F.D.A. Permits Expanded Use of Convalescent Plasma to Deal with Coronavirus Sufferers

F.D.A. Allows Expanded Use of Convalescent Plasma to Treat Coronavirus Patients

The Food and Drug Administration on Sunday issued emergency clearance for the expanded use of antibody-rich blood plasma to help hospitalized coronavirus patients. President Trump, who has put pressure on the agency to act faster on the pandemic, may move forward on the eve of progress on the Republican Convention.

Mr Trump cited the approval, held back by concerns from top government scientists about the data behind it, as welcome news in fighting a disease that has caused 176,000 deaths in the United States and left the nation far behind most has in the effectiveness of his answer.

At a press conference, he described the treatment as "a powerful therapy" made possible "by bringing together the full power of the federal government".

The decision will expand the use of a treatment that has been given to more than 70,000 patients. But the F.D.A. cited benefits only for some patients. And unlike a new drug, plasma cannot be made in millions of doses. Availability is limited by blood donations. Mr Trump urged everyone who recovered from the virus to donate plasma, saying there was a nationwide campaign to collect it.

Mr Trump has presented his calls to cut red tape and expedite the approval of treatments and vaccines as a necessary response to a public health emergency.

However, Sunday's announcement came a day after he reiterated his unsubstantiated claim that the F.D.A. deliberately delayed decision-making until after the election, this time citing a "deep state". This allegation heightened concerns among some government scholars, outside experts and Democrats that the president's political needs could undermine the integrity of the regulatory process, undermine public confidence in safety, and introduce another risk to public health.

No randomized trials of the type that researchers believe are the most robust have so far shown that they benefit from convalescent plasma. But the F.D.A. The data available to date, including more than a dozen published studies, showed that "it is reasonable to believe" that treatment "may reduce the severity or duration of Covid-19 disease in some hospitalized patients". “Especially those who get it early.

Patients under 80 years of age who received plasma containing high levels of anti-virus antibodies within three days of diagnosis and who did not receive a respirator were about 35 percent more likely to be alive a month later than patients who the plasma received with a low level of antibodies, according to Dr. Peter Marks, director of the FDA Center for Biologics, Evaluation and Research.

Mr Trump removed the agency's nuanced language during his appearance before reporters at the White House, saying that convalescent plasma "has been shown to reduce mortality by 35 percent".

The FDA, which is responsible for approving new drugs, delayed approval by about a week after senior health officials including Dr. Francis S. Collins, the director of the National Institutes of Health, and Dr. Anthony S. Fauci, the chief who had approved the infectious disease specialist, questioned whether the data were adequate.

Mr Trump complained in a tweet on Saturday, claiming without evidence that officials "hoped to postpone response until after November 3rd" – election day – and urged the F.D.A. focus on speed and save lives!

White House chief of staff, Mark Meadows, over the weekend accused government regulators of being slow to act on the permit, calling it "a fumble". Mr. Meadows said Mr. Trump was not trying to "cut corners" but "was really frustrated with some of the bureaucrats who believe they can just do this the way they normally do".

At his press conference, Mr. Trump was more positive, saying the agency had "really grown," especially "in the last few days."

Democrats and some health experts said the president's criticism of federal regulators undermined public confidence and undermined the credibility of the agency charged with determining whether drugs and medicines are safe and effective.

Nancy Pelosi, the House's spokeswoman, described Mr. Trump's Saturday tweet as "very dangerous".

White House officials called for swift approval of not only Covid-19 treatments but vaccines as well. Her public statements that a safe and effective vaccine might be just around the corner have alarmed scientists who fear that White House pressure will lead to an early approval to increase the president's chances of re-election.

At a July 30 meeting with Ms. Pelosi and Senator Chuck Schumer of New York, leader of the Democratic Minority, senior government officials suggested that the government could issue emergency vaccine approval before Phase 3 trials in the United States are completed, possibly as early as September, according to two people informed of the discussion. Such a move would be highly unusual and would most likely lead to more concern about government pressure on the F.D.A. Approve drugs for political purposes.

During the discussion in Ms. Pelosi's conference room, those briefed said that Mr. Meadows had indicated that a vaccine developed by AstraZeneca and Oxford University was the most likely candidate for early approval. Their discussion was first reported by the Financial Times.

AstraZeneca is conducting phase 3 trials in the UK, South Africa and Brazil, but only started its phase 3 clinical trial in the US just a few days ago.

Senior administrators denied the report of the meeting, saying that Mr. Meadows and Treasury Secretary Steven Mnuchin were either misquoted or all major issues were misunderstood.

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However, what they said suggested to at least some participants that the administration hoped that robust results from AstraZeneca's overseas trials would lead to early emergency clearance, with the same agency as the F.D.A. used to green light the use of convalescent plasma. An employee of Ms. Pelosi said she warned officials at the meeting not to take short cuts.

The F.D.A. Clinical trials with American patients are usually required before vaccines are approved for use in that country. Although there have been exceptions to this rule, experts would say that getting a coronavirus vaccine approved based on studies overseas would be challenging for regulators, in part due to differences in demographics as well as the size of the studies.

A senior administration official, who was briefed on the meeting and refused to speak of the discussion on the file, said neither Mr Meadows nor Mr Mnuchin had proposed approving a vaccine as early as late September. The official said the administration would approve a vaccine based on more than just foreign clinical trials.

The spokesmen for Mr. Meadows and Mr. Mnuchin said neither spoke about AstraZeneca.

On Sunday, Mr Trump re-raised hopes for a successful vaccine, saying "you will hear about it" that "very soon, very soon". Dr. Collins, the N.I.H. Director said it would be "amazing" if a vaccine was ready for approval by October – and that even November or December are very optimistic.

The White House's decision to put pressure on the F.D.A. injected a political element into what some scientists have called a remarkable advance in expanding the use of convalescent plasma. Other experts were cautious, saying the evidence is still preliminary.

In a statement, the President of the Infectious Disease Society of America, Dr. Thomas M. File Jr. said that the treatment data show "some positive signals" but that we are "lacking the randomized controlled trial data we need to better understand how useful it is in treating Covid-19. "

In a phone call with reporters on Sunday, Dr. Stephen Hahn, the F.D.A.'s appointee, said the agency would continue to work with researchers investigating the treatment and possibly update the approval. He encouraged the continuation of randomized trials to prove the effectiveness of the treatment.

"This is not the end," he said.

Dr. Hahn tempered the president's claim that the treatment reduced mortality by 35 percent, saying it will "if the data continues to be made public". It wasn't immediately clear where the 35 percent figure was coming from; It did not appear to be included in any technical documents released by the Agency in support of the decision.

Dr. Marks told reporters that more than 70,000 patients have received convalescent plasma through a special agency program. The decision to approve the treatment so more doctors can use it was based on an analysis of months of data suggesting that plasma "early on in the disease can improve outcomes and reduce mortality," he said.

"We are confident that convalescent plasma can be used safely in this environment," he said after reviewing the results of the first 20,000 patients who received it.

Dr. Hahn said the decision to approve treatment was made "solely on the basis of science and data, and nothing else".

Coverage was contributed by Katie Rogers, Nicholas Fandos, Andrew Jacobs and Carl Zimmer.


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