S

TRATFORD, N.J. — There was a stranger waiting for Sarah Fuller when she visited her doctor to discuss switching medications for her back and neck pain — a saleswoman pitching a prescription version of the potent opioid fentanyl.

The drug, called Subsys, is so powerful, and the risk of addiction and overdose so formidable, that the Food and Drug Administration requires doctors to undergo special training before they are allowed to prescribe it. And it has approved Subsys only for cancer patients who suffer intense flares of pain.

Fuller didn’t have cancer. She had been in two car accidents and been diagnosed with painful fibromyalgia. Yet her physician “let the sales rep start talking about helping her with the pain,” David Fuller, who accompanied his daughter to the appointment, told STAT.

Sarah's father, David, was present when his daughter met with Dr. Vivienne Matalon and the sales rep from Insys.

Just over a year after that January 2015 office visit, 32-year-old Sarah Fuller was found dead in her bedroom by her fiance. The county medical examiner ruled her death 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. There was also a small amount of the anti-anxiety medication Xanax in her system.

Synthetic forms of fentanyl, most of it illegally shipped from China, have flooded into the US and Canada in the past year, causing hundreds of overdose deaths. But Sarah Fuller’s case shows that the prescription version of the drug can also be dangerous when it’s prescribed “off-label” for conditions it’s not approved for — and that Insys Therapeutics sales reps have encouraged doctors to do just that.

“They killed her,” Sarah’s mother, Deborah Fuller, said of those involved in putting her daughter on a high-dose regimen of fentanyl, which is up to 100 times more potent than morphine. “You took a beautiful girl getting ready for her wedding, something she dreamed of.”

There is no indication her fentanyl use and subsequent death was from anything other than the legal drug she was prescribed for her pain, said Richard Hollawell, a Marlton, N.J., attorney hired by Sarah’s family to investigate her death. He said the family plans legal action against both Insys and Dr. Vivienne Matalon, the Cherry Hill, N.J., physician who prescribed the Subsys.

Telephone messages and emails to Insys’s public relations representative and a company official were not returned. Matalon did not return multiple messages left at her office and home.

TLC-Healthcare
The Cherry Hill, N.J., strip mall where Dr. Vivienne Matalon practices. Dominick Reuter for STAT
Sarah's mother, Deborah, says Matalon and the sales rep are responsible for her daughter's death.

While doctors are allowed to prescribe drugs for off-label conditions, drug makers aren’t permitted to promote medications for these purposes. Insys, based in Chandler, Ariz., is under investigation by several state attorneys general and federal prosecutors for the marketing of Subsys, according to disclosures the company has made in public securities filings. On Thursday, 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 fentanyl.

Insys has already settled one case, in Oregon. The attorney general there alleged Insys was “implicitly misrepresenting to patients that Subsys should be used to treat migraine, neck pain, back pain, and other off-label uses for which Subsys is neither safe nor effective.” Subsys settled the case last year by making a payment of $1.1 million. It did not admit to any improper behavior.

In addition, both an Insys sales rep in Alabama and a nurse in Connecticut have pleaded guilty to federal kickback charges related to off-label Subsys prescribing. Those cases alleged that doctors and a nurse were paid kickbacks by company employees to prescribe the drug. The sales rep in Alabama was paid a base salary of $40,000 but received more than $700,000 in commissions from 2013 to 2015 based on the volume of off-label prescriptions written by doctors she called on, according to court records.

The aggressive and illegal marketing of Subsys comes as the country deals with an epidemic of opioid addiction. It follows other instances of the illegal marketing of opioids that have been blamed for helping to fuel the crisis. In 2007, Purdue Pharma, the maker of the painkiller OxyContin, pleaded guilty to a criminal charge related to its marketing of the drug and paid more than $600 million in fines.

“We have created a system by which [drug] companies go out and break the law, they may or may not get caught, and if they do get caught, they are just going to pay a settlement,” said Eric Campbell, a professor of health policy at Harvard Medical School who also is as an expert witness for the federal government in an ongoing off-label marketing case. “The settlement they pay is going to be less than they make doing these activities. It is just like parking tickets on delivery trucks.”

Sarah Fuller is not the only Subsys patient who is alleged to have died from taking the prescription drug. A case filed in July in Jacksonville, Fla., alleges Carolyn Markland died in 2014, only hours after taking Subsys in her doctor’s office. She was being treated for chronic back pain.

