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The good, the bad, the dirty of the Science, Technology, Engineering and Math world.
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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 ...
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 ...
“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 ...
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 unc...
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 Ma...
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 sober...
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? ...
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...
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 innova...
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...
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 ...
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, ...
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