Dozens of U.S. Hospitals Poised to Defy FDA’s Directive on COVID Plasma

Kaiser Health News ^ | 09/03/2020 | By JoNel Aleccia

[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.

[madprof98]

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

[bioqubit]

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.

[airborne]

45 hospitals?

A drop in the bucket!

[newzjunkey]

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

[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.

Just more journocrapism.

[livius]

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.

[Buckeye McFrog]

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

[con-surf-ative]

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

[SauronOfMordor]

>>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.

[Mastador1]

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.

[conservatism_IS_compassion]

>>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.