he New Jersey attorney general is seeking to suspend the medical license of a doctor who prescribed the powerful painkiller fentanyl to a patient who later fatally overdosed. Attorney General Christopher Porrino also warned other physicians on Monday to use extreme caution in prescribing the drug, marketed as Subsys.
The complaint against Dr. Vivienne Matalon of Cherry Hill, N.J., also announced Monday, comes amid concerns that many physicians are inappropriately prescribing Subsys to patients for whom it’s not intended, putting them in danger and helping to further fuel the epidemic of opioid abuse in the country. Subsys is approved for use in cancer patients who are suffering sharp bouts of pain despite taking other opioids. But many physicians are prescribing the drug “off-label” for patients who do not have cancer.
Porrino’s action comes after a STAT story last month chronicled the case of Sarah Fuller, a 32-year-old New Jersey woman who died of a fentanyl overdose after Matalon prescribed her Subsys. Fuller did not have cancer. She suffered from neck and back pain from two car accidents and was also diagnosed with fibromyalgia.
The attorney general’s worries about improper prescribing go beyond this one doctor.
“We’re warning everyone — doctors and patients alike — that Subsys is a fast-acting, extremely powerful drug approved only for a singular narrow purpose — to relieve breakthrough cancer pain,” Porrino said in a press release. “Given this risk, I have instructed the Division of Consumer Affairs to investigate the potential misuse of this highly addictive medication by other providers.”
The attorney general said state investigators recently conducted inspections of six other doctor offices in the state to see whether they are prescribing the drug properly. The information gathered from those inspections is still being analyzed. In addition, the state has issued subpoenas for patient records from 10 other physicians.
“Any physician found prescribing Subsys to patients not qualified for the treatment will be subject to disciplinary action,” said Steve Lee, director of the Division of Consumer Affairs. “We will not allow patients’ lives to be endangered by prescribers who disregard the federal restrictions placed on this drug.”
The complaint alleges Matalon “indiscriminately” prescribed Subys, which is a quick-acting version of fentanyl sprayed under the tongue. It describes two other patients it claims Matalon inappropriately prescribed Subsys for, including one case in which she is alleged to have fraudulently represented to an insurer that a patient had cancer. In the third case, the patient’s insurer rejected attempts by Matalon to prescribe Subsys because the patient did not have cancer, according to the complaint.
Doctors are allowed to prescribe drugs for purposes other than what they are approved for, a practice called “off-label prescribing.” But the attorney general alleged in his complaint that Matalon’s conduct represents “gross negligence that endangered the life, health, safety, and welfare” of the three patients. The complaint, filed with the New Jersey State Board of Medical Examiners, requests the agency consider suspending or revoking the license of Matalon because her continued practice “presents a clear and imminent danger.” Matalon was ordered to appear before the board on Oct. 26 to answer the complaint.
Matalon did not respond to a telephone message requesting comment. Matalon operates a practice called TLC Healthcare in Cherry Hill, and also maintains an office in Camden, N.J., according to the complaint.
Fuller is identified in the complaint by her initials, S.F. It states she first became a patient of Matalon’s in August 2014. The family went to Matalon because Fuller had abused opioids in the past and they were trying to wean her off prescription painkillers. Matalon, according to the complaint, promised she would treat Fuller’s pain using “alternative treatment methods.”
In a follow-up visit in December 2014, Matalon allegedly told Fuller and her father that there was a “new drug that could be used to treat” Fuller’s pain. The doctor also told them that at the next visit, a sales representative from the company that makes the drug would be present to “teach them all about the new medication.”
Fuller and her father returned to Matalon’s office on Jan. 5, 2015. A salesperson from the company that makes Subsy, Insys Therapeutics, was there. The complaint identifies the Insys representative as Melina Ebu-Isaak. A LinkedIn account for a person with the same name indicates she left Insys in July and now works for a genetic testing company. A telephone message left for her was not returned.
“During the visit, (Matalon) and Ms. Ebu-Isaak explained to S.F. that Subsys would help S.F. greatly with her chronic pain, demonstrated to S.F. how Subsys should be consumed, and noted that Subsys would be mailed directly to S.F’s home,” according to the complaint. What they didn’t tell Fuller, the complaint alleges, is that Subsys was an opioid, nor did they explain the risks and dangers associated with its use.
New users of Subsys, according to a special US Food and Drug Administration program designed to limit abuse of the drug, are supposed to be started on the lowest dose of the product. Fuller’s initial dose was twice the lowest dose, and within three weeks Matalon tripled that dose, according to the complaint. In August 2015, Matalon instructed Fuller to start taking the higher dose six times a day, up from four.
