nj.com: Doctors raked in cash to push fentanyl as N.J. death rate exploded
6/29/2017
ebbie Fuller holds a locket with her daughter, Sarah's, picture. Sarah, who had a history of opioid abuse, died of an overdose after her doctor prescribed her fentanyl for chronic pain.
The most powerful opioid ever mass-marketed was designed to ease cancer patients into death.
It's ideal for that: the drug is fast acting, powerful enough to tame pain that other opioids can't and comes in a variety of easy delivery methods -- from patches to lollipops.
But a dose the size of a grain of sand can kill you.
Meet fentanyl. It's heroin on steroids. It's killing people in droves. And, in New Jersey, you can get it after having your tonsils removed.
In fact, doctors who treat children's colds and adult's sore knees are prescribing it with alarming frequency, far more than oncologists easing end-of-life cancer pain.
The surge is stoked by companies that shell out hundreds of thousands of dollars a year to doctors, wining and dining them in hopes of convincing them that their particular brand of fentanyl is the solution to all their patients' pain problems.
Evidently, it's working.
An NJ Advance Media analysis has found that eight medical specialties in New Jersey have filed more Medicare claims for fentanyl than those by oncologists. Family practitioners, for example, filed at least five times as many claims for fentanyl from 2013 to 2015 than did cancer doctors.
"There are some powerful drivers of opioid prescriptions that have little to do with the presence of pain in the population," said Dr. Caleb Alexander, co-director of the Center for Drug Safety and Effectiveness at Johns Hopkins University.
The investigation also reveals:
- From 2013 to 2015, doctors in New Jersey were paid at least $1.67 million by pharmaceutical companies marketing various forms of fentanyl. In the same time period, fentanyl deaths in New Jersey increased from 42 in 2013 to 417 in 2015.
- Since late 2011, enough fentanyl has been dispensed to allow every person who has died of cancer in New Jersey to fill a prescription for the drug eight times.
- Doctors are being disciplined for improperly prescribing fentanyl, in several cases losing their licenses after their patients die while taking the drug.
How we did our analysis
Data and documents show a system where pharmaceutical companies and doctors remain in a cozy and ethically dubious relationship, at best. It's a system where cash and prescriptions go hand-in-hand. And it's a system where, time and again, patients suffer and even die when something goes wrong, an occurrence that is far from rare.
"There's enough money going around that if you saw this in the abstract, you'd think there was a drug cartel happening," said Arthur Caplan, head of the Division of Bioethics at New York University.
Seller and slave
Jeffery Pearlman, a regional sales manager for drug maker INSYS Therapeutics, knew his product better than most. He was pushing a new pain wonder drug -- Subsys -- a form of fentanyl that could be sprayed under the tongue to instantly treat intense pain in cancer patients.
Pearlman knew the pull of fentanyl all too well because, according to court papers filed by his attorney, Michael Rosensaft, he was hopelessly addicted to Subsys himself.
Pearlman denies involvement in the alleged INSYS scheme, and the company did not return requests for comment. Pearlman's attorney says his client was an inexperienced middle manager struggling through his own addiction and had no knowledge of any impropriety.
As of this writing, at least three doctors and two INSYS employees have either pleaded guilty or been convicted of wrongdoing in the scheme, and a whistleblower claimed she had fabricated oncology records while working for the pharmaceutical company.
In February, Pearlman's attorney pleaded with a federal judge for his client to forgo drug testing so his client could continue taking medical marijuana. In court papers, Rosensaft said the Edgewater resident used marijuana to treat chronic pain after he "courageously liberated himself from opioids," including Subsys, which he was taking enough of to kill a man.
The deadliest drug
Fentanyl has gained notoriety in recent years because it has proliferated in the illegal drug market. A completely synthetic opioid, fentanyl is used to treat severe pain often associated with terminal diseases when other opioids fall short.
Dr. Iqbal Jafri has led the pain management program at JFK Medical Center in Edison for more than two decades. When asked when it would be appropriate to prescribe fentanyl, his voice sharpened.
And according to court papers, Pearlman made sure it was flying off the shelves.
In late 2013, he received a $95,000 bonus for making sure Subsys got into the hands of as many patients as possible. Life, by all appearances, was good for Pearlman.
But according to the federal government, it was also a house of cards.
Pearlman was one of six INSYS employees arrested late in 2016 for allegedly running a cash-for-prescriptions scheme that paid off and bullied doctors into improperly prescribing Subsys, one of the most powerful and addictive drugs on the market today.
"I don't usually, at all," he said. "This should not be a first-line of defense, second-line of defense against pain. Fentanyl is something to be used when you have exhausted all other options. I can think of no appropriate reason why the use of any kind of fentanyl should be increasing."
The box warning that blares across packaging for its many brands and their websites mentions "death" more than a dozen times.
Patches, pills and lollipops: 4 things to know about fentanyl
But because of its synthetic chemical structure, fentanyl is easily manufactured and can be moved in much smaller amounts than other drugs -- making it ideal for drug traffickers.
It killed 417 people in New Jersey in 2015, up from just 42 three years earlier.
