Who Watches the Watchmen?

A few times each year, the FDA convenes advisory committees to weigh difficult scientific questions and make recommendations.

Most Americans couldn't name a single member of one of these committees.

Neither could I.

And that's probably how it's supposed to be.

The entire system depends on a simple assumption. Somewhere, behind the scenes, qualified experts are reading the evidence, arguing with one another, disclosing conflicts of interest, and ultimately giving regulators their best scientific judgment.

Whether the FDA follows that advice is another matter. But the process itself is supposed to inspire confidence. It’s the foundation that public faith in the entire US medical system is built upon.

Every day, millions of Americans swallow pills they don't understand, receive injections they can't independently evaluate, and undergo treatments whose underlying science they'll never read. Medicine only works because we've built institutions that patients are willing to trust.

That trust took a major hit Monday when the FDA announced the members of the committee that will recommend whether restrictions on peptide compounding should be loosened.

I've already written more than enough about experimental peptides. If you've been reading Drugstore Cowboy for a while, you know where I stand. I don't believe compounds like BPC-157 and TB-500 have earned a place in routine medical practice. Not because I'm philosophically opposed to them, but because I still believe drugs should be expected to demonstrate that they are safe and actually work before they become widely available and aggressively marketed.

I promise, however, that this isn't another article about peptides.

It's about the erosion of trust in our healthcare system.

Two days ago, the FDA released the membership of the advisory committee that will meet next month to consider whether several experimental peptides should once again become eligible for compounding. According to reporting from STAT, many of the eight newly appointed members either operate longevity clinics, prescribe peptide therapies, publicly promote peptide use, or work for businesses that could benefit if restrictions are relaxed.

To put it bluntly, a significant majority of the committee members stand to gain an immense financial windfall if the committee meeting goes their way.

Maybe every vote they cast will be based entirely on the evidence.

I hope that's true.

But it’s far more likely that their personal interests override their ability to be impartial.

In this country, medicine doesn't simply require good decisions.

It requires decisions that the public can reasonably believe were made for the right reasons.

That's why judges recuse themselves from cases involving personal interests. It's why jurors are dismissed over potential biases before a trial even begins. It's why publicly traded companies spend enormous effort constructing boards with independent directors.

The point isn't that every conflict of interest inevitably produces corruption.

The point is that public confidence is too valuable to gamble with.

Medicine shouldn't hold itself to a lower standard.

Institutions don't merely have an obligation to be impartial. They also have an obligation to appear impartial.

Imagine Pfizer developed a new drug tomorrow and the FDA assembled an advisory committee to evaluate whether it is safe and effective for the public.

Now imagine that several members of the advisory committee owned clinics built around prescribing that drug. Others had spent years publicly promoting it. A few had businesses that would directly benefit if demand exploded after a favorable recommendation.

The meeting wouldn't even start before people questioned its legitimacy.

And they would be right to.

That principle shouldn't change simply because a constituency of voters is shouting for this to happen or RFK believes peptides are good.

In fact, that's part of what makes this moment so strange.

I wrote about this recently, but for years RFK has argued that conflicts of interest have undermined confidence in American medicine. He has criticized relationships between regulators and industry. He has questioned whether advisory committees are sufficiently independent. One of the central themes of the Make America Healthy Again movement has been that Americans deserve institutions they can trust.

It's a fair aspiration.

Which is exactly why this committee feels so difficult to reconcile.

Even the Associated Press noted the irony. Kennedy has spent years criticizing federal advisory panels for financial conflicts while this newly constituted committee includes multiple physicians and pharmacists who prescribe, market, or sell peptide therapies themselves.

You don't have to believe peptides work.

You don't have to believe they don't.

You don't have to like RFK.

You don't have to dislike him.

The underlying principle should be remarkably easy to agree on.

The people evaluating evidence should be as independent from the outcome as reasonably possible.

If that standard applies when Pfizer seeks approval for a new drug, it should apply when the wellness industry seeks broader access to experimental peptides.

Otherwise we've just replaced one form of special treatment with another.

The deeper problem is that moments like this don't exist in isolation.

Over the past decade Americans have steadily lost confidence in nearly every part of healthcare. Pharmaceutical companies. Insurance companies. PBMs. Hospitals. Physicians. Even the FDA itself. Some of that skepticism has been earned. Some hasn't. But every institution that appears indifferent to conflicts of interest makes it a little harder for patients to separate science from salesmanship.

Eventually every recommendation starts to sound like a sales pitch.

That may be the greatest risk here.

Not that the committee reaches the wrong conclusion about peptides.

The evidence may ultimately support wider access. It may not. That's exactly what advisory committees are supposed to evaluate.

The greater risk is convincing millions of Americans that the answer wasn’t decided before the meeting even began.

Because once people stop trusting the referees, they stop trusting the game itself. 

And medicine is one of the few professions that simply cannot function without that trust.

Giddy up.

Alec Wade Ginsberg, PharmD, RPh
4th-Gen Pharmacist | Owner & COO, C.O. Bigelow
Founder, Drugstore Cowboy