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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: dp0622

“Bro that’s so weak you should be embarrassed.”

just as weak as the bullshit about Dr. Fauci’s emails to hillary ...


101 posted on 03/22/2020 10:36:56 AM PDT by catnipman (Cat Nipman: Vote Republican in 2012 and only be called racist one more time!)
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To: SeekAndFind

There are those that like Dr Fauci. I don’t. Dragging his feet on approval of a known cure that is inexpensive. Poland has approved it for treatment of corona as have other governments. Appears Fauci in the hip pocket of big pharma pushing for a new and expensive drug.


102 posted on 03/22/2020 10:47:17 AM PDT by Chauncey Gardiner
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To: tflabo

He’s a scientist AND a BUREAUCRAT. Judging by his performance during the H1N1 (during the OBAMA administration), I believe he’s doing his best to DELAY this treatment.

Flame me, but that’s what I believe.


103 posted on 03/22/2020 10:52:19 AM PDT by Peter W. Kessler ("NUTS!!!")
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To: SeekAndFind
> anecdotal

Can anyone point me to a double blind, controlled study proving 'social distancing' and 'lockdowns' work on any epidemic? There's lab science and historically somewhat controlled data for them—as there is for antimalarials here—but nothing that meets the FDA's standard. Heck, have there even been rudimentary safety or dosing trials on them?

104 posted on 03/22/2020 11:01:08 AM PDT by JohnBovenmyer (waiting for the tweets to hatch)
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To: SeekAndFind

its called big pharma money.....


105 posted on 03/22/2020 11:02:04 AM PDT by cherry
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To: DoodleDawg

It was tested on people in France, currently being used on people in New York and officially recommended by the National health officials of South Korea after its successful use there.


106 posted on 03/22/2020 11:22:52 AM PDT by CMAC51
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To: SeekAndFind

This drug may not be a “cure”. But if it helps those infected recover.
release the drug for widespread use. Fauci should resign or be fired.
This Hillary butt licker wants the virus to get worse to hurt Trumps chances
of winning re-election.


107 posted on 03/22/2020 11:26:56 AM PDT by tennmountainman (eThe Liberals Are Baby Killers)
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To: SeekAndFind

I think President needs to tell Fauci “You’re outta here”


108 posted on 03/22/2020 12:20:45 PM PDT by Kaslin
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To: JD_UTDallas
Even if they work no drug is 100% we still need a vaccine to break the chains of infection these drugs only treat people who are sick enough to seek out hospital care. There’s not enough supply to treat tens of millions of people which would be the case if we let everyone back into circulation again. This bug is at least twice as contagious as flu and flu infects tens of millions in a season. There’s simply not enough doses available and since the drugs likely take precursor chemicals from China the hope of ramping up what production we have stateside is probably slim.

How many millions in malaria prone countries take them prophylactically, at one dose a week? I suspect more collectively than there are millions in America. There existed global production enough for that. It likely can be increased. Articles keep saying the stuff is not hard to make. Trump needs to determine what can be done to maximize production. If raw materials are the limit, figure out who and how can make more of them. If plant capacity of existing manufacturers is a limit get them to license additional manufacturers to make it. Heck, Trump already has Detroit making ventilators and Hanes make face masks. If approval or inspection by our government is the limit inform the paper pushers they are on a wartime footing and appoint someone like Gen. Groves to drive them. Look globally. Maybe Brazil or Nigeria have excess capacity. Draft swamp FDA grunts to supervise there. If most of our meds were already coming from China or India we shouldn't complain about additional third world sources of old, simple drugs in an emergency.

Seems that the bureaucracy didn't act on the early clues and start goosing production a month or more ago. They waited for Trump to notice the need. There are anecdotal reports of antimalarial shortages, which isn't surprising with a sudden surge in demand. Some have reached the formal drug shortage reports:

ashp chloroquine shortage page
ashp hydroxychloroquine shortage page
FDA chloroquine shortage page - interestingly lists 3/25/20 as shortage end
FDA chloroquine shortage page - drug isn't listed as a shortage there currently

Millions of doses have been promised so far and will be entering the pipeline within the next couple weeks, likely enough for those needing hospital care. Treating people who've been exposed, or who are at high risk for complications, or even treating all healthy folks who want to take it prophylactically and lack contraindications would take significantly more drug and raise more questions. While awaiting the drug surge to arrive we should spend a small portion of our current supplies on trials to determine whether prophylaxis works and, if so at how low a dose. We have some useful safety precedents on a range of dosing. A dose a week, as for malaria prophylaxis, is safe enough for chronic OTC treatment of most people in many countries. If we were facing a malaria pandemic instead of the covid one people would want to do that. Daily doses are used here for RA and lupus long term. That experience suggests most folks would tolerate such for a couple months without much trouble. How much drug it takes and just how much you can get in time may limit our options.

