So the saga aka circus in health care in Washington continues. This week Marty Makary MD, the Commissioner of the FDA, resigned/was fired by RFK,Jr. and the Trump administration. I didn’t know Dr. Makary but I have colleagues who do. We once presented at the same conference and were in a room together, but I don’t have much of a sense of him as a person. He is a cancer surgeon who worked at Johns Hopkins and who thought, talked and wrote about medical error and how medicine gets off on the wrong track. He was a critic of Covid lockdowns and the US Covid response and was a reasonable but somewhat odd choice to run FDA.
FDA has always been a fairly staid organization, with more ties to pharma and the medical device industry than I’d like. FDA focuses on the safety of drugs, vaccines, and medical devices and does that reasonably well, with some rigor and consistency, though their careful science stops too soon, in my view, in safety evaluations – it requires new drugs to be tested on five thousand people, which tells us about dangers that occur once in five thousand people, but that doesn’t tell us enough about rarer but sometimes equally dangerous risks. That said, FDA is a very bureaucratic place, stodgy, and trapped between safety advocates, who want more careful testing, and industry, that want to hurry to get new drugs on the market. The FDA is the Federal Reserve of health care, balancing conflicting priorities.
Makary’s FDA got involved in more controversy than we usually see at FDA, with lots of push and pull around safety science and its quality, which is a good thing, and lots of complaints from industry and the Wall Street Journal, which likes industry, as Makary et. al. tried to thread a difficult needle.
The challenge in public health is always around communication, consensus and consistency – around how to be clear about the science and its quality, build scientific consensus, and give the public and industry a consistent set of rules that are fair and well-articulated. FDA’s job is protecting the public’s health, which always must come first. But Makary’s FDA was a bit all over the place, and didn’t deliver on trust, because it wasn’t great at clear and consistent public communication. But he and the FDA did try to lean into the science, which was a good thing. They just weren’t great about building consensus, being clear and consistent when they talked about what they were doing and why they were doing it.
That said, it wasn’t science or even communication that brought Makary down. It was politics, and vaping. Vaping! FDA, which has tried slowly but consistently over the years to exert authority over tobacco, which is a very dangerous drug, and vaping, a habit that has its own risks, were accused by vapers and industry about going slow on approving flavored vapes, which many of the President’s supporters apparently like. But earth to Washington: it was the FDAs job to go slow and probably not to approve flavored vapes, which are thought to provide a pathway to more people vaping, lung injury, and perhaps, eventually, smoking. And Makary was doing that job, vis’a’vis vaping. And that’s what he got fired for.
What a world! We now have a world where we hire regulators to protect the public’s health and then fire them when they act to protect that health, just because some people want the freedom to do what they want, even if that puts others at risk. That’s even more crazy than saying bleach and ivermectin were good treatments for Covid-19 — or crystals and moonlight cure cancer.
A brief note on a possible coming health care apocalypse. You may have heard that more and more primary care doctors are doing Direct Primary Care or Concierge Care, which means they either stop taking health insurance and charge a monthly subscription fee — usually $75 to $125 a month (DPC) — or they accept insurance but charge a monthly subscription fee on top of that, often $250 to $1000 a month (Concierge) – and at the same time they reduce the number of people they take care of, often to 200 to 500 people, down from 2000 to 3000 people.
As a patient that means your doctor can spend lots more time with you and will have much more time available – if you can afford the monthly fee. For primary care doctors, having spent 30 years being tortured by insurance companies and government, this is the only way to practice that make sense, other than working for community health centers, which care for the poor and immigrant populations, a noble endeavor and why many of us went to medical school in the first place.
But for the state and the nation, this transition is a disaster. Most of us won’t have access to robust primary care, so most of us will use urgent care and ERs when we are sick, which will drive the cost of health insurance even higher, and make health insurance completely unaffordable. Which is crazy.
(This transition is happening before our eyes and represents a tectonic shift in health care. I’m hearing about it from patients and colleagues every day. If you have a doctor you like who is going DPC and if you can afford it, I’d suggest you participate. Don’t wait. They will fill fast. But more: everyone should be all over folks in government to address this coming disaster today. We need more medical school slots, we need primary care residencies (like one at Newport Hospital, just saying), we need scholarship programs so our kids can afford to go to medical and nursing schools, we need way better payment and a better approach to paying for primary care, we need leadership around health policy and we need it all yesterday. Earth to the Governor and legislature: come in please. Primary care for everyone is the only way to make and keep health care affordable. Car 54, where are you?)
You can find Michael Fine’s commentaries and short stories on
https://michaelfinemd.substack.com/and on http://www.michaelfinemd.com
