Food and Drug Administration head Stephen Hahn watches Donald Trump’s White House appearance, August 23, 2020 (Pete Marovich/Getty/TNS)
The Food and Drug Administration is in turmoil, after Donald Trump’s claim that the “Deep State” is delaying a Coronavirus vaccine to prevent his re-election.
Trump’s conspiracy theory set off a chain of events leading to the false declaration, by Trump and FDA Administrator Stephen Hahn, of the efficacy of convalescent plasma in treating the virus.
A senior public relations expert who advised Hahn to withdraw the misleading plasma statement has now been fired. Wayne Pines said that he was not told why his contract was terminated, but confirmed his advice to Hahn:
I did recommend that he correct the record. If a federal official doesn’t say something right, and chooses to clarify and say that the criticism is justified, that’s refreshing.
Angered that Hahn stepped back on Monday from the claim of plasma efficacy, Health and Human Services Department officials began the process of severing Pines’ contract, said “a person with direct knowledge of the matter”.
On Friday the FDA’s chief spokeswoman, Erica Miller, was removed after only 11 days in her post.
No reason was given, but FDA sources said Miller lacked even a basic understanding of medical information. One health official said, “There was an inability to do anything inside the agency. She couldn’t even pronounce convalescent plasma.”
Miller, the author of “Emily Gets Her Gun: But Obama Wants to Take Yours”, previously worked for the re-election campaign of Sen. Ted Cruz and for the right-wing outlet One America, a favorite of Trump at his White House appearances and in his Twitter feed.
The US death toll from Coronavirus reached 181,775 on Friday, with 961 fatalities in 24 hours. Confirmed cases are 5,917,817, a rise of 51,764.
From “Deep State” to False Statement
A week ago Trump, trailing Democratic Presidential nominee Joe Biden in polls and unsettled by the Democratic National Convention, sent a message to the FDA’s Hahn via a tweet.
The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives! @SteveFDA
— Donald J. Trump (@realDonaldTrump) August 22, 2020
He again touted the ineffective and dangerous hydroxychloroquine, normally used to treat malaria and lupus, as a wonder cure, challenging the FDA’s revocation of emergency authorization for its use.
Less than four hours later, White House Press Secretary Kayleigh McEnany tweeted that Trump, accompanied by Hahn and Health Secretary Alex Azar, would announce a Coronavirus “breakthrough” on Sunday.
Trump then proclaimed his approval of convalescent plasma, which had already been administered to more than 70,000 patients. He said that the treatment had been “proven to reduce mortality by 35%”.
See TrumpWatch, Day 1,312: Trump’s Political Claim Over Coronavirus
That was a serious distortion of the medical position. The claim applied only to patients less than 80 years old who received plasma with a high level of antibodies within three days of diagnosis, and who were not on a respirator.
And the 35% was not about overall mortality, but about the position of those patients after a month, compared with those who received low-level antibody plasma.
Hahn did not correct Trump, but that the 35% reduction in mortality would be established “if the data continues to pan out”.
He did not mention that there had been no randomized trials of the treatment to establish efficacy. Nor did he cite the questions by senior medical officials, including National Institutes of Health Director Dr. Francis S. Collins and the Government’s top infectious disease specialist Anthony Fauci, if the data was sufficient.
“Potential for Disastrous Situation”
Medical experts and at least three former FDA commissioners challenged the misleading statements, saying that they undermined public trust in the Agency. But in his convention speech on Thursday, Trump repeated his hyperbole that convalescent plasma “will save thousands and thousands of lives.”
Emily Brunson, a medical anthropologist at Texas State University, summarized the fallout with anti-vaccination activists spreading conspiracy theories and many people wary of any vaccine.
There’s almost not enough adjectives to describe how appalling this is….[Politicizing the vaccine] is an added component that is unique in modern times, and it has the potential to really make this a disastrous situation.
A former FDA spokesperson said, “The damage that has been done will take at least 10 years to repair.”
Health and Human Services denied any connection between the dismissal of public relations experts Pines and the convalescent plasma statement.Chief of Staff Brian Harrison maintained that it was “100% coincidence”: “HHS has been reviewing and canceling similar contracts, so I had it sent to our lawyers, who recommended termination. This was routine.”
He then belittled the consultant, “I learned more about what Wayne Pines had been doing after the contract was canceled. We don’t countenance contracts like this.”
But an FDA source confirmed that the removal of Pines was “not routine”, and was driven by his advice that Hahn apologize.
