Having a man who has for the last two decades arguably been America’s most famous and intellectual antivax activist in charge of the Department of Health and Human Services (HHS) has been exhausting. Every week, I say that I’m not going to write about whatever new horror Robert F. Kennedy Jr. is inflicting on US federal health, public health, and biomedical research, but then every week he comes up with something new that, to those of us paying attention, is not really new at all. Last week, it was this announcement showing up in all sorts of news stories, for example, The Washington Post:
Health and Human Services Secretary Robert F. Kennedy Jr. intends to shift the way vaccines are tested, a move that the agency said will increase transparency but that medical experts fear could limit access to vaccines and undermine the public’s trust in immunization depending on its implementation.
The potential change outlined in a statement says all new vaccines will be required to undergo placebo testing, a procedure in which some people receive the vaccine and others receive an inert substance — such as a saline shot — before the results are compared.
“All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices,” an HHS spokesperson told The Washington Post in response to questions about Kennedy’s comments on the measles vaccines and general vaccine policy.
As soon as I started reading these stories and seeing them pop up on TV in news reports, I realized that this was simply the implementation of something that antivaxxers and COVID-19 contrarians had been doing all during the pandemic, riffing on an antivax trope that long predated the pandemic. Indeed, less than a year and a half ago, I wrote a post about it entitled 2023: The year that the evidence-based medicine (EBM) paradigm was weaponized against vaccines and public health. Sadly, I never thought I’d be doing an update to this post in which I felt the need to explain that this weaponization of the EBM paradigm is now federal vaccine policy—and, no doubt, soon to be policy regarding all public health—but here we are.
Think I’m overreacting? Here’s the “tell” from the HHS statement:
In recent weeks, the Trump administration has injected uncertainty into the annual process for approving an updated coronavirus shot traditionally offered in the fall, indicating there may need to be more data.
“Except for the COVID vaccine, none of the vaccines on the CDC’s childhood recommended schedule was tested against an inert placebo, meaning we know very little about the actual risk profiles of these products,” HHS said in its statement.
This is a straight-up antivax trope, one that I’ve written about a number of times, specifically the claim that none of the vaccines on the CDC’s childhood recommended vaccine schedule was tested against an “inert placebo.” Usually the antivax version of this specifies a saline placebo as The Only One True Inert Placebo permitted, but, whatever the term, the trope remains. It’s a trope long repeated by RFK Jr. and Aaron Siri, an antivax lawyer with whom RFK Jr. has frequently worked, and therefore one that I’ve written about before, specifically how the trope is based on a deceptive half-truth based on on a misuse of EBM that I like to call methodolatry.
Before I discuss why that is, I also have to note that it’s a straight up lie to claim that “none of the vaccines on the CDC’s childhood recommended schedule was tested against an inert placebo” (emphasis mine). The HHS statement itself even concedes that the COVID-19 vaccine, which is currently—although probably not for much longer—on the CDC’s recommended childhood vaccination schedule was tested against placebo. That actually surprised me, given the RFK Jr.’s propensity to lie about vaccines. In any case, it’s easy to see that the varicella vaccine, for example, was tested against saline placebo.
I’ll start by defining “methodolatry,” after which I’ll explain why it is, depending on your point of view, either a weakness of the EBM paradigm that is baked in or a fundamentalist version of EBM that ignores medical ethics in favor of supposed scientific rigor. Then I’ll discuss why this new HHS diktat, although represented as “gold standard science”—a term RFK Jr. and his minions love to throw around and something they claim to be “restoring” to federal vaccine policy—is, in actuality, a strategy to undermine trust in vaccines by portraying vaccines on the current CDC childhood schedule as inadequately tested and potentially unsafe. It is also a strategy that, depending on how “new vaccine” is defined, could prevent the approval of updated COVID-19 and flu vaccines and even provide a seeming “gold standard science” rationale for delicensing some currently licensed vaccines, all while falsely claiming the scientific high ground in doing so.
Think of it this way. The reality-challenged insinuation that the current childhood vaccine schedule is unsafe because its constituents haven’t been tested in placebo controlled RCTs notwithstanding, placebo-controlled RCTs demonstrating efficacy and safety have always been required for new vaccines against diseases that currently have no licensed vaccine.
Methodolatry: EBM fundamentalism that ignores ethics and practicality
Way, way back in the day in 2009, I came across the term “methodolatry” in a blog post by a senior epidemiologist who blogged under the ‘nym “revere,” who during the H1N1 influenza pandemic, called out a hagiography published in The Atlantic of Dr. Thomas Jefferson, an EBM guru at the Cochrane Collaborative known for having cast doubt on the efficacy and safety of flu vaccines, setting up his use of the term thusly:
Brownlee and Lenzer rely upon (and romanticize as a martyr and truth-teller) Dr. Thomas Jefferson, someone who is fast establishing himself as an “Evidence Based Medicine” (EBM) crank who who courts notoriety by being a contrarian. The kind of EBM practiced by the likes of Jefferson and some other randomized trials zealots is far from the judicious weighing of the evidence envisaged by its early proponents.
