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Mike Pence: FDA approving 'off-label' use for hydroxychloroquine to help coronavirus patients
Fox News ^ | 03/24/2020 | Talia Kaplan

Posted on 03/24/2020 12:45:49 PM PDT by SeekAndFind

Vice President Mike Pence said Tuesday that “the FDA [Food and Drug Administration] is approving off-label use for the [anti-malarial drug] hydroxychloroquine right now" to help coronavirus patients.

Pence made the comment during Fox News’ virtual coronavirus town hall in response to a question from Dr. Mehmet Oz about the drug, which has shown encouraging signs in small, early tests. A similar drug, Chloroquine has also showed positive signs.

Dr. Oz noted that “the FDA appropriately desires randomized critical trials for proof to guide the medical community,” but asked the vice president how the clinical trials can be accelerated “while also satisfying the demand from physicians, front-line doctors, who want to use these pills for their patients and themselves?”

In response, Pence said, “The good news is, the chloroquine medication, we actually deployed in the state of New York resources to be able to be administered to the people.”

New York has reported more than 25,600 confirmed coronavirus cases and 210 deaths, the most in the U.S., according to data compiled by Fox News.

“Doctors can prescribe that medication, which as you know is a perfectly legal and approved malaria medication," Pence told Dr. Oz, "but doctors can now prescribe chloroquine for that off-label purpose of dealing with the symptoms of coronavirus. We are making that clear across the country."

Preliminary studies sparked intense interest after President Trump tweeted that hydroxychloroquine plus an antibiotic could be “one of the biggest game changers in the history of medicine” and should “be put in use immediately.” The president cited a French study that gave the combination to thirty six patients.

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


TOPICS: Culture/Society; Government; News/Current Events
KEYWORDS: corona; coronavirus; covid; covid19; fda; hydroxychloroquine; mikepence; zelenko
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IT IS BEING TESTED IN NEW YORK STARTING TODAY.

(FROM THE ARTICLE):

Some French doctors and politicians want to expand hydroxychloroquine’s use as well. However, scientists say major studies are needed to prove the drugs are safe and effective against coronavirus.

During a news conference on Sunday, New York Gov. Andrew Cuomo announced that the state has acquired 70,000 doses of hydroxychloroquine, 10,000 doses of the antibiotic zithromax and 750,000 doses of chloroquine, with trials set to start Tuesday.

“The president’s very optimistic, he’s very hopeful that some of these anecdotal results that we’ve seen around the country will prove out to be true,” Pence said on Tuesday. “I want to assure you, there is no barrier to access the chloroquine in this country. We’re working to add to that supply even as we speak.”

He went on to say that the Trump administration is working with companies that produce vast amounts of chloroquine, adding that at the same time “we are engaging in a clinical trial while we make this broadly available for off-label use. Because we do want to take the opportunity, we are doing that in New York state, to study the results of this so that we can better understand the impact going forward.”

1 posted on 03/24/2020 12:45:49 PM PDT by SeekAndFind
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To: SeekAndFind

In a ‘clinical trial’ some patients get a placebo.................IOW, NADA.......................


2 posted on 03/24/2020 12:47:30 PM PDT by Red Badger (If people were to God like dogs are to people, the world would be a really great place..............)
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To: Red Badger

Well, at least the other half gets them. It’s better than none.


3 posted on 03/24/2020 12:50:30 PM PDT by SeekAndFind (look at Michigan, it will)
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To: Red Badger

I read that the drugs work quickly and if the patient doesn’t improve, they start with the “real” drug immediately, And it seems to work.


4 posted on 03/24/2020 12:51:09 PM PDT by livius
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To: SeekAndFind

Rachel Maddow is going to be PISSED to hear this.

The editors at the New York Times will also be very cross.

