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Medicine United States

FDA Issues Limited Emergency Use For Two Drugs Used To Treat Malaria (cnn.com) 151

Posted by BeauHD from the fast-tracked dept.
knorthern knight shares a report from CNN: The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization for chloroquine and hydroxychloroquine to treat patients hospitalized with COVID-19. [...] Do the drugs work? In its statement, HHS said: "Anecdotal reports suggest that these drugs may offer some benefit in the treatment of hospitalized COVID-19 patients. The safety profile of these drugs has only been studied for FDA approved indications, not COVID-19." The authorization is limited to patients who are currently hospitalized and weigh at least 50kg, or about 110 pounds. Under the emergency use authorization, health care providers must contact their local or state health department to access the drugs. "It would take several months of clinical trials to gauge its effectiveness, but we don't have the luxury of time," adds Slashdot reader knorthern knight. "We do know that it helps some COVID-19 patients, and has been in use for many years to treat malaria and other diseases. So it's not poisonous (and no, don't confuse it with fish tank cleaner)."
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FDA Issues Limited Emergency Use For Two Drugs Used To Treat Malaria More

FDA Issues Limited Emergency Use For Two Drugs Used To Treat Malaria

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  • that passed local state orders saying NO, you can't use it to save lives?

  • Could it work? (Score:5, Informative)

    by transporter_ii ( 986545 ) on Monday March 30, 2020 @08:15PM (#59890620) Homepage

    https://www.livescience.com/ch... [livescience.com]ne-coronavirus-treatment.html

    In February, a research group led by virologist Manli Wang of the Chinese Academy of Sciences put the idea to the test and found that chloroquine successfully stopped the spread of SARS-CoV-2 in cultured human cells. Preliminary reports from China, South Korea and France suggest that the treatment is at least somewhat effective in treating human patients, and some hospitals in the U.S. have begun administering the drug, according to The New York Times. In addition, the FDA is organizing a large clinical trial to formally assess the drug's effects, the Times reported.

    However, due to a short supply of chloroquine in China, and the fact that an overdose can lead to acute poisoning or death in humans, Wang's team also investigated the closely related drug hydroxychloroquine. Though it shares a similar structure, hydroxychloroquine shows lower toxicity in animals than its chemical cousin and remains widely available as a treatment for lupus and rheumatoid arthritis, the authors noted.
    Wang's team tested hydroxychloroquine in primate cells and found that, like chloroquine, the drug prevented SARS-CoV-2 replication, according to a report published March 18 in the journal Cell Discovery. As of Feb. 23, seven clinical trials had been registered in the Chinese Clinical Trial Registry to test the drug's effectiveness against COVID-19 infection, the authors noted.

    In the U.S., the University of Minnesota is studying whether taking hydroxychloroquine can protect people living with infected COVID-19 patients from catching the virus themselves, according to the Times.
    Both chloroquine and hydroxychloroquine have been in short supply since earlier this month, according to the American Society of Health-System Pharmacists. But on March 19, the pharmaceutical company Bayer donated 3 million tablets to the federal government, and Novartis, Mylan and Teva are moving to follow suit, according to FiercePharma.

    Although we won't know the results of these trials for some time, the advantage of trying out chloroquine and hydroxychloroquine as COVID-19 treatments is that the drugs' safety profiles are well understood, Horovitz said. Both drugs are generally well tolerated at prescribed doses but can cause stomach pain, nausea, vomiting, headache and more rarely, itchiness, according to the Centers for Disease Control and Prevention (CDC). When taken in high doses over many years, the drugs can cause a rare eye condition known as retinopathy.

    Both medications can interact with other drugs and doses should be adjusted to account for drug interactions. Those with psoriasis should not take either drug, the CDC notes. In their current form, the drugs are also not safe for those with heart arrhythmia, or those with impaired kidneys or liver, the Times reported.

    Assuming the drugs are well tolerated in clinical trials and seem effective at treating COVID-19, the FDA will take measures to increase the nation's supply, according to Hahn.