Subsys is the only brand-name drug Insys sells. In 2011, the year before it hit the marketplace, Insys was operating at a loss with no reported revenue. Last year, company revenues were $330 million and it reported a profit of $58.5 million.

The company recently announced that its founder, John Kapoor, would be stepping down as chief executive. According to a March financial filing, Kapoor is the largest shareholder in the company, with a stake valued at just under $600 million based on the most recent closing price of Insys shares.

Sarah's parents describe how opioids changed their daughter.

Sarah first started to heavily use painkillers following an auto accident a decade ago, her family said during an interview inside the modest ranch-style home where Sarah lived just outside Philadelphia.

Her car was broad-sided by another vehicle and she suffered several herniated discs in her back and neck. Just two years earlier, her vehicle had been hit from behind at a stop sign. That accident also left her with spinal pain.

It was not long before she was completely dependent on the drugs. She was on so many medications that in 2014, her kidneys failed, according to father, a baker, and her mother, who worked as an office administrator.

Her family said Sarah’s personality and physical condition changed after she became a chronic user of opioids. As a child, she was a standout soccer player. After high school, she worked for several years as an aide at nursing homes. She would frequently pick up extra hours, working back-to-back shifts for additional money. She enjoyed going out with friends.

On the drugs, she was lethargic and unmotivated, her family said. She gained 100 pounds. Walking even as far as the length of the driveway proved difficult. She would spend days in her pajamas and slippers, with the shades drawn.

A printout of her prescriptions from a local Rite Aid pharmacy, beginning in mid-2007 and continuing until her death in March, runs 122 pages. There are 974 individual prescriptions listed, many of them for 30-day supplies and some for longer. The drugs include the painkillers OxyContin and Percocet, antidepressants, and anti-anxiety medications.

Sarah received her first shipment of Subsys on Jan. 9, 2015: a box with a 20-day supply of the 200-microgram dose of the drug, delivered by FedEx. Medicare, which covered Sarah after she was determined to be disabled following a second car accident, paid $5,509 for the prescription, according to a pharmacy billing ledger.

The following month, Sarah’s dosage of Subsys was tripled to 600 micrograms, and the cost to Medicare doubled. In August 2015, Sarah started to receive 30 days of supply instead of 20. Her last delivery was on March 22, 2016, just three days before she died. The box contained 180 doses of Subsys at a cost of $19,657 to Medicare.

Subsys
The last box of Subsys medication that was delivered to Sarah Fuller. Richard Hollawell
Subsys

During the 15 months Sarah was on Subsys, Medicare paid $250,544 for the Subsys she was prescribed, according to a billing ledger prepared by Linden Care, a Woodbury, N.Y., specialty pharmacy.

After starting to take fentanyl, her need for opioids was more intense. Subsys is administered by a spray under the tongue and rapidly enters the bloodstream. It is intended to be taken every four hours. Sarah would set her alarm during the night to make sure she woke up to take a dose on time. If she waited longer than four hours, she would start to shake and become agitated. The drug also intensified feelings of depression, her family said.

She would take additional doses at times. Some months, she would run out before her next delivery arrived. To get her through the days she didn’t have Subsys, Sarah would take OxyContin she was also prescribed, her mother said.

Dr. Adriane Fugh-Berman, a physician and Georgetown University professor who helped the District of Columbia develop training programs for opioid prescribers, said the high doses of fentanyl prescribed to Fuller were likely inappropriate.

“They don’t work well for chronic pain,” she said of drugs like Subsys. Over the long-term, daily use of high doses of fentanyl can reduce oxygen levels in the blood. The respiratory system is depressed, and Fugh-Berman said it is not uncommon for some people on heavy doses of opioids to die in their sleep.

Sign up to our Weekend Reads newsletter

Please enter a valid email address.

Asked about the presence of the Insys drug rep in the doctor’s meeting with Fuller, Fugh-Berman called it a “new level of outrageous behavior and inappropriateness.”

Hollawell, the lawyer representing the Fuller family, said he confirmed the sales rep was at the meeting from notes kept in Sarah’s medical file at her doctor’s office.

The amount of fentanyl found in Sarah’s blood after she died was 15 to 20 times the therapeutic level and well above rates considered lethal, said Dr. Lewis Nelson, the chair of emergency medicine at Rutgers New Jersey Medical School. “This is clearly a fentanyl death,” he said.

“It’s very possible she was just on this drug chronically and overdosed a little bit,” Nelson said. “She either took too much by accident or by purpose.”

Subsys, Nelson added, is being “marketed well beyond its indicated use.”

Leave a Comment

Please enter your name.
Please enter a comment.

  • Another one sided story about the “da gerous big bad opiates” god, enough of this S*** already. I am so sick and tired of hearing and reading about these stories. Literally they are ALWAY’S the same Big bad DR pushed deadly powerful 100 times stronger than morphine opiate, Innocent poor patient not knowing better takes opiate, 1 month to Several years later poor patient found dead somewhere, Big bad opiate to blame for patient’s pathetic downward spiral…and untimely death and that Big bad Dr…Well, he unfortuanetly has met the Big bad Fed’s and the DEA and will probably lose his license to practice and/or lose his ability to prescribe ALL opiate schedule medication’s. Same Story, different day….and it is all a Bunch of C***. You see these stories ALWAY’S have something else in Common…the simple fact is that the big bad opiate WASN’T THE ONLY MEDICATION FOUND IN DECEASED PATIENT’S SYSTEM a liitle benzo also known as “Xanax” and I will tell you without a doubt 100% that Girl is dead because she was using a Benzo IN COMBO WITH THE OPIATE. But here we are so quick to point fingers and say the opiate all ALONE caused her death and nothing else. WRONG. As long as she was opiate tolerant and by reading her dosage amounts she was opiate tolerant than her body was very use to having the drug in her system in those amounts she wouldn’t have died from it a YEAR AND A HALF LATER just all of a sudden…it just doesn’t work that way…the XANAX suppressed her breathing in combo with the opiate. Bottom line if she hadn’t of used Xanax she would still be alive presuming that she didnt commit suicide. Fast Forward to Today’s reality that is No DR left willing to help chronic pain patient’s, or prescribe opiate medication for those living with chronic intractable non cancer pain because of people such as this patient and the few” bad seeds” also know as “addicts” that have made it impossible to be treated with medication’s that most people living in daily pain will tell you are a god-send and have allowed their life to be worth living. I have also seen people with depression and pain so bad that they couldn’t function on a day to day basis in their own home, let alone society who were given an opiate medication and it completely turned their life around, people who were down and out, desolate, isolated, and living without meaning who FULLY REGAINED their life, NO more depression, people who hadn’t worked in decade’s holding down jobs, out and about in society,and functioning more so then they did when they were in their 20’s all because the opiate medication not only made their pain tolerable but it also knocked their depression something no anti-depressant was EVER ABLE TO DO. You see these medications can and do have a purpose and for MANY have made life worth living again. But the reality today is that people like this who made poor choices, or decided to be dumb and overuse, or addicts etc…have made it so people who truly benefit from these medication’s can no longer get them. I have seen more pain patient’s people who truly have every legitimate reason in the book to be receiving these medications be weaned off of them, and stopped completely all because the Dr’s are too fearful of getting shut down because of the medication they were prescribing their patient, who had shown great improvement in quality of life and had never had any problems but can no longer receive their medication because the risk to the DR is too great. This is what our society has come too, yes, we have the medication’s too help those who have a legitimate need to have them, However, no Dr is left that will take a risk to prescribe them, and if those few are lucky enough to get a small amount for pain they may have a hard time even filling the prescription due to many pharmacy’s refusing to fill opiate meds even though it is a legitimate RX. You want to write stories based on ALL the negatives of opiate’s well here is a HUGE STORY on how NO ONE can get help for pain anymore and how the DR’S ARE TOO AFRAID TO PRESCRIBE. This is the REALITY NOW, they used to use these medication’s and now the pendulum has swung SO FAR IN THE OPPOSITE direction its unbelievable. Now the “standard of care” is too let the “pain patient” suffer at whatever cost because the risk is too great to help them with opiates. This has become a full blown crisis in this nation and something needs to be done. This is where the real story is how so many people have been ripped off their medications, medications that were helping them, medication’s that made their lives tolerable but how they can no longer get them. Same story in EVERY STATE ACROSS THE COUNTRY. You want to talk about the live’s lost to opiates??? Try looking into to the increase in suicide due to pain patients taking their own lives because they can no longer fight and life isn’t tolerable anymore since they lost their pain medication. Just had a friend of the family last year blow her head off, she left behind 2 sons, and 1 new grandbaby. She was a loving wife and mother/grandmother but is no longer here because her Dr said he could no longer prescribe her pain meds it was too “risky” and he was in fear of losing his license to practice. She had done nothing wrong, she was a model patient but was punished because of others and a few bad seeds…just like all the rest of the legitimate pain patients who can no longer get their medication’s. It’s very sad what the medical community has come to and the “war on pain patients/pain meds” has gotten damn out of hand. Do a story on this, Im sure you will find plenty of pain patients and DR’s to interview.

    • Yes you are right and before long you will stories of people lying in bed in Agony because Doctors refuse to Wright for Pain Meds

  • She wasn’t properly educated on the safe use of her medication. You can’t blame the drugs for this one. The problem is always the people, never the drugs

    • Regardless of safe use education, when taking a highly addictive drug, it takes control and the patient loses their control. Shame on you for not being educated on Subsys.

  • I see these crooked animals were arrested today. What makes these people different than a street level heroin dealer. Nothing. In fact this is much worse. These people were blindly trusted because of their degrees and lab coats. They abused that trust for a few dollars. I hope they do some serious hard time.

  • Some notable DOJ settlements over the course of the past several years…

    – Eli Lilly (E.D. Pa. Jan. 2009): $1.4B for Zyprexa.
    – Cephalon (E.D. Pa. Sept. 2008): $425M for Actiq, Gabitril, & Provigil
    – Bristol-Myers Squibb (D. Mass. Sept. 2007): $515M for Abilify & Serzone
    – Purdue Frederick Co., Inc. (W.D. Va. May 2007): $635M for OxyContin
    – Serono (D. Mass. Oct. 2005): $704M for Serostim
    – Warner Lambert (D. Del. May 2004): $430M for Neurontin

    Government wants even more money…on top of all the costs they already pocketed just for the company to get their product to market. When the government and media smell blood in the water…watch out. You’ve already lost. Whether guilty or not. They’ll tear you down and make you into the villain (“We’ll protect you poor innocent people from those corrupt greedy rich murderers! No not us! We’re the good guys! Them! Those guys!”…all the while they’re the only ones who’s pockets are getting deeper.

    • The drug company’s pockets were absolutely deepened!!! And the finger still points to THEM.

  • I read your comments. You need to look into what people are telling you. Do the work. Why would you report so one sided.
    It’s like you don’t care that the elderly , our Vets, chronically ill people are laying in bed screaming in pain. I know you have people in your family that are very ill. Are they getting their pain medication ? Interesting. They have some people around you putting out some big money to stop chronic pain patients from getting help. Big Pharma has people in their pocket. Very sick people are being make to spend 9,000 a month going to pain clinics and some to Palliative Care, which Palliative Care is a big joke in Olympia, WA , to beg them to help with pain. This you have to go to every month. They are also making money off us.
    Well not as much money as the drug companies are making by telling them give them this medication et on an on a long list of unchecked meds straight off the line. Shame on you people shame on you.
    You take one bad story an you never report anything good that comes from medication that helps people. Medication they can afford. Shame on you

    • I agree I can’t see letting people suffer with screaming pain because of such things some say Dr’s are afraid to giv patients meds no body should be in agony pain if that be the case why didn’t parent see so much change and stop some of the meds check was probably bought drugs from streets like street drugs should be stopped yes and u wont stop that shame on our government to stop meds so elderly people vets injured people be in cronic pain u will find more deaths of people who rather be dead than be hurting all the rest of thier lives sorry I don’t agree with shutting down pain clinics Dr prescrbe meds they can’t go home with patients and watch them take them over taking meds is a person’s on doing concerned I am

  • Im sorry, but why didn’t the family do something WHILE this woman was taking this drug??? I dont believe they didn’t know what kind of drug it was, not with so much info right at our fingertips today, such as on the internet.Looks to me this person had emotional problems, and addiction problems, and probably used more of this medicine than she should have, killing herself as a result. it’s very sad, But it was HER choice to use these medications. Now the family says “they killed her” (yawn) It’s always blame someone else, and in this case, sue someone and get some big bucks out of the deal.

Recommended Stories

Sign up for our biotech newsletter, The Readout

A guide to what’s new in biotech — delivered straight to your inbox every weekday morning.