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FDA Must Approve Hydroxychloroquine Now
American Thinker ^ | 03/22/2020 | Andrew Longman

Posted on 03/22/2020 8:28:02 AM PDT by SeekAndFind

[Editor's note: Lack of FDA approval does not prohibit off-label use of drugs for other threapeutic purposes, but would inhibit widespred use.]

You are being lied to about the drugs that heal COVID19.

America's FDA, and National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci, are dragging their feet on approving a drug that provides very strong positive effect on COVID19.

Fauci, speaking from the White House, said on the matter of approving Hydroxychloroquine and azithromycin:

"It's it's essentially what I said multiple times from this podium. Is that when you have, first of all, we're trying to develop de novo drugs that are not yet out there, not that approved, that ultimately will be effective. And the way you prove that is to  do a randomized controlled trial to prove safety and efficacy. Uh, I am not a totally sure what the the President was referring to, but I believe he's referring to a report that used both Hydroxychloroquine and azithromycin together uh to have some uh possibility of being an effect. Many of the things that you hear out there are are what I had called anecdotal reports. They may be true. But they’re anecdotal."

Please notice that Dr. Fauci just called the effectiveness of Hydroxychloroquine and azithromycin against COVID19 anecdotal.  That will be very important in a moment.

Fauci continued, "So the only thing that I was saying is that if you really want to definitively know if something works that you've gotta do the kind of trial that you get the good information," by which he dismissed the body of scientific work that supports the use of Hydroxychloroquine.

Fauci went on,


(Excerpt) Read more at americanthinker.com ...


TOPICS: Culture/Society; Government; News/Current Events
KEYWORDS: chinavirusdrugs; chinavirustreatment; coronavirus; covid19; fauci4hrc; faucivsamerica; faucivsamericans; fda; hydroxychloroquine
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To: Jim Noble

RE: Hydroxychloroquine is an FDA-approved drug already.

Not really. FDA’s stance is this -— Hydroxychloroquine has shown some promise against the coronavirus in a very small French study, but it is not federally approved to treat the COVID-19 because no official studies have been conducted to determine whether it’s both safe and effective for those sick patients.

SEE HERE:

https://www.modernhealthcare.com/politics-policy/trump-wrongly-claims-fda-approved-covid-19-drug

(EXCERPT)

But FDA Commissioner Dr. Stephen Hahn walked back Trump’s remarks minutes later, clarifying that the FDA will conduct a clinical trial to determine whether chloroquine is a safe and effective coronavirus treatment and at what dosage.

“That’s a drug that the president has directed us to take a closer look at,” Hahn said. “We want to do that in the setting of a clinical trial, a large pragmatic clinical trial to actually gather that information and answer the question that needs to be answered.”


61 posted on 03/22/2020 9:13:53 AM PDT by SeekAndFind (look at Michigan, it will)
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To: SeekAndFind

You do u do understand it can and is being used in this country today riight? Take a breath and go find a real issue to hyperventilate about


62 posted on 03/22/2020 9:14:20 AM PDT by Mom MD
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To: freeandfreezing

Here’s a link to the Hydroxychloroquine dosage for diseases:

https://www.drugs.com/dosage/hydroxychloroquine.html

Please look at it; no need to read it in detail. All those protocols and warnings are developed from extensive scientific studies, not from one or two limited trials.

Please understand there is absolutely no government restriction on using hydroxychloroquine right now to help people who need it. It is already defined for usage on an empirical basis in a number of hospitals for treating coronavirus patients.


63 posted on 03/22/2020 9:14:25 AM PDT by budj (Combat vet, 2nd of three generations.)
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To: freeandfreezing
Every MD and DO in the USA has the ability to prescribe drugs for off label use.

True, but the health insurance companies will only pay for FDA approved protocols. Thusly, the doctor can prescribe an off label drug use, but the patient ends up paying a multi thousand dollar bill.

64 posted on 03/22/2020 9:14:57 AM PDT by Thommas
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To: Mom MD
until there are clinical trials it is anecdotal. You do understand the definition of anecdotal? That doesn’t mean it doesn’t work

There are clinical trials, with published results from researchers in other countries. That is the reason people are pushing back on Fauci's comment which was seized upon and repeated by the anti-Trump press.

Here is one example.

It is not the only one.

65 posted on 03/22/2020 9:15:05 AM PDT by freeandfreezing
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To: JD_UTDallas

HYDROXYCHLOROQUINE IS FDA APPROVED AND HAS BEEN FOR YEARS.

What it’s NOT is “indicated as safe and effective” for treatment of SARS-CoV-2 infection. This process is defined by statute, it has nothing to do with Trump, or Fauci, or the commissioner.

If Congress changes the law, then an additional FDA indication for SARS-CoV-2 can be granted sooner. If they don’t, it can’t.


66 posted on 03/22/2020 9:15:17 AM PDT by Jim Noble (There is nothing racist in stating plainly what most people already know)
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To: E. Pluribus Unum

WHO CARES WHAT THE FDA SAYS.....ANY DOCTOR WITH HIS PATIENTS INTEREST WOULD PRESCRIBE MALARIAL DRUGS TO COMBAT COVID19 INSTEAD OF WAITING FOR A YEARS TESTING.


