On the evening of July 1, 2014, Carolyn “Suzy” Markland, a 58-year-old Jacksonville, Florida, resident with a degenerative disc disease, took her prescribed medicine — a 400-microgram dose of a Fentanyl spray called Subsys — and went straight to bed.
Despite the fact that she regularly experienced pain, taking Subsys was not an everyday affair for Markland. Her prescription had been filled several months prior but she almost never took the stuff; her longtime family doctor and pharmacist had expressed to her plenty of no-holds-barred skepticism about it. On the three occasions she had taken Subsys, her family noticed that its sedative and respiratory effects were noticeably sharper than those of another strong painkiller she took, Exalgo.
On July 2, Markland visited Dr. Orlando Florete, her pain-management physician of five years, for a scheduled injection for her lower spine. As part of her anesthesia mix prior to the procedure, she received another Fentanyl dose. Unlike what was the case after previous procedures, however, she wasn’t up and moving some 20 to 30 minutes afterward; this time it took about an hour until her oxygen levels allowed for her to be safely released.
Markland was tired for the balance of the day and headed to bed early, skipping her usual cup of decaf beforehand.
She never woke up.
With Markland pronounced dead at 7:01 a.m. on July 3, the Jacksonville medical examiner’s office listed the cause of her death on its report as “drug toxicity,” noting the presence of Fentanyl and Exalgo. Her death was classified as “accidental.” The report also noted that Markland’s family doctor refused to sign the death certificate; Dr. Florete did.
Bob Markland, Carolyn’s husband of 19 years, declined to comment apart from providing a timeline of her Subsys use.
The medical examiner’s report of a lethal combination of Fentanyl and other drugs in Carolyn Markland’s blood is puzzling and sad, seemingly emblematic of a strain in modern American medicine whereby solutions to pain can be as scarce as the medication for that pain is abundant.
In another sense, this tale recounting Dr. Orlando Florete’s treatment presents a parallel trend in American medicine — that of the physician as a compensated endorser. According to figures from the Center for Medicare & Medicaid Services’ Open Payments database for the last five months of 2013, Florete was
But that level of growth ought to warrant a raised eyebrow: Achieving in just two years more than $222 million in sales (from a level of about $15.5 million) without having invented something like a better search engine is no mean feat. Fentanyl, after all, has been around for many years. And while Subsys is the only spray version available, several Insys competitors are well-established and better capitalized and have sales forces that reach all 50 U.S. states.
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Many of Burlakoff’s former colleagues, however, described a very different experience with the speakers program.
A qui tam claim filed last year by former Insys salesman Ray Furchak alleged that the speakers program’s sole purpose was, in the words of his then supervisor Alec Burlakoff, “to get money in the doctor’s pocket.” The catch, Furchak alleged, was that the doctors who increased the level of Subsys prescriptions, and at higher dosages (such 400 or 800 micrograms instead of 200 micrograms), would receive the invitations to the program — and the checks.
The claim described texts from Burlakoff to Furchak and other sales colleagues regularly demanding that “doctors be held accountable” and that “doctors who are not increasing their clinical experience [prescription writing], please cancel, suspend, and cease doing speaker programs.”
The Department of Justice chose not to join Furchak’s suit and he withdrew it. Reached at his new job, Furchak said he stood by everything he had alleged but declined to comment further.
Conversations with former sales staff members support Furchak’s allegations that the speakers program was regularly used as a lever to pressure doctors to increase dosage strength as well as the frequency of their prescriptions for Subsys. In return, former sales staff members (who were granted anonymity in this story because of their involvement with the Department of Justice’s grand jury proceedings) often had to deal with doctors’ annoyance about payment levels or delays in receiving their checks.
The speakers program events have often been held at branches of Roka Akor, a tony sushi-steak restaurant company with venues in Scottsdale, Chicago and San Francisco that’s owned by Insys founder John Kapoor. Based on interviews with multiple attendees, the expenses often run into the thousands of dollars and, given the sheer number of events, have helped his restaurants capture a handsome revenue stream. An email to Insys CEO Michael Babich seeking comment was not returned by the time of publication of this article.
Former sales staff members also disagreed that Burlakoff’s full-throated rejection of off-label sales was shared by upper management. As evidence of this, two former salespeople pointed to a quarterly meeting in Atlanta for the Southeast region sales team in a June 2014 when CEO Michael Babich, during a question and answer session, read a question about the risk of off-label sales, given Cephalon’s steep penalty in 2008.
