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

[Slavister]

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

Yes they did - some did it for severe ones and others for mild cases.

 

[bubbabgone]

Absolutely not! A drug designed for treating a bacteria which has potentially serious side effects if used for a viral condition, including death? Are you kidding?

Hydroxychloroquine Has No Benefit, 'Only Risks' in COVID-19

Can't tell anything from what you linked.
Couldn't read it and couldn't tell the characteristics of the patients from what was visible.
What did the invisible portion say?
Considering HCQ has been used for many years I would be wary of believeing that it's deadly all of a sudden and I'd be alert for ties to Pharma for doctors who issue such a warning.

There are doctors the world over who continue to prescribe HCQ for early infected patients

 

[bubbabgone]

Yes they did - some did it for severe ones and others for mild cases.

I showed a link to dozens of studies that showed a positive result for early cases.
Show me dozens of studies that didn't show a positive result for early cases.

 

[bubbabgone]

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.

It wasn't a lie.

After the formal live presentation there was a question from the gaggle.
The question was essentially "Can't what you are describing be considered a 'Right to try' situation.
Both Hahn and Trump said "Exactly. That's a great question".

So the questioner recognized the thrust of what he had been told.
But the media decided they had to take it down. That was the lie.

 

[snakestretcher]

Can't tell anything from what you linked.
Couldn't read it and couldn't tell the characteristics of the patients from what was visible.
What did the invisible portion say?
Considering HCQ has been used for many years I would be wary of believeing that it's deadly all of a sudden and I'd be alert for ties to Pharma for doctors who issue such a warning.

There are doctors the world over who continue to prescribe HCQ for early infected patients

This might be better:

FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems | FDA

MHRA instructs all UK hydroxychloroquine COVID-19 clinical trials to suspend recruitment | News | Pharmaceutical Journal

 

[bubbabgone]

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

This might be better:

FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems | FDA

MHRA instructs all UK hydroxychloroquine COVID-19 clinical trials to suspend recruitment | News | Pharmaceutical Journal

It's better all right ... for my position.
The 1st link is old news and not relevant as far as pertaining to how HCQ is prescribed and to whom.

Your 2nd link confirmed what I've been telling you.

However, Martin Llewelyn, lead investigator of the ‘Chloroquine/hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting’ (COPCOV) trial, said that the case for prevention trials involving hydroxychloroquine was “stronger than ever.”

“In the Boulware [NEJM] paper, in which participants were given hydroxychloroquine several days after exposure, the point estimate for impact on risk of COVID was 0.825 (so over 17% reduction). The effect was also stronger in patients treated earlier,” he said.

“These results are entirely compatible with a protective effect which would be most evident if participants were already on hydroxychloroquine at the time of exposure.”

The Boulware study one of those at COVID-19 Treatment - Analysis of 82 global studies showing high effectiveness for early treatment

 

[Slavister]

I showed a link to dozens of studies that showed a positive result for early cases.
Show me dozens of studies that didn't show a positive result for early cases.

Your dozens of studies were NOT RTCs. RTC for early cases showed it is NOT effective.

 

[HonestJoe]

It wasn't a lie.

The President and the FDA sad that the treatment was proven to prevent the death of 35% of patients. That specific statement was a lie, it is really that simple. Are you denying they said that are are you claiming it is true?

The fact the real evidence still supported progressing with further work using this form of treatment doesn't change the fact that their political spin included an outright lie, it actually makes the lie even more egregious since it was totally unnecessary to support their policy so it's purpose can only have been about spin and politics. It didn't even require a political press conference to announce this in the first place, the FDA and the organisations and companies doing the actual work could have just got on with it. It seems clear that the administration wanted a simple, positive story in the media and the spin doctors were allowed to manipulate the facts to try to create that simple story to the point that they created the lie, either without caring or without even realising.

 

[dave8383]

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.

One problem with that 35%, that's a short number of days out. If you wait longer than that percentage drops. They fudged the numbers. Furthermore, if they got to these patients early than what else were they given early and how do you know it wasn't those other treatments that they received early?

