The End of Science at the FDA

A single study reveals the incompetence (at best) of its incoming leadership

Donald Trump is master of the dancing monkey that distracts us all while our pockets are being picked. In a normal world, the installation of an incompetent team at the helm of the agencies responsible America’s health would be front page news, but we hit escape velocity from planet normal when RFK Jr became head of HHS. Only an anti-science lunatic could make Jay Bhattacharya, the economist who pushed the bizarre notion that we manage a novel infection by letting almost everyone get the disease seem like a reasonable choice to lead NIH. Bhattacharya, in turn, made Marty Makary, a gastrointestinal surgeon and new director of the FDA into a veritable Jonas Salk. But Trump’s magic distraction machine made the appointments of Bhattacharya and Makary invisible. But Makary’s appointment and his immediate selection of COVID minimizer, Tracy Hoeg as his assistant, reveals the depth of the rot being introduced to key scientific agencies. The tale of a single paper, co-authored by Makary and Hoeg, purporting to evaluate the evidence on vaccine safety, exactly the kind of research assessment they would be charged with at FDA, should, by itself, disqualify them from ever working at the agency.

Defining the Anti-vaccine Narrative

This story begins in August of 2022, when a medical anthropologist and a team of six co-authors published an essayarguing that mandating vaccination “adversely affects health and wellbeing”. They make this assertion with no specific evidence, instead calling for “social and behavioral scientists, bioethicists, epidemiologists, legal scholars, and others to assess the benefits and harms of COVID-19 vaccination policies.” The unusual fact that the authors declared the results of an epidemiological risk benefit assessment before doing it raises questions about their objectivity as researchers. Their suggestion that bioethicists and legal scholars should be on the team to do that epidemiology seems stranger still. Either way, within four months, the anthropologist and three of his colleagues had assembled the team to do the job. Among them, were Tracy Hoeg and Marty Makary. Joining them were an oncologist and “a boutique science communications consultant”. Not one of them had any experience studying vaccines prior to COVID.

In short order, this team conducted a Risk Benefit Assessment (RBA) of vaccine mandates for young men, which produced exactly the results the authors of the opinion piece had anticipated, asserting that they “cause a net harm”. As documented in detail elsewhere, the study is so biased and riddled with flaws that it would be laughable, had it not played such a pivotal role in the demonization of the vaccine.

Torturing the Data Until It Confesses

The study has at least a dozen major flaws, all tending to either overemphasize the risks of the vaccines or understate their benefits. Given that Makary and Hoeg will be at an organization with the evaluation of clinical trials central to its core mission, consider how they managed data from just one of the trials of the COVID vaccine.

Results of a randomized clinical trial of the Pfizer vaccine cited by Hoeg and Makary.

The trial of the Pfizer vaccine found that there were 50% more serious adverse events among the group receiving the placebo. Hoeg, Makary, and their team, did not merely misinterpret the data from the trial. They ignored it.

Well, almost. Out of 10, 075 subjects, the ignored 10,072. The surgically removed three cases that the research team had speculated to be potentially vaccine related and pretended they were the only thing that had happened. Rather than correctly indicating that the increase in serious adverse events associated with the booster was zero, they built a menacing red monolith out of those three cases, a number, in this context, not statistically different from zero.

A graph from the Makary and Hoeg vaccine risk benefit assessment, which ignores the results of a clinical trial and inaccurately assesses the reductions in hospitalization associated with the COVID booster.

The next graph compares COVID hospitalizations prevented by the vaccine to milder reactions to the vaccine, known as reactogenicity. Not only do they again ignore the placebo group, but they make a totally inappropriate comparison or reactogenicity to hospitalization. The definition of reactogenicity, which is included in the paper, is “local/systemic adverse events that prevent daily routine activity or require use of a pain reliever (grade 3) or require an emergency room visit or hospitalisation (grade 4)”. How many hospitalizations were there in the group that received the vaccine? A look at the raw data reveals the answer. Zero. None.