Fuller died this past March from what the county medical examiner ruled was the result of the “adverse effect of drugs.” A toxicology screen revealed a level of fentanyl in her blood that experts consulted by STAT said is lethal.
In a second case, Matalon twice prescribed Subsys to a 61-year-old woman who had been cancer-free for nearly a decade. In both instances, the patient stopped taking Subsys after complaining of side effects, including nausea, vomiting, and dizziness, every time she used it.
Before Matalon prescribed the woman Subsys, the patient’s oncologist informed Matalon the patient had been cancer-free for a decade and had no complaints related to pain. Matalon allegedly submitted a form to the patient’s insurer claiming a cancer diagnosis, and in her own records noted that the patient had a current diagnosis of cancer, according to the complaint.
With Subsys, the risk of abuse and addiction is so formidable that the FDA requires doctors to successfully complete special training before they are allowed to prescribe it. Fentanyl can be more than up to 100 times more potent than morphine. Matalon completed the training, according to the complaint.
“Fentanyl is a very potent opioid that can cause respiratory depression in microgram quantities,” the FDA notes in its prescribing materials for Subsys.
While doctors are allowed to prescribe drugs for off-label conditions, drug makers aren’t permitted to promote medications for these purposes. Insys is under investigation by several state attorneys general and federal prosecutors for the marketing of Subsys, according to disclosures made by the company. Last month, federal prosecutors in Connecticut charged a former Insys district sales manager, whose territory included New Jersey, with allegedly paying kickbacks to doctors to get them to prescribe Subsys.
Much of the fentanyl abused in the United States is produced illicitly in China and then funneled into the country by Mexican drug cartels. It has quickly replaced heroin and other prescription painkillers as the leading cause of fatal opioid overdoses in some regions of the country and was cited as the cause of death in the case of the pop star Prince.
In New Jersey, according to the Matalon complaint, fentanyl-related deaths tripled from 2013 to 2014, and in the first six months of 2015 caused more deaths than in all of the previous year.
The case of Fuller highlights another concern regarding fentanyl — the overdosing of patients legally prescribed the drug for treatment of pain. “For many, the path to opiate addictions begins with legally prescribed pain medications,” the attorney general’s complaint states.
Matalon was licensed to practice in New Jersey in 1989 after attending medical school in the Dominican Republic. Her father, Raphael, founded Matachem Research in Cherry Hill in 1960 after immigrating to the United States from England.
Matalon’s practice for several years was largely focused on weight loss and alternative medicines, including herbal therapies, homeopathy, and a form of acupuncture.
Matalon was identified as an unpaid member of the medical advisory board for a Utah company called 4Life. In a testimonial featuring a photograph of her, Matalon is quoted endorsing the company’s “transfer factor” products.
The company describes transfer factors as “products that educate your immune cells, supporting your immune system’s ability to recognize, respond to, and remember potential threats.” The company’s products are sold in various formulations using peptides from cow colostrum, which is the milk produced in the first few days after giving birth, and chicken egg yolk, along with what the company describes as its patent-protected 4Life Transfer Factor proteins.
“When do you need it?” Matalon is quoted as asking. “You need it all the time. And who needs it? Actually, everyone. Not only you as an adult, but also your children and pets. And it’s safe.”
In 1996, she was identified in a story from the Knight-Ridder News Service as a consultant for an Israeli cosmetic company selling products that incorporated minerals from the Dead Sea.
In the most recent three-year reporting period, Matalon received 231 payments from nearly three dozen pharmaceutical companies, according to records filed with the federal government. Among those paying her were companies that market painkillers, including OxyContin maker Purdue Pharma and Pfizer, as well as makers of diabetes medications, antidepressants, and weight loss drugs.
The most payments, 44, came from the Chandler, Ariz.-based Insys and all were to cover “food and beverage” expenses. They range in amounts from 48 cents to $119.95 and totaled $733. The total of all payments from companies was $7,434.
The story of Fuller’s death also prompted US Senator Edward Markey, a Massachusetts Democrat, to urge federal agencies to limit the use of Subsys. The government insurer, Medicare, paid $250,544 for a 15-month supply of Subsys prescribed to Fuller, billing records show.
Medicare is paying for “tens of millions of dollars in Subsys prescriptions that may have also led to the overdose deaths of people who should never have received the drug in the first place,” Markey wrote to Andy Slavitt, the acting administrator for the Centers for Medicare and Medicaid Services. Medicare paid $30 million for Subsys in 2013 and then $97 million just a year later in 2014, according to Markey’s letter.