109 posted on 03/22/2020 12:30:39 PM PDT by JohnBovenmyer (waiting for the tweets to hatch)
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To: JD_UTDallas

For hydroxychloroquine BY ITSELF, we already know all those answers from its use as an antimalarial drug, including its long-term use as a malarial prophylaxis.

What we need more extensive study on is the use of COMBINATIONS of hydroxychloroquine with azithromycin...but any use of that (and other) combinations will only be done on the very sickest of patients and under strict physician supervision.

What we have NO DATA on is the use of hydroxychloroquine ALONE as a preventative/prophylaxis agent. THAT requires giving the drug to “non-sick” but “at risk” people and seeing if they “get the virus”.

IMO, if anyone tests positive for COV19 they should be given hydroxychloroquine ALONE at the “malarial safe dose”, even if not displaying symptoms, and testing them for viral load.


110 posted on 03/22/2020 12:53:20 PM PDT by Wonder Warthog (The Hog of Steel and NRA Life Member)
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To: freeandfreezing

It is neither twisted nor incorrect.

We are beset ever evening with lawyers trolling for people to come forward to make claims for the money awarded but is unclaimed for judgements by judges against manufacturers

They can and will make lawyerly claims for the protection
of the public. The disgraceful action against Round UP and the 3M ear plugs are are glaring examples of the practice at it’s worst. The congress was used to allow action against 3M for future face mask claims but the Republicans beat back the effort.

The lawyers cling together refusing to take action against their brothers in the law

America is a tyranny of lawyers


111 posted on 03/22/2020 1:08:17 PM PDT by bert ( (KE. NP. N.C. +12) Progressives are existential American enemies)
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To: Mom MD

until there are clinical trials it is anecdotal. You do understand the definition of anecdotal?

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

Actually I think you were lured into accepting Dr. Fauci’s definition of ‘anectodal’. There is lots of evidence to indicate this was a misleading statement on his part, unless you assume that everything outside his bureaucratic world is ‘anecdotal’.

https://www.americanthinker.com/articles/2020/03/fda_must_approve_hydroxychloroquine_now.html


112 posted on 03/22/2020 2:03:29 PM PDT by Starboard (has so far)
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To: Jim Noble

Glad to hear from a medical professional.

Is there going to be a problem with the patient’s insurance company paying for your services since the drug was prescribed “off label?”


113 posted on 03/22/2020 2:04:02 PM PDT by upchuck (Democrats are always the problem, never the answer.)
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To: SeekAndFind

The FDA has already given doctors the authority to prescribe it. Fauci is a liberal Hillary-supporting synchophant. That’s why he is dragging his feet.


114 posted on 03/22/2020 2:08:40 PM PDT by WASCWatch
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To: bert

Doctors and pharmaceutical companies have already been given immunity for prescribing this drug under “right to try” legislation.


115 posted on 03/22/2020 2:10:55 PM PDT by WASCWatch
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To: WASCWatch

Please see the article linked in my #112. Fauci is not being honest with us.


116 posted on 03/22/2020 2:12:23 PM PDT by Starboard (has so far)
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To: upchuck

Sometimes insurance won’t pay for a DRUG that is prescribed off label. This is much more common with cancer drugs that cost $10000-$100000 per dose, I have never seen it with a drug like Plaquenil, the course of treatment for COVID-19 costs about $7.00.

I have never not been paid for a visit that resulted in an off label prescription. Not once in 45 years.


117 posted on 03/22/2020 2:24:18 PM PDT by Jim Noble (There is nothing racist in stating plainly what most people already know)
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To: Jim Noble

This stuff is cheap if insurance companies won’t pay should be very easy for Americans to afford it!!


118 posted on 03/22/2020 2:25:48 PM PDT by Trump Girl Kit Cat (Yosemite Sam raising hell)
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To: Starboard

there are no randomized controlled trials proving hydroxychloroquine is safe and effective treating covid. Therefore the data is anecdotal. Notice i did not say there is no data or that hydroxychloroquine does not work. We just do not have enough trials to say that definitively


119 posted on 03/22/2020 3:19:17 PM PDT by Mom MD
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To: Jim Noble

I have never not been paid for a visit that resulted in an off label prescription. Not once in 45 years.
_____________________________________________________________

Yep, cardiologists prescribe Amiodarone for A-Fib(OFF LABEL) when it is only approved for “life threatening V-Tach”.
Wifey got it for V-Tach post-op. https://www.doyleapc.com/prescription-drugs/the-off-label-marketing-of-cordarone-amiodarone-to-treat-a-fib/

Very nasty drug that can lead to PULMONARY FIBROSIS....sort of like CCP-19 does! Also learned that using NAC(N-acetyl cysteine) and acetyl L-carnitine minimizes and/or prevents pulmonary fibrosis when on amiodarone....so wifey was using those and her lungs got through it ok.
Those 2 supplements are now in our defense meds for CCP-19 should it show up here, we’re both 60+.


120 posted on 03/22/2020 3:28:28 PM PDT by JCL3 (As Richard Feynman might have said, this is reality taking precedence over public relations.)
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