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Medicine

FDA Ends Emergency Use Authorization For Hydroxychloroquine To Treat COVID-19 221

The Food and Drug Administration has ended its emergency use authorization for hydroxychloroquine and chloroquine, drugs the president touted in the fight against coronavirus. Mr. Trump took a 14-day regimen of hydroxychloroquine himself. CBS News reports: Based on the FDA's continued review of the available scientific evidence, it determined the drug is "unlikely to be effective in treating COVID-19 for the authorized uses," the FDA said. The agency added that "in light of ongoing serious cardiac adverse events and other serious side effects, the known benefits "no longer outweigh the known and potential risks."

A study published earlier this month concluded that the drug is not effective at preventing the disease. As CBS News chief medical correspondent Dr. Jon LaPook explains, controlled clinical trials are the only way to prove if a drug works better than a placebo or other treatment, or if its potential benefits outweigh the risks.
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FDA Ends Emergency Use Authorization For Hydroxychloroquine To Treat COVID-19

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  • by MikeDataLink ( 536925 ) on Monday June 15, 2020 @09:35PM (#60187818) Homepage Journal

    I am so sick of this. It's a dead horse. It doesn't work. It never worked. It was only political because Trump said it.

    • Re: (Score:2, Insightful)

      by rsilvergun ( 571051 )
      It was political because one of Trump's largest donors owns the company that makes the stuff. Trump is a saleman, showman and businessman. This is the sort of thing to be expected. It would be funny if it wasn't putting folks lives at risk.
      • It was political because one of Trump's largest donors owns the company that makes the stuff.

        Doesn't Trump do enough bad things on his own without you having to make things up out of thin air? There are more than a dozen companies "that makes the stuff", not one. Most aren't based in the US. Most are publicly traded and have broadly distributed ownership.

        Name the donor, name the amount donated, name the company, and I'll shut up (for now).

    • by backslashdot ( 95548 ) on Monday June 15, 2020 @09:54PM (#60187860)

      Trump seems to have the worst judgment ever. He hired people he later claimed were idiots (Mathis etc.). He said China had COVID under control. Then in May he said if there were under 100,000 covid deaths he be doing well. He blames his own federal agencies for incompetence when he's their boss. Did he not learn in eleementary school or at least on Sesame Street that the president has control of the federal branch?

      • And yes I meant executive branch. Don't fixate on pedantics.

      • he said if there were under 100,000 covid deaths he be doing well.

        And if it was over 100,000 then that's what his administration had predicted.

        He can't lose either way.

      • by jeti ( 105266 )
        Leadership: Whatever happens, you're responsible. If it doesn't happen, you're responsible.
        Donald J. Trump [twitter.com]
    • Remember back in March when doctors were hoarding the stuff? That should have been more of a story. Screw you, doctors.
    • Re: (Score:2, Redundant)

      by eclectro ( 227083 )

      The lesson to learn here is that politics trumps (no pun intended) scientific investigation and fact. This hurts science across the board, not just that abou HCQ

      Saying something does or does not work requires further scientific investigation. Which simply has not taken place with the combination HCQ/Azithromycin/Zinc. As it stands now there is no double blind study on this, though other doctors in other countries say that there is a positive effect.

      This is not about pushing a single treatment for Covid19, b

      • by Kernel Kurtz ( 182424 ) on Monday June 15, 2020 @10:52PM (#60187980)

        Saying something does or does not work requires further scientific investigation. Which simply has not taken place with the combination HCQ/Azithromycin/Zinc. As it stands now there is no double blind study on this, though other doctors in other countries say that there is a positive effect.

        Obviously a huge global conspiracy. If only some government health agency had hired you, you would save the world.

        I've seen that mindset before, even recently LOL.

      • by dfghjk ( 711126 )

        "Saying something does or does not work requires further scientific investigation. Which simply has not taken place with the combination HCQ/Azithromycin/Zinc. As it stands now there is no double blind study on this, though other doctors in other countries say that there is a positive effect."

        And those countries have since changed their positions, and the whole "combination" things has always been part of a misinformation campaign. The most insulting thing, though, is the insinuation that the research comm

    • It is unfortunately political, but according to real doctors, not the armchair kind, HCQ is useful to suppress a Cytokine Storm, which is one of the complications of Covid19. So, no it doesn't cure Covid19, but in certain specific cases, it helps and when Remdesivir is unavailable, HCQ is all they got.
      • For the exact same reasons that it would be useful to treat cytokine storm syndrome it would be a bad idea to give it otherwise. This is serious "duh," or "downhill both ways" territory.

