The World Health Organization on Thursday recommended against continuing to use the antiviral belt disivir to treat COVID-19, saying the drug, which President Trump received in October when he was hospitalized with coronavirus, “had no meaningful effect on mortality or on others. important results for patients. ”
This stinging scientific reprimand 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 researchers found that the drug shortened the recovery time for COVID-1
In its decision to approve CODID-19 for the treatment of CODID-19, the FDA also relied on data from Gilead Sciences, the drug manufacturer, which critics consider unreliable because the results were not compared with placebo treatment, the New York Times reported.
The FDA, meanwhile, has “never consulted a group of external experts as it is ready to weigh complicated antiviral drug issues,” Science News reported.
On May 1, with the first wave of the pandemic still spreading across the United States, the FDA announced that it was giving the belt device for emergency use. That same day, Trump, Gilead Sciences CEO Dan O’Day and FDA chief Stephen Hahn attended a briefing by the coronavirus task force to praise the drug as a milestone in the treatment of the disease.
Trump boasted that thanks to remdesivir “we get some really incredible results” in helping patients.
With the prospect of a stormy income in Gilead, O’Day announced that the company would donate 1.5 million vials for patient use.
Hahn, who was already under fire for the FDA’s approval for emergency use of hydroxychloroquine, the recycled drug for malaria, which Trump called a “game changer” for COVID-19, also praised the potential for remdevir.
“This is an important clinical advance that showed a statistically significant reduction in time to recovery for patients with COVID-19. And it’s the first approved therapy for COVID-19, so we’re really proud to be a part of it, Mr President. And thank you for your leadership. ”
On July 29, Gilead Sciences established a $ 3,120 price tag for a remdesivir treatment course for the average private insurance patient. The same day, the Department of Health and Human Services announced that it had agreed to purchase large supplies of the drug.
“President Trump has entered into an astonishing agreement to ensure that Americans have access to the first approved therapeutic treatment for COVID-19,” HHS Secretary Alex Azar said in a statement. “To the extent possible, we want to make sure that any American patient who needs a belt strap can get it. The Trump administration is doing everything in our power to learn more about life-saving therapy for COVID-19 and ensure access to these opportunities for the American people. ”
Following a contract with COVID-19 on October 2, Trump became seriously ill and was transferred to Walter Reed Medical Center. There he received several drugs to treat the disease, including a five-day course of remdesivir, steroid dexamethasone, and a monoclonal antibody manufactured by Regeneron Pharmaceuticals.
While the president recovered quickly, cases of COVID-19 and deaths from it continued to rise sharply during the month of October, and the demand for belt straps rose sharply. When the FDA formally approved the drug on October 22, Gilead Sciences shares rose sharply after trading in hours. Thanks to an agreement to supply the drug to the EU, Gilead Sciences has so far generated well over 1 billion. $ In revenue from sales of belt veneer.
While the FDA revoked its emergency use approval of hydroxychloroquine after several studies showed health risks and little or no benefit to patients taking the drug, as of Friday afternoon, it had not taken any steps toward strapsivir.
Trump has 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 will take effect next July, unless President-elect Joe Biden withdraws it.
At a time when the FDA is also reviewing an emergency use approval of Pfizer’s vaccine against the disease, White House coronavirus task forces are fighting to reassure the public that no corners will be cut in the drug approval process. As Dr. Anthony Fauci noted at a Thursday briefing of the task force for Coronavirus in the White House, to establish that trust will be the key to determining how long the pandemic lasts.
“The only way you can get an effective program is when people take the vaccine,” said Dr. Anthony Fauci at a news conference Thursday. “I hear a lot now when we published these messages last Monday and then two Mondays ago about some restraint among people – ‘Well, did you hurry here?’ “Was this too fast?” ‘Is it really safe, and is it really effective?’ The process of speed did not compromise safety at all, and it did not jeopardize scientific integrity. ”
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