Ever since antivax activist turned presidential candidate Robert F. Kennedy Jr. bent the knee to Donald Trump in exchange for a high-ranking position related to health in the Trump administration under the false banner of “make America healthy again” (MAHA), I’ve been warning what a threat he is to the federal government’s public health and science programs, warnings that, in retrospect, turned out to have been, if anything, not dire enough. The most dire threat, of course, is to public health in general and vaccines in particular, and, although he hasn’t tried this yet, I think I’ve found yet another way that RFK Jr. will try to undermine vaccines by co-opting a narrative that they are all “experimental.”
First, however, let’s go through a bit of background. The other day, I was on social media warning people about Secretary of Health and Human Services Robert F. Kennedy, Jr. and vaccines. Specifically, I warned them pointedly not to underestimate RFK Jr.’s determination to eliminate all vaccines in the US. and that, every time he’s claimed that he doesn’t want to take away anyone’s vaccines, he was lying through his teeth. Indeed, RFK Jr. will find ways to eliminate as many vaccines as he can before 2029. First, as I have been predicting ever since RFK Jr. was nominated to be HHS Secretary, he will try to delicense specific vaccines, starting with COVID-19 vaccines. (The Wall Street Journal reported last week that HHS plans to bypass the Advisory Committee on Immunization Practices and stop recommending routine COVID-19 vaccination for children and pregnant people, almost certainly just the first step in this process.) Next, most likely he will move on to more vaccines, probably starting first with the human papilloma virus and hepatitis B vaccines, both long hated by antivaxxers in general and fundamentalist Christians in particular.
He will wait a while to move against the MMR vaccine, if only because it looks bad to attack the measles-mumps-rubella (MMR) vaccine during a large measles outbreak. He’s probably counting on high case numbers of meals to become normalized before he does anything on MMR, even as he tries his best to deemphasize the importance of getting children vaccinated with MMR whenever asked about the measles outbreaks. Basically, count on RFK Jr. to find creative ways to take various vaccines off the CDC-recommended schedule, so that insurance doesn’t have to cover them anymore, and also find ways to prevent Medicare and Medicaid covering them. Failing that, RFK Jr. will cherry pick bad science in order to “discover” that vaccines cause horrible side effects and/or cause autism and then use those “findings” to to put black box warnings on the label for vaccines. Such warnings would greatly discourage their use.
RFK Jr. has also made official HHS policy deceptive antivax narratives designed to weaponize informed consent into what I like to call “misinformed refusal” in order to discourage people from vaccinating and to use methodolatry with respect to the evidence-based medicine model to falsely claim that the childhood vaccination schedule has never been adequately tested in randomized controlled clinical trials because most of them haven’t been tested against his preferred comparator, saline, and is therefore dangerous. Of course, as I have explained time and time again, first generation vaccines for diseases that don’t have approved vaccines are tested against an inert placebo, usually saline, but, once there is a vaccine against a disease, it is highly unethical to test a new second generation vaccine against that disease because that would require subjecting the control group to a placebo that doesn’t protect them against the disease; i.e., one that is less than the standard of care. In the case of second generation vaccines, the only ethical comparator to use for the control group is the first generation vaccine, to test if the new vaccine is better than the old, or at least not inferior.
Look to antivaxxers to try to do a Pee-wee Herman—”I know you are, but what am I?”—and try to accuse the current vaccination program of violating medical ethics. It’s an old tactic, but I can see it being added to the “no saline placebo gambit” fairly easily. I was thinking about these issues three weeks ago when I came across a Substack post by antivax activist James Lyons-Weiler entitled Uncontrolled Trials: Modern Vaccine Policy Violates Core Principles of Medical Ethics — and How to Build an Ethical Alternative. Yes, you read that right. An antivaxxer is trying to make an argument from medical ethics to attack the current vaccination program. Longtime readers, I suspect, will find some of this familiar, just wrapped in pseudo-ethical and pseudomedical language.
Let’s dive in.
The vaccination program is experimental?
