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Wednesday, Aug 26 2020

Full Issue

FDA's Positive Plasma Claims Are Walked Back

Food and Drug Administration Commissioner Stephen Hahn even apologized for overstating the results of convalescent plasma treatments.

Responding to an outcry from medical experts, Food and Drug Administration Commissioner Stephen Hahn on Tuesday apologized for overstating the life-saving benefits of treating COVID-19 patients with convalescent plasma. Scientists and medical experts have been pushing back against the claims about the treatment since President Donald Trump鈥檚 announcement on Sunday that the FDA had decided to issue emergency authorization for convalescent plasma, taken from patients who have recovered from the coronavirus and rich in disease-fighting antibodies. (Perrone and Riechmann, 8/25)

The World Health Organization (WHO) on Monday warned that the use of plasma from recovered coronavirus patients as a treatment for COVID-19 remains experimental despite the White House鈥檚 authorization of it Sunday. 鈥淭he results are not conclusive鈥 on the treatment鈥檚 effectiveness, the WHO鈥檚 chief scientist Soumya Swaminathan said in a press briefing, according to聽The Associated Press. The same treatment has been used historically for flu and measles outbreaks and the Ebola outbreak that hit several West African nations. (Budryk, 8/25)

Peter Navarro--a White House trade adviser--said that calls for randomized control trials of the convalescent plasma treatments is a 鈥渃razy talking point.鈥 Some experts say it should be studied further in randomized clinical trials before widespread use.聽鈥淚 don鈥檛 accept that premise. To me that鈥檚 a crazy talking point,鈥 the White House economist told MSNBC's Andrea Mitchell. (Moreno, 8/25)

In related news 鈥

Scientists who weren鈥檛 involved in the recent convalescent plasma studies agreed that there is a case to be made in support of the FDA decision. What鈥檚 been missing is an open discussion about the pros and cons of the emergency authorization and its consequences, said Joshua Sharfstein, a professor at Johns Hopkins Bloomberg School of Public Health and former senior FDA official who was involved with EUAs during the swine flu outbreak in 2009. (Marcus and Burton, 8/25)

President Donald Trump turned one of the most promising new treatments for COVID-19 into a political football this week, bragging that he pushed through emergency use authorization of convalescent plasma by confronting what he calls the government鈥檚 鈥渄eep state.鈥 Trump鈥檚 statements, if true, suggest the U.S. Food and Drug Administration acted at his behest 鈥 on the eve of the Republican National Convention -- instead of making its decision based on data. (Flaherty, 8/25)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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