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WASHINGTON — President Trump has instigated an all-out crusade against the Food and Drug Administration at a critical point in the federal government’s fight against Covid-19.

Three senior FDA officials and several outside experts told STAT that Trump’s attacks threaten to permanently damage the agency’s credibility — especially when combined with a disastrous series of public misstatements on Sunday from Stephen Hahn, the cancer doctor who became FDA commissioner in December.

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 Nov. 3 election. A premature approval, experts said, could further weaken Americans’ confidence in vaccine safety, especially if it appears rushed or politically motivated.

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“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.”

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 spokeswoman — empowering her to aggressively reshape the FDA’s typically nonpolitical, straight-laced public messaging. On Saturday, Trump, with no evidence, accused the FDA of taking part in a “deep state” political conspiracy to harm his reelection campaign. And two key White House aides, including Trump’s chief of staff, have taken the rare step of criticizing the agency publicly, with one reportedly advocating for the approval of an unproven plant extract as a Covid-19 cure.

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Presidents have sparred with the Food and Drug Administration 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.

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 authorizations 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.

In a statement, 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 labeled 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 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 Aug. 17 as assistant commissioner for media affairs. The position is typically filled by nonpolitical civil servants, not overtly political activists, making her appointment all the stranger. Miller is now the agency’s top spokeswoman 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.

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, D.C. (Miller writes that a D.C. 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 pedophiles,” 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.

Her presence is already evident: A press release sent soon after Miller joined the agency, announcing the emergency authorization of blood plasma as a Covid-19 therapy, took a political tone that unnerved longtime 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 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 reelection bid.

“Trump is in a reelection battle,” said Daniel Carpenter, a Harvard 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 spokesman 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 authorizations 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 reelection odds by intentionally slowing down medical product approvals.

At an Aug. 19 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. Sunday evening, he announced the emergency authorization 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 authorization for oleandrin, a plant extract, be approved for use as a Covid-19 treatment. There is no scientific backing for his interest: Instead, Axios 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 authorization 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?”

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 fulfill its public health duties.

Trump’s scientific overreach during Covid-19 is not specific to the FDA: On Wednesday, CNN reported, the Centers 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 delegitimize 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, Sen. 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.”

Nicholas Florko and Ed Silverman contributed reporting. 

  • I think it’s time to make sure we don’t spout misleading and incorrect conclusions on Trump and the bleach/oleandrin issues.

    We can debate whether Trump’s statements are sufficiently judicious, but on the other hand, he is not responsible for the mental processes of other people including people who do stupid things, like drink fish water or write misleading internet posts.

    First, on bleach, see:
    https://www.politifact.com/article/2020/apr/24/context-what-donald-trump-said-about-disinfectant-/

    Here’s the money quote form Politifact.

    “…several websites and social media posts have taken [Trump’s remarks} out of context. The briefing transcript shows that Trump did not say people should inject themselves with bleach or alcohol to treat the coronavirus. He was asking officials on the White House coronavirus task force whether they could be used in potential cures.”

    On oleandrin, Trump was simply mentioning the idea, which, in turns out is not some crazy idea necessarily. Don’t believe me? go here:

    https://cen.acs.org/biological-chemistry/natural-products/oleandrin-compound-touted-possible-COVID/98/web/2020/08

    I hope folks aren’t considering cancelling Professor Harrod?

    Quote:
    “Robert Harrod, a virologist at Southern Methodist University, has studied oleandrin’s ability to block human T-cell leukemia virus, type 1, a retrovirus that causes a fatal blood cancer, from spreading to other cells in test tubes (J. Antivir. Antiretrovir. 2019, DOI: 10.35248/1948-5964.19.11.184). He says oleandrin probably does this by blocking cells from binding to the virus’s glycoprotein spike—a process he says could be general for envelope viruses, including SARS-CoV-2.

    “He notes that there’s a lot more research needed to go from the preprint to giving oleandrin to people, including tests in human cells, animal models, and early clinical trials. ‘Even if it does make it into treatment of coronavirus as a therapeutic, this is going to have to be monitored very closely by doctors,’ Harrod says. ‘It is a very dangerous compound.’ Even so, he’s not willing to dismiss the idea. ‘We should wait and look at the data before making a decision,’ he says.”

    • umm, small molecules that have some antiviral activity in a DISH are a DIME A DOZEN. Pick one, any one…. start a rumor (and it might actually get promoted by the POTUS, just to keep people distracted from reality and thinking he actually cares).

    • Dear, Dear Abbie…so dismissive of a successful researcher who used to work at the NIH, is a director of graduate studies at SMU, and is being published in the leading virology journals.

      It makes one think you might be anti-science.

    • I saw the Trump Bleach/UV light fiasco live. He clearly was having a “Eureka” moment and was bouncing off his new insight to Birx et al. You leave out the part where a reporter basically asks,” don’t you feel it is reckless for you to talk about support unproven claims”. Trump was not happy that his brilliance wasn’t immediately recognized and walked off. The next day he claimed he was being sarcastic. Not even close. He was being Trump, the Judge Judy of all truth.

      Only an administration that gives Mr. Pillow an audience with the CV19 task force would discuss the possibility of studying a Poison that has not even been tested on Humans at all. Mr. Pillow discusses Oleander ( one of the leading ways to kill yourself in Africa), with Dr Ben Carson. Earth to Dr Carson, you’re talking to Mr. Pillow.

