Trump “grossly misrepresented” data about the therapy during press conference.

President Donald Trump and Food and Drug Administration Commissioner Dr. Stephen M. Hahn have come under fire this week for misrepresenting data on blood plasma and its efficacy in fighting COVID-19. 

Over the weekend, Trump and two of his officials announced an “emergency use” approval of blood plasma to treat hospitalized COVID-19 patients. Trump touted the approval as a “breakthrough” just one day before the start of the Republican National Convention. His remarks came just days after suggesting, without evidence, that opponents working in the FDA were holding up emergency approval until after the national election. 

During the press conference, Trump cited a statistic that treatment with blood plasma reduced deaths from the virus by 35%. But scientists and doctors across the country raised concerns with that data point, which seemed to be calculated from a small subgroup of hospitalized coronavirus patients, all of whom were under 80 years old, not on ventilators, and received plasma within three days of their diagnosis. 

In other words, the study was performed on a subgroup within a subgroup. What is even more puzzling is that the figure was not mentioned in the official authorization letter from the FDA, or the 17-page memo that accompanied the agency’s approval. 

“For the first time ever, I feel like official people in communications and people at the F.D.A. grossly misrepresented data about a therapy,” Dr. Walid Gellad, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, told the New York Times. 

Former FDA Commissioner Dr. Scott Gottlieb noted in an interview with CNBC that while blood plasma treatment may be somewhat effective, “it doesn’t look like a home run.” 

In the beginning of the pandemic, the FDA allowed doctors to use plasma to treat patients with COVID-19 on a case-by-case basis. Going forward, according to the FDA, clinical trials to pinpoint the treatment’s effectiveness will “remain ongoing.” 

“So the standard isn’t the typical standard of safe and effective as it is for a new drug approval,” Gottlieb said. “I think on the basis of the data set that’s available, it’s reasonable to conclude that this may provide a benefit to patients who are suffering from Covid.”