Officials at the state medical examiner's office said they do not track how many deaths occurred because of illegal versus prescribed fentanyl. But NJ Advance Media's analysis shows doctor-prescribed fentanyl has been implicated in multiple deaths, serious injuries and powerful addictions in recent years, spawning a litany of lawsuits and other legal action.
Among them:
- An Edison doctor was sued in 2014 after allegedly prescribing fentanyl to a patient with a history of drug and alcohol abuse. The patient suffered severe brain damage.
- A Maplewood doctor lost her medical license after prescribing fentanyl to patients recovering from tonsillectomies in 2012, leading to the death of one of them.
- Last year, a Red Bank foot doctor allegedly prescribed fentanyl as "a favor" to clients, until one died.
- State investigators were examining the records of more than a dozen state doctors connected to fentanyl in late 2016.
But the fentanyl keeps flowing. It was dispensed by pharmacies in New Jersey at least 142,000 times in 2015 and 127,000 times in 2016.
The FDA approvals for fentanyl, starting in 1998, were specifically for cancer pain, but that doesn't legally prohibit doctors from prescribing drugs they feel will help their patient. And an analysis shows the majority of prescriptions for the drug in New Jersey aren't coming from oncologists.
The top field for fentanyl prescriptions was internal medicine, with more than 27,000 claims filed with Medicare in 2014. Next on the list are family practices, nurse practitioners, physical therapists, anesthesiologists and pain management clinics, each of which filed more than 2,500 Medicare claims for fentanyl.
Deep on the list are oncologists, who would normally work with the late-stage cancer patients. Oncologists, in comparison, filed up to 2,200 claims.
Though comparatively they account for a small number of overall prescribers, eight of the top 20 prescribers of fentanyl were pain management specialists.
On average, pain management specialists prescribed fentanyl to Medicare patients 60 percent more often than oncologists did.
Physician's assistants and nurse practitioners also were heavy prescribers, data show.
"It's unclear who's supervising these physicians' assistants," Caplan said. "And are these family doctors trained in pain medicine? Do they know of the alternative treatments?"
On the whole, New Jersey has been strong on limiting prescribing by doctors. A newly passed law makes it impossible for doctors to prescribe any opioid for longer than five days without a follow up consultation and Gov. Chris Christie recently said the state now has the lowest prescribing rate in the nation.
A trust, broken
Debbie Fuller started to wonder if her daughter Sarah was on the right drug.
Sarah Fuller would fall asleep mid-conversation. She fell asleep in the bathroom, hitting her head on the bathtub. Her hands would shake if she went more than four hours without taking Subsys.
But Sarah Fuller followed her doctor's orders -- her body would adjust, she was told -- right up until the day Subsys killed her.
Debbie Fuller said her family had implicit trust in their general practitioner, Vivienne Matalon, when she prescribed Subsys to her daughter.
Sarah Fuller, a 31-year-old Stratford resident, had chronic pain issues due to two car accidents and fibromyalgia. She also had a history with opioid addiction Matalon was aware of.
"(Matalon) said she was going to wean her off," Debbie Fuller said, her daughter's violet gemstone engagement ring glinting in the light of her attorney's office.
But shortly after beginning to see Matalon, a general practitioner, in 2014 Sarah Fuller was allegedly introduced to a drug sales representative for INSYS.
"They preyed on her. She had a learning disability. She put trust in what doctors said," said Debbie Fuller. "My husband felt the same. We didn't know what Subsys was. They never said one word about what it was or how addictive it could be."
Sarah Fuller was prescribed to take 200 micrograms of Subsys every four hours. Weeks later, it was upped to 600.
Debbie Fuller noticed changes in her daughter. She described her bedroom as a "lair," with blackout curtains drawn all the time. She would frequently fall out of bed, and wake up the next morning on the floor.
"I kept telling her she needed to tell her doctor about these things, and she said she did," Debbie Fuller said. "She told me that Matalon would tell her 'Don't worry, your body will adjust.' In her mind, if a doctor is telling you that, it must be true."
Sarah Fuller had Subsys shipped to her doorstep for 14 months through prior authorization. Her mother said she was obsessive about being home for the next shipment of Subsys.
"She would tell me 'no, I can't leave. They're going to be here between this time and this time and I have to be here,'" Debbie Fuller said. "She made sure she was at the door when it came."
One day, in March of 2016, Sarah Fuller didn't wake up. Her fiance found her dead in bed. It would be months before her parents would find out, through a toxicology report, that Sarah Fuller had died of a fatal overdose of fentanyl.
Matalon has since had her license suspended, and the Fullers have filed a lawsuit against INSYS. Matalon's attorney, Douglas C. Maute, declined comment.
INSYS has filed a motion to dismiss the wrongful death suit -- a judge in Middlesex County is scheduled to hear the case this afternoon.
Medicare data shows Matalon received $733 in 2014 and 2015 from INSYS, mostly for meals -- the only money she received from a company marketing fentanyl. But she had constant contact with pharmaceutical companies throughout that time, being treated to meals on almost a weekly basis by drug reps, according to federal payment data.
