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Trump hails FDA's authorization of plasma treatment for coronavirus, after slamming agency


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Trump hails FDA's authorization of plasma treatment for coronavirus, after slamming agency

By Nandita Bose and Aram Roston

 

2020-08-24T023105Z_1_LYNXMPEG7N051_RTROPTP_4_HEALTH-CORONAVIRUS-USA-TRUMP.JPG

U.S. President Donald Trump gestures towards media members, who raise their hands to ask questions, during a news conference about the latest coronavirus disease (COVID-19) developments, in the Brady Press Briefing Room of the White House in Washington, U.S. August 23, 2020. REUTERS/Erin Scott

 

(Reuters) - President Donald Trump on Sunday hailed FDA authorization of a coronavirus treatment that uses blood plasma from recovered patients, a day after accusing the agency of impeding the rollout of vaccines and therapeutics for political reasons.

 

The U.S. Food & Drug Administration (FDA) announcement of its "emergency use authorization" of the treatment came on the eve of the Republican National Convention, where Trump will be nominated to lead his party for four more years.

 

"This is what I've been looking to do for a long time," Trump told an unusually brief White House news conference. "Today I'm pleased to make a truly historic announcement in our battle against the China virus that will save countless lives."

 

The FDA, explaining its decision, cited early evidence suggesting blood plasma can decrease mortality and improve the health of patients when administered in the first three days of their hospitalization.

 

The agency also said it determined this was a safe approach in an analysis of 20,000 patients who received the treatment. So far, 70,000 patients have been treated using blood plasma, the FDA said.

 

"It appeared that the product is safe and we're comfortable with that and we continue to see no concerning safety signals," Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, told reporters in a conference call.

 

A day before the FDA's announcement, Trump tagged the agency's Commissioner Stephen Hahn in a Twitter post in which he said, "The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics." "Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!"

 

Trump is looking to boost his lagging poll numbers during the Republican convention this week, and progress in treatments or an effective vaccine to gain control of the virus would aid his re-election chances.

 

At least 5,686,377 cases of COVID-19 have been reported in the United States, according to a Reuters tally, and more than 176,000 Americans have died.

 

Michael Steele, who served as chairman of the Republican National Committee from 2009 to 2011, said the Trump administration was putting politics ahead of science.

 

"This is not about good science or even your health, it’s about his re-election," Steele wrote on Twitter.

 

Plasma is the element of blood that carries water, enzymes and blood cells throughout the body. It also carries the antibodies humans form to fight off disease and boost immunity.

 

COVID-19 patients have been receiving convalescent plasma for several months through clinical trials at medical centers such as New York's Mount Sinai Hospital and Johns Hopkins.

 

Supplies of plasma are limited because they require that a recovered COVID-19 patient donate blood and that it matches the blood type of the recipient.

 

Reuters reported that COVID-19 plasma supplies are dwindling, with the American Red Cross saying its stockpile of plasma for COVID-19 patients declined 70% in July.

 

U.S. regulators provided emergency authorization for Gilead Science Inc's remdesivir as a therapeutic treatment for COVID-19 earlier this year. Reuters reported that a senior administration official said therapeutic drugs that are being studied specifically for COVID-19 could be authorized for use and making doses by fall.

 

The White House declined to comment on a separate report in the Financial Times that the administration is considering fast-tracking an experimental COVID-19 vaccine being developed by AstraZeneca Plc and Oxford University for use in the United States ahead of the Nov. 3 elections.

 

One option being explored would involve the FDA awarding emergency use authorization in October to the potential vaccine, which was developed by Oxford and licensed to AstraZeneca, the FT reported https://www.ft.com/content/b053f55b-2a8b-436c-8154-0e93dcdb3c1a, citing people briefed on the plan.

 

A spokeswoman for AstraZeneca denied the company had discussed an emergency use authorization for its potential vaccine with the U.S. government and said it would be premature to speculate on that possibility.

 

The company said the late-stage Phase 2 and Phase 3 trials for its vaccine candidate are still ongoing in Britain and other markets globally and that it did not anticipate efficacy results until later this year.

 

There are no approved vaccines for COVID-19, but AstraZeneca's shot, called AZD1222, is widely seen as one of the leading candidates.

 

(Reporting by Nandita Bose in Washington, Carl O'Donnell in New York, and Shubham Kalia and Bhargav Acharya in Bengaluru; Writing by Phil Stewart and David Lawder; Editing by Chizu Nomiyama, Daniel Wallis and Diane Craft)

 

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-- © Copyright Reuters 2020-08-24
 
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They're using this 100+ years old method all around the world already.

 

Why is there so much red tape in the US that it needs some kind of presidential intervention to use a 100 year old treatment?

 

They used to use horses to create 'serums' towards the end of the 1800's just before this method was used.

 

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38 minutes ago, Proboscis said:

As someone who knows something about this, there is no vindication for Trump. Plasma therapy has been around for a long time for a variety of diseases that lack a medication and a vaccine. But the situation is complex......