    "If clinical data suggests this product may be promising in treating COVID-19, we know there will be increased demand for it," Hahn said in the FDA statement. "We will take all steps to ensure chloroquine remains available for patients who take it to treat severe and life-threatening illnesses such as lupus."

    • Re:Could it work? (Score:5, Informative)

      by mrclevesque ( 1413593 ) on Monday March 30, 2020 @08:26PM (#59890656)

      The right link https://www.livescience.com/ch... [livescience.com]

    • Oh, great, these drugs shouldn't be taken by those with psoriasis or heart arythmias. I have both. If it's going to do any good, it's going to have to drive the existence of the damned virus down to zero in everyone around me so's there's no one I can catch it from.

      If anything can go wrong, it will.

  • Is there enough? (Score:2, Insightful)

    by rsilvergun ( 571051 )
    what worries me is that the drug might not actually do anything, but that it might divert supplies from actual malaria patients...

  • We don't know it's helpful for some (Score:5, Informative)

    by redmid17 ( 1217076 ) on Monday March 30, 2020 @08:19PM (#59890640)
    We have anecdotal evidence and a non-peer reviewed study (French doctor) that had no confirmed COVID-19 cases.

    The only study that's actually been done properly found it didn't help and the side effects were pretty bad for 4 of the 32 participants (liver function worsened and diarhhea) and one's condition got worse.

    I'm all for the trials but frankly this medicine is used by a lot of people who suffer from auto immune diseases like lupus and RA, and we're already suffering shortages because of asshole and doctors who've been hoarding it. The way NY is handling it is probably the best way to approach it. There are countries that have even banned export of HC because they need it to fight malaria and other viruses.

    • Re: (Score:3)

      by Hadlock ( 143607 )

      I think the medication is only dosed for 4-6 days. Side effects largely include vivid dreams/nightmares, sensitivity to sunlight etc in the short term.
       
      Long term side effects don't kick in until at least 4 weeks, generally starting around month 6
       
      Dosage for covid19 would be maximum 21 days, likely 7 days

    • Re: (Score:3)

      by sjames ( 1099 )

      Read the reports more carefully please. The UK did not ban export to treat malaria (it's not even endemic to the UK), they did it to preserve supplies to treat domestic cases of COVID-19. The french study was on confirmed cases of COVID-19.

      Chloroquine is often prescribed as prophylaxis for people who will travel where malaria is endemic and has been for decades.

      • Re: (Score:3, Insightful)

        by redmid17 ( 1217076 )
        India banned it to treat malaria, like early last week. Where did you get the UK?

        And yes you're right, the French study did have COVID-19, but the CDC and several other organizations have seriously methodological issues with the study and say it didn't assess clinical benefit. And once again the chinese study didn't show anything either.

        There's a good reason to be skeptical of its use outside of small, limited trials and there's damn good reasons not to prevent people with chronic illnesses from getti

        • Re: (Score:2)

          by sjames ( 1099 )

          The UK also restricted the export of chloroquine because they intend to use it to treat COVID-19.

          As for the French study, they didn't have a formal control group but they did have the baseline of previous patients that had not been treated to compare to.

          This is a great time to work from informal field studies, it's not like we're dealing with drugs never before used in humans. It's also a good time to ramp up production so people already on it can continue to get it.

          • Re: (Score:2)

            by Cederic ( 9623 )

            The UK also restricted the export of chloroquine because they intend to use it to treat COVID-19.

            That's supposition.

            The same order banning the export of chloroquine also bans the export of the chemical NaCl.

            I'm not sure that's been suggested yet as a cure for Coronavirus.

        • And once again the chinese study didn't show anything either.

          The Chinese study found no benefit over "standard treatment", but "standard treatment" in their study included other antiviral drugs. And all of the patients in the Chinese study (both the control group and non-control group) recovered so I'm not sure how you are drawing the conclusion that it definitely doesn't work from that study. The most you can say is that it doesn't work better than other antiviral drugs.

