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.
FDA Chief Apologizes For Overstating Plasma Effect On Virus
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’s 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)
WHO Warns Coronavirus Treatment Touted By Trump Still Experimental
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’s authorization of it Sunday. “The results are not conclusive” on the treatment’s effectiveness, the WHO’s chief scientist Soumya Swaminathan said in a press briefing, according to 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)
Navarro: Experts Call For Randomized Plasma Trials A 'Crazy Talking Point'
Peter Navarro--a White House trade adviser--said that calls for randomized control trials of the convalescent plasma treatments is a “crazy talking point.” Some experts say it should be studied further in randomized clinical trials before widespread use. “I don’t accept that premise. To me that’s a crazy talking point,” the White House economist told MSNBC's Andrea Mitchell. (Moreno, 8/25)
In related news —
The Wall Street Journal:
Science Behind Convalescent Plasma For Covid-19 Is Clouded By Politics In FDA Authorization
Scientists who weren’t involved in the recent convalescent plasma studies agreed that there is a case to be made in support of the FDA decision. What’s 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)
Convalescent Plasma Went From Promising To Politically Tainted: 3 Things To Know
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’s “deep state.” Trump’s statements, if true, suggest the U.S. Food and Drug Administration acted at his behest – on the eve of the Republican National Convention -- instead of making its decision based on data. (Flaherty, 8/25)