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

[bubbabgone]

Ok, so you still got NOTHING then.



That's exactly why they are the gold standard - because they truly show whether the drug does its job or not. All those studies from your anonymous website are only useful to establish that RCTs should in fact be done. Guess what. They WERE done and showed that HCQ is useless for both early and late stage of the diseases. Other than additional side effects, they don't improve anything.

But you refuse to believe those RCTs because they don't fit Trump narrative apparently. Heck, even Trump stopped touting it I think.

There are many studies and there are many physicians who prescribe HCQ for their patients in early stages of COVID with positive results. You didn't know that?

Since it's the gold standard, where are those RCTs that focus on HCQ treatment for early stage COVID infections that show it's NOT effective? Let's see 'em.
The Lancet story? Is that what you have?

 

[Slavister]

There are many studies and there are many physicians who prescribe HCQ for their patients in early stages of COVID with positive results. You didn't know that?

Since it's the gold standard, where are those RCTs that focus on HCQ treatment for early stage COVID infections that show it's NOT effective? Let's see 'em.
The Lancet story? Is that what you have?

I already gave you two of those. You dismissed both of them.

You have no idea about number of physicians prescribing HCQ in early stages and that HCQ has any kind of "positive" result. That's because without RCTs showing that HCQ has positive results, you have no idea if that was HCQ or anything else that led to any kind of results. And all RCTs that were done for early stages showed HCQ was USELESS.

 

[bubbabgone]

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

I already gave you two of those. You dismissed both of them.

You have no idea about number of physicians prescribing HCQ in early stages and that HCQ has any kind of "positive" result. That's because without RCTs showing that HCQ has positive results, you have no idea if that was HCQ or anything else that led to any kind of results. And all RCTs that were done for early stages showed HCQ was USELESS.

Dismissing them for reason is addressing them.
I showed you one did not say what you think it said, and the other wasn't peer reviewed for accuracy. That's how Lancet got into trouble. Remember? Pay attention.

As for physicians prescribing HCQ, do a search on "physicians prescribing hydroxychloroquine". You'll find a lot of hits. I use Bing but maybe some hits will squeak by Google.
Physicians the world over have been prescribing it. You were unaware of that?
Here's an excerpt of an article from July 31 ...COVID Doc Says Hydroxychloroquine 'Highly Effective' and Fears Are Overblown - Now FDA Chief Admits It Might Help | CBN News.
It was quite easy to find if you had been motivated to look.

Dr. Tom Rogers is one of those physicians who prescribe hydroxychloroquine to his COVID-19 patients. He told CBN News he personally has found the drug to be a "highly effective" way to treat the virus, provided the drug is prescribed in the early stages of the disease and is combined with the antibiotic azithromycin and a zinc supplement.

"It's a very controversial, kind of 'Trump drug'," he told CBN News. "There were initially a bunch of studies that said it worked, and then the powers that be came out with some other studies that said it didn't work. But there are many, many studies and many doctors who I've talked to personally, on the front lines that use it all the time and it works."

He continued, "You have to use it very early," he said. "The studies that said it didn't work, those were hospitalized patients that were very sick."

He said possible negative consequences of taking hydroxychloroquine are over-blown. "They're claiming it causes cardiac arrhythmia, which is rare," he says. "I've never seen that. I've talked to rheumatologists who've used it for decades, they've never seen it."​

Don't bitch about the source because it'll show you know your accepted narrative has been damaged.

 

[JasperL]

BTW, did you actually see the presentation you're sure you know all about or didn't you?

The FDA bus has run you over, backed up, and did it again. I don't know why you're defending them when they're not defending themselves or those statements. It's truly bizarre behavior.

It's confirmation again that much of what is 'conservatism' these days is simply opposing anything liberals are for. That's it. The End. We're criticizing FDA for making false statements, and since we can't be correct, you have to argue. SAD!!

 

[bubbabgone]

The FDA bus has run you over, backed up, and did it again. I don't know why you're defending them when they're not defending themselves or those statements. It's truly bizarre behavior.

It's confirmation again that much of what is 'conservatism' these days is simply opposing anything liberals are for. That's it. The End. We're criticizing FDA for making false statements, and since we can't be correct, you have to argue. SAD!!

You still argue about something you haven't seen or heard. That's what's sad ... but not unusual.

 

[jaeger19]

You still argue about something you haven't seen or heard. That's what's sad ... but not unusual.

Why is it so important to you that HCQ be seen as effective???. Please explain.

There has been multiple studies done on HCQ.. and its not been seen as statistically effective.

