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

By Nandita Bose and Aram Roston

 

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)

 

-- © Copyright Reuters 2020-08-24

 

- Whatever you're going through, the Samaritans are here for you

- Follow Thaivisa on LINE for breaking COVID-19 updates

Vindication for Trump.  Others eat crow.

Trump got what he want by asserting pressure and FDA buckled. No longer a deep state in just 1 day. FDA under Section 564 now allow unapproved medical products to be used and possible risk to patients due to inadequate testing and studies. Meanwhile Trump got his timely political talking point in time for the RNC. Totally selfish and irresponsible and so typical of him. 

32 minutes ago, webfact said:

The deep state, or whoever, over at the FDA is making it very difficult [...]

There's the reason to not trust this.  Thanks for the warning, Donnie.

 

43 minutes ago, Tippaporn said:

Vindication for Trump.  Others eat crow.

Ahhhh noooo another example of trump intimidateing a federal agency against their better judgment that beeing said hopefully it pans out at least it’s a step up from injecting Lysol and sticking a light up were it don’t normally shine but vindication no nothing of the sort

1 hour ago, webfact said:

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,

Hmm, curious timing

 

(major sarcasm alert). 

1 hour ago, webfact said:

 

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.

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...

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?

3 hours ago, Tug said:

<snip> another example of trump intimidateing a federal agency against their better judgment <snip>

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?

4 hours ago, Tippaporn said:

Vindication for Trump.  Others eat crow.

Vindication for Trump? What about his attack on the FDA just the other day? It showed once again his giant ego and never-ending narcissism: a good vaccin becoming available soon would mean the lives of countless people will be saved, but to Trump that is apparently irrelevant, because the only thing that matters to Trump is Trump himself. His obsession with “Deep State” trying to sabotage his every move, including getting re-elected, is just insane.

9 minutes 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?

Making things up as he goes along is largely Trump’s MO, isn’t it?

8 minutes 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?

No browbeating? Have you been following Trump's comments about the FDA?

 

Also, take a gander at the tweet the FDA issued. Not exactly the usual tone for an agency that's supposed to be politically independent:

"Another Achievement in Administration’s Fight Against Pandemic" Really? People familiar with the FDA say they've never seen a press release from them like it. Especially considering that it's an emergency authorization and is not an endorsement of convalescent plasma any more than their emergency approval of hydroxychlorquine was an endorsement.

 

And there is also this:

Behind the scenes: According to two sources in the Monday meeting, Navarro had aggressively confronted FDA officials, saying, "You are all Deep State and you need to get on Trump Time." (That's the expression Navarro uses to describe the speed that he says Trump demands.)

https://www.axios.com/trump-peter-navarro-fda-deep-state-12563e41-de4a-4635-9319-ff0eca41f126.html

5 hours ago, webfact said:

It appeared that the product is safe and we're comfortable with that

 

pretty simple explanation.  out of all the bat**** crazy demands from the boy emperor, this one is the least worst.

 

there may be no proven benefits to plasma treatment, but at least it shouldn't cause any additional unnecessary deaths beyond the 175,000 from the bungled response.

 

the fda has decided to give trump this "win" to crow about, so they can get back to trying to do their job without further interference.

5 hours ago, Tippaporn said:

Vindication for Trump.  Others eat crow.

Vindication for Trump? How so? Doctors have been using this treatment for months however there have been no blind studies to show the treatment is actually effective. So, kudos to Trump who help a press conference to announce a treatment already being used which may or may not be helpful. ????

6 hours ago, Tippaporn said:

Vindication for Trump.  Others eat crow.

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 - it is not like giving someone a product that has been prepared from scratch in a factory. Plasma has to come from another person voluntarily. That person must already have had Covid-19. And it has to be certain that they have produced antibodies. And it has to be ascertained that there is nothing else in the blood product that could cause the original patient who is very ill and vulnerable any harm.

 

The FDA has not given general authorization for this use of such plasma - instead it has given authorization for EMERGENCY use of this plasma. In other words, this is the sort of risky treatment that a clinician would provide only when the patient's life is in danger and there is no other option. Since such actions are authorized for physicians, what the FDA has done is made official what many physicians are doing anyway.

 

So hardly any vindication for Trump and no non-nutricious crow dinner for anyone either.

6 hours ago, webfact said:

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,

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.   

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.

 

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 August 24, 20205 yr by Phoenix Rising

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!"

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? 

9 hours ago, Tippaporn said:

Vindication for Trump.  Others eat crow.

Vindication? He's well beyond redemption at this point much less vindication. 

 

You're digging deep for that one buddy. 

Eat crow? So you consider virus therapies a zero sum political game? 

 

Oh nevermind. Don't answer. It's a rhetorical question. 

Edited August 24, 20205 yr by RocketDog

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

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. 

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?

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!

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

Off-topic posts and replies removed.  

 

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

This isn’t new-70,000 patients have already used this-there isn’t enough plasma.

 

Astro-Z has not been communicated with-they decide-its their reputation at stake 

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