NEWARK – Attorney General Christopher S. Porrino and the Division of Consumer Affairs today announced that the State is seeking to revoke the license of a Warren County doctor who allegedly accepted more than $136,000 from a drug maker while indiscriminately prescribing the powerful fentanyl painkiller “Subsys” to patients who did not meet the federal criteria for receiving the highly addictive cancer pain medication.

Dr. Kenneth P. Sun, a pain management practitioner in Phillipsburg, was paid up to $12,100 a month by drug maker Insys Therapeutic Inc. (“Insys”) for speaking engagements and consulting services, all the while prescribing to patients Subsys, a tightly-restricted oral spray medication approved by the federal Food and Drug Administration (“FDA”) strictly for use in treating breakthrough cancer pain in opioid-tolerant patients.

In a Complaint filed with the state Board of Medical Examiners (‘the Board”) yesterday, the State alleges that a reasonable person would recognize that Sun received those payments for his prescribing of Subsys, in violation of Board regulations.

While paying Sun, Insys closely monitored Sun’s prescribing habits, frequently reminding him of the need to keep prescribing Subsys; notifying Sun when the number of his prescriptions dipped too low; and encouraging him to “keep them rolling” when a patient received insurance approval to start another patient on the drug,

Sun wrote more than 775 Subsys prescriptions from 2012 through 2016. The Complaint alleges that he indiscriminately prescribed the drug to eight patients who were not suffering from breakthrough cancer pain and/or who were already on stable pain management prescribing routines, the State alleges. His prescriptions generated more than $4.8 million in revenues for Insys and earned Sun $136,768 in compensation from the drug company, the State alleges.

“We contend that Dr. Sun and Insys were working together to make money in the cruelest and sickest way possible, by pushing a dangerous and addictive opioid painkiller on patients who didn’t need it and weren’t approved to receive it,” said Attorney General Porrino. “The more drugs Dr. Sun prescribed, the more money he appeared to have made. This kind of profit-based drug dispensing is what you’d expect from a street-corner dealer, not a trusted health care provider, and it will not be tolerated in New Jersey.”

Earlier this month the State filed suit against Insys, charging the company unlawfully directed its sales force to push Subsys for prescription to a broader patient population – patients suffering any type of chronic pain – and at higher doses.

The actions against Sun and Insys are the latest in the State’s ongoing investigation into the “off-label” prescribing of Subsys – a fentanyl-based opioid medication approximately fifty times more powerful than heroin and one hundred times more powerful than morphine.

Subsys is one of six transmucosal immediate release fentanyl ("TIRF") medications that instantly deliver the powerful painkiller fentanyl through the oral membranes. The only federally approved use for TIRF substances, including Subsys, is for the management of breakthrough pain in adult cancer patients who are already receiving, and who are tolerant to, around-the-clock opioid therapy for their underlying persistent cancer pain.

The State began investigating the use of Subsys in October 2016 after Cherry Hill family physician Vivienne Matalon prescribed Subsys to three patients who did not meet the criteria for receiving the drug, one of whom died.

In response to the death, Attorney General Porrino and the Division of Consumer Affairs took the unprecedented step of announcing investigations and issuing a public alert warning patients and doctors alike of the risks associated with prescribing Subsys and other TIRFs medications outside their approved use.

As part of the State’s initiative to determine whether doctors have been prescribing Subsys appropriately, and as was announced publicly in October 2016, investigators with the Enforcement Bureau of the Division of Consumer Affairs inspected patient records at numerous doctors’ offices statewide, and subpoenaed patient records from others.

An inspection of Sun’s patient records allegedly showed he had prescribed Subsys to several non-cancer patients for whom such a drug was “contraindicated” because of the associated risks of addiction, overdose and death.

In the wake of those alleged findings, Sun agreed to the temporary suspension of his license.

In a formal Complaint filed yesterday, the State alleges that Sun engaged in professional misconduct and gross negligence by indiscriminately prescribing Subsys
to his patients. The Complaint also alleges Sun engaged unlawful conduct by accepting money from Insys intended to induce his prescribing and engaged in fraud by mischaracterizing patient diagnoses to ensure insurance coverage for patients’ prescriptions.

"Doctors who prescribe Subsys for non-approved uses are deviating from a well-established standard of care regarding this drug and placing their patients at risk of serious harm," said Sharon Joyce, Acting Director of the Division of Consumer Affairs. "That Dr. Sun allegedly did so at the same time he was accepting payments from the drug’s manufacturer makes this case all the more troubling. Public safety demands that Dr. Sun be prohibited from practicing medicine until this very serious matter is resolved.”

According to the Complaint, Sun’s’ relationship with Insys began on March 30, 2012 when an Insys sales representative called him to discuss Subsys. Sun wrote his very first Subsys prescription on April 10, 2012.

Sun received money from Insys purportedly for being part of a Subsys speaker program in which physicians who utilized Subsys were paid for being speakers at promotional forums encouraging the use of the drug; serving as a consultant for the company; and participating on its advisory board.

During this course of his relationship with Insys, Sun allegedly was made aware that his prescribing was being monitored by the drug company and that he was expected to keep prescribing Subsys.

The Complaint alleges, among other things, that:

• When Sun could not attend a July 2012 speaker training, he told a sales representative the he “owes her a few [Subsys] scripts for missing the web training”.
• When the sales representative’s supervisor informed her via email in March 2015 that Sun was “$30K short still just of breaking even” for that quarter,” she forwarded that email to him.
• When a mail-order pharmacy which frequently filled Subsys prescriptions, contacted the sales representative expressing concern that “we have not seen many scripts from (Sun)” she forwarded the email to Sun.
• Whenever the sales representative received an email from a supervisor informing her that Sun had written a Subsys prescription for a “low strength”, i.e. not as profitable, she would contact Sun.
• When Insys obtained Subsys insurance coverage for Sun’s patients, the sales representative would forward emails conveying the news of the coverage approval to Sun.
• In March 2013, the sales representative forwarded Sun an email informing him that Insys had obtained approval for a patient and exclaimed “Keep them rolling” with a smiley emoticon.

Because TIRF medicines, including Subsys, carry a high risk for misuse, abuse, addiction, overdose, and serious complications due to medication error, the FDA has subjected these medications to significant restrictions. Doctors who wish to prescribe Subsys must enroll in the TIRF REMS (Risk Evaluation and Mitigation Strategy) Access Program. The Program requires prescribers to undergo educational training about the drug's risks and enroll their Subsys patients in the program.

By enrolling in the Program, Sun acknowledged he had read the risks associated with Subsys, and understood that it was approved only for narrow uses as a cancer pain medication and that any "off-label" use could result in a fatal overdose, according to the State's Complaint.

Nonetheless, the State alleges, Sun prescribed Subsys to eight patients, identified in the Complaint by their initials, who did not fit the criteria for receiving the drug. The State alleges Sun’s actions constitute professional misconduct and gross negligence which endangered the life, health, welfare, and safety of his patients.

If proven, Sun’s actions provide the Board with grounds to suspend or revoke his license, according to the State’s allegations.

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