FDA approves COVID-19 plasma treatment in Trump pressure

President TrumpDonald John TrumpTwo “Apprentice” Producers Supporting the Republican National Convention Masking could save about 70,000 lives in the near future: Researcher Trump declares disaster in California as wildfire intensifies More The Food and Drug Administration (FDA) announced Sunday that convalescent plasma has been approved for emergency treatment of patients with the new coronavirus.

Mr Trump, who was trying to announce progress in the fight against the virus, advertised the news as a “historical breakthrough” at a White House press conference on Sunday, “extending access to this treatment dramatically.”

Experts have expressed optimism about the treatment, but former FDA member Scott Gottlieb called the move “gradual” early Sunday, with convalescent plasma already available to thousands of patients. Said it is possible. The move is also driven by political pressure from Trump on the FDA and concerns about whether the authorities will prematurely approve treatments without adequate data on their effectiveness.

The FDA Commissioner Stephen Hahn said the decision was made by an “independent judgment” of FDA experts and scientists, and convalescent plasma showed “promising efficacy” as a treatment for patients with coronavirus.

“These scientists conclude that COVID-19 convalescent plasma is safe and shows promising efficacy, thereby meeting the criteria for emergency use permits,” Khan said at a briefing. It was.

Some experts raised the concern that plasma is already widely available, and given that many patients could be treated outside, through randomized clinical trials that have struggled to recruit volunteers. A trial that impedes the ability to study exactly how well plasma actually works.

“We were optimistic about convalescent plasma as a treatment, but optimism was not science,” said Ashish Jha, head of Harvard Global Health Institute. Yes, EUA issuance [emergency use authorization] Without it, such a trial would be difficult. And it compromises the credibility of the FDA. “

The announcement condemns the “deep state” of the authorities and concerns about the politicalization of the authorities’ approval as Trump attacked the FDA in an unusual way, slowing the development of treatments and vaccines before the November elections. Because I expressed.

Trump seemed to reiterate that belief on Sunday and during the interrogation he thought reporters believed that some health officials had allowed the decision to “hold” a decision for “political reasons.” Told.

“I think there are some people in the FDA, and in fact, in large departments, who can see things stagnant and don’t care so much. It’s my opinion, it’s a very strong one. “Trump both said and gestured to Mr Hahn and Secretary of Health and Welfare’s Alex Hazard who attended the briefing.

“It’s for political reasons. It has nothing to do with politics. It has life and death,” he continued.

Earlier data show that patients treated with convalescent plasma have improved survival by 35%, according to Hahn. At the end of the briefing, he did not answer the yelling question as to whether the decision was pressured.

Hazard described the development as “a major breakthrough in the treatment of patients.”

Convalescent plasma is made from the blood of individuals who have recovered from coronavirus and is used to treat other viruses such as MERS, SARS, and Ebola.

Convalescent plasma has already been used to treat approximately 70,000 Americans infected with coronaviruses.

Gottlieb, a former FDA member under Trump, said at the beginning of Sunday at CBS’s “Face of Nations,” giving an emergency permit for treatment would enable “easier access in certain situations.” Said, but already said that it is widely available.

Gottlieb said, “Urgent licenses will probably allow more commercial distribution and will make it easier for manufacturers or plasma products to recoup their costs.”

“The point is that it’s widely used today. Patients understand it,” he continued. “It’s gradual, and gradual profit is important here, but we need to see what it is.”

Trump is a strong supporter of convalescent plasma as a treatment for COVID-19 and has publicly sought to donate plasma to individuals who have recovered from the virus.

Mr Trump told reporters at a news briefing last week that the FDA was in politics in deciding on an emergency permit for convalescent plasma. Mr Trump said he didn’t want to be “lagging” in the decision-making process.

Sunday’s announcement came on the eve of the Republican National Convention, where Trump calls for political backing of his fight for re-election against Democratic candidates. Joe Biden.. At the Democratic National Convention last week, many prominent Democrats concentrated on Trump’s handling of the coronavirus. It infected a total of approximately 5.7 million Americans and killed more than 176,000 in the United States.

Officially nominated on Monday, Mr. Trump gets some coverage every day of the tournament, and the event culminates in his acceptance speech from the White House on Thursday.