Deborah Fuller is clear about what she will tell Sen. Claire McCaskill next week about the pharmaceutical industry's role in her daughter's overdose last year:
"Basically, you know, they set her up to die."
She will say this in Washington on Tuesday because she has proof: a 2015 audio recording of a drug industry representative pretending to work for the Cherry Hill doctor who was treating Sarah Fuller. On the recording, the rep can be heard misrepresenting Sarah's diagnosis so that she could receive one of the most powerful and deadly opioids on the market. The motivation? This drug, approved only for cancer patients, costs over $20,000 a month. In Sarah Fuller's case, the bill to taxpayers came to more than a quarter-million dollars, since she was disabled and covered by Medicare.
That recording is the most explosive part of a report McCaskill released about the actions of Insys Therapeutics Inc., the company accused of setting up an entire department to divert calls and feed insurance companies false details about patients to qualify them for a drug approved only for cancer pain so severe that it "breaks through" other medicines.
McCaskill has been investigating the roles that five pharmaceutical manufacturers, including Chandler, Ariz.-based Insys, played in fueling an epidemic that has killed more than 180,000 Americans since 1999. Over the summer, the Missouri Democrat she added four — among them Endo International of Malvern and Teva Pharmaceuticals, with North American headquarters in North Wales — along with the three dominant distributors of prescription medications, including AmerisourceBergen Corp. of Chesterbrook.
Fentanyl has soared to the top of the list of opioid killers in the United States. Though it can be a legitimate medicine, it also can be made and distributed illegally. Cartels from China have produced and shipped the illicit product, and dealers here mix it with heroin and other drugs, lowering their cost and increasing their potency. Fentanyl is estimated to be 50 times as powerful as heroin; Pennsylvania coroners detected it in the bodies of more than 2,000 accidental overdose victims last year, according to an analysis by the U.S. Drug Enforcement Administration's local division.
While illegal fentanyl is responsible for the overwhelming majority of deaths, pharmaceutical brands also are dangerous and tightly regulated. Subsys, a brand that is sprayed under the tongue and absorbed quickly — a new dose must be given every four hours, round the clock — was approved in 2012 for cancer patients with breakthrough pain. The U.S. Food and Drug Administration added bold warnings and requires prescribers to receive special training.
Insys has been implicated in numerous state and federal investigations involving the marketing of Subsys, the only drug it has on the market. FBI agents arrested a former CEO and five other executives last year on charges that they bribed physicians to prescribe Subsys. The 31-page report released by McCaskill, the ranking Democrat on the Senate Homeland Security and Governmental Affairs Committee, pulls together previous investigations under the title "Fueling an Epidemic: Insys Therapeutics and the Systemic Manipulation of Prior Authorization."
In a statement released in response to the report, Insys said it has "cooperated extensively" with the investigation. "The report relates to activities of former employees of our company and matters that the company has addressed in its own efforts and in connection with investigations by the Department of Justice and state attorney general offices," it said, noting that it had "invested significant resources in establishing an effective compliance program" that would "ensure high standards of integrity from our current employees."
Insys also released a letter to McCaskill from Saeed Motahari, its president and chief executive officer.
According to the Senate report, FDA efforts to limit distribution of Insys' sole product led pharmacy benefits managers to approve only about 30 percent of requested reimbursements for the $20,000-a-month drug. "In response to these challenges, Insys allegedly created a prior authorization unit, known at one point as the Insys Reimbursement Center (IRC), to intervene," the report says, and "boost the rate of Subsys authorizations."
Employees claiming to be from doctor's offices used a toll-free phone number — later traced to Insys — to call benefits managers and give false information about patients. Approval rates more than doubled. Elizabeth Gurrieri, the former head of the IRC, pleaded guilty "to having conspired to defraud insurers" in June.
Sarah Fuller, who lived in Stratford, went to her doctor's office in January 2015 to hear about a new medication that might help her chronic head and neck pain, which resulted from two car accidents. A sales rep did most of the talking, recalled her father, David, who accompanied her to the appointment and said there was no mention of significant risks or that the drug was approved only for cancer patients. (The doctor's license has been suspended.)
An audio recording of a conversation that followed between an Insys representative and the pharmacy benefits manager captured what happened after the prescription was submitted. The nearly nine-minute recording — excerpted in the Senate report and posted here in full — begins with the Insys representative saying, "I'm with the doctor's office," and seeking prior authorization for Subsys. Later in the conversation with the Envision Pharmaceutical Services representative, the rep refers to "breakthrough pain" rather than "breakthrough cancer pain," suggesting wrongly that Fuller is eligible for the drug:
Fifteen months later, with Subsys arriving monthly by FedEx, Fuller's fiance found her unresponsive at their Camden County home. A toxicology report found fentanyl in her blood.
Richard Hollawell, a personal-injury attorney in Marlton, obtained the audio recording from Envision in response to a subpoena for a civil suit he filed against Insys on behalf of Fuller's estate in March, and turned it over to McCaskill's committee. He is expected to testify at next week's hearing, which the senator announced on Thursday. Hollawell also has sued Teva over the role that the marketing of its own brand of fast-acting fentanyl, the Actiq "lollipop," allegedly played in the death of a man in Philadelphia.
Hollawell's "heart sank," he said, when he listened to the recording. Then he called Deborah Fuller. "One of the most difficult things I ever had to do was play that call for her," the attorney said.
"I still hear that [recording] in my head," Fuller said. "Basically, you know, they set her up to die."
Sarah's wedding day was to have been Aug. 18. "So instead of going to the church and having a nice reception, we went to the cemetery," her mother said. "Her fiance left flowers, my daughter and I left wedding balloons, and my husband left two giant champagne flutes and a cake topper."