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

[progressive nobody]

Am I understanding this correctly?

[Native]

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

[DeminPennswoods]

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.

[Native]

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

[progressive nobody]

4. I'm not sure about that.

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

[DeminPennswoods]

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.

[Igel]

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.

[DeminPennswoods]

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.

[Cartaphelius]

13. Are YOU volunteering?

[DeminPennswoods]

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.

[Poiuyt]

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

[underpants]

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

Oh, having you been drinking enough water?

[dewsgirl]

9. I hate the way he says plozma.

[JDC]

10. Tomorrow he formally authorizes the sun to rise

[louis-t]

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