“I understand why you’re asking that question,” said Babich. “But Cephalon didn’t have TIRF-REMS; we do. You are protected because both the MD and the patient have signed it.”
Asked to elaborate, Babich said because of the TIRF-REMS requirement that the patient be extensively briefed on the risks of Subsys, there couldn’t be a plausible claim that the patient (or doctor) did not know what he or she were doing.
As one of the two attendees who described this event to SIRF put it, “There wasn’t much else to say about the issue when your CEO sees an information protocol as an insurance policy.”
Putting Insys’ assertions about serving cancer patients aside, the company’s bread is buttered by pain-management and physical-rehabilitation doctors, according to Tricare’s reimbursement and prescription data from Jan. 1, 2013, to May 31, 2014. Tricare represents about 9.5 million people, or 3 percent of the U.S. population.
Listed below are Tricare’s top 15 prescribers of Subsys.
Among the top 25 Subsys prescribers within the Tricare system, there are 20 pain-management physicians, one osteopath, one nurse practioner and three physician assistants. (See a full list of the top 25.)
The Southern Investigative Reporting Foundation attempted to contact Dr. Xiulu Ruan and Dr. Patrick Couch, partners in a Mobile, Alabama, practice, about the fact that they were the leading Subsys prescription writers by an impressive margin, to discuss this, as well as their ownership of C&R Pharmacy, which dispenses the drug to their patients. (About 50 percent of the Subsys dispensed in the United States is handled by Linden Care, a specialty pharmacy on New York’s Long Island, owned by Bell Health Ventures, a private-equity fund.)
Anthony Hoffman, a lawyer representing the practice, told the Southern Investigative Reporting Foundation, “Based on your representation of the [Tricare] data you discussed with my client, we believe it to be inaccurate and encourage you not to publish it.” He did not specify what was wrong with the data and declined to provide further comment.
As first reported in The New York Times, a series of Insys’ leading prescribers have been at the center of serious allegations involving their prescription-writing practices.
Last May federal prosecutors filed a complaint against Gavin Awerbuch, a Michigan-based pain-management physician and the company’s largest prescriber under Medicare (and third most compensated), for allegedly bilking Medicare out of $5 million over several years. Prosecutors allege that he wrote 20 percent of the Subsys prescriptions dispensed to Medicaid recipients nationwide from 2009 to 2014. (Subsys, however, has only been FDA-approved since January 2012.)
In December 2013 Judson Somerville, a Laredo, Texas-based pain-management physician (the No. 8 prescriber under Medicare and the most compensated) had his prescription-writing privileges “temporarily suspended” by the Texas Board of Medical Examiners for a host of findings, including having three patients die with six months of 2012; it was not the first time he had regulatory trouble.
Stewart Grote, a Lansing, Kansas, pain physician and the company’s fourth biggest Tricare prescriber (he received $8,48.05 from Insys), was sanctioned for multiple standard of care lapses and is no longer registered as a physician in that state, according to licensing records; he also had an earlier regulatory issue in 2010.
The Florida Department of Health sued Paul Wand and Miguel de la Garza, the No. 11 and 23 Tricare prescribers, in 2012. (Wand received $20,169.06 from Insys; de la Garza $17,019.04.) The department alleged Wand’s standard of care did not meet professional standards for a series of patients, particularly with regard to his prescription writing. With respect to de la Garza, the department claimed he did not professionally administer care to one specific patient. According to the Florida Board of Medicine’s Web site, both cases appear to be ongoing.
Chicago-based pain-management physician Paul Madison is not among the top 25 Tricare prescribers but he was the 17th most compensated under the speakers program. He was indicted in 2012 in connection with an alleged $3.5 million false insurance billings scam. The case is ongoing.
Heather Alfonso, the 25th largest Tricare prescriber of Subsys and a Derby, Conn.-based nurse practitioner, surrendered her state and federal nursing and prescription-writing licenses within the past month amid a Connecticut Department of Public Health investigation into her conduct. A February Connecticut Health I-Team story reported that in 2012, the most recent year for which data was available, she was among the nation’s top 10 prescribers of Schedule II substances within Medicare’s drug program.
The Southern Investigative Reporting Foundation asked CEO Michael Babich for comment via a detailed voice message left on his office phone and a pair of emails. He did not reply by publication time.
Clarification: This piece has been updated to clarify the description of former work roles of Jeff Pearlman, Insys’ New York regional sales manager. He served as the sales and marketing chief of an aquarium company. He also worked at two medical technology companies.
Update: This story was updated on March 22, 2016.