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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: freeandfreezing

Well then what is the whining all about?

Jeez...you guys get worked up about one side, and then the other.

There is no pleasing you....


81 posted on 03/22/2020 9:28:25 AM PDT by Vermont Lt
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To: Mom MD
There are no large scale randomized clinical trials.

As you noted that kind of testing is difficult in an epidemic situation. Probably the best alternative is to try to compare the outcomes of treated patients vs. a randomized selection of patients who were not treated using the combination for one reason or another. It will be difficult to remove the other potential influencing factors for patients who have contraindications to hydroxychloroquine or azithromycin, but that provides a starting basis for a control pool.

Data from other countries before the usage of the therapy might also be helpful in the analysis.

82 posted on 03/22/2020 9:29:13 AM PDT by freeandfreezing
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To: Starboard

tbere is data but not enough to say with certainty how effective it is, which combination is best or what dosing is optimal. Fauci is not one of my ca if it’s people. it be happens to be right on this one. The drug is still being used as it should be but a lot more study is needed to know the best way to go from here. There may be other even more effects give drugs and regimens. It needs more study


83 posted on 03/22/2020 9:29:45 AM PDT by Mom MD
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To: freeandfreezing

chloroquine is already in common use in malaria prophylaxis.

https://www.ncbi.nlm.nih.gov/pubmed/9053622

yet we cannot get it prescribed if we suddenly come down with covid-19 symptoms? or worse, one of our loved ones with pre existing conditions or dispositions suddenly comes down with covid-19 symptoms?

apparently doctors can always prescribe chloroquine for their loved ones based on a (manufactured) scheduled trip to a swampy area.

this seems questionable at best and open to abuse at worst, encouraging shortages at the expense of people at or close to the front lines.


84 posted on 03/22/2020 9:30:43 AM PDT by SteveH (intentionally blank)
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To: SeekAndFind
RE: Hydroxychloroquine is an FDA-approved drug already. Not really

Yes really.

You continue to mix up "approval" with "adding an indication".

Any doctor can prescribe any approved drug. No doctor can prescribe an unapproved drug.

The reason everyone is prescribing hydroxychloroquine and most patients are on it is BECAUSE it is an approved drug.

The FDA does not "approve" drugs to treat specific diseases. They issue a declaration that a drug has been PROVEN "safe and effective" for a specific disease, this process is codified in statutory law and NOBODY can deviate from it without a change in the law.

85 posted on 03/22/2020 9:32:03 AM PDT by Jim Noble (There is nothing racist in stating plainly what most people already know)
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To: SteveH
yet we cannot get it prescribed if we suddenly come down with covid-19 symptoms?

Why not? I prescribed it for COVID-19 yesterday.

86 posted on 03/22/2020 9:33:55 AM PDT by Jim Noble (There is nothing racist in stating plainly what most people already know)
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To: Thommas

Thusly, the doctor can prescribe an off label drug use, but the patient ends up paying a multi thousand dollar bill.
******************
No, this stuff is inexpensive. I don’t have it handy but an article the other day said the cost was around $20 for a one month supply at the dosage used for malaria IIRC.


87 posted on 03/22/2020 9:36:55 AM PDT by Yardstick
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To: SeekAndFind

ping


88 posted on 03/22/2020 9:37:45 AM PDT by Java4Jay (The evils of government are directly proportional to the tolerance of the people.)
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To: SeekAndFind

“in vitro” ... wish they were “in vivo” results


89 posted on 03/22/2020 9:40:04 AM PDT by qwertyz
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To: dp0622

“After the gushing hillary emails coming to light...he can’t be trusted.”

Donald Trump went to Chelsea Clinton’s wedding so he can’t be trusted either ...


