This archive report was first published on 25 August 2020.
F.D.A. Misrepresents Blood Plasma Data, Scientists Allege ¶
On August 23, 2020, President Trump and top health officials announced the emergency approval of blood plasma for hospitalized COVID-19 patients, citing a 35% reduction in deaths. However, scientists claim the FDA misrepresented data, highlighting concerns over the politicization of the approval process.
According to the Mayo Clinic study, the 35% figure was calculated based on a small subgroup of patients under 80 years old, not on ventilators, and receiving plasma with high levels of virus-fighting antibodies within three days of diagnosis. The number was not mentioned in the official authorization letter or a 17-page memo written by FDA scientists.
Dr. Walid Gellad, a scientist at the University of Pittsburgh, stated, '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.' He expressed concern that this misrepresentation could lead to the politicization of the approval process, which could compromise the safety of potentially millions of people relying on the FDA's scientific judgment.
When asked about the origin of the 35% figure, an FDA spokeswoman initially directed a reporter to a graph of survival statistics buried in the Trump administration's application for emergency authorization. The chart analyzed the same tiny subset of Mayo Clinic study patients but did not include numerical figures.
On August 24, 2020, Dr. Peter Marks, the director of the FDA's center for biologics, evaluation, and research, stated that the agency reviewed published studies of plasma and conducted its own analysis of data from the Mayo Clinic's program. He claimed that there appears to be roughly a 35% relative improvement in the survival rates of patients who received plasma with higher versus lower levels of antibodies.
However, statisticians and scientists disputed Dr. Hahn's statement, claiming that he overstated the benefits of convalescent plasma. Dr. Robert Califf, a former FDA commissioner, tweeted that Dr. Hahn should correct his statement. Dr. Hahn did not respond to repeated requests for clarification.
