Insys Therapeutics And The New ‘Killing It’

On the evening of July 1, 2014, Carolyn “Suzy” Markland, a 58-year-old Jacksonville, Fla., 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 paid $18,874.03 by Subsys’ manufacturer to travel and speak to fellow doctors. The firm isa small but rapidly growing pharmaceutical company called Insys Therapeutics.

Additionally, the 16 Subsys prescriptions written by Dr. Florete from Jan. 1, 2013, to May 31, 2103 , according to documents obtained by the Southern Investigative Reporting Foundation through the Freedom of Information Act, cost the U.S. military primary health insurance plan Tricare $133,770.36.

Pharmaceutical companies’ compensating physicians for discussing their product — or even attending carefully scripted seminars — is a longstanding, and legal, practice. To be certain, many within the medical community have been concerned about this for a while, and in 2013 regulations were put in place to ensure disclosure of all physician payments. (Pro Publica has published a wealth of information on the issue.)

A phone message seeking comment from Dr. Florete about his relationship with Insys and his Subsys prescription writing was not returned by the time of publication.

Like Dr. Florete’s speaking engagements, another unremarked-upon issue was the nature of Carolyn Markland’s Subsys prescription. The drug indicated to treat breakthrough cancer pain was prescribed for a bad back. The law affords doctors great latitude in determining whether drugs can be prescribed for reasons other than what they are designed for. On the other hand, doctors’ writing prescriptions based on off-label marketing have been at the center of nearly two dozen False Claims Act cases in the past 20 years, resulting in more than $13 billion in pharmaceutical company fines and settlement payments.

In the case of Subsys, its official label — indicated by the folded paper insert with the impossibly small typeface that comes with the package — notes that it’s contraindicated for those with headache pain and people not tolerant of the opioid class of drugs. According to the Centers for Disease Control and Prevention, 175,000 people died from some form of prescription opioid abuse from 1999 to 2010 compared with 120,000 from heroin and cocaine overdoses.

Like Dr. Florete, Insys Therapeutics has been doing pretty darn well. The company has had a remarkable level of financial success and its soaring stock price, as shown in the chart below, has made it a darling on Wall Street.

Screen Shot 2015-04-23 at 7.55.46 AM

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.

While details about this breakthrough cancer pain medication are hard to find, or at least ones that are not self-serving management hype, veteran sales staff members from Insys and other pharmaceutical firms projected the company’s future growth rate to be roughly 10 percent a year. If this ends up being the case and the company is selling to oncologists, then the growth possibilities for Insys should be a function of that plus whatever business it can take away from its larger competitors. Many companies would be happy for those odds.

But Insys’ revenue grew north of 100 percent: Whatever organic growth the company is achieving is being aided by a whole lot of doctors who have grown profoundly fond of an expensive drug that’s accompanied by an acre of governmental red tape and one that the largest pharmacy benefit managers will no longer touch.

The question then becomes “how?”and “why?”

An investigation of Insys by the Southern Investigative Reporting Foundation reveals that this growth has come at a remarkable price: Food and Drug Administration data shows that Subsys is proving lethal to a growing number of patients, many of whom, like Carolyn Markland, are taking it for so-called off-label indications, such as headaches and back pain.

In reporting this story, the Southern Investigative Reporting Foundation repeatedly encountered former Insys employees who had received subpoenas requiring their appearance in front of a Department of Justice grand jury that has been empaneled in Boston. Still others had been interviewed for an investigation of the Department of Health and Human Services’ Office of the Inspector General.

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Disclosure: Neither SIRF nor its employees, contractors, board members or advisors has any economic stake in what we report on, before or after the release of the investigation. No one sees or is ...

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