Price of Addiction: Oregon AG outlines drug-maker’s use of aggressive tactics to win over doctors
When you have attorneys practicing medicine.. this is what you get… they made the determination that cancer pain is dramatically different than non-cancer pain.. All opiates are only FDA approved for cancer pain and they are all used regularly – off label – for non-cancer pains.. The medication involved is Fentanyl.. been around for treating pain.. for a couple of DECADES… Putting medication under the tongue.. sublingual .. its onset is nearly as rapid as a shot… Perhaps none of these attorneys have had migraines and/or they prefer to wait – with a throbbing migraine – for 30-45 minutes for a oral med to start working. And of course, they state that Fentanyl is HIGHLY ADDICTIVE… not the truth … POTENTIALLY ADDICTING..
Behind the $1.1 million settlement between Oregon Attorney General Ellen Rosenblum and a drug manufacturer lies a tale of “unconscionable, false and deceptive sales tactics,” including wining and dining, and even flirting with, Oregon doctors.
The settlement outlines in great detail how Chandler, Arizona-based Insys Therapeutics went about marketing Subsys, an FDA-approved opioid for cancer pain. The fentanyl-based narcotic is administered with an under-the-tongue spray and rapidly absorbed in the bloodstream.
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The FDA approved Subsys for breakthrough cancer pain, but not other kinds of pain treatment. Insys, however, implicitly misrepresented 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,” according to the state Department of Justice’s Notice of Unlawful Trade Practices and Proposed Resolution.
Opioids, including fentanyl and Oxycodone, are highly addictive and often ineffective for chronic pain. Oregon led the nation in nonmedical use of prescription drugs in 2012.
According to the notice, even though Insys knew the drug was being used off-label, the company paid patients’ insurance co-pays, provided free samples and made payments to doctors intended as kickbacks so they’d prescribe Subsys.
Insys, which could not be reached for comment, started promoting Subsys in Oregon in January 2012, selling $511,000 in the state since then. Almost half that amount was prescribed by a single “problem doctor,” according to the notice.
The FDA had stipulated Subsys never be used for migraines, it should only be prescribed by pain specialists and at the lowest possible dose.
Yet within two years of Subsys’ release, 80 percent of its prescriptions were for off-label uses. And the company pressured its sales reps to persuade doctors to prescribe higher doses.
“Insys earns more money when a higher dose is prescribed, as do Insys sales representatives whose compensation is based on commission,” according to the notice.
Insys didn’t focus its efforts on cancer specialists. Instead, it targeted doctors who primarily treat non-cancer pain.
One target was a Tigard doctor identified in court documents only as “Roy,” who cooperated with the investigation. Insys hired the doctor’s son as its Subsys sales rep, even though he had no background in pharmaceutical sales or health care.
Here’s what happened next, according to the notice:
The doctor’s son set up a meeting between his father, Insys regional sales director Beth McKey, and Dr. Stuart Rosenblum, “an anesthesiologist with a long history of speaking on behalf of pharmaceutical companies about drugs, including drugs that were unlawfully promoted off-label to treat certain types of pain,” according to theDepartment of Justice documents. The meeting took place at Riccardo’s Ristorante in Lake Oswego and cost $100 per person.
The son told Insys his father likely wouldn’t prescribe Subsys. On Nov. 1, 2013, he texted his father: “These people from my company are relentless and it’s kind of pissing me off. … I need you to help me to figure out what to say to them to calm them down.”
Insys’ founder contacted his father, McKey proposed “tequila dates” and Insys offered to make Roy a Subsys promotional speaker. The doctor ultimately wrote no prescriptions for Subsys and the son resigned three months into his job.
Insys also targeted “problem doctors,” according to the notice.
For example: one doctor who was not a pain specialist and was ordered by the Oregon Medical Board in late 2013 to cease prescribing controlled substances for chronic pain patients. Insys sales representatives visited the doctor’s office at least 80 times and bought him coffee or snacks on 28 occasions.
Insys paid its top Oregon doctor/consultant $2,400 to speak at a catered lunch. Rosenblum’s office described those talks as “shams” engineered to incentivize doctors to increase Subsys prescriptions. The doctor, though, still wasn’t prescribing enough to satisfy Insys and was told he wouldn’t be used as a speaker again.
Filed under: General Problems
“All opiates are only FDA approved for cancer pain and they are all used regularly – off label – for non-cancer pains”
Opiates are FDA approved for different levels of pain, including moderate, severe, and (specifically) cancer pain.