Pharma execs used strip clubs, broke FDA laws to boost opioid sales

Summary

This 60 Minutes investigation exposes the reckless marketing and illegal sales practices of opioid drugs, particularly fentanyl. The documentary highlights how pharmaceutical companies, like Cephalon and INSYS, aggressively promoted these drugs for off-label use, targeting non-cancer patients and bribing doctors with money and luxury perks. Despite early warnings from federal agents, law enforcement struggled to prosecute executives. The video delves into the devastating consequences of these actions, including widespread addiction, the collapse of lives, and eventual legal repercussions, including prison sentences for top executives at INSYS.

Takeaways

• 💊 Nearly 70,000 Americans die each year from drug overdoses, predominantly from opioids.
• 🚀 The surge in opioid supply and demand was fueled by aggressive pharmaceutical marketing.
• 🔎 A year-long investigation revealed the sales practices that led to a prescription explosion.
• 👤 Insiders, including a top opioid salesman and a federal agent, shared their experiences and insights.
• 📚 The FDA was lenient on drug companies, treating violations as misdemeanors and not prosecuting individuals.
• 🚨 Cephalon was found to be blatantly disregarding FDA regulations in promoting their opioid, Actiq.
• 💸 Pharmaceutical companies profited immensely, even when fined, as the penalties were a fraction of their earnings.
• 📈 Sales reps were incentivized to push opioids aggressively, often ignoring legal and ethical boundaries.
• 💼 Cephalon's internal documents exposed a strategy to expand opioid use beyond cancer patients to general pain sufferers.
• 📉 The federal investigation into Cephalon was stymied by internal resistance within the FDA.
• 🏥 iNSYS Therapeutics faced legal consequences for its illegal promotion and bribery of doctors to prescribe their opioid, Subsys.

Q & A

How many Americans die each year from drug overdoses, primarily from opioids?

Nearly 70,000 Americans die each year from drug overdoses, with the majority being from opioids.

What was the role of aggressive marketing of narcotics in the opioid crisis?

The aggressive marketing of narcotics to treat chronic pain is reported to have initiated the explosion in both the demand and supply of pharmaceutical opioids.

What is fentanyl and how is it related to the opioid crisis?

Fentanyl is a powerfully addictive, fast-acting opioid that is 100 times more powerful than morphine. It was initially intended for severe cancer pain but was later aggressively marketed for off-label use, contributing to the opioid crisis.

What was the significance of the Cephalon case in the context of the opioid crisis?

The Cephalon case is significant because it involved the company violating FDA laws on drug promotion, including the off-label promotion of a powerful synthetic opioid called Actiq, which contributed to the opioid crisis.

What is off-label promotion and why is it illegal?

Off-label promotion is the practice of pushing drugs for patient groups not listed on the FDA-approved label or spreading misleading information about a drug's safety. It is illegal because it can lead to the misuse of potentially dangerous drugs and undermines the FDA's regulatory authority.

How did Cephalon's sales representatives promote Actiq off-label?

Cephalon's sales representatives were trained to ignore the FDA's off-label promotion laws and promote Actiq for any type of pain, regardless of the drug's FDA-approved use for severe cancer pain only.

What was the outcome of the federal investigation into Cephalon?

The federal investigation led to Cephalon pleading guilty to a misdemeanor for illegal promotion and paying $425 million in fines and settlements, which was less than a quarter of what the company made in one year.

What was the role of Alec Burlakoff in the opioid crisis?

Alec Burlakoff was a star sales representative at Cephalon and later at iNSYS Therapeutics, where he was involved in illegal sales tactics, including bribing physicians to prescribe opioids off-label, contributing to the opioid crisis.

How did iNSYS Therapeutics' executives, including John Kapoor, contribute to the opioid crisis?

iNSYS Therapeutics' executives, including John Kapoor, contributed to the opioid crisis by illegally promoting the opioid painkiller Subsys for off-label use, bribing doctors to prescribe the drug, and engaging in insurance fraud to ensure the drugs were paid for by insurance companies.

What was the result of the legal case against John Kapoor and iNSYS Therapeutics?

John Kapoor and several of his top executives were found guilty of racketeering, mail and wire fraud, and conspiracy to illegally boost profits from Subsys. Kapoor received a sentence of five and a half years, while his lieutenants received sentences ranging from 12 to 33 months.

What was the impact of the prosecution on the pharmaceutical industry and the approach to corporate crime?

The prosecution of iNSYS Therapeutics and its executives marked a new, tougher approach to corporate crime, especially in the pharmaceutical industry, where white-collar criminals are often treated with more leniency. The case set a precedent for holding pharmaceutical executives accountable for their role in public health crises.