Public health experts on Saturday decried the Food and Drug Administration’s “troubling” approval of a Covid-19 treatment which has not been proven to help patients who are severely ill with the disease.
The FDA expanded its emergency authorization on remdesivir on Friday evening, allowing its use for all patients who are hospitalized with Covid-19. Previously, the drug had been approved — and shown to benefit — only patients who are not ill enough to require the use of a ventilator.
FDA Commissioner Stephen Hahn claimed that “the data show that this treatment has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus,” but epidemiologists and other experts pushed back.
“No published research supports such widespread use,” tweeted Eric Fiegl-Ding, a fellow at the Federation of American Scientists.
Ugh—The FDA has done it again—approved something without trial data to back it up. FDA just allowed the drug remdesivir to be used on all patients hospitalized with #COVID19, although no published research supports such widespread use. https://t.co/8SaTA0shD0
— Eric Feigl-Ding (@DrEricDing) August 29, 2020
Remdesivir has been shown to improve recovery time for patients who require oxygen but not ventilation, but has not been shown to save lives in the sickest patients, according to data from the New England Journal of Medicine.
“It seems to be a pattern of approval without science, without data, without evidence,” Eric Topol, vice president for research at Scripps Research in La Jolla, California, told USA Today.
Earlier this week, Topol expressed “horror” at claims made by Hahn and President Donald Trump about the efficacy of convalescent plasma in treating the coronavirus. Hahn later apologized publicly for overstating the benefits of plasma from patients who have recovered from Covid-19.
On Friday, two public relations officials were fired from their jobs at the FDA. Both had been involved in the agency’s messaging regarding plasma, and one had encouraged Hahn to apologize for his original statement about the treatment. The dismissals, as well as Trump’s repeated claims that the agency is standing in the way of his reelection chances by holding back approval for treatments and vaccines, raised alarm among public health experts who fear the politicization of the FDA in the midst of the Covid-19 pandemic.
For many members of the public, Topol told USA Today, the FDA’s credibility has “already been sacrificed.”
As Common Dreams reported earlier this week, the White House has recently suggested that a vaccine for Covid-19 could be approved by the FDA as early as September, even though phase 3 trials—the standard randomized, controlled studies generally required before authorization. The Trump campaign reportedly refers privately to a vaccine approval by October, just ahead of the general election, as “the holy grail.”
4) What I worry about the most…. is an October surprise… of FDA being forced to do something it doesn’t want to or science doesn’t support. That keeps me awake at night.
— Eric Feigl-Ding (@DrEricDing) August 29, 2020
“I hope Stephen Hahn will find his conscience and think about the greater good and greater harm his agency can cause,” tweeted Feigl-Ding on Saturday. “Bending to Trump White House pressure will only harm trust in the longtime venerable institution and hurt public health for generations to come.”
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