Nicole Shamoon

Associate Editor

Loyola University Chicago School of Law, JD 2020

At first, the story of John Kapoor’s rise to the top of the pharmaceutical industry sounds like the American dream played out in real life. The first to attend college in his family, Kapoor graduated from Bombay University in India with a degree in pharmacy. He came to the United States after securing a fellowship at the University of Buffalo, and earned his Ph.D. in 1972. His scientific and business savvy was evident from the start – in a matter of a decade, Kapoor took over a struggling pharmaceuticals business, turned it around, and netted a personal gain of $100mm. From there Kapoor became a serial entrepreneur, with INSYS Therapeutics marking the pinnacle of his success. The company made him a billionaire, but later made him the target of a criminal racketeering investigation and the face of one of America’s darkest problems.

130 overdose deaths per day

The opioid epidemic is one of the most serious issues facing the United States today. In 2017, more than 47,000 Americans died as a result of an opioid overdose. An estimated 1.7 million suffered from a substance abuse problem relating to prescription opioids. It has become a major focus of politicians and regulatory agencies and a rare topic with bipartisan agreement on the importance of reversing the trend.

Subsys success makes Kapoor a billionaire

Kapoor founded INSYS Therapeutics, which made drugs that provide support and therapy to cancer patients. The company went public in May of 2013, and Kapoor was officially a billionaire less than six months later after INSYS stock quintupled in price. This rapid rise was driven by successful launch of Subsys, an under-the-tongue, extremely potent fentanyl spray designed to alleviate breakthrough pain for cancer patients. The company began selling Subsys in April of 2012, and by February 2013 it was the second most prescribed branded drug in its category. Kapoor attributed this success to the efficacy of his product. Federal investigators uncovered other reasons.

National emergency

On the same October 2017 day President Trump declared the opioid crisis a “national emergency,” John Kapoor and four other INSYS executives were arrested for their role in accelerating the crisis. Earlier this month, all were found guilty of bribing doctors to prescribe Subsys and misleading insurers about patients’ need for the drug all in a concerted effort to raise sales. INSYS bribed doctors to needlessly prescribe the highly addictive Subsys to patients that did not even have cancer. The conviction was a rare criminal prosecution against corporate officials and marked a victory in the government’s fight against the opioid epidemic.

Charges and lawsuits gaining momentum

Felony drug trafficking charges were leveled against Rochester Drug Cooperative (a major pharmaceutical distributor) and two former executives. State attorneys general in Massachusetts and New York recently sued Purdue Pharma (maker of OxyContin) as well as the family that owns the company, who had largely escaped any personal legal penalties. As more attention focuses on the underlying drivers of the opioid epidemic, it seems likely that both criminal and civil cases will pick up. Patients’ lives depend on companies with products that can lead to addiction and overdose operating with the highest levels of transparency and ethics.  INSYS, Rochester, Purdue, and others have failed in this regard, but patients are also being failed every day by a system that misaligns the interests of physicians and patients.

Conflicts of interest

Although the INSYS verdict was a step towards recovery, much more needs to be done about the root causes of the epidemic. INSYS reps were outright bribing doctors to prescribe Subsys, but legal marketing practices carried out by pharmaceutical companies may also be contributing to overdoes deaths. While drug sale representatives play a legitimate role in education physicians, there are other ways to learn about drugs including conferences and continuing education courses. A recent study found payments to doctors for meals, speaking, consulting, and travel led to increased prescriptions by physicians as well as higher opioid overdoses. This type of marketing is known as “detailing” and it is legal in most of the country. It also has a demonstrable influence on prescriber decision-making. In 2017, New Jersey instituted a cap on the amount of marketing money prescribers can receive from drug companies. Kickbacks are obviously illegal, but pharmaceutical companies legally pay doctors hundreds of millions of dollars a year and studies show these payments contribute to increased prescriptions. Purdue Pharma stopped its marketing of opioids to physicians, but it has become the face of prescription opioid abuse and likely took this action out of self-preservation.  Makers of cancer drugs, blood