      Dr Simone Immanuel, “God’s Battle-ax” was also complemented by Trump. Even a full 24 hours after her claim that “we already have a cure for Covid”. Don’t you think that someone could at least Vet the people he praises. If they had, her “important voice that needs to be heard”(Trump), they would have found that she has also caused spontaneous abortions of Parishoners carrying the Devil’s fetus.

      Apparently there are some Trump Trolls who would defend him no matter how ridiculous or dangerous his actions are. If you are one of them, be sure to at least try to use observable facts, not blind loyalty in your comments.

  • As long as Trump is in the White House, the gong-show of political infiltration and scientific demise will worsen. He is a self-aggrandizing bully, pushing for re-election, with “I am a hero” bravado and premature approval of tests, drugs, vaccines. How and why did who elect this idiot – and why is he bullet-proof?

    • Consuming a disinfectant that would destroy the virus isn’t a stupid idea, it’s an excellent idea. It’s just unfortunate that the CDC employees suffering from dementia seem to insist this must mean Clorox bleach, perhaps because they are all swallowing Tide-Pods to treat their own conditions. Instead of being so contrarian and counter-productive, why not initiate a research study into doing exactly that? I know that’s asking a lot from people intent on facilitating the democrat agenda of allowing 120,000,000 illegal aliens to stampede into the country as soon as they destroy the wall, and appropriate, direct, and divert all and any future welfare funds intended to be allocated to citizen blacks, browns, whites, and asians to themselves instead.

  • Like the Justice Department, The Center for Disease Control, The State Department and everything Trump touches, he will destroy the FDA, negatively impacting lives.

  • All medical innovations SHOULD be tested in blinded fashion in which the procedure or medication is tested against another procedure or medication with a known risk factor and effectiveness (or cure rate) and complication rate. The distribution and outcomes (cure rate and side effects) are then compared. Neither doctor nor patient knows which drug they are getting. New drugs and procedures should be so evaluated. New does not always mean better.

  • Great this conversation turned toward some real, non-political issues. Gold Standard’s implicit assumption is that all illnesses share the same etiology and therefore should require the same or Me-too treatments. “One size fits all” turns out to be ludicrous for humans, more appropriate for the non-living inquiries.

    For example, people get lower back pain for reasons other than lumbar spinal issues. Surgery is not the answer for referred pain and can lead to increased pain. Yet surgery is what’s offered if nothing else helps.
    Depression has many causes, including “physical” illnesses beyond the brain. An antidepressant or even three different trials of these meds may not help depressions caused by a hormonal, circulatory or other physical conditions.

    Depression related to altered brain functioning is also not “one disease,” either. Rather, it’s a syndrome of symptoms that has many subtypes responsive to different interventions. Knowledge of the subtypes are limited. Current double blind group selection is based on similarities that may be irrelevant to these subtypes. Any current (heterogeneous) group selected for treatment may lead to false negative outcomes because the group was not sufficiently homogeneous for that subtype.
    This happens with ADHD diagnosis in children. Many don’t respond to any stimulants. Red dye may aggravate or even cause the hyperactivity syndrome in some kids, but not often “enough” to show up as statistic of significance. That’s why the food dye remains a staple of candy when natural red food coloring is available. Yet if red dye effects your child, they will go “nuts” 100% of the time they ingest it.
    We need to be able to define subtypes and may be helped by case studies that report unusual responses to treatment. These may point to what subtypes exit. The same subtype may never “show up” (with statistical significance) by looking through the Gold Standard lens.
    Peggy Finston MD

  • Another example of the failure of journalists to present an objective perspective. The FDA has failed us on many occasions. Political and economic agendas have driven the FDA’s decision to prematurely approve many drugs and vaccines, one obvious example: Essure.
    No one has held the FDA, nor the CDC, accountable for their agenda driven policies and recommendations which are often detrimental to the health and well-being of Americans. I am thankful to President Trump for leading this investigation into the FDA and ensuring that it does the job that it was tasked to do, rather than continue to be an arm of big Pharma, the vaccine manufacturers, and others who have a different vision of what America should be.

  • Well I don’t blame Trump for his skepticism of the FDA. For at least the past 40 years they have catered to the big pharmaceutical companies with little regard for what their ‘concoctions’ may or may not do to/for the American people, which is the exact opposite of what that agency was designed to do. They quit following ‘the design’ years ago, for the most part. Have you ever noticed that most of their resigning CEOs go to work for the Pharmaceutical Industry?–

  • To me, the notion of a “control group” that needs to receive a placebo in double-blind testing is somewhat obsolete. The receivers of placebo are just there to reflect the “background”, ordinary statistical rates expected in an un-treated population. Something we should already have a handle on (rates of prostate cancer, pancreatic, liver disease, etc). We generally shouldn’t need a placebo group to give us the background rates. Some consider it unfair, (and rightfully so) to be denied access to the drug being tested if they happen to be the unlucky people who got the placebo during the study instead of the treatment. FDA would be better off, in many cases, to double their sample size by giving EVERYONE in the study the test drug – you’d get much better statistics on its efficacy and risks.

    • The first rule of a Bureaucracy like the FDA is to do no harm. Do no harm, that is, to one’s career. And the best way to protect one’s job is to do nothing, to not give permission, to not risk anything.

      Trump, a businessman, has done a miraculous job in bringing a potential Covid killer to market in record time. Credit where credit is due.

    • Clearly you know nothing of how cancer clinical trials are done. The placebos in cancer studies are always recognized standard of care versus recognized standard of care plus new drug. It would not be ethical to not give a cancer patient a valid treatment of some kind.

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