 

[Oborosen]

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

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

I wonder how long it's been a practice, to just find one person who can side with your own agenda and then you can take their comment. Then use it to invalidate basically anything, that anyone says, ever.

Because this little song and dance is getting rather annoying. You can say "it seems" and allege all you want. But you have no power to actually determine anything of the sort and neither does someone like Dr. Topal.

This idiotic rat race of politicizing anything and everything, for every wrong reason imaginable. Is started to get old.

 

[snakestretcher]

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

It's better all right ... for my position.
The 1st link is old news and not relevant as far as pertaining to how HCQ is prescribed and to whom.

Your 2nd link confirmed what I've been telling you.


The Boulware study one of those at COVID-19 Treatment - Analysis of 82 global studies showing high effectiveness for early treatment

Not one of those 'studies' gives details of how they were carried out; whether they were done in accordance with established protocols for clinical trials, using double blinds, placebo and randomisation. A graph with no substantiating data is meaningless. But you're welcome to go with that.

 

[bubbabgone]

Your dozens of studies were NOT RTCs. RTC for early cases showed it is NOT effective.

I didn't say they were.
And you didn't show any RCTs that show it wasn't effective for early cases.
If a patient has already been hospitalized they're no longer recently exposed.
Now ... show the studies you keep referring to.

 

[bubbabgone]

The President and the FDA sad that the treatment was proven to prevent the death of 35% of patients. That specific statement was a lie, it is really that simple. Are you denying they said that are are you claiming it is true?

The fact the real evidence still supported progressing with further work using this form of treatment doesn't change the fact that their political spin included an outright lie, it actually makes the lie even more egregious since it was totally unnecessary to support their policy so it's purpose can only have been about spin and politics. It didn't even require a political press conference to announce this in the first place, the FDA and the organisations and companies doing the actual work could have just got on with it. It seems clear that the administration wanted a simple, positive story in the media and the spin doctors were allowed to manipulate the facts to try to create that simple story to the point that they created the lie, either without caring or without even realising.

They may have said "shown" or "indicate" but did they say "proven"? You'll have to produce the entire transcript so we cane see.

 

[bubbabgone]

One problem with that 35%, that's a short number of days out. If you wait longer than that percentage drops. They fudged the numbers. Furthermore, if they got to these patients early than what else were they given early and how do you know it wasn't those other treatments that they received early?

we don't know that.

 

[bubbabgone]

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

Not one of those 'studies' gives details of how they were carried out; whether they were done in accordance with established protocols for clinical trials, using double blinds, placebo and randomisation. A graph with no substantiating data is meaningless. But you're welcome to go with that.

I will go with that because you can take the active links to find out more about those studies if you were interested..

 

[snakestretcher]

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

I will go with that because you can take the active links to find out more about those studies if you were interested..

I did, and none of the clinical trial protocols I outlined were shown in ANY of the first five 'studies' I examined. No mention made of randomisation, placebo or double blinds. Only retrospective data were were used in the majority of the 'trials', for example, and only just over 50% were peer-reviewed (by whom?). Examine your sources more closely.

 

[Slavister]

I didn't say they were.
And you didn't show any RCTs that show it wasn't effective for early cases.
If a patient has already been hospitalized they're no longer recently exposed.
Now ... show the studies you keep referring to.

Here is one such RCT

https://www.nejm.org/doi/full/10.1056/NEJMoa2016638

Now you show me an RCT for such patients that showed HCQ was effective. Go ahead...

 

[HonestJoe]

They may have said "shown" or "indicate" but did they say "proven"? You'll have to produce the entire transcript so we cane see.

You seemed so definitive that there wasn't a lie but suddenly you don't know exactly what was said and are expecting clarification? If you'd actually read the OP article it should be perfectly clear what the issues (plural) with the various statements in the press conference were but I can save you the 30 seconds it took to find the official transcript;

Remarks by President Trump in Press Briefing | August 23, 2020
"THE PRESIDENT: ... and it has proven to reduce mortality by 35 percent. It’s a tremendous number."
"DR. HAHN: ... 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."

