On Sunday night at a brief press conference with President Donald Trump, Hahn said that blood plasma from Covid-19 survivors given to new patients could save huge numbers of lives. Trump, in turn, tried to “oversell” the FDA’s evaluation, claiming the FDA said the plasma is “safe and very effective.”
“What that means is — and if the data continue to pan out — 100 people who are sick with Covid-19, 35 would have been saved because of the administration of plasma,” Hahn said, reports Bloomberg.
Hahn’s remarks followed Trump’s praise for experimental therapy. Trump touted the therapy, saying it was “proven to reduce mortality by 35 percent,” according to Health and Human Services Secretary Alex Azar.
Needless to say, I was not the only journalist here at Digital Journal to question the FDA’s move. DJ’s resident medical scientist, Dr. Tim Sandle, also questioned Trump’s push to get the FDA to bypass scientic protocols and medical advice just to please the president’s wanting to make a great impression on his voter base.
Dr. Sandle wrote: “In overriding medical experts, Trump also displayed a lack of awareness of the use of convalescent plasma, stating that it was a ‘new’ treatment, despite convalescent plasma first being tried during 1918 Spanish flu pandemic (this had mixed results, although more recent success has been shown with plasma transfusion from selected donors in relation to the Ebola virus).”
Read: Why Trump’s overruling of the FDA over COVID-19 therapy is risky
I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.
— Dr. Stephen M. Hahn (@SteveFDA) August 25, 2020
As most of us can guess, Hahn spent much of Monday taking heat from health experts, including two former FDA commissioners, for his remarks. Hahn, of course denied he was influenced in his decision to go ahead and authorize the use of convalescent plasma therapy, claiming his decision “was based on sound science and data,” according to the Wall Street Journal.
“That was not the way that I would have worded it,” said one of the doctors who led the blood plasma study, Arturo Casadevall, chair of the department of molecular microbiology and immunology at the Johns Hopkins School of Public Health. “I hope they will issue a clarification,” he said earlier Monday.
Margaret A. Hamburg is a physician and former commissioner of the Food and Drug Administration, and Joshua M. Sharfstein is a physician and former principal deputy commissioner of the FDA.
In an opinion ptece in the Wall Street Journal on Tuesday, they wrote: “The president turned a question of medical science and policy into a political hot potato that has damaged the agency’s reputation for independence and science at a critical time for Americans’ health.”
