The War on Evidence

Vinay Prasad tried to raise the FDA’s scientific standards. The system showed him how it survives.

Somewhere in America, a mother is sitting at her kitchen table reading a press release from a pharmaceutical company. It says they’ve developed a treatment for her son’s lethal disease.

The language is familiar: unprecedented, transformative, paradigm-shifting. And it’s the first thing that has sounded like hope to her in years.

The company knows something she doesn’t. Their clinical trial data isn’t actually as good as the headline implies. But she won’t know that for a while yet.

How could she?

As she reads, she can feel her body losing control. She clutches her hands in front of her chest and holds her breath. She’s shaking violently as the tears begin to spill over.

The patient advocacy group that emailed her the press release receives funding from the drug company. But she doesn’t know that either.

How could she?

She sobs. Deep heaves that start at her core.

What she knows too well is that her son is getting worse — and this document is the first thing that has made her feel something other than helpless since the diagnosis.

She thanks God over and over. She won’t sleep that night.

Tomorrow she will call her congressman and next month she will sit across from a federal regulator, holding a picture of her boy, while he tries to explain that the data doesn’t actually mean what she’s been told.

The press will photograph the mother’s tears. They will not photograph the data.

The pharmaceutical company will use the photograph of the mother to tell the story.

So will everyone else.

It’s how it works. Not sometimes. Almost every time.

It’s the most reliable communications playbook in American industry, and it has been running for decades, often funded by companies that charge millions for drugs that don’t work - or worse.

If that doesn’t make you sick, please stop reading. This piece isn’t for you.

What Happened to Vinay Prasad

Now let me tell you about someone who tried to stop it. Someone I respect.

Vinay Prasad is a rare thing in American medicine: a credentialed insider. Honest. Brave. He’s tenured, published, and despite his outspoken nature (or perhaps because of it) - taken seriously by the institutions that matter.

He made a choice a long time ago to say out loud what his colleagues whisper at the bar after conferences - that the drugs getting approved are often backed by evidence so thin you could read their press release right through it. That companies have learned to completely game the system by picking the right surrogate marker, designing the trial against a weak comparator, manufacturing excitement for the New York Times, and converting that excitement into approval before anyone answers the harder question: does this actually help the patient?

In many cases, those paying attention know the answer reveals itself (often years too late) to be a definitive, ‘no’.

Prasad spent years saying this (and more) bravely and loudly from the outside. Then, in May 2025, the Trump administration gave him the chance to do something about it. He was appointed Chief Medical and Scientific Officer of the FDA and Director of the Center for Biologics Evaluation and Research (CBER) — the division that oversees vaccines, gene therapies, and blood products.

His job was simple: make sure the drugs the FDA approves actually work.

Not “moved a number that doesn’t matter on a lab report” work. Actually work. Meaning patients live longer. Patients feel better. Patients stop getting worse. He held that line.

The machine came for him. Because every approval decision in that office can be worth billions.

The Playbook

Notably, at least three times in ten months, Prasad made a decision the science supported and the industry couldn’t tolerate. And three times, the same playbook ran.

One company’s gene therapy became embroiled in controversy after deaths were reported among patients who received the treatment — including boys in a population that had not been represented in the original study. When regulators asked the company to pause distribution while the safety questions were reviewed, a political influencer attacked Prasad fiercely from inside the tent within days. The pressure escalated quickly. Prasad resigned briefly and returned to the role roughly two weeks later - but by that time, it was too late - that narrative had already been written.

Another company designed a vaccine trial using a comparator the CDC’s own advisory committee doesn’t recommend for the population being studied. By that point, everyone knew Prasad wanted real science. What showed up instead was the usual. When Prasad rejected the application — and signed the rejection himself, which almost never happens — the company released his letter to reporters. Unsurprisingly every major outlet ran a personality story with the framing that benefited you-know-who. And of course, his actual objection (the actual science) was in paragraph nineteen - if it was mentioned at all.

A third company ran a randomized trial of its millions-of-dollars-per-patient brain injection. The trial design meant it couldn’t show whether the drug actually helped patients. Yet the company’s alternative analysis claimed a 60–75% benefit. Both cannot be true. When the FDA asked for a proper trial the usual suspects showed up portraying Prasad as a literal monster blocking life-saving treatment.

Same playbook. Funded, coordinated, deployed in real time.

And every time, there was a mother at the kitchen table. Reading the press release. Believing the hope. Turning to social media. Being used.

The truth is entirely negotiable.

On February 11th, during the second debacle mentioned above, the Wall Street Journal published a story alleging Prasad was under investigation for — among other things — sexual harassment.

Nineteen days later, the paper issued a correction stating that an HHS spokesman had confirmed that no allegations of sexual harassment had actually been filed against Prasad, and their earlier version of the article had been incorrect.

A blurb added to an article that had been published already for weeks.

It’s worth noting that in modern media cycles, nineteen days is an eternity. Long enough for every outlet that picked it up to bake it into the story. Long enough to become the first page of every Google search for a man with a family and a career.

Long enough to do exactly, what I suppose, it was designed to do.

