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

AAs the United States continues to make unprecedented changes to its vaccination recommendations, one figure is emerging unexpectedly: Tracy Beth Høeg, a Danish-American sports doctor and epidemiologist who first rose to prominence by questioning Covid vaccines during the pandemic and who focused on possible deaths after Covid vaccination during her short tenure at the US Food and Drug Administration (FDA).

Health officials planned to announce sweeping changes to the childhood vaccination schedule earlier this month, bringing the United States in line with Denmark’s vaccination schedule, sources said — a major change that would put the United States out of step with much of the world with no evidence of an advantage. The announcement was postponed until the new year.

Instead of Vinay Prasad, the top vaccine official, Høeg will 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.

Høeg’s interim appointment could mean a closer partnership between the drug and vaccine centers as Høeg and Prasad consolidate their power within the agency — and it signals a greater focus on dismantling already-approved vaccines at the FDA.

Høeg has often advocated ending some childhood vaccine recommendations in the United States in order to be more like Denmark, a country with universal health coverage and a population roughly equal to that of Wisconsin.

In her public appearances so far, she has continued to focus on vaccines — which typically reports to 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 tried to involve drug regulatory employees in vaccine regulatory work, but Høeg and Prasad have worked closely both at the FDA and co-performing research in recent years.

Høeg has no apparent experience in drug development, regulation or management, which was typical of previous CDER directors. She has worked at the FDA as a senior advisor to Commissioner Marty Makary and CBER since March.

“She doesn’t seem to have any of the qualifications” to head the drug regulatory department, said Jonathan Howard, a neurologist and psychiatrist who has closely followed anti-Covid people, notably in his new book, Everyone is Lying to You. “She has never conducted a randomized controlled trial. She has no expertise in running a large organization. She has no expertise in industrial regulation or drug approval.”

Former CDER directors “would understand the laws and regulations and the science of drug development,” said Janet Woodcock, former acting FDA commissioner and former CDER director. “Objectively, she doesn’t have the kind of experience that previous CDER leaders had.”

The pharmaceutical center has a huge portfolio at the FDA, Woodcock pointed out.

“Everyone pays attention to the new drug program, but the generic program approves thousands of generic drugs. There’s a biosimilar program, an over-the-counter program, etc., and all of that needs to be monitored,” Woodcock said. “The thing you don’t watch out for is the thing that I always told people was going to bite you in the butt.”

This position also has a significant leadership component, overseeing over 5,000 employees. “It’s a huge management job, if you do it right,” Woodcock said.

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

“This experience matches the responsibilities of his role,” Hilliard said, noting Høeg’s months advising the FDA commissioner on “drug safety and regulatory science, including computer safety modeling and vaccine monitoring.”

As interim 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 chosen for this voucher program? Who makes the decisions?” Howard said. “There’s a lot of secrecy at the FDA right now.”

Overall, he said, “the FDA appears to be moving toward more lax regulation for all drugs except vaccines.”

With vaccines, Høeg has a more established, if troubling, track record, Howard said. She published a study using unconfirmed crowdsourced reporting to determine the rate of heart inflammation after Covid vaccination. She informed Florida Surgeon General Joseph Ladapo, who allegedly 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 in a podcast with Christine Stabell Benn, one of the Danish researchers who recently received a controversial grant from the CDC to study hepatitis B vaccines in Guinea-Bissau. At the FDA, Høeg reportedly proposed excluding young men from the Covid vaccine.

“She is an all-around ideologue who takes her conclusions and works backwards to revise the evidence in a very misleading and dishonest way,” Howard said.

Høeg joined other mavericks, such as Marty Makary, Vinay Prasad and Jay Bhattacharya, in sharply criticizing the handling of the Covid pandemic, particularly vaccination; they all secured high-level positions within the Trump administration.

“They are totally consolidating power, these anti-Covid people,” Howard said. “Everything that’s happening now is a direct result of the rage and anger over Covid mitigation measures. These people are furious – furious that their genius has not been recognized. So they are on a sort of revenge tour.”

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

Raymond Pollak, an advisor to the Advisory Committee on Immunization Practices (ACIP) and a transplant surgeon, noted that “our patient population in the United States is culturally very different” from that of Høeg’s adopted country 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 country of 6 million people – less than the population of New York City.

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

By comparison, each year in the United States, 500,000 pregnant women are never tested for hepatitis B, and many infants born to positive parents or whose status is unknown 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 United States has different disease profiles and risks than most other countries.

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

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

Høeg also presented several anti-vaccine talking points in her comments during a presentation she gave on Danish vaccination schedules at ACIP. When discussing how many vaccines a child receives in the United States, Høeg questioned how much aluminum is in each shot.

“I don’t think we have data showing 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 at once. Aluminum adjuvants help vaccines work effectively and have been shown to be safe, and it is safe to administer multiple vaccines at once, according to the CDC.

Høeg also took aim at RSV injections that significantly reduced hospitalizations among American babies, saying that in trials the mortality rate was higher, although she admitted it was “not quite statistically significant.” No such safety signals have been announced during the rollout of RSV shots in recent years, but the FDA is still launching an investigation into their safety.

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

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

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