The Tea in STEM

 In this episode of Dark History, we revisit one of the most infamous studies in clinical research — the Tuskegee Syphilis Study. While nearly every researcher has heard of it as the cornerstone example of why IRBs exist, the deeper story is often reduced to a single sentence in textbooks. For forty years, Black men in Tuskegee, Alabama were denied proper treatment for syphilis — even after penicillin was proven curative — under the guise of “free healthcare.” We’ll unpack not just what happened, but why it was allowed to continue, the systemic racism and exploitation it revealed, and how its legacy continues to shape medical mistrust and research ethics today. 

 In this episode, we dive into a chilling case where a promising T-cell therapy showed remarkable results in adolescents and pediatric patients — but when tested in adults, the outcome was tragically different. Phase 1 looked fine, Phase 2 turned deadly. To this day, we still don’t fully understand why. Was it biology? Trial design? Or something deeper about the risks of pushing boundaries in science? Join us as we unpack what went wrong, and what this story teaches us about the fragile line between breakthrough and disaster in clinical research. 

“Good Intentions, Bad Paperwork” Meet the city doc everyone loved — champion of public health, hero of harm reduction, and the driving force behind making Narcan accessible without a prescription. But when his passion for helping people collided with the rigid rules of an HIV clinical trial, things got messy. This episode dives into how one man’s altruism, while admirable, ran head-first into FDA regulations, resulting in a 483B. It’s a cautionary tale of how even the best intentions need a protocol to match. 

In this powerful installment of Dark History of Clinical Trials, we examine one of the most tragic and transformative episodes in pharmaceutical history: the thalidomide disaster.Marketed as a safe sedative and morning sickness treatment in the late 1950s, thalidomide was distributed to thousands—only to cause severe congenital deformities and pregnancy losses across the globe. This catastrophe exposed critical flaws in drug testing, marketing, and approval processes.In this episode, we uncover:The rise and reckless distribution of thalidomideThe real human cost behind corporate and regulatory failuresHow this tragedy reshaped modern drug approval lawsThe birth of the FDA’s MedWatch program and tighter safety controlsWhy we now distinguish between OTC and controlled medicationsUnderstanding this dark chapter is key to appreciating the safeguards we often take for granted today.

In this episode, we dive deep into the recent FDA action that exposed a pharmaceutical manufacturer distributing counterfeit codeine cough syrup. What began as a quiet compliance concern quickly escalated into a full-scale investigation—leading to shutdowns, criminal charges, and regulatory fallout.

When 26-year-old Markinson suffered a psychotic break, he was given a choice no one should ever face: participate in a clinical trial or face long-term involuntary confinement. What followed was a tragic chain of events—his worsening condition, the helpless fight of a mother trying to save her son, and ultimately, a suicide that would spark a national conversation about ethics, consent, and mental illness in clinical research.In this episode, we examine the heartbreaking story of the Markinson case—a chilling example of how regulatory systems meant to protect can fail the most vulnerable. We explore IRB bias, the complexities of informed consent under duress, and the urgent need for advocacy in mental health trials.

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. 

 In this episode, we uncover the shocking and often tragic history of clinical trials gone wrong. These cases exposed the dire need for ethical oversight in medical research. But from these dark moments came progress: the Belmont Report, informed consent, and strict regulations that protect patients today. Join us as we explore how past mistakes shaped the ethical frameworks that safeguard clinical trial participants now. 

Brittney is back with the Tea in STEM to discuss what she wished she knew as a new coordinator. Some common issues or struggles, and some ways to overcome them.

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 5 of Wild FDA audit stories. 

 In this episode of Tea in STEM, we're joined by Nikki Jundt, a seasoned regulatory specialist, to delve into the complexities of Investigator Site File (ISF) maintenance. Nikki shares her expertise and highlights critical challenges faced by research sites, drawing from her recent experience on a CDISC conference panel alongside FDA auditors and CRO representatives. This episode discusses DOA regulations, Re-consenting issues, SUSAR management and Central document distribution. Tune in to uncover how to navigate the evolving regulatory landscape with confidence! 

