WASHINGTON — A group of medical experts advising the National Institutes of Health says there is not enough evidence to recommend for or against the use of plasma therapy for patients hospitalized with COVID-19.
The nonendorsement by government advisers came a week after the Food and Drug Administration granted emergency authorization to the treatment. That decision followed threats from President Trump about the slow pace of FDA’s review, raising concerns that the agency felt pressure to greenlight the therapy.
So-called convalescent plasma is taken from patients who have recovered from the coronavirus and is rich in disease-fighting antibodies. But its use against COVID-19 has not been studied in rigorous trials.
The NIH panel says the plasma shouldn’t be considered “standard of care” treatment because of the lack of data confirming its safety and effectiveness.
The FDA granted its emergency use based on preliminary results gathered from tens of thousands of patients tracked by the Mayo Clinic. The decision merely means that the treatment’s potential benefits outweigh its risks.
But the Mayo study does not have the type of controls needed to draw conclusions about clinical benefits, including overall survival. FDA Commissioner Stephen Hahn was forced to backtrack last week after he overstated the potential life-saving effect suggested by the data.
NIH’s experts urged doctors and patients to enroll in proper studies of the plasma.