Drugmaker pushed opioid cancer drug on patients with neck pain: state lawsuit
Illinois Attorney General Lisa Madigan has sued an Arizona drug company for allegedly pushing its powerful opioid painkiller, Subsys, beyond its intended use on cancer patients.
The lawsuit, filed Thursday in Cook County Circuit Court, claims Insys Therapeutics deceptively marketed and sold Subsys — a spray form of the prescription opioid drug fentanyl — to physicians treating patients for conditions such as neck and back pain.
"This drug company's desire for increased profits led it to disregard patients' health and push addictive opioids for non-FDA approved purposes," Madigan said in a news release. "It's this type of reprehensible and illegal conduct that feeds the dangerous opioid epidemic and is another low for the pharmaceutical industry."
The consumer fraud lawsuit follows an investigation by the state into allegations that Insys was marketing Subsys broadly for chronic pain in noncancer patients, despite the lack of Food and Drug Administration approval for such use.
An Insys spokeswoman did not respond to a request for comment Thursday.
Subsys, a fine mist sprayed under the tongue, was approved by the FDA in 2012 to treat "breakthrough" pain in cancer patients. Since late 2014, it has been the most prescribed transmucosal immediate-release fentanyl, with a 48 percent market share, according to the company's website.
The lawsuit claims Insys directed its sales and marketing efforts in Illinois to "high-volume opioid prescribers" who are not oncologists, including one Chicago doctor responsible for 58 percent of Subsys prescriptions in Illinois over three years. Insys sold nearly $12 million of Subsys prescriptions in Illinois between April 2012 and March 2015, the lawsuit said.
Dr. Paul Madison, an anesthesiologist and former owner of the Watertower Surgicenter on North Michigan Avenue in Chicago, was identified in the lawsuit as the top prescriber of Subsys in Illinois, with 95 percent of the prescriptions unrelated to cancer pain.
"I've done nothing wrong," Madison said Thursday. "It was a really outstanding medication. We just used it for people who had severe pain."
While the sale of prescription drugs for "off-label" use is not prohibited, the drugmaker may not promote such use, according to a spokeswoman for the attorney general's office.
Madigan's investigation revealed that Insys not only touted the sale of Subsys for off-label use, but encouraged doctors to increase the dosages of the drug to be more "effective," according to the lawsuit.
The lawsuit also claims Insys paid top Subsys prescribers "sham" speaking fees to promote the drug at events, almost all of which took place at upscale Chicago restaurants. Madison received a total of $84,400 in Subsys speaking fees, appearing at 46 events from November 2012 to June 2015, according to the lawsuit, a figure he confirmed.
"I would have done it without getting a stipend," Madison said. "We're just trying to teach each other — that's how we learn. It's a great medication."
Madison was indicted in 2012 on federal charges of allegedly submitting nearly $3.6 million in false medical bills for insurance reimbursement. The criminal case is pending in Chicago federal court, a spokesman in the U.S. attorney's office in Chicago said.
Madison declined to comment on the federal case, and his attorney did not immediately respond to a request for comment.
Madison, who operates pain clinics in Riverside and Michigan City, Ind., no longer prescribes Subsys regularly, citing the expense, the difficulty getting insurers to cover it for noncancer use and "all the controversy" over its use.
In August 2015, the Oregon attorney general reached a $1.1 million settlement with Insys to resolve similar allegations that Subsys was marketed for off-label uses such as noncancer neck and back pain.
The Illinois lawsuit asks the court to stop Insys from doing business in Illinois if the company doesn't reform its practices, and seeks civil penalties and "further equitable relief."