FDA Exposed: Hundreds of Drugs Approved Without Proof They Work

By quoth the raven – Zerohedge

Coming into 2025, I was openly skeptical of Big Pharma’s direction, which is why I included a short position on PPH (Invesco Pharmaceutical ETF) in my “25 Stocks to Watch for 2025” list. YTD the ETF is underperforming the SPY by about 3.5%.

My conviction stemmed from the belief that much of the sector’s valuation was built not on true efficacy or transparency, but on regulatory capture, lobbying power, and narratives shaped more by marketing than data.

Over the past few years—especially in the wake of COVID—it became increasingly clear to me that anyone objectively analyzing the FDA and broader public health apparatus would see glaring gaps in oversight, transparency, and scientific rigor.

The pandemic cracked open a window into the inner workings of these institutions, revealing just how intertwined regulatory decisions and corporate interests had become.

That’s why I was vocal years ago in considering a short position on Moderna. Since that date, Moderna is down -85.7% vs. the S&P rising about 63%. I get a lot of shit wrong, but that call was not one of them.

It was easy: the evidence simply didn’t support the long-term safety and efficacy claims made about its mRNA vaccine, particularly as guidance shifted—now explicitly recommending against its use in pregnant women and children.

As the tide turns and empirical data becomes a requirement instead of an afterthought, I believe many next-gen platforms will face the same fate: no longer propped up by lobbying dollars but judged by clinical merit.

With RFK Jr. now at the helm of HHS, I continue to believe this shift is accelerating.

His push for regulatory reform and rejection of industry influence gives me confidence that true innovation—such as developments in psychedelics—will be rewarded. That’s why I still stand by my early 2025 positioning: short PPH, long psychedelics.

The article below reinforces that this trajectory isn’t just wishful thinking, and it’s why I’m happy to share it with you today.

FDA Exposed: Hundreds of Drugs Approved Without Proof They Work

By Maryanne Demasi, Brownstone Institute

The US Food and Drug Administration (FDA) has approved hundreds of drugs without proof that they work—and in some cases, despite evidence that they cause harm.

That’s the finding of a blistering two-year investigation by medical journalists Jeanne Lenzer and Shannon Brownlee, published by The Lever.

Reviewing more than 400 drug approvals between 2013 and 2022, the authors found the agency repeatedly ignored its own scientific standards.

One expert put it bluntly—the FDA’s threshold for evidence “can’t go any lower because it’s already in the dirt.”

A System Built on Weak Evidence

The findings were damning—73% of drugs approved by the FDA during the study period failed to meet all four basic criteria for demonstrating “substantial evidence” of effectiveness.

Those four criteria—presence of a control group, replication in two well-conducted trials, blinding of participants and investigators, and the use of clinical endpoints like symptom relief or extended survival—are supposed to be the bedrock of drug evaluation.

Yet only 28% of drugs met all four criteria—40 drugs met none.

These aren’t obscure technicalities—they are the most basic safeguards to protect patients from ineffective or dangerous treatments.

But under political and industry pressure, the FDA has increasingly abandoned them in favour of speed and so-called “regulatory flexibility.”

Since the early 1990s, the agency has…(READ THIS FULL ARTICLE HERE).