
FDA emergency use auth for the use of hydroxychloroquine against Covid-19 - blhack
https://www.fda.gov/media/136534/download
======
nradov
US physicians have already been able to prescribe and administer those drugs
to COVID-19 patients. This order merely opens distribution from the government
stockpile to mitigate current supply shortages while production ramps up. So
it's a good move. The efficacy in treating COVID-19 is still being studied but
in the meantime patients who need the drugs for other conditions have had
trouble filling their prescriptions.

------
blhack
To those who think this is bad: why? What is the downside to trying this, or
at least manufacturing a stockpile, that all of the health officials seem to
be missing.

Essentially: if you could talk directly to the FDA, what new information would
you give them that would cause them to reverse course on this? Same question
for any of the countries who have made this a part of their standard
treatment. What do you know about this that they don’t, why are they wrong to
have done what they are doing?

~~~
DanBC
I'm not saying they shouldn't do it.

We don't know if it works, so if they're going to try it they can at least run
it as an RCT.

We do know that chloroquine and hydroxychloroquine can have significant side
effects, especially if combined with azithromycin. This combination requires
careful monitoring. That monitoring is harder to achieve during the current
very highly pressured treatment environment, where we have a bunch of people
with less experience in very busy wards and field hospitals using unfamiliar
equipment.

~~~
mc32
If I have read correct information; those negative side effects are from long-
term use (years), not from multi-day treatment dosages.

~~~
DanBC
The heart problems are from short term use in combination with azithromycin.

Here's some guidance from the American College of Cardiology:

[https://www.acc.org/latest-in-
cardiology/articles/2020/03/27...](https://www.acc.org/latest-in-
cardiology/articles/2020/03/27/14/00/ventricular-arrhythmia-risk-due-to-
hydroxychloroquine-azithromycin-treatment-for-covid-19)

• Safety considerations for inpatient and outpatient use of
hydroxychloroquine-azithromycin in clinical practice are outlined below.
Additional sources of expert guidance are also available here.

• The intensity of QT and arrhythmia monitoring should be considered in the
context of risk level, resource availability and quarantine considerations.

• Hydroxychloroquine or chloroquine therapy should occur in the context of a
clinical trial or registry, until sufficient evidence is available for use in
clinical practice.

• IRB-approved protocols should guide use of hydroxychloroquine or chloroquine
for pandemic research; suggestions for researchers are outlined below.

• Hydroxychloroquine or chloroquine use outside of a clinical trial should
occur at the direction of an infectious disease or COVID-19 expert, with
cardiology input regarding QT monitoring.

~~~
MockObject
> at the direction of a...COVID-19 expert

There aren't any of those.

~~~
jacquesm
Au contraire, this thread is full of them.

------
yread
There is more and more evidence that the only proper trial where it worked was
a "nothingburger"

[https://forbetterscience.com/2020/03/26/chloroquine-
genius-d...](https://forbetterscience.com/2020/03/26/chloroquine-genius-
didier-raoult-to-save-the-world-from-covid-19/)

[https://blogs.sciencemag.org/pipeline/archives/2020/03/29/mo...](https://blogs.sciencemag.org/pipeline/archives/2020/03/29/more-
on-cloroquine-azithromycin-and-on-dr-raoult)

EDIT: Hmm I haven't seen this one before, that actually looks better
[https://www.medrxiv.org/content/10.1101/2020.03.22.20040758v...](https://www.medrxiv.org/content/10.1101/2020.03.22.20040758v1)

~~~
SpicyLemonZest
These articles both seem to summarize the same set of evidence, and it
primarily consists not of studies where it doesn't work but evidence that Mr.
Raoult is untrustworthy. Which he does seem to be, don't get me wrong, but
that's very different than affirmative evidence it's ineffective.

~~~
timr
_" affirmative evidence it's ineffective."_

There's no such thing as affirmative evidence of ineffectiveness. You can't
prove a negative.

Drug trials are designed to prove _effectiveness_ , because the null
hypothesis is always that your therapy is ineffective.

