A couple of weeks ago, I wrote a post speculating about the strategies that our new Secretary of Health and Human Services, longtime antivax activist Robert F. Kennedy Jr., will likely use to undermine and dismantle federal vaccination policy and programs now that he is in charge of all nonmilitary medical, public health, and biomedical research policy and programs. Of course, since then a large and growing measles outbreak in an undervaccinated population in western Texas has forced RFK Jr. to pivot from his initial response of a shoulder shrug and “What, me worry?” to actually writing an op-ed for Fox News that, superficially at least, appeared to advocate vaccination with the measles-mumps-rubella (MMR) vaccine. Although RFK Jr. did, in fact, admit grudgingly that vaccines “not only protect individual children from measles, but also contribute to community immunity, protecting those who are unable to be vaccinated due to medical reasons,” he undermined that message with antivax dogwhistles, including wording sentences to imply many people die “with” measles rather than “of” measles; noting that measles deaths were declining before the vaccine, a deceptive antivax trope that I dubbed the “vaccines didn’t save us” misdirection 15 years ago; claiming that vitamin A is effective treating measles when it has only ever been shown to decrease mortality from measles in populations where malnutrition and vitamin A deficiency are common; deceptively stating that good nutrition “remains a best defense against most chronic and infectious illnesses,” the implication being that it also prevents measles; and emphasizing how the “decision to vaccinate is a personal one,” rather than an exhortation to the unvaccinated to get vaccinated and to get their children vaccinated.
The bit about “personal choice” is, of course, another familiar antivax dog whistle that is closely related to another trope that RFK Jr. is emphasizing. As I noted two weeks ago, RFK Jr. has instructed the CDC to “refocus” its messaging with respect to vaccination to emphasize “informed consent”:
The Department of Health and Human Services’ assistant secretary for public affairs informed the CDC that HHS Secretary Robert F. Kennedy Jr. wanted advertisements that promote the idea of “informed consent” in vaccine decision-making instead.
Informed consent is the principle that people should be notified of all the risks, as well as benefits, of any medical intervention they receive or any drug they are prescribed. It is a cornerstone of health care delivery.
If you, as is the case with most people, happen to be unaware of antivax messaging with respect to informed consent over the last two or three decades, you might see a passage like this and wonder what the big deal is. After all, who could object to “informed consent” with respect to vaccines? The fact is, no physician objects to scientifically accurate and truthful informed consent with respect to any medical intervention, vaccines included. The problem here is that the antivaccine version of “informed consent” means exactly the opposite, which is why, long ago I dubbed it “misinformed refusal,” the refusal of vaccines based on scientific and medical misinformation. Since RFK Jr.’s messaging about “informed consent” is back and likely to become the official policy of the federal government with respect to vaccines—although, I note pointedly, not with respect to all the quackery and dubious medicine lumped in with RFK Jr.’s slogan “Make America Healthy Again” (MAHA)—I thought I’d discuss why, whenever you see an antivaxxer invoking “informed consent,” you should replace that term with a more accurate one: Misinformed refusal.
Before I discuss in more detail what I mean by “misinformed refusal,” first let’s discuss informed consent as it should work.
Informed consent: The cornerstone of the physician-patient relationship
To contrast what RFK Jr. likely means by “informed consent” with what physicians and bioethicists mean by “informed consent,” it’s probably helpful to find some definitions of informed consent. The AMA Code of Medical Ethics on informed consent is as good as any, so I start there:
Informed consent to medical treatment is fundamental in both ethics and law. Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care. Successful communication in the patient-physician relationship fosters trust and supports shared decision making. Transparency with patients regarding all medically appropriate options of treatment is critical to fostering trust and should extend to any discussions regarding who has access to patients’ health data and how data may be used.
Basically, informed consent is, in essence, transparency and acknowledgement by the physician that the patient is an autonomous human being who can choose or refuse treatment, as long as the person is informed by being given a lay summary of the options, existing evidence for these options, and the risks and benefits of the options, including the option of doing nothing. In the case of patients who cannot give informed consent (e.g., children, adults with dementia, people in comas, etc.), a trusted surrogate makes the decision. But how does a physician or other healthcare provider go about obtaining informed consent?
