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FDA allows emergency use of plasma therapy for Covid-19 after Trump links agency to deep-state conspiracy theory

However, experts have said there is limited evidence on the safety and efficacy of plasma therapy as studies are still underway

The US Food and Drug Administration (FDA) announced an emergency approval for plasma therapy at a press conference. Hailing it, US President Donald Trump called the experimental treatment "very safe and effective" for Covid-19 patients. However, experts have called the move "rushed" as studies are still underway.

"Today, I am pleased to make a truly historic announcement in our battle against the China virus (the new coronavirus) that will save countless lives," Trump said at a White House briefing. "Today's action will dramatically increase access to this treatment." The announcement comes after the president accused the FDA of slowing down approval for Covid-19 treatments. He also linked the federal agency to the deep-state conspiracy theory.

On August 22, Trump tweeted: "The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after 3 November. Must focus on speed and saving lives!"

Plasma therapy was used against flu and measles in the past and Covid-19 brought it back into the spotlight. According to the FDA, more than 70,000 patients had been treated with convalescent plasma, a yellow liquid portion of the blood collected from survivors of the disease. Plasma contains antibodies — proteins that help fight the virus. The emergency approval will now allow doctors to administer it to their patients.

At the conference, Trump said: "It (plasma therapy) is proven to reduce mortality by 35 percent. It’s a tremendous number." He went on to incorrectly add the treatment is very safe and very effective based on the data. Dr Vivek Murthy, the 19th Surgeon General of the US, expressed concerns in a series of tweets.

The best method to evaluate treatments is large, randomized, controlled clinical trials. These unbiased experiments are currently investigating the safety and effectiveness of plasma therapy. Though some studies have shown promise, they were small and inconclusive, according to Wired.

Other experts have also expressed their disappointment over Trump's unwillingness to listen to public health experts. A breakthrough will need a collection of data on safety and efficacy, Ben Corb, public affairs director for the American Society for Biochemistry and Molecular Biology, said. "This process is necessary to ensure our safety, and to ensure that a treatment isn't worse than the disease," Corb's statement read. "I am deeply concerned by this action and concerned about the timing."

A case in point was Trump's endorsement of the antimalarial hydroxychloroquine and chloroquine for Covid-19. He pressured the FDA into granting emergency approval for the drugs. But after studies suggested that they were causing harm, the federal agency revoked the authorization.

Dr Murthy said that plasma therapy might work. "It is unlikely to be a game-changer, but it may have a modest impact. Unanswered questions: does it reduce mortality, who will benefit most, what dose (or) duration is best, what kind of antibodies matter. We still don’t have quality data to answer these questions," he tweeted.

"I think this administration has put more pressure on the Food and Drug Administration than I can remember," Dr William Schaffner, an infectious diseases expert at Vanderbilt University, told the Associated Press. "Everybody is just a little bit nervous."