(NBC News) – The Food and Drug Administration has issued an emergency authorization for the use of convalescent plasma therapy in treating COVID-19.
The move comes as the national death toll approaches 180,000.
President Trump announced the authorization Sunday, calling it a major “therapeutic breakthrough.”
The announcement comes after the White House suggested the Food and Drug Administration has delayed approval of a vaccine and therapeutics, and after internal FDA debate over whether the agency had enough data on the therapy.
“The fact that the appearance that the president can basically pressure the FDA into bypassing their regular processes is concerning and concerning to scientists and doctors like me,” Dr. Nahid Bhadlia says.
Patients who have recovered from COVID-19 have been donating plasma as part of ongoing studies.
Doctors and researchers say there is data the treatment can aid in the recovery of some patients, but no randomized control trials have been completed to prove its effectiveness.
“Occasionally early enthusiasm turns out not to be correct. We saw that with hydroxychloroquine. Once the rigorous studies were done, it wasn’t useful at all,” says Dr. William Schaffner, an infectious disease specialist at Vanderbilt University Medical Center.
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