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Medicine Science

FDA Approves Gilead's Remdesivir as Coronavirus Treatment (cnbc.com) 77

Posted by msmash from the breaking-news dept.
The Food and Drug Administration on Thursday approved Gilead Sciences' antiviral drug remdesivir as a treatment for the coronavirus. From a report: In May, the FDA granted the drug an emergency use authorization, allowing hospitals and doctors to use the drug on patients hospitalized with the disease even though the drug has not been formally approved by the agency. The intravenous drug has helped shorten the recovery time of some hospitalized Covid-19 patients. It was one of the drugs used to treat President Donald Trump, who tested positive for the virus earlier this month. Earlier in the year, Dr. Anthony Fauci, the nation's leading infectious disease expert, said the drug would set "a new standard of care" for Covid-19 patients. The drug will be used for Covid-19 patients requiring hospitalization, Gilead said. Remdesivir is now the first and only fully approved treatment in the U.S. for Covid-19, which has infected more than 41.3 million and killed more than 1 million, according to data compiled by Johns Hopkins University.
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FDA Approves Gilead's Remdesivir as Coronavirus Treatment More

FDA Approves Gilead's Remdesivir as Coronavirus Treatment

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  • I trust FDA (scientists) and WHO. WHO recently rejected Remdesivir for COVID treatment. Anyone know of Dr Fauci still stands by his earlier statement on efficacy of Remdesivir?

    • Don't see where WHO rejected Remdesivir, it does not appear to be an officially published position. I was able to find some news article about a WHO sponsored study that has not been peer reviewed or published in a scientific journal that states that Remdesivir appears to be ineffective, but it's not the same thing as rejection. If you have a source where WHO rejects, I would like to see it (preferably from the who.int website)

      • Re:Don't know who to trust (Score:5, Informative)

        by sinij ( 911942 ) on Thursday October 22, 2020 @04:19PM (#60637364)
        Here is BBC link Remdesivir 'has little or no effect' on survival, says WHO [bbc.co.uk]

        • Re: (Score:2)

          by cowdung ( 702933 )

          Remdesivir appears to have little effect over MORTALITY rates, but it IS effective in some cases in reducing hospital stays.

          I guess that based on that merit, the drug is being approved since overwhelming hospitals is a major problem with COVID.

          • Re: (Score:1)

            by Anonymous Coward

            "Remdesivir appears to have little effect over MORTALITY rates, but it IS effective in some cases in reducing hospital stays."

            If you live in a big white house with ICU in the basement.

          • Re: (Score:2)

            by Tablizer ( 95088 )

            Remdesivir appears to have little effect over MORTALITY rates, but it IS effective in some cases in reducing hospital stays.

            So it reduces the mortality of insurance co. profits.

            • Re: (Score:2)

              by cowdung ( 702933 )

              So it reduces the mortality of insurance co. profits.

              I suppose.

              Though you could argue that if people stay less time in the hospital they'll be charged less as well.

            • The longer people stay in hospitals, the more "bed-days" are needed for patients overall. If you have 20 beds, over 30 days you can treat 600 bed-day worth of patients. If patients require on average 5 days hospital time you can treat 120 patients. If they require 10 days, you're down to 60 patients. Naturally, this doesn't account for point-in-time surges over capacity, but is still extremely important long-term and even to help with point-in-time surges, because patients that have extended stays are takin

            • Re: (Score:2)

              by deKernel ( 65640 )

              Ah, so you would prefer to stay in the hospital for an extra few days to help increase your exposure to other illnesses...gotcha. Good thinking, much better to screw the insurance company for a few extra days in the hospital....*face_palm*.

          • Remdesivir appears to have little effect over MORTALITY rates, but it IS effective in some cases in reducing hospital stays.

            I guess that based on that merit, the drug is being approved since overwhelming hospitals is a major problem with COVID.

            Your assertion is in contradiction to what the article says. From the article:

            The results, which are yet to be peer-reviewed, suggest that none of these treatments has a substantial effect on mortality or on the length of time spent in hospital, the WHO said on Thursday.

            WHO chief scientist Soumya Swaminathan said on Wednesday that their trials on hydroxychloroquine and lopinavir/ritonavir were stopped in June because they had already proven ineffective. However, the other trials continued.

            The WHO's results appear to contradict a previous study from earlier this month, conducted by Gilead, which concluded that treatment with remdesivir cut Covid recovery time by five days compared to patients given a placebo. About 1,000 patients took part in that trial.

            So no, not just mortality rates, but also hospital stay duration according to the WHO study as reported in the article.

