Since its introduction in 1996, OxyContin has sown an opioid epidemic that has caused more than 1 million fatal overdoses in the US, ravaged regions like Appalachia and the Rust Belt, and may have helped elect Donald Trump. But no one at Purdue Pharma, maker of the addictive painkiller, went to jail for misleading doctors, patients, and regulators about its dangers, not even after the firm pleaded guilty in 2007 to federal charges.
The dubious honor of being the first pharmaceutical company whose executives went to prison for misdeeds in the opioid crisis belongs to a small and briefly high-flying startup in Arizona called Insys Therapeutics. After a closely watched federal trial in Boston in 2019, seven former executives were sentenced to up to 5½ years behind bars. They had been convicted of running a nationwide racketeering scheme to bribe health care providers to prescribe Subsys, an under-the-tongue spray containing the potent and addictive synthetic opioid fentanyl.
Now, almost exactly three years after the start of the trial at US District Court in the Seaport District, Evan Hughes has written “The Hard Sell: Crime and Punishment at an Opioid Startup.” It is a tightly focused and insightful account of how a company that went public in the most successful IPO of 2013 soon ended up a poster child for corporate greed and chicanery, a firm so corrupt that prosecutors brought it to heel using federal statutes created to fight the Mafia.
I was among the journalists who covered the 10-week trial, and for many of us the most jaw-dropping moment came when prosecutors played jurors a polished, thumping rap video produced by two young members of Insys’s sales force for a national sales meeting in 2015. Wearing sunglasses and hoodies, the salesmen danced next to an executive dressed as a Subsys spray bottle and sang their own lyrics to an A$AP Rocky song to prod co-workers to get more doctors to prescribe the painkiller. Subsys was up to 100 times as potent as morphine, but the dancing duo could have been promoting a product as innocuous as Doublemint chewing gum.
Although the five-minute video was breathtakingly tone deaf, “The Hard Sell” suggests it made eminent sense given Insys’s hell-be-damned business model. Under the leadership of the company’s Indian-born billionaire founder, John Kapoor, sales executives identified a few dozen doctors and nurses across the US with a history of prescribing large quantities of opioids. The firm then paid each tens of thousands of dollars to prescribe Subsys as part of a sham speaker’s program. Insys employees dubbed the prodigous prescribers “whales.”
The US Food and Drug Administration had approved Subsys in 2012 to treat a relatively small group of people: cancer patients already taking an around-the-clock regimen of opioids such as OxyContin but still suffering from so-called breakthrough cancer pain. These patients needed relief, fast. Subsys was competing against several other fentanyl-based medications made by rival drug firms for the niche market.
But the whales bribed by Insys prescribed Subsys for everything from back pain to migraines. Off-label prescribing by doctors is legal and common, but it’s illegal for drug makers to promote the practice. “The rationale is in determining what is safe and appropriate for a patient, a highly trained doctor should be given leeway to depart from FDA guidance, but a drugmaker should be given no leeway at all, in view of its obvious bias,” Hughes writes.
Not only did Insys encourage off-label prescribing, it did little to hide that it was using payoffs as an inducement. One of the most damning government exhibits at trial was a company spreadsheet that Kapoor insisted underlings create over their strenuous objections. It showed the ROI, or return on investment, that the company received from each “speaker” for every dollar Insys paid the doctor or nurse.
“In other words, he wanted a written analysis of whether the bribes were working,” writes Hughes.
Several Insys executives came from rival drug firms with similar speaker programs and were hardly averse to paying prescribers. But they knew better than to put an ROI in writing or to describe a prescribing doctor in an e-mail as a “very shady pill mill,” as one member of the Insys sales force did.
Subsys didn’t come cheap. A typical prescription in 2013 ranged from $3,000 to $17,000 a month, depending on the dosage. Medicare paid over $70,000 for one patient’s 10-month supply prescribed by a Michigan doctor who was arrested by federal authorities and became a cooperating witness against Insys executives.
Given Subsys’s high cost and the fact that it had been approved to treat cancer breakthrough pain, Insys faced resistance from health insurers to cover it. So the drug firm concocted a “reimbursement center” where Insys employees posed as staffers in doctors’ offices and called insurers to say patients were being treated for cancer pain when they weren’t.
Marbled throughout “The Hard Sell” are vivid portraits of key executives. The most fascinating may be Alec Burlakoff, the shameless if brilliant pharmaceutical sales veteran behind the speakers program who wore the Subsys spray-bottle costume in the rap video. (He pleaded guilty before trial and became a star witness for the government, receiving a reduced sentence of 26 months in prison.)
The book deftly showcases several lawyers in the case, too, including Assistant US Attorney Fred Wyshak Jr. He knew little about health care fraud but a lot about racketeering, having helped prosecute the notorious James “Whitey” Bulger. Sounding like someone the average juror might know from the neighborhood, Hughes writes, Wyshak “portrayed the defense’s arguments as nitpicky technicalities that he was going to counter with some straight talk, with a tone of let’s cut the BS.”
If there’s one element that gets relatively short shrift, it’s the patients who got addicted to Subsys. Although no one contends that the painkiller played remotely as big a role in the opioid crisis as OxyContin, I wanted to read more about people who took it for aches that had nothing to do with cancer and got hooked.
Still, as a gripping tale of one drug firm’s unscrupulous efforts to profit from pain, “The Hard Sell” is hard to beat.
THE HARD SELL: Crime and Punishment at an Opioid Startup
By Evan Hughes
Doubleday, 288 pages, $28.95
Jonathan Saltzman covers life sciences at the Globe.
Jonathan Saltzman can be reached at firstname.lastname@example.org.