          • If all of the patients recovered, you can't even conclude that this medication isn't better than X. To make that conclusion, you'd need to have enough patients that a statistically significant number didn't recover. Then you could compare the statistically significant numbers.

            What can be said from a study where every patient recovers is simply that:
            Some patients got this medication and all of the patients recovered.

      • Comment removed based on user account deletion

        • Re: (Score:2)

          by sjames ( 1099 )

          Malaria is actually responsible for the gin and tonic. The tonic had quinine in it and British officers added gin to make it palatable (or at least that was the excuse).

    • The same French group behind the original 40-patient study just released a second study yesterday, this time with 80 patients. The results were as impressive as the first study. Here is the second study report: https://www.mediterranee-infec... [mediterran...ection.com] Of course it hasn't been peer-reviewed, that takes months under normal circumstances. We don't have the luxury of that kind of time. Maybe someone will find time to review it sooner given the urgency of the situation.

    • A trial in China is reported here (not yet peer reviewed): https://www.medrxiv.org/conten... [medrxiv.org]. 31 patients in each of the treatment group and the control group. It reports a significantly improved time to clinical recovery; 4 patients in the control group progressed to "severe" illness, none in the treatment group. It wasn't a silver bullet, but at least in that trial it seemed to help.

    • Re: (Score:2)

      by gtall ( 79522 )

      I believe there was also a report out of China, but then no one rational believes anything out of China.

    • Comment removed based on user account deletion

  • No evidence HCQ or CQ works for COVID-19 (Score:5, Informative)

    by serrin19 ( 6728332 ) on Monday March 30, 2020 @08:28PM (#59890664)
    The trials that support HCQ's use in COVID-19 are small and have many methodological flaws. People out there would like to believe that there is some sort of treatment for SARS-CoV-2 but the simple answer is that currently nothing out there works, and that there has rarely ever been a pre-existing medication with significant antiviral properties against a new emerging virus. This review of Gautret et al.'s work raises a lot of questions about its scientific vigour: https://scienceintegritydigest... [scienceint...digest.com] This paper suggests that HCQ prolongs viral shedding (but not in a statistically significant way. Also at least this study was randomised): http://www.zjujournals.com/med... [zjujournals.com] But who knows, there's worse things to die of that torsades and optic neuritis.

    • Re: (Score:2)

      by sjames ( 1099 )

      Optic neuritis only happens with long term use for lupus or RA.

      Of course, if you end up with severe COVID-19, it is your right to refuse chloroquine if you're that worried about it.

    • Yeah, we should completely ignore reports by actual doctors in the field of this working and wait a year for the clinical trial to finish. After all, these doctors didn't do a double blind randomized placebo controlled trial with a +100 N, how could they possible know whether it works or not? It's just too dangerous to let those gasping for their last breath take this drug for 10 days. We should give it to them after the trial is complete sometime in June 2021.

  • or just prayer.

    If there are adverse side effects, like umm death from Malaria drugs, maybe save them for the most impacted?

  • The main problem here (Score:5, Interesting)

    by clonehappy ( 655530 ) on Monday March 30, 2020 @09:37PM (#59890888)

    Is that the combination of Hydroxychloroquine and Azithromycin is more of a prophylaxis than a cure. It gets rid of the disease before it has a chance to take hold. With the new fast tests available, these drugs (don't forget the Azithromycin to knock out the secondary infections before they overrun the immune system) should be prescribed at the first sign of developing COVID infection. They seem to knock things out right quick.

    The thing is, once you're in the hospital having trouble breathing it's about 50/50 that you're as good as dead regardless of what you take. Hence the panic about ventilators. Wouldn't it be better to not need the ventilators at all? Why wait until someone is hospitalized when they can be cured early and greatly increase their chance of survival?

