Trump announces Covid-19 Breakthrough!

keith99

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Trump to announce emergency authorization of convalescent plasma as ‘breakthrough’ covid-19 treatment

Plasma therapy!

As to be expected it has mixed results and is rather old, as in it was being used in China before Covid-19 ever hit the States.

But a breakthrough as Donald sees things.
I am sure we were all hoping for something more substantial. There was coincidentally a Phase 1 study of the Abcellera/Lilly anti-Covid-19 monoclonal antibody that was scheduled to end today - but that study wasn't measuring efficacy, only toxicity and PK, so that was a real long shot as far as my particular hopes were concerned.
 
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Nithavela

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Wow, he announces a treatment that's been used since april. Amazing. Good thing Dr. Trump saved us all, time to reward him at the polls.
 
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Hans Blaster

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Wow, he announces a treatment that's been used since april. Amazing. Good thing Dr. Trump saved us all, time to reward him at the polls.

I'm pretty sure that this could have been covered by an FDA press release. At least then we wouldn't be subjected to their uninformed press flack mispronouncing plasma.
 
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HannahT

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This has already been used very widely. Many people are upset that we still don’t have controlled studies showing whether it works, though there are strong indications that it does.

That is what the announcement was about. They were speaking of the study, and the FDA starts speaking about 10:39 into the video. He also continues to speak about the study at about 14.51 when reporters started to ask questions about this. So, he expands a bit there too.

They are basically asking those that have recovered from Covid to please donate plasma, because of the the studies that they have had - and other ones as well. It's an ongoing circumstance as the data continues to come in, but the FDA almost seemed giddy about the results of the studies so far.
 
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hedrick

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That is what the announcement was about. They were speaking of the study, and the FDA starts speaking about 10:39 into the video. He also continues to speak about the study at about 14.51 when reporters started to ask questions about this. So, he expands a bit there too.

They are basically asking those that have recovered from Covid to please donate plasma, because of the the studies that they have had - and other ones as well. It's an ongoing circumstance as the data continues to come in, but the FDA almost seemed giddy about the results of the studies so far.
A study at Mayo gives a pretty good indication that it's useful. But it's not a randomized, controlled study. An emergency use authorization means, by definition, that there's reason to think it's useful but not enough to give it full authorization. This isn't new. 70,000 people have already been treated. The new authorization simplifies the process of getting access to it. It's useful, but not breakthrough, in the sense of something that hasn't been known or used before.
 
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HannahT

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A study at Mayo gives a pretty good indication that it's useful. But it's not a randomized, controlled study. An emergency use authorization means, by definition, that there's reason to think it's useful but not enough to give it full authorization. This isn't new. 70,000 people have already been treated. The new authorization simplifies the process of getting access to it. It's useful, but not breakthrough, in the sense of something that hasn't been known or used before.

I have known three people that have passed (last funeral this week), and I'm hoping the press gets the word out that they are looking for plasma volunteers. No doubt the families in to those studies that had their member saved by plasma are thankful. Anything to bring the numbers down.

Hopefully the contempt for the President doesn't effect that, because we all need to be above that. Their minimization of it could costs lives.
 
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Hans Blaster

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I have known three people that have passed (last funeral this week), and I'm hoping the press gets the word out that they are looking for plasma volunteers. No doubt the families in to those studies that had their member saved by plasma are thankful. Anything to bring the numbers down.

Hopefully the contempt for the President doesn't effect that, because we all need to be above that. Their minimization of it could costs lives.

Something like 70,000 people have already been treated with convalescent plasma for COVID under an emergency use permit. I'm not even completely sure what tonight. Was it an extension or renewal? There was a new study showing 35% improvement in survival for a subset of recipients, but it wasn't a proper double-blind study.
 
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ZNP

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This has already been used very widely. Many people are upset that we still don’t have controlled studies showing whether it works, though there are strong indications that it does.
We have a long history of giving patients plasma, so the risk of this causing harm is virtually nil. Although we haven't done extensive testing the early indications are that this could reduce mortality by 35%. The only plausible complaint about rolling this out now is that it will be hard for researchers to complete double blind studies.
 
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HannahT

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Something like 70,000 people have already been treated with convalescent plasma for COVID under an emergency use permit. I'm not even completely sure what tonight. Was it an extension or renewal? There was a new study showing 35% improvement in survival for a subset of recipients, but it wasn't a proper double-blind study.

I'm not sure what you point is.

