In recent news regarding the opioid epidemic, we’ve heard of devastated communities, torn apart families trying to cope, the loss of loved ones, and overcrowded treatment facilities. But it has been hard to comprehend how some drugs spread so quickly as we try to understand this epidemic of epic proportions.
Let me introduce you to Insys Therapeutics. Ever heard of it? Me neither. Until now.
The story of Insys and a growing list of alleged schemes with their only FDA approved product called Subsys can teach us a lot about the sickening growing role of corporate greed in the opioid crisis.
Who Are They
Insys Therapeutics is the epitome of corporate greed. They are a specialized pharmaceutical company based in Chandler, Arizona. Their “vision” is to improve the lives of patients (supposedly cancer patients). Their website states their focus is primarily on cannabinoids and “novel drug delivery systems” which address unmet patient needs.
However, last week things came to a head when the billionaire founder of the company, John Kapoor, was arrested on federal charges for spearheading a nationwide conspiracy to bribe doctors to prescribe a fentanyl-based painkiller for cancer patients called “Subsys.”
The charges escalate the continuing inquiries into Insys related to Subsys, an under-the-tongue spray that contains fentanyl, a highly addictive synthetic opioid. They came as President Trump declared the country’s opioid problem a public health crisis.
Subsys are Insys main product. It is only FDA approved for “the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.”
Subsys were launched in 2012. Due to their declining success, founder Kapoor and CEO Michael Babich grew dissatisfied and devised a scheme to pay bribes in the form of speaker fees, food, and entertainment to medical practitioners to prescribe Subsys and to increase the dosage and volume of existing prescriptions. They also sought to mislead and defraud insurers who were reluctant to approve payment for Subsys when it was prescribed to patients who did not have cancer.
Outraged? Me too.
Karen Hill, a sales representative for Insys admitted that their targets were certain high prescribing doctors. The way the scheme worked was that doctors who were prescribing high volumes of Subsys, or those who had the ability to do so in short order, were signed up by Insys as “speakers.” The doctors would put on short presentations about the drug and then would receive an honorarium ranging typically ranging from $1,600.00 to $3,000.00. As part of her plea, Hill admitted that the speaking programs were merely a pretext through which Insys could line the pockets of certain doctors.
During her time as a sales representative, Hill taught other sales representatives how to entice doctors to prescribe Subsys. Hill told another sales representative that the key to getting doctors to prescribe Subsys was not selling them on the drug itself, but rather finding out what motivated the doctor. She stated that some of her doctors were motivated by money, chocolate, and spending time with her. 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.”
What’s Happening Now?
Sen. Claire McCaskill, the Missouri Democrat, included Insys in her recently launched investigation into the marketing programs of opioid manufacturers.
“This company has repeatedly gotten away with fines that amounted to a slap on the wrist for actions that helped fuel a nationwide epidemic that’s claimed hundreds of thousands of American lives,” she said. “Anyone, including top executives, who potentially violated criminal law should be aggressively prosecuted.”
“Not only did the defendants in this case allegedly bully sales reps into pushing this highly addictive drug, they paid doctors to prescribe it to patients,” FBI Assistant Director Diego Rodriguez said. “The more prescriptions written, the more money the doctors made.”
The indictment alleges and Kapoor, along with six former executives were responsible in conspiring to mislead and defraud health insurance providers.
Subsys-prescribing doctors in some states have received subpoenas, too, according to company filings. It’s no wonder then that Insys experienced a 32% decline in Subsys prescriptions from the fourth quarter of 2016 to the first quarter of 2017.
The charges of conspiracy to commit RICO (Racketeer Influenced and Corrupt Organizations Act) and conspiracy to commit mail and wire fraud each provide a sentence of no greater than 20 years in prison, three years of supervised release, and a fine of $250,000. The charges of conspiracy to violate the Anti-Kickback Law provide for a sentence of five years and a $25,000 fine.
United States Attorney, William Weinreb stated, “in the midst of a nationwide opioid epidemic that has reached crisis proportions…today’s arrest and charges reflect our ongoing efforts to attack the opioid crisis from all angles. We must hold the industry and it’s leadership accountable – just as we would the cartels or a street-level drug dealer.”
On the heels of the President’s declaration of a Public Health Emergency, we hope this spearheads and sheds light onto the major players of the pharmaceutical industry and the role that they play in the opioid crisis. The players in this case seem nervous, as they should be.
John Kapoor along with the six others will appear at the U.S. District Court in Boston at a later date.