FDA ousts spokesman, PR consultant after blood plasma fiasco

WASHINGTON (NYTIMES) – The head of the US Food and Drug Administration ousted its top spokesman from her position Friday (Aug 28) in an urgent bid to restore the tarnished credibility of the agency after he made erroneous claims that overstated the benefits of plasma treatments for Covid-19 at a news conference with President Donald Trump.

The decision came just a day after the FDA’s parent agency, the Department of Health and Human Services, terminated the contract of a public relations consultant who had advised the FDA commissioner, Dr Stephen M Hahn, to correct his misleading claims that 35 out of 100 Covid-19 patients “would have been saved because of the administration of plasma.”

The ousted spokesman, Emily Miller, had little experience in health care and was in her agency post for just 11 days.
The ousted spokesman, Emily Miller, had little experience in health care and was in her agency post for just 11 days.PHOTO: FDA

The removals come at a moment when the agency, which will be making critical decisions about whether to approve coronavirus vaccines and treatments, is struggling to salvage its reputation as a neutral scientific arbiter.

The ousted spokesman, Emily Miller, had little experience in health care.

She had spent years working in Washington for Republicans, including former Representative Tom DeLay and Senator Ted Cruz, both of Texas, and as a journalist for One America News, the conservative cable network.

She was in her agency post for just 11 days.

“This is a low moment for the FDA in at least a generation,” Daniel Carpenter, a professor at Harvard University who studies the agency, said of Hahn’s failure to control the public message about the plasma authorisation.

“This was a major self-inflicted wound.”

The most recent controversy over plasma follows a series of missteps by the FDA that have fuelled concerns that the agency is losing the public’s trust as the nation faces a presidential election in November and a pandemic that has taken more than 180,000 American lives.

Hahn notified senior leadership at the FDA on Friday that Miller would no longer be the official spokesman for the agency and that he would be appointing someone to replace her in an interim capacity.

Miller could not be reached for comment.

The consultant who was removed by the health and human services department, Wayne L Pines, said he wasn’t told why his contract was severed.

“I did recommend that he correct the record,” he said.

“If a federal official doesn’t say something right, and chooses to clarify and say that the criticism is justified, that’s refreshing.”

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

It was “100 per cent coincidence,” said Brian Harrison, the department’s chief of staff.

“HHS has been reviewing and cancelling similar contracts, so I had it sent to our lawyers, who recommended termination. This was routine,” he said.

Nevertheless, the decision by Hahn to clarify his remarks and to grant a series of media interviews appears to have rankled HHS officials, who saw it as ill-timed, given that the Republican convention was underway.

Trump administration officials are often reluctant to publicly admit error out of concern that doing so provides political ammunition to their critics.

Pines is president of the large health care practice at Apco Worldwide, a public relations and lobbying firm that represents health companies that do business before the FDA.

He said he did this work on his own, outside of his Apco practice. He would not say how much he was paid, but noted that as a friend to Hahn, he is willing to continue advising him for free.

Meredith McGehee, executive director of Issue One, which promotes bipartisan political reform, was critical of the contract, noting the potential for conflicts of interest in Pines’ work for the FDA and his company’s health care client base.

“This notion that, ‘Oh, I’m doing it in my private capacity, on the one hand, and I’m representing health care interests, on the other,’ it doesn’t pass the smell test,” McGehee said.

The FDA did not respond to requests for comment Friday about Pines’ contract or whether it was vetted for conflicts of interest.

The FDA had been considering allowing the use of convalescent plasma as a treatment for Covid-19 on an emergency basis, but last week The New York Times reported that the decision had been delayed after top health officials Dr Francis Collins and Dr Anthony Fauci intervened and expressed concern that the available evidence on the effectiveness of the treatment was too weak.

FDA officials argued that although the data was preliminary and needed continued analysis as more patients are treated, plasma still met the agency’s standard for emergency use authorisation.

On Saturday morning, Trump tweeted that the “deep state” at the FDA was slowing drug development.

Late that night, the White House press secretary tweeted that the president would have a news conference the next day “concerning a major therapeutic breakthrough.”

The announcement should have been a rare win for the FDA, which for months had fended off criticism of its track record on the pandemic, and questions about the independence of Hahn, who was previously pressured by Trump to authorise malaria drugs that turned out to be ineffective for Covid-19 and carried risks of harmful side effects.

But last weekend, finally, the agency could reveal some legitimate good news: convalescent plasma, the antibody-rich plasma donated by Covid-19 survivors, showed promise for a subset of patients when given early.

The announcement, made at the White House on Sunday, has instead spurred a week of recriminations, anger and mistrust between the FDA and HHS.

The officials’ statements Sunday cast nuanced and preliminary data as “a very historic breakthrough,” as Trump put it.

The exaggerated statements drew criticism from scientists and at least three former agency commissioners.

Within the FDA and HHS, officials have offered conflicting accounts for how a single misleading statistic – that plasma led to a 35 per cent reduction in deaths – appeared in the remarks of Trump, Hahn and Alex Azar, the Health and Human Services secretary.

It was also unclear why Hahn, a longtime cancer doctor, and Azar, a former pharmaceutical executive, did not themselves catch the overstated statistic.

No randomised trials have found a survival benefit for convalescent plasma.

The 35 per cent number referred to a tiny subset of patients and was a relative comparison between two groups, not an absolute reduction in deaths.

At a speech at the convention Thursday evening, the president again overstated what’s known about the benefits of plasma, promising it “will save thousands and thousands of lives.”

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