    It seems like such a no-brainer that I am confused why everyone is so against it. The malaria drug is well tolerated, it's commonly used as a prophylactic before international travel to countries where it is uncontrolled (it only causes the bad side effects after long-term use such as for Lupus or RA at high dosages), and the other drug is a well known safe antibiotic. Even if it only has a 50% chance of knocking out the infection? Wouldn't it be worth it?

    • They're against it because Trump said something positive about it. Think about that for a minute. Mainstream news was even crowing about someone dying from Trump's recommended treatment even though the guy drank fish tank cleaner. It is sickening that people have to be automatically against anything Trump says.

      • They're against it because Trump said something positive about it. Think about that for a minute. Mainstream news was even crowing about someone dying from Trump's recommended treatment even though the guy drank fish tank cleaner. It is sickening that people have to be automatically against anything Trump says.

        Yep, it is sickening.

        The impulse to hate and blame is strong. Even, perhaps especially, at a time like this.

    • Not enough supply

      Current patients have been denied refills

      Not enough tests available to get a diagnosis early enough to have any effect

      Bad side effects

      This is like going to the doctor for a cold of flu and getting antibiotics. For each patient it might be a case of "it can't hurt, might even help" but over time that causes more problems. If the facts change the guidance should change. But we do not need to be redirecting supply from existing patients when it may or may not help.

    • Wouldn't it be better to not need the ventilators at all? Why wait until someone is hospitalized when they can be cured early and greatly increase their chance of survival?

      It seems like such a no-brainer that I am confused why everyone is so against it.

      Two reasons:

      1. Hard to monetize an old drug.

      2. A certain someone said that this could be a game changer, so therefore it can't be allowed to be true.

  • No, we do _not_ know that it helps (Score:5, Insightful)

    by gweihir ( 88907 ) on Monday March 30, 2020 @09:56PM (#59890950)

    The history of medical research is full of cases where the researchers are kidding themselves, misinterpreting observations and overemphasizing seemingly positive effects while ignoring negative ones. That is the very reason why double-blind studies are the gold-standard and even these are not perfect. Anything less does not do it at all. The only thing we know at this time is that these substances seem to not have a high probability to make things worse. We do _not_ know anything else.

    For all we know, the actual effects could still be somewhat negative and there could well be a placebo-effect at work that would be stronger with an actual placebo.

    • I think this is the most measured response I've read so far. There are a lot of people discounting this treatment completely, and I don't think that's the correct response. But I also don't think that unwavering optimism is appropriate, either. Suspending belief is the most difficult thing to do, especially when lives are at stake (and, on a forum like this, where opinions are voiced). But suspending belief is the only appropriate course of action while further testing is conducted.

      I'm all for COVID-19 pati

      • I also don't think that unwavering optimism is appropriate, either.

        This is simple. Let's say your doctor tells you have have a 1.5% chance of dying. Let's say that your doctor says that the numbers for the meds are 699 cases, no deaths, no intubations. What is your choice? It isn't unwavering optimism, you are wildly confused. It's the opportunity to not die. It literally is that simple. Sure, you might die, but the stats are right now, that unless you doctor is an idiot an prescribes aquarium cleaner, you won't die. Sure, we'd love a 1M person study, double blind,

        • Re: (Score:2)

          by gweihir ( 88907 )

          This is simple. Let's say your doctor tells you have have a 1.5% chance of dying. Let's say that your doctor says that the numbers for the meds are 699 cases, no deaths, no intubations.

          If your doctor tells you that at this time, then said doctor is unethical to a level that should have this quack immediately stripped of the license to practice medicine.

          Bad medical "facts" are an extreme killer. Not only directly, but also indirectly because they prevent looking for real solutions. The standard of "double blind" is not a luxury. It is a dire necessity born out of an immeasurable amount of pain, suffering and death that lesser approaches have created and the current situation is very much n

        • Let's say that your doctor says that the numbers for the meds are 699 cases, no deaths, no intubations.

          First, I don't know where you got that number, but I would certainly still have questions. Were these 699 cases people who were relatively healthy? Basically, were these people given the drug because they seemed to be the type that wouldn't be greatly affected by adverse side effects? These are the same people who are most likely to withstand the virus. That's the concern here. When you have numbers that are detached from a transparent methodology, I don't know if those numbers mean anything.

