FDA spokeswoman Emily Miller fired, sources say

She had only been in the post for a few days, but had already created problems among career managers within the agency. She was involved in the commissioner’s preparation and press materials for the announcement of the emergency use authorization for convalescent plasma, although it is not known if this is what ultimately led to its withdrawal.

Her sudden departure comes at a time when the agency, particularly the way it handled messaging during the coronavirus, has come under scrutiny.

CNN contacted Miller. In an article posted to Miller’s personal Facebook page before her ouster, she wrote that as long as she is in the job, she “will work around the clock to get information on COVID-19 testing, treatments and the vaccination process. communicated as accurately to people. and as quickly as possible. ”

“I will not lie. I will not do anything that violates my ethics and my personal values,” the post read.

Hahn was recently criticized after attending a press briefing with President Donald Trump and Health and Human Services Secretary Alex Azar to announce that the FDA had granted emergency use authorization for plasma treatment .

Medical experts said Hahn overstated the vital benefits of the treatment and that Hahn later apologized for the way he presented the data. He had previously said that data from the Mayo Clinic showed that the use of convalescent plasma reduced the risk of death by 35%, and that meant that if 100 people contracted coronavirus, 35 would survive through treatment.

But that was incorrect; the study, which has not yet been peer reviewed, showed that 8.7% of patients treated within three days of diagnosis died, compared with 11.9% of patients treated four or more days after their diagnosis – a difference of about 37%.

Those treated with plasma containing the highest levels of antibodies had a 35% lower risk of dying within a week compared to those treated with less rich plasma. The study did not show that the use of plasma reduced the overall death rate by 35%.

Hahn said the criticism of how he initially presented the data was “justified.” The New York Times first reported on his ouster.

Hahn also denied earlier this week that the emergency use authorization for convalescent plasma was made for reasons other than legitimate medical reasons, telling CNN he “was never invited to make a decision at the FDA based on the policy. ”

“The decisions that FDA scientists make are based purely on data,” the commissioner said in a statement.

Miller previously worked for Senator Ted Cruz, R-Texas and One America News.

She came to the FDA from the White House personnel office, according to a familiar person.

This story has been updated with additional developments and background information.

CNN’s Devan Cole and Joe Johns contributed to this report.

Source link