Sound familiar? Let’s just say that EBM fundamentalist zealots like Drs. Vinay Prasad, John Mandrola, and Adam Cifu are nothing new. Indeed, they are simply the latest generation of methodolatrists, “intellectual”—if you can call it that—descendants of, for example, Tom Jefferson and Peter Gøtzsche, who used it to cast doubt on the safety of Gardasil. (Never mind that the existence of long term studies like this one that did compare HPV vaccines to saline placebo controls rather undermines this particular antivaccine talking point.) The difference, of course, is that that Prasad and colleagues have way less experience in actually doing EBM. But what is methodolatry? Heed the words of revere, nearly 16 years ago:
There is nothing judicious about Jefferson, whose problem was described by one of my colleagues as “methodolatry,” the profane worship of the randomized clinical trial as the only valid method of investigation.
The very first comment after revere’s post describes the consequences of methodolatry, or what I sometimes also call EBM fundamentalism:
Even if in his case the agenda might be “That’s sufficient evidence?”, which if thoroughly applied would declare many treatments to be not effective and ultimately—if you follow the logic of EBM—not approved or allowed?
My specific point is that we have here a concrete example of the misuse of EBM that is having real world effects, perhaps to the point that one or more people will die from novel H1N1 because this article convinced them the benefit of getting inoculated is so low it doesn’t outweigh the perceived risks.
Again, does this sound familiar? It’s exactly what has been done by COVID-19 contrarians deceptively claiming the scientific high ground by demanding randomized controlled clinical trials (RCTs) on everything from mask mandates to other nonpharmaceutical interventions, while almost never actually proposing how one would do such a trial in the middle of a pandemic. As our very own Dr. Jonathan Howard has frequently pointed out, it’s all performative, designed to cast doubt on existing evidence and demand a standard of evidence that in the real world is often impossible to attain for whatever interventions they don’t like, be they COVID-19 boosters, masks, or whatever.
As I wrote at the time, you could take a number of articles citing the lack of RCTs about various non-pharmaceutical interventions for COVID-19 or for COVID-19 boosters or for a number of issues that have come up during the pandemic and change the words “novel H1N1” to “novel coronavirus” or “COVID-19,” and revere’s observations are just as valid today as they were in 2009. The only difference today is that far more EBM gurus seem to be promoting the same simplistic and misleading message that Tom Jefferson was back then; worse, the same idea is metastasizing from COVID-19 to the childhood vaccination schedule. If you doubt me, must look at how Vinay Prasad, eager to suck up to RFK Jr., suggested that the childhood vaccination schedule should undergo a “a multi-arm, factorial RCT…before public distrust gets too out of control,” without, as I pointed out, ever actually saying how such a massive trial could be done ethically. (Hint: It can’t, for reasons that I will explain.) Indeed, Dr. Prasad is prone to proposing RCTs for questions that are not even medical, such as testing various methods of deciding which grant applications are funded by the NIH.
Why is methodolatry so deceptively appealing? In brief, the way it is being used now by HHS under RFK Jr. depends on a very simplistic version of EBM as promoted by EBM/RCT zealots and understood by those knowledgeable enough to be aware of the basic tenets of EBM but who do not understand EBM sufficiently well to know the caveats; i.e., when we have to do with “lesser” evidence.
At this point, it’s useful to briefly explain the EBM paradigm that puts RCTs near the very top of the EBM pyramid—or hierarchy—of evidence, with the only evidence ranking higher being systematic reviews and meta-analyses of multiple RCTs. First, though, keep in mind these two bedrock principles of bioethics, the first relevant to all human subjects research including RCTs, the second being more relevant to RCTs:
- No subject should receive anything less than current standard-of-care medicine, be it the intervention being tested or any other medical intervention that they might undergo during the trial.
- There must be genuine clinical equipoise between all groups, including control groups, in any RCT. Clinical “equipoise” means that there must be genuine scientific uncertainty regarding whether the experimental intervention is truly better than what the control group receives. Obviously, physicians don’t carry out clinical trials if they don’t think that the intervention being tested is likely to be at least as good as the control group, and one can argue about what constitutes an adequate level of “uncertainty” to justify an RCT, but clinical equipoise is one bedrock principle that determines if an RCT can be ethical. In other words, you can’t ethically randomize human subjects to an experimental group that you know to be an inferior treatment.
