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Upon typing Insys Therapeutics in the Google search bar, the searcher is lead to a website that is couched in legalese. In addition to informing the reader that the company she is looking for has gone bankrupt, the website also offers an option to lodge a third party claim against the company, in the event she has suffered adverse consequences post using the company’s products. While the how and where of the claims themselves are dealt with by the website, the intriguing parts relating to the who, why and what of a now defunct entity and its buccaneering stewards, are revealed in a jaw dropping manner by reporter Evan Hughes in his rip roarer of a book “The Hard Sell”.
Hobnobbing with doctors of a suspect character doling out prescriptions from virtual ‘pill mills’, recruiting exotic dancers from strip tease clubs to double up as medical representatives to gain speedy and beneficial access to medical practioners, hoodwinking insurance agencies by misrepresenting both the nature and severity of the patients’ illnesses, and sponsoring sham ‘speaker programmes’ which were brazen euphemisms for bribe, the top brass at Insys Therapeutics consistently and liberally pushed the envelope of greed and chance.
An ebullient founder (John Kapoor), in cahoots with an enigmatic CEO (Michael Babich), an eccentric vice president of sales (Alec Burlakoff) and an enthusiastic vice president of marketing (Matthew Napoletano) formed an unlikely quartet at Insys Therapeutics. Buoyed by the FDA approval for their blockbuster pain medication Subsys, the Four Musketeers wanted their company to be the unquestioned colossus in its domain. Subsys itself represented a very niche product falling under the category of rapid-onset opioids. Technically termed, “TIRF” (an abbreviation for transmucosal immediate-release fentanyl), Subsys was to be used solely to treat ‘breakthrough’ pain (pain that breaks through all layers of protection) experienced by cancer patients. To be prescribed with immense discretion and care, fentanyl was an opioid capable of causing untold physical and mental damage. Hundred times as powerful as morphine and approximately fifty times as influential as heroin, fentanyl represented one of the prime reasons behind the opioid epidemic roiling the United States.
Let the opioid crisis be damned, Kapoor and his cronies found themselves gripped in the throes of an ambition that was as suicidal as it was fantastical. Spending hundreds of thousands of dollars as an incentive for prescribing Subsys as part of a sham speaker’s program, Insys employees identified the top ‘decile’ doctors specialising in pain management and dubbed these medical practioners, “whales.” The identification of the whales itself was a laughable administrative charade of Shakespearean proportions. Due to its dangerously unique properties, the distribution of TIRF drugs had to adhere to a protocol named REMS (Risk Evaluation and Mitigation Strategy). Every prescriber of a TIRF drug had to enroll in the TIRF REMS access programme and pass a “knowledge assessment” quiz. Incredulously, this REMS programme was sponsored and administered by the very manufacturers producing the TIRF drugs! Talk about appointing a fox to guard the chicken coop!
The whales identified by Insys were all enrolled into the infamous ‘speaker programme’ from where began to grind the finely lubricated levers of an unabashed quid pro quo arrangement. As Insys ingratiated itself in a myriad number of abominable ways to the doctors (sales reps even took the doctors’ dogs out on walks, brought in their cars to the mechanics and picked up relatives from airports), the satiated and unscrupulous doctors began prescribing Subsys as if there was no tomorrow. A drug that was to be solely and stringently administered to make the last days of terminally ill patients as painless as possible was being administered to treat back pains, migraines and everything in between. Astonishingly, Insys also maintained a spreadsheet that exhibited the return on investment, that the company received from each “speaker” for every dollar expended by the company on a doctor or a nurse.
As Evan Hughes illustrates in a vindictive and eviscerating fashion in the closing chapters of his book, the rot of corrupt practices has its roots, an intransigent system ringfenced by an insouciant set of rules. The gall and temerity showcasing the misdeeds of the executives at Insys, had their genesis in the allure of past precedents. Purdue Pharma, a company owned by the ignominious Sackler family was singularly responsible for the devastation wrought by the abuse of the powerful opioid, Oxycontin. As a punishment for engaging in reckless behaviour and imperiling the lives of millions of innocent patients, Purdue Pharma barely got a rap on its knuckles and was let off by paying a significant sum as ‘penalties’. Not a single member of the Sackler family saw the confines of a prison.
It is not just Purdue that has gotten away lightly for all its excesses. As a 2018 research report by the consumer advocacy group Public Citizen, disconcertingly illustrates pharma companies pled guilty to federal crimes at least forty-eight times from 1991 to 2017. Household names such as Pfizer, GlaxoSmithKline, Novartis, Bristol Myers Squibb, Teva, Merck, Johnson & Johnson, AstraZeneca all paid to settle Justice Department investigations between 1991 and 2017.
The prosecutors therefore decided to make an ‘example’ out of Insys. It is left to the readers to decide whether judgment in Insys was a trail blazer and a sign of things to come or the defenestration of an easily accessible scapegoat. An absolutely callous attitude towards documentation practices and an inexplicable reluctance to appoint a legal compliance team made it convenient for the law enforcement authorities to apply the dreaded provisions of the Racketeer Influenced and Corrupt Organizations Act (“RICO”) against Insys and its chieftains. A powerful weapon to penalize and prosecute the mafia, RICO is a persuasive tool when wielded with vigour.
Babich, and Burlakoff escaped with light sentences after striking a deal with the Department Of Justice and testifying under immunity against Kapoor. Both were sentenced to around thirty months in prison. Kapoor copped a jail time of 5 years and at the time of writing is serving his sentence.
The two biggest whales, Dr. John Patrick Couch and Dr. Xiulu Ruan were sentenced to 240 months and 252 months, respectively, in federal prison for running a massive pill mill in Mobile, Alabama. The two doctors and owners of C&R Pharmacy, split 75% of the profits attributable to the prescription drug reimbursements. Approximately 91% of the prescriptions written by the two doctors cost patients’ insurance anywhere between $1,000- $24,000 per month. Dr. Couch even permitted one of his nurse practitioners, Justin Palmer, to forge Dr. Couch’s name on prescriptions for Controlled Substances more than a dizzying 25,000 times!
Even Hughes, “The Hard Sell”, along with Patrick Radden Keefe’s “Empire of Pain” (a book chronicling the hubristic fall of Purdue Pharma), represents two of the finest books written about the miasma plaguing the inner workings of the pharmaceutical industry.