Opioid drug reps were told to push for off-label synthetic drug use.
A year-long 60 minutes investigation into the market infiltration of the powerful synthetic opioid fentanyl revealed the underhanded tactics used by sales reps and executive to ensure clients were hooked – and stayed that way. Two insiders to the pharmaceutical industry, a high-ranking opioid salesperson and federal agent Greg Tremaglio, were asked about pushing for fentanyl for uses not on its label.
Tremaglio explained the mindset of profiteers in the world of opioids. “If you’re gonna intentionally, knowingly break the law your profits have to be so significant that when the FDA comes knocking and they hit you with the $425 million penalty, you’re still smiling. You’re sad in front of them, but when you walk out the door, you’re smiling. You’re smiling because you just made a billion dollars-worth of profit. And it’s worth it to them. It’s worth it.”
In 2003, Tremaglio was the senior special agent assigned to the undercover arm of the Food and Drug Administration’s (FDA) D.C. Office of Criminal Investigations targeting Cephalon, one of several drug companies outside of FDA regulations. He said that executives and key players weren’t afraid of the FDA because, back then, they received little more than a slap on the wrist if caught operating in violation of the law.
Temaglio said, “Why would they be? Back then, you only received a misdemeanor. Nobody was prosecuted.”
In the early 2000s, federal prosecutors would usually negotiate corporate settlement agreements without holding individual pharmaceutical executives accountable. But Tremaglio found Cephalon was violating drug promotion laws with three of its products, including a synthetic opioid, Actiq, and he hoped the company would receive a harsher punishment. Synthetic opioids are supposed to only be used for patients with end stage cancer.
“These drugs are so powerful that they received approval by FDA for their indicated use, which was strictly for cancer patients with severe pain that have a tolerance level to other opioids,” he explained, “So morphine’s not working for them anymore, and they’re in – still in severe pain. And they need something that’s gonna give ‘em a recovery immediately. That’s what this lollipop is.”
In the medical world, doctors are able to prescribe drugs in a way if they believe they will help their patients. However, regulators mandate that physicians receive factual information regarding the drugs before prescribing, including all risks and side effects. Actiq’s packaging label acts as a legally binding agreement between the FDA and drug companies, limiting how sales reps can promote a drug. Pushing a drug for “patient groups not listed on the label, spreading misleading information, or publicizing a potentially deadly drug as less dangerous than FDA evaluations indicate,” is referred to off label promotion, which illegal.
Alec Burlakoff, however, said he would say almost anything to convince doctors to prescribe Actiq because of the commission he would receive for his efforts, even if it meant going against FDA regulations.
“I was taught to forget the patient. To not think about the patient. Take the human aspect out of it. It’s like selling widgets,” he said, adding, “The key to success? The less of a conscience you had, the better.”
Cephalon’s “master plan” for promoting its powerful drug, Actiq, which was eventually unsealed was essentially a “how-to” guide for adverting the law. It specifically included a strategy for getting doctors to prescribe the drug off label referred to as “the most critical component of the Actiq tactical plan.”
Tremaglio got approval from federal prosecutors to wire up the sales rep and conduct surveillance, and the case finally concluded in 2008, when Cephalon pleaded guilty to a misdemeanor for illegal promotion and paid $425 million in fines and settlements. The company was eventually sold for $6.8 billion, and Burlakoff found a new job at Insys when he could pick up right where he left off selling Subsys.
More recently, prosecutors alleged, “Insys set up a fake speakers program to extend cash to physicians, adjusted payments based on how many Subsys prescriptions were written, thus incentivizing the sale of the drug, misrepresented patients’ medical histories so insurance companies would cover Subsys for people without cancer, and even hired a stripper and escort service manager as one of its key sales executives.” A jury had found its top executives guilty of racketeering, mail and wire fraud. CEO John Kapoor received five and a half years behind bars and his cohorts received from 12 to 33 months. Burlakoff, the senior vice president of sales at Insys, pled guilty and cooperated with prosecutors.