Keep these principles in mind as I discuss how the EBM paradigm can become methodolatry. I will then describe how the HHS diktat could easily be methodolatry, depending upon how it is operationalized.
The EBM paradigm vs. methodolatry
The EBM paradigm is often described in terms of the “evidence pyramid,” in which types of scientific evidence applied to medicine are ranked thusly:
Randomized controlled clinical trials are just that: clinical trials in which subjects are randomized to receive either the intervention or a control (such as a saline placebo) and then followed to determine which group has better outcomes, which are prespecified in the clinical trial protocol. The reason for randomization is to ensure that the two groups being compared resemble each other as closely as possible in characteristics relevant to the outcomes being tested. For example, if you’re testing a drug to treat hypertension, you would want the groups to be matched as closely as possible for, among other characteristics, age, race, sex, severity of hypertension, and relevant risk factors for poor outcomes. Ideally, these RCTs are then double-blinded, so that neither the subjects nor the doctors or medical personnel administering the drugs and assessing outcomes know which group any given subject is in. Moreover, such clinical trials have strict inclusion and exclusion criteria, which ensure that those being treated actually have the disease, do not belong to a group that might be harmed by the drug, and are subjects who are likely to benefit if the drug does have efficacy; i.e., does work.
As you can see in the image above, in the EBM paradigm RCTs are ranked near the top of the pyramid for strength of evidence. Actually, as far as original clinical studies go, they are at the top. It is true that systematic reviews and meta-analyses of RCTs are ranked higher (i.e., as more rigorous), but remember that these are syntheses of existing RCTs, not original experimental clinical studies in which one intervention is tested against placebo or another intervention. Moreover, it is also true that, for certain questions, RCTs truly are the gold standard, as an RCT is the design that best minimizes bias, thanks to randomization and careful matching of the experimental versus the control group, plus blinding, which when done properly minimizes bias due to observation.
Let’s look at a concrete example that I like to cite, the strict EBM paradigm as applied to whether the MMR vaccine causes autism. (RFK Jr. has been saying for many years now that he believes it does.) Regular readers of SBM likely already know that in reality the evidence base of studies examining the question of whether vaccines cause autism is very large and has failed to find even hint of a whiff of an association between MMR (or MMRV) and autism. Yet, because the bulk of these studies consists of epidemiology, including one that encompassed 537,303 children representing 2,129,864 person-years of study, the certainty of the evidence behind the conclusion of the relevant Cochrane review that the MMR vaccine does not cause autism can never be more than “moderate” because by the very definition of the EBM paradigm and its ranking of sources of evidence, epidemiological studies always rank below RCTs. Note that it will never be possible to do an RCT to answer the question of whether vaccines like MMR increase the risk of autism because such a trial would be inherently unethical, not to mention also very impractical, as defenders of science-based vaccine requirements were explaining 15 years ago.
I discussed the nitty gritty of EBM levels of evidence the last time around, including some newer definitions and acknowledgment that certain questions can’t be answered by RCTs, if only for ethical reasons. I’ve also discussed how the EBM paradigm can “inspire” those who take it too far to want to argue that RCTs are the only valid method of investigation, even for questions for which they are ill-suited. I also note that EBM fundamentalists frequently ignore the precept that “if RCTs are impractical or unethical,” then cohort and case control studies must suffice. While it’s always difficult to tell whether EBM fundamentalists are true believers or are intentionally misusing the EBM paradigm of RCTs über alles, in the case of RFK Jr. I am willing to say that it is almost certainly intentional misuse of the paradigm. Let me explain through the example of the childhood vaccination schedule and the longstanding antivax half-truth that childhood vaccines have never been tested in proper RCTs.
RFK Jr: Weaponizing EBM fundamentalism against the childhood vaccination schedule
The idea that the vaccines in the childhood vaccination schedule have never been tested in “proper” RCTs for safety and efficacy is an old antivax trope, long championed by Aaron Siri, a shyster—IMHO, of course!—who’s long worked with antivax activists RFK Jr. and Del Bigtree and his antivax organization ICAN harassing various governments and companies with—again, IMHO—frivolous lawsuits designed to cast doubt on the safety and efficacy of vaccines. It was the central subject of an antivax book, Turtles All the Way Down, whose title appears to be an analogy to the actual situation with the childhood vaccination schedule, as you will see, particularly if you look at the book’s cover art:
The central premise of Siri and RFK Jr.’s claim that most childhood vaccines have not been tested against a saline placebo—rephrased in the HHS statement as “inert placebo”—has also been misrepresented as a “placebo pyramid scheme”:
Or, as Dr. Vincent Iannelli at Vaxopedia represented it
It is, of course, true that many of the current vaccines in the childhood vaccine schedule were never tested an RCT vs. saline placebo, but there is a very good reason for that. Go back to the first ethical principle of human subjects research that I listed above. I’ll repeat it again for emphasis:
No subject should receive anything less than current standard-of-care medicine, be it the intervention being tested or any other medical intervention that they might undergo during the trial.