We have heard for quite a while that we need FDA approved treatments, etc to help fight the virus. So, they worked with the Mayo Clinic to do this study to make sure they saw hope and effectiveness to help those that are sick. They received a very good response medically from a new type of virus that may save thousands or hundreds of thousands of lifes.

Now they are encouraging the media to put out the call to American Citizens to please donate plasma to help others from those that are covid survivors. It's needed to save lives.

My hope is that the media will follow through, and put out the call from the FDA to increase the amount of plasma that could help others. My hope is also that they don't delay due to politics. We must try to help save as many citizens as possible with any means we can safely come up with.
 
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sesquiterpene

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I'm not sure what you point is.

We have heard for quite a while that we need FDA approved treatments, etc to help fight the virus.
What is needed are effective treatments, not just FDA approval. Yet even after treating ~100,000 patients, we still don't know whether it works or how effective it is, because the Mayo study wasn't a controlled prospective study. I am continually disappointed in our medical establishments unwillingness to conduct proper clinical trials. This treatment looks so good in theory, but we really need to demonstrate it.

Instead we have the FDA caving in to political pressure, making it nigh impossible to conduct the necessary studies in the USA. The world will have to look elsewhere for leadership on this issue.
 
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ZNP

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What is needed are effective treatments, not just FDA approval. Yet even after treating ~100,000 patients, we still don't know whether it works or how effective it is, because the Mayo study wasn't a controlled prospective study. I am continually disappointed in our medical establishments unwillingness to conduct proper clinical trials. This treatment looks so good in theory, but we really need to demonstrate it.

Instead we have the FDA caving in to political pressure, making it nigh impossible to conduct the necessary studies in the USA. The world will have to look elsewhere for leadership on this issue.
It is a very tough decision. You have a very safe treatment, so the risk of causing harm is essentially nil. You have compelling evidence that this is an effective treatment and perhaps even a very effective treatment.

If you hold off while you complete a double blind study people will die, perhaps thousands, and there is little or no justification for that. Instead I think you can continue with a double blind study in a third world country that has no therapies. People would jump at getting free treatment, even if it means you only get a 50/50 chance of actually getting the plasma.
 
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sesquiterpene

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It is a very tough decision. You have a very safe treatment, so the risk of causing harm is essentially nil.
You really can't just assume that - it's not like we haven't had thousands of deaths due to contaminated blood products. Even though we can test for HIV and Hep C now, it doesn't make the procedure risk free. That is part of the reason to do prospective studies, to show that the benefits outweigh the risks.
If you hold off while you complete a double blind study people will die, perhaps thousands, and there is little or no justification for is that.
Part of the reason I'm irked at this is that we should already have this data. A tiny percentage of the 100,000 already treated -perhaps 2000 to 4000 -is all that would be needed for controlled studies. They should wait until the enrollment is complete, and concurrently treat the compassionate use patients. I just don't see that it is ethical to do otherwise.

This is similar to the retrospective study of HQC published by Henry Ford Hospital in Detroit a few weeks ago. An accompanying article by the editors chastised the authors, saying essentially "you had the resources to do a proper study, but chose not to. Why?"
 
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ZNP

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You really can't just assume that - it's not like we haven't had thousands of deaths due to contaminated blood products. Even though we can test for HIV and Hep C now, it doesn't make the procedure risk free. That is part of the reason to do prospective studies, to show that the benefits outweigh the risks.
Yes you can say this because doctors have been giving plasma to patients for years. There are risks with taking tylenol, but it has been used for years, been tested, and we understand what the risks are and how to mitigate them.

Part of the reason I'm irked at this is that we should already have this data. A tiny percentage of the 100,000 already treated -perhaps 2000 to 4000 -is all that would be needed for controlled studies. They should wait until the enrollment is complete, and concurrently treat the compassionate use patients. I just don't see that it is ethical to do otherwise.
Since there are really no valid risks to the procedure it is unethical to not do this. I think if you were in the ICU being put on a ventilator you might have a different opinion.
 
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ZNP

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I am wondering if there is anyone who has a "pro Trump" post they can point us to that feels this is a bad decision.

Likewise, is there a person with a very clear "anti Trump" post they have made that they can point us to that feels this is a good decision?
 
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hedrick

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Hahn has acknowledged that the 35% number was described in a way that could be misleading. There’s no evidence that plasma would save 35% of the patients. In fact it might have reduced the mortality rate about 35%: So in one case from 12% to 9%. It’s hard to know whether anyone was misled. What he said wasn’t wrong. But it is worth clarifying. F.D.A. ‘Grossly Misrepresented’ Blood Plasma Data, Scientists Say
 
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