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Thread: Huge COVID study finds remdesivir doesn’t work—FDA grants approval anyway

  1. #1

    Huge COVID study finds remdesivir doesn’t work—FDA grants approval anyway

    The US Food and Drug Administration on Thursday issued a full approval of the antiviral drug remdesivir for treating COVID-19—just days after a massive global study concluded that the drug provides no benefit.

    “The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” FDA Commissioner Stephen Hahn said in a statement. “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic.”

    Early results

    The FDA made its decision based on three clinical trials on remdesivir, a repurposed experimental antiviral drug brand-named Veklury. One was a randomized, double-blind, placebo-controlled trial run by the National Institute of Allergy and Infectious Diseases. It included 1,062 hospitalized COVID-19 patients, 541 of which received remdesivir. The trial concluded that remdesivir shortened the median recovery time from the infection from 15 days to 10 days. The researchers running the trial defined “recovery” of a patient as either a patient being discharged from the hospital—regardless if the patient still had lingering symptoms that limited activities or required supplemental oxygen to be taken at home—or a patient remaining in the hospital but no longer requiring medical care, such as if they were kept in the hospital for infection-control reasons.

    The other two trials the FDA considered were conducted by Gilead, the company that makes remdesivir. One trial looked at about 600 people with moderate cases COVID-19. Patients were split into three groups, each about 200 people—a group that got a 10-day course of remdesivir, a group that got a 5-day course, and a control group that got standard treatments. At day 11 of treatments, the group that had the 5-day course of remdesivir showed a statistically significant improvement in symptom scores compared with the control group. The group that got a 10-day course of remdesivir did not have a statistically significant improvement over the control group, though.

    The other Gilead trial looked at 400 patients with severe COVID-19. They were split about evenly into just two groups—a group that got a 5-day course of remdesivir and a group that got a 10-day course. There were no statistically significant differences in recovery or deaths between the two groups.

    Missing data

    “The [FDA] approval of Veklury marks an important milestone in efforts to help address the pandemic by offering an effective treatment that helps patients recover faster and, in turn, helps preserve scarce healthcare resources,” Barry Zingman said in a press statement released by Gilead. Zingman is a professor at Albert Einstein College of Medicine and one of the researchers who conducted the NIAID trial of remdesivir.

    But the FDA’s approval of remdesivir falls on the heels of data form the fourth and largest trial of the drug, and that trial showed no benefit. The data comes from the World Health Organization’s massive Solidarity trial, which set up an international network of trials enrolling nearly 12,000 patients at 500 sites in over 30 countries, testing multiple repurposed therapeutics. Remdesivir was initially developed over a decade ago as a potential treatment for hepatitis C and RSV (respiratory syncytial virus). It has also been tested against Ebola but was beat out by other treatments.

    According to preliminary results from the Solidarity trial—reported online last week ahead of its planned publication in the New England Journal of Medicine—remdesivir was given to 2,743 patients, and their outcomes were compared with those of 2,708 patients given standard treatments. Between the two groups, WHO found that remdesivir did not reduce mortality. It also did not change how many patients progressed to needing mechanical ventilation, nor did it change the proportion of patients discharged after seven days of hospitalization.
    "The one permanent emotion of the inferior man is fear - fear of the unknown, the complex, the inexplicable. What he wants above everything else is safety."
    H. L. Mencken

    Quote Originally Posted by Contumacious View Post
    Yes, indeed , we will never be able to prove fraud.

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  3. #2
    Abolish the FDA.

    Frédéric Bastiat (1801-1850)

    • "When law and morality are in contradiction to each other, the citizen finds himself in the cruel alternative of either losing his moral sense, or of losing his respect for the law." - The Law (p. 54)
    • "Government is that great fiction, through which everybody endeavors to live at the expense of everybody else." - Government (p. 99)
    • "[W]ar is always begun in the interest of the few, and at the expense of the many."
      - Economic Sophisms - Second Series (p. 312)
    • "There are two principles that can never be reconciled - Liberty and Constraint."
      - Harmonies of Political Economy - Book One (p. 447)

    · tu ne cede malis sed contra audentior ito ·
    MOFA (Make Orwell Fiction Again)

  4. #3
    Everybody knows Remdesivir is not a good treatment at this point. I'm not even convinced that the president actually took it when he got sick.
    "Perhaps one of the most important accomplishments of my administration is minding my own business."

    Calvin Coolidge

  5. #4
    This article is why I am voting for Trump. This isn't just good Trump. This is a Trump administration at its best. The FDA probably shouldn't exist but if they do, they should only focus on safety. There is no reason not to approve this drug for Covid. Trump's administration has been a step in the right direction with the FDA with expanding compassionate use as well.

    Only a complete anti-liberty troll thinks approving this Gilead drug is a bad thing. Also..

    "A new report out from PricewaterhouseCoopers shows that the agency reined in its issuance of new federal regulations to a 20-year low in 2017, as the Scott Gottlieb stepped up to the helm as commissioner."

    "the number of new drug approvals has soared to a record high, with 53 new approvals"
    Last edited by Krugminator2; 10-24-2020 at 08:13 AM.

  6. #5
    Frau Doktor Mole, the Ars Technica reporter, does a horrendous job explaining (surprised aren't we) the FDA approval process to an average reader. While there may be many clinical trials with their results in the public domain, the only ones that the FDA can consider during an approval are those submitted by the sponsor. The reviewers are looking for broad indicators of safety (their primary concern) and narrow indicators of efficacy AS DEFINED by the sponsor. Once approved, the sponsor can only make the efficacy claims that are in the FDA approval. If they discover new efficacy indicators in post-market Phase IV trials they will need to go back to the FDA for an addendum to the original approval. After the approval, the FDA can consider subsequent clinical trial outcomes from anywhere on the basis of safety to rescind and approval or issue a black box warning.

    Big PDF warning.
    Here is the FDA document Q&A on remdesivir released just a few hours ago.

    "They sell us the president the same way they sell us our clothes and our cars. They sell us every thing from youth to religion the same time they sell us our wars. I want to know who the men in the shadows are. I want to hear somebody asking them why. They can be counted on to tell us who our enemies are but theyre never the ones to fight or to die." - Jackson Browne Lives In The Balance

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