James Lyons-Weiler (henceforth JLW) is a longtime antivaxxer who happens to be one of the rare ones with an actual scientific background, not that it stopped him from weaving among the very first “lab leak” conspiracy theories shortly after the publication of the nucleotide sequence of SARS-CoV-2 had just been published. Using his super-duper molecular biology skills, JLW claimed to have found evidence of “engineering” in the form of plasmid sequences in the newly published sequence, but it was all nonsense. Before that, JLW would lose his mind over studies that concluded that autism was mostly genetic in nature, all while publishing utter dreck claiming to link vaccines to autism, the most recent of which has been promoted by RFK Jr. and others. Most recently, JLW’s Institute for Pure and Applied Knowledge (IPAK)—that’s it’s real name, I kid you not—has started a journal, Science, Public Health Policy and the Law, that appears to me to be nothing more than a WordPress blog with an “editorial board” full of antivax pseudoscientists designed to publish bad antivax “science” and launder antivax studies that were retracted from actual journals that had made the mistake of publishing them.
But let’s get to JLW’s Substack, where he proclaims:
There was a time when vaccines symbolized the triumph of science — a rare point of agreement between medicine and ethics. Today, that symbolism is being dangerously eroded.
Oooh. How is that “symbolism” being eroded, pray tell:
Behind the sanitized language of “routine care” and “wellness check visits” lies a truth that is harder and harder to ignore: modern pediatric vaccine programs are systematically violating the foundational principles of medical ethics — and the very laws designed to protect human subjects.
This article will expose how financial incentives, regulatory capture, and structural coercion have hollowed out informed consent. But we will not stop at diagnosis: we will outline a path forward — a vision of what a truly ethical vaccine program would look like, anchored in the enduring principles of Nuremberg, Belmont, and the Common Rule.
Oh, goody. Remember the antivax narrative of Nuremberg 2.0? It looks as though we’re going there again. I will give credit to JLW for realizing that the ethics of medical research involving human subjects has evolved since the Nuremberg Code was first published in 1947 after the Nuremberg Medical Trials, where Nazi physicians were put on trial for crimes against humanity based on their deadly and highly unethical medical experiments carried out on prisoners in their concentration and death camps. As I explained back then, the Nuremberg Code was a start, but far from complete. It was built upon through the Belmont Report, which forms the basis for the Common Rule (which is the HHS regulatory framework governing human subjects research). Oddly enough, JLW doesn’t mention what is arguably the most comprehensive statement of ethical principles governing human subjects research, the Declaration of Helsinki, which has been periodically updated since it was first published in 1964.
One thing you must remember about these ethical principles is that they govern only human subjects research. That means more than just randomized clinical trials. It means preliminary trials, observational studies, or any study in which the experimentation might cause significant harm to research subjects. Again, though, it does not mean medical practice. It does not mean standard-of-care medical interventions, like approved vaccines. Does that stop JLW? Of course not. It just motivates him to find a way to misrepresent the vaccination program as experimental. Again, longtime readers will not find this to be surprising. Antivaxxers have been misrepresenting the childhood vaccination program as “experimental” almost as long as I’ve been paying attention.
Let’s see how JLW tries to do this:
In theory, pediatric vaccination programs are public health interventions.
In reality, they have become massive, ongoing, post-market safety studies — involving human subjects without proper informed consent.Violation 1: Coercion and Penalty for Refusal
Parents who decline vaccines for their children face a cascade of penalties: expulsion from pediatric practices, exclusion from schools, and social vilification.
This is textbook coercion, forbidden under both the Nuremberg Code and 45 CFR 46.Violation 2: Failure to Disclose Experimental Status
Parents are not told that many vaccines continue to be monitored under post-marketing surveillance (“pharmacovigilance”), meaning safety and efficacy are still under study.
Pregnant women are routinely advised to take vaccines without disclosure that many vaccines were never tested in pregnant populations before licensure.Violation 3: Inadequate Protections for Vulnerable Populations
The Common Rule demands extra protections for fetuses, infants, and children.
Instead, these groups are pushed into vaccine programs without the disclosure, protections, or opt-out options that ethical standards require.Violation 4: Financial Incentives Over Health Outcomes
Physicians and practices are rewarded financially based on vaccination rates, not patient-centered outcomes.
Quantity, not quality, defines success — directly violating the principle of Beneficence.
As you can see, Violations 1-4 only make sense if you accept the deceptive and false premise that vaccines are all experimental. To try to convince you of this, note how JLW tries to claim that, because there are postmarketing vaccine safety surveillance programs, a.k.a. pharmacovigilance, then vaccines are still “experimental.”
