US FDA commissioner apologises for saying 'plasma reduces COVID-19 deaths by 35%'

The commissioner of the US Food and Drug Administration Dr Stephen Hahn, on August 25, apologised for misrepresenting a key statistic on how effective blood plasma is for treating coronavirus. Hahn, while issuing emergency approval for plasma taken from recovered COVID-19 patients, had said that blood plasma can reduce mortality by 35 per cent. He had said that if the data continue to pan out, 100 people who are sick with the virus, 35 would have been saved because of the administration. 

Hahn and other senior health officials came under fire from experts after repeating a claim made by US President Donald Trump that blood plasma from recovered COVID-19 patients reduced mortality rates by 35 per cent. Apart from Hahn, Health Secretary Alex Azar also reportedly said that ’35 per cent mortality reduction’ is a ‘major advance’ in the treatment of patients. Such a reduction would have been a game-changer, however, the statistics were false. 

READ: WHO Warns Against COVID-19 Plasma Therapy As US Issues Emergency Authorization

The health officials had said that the results came from a study of 35,000 patients conducted by Mayo Clinic, however, Dr Scott Wright, the study’s leader, reportedly said that it did not come from his institution’s research. While speaking to an international media outlet, Wright said that he believes that it might be an integrated analysis’ that the FDA had arrived at by looking at both Mayo’s work and other studies. 

After being criticised for the false data, Hahn took to Twitter on Tuesday and apologised for the false claims. He said that he should have said that the data show a ‘relative’ risk reduction and not ‘absolute’. FDA Spokeswoman Emily Miller also tweeted that 35 per cent referred to the ‘relative difference’ in mortality risk between those patients in Mayo’s study who received a high level of antibodies against those who received a low level of antibodies. 

READ: UN Cautions That Virus Plasma Treatment Still Experimental

Convalescent plasma shows ‘promising data’ 

Meanwhile, in a press release, FDA wrote that it was giving an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19, citing its effectiveness, based on scientific evidence available. “This product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product,” it said. “I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives. We’re encouraged by the early promising data that we’ve seen about convalescent plasma,” Hahn said. 

(Image: @cahulaan/Twitter) 

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