‘Insufficient Evidence’: How Modern Medicine is Controlled

tattoo

I have only one tattoo, which I got in 2023, two words on my left arm in big block letters (see above).

It started as a joke. After enough years of newspapers, critics, and colleagues reminding me that the treatments I used and advocated for (and against) in Covid had “insufficient evidence,” I kept joking I should get it tattooed on my arm as I figured I could save everyone the bother of attacking me. Acknowledge the objection in advance. Perhaps then we could get on with discussing what happened to the patients.

That was the thinking, anyway.

Then one day, on vacation in Puerto Rico with my three daughters and ex-wife, my doppelganger (our middle child) snuck off with her older sister and came back to the beach with her first tattoo (and now, unfortunately, many more). It was the word “Angel” in cursive on the back of her arm, the word I use whenever I address my daughters, so she used that to defend her decision, as some sort of “ode” to me. “Aren’t you happy?” she asked. After her mother and I got over our shock, I went over to her and whispered, “Evie, you got a tattoo guy? Take me to him.” Off we went.

But you don’t permanently mark your body over a joke alone. During Covid, the question of sufficient versus insufficient evidence became central to my career, my bedside decisions, and eventually my understanding of what it means to be a doctor. It became almost existential. What was I allowed to conclude from what I saw? What evidence justified acting? What justified waiting—and who bore the consequences while we waited?

I had spent decades making those decisions in intensive care, where uncertainty came with every admission and doing nothing was a decision with consequences of its own. You used the available research, your knowledge of physiology, your experience, and the response of the patient in front of you. You kept questioning yourself. You changed course when you needed to. You rarely had the luxury of certainty.

evidence

Yet “insufficient evidence” was increasingly presented as if it settled the question.

Insufficient for what? To establish a mechanism? To recommend a treatment to every patient? To justify offering it to one desperately ill person? Those are different decisions. They require different judgments.

And sufficient according to whom?

That latter one is the question behind the tattoo. It is also the question behind this post: who gets to decide when the evidence is enough for a doctor to act?

Experts will reject the Evidence Act chapters which appear in my new books “The Silent Aquifer: Humanity’s Accelerating Food and Water Crisis” and Earth’s Living Water: Its History, Its Ruin, and the Way Back, where I present evidence showing dramatic improvements when Themarox (e.g., Aurmina, Primora-Bio) treated water is used across all of biology – soil, microbes, plants, fish, rats, and humans, repeated demonstrations in the yield, growth, and vitality. They will reject the evidence I present almost as soon as they begin reading it, not after weighing it, but the moment they recognize what kind of evidence it is.

The words will be familiar: small, uncontrolled, observational, old, translated, anecdotal, hypothesis-generating only. They sound scientific, and sometimes they are. They can also do the opposite of science when a descriptor meant for a single flawed study is turned against dozens of converging studies at once, before anyone asks whether a plausible mechanism could explain why they line up.

I say this after twenty years inside academic medicine. I analyzed myriad published clinical trials, taught guidelines, sat on committees, and helped decide whether to adopt therapies at the bedside. I also spent those years as a clinician, which meant I learned medicine in a way the modern evidence hierarchy no longer values.

Although I was a clinical leader within one of the largest academic medical centers in the country, I was never one of the highly recruited “physician-scientists,” or what my clinician colleagues and I derisively called “lab rats.” You know, the kind who spend most of their time writing major research grants, running basic science labs, and publishing in journals that bring institutions money and prestige. I belonged to a different class: the clinician-educators. We cared for patients, worked closely with nurses, taught students, residents, and fellows, held units together, communicated with families, and helped them endure the worst hours of their lives while keeping the ICU running day and night. The ICU-trained lab rats would (try to) do the same, but for far, far fewer weeks a year.

That primary clinical role built a different kind of expertise. Clinicians who live at the bedside see far more patients than most physician-scientists do. Volume builds pattern recognition, and pattern recognition is one of, if not the, defining qualities of an expert. For my first five years out of training, I worked in a really busy hospital in lower Manhattan; I saw an unusual amount of volume. The department I initially joined was chronically short-staffed (every time we hired someone, we lost someone else), and for long stretches my partner Sam Acquah (now ICU Director at Mount Sinai) and I held the service together, each of us carrying far, far more than a full clinical load.

The sheer number of patients, diseases, and complications that passed through our hands in those years set us apart, even from other hard-working physicians in what is considered one of the hardest-worked specialties; it compressed a career’s worth of cases into a handful of years. As an ICU and pulmonary physician, I regularly encountered respiratory failure, shock, infection, and multi-organ collapse in every form and at every stage, where I learned from timing, physiology, response patterns, and consequences.

Over the past few decades, the academic hierarchy (specifically, the conceptual framework called “Evidence-Based Medicine”) has come to dismiss that kind of knowledge as “anecdotal evidence.” I still remember the first time the word was aimed at me. I gave a lecture on the lifesaving benefits of intravenous vitamin C in septic shock that I had observed, and a physician (err, lab rat) dismissed it as “anecdotal.” I recoiled. How could something I had watched happen again and again, where the impact of what I did, or failed to do, was clearly written into whether a patient recovered or died, be waved away as an anecdote? I had seen it with my own eyes, more times than I could count. It was my lived experience, and I knew it to be true.

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And yet here that knowledge was, filed under a word that means a story told once and never validated. I have chafed at the term ever since. An anecdote is a single tale; what I was describing was a pattern: the same cause and the same consequence, observed over and over until the link between them was as firm as anything a trial could hand me. I would learn, much later, that roughly half of all recommendations in clinical practice guidelines rest on nothing sturdier than the opinion of the people writing them.1 2

Expert opinion was permitted to establish medical truth after all. It just had to be those of the right kind of experts (e.g., the bought-and-paid-for ones). In critical care, relying on my expert opinion meant the difference between acting while the patient could still be saved and waiting for evidence that might never arrive (or worse, before those “opinions” told me I was wrong).

The gate that “Evidence-Based Medicine” (EBM) would later become could not have been built on open ground. It had to be cleared first. The 1910 Flexner Report, funded by the Carnegie Foundation and supported by the Rockefeller Institute, standardized American medical education on a single model. Within two decades, roughly half of US medical schools had closed.3 When hundreds of competing schools existed, no single set of institutions could define what a doctor learned; once the field narrowed, influencing a small number of institutions was sufficient.4

EBM is a younger idea than it feels. The phrase was coined in 1991 by Gordon Guyatt and colleagues at McMaster University in Canada, and set out the following year in a landmark paper that proposed a new way to teach and practice: that clinical decisions rest, wherever possible, on the best available research evidence, meaning on systematic, published study, rather than on tradition, authority, or a physician’s unexamined experience. It was, at bottom, a demand that medicine show its work.5

It began as a necessary corrective. Medicine needed discipline, and physicians needed humility. We needed protection from our tendency to remember a treatment’s successes more vividly than its failures, and, most of all, from the delayed harms we are poor at identifying. But the need went further than protection. We needed a disciplined way to compare two treatments and determine which was genuinely better. We also needed a way to detect benefits too small, too subtle, or too slow to show themselves at the bedside: effects that unfold over years, across a distance between cause and consequence too wide for any one clinician to trace by eye.

read the rest at pierrekorymedicalmusings.com

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