This is also as good a summary as I can find:
Every surgeon, myself included, does this with every patient being considered for a surgical procedure, after which the patient signs the informed consent form. Most surgeons also document the discussion in their clinic notes and their operative report. (I certainly do.) The same is true for basically all physicians. Oncologists, for instance, are very detailed about the risks and expected benefits of chemotherapy, even when the benefits might only be a single digit percentage increase in relative survival. Of course, physicians being human beings, some of us are better than others at discussions of informed consent, and, given differences in ability and the constrained timeframe of many clinic visits (especially for primary care physicians), some of us might not be as detailed as we might like. Moreover, there are patients, as any physician knows, who don’t want to hear it and just want to commence with treatment, especially in the case of life-threatening diseases like cancer.
Informed consent takes on even more importance when it comes to medical research. Indeed, HHS and the NIH have copious policies on informed consent in research, based on documents like the Nuremberg Code, which was first drafted after World War II as a response to the horrific abuses to which prisoners were subjected in Nazi medical experiments. Indeed, you can get a flavor of how antivaxxers distort the concept and practice of informed consent by simply looking at their unhinged claims that COVID-19 vaccine programs were a massive violation of the Nuremberg Code. What a lot of my colleagues didn’t know then was that the appeal to the Nuremberg Code and the portrayal of vaccines as a violation of medical ethics laid out there was not a new antivax trope. Antivaxxers had long been using it to mischaracterize the childhood vaccination schedule and demand new “Nuremberg tribunals” for doctors, public health officials, and government officials, a call that became “Nuremberg 2.0” during the pandemic, complete with a bloodthirsty call to hang those “found guilty,” often with photos of scaffolding and nooses. One antivaxxer in particular, a former Trump official during 2020, Dr. Paul Alexander, is so full of bloodlust that he frequently includes calls to “hang them all,” complete with an image from the 1970s Clint Eastwood western Hang ‘Em High.
I thought I’d start by looking at the HHS website. I used the Wayback Machine at Archive.org and sought the most recent version of the HHS FAQs on informed consent before President Trump was sworn in on January 20 in order to protect against possible changes that HHS might make to the webpages in the future. The key elements of informed consent in this context include:
- a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
- a description of any reasonably foreseeable risks or discomforts to the subject;
- a description of any benefits to the subject or to others which may reasonably be expected from the research;
- a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
- a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
- for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
- an explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject; and
- a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
In addition, there’s all sorts of information on that webpage describing what constitutes coercion or undue influence, other information that should be given to potential participants in some contexts, as well as some of the nitty-gritty of all sorts of practical issues around obtaining informed consent. Obviously, the informed consent process for a research study is much more involved than it is for day-to-day interactions with patients about medical treatment.
In any event, as I described, the Nuremberg Code was written as part of the verdict of the Doctors Trial at Nuremberg as a first attempt to codify what principles should govern ethical human subjects research. It was a decent first crack, emphasizing patient autonomy, consent, the ability of a patient to withdraw from a study at any time, design of experiments to avoid suffering as much as possible, and the requirement that the study should be expected to produce results that will further medical science.
Of course, as I also noted, the Nuremberg Code, as important as it has been in the history and development of human subjects protections during medical research, has largely been supplanted by the Belmont Report (published in 1976) and the Declaration of Helsinki. The Belmont Report, for instance, goes beyond the Nuremberg Code by delineating the boundaries between medical practice and research. It also rests on basic ethical principles of respect for persons, beneficence, and justice, while emphasizing the importance of voluntariness (as the Nuremberg Code), a detailed discussion of benefits and risks (informed consent), and the selection of subjects. The Declaration of Helsinki is similar, but goes into much more detail about informed consent. It also addresses the ethics of the use of placebos, post-trial provisions, and the dissemination of results. It even addresses the use of unproven interventions in clinical practice outside of clinical trials. We don’t have to go into detail here, other than to understand that informed consent is now “baked into” medical treatment and research. Although no physician (I hope), least of all I, would deny that there is still some paternalism in medicine, medicine has progressed a long way since the 1940s in changing the paternalistic relationship between physician and patient to more of a collaborative one, and the ethical requirement for informed consent is part of that.