The first randomized clinical trial testing hydroxychloroquine as an early treatment for mild covid-19 found the drug was no better than a placebo in patients who were not hospitalized.

The trial results were published Thursday in the journal Annals of Internal Medicine. The study, conducted by researchers at the University of Minnesota Medical School, involved 491 adults and showed that the medication did not work better than a placebo at reducing the severity of symptoms over 14 days. Results from a similar trial conducted in Spain were published shortly afterward.

 

[Gimmesometruth]

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

Why is it so important to you that HCQ be seen as effective???.

Oh thats easy...cuz dear leader said it was so, and we all must work toward dear leader!


Ian Kershaw - Wikipedia

 

[jaeger19]

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

Oh thats easy...cuz dear leader said it was so, and we all must work toward dear leader!


Ian Kershaw - Wikipedia

Excuse me.. I think thats "SUPREME".. leader.. not dear leader.

 

[bubbabgone]

Why is it so important to you that HCQ be seen as effective???. Please explain.

There has been multiple studies done on HCQ.. and its not been seen as statistically effective.

Accuracy and honesty is important to me. Aren't they important to you?
But what does this thread have to do with HCQ?

 

[Gimmesometruth]

Accuracy and honesty is important to me. Aren't they important to you?
But what does this thread have to do with HCQ?

Wow, spends multiple pages arguing for HCQ, then wonders why people are debating it.

 

[jaeger19]

Accuracy and honesty is important to me. Aren't they important to you?
But what does this thread have to do with HCQ?

Accuracy and honesty is important to me as well.

So again..why are you so dead set on HCQ being effective.. when all available evidence disagrees with you?

As far as "what has this thread to do HCQ?"....well the thread is about the disinformation thats being presented by the administration that is at odds with the actual science. YOU brought up HCQ.. and argued for it... despite the actual science.

So I ask you.. whats your need to see that HCQ is effective?

 

[bubbabgone]

Wow, spends multiple pages arguing for HCQ, then wonders why people are debating it.

Waddya gonna do.
As Joe Biden says, you know, the thing.

 

[bubbabgone]

Accuracy and honesty is important to me as well.

So again..why are you so dead set on HCQ being effective.. when all available evidence disagrees with you?

As far as "what has this thread to do HCQ?"....well the thread is about the disinformation thats being presented by the administration that is at odds with the actual science. YOU brought up HCQ.. and argued for it... despite the actual science.

So I ask you.. whats your need to see that HCQ is effective?

Join me on the thread I started for HCQ studies if that's what you want to discuss.

As for this thread, we should start by asking if you saw the full presentation by Hahn, heard the full presentation, or read the full transcript of the presentation, including the questions afterwards.
If not, then you're reacting to only what's been reported and you shouldn't comment further.
That's not where accuracy and honesty lives.

 

[jaeger19]

Join me on the thread I started for HCQ studies if that's what you want to discuss.

As for this thread, we should start by asking if you saw the full presentation by Hahn, heard the full presentation, or read the full transcript of the presentation, including the questions afterwards.
If not, then you're reacting to only what's been reported and you shouldn't comment further.
That's not where accuracy and honesty lives.

I did. I read the full transcript.

And you are avoiding answering why you are so desperate to support HCQ when the research indicates there is no significant benefit for Covid in any stage.

 

[Threegoofs]

I did. I read the full transcript.

And you are avoiding answering why you are so desperate to support HCQ when the research indicates there is no significant benefit for Covid in any stage.

I think we both know why.

I dont think he’s actually thought about it, because the cognitive dissonance would turn him into a blubbering pile of jello.

 

[bubbabgone]

I did. I read the full transcript.

And you are avoiding answering why you are so desperate to support HCQ when the research indicates there is no significant benefit for Covid in any stage.

I'm trying to tell you that you're very likely wrong about what you believe. Go to the right thread to discover why and bring your research with you.

As for this thread ...
What was in the transcript that quoted Hahn as supporting a lie? Provide the quotes.
Did the transcript you read include the question after the presentation?
Does FDA emergency authorization for use of blood plasma require what you would consider proof of efficacy?
Do you realize the FDA is considering emergency authorization for a new vaccine? Would that require proof of efficacy for you?

 

[jaeger19]

I think we both know why.

I dont think he’s actually thought about it, because the cognitive dissonance would turn him into a blubbering pile of jello.

exactly. Which is so amazing. I am learning more about people than ever. Its this epidemic has been a fascinating window into human psychology.

Why such denial of reality? Its pretty amazing.

 

[jaeger19]

I'm trying to tell you that you're very likely wrong about what you believe. Go to the right thread to discover why and bring your research with you.

