The eighth of December 2016 was a bad day for former employees of an Arizona-based pharmaceutical company called Insys Therapeutics. According to a press release from the US Attorney’s Office in Massachusetts, six top execs were dragged out of their homes and arrested on charges that they led a nationwide conspiracy to bribe medical practitioners to unnecessarily prescribe a mega-powerful opioid pain medication and defraud insurance companies. It’s a scenario straight outta my favorite Macklemore song. The one that goes, “My drug dealer was a doctor, doctor/Had the plug from Big Pharma, Pharma…”
Insys is the manufacturer of a Fentanyl spray called Subsys that’s 100 times stronger than morphine. The drug, which is administered sublingually (that’s sprayed under the tongue for those of you who don’t speak drug ingesting lingo), is only supposed to be prescribed by oncologists and pain specialists to cancer patients who are already being treated with opiates and experiencing breakthrough pain. We’re talking sick people with major pain and an established tolerance for heavy drugs—otherwise this shit is lethal. In fact, it’s already been blamed for hundreds of deaths.
What the Heck?
Subsys is so powerful, and the risk of addiction and overdose so formidable, that the FDA requires doctors to undergo special training before they are even allowed to prescribe it. However, data which analyzes drug trends indicates that just one percent of Subsys prescriptions in 2014 were written by oncologists. About half of the ‘scripts were written by pain specialists, and a wide range of doctors prescribed the rest, including general practice physicians, neurologists and even dentists and podiatrists. Yes, people—we’re talking about people being given a cancer drug for foot pain.
Interviews that have been conducted with several former Insys sales reps suggest the company aggressively marketed the painkiller to physicians who did not treat many cancer patients, among others. They also paid its sales force larger commissions for selling higher doses of the drug. Even in the shady world of pharmaceutical sales, this is egregious. While doctors are technically allowed to prescribe drugs for off-label conditions, drug makers are strictly forbidden from marketing or promoting the use of medications for these purposes.
Déjà vu
The Massachusetts case is just the latest chapter in the saga of Insys’ misdeeds. The company is under investigation by several state attorney general and federal prosecutors for the marketing of Subsys, according to disclosures the company has made in public securities filings. Insys has already settled one case in Oregon where the attorney general alleged that Insys was “implicitly misrepresenting to patients that Subsys should be used to treat migraine, neck pain, back pain, and other off-label uses for which Subsys is neither safe nor effective.” Subsys settled the case in 2015 by making a payment of $1.1 million. It did not admit to any improper behavior.
In addition, both an Insys sales rep in Alabama and a nurse in Connecticut have admitted they’re guilty of taking federal kickback charges related to off-label Subsys prescribing. Yes, allegedly doctors and a nurse were paid kickbacks by company employees to prescribe the drug. According to court records, the sales rep in Alabama was paid a base salary of $40,000 but received more than $700,000 in commissions from 2013 to 2015 based on the volume of off-label prescriptions written by doctors she called. Now the new charges take these allegations a step further. The indictment also alleges that the (now former) Insys execs defrauded health insurance providers who were reluctant to approve payment for the drug when it was prescribed for non-cancer patients. They did this by setting up a system dedicated to obtaining prior authorization directly from insurers and pharmacy benefit managers so that the drug was already guaranteed to be covered before the doc disclosed the purpose of the prescription.
Another Brick in the Wall
The aggressive and illegal marketing of Subsys comes in the midst of America’s raging epidemic of opioid addiction. It’s just the latest example of how pharmaceutical companies get away with (literally) murder because the money they usually pay in fines is pennies compared to the profits they make. This follows other instances of the illegal marketing of opioids that have been blamed for helping to fuel the crisis. In 2007, Purdue Pharma, the maker of the painkiller OxyContin, pled guilty to a criminal charge related to its marketing of the drug, paying more than $600 million in fines.
The latest investigation into Insys is hardly groundbreaking in its size and scope—even though it’s huge and was conducted by a team that included the FBI, FDA Office of Criminal Investigations, the Drug Enforcement Administration, the Department of Labor, the US Postal Inspection Service and the Department of Veterans Affairs, among others. Because the company is based in Arizona and the defendants live all over the country, the US Attorney in Massachusetts cooperated with other US Attorney’s offices engaged in parallel investigations. Although the accused pharmaceutical executives each face up to 25 years in prison and nearly $300,000 in fines, the reality is that they will probably not serve a day.
Sounds like it may be time for Macklemore to go back in the studio for a sequel.
Sponsored DISCLAIMER: This is a paid advertisement for California Behavioral Health, LLC, a CA licensed substance abuse treatment provider and not a service provided by The Fix. Calls to this number are answered by CBH, free and without obligation to the consumer. No one who answers the call receives a fee based upon the consumer’s choice to enter treatment. For additional info on other treatment providers and options visit www.samhsa.gov.