Of course, we must expect them to reject taking the drug if they get coronavirus. We don’t want them to accept “false hope”


5 posted on 03/24/2020 12:51:22 PM PDT by rintintin (qu)
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To: Red Badger
In a ‘clinical trial’ some patients get a placebo

You do not want to be in the control group.
6 posted on 03/24/2020 12:51:22 PM PDT by JoSixChip (I no longer support this government)
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To: AdmSmith; AnonymousConservative; Arthur Wildfire! March; Berosus; Bockscar; cardinal4; ColdOne; ...

7 posted on 03/24/2020 12:51:30 PM PDT by SunkenCiv (Imagine an imaginary menagerie manager imagining managing an imaginary menagerie.)
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To: SeekAndFind

If in a ‘clinical trial, the ones getting the real drug show marked improvement quickly, then the trial is stopped and the control patients get the real thing...................


8 posted on 03/24/2020 12:53:16 PM PDT by Red Badger (If people were to God like dogs are to people, the world would be a really great place..............)
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To: SeekAndFind

Does off-label use require FDA approval?


9 posted on 03/24/2020 12:56:15 PM PDT by nwrep
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To: SeekAndFind

Fine and dandy. But unnecessary. Doctors can already prescribe it


10 posted on 03/24/2020 12:56:18 PM PDT by faithhopecharity ("Politicians are not born, they are excreted." Marcus Tullius Cicero (106 to 43 BCE))
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To: Red Badger
In a ‘clinical trial’ some patients get a placebo.................IOW, NADA.

In the majority of cases, the effects of this disease are not life-threatening, and a placebo as a control group treatment is completely ethical.

11 posted on 03/24/2020 12:57:17 PM PDT by Lou L (Health "insurance" is NOT the same as health "care")
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To: rintintin

RE: Rachel Maddow is going to be PISSED to hear this.

What if she gets the virus and Doctors offered the drugs to her? What will she do?


12 posted on 03/24/2020 12:57:25 PM PDT by SeekAndFind (look at Michigan, it will)
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To: SeekAndFind

And Cuomo just banned it in NY. The more people that die then the more in benefits the democrats.


13 posted on 03/24/2020 12:59:01 PM PDT by Revel
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To: SeekAndFind

“What if she gets the virus and Doctors offered the drugs to her? What will she do?”

She’ll refuse it, I’m confident, because if is “false hope”


14 posted on 03/24/2020 12:59:40 PM PDT by rintintin (qu)
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To: SeekAndFind
This whole situation is very confusing. According to the link below, off-label prescriptions do not have to be approved by the FDA.

Off Label

The article above does not cover a prescription "cocktail" where 2 approved drugs are prescribed together. This may require FDA approval.

15 posted on 03/24/2020 12:59:55 PM PDT by FtrPilot
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To: Revel

He said he would start the clinical trials today what happened??


16 posted on 03/24/2020 1:04:11 PM PDT by Sarah Barracuda
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To: SunkenCiv

Ping


17 posted on 03/24/2020 1:08:10 PM PDT by mikelets456
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To: Revel

Reference please, I am looking all over the net and can’t seem to find where Cuomo banned hydroxychloroquine


18 posted on 03/24/2020 1:10:46 PM PDT by Trump.Deplorable
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To: Trump.Deplorable

He’s posting this bs in other threads I’m seeing nothing of it. I scoured everywhere and nada. Ignore him


19 posted on 03/24/2020 1:11:48 PM PDT by mikelets456
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To: Sarah Barracuda; Trump.Deplorable; PapaBear3625; ClayinVA; SeekAndFind

Yes it can be used in limited trials. Why do you all think that is a big deal. I stated why it is not in another post. I would like to add that Trials takes months or years. Small group. You do not get to choose. And here is what I am reffering to:

“On Monday evening, New York Gov. Andrew Cuomo released an executive order that effectively ended pharmacists’ ability to prescribe hydroxychloroquine for use in treating Covid-19, and prohibited any experimental use of the drug outside of state-approved clinical trials.”

https://www.freerepublic.com/focus/f-chat/3827887/posts


20 posted on 03/24/2020 1:14:57 PM PDT by Revel
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