Two FDA public relations experts ousted after blood plasma fiasco

Two senior public relations experts advising the Food and Drug Administration have been removed from their posts after awkward communications about blood plasma treatment for Covid-19. President Trump and the chief of the FDA had falsely bragged on the eve of the Republican National Convention that the treatment significantly reduced mortality from the disease.

FDA Commissioner Dr Stephen M. Hahn on Friday fired Emily Miller, the agency’s chief spokesperson. The White House had installed Ms Miller, who had previously worked in communications for Senator Ted Cruz’s re-election campaign and as a reporter for One America News, the conservative cable network, in that position just 11 days ago.

Dr Hahn informed FDA senior management on Friday that Ms Miller would no longer be the agency’s official spokesperson and would appoint someone to replace her on an interim basis. Ms Miller could not be reached for comment.

Ms Miller’s pullout came a day after the FDA’s parent agency, the Department of Health and Human Services, terminated the contract of a public relations consultant who advised Dr Hahn to correct the comments misleading about the benefits of blood plasma for Covid-19.

“I recommended that he fix the file,” said consultant Wayne L. Pines, who said he was not told why his contract was broken. “If a federal official doesn’t say something right, and chooses to clarify and say the criticism is warranted, that’s refreshing,” Pines said.

The Department of Health and Human Services denied that Mr Pines’ contract was terminated due to his involvement in plasma messaging.

It was “a 100% coincidence,” said Brian Harrison, chief of staff for the department. “HHS has reviewed and canceled similar contracts, so I had it sent to our attorneys, who recommended termination. It was routine, ”he says.

Mr. Pines is chairman of the large healthcare firm of APCO Worldwide, a public relations and lobbying firm that represents healthcare companies doing business before the FDA. He said he was doing this work alone, outside of his APCO practice. He did not say how much he was paid, but noted that as a friend of Dr Hahn’s he is willing to continue counseling him for free.

The FDA had considered allowing the use of convalescent plasma as an emergency treatment for Covid-19, but last week the New York Times reported that the decision was delayed after Dr Francis S. Collins and Dr Anthony S Fauci intervened and expressed concern that the available evidence on the effectiveness of the treatment was too weak. FDA officials argued that even though the data was preliminary and required continued analysis as more patients were treated, the plasma still met the agency’s standard for authorization to use d ’emergency.

Saturday morning Mr. Trump tweeted that the FDA’s “deep state” was slowing drug development. Late at night, the White House press secretary tweeted that the president would hold a press conference the next day “concerning a major therapeutic breakthrough”.

The announcement should have been a rare victory for the FDA, which for months had rebuffed criticism over its track record of the pandemic, as well as the independence of Dr Hahn, who had previously been pressured by Mr Trump to allow antimalarial drugs. this was found to be ineffective for Covid-19 and carried risks of harmful side effects. But last weekend, finally, the agency could reveal legitimate good news: Convalescent plasma, administered early, showed promise for a subset of Covid-19 patients.

The announcement, made at the White House on Sunday, instead sparked a week of recriminations, anger and mistrust between the FDA and the HHS. Statements from officials on Sunday inflated the nuanced, preliminary data into “a very historic breakthrough,” as Mr. Trump puts it. It drew criticism from scientists and at least three former agency commissioners, who said the exaggerated claims were undermining public confidence in the FDA.In a speech at the convention Thursday night, the president said again exaggerated what is known of the benefits of plasma, promising that it will save thousands upon thousands of lives. “

Health experts have expressed dismay at Dr Hahn’s inability to control the public message regarding the authorization of plasma.

“It’s been a low time for the FDA for at least a generation,” said Daniel Carpenter, professor at Harvard University studying the agency. “It was a major self-inflicted injury.”

These extraordinary missteps by a federal agency that bragged about its scientific independence have heightened fears that the American public is unwilling to take an agency-approved vaccine, especially if the decision is seen as having been taken under pressure from President Trump. .

“There are hardly enough adjectives to describe how appalling it is,” said Emily K. Brunson, a medical anthropologist at Texas State University. Opinion polls have shown that many Americans are already hesitant to get vaccinated against the virus.

But making the issue political, she said, “is one more piece that’s unique in modern times, and it has the potential to really turn this situation into dire straits.”

Sharon LaFraniere contributed reporting from Washington.