FDA ‘grossly misrepresented’ blood plasma data, scientists say

The scientific community is distancing itself from the Trump administration’s claim that convalescent blood plasma curtails COVID-19 deaths by 35%. The president, along with the heads of FDA and HHS, cited the statistic on Sunday as they announced emergency authorization of the treatment. Experts, however, were perplexed by the source of that figure since it does not appear in any of the documents issued by FDA or by the Mayo Clinic, which led the study on which emergency authorization was based. The brunt of the criticism was leveled at FDA Commissioner Stephen M. Hahn, MD, who said that 35 out of 100 COVID-19 patients “would have been saved because of the administration of plasma.” Several statisticians and scientists criticized what they said was a gross overstatement of the benefits, with some calling for him to walk back his comments. Hahn did so on Monday evening, tweeting that his statement Sunday suggested an absolute reduction in risk when it actually referred to the relative risk of a certain group of patients compared with one another. Controversy over the Trump administration’s framing of the blood plasma data aside, scientists are cautiously optimistic about the treatment. However, as the World Health Organization’s chief scientist, Soumya Swaminathan, MD, notes, “At the moment, it’s still very low-quality evidence.”