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. 

  • 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.

  • I agree with Erik. Perhaps the credentialists need to become less arrogant and more practical. To take the testing of hydroxy, instead of a 10,00 patient ten year double-blind placebo trial, why couldn’t they just direct 10,000 doctors to each dose a single patient, with various dosages starting at various times in the progression of the illness, record the results and tabulate. It’s called “parallel processing”. Doesn’t take a rocket surgeon to figure that out.

    • You seem, Erik, to be unaware of the gold standard that the FDA has required for some decades, and that is the requirement of at least one double blind placebo controlled study over a suitably large patient population in order to provide suitable proof oF both the safety and efficacy of any new drug or biologic so as to ensure that said new product will both benefit the population at large and without undue side effects such as death. All the more so this required for a drug or biologic that will be offered to millions of people. How many deaths would you like to have on your conscience?

  • Also needed are stronger laws against profiting from one’s employment in government, something like disallowing lobbying by former top elected officials and political staff for a number of years after leaving their jobs, from which they typically take valuable inside information that can enrich lobbying firms.
    I’ve felt particularly strong about this since reading about the U.S. Food and Drug Administration commissioner, Arthur Hull Hayes Jr, who decades ago permitted the potentially health damaging artificial sweetener Aspartame to be placed in many foods and drinks, before he then left his FDA position for a lucrative job with the public relations firm owned by the Aspartame patent holder and producer, G.D. Searle Company.
    This, despite being urged by credible health academics to refrain from immediately granting FDA approval of the sweetener—a chemical concoction discovered accidently in 1965 while G.D. Searle Company chemist James Schlatter was testing an anti-ulcer drug.

  • Because of the politicization and manipulation of data, I believe any vaccine or medication approved form now on should not be taken unless approved by a legitimate outside agency such as WHO or European health agency./ Thbe FDA and CDC have had their credibility destroyed

  • Hydroxi, Harvey Reisch, “this is the most important election in the history of our country”–nuf said.

  • The FDA isba disaster and needs to be cleaned out. The drug and device testing process is so expensive, slow, and cumbersome, only giant corporations can get most things through. Many great existing products and promising new ones have been wiped out of existence by this horrible agency.

    • Wake up Karl! One, I did not vote for Trump so you are the Kool aid drinker, not me. Two, there are thousands of examples of perfectly good products and drugs that work and are safe, but did not have the resources to make it through the FDA corrupt system.

      I’m guessing you are not smart enough or willing to find them on your own, so here is one. Google terumo elemano. It was a fantasticb automatic blood pressure monitor that was safe and accurate and didn’t over inflate. The FDA arbitrarily changed their rules on electronic circuitry. The company had to discontinue it because they could not justify the cost of the changes and reapproval process.

      So Karl, you have no idea what you are talking about. If people like you don’t get a clue, this country is doomed.

  • Please Stat, turn off comments for people that aren’t subscribers. Some of us have paid for a subscription for many years because this service fills an important need for real, in depth biotech and pharmaceutical reporting. This is a good article and those of us who have dealt with the FDA for years are alarmed by what is happening. I appreciate making COVID 19 news free to the public but why do we need to be subject to anti science nonsense in comments by people who think everything is political?? The comments used to be valuable on this site from people with industry or scientific expertise. Not anymore on these free articles.

    • Sadly Dan, that is not what is happening. You are doing what is called cancel culture. The FDA has major issues going back way before Trump. You were in a nice safe echo chamber before, but now you are seeing opinions you don’t agree with. Instead of intelligently arguing, you just want anyone that disagrees with you to go away so you can be safe in your echo chamber where the “smart” and “informed” people are.

    • @Erik – it is a bubble of those with relevant experience that can have intelligent debates on issues v a free for all where conspiracy theorists who could barely pass High School biology make wild ass claims. Impress me Erik and provide your credentials and some actual detail to your claims about historical FDA “issues” when it comes to drug approvals.

  • In the tech industry there is the saying “Move fast and break things”. Trump is shaking up the FDA and bringing it into the 21st Century. The howls of disapproval you hear are coming from the tired, old boys having their comfortable lives upended.

    • Trump is neither smart enough nor strategically-minded to “move fast and break things.” I worked in tech, I understand how that strategy works and I’ve implemented the approach myself. Trump is not moving fast and breaking things. He neither understands nor has the curiosity to learn how to improve the FDA. His management style is cronyism, hiring neither smart nor strong leaders. He’s just breaking things and undermining science because he only cares about his election, not about American lives, and certainly not about improving the FDA.

    • Yeah because tech and drug regulation are the same things. So stupid! In drug discovery the things you “break” are human beings. Stick to coding.

    • Except convalescent plasma is a widely used and well-established therapy. As is hydroxy, used by millions for arthritis and lupus. The FDA had merely to look at whether incidents of severe Covid were lower in this already existing test group that was already taking the drug. But they didn’t even have the competency level to do that. The demand that they do some practical real-world testing on plasma was not unreasonable.

  • It really bothers me when medical journals can’t stay neutral.
    Tell the facts as you see them without involving and attacking the administration of Obama or Trump.
    Make an effort not to destroy our profession.

    • @ Nowak, it should bother you that our President disrespects scientific expertise. This excellent, fact-based article is not political, but rather points out how science has become hyper-politicized by the anti-science president and his minions. It is frightening as a citizen to see 180,000 Americans dead, and still rising, more than any other Western country whether as a number or as a percent, because a greedy, soulless, uncurious and uninformed “president” cannot learn, listen or act on advice from anyone, particularly scientists.

  • Authors appear to be real left wingers. The FDA has always been political. Members move in and out of Big Pharma regularly. No conflict of interest, ha.

    • George, nothing good ever came out of “right wingers” (religiously-minded people). Give the “left wingers” (levelheaded people) a try and see where it goes.

    • “…. Give the “left wingers” (levelheaded people) a try and see where it goes….”

      Well, we gave them a chance with the USSR, Cuba, Venezuela, Communist China and more and wound up with 100’s of millions dead. So we will pass on letting you “level headed” folks try it here.

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