Before I move on to discuss the funhouse mirror version of informed consent that is the antivax version Doppelganger, let me also emphasize that informed consent is required and given for vaccination. Indeed, every year when I get a flu vaccine I sign an informed consent form, which lists the benefits and risks of the vaccine, as well as making sure that people with egg allergies do not receive the vaccine, given that influenza vaccines are manufactured using eggs. Then there is the package insert, which lists pretty much everything you could want to know about the vaccine. Indeed, there is a variety of antivax “argument” that I like to refer to as “argument by package insert.” It’s a ploy that ignores the fact that package inserts are not medical documents, but legal documents. They are, to put it briefly, a “CYA” document. As such, they list every adverse event ever reported in any clinical trial of the vaccine, whether the AE is related to the vaccine or not. Given that, a package insert often provides a more negative picture of the vaccine than the gestalt of clinical and epidemiological evidence does. That is, of course, why antivaxers love to point to package inserts that note that autism was reported in clinical trials of vaccines used for FDA approval, even though if you actually look at the study you’ll see that there was no evidence that the vaccine had anything to do with autism. Also, as I keep writing again and again, there are numerous epidemiological studies failing to find a link between vaccines and autism.
Moreover, contrary to what antivaxxers claim about school vaccine mandates, even there informed consent exists. They can refuse to vaccinate their child, but if they do then they might not be allowed to enroll their child in school. Moreover, most states have risibly easy processes for “religious” or “personal belief” exemptions to school vaccine mandates.
Now let’s look at the antivax version of informed consent, “misinformed refusal.”
Misinformed refusal: Turning informed consent on its head
When I sat down to write this post, I wondered when I first used the term “misinformed consent” to describe the antivax version of informed consent. What I did remember was that the first version that I coined was “misinformed consent,” which I coined in 2011 in a post about the antivaccine rhetoric running rampant on Mothering.com discussion boards. I soon noticed that this version of “informed consent” was common beyond just the antivaccine movement. The “health freedom” movement used it a lot and even tried to codify it into law to protect those making overinflated health claims for supplements from the FDA. In the era of the pandemic, “misinformed refusal” that painted hospital COVID-19 protocols as either mass murder or unethical human experimentation ran rampant (and still does). One example that I used 14 years ago was that of a cherry grower in Michigan making health claims about his cherries when he writes on his website:
The FDA does not want the cherry industry to tell people that recent studies show that tart cherries contain substances that are potentially 10 times stronger than aspirin or ibuprofen for relieving pain. It does not want the public to know that substances in tart cherries may kill cancer cells and prevent cancer. It makes no difference whether these statements are true. What’s important is that the public not be told that a natural substance (tart cherries) has been shown to work as well as or better than an unnatural one (ibuprofen). Only drugs, according to the FDA’s legal doctrine, can prevent, treat, mitigate, or cure disease.
This same cherry grower then went on to list even more claimed health benefits of cherries. The problem, of course, was that most of these studies cited were either preclinical studies, studies using compounds isolated from natural sources, or otherwise studies whose direct applicability to health claims for the food in question were tenuous at best.
