FDA 'Grossly Misrepresented' Blood Plasma Data, Scientists Say
,The New York Times•August 25, 2020
Javier Alvarez donates his plasma at Houston Methodist Hospital in Texas on July 6, 2020, after his grandmother died from the coronavirus. (Erin Schaff/The New York Times)
Javier Alvarez donates his plasma at Houston Methodist Hospital in Texas on July 6, 2020, after his grandmother died from the coronavirus. (Erin Schaff/The New York Times)
At a news conference Sunday announcing the emergency approval of blood plasma for hospitalized COVID-19 patients, President Donald Trump and two of his top health officials cited the same statistic: that the treatment had reduced deaths by 35%.
Trump called it a “tremendous” number. His health and human services secretary, Alex Azar, a former pharmaceutical executive, said, “I don’t want you to gloss over this number.” And Dr. Stephen M. Hahn, commissioner of the Food and Drug Administration, said 35 out of 100 COVID-19 patients “would have been saved because of the administration of plasma.”
But scientists were taken aback by the way the administration framed this data, which appeared to have been calculated based on a small subgroup of hospitalized COVID-19 patients in a Mayo Clinic study: those who were under 80 years old, not on ventilators and received plasma known to contain high levels of virus-fighting antibodies within three days of diagnosis.
What’s more, many experts — including a scientist who worked on the Mayo Clinic study — were bewildered about where the statistic came from. The number was not mentioned in the official authorization letter issued by the agency, nor was it in a 17-page memo written by FDA scientists. It was not in an analysis conducted by the Mayo Clinic that has been frequently cited by the administration.
“For the first time ever, I feel like official people in communications and people at the FDA grossly misrepresented data about a therapy,” said Dr. Walid Gellad, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.
It is especially worrisome, he said, given concerns over how Trump has appeared to politicize the process of approving treatments and vaccines for the coronavirus. Over the next couple of months, as data emerges from vaccine clinical trials, the safety of potentially millions of people will rely on the scientific judgment of the FDA. “That’s a problem if they’re starting to exaggerate data,” Gellad said. “That’s the big problem.”