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Given that the United States proceeds with historic revisions to its vaccine recommendations, an unexpected name has surfaced in a surprising turn: Høeg, an American of Danish descent sports medicine doctor and public health researcher who first made her name by questioning coronavirus vaccines during the global health crisis and has zeroed in on alleged fatalities after COVID-19 vaccination in her short tenure at the US Food and Drug Administration (FDA).

Scheduled Changes to Childhood Vaccine Program

Agency leaders were set to announce sweeping revisions to the childhood vaccination calendar in December, aligning the US with Denmark’s vaccine program, according to reports – a substantial departure that would put the US at odds with many the global community with little proof for benefit. This reveal has been postponed until the new year.

Rather than the top vaccines chief, Høeg is set to address the audience at the gathering. She was newly appointed interim head of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth individual to lead the center this year.

A Shift at the Regulatory Body

The acting appointment might represent a closer partnership between the drug and biologics divisions as Dr. Høeg and Dr. Prasad consolidate power at the FDA – and it suggests a renewed priority upon rolling back already-approved vaccines at the FDA.

Dr. Høeg has frequently advocated for discontinuing specific pediatric shot schedules in the US to become more in line with Denmark, a country with comprehensive healthcare and a citizenry roughly the size of the state of Wisconsin.

In her initial statements, she has kept her attention on vaccines – traditionally the purview of Prasad, director of the FDA’s vaccine center – rather than pharmaceutical oversight.

Doubts Over Expertise

Dr. Høeg has no apparent experience in medication creation, approval processes or administrative roles, which has been customary for previous leaders of the Center for Biologics Evaluation and Research. She has worked at the FDA as a key advisor to the agency head and CBER since March.

“It seems she lacks to have any of the qualifications” for leading the CDER, remarked a neurologist and psychiatrist. “She has not conducted a randomized controlled trial. She is not versed in running a large organization. She has no expertise in drug approvals.”

Past directors of the center would “be deeply familiar with regulatory frameworks and the research of pharmaceutical innovation”, commented a former acting FDA commissioner. “Frankly, she lacks the type of experience that former directors who headed the center have had.”

CDER has an immense range of responsibilities at the FDA, the former commissioner pointed out.

“Everybody just focuses on the innovative therapies, but the off-patent medication office approves numerous generic drugs. There’s a biosimilars division, over-the-counter program and so forth, and all of those need to be supervised,” Woodcock explained. “The responsibility you overlook, that’s the thing that I always told people is going to cause problems.”

Furthermore, a significant administrative aspect to the job, which oversees in excess of 5,000 employees. “It’s a huge leadership role, if you do it right,” she said.

Agency Reaction and Controversial Initiatives

When asked about questions about Dr. Høeg's fitness for the role and whether this appointment signifies increased cooperation among agency officials on vaccines, a spokesperson said that the “inquiries rely on inaccurate premises”.

“Her experience is consistent with the duties of her job,” the spokesperson explained, pointing to the period Dr. Høeg spent guiding the FDA commissioner on “pharmaceutical safety and oversight research, including predictive safety algorithms and shot safety tracking”.

As acting director, Dr. Høeg inherits the agency head's controversial priority voucher program, a disputed expedited therapy clearance system that reportedly concerned her predecessors. “By what process are these therapies being picked for this voucher program? Who makes the calls?” Dr. Howard said. “There is a lot of secrecy happening at the regulatory body right now.”

In general, he said, “the FDA seems to be moving towards less stringent rules of pharmaceuticals, except for vaccines.”

Documented Past Work on Immunizations

With immunizations, Høeg has a clearer, if problematic, track record, some experts observe. She authored a study using unconfirmed crowd-sourced reports to assess the incidence of heart inflammation after Covid vaccination. She advised the state of Florida surgeon general Joseph Ladapo, who reportedly have changed statistics to imply COVID-19 vaccinations are more dangerous than they are.

Among her “policy goals” for the incoming government included revising rules for recently developed shots and ending “optional” immunizations, she stated following the vote on a podcast. At the FDA, Dr. Høeg has allegedly suggested preventing adolescent males from getting Covid vaccinations.

“She is an complete ideologue who starts off with her preconceived notions and tailors the evidence to fit the data in a extremely disingenuous, dishonest manner,” Dr. Howard said.

Taking Control and a “Revenge Tour”

Dr. Høeg joined fellow skeptics, {like|