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Dozens of U.S. Hospitals Poised to Defy FDAs Directive on COVID Plasma
Kaiser Health News ^ | 09/03/2020 | By JoNel Aleccia

Posted on 09/03/2020 7:49:02 AM PDT by SeekAndFind

Dozens of major hospitals across the U.S. are grappling with whether to ignore a federal decision allowing broader emergency use of blood plasma from recovered COVID patients to treat the disease in favor of dedicating their resources to a gold-standard clinical trial that could help settle the science for good.

As many as 45 hospitals from coast to coast have expressed interest in collaborating on a randomized, controlled clinical trial sponsored by Vanderbilt University Medical Center, said principal investigator Dr. Todd Rice.

Officials at some hospitals said they are considering committing only to the clinical trial — and either avoiding or minimizing use of convalescent plasma through an emergency use authorization issued Aug. 23 by the federal Food and Drug Administration.

The response comes amid concerns that the Trump administration pressured the FDA into approving broader use of convalescent plasma, which already has been administered to more than 77,000 COVID patients in the U.S. President Donald Trump characterized the treatment as a “powerful therapy,” even as government scientists called for more evidence that COVID plasma is beneficial.

A National Institutes of Health panel this week countered the FDA’s decision, saying that the therapy “should not be considered the standard of care for the treatment of patients with COVID-19” and that well-designed trials are needed to determine whether the therapy is helpful. Data so far suggests the treatment could be beneficial, but it’s not definitive.

“It’s an important scientific question that we don’t have the answer to yet,” said Rice, an associate professor of medicine and director of VUMC’s medical intensive care unit.

(Excerpt) Read more at khn.org ...


TOPICS: Culture/Society; Government; News/Current Events
KEYWORDS: covid19; fda; hospitals; plasma

1 posted on 09/03/2020 7:49:02 AM PDT by SeekAndFind
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To: SeekAndFind

I am so glad we have “experts” to make sure people die who might otherwise live. Democrats are so wonderful!


2 posted on 09/03/2020 7:53:25 AM PDT by madprof98
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To: SeekAndFind

Thank God there are professionals who recognize that the FDA has reached such a pitch of being politicized that they become a risk to public safety.

Pressure washing will be needed to clean up the shit that infests the FDA/CDC, starting at the top.


3 posted on 09/03/2020 7:55:53 AM PDT by bioqubit (bioqubit: Educated Men Make Terrible Slaves - Aristotle)
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To: SeekAndFind

45 hospitals?

A drop in the bucket!


4 posted on 09/03/2020 7:56:35 AM PDT by airborne (I don't always scream at the TV but when I do it's hockey season!)
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To: SeekAndFind

That’s the whole point of emergency use authorization. They’re not required to use it but it’s there as an option.


5 posted on 09/03/2020 8:04:05 AM PDT by newzjunkey (Vote Giant Meteor in 2020)
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To: SeekAndFind
Splain how a hospital can 'defy' a ruling from the FDA that allows, 'allows' the use of a procedure, not directs that they 'must use' but simply allows the use. Sounds to me like that ruling simply gave the hospitals greater latitude in the the tools available to them.

Just more journocrapism.

6 posted on 09/03/2020 8:11:09 AM PDT by Mastador1
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To: bioqubit

The FDA has actually approved the plasma therapy (the article says because of “pressure from Trump”) and the NIH and some hospitals, for purely political reasons, are considering rejecting the therapy and refusing to use it.

Utterly bizarre, and something that makes it very obvious that they have never wanted a treatment or a cure, because their whole goal is to keep this going forever to handicap Trump.


7 posted on 09/03/2020 8:11:13 AM PDT by livius
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To: madprof98

We’re learning that our entire medical system is just a mess. We need to fire nearly everyone in charge and start over.


8 posted on 09/03/2020 8:16:04 AM PDT by Buckeye McFrog (Patrick Henry would have been an anti-vaxxer.)
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To: Mastador1

Exactly. There is nothing that requires use of plasma treatment. The media is so desperately trying to spin this as part of the “resistance.”


9 posted on 09/03/2020 8:18:58 AM PDT by con-surf-ative
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To: Mastador1

>>Splain how a hospital can ‘defy’ a ruling from the FDA that allows, ‘allows’ the use of a procedure, not directs that they ‘must use’ but simply allows the use. Sounds to me like that ruling simply gave the hospitals greater latitude in the the tools available to them.<<

By prohibiting doctors at the hospital from using that procedure on patients.


10 posted on 09/03/2020 8:19:28 AM PDT by SauronOfMordor (A Leftist can't enjoy life unless they are controlling, hurting, or destroying others)
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To: SauronOfMordor

Again, the ruling doesn’t mandate the hospitals use the procedure so by not using it or making it available they are not defying the FDA the FDA’s ruling. I will agree that by not making the procedure available to patients they are putting some patients at risk.


11 posted on 09/03/2020 8:23:53 AM PDT by Mastador1
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To: SauronOfMordor; Mastador1
>>Splain how a hospital can ‘defy’ a ruling from the FDA that allows, ‘allows’ the use of a procedure, not directs that they ‘must use’ but simply allows the use. Sounds to me like that ruling simply gave the hospitals greater latitude in the the tools available to them.<< Mastador1
By prohibiting doctors at the hospital from using that procedure on patients
. . . thereby defeating the patient’s “right to try?”

My understanding is that setting up the patient’s “right to try” is all that the announced change actually did.


12 posted on 09/03/2020 6:10:40 PM PDT by conservatism_IS_compassion (Socialism is cynicism directed towards society and - correspondingly - naivete towards government.)
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