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F.D.A. ‘Grossly Misrepresented’ Blood Plasma Data, Scientists Say

Rogue Valley

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F.D.A. ‘Grossly Misrepresented’ Blood Plasma Data, Scientists Say

24VIRUS-PLASMA1-facebookJumbo.jpg

8/24/20
At a news conference on Sunday announcing the emergency approval of blood plasma for hospitalized Covid-19 patients, President Trump and two of his top health officials cited the same statistic: that the treatment had reduced deaths by 35 percent. Mr. Trump called it a “tremendous” number. His health and human services secretary, Alex M. Azar II, a former pharmaceutical executive, said, “I don’t want you to gloss over this number.” And Dr. Stephen M. Hahn, the commissioner of the Food and Drug Administration, said 35 out of 100 Covid-19 patients “would have been saved because of the administration of plasma.” But scientists were taken aback by the way the administration framed this data, which appeared to have been calculated based on a small subgroup of hospitalized Covid-19 patients in a Mayo Clinic study: those who were under 80 years old, not on ventilators and received plasma known to contain high levels of virus-fighting antibodies within three days of diagnosis. What’s more, many experts — including a scientist who worked on the Mayo Clinic study — were bewildered about where the statistic came from. The number was not mentioned in the official authorization letter issued by the agency, nor was it in a 17-page memo written by F.D.A. scientists. It was not in an analysis conducted by the Mayo Clinic that has been frequently cited by the administration.

“For the first time ever, I feel like official people in communications and people at the F.D.A. grossly misrepresented data about a therapy,” said Dr. Walid Gellad, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. It is especially worrisome, he said, given concerns over how Mr. Trump has appeared to politicize the process of approving treatments and vaccines for the coronavirus. Over the next couple of months, as data emerges from vaccine clinical trials, the safety of potentially millions of people will rely on the scientific judgment of the F.D.A. “That’s a problem if they’re starting to exaggerate data,” Dr. Gellad said. “That’s the big problem.” Dr. Robert Califf, who was F.D.A. commissioner under President Barack Obama, said on Twitter on Sunday that Dr. Hahn should correct his statement. Dr. Eric Topol, a professor of molecular medicine at Scripps Research in La Jolla, Calif. and a longtime expert in clinical trials, said that convalescent plasma has not yet shown the benefit that Dr. Hahn described — and that he should issue a correction. “He needs to come out with that, and until he does, he has no credibility as an F.D.A. commissioner,” Dr. Topol said. In an interview on Monday, one of the Mayo Clinic study’s main authors, Dr. Arturo Casadevall of Johns Hopkins University in Baltimore, said he was also stumped. “Do I know where the 35 percent comes from?” he said. “No.”

A placebo control group was not even used in the 'convalescent plasma' Mayo Clinic study.

It seems Trump is pressuring and co-opting officials at the FDA to exaggerate test results and cut safety corners. Trump wants a COVID vaccine approved before the November election no matter what.

This is remarkably similar to how the Putin regime manages COVID. Massage the infection/death numbers, and then approve a vaccine before all phases of clinical trials are complete.

Related: 'Outrageous': Trump Announcement on Convalescent Plasma Blasted by Scientists
 

Rexedgar

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Trump overstated something............reaching for straws.

Friday the FDA was part of the ‘deep state’ and Sunday they are the best?
 

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F.D.A. ‘Grossly Misrepresented’ Blood Plasma Data, Scientists Say

24VIRUS-PLASMA1-facebookJumbo.jpg



A placebo control group was not even used in the 'convalescent plasma' Mayo Clinic study.

It seems Trump is pressuring and co-opting officials at the FDA to exaggerate test results and cut safety corners. Trump wants a COVID vaccine approved before the November election no matter what.

This is remarkably similar to how the Putin regime manages COVID. Massage the infection/death numbers, and then approve a vaccine before all phases of clinical trials are complete.

Related: 'Outrageous': Trump Announcement on Convalescent Plasma Blasted by Scientists

Trump poisons everyone he touches. To serve his administration means to become a liar willing to do anything to promote Trump's interests. It's a shame to see someone shred their integrity in real time like the head of FDA is doing.
 

bubbabgone

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F.D.A. ‘Grossly Misrepresented’ Blood Plasma Data, Scientists Say

24VIRUS-PLASMA1-facebookJumbo.jpg



A placebo control group was not even used in the 'convalescent plasma' Mayo Clinic study.

