New York: Scientists and public health officials said they are skeptical that convalescent plasma, hailed by President Donald Trump as a “breakthrough,” is an effective treatment for patients hospitalized with Covid-19.
The Food and Drug Administration said Sunday it granted an emergency use authorization, allowing health-care providers in the U.S. to use the plasma to treat patients hospitalized with Covid-19. The agency said it was reasonable to believe the treatment may be effective in treating Covid-19 patients, and the known and potential benefits outweigh the known and potential risks.
However, scientists and health officials say more data from randomized controlled trials, which are considered the “gold standard” in science, is still needed to know whether it is safe and effective. Results of a study by the Mayo Clinic that the FDA cited in its authorization suggested the plasma may reduce mortality in some hospitalized patients. The study had no placebo group to compare the results, making it hard to determine whether the treatment actually worked.
“The EUA was granted without a published peer review study and rolled out with political fanfare,” said Lawrence Gostin, a professor and faculty director of the O’Neill Institute for National and Global Health Law at Georgetown University.