Why is this principal of clinical trial ethics so important regarding the childhood vaccination schedule? Simple. Consider first the case of a disease for which there is no existing FDA-licensed safe and effective vaccine; i.e., a first generation vaccine. To test an experimental first-generation vaccine, it is ethical to do an RCT, because there currently exists no vaccine that is licensed and standard-of-care, and that’s exactly what is required of such a new vaccine. In fact, that is what has always been required for new first generation vaccines. It’s the reason why, to be approved for use in children, the COVID-19 vaccines were required to undergo an RCT in children. Even the HHS statement conceded that COVID-19 vaccines had undergone placebo-controlled RCTs in children before being licensed.
Now let’s consider the case of a new vaccine for a disease for which there already exists a licensed vaccine that is safe and effective and considered by pediatricians to be standard-of-care, for example, vaccines against measles; i.e., a second, third, or even fourth generation vaccine. (I’ll call these second generation vaccines, for brevity’s sake.) Alternatively, consider the development of multivalent vaccines; i.e., multiple existing vaccines against different diseases combined into one shot for convenience of administration, such as measles-mumps-rubella (MMR) or measles-mumps-rubella-varicella (MMRV). In the case multivalent vaccines combining approved vaccines and of second generation vaccines, there already exists a vaccine licensed as safe and effective against an specific disease (or safe and effective vaccines against specific diseases) that are considered standard of care by pediatricians and other relevant medical specialties.
In these cases, other than rare cases, doing an RCT with a saline or “inert” placebo would be completely unethical because it would require randomizing a number of subjects to be in a group that receives less than the standard of care with respect to vaccines and who would therefore be intentionally left vulnerable to the diseases prevented by both the old vaccine and the new vaccine being tested. In the case of, for example, a new vaccine against a disease, the only ethical way to carry out an RCT of a second generation or of a new multivalent vaccine would be to test the new vaccine against the existing vaccine for that disease in order to determine that the new vaccine is at least as effective and safe as the old vaccine. This is called a non-inferiority trial. Even if a non-inferiority trial doesn’t show that the new vaccine is better than the old at preventing disease, there might still be reasons to favor the new vaccine even if it is only “as good as” the older vaccine. Reasons for favoring the new vaccine might include, for example, that it’s cheaper, easier to dose, or has a more tolerable side effect profile. Of course, ideally, we would prefer to be able to show that the new drug is better than the existing standard-of-care, but this is often very difficult to do, which is why noninferiority trials are more common.
In addition, remember the second ethical principle I mentioned. Regardless of the scientific rigor of the trial, randomization requires clinical equipoise; i.e., the existence of genuine uncertainty based on existing science and evidence about which group, control or experimental, will do better. Clinical equipoise is not just a requirement, but absolute requirement for randomization of clinical trial subjects to be considered ethical. Note that clinical equipoise does not mean that there is no evidence that a treatment works or is better than existing treatments. After all, the reason we do clinical trials is to find drugs that work where there currently are none and to find drugs that work better than current therapy, and there has to be compelling preclinical evidence from laboratory and animal studies, as well as preliminary early stage clinical trials, to justify testing a drug or vaccine in an RCT. There also has to be genuine scientific uncertainty, even if, as is usually the case, investigators think that it is more likely than not that the experimental group will do better than the control group. Absent that legitimate uncertainty, an RCT to test an intervention is unethical, as is the case in randomizing a child to be left unprotected against measles to test a new measles vaccine or formulation of vaccines that includes the measles vaccine.
I note that these two principles are general principles governing all clinical trial ethics as well. In my area of specialty, for instance, oncology, we don’t test new chemotherapeutic drugs against placebo if there already exist effective chemotherapy regimens with a side effect profile deemed tolerable. Instead, we either add the new drug to the existing chemotherapy regimen and test it against the existing chemotherapy regimen without the new drug, or, in the case where the existing chemotherapy regimen is only marginally effective, it can sometimes be ethical to test the new chemotherapy against the existing chemotherapy regimen. The principle to be remembered is that in no case should any human subject enrolled in the clinical trial ever receive anything less than the existing science-based standard-of-care. To do otherwise would be unethical. Indeed, this is codified in a multinational set of guidelines to which the FDA has adhered. I cited above and that could be fit into the FDA regulation that allows an active treatment concurrent control:
The use of a placebo control group does not imply that the control group is untreated. In many placebo-controlled trials, the new treatment and placebo are each added to a common standard therapy (so called add-on studies, see section 2.1.5.2.1).
