7 ms·
FDA emergency use auth for the use of hydroxychloroquine against Covid-19
- KaiserPro 7y agoThere 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?
- beat 7y agoWell, there should be plenty of patients for studies soon. 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.
- mrfusion 7y agoThanks for setting out an arbitrary criteria for us ...
- KaiserPro 7y agowhich bit is arbitrary? the double blind study, or the number of participants?
- beervirus 7y agoDouble blind isn't arbitrary. The number of participants sure looks arbitrary though. (Powers of 10 should be treated as presumptively arbitrary.)
- throwanem 7y agoThat's a much lower bar than most drug trials impose. 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.
- dang 7y ago"Please respond to the strongest plausible interpretation of what someone says, not a weaker one that's easier to criticize. Assume good faith." "Don't be snarky." https://news.ycombinator.com/newsguidelines.html https://news.ycombinator.com/newsguidelines.html
- syshum 7y agoYes, lets forbid people from trying to save their life because there has not been a double blind study to prove to you it helps good plan
- dang 7y ago"Please respond to the strongest plausible interpretation of what someone says, not a weaker one that's easier to criticize. Assume good faith." "Don't be snarky." https://news.ycombinator.com/newsguidelines.html https://news.ycombinator.com/newsguidelines.html
- adamgamble 7y agoDid we do this because Trump pushed it through? Or do they actually think it might work?
- jacobush 7y agoSo, 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 7y agoThe 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.
- jacobush 7y agoOk, if you feel things are still in such a good shape, great for you. At my distant vantage point, it seems it could be difficult to keep up with all the ways the WH (we do not speak its name) is or could be interfering with just about anything it has a tangential interest in. 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.")
- kadoban 7y agoYou can't assume all possible things will get whistleblown, especially after what happened to the last couple.
- beat 7y agoDo you know the CDC has been "silent", or have you just not seen anything about this before? Two weeks is pretty rapid to push through a decision like this, even in an emergency.
- JoeAltmaier 7y agoPart hail mary, part public relations?
- yread 7y agoThere is more and more evidence that the only proper trial where it worked was a "nothingburger" https://forbetterscience.com/2020/03/26/chloroquine-genius-didier-raoult-to-save-the-world-from-covid-19/ https://forbetterscience.com/2020/03/26/chloroquine-genius-d... https://blogs.sciencemag.org/pipeline/archives/2020/03/29/more-on-cloroquine-azithromycin-and-on-dr-raoult 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/10.1101/2020.03.22.20040758v1 https://www.medrxiv.org/content/10.1101/2020.03.22.20040758v...
- twomoretime 7y agoThere were other reports before this weird doctor. Including out of China.
- SpicyLemonZest 7y agoThese 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 7y ago"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 7y agoSure, yes, but evidence that the guy's untrustworthy isn't a failure to refute the null hypothesis either.
- s1artibartfast 7y agoIn terms of clinical trials, you can run a non-superiority trial. They aren’t run as part of the drug approval process but can be and are run by clinicians and health services.
- nradov 7y agoUS 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.
- mrfusion 7y agoGood news. Lots of studies being done on this. Here’s a Recent promising study. https://www.medrxiv.org/content/10.1101/2020.03.22.20040758v1 https://www.medrxiv.org/content/10.1101/2020.03.22.20040758v...
- twomoretime 7y agoI 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.
- JoeAltmaier 7y agoOther president wouldn't have tweeted. Would have the appropriate agency issue recommendations. Not be a glory-hog and blowhard. It's natural to doubt, when random things come out that channel everyday. In any case, this is a political act. Or a hail mary, one or the other. Not credible medical advice, not at this point.
- twomoretime 7y ago>Would have the appropriate agency issue recommendations. POTUS operates Twitter as a direct line to the people. This would be akin to an announcement at a press conference or a daily briefing. This particular tweet was neither glory-hogging or blowharding, and for some reason people are unable to treat it appropriately. >It's natural to doubt, when random things come out that channel everyday There's no excuse to doubt this when you have access to multiple journal articles going back to January. It was merely a mention of a promising treatment. You can verify the multiple studies yourself, instead of just blindly dismissing it because you don't like Trump. Imagine if we pass over a possible treatment because people can't stifle their bias against the president? >In any case, this is a political act. Or a hail mary, one or the other. Not credible medical advice, not at this point What? Every move by the POTUS is a political act. This isn't supposed to be "credible advice." The POTUS is letting the country know there's at least one promising treatment available, and that's not a lie. This hysteria is irrational. Pure emotional bias. You don't have to like the guy but a psychologically healthy person should be able to evaluate his statements individually - not literally ignore everything he says because you think he's racist or sexist or xenophobic or whatever.
- blhack 7y agoTo 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 7y agoI'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 7y agoIf I have read correct information; those negative side effects are from long-term use (years), not from multi-day treatment dosages.
- DanBC 7y agoThe 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/2020/03/27/14/00/ventricular-arrhythmia-risk-due-to-hydroxychloroquine-azithromycin-treatment-for-covid-19 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.
- Symmetry 7y agoPersonally 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 7y agoWhy is your money on that drug?
- christkv 7y agoIts a general anti-viral that targets RNA viruses in general so might be more effective.
- tyingq 7y agoDoes the "general" make it more promising than Remdesivir to you?
- Symmetry 7y agoThe preliminary clinical trail results seem to be the best so far, that's all. I haven't been following it that systematically and reporting is noisy so I'm not confident it'll be the best, it just seems to be in front at the moment.
- nradov 7y agoFavipiravir looks like a fairly simple molecule: C₅H₄FN₃O₂. Would any organic chemists care to comment on how difficult it would be to synthesize for large-scale medical grade production?
- eric_b 7y agoThere 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 7y agoIMO 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.
- avgDev 7y agoI 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 7y agoTamiflu works, you just have to be within the window.