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 thalidomide
• The real human cost behind corporate and regulatory failures
• How this tragedy reshaped modern drug approval laws
• The birth of the FDA’s MedWatch program and tighter safety controls
• Why we now distinguish between OTC and controlled medications

Understanding 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.