 In Part 2 of our discussion on the FDA’s new guidance for clinical trials, we move from theory to practice. Ted B. from Medvector joins us again to dive into solutions for addressing potential challenges when implementing this new flexibility allowing healthcare providers (HCPs) to conduct visits with Principal Investigator (PI) oversight. 

 In this episode, we dive into the latest FDA guidance expanding flexibility for clinical trials by allowing healthcare providers (HCPs) to conduct visits under Principal Investigator (PI) oversight. What does this mean for patients, research sites, and sponsors? Join us as we sit down with Ted Barduson, COO and Co-founder of Medvector to discuss the practical implications of this groundbreaking change. From improving patient access and engagement to navigating oversight and compliance, we explore how this new guidance can reshape the clinical trial landscape. Tune in for insights and actionable tips to put this into practice at your site. 

Brittney joins us again for another episode of Interview with a CRC. Today we discuss some of the common problems and issues facing new CRC's and lessons we wish we learned earlier on in our careers. 

Welcome back to Daniel, an accomplished CRA, as he tells us some of his horror site stories! Bonus:  Daniel discusses his side gig.The CRA Coach - CRA Training, Clinical Research Associate Training

Join us as we interview Daniel, a CRA with an impressive career. Anna and Daniel discuss trials and tribulations of the CRA role and the training program Daniel has created to help support CRA's. The CRA Coach - CRA Training, Clinical Research Associate Training 

Not all Scientists match the image of a nerdy, pocket protector wearing, loner, in fact, sometimes they are the ones throwing the biggest parties.

The Happy Accident of how both the understanding and treatment for ED changed. 

Join us as we share some stories written in about CRA's that were not so ethical in their practices. 

Today we discuss the story of the father of Gastroenterology and his early experiments. TW: Graphic wounds verbally described 

Brittney Joins us again to discuss some of the hardships of the CRC role. We talk about sponsor/CRC communication, PI involvement, and some of the struggles in recruitment. 

Ever wonder what happens to devices/IP after it leaves the site? Join us as we discuss FDA Audits with J, who has experience with FDA audits in medical device manufacturing, and how these differ from pre-approval research audits. 

Bigfoot- the Myth and Legend and the Scientist who gave up his social standing to try to prove its existence. 

CRA Horror stories, Catching the bag guy before the FDA does. This Coordinator was caught by their CRA enrolling an ineligible patient as a birthday gift to their boss. 

Majority of STEM fields are male dominated, but how close is social media to real life of a new woman entering the STEM field. Join us for Interviewing Carmen, a Project Manager in Construction. 

Friendship between scientists that lead to one of the biggest fall-outs in history and also some of the biggest discoveries. 

Physicians taking on too much, when it rains it pours, how to handle a divorce and FDA audit at the same time. 

Join us for our first interview with a Clinical Research Coordinator. On this episode we discuss Sponsor/Pharma involvement and communication with the site and the inclusivity of technology for patients with diverse backgrounds. 

Dr. Pare the doctor of surgery brought attention to the field and supported new techniques

Unconsented patients, staff untrained... when is busy too much?

Follow the discovery of amazing world of parasites

If there is one thing we know for sure, that is when it comes to the FDA, if you f*** around they will find out

Find out who actually invented the telephone... 

Explore the happy accidents that have led to amazing discovery!

Jurassic park showed the dangers of bringing back the dinosaurs, but what if this concept was used for a more recently extinct species. 

Explore the Happy Accidents that have led to some of the most amazing scientific advancements! 

31 Scientists in Mexico are being charged with organized crime?!

Have you ever wondered how a mishap in the lab has led to some of science's greatest discoveries?

What happens when vunerable populations are not protected?

Have you ever wondered how a mishap in the lab was the reason for some of our biggest scientific breakthroughs? 

Introduction to the voices behind the stories, why we started this podcast!

Uncover the story of how a surgeon got ahold of his most prized possession... ... a giant.