Trump announces emergency clearance for new COVID-19 treatment after accusing FDA of deliberately delaying research

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President Donald Trump announced on Sunday that his administration is providing emergency clearance for the use of convalescent plasma to treat COVID-19, a treatment more than 70,000 patients have already received.

A day before the start of the Republican National Convention, Trump made the announcement at an evening press conference. He said the authorization “will significantly expand access to this treatment.”

“We are years ahead of approvals if we keep pace with past administrations,” Trump said, adding, “And that includes vaccines. “

The treatment, which involves taking a blood product rich in antibodies from recovered coronavirus patients and providing it to people with the virus, has shown some benefit for patients, but the evidence remains inconclusive as to its effectiveness and dosage. appropriate. The trials were riddled with delays and problems finding volunteers.

“I am committed to releasing safe and potentially useful treatments for COVID-19 as quickly as possible to save lives,” FDA Commissioner Stephen Hahn said on Sunday. “We are encouraged by the first promising data that we’ve seen on convalescent plasma. ”

Hahn noted that the treatment has yet to undergo randomized clinical trials to determine its safety and effectiveness.

Speaking to CBS’s “Face the Nation” on Sunday, Trump’s former Food and Drug Administration commissioner Scott Gottlieb said the treatment is “probably beneficial” although emergency clearance equates to a “gradual” change.

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“The emerging data doesn’t suggest that recovering plasma is that great,” Dr. Carlos Del Rio, infectious disease physician at Emory University, told NBC News. “It’s a gradual improvement at best but not a game changer.”

Nearly 180,000 Americans have already died from the virus, according to an NBC News tracker. With a vaccine not expected to be widely available until 2021, the pressure for effective treatments has intensified.

The clearance comes as Trump has stepped up criticism of his own administration, alleging slow approvals for vaccines and therapies. On Saturday Trump asserted without any evidence, “The Deep State, or whoever, at the FDA, makes it very difficult for drug companies to get people to test vaccines and therapeutics.

Trump has repeatedly promoted the conspiratorial idea that a “deep state” of officials across the administration is working against him and has openly criticized senior health officials who challenge his unproven claims. On Saturday, he accused the FDA of delaying approval of a vaccine until after the November election, which is much earlier than most experts predicted a vaccine might be available.

“Obviously, they’re hoping to delay the response until Nov. 3,” Trump tweeted. “Must focus on speed and save lives! “

Earlier this month, Hahn said the agency would not “cut corners” to approve a vaccine, which Trump has promised before the end of the year. Top biotech executives responded to Trump’s tweet saying politics could play no role in the development of vaccines and therapies and said the FDA was moving at record speed to get the drugs approved.

The president also expressed contempt for the FDA months ago, which withdrew its authorization for the emergency use of hydroxychloroquine to treat hospitalized COVID-19 patients, which it says agency, carries too many risks without any apparent benefit.

White House Chief of Staff Mark Meadows played down the tweets in an ABC “This Week” interview on Sunday, saying Trump was just trying to make sure officials want to act as quickly as he does.

“They want to do things the way they always have,” Meadows said of FDA career employees. “This president wants to cut red tape. That’s what the tweet meant. “

Meadows added that he thinks that “there are a number of people who don’t see the same sense of urgency as [Trump] sees “in the approval of drugs to fight the coronavirus.”

In July, former Vice President Joe Biden, the 2020 Democratic presidential candidate, called on Trump to “assure us all that the White House will respect the independent authority of the FDA to decide, without political pressure, whether the vaccine is safe and effective. . ”

Speaking to “This Week,” Biden’s deputy campaign manager Kate Bedingfield said “the American people need to be sure that the process of obtaining a vaccine is not politically manipulated.”

“And, at the moment, we don’t have much reason to believe that,” she said, adding, “And so, I think Americans are obviously looking forward to a vaccine, they have to be sure that the process is not. manipulated politically and they also need to be confident that the president will be able to… get a vaccine fairly and quickly to people across the country. ”

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