The Truth of the Anecdote

Covid vaccine mandates and the limits of Evidence-Based Medicine

Image by Alexey Kljatov - CC BY 2.0

During peak politicization of covid vaccines in early 2022, former Biden administration covid advisor, Dr. Michael Osterholm, went on the Joe Rogan podcast to shore up the mainstream narrative on the pandemic response. Rogan’s podcasts are long and it’s easy to miss some of the most significant remarks made by his guests. One of Dr. Osterholm’s passing comments during this interview was especially revealing. In response to Rogan’s use of the term, “anecdotal evidence,” Dr. Osterholm stated: “In my world, anecdotal evidence is not really evidence.”

Dr. Osterhom’s statement encapsulates the worldview of Evidence-Based Medicine (EBM). EBM has its origins in academic medical schools and was touted as a “new paradigm” for the study and practice of medicine in the early 1990s. According to the British Medical Journal (BMJ), EBM seeks to replace “Tradition, anecdote, and theoretical reasoning from basic sciences” with “high quality” forms of evidence in order to make clinical practice more “scientific and empirically grounded.”

While RCTs may make medicine more “empirically grounded,” I argue that they cannot provide a moral grounding for medical practice. This becomes abundantly clear when we examine the views of many EBM advocates on covid vaccine mandates. To make sense of those views, we must first understand the essence of the EBM worldview.

EBM and the RCT

The EBM paradigm endows randomized controlled trials (RCTs) with a special status among all forms of evidence. RCTs randomly assign study participants into different groups in order to remove as much bias as possible when evaluating the effects of a new intervention or treatment. As such, RCTs are considered the “gold-standard for studying causal relationships” in medicine due to their tightly-controlled design.

Despite their undeniable power, RCTs are frowned upon in certain cases. Recommendations against cigarette smoking, for example, are based on observational studies rather than RCTs. In this case, the preponderance of observational data on the deleterious health impacts of smoking is considered sufficient to recommend against it even without the support of RCTs.

This kind of ethical limit to the RCT is widely accepted and is one reason why metanalyses of observational studies are also acceptable (if not preferred) forms of evidence in the EBM framework. That said, EBM advocates can still insist on the imperative of RCTs in the majority of situations.

Even if we accept that the RCT has a special status among all forms of evidence, I believe that the EBM paradigm suffers from a deeper ethical problem: the displacement of the human being from the center of medicine’s moral universe. It is this problem that lies at the root of Dr. Osterholm’s dismissal of “anecdotal evidence” and the broader inability of EBM advocates to take a moral stand against covid vaccine mandates.  

The Dark Side of EBM

As we have seen, proponents of EBM argue that only RCTs can distinguish “ambitious thinking” from “real effects” in medicine. This position contains within it an implicit ethical principle for clinical practice: Recommendations to patients are more reliable and, therefore, more moral, when they are based on data from RCTs as compared with “inferior” forms of evidence like anecdotes. In other words, the EBM paradigm implies that RCTs are not only methodologically preferable to other forms of evidence, but that they also lead to an ethically superior form of medicine. 

I agree with this argument up to a point. Recommendations derived from RCTs are clearly an advancement over recommendations based on cherry-picked observational data, and it seems reasonable to suggest that the average patient would be better off following the former rather than the latter. Moreover, EBM advocate Dr.

Vinay Prasad

’s observation that “the majority of medical treatments have a modest to minimal risk reduction in harm” is a basic (yet often overlooked) point which supports the idea that RCTs can play a pivotal role in holding the approval of any new drug or treatment to a very high standard. Indeed, at their best, EBM proponents like Prasad withhold recommendations for novel drugs and other medical interventions (like masks during pandemics) until sufficient RCT data is provided to support their safety and efficacy. This is a praiseworthy approach.

However, during the pandemic, many EBM advocates were silent about or actively supported covid vaccine mandates. Dr.