A Figure from the Hoeg and Makary study showing their inaccurate and inappropriate comparison of hospitalizations to vaccination reactions sufficient to require a pain reliever

So, despite the fact that these were explicitly NOT hospitalizations, Makary and Hoeg created a graph that effectively equates discomfort requiring an aspirin with hospitalization. But it gets worse. They not only compared apples to oranges, but they also miscounted the fruit. In the six months before they submitted their paper, COVID put young men in the hospital at a rate of 1498 per million. Studies showed that the COVID booster reduced hospitalizations by 91% suggesting prevention hospitalizations at a rate of 1359 per million. Makary and Hoeg had invoked a bizarre collection of assumptions to reduce that number to 55.

The more apt comparison for “local/systemic adverse events that prevent daily routine activity or require use of a pain reliever” would be cases of symptomatic COVID prevented by the vaccine, which other clinical trials suggest would have numbered in the tens of thousands. Correctly presented the risks and benefits of COVID boosters looks more like this. Note that I have added a graph for deaths, which the booster does not cause and which the vaccine definitely reduces.

A RBA assessment of the booster vaccine that includes benefits ignored by Hoeg and Makary (symptomatic COVID and COVID deaths), makes appropriate comparisons and corrects errors in their calculations.

I could go on, but this should be enough. Hoeg, because she was one of the very few people with a PhD in epidemiology who was willing to endorse the perspective of the COVID denialists, was the person they trotted out again and again to lend legitimacy to these sorts of studies, ignoring the fact that her only, very limited, research experience was in the obscure field of ophthalmological epidemiology. Unfortunately, what she proved over and over is that credentials do not guarantee credibility.

Were Hoeg and Makary simply returning to their chosen, pre-COVID fields of rehabilitative medicine and gastrointestinal surgery, we could let this go as just dirty water under the bridge. But they will now oversee the nation’s assessment of exactly the kind of data considered in this study. This is not a simple honest disagreement over how data should be interpreted. This is the flagrant, repeated torture of data until it confessed. Think of it as conclusion-first science.

Their disdain for subject matter experts is palpable. Their risk-benefit assessment cites but ignores the results of a CDC study that had looked at the same data and concluded that the booster was preventing 114 hospitalizations for every seven hospitalizations it caused in the same demographic group. They completely ignore a far more comprehensive RBA by leading British epidemiologists, data scientists, and virologists, which also found vaccine benefits dramatically exceeded risks in adolescents. Instead, they drop the assertion that the booster “may result in a net harm to healthy young adults” and amplify it in the unmonitored halls of social media, where it echoes to this day.

Results from two Risk Benefit Assessments ignored by Hoeg and Makary

Alternative Science Fits the Regime of Alternative Facts

Makary nor Hoeg appear to come by their lack of competence in vaccine research naturally. A search of PubMed finds that Hoeg has never collaborated on a clinical trial of any kind and Makary has participated in a single vaccine trial (on which he was the 38^th of 48 authors). But it seems that, in this administration, incompetence and lack of experience is a feature, not a bug. Their willingness, if not eagerness, to subvert scientific objectivity and rigor in the name of a presumed truth is perfectly suited to serving under an HHS Secretary with no understanding of science and a dangerous anti-vaccine agenda and a President wildly untethered from objective reality.

Even the Congress struggled with this nomination. Before Trump, there were 8 FDA directors who required confirmation. Only two went to a roll call vote, the closest of which was a 72-18 landslide. Trump’s naked politicization of science has changed all that. Makary squeaked by with a 56-44 vote, better than Bhattacharya at 53-47, but not inspiring.

But Makary does hold the most coveted of qualifications in this administration, one he shares with 20 other Trump appointees. Duly employed as a Fox News contributor, Makary is a certified expert in alternative facts. It is notable and deeply worrisome to note that, since RFK Jr. took over HHS, key references relevant to this study, which were cited in their study and which were used in this analysis have disappeared from the CDC website. The truth is being crushed before our eyes.

There is only one problem. In the world of medical science, alternative facts kill.