FDA cleans house following bungles over convalescent plasma

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In moves seen as an effort to restore the credibility of agency, the US Food and Drug Administration (FDA) has fired a Trump appointee after only 11 days on the job, following fallout over convalescent plasma claims.

The Washington Post reports that the FDA’s chief spokesperson, Emily Miller, who has been in the job less than two weeks, was removed from her role as of noon Friday (28 August), part of continued fallout from a White House news conference featuring inaccurate claims that convalescent plasma dramatically reduced mortality for patients with COVID-19.

It remains unclear whether Miller, who was assistant commissioner for media affairs, will remain at the agency in some capacity, said a senior administration official, who spoke on the condition of anonymity. Miller formerly worked for One America News, a conservative cable news network and for Senator Ted Cruz. She does not have a health or science background and has been a strong advocate for gun rights.

Politico reports that FDA Commissioner Dr Stephen Hahn officially removed Miller, a fellow Trump appointee, ending a tenure that was marked by infighting and a damaging controversy this week over the FDA's emergency authorisation of convalescent plasma as a COVID-19 treatment.

Colleagues said that Miller, with no prior medical or science experience, was a bad fit inside an agency rushing to fight a pandemic. "There was an inability to do anything inside the agency," said one health official. "She couldn't even pronounce convalescent plasma."

The New York Times reports that 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 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 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.

 

It was earlier report that US President Donald Trump has instigated an all-out crusade against the FDA at a critical point in the federal government’s fight against COVID-19. Three senior FDA officials and several outside experts are quoted in STAT News as saying that Trump’s attacks threaten to permanently damage the agency’s credibility – especially when combined with a disastrous series of public misstatements from Stephen Hahn, the cancer doctor who became FDA commissioner in December.

The report says beyond long-term concerns, these officials expressed a more immediate fear: that political incentives could interfere with approval decisions surrounding a COVID-19 vaccine, which Trump has repeatedly suggested could come before the 3 November election. A premature approval, experts said, could further weaken Americans’ confidence in vaccine safety, especially if it appears rushed or politically motivated.

“It’s a political agency, and it has a political appointee at the head, but it has maintained a reputation for decades of being a science-focused agency,” said Holly Fernandez Lynch, a health policy expert and University of Pennsylvania professor of medical ethics. “There have definitely been slip-ups, but the level of interference that we’re seeing from the White House is so concerning.”

STAT News reports that in the past two weeks alone, the Trump administration has installed a right-wing journalist best known for her gun-rights advocacy as the FDA’s top spokesperson – empowering her to aggressively reshape the FDA’s typically non-political, straight-laced public messaging. Trump has, with no evidence, accused the FDA of taking part in a “deep state” political conspiracy to harm his re-election campaign. And two key White House aides, including Trump’s chief of staff, have taken the rare step of criticising the agency publicly, with one reportedly advocating for the approval of an unproven plant extract as a COVID-19 cure.

The report says presidents have sparred with the FDA for decades: over birth control, over tobacco, and over Americans’ right to take untested drugs that aren’t yet proven to be safe. But taken together, the actions represent an extraordinary new frontier for presidential attacks on the scientific agency.

White House spokesman Judd Deere told STAT: “Every decision the FDA has made under the Trump administration has maintained the agency’s gold standard for safety and been data-driven to save lives,” and labelled accusations that politics influence approvals as a “false narrative.” An FDA spokeswoman declined to comment.

Political interference at the agency “has been an issue in past administrations Republican and Democratic,” said Margaret Hamburg, the FDA commissioner who served under President Barack Obama from 2009 to 2015 who had a major dust-up with Obama’s health secretary, Kathleen Sebelius, over emergency contraceptives. “But never at this level, and never accompanied with the kind of public derision and undermining of both the employees who work at the agency and, frankly, the very mission of the agency.”

The report says the most striking change at the agency is the appointment of ultra-political conservatives – an emerging pattern that some FDA insiders see as the start of a takeover of an otherwise largely apolitical agency.

The appointment of Emily Miller, a right-wing activist who has ping-ponged between government and conservative journalism for the past two decades, has particularly dispirited FDA staff, senior agency officials said, speaking on the condition of anonymity.
Miller joined FDA on 17 August as assistant commissioner for media affairs. The position is typically filled by non-political civil servants, not overtly political activists, making her appointment all the stranger. Miller is now the agency’s top spokesperson and liaison to the public, wrangling Hahn’s media interviews and providing information to journalists covering the agency.

Miller is an unconventional choice. She has no experience in science or medicine, and her work in politics and journalism has focused far more on foreign policy or gun-rights issues than on health care. The report says Miller’s book, titled “Emily Gets Her Gun: But Obama Wants to Take Yours,” is a treatise on gun rights and the difficulties of buying firearms in Washington, DC (Miller writes that a DC home break-in motivated her to purchase a gun, though her description of the incident is factually inconsistent with police reports.)

As a Washington Times columnist, Miller penned articles with titles including, “Maryland’s bathroom bill benefits few transgenders, puts all girls at risk from paedophiles,” and, referencing advertisements promoting insurance coverage for birth control, “New Obamacare ads make young women look like sluts.” She later worked as a correspondent for the cable channel One America News Network, a right-wing news source openly allied with Trump and known for promoting conspiracy theories.

STAT News says that even before the latest examples, the president repeatedly challenged the agency’s decision-making on a litany of potential COVID-19 treatments, misleadingly casting scientifically dubious treatments as “breakthroughs.” The FDA ended up issuing emergency authorisations for two of the products: the malaria drug hydroxychloroquine and blood plasma from recovered COVID-19 patients. Trump has even agitated for the FDA to approve oleandrin, an unproven plant extract, touted, without evidence, by the CEO of MyPillow.Com, a major Trump backer, though the agency has made no move to sanction its use.

STAT News says her presence is already evident: A press release sent soon after Miller joined the agency, announcing the emergency authorisation of blood plasma as a COVID-19 therapy, took a political tone that unnerved long-time FDA observers: The emergency approval, it said, represented “Another Achievement in Administration’s Fight Against (the) Pandemic.”

Shortly thereafter, Miller aggressively defended Hahn, the agency chief, after he made scientifically misleading claims about plasma’s medical benefits while standing alongside Trump at a press briefing Sunday night. In a series of tweets, she falsely asserted that the treatment, known as convalescent plasma, “has shown to be beneficial for 35% of patients.”

The report says the misleading claim alarmed agency scientists, according to two senior FDA officials: Not only did it misrepresent scientific data, they said, but it was seen as a politically motivated attempt to co-opt the FDA’s message to bolster Trump’s re-election bid. “Trump is in a re-election battle,” said Daniel Carpenter, a Harvard University professor of government and FDA expert. “And unlike past presidents, he’s willing to use the FDA as part of his arsenal.”

Some agency higher-ups view Miller’s hiring, and that of her boss, former Republican National Committee operative and Veterans Affairs spokesperson John “Wolf” Wagner, as being driven by Michael Caputo, a Trump loyalist who serves as the top communications official at the Department of Health and Human Services, the FDA’s parent agency. (FDA officials, however, only expressed concerns about Miller, and largely reserved judgment about Wagner.)

Another hiring earlier in 2020 has similarly troubled FDA insiders: that of David Gortler, a former policy adviser at the Heartland Institute, a conservative think tank. Gortler has extensive experience in drug regulation and has served at the FDA previously, but is also a known agency critic: In a 2016 STAT op-ed, he advocated for “a good personnel sweep,” calling a number of FDA colleagues “petty people who have personal agendas” and who “abuse” small drug companies.

Gortler, one FDA official said, returned to the agency in June. But the Heartland Institute, his former employer, trumpeted his hiring only in the wake of the controversy over blood plasma. In a statement on Monday, the think tank described the FDA as a “sclerotic” agency that “deprives Americans of the latest available biotechnology.”