Even small payments can be influential, Alexander said.
"Doctors are influenced sometimes in ways they're not even aware of ... They're no less human than any other person," he said.
Cash for addiction
Paging through INSYS' payments to doctors, a common theme emerges: Speeches.
The records contain scores of $1,000-plus payments to doctors for speaking engagements. But according to federal prosecutors, it was all a sham.
INSYS called them "Speaker Programs," and they happened at high-end restaurants, like Carmen Anthony's, then a high-end steakhouse in New Haven.
Here, prosecutors allege friends and co-workers would gather on the company dime. No one capable of prescribing fentanyl attended, prosecutors allege, yet INSYS employees used the gatherings to authorize thousands of dollars in payments to doctors by billing them as educational events.
All INSYS asked of the doctors was to keep the prescriptions rolling, authorities said.
And it seemed to work -- the number of prescriptions filled for Subsys in New Jersey went from 400 in 2012 to about 1,800 in 2013 and 3,000 in 2014, according to data from the Division of Consumer Affairs.
Prosecutors allege that Pearlman and others promised to keep the speaker fees rolling in as long as prescriptions of Subsys kept rolling out.
If prescriptions weren't up doctors would hear about it, allegedly receiving bullying emails from Pearlman and others, who threatened to halt payments.
"Very simply when I look at return on investment as (Cooperating Witness 1) has not motivated any new prescribers as of yet and (he/she) is not increasing (their) own business, I am going to have tremendous difficulty in justifying more programs," Pearlman said in an email to another sales representative about a doctor's dwindling prescriptions.
According to the indictment, when one cooperating witness questioned the legality of being paid for speeches he wasn't giving, Pearlman brushed it off.
"Don't worry about the dinners," Pearlman is quoted as saying in the indictment. "Let [redacted] worry about the dinners. You just worry about writing scripts."
Manoj Patharkar, Pearlman's own doctor, received nearly $106,000 from 2013 to 2015. He lost his medical license late in 2016 due to improper prescribing. His lawyer did not return requests for comment.
But big payouts to doctors from drug companies pushing fentanyl aren't restricted to INSYS; they're ubiquitous.
NJ Advance Media acquired pharmaceutical payout data for three of those years (2013 to 2015) and found that companies marketing fentanyl poured at least $1.67 million into the pockets of state doctors, pushing prescriptions for ever-more accessible delivery methods of one of the most powerful opioids ever marketed.
Dr. Joseph Valenza, a Chester-based pain specialist, was paid at least $240,000 in speaking and other fees from drug companies from 2013 to 2015, mostly for Fentora, a lozenge form of fentanyl marketed by Teva Pharmaceuticals.
Dr. Louis Spagnoletti, another pain specialist based in Marlton, received at least $102,000 in speaking and other fees from INSYS, Teva and DepoMed Inc., each of which market a different brand of fentanyl, during the same time period.
Neither was an idle prescriber, ranking in the top 20 claimants for fentanyl in the state among Medicare patients in 2014.
Spagnoletti and Velenza did not return requests for comment.
The difference, according to federal prosecutors, is that INSYS reps allegedly gave explicit instruction to doctors to prescribe their drug in exchange for cash. Absent that key point, and you have a legal practice that occurs in New Jersey and the United States every day for a variety of pharmaceuticals.
Drug companies annually pay out billions of dollars to doctors to market their wares. Alexander said the amount spent on marketing amounts to a "thought leadership campaign" to affect prescribers' comfort level with the drug.
"It's unpalatable, but welcome to the world of modern medicine," he said.
All told, dozens of doctors in New Jersey each received more than $10,000 from pharmaceutical companies marketing fentanyl between 2013 and 2015, the only years for which data is available.
Dr. Andrew Kolodny, executive director of Physicians for Responsible Opioid Prescribing, described a system where pharmaceutical companies would pay doctors legitimate-seeming consulting or advising fees with the "understanding" that they would in turn raise their prescription numbers.
"It's an indirect way of incentivizing them to prescribe the drug," he said.
Jafri, who promotes the use of alternate pain therapy to opioids, said he's troubled by their continued wide usage and the influence of pharmaceutical companies.
"I'm really very much concerned," he said. "I need to see more response from the medical community, more vigilance. We are losing people. Families are losing loved ones. So I'm concerned, not for me, but for the entire United States."
Arthur Caplan of New York University sees parallels to the rise of Oxycontin, the opioid medication Purdue Pharmaceuticals began to market in the 1990s as a safe, non-addictive way to treat pain.
Sales of Oxycontin alone have reached $35 billion since its time-release version of the painkiller was introduced in 1995. Many blame Purdue and other pharmaceutical companies with spurring the current opioid crisis in the United States.
In May 2007, Purdue admitted to lying in its marketing and paid $600 million in fines.
"Oxycontin spiraled out of control. The feds were asleep at the switch while doctors were overprescribing," Caplan said. "We've failed our citizens with respect to pain-relieving meds. Businesses failed, medicine failed, the media failed, everyone failed."