With a career spanning the highest echelons of policy and legislation, Donald Gainsborough, head of Government Curated, offers a rare look inside the complex machinery of U.S. health policy. His insights pull back the curtain on the recent, tumultuous internal debates at the Department of Health and Human Services, revealing the clash between political influence and scientific process. In this conversation, we explore the dramatic, last-minute cancellation of a major announcement with RFK Jr., the behind-the-scenes maneuvering that led to a presidential directive on vaccine schedules, and the deep-seated tensions over public trust and the science of immunization in a post-pandemic world.
The article details a planned announcement with RFK Jr. and Tracy Beth Høeg that was abruptly canceled. Can you describe the internal debate at HHS in the hours leading up to the cancellation? What specific arguments from critics ultimately proved most persuasive in stopping the event?
It was chaotic. In the final hours, the building was split. On one side, you had proponents who saw this as a bold move, a way to recapture public trust. They were energized by the idea of offering the Danish schedule as a government-sanctioned alternative. But on the other side, there was a growing sense of alarm, almost panic. The critics, and this included very senior people and legal minds, were making it clear this was a train wreck in the making. Their core argument was twofold: process and perception. They argued that rolling out a new schedule without rigorous scientific groundwork and bypassing the normal regulatory process was not just sloppy, it was indefensible. It would invite immediate, credible accusations that politics, not science, was driving policy. The second, and perhaps more powerful, argument was that this would achieve the exact opposite of its intended goal. Instead of restoring trust, it would signal to the public that the government had doubts about its own long-standing recommendations, potentially undermining routine immunization for years to come. That fear of creating a self-inflicted wound to public health is what ultimately tipped the scales and forced the cancellation.
The December 5th presidential memorandum directed HHS to review peer-country vaccine schedules. Could you elaborate on the process by which RFK Jr. and Stefanie Spear sold this framing to the West Wing? What specific anecdotes or metrics did they use to get this directive signed?
That memorandum was the culmination of a very savvy political play. Kennedy and Spear understood that a frontal assault on the U.S. vaccine schedule would be met with overwhelming resistance from the entire medical establishment. So, they reframed the issue. It wasn’t about being “anti-vaccine”; it was about being “pro-best-practices.” They took the internal skepticism and packaged it in a way that was palatable to the West Wing. The “peer-country” framing was brilliant because it sounds reasonable and data-driven. They would point to countries like Denmark, Japan, and Germany—all highly developed nations—and simply ask, “Why do their schedules recommend shots for only 10 diseases while ours covers 17? Are we over-vaccinating our children?” This approach allowed them to bypass a complex scientific debate and turn it into a straightforward comparison that anyone could grasp. They effectively turned internal doubt into an official, signed White House directive, giving them the top-down authority they needed to force the issue inside HHS.
Inside HHS, proponents pitched the Danish schedule as a “reset” to restore public trust after the pandemic. What data or specific examples did they use to support this strategy? Conversely, what were the step-by-step legal and scientific arguments that opponents, including the general counsel’s office, used to push back?
The “reset” argument was born directly out of the COVID-19 experience. Proponents argued that public trust had been shattered by mandates and by early claims that the shots would stop transmission, which didn’t hold up. They saw a public that was weary and skeptical. Their pitch was that offering the slimmer Danish schedule—which excludes vaccines for diseases like chickenpox, the flu, and hepatitis A and B—was an olive branch. It was a way of saying, “We hear your concerns. Let’s go back to a more basic, core schedule.” They believed this would bring hesitant parents back into the fold. The pushback, however, was methodical and fierce. Scientifically, critics pointed out that the U.S. schedule is based on decades of data specific to our population and disease patterns. Legally, the general counsel’s office, under Mike Stuart, laid out a clear warning: this move was procedurally flawed. Making such a drastic change without going through the established regulatory process would make the department incredibly vulnerable to lawsuits. They had a fresh, potent example in the pending lawsuit from the American Academy of Pediatrics over recent changes to COVID vaccine recommendations, which argued HHS had violated those very rules. The legal threat of being successfully sued for arbitrary and capricious decision-making was a powerful brake on the whole proposal.
After FDA regulator Tracy Beth Høeg presented her “U.S. vs. Danish Vaccine Schedule” comparison, it circulated among top HHS officials. Can you detail the chain of events that followed? How did this one presentation evolve into a formal proposal to offer an alternative government-recommended schedule?
That presentation was the spark that lit the fuse. It started publicly, at a CDC advisory committee meeting, which gave it an initial veneer of legitimacy. Once the CDC posted her slide deck, it became an official document that could be circulated internally. It landed on the desks of top officials at HHS, and for the political appointees who were already aligned with Kennedy’s skepticism, it was exactly the tool they needed. It took a complex issue and distilled it into a simple, compelling side-by-side comparison. This document transformed a vague ideological stance into a concrete policy option. The conversation quickly shifted from “Are we vaccinating too much?” to “Why don’t we just offer the Danish schedule?” It was seized upon by supporters who then formally proposed it not as a replacement, but as a government-recommended alternative. This was a key strategic shift, making it seem less radical while still achieving the goal of officially validating a scaled-back immunization approach.
The article contrasts Kennedy’s claims about autism’s cause with the new $50 million NIH Autism Data Science Initiative. How does HHS navigate this internal conflict? Can you share any anecdotes about how scientists and political appointees interact on this sensitive and publicly debated topic?
It’s a state of constant, low-grade warfare. On one side, you have political leadership, with Kennedy at the forefront, who is publicly convinced of a link and has even promised to reveal the cause of autism, a claim that career scientists find completely unrealistic. His beliefs are amplified by the staggering rise in diagnoses, from one in 150 children two decades ago to one in 31 today, which creates immense public pressure for answers. On the other side, you have the department’s research arm, the NIH, which is methodically pursuing the science. They just launched this massive $50 million initiative with 13 different projects to investigate potential causes, which they believe are likely genetic with possible environmental factors—not vaccines. The interaction is tense. The scientists feel their work is being undermined and misrepresented for political gain. The appointees, in turn, often view the scientists as being stuck in dogma and unresponsive to public concern. It’s a culture clash played out in budget meetings and policy debates, a struggle between the need for sound, long-term science and the desire for immediate, politically satisfying answers.
What is your forecast for the U.S. childhood immunization schedule over the next few years?
I don’t foresee a wholesale abandonment of the current schedule for something like the Danish model. The scientific, public health, and legal barricades are simply too high. However, the battle is far from over. What I expect to see is a strategy of attrition. Instead of a frontal assault, we will likely see continued political pressure to chip away at the edges of the schedule. Look at what already happened with the COVID boosters for people under 65; the recommendation was softened from a direct endorsement to a “talk to your doctor” approach. I predict we’ll see similar attempts to introduce more “flexibility” or “parental choice” around specific vaccines on the childhood schedule, particularly those perceived as being for less severe illnesses. The fundamental tension between the political desire for a “reset” and the medical establishment’s reliance on the existing, data-driven process will define this issue for the foreseeable future. The outcome of pending lawsuits, like the one from the American Academy of Pediatrics, will be critical in determining just how much power the political side has to bypass the established scientific process.