It seems Trump is pressuring and co-opting officials at the FDA to exaggerate test results and cut safety corners. Trump wants a COVID vaccine approved before the November election no matter what.

This is remarkably similar to how the Putin regime manages COVID. Massage the infection/death numbers, and then approve a vaccine before all phases of clinical trials are complete.

Related: 'Outrageous': Trump Announcement on Convalescent Plasma Blasted by Scientists

There was no exaggeration.
There was no claim of proven effectiveness after randomized control trials.
It was clear that these were observational results.
"Randomised control trials are the gold standard for determining the effectiveness of a new treatment." hasn't changed and it hasn't been forgotten.
But until those test are completed we have the observational results and likely people dying whose death could be prevented.
And I dare say, if you were currently infected and had the opportunity to receive the plasma treatment your politics wouldn't prevent you from saying "yes, please, I'd love to be among the 35%".
Assuming you're under 80.
 

BlueTex

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The head of the U.S. Food and Drug Administration walked back his claim that an experimental therapy had provided a dramatic benefit to Covid-19 patients, a rare reversal for an agency that has prided itself on rock-solid science and public trust.

FDA Walks Back Claim of Dramatic Benefit From Covid Therapy
 

Slavister

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There was no exaggeration.
There was no claim of proven effectiveness after randomized control trials.
It was clear that these were observational results.
"Randomised control trials are the gold standard for determining the effectiveness of a new treatment." hasn't changed and it hasn't been forgotten.
But until those test are completed we have the observational results and likely people dying whose death could be prevented.
And I dare say, if you were currently infected and had the opportunity to receive the plasma treatment your politics wouldn't prevent you from saying "yes, please, I'd love to be among the 35%".
Assuming you're under 80.

Says the guy pushing HCQ observational studies which have been shown to be ineffective after RCTs were done.
 

Slavister

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False on all.

Reread the thread then. First you were told about RCTs showing ineffectiveness, and you still tried to hold on to the hope of HCQ being good for non-severe cases, but then RCTs came out for those too and still showed it ineffective.
 

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As I stated yesterday. Something fishy. on the 19th it was reported they were killing the emergency approval and on Sunday it was the greatest thing since sliced bread.
 

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There was no exaggeration.
There was no claim of proven effectiveness after randomized control trials.
It was clear that these were observational results.
"Randomised control trials are the gold standard for determining the effectiveness of a new treatment." hasn't changed and it hasn't been forgotten.
But until those test are completed we have the observational results and likely people dying whose death could be prevented.
And I dare say, if you were currently infected and had the opportunity to receive the plasma treatment your politics wouldn't prevent you from saying "yes, please, I'd love to be among the 35%".
Assuming you're under 80.

LOL, as you didn't read the article and so have no idea what claims WERE misrepresented. Classic Trump MAGA! :lamo

Screen Shot 2020-08-25 at 7.49.59 PM.jpg
 
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bubbabgone

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Reread the thread then. First you were told about RCTs showing ineffectiveness, and you still tried to hold on to the hope of HCQ being good for non-severe cases, but then RCTs came out for those too and still showed it ineffective.

The randomized trials didn't isolate participants by their characteristics for which the HCQ is effective.
I shouldn't have to keep repeating that.
 

bubbabgone

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LOL, as you didn't read the article and so have no idea what claims WERE misrepresented. Classic Trump MAGA! :lamo

View attachment 67292817

Nope. I saw the presentation when it was made and I read what he said afterwards.
What I said was essentially what he said afterwards.
He was saying it can't be considered definitive because "Randomised control trials are the gold standard for determining the effectiveness of a new treatment."
You should be able to understand what that means relative to the results of observational studies.
That was his point which you would have understood if you didn't have your mind made up before anyone said anything.
 

JasperL

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Nope. I saw the presentation when it was made and I read what he said afterwards.
What I said was essentially what he said afterwards.
He was saying it can't be considered definitive because "Randomised control trials are the gold standard for determining the effectiveness of a new treatment."
You should be able to understand what that means relative to the results of observational studies.
That was his point which you would have understood if you didn't have your mind made up before anyone said anything.