As for this thread ...
What was in the transcript that quoted Hahn as supporting a lie? Provide the quotes.
Did the transcript you read include the question after the presentation?
Does FDA emergency authorization for use of blood plasma require what you would consider proof of efficacy?
Do you realize the FDA is considering emergency authorization for a new vaccine? Would that require proof of efficacy for you?

Yes.. I get that you think I am wrong as well as all the researchers who have found that HCQ has little statistical efficacy.

What was in the transcript that quoted Hahn as supporting a lie? Provide the quotes.

What was in the transcript that quoted Hahn as supporting a lie? Provide the quotes.

Ummm transcript that quoted Hahn? Not sure what you meant. I read the transcript of the press conference in which Hahn spoke. His actual words: "

In the optimal treatment — the optimal patients, as described by Secretary Azar, treated with convalescent plasma at the highest titers, there was a 35 percent improvement in survival, which is a significant clinical benefit."

Then he goes on:

So, let me just put this in perspective. Many of you know I was a cancer doctor before I became FDA commissioner, and a 35 percent improvement in survival is a pretty substantial clinical benefit. What that means is — and if the data continue to pan out — 100 people who are sick with COVID-19, 35 would have been saved because of the administration of plasma.

That is what was what Hahn stated.

Did the transcript you read include the question after the presentation?

Yep.. here is what Hahn answered in the question:

Q So it’s a promising treatment; it’s not — you couldn’t say it’s very effective just yet?

DR. HAHN: So I would say that a 35 — if you’re one of those 35 out of 100 people who these data suggest or show survive as a result of it, this is pretty significant for that person and their family.

Does FDA emergency authorization for use of blood plasma require what you would consider proof of efficacy?

Well to some degree yes. A an emergency authorization can be revoked of the product doesn't appear to be effective:

FDA may revise or revoke an EUA if the circumstances justifying its issuance (under section 564(b)(1)) no longer exist, the criteria for its issuance are no longer met, or other circumstances make a revision or revocation appropriate to protect the public health or safety.58 Such circumstances may include significant adverse inspectional findings (e.g., when an inspection of the manufacturing site and processes has raised significant questions regarding the purity, potency, or safety of the EUA product that materially affect the risk/benefit assessment upon which the EUA was based); reports of adverse events (number or severity) linked to, or suspected of being caused by, the EUA product; product failure; product ineffectiveness (such as newly emerging data that may contribute to revision of the FDA's initial conclusion that the product "may be effective"

Do you realize the FDA is considering emergency authorization for a new vaccine? Would that require proof of efficacy for you?

Yes.. there probably will have to be some proof of efficacy. Usually there has to be some proof.. which is why there is an emergency authorization. There is some evidence or proof of its effectiveness to warrant the authorization in the first place.

Otherwise you could ask the FDA to do an emergency authorization on virtually every drug that has been found to be safe to be given to the general population.

 

[bubbabgone]

Yes.. I get that you think I am wrong as well as all the researchers who have found that HCQ has little statistical efficacy.

What was in the transcript that quoted Hahn as supporting a lie? Provide the quotes.

Ummm transcript that quoted Hahn? Not sure what you meant. I read the transcript of the press conference in which Hahn spoke. His actual words: "

Then he goes on:



That is what was what Hahn stated.



Yep.. here is what Hahn answered in the question:


Well to some degree yes. A an emergency authorization can be revoked of the product doesn't appear to be effective:



Yes.. there probably will have to be some proof of efficacy. Usually there has to be some proof.. which is why there is an emergency authorization. There is some evidence or proof of its effectiveness to warrant the authorization in the first place.

Otherwise you could ask the FDA to do an emergency authorization on virtually every drug that has been found to be safe to be given to the general population.

I hope you realize that everything from Hahn you quoted were all qualified statements of possible efficacy. Nothing was a lie. Nothing was said to be proof. The answer to the question was also very clear in that respect. And the question at the end elicited the description of the FDA's position as a comparison to "right to try". That in and of itself is evidence that there was no intention to present anything as proof. You are way off base with this one because of who else was standing on that stage.

Evidence of efficacy first comes via ... what ... say it ... evaluation of data - anecdotal evidence - observational evidence. Same as HCQ which the FDA once gave emergency authorization then withdrew it.

The FDA issued an emergency authorization for the blood plasma treatment because they felt it had some merit.
They may do the same for the vaccine(s).
You don't want them to do that in either case?

You're letting your politics influence your decisions too much.