Paul Offit

, an acclaimed vaccinologist and pediatrician at the Children’s Hospital of Philadelphia, is an excellent example. Dr. Offit stated in a 2022 interview that the Vaccine Adverse Event Reporting System (better known as VAERS) is “a hypothesis generating mechanism at best” due to its anecdotal nature. He quickly followed this statement with the EBM slogan that “scientific studies at all levels” are “the study of control.” In other words, without being subjected to the privileged methodology of the RCT, anecdotes are meaningless.

If he were consistent, Dr. Offit could have suggested the following: The massive increase in VAERS reporting during covid vaccine rollout ought to prompt a proportionately massive investment in RCTs to parse out correlation from causation among the vast array of adverse events associated with the vaccines. However, later in the very same interview, Dr. Offit remarkably relies on the fact that “3.5 billion people have been fully vaccinated” to attest to the safety of the vaccines. All of a sudden, stoic statements about science as “the study of control” and the non-negotiable necessity of RCTs in medicine gives way to truisms about uncontrolled population-level data. When it comes to the investigation of covid vaccine safety, ignorance is bliss for the likes of Dr. Offit.

This blatant lack of consistency in Dr. Offit’s methodology and reasoning itself casts significant doubt on his conclusions. Even more troubling was his 2021 article for CNN, in which Dr. Offit and his co-author argued that “It’s time for state and local governments to issue vaccine mandates” as well as “fines” for the unvaccinated, despite the fact that there was no evidence at the time that the vaccines prevented transmission (they don’t). Even more importantly, there was ample anecdotal evidence that the vaccines would not be safe for everyone subjected to a mandate.

I believe that Dr. Offit’s position illuminates the dark side of EBM: the assumption that a lack of overwhelming RCT evidence against a novel and irreversible medical intervention means that the intervention can and should continue to be recommended or—in the case of covid vaccines—mandated. Only when the myocarditis data began to present did Dr. Offit advise his 20-something son not to get a booster shot. But this was never a principled ethical opposition to the mandates as such, only a post facto adjustment based on retrospective data.

It bears repeating that evidence which challenged the “safe and effective” narrative did exist before Dr. Offit expressed his skepticism about booster mandates. The problem was that this evidence was merely anecdotal and, therefore, inadmissible in the high court of Evidence-Based Medicine. After all, the first case of vaccine-induced myocarditis was, by definition, of the “anecdotal” variety, and the same goes for the multitude of other “serious adverse events of special interest” associated with the covid vaccines.

Remember: The data on vaccine-induced myocarditis was only taken seriously after the vaccine was mandated for thousands of young men. As long as the pharmaceutical companies failed to detect or disguised the safety signals in their rushed RCTs, many EBMers had no problems with the continued mandates, or, in Dr. Offit’s case, actively pushed for them. If these RCTs couldn’t detect vaccine-induced myocarditis—now universally recognized as an undeniable risk from the vaccines—what other “anecdotes” were (dis)missed in these trials and in the real-world vaccine rollout that followed?

As

Robb Wolf

suggests, we should “not ascribe end-stage scientific weight to anecdote, but it’s also ridiculous to dismiss it out of hand.” In a world where the pharmaceutical industry funds and conducts most RCTs, leading authors in the BMJ to call EBM an “illusion,” Wolf’s point is all the more salient. RCTs may provide the illusion of certainty, but the anecdote speaks to a level of truth toward which the RCT cannot even gesture. We ignore that level of truth at our own peril.

RCTs or the Human Being?

Despite EBM’s implicit claim to RCT-derived moral superiority in the practice of medicine, the EBM worldview does not guarantee bioethically sound policy. In fact, the EBM worldview can produce clear moral repugnancies, as in the case of Dr. Offit’s advocacy for sanctions on the unvaccinated.

One possible way out of this predicament is to limit the overwhelming influence of the pharmaceutical industry in the funding and execution of RCTs. Better, less compromised RCTs would certainly go a long way toward improving the practice of EBM. However, EBM suffers from a more intractable ethical quandary that cannot be resolved by improved RCTs alone. Why? Because the very logic of the RCT—by design—removes the human being from the center of the medical moral universe. In other words, EBM substitutes the method of the RCT for the moral weight of the human being.

