‘She has no expertise’: the US medical community girds for Tracy Beth Høeg’s tenure at the FDA

As the US continues making unprecedented changes to its vaccination recommendations, one figure appears unexpectedly: Tracy Beth Høeg, a Danish American sports physician and epidemiologist who first made her name casting doubt on Covid vaccines in the pandemic and has focused upon possible deaths after Covid vaccination in her short tenure at the US Food and Drug Administration (FDA).

Health officials planned to announce radical changes to the childhood vaccine schedule earlier this month, aligning the US with Denmark’s immunization schedule, sources say – a major change that would put the US out of step with much of the world with no evidence for benefit. The announcement has been postponed until the new year.

Instead of Vinay Prasad, the top vaccines chief, Høeg is listed to speak at the event. She was recently named acting director of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth person to lead the center this year.

The acting appointment of Høeg could signify a closer partnership between the drug and vaccine centers as Høeg and Prasad consolidate power at the agency – and it signals a greater focus upon dismantling already-approved vaccines at the FDA.

Høeg has frequently advocated for ending some childhood vaccine recommendations in the US in order to be more similar to Denmark, a nation with universal health coverage and a population roughly the size of Wisconsin’s.

So far in public appearances, she has continued to focus on vaccines – typically the purview of Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER) – rather than drug regulation.

Høeg’s predecessors reportedly clashed with Prasad when he attempted to pull drug-regulatory employees into vaccine-regulation work, but Høeg and Prasad have worked together closely both at the FDA and by co-authoring research in recent years.

Høeg has no apparent experience in drug development, regulation or management, which has been typical for past directors of the CBER. She has worked at the FDA as a senior adviser to the commissioner, Marty Makary, and CBER since March.

“She doesn’t seem to have any of the qualifications” for running the drug-regulation department, said Jonathan Howard, a neurologist and psychiatrist who has closely tracked Covid contrarians, including in his new book, Everyone Else Is Lying to You. “She’s never run a randomized controlled trial. She has no expertise leading a large organization. She has no expertise in industry regulation or drug approvals.”

Past directors of CBER would “understand laws and regulations and the science of drug development”, said Janet Woodcock, former acting FDA commissioner and former CBER director. “Objectively, she doesn’t have the kind of background that previous people who ran CBER have had.”

The drug center has an enormous portfolio at FDA, Woodcock pointed out.

“Everybody just pays attention to the new drug program, but the generic program approves thousands of generic drugs. There’s a biosimilars program, over-the-counter program and so forth, and all of those have to be looked after,” Woodcock said. “The thing you don’t keep your eye on, that’s the thing that I always told people is going to bite you in the behind.”

There is also a significant leadership component to the position, which oversees more than 5,000 employees. “It’s a huge management job, if you do it right,” Woodcock said.

In response to the Guardian’s questions about Høeg’s qualifications and whether this appointment signifies greater collaboration among FDA leaders on vaccines, the “questions rely on incorrect assumptions”, said Emily Hilliard, press secretary for the Department of Health and Human Services.

“This background aligns with the responsibilities of her role,” Hilliard said, pointing to the months Høeg spent advising the FDA commissioner on “drug safety and regulatory science, including computational safety modeling and vaccine surveillance”.

As acting director, Høeg inherits the commissioner’s new priority voucher program, a controversial one-day drug-approval program that reportedly troubled her predecessors, Richard Pazdur and George Tidmarsh. “How are these drugs being chosen for this voucher program? Who makes the decisions?” Howard said. “There’s a lot of secrecy going on at the FDA right now.”

Overall, he said, “the FDA seems to be moving towards laxer regulations of all drugs, except for vaccines”.

With vaccines, Høeg has a more established, if troubling, track record, Howard said. She published a study using unconfirmed crowd-sourced reports to determine the rate of heart inflammation after Covid vaccination. She advised the Florida surgeon general Joseph Ladapo, who reportedly altered data to suggest Covid vaccines are more dangerous than they are.

