Donald Trump Announces Emergency Authorization for Coronavirus Plasma Treatment After Attacking FDA

On Sunday night, President Donald Trump issued an emergency use authorization (EUA) for convalescent plasma treatments on COVID-19 patients in the United States. This move is controversial among scientists and researchers, and comes after Trump publicly criticized the U.S. Food and Drug Administration (FDA) for not passing the authorization itself. Studies on the treatment so far have been inconclusive.

Convalescent plasma treatment is done by taking the blood of patients who have survived COVID-19 and isolating the antibodies against the virus in their plasma. They can then be administered to new patients to improve their immune response. The treatment has been used for about 130 years on different ailments, with mixed results, according to a report by Politico. Researchers were hopeful it would work in this case because it has shown success with other forms of coronavirus — particularly SARS and MERS.

The EUA authorizes the distribution of #COVID19 convalescent plasma in the U.S. and its administration by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in hospitalized COVID-19 patients.

— U.S. FDA (@US_FDA) August 23, 2020

On Sunday, Trump announced the EUA for convalescent plasma treatments during a televised press conference, along with FDA Commissioner Stephen Hahn. Trump lashed out at Hahn in a tweet last week, suggesting that Hahn and others at the FDA were intentionally slowing the development and deployment of COVID-19 treatments just to hurt Trump's chances at re-election. There is no evidence to support this conspiracy theory.

On Sunday Hahn said that "scientists have concluded that COVID-19 convalescent plasma is safe and shows promising efficacy, thereby meeting the criteria for an emergency use authorization." However, other scientists have raised concerns, including White House adviser Dr. Anthony Fauci.

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 November 3rd. Must focus on speed, and saving lives! @SteveFDA

— Donald J. Trump (@realDonaldTrump) August 22, 2020

So far, about 60,000 Americans have gotten plasma treatment for COVID-19 in trials in the U.S. Some of these studies have not been peer-reviewed, did not feature control groups, and lacked other forms of scientific rigor. A Mayo Clinic study found that 21.6 percent of patients given the treatment within three days of diagnosis died, whereas 26.7 percent of patients who got it later than that died.

Some experts did not take this as promising data at all. Dr. Eric Topol tweeted that "if it has efficacy, it will be relatively modest at best," while Dr. Sanjay Gupta wrote: "The data so far has been fairly limited and inconclusive."

"Let's get the trials done & if the results are life saving, let's make it standard of care, thus benefiting hundreds of thousands to millions," tweeted former FDA Commissioner Robert Califf this week. "If not we can avoid the huge expense & effort & keep looking for best treatments."