Coming back to the childhood vaccine schedule, the true situation is that, in any cases for which a current vaccine in the schedule wasn’t tested against placebo, if you go back far enough you will inevitably find that the original vaccine against that disease was tested in a placebo-controlled RCT. As friend of the blog Skeptical Raptor put it:
So, let’s be clear here. Any new vaccines that replace older vaccines will probably not use a true placebo-controlled group. The new vaccine will almost always be compared against the older version of the vaccine, but there may be a way around that; I don’t see it.
Nor do I. As Dr. Stanley Plotkin puts it:
Stanley Plotkin, a pioneer in the field who developed the rubella vaccine, said that when scientists test vaccines against a new disease, they typically look for evidence that the vaccinated individuals do not get a disease, compared with those who received a placebo. This is how the coronavirus vaccines were tested, in 30,000-person trials in which half of the participants received saline shots.
But when a disease is already well understood, scientists can look for evidence that vaccines induce a biological response that has been scientifically shown to protect against the disease — what scientists call “a correlate of protection.”
In the case of diseases that cause serious illness and can even be fatal, if there are existing interventions, the use of placebos is often not considered ethical.
“Ethics must be taken into account when you set up a study,” Plotkin said. “Can I ethically agree to having people acquire the disease because they receive a placebo?”
Precisely.
Moreover, as vaccine scientist and advocate Dr. Paul Offit pointed out, even doing RCTs for new vaccines against diseases for which there is currently no safe and effective vaccine has an ethical price. Pointing to the original RCT of Jonas Salk’s original vaccine against polio in the 1950s, he called it the “casual cruelty of placebo-controlled trials,” because 34 of the 36 children paralyzed by polio in that study were in the placebo group.
Over on Threads, Dr. David Higgins provided some comparisons to give you an idea why requiring placebo-controlled RCTs of second generation vaccines instead of the case now, trials comparing the new vaccine to existing vaccine, is so off-base:
I’ll also point out that the way that HHS emphasizes “inert” placebos is another antivax trope. To the likes of RFK Jr., Del Bigtree, and Aaron Siri, the only acceptable placebo is saline. This emphasis of “inert”—cough, cough, saline!—placebos is another strategy to falsely delegitimize the RCTs used to license some vaccines because, for example, some RCTs use something other than saline. For example, the original HPV vaccine trial used a placebo that contained the same aluminum adjuvant as the vaccine, because it made it very difficult for subjects and their doctors to see any difference in local skin reactions between placebo and vaccine. Sometimes vaccine trials will use the diluent used for the vaccine, minus the antigen(s) used to provoke the immune response, in order to make the two as similar as possible other than the “stuff” that provokes immunity.
The real purposes of the HHS vaccine placebo diktat
With that background in mind, I turn my attention to what I view as the real purpose of the HHS diktat that, henceforth, all new vaccines will be tested against “inert” placebo before they can be licensed. You won’t be surprised to learn that my conclusion is that the purpose of this diktat is, first of all, to suggest that the current CDC childhood vaccination schedule is somehow unsafe and not evidence- or science-based, when it most certainly is. Again, the “tell” is how the HHS statement claims that none of the current vaccines, save COVID-19 vaccines, have been tested in what RFK Jr. considers “real” placebo-controlled RCTs. If HHS had simply said that all new vaccines will be tested against inert placebo, I probably would have shrugged my shoulders and said, in essence, “That’s how they’ve always been tested.” HHS stating that vaccines in the current childhood vaccine schedule tells me that this diktat is at least about casting doubt on the safety and efficacy of childhood vaccines.
I’d argue, though, that the HHS diktat has a more sinister, more explicitly antivax purpose that will depend upon how HHS operationalizes it and defines “new vaccines.” Multiple actions and statements by HHS made me suspect this more sinister purpose. The first occurred month ago, when the date of April 1 came and went without the reformulated version of Novavax being fully licensed, as previously planned by FDA before President Donald Trump and HHS Secretary RFK Jr. took over. Worse, in a highly unusual step, the FDA is now requiring that the new Novavax formulation go through a large RCT before licensure. The new FDA Commissioner, Dr. Marty Makary, who has sworn up and down during the pandemic that he isn’t antivax, is fully on board as well, even to the point of parroting RFK Jr.’s line of “gold standard science”:
Or, as Tara Smith put it:
This happened shortly after it looked as though the FDA was going to grant full licensure to the new Novavax formulation, after all. Worse:
“It’s now been years since COVID has presented the threat it once did, and the urgency to rush approval of boosters without normal oversight no longer exists,” said Andrew Nixon, a Health and Human Services spokesman, in a statement.