And it's at this point where the trump base tunes out.

Edited by Phoenix Rising
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1 hour ago, Tippaporn said:

Axios, LOL.  "According to two sources . . . "  LOL.  And you believe it as gospel without question?  It does fit your narrative.  Seems rather convenient.

 

Covid had been politicized almost immediately and continues to be politicized.  There are those working for a therapeutic and those against.  What more do you need to know?

What has been reported in the article is completely coherent with Trump's tweet:

 

"The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics," the president tweeted. "Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!"

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8 hours ago, webfact said:

This is what I've been looking to do for a long time," Trump told an unusually brief White House news conference. "Today I'm pleased to make a truly historic announcement in our battle against the China virus that will save countless lives."

Truly historic? 

Truly? 

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1 hour ago, ukrules said:

They're using this 100+ years old method all around the world already.

 

Why is there so much red tape in the US that it needs some kind of presidential intervention to use a 100 year old treatment?

 

They used to use horses to create 'serums' towards the end of the 1800's just before this method was used.

 


Yes, I find some of the rationale on this thread bewildering. Trump didn't discover plasma but he has been championing it's effectiveness, including his support in July behind a CSL study in Australia. Red tape would seem to be an issue in the US and FDA has come around after Trump hassled them about delays. What's the problem guys?

I'm no fan of Trump, but surely he's entitled to rattle the chain to move things along. Here's recent trial data... https://www.theaustralian.com.au/business/the-wall-street-journal/convalescent-plasma-reduced-death-rate-among-covid19-patients-study-signals/news-story/8da3e70261a2eabd88cca042f49cce4b

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2 hours ago, Eric Loh said:

Most countries like the EMA (EU) or the NMPA (China) will only grant emergency use authorization for terminally cases. This is unprecedented by FDA headed by a Trump appointee. They are taking a big risk to please Trump without going through the proper due process. Trump has once again destroyed the reputation of another government agency.   

Alternatively they have destroyed their own credibility by caving in to his lunacy. Just like the GOP and CDC. 

Truly credible and self-respecting people have left his sway already or are doing so almost daily. 

 

The lines are being drawn more clearly every day as his desperation exacerbates his insanity. He sounds more unhinged every time he opens his mouth. Even his supporters cringe when he does. 

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11 minutes ago, Donga said:


Yes, I find some of the rationale on this thread bewildering. Trump didn't discover plasma but he has been championing it's effectiveness, including his support in July behind a CSL study in Australia. Red tape would seem to be an issue in the US and FDA has come around after Trump hassled them about delays. What's the problem guys?

I'm no fan of Trump, but surely he's entitled to rattle the chain to move things along. Here's recent trial data... https://www.theaustralian.com.au/business/the-wall-street-journal/convalescent-plasma-reduced-death-rate-among-covid19-patients-study-signals/news-story/8da3e70261a2eabd88cca042f49cce4b

Because he understands the scientific issues surrounding questions of its efficacy?

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10 hours ago, webfact said:

"This is what I've been looking to do for a long time," Trump told an unusually brief White House news conference. "Today I'm pleased to make a truly historic announcement in our battle against the China virus that will save countless lives."

Lie 01: looking to do for a long time (it just sprung to mind)
Lie 02: I'm pleased (he doesn't care at all)
Lie 03: truly historic announcement (nothing historic, nobody will remember in 2 days)
Lie 04: China virus (it is called Covid-19 or Corona virus)
Lie 05: save countless lives (hopefully a few)

 

I get so tired of his endless never-ending lies... Hopefully america comes to its senses before election time!

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9 hours ago, Bluespunk said:

Hardly the most ringing endorsement, however if it helps then that is a good step forward.

 

Well done those medical researchers and practitioners who have helped develop this treatment.
 

Such a shame that your achievement was not recognised in trumps announcement...

It is not a new treatment But an old practice, and from what I learned this morning, they have already used it world wide, and only in us around 70 000 patients got this treatment already

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6 hours ago, Pedrogaz said:

Could you imagine living in a country where an unqualified man with no medical or scientific background and is widely regarded as insane, makes medical policy for the nation? Why doesn't he just shut up and leave it to the scientists?

 

"Why doesn't he just shut up and leave it to the scientists?"

 

Because

 

Everything Trump says he knows "more about than anybody"

https://www.axios.com/everything-trump-says-he-knows-more-about-than-anybody-b278b592-cff0-47dc-a75f-5767f42bcf1e.html?te=1&nl=frank-bruni&emc=edit_fb_20200311

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13 hours ago, Tippaporn said:

I reread the article several times and still could not find where it accused Trump of browbeating the FDA against their better judgment.  You're not making that up, are you Tug?

Oh gosh no just look at any reputable msn source not hoax news(Fox) britebart infowars ect ect you know the ones that face consequences when they get it wrong

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