 

[bubbabgone]

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

I did, and none of the clinical trial protocols I outlined were shown in ANY of the first five 'studies' I examined. No mention made of. Only retrospective data were were used in the majority of the 'trials', for example, and only just over 50% were peer-reviewed (by whom?). Examine your sources more closely.

They're not my studies.
Do in-depth research on any study you like if you want for whatever detail you like.
There was no claim of randomisation, placebo or double blind methodology made.
These were studies of data to examine the effect of HCQ on patients with early presentation of COVID symptoms.

 

[snakestretcher]

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

They're not my studies.
Do in-depth research on any study you like if you want for whatever detail you like.
There was no claim of randomisation, placebo or double blind methodology made.
These were studies of data to examine the effect of HCQ on patients with early presentation of COVID symptoms.

Exactly my point. If those gold-standard clinical trial protocols were not used those 'trials' are about as useful as anecdotal evidence. In other words not at all.

Randomised controlled trials—the gold standard for effectiveness research

 

[bubbabgone]

Here is one such RCT

https://www.nejm.org/doi/full/10.1056/NEJMoa2016638

Now you show me an RCT for such patients that showed HCQ was effective. Go ahead...

That's the Boulware study and it's listed in the collection of studies included in the link in #31.
If you look at the NOTE at that entry it offers the explanation ...

Post Exposure Prophylaxis study Source Study Page
Boulware et al., NEJM, June 3 2020, doi:10.1056/NEJMoa2016638 (Peer Reviewed)
A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19
COVID-19 cases are reduced by [49%, 29%, 16%] respectively when taken within ~[70, 94, 118] hours of exposure (including shipping delay). The treatment delay-response relationship is significant at p=0.002. PEP delayed treatment RCT.
Currently this is the only study where we have evaluated the result as positive while the authors indicate it is negative. We provide a detailed explanation of why the results presented here are positive [1]. Note that author comments also differ from the published conclusion.
Also see: [2, 3]


[1] c19study.com/boulware.html
[2] drive.google.com/file/d/1NZOJ57fM0RTaHD1t_9w2iua7lUJhOgWT/view
[3] arxiv.org/abs/2007.09477​

 

[bubbabgone]

You seemed so definitive that there wasn't a lie but suddenly you don't know exactly what was said and are expecting clarification? If you'd actually read the OP article it should be perfectly clear what the issues (plural) with the various statements in the press conference were but I can save you the 30 seconds it took to find the official transcript;

Remarks by President Trump in Press Briefing | August 23, 2020
"THE PRESIDENT: ... and it has proven to reduce mortality by 35 percent. It’s a tremendous number."
"DR. HAHN: ... 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."

Right, what do you think "if the data continue to pan out" means?
And it says just what I said it would . Used words like "suggest" and "promising".
"safe and shows promising efficacy, thereby meeting the criteria for an emergency use authorization"
I'm afraid you're barking up the wrong tree.

 

[bubbabgone]

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

Exactly my point. If those gold-standard clinical trial protocols were not used those 'trials' are about as useful as anecdotal evidence. In other words not at all.

Randomised controlled trials—the gold standard for effectiveness research

In the absence of that kind of time consuming study, anecdotal/observational studies are typical and are useful because of the urgency.

 

[Threegoofs]

Here is one such RCT

https://www.nejm.org/doi/full/10.1056/NEJMoa2016638

Now you show me an RCT for such patients that showed HCQ was effective. Go ahead...

Bubba doesn’t know this because he’s afraid to read my posts, so you can show him this study, which in conjunction with Boulware, has basically killed any concept of this drug being effective in post exposure prophylaxis.


A Cluster-Randomized Trial of Hydroxychloroquine as Prevention of Covid-19 Transmission and Disease | medRxiv

 

[iguanaman]

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

That means what? That the RCT's were run by idiots and you know better? I classify that as extremely unlikely.