FDA allows unproven plasma treatment for COVID-19 after political pressure from the White House
- The US Food and Drug Administration on Sunday announced an emergency authorization for the use of convalescent plasma to treat COVID-19.
- The treatment, which has not been proved effective against the coronavirus in clinical trials, involves injecting plasma from people who have recovered into patients still fighting the virus.
- The move came after political pressure from President Donald Trump, who claimed without evidence that the FDA was slow-walking approval of the treatment to help Democrats.
The US Food and Drug Administration has issued an emergency authorization for convalescent plasma to treat COVID-19, a move following evidence-free claims from President Donald Trump that a shadowy "deep state" had sought to block the treatment until after this year's 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 maintains that the use of plasma — taken from those who have recovered from the coronavirus and injected into 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 is not full approval but reduces the bureaucratic obstacles to deploy the treatment, which has already been tried on some 53,000 patients in the US. It is still unclear, however, whether the treatment actually works.
"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 plasma treatment, seeking a win in the fight against COVID-19 ahead of the 2020 election. Dr. Luciana 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 was "yielding to political pressure."
Before Sunday's announcement, 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," he said without evidence.
CNBC reported on Sunday that the Trump administration was also seeking to fast-track the approval of a coronavirus vaccine before the November election, which could echo efforts by Russian President Vladimir Putin to declare victory before the completion of clinical trials.
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