~~~
SpicyLemonZest
Sure, yes, but evidence that the guy's untrustworthy isn't a failure to refute
the null hypothesis either.

------
KaiserPro
There is still no compelling clinical evidence that it works either as a
prophylaxis or "cure".

has any double blind study with more than 100 participants actually reported
yet?

~~~
mrfusion
Thanks for setting out an arbitrary criteria for us ...

~~~
KaiserPro
which bit is arbitrary?

the double blind study, or the number of participants?

~~~
beervirus
Double blind isn't arbitrary. The number of participants sure looks arbitrary
though. (Powers of 10 should be treated as presumptively arbitrary.)

------
Symmetry
Personally my money is on Favipiravir if I had to bet on which of the drugs in
trial is mostly likely to turn out to be the best treatment but there are lots
of drugs in trial and we still need to know much more about all of them. In
the meantime we're advancing our understanding of how to treat Covid-19 in
other ways as well, such as finding out that proning patients can help in some
circumstances.

~~~
blhack
Why is your money on that drug?

~~~
christkv
Its a general anti-viral that targets RNA viruses in general so might be more
effective.

~~~
tyingq
Does the "general" make it more promising than Remdesivir to you?

------
mrfusion
Good news. Lots of studies being done on this.

Here’s a Recent promising study.

[https://www.medrxiv.org/content/10.1101/2020.03.22.20040758v...](https://www.medrxiv.org/content/10.1101/2020.03.22.20040758v1)

------
twomoretime
I can't help but feel that people are bending over backwards now to deny the
potential efficacy of this treatment because Trump tweeted about it.

The potentially positive results are some 2 months old now, there have been
multiple (admittedly nonideal) reports out of China first, then Europe, that
these drugs may work, and we have a theorized mechanism of action.

These drugs were also reported to work on SARS.

A tweet may not be an appropriate venue but it was absolutely a good idea to
give people hope, and these drugs undeniably do show promise. Any other
president would have been lauded.

~~~
syshum
The TDS is very strong in the world today...

------
avgDev
I guess we never learn from history. I suggest looking into temiflu fiasco.

I even got it prescribed recently when I got diagnosed with influenza.
Basically, the US and European governments have spent massive amounts of money
on this drug to help with the flu. People soon learned that temiflu is very
close to placebo in efficacy.

~~~
sjg007
Tamiflu works, you just have to be within the window.

------
eric_b
There is a hospital in France using the Hydroxychloroquine + Azithromycin
treatment on patients and publishing the ongoing numbers:

[https://www.mediterranee-infection.com/covid-19/](https://www.mediterranee-
infection.com/covid-19/)

They don't publish demographics that I could find, but certainly the fact that
1,283 people have been given that treatment and only 1 person that received it
for at least three days has died, that strongly suggests it's better than
"nothing".

~~~
lbeltrame
IMO the impact of the drugs should be, more than preventing deaths, in
reducing hospitalization or even prevent going into the ICU, which can mean
removing load off the healthcare system and make infections manageable (far
more than waiting out for a vaccine).

In fact, some the remdesivir trials which will end next month (end of April)
measure also the time spent in the hospital.

------
JoeAltmaier
Part hail mary, part public relations?

------
adamgamble
Did we do this because Trump pushed it through? Or do they actually think it
might work?

~~~
jacobush
So, as a foreigner that seems an entirely reasonable question. Interesting
that you got downvoted.

Edit: why would I wonder? Not only because the commander in chief is quickly
flipping between standpoints, but why is the CDC silent since March 14?

~~~
wmil
The NYT and other media is very friendly to federal bureaucrats who complain
about political interference.

If the WH was directing them to approve something against their judgment there
would have been headlines on major news sites.

~~~
kadoban
You can't assume all possible things will get whistleblown, especially after
what happened to the last couple.