Prof. Morris is correct. The only difference between the updated Novavax vaccine and the original version of the vaccine is that the company is updating the COVID-19 strains in the vaccine to reflect better what is circulating now. In addition, given that the mRNA vaccines have been treated the same way as Pfizer and Moderna have updated the strains included in them to reflect better the COVID-19 strains in circulation, does the FDA plan on applying a similar logic to COVID-19 vaccines? Note that the administration is using the claim that COVID-19 is supposedly no longer a threat as justification for this move.
Interestingly, in response to concerns about whether or not this precedent will be applied to influenza vaccines, HHS responded:
Nixon, the HHS spokesman, suggested the policy might not apply to the flu shot, “which has been tried and tested for more than 80 years.”
This sounds to me like nothing more than a sop to the old guard, or something that Dr. Makary can say for now in order to reassure himself that he isn’t just a figurehead carrying out RFK Jr.’s assault on vaccines in the US. (Hint: He most definitely is nothing more than a useful idiot chosen to serve as the face of the dismantling the FDA, no matter how much he tries to deny it.) Under RFK Jr. and the spineless Makary, I have little doubt that reasons will be found to expand this requirement for RCTs for “new vaccines” to seasonal flu vaccines by simply redefining each season’s flu vaccine as a “new vaccine.” That’s all it would take to make flu vaccines unavailable in the US, and I have little doubt that this is part of RFK Jr.’s endgame. Indeed, my prediction is that the delicensing of vaccines begins with Novavax, will expand to include mRNA vaccines against COVID-19, and then further expand to end seasonal flu vaccines. Think I’m exaggerating? The administration has arguably been at war with mRNA technology since Trump was inaugurated, as evidenced by the NIH defunding grants to study the technology and the promised increased scrutiny on such vaccines. As for flu vaccines, these have long been the target of antivaxxers as the “low-hanging fruit,” given how their efficacy varies so much from year to year based on how accurately scientists are each year at predicting in the winter the strains that will be circulating the following fall and winter.
The second thing that made me suspect a more sinister purpose to this diktat has been RFK Jr.’s characterization of current vaccine safety monitoring systems. For example, a Fox News story about the “placebo only” diktat, included this statement about vaccine safety monitoring:
HHS also claimed that the CDC has not been monitoring vaccine complications adequately, and criticized its current surveillance system.
“The CDC’s former practice of suppressing information about vaccine injuries has badly eroded trust in our public health agencies,” the agency said.
“The CDC’s own research has shown that the post-licensure surveillance system, VAERS, captures fewer than 1% of vaccine injuries,” the HHS spokesperson said. “It’s a system that was designed to fail. The Vaccine Safety Datalink (VSD) — intended as a backup to VAERS — is virtually unusable for serious research. Both systems have become templates of regulatory malpractice.”
Antivaxxers have frequently attacked the Vaccine Adverse Events Reporting System (VAERS) database and/or weaponized it to give a false picture of the safety of vaccines. Indeed, the weaponization of VAERS against COVID-19 vaccines started almost before COVID-19 vaccines had received emergency use authorization (EUA) in December 2020. (Read here for details. It’s a subject that I’ve written about more times than I can remember, going back to 2006.)
But what about VSD? Why is RFK Jr. attacking the Vaccine Safety Datalink (VSD), which, if you believe what he says about a vaccine safety monitoring system, should be about as close to the “Gold Standard Science” that he claims to want? After all, unlike VAERS, VSD is an active, rather than passive reporting system, that surveys the electronic health records of several large health care organizations, including Kaiser Permanente in California. Last week, a story was published in NBC News, The little-known database at the heart of Kennedy’s vaccine conspiracy theory, that gives an indication why:
Kennedy now oversees the Centers for Disease Control and Prevention — including the Vaccine Safety Datalink — and one of his first initiatives as health secretary was to launch his long-dreamed-of study using the VSD to investigate the link between childhood vaccines and autism. It’s a theory that has already been disproven in dozens of studies, many using VSD data.
“We’re going to be able to get into these databases and give answers to the American public,” Kennedy said last month. He told President Donald Trump at recent Cabinet meeting that he would reveal the cause of autism by September.
But:
Without evidence, anti-vaccine lawyer Aaron Siri and activist Del Bigtree have claimed on the internet show “The HighWire” that the CDC scattered the vaccine safety data after Kennedy took office, making it unavailable for Kennedy’s team to examine. The goal, according to Siri, was to “thwart the ability for the current administration to actually conduct a study in the VSD.”