In those nineteen days, there was no official rebuttal. Not even from Prasad himself. No rapid response. Not one credible, positioned voice went on the record to say: this is false, there are no such reports, here is what this man actually did, and here is perhaps why the people who want him gone might be willing to fabricate allegations to make it happen.

The story spread.

None of This Changes a Harder Truth

A small part of this is on Vinay of course.

I say that because nothing is ever entirely one-sided. I also say it with buckets of respect, and I mean it.

What he attempted to do at the FDA was brave and necessary. And the fact that someone can be so right on the data and still not survive the institutional backlash should terrify all of us.

The person who takes over for him needs to understand something this tragedy revealed: the science is the floor, not the ceiling. The ceiling has always been coalition. And for whatever reason, Vinay struggled to bring enough people along with him to stand behind his excellent work.

A federal agency the size of the FDA will not change its direction just because evidence standards are now being upheld, because it’s never just about being correct — it’s about building alignment across thousands of people who have been operating under different rules for years.

The career staff at the FDA are not all captured by the system- they can’t be. Many of them must have spent years watching weak science get approved and quietly wishing someone would challenge it. Those people should have been powerful allies for Prasad, but for whatever reason they remained silent or turned away.

This issue will continue to threaten progress until it is solved by Commissioner Makary and whoever replaces Prasad. I have confidence it will be righted with time.

What Needs to Exist

The honest people who lead these agencies shouldn’t have to do this alone.

Modern regulatory fights are fought as much in the information ecosystem as they are in advisory committees and briefing documents. It is not a criticism of any individual to say that the communications infrastructure this movement needs does not yet exist.

But the question is, who builds it?

That question is no longer abstract. It has a body count — not only in lives lost, but also in reformers destroyed, in policies reversed, in mothers lied to, and in patients that will be harmed in the future.

So I am speaking directly now to every MAHA-adjacent organization, policy group, PAC, and advocacy operation that raises money on the promise of reforming American health care.

If you want to win — actually win, not just rally the base and cash the checks — the base cannot be the only battlefield. The base is already with you. We believe.

The fight must now be brought to the unfriendly media and to the persuadable middle. The mother at the kitchen table. The reporter on deadline who will write whatever story she’s handed because no one’s given her a better one. The voter who sees “Regulator Blocks Life-saving Drug” in a headline and takes it at face value because no one — not one person — has made the counter-case in language he can understand.

Reaching those people requires a professional, full-scope operation.

• Credible insiders with clinical and policy credentials positioned to speak to mainstream outlets, not just friendly podcasts.

• Rapid response capability that can reframe a false narrative within hours, not weeks.

• Science translated into language a reporter on deadline and a mother at a kitchen table can both follow.

• Message coordination between the people doing the reform work inside government and the people explaining it outside — within every ethical and legal boundary (and there are many), but within those boundaries there is an enormous amount of work that is simply not yet being done.

This is not optional anymore. It’s the whole mission.

This is how the other side has been winning, and until we match it, we will keep watching our people get destroyed in public while the companies that massage the data celebrate.

There’s a structural reason the government may not be in a position to lead this work - even when it wants to. As much as it pains me to admit winning elections requires coalitions, and coalitions require compromises — often with the very industry interests that reform threatens.

Those debts don’t disappear on Inauguration Day. MAHA-aligned outside organizations answer to none of that. Their donors came to this fight specifically to win it. So if the government can’t, or won’t, fund this then it falls to us.

To every person who has seen the truth about how this system works and can’t unsee it. To every organization that claims this calling. If we see the work that needs to be done and we don’t build the infrastructure to protect the people doing it, then we are not a movement. We are simply an audience playing games that make us feel good about ourselves while accepting defeat and calling it ‘activism.’

This has to go both ways of course. The best surrogate operation in the world is useless if the leaders inside government don’t want it. Which means supporting the unglamorous work of crafting the narratives that make reform durable instead of dramatic. Our organizations can help build it. But our leaders will have to support it.

To the Next Vinay Prasad

Vinay Prasad’s science was right. His regulatory instincts were right. The system he challenged had a playbook. He didn’t.

He’s leaving the FDA ten months in, reputation shredded by lies and spin while the drug companies and newspapers that tell the public what to think, continue playing fast and loose with the facts - in all regards.

On Friday, when Prasad’s exit was announced, the biotech ETF rallied on the news. Which tells you everything you need to know about who thinks they won this battle.

And somewhere tonight, a mother is sitting at her kitchen table.

• She’s reading a press release.

• She doesn’t know the trial wasn’t good enough.

• She doesn’t know the advocacy groups are funded by the drug company.

• She doesn’t know that one of the last people trying to protect her son just got run out of Washington.

All she knows is that someone finally gave her hope. And she may find out that it was false hope in the most painful way possible.

She deserves better than this. We all do.

To Vinay Prasad, I’m truly sorry.

To the next Vinay Prasad, we see you. And this time, God willing, we’ll support you better. We’ve learned. And you won’t have to walk in alone.

And if you want to read more, catch up on last week’s article here: