Posted on 03/18/2020 2:00:17 PM PDT by Hojczyk
Most likely, the FDA is applying the same, very unhelpful, regulatory logic that led them to block deployment of new virus tests. The FDA is used to operating on their own timeline in situations where delays are either not noticed or don’t cause significant downsides. This is a different situation, and a different decision framework is required.
The WSJ briefly reports that President Trump has “considered issuing an executive order greatly expanding the use of investigational drugs against the new coronavirus, but was met with objections from Food and Drug Administration scientists who warned it could pose unneeded risks to patients[.]” The Journal report bears on our push to raise awareness of possible therapies and get some action on them. Our friend Brian Sullivan comments:
I am not sure why the FDA would object to expediting trials of drugs that have already been approved for other diseases or recognizing the legitimacy of their use as off-label options for patients whose disease is progressively worsening. The safety profile of these approved drugs is generally well understood.
Yes, these drugs have side effects that will pose some health risks to some patients – they are not suitable for every patient. But doctors make treatment decisions every day that factor in the tradeoff between a therapy’s potential side effects and its potential benefits.
In cases where patients have a very poor prognosis, doctors often prescribe drugs off-label as a last resort. That is exactly what took place in the treatment of the US’s first patient, as you posted on Power Line. Patient 1 should be very thankful the FDA wasn’t in charge of his care.
(Excerpt) Read more at powerlineblog.com ...
Bureaucrats
there are GRAS [generally recognized as safe]
drugs that work BUT this is about $$$$ and control.
“I’m from the government and I’m here to help.”
They still have the military, don’t they? Line them up and start testing. That’s what they did to me when they needed to test the Swine flu vaccine. Only flu shot I’ve ever had.
POTUS said that Thursday he will be announcing good news concerning the FDA.
“I am not sure why the FDA would object to expediting trials of drugs that have already been approved for other diseases or recognizing the legitimacy of their use as off-label options for patients whose disease is progressively worsening. The safety profile of these approved drugs is generally well understood.”
If the drugs are approved the doctors can use them what’s called off label.
The FDA clearly says they do not tell doctors how to practice medicine.
The FDA is first and foremost a safety agency that determines use of a drug is safe.
Doctors are free to use them as they wish.
Doctor could get in trouble if he used the drug off label in an unreasonable manner where ill-effects could be envisioned, e.g. too high a dose etc...
In off label use for treating the virus it is doubtful the usage would differ much from standard indicated usage.
Just shut the useless thing down.
there are GRAS [generally recognized as safe]
drugs that work BUT this is about $$$$ and control.
—
Good point.
But I see it that it’s about liability. Doctor can use any approved drug for anything he wants, and gras drugs are perfect for that, but if it’s not standard of care they open themselves up to malpractice lawsuit.
Why is it that the FDA is never held responsible for drugs it approves for use begin to have terrible side effects a few years later?
The craphouse lawyers always go after the manufacturers, but the FDA always is exempt from repercussions
Bureaucrats, indeed
Good. Hope he is cutting all of their red tape.
Field a vaccination quickly and one is hundred thousand dies, lawsuit city. . .field a vaccination at regular pace and ten out of thousand die, all heck comes down on the FDA. . .sue city.
Lawsuit threat is driving risk avoidance by pharma, and every politician - especially dems - demonize big pharma as the root of all evil but now are complaining big pharma isn’t acting quick enough.
“if it’s not standard of care they open themselves up to malpractice lawsuit”
Indeed.
Yup at Ft Bragg in 76. I didn’t know until 60 Minutes released footage of an Army unit and there we were!
I’v said for the last 40 years “KILL 98% OF ALL THE LAWYERS”, the last 2% are to be held legally and financially responsible for any lawsuit that is NOT IN THE PUBLIC INTEREST.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.