Cardiologist and healthcare gadfly Dr. Eric Topol leveled a blistering critique at U.S. Food and Drug Administration (FDA) chief Dr. Stephen Hahn over the agency's approval of a blood plasma treatment for COVID-19. Topol accused Hahn of politicizing the agency and suggested he should resign.
Hahn, a radiation oncologist who was confirmed as FDA commissioner in December 2019, has come under fire for statements he made during an August 23 press conference with President Donald Trump announcing the approval. Hahn claimed that the treatment was a breakthrough that produced a 35% mortality reduction from COVID-19, calling it "a major advance in the treatment of patients."
But in an August 31 commentary on Medscape, where he is editor in chief, Topol called that statement and other comments Hahn made "incorrect and a blatant misrepresentation of the data." Topol pointed out that the as-yet unpublished study Hahn was referring to did not include a control group of patients who did not receive the blood plasma therapy.
The 35% mortality reduction was the relative difference after seven days between one group of patients who got the therapy early in their treatment, with a mortality rate of about 9%, and those who received it later, who had a mortality rate of 12%. Hahn later apologized for the way he characterized the study's findings.
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
But the fallout from the press conference didn't end with Hahn's apology. The FDA a few days later fired two communications staffers, including its top spokesperson, in what the New York Times said was "an urgent bid to restore the tarnished credibility of the agency."
In his Medscape commentary, Topol called Hahn's apology "grossly insufficient," accused him of ignoring scientific evidence for other COVID-19 treatments, and said he was "complicit with the Trump Administration's politicization of America's healthcare institutions."
Topol concluded by recommending that Hahn hold a press conference in which he "tell the truth" about whether he was pressured into making the statements about blood plasma being a treatment breakthrough. If Hahn is unable to do so, he should resign, Topol concluded.
