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As America undertakes historic changes to its immunization guidelines, a particular individual has surfaced somewhat surprisingly: Høeg, a US-based sports medicine doctor and public health researcher who initially gained attention by expressing skepticism about coronavirus vaccinations throughout the global health crisis and has focused upon possible deaths following COVID-19 vaccination in her recent time at the FDA.

Scheduled Overhauls to Childhood Immunization Schedule

Public health authorities were set to announce radical changes to the pediatric vaccine schedule in December, synchronizing the US with Denmark’s vaccine program, sources say – a major change that would place the US out of alignment with a large portion of the global community with no evidence for public health gain. The announcement has been pushed back until the coming year.

Rather than the director of the vaccine center, Høeg is set to present at the event. She was newly appointed temporary leader of the FDA’s drug evaluation center, the fifth person to run the center this year.

A New Direction at the Agency

Høeg's temporary position could signify a strengthened alliance between the pharmaceutical and biologics branches as Høeg and Dr. Prasad consolidate power at the FDA – and it points to a greater focus upon reevaluating already-approved vaccines at the FDA.

Høeg has repeatedly called for ending some pediatric immunization guidelines in the US to become more similar to Denmark's approach, a society with nationalized medicine and a population approximately the population of the state of Wisconsin.

To date comments, she has persisted in emphasizing on vaccination policy – traditionally the purview of Dr. Prasad, chief of the FDA’s Center for Biologics Evaluation and Research (CBER) – instead of pharmaceutical oversight.

Concerns Over Qualifications

Dr. Høeg has little discernible track record in pharmaceutical research, approval processes or leadership, which has been standard for past heads of the CBER. She has served at the FDA as a senior adviser to the FDA chief and the vaccine center since earlier this year.

“She appears not to have the necessary background” for overseeing the CDER, stated Jonathan Howard. “She has not conducted a randomized controlled trial. She has no expertise in managing a large organization. She has no expertise in industry regulation.”

Former directors of the center would “understand regulatory frameworks and the underlying principles of medication creation”, noted Janet Woodcock. “Frankly, she lacks the sort of resume that prior appointees who led CBER have had.”

The drug center has an immense range of responsibilities at the agency, Woodcock emphasized.

“Many people just pays attention on the innovative therapies, but the off-patent medication office approves thousands of generic drugs. There is also a biosimilars program, OTC medication office and so forth, and all of those need to be supervised,” Dr. Woodcock explained. “The thing you neglect, that is the part that I always told people is going to cause problems.”

Additionally, a significant management aspect to the job, which supervises in excess of 5,000 staff members. “It’s a massive management job, if you perform it correctly,” the former official concluded.

Agency Reaction and Controversial Initiatives

In response to questions about Dr. Høeg's fitness for the role and whether this selection represents greater collaboration among agency officials on vaccines, a representative responded that the “concerns are based on incorrect presumptions”.

“This background is consistent with the functions of her job,” the official explained, citing the period Høeg spent counseling the FDA commissioner on “medication safety and regulatory science, including computerized risk analysis and immunization monitoring”.

In her interim role, Høeg inherits the agency head's new fast-track approval initiative, a contentious rapid medication authorization process that apparently troubled her predecessors. “By what process are these therapies being chosen for this expedited pathway? Who makes the calls?” Howard said. “There is a lot of secrecy happening at the FDA right now.”

Broadly speaking, he stated, “the FDA looks to be trending towards more relaxed rules of most medications, aside from immunizations.”

Public Past Work on Vaccines

With immunizations, Dr. Høeg has a more established, if troubling, past, some experts said. She authored a research paper using non-validated crowd-sourced reports to estimate the rate of myocarditis after COVID-19 immunization. She consulted for the Florida top health official Dr. Joseph Ladapo, who was said to have changed statistics to imply COVID-19 vaccinations are more dangerous than they are.

Part of her “wish list” for the new government featured altering guidelines for new vaccines and discontinuing “optional” immunizations, she said after the election on a audio program. At the FDA, Høeg has according to sources floated the idea of preventing teenage boys from getting Covid vaccinations.

“She’s an thorough ideologue who starts off with her conclusions and tailors the evidence to fit the data in a very disingenuous, fraudulent manner,” Howard stated.

Taking Control and a “Revenge Tour”

Dr. Høeg became part of other contrarians, {like|