Not exactly:
There’s one thing that Bigtree and Siri have right: The data in the VSD is not actually housed at the CDC — but that’s not a recent change.
The VSD is a collaboration between a small team at the CDC’s Immunization Safety Office and 11 private health care organizations. Since the 1990s, it’s been used to monitor vaccine safety and conduct studies of rare side effects.
“These studies that use the VSD are able to tell the difference between a condition that coincidentally happens after vaccination and a condition that may actually be the result of vaccination,” said Dr. Joshua Sharfstein, vice dean for public health practice at the Johns Hopkins Bloomberg School of Public Health.
The health care organizations used to send their anonymized medical data to the CDC each year for analysis, but since 2001, the organizations have kept the data on their own servers, to ensure it stays secure.
That’s what’s likely upsetting RFK Jr. He can’t snap his fingers and have immediate access to the data in VSD to torture until it confesses that vaccines cause autism because the data are stored not on CDC or FDA servers, but on the servers of the individual healthcare organizations that contribute to the VSD. Worse for him, although outside researchers can get access to VSD data, they have to go through the institutional review board of Kaiser Permanente, which, unlike the CDC, NIH, and FDA is not controlled by RFK Jr. and therefore can’t be tampered with. You might remember that in 2003 Mark and David Geier, the latter of whom was hired by NIH to do RFK Jr.’s study to look at vaccines as a risk factor for autism, got busted for trying to merge datasets in a manner that could compromise protected health information (PHI) in violation of HIPAA and to copy some of the data, both of which violated their IRB-approved protocol. The news story notes that David Geier has viewed that as “oppression” and “coverup”:
For the Geiers, the experience was one of oppression. At anti-vaccine conferences, they presented PowerPoints alleging that the CDC had “restricted” their access to data and “attacked” their findings.
At the same conferences, Kennedy, who has consistently praised the Geiers, told a similar story.
“Oh, they’ve hidden it, and they won’t let anybody in it, except their own guys who cherry-pick and design these fabricated studies and change the protocols constantly to try to use it to defend vaccines,” Kennedy said in a 2017 keynote at AutismOne, an anti-vaccine conference for parents of autistic children where the Geiers also presented. “It’s being used instead to craft these fabricated, fraudulent studies,” he said, “to fool the public about vaccine safety.”
Far be it from me to say that better postlicensure safety monitoring for vaccines—for all pharmaceuticals, really—wouldn’t be desirable and an objectively good thing. (Indeed, I’ve argued the opposite.) However, also far be it from me to fall for RFK Jr.’s claim that all he wants to do is to improve vaccine safety monitoring. Indeed, he is the last person I would put in charge of vaccine safety monitoring; sadly, the same was not true of President Trump, and here we are, with RFK Jr. overseeing the agencies that are in fact responsible for vaccine safety monitoring. Until RFK Jr. is no longer in charge, the best that can be done is to try to protect, as much as possible, the integrity of existing vaccine safety monitoring systems. In any event, it’s clear that what RFK Jr. really wants is access to the data to cherry pick in a manner to “prove” a connection between autism and vaccines or to blame vaccines for all the things that antivaxxers like to attribute falsely to vaccines.
Finally, the last (or at least he most recent) tell that RFK Jr. is working to eliminate vaccines also appeared news stories with titles like Kennedy Orders Search for New Measles Treatments Instead of Urging Vaccination.
Basically:
“Secretary Kennedy will be enlisting the entire agency to activate a scientific process to treat a host of diseases, including measles, with single or multiple existing drugs in combination with vitamins and other modalities,” the HHS spokesperson said in a statement to CBS News.
The statement said the CDC effort would involve working with universities “to develop protocols, conduct testing, and pursue approval for new uses of safe and effective therapeutics that meet the highest scientific standards.”
While the CDC is continuing to recommend vaccination “as the most effective way to prevent the disease,” the statement says they recognize some Americans “may choose not to vaccinate.”
“Our commitment is to support all families — regardless of their vaccination status — in reducing the risk of hospitalization, serious complications, and death from measles,” the statement said.
Unfortunately, as is the case with most viral diseases, the only treatment for patients who have been infected is supportive care. True, in children who are malnourished—which is not the majority of American children—treatment with vitamin A could have some beneficial effects but is useless for most children, but nothing beats vaccination to prevent the disease in the first place. While it might sound benevolent and high-minded to say that he’s supporting “all families regardless of vaccination status,” what RFK Jr. is really doing is, as he’s been doing all along, paying lip service to the MMR vaccine (grudgingly) while deemphasizing it in favor of quackery and unproven treatments like the steroid inhaler budesonide. It’s the same playbook that COVID-19 deniers used with COVID-19: Tout hydroxychloroquine and ivermectin, neither of which have any therapeutic activity against COVID-19, the implication being that you don’t need to get vaccinated because there is an effective, safe, and inexpensive cure that you can use if you contract the disease.
