A lawsuit was filed this Thursday against Arizona drug company Insys Therapeutics, alleging that the company pushed the use of its opioid painkiller, Subsys, beyond its original scope. Illinois Attorney General Lisa Madigan claims in the suit that the drug – which is a spray form of the immensely powerful opioid analog fentanyl – is being used to treat patients with neck and back pain, when it was originally FDA approved strictly for the treatment of cancer patients.
Illinois’ lawsuit comes out a state investigation into accusations that the company was marketing Subsys for uses outside of its approved treatments by the Food and Drug Administration. In a news release this week, Lisa Madigan said: “this drug company’s desire for increased profits led it to disregard patients’ health and push addictive opioids for non-FDA approved purposes. It’s this type of reprehensible and illegal conduct that feeds the dangerous opioid epidemic and is another low for the pharmaceutical industry.”
Subsys is currently the most prescribed transmucosal immediate-release fentanyl, claiming a 48 percent market share, according to the product’s website. A spokeswoman for Insys Therapeutics provided no response to requests for comments on Thursday.
The lawsuit also lists “high-volume opioid prescribers,” who gave the medication to patients suffering broadly from chronic pain. According to the lawsuit, Dr. Paul Madison, an anesthesiologist in Chicago, is responsible for 58 percent of Subsys prescriptions in the state of Illinois in the last three years. Moreover, 95 percent of those prescriptions were found to be unrelated to cancer pain.
Among the other damning claims in the suit, it was found that Insys paid its top prescribers speaking fees to promote the drug at public events, most of which took place at upscale restaurants in downtown Chicago. Madison confirmed that he had received $84,400 dollars in speaking fees from the company, having appeared at 46 public events from November of 2012 to June 2015.
Civil penalties and “further equitable relief,” are being sought if Insys fails to reform its practices in a timely manner. The lawsuit also suggests that continued unwillingness to cooperate should result in Insys’ being barred from doing business in the state of Illinois.