90 posted on 03/22/2020 9:42:07 AM PDT by catnipman (Cat Nipman: Vote Republican in 2012 and only be called racist one more time!)
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To: SeekAndFind

“Lack of FDA approval does not prohibit off-label use of drugs for other threapeutic purposes, but would inhibit widespread use”

even that’s a completely false statement ... large numbers of drugs are widely used every day off-label WITHOUT FDA APPROVAL because approval is not necessary ... good examples are gabapentin, low dose naltroxone, and almost all antivirals and antibiotics, because these latter were initially approved for only the few bugs they were originally tested against during the original drug approval trials but work against many, many other bugs ... i’d hazard to guess that most drug prescriptions are off-label ...

I’m sick of seeing these bullshit articles posted here trying to make people believe that U.S. doctors can’t or won’t use Plaquenil (hydroxychloroquine) for COVID-19 infections (a drug that is ALREADY widely used off-label for a variety of other purposes) without being blessed by the FDA ...

all these posts do is feed the anti-trump trolls here who attack President Trump’s COVID-19 team because they don’t have the balls to attack Trump himself ... because you like to post these kinds of things here, i can only assume you are deliberately helping to feed these anti-trump trolls ...

Mylan and Teva are gearing up to produce millions of doses of this generic drug and donate them to U.S. hospitals ... Why would they be doing that if the doctors weren’t going to be using the drug?


91 posted on 03/22/2020 9:45:42 AM PDT by catnipman (Cat Nipman: Vote Republican in 2012 and only be called racist one more time!)
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To: Mom MD

I take plaquenil for Lupus and have for several years. I just don’t want to lose access to this drug that I depend on because supply doesn’t meet demand.


92 posted on 03/22/2020 9:46:07 AM PDT by tuffydoodle (God's character and moral nature are absolute, eternal, and unchanging.)
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To: catnipman

Bro that’s so weak you should be embarrassed.

Don’t bother me again.


93 posted on 03/22/2020 9:46:17 AM PDT by dp0622 (Radicals, racists my curseoint fingers at me I'm a small town white boy Just tryin to make ends meet)
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To: Jim Noble

thanks for your candor. i am inquiring with my hmo about its protocol, and so far all i have been given is an indirection to an unnamed infectious disease specialist and an admonition not to worry. and regrettably i am not in a position to prescribe it for myself or my loved ones.


94 posted on 03/22/2020 9:46:59 AM PDT by SteveH (intentionally blank)
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To: tuffydoodle

You are in a tough spot. I would ask your doc for a 90 day supply and keep refilling as early as you can to build up a supply. Hopefully since it is used widely in the world for malaria supplies can be cranked up soon.


95 posted on 03/22/2020 9:50:35 AM PDT by Mom MD
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To: Mom MD

Thanks, I will ask her tomorrow.


96 posted on 03/22/2020 9:58:05 AM PDT by tuffydoodle (God's character and moral nature are absolute, eternal, and unchanging.)
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To: SeekAndFind

Why should they approve it now? It’s a DNC - media hoax and it’s no worse than the flu or the common cold. After all - 19K people die from that every year. So - why do we need to approve this at all? This is yet ANOTHER plot to bring down Trump! /sarcasm (for those too stupid to get it)


97 posted on 03/22/2020 9:59:54 AM PDT by NELSON111 (Congress: The Ralph Wolf and Sam Sheepdog s<how. Theater for sheep. My politics determines my "hero")
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To: Mom MD

‘Remdesivir which is. it approved is also being used u dear compassionate use.’

Huh...?


98 posted on 03/22/2020 10:06:25 AM PDT by IrishBrigade
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To: IrishBrigade

sorry. small keyboard and big fingers. It is currently being used under compassionate use criteria. Point is no one is being denied treatment


99 posted on 03/22/2020 10:10:54 AM PDT by Mom MD
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To: SeekAndFind

Trump has already over ridden the FDA. Docs are allowed to use it off schedule and are doing so


100 posted on 03/22/2020 10:27:41 AM PDT by Nifster (I see puppy dogs in the clouds)
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