Why Vinay Prasad Is Exactly What CBER - And America - Needs Right Now
The media doesn’t want you to know, but the FDA just did something amazing.
On May 6, FDA Commissioner Dr. Marty Makary named Dr. Vinay Prasad to head the Center for Biologics Evaluation and Research (CBER)- the division that oversees vaccines, gene therapies, and other biological products.
And the pharmaceutical industry is terrified.
Insider knowledge? Nope. Just look at what happened to biotech stocks when the news broke. They tanked.
The smart money knows what's coming - actual scientific standards.
For those who don't know, CBER is arguably the FDA's most powerful division. It controls the approval process for vaccines, gene therapies, blood products, and other biologics - treatments that can cost upwards of millions per dose. Products that are too often approved based on the flimsiest of evidence. Products that have made pharmaceutical executives unfathomably rich even for products that leave patients wondering if the treatments they're getting actually work.
Prasad, a UCSF professor, hematologist-oncologist, and author of over 500 academic papers and several books- has spent years exposing how the FDA and Big Pharma game this system.
How surrogate endpoints replace actual patient outcomes.
How accelerated approvals never lead to confirmatory trials.
How conflicts of interest infect every level of the process.
Of course, the media coverage of his appointment has been exactly what you'd expect.
They've called him "controversial." A "critic." A "contrarian." Proudly - he is, but what they really mean is that he's not in Pfizer's pocket.
And a brave “contrarian” is exactly who we need right now.
CBER has operated for too long as essentially a rubber stamp for the pharmaceutical industry. Remember how Peter Marks, the previous CBER director, pushed COVID boosters for five-year-olds despite zero evidence they needed them?
Prasad had the courage to question the establishment- to ask for evidence in an era when merely asking questions got you labeled a "denier" or "anti-science."
The irony couldn't be richer: the people screaming loudest about "following the science" were the ones most desperate to shut down scientific inquiry.
We all know that hundreds of billions of dollars flowed to pharmaceutical companies during the pandemic. What remains less clear to a subset of the population is that anyone who questioned whether these products should be pushed with the same urgency on children with natural immunity and 80 year olds with diabetes and no immunity at all or even whether they worked as advertised- was threatening the greatest cash grab in pharmaceutical history.
They had to be ‘canceled,’ discredited or at least minimized. But of course, truth is hard to hide forever.
I've followed Prasad's work for years. His 2015 book "Ending Medical Reversal" should be required reading for anyone who wants to understand how much of modern medicine is built on sand. His 2020 book "Malignant" exposed how cancer treatments that cost hundreds of thousands of dollars often extend life by mere weeks - if at all.
But Prasad's greatest contribution has been his fearless analysis during COVID.
While most of academic medicine abandoned scientific principles to embrace whatever narrative was politically expedient, Prasad consistently demanded evidence.
When data showed that healthy children faced minimal risk from COVID but real risks from vaccines, he said so - even as his colleagues tried to silence him.
I agree that Prasad IS a renegade of today’s medical establishment. Why? Because he follows data, not dogma.
When he's wrong, he says so and adjusts his position.
When new evidence emerges, he incorporates it. This shouldn't be revolutionary - it's literally the scientific method - but in today's captured regulatory environment, it's practically heresy.
As CBER director, Prasad will be responsible for evaluating the next generation of biological products - treatments that will cost millions per dose and that are being tested on increasingly small populations with surrogate endpoints.
The pharmaceutical industry is pushing for even faster approvals with even less evidence. They want to use computer models instead of clinical trials. They want to use biomarkers instead of patient outcomes.
Prasad understands these games. He's spent years documenting them, exposing them, and fighting against them. Which is exactly why his appointment terrifies the industry and thrills anyone (myself included) who believes FDA approval should actually mean something.
To anyone paying attention, it’s clear that the FDA has largely failed at its core mission.
It was created to protect the public from unsafe and ineffective medications. Yet it now operates as a ‘partner in crime’ to the exactly industry it's supposed to regulate.
Advisory committees have historically been stacked with consultants who receive pharmaceutical money.
Accelerated approvals are granted based on optimistic predictions rather than evidence.
Safety signals are downplayed or ignored entirely.
Prasad isn't perfect.
During COVID, he got some things wrong - we all did.
But he had the courage to follow the evidence where it led, even when doing so made him a target. That's precisely the quality we need in someone overseeing the approval of products that will be injected into millions of Americans and have the potential to bankrupt our society.
The pharmaceutical industry will fight him at every turn. They'll leak negative stories to their media allies. They'll pressure politicians who receive their campaign contributions. They'll do everything they can to preserve the system that has made them rich beyond imagination.
But for now, at least, we have a chance - a chance to restore scientific integrity to one of our most important regulatory bodies.
A chance to ensure that "FDA approved" actually means something again.
And that's the truth about Vinay Prasad.
Until next time,
Tiffany
*not medical advice/ all opinions mine
Yesssss!
There’s a serious danger in trading one form of corruption for another under the guise of “truth-telling.” Vinay Prasad’s appeal to many lies not just in his critique of institutional failures—some of which, like the revolving door between FDA and industry, are legitimate concerns—but in the way his platform is increasingly propped up by figures like RFK Jr., who fundamentally reject the scientific method.
We should not lose sight of the fact that there's a difference between criticizing science and misunderstanding it. Too often now, we see dangerous conflations and fallacies pushed into the mainstream: treating genetic disorders as synonymous with hereditary ones, equating correlation with causation, or engaging in circular reasoning masked as contrarian insight. These are not hallmarks of scientific skepticism—they’re signs of scientific illiteracy.
The answer to systemic problems like industry influence isn’t to replace evidence-based review with populist pseudoscience. What we need is structural reform: a Division of Scientific Review, for instance—an independent body that can critically appraise studies, examine conflicts of interest, and provide transparent guidance. A checks-and-balances model rooted in methodological rigor, not personalities.
Medical advancements like CAR T therapy didn’t emerge from a vacuum; they were products of the very system now being vilified wholesale. Yes, that system needs fixing. But discrediting it entirely in favor of influencers who can’t distinguish between causation and coincidence is not reform—it’s regression.
In a country where only about 20% of the population is scientifically literate, this kind of substitution is more dangerous than people realize. RFK Jr. doesn’t just tap into public discontent—he exploits it, offering the illusion of truth without any of the accountability that real science demands.
Let’s stop romanticizing lone voices and start building robust, depersonalized institutions of scientific integrity.