FDA emergency use auth for the use of hydroxychloroquine against Covid-19
fda.gov
fda.gov
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?
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.
Here's some guidance from the American College of Cardiology:
https://www.acc.org/latest-in-cardiology/articles/2020/03/27...
• 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.
There aren't any of those.
Is this true? I keep hearing this but it is not supported by your source. It seems that it is the azithromycin that is of concern, and with a death rate of 47 per million. Is there any data suggesting this is worse when co-administered?
>Chloroquine, and its more contemporary derivative hydroxychloroquine, have remained in clinical use for more than a half-century as an effective therapy for treatment of some malarias, lupus, and rheumatoid arthritis. Data show inhibition of iKr and resultant mild QT prolongation associated with both agents. Despite these suggestive findings, several hundred million courses of chloroquine have been used worldwide making it one of the most widely used drugs in history, without reports of arrhythmic death under World Health Organization surveillance.4 Nonetheless, the absence of an active drug safety surveillance system in most countries limits reassurance from these observations.
Azithromycin, a frequently used macrolide antibiotics lacks strong pharmacodynamic evidence of iKr inhibition. Epidemiologic studies have estimated an excess of 47 cardiovascular deaths which are presumed arrhythmic per 1 million completed courses, although recent studies suggest this may be overestimated.6-7 There is limited data evaluating the safety of combination therapy, however in vivo studies have shown no synergistic arrhythmic effects of azithromycin with or without chloroquine.
What side effects? Could you expand on this for a layman? And at what doses and are there drug interaction requirements to get these side effects? What percentage of people experience these side effects?
I’m not an expert on this like you appear to be so my experience is anecdotal. Basically that I know multiple people who take this drug for various reasons. And the claim of it being some dangerous drug doesn’t seem consistent with their experience.
Obviously if used improperly that is true, but the same is true for anything, so I’m not sure that that fact rises above the rhetorical noise floor for me.
It talks about the hopefulness of this treatment, but also asks for better quality research to happen, and warns against blanket use of an experimental treatment especially in a group of patients that includes people who were often pretty ill even without covid-19.
> Basically that I know multiple people who take this drug for various reasons. And the claim of it being some dangerous drug doesn’t seem consistent with their experience.
With any medication we do a balancing exercise. "Do the risks of taking the meds outweigh the harm I experience from not taking the meds?" (One of the most important questions you can ask your doctor is "What happens if we do nothing?")
We don't really know what that balance is with covid-19 yet, and the only way we find out is by running good quality science.
(Downvoting on HN is currently pretty weird. I upvoted you.)
>This combination requires careful monitoring.
It appears that the FDA agrees with both of these points and specifically addresses them in the authorization. From the original post:
"The hydroxychloroquine sulfate may only be used to treat adult and adolescent patients who weigh 50 kg or more hospitalized with COVID-19 for whom a clinical trial is not available, or participation is not feasible."
"Public health authorities about the need to have a process in place for performing adverse event monitoring and compliance activities designed to ensure that adverse events and all medication errors associated with the use of the authorized chloroquine phosphate or hydroxychloroquine sulfate are reported to FDA, to the extent practicable given emergency circumstances"
https://forbetterscience.com/2020/03/26/chloroquine-genius-d...
https://blogs.sciencemag.org/pipeline/archives/2020/03/29/mo...
EDIT: Hmm I haven't seen this one before, that actually looks better https://www.medrxiv.org/content/10.1101/2020.03.22.20040758v...
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.
>national authorities including French government decided to deploy chloroquine as the medicine to treat COVID19. All based on Trump’s tweets which in turn was based on Fox News promotion of this study by Raoult.
This is absurd, and is insulting to every health official in any of the countries using this treatment. The idea that the French government is taking medical advice from Trumps twitter, or from Fox News is ridiculous. Moreso when the doctor and researcher they are talking about is a French citizen and infectious disease expert.
And also raoult is a major liar. If you look at the study he omits a lot of information and refuses to release 14 day endpoint data. Plus he's been a co-author to several papers which have had their results manipulated
[1] https://forbetterscience.com/2020/03/26/chloroquine-genius-d...
A French infectious disease expert publishes a paper which outlines the results of a small clinical trial and which is in agreement with anecdotal experiences in China, and with evidence gathered in vitro. The French authorities ignore their expert until Donald Trump posts about it on twitter, which they take as medical advice.
That seems insulting to France, and also like complete fantasy. In fact I would go so far as to say it sounds like something somebody with an obvious agenda would say.
has any double blind study with more than 100 participants actually reported yet?
The timing actually makes some sense. Getting it into the field in a "can't hurt" way allows us to start studying its effectiveness quickly, before the medical system gets totally overwhelmed and studies become nearly impossible.
the double blind study, or the number of participants?
Given the severity of the situation, trying anything that might work and isn't obviously worse than the disease makes sense right now. But equally, given the side effects of chloroquines and also the postulated mechanism of action for an antiparasitic against a virus being literally just "zinc stuff? idk lol ¯\_(ツ)_/¯" right now, I think it's no less reasonable to want to see some more rigorous evaluation before regarding it as the panacea it's been claimed in many quarters to be.
"Don't be snarky."
good plan
"Don't be snarky."
Here’s a Recent promising study.
https://www.medrxiv.org/content/10.1101/2020.03.22.20040758v...
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.
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.
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".
In fact, some the remdesivir trials which will end next month (end of April) measure also the time spent in the hospital.
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?
If the WH was directing them to approve something against their judgment there would have been headlines on major news sites.
Also your reassurance hinges on that every federal bureaucrat would complain to media in every circumstance. From my experience of bureaucracies you have to pick your battles and resisting or leaking is not always in the cards if you want to keep your job or career prospects. ("Live and let live.")
Then the CDC wants to chip in, but by then they were no longer ahead of the narrative.
The CDC did Not give people sufficient forewarning of what’s to come, and foreign agencies, scientists, business leaders, and news media took control because they were in fact providing more signal. America is normally a beacon of confidence during crisis.