67 posted on 03/22/2020 9:15:38 AM PDT by chopperk
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To: MrEdd

And once approved, the marker will soar.


68 posted on 03/22/2020 9:15:56 AM PDT by DownInFlames (Galsd)
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To: SeekAndFind

There is much in print.
However Faci walked it back at the last press conference & said he was sorry his words had been interpreted that way. Millions of does are on the way to NY. Why would that be if they were not going to be used.


69 posted on 03/22/2020 9:16:16 AM PDT by JayGalt (You can't teach a donkey how to tap dance. Nemo me impune lacessit!)
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To: SeekAndFind

Any doctor can prescribe this whenever they want.

Insurance is not going to pay for it. And he could loose his DEA creds for misuse..but I guess they could leave them on the desk and walk away.


70 posted on 03/22/2020 9:17:02 AM PDT by Vermont Lt
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To: freeandfreezing

There are no large scale randomized clinical trials. there may never be because you can or withhold a likely effective drug from people who are ill. I hope to see some trials with multiple drugs against each other so we can eventually determine which regimen is most effective but the goood news is we have multiple drugs that appear to be useful


71 posted on 03/22/2020 9:19:32 AM PDT by Mom MD
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To: freeandfreezing

That doesn’t meet the criteria for FDA approval in the US.

If a doctor prescribes this they could loose their license, be subject to malpractice, and be unable to help others.

If a hospital allows it they become subject to the lawsuit, their pharmacy and DEA creds are subject to penalty.

Unless they repeal malpractice law, no one is going to do this unless the dead are literally piling up.


72 posted on 03/22/2020 9:19:51 AM PDT by Vermont Lt
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To: budj
I have already read the entire drug profile. Many of the reported interactions, side effects, and risk factors were determined based on the original studies and reports of adverse events to the FDA over time.

Studying drug usefulness for a new infectious agent is a good idea, but once you have a drug which has been FDA approved, as you note there is no reason not to use it against a new infectious agent. That is doubly so once you have some clinical test results showing it is effective in treating the new infectious agent.

73 posted on 03/22/2020 9:19:53 AM PDT by freeandfreezing
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To: SeekAndFind

New York will start implementing the trial drugs to treat Coronavirus.

NY has acquired:
- 70,000 Hydroxychloroquine
- 10,000 Zithromax
- 750,000 Chloroquine

From the Federal Government.

Trials will start Tuesday.

https://twitter.com/bennyjohnson/status/1241749428492537864

Who needs FDA approval? Not the WH now. Rules have been changed


74 posted on 03/22/2020 9:21:16 AM PDT by Pollard (If you don't understand what I typed, you haven't read the classics.)
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To: tflabo
I’ll sign the waivers should it not work out.

No waivers are necessary for prescription of a drug "off label", as long as it is consistent with good practice.

For example: I am treating a COVID-19 patient with hydroxychloroquine today. This requires no consents, no waivers, it is certainly is good medical practice - the FDA process played no role in my thinking, none at all.

If I used hydroxychloroquine to treat migraines, for which there is no evidence, and there was a problem with a side effect, I would be in deep doodoo even IF the patient signed a waiver - because it's long established law that you can't waive your right to proper treatment and you can't consent to malpractice.

75 posted on 03/22/2020 9:21:48 AM PDT by Jim Noble (There is nothing racist in stating plainly what most people already know)
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To: Buckeye McFrog

> The protocol would be to give it to anyone in the hospital in life threatening condition (since most of us apparently recover on our own). Addresses the immediate problem of outstripping hospital resources.

Yes, but i am only getting an e-visit kickout when i attempt to ask about the existing protocol via the e-visit and that does not allay my fears of hoarding at the hospital and elsewhere.


76 posted on 03/22/2020 9:21:50 AM PDT by SteveH (intentionally blank)
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To: Vermont Lt
Sorry, but you are misinformed. Doctors in the USA prescribe medications every day which don't have FDA approval for a particular use, but are FDA approved in general.

Suggesting that a doctor who prescribes a drug off label is subject to the kind of risks you describe is just wrong, particularly when the off label use has support from other clinicians and from research tests.

77 posted on 03/22/2020 9:22:10 AM PDT by freeandfreezing
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To: willk
Doctors are already allowed to use this for Wuhan Virus patients here in the US. Am I correct?

100% correct. I am using it today for this.

78 posted on 03/22/2020 9:23:07 AM PDT by Jim Noble (There is nothing racist in stating plainly what most people already know)
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To: Vermont Lt

Hydroxychloroquine is being used off label now widely in this country. Try again. Remdesivir which is. it approved is also being used u dear compassionate use. No one is being denied drugs. We are looking for the best ways to use them


79 posted on 03/22/2020 9:24:08 AM PDT by Mom MD
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To: Mom MD

You do understand the definition of anecdotal?

************

No need to be condescending or patronizing. I understand the meaning of the term.

Because Fauci doesn’t think there have been enough clinical trials it doesn’t necessarily mean that there is no data. Its just not enough to satisfy his testing protocols.


80 posted on 03/22/2020 9:25:46 AM PDT by Starboard (has so far)
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