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The World Health Organization on Thursday recommended not to continue using the antiviral remdesivir to treat COVID-19, saying the drug, which President Trump received in October during his coronavirus hospitalization, did not had “ no significant effect on mortality or other important patient outcomes. “
This scathing scientific rebuke comes a month after the U.S. Food and Drug Administration approved remdesivir as a treatment for coronavirus infection, despite limited and conflicting evidence of its effectiveness. While a clinical trial conducted in May by federal scientists found that the drug reduced recovery time for patients with COVID-19, a more comprehensive WHO study found that remdesivir did not prevent death patients who took it.
In its decision to approve remdesivir to treat COVID-19, the FDA also relied on data provided by Gilead Sciences, the drug’s maker, which critics consider unreliable because the results have not been compared. to treatment with a placebo, The New York Times reported.
The FDA, meanwhile, “has never consulted with a panel of outside experts it is willing to weigh in on complex issues of antiviral drugs,” Science News reported.
On May 1, with the first wave of the pandemic still spreading in the United States, the FDA announced it was granting emergency use clearance for remdesivir. On the same day, Trump, Gilead Sciences CEO Dan O’Day, and FDA chief Stephen Hahn attended a coronavirus task force briefing to hail the drug as a milestone in treatment of disease.
Trump boasted that with remdesivir “we’re going to have some really amazing results” in helping patients.
Looking ahead to a revenue windfall for Gilead, O’Day announced the company will donate 1.5 million vials for patient use.
Hahn, who was previously criticized for the FDA’s emergency use clearance for hydroxychloroquine, the reused antimalarial drug Trump called a “game changer” for COVID-19, also praised the potential of remdesivir .
“This is an important clinical breakthrough that has shown a statistically significant reduction in recovery time for patients with COVID-19. And this is the first therapy authorized for COVID-19, so we are really proud to be a part of it, Mr. President. And thank you for your leadership.
On July 29, Gilead Sciences set a price of $ 3,120 for treatment with remdesivir for the average patient with private insurance. On the same day, the Department of Health and Human Services announced that it had agreed to purchase large quantities of the drug.
“President Trump has made an incredible deal to ensure Americans have access to the first authorized treatment for COVID-19,” HHS Secretary Alex Azar said in a statement. “Whenever possible, we want to make sure that any patient in the United States who needs remdesivir can get it. The Trump administration is doing everything in its power to learn more about life-saving therapies for COVID-19 and to secure access to those options for the American people.
After contracting COVID-19 on October 2, Trump fell seriously ill and was transferred to Walter Reed Medical Center. There he was given several drugs to treat the disease, including a five-day course of remdesivir, the steroid dexamethasone, and a monoclonal antibody made by Regeneron Pharmaceuticals.
As the president quickly recovered, cases of COVID-19 and death continued to rise sharply during October, and demand for remdesivir skyrocketed. When the FDA officially approved the drug on Oct. 22, Gilead Sciences stock rose sharply after hours of trading. Thanks to an agreement to supply the drug to the European Union, Gilead Sciences has so far generated more than $ 1 billion in revenue from the sale of remdesivir.
As the FDA revoked its emergency use authorization for hydroxychloroquine after other studies showed health risks and little to no benefit to patients taking the drug, Friday afternoon , she had not taken any action on the remdesivir.
Trump announced that the United States intends to withdraw from the World Health Organization, the international body that, among other functions, helps coordinate the response to pandemics. The withdrawal takes effect next July, unless President-elect Joe Biden dismisses it.
At a time when the FDA is also reviewing an emergency use authorization for Pfizer’s disease vaccine, officials of the White House Coronavirus Task Force are scrambling to assure the public that no corner is cut in the drug approval process. As Dr Anthony Fauci noted in a briefing Thursday from the White House Coronavirus Task Force, establishing that trust will be critical in determining the duration of the pandemic.
“The only way to have an effective program is when people take the vaccine,” Dr Anthony Fauci said during a press briefing Thursday. “I hear a lot now when we made these announcements last Monday and then two Mondays ago about some reluctance among people – ‘Well, did you rush that?’ “Was it too fast?” “Is it really safe and is it really effective?” The speed process did not compromise safety at all, nor did it compromise scientific integrity.
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