Part of her “wish list” for the new Trump administration included changing regulations for new vaccines and ending “unnecessary” vaccines, she said after the election on a podcast with Christine Stabell Benn, one of the Danish researchers who recently received a controversial CDC grant to study hepatitis B vaccines in Guinea-Bissau. At the FDA, Høeg has reportedly proposed excluding young men from getting Covid vaccines.

“She’s an all-around ideologue who starts off with her conclusions and works backwards to retrofit the evidence in a very disingenuous, dishonest way,” Howard said.

Høeg joined other contrarians, like Marty Makary, Vinay Prasad and Jay Bhattacharya, in sharply criticizing the handling of the Covid pandemic, particularly vaccination; they’ve all been given high-profile positions in the Trump administration.

“They’re totally consolidating power, these Covid contrarians,” Howard said. “Everything that’s happening now is a direct consequence of rage and anger over Covid mitigations. These people are furious – livid that their genius wasn’t acknowledged. So they’re on kind of a revenge tour.”

In the pandemic, the contrarians were like “armchair quarterbacks”, Woodcock said. “The problem with that is, they think they can play the game. They can’t play the game. They’ve never played the game, they just criticized every play.”

Raymond Pollak, an Advisory Committee on Immunization Practices (ACIP) adviser and transplant surgeon, pointed out that “our patient population in the United States is very different culturally” from Høeg’s homeland of Denmark.

Denmark does not routinely vaccinate against hepatitis B (at birth), chickenpox, influenza, rotavirus, hepatitis A, meningococcal disease or RSV. As a result, there are tens of thousands of vaccine-preventable diseases each year in Denmark, a nation of 6 million people – less than the population of New York City.

There are other major differences as well. Prenatal care is free for all in Denmark, and the country has a national health registry. More than 95% of pregnant women in Denmark are screened for hepatitis B, and pregnant people who test positive – and their babies – are monitored to ensure that they are vaccinated.

In comparison, each year, 500,000 pregnant people in the US are never tested for hepatitis B, and many infants born to positive or status-unknown parents are lost to follow-up as soon as they leave the hospital, said Adam Langer, acting principal deputy director and associate director for science at the Centers for Disease Control and Prevention’s National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention.

And the US has different disease patterns and risks compared with most other countries.

“The United States is a unique country. I think that most of us would agree that we don’t really have a peer nation in this world,” Langer said at an ACIP meeting earlier this month. The closest might be Canada, he said – and they are moving toward the same birth dose recommendations the US just jettisoned. “So let’s talk about apples to apples, not apples to oranges,” Langer said.

Yet Høeg cast doubt on the evidence behind hepatitis B vaccination, stating that “from a regulatory perspective” officials in the second Trump administration “have a very low level of confidence” in saying that these benefits of the vaccines outweigh the risks, while presenting no new evidence of risk.

Høeg also featured several anti-vaccine talking points in her comments during a presentation she made on the Danish vaccination schedules to the ACIP. When discussing the number of vaccines a child receives in the US, Høeg questioned the amount of aluminum in each shot.

“I do not feel like we have the data to show that there is an established safe amount that children can receive before the age of two, before the age of 18,” she said, and she also doubted the data on the effects of giving multiple vaccines concurrently. Aluminum adjuvants help vaccines work effectively and have been shown to be safe, and it is safe to give multiple vaccines at once, according to the CDC.

Høeg also took aim at the RSV shots that have dramatically reduced hospitalization among US babies, claiming that in the trials there was a higher death rate, though she admitted it was “not quite statistically significant”. No such safety signals have been announced in the rollout of RSV shots over the past several years, but the FDA is still launching an investigation into their safety.

In December, 12 former commissioners of the FDA penned a warning in the New England Journal of Medicine about the lack of transparency in announcing new changes to vaccine regulations. In the past, regulatory officials were rigorous about documenting benefits and harms based on publicly available evidence, said Woodcock, one of the signatories to the letter.

“The commissioners are writing because that is not the process that has been followed, and it’s not generally a scientific process of open debate,” Woodcock said.

“You can just make decisions because you have the pen and say: ‘It’s because I said so.’ But that doesn’t lead to, over time, a lot of trust in the system.”