FDA grants emergency authorisation to chloroquine for COVID-19

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FDA grants emergency authorisation to chloroquine for COVID-19​

March 30, 2020 PM Live. Lucy Parsons

The US Food and Drug Administration (FDA) has approved the use of the decades old anti-malaria drugs hydroxychloroquine and chloroquine after preliminary data showed they had efficacy against COVID-19, the disease caused by the novel coronavirus.

The emergency authorisation comes on the back of results from a small study in France, in which four out of five COVID-19 patients who were treated with chloroquine had ‘favourable’ outcomes.

The results also demonstrated that 65 of the 80 patients receiving chloroquine treatment improved and were discharged from hospital in an average of less than five days.

This data supports earlier preliminary results from a small study of hydroxychloroquine in combination with the antibiotic azithromycin, and as a monotherapy.

Although the drug was effective on its own, when added to the antibiotic azithromycin, hydroxychloroquine was found to produce a superior response, by a significant margin.

The drug has already been touted as a potential treatment by President Donald Trump, who implied that the drug was approved for use in COVID-19 on 20 March. . . .
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Remember. “FDA approval” is for ADVERTIZING (and other aspects). Not necessarily for physician USAGE in patients.

Physicians successfully use medications “off-label” for many things.

It also helps in legal issues.

The difference between this regimen and nothing
is so stark so far,
that many people think randomizing them to “placebo” in a prospective double-blind study at this point would be unethical.
 
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More information can be found here (although some of it is already out of date).
An array of drugs approved for other indications as well as several investigational drugs are being studied in several hundred clinical trials that are underway across the globe. The purpose of this document is to provide information on two of the approved drugs (chloroquine and hydroxychloroquine) and one of the investigational agents (remdesivir) currently in use in the United States. . . .
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The slow-moving bureaucracy of a government in often an unnecessary stumbling block. It’s good that President Trump has removed many unnecessary regulations and red tape,
 
LeafByNiggle . . .
Here’s the drug that is being seriously tested now, and with some encouraging early results: Remdesivir.
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There are a lot of drugs being seriously looked at.
I was just commenting on that today elsewhere (here).

Cathoholic . . .
Look up “Camostat” and “Cathoholic”.

Look up “remdesivir” and “Cathoholic”.

Look up “plasma” and “Cathoholic”.

It is being talked about.

But there are a couple of things at play here.
  1. The medical community has vast experience with Plaquenil (hydroxychloroquine) and azithromycin. The docs know how to use these medications and what likely that they need to be looking for.
I talked to an optometrist-friend of mine recently who said he has had referrals from physicians for many years regarding there plaquenil patients. He has seen one eye complication, told the physician, who stopped the drug and the patient got better. He has never even HEARD of an eye complication with someone on Plaquenil (hydroxychloroquine) on short duration treatment.

Likewise the other side effects. The physicians know what they and their patients are getting into with these drugs. What to watch for.
  1. A political dimension. Since President Trump talked favorably about the regimen, there are foolish self-destructive people in the media that WANT President Trump to be wrong because . . . Well because it is President Trump. They would rather see the country suffer than admit Trump is correct.
Their readers can pick-up on that disinformation unwittingly.
  1. A lot of big pharma see a potential cash cow here.
    It may be from a new medication. It may be from a new vaccine. Or some other factor.
And if we have good treatment now, at our proverbial fingertips, this destroys that cash-cow.

I’m not saying these guys will go to the lengths the media has gone to hurt Americans, I am just saying they will tend to be hypercritical of this regimen (eventually) and hyper-uncritical about their own solution options.
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Cathoholic said:
A political dimension. Since President Trump talked favorably about the regimen, there are foolish self-destructive people in the media that WANT President Trump to be wrong because . . . Well because it is President Trump. They would rather see the country suffer than admit Trump is correct.
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Not just in the media. We see a lot of it right here.
 
Trump people can be the test pilots and rely on their Trump faith. We will cheer them on.
 
I’ve taken Hydroxychloroquine for years. It is a very common medication with very few and very rare long term side effects. For those of us who take it long term there is a period of adjusting to it which is why don’t start at the therapeutic dose, but gradually move toward it. There is a hard limit of how much a doctor can prescribe. It is a well know medication, especially for Rheumatologists who tend to prescribe it most often in the US.

There is a risk of damage to the retinas which is why we have to see an ophthalmologist at least once a year to have our eyes checked. This is also a very rare side effect.

Given the very short time Covid-19 patients are given the drug, a few days, the real issue is you unwillingness to accept anything Trump says as truth. I pray your life or the life of someone you love doesn’t depend on it.
 
Ridgerunner . . .
We see a lot of it right here.
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True enough. But the readers will have to look at the info. and draw their own conclusions on that.

But they are pretty obvious.

I won’t get into WHY some are against others benefiting, but interiorly it suggests the sin of envy. It is awful.
 
LeafByNiggle . . .
No one is against others benefiting. But of course you knew that.
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Some are against others benefiting. But of course you knew that.
 
Horton said:
I’ve taken Hydroxychloroquine for years.
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I’m in the same boat.

I started at 400mg a day, 8 years ago, and I still take that dose.

Like you have to have my eyes checked at least once a year. Although it was every six months, just a year ago.

I’m also part of a drug trial. I take a medication that has not been approved for use. I’ve been on it for about 18 months. For the first year, I could have been part of the placebo group. After that year, because the drug seemed to be working so well, everyone that had stuck it out for that year were guaranteed to be receiving the actual drug. I was then told that I had already been on the actual drug and I would continue to receive the same dose.

They did this because they felt that it was unethical to deny this drug to people that were suffering with lupus.

This didn’t change what I was doing, but I am sure that there are people that benefited from this change.

I will also say, I have taken numerous drugs “off label.”

Terbutaline, Reglan, methotrexate and hydrochloroquine. And that is just off of the top of my head. It really isn’t as big of a deal as people seem to think.
 
I get it. I’ve been there.

I believe the only reason so many people are going bonkers over the off label use of hydroxychloroquine is because President Trump supports the use of it. If several doctors had announced this drug was working on covid 19 patients, it either would just be ignored or celebrated how smart those doctors are.
 
Doctors are free to say and do say whatever they want about the drug. Trump and what he says is independant.
Bonkers has to do with credibility
 
Maximus1 said:
Doctors are free to say and do say whatever they want about the drug. Trump and what he says is independant.
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Where do you think President Trump heard about Hydroxychloroquine? From doctors who had been using it.
 
Horton said:
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Maximus1:
Doctors are free to say and do say whatever they want about the drug. Trump and what he says is independant.
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Where do you think President Trump heard about Hydroxychloroquine? From doctors who had been using it.
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He picked up on some anecdotal mention of it, likely misunderstood the technical medical aspects of what he heard, and then irresponsibly promoted it without sufficient evidence. It is too soon.
 
In fairness, you think that because there is a good chance it is true.
What we can say definitively is:
He didn’t independently read it in any sophisticated way, so as to render opinions of value.
And
His ears here about such things via the prism of short term transactional gain.
 
That’s some solid, unsubstantiated nonsense you posted there.

If you have proof of ANY of that, feel free to share. Otherwise, continue demeaning someone with a shred of evidence.
 
LeafByNiggle said:
He picked up on some anecdotal mention of it, likely misunderstood the technical medical aspects of what he heard, and then irresponsibly promoted it without sufficient evidence. It is too soon.
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You are lacking any credibility in your projection.

The FDA fast tracked it’s approval because there is sufficient evidence to move forward.
 
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