        • Multiple studies have shown that if given early in the infection, remdesivir indeed helps the outcome better (particularly looks at the early treatment versus standard treatment , within cohort with low flow oxygen versus high flow oxygen). But while the WHO study has a larger population, AFAIK it was not double blinded, neither did it consider at which point in the treatment to give remdesivir, nor did it consider whether the patient was in a high flow cohort, or low oxygen flow cohort. Looking at all stud

    • Re:Don't know who to trust (Score:4, Informative)

      by Drishmung ( 458368 ) on Thursday October 22, 2020 @04:29PM (#60637390)
      Here is a useful analysis of what we know so far. [sciencemag.org] (i.e. about 16 Oct)

      TL;DR

      This absolutely excludes the suggestion that Remdesivir can prevent a substantial fraction of all deaths. The confidence interval is comfortably compatible with prevention of a small fraction of all deaths, but is also comfortably compatible with prevention of no deaths.

      • I read that article you linked to. There seem to be quite a lot of drugs that look promising for various good medical reasons, but turn out to be nearly useless against Covid-19, or maybe even harmful in practice. I think doctors should continue testing likely treatments, in the hope of reducing the worst symptoms, and preventing deaths.

        I do not think anyone is saying that remdesivir is a cure for Covid-19, but if it helps some patients recover, then go for it. If I were ill in hospital with Covid-19, I wou

    • Re: (Score:2)

      by GuB-42 ( 2483988 )

      What I've seen is that Remdesivir may not help reducing mortality but it helped patients recover faster.

      Now the question is about the value of a very expensive drug with only a small but real effect.

    • > I trust FDA (scientists)

      The FDA is politicians who have scientists on staff. They don't always agree.

      Go do you own research on why first-line doctors all over the world have themselves on ivermectin, how much it helps with combination therapy, then ask why the FDA is pushing Remdesivir.

      cf. Regulatory Capture

  • ...anti abortion? (Score:3)

    by holophrastic ( 221104 ) on Thursday October 22, 2020 @03:55PM (#60637288)

    Now we get to see how pro-life principles hold-up. So, would you steal bread to feed your starving family?

    • Depends. Is it amazing banana bread or disgusting whole wheat bread?

      Alternative reply 1:
      What do you mean? African or European bread?

      Alternative reply 2:
      Steel bread? I guess it's okay if you have an iron deficiency.

      • It's a proper caraway rye bread, which is technically a whole wheat bread, since rye flour is wheat flour, but done properly, it's also a bit of a sourdough culture too.

        Alternative reply 1:
        Banana bread sucks when it's plain banana bread, but glorious when it's got chocolate chips inside and unsweetened whipped cream on top, with lime zest wherever.

        Alternative reply 2:
        European bread, every time. But not that german one, that's bitter as hell.

        • Eh? Rye is a different plant hence rye flour is not wheat flour. The kind of bread you are talking about should be made of mixed rye and wheat flour because rye doesn't have enough gluten resulting in a not so pleasant mouthfeel.

        • Ray and Wheat are two completely different plants like Apple and Pear or Orange and Grapefruit.

          And the bread you make from them is so far away from each other, the above comparison is a joke in relation.

          But not that german one, that's bitter as hell
          As there is nothing bitter in German bread that does not sound plausible. Perhaps you know a specific brand/type? Some breads contain spices like fennel or Caraway seed, but both are not bitter.

          • Alas, I don't remember the dense, black, german bread that I disliked. There were no seeds visible. Perhaps "bitter" isn't the best term, but I found the crumb quite unpalatable -- which is rare for my palate. Black crumb, black crust, floured crust, dense, heavy, stiff. All of those are good properties in my mind, btw, but the taste was not.

    • Everyone who did not steal that bread, died out.

      Case closed. :)

    • Re: (Score:3, Insightful)

      by Jarwulf ( 530523 )
      Remdesivir is not literally made of aborted babies. An immortalized cell line from the 70s was simply used during some of the tests of its effectiveness. Its such a diluted indirect line of connection the proabortionists crowing about it implying its literally dead babies are just as bad as the hardcore prolifers implying its literally dead babies.

      • Re:...anti abortion? (Score:4, Insightful)

        by ranton ( 36917 ) on Thursday October 22, 2020 @04:25PM (#60637378)

        Its such a diluted indirect line of connection the proabortionists crowing about it implying its literally dead babies are just as bad as the hardcore prolifers implying its literally dead babies.