The future looks grim
As I was writing this, it was difficult not to note that, at 935 cases, the number of measles cases in the current outbreak continues to climb. Fortunately, there have been no further deaths (yet) since the second child died a month ago. However, the number of children who have died of influenza thus far has hit 216, the most since the H1N1 pandemic in 2009-2010, thanks to declining vaccination rates. That’s not all, however. The number of whooping cough cases is also skyrocketing, with 8,400 cases already reported thus far, which is double what was reported this time last year, which was double what was reported in 2023 at this time. (In my own state of Michigan, cases have surged by nearly 1,800%.
As I like to say, measles tends to be the canary in the coal mine when it comes to declining vaccine uptake, if only because it’s the most contagious. It almost always comes back first, because the highest level of population immunity (a.k.a. herd immunity) is required to keep it in check. Then, as vaccination rates continue to fall, next up we would expect to see the return of pertussis, which is also very contagious and for which the vaccine is not as effective. Then we have influenza, for which not enough children were vaccinated even before the pandemic resulted in the turbocharging of antivax misinformation and conspiracy theories. it was also just last week that I discussed a modeling study that shows the catastrophic possibilities if vaccination rates continue to fall, with measles becoming endemic and even polio returning. Even if RFK Jr. were removed and replaced with a pro-vaccine HHS Secretary today, sadly, I fear that a huge resurgence of vaccine-preventable diseases is inevitable, given how much time it will take to reverse the mistrust fueled by the pandemic and the devastation that RFK Jr. has already in less than three months inflicted on the CDC and FDA.
But wait, I hear RFK Jr. apologists saying, what about the new $500 million next-generation universal vaccine platform announced last week? Let’s just say that it’s a lot less than it seems:
That HHS and NIH are going to continue to invest in efforts to make vaccines that could reduce the impact of future pandemics was good news, many thought. But why spend so much money on using whole killed viruses — an approach pioneered in the last century — as the basis of the vaccines?
“I was confused by the messaging, because it is a 70-year-old technology,” said one scientist who works in vaccine development, noting this was the method used by Jonas Salk to create the world’s first polio vaccine in the early 1950s.
Another scientist familiar with the scope of research that is being done to try to develop a so-called universal flu vaccine to protect against a range of dangerous strains — like H5N1 bird flu — was blunt. “There is incredible work going on. This is not it.”
Of course, our new NIH Director Dr. Jay Bhattacharya portrays using whole-virus vaccines as a “preserve the virus’s structural integrity while eliminating infectivity,” even though whole virus vaccines were how flu vaccines were made for decades before newer technologies arose, and the influenza virus still managed to evolve quite handily to avoid preexisting immunity. Truly, everything old is new again, as is the likely grift, given that this project is totally in-house and therefore bypasses traditional peer review, likely to funnel money to favored researchers. Color me unimpressed; in reality this initiative strikes me as a way of deflecting from the rejection of the mRNA platform that produced COVID-19 viruses.
A couple of months ago, I wrote a post speculating on what RFK Jr. might do to undermine the US vaccination system at the federal level, and, make no mistake, that is what he is about, his lies that he is “not antivaccine” and only wants to improve trust and make vaccines safer notwithstanding. Disturbingly, he’s actually doing more than I had predicted. Although I foresaw, for instance, his changing CDC—and HHS—messaging on vaccines, meddling with the Advisory Committee on Immunization Practices, promoting research aligned with antivaxxers, and the like, I should have foreseen this shift to requiring placebo-controlled trials for basically everything.
I fear that this move is a prelude that lays the groundwork for RFK Jr. to start delicensing vaccines. He’ll start first by refusing to approve any new COVID-19 vaccines without large placebo-controlled RCTs, and then likely move on to doing the same for flu vaccines, probably not this year but next year or the year after. In the meantime, he’ll look at vaccines on the childhood schedule for ways he can justify delicensing them—or at least taking them off the CDC’s recommended vaccine schedule so that insurance is no longer required to pay for them—and requiring new, large RCTs to license them again, likely starting with HPV vaccines and the birth dose of hepatitis B vaccine. He’ll weaponize VAERS and, if he can get his hands on it, VSD, in order to create apparent adverse reactions attributable to specific vaccines, in particular autism, in order to justify delicensing them and requiring new, long term RCTs to relicense them. In the meantime, vaccine-preventable diseases will come roaring back, as they always do whenever vaccination rates fall. Children will die, as well adults. I hope I’m wrong, but I really do fear that this is what RFK Jr.’s “make America healthy again” will mean in practice.
