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FDA Commissioner walks back plasma comments, but EUA still ok

The Food and Drug Administration’s Commission, Dr. Stephen Hahn, has walked back his comments made at the White House when speaking of the FDA’s Emergency Use Authorization (EUA) for convalescent plasma as a potential treatment for COVID-19.  The EUA authorizes physicians to use convalescent plasma as a treatment for COVID-19, although there are no completed clinical trials yet to determine its effectiveness and safety.  But it notes that early results show that convalescent plasma’s benefits outweigh possible harm.

Hahn, President Donald Trump, and Health and Human Services Secretary Alex Azar said a study found use of convalescent plasma resulted in a 35 percent improvement in survival.

At the White House on Sunday, during the announcement by President Trump, Hahn said “Many of you know I was a cancer doctor before I became FDA commissioner,” Hahn said at the White House on Sunday. “And a 35 percent improvement in survival is a pretty substantial clinical benefit. 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.”

Experts say Dr. Hahn misinterpreted the data, and today on Twitter, Dr. Hahn said:
“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.”
However, he went on to say that the FDA was justified in granting an Emergency Use Authorization for COVID-19, as it does appear to have a positive benefit in many patients.
Up until this announcement, the Mayo Clinic was working in partnership with the FDA on testing whether convalescent plasma was safe and effective, how it helped patients with COVID-19, and what any side effects might be.  But as of August 28, 2020, Mayo Clinic has suspended its Convalescent Plasma Expanded Access Program, in light of the FDA’s issuing the Emergency Use Authorization.
On May 1, the FDA approved the use of the drug remdesivir in hospitalized COVID-19 patients, as early results showed that remdesivir could reduce the severity and duration of the disease.
Photo is Dr. Stephen Hahn, FDA Commissioner

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