I used the term “misinformed consent” for a number of years, but then did more thinking and realized that it is a poor term to describe what antivaxxers—and “health freedom activists” like MAHA advocates—are really doing when they invoke “informed consent.” That’s when I came up with the term “misinformed refusal.” Amusingly enough, the year was 2016, and I first used the term to describe what antivax comedian Rob Schneider was doing when he trumpeted the “right” to refuse vaccines. Here’s what I wrote at the time:
In reality, what antivaccinationists want is not informed consent, but what I used to like to call “misinformed consent,” because what antivaccinationists want to use as the basis for informed consent are misinformation and pseudoscience that vastly exaggerate the risks of vaccines and vastly underestimate the benefits. I say I used to like to call it that because these days I think I prefer calling it “misinformed refusal,” to contrast it better with true informed consent. Maybe I’ll start doing that, because “misinformed refusal” of vaccines is exactly what people like Rob Schneider are promoting, while invoking freedom…
Oddly enough, I had used the term once in 2012, but for some reason didn’t latch onto it and use it consistently until four years later. Oh, well…
But back to the term misinformed refusal. One way to get a feel for what antivaxxers mean when they invoke “informed consent” is to take a look at the antivax group that very intentionally includes “informed consent” in its name, Physicians for Informed Consent. I’ve discussed this group before in the context of the misguided decision of former Nordic Cochrane luminary Peter Gøtzsche’s agreement to speak to a PIC conference, only to be shamed out of it when he figured out that RFK Jr. himself would share the bill with him, along with several other prominent figures in the antivax movement. Later, he bitterly complained about being lumped together with antivaxxers, forgetting that he did indeed agree to speak at an antivax conference where he and RFK Jr. were going to be the keynote speakers. (Seriously, did he not bother to look at the list of other speakers when he accepted PIC’s invitation, or was he that hard up for speaking engagements?) I also note that, before his entry into politics, one of the antivax groups with which RFK Jr. worked was Informed Consent Action Network, an organization founded by antivaccine activist and friend of RFK Jr., Del Bigtree, that creates “model bills” for state legislatures designed to weaken vaccine requirements and mandates, using legislative language based on requiring the antivax version of “informed consent.”
Perusing the PIC website, you can see that its leadership is packed with antivax physicians, scientists, and activists, some of whom we’ve written about right here, including Jane Orient, Christopher Shaw, Shira Miller (the founder of PIC), Paul Thomas, and others. Moreover, PIC is part of a coalition called the Coalition for Informed Consent, which includes a whole host of antivax groups, some of which we’ve written about, such as RFK Jr.’s old antivax group Children’s Health Defense, Michigan for Vaccine Choice, SANE Vax, and that old perennial all-purpose John Birch Society for physicians, Association of American Physicians and Surgeons (AAPS). Let’s look at PIC’s “vision“:
The vision of Physicians for Informed Consent is that doctors and the public are able to evaluate the data on infectious diseases and vaccines objectively, and voluntarily engage in informed decision-making about vaccination.
Sounds pretty benign, right? Who could possibly argue with something so seemingly unobjectionable? I can, based on what follows:
Note that that 2019 “workshop and luncheon” was the one that featured antivax luminaries like RFK Jr. and antivax lawyer Mary Holland and was the same “workshop” that Peter Gøtzsche had to back out of after the furor the announcement of his appearance caused. Indeed, every “milestone” touted by PIC involves exaggerating the risks of vaccines, such as the 2020 attack on aluminum adjuvants, which are safe.
Let’s take a look what PIC says about measles and the measles vaccine, specifically the MMR. If you explore the rhetoric, you’ll find the same sorts of tropes that I discussed two weeks ago, such as the “vaccines didn’t save us” gambit in which it’s pointed out that mortality from measles had fallen dramatically in the decades before the vaccine, while failing to note that, even in the early 1960s right before the vaccine was introduced in 1963, there were still 400-500 deaths and close to 50,000 hospitalizations per year due to measles while also failing to note that introduction of the vaccine and recommendation that all children without a medical contraindication be vaccinated against measles caused a very rapid decline in the incidence of measles. I’ve discussed this already, twice in the last two weeks, including when RFK Jr. invoked the very same fallacy earlier last week.
