It was a classic “gotcha” interview that centered on one main point: The FDA is no longer pushing products on people without their consent and with consultation from the doctor.
The language now is “shared clinical decision-making,” meaning that the patients should make the decision based on the best information they have. We used to call this informed consent.
“The worst thing you can do in public health is to put out an absolute universal recommendation in young, healthy kids,” Makary said.
That’s a good principle, one that could be expanded to the entire routine childhood schedule. Now that the COVID-19 shot has been removed and placed into the category of essentially optional, other shots will likely follow. When I was a kid there were two. It will be a herculean task to pare back the vaccine gold rush that happened after all liability for harm was removed in 1986.
The biggest barrier might be the core problem that Brennan kept raising. She repeatedly demanded a clear and centralized decision that pertained to everyone, likely imposed by enough nudging to become forceful. Her seeming outrage was the claim that people should be in a position to decide on their own.
“It is still unclear what pregnant women now should do,” she said.
The presumption behind shared decision-making and informed consent is the undeniable truth that all individuals have unique health needs. We deal with that reality as civilized people by letting people decide what is best for them. That’s why doctors have generally been granted the liberty and right to practice medicine on their own volition in cooperation with patient needs.
It’s remarkable how we somehow lost touch with this basic idea, to the point that when the head of the FDA makes that point, a mainstream reporter is baffled, confused, and outraged, as if it were some kind of radical statement.
How did we go from the idea of informed consent to one recommendation for all, followed by imposition and mandates? How did we mutate from methodological individualism into a utilitarian calculus that says what’s good for the whole is more important than free will?
All of this might seem good on the surface, but underneath, these trends will be fatal for the species. In nature, the fittest survive and flourish, but with all the new technologies and prosperity, everyone survives longer and thrives, thus disrupting the natural evolutionary process. In other words, his work encouraged the view that the lesser breeds of humanity pose a long-term threat to their betters.
This book spawned a huge flurry of literature and political movements too, one that developed in the midst of rising migration, improved medicine and food, and exploding populations. The book unleashed a kind of moral panic about the problems of freedom itself. What seems to be a good thing might actually pose an existential threat.
Over time, the thesis mutated to the formation of whole professional societies dedicated to a more rational culling of humanity in the form of eugenics. Such literature and organizing thrived as a well-funded movement from the 1880s through the 1930s, with almost no pushback from elite sectors of society.
At the very same time, we started to see advances in what was called “public health.” This term was initially used to refer to cleanliness in the commons of water and air. It prompted a movement to clean up the cities, monitor the water supplies, and otherwise contain the spread of infectious disease.
With that came innovations in vaccine technology, particularly as it pertained to smallpox, a highly stable virus that is deadly and preventable. It became clear that the health of all depended on maximum compliance. This was especially true once the goal of complete eradication seemed to be on the horizon. Here would be a paradigmatic case of how medicine, expertise, and the surrender of individual autonomy would benefit the whole.
The notion that all of humanity consisted of a unitary blob to be managed by scientists gained and secured adherents in intellectual circles, rather unquestioned for decades. The events of World War II and the discovery of Nazi science experiments and eradication attempts of whole classes and races shocked the world. What no one was willing to admit then or now is that the impetus for this draws from a deep well that had been dug for the previous century.
The Nuremberg Code of 1947 is one result that emerged: “The voluntary consent of the human subject is absolutely essential.
“The person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion.”
That’s a sketchy history of an idea, to be sure, with many twists and turns along the way, but the general outlines are correct. And the final principle of informed consent is “absolutely essential” to reversing the dangerous presumptions that drove Darwin to write what he did and for generations of scientific and political leaders to attempt to impose his ideas on humanity.
Even now, informed consent is a fragile principle. We experienced some of the fallout in our own times with the COVID response. The presence of a new virus incited a global response with the persistent theme: “We are all in this together.”
It was a science experiment that culminated in forced medicine on billions of people worldwide, a direct contradiction to the principles of the Nuremberg Code.
My genuine concern is that the generation of journalists who propagandized for years for the pandemic response have been heavily socialized to disparage informed consent and the very notion that health and medicine is and must remain an individualized matter between one person and caregivers of their own choosing. This is the idea that seemed to shock Brennan, but she is hardly alone.
Clawing back the principles of voluntarism and freedom in health is clearly going to be a long process.
