Two public relations experts lost their jobs with the FDA after Commissioner Stephen Hahn, MD, made misleading statements about the effectiveness of blood plasma as a COVID-19 treatment, The New York Times reported.
Dr. Hahn removed Emily Miller, the agency's chief spokesperson, Aug. 28, 11 days after her appointment to the role. Ms. Miller previously worked on a reelection campaign for Sen. Ted Cruz, R-Texas. Dr. Hahn said he'd appoint her interim replacement, according to the Times.
HHS terminated the contract of public relations consultant Wayne Pines on Aug. 27. Mr. Pines had advised Dr. Hahn to correct misleading statements about the benefits of blood plasma for COVID-19, the Times reported.
Mr. Pines wasn't told why his contract was terminated, but HHS denied that it had anything to do with his involvement in the blood plasma messaging, the Times reported. The FDA is an agency under the authority of HHS.
Blood plasma was granted emergency use authorization from the FDA as a treatment for hospitalized COVID-19 patients Aug. 23. The move came just a week after top health officials urged the FDA to hold off on the authorization, saying the data was not strong enough to warrant emergency approval.
The plasma, known as convalescent plasma, is collected from people who have recovered from COVID-19 and contains antibodies that may treat people infected with the virus.
Dr. Hahn said during an Aug. 23 news conference announcing the emergency approval that 35 out of 100 COVID-19 patients "would have been saved because of the administration of plasma," according to the Times.
That number wasn't mentioned in the official FDA authorization letter, a 17-page memo written by the FDA, or in an analysis conducted by the Mayo Clinic, which was cited by the administration as a reason for the emergency approval.
Data from the Mayo Clinic showed that, among a group of more than 35,000 patients, when plasma was given within three days of COVID-19 diagnosis, the death rate was about 22 percent, compared with 27 percent when it was given four or more days after diagnosis, the Times reported.
Dr. Hahn tweeted Aug. 24 that he should have said the data shows a relative risk reduction and not an absolute one and criticism of his comments during the news conference was "entirely justified."
"For the first time ever, I feel like official people in communications and people at the FDA grossly misrepresented data about a therapy," said Walid Gellad, MD, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, in the Times article.
Read the full article here.