      • the doses needed to make that suppression work are likely to give you a heart attack.

        There are lots of drugs out there that can treat you but who's risks outweigh the benefit. HCQ is one of them. What matters is the dose needed to achieve the effect.
    • by Tablizer ( 95088 )

      Trump taking more of it is one the few issues both sides agree on. A toast to bipartisanship!

    • Comment removed based on user account deletion
    • Except for all the trials, studies and countries that have used it successfully anyways. The Association of American Physicians and Surgeons started keeping track with their own database of studies showing where it has been successfully used after getting annoyed politics getting inserted into medicine.

      To date, the total number of reported patients treated with HCQ, with or without zinc and the widely used antibiotic azithromycin, is 2,333, writes AAPS, in observational data from China, France, South Korea,

      • Onyxruby says:"To date, the total number of reported patients treated with HCQ, with or without zinc and the widely used antibiotic azithromycin, is 2,333, writes AAPS, in observational data from China, France, South Korea, Algeria, and the U.S. Of these, 2,137 or 91.6 percent improved clinically."

        This.

        It is well-understood that even a single properly-executed exploratory study can provide more information than multiple double-blind placebo controlled studies done poorly. Journalists don't understand this

        • by dog77 ( 1005249 )

          a single properly-executed exploratory study can provide more information than multiple double-blind placebo controlled studies done poorly.

          I think the University of Minnesota double blind randomized HCQ trial is an example of this ( https://www.nejm.org/doi/full/... [nejm.org] ). I am not saying it was a useless study, but the result of HCQ not working is not as clear cut as the news headlines want to make it out to be.

          To begin with it was not well controlled. The drugs were administered by the participants with no oversight. The results were conducted through surveys.

          The study was not able to mask very well on whether the participants got the

  • If I were to venture a guess, they probably don't want to dry up the supply so people with malaria and lupus still have readily available access to medication
    • Finally those werewolves will be able to get the medication they need again. Must have been some real white-knuckle full moons for a while.
  • Sorry (Score:4, Insightful)

    by sphealey ( 2855 ) on Monday June 15, 2020 @09:48PM (#60187850)

    Sorry dead and injured people.
    Sorry wasted money.
    Nobody could have predicted...

  • How about intravenous bleach? I hope the liberals don't get that one on the FDA Not Recommended list.

    • Don't worry, there are plans available on-line for a do-it-yourself lung and throat treatment - all you need is a bottle of bleach and a cool mist humidifier.

  • by ClarkMills ( 515300 ) on Monday June 15, 2020 @11:29PM (#60188082)

    ...we just had a couple of people fly in with the virus. Driven half way down the country (Akl --> Wgn). Apparently one of them felt sick before leaving but went anyway. Usual fun trying to track down the cloud of doom they've sprayed behind them...

    https://www.stuff.co.nz/nation... [stuff.co.nz]

    • Was one of them James Cameron?

  • On the up side, people who really need hydroxychloroquine to treat lupus, rheumatoid arthritis and malaria will no longer face shortages caused by idiots vaccuuming up supplies to waste on COVID-19.

    Down side: fewer Trump supporters will fall victim to the side effects.

  • by 91degrees ( 207121 ) on Tuesday June 16, 2020 @05:52AM (#60188590) Journal

    "Mr. Trump took a 14-day regimen of hydroxychloroquine himself."

    No. Trump claimed to have been taking it himself. He's the only person to have made this claim, and he's not known for telling the truth.

    • by dfghjk ( 711126 )

      Exactly. It is amazing what suckers people are. There is absolutely no reason to believe Trump ever took HCQ. He PROMOTED it.

    • No. Trump claimed to have been taking it himself. He's the only person to have made this claim, and he's not known for telling the truth.

      No Trump claimed it, the White House official statement repeated it, and his doctor penned and signed and official statement to the fact that he was taking it under his supervision: https://twitter.com/anitakumar... [twitter.com]

      Now as to how deep the web of lies goes you can make your own claim. But honestly it doesn't matter what you believe, and it matters even less if he did in fact take it. The statement itself carries far more weight than the action. No one gives a shit what's in Trump's blood and whether he did or

  • big shakeup coming to top ranks at FDA.

Truly simple systems... require infinite testing. -- Norman Augustine

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