Lol. This is why arguing with MAGAs is so pointless. I screen shotted Hahn himself admitting to the misrepresentation, and you say, "NUH UH!!! He didn't do what he's admitted to doing to the whole world!! MAGA!!"
 

Cardinal

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If you've lived an existence in which professionalism has always reigned, it must be demoralizing beyond belief to have that wall of professionalism and expertise come under such assault by an environment increasingly dominated by inexpertise, malevolence, corruption and incompetence.

Hahn wasn't strong enough to withstand it. So if you're a basically decent guy who just wants to do the right thing, and if it looks like you're going to end up working for trump, you really have to ask yourself if you have what it takes to withstand him. Cause sure as hell you're not gonna change him. If anybody's getting changed, it's you.
 

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HonestJoe

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Nope. I saw the presentation when it was made and I read what he said afterwards.
What I said was essentially what he said afterwards.
He was saying it can't be considered definitive because "Randomised control trials are the gold standard for determining the effectiveness of a new treatment."
You should be able to understand what that means relative to the results of observational studies.
That was his point which you would have understood if you didn't have your mind made up before anyone said anything.
I think you're missing the key point. The administration and (more worryingly) the FDA stated that the study results concluded that the treatment saved the lives of 35% of the patients. That was an outright lie.

The irony is that the actual results of the study do justify expanding the use of this treatment to gather more and better data but regardless, it seems the politicos preferred a simple, definitive but false message rather than a nuanced, conditional but accurate one.
 

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I think you're missing the key point. The administration and (more worryingly) the FDA stated that the study results concluded that the treatment saved the lives of 35% of the patients. That was an outright lie.

The irony is that the actual results of the study do justify expanding the use of this treatment to gather more and better data but regardless, it seems the politicos preferred a simple, definitive but false message rather than a nuanced, conditional but accurate one.


The politician who boasted that “no experience necessary” is an asset, wants a magic bullet. He grasps at every one of them.
 

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False on all.

No, you got duped and you know it. HCQ is potentially very dangerous and there have been NO (0), trials conducted with it according to established clinical protocols. The only 'data' is anecdotal at best, and the result of poorly conducted observational 'trials' of tiny cohorts.
 
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snakestretcher

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If you've lived an existence in which professionalism has always reigned, it must be demoralizing beyond belief to have that wall of professionalism and expertise come under such assault by an environment increasingly dominated by inexpertise, malevolence, corruption and incompetence.

Hahn wasn't strong enough to withstand it. So if you're a basically decent guy who just wants to do the right thing, and if it looks like you're going to end up working for trump, you really have to ask yourself if you have what it takes to withstand him. Cause sure as hell you're not gonna change him. If anybody's getting changed, it's you.

Hahn will doubtless be looking over his shoulder, wondering when the first attack from Baby Brain will come.
 

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Lol. This is why arguing with MAGAs is so pointless. I screen shotted Hahn himself admitting to the misrepresentation, and you say, "NUH UH!!! He didn't do what he's admitted to doing to the whole world!! MAGA!!"

you just didn't understand what he was talking about.
 

bubbabgone

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I think you're missing the key point. The administration and (more worryingly) the FDA stated that the study results concluded that the treatment saved the lives of 35% of the patients. That was an outright lie.

The irony is that the actual results of the study do justify expanding the use of this treatment to gather more and better data but regardless, it seems the politicos preferred a simple, definitive but false message rather than a nuanced, conditional but accurate one.

As I recall they were pretty clear in describing it as a promising finding. The FDA allowed it's use as an emergency treatment.
 

bubbabgone

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No, you got duped and you know it. HCQ is potentially very dangerous and there have been NO (0), trials conducted with it according to established clinical protocols. The only 'data' is anecdotal at best, and the result of poorly conducted observational 'trials' of tiny cohorts.


So you wouldn't take HCQ if you started to show symptoms?
 

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As I recall they were pretty clear in describing it as a promising finding. The FDA allowed it's use as an emergency treatment.
Yes, and that aspect remains perfectly reasonable. They still lied about the data though.

That lie was totally unnecessary from a practical or policy point of view, it can only have had political motivation (however warped and irrational). If it had just been Trump lying it would have been barely worth commenting but the fact the FDA were dragged in to it should be extremely concerning.
 
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