The Hard Sell: CRIME AND PUNISHMENT IN AN OPIOID STARTUP
Author: Evan Hughes
Publisher: Pan Macmillan
Pages: 231
Price: Rs 750
The opioid epidemic in the US that led to over 645,000 deaths due to overdose of pain medication between 1999 and 2021 has featured extensively in the US media. Most stories have focused on the role of the Sackler family, which controlled Purdue Pharma, though a few journalists and writers went beyond just the Sackler family’s shenanigans. The Hard Sell by Evan Hughes is the story of John Kapoor, another entrepreneur who also aggressively pushed and made a fortune from a painkiller he developed — though his role was, of course, much smaller than that of the Sackler family.
Painkillers of various descriptions have been around for centuries. But painkiller addiction in the US (and globally) was not a big problem until Purdue Pharma came up with a brand called OxyContin, based on Oxycodone HCL, and started marketing it aggressively in the mid-1990s. This was also the time when prescription oversights were changing— from the paper trail that would see a copy of any prescription being maintained by the prescribing physician, the pharmacist and the state drug monitoring agency to an electronic monitoring system. In theory, electronic monitoring should have made tracking opioid prescriptions easier but in real life it did not.
Purdue Pharma spent millions in ads to promote a “pain-free” life to potential patients and pursued doctors to prescribe OxyContin. Most painkillers can be highly addictive. That is because, among other things, they also activate the reward centres in the brain. Though the majority of doctors in the US were cautious about giving painkillers, there were enough who were willing to write prescriptions without asking too many questions. The Sackler family’s role in the opioid crisis is captured very well in the book The Empire of Pain by Patrick Radden Keefe.
John Kapoor’s role was less written about until Mr Hughes decided to tell his story. Mr Kapoor, an Indian-origin scientist and entrepreneur, created an even more powerful painkiller than OxyContin. This was based on Fentanyl, a synthetic opioid, which is considered a hundred times more potent than morphine.
Fentanyl is not a new drug and its dangers are well known. It is almost exclusively prescribed for the pain management of patients with advanced cancer. Most of the Fentanyl-based drugs could only be prescribed in a hospital setting — that is, it would be given only if the patient was being treated in the hospital and monitored by physicians. A few branded Fentanyl-based drugs could be prescribed for home use — but again, these were primarily for cancer-related pain management only. Mr Kapoor’s firm developed a patented drug called Subsys. It was not a new molecule that was developed but a different delivery mechanism that helped it get a patent and the US Food and Drug Administration clearance. It was administered as a spray that the patient would shoot under his tongue.
The dangers of the drug were well known and it would not have been abused if Mr Kapoor had not put together a top team that would find pliable doctors and bribe them to start actively suggesting Subsys even to patients who did not need them. By the time Mr Kapoor and his team were caught and prosecuted by the authorities, thousands of lives were lost or destroyed, while he made hundreds of millions.
The story is interesting because Mr Kapoor is a Jekyll and Hyde character. He was already rich — probably a billionaire — when he threw himself into developing Subsys. He had sold his first generics company and made millions, which had allowed him to invest in other promising pharma startups. He had been accused of cutting corners and not maintaining proper records in the first generic company that he sold. However, nothing much came of it. But he was known for being rich and also prone to bend regulations. Equally, he was philanthropic, and not just for tax purposes. He believed in causes and he had adopted several children with special needs.
His wife Editha, on whom he doted, battled breast cancer and eventually died from it. Her last days were highly painful and Mr Kapoor had devoted himself to taking care of her. After she died, he was distraught.
He would say that it was his wife’s suffering that pushed him to develop Subsys. His top management team told a different version when the authorities caught up with them. They thought he was driven by ambition to create his own branded best-selling drug by hook or by crook because he had primarily been known for his generics play till then.
Either way, Mr Kapoor and his team did enough damage. They aggravated a crisis that had already reached alarming proportions. All the members were punished by the US judicial system eventually, though the sentences varied.
The book is well written. The real relevance of the book, however, lies in the author’s insights about the flaws in the US drug administration and prescription regulations that provided Mr Kapoor the opportunity to push his drug indiscriminately. And it is those loopholes that the US policymakers need to plug to ensure that they cannot be exploited by unscrupulous businessmen.
The writer is former editors of Business Today and Businessworld, and founder of Prosaic View, an editorial consultancy