 

[jaeger19]

I hope you realize that everything from Hahn you quoted were all qualified statements of possible efficacy. Nothing was a lie. Nothing was said to be proof. .

You don;t seem to realize.. the LIE was not in saying whether it was possible or proof.. the LIE.. was in purposely misrepresenting the actual data.

DR. HAHN: So I would say that a 35 — if you’re one of those 35 out of 100 people who these data suggest or show survive as a result of it, this is pretty significant for that person and their family.

In no way did the evidence show or suggest that 35/100 people would survive. The study DID NOT SHOW THAT. PERIOD. The study did not show it was a possibility.. it did not show that it was proof. Hahn.. lied about the statistic.

thats why he got called to the carpet by the scientific community. Because his numbers were wrong. And its why he walked it back. (of course in walking it back.. he also again got the statistics wrong).

You are way off base with this one because of who else was standing on that stage.

Ummm.. no.. I am not way off base.. he gave the wrong statistical information. PERIOD. If he had said "the study showed that cats have horns".. he would have been just as wrong. because the study.. did not.. show anything like a survival rate of 35/100. Thats a made up NUMBER.

You sir are way off base because 1. You don;t understand science and statistics 2. You are inclined to support anything Trump says or supports. .

 

[Threegoofs]

You don;t seem to realize.. the LIE was not in saying whether it was possible or proof.. the LIE.. was in purposely misrepresenting the actual data.



In no way did the evidence show or suggest that 35/100 people would survive. The study DID NOT SHOW THAT. PERIOD. The study did not show it was a possibility.. it did not show that it was proof. Hahn.. lied about the statistic.

thats why he got called to the carpet by the scientific community. Because his numbers were wrong. And its why he walked it back. (of course in walking it back.. he also again got the statistics wrong).



Ummm.. no.. I am not way off base.. he gave the wrong statistical information. PERIOD. If he had said "the study showed that cats have horns".. he would have been just as wrong. because the study.. did not.. show anything like a survival rate of 35/100. Thats a made up NUMBER.

You sir are way off base because 1. You don;t understand science and statistics 2. You are inclined to support anything Trump says or supports. .

I don’t think Hahn lied.

I think he misspoke, and was confused about RR vs absolute risk.

Happens all the time, but he should be more competent than this when addressing a national audience on live TV.

 

[bubbabgone]

You don;t seem to realize.. the LIE was not in saying whether it was possible or proof.. the LIE.. was in purposely misrepresenting the actual data.



In no way did the evidence show or suggest that 35/100 people would survive. The study DID NOT SHOW THAT. PERIOD. The study did not show it was a possibility.. it did not show that it was proof. Hahn.. lied about the statistic.

thats why he got called to the carpet by the scientific community. Because his numbers were wrong. And its why he walked it back. (of course in walking it back.. he also again got the statistics wrong).



Ummm.. no.. I am not way off base.. he gave the wrong statistical information. PERIOD. If he had said "the study showed that cats have horns".. he would have been just as wrong. because the study.. did not.. show anything like a survival rate of 35/100. Thats a made up NUMBER.

You sir are way off base because 1. You don;t understand science and statistics 2. You are inclined to support anything Trump says or supports. .

Doctor E., That's a good example of the truism that the left will always accuse you of doing what they themselves are doing.

 

[jaeger19]

I don’t think Hahn lied.

I think he misspoke, and was confused about RR vs absolute risk.

Happens all the time, but he should be more competent than this when addressing a national audience on live TV.

Looking at the data.. I think he lied. That might be a strong term.. but there is nowhere that a figure of 35/100 could have come up. I could not see how he arrived at that figure. whether relative risk or absolute risk.

his explanation that he mixed up the two.. doesn't fly.

Now.. perhaps he didn;t "LIE".. in the terms that he relied on someone else that made up that figure of 35/100.. probably from the administration and he was just repeating what the administration told him. But thats the problem.

 

[jaeger19]

Doctor E., That's a good example of the truism that the left will always accuse you of doing what they themselves are doing.

Well.. to point out.. you are doing it. You didn;t understand the mistake Hahn made in using made up statistics. and you accused me.. a conservative republican.. of carrying more about who was president.. than the actual science.

 

[bubbabgone]

Well.. to point out.. you are doing it. You didn;t understand the mistake Hahn made in using made up statistics. and you accused me.. a conservative republican.. of carrying more about who was president.. than the actual science.

You did it.
Yes.
I think you do.

I do understand what was said.
Look at it this way, when you buy the conclusion that HCQ is ineffective when it's tested on hospitalized patients with advanced infections it's sloppy data analysis too. But you did it anyway.