In this chilling episode of Dark History of Clinical Trials, we explore the devastating 2016 Phase 1 clinical trial in Rennes, France, that left one man dead and several others with lasting neurological damage. Designed to test a new painkiller, the study went catastrophically wrong after investigators escalated the dose without properly analyzing earlier data. We uncover what went wrong, the oversight failures, and how it shook public trust in drug development.

This tragedy serves as a sobering reminder of why data review, transparency, and ethical safeguards in early-phase trials are not just protocols—they are matters of life and death.

In Part 3 of our series on government-funded clinical trials, we shift the focus to the upsides of working in publicly funded research. From greater patient diversity and broader public health impact to mission-driven work and long-term study follow-through, we highlight what makes this space both rewarding and unique.

We also explore what kind of professionals thrive in this environment. Is it the detail-oriented? The mission-focused? The ones who care deeply about equity in access to care?

Tune in as we explore why some coordinators and investigators choose this path—and why they stay.

In this continuation of our deep dive into government-funded clinical trials, we explore real-world examples of how these studies operate differently from private pharma-sponsored research. Our guest shares firsthand insights into challenges like proving adverse events without medical records, navigating patient compensation differences, and the disconnect between research benchmarks and real-life feasibility. We also discuss the impact of wealth distribution on patient access and trial participation. What happens when hospitals close patient accounts, but research teams still need documentation? How do these trials ensure continuity of care? Join us as we unpack the complexities of conducting research in a government-funded setting.

Part 1: Regulatory

In this episode, we sit down with a clinical research coordinator from a government-funded hospital to explore the unique challenges and regulatory differences between publicly funded and private pharmaceutical company-sponsored trials. We discuss key topics such as study selection, start-up timelines, and the distinct approval processes that shape the landscape of government-backed research. How do these differences impact trial efficiency, patient access, and innovation? Tune in for an insider’s perspective on the critical nuances of conducting research outside the private sector. Stay tuned for Part 2.

Episode 7: Big Pharma… in a Kitchen?! 🍳💊🚔

What happens when a man decides to skip the lab, the regulations, and basic ethics—and mass-produce fake medication in his own kitchen?

The FDA found out. And let’s just say… he fked around and definitely found out.

In this episode, we unravel the insane true story of a DIY “pharmaceutical empire,” the dangerous fake drugs that hit the market, and how it all ended with a one-way ticket to prison.

🔥 How did he pull this off?
🔥 How many people did this scam affect?
🔥 And how did the FDA finally shut him down?

Tune in to hear how one man thought he could outsmart the system—until the system came knocking. 🚨

Not all medical disasters stem from unethical research—sometimes, even the most promising trials take a devastating turn. In this episode, we examine a clinical trial that had a flawless safety profile in pre-clinical testing but went horribly wrong when tested in humans. What critical mistakes were made? How did the researchers miss the warning signs?

Last time, we uncovered the shocking moment when a doctor running shady clinical trials told the FDA:
“This isn’t your jurisdiction.”

Well… the FDA disagreed.

Now, in Part 2, we’re looking at what happened next. What punishments did he face? Where is he now? And did justice really get served?

What happens when you tell the FDA "Monitoring my clinical trials is not your jurisdiction". The FDA is known for many things, but in the world of clinical trials, we know that if you F*** around, the FDA will find out.

Episode 6 part 1 of Wild FDA audit stories.