Madigan sues drug company for illegal marketing of opioids

Insys Therapeutics has deceptively marketed and sold nearly $12 million worth of an opioid pain drug in Illinois, according to a lawsuit filed by Illinois Attorney General Lisa Madigan.

Subsys is the addictive narcotic fentanyl, which is sprayed under the tongue for quick absorption. The FDA-approved use of this drug is for patients who have persistent cancer pain. But the suit filed Thursday in Cook County Circuit Court claims Insys targeted Illinois doctors who prescribe a high-volume of pain medication, but are not oncologists or pain specialists who treat cancer.

Insys marketed Subsys to treat “breakthrough pain” instead of “breakthrough cancer pain” in order to broaden the appeal. Sales representatives also inserted themselves into the prescription-writing process for off-label use and pushed a higher effective dose, according to the suit.

Prescribing a medication off-label is when a doctor prescribes a medication for uses other than what the FDA has approved. It is a common practice and while doctors are allowed to prescribe drugs this way, it is illegal for drug-makers to advertise or promote their products for off-label use.

“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 press 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 suit claims that Insys paid doctors to prescribe Subsys through a “sham” speaker program.

Also, Insys sales representatives were instructed to call a list of doctors who had a history of prescribing opioids multiple times a week and some representatives visited those prescribers nearly every day. Alec Burlakoff, the former vice president of sales for Insys Therapeutics, told the sales department to, “… pack your bags – move in – don’t leave until you have seen the Subsys prescription you need on a daily basis with your own two eyes,” according to the suit.

From April 2012 to March 2015, Insys sold nearly $12M worth of Subsys in Illinois. The highest volume Subsys prescriber in Illinois was Dr. Paul Madison, the suit claims.

“Subsys is the best pain medication I’ve seen in the past 10 years. There seems to be a problem with their marketing, but the product is really great,” Madison told the Chicago Sun-Times. “Medication can be used off-label. We use it when we can, we use it correctly.”

Over 95 percent of Subsys prescriptions written by Madison were for patients that experienced back pain, neck pain and other types of chronic pain, the suit alleges.

“Personally, I never saw anything done inappropriately in a marketing perspective. I never saw it marketed as anything other than a cancer pain drug,” Madison said.

According to the suit, Madison received $84,000 from Subsys for 46 speaking events in the Subsys Speaker Program.

The suit goes on to allege that an Insys sales representative wrote in an email to his supervisor that Madison, “…basically just shows up to sign his name on the prescription pad, if he shows up at all.” The supervisor, then Insys CEO Michael Babich, responded by telling the sales representative that Madison could be his “go-to physician” and to “stick with him.”

In December 2012, Madison was indicted on federal charges of false claims for allegedly billing insurers for procedures that were never performed. In April 2014, the Illinois Department of Financial and Profession Regulation reprimanded Madison for prescribing controlled substances without an Illinois Controlled Substance License, according to the suit.

Madison is just one of the Subsys prescribers that Illinois has a problem with, the suit claims. Another unnamed high-volume Subsys prescriber is being disciplined by the Illinois Department of Financial and Professional Regulation.

The one-count suit charges Insys for consumer fraud and deceptive business practices and seeks at least $50,000.

A representative for Insys Therapeutics could not be immediately reached for comment on the suit Thursday evening.