The RCT method takes as its fundamental unit of understanding not the individual human being in all of her bioindividuality but, instead, the large, impersonal assemblage of data that constitutes the RCT. Without the sui genericity of the anecdote—which necessarily operates at the human level—EBM facilitates an inherently dehumanizing medical enterprise.

“Anecdotes” don’t matter in the EBM framework. Adverse events are dismissed as “rare” rather than acknowledged as real. The human being is sacrificed at the altar of randomized data. When medicine fails to recognize the human being as the proper level at which ethics must operate, these are the kinds of moral repugnancies that naturally follow.

If it’s hard to make this connection, perhaps the following passage (itself an anecdote) written by two American doctors will be clarifying. The doctors recount their experience participating in a mass vaccination campaign in India:

In the middle of gentle Indian night, an intruder burst through the bamboo door of the simple adobe hut. He was a government vaccinator, under orders to break resistance against smallpox vaccination. Lakshmi Singh awoke screaming and scrambled to hide herself. Her husband leaped out of bed, grabbed an axe, and chased the intruder into the courtyard. Outside a squad of doctors and policemen quickly overpowered Mohan Singh. The instant he was pinned to the ground, a second vaccinator jabbed smallpox vaccine into his arm. Mohan Singh, a wiry 40 year-old leader of the Ho tribe, squirmed away from the needle, causing the vaccination site to bleed. The government team held him until they had injected enough vaccine…While the two policeman rebuffed him, the rest of the team overpowered the entire family and vaccinated each in turn. Lakshmi Singh bit deep into one doctor’s hand, but to no avail. 

This was written before EBM was codified, and it would be unfair to retroactively blame this kind of moral monstrosity on EBM advocates. However, just as these doctors could not see what was wrong with this picture in the 1970s, most proponents of EBM failed to see what was wrong with the covid vaccine mandates in the 2020s. The difference between pinning the Ho tribesman down for a smallpox vaccination and barring a Black American child from going to school or eating at a restaurant unless he takes a novel injection is a matter of degree, not kind.

What’s more, there is a direct through-line from the violence enacted against tribal peoples in India to advocacy for covid vaccine mandates. Dr. Larry Brilliant, World Economic Forum member and one of the authors of the passage quoted above, has pushed aggressively for childhood covid vaccination. Dr. Brilliant argued for forced vaccinations not unlike the ones he oversaw in India over 40 years earlier with the World Health Organization, telling Wired in 2021 that “You've got the right to vaccinate a community and to keep the community safe.” And when Dr. Brilliant says “vaccinate a community,” we have all too clear a picture of what that can look like.

The RCT Is a Tool, Not An Ethics

Don’t get me wrong: The RCT is a powerful tool. When kept in its proper place, it can be used to serve rather than replace the human being. But to do this, the internal logic of the RCT must be kept in check by qualitatively different principles in the practice of medicine, principles which insist unequivocally that the human being comes before randomized data sets.

While RCTs provide tremendously useful data—data that can illuminate causal relationships in the sea of correlation—they cannot provide a moral grounding for medicine. If the RCT mentality is left unchecked, it produces an array of moral repugnancies, repugnancies enabled by Dr. Osterholm’s statement that “anecdotal evidence is not really evidence” and demonstrated in practice by Dr. Offit’s flippant dismissal of VAERS reporting and unrepentant efforts to punish the unvaccinated.

By mistaking a tool for an ethics, many proponents of EBM have, at best, failed to speak out against the covid vaccine mandates and, at worst, actively advocated for the mandates. This is not primarily due to individual EBMers’ moral failings; rather, EBM as an ideological project has—whether they realize it or not—ethically compromised the positions of even its most well-intentioned adherents.

When a tool is misconstrued as an ethics, it becomes more than a tool. It takes on a life of its own and begins to devour the lives around it (often in the name of saving them). This is the fate of the RCT in the hands of a myopic EBM hellbent on banishing the truth of the anecdote from its blinkered worldview. Anecdotes are a testament to a level of truth rejected by EBM—truth at the level of the human being. Only a recognition of and reverence for this human-level truth can provide a moral grounding for medicine.