I think people are getting hung up on the meaning of "approval".
In the US, doctors have the ability to prescribe a drug for off-label use, if they believe it is safe for the patient and effective for the intended purpose.
What the FDA is reportedly streamlining is a way to report the results, so they can incorporate it into a clinical trial and establish whether it is effective, at what dosages, etc. Another question will be: when does it not work?
I can't read the small print, and the OP didn't provide a link to the article. So, I don't know what they are complaining about.
I think they approved a widespread trial (basically any doctor can prescribe and say they are part of the trial) to facilitate more rapid assessment. If I understood correctly, it's not "approved" yet but and doctor can prescribe it, and if all the results are good it will be approved sooner.
Doctors can prescribe it for “compassionate use” but that requires requesting permission from the FDA and then tracking results and reporting them to the FDA. The FDA hopes that this will allow them to collect more data.
The medication has not received general FDA approval and clinical trials are ongoing. Those require control arms where some people get placebo.
The FDA is by its nature extremely careful about “approving” things.
Nothing wrong with caution because there have not been large scale studies on effectiveness against COVID19, and large, controlled studies are needed before the FDA can endorse it. But these are common, well-studied, and cheap drugs that MDs can prescribe off-label regardless of FDA's endorsement.
I dunno about that. The drug only shortens a 20 day infection to 4 days. The vaccine is for people who haven't gotten it at all yet. Still plenty of money to be made with the vaccine.
If I'm not mistaken the FDA approved this drug today. How are they obstructing?
I think people are getting hung up on the meaning of "approval".
In the US, doctors have the ability to prescribe a drug for off-label use, if they believe it is safe for the patient and effective for the intended purpose.
What the FDA is reportedly streamlining is a way to report the results, so they can incorporate it into a clinical trial and establish whether it is effective, at what dosages, etc. Another question will be: when does it not work?
I can't read the small print, and the OP didn't provide a link to the article. So, I don't know what they are complaining about.
I thought they approved its use? Wasn’t that what was said this morning?
I think they approved a widespread trial (basically any doctor can prescribe and say they are part of the trial) to facilitate more rapid assessment. If I understood correctly, it's not "approved" yet but and doctor can prescribe it, and if all the results are good it will be approved sooner.
Doctors can prescribe it for “compassionate use” but that requires requesting permission from the FDA and then tracking results and reporting them to the FDA. The FDA hopes that this will allow them to collect more data.
The medication has not received general FDA approval and clinical trials are ongoing. Those require control arms where some people get placebo.
The FDA is by its nature extremely careful about “approving” things.
plz provide a link to the (archived) article.
There's also something funky going on. In France, Hydroxychloroquine was an over the counter drug. But they issued an order to make it prescription only on January 15th, just as the virus was spreading there.
I don't believe in coincidence.
People are absolutely able to read the literature and accept the risks of the unwanted side effects and consent to these risks before taking it
These are drugs that are decades old. THeir side effects ARE KNOWN
THere is no G D reason why the FDA should not approve this drug for COVID19, because it's already being used and very successfully
ALSO, this map shows that it works on a societal scale
https://thedonald.win/p/FMADg2ap/malaria-vs-covid19-world-map---c/c/
Nothing wrong with caution because there have not been large scale studies on effectiveness against COVID19, and large, controlled studies are needed before the FDA can endorse it. But these are common, well-studied, and cheap drugs that MDs can prescribe off-label regardless of FDA's endorsement.
I dunno about that. The drug only shortens a 20 day infection to 4 days. The vaccine is for people who haven't gotten it at all yet. Still plenty of money to be made with the vaccine.
Somebody didn't watch todays presser, where Trump claims the opposite.