apply in assessing vaccine candidates for the U.S. population.

I'm concerned this could ignite a race to the bottom.

i don't know anything about this stuff but in response to the EU guy approving it if it showed effectiveness in less than half the people who take it why does that matter. who cares? if it helps ten percent of the people shouldn't it be approved? the distinction i'm making is between helpful and harm. if the issue is that it isn't as effective as we'd like so what. if the issue is that it produces side effects, is harmful, then of course shut it down.

 

[JamieDimonsBalls]

i don't know anything about this stuff but in response to the EU guy approving it if it showed effectiveness in less than half the people who take it why does that matter. who cares? if it helps ten percent of the people shouldn't it be approved? the distinction i'm making is between helpful and harm. if the issue is that it isn't as effective as we'd like so what. if the issue is that it produces side effects, is harmful, then of course shut it down.

It's a valid question and some experienced people may conclude that it makes sense, even if it can be modestly effective. Here are the arguments against it:

1) A vaccine rushed out with inadequate efficacy gives a false sense of security and can lead to a spike in potential infections

2) If 50%+ of those taking the vaccine experience no benefit (meaning it does not work and they still contract COVID or have the potential to attract COVID), it severely reduces the likelihood of those people being willing to take another vaccination

3) We're already battling against anti-vaxxers and this is only going to amplify the mistrust and vocal rhetoric against vaccines more broadly, which is terrible for global public health

 

[iuwclurker]

It's a valid question and some experienced people may conclude that it makes sense, even if it can be modestly effective. Here are the arguments against it:

1) A vaccine rushed out with inadequate efficacy gives a false sense of security and can lead to a spike in potential infections

2) If 50%+ of those taking the vaccine experience no benefit (meaning it does not work and they still contract COVID or have the potential to attract COVID), it severely reduces the likelihood of those people being willing to take another vaccination

3) We're already battling against anti-vaxxers and this is only going to amplify the mistrust and vocal rhetoric against vaccines more broadly, which is terrible for global public health

Plus, figuring out that it doesn’t even work for 50% might be difficult.

 

[JamieDimonsBalls]

More bad news

Regeneron trial halted for seriously ill patients (oxygenated). Still enrolling for milder cases

Subscribe to read | Financial Times

News, analysis and comment from the Financial Times, the worldʼs leading global business publication

www.ft.com

 

[JamieDimonsBalls]

More bad news

Regeneron trial halted for seriously ill patients (oxygenated). Still enrolling for milder cases

Subscribe to read | Financial Times

News, analysis and comment from the Financial Times, the worldʼs leading global business publication

www.ft.com

better link for those without a sub

In a second big setback for Covid-19 antibody treatment hopes, Regeneron halts enrollment for more severe patients

Regeneron has just delivered more bad news for the hope that neutralizing antibodies could be used to treat patients with more severe forms of Covid-19. The New York biotech said today that an independent monitoring committee recommended halting enrollment of patients who need high-flow oxygen...

endpts.com

 

[Spartans9312]

More bad news

Regeneron trial halted for seriously ill patients (oxygenated). Still enrolling for milder cases

Subscribe to read | Financial Times

News, analysis and comment from the Financial Times, the worldʼs leading global business publication

www.ft.com

I think monoclonal antibodies are going to be the ticket.

 

[JamieDimonsBalls]

I think monoclonal antibodies are going to be the ticket.

Huh?

 

[Marvin the Martian]

Pfizer says early data has its vaccine effectiveness at 90%, which is better than most thought possible. Now it is with just over 90 infections, so a smaller sample size. But they only need 164 infections to have the full sample, so over halfway there. No indication if these infections are in person or early mail in . https://www.cnn.com/2020/11/09/health/pfizer-covid-19-vaccine-effective/index.html

 

[Spartans9312]

Pfizer says early data has its vaccine effectiveness at 90%, which is better than most thought possible. Now it is with just over 90 infections, so a smaller sample size. But they only need 164 infections to have the full sample, so over halfway there. No indication if these infections are in person or early mail in . https://www.cnn.com/2020/11/09/health/pfizer-covid-19-vaccine-effective/index.html

Cue the timing is convenient crowd

 

[anon_mlxxvlbug9dpa]

Right...but evil pharma ditching good process in order to appease and evil Pub POTUS at the expense of American lives is way too delicious of a narrative for some here to pass up.

Besides... "Maddow said...."

This didn’t age well