• #Remdesivir approved by #FDA to treat #COVID-19, but the evidence is mixed - Vox

    Faust said one of his concerns with the FDA’s remdesivir approval is a phenomenon known as #indication_creep, in which a treatment shown to work in only a limited set of circumstances gets prescribed to more and more people. The worry here is that remdesivir, which is approved only for Covid-19 patients over 12 years old who required hospitalization, could start being used in patients with milder Covid-19 illness, or in more severe cases past the point where it could be effective.

    “What will happen, I guarantee, is people will start to use the medication more than they need it,” Faust said. Since the course of treatment is five days, it could also extend the length of hospital stays in patients who would otherwise be discharged earlier, saddling them with unnecessary costs.

    Another concern is that the approval of remdesivir, especially with such mixed evidence for its effectiveness, could undermine further research.

    Topol noted that with remdesivir now as the only fully approved drug, it becomes much more difficult to conduct studies on other therapies because they now have to be compared against remdesivir, the new standard treatment, as well as a a placebo.

    That raises the cost and complexity of trials, delaying results. Such comparisons are worthwhile if the standard of care is effective, but it adds unnecessary complications if it’s not.

    It also makes it harder to recruit people for subsequent clinical trials of the drug to better validate its effectiveness. People may be more reluctant to sign up for a trial where they could get a placebo when they know they could get the actual drug.

    “The biggest, most serious problem is that we won’t get to the truth,” Topol said.

    It’s worth noting that remdesivir could still be a viable treatment for Covid-19, but the evidence presented so far is contradictory and more investigation is needed to clarify its effectiveness. So why did the FDA go ahead with its approval, then?

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    La FDA a approuvé le remdesivir pour traiter le Covid-19. Les scientifiques remettent en question les preuves. - News 24

    La FDA a déjà pris des décisions controversées concernant les médicaments pour traiter Covid-19. En mars, l’agence a accordé une autorisation d’utilisation d’urgence pour l’hydroxychloroquine, un médicament antipaludique, après que le président Trump l’a qualifié de « changeur de jeu ». Puis, en juin, la FDA a révoqué l’EUA, affirmant que l’hydroxychloroquine était « peu susceptible d’être efficace » et pourrait entraîner des problèmes cardiaques.

    Puis en août, l’agence a accordé une EUA pour le plasma de convalescence pour traiter Covid-19. Mais les National Institutes of Health ont déclaré que les preuves utilisées par la FDA étaient « insuffisantes ».