Per PIC:
The measles vaccine was introduced in the U.S. in 1963 and is now available as a component of the measles, mumps, and rubella (MMR) vaccine. It has significantly reduced the number of reported measles cases; however, immunity from the vaccine wanes so that by age 15, about 60% of vaccinated children are susceptible to subclinical infection with measles virus, and by age 24–26, a projected 33% of vaccinated adults are susceptible to clinical infection.24
I note that the study cited doesn’t actually quite show that. For one thing, nowhere in the study did it say that anywhere near that many children or adults remain susceptible to subclinical measles infection. Indeed, the authors note that low titers of measles antibodies do not mean lack of immunity:
A rise in the proportion of persons with low antibody levels suggests an increase in potential susceptibility, but low titers are unlikely to represent the same risk of illness or viral transmission as absent antibodies.28,37–39 In our study, none of the children with low titers had positive or even indeterminate IgM responses to MMR2, in contrast to the majority of those with negative titers, suggesting that those with low titers may generate an anamnestic response to wild-type virus, consistent with previous studies.37–39 If ongoing viral transmission requires that a substantial portion of the population be antibody-negative, our data suggest that such a situation may be several decades away. Furthermore, as demonstrated by Ward et al37 and Gans et al,40,41 cell-mediated immunity plays an important role in resistance to measles infection, an issue we did not address.
Moreover, as I like to point out, if waning immunity is a problem, the solution is to add another booster at an appropriate time point. Indeed, back during the last wave of measles outbreaks in 2019, I myself got an MMR booster because I was concerned that, having been vaccinated as a child in the 1960s, my immunity might be waning.
Elsewhere, PIC tries to imply that MMR is more dangerous than measles, mumps, and rubella:
It has not been proven that the MMR vaccine is safer than measles, mumps, and rubella. The vaccine package insert raises questions about safety testing for cancer, genetic mutations, and impaired fertility. Although VAERS tracks some adverse events, it is too inaccurate to measure against the risk of measles, mumps, and rubella. Clinical trials do not have the ability to detect less common adverse reactions, and epidemiological studies are limited by the effects of chance and possible confounders. Safety studies of the MMR vaccine are particularly lacking in statistical power. A review of more than 60 MMR vaccine studies conducted for the Cochrane Library states, “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.”19 Because permanent sequelae (aftereffects) from measles, mumps, and rubella are so rare (especially in children with normal levels of vitamin A and infected after birth),6,15-17 the level of accuracy of the research studies available is insufficient to rule out the possibility that the MMR vaccine causes greater death or permanent disability than measles, mumps, and rubella.
This is a veritable Gish gallop of nonsense. First, there’s the trope I mentioned before of the appeal to the package insert. Then there’s the spreading of fear, uncertainty, and doubt (FUD) by misusing the Vaccine Adverse Events Reporting System (VAERS), complete with additional handwaving about how clinical trials don’t have enough subjects in them to detect rare adverse events (AEs), which is true but also irrelevant given that post-licensure safety studies and epidemiological studies do have more than adequate statistical power to detect rare AEs. I also note selective quoting of the Cochrane review, as the authors also add, “The evidence of adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases.” The authors also use an old version from 2012. The most recent Cochrane review of the MMR vaccine is from 2021 and concludes:
Existing evidence on the safety and effectiveness of MMR/MMRV vaccines support their use for mass immunisation. Campaigns aimed at global eradication should assess epidemiological and socioeconomic situations of the countries as well as the capacity to achieve high vaccination coverage. More evidence is needed to assess whether the protective effect of MMR/MMRV could wane with time since immunisation. In another page, PIC hypes the risk of febrile seizure after MMR vaccination, even though febrile seizures rarely cause serious negative sequelae. Seizures are scary, though; even the thought of them might be enough to frighten parents away from vaccinating.
See what I mean? Misinformed refusal.
There are numerous other examples of this sort of deception on the PIC website, so many that one could do a series of posts deconstructing them all. I only discussed the ones above in order to provide you with examples of the sort of twisting and misrepresentation of existing science that goes into misinformation behind misinformed refusal.