          The "YOU" argum

          • Re: (Score:3)

            by gweihir ( 88907 )

            Well said. Also, doctors have a tendency to become irrational when their patient's lives are at stake. Speaks well for them as people, but makes them abysmally bad researchers. This is one of the reasons why double-blind studies are never designed or evaluated by the doctors doing them.

            Getting to the truth is generally hard. It becomes a lot harder when your own life or the life of somebody you care about is at stake. Double-blind studies are the only tool that still work reasonably well under these circums

      • Re: (Score:2)

        by gweihir ( 88907 )

        I think this is the most measured response I've read so far.

        Thank you.

    • Re: (Score:2)

      by ghoul ( 157158 )

      All I know is that there is a shortage as doctors are writing scrips for it for themselves and their friends and families. Maybe it doesnt work but it cant do harm. its an old drug used for 60 years and is dirt cheap as a generic.
      The only harm it may do is to the stock of all the companies working on an anti, viral, vaccines, ventilators and home delivery if taking a 3 day course of a 5 dollar pill is all you have to do to beat SARS2

    • > double-blind studies are the gold-standard

      Yes, that's true. It'll be great when we have long-term studies on thousands of patients, carefully controlled.

      It is error to think that the best proof possible is the only thing of any value, that anything other than "the gold standard" is worthless.

      Every day you see people that you recognize, and you interact with them appropriately - without performing a DNA test to confirm their identity. You *might* be talking to their identical twin. Your alarm clock mi

      • Your car and clock are designed for those purposes. Antibiotics and anti parasite meds are not designed to be antiviral. And you say "probably" in terms of their effectiveness when nothing backs you up. Poorly done studies are not evidence.

        If we go with these, I'd expect large scale documentation on each patient. How soon the treatment started, severity, and success. Report the numbers. A large scale formal study. Not the "prescribe if if you want" free for all that seems to be happening.

      • Re: (Score:2)

        by hey! ( 33014 )

        It is error to think that the best proof possible is the only thing of any value, that anything other than "the gold standard" is worthless.

        That's not the problem, though. The problem is this: does the evidence justify prioritizing choroquine over other promising treatements?

        How did chloroquine suddenly become the centerpiece of US government efforts? It was a hot tip from Larry Ellison (yes, *that* Larry Ellison) to Donald Trump on a phone call. It's getting a lot of buzz in tech billionaire circles. But I'm not so sure I want tech billionaires in the driver's seat on this.

        They may be right on this one. But if they're wrong they'll have a

        • Re: (Score:2)

          by gweihir ( 88907 )

          That's not the problem, though. The problem is this: does the evidence justify prioritizing choroquine over other promising treatements?

          Indeed.

          How did chloroquine suddenly become the centerpiece of US government efforts? It was a hot tip from Larry Ellison (yes, *that* Larry Ellison) to Donald Trump on a phone call. It's getting a lot of buzz in tech billionaire circles. But I'm not so sure I want tech billionaires in the driver's seat on this.

          They may be right on this one. But if they're wrong they'll have a lot to answer for.

          You mean that Trump that is unable to understand what is happening and at the same time desperate to appear to be in control? That Trump that wishes for nothing more to be able to present a miracle cure as his great plan, but that at the same time does not even have a basic understanding how medicine works? That trump that already has a very high body-count that will continue to grow because he first tried to ignore the problem and then tried to claim it was not serious? That one?

        • Several medications should be studied - and they are being studied.

          If I were very sick, I'd rather get ANY of the medications being studied than get nothing, because for each there is a reasonable likelihood that they will work.

