Drug company faked cancer patients to sell drug

By Aaron M. Kessler
Updated 9:02 PM ET, Wed September 6, 2017

When Insys Therapeutics got approval to sell an ultra-powerful opioid for cancer patients with acute pain in 2012, it soon discovered a problem: finding enough cancer patients to use the drug.

To boost sales, the company allegedly took patients who didn't have cancer and made it look like they did.

The drug maker used a combination of tactics, such as falsifying medical records, misleading insurance companies and providing kickbacks to doctors in league with the company, according to a federal indictment and ongoing congressional investigation by Sen. Claire McCaskill, a Democrat from Missouri.

Because of the high cost associated with Subsys, most insurers wouldn't pay for it unless it was approved in advance. That process, likely familiar to anyone who's taken an expensive medication, is called "prior-authorization."
So Insys set up an elaborate charade -- with employees that pretended to be doctors' offices -- to fool insurance companies into approving the drug, according to the Senate report.

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Insys even went so far as to obscure its outgoing phone number on caller IDs, so that calls wouldn't be traced back to the company, the report said. And if an insurer needed a phone number for a return call, company employees "reportedly provided a 1-800 number manned by another Insys representative -- instead of contact information for the prescribing physician," according to McCaskill's report.

During such calls, there was usually a key question: did the patient have acute pain caused by cancer, known as "breakthrough" pain? Cancer was a requirement for prior clearance to prescribe Subsys.

Insys got around this by finding calculated ways for its employees to create the impression on the phone calls that the answer was yes, they did have cancer, without explicitly saying so, according to the report.

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In December, federal prosecutors in Boston criminally charged six former Insys executives, including its former CEO, with fraud and racketeering charges related to Subsys. Prosecutors described a "nationwide conspiracy to bribe medical practitioners to unnecessarily prescribe a fentanyl-based pain medication and defraud health care insurers."

"As alleged, top executives of Insys Therapeutics, Inc. paid kickbacks and committed fraud to sell a highly potent and addictive opioid that can lead to abuse and life threatening respiratory depression," said Harold H. Shaw, special agent in charge of the Federal Bureau of Investigation's Boston field office, in a statement in December.

Other federal charges have also subsequently been brought against individuals connected to Subsys, and several state attorneys general have filed lawsuits of their own.

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In July, former Insys regional manager for the Southeast, Karen Hill, pled guilty in a related federal case in Alabama. She described in recorded conversations excerpted in court filings how she taught salespeople to entice doctors.

"She gave examples that some of her doctors were motivated by money, chocolate and spending time with her," federal prosecutors in Alabama said in a release announcing her plea. "When the sales representative asked Hill how to identify doctors who were financially motivated to prescribe Subsys, Hill explained that she looks for doctors that are 'money hungry,' and went on to describe how to figure out if a doctor has a 'light in their eyes' and is willing to 'play ball.'"