        No pro-choice individuals are implying it is literally dead babies. They are pointing out hypocrisy in those who would otherwise reject treatments whose research and/or testing were assisted by cells from those cell lines as long as they don't personally need the treatment. Those are very different things. One side has a diluted line of reasoning, and the other is just mocking those with a diluted line of reasoning.

        • None? Did you literally poll every single prochoice person commenting on this in the world and confirmed they fully understood what remdesivir is and how its manufactured? And its not anywhere close to other uses of stem cells. Its like saying a vegan who has a meat eater prepare their pizza or cows provide the sh45 that grew their veggies broke their ethics in the same way as if they directly gulped down a steak.

          • Re: (Score:2)

            by ranton ( 36917 )

            None? Did you literally poll every single prochoice person commenting on this in the world and confirmed they fully understood what remdesivir is and how its manufactured?

            No, but simply being a pro-choice individual places them outside of the group who view fetal tissue as dead babies. My guess is a minuscule number of pro-choice people even know about this Remdesivir controversy, so they are obviously not saying Remdesivir comes from dead babies. Those who are aware either know it was developed with help from immortalized fetal cells from the 70's, or they mistakenly think the cells came from fetal stem cells. Either way, they won't think the drug comes from dead babies.

            My

      • Re: (Score:1)

        by Tablizer ( 95088 )

        Let's see how many of those people actually refuse treatment if sick. I'm torn on whether to admire such people for sticking with their (silly) principles into their own potential death. Dead non-hypocrites.

        • Yeah, admire seems a bit of a strong word, but I can at least respect the conviction of those who are willing to die for their principles, even if I disagree with them.

          Those who would deny the treatment to others, but eagerly embrace it for themselves when it's needed? They deserve no respect at all. (Which includes all those politicians who fight against abortion rights, while secretly getting abortions for their mistresses, daughters, etc)

          Then there's the utilitiarian perspective: you can believe that so

    • Anti-abortion people have shown quite clearly they aren't the least bit interesting in either preserving a quality of life, survival of the parties involved at the time of birth, and overwhelmingly are in favour of preventing welfare for unwanted births, and ironically preventing the pregnancy in the first place.

      Pro-lifers aren't pro-life at all. They are pro-birth. Life itself is something to be tossed away because God only cares about you popping out of a vagina and after that you're on your own.

  • Is anyone else just creeped out by their name?
    Handmaids Tail, for anyone who doesn't get why.

    • Is anyone else just creeped out by their name? Handmaids Tail, for anyone who doesn't get why.

      In these stressful 2020's . . . everyone would feel better with a wee bit of Handmaiden's Tail.

      In fact . . . I am quite confident that Anthony Fauci would recommend everyone get their dose of Handmaiden's Tail . . .

      . . . but American Style . . . do it in the dark, with your clothes on.

    • Re: (Score:2)

      by tsqr ( 808554 )
      I watched that show. None of the Handmaids had tails, which I found a bit disappointing.

      • As only Offred and Ofglen were seen without their outer robes on, they may have been statistical outliers. Yet another reason they were particularly targeted.

    • Re:Company name (Score:4, Interesting)

      by Darinbob ( 1142669 ) on Thursday October 22, 2020 @04:49PM (#60637470)

      Gilead is mentioned in the Bible as the name of two geographical regions and a few people as well. The word has been used long before Margaret Atwood wrote her book and is relatively well known. The name of Gilead Sciences comes from "Balm of Gilead", a supposed universal cure.

      The original name of Gilead Sciences was... Oligogen. Thankfully the name changed.

      • Gilead is mentioned in the Bible as the name of two geographical regions and a few people as well. The word has been used long before Margaret Atwood wrote her book and is relatively well known. The name of Gilead Sciences comes from "Balm of Gilead", a supposed universal cure.

        The original name of Gilead Sciences was... Oligogen. Thankfully the name changed.

        I am aware of the biblical references to Gilead, but as I have read The Handmaids Tale much more recently than I have read the Bible, that is the reference that sticks with me.

    • Handmaid's Tail? I believe that was the porno version.

  • If that loser Fauci recommended it, how good can it be? What does he know?

  • It has been exactly 7 days since the Democrat media went on a crazed propaganda blitz that Remdesivir failed its trial tests. And now it is approved. Can you believe anything that the old-world media outlets is true?

  • But doesn't improve mortality.

  • China and Russia have given emergency approval or other treatments well before this narrow oversupplied emergency PR release. Or perhaps this drive the risk down to SFA cure was overlooked https://covexit.com/australian... [covexit.com] As usual, best outcomes occur when doctors are not told by administrators what works, and what does not.

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