The World Health Organization on Thursday recommended against continuing to use the antiviral remdesivir to treat COVID-19, saying the drug, which President Trump received in October when he was hospitalized with the coronavirus, has “no meaningful effect on mortality or on other important outcomes for patients.”
That stinging scientific rebuke comes one month after the U.S. Food and Drug Administration approved remdesivir as a treatment for coronavirus infection, despite limited and conflicting evidence on its effectiveness. While a clinical trial conducted in May by federal scientists found that the drug shortened recovery time for COVID-19 patients, a more comprehensive study by the WHO found that it did not prevent death for 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 manufacturer, which critics consider unreliable because the results were not compared to treatment with a placebo, the New York Times reported.
The FDA, meanwhile, “never consulted a group of outside experts that it has at the ready to weigh in on 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 it was giving remdesivir emergency use authorization. That same day, Trump, Gilead Sciences CEO Dan O’Day and FDA chief Stephen Hahn attended a briefing of the White House coronavirus task force to praise the drug as a milestone in the treatment of the disease.
Trump boasted that, thanks to remdesivir, “we’re going to be having some really incredible results” in helping patients.
With the prospect of a windfall in revenues for Gilead, O’Day announced the company would donate 1.5 million vials for use by patients.
Hahn, who was already under fire for the FDA’s emergency use authorization for hydroxychloroquine, the repurposed antimalarial medication that Trump called a “game changer” for COVID-19, also hailed the potential for remdesivir.
“This is an important clinical advance that showed a statistically significant reduction in time to recovery for patients with COVID-19,” Hahn said. “And it’s the first authorized therapy for COVID-19, so we’re really proud to be part of it, Mr. President. And thank you for your leadership.”
On July 29, Gilead Sciences established a price of $3,120 for a course of treatment with remdesivir for the average patient with private insurance. That same day, the Department of Health and Human Services announced it had agreed to purchase large supplies of the drug.
“President Trump has struck an amazing deal to ensure Americans have access to the first authorized therapeutic for COVID-19,” HHS Secretary Alex Azar said in a statement. “To the extent possible, we want to ensure that any American patient who needs remdesivir can get it. The Trump Administration is doing everything in our power to learn more about life-saving therapeutics for COVID-19 and secure access to these options for the American people.”
After contracting COVID-19 on Oct. 2, Trump fell seriously ill and was transferred to Walter Reed National Military 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.
While the president quickly recovered, cases of COVID-19 and deaths from it continued to rise sharply over the month of October, and demand for remdesivir skyrocketed. When the FDA formally approved the drug on Oct. 22, Gilead Sciences stock rose sharply in after-hours trading. Thanks to a deal to provide the drug to the European Union, Gilead has so far generated well over $1 billion in revenue from the sale of remdesivir.
While the FDA did rescind its emergency use authorization for hydroxychloroquine after more studies showed health risks and little or no benefit for patients who took the drug, as of Friday afternoon it had taken no action on remdesivir.
Trump has announced that the U.S. 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 rescinds it.
At a time when the FDA is also reviewing an emergency use authorization for Pfizer’s vaccine for the disease, officials with the White House coronavirus task force are scrambling to assure the public that no corners are being cut in the drug approval process. As Dr. Anthony Fauci noted at a Thursday briefing of the task force, establishing that trust will be key in determining how long the pandemic drags on.
“The only way you can get an effective program is when people take the vaccine,” Fauci said. “I hear a lot now when we made these announcements this past Monday and then two Mondays ago about some reticence among people — ‘Well, did you rush this?’ ‘Was this too fast?’ ‘Is it really safe, and is it really efficacious?’ The process of the speed did not compromise at all safety, nor did it compromise scientific integrity.”
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