The Food and Drug Administration Urgently Authorized the New Coronavirus Plasma Therapy. Trump Boasted of a 'Historical Breakthrough'



Trump, who has been seeking effective treatments for new coronavirus pneumonia, has recently found a new 'major breakthrough'. This time he recommended plasma therapy.

According to the U.S. 'Capitol Hill' report on August 23 local time, at the White House briefing that day, the U.S. Food and Drug Administration (FDA) announced an emergency authorization of convalescent plasma therapy to treat patients with new coronavirus. Trump said at the briefing that this will 'greatly expand the treatment methods' and is a 'historical breakthrough'.




'Under Trump's pressure, the Food and Drug Administration approved the new coronavirus plasma therapy', a screenshot of the Capitol Hill report

Trump obviously attaches great importance to this therapy, and deliberately tweeted a 'preview' before the start of the briefing: 'Today (23rd local time) at 5:30 pm, there will be a very important White House briefing. Good news!'

U.S. Food and Drug Administration Director Stephen Hahn also attended the briefing. He and Trump announced the decision and expressed their endorsement of plasma therapy, 'Scientists have concluded that the new coronavirus recovery period plasma is safe and has a certain therapeutic effect, so it meets the standards of emergency authorization.'

Hahn claimed that their latest data showed that the survival rate of patients receiving convalescent plasma treatment 'increased by 35%'. But when reporters asked him aloud whether he felt pressured by the decision, Hahn did not answer. The 'Capitol Hill' stated that the decision of the Food and Drug Administration was probably made under Trump's pressure.

The Secretary of Health and Human Services Alex Azar, who also attended the briefing, also praised plasma therapy, describing this progress as a 'significant advancement in the treatment of new coronavirus patients'.

Convalescent plasma is collected from patients recovered from the new coronavirus and treated with
virus-specific antibodies produced by them. This treatment method has been used in the treatment of infectious diseases such as SARS and Middle East Respiratory Syndrome (MERS). According to reports, nearly 70,000 new crown patients in the United States have received plasma therapy.



US Food and Drug Administration Director Stephen Hahn, video screenshot


Although this treatment has been 'endorsed' by the U.S. government, the public is also worried about whether the Food and Drug Administration has approved the treatment prematurely without sufficient data. Some American medical experts are also cautious and even skeptical.

Ashish Jha, director of the Harvard Institute for Global Health, said, 'I have always been optimistic about plasma therapy, but optimism is not the same as science... We still need sufficient randomized trial results, and emergency approval will only make such trials more difficult. This may damage the credibility of the Food and Drug Administration.'

Scott Gottlieb, the former director of the US Food and Drug Administration, said that plasma therapy has begun to be widely used in the United States. This will be a 'gradual' process, but relevant agencies still need to figure out the specific effect.of the therapy.

The New York Times also mentioned in a report on the 19th that Fauci and his colleagues, the top US infectious disease expert, publicly stated last week that they believe that the current research data is not enough to prove the effect of plasma therapy and requested the Food and Drug Administration to postpone related approvals. The Food and Drug Administration indeed shelved the approval of plasma therapy for a while.




Experts such as Fauci believe that the data is insufficient. The Food and Drug Administration postponed the approval of plasma therapy on the 19th. Screenshot of the New York Times report on the 19th

Although Hahn insisted at the meeting that the decision was made after 'independent judgment', the American people still suspected that it was the result of Trump's political pressure. On the 19th, after the Food and Drug Administration shelved the approval of plasma therapy, Trump publicly criticized the department, accusing it of a 'political conspiracy' against him and intended to 'delay the authorization until after the election.'

At the briefing on the 23rd, Trump also reiterated this point again. He criticized the Food and Drug Administration in front of Hahn, saying, 'I guess in the Food and Drug Administration and some large departments, there must be someone who is very happy to see this being shelved. I am very sure of this.'

It is worth noting that Trump and the U.S. Food and Drug Administration's statement happened to be issued on the eve of the Republican National Congress, which is scheduled to be held from the 24th to the 27th local time. Trump will formally accept the Republican presidential nomination at the convention. The 'Capitol Hill' analyzed that plasma therapy may be one of Trump's methods to gain political support.

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