There are also some other doozies in there. For example, Violation 4 is the classic half-truth. Yes, many primary care practices, particularly pediatrics practices, are rewarded by health insurers for maintaining certain metrics with respect to evidence-based health interventions. One of those is, of course, vaccine uptake of recommended vaccines, because those recommended vaccines are evidence-based standard of care, no matter how much JLW tries to mislabel them as “experimental.” Nor are vaccines the only metric. Practices can receive incentives for rates of cancer screening (adult). Here’s an example from just one health insurance program. Physician practices can receive incentives for:
- Breast Cancer Screening
- Care for Older Adults – Pain Assessment
- Care for Older Adults – Medication Review
- Colorectal Cancer Screening
- Controlling High Blood Pressure
- Diabetes Care – Blood Sugar Controlled (A1c<9)
- Diabetes Care – Retinal Eye Exam
- Medication Adherence for Cholesterol (Statins)
- Medication Adherence for Diabetes Medications
- Medication Adherence for Hypertension
- Medication Reconciliation Post-Discharge
- Statin Therapy for Patients with Cardiovascular Disease
- Statin Use in Persons with Diabetes
My reaction?
Note that many of these are patient-centered outcomes (e.g., control of blood sugar in diabetes, blood pressure control), contrary to what JLW claims. Moreover, some health insurers work with physicians collaboratively to come up with patient-centered metrics. Don’t get me wrong. I’m painfully aware that most health insurers are for-profit entities—and often rapaciously so, at that—and I am not defending them. (Any physician who’s ever had to deal with insurance company preauthorizations would never defend insurance companies.) I’m just pointing out that, as rapaciously for-profit entities, insurance companies wouldn’t spend money on something that wouldn’t improve their bottom line by preventing disease and complications based on the rationale that it is almost always much less expensive to prevent than it is to treat. In other words, sometimes being rapaciously for-profit can provide incentives for investing relatively small amounts of money in order to prevent or decrease payouts that would cost far more money.
Going back to the rest of the “Violations” claimed by JLW, again, the vaccination program is not human experimentation; so the Common Rule doesn’t apply, making JLW’s further characterization completely misleading:
Modern pediatric vaccination programs function as large-scale, uncontrolled clinical trials — but without the oversight, consent, and protections required of real research.
- There is no independent IRB monitoring the administration of vaccines in general pediatric practice.
- There is no opt-out mechanism that respects voluntariness without penalty.
- There is no routine, transparent, long-term tracking of health outcomes comparing vaccinated to unvaccinated children.
In any other context — a university clinical trial, a pharmaceutical company study — these conditions would result in massive regulatory penalties.
In vaccine policy, they are normalized, rationalized, and even celebrated.
It is not alarmist to say: we have legalized what Nuremberg condemned.
No, we have not “legalized what Nuremberg condemned.” Again, the childhood vaccination program is not human experimentation, making the proposed requirement that an institutional review board oversee the administration vaccines in general pediatric practice utter nonsense. Moreover, does JLW even think about what accepting his false premise that, because there are pharmacovigilance programs examining postlicensure safety and efficacy of vaccines, might mean. If you claim that vaccines are experimental because there is postmarketing surveillance for adverse events, then by that “logic” (such as it is) all drugs and medical devices, even after having been approved by the FDA, must also be experimental, because pharmacovigilance applies to more than just vaccines. So why isn’t JLW demanding the same standard for all drugs and medical devices?
Inquiring minds want to know. Inquiring minds also want to know where JLW is going with this.
Weaponizing EBM? That’s for amateurs. This is weaponizing medical ethics
Looking back at how RFK Jr. is proposing to weaponize methodolatry in the EBM paradigm by demanding saline placebos as The One True Comparator and the only control allowed in studies of vaccines, no matter how unethical it would be to use saline placebos for second generation vaccines, I realize that JLW is simply suggesting weaponizing the structure of medical ethics with respect to human subject experimentation codified at Nuremberg and built upon in the nearly 80 years since by classifying all vaccines as experimental, no matter how long they’ve been used safely and effectively.
Let’s review the steps of experimentation that lead to an intervention, like a vaccine, being first accepted as safe and effective based on science and then being approved by the FDA for marketing for a given indication. This is a much simplified version; friend of the blog Skeptical Raptor has listed a more detailed version of vaccine approval. Basically, these are the steps in evidence.
- Preclinical (basic science). The vaccine is developed and refined, with the antigen to be used carefully selected, along with the delivery mechanism. In vitro cell culture studies and animal studies are done in order to develop evidence that the vaccine will be effective and safe in humans.
