If Pharma Pushes Out Regulators Who Regulate, Then What's the FDA Even There For?

The FDA does not exist to regulate drugs. It exists to approve them. Marty Makary has resigned this afternoon.

Midpandemic, I would come home from a run of nights in the ER, fall asleep on the couch for a few hours, and try to figure out how the hell we got here.

None of us went into medicine to hurt people, but the building I worked in ended up doing exactly that every single day. The hospital was always running out of beds, running out of staff, running out of time and the pretense that any of this was about the patient.

Marty Makary kept me sane.

He was a Johns Hopkins surgeon who had written a tell-all explainer describing the health care racket from the inside. He named the billing fiction. He named the pricing games. He named the patient as the product.

He said all of the naughty things out loud while still wearing his white coat - and he got away with it.

His courage is what drew so many of us to him.

Not his credentials (although they speak for themselves), but his willingness to say what the rest of us were watching from inside our own corners of the system and could not find the words to speak out loud. So when his name came up for FDA Commissioner, of course it brought hope. This time the truth-sayer would be the regulator - and oh what a world that would be. Someone with statistical savvy and ethics would lead. The man who wrote the book on accountability would sit in a seat where he could do something about it.

That was the dream anyway.

This afternoon he resigned.

Here is the simplest way to understand what happened:

The man in charge of regulating drugs got pushed out of his chair for the crime of trying to regulate.

Pharma came at him until he broke because, well… of course they did.

The Wall Street Journal editorial board ran half a dozen pieces hammering his stewardship of the agency. Career staff inside the building leaked against him to anyone who would listen. His friend and colleague, Vinay Prasad, was absolutely slandered in the press and then sent packing for enforcing scientific standards.

Each hit followed a threat to pharma. Each hit showed us who was in charge.

Marty held the line for fourteen months until he just couldn’t anymore.

You will hear other reasons because that’s part of how the game is played. They’ll write that it was his fault because he didn’t crack down hard enough on mifepristone for the social conservatives. Or he didn’t move fast enough to approve flavored vapes (even though flavored vapes don’t reduce harms from cigarette smoking and therefore are not allowed to be sold by law). You’ll read how MAHA wanted COVID shots pulled, and he didn’t pull them.

Was all of that Marty or was it the White House? We can’t know.

The cross-pressure is the camouflage, but the pharma pressure is the punch.

Within all of this noise is a signal worth paying attention to.

If doing the job gets you fired from the job, the job was never the job. The FDA does not exist to regulate drugs. It apparently exists to approve them.

And if that sounds familiar, you aren’t imagining it. Maybe you just read Jeffrey Tucker’s latest piece.

The agency was born captured.

Brownstone Institute’s Jeffrey Tucker (in addition to being wildly funny and undeniably the best-dressed man I’ve ever met) has a gift for spelling out truth. His article What If the FDA Were Eliminated outlines the origins and incentive structure nicely.

Five years ago it would have been intellectual porn - the kind of free-market thought experiment you turn over in a bar off the cobblestone streets of Cambridge for fun, but after living through the last fourteen months, it reads like a proposal that deserves a serious hearing.

Tucker’s argument is straightforward.

The FDA was not built to protect you from the drug companies. It was built at the urging of the drug companies to increase public trust so the public would take more drugs.

Tucker explains how its lineage runs through two acts of Congress, both lobbied for by the industries supposedly being regulated. In 1902, after contaminated vaccines killed children in St. Louis and Camden, the manufacturers themselves pushed for federal oversight to rebuild public trust and crowd out smaller competitors. The push was led by Parke-Davis, which Warner-Lambert acquired in 1970 and Pfizer absorbed in 2000.

Four years after Parke-Davis got its way, the meatpackers Upton Sinclair had just exposed in The Jungle took the same cue and lobbied for the Pure Food and Drug Act. Those two laws became the foundation of what we now call the FDA.