Think of it this way. Let’s say you’re an average, reasonably intelligent person but that you don’t have a scientific or medical background. Now let’s say you read the information on the PIC website, all of which paints a picture downplaying the benefits of vaccines in preventing disease and death and exaggerates the risks, in some cases inventing risks not supported by evidence (autism). Here’s an example, in which they choose a single study and then try to appear reasonable by conceding the MMR doesn’t cause 1% of vaccinees to become autistic but that it might cause a smaller number to become so:
Although Hviid et al.’s study provides compelling evidence that MMR is not causing autism in 1 in 100 cases, it has provided no evidence that MMR is not causing autism in more than 1 in 50,000 cases (more than the risk of fatal or permanently disabling measles, mumps, and rubella for children at normal risk). To the contrary, the study did not rule out the possibility of MMR causing autism in 1 in 3,000 children overall, 1 in 540 children followed for a 10-year period, 1 in 520 children at low risk of autism, and 1 in 130 children who had a similar DTaP-IPV/Hib vaccination history.
Of course, that study is only one of a number of studies that failed to find a link between MMR and autism, but notice the technique. We’re not saying that MMR causes autism, PIC says. We’re just saying that a link can’t be ruled out based on this one study. Again, it’s FUD.
The tactic—and, make no mistake, it is an intentional tactic of misinformation and disinformation—behind misinformed refusal is to claim that parents and patients are not receiving genuinely real “informed consent” from doctors. In the antivax narrative, if they are not hearing all the exaggerated claims for harms—including the harms attributed to vaccines by antivaxxers for which there is no good scientific evidence, like autism—and all the minimization or outright denial of the benefits of vaccines in preventing infectious disease that antivaxxers promote, patients and parents are not getting the “whole story” and therefore can’t really be engaging in “informed consent.” Antivaxxers then portray themselves as being for “informed consent,” even though in reality their narrative is pure misinformation promoting FUD about vaccines based on cherry-picked studies, bad studies, pseudoscience, and outright conspiracy theories. The idea is to promote anything that is a science-based assessment of the risk-benefit ratio of vaccines as falling short of “informed consent.”
The idea behind this tactic is, of course, to sell a narrative to people thinking of being vaccinated in which the benefits of vaccination are falsely denied or minimized and the potential harms of vaccines are hugely exaggerated and even made up and completely unsupported by science. (Again, the example of vaccines supposedly causing autism comes to mind.) After all, what reasonable person confronting a narrative in which vaccines have little or no benefit but come with a great risk of harm would, if they believed that narrative, agree to be vaccinated? Almost no one, obviously! That’s the idea behind misinformed refusal. Reasonable people decline vaccines based on a hugely distorted picture of the risk-benefit ratio of being vaccinated. That narrative can be further enhanced by doing what RFK Jr. did and suggesting that there are alternatives to vaccination that are effective and safer, as well as by falsely portraying the disease being vaccinated against as “harmless.”
Unfortunately, misinformed consent masquerading as informed consent will likely soon come to be a major component of CDC messaging regarding vaccines, particularly after Dr. Dave Weldon, also an antivaxxer, is confirmed as CDC Director. (He will be confirmed, too. If the Senate couldn’t muster the courage to reject a rabid antivaxxer with a 20 year history of antivaccine activism like RFK Jr., it’s not going to blink at confirming a much more minor character in the antivaccine movement 20 years ago like Weldon.)
I predict the misinformed refusal won’t be as blatant as, for example, that found on the PIC website. Rather, I predict that it will start more subtly. Indeed, RFK Jr.’s tepid messaging recommending the MMR vaccine, coupled with all sorts of dog whistles to downplay its importance and suggest that there are alternatives like good nutrition and vitamin A that will keep you safe, will be how it starts. From there, it will slowly accelerate until faith in the vaccination program is driven to all-time low levels and a public health disaster ensues, most likely a few years from now, when it will no longer be RFK Jr.’s or President Trump’s problem. Worse, once confidence is destroyed, it could take a generation to build it back; that is, if anyone wants to put in the effort and resources to do that anymore.