          Re which should be studied MOST -
          it seems to me that's a function of the likelihood they will work and the ability to produce them quickly and in large quantities. A medication that works great but costs a billion dollars per person is no good - we don't have a billion dollars per p

          • Re: (Score:2)

            by hey! ( 33014 )

            I hope it works too. But raising public hopes and expectations for just one drug is a bad idea. That can undermine supplies before it is even proven. And we should fast track what *experts* think are the most promising drugs, not what some political donor has heard is going to be a silver bullet.

      • Re: (Score:2)

        by gweihir ( 88907 )

        You are wrong. The "gold standard" is the _minimal_ standard needed to get meaningful reliable results. All else is known to produce faulty, often extremely faulty results. Other approaches are not worthless, they can produce ideas as to where to look. They _cannot_ verify those ideas. These ideas are very valuable, but most do not pan out and any competent medical researcher understands that. Do you think anybody would do expensive double-blind studies if there was some other, simpler approach that actua

        • > Do you think anybody would do expensive double-blind studies if there was some other, simpler approach that actually worked? Certainly not.

          They don't do the expensive studies on random substances. They actually do the expensive studies to.prove it AFTER they do less expensive and less reliable experiments to find out which will *probably* work.

          Again, you're confusing "the best possible proof" with "reasonable evidence". Both concepts exist.

          When a guy walks into a bank wearing a ski mask in the summer

          • Re: (Score:2)

            by gweihir ( 88907 )

            Have you understood anything I wrote? Have you looked at medical history and its countless, often severe failures because people thought things looked reasonable when they did not? Apparently not. This is not an issue for debate. This is a settled issue. You are just ignorant of the known facts.

            • It's been widely used since the 1940s, including for long-term use. Many studies have been done proving the safety even for long-term use, much less short-term as applies here. So this is NOT a case where a new study this year is going to show that there were dangers that aren't immediately obvious. Those have been most of the big screw ups.

              Either people recover at a higher rate with this medication or they don't. It's really not that hard to get fairly strong evidence for or against that either way.

              • Re: (Score:2)

                by gweihir ( 88907 )

                Either people recover at a higher rate with this medication or they don't. It's really not that hard to get fairly strong evidence for or against that either way.

                It is. You really do not know what you are talking about.

                • Well, I think we both expressed our thoughts and at this point we're just repeating ourselves. Thanks for the conversation and stay safe.

                • A thought just occurred to me.
                  The experiments done so far are of absolutely zero value, right?
                  There is no reason at all to think hydroxychloroquine is a good medication for covid 19, if I'm understanding you right. No evidence.

                  With over 25,000 different medications in use for different things, for a layman to pick the one that just randomly ends up being effective, he'd have to be psychic or something, right?

                  Given that there is NO REASON to think hydroxychloroquine + azithromycin will be proven effective,

          • Re: (Score:2)

            by jbengt ( 874751 )
            The problem with your post was the use of the word "probably" rather than "possibly".

    • Well gee, if the placebo effect is helping save lives....more power to it. Right?

  • If you squint hard enough, you can see patterns in the noise. Especially if you want to believe. Hopefully this is legit. But I totally get how tricky identifying cause and effect in a system as complex as the human body can be. Imagine a massive complex legacy system for which there is no source code, only core dumps and input-output tests. Hopefully this isn't a will-o-the-wisp [wikipedia.org]. Time will tell. I expect there will be a few before this thing is brought under control.

  • This is a drug that has for a long time been freely prescribed for healthy people traveling internationally to malaria hot zones. That ship has already sailed - it's already a prophylactic medication, albeit for a protozoan instead of for a virus. But if there is even anecdotal evidence that it interferes with coronavirus replication, doctors should absolutely be free to prescribe it to their patients. Let the doctors decide.

    Unfortunately, some people's case of TDS has interfered with their rationality. If

  • Not poisonous? (Score:3)

    by Can'tNot ( 5553824 ) on Tuesday March 31, 2020 @06:00AM (#59891750)
    Hydroxychloroquine exists because it's less toxic than chloroquine, and they're both quite dangerous with a lethal dose which can be only around twice that of the treatment dose. Calling them "not poisonous" is misunderstanding how they're used.

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