So the agency was indeed not “captured” by industry in recent times the way most Americans assume. It was actually born captured. Created to allow drug companies to succeed in furthering their push to sell more drugs. And every reformer who walks through the door is fighting the agency’s reason for existing.

Given that history, should it surprise anyone that the corruption outlives the people attempting to enforce standards?

The pattern didn’t end with the meatpackers. It continued.

In 1986, the vaccine industry won its liability shield by telling Congress it would otherwise face complete bankruptcy. The industry said, on the record, that due to the safety profile of vaccines which are given to healthy patients (and not as a treatment for disease) its products could not survive a normal market with normal liability. So they asked Congress to build a special market with special rules. As Tucker observes, under ordinary liability standards the cost of insuring these manufacturers would have made the whole enterprise unaffordable. The shield is still in place forty years later eliminating the pressure to improve or withdraw problematic formulas.

Born captured in 1902. A huge chunk indemnified in 1986.

Here’s how I see it: If Vinay Prasad and Marty Makary cannot lead reform of the agency, no one can.

They had the credentials. They had public backing. They had the Secretary. They had the entire health freedom movement in their corner. It wasn’t enough. The industry beat them.

Leading FDA was never the prize.

The media thinks they took something from us this afternoon. They didn’t.

They took a man out of a seat that was more of a leash than an opportunity.

The medical freedom movement that has been building around the agency for decades didn’t lose anything when he walked out the door.

What it did was confirm, in clearer terms than ever before, where the real fight actually is.

The fight is where you live.

You stopped trusting the morning news a long time ago. You started reading independent voices directly. You found a primary care doctor who does not take insurance, or you thought about it. You joined CrowdHealth or a healthshare, or you looked into one. You started buying meat from a farmer whose name you know. You talked to your kids about asking more questions. You read books and Substacks the algorithm did not put in front of you. You found me.

Every one of those choices is the movement.

Every one of them is happening outside of the FDA. Outside of Capitol Hill. Outside of the White House or any other government building.

What would it look like to have an FDA that was free to put the interests of the public over industry?

We don’t know. And we may never know.

The silver lining of the COVID response was that it was so illiterate, awful, and dumb that a lot of people woke up. The same thing is happening today.

It is so absurd that regulators would be pushed out for upholding the standards of science that more of us than ever are going to start asking the obvious questions:

Why do we even care about the FDA as it is? What would we even lose if this captured agency ceased to exist?

My answer is, I don’t really. And not much. And that is the part that should give you a little hope today instead of grief.

The parallel world we have been building has grown faster every single year the captured machinery has tried to crush it. They made Bobby Kennedy Jr. a household name by trying to silence him. They made Vinay Prasad a legend by smearing him. Every hit piece they ran against Marty this month is going to read, six months from now, like more proof of how screwed up things already are- emboldening us to choose differently.

The media and the pharma shills haven’t figured that out yet, but it’s real.

Here is what MAHA should do immediately: stop measuring wins by whose butt is in which seat. Vinay and Marty just proved that those particular seats are a waste of time. Start measuring wins by how many people are crossing into this alternative world we have been building outside them.

Let’s shift our focus to what will work:

State-level medical freedom laws that survive any administration in Washington. Direct-pay doctors and surgical centers who don’t answer to insurance companies. Cash-pay independent pharmacies. Real food sourced from people you can call by name. Real journalism funded by readers instead of pharma advertisers. Real science published outside the captured journals.

None of that requires the FDA Commissioner’s office.

All of it requires you.

Marty did the job for as long as a human being could do it from inside that building, and then he walked out so he could keep telling the truth from somewhere bigger. Somewhere they cannot fire him from. Somewhere he is free to speak without asking for permission.

The lesson is not that we failed.

The lesson is that the building was never going to let any of us succeed inside it, and the work was always going to have to be done somewhere else.

The building is not the movement, and no one is coming to save us. We have to save ourselves.