FDA approves unproven plasma treatment for COVID-19

  • The FDA on Sunday announced an emergency authorization for the use of convalescent plasma to treat COVID-19.
  • The unproven treatment involves injecting plasma from people who have recovered into patients still fighting the coronavirus.
  • The move comes after political pressure from President Trump, who claimed without evidence that the FDA had not already approved the treatment in order to help Democrats.
  • Visit Business Insider’s homepage for more stories.

The US Food and Drug Administration has issued an emergency authorization to use convalescent plasma to treat COVID-19, a move that follows evidence-free claims from President Trump that a shadowy “deep state” was blocking the treatment until after the election.

Speaking from the White House on Sunday, Trump asserted that the approval marked “a breakthrough” in the treatment of the coronavirus.

But, as the Associated Press reported, the FDA has warned that the use of plasma — taken from those who have recovered from the coronavirus and injected in those who are still fighting it — “should not be considered a new standard of care for the treatment of patients with COVID-19.”

The emergency authorization reduces the bureaucratic obstacles to deploy the treatment, which has already been tried on some 53,000 patients in the US. That, however, will also make it harder to determine if the treatment actually works, leaving researchers with only anecdotal evidence.

 

“Without a randomized control trial, it’s very difficult to be certain that what you have is meaningful,” Dr. W. Ian Lipkin, who had been leading a clinical trial of the treatment at Columbia University, told The New York Times earlier this month.

But the Trump administration has been pressuring to the FDA to authorize the use of plasma, seeking a win in the fight against COVID-19 ahead of the 2020 election. Dr. Luciano Borio, a public health expert who served on the National Security Council under Trump, told the Times that approving the treatment would be a sign the FDA is “yielding to political pressure.”

Before Sunday’s announcement, President Trump tweeted that “the deep state, or whoever, over at FDA” was hindering efforts to find a cure for COVID-19. “Obviously, they are hoping to delay the answer until after November 3rd.”

As CNBC reported on Sunday, the Trump administration is also reportedly seeking to fast track the approval of an experimental vaccine before the November election, mirroring efforts by Russian President Vladimir Putin to declare victory before the completion of clinical trials.

Have a news tip? Email this reporter: cdavis@insider.com

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