- Clinical trials. These start with phase I trials (“first in human”), which are designed to evaluate the safety and tolerability of the intervention (in this case, a vaccine), as well as to determine the appropriate dosage and administration schedule. These generally involve small numbers of human subjects (less than 100, often less than 30), and in particular look for severe toxicities. Next are phase II trials, which are somewhat larger trials, usually randomized placebo-controlled (unless using an inert placebo would be unethical) designed to test for a signal of efficacy and to identify adverse reaction. Finally, phase III trials are much larger randomized controlled trials, double blind with appropriate comparator (inert placebo or previous intervention) designed to test efficacy and safety. The number of subjects can be in the tens of thousands, depending on how many are needed based on analyses of statistical power.
- Approval and post approval. Assuming the results of the phase III trials demonstrate efficacy and sufficient safety, the FDA will grant licensure to the vaccine to be marketed. However, that’s not the end of the process, mainly because even large RCTs can miss rare adverse events. Consequently, as the vaccine goes on to be used by millions, pharmacovigilance programs monitor for safety. In the US, the Vaccine Adverse Events Reporting System (VAERS, a passive reporting system) and the Vaccine Safety Datalink (VSD, an active monitoring system) are the two main systems used.
Basically, after successful phase III RCTs, the scientific community will no longer consider an intervention “experimental,” and, from a regulatory standpoint, it is no longer experimental either, regardless of what JLW says. None of this stops him from arguing:
Post-market surveillance of vaccines — the ongoing collection of safety data after approval — would be treated with the seriousness it demands. Every vaccination would be part of a formally monitored, IRB-approved research system, just as any other drug undergoing study would require. Parents would be told explicitly that participation contributes to ongoing safety assessment, and they would retain the right to withdraw at any time. Adverse event tracking would be mandatory, rigorous, and publicly transparent.
And:
Today, pediatric vaccine policy has wandered dangerously far from those ethical moorings. The lure of expediency — the desire to maximize compliance, minimize resistance, and achieve statistical targets — has led to a profound disregard for the dignity, autonomy, and rights of individuals. It has created a system where human subjects are enrolled in ongoing experiments without their knowledge, where refusal is punished, and where profit too often eclipses principle.
Everything JLW says here is wrong, except that postmarketing surveillance of vaccines could be better. I’ve even argued that myself, mainly because the FDA has long been underfunded and therefore had inadequate resources to be as detailed and rigorous as some might argue that it should be. Unsurprisingly, Aaron Siri (who has worked with RFK Jr. on antivax legal actions) has twisted the words of vaccine pioneer Stanley Plotkin when he suggested that there should be more funding for FDA postauthorization monitoring programs to falsely suggest that Plotkin was “admitting” that vaccines aren’t adequately studied. As I pointed out at the time, this was a reasonable policy debate about how, how much, and whether more money should be appropriated for postlicensure vaccine safety monitoring; it does not, however, indicate that vaccines are unsafe or “experimental.”
Then there’s this from JLW:
Financial incentives would be restructured from the ground up. Pediatricians would not be rewarded based on the sheer number of vaccinations administered. Instead, they would be compensated for spending time educating patients, fostering informed decision-making, and promoting genuine preventive health — across the full range of strategies, not merely immunization. Quality of communication, integrity of care, and health outcomes over time would matter far more than throughput metrics.
“Full range of strategies, not merely immunization”? In other words, JLW is turning medical ethics on its head by proposing incentivizing physicians to lie to patients. For most vaccine-preventable diseases, there aren’t a good “full range of strategies.” There tend to be no good treatments for such diseases, no matter how much, for example, RFK Jr. might claim that steroids or castor oil can treat measles. That’s why physicians and scientists went through the time and expense to develop vaccines against those diseases in the first place!
Reading JLW’s post, I couldn’t help but keep thinking back to this post on X by him:
JLW considers Secretary Kennedy to be his “friend” and has been one of RFK Jr.’s advisors. Given that background knowledge, I can’t help but wonder whether JLW’s ideas with respect to treating all vaccines as experimental might ultimately inform HHS policy. This would not be an easy set of policies to change, although, given how this administration has thus far sidestepped the usual public comment and bureaucratic process to make major changes in policy (e.g., such as mass-canceling NIH grants), I could see a “tweak” such as saddling vaccines with a label of “experimental” until some onerous postlicensure process had occurred might be the next step in the dismantling of the US federal vaccination program.
Make no mistake. That is the endgame here, no matter how much RFK Jr. lies when he says he doesn’t want to take vaccines away from anyone who wants them.