FDA staff have been equally alarmed by overt attempts from Trump and other administration officials to influence decisions about emergency authorisations for medical products that would otherwise be based solely on safety and evidence. Heightening that alarm: Trump’s baseless new assertion that the agency is part of a “deep state” plot intent on hurting his re-election odds by intentionally slowing down medical product approvals.

At an 19 August press conference, Trump suggested scientists at the National Institutes of Health were holding up an emergency approval for blood plasma as a COVID-19 treatment for political reasons. Saturday morning, he tweeted his displeasure with the FDA alongside his “deep state” accusation. He announced the emergency authorisation from the White House podium alongside Hahn and health secretary Alex Azar, both of whom dramatically overstated the treatment’s anticipated impact on coronavirus death rates.

Trump, reportedly, has expressed his wish that the FDA issue a similar authorisation for oleandrin, a plant extract, be approved for use as a COVID-19 treatment. There is no scientific backing for his interest: Instead, it was reported Trump’s interest stems from the recommendation of Mike Lindell, a major Trump backer who works as the CEO of MyPillow.Com and recently acquired a stake in a company developing the experimental dietary supplement.

The FDA antagonism extends to Trump’s senior aides, too. Peter Navarro, a top White House trade adviser, has reportedly told FDA officials: “You are all Deep State, and you need to get on Trump Time.”

Mark Meadows, the former Republican congressman serving as Trump’s chief of staff, also defended the president’s “deep state” tweet in an ABC News interview, citing “a real frustration with some of the bureaucrats” and a desire to make sure FDA scientists “feel the heat.”

The drama over plasma mirrors the spring controversy over the FDA’s emergency use authorisation for hydroxychloroquine, the malaria drug that Trump cast as a COVID-19 cure-all for months. When the FDA rescinded its emergency approval for hydroxychloroquine, Sean Hannity, the Fox News commentator and a de facto Trump adviser, agitated for mass firings: “If we have an FDA that is not looking out for the best interests of the American people,” he said, “why don’t we clean that out?”

The report says FDA officials also expressed concern over the Trump administration’s recent decision to bar the agency from regulating some lab-developed diagnostic tests, including many that test for COVID-19. While the move likely has little to do with presidential politics, FDA insiders nonetheless see it as yet another Trump administration move to reduce the agency’s scope and authority. Scott Gottlieb, the first FDA commissioner under Trump, has slammed the move, arguing it would hamper the FDA’s ability to fulfil its public health duties.

The report says Trump’s scientific overreach during COVID-19 is not specific to the FDA: The US Centres for Disease Control and Prevention suddenly changed its coronavirus testing guidelines, enraging public health officials by advising that even those who’ve come into close contact with infected individuals don’t need tests. The directive reportedly came from the Trump administration’s “upper ranks.”

Trump’s moves to delegitimise FDA, and other administration decisions that effectively stripped it of regulatory power, have taken place against the backdrop of other controversial advocacy surrounding the agency’s authority. In the first years of his presidency, Trump aggressively supported “right-to-try” legislation, which became law in 2018. The administration has argued the law helps patients with terminal illnesses request unapproved drugs from pharmaceutical companies as a last resort, even if they haven’t been thoroughly vetted for safety or effectiveness.

That law has not led to a significant increase in patients’ access to investigational, unapproved drugs, but the debate surrounding it is reflective of a broader school of thought regarding FDA’s role. The Bill’s sponsor, Senator Ron Johnson (R-Wis.), told then-commissioner Scott Gottlieb in a 2018 letter: “This law intends to diminish the FDA’s power over people’s lives, not increase it.”

“It plays into the same theme,” said Hamburg, the former commissioner. “It also signals that even after we get out from under this COVID crisis, the FDA will be very, very vulnerable if Trump remains in office and these kinds of anti-FDA, anti-regulatory policies continue to be elaborated and implemented.”

 

Full STAT News report

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