The State Board of Medical Examiners has revoked the license of a Warren County doctor after concluding he placed patients at risk by prescribing the tightly-restricted cancer pain medication “Subsys” to patients who did not meet the criteria for receiving it, and that he accepted more than $100,000 from the drug’s maker, Insys Therapeutics Inc., to push prescriptions of the powerful opioid painkiller.
Dr. Kenneth P. Sun, a pain management practitioner in Phillipsburg, is the latest New Jersey doctor to have his license revoked for allegedly ignoring explicit prescribing restrictions placed on Subsys, a potent under-the-tongue opioid spray approved by the federal Food and Drug Administration (“FDA.”) only to treat breakthrough pain in cancer patients already receiving, and tolerant to, around-the-clock opioid therapy for their underlying cancer pain. Prescribing Subsys outside its approved parameters exposes patients to grave risks, including the risk of a fatal overdose.
Sun is among numerous doctors nationwide who accepted payments from Insys – in the form of speaking and consulting fees – that were, in reality, cash incentives to promote prescriptions of Subsys beyond its approved parameters.
“We cannot end the opioid crisis unless we crack down on doctors who put profit over patient care,” said Attorney General Gurbir S. Grewal. “Dr. Sun pushed a dangerous opioid painkiller on patients who didn’t need it and weren’t approved to receive it. The revocation of Dr. Sun’s license is simply the latest in a growing list of actions we are taking against the doctors who have fueled this public health crisis.”
In October 2017, the State filed a lawsuit against Insys Therapeutics (which was later amended to include its billionaire founder John N. Kapoor as a defendant) accusing them of endangering the public through a greed-driven, unlawful and deceptive marketing campaign designed to exponentially increase sales of Subsys by making fraudulent claims and paying kickbacks to prescribers in the form of speaker fees.
The pending suit, filed in Superior Court in Middlesex County, alleges that Insys unlawfully directed its sales force to push Subsys for prescription beyond its narrow purpose as a cancer pain medication to a broader population – patients suffering any type of chronic pain – and at higher doses. The State alleges that the greed of Kapoor and Insys put “hundreds” of lives in jeopardy and “led to the death of at least one New Jersey resident.”
Two weeks after filing its suit against Insys, the State filed a Complaint with the medical board, seeking to revoke Sun’s license for allegedly accepting kickbacks from Insys to indiscriminately prescribe its flagship opioid product.
The state alleged that while paying Sun for speaking and consulting fees, Insys closely monitored Sun’s prescribing habits, frequently reminding him of the need to keep prescribing Subsys; notifying Sun when his prescriptions dipped too low; and applauding him to “keep them rolling” when he received insurance approval to start another patient on the drug.
From 2012 through 2016, Sun wrote more than 775 Subsys prescriptions indiscriminately prescribing the drug to patients who did not have breakthrough cancer pain and/or who were already on stable pain management prescribing routines, the State alleged. His prescriptions generated more than $4.8 million in revenues for Insys and earned Sun over $117,000 in compensation from the drug company, according the State’s Complaint.
“Dr. Sun was willing to violate standards of professional and ethical conduct to enrich himself, without regard for the lives he put at risk,” said Paul R. Rodríguez, Acting Director of the Division of Consumer Affairs. “There is no place in the medical profession for doctors who sacrifice the safety of their patients in exchange for payments from drug manufacturers, and the Division will continue to provide oversight to prevent such abuses.
Sun, whose license had been temporarily suspended since December 2016, agreed to settle the State’s allegations against him by consenting to the revocation of his license and his New Jersey Registration that allows him to prescribe controlled dangerous substances.
In a Consent Order filed on August 27, the Board found that Sun had engaged in the indiscriminate prescribing of controlled dangerous substances, and other misconduct that constituted professional misconduct and gross negligence, or gross incompetence, that endangered the health, welfare, and safety of his patients.
Specifically the Board found:
By prescribing Subsys to patients who did not suffer from breakthrough cancer pain, Sun jeopardized his patients’ welfare in reckless or willful disregard of the drug’s unequivocal and well-established risks, and disregarded the parameters pertaining to its appropriate use, notwithstanding his express acknowledgement that he understood those risks and his commitment to abide by restrictions on prescribing Subsys.
Sun’s acceptance of $117,000 from Insys Therapeutics Inc. for advisory and consulting services and participation as a Subsys-promoting speaker at Insys-sponsored and Insys-organized informational event can readily be seen as having improperly influenced Sun and encouraged his Subsys prescribing. And that because “a reasonable person would recognize” that the purpose for which Insys paid Sun such a substantial amount of money was to promote his Subsys prescribing, Sun’s acceptance of the money violated laws governing professional conduct.
Sun committed several violations of the Board’s regulations regarding the prescribing of CDS for pain management, with respect to the eight Subsys patients whose medical records the Attorney General subpoenaed. For all of them, Sun failed to periodically make reasonable effort to stop the use of the prescribed opioid or to take any other steps in an effort to reduce the potential for abuse or the development of physical or psychological dependence. Moreover, Respondent failed to keep accurate and complete medical records for each of the eight Subsys patients at issue, and in some instances maintained within his patient record documentation which mischaracterized the patients’ diagnoses and/or the etiology of their pain.
Subsys is one of six transmucosal immediate release fentanyl (“TIRF”) medications that instantly deliver the powerful painkiller fentanyl through the oral membranes. Because TIRF medicines 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 to enroll their Subsys patients in the program.
The State alleged in its Complaint that by enrolling in the Program, Sun acknowledged that he had read the risks associated with Subsys, understood that it was approved only for narrow uses as a cancer pain medication, and understood that any “off-label” use could result in a fatal overdose.
In addition to revoking Sun’s license and CDS Registration, the Consent Order requires Sun to pay a civil penalty of $60,000 and to reimburse the State $13,800 for attorney’s fees. Under the terms of the Order, Sun is prohibited from reapplying for a medical license for a period of three years. Before reapplying for his license, Sun must provide the Board with proof that he has taken and successfully completed courses in medical ethics; recordkeeping; and (should he wish to resume prescribing CDS) the safe use and prescribing of opioids for the management of acute and chronic pain.
Sun is the third NJ doctor whose license was revoked in connection with improper prescribing of Subsys.
In May 2018, the Board revoked the license of Dr. Vivienne Matalon, a Cherry Hill family physician who indiscriminately prescribed Subsys to three patients, including a woman who died while taking the drug. In November 2016, the Board revoked the license of Dr. Manoj Patharkar, who owned pain management centers in Middlesex and Passaic counties. In revoking Patharkar’s license, the Board cited his indiscriminate prescribing of Subsys, as well as his criminal conviction in an unrelated medical fraud scheme.
Investigators with the Enforcement Bureau within the Division of Consumer Affairs conducted the investigation. Deputy Attorney General David M. Puteska, Assistant Section Chief of the Professional Boards Prosecution Section in the Division of Law, represented the State in this matter.
Persons who believe they or their loved ones were prescribed Subsys or any other TIRF medication in violation of the FDA restrictions should contact the Division of Consumer Affairs by calling 1-800-242-58?46 (toll free within New Jersey) or 973-504-6200
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