They made the most of the opioid crisis. Until they don’t.

Crime and punishment in an opioid startup
By Evan Hughes

The pharmaceutical industry is experiencing a very good crisis. The rapid development of safe and effective Covid-19 vaccines and treatments has turned pharmaceutical companies into much-loved heroes. Chipper executives boast of having saved billions of lives. Shareholders swim in profits.

It’s a remarkable turnaround for an industry that had been widely reviled. Before the pandemic, pharmaceutical companies were regularly berated for the exorbitant prices they charged for drugs developed with taxpayer support. They were hauled before grand juries for their role in what was, until the onset of Covid-19, the nation’s most pressing public health crisis: the opioid epidemic.

Although overshadowed by the coronavirus, the opioid crisis has worsened. In the most recent 12-month period for which data is available, more than 100,000 Americans – a record number – died of drug overdoses. Many have been killed by fast-acting synthetic opioids like fentanyl, which is found in street drugs and prescription painkillers.

Anyone who has read “Empire of Pain,” Patrick Radden Keefe’s epic expose of the Sackler family behind Purdue Pharma, is aware of the dirty hands of opioid peddlers. But until I read “The Hard Sell,” about the outrageous behavior of an obscure pharmaceutical company, I hadn’t appreciated the full extent of the dirt or dark stain that the opioid industry has left over the entire industry.

“The Hard Sell,” by journalist Evan Hughes, is a fast-paced, maddening account of Insys Therapeutics, whose entire business model seemed to be based on dishonesty. (The book is based in part on a 2018 article Hughes wrote for The New York Times Magazine.) His only branded product was Subsys, a fentanyl-based liquid that patients sprayed under their tongue. Insys executives have gone to extraordinary – and sometimes criminal – lengths to get their addictive and dangerous drug into as many mouths as possible.

The company was founded in Arizona by “an Indian-born visionary”, John Kapoor. He was a serial entrepreneur at a pharmaceutical company who, despite repeated run-ins with regulators, investors and business partners, managed to emerge, again and again, with his fortune and reputation largely intact. (A judge found that one of her early ventures had been, as Hughes puts it, “full of misconduct,” and the Food and Drug Administration reprimanded her for endangering the health of patients.)

Kapoor was cut from a mold that will be familiar to readers of “Bad Blood” or “The Cult of We” (about the Theranos and WeWork debacles, respectively). He was blindly ambitious, with a sympathetic origin story that masked his broken moral compass. While Elizabeth Holmes told people she started her pinprick blood testing company because she feared needles, Kapoor claimed he got the idea for Subsys after watching his wife endure excruciating pain as she died of breast cancer.

Hughes is skeptical of this cover story. The most likely explanation, he suggests, is that Kapoor sensed a lucrative opportunity to jump into the booming opioid market with a cutting-edge narcotic.

The innovation with Subsys was not the drug itself – its active ingredient, fentanyl, has been around since 1960 – but the delivery mechanism. An arms race was underway to develop the fastest opioids. Spraying fentanyl molecules under the tongue has been shown to be a super-effective way — “close to the speed of intravenous drugs given in a hospital,” writes Hughes — for pain relief.

Kapoor’s company won FDA approval for Subsys to be used as a treatment for cancer patients. But it was a limited and already crowded market. From the outset, Insys’ goal was to tap into the much larger pool of people suffering from a wide range of pain conditions. To do this, Kapoor and his team at Insys borrowed tactics from their rivals and exploited the idiosyncrasies of the pharmaceutical industry.

The company bought access to pharmacy data that showed which doctors were prescribing a lot of fast-acting synthetic opioids. About 170 doctors nationwide were responsible for about 30% of all prescriptions for these drugs, and Insys sent its sales force to persuade this small group of like-minded doctors to start prescribing Subsys. (Yes, it’s crazy that pharmaceutical companies are allowed access to this kind of easily actionable data.)

Allowing for even more precise targeting of susceptible physicians, the FDA required drug companies like Insys to closely monitor who was prescribing their drugs. “The purpose of collecting this data was to protect patient safety, but Insys ended up with a marketing gold mine,” writes Hughes. Soon, doctors prescribing Subsys began finding Insys salespeople in their offices, pushing them to write more scripts.

The Insys sales force initially tried to pitch Subsys on its merits, but there was a problem: Competitors were showering this small group of doctors with free meals, gifts, and cash. To succeed, Insys had to play the same game.

Corruption is frowned upon, so in addition to being stuffed with food, booze, and fun, doctors were paid to give speeches about Subsys to small audiences—sometimes to staff in their own offices. “The idea was to funnel money to the speaker to prescribe Subsys in return,” writes Hughes. “If he didn’t keep his end of the bargain, he wouldn’t be paid to speak. It was a quid pro quo. »

The entire opioid trade appears to have been inundated with these underhanded tactics; as Hughes notes, “Nothing Insys did was really new.” Indeed, what’s most surprising and powerful about “The Hard Sell” isn’t a company’s criminality – we’re used to companies misbehaving – as much as how these practices have been institutionalized in the modern pharmaceutical industry.

For Insys and its senior executives, it has been very profitable. Some Subsys prescriptions were priced in the tens of thousands of dollars. (When insurance companies became hesitant to cover these costs, Insys set up a centralized office to secretly file and process documents on behalf of doctors.) Insys went public in 2013 and was the introduction in best-performing stock exchange of the year, its shares having more than quadrupled.

At that time, even as Wall Street and the business media celebrated Insys, the wheels began to come off.

Conscientious insiders have warned the government about the company’s fraudulent and abusive practices. Soon, federal investigators were closing in. Kapoor and his entourage are said to be the few business executives to face criminal charges. Hughes recounts the prosecution and trial in dramatic fashion.

My one big complaint about “The Hard Sell” is that it’s unclear how much damage Subsys has done in the context of the broader opioid epidemic. Hughes includes stories of people overdosing and becoming addicted, of shattered lives and families, but I wasn’t sure if prescription drugs like Subsys were a root cause of the fentanyl crisis, a contributing factor, or a meaningless blip .

Sometimes I wondered if the answer might be the last, and if Hughes was dodging an awkward fact so as not to deflate an otherwise compelling story. If so, he doesn’t need to worry. Even if Insys turns out to be a footnote in the opioid epidemic, it’s worth exposing the world to the grimy underside of a powerful industry – especially one that has suddenly become the focus of so much of public gratitude.

About Christopher Rodgers

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