Just one week ago, the results of the first large-scale study on the use of convalescent blood plasma as a treatment for COVID-19 were decidedly confusing. So confusing, in fact, that a team of experts—including Dr. Anthony Fauci—recommended that the FDA place a hold on issuing an Emergency Use Authorization (EUA) that would have made it easier for doctors and hospitals to use plasma in treating patients. Then, just days later, FDA Commissioner Stephen Hahn was standing with Donald Trump at a Sunday night press conference to support claims that plasma was a “breakthrough” treatment for COVID-19, and that its use could save over a third of all patients. It was an amazing thing to say, not just because it was counter to the recommendations of the experts, but because there seemed to be nothing in the study that actually supported the numbers that Hahn was claiming. Hahn overruled recommendations and went ahead with the EUA.
But on Tuesday, Hahn was singing a different tune. “I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma,” tweeted Hahn. “The criticism is entirely justified.”
Hahn admitted what was obvious to anyone who even glanced at the original study—or any article on that study—that it was impossible to tell how much benefit is generated through the use of convalescent plasma because the study had no control group for comparison. The study did indicate that giving patients plasma early appeared to be better than giving it to them later, but this was just a small relative difference.
The pre-print of the study indicates that patients who got a plasma infusion after four days had a seven-day mortality rate of 11.9%. Patients who got an infusion within their first three days had a seven-day mortality rate of 8.9%. That’s all it showed. It says nothing about long-term survival, nothing about any other consequences, and absolutely nothing about how patients receiving plasma compare with those getting standard of care without plasma. In any case, the numbers—which come from a selected group of patients that was in no sense random—don’t show that plasma saves over a third of patients. There is no way to get to what Hahn said from what the report provides.
Still, Hahn’s Tuesday admission comes at the end of a long thread responding to criticism of the FDA providing an EUA for plasma after experts specifically recommended placing a hold on such action. Hahn repeatedly states in this thread that the “decision was made by FDA scientists” and that the FDA “[does] not permit politics” to be involved in these decisions.
Not explained in Hahn’s thread is why the FDA chose to go against the hold recommended by director of the National Institutes of Health Francis Collins, infectious disease expert Dr. Anthony Fauci, and clinical director at the National Institute of Allergy and Infectious Diseases Dr. Clifford Lane.
However, there is an explanation. On Saturday, one day before Hahn joined Trump to announce the EUA for plasma, Trump tweeted: “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd.”
The data to show how much plasma helps as a treatment for COVID-19 remains unclear. Unfortunately, how Hahn reached the decision to issue the EUA despite recommendations for a hold is way too clear.
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