By Taylor Knopf
N.C. Attorney General Josh Stein is suing a drug manufacturing company over incentivizing physicians to prescribe its fentanyl spray for inappropriate uses and deceiving insurance companies into paying for it.
The drug company Insys produces a fentanyl spray called Subsys, which the Food and Drug Administration approved only for “breakthrough” pain in cancer patients, the kind of pain that occurs when other opioid medications fail.
However, Stein alleges that Insys gave rewards to pain doctors to give speeches promoting other uses for Subsys.
The attorney general’s office is already investigating a number of opioid manufacturers to find out if the companies who have been profiting from the growing national opioid crisis broke the law while promoting their products. Stein signed onto a suit with at least 40 other state attorneys general in September.
In North Carolina, Stein said that Insys sponsored a speaker at a headache clinic in Chapel Hill to promote Subsys. Stein also claims that the Charlotte-based vice president of sales for Subsys told one sales representative, “They do not need to be good speakers, they need to write a lot of Subsys prescriptions.”
Stein said that the product is 50 times stronger than heroin and 100 times stronger than morphine.
“This is the worst drug to use for a headache,” said Christopher Grubb, a Greenville pain specialist during a press conference with Stein announcing the lawsuit Thursday.
Fentanyl is an extremely potent painkiller used mostly in operating rooms by anesthesiologists, Grubb said.
He added that when sprayed under the tongue, fentanyl is introduced into the bloodstream and reaches the brain within five to 10 minutes. It’s a very effective delivery system, almost as instantaneous as an IV. This is why fentanyl is heavily regulated by the FDA, Grubb said.
Fentanyl, when added to street drugs, is the substance that’s been driving many heroin overdoses and deaths.
According to the N.C. Office of the Chief Medical Examiner, deaths involving fentanyl or its analogues increased by 45 percent from 2014 to 2015 in North Carolina. Based on preliminary data, deaths involving fentanyl increased 99 percent from 2015 to 2016.
The Center for Disease Control and Prevention also announced Thursday that life expectancy in the United States declined for the second year in a row during 2016. This is the first time mortality has dropped two years in a row since the early 1960s. Much of that decline in life expectancy was driven by fatal opioid overdoses.
At the same time, the CDC released its latest opioid statistics showing a 21 percent increase in overdose deaths in 2016, with more 63,600 across the United States. The largest percentage increase in deaths occurred among people between the ages of 15 and 44.
Stein also accused drug manufacturer employees of tricking insurance companies into approving prior authorizations for the fentanyl spray for people without cancer diagnoses.
“Concerned insurance companies wouldn’t pay for Subsys when prescribed to non-cancer patients. Insys employees inserted themselves in the communication between the prescriber and insurance company,” Stein said.
“Insys employees contacted insurers, often posing as the prescriber or their staff, and invented medical histories for patients to ensure that the drug would be covered by the insurance company.”
He added that Insys even used confidential patient health information to sell their stories to insurance companies. This scheme paid off for Insys, Stein said.
Prior authorizations for the fentanyl spray increased from 30 percent initially to 85 percent. Stein claims that only about 10 percent of prior authorizations were actually prescribed for cancer patients.
“As millions of Americans were becoming addicted to these prescription painkillers and communities were struggling to respond to the crisis, we allege that Insys unlawfully pushed these powerful painkillers on North Carolina patients just to make more money,” Stein said.
“It’s unconscionable. It’s unacceptable. It’s illegal,” he added. “And today, I am taking action to put a stop to it.”