Minnesota has become the 10th state to take action against Arizona-based drug maker Insys Therapeutics, alleging the company illegally pressured physicians to prescribe its fentanyl painkiller Subsys. Attorney General Lori Swanson and the Minnesota Board of Pharmacy filed a lawsuit last week accusing Insys of using “brazen and crass” marketing tactics to convince 17 Minnesota doctors to prescribe the opioid painkiller for unapproved conditions at doses higher than the FDA recommended.
The company’s sales reps were given quotas and doctors were paid “sham” speaker fees to recommend the drug, Swanson said. “I’ve seen a lot of greedy conduct by pharmaceutical companies in this office,” Swanson said at a news conference. “This conduct in this case is as brazen as anything you could imagine a pharmaceutical company doing.”
In a statement, Insys said it takes allegations of “past wrongdoing by former employees with the greatest seriousness.” The company is “determined to take responsibility for the past and learn from it,” the statement said.
Minnesota is one of 10 states to accuse Insys of wrongdoing, either by filing civil suits or indicting company officials. Four of those states have settled with the company and the others have cases that are continuing.
Administered with a spray under a patient’s tongue, Subsys was approved by the Food and Drug Administration in 2012, as the sixth trans-mucosal immediate-release fentanyl product approved by the FDA for breakthrough pain in cancer patients already taking opioids. By 2016, Subsys had 42 percent of this market, making it the most prescribed product in its class, according to the attorney general.
Several company executives, including its former vice president of sales and former CEO, were indicted by the United States Attorney in Massachusetts for their role in marketing Subsys.
Swanson’s lawsuit, filed in Hennepin County, alleges Insys illegally marketed the drug for other treatments and encouraged doctors to prescribe much higher doses than were approved by the FDA. About 80 percent of the Subsys prescriptions in Minnesota were above the FDA-approved dose.
Insys allegedly urged its sales reps to “camp out” in doctor’s offices to get them to prescribe the drug, according to emails obtained by Swanson. The company used bonuses of up to $3,000 to increase sales and paid two doctors $43,000 in speaker fees.
Those doctors became the top prescribers of the drug in Minnesota. Swanson’s lawsuit alleges the 36 speaking events they were paid for were “shams” to get around state laws prohibiting payments by drug companies to doctors.
Swanson said Insys’ actions showed it cared more about profits than patients. “They are talking in such cavalier, crass ways about patients,” Swanson said. “Calling patients annuities. Saying you can ‘win big’ if you prescribe this drug … It seems like the companies are just playing games with the patients’ lives.”
Last year, 401 Minnesotans died of opioid overdoses. Cody Wiberg, the executive director of the state Board of Pharmacy, said investigators haven’t yet connected Subsys to any overdose deaths, but that any opioid can be abused and cause addiction.
When it approved the drug in 2012, the FDA cautioned that Subsys was only to be used by oncologists and pain specialists skilled in cancer pain treatment, and that all patients must be started at the lowest dose of 100 micrograms.
The attorney general alleges that the company incentivized its sales agents to get physicians to increase the doses prescribed to patients. The FDA states that prescribers should always start patients at 100 micrograms and use the lowest possible effective dose. But, in its marketing materials for physicians, Insys said that “75 percent of patients found an effective SUBSYS dose between 600 and 1600 mcg” and that “only 4 percent of patients reported 100 mcg as an effective dose.”
Insys offered its sales force extra bonuses for higher doses, paying them $340 per quarter for 100 microgram prescriptions, but $2,352 per quarter for 1,200 microgram prescriptions, Swanson said.
The state’s investigation showed that more than 80 percent of initial Subsys prescriptions by Minnesota physicians were above the FDA-approved 100 mcg initial dose.
The company also gave cash incentives of up to $3,000 to salespeople who convinced doctors to switch from prescribing a competitor’s product, calling such doctors “low hanging fruit ready for the picking,” Swanson said.
Minnesota law prohibits pharmaceutical manufacturers from paying gifts to health care practitioners of more than $50 per year. There is an exemption for reasonable honoraria and expense of a “practitioner who serves on the faculty at a professional or educational conference or meeting.”
Insys ran a “Speaker Program” that paid more than $43,000 to two Minnesota physicians for 36 Speaker Program events. Those physicians became the company’s top prescribers in Minnesota, Swanson said.
The lawsuit alleges that these payments violated Minnesota’s gift ban statute because they were not “reasonable honoraria” for bonafide faculty members and instead were payments to incentivize the physicians to prescribe Subsys. Insys was unable to provide evidence that some of the supposed “speeches” had any audience other than the sales agent or physician’s office staff, Swanson said.
The two physicians who were paid to speak on behalf of Insys and its drug Subsys have been referred for disciplinary action, Wiberg said. The Board of Pharmacy is also considering penalizing the company.
Swanson said her office continues to gather evidence related to other opioid manufacturers and distributors and their alleged lies to doctors about the safety of prescribing opioids long-term to patients. “Stay tuned for that,” Swanson told the St. Paul Pioneer Press. “We are knee-deep in that investigation.”