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Sun Aug 23, 2020, 05:55 PM

 

Twitler is authorizing Plasma Treatment that has been known & already used?

Am I understanding this correctly?

14 replies, 1473 views

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Reply Twitler is authorizing Plasma Treatment that has been known & already used? (Original post)
progressive nobody Aug 2020 OP
Native Aug 2020 #1
DeminPennswoods Aug 2020 #3
Native Aug 2020 #5
progressive nobody Aug 2020 #4
DeminPennswoods Aug 2020 #7
Igel Aug 2020 #6
DeminPennswoods Aug 2020 #11
Cartaphelius Aug 2020 #13
DeminPennswoods Aug 2020 #14
Poiuyt Aug 2020 #8
underpants Aug 2020 #2
dewsgirl Aug 2020 #9
JDC Aug 2020 #10
louis-t Aug 2020 #12

Response to progressive nobody (Original post)

Sun Aug 23, 2020, 05:57 PM

1. But Fauci and company put a halt to it because they wanted more data, right?

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Response to Native (Reply #1)

Sun Aug 23, 2020, 06:03 PM

3. Yes

The Mayo Clinic gave plasma to 66,000 patients, but it wasn't a controlled study as no one got a placebo.
That's what Fauci, Collins and Lane objected to.

But, the convalescent plasma evidently did save some lives and I'm sure the survivors are grateful for it.

Personally, I think delaying the EUA was a mistake. They could've still done a study while allowing the use. There was no evidence the treatment was harmful and in some cases it was apparently helpful.

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Response to DeminPennswoods (Reply #3)

Sun Aug 23, 2020, 06:07 PM

5. That's what I thought. So, again we have the FDA capitulating to Trump.

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Response to Native (Reply #1)

Sun Aug 23, 2020, 06:04 PM

4. I'm not sure about that.

 

I do know there is a narrow window to get the plasma.

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Response to progressive nobody (Reply #4)

Sun Aug 23, 2020, 06:11 PM

7. Clarification

Link: https://www.newsweek.com/what-blood-plasma-treatment-1526209

The FDA was going to issue an EUA, but Fauci and Collins stopped it because of a study by the Mayo Clinic of 60,000 people with covid19.

However, top federal health officials, including Dr. Francis Collins, director of the National Institutes of Health, and Dr. Anthony Fauci, the government's top infectious disease expert, stepped in to prevent the agency issuing the EUA, arguing that emerging data regarding the efficacy of blood plasma therapy against COVID-19 was not strong enough yet, two senior administration officials told the Times.

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Response to Native (Reply #1)

Sun Aug 23, 2020, 06:09 PM

6. How do you get more data if you don't use it?

Hence the problem.

Note that when/if a vaccine if finally approve for use, it will have been (apparently non-)used before hand on hundreds of thousands of people.

So the FDA will approve something that's already known and in use.

In this case the "plasma treatment" is getting the hydroxychloroquine treatment from the other side.

https://www.webmd.com/lung/news/20200820/fda-halts-approval-for-plasma-to-treat-covid-19

It was given emergency approval. It's not working out as useful. FDA nixes it. Trumpster comes along and pushes for it to be used. Causing heads to explode because while hydroxychloroquine was the oddball anecdotal treatment of choice from the right (mostly), convalescent plasma was the choice on the left. Both sides adduced articles quoting doctors saying it was a cure-all. The Trumpster's only been widely quoted in stuff I've seen on DU when supporting hydroxychloroquine.

Let's hope this news (https://www.statnews.com/2020/08/23/fda-under-pressure-from-trump-expected-to-authorize-blood-plasma-as-covid-19-treatment/) really is just an emergency use authorization. The "small but statistically significant" bit is nice; the lack of a control makes it meaningless.

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Response to Igel (Reply #6)

Sun Aug 23, 2020, 06:21 PM

11. Convalescent plasma hasn't been shown to be harmful

and it apparently has helped some people recover.

There's really no reason the CDC/FDA couldn't do an EUA while still doing the kind of rigorous study they crave. I get that scientists want to be rigorous, but sometimes you have to go with trial and error.

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Response to DeminPennswoods (Reply #11)

Sun Aug 23, 2020, 07:38 PM

13. Are YOU volunteering?

 


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Response to Cartaphelius (Reply #13)

Sun Aug 23, 2020, 09:17 PM

14. If I was

hospitalized with SARS2, would I want to give it a try? Heck, yeah. It's plasma with antibodies. The side effects appear limited to mild flu-like symptoms.

If one of my parents was in the same situation, I'd sure want it as a treatment option.

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Response to Native (Reply #1)

Sun Aug 23, 2020, 06:16 PM

8. Most of the studies have not given sufficient data

On Thursday, Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said that doctors have treated so many Covid-19 patients with convalescent plasma, it has been difficult to figure out if the treatment works.

"The problem with convalescent plasma is the great enthusiasm about it," Woodcock said in an online conversation about the latest science behind monoclonal antibody treatments and convalescent plasma. "It exceeded anyone's expectation as far as the demand."

Woodcock, who has shifted to lead therapeutic efforts under the Trump administration's Operation Warp Speed, said plasma has shown some promise in early studies, but said Thursday there is still not yet enough evidence that it works.

Her team counted 162 prospective studies and several more observational studies, but she said only six met the standard that could produce actionable results. There is no randomized clinical trial data yet, she said, but some of those trials are ongoing.

"We continue to have hints that this is an effective treatment in this particular virus," Woodcock said, adding that the NIH will initiate or boost additional trials to find out for sure, she said.

https://www.cnn.com/2020/08/23/health/covid-19-convalescent-plasma-eua-white-house/index.html

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Response to progressive nobody (Original post)

Sun Aug 23, 2020, 06:01 PM

2. Next up: take two aspirin and call someone in the morning

Oh, having you been drinking enough water?

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Response to progressive nobody (Original post)

Sun Aug 23, 2020, 06:17 PM

9. I hate the way he says plozma.

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Response to progressive nobody (Original post)

Sun Aug 23, 2020, 06:18 PM

10. Tomorrow he formally authorizes the sun to rise

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Response to progressive nobody (Original post)

Sun Aug 23, 2020, 06:36 PM

12. Hmmm, will he say "game changer"?

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