NIH panel refutes FDA’s claims of the benefits of coronavirus plasma treatment
Convalescent plasma from a recovered coronavirus disease (COVID-19) patient is seen at the Central Seattle Donor Center of Bloodworks Northwest during the outbreak in Seattle, Washington, April 17, 2020.
Lindsey Wasson | Reuters
A panel of experts convened by the National Institutes of Health said Tuesday there is “insufficient data” to show convalescent plasma works against the coronavirus, refuting claims made by President Donald Trump and the head of the Food and Drug Administration.
The panel said it reviewed available data on the treatment and found no data from “well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma” for the treatment of Covid-19. It also said “there was no difference in 7-day survival” for patients, contradicting FDA Commissioner Dr. Stephen Hahn, who said the treatment resulted in a 35% improvement in survival.
“There are insufficient data to recommend either for or against the use of convalescent plasma for the treatment of COVID-19,” the panel said in a statement. “Convalescent plasma should not be considered standard of care for the treatment of patients with COVID-19.”
The FDA granted the treatment emergency authorization on Aug 23., allowing U.S. health-care providers to use the plasma to treat suspected or confirmed infections in hospitalized patients.
Results of a study by the Mayo Clinic that the FDA cited in its authorization of the plasma treatment indicates that patients below age 80 who were not on a respirator and received plasma with a high level of antibodies within three days of diagnosis fared better than patients who received plasma with a low level of antibodies. A weakness of the Mayo study was that it did not include a controlled group of patients receiving a placebo.
The FDA’s decision to authorize emergency use came a day after Trump accused the FDA of delaying enrollment in clinical trials for Covid-19 vaccines or therapeutics. The criticism from Trump and action from the FDA led some scientists to say the emergency use was politically motivated, especially since it was announced on the eve of the Republican National Convention.
Hahn, under intense criticism, later walked back comments he made on the benefits of convalescent plasma, saying he could have done a better job of explaining the data on its effectiveness.
He also said he wasn’t bowing to pressure from Trump. “The decision was made by FDA career scientists based on data submitted a few weeks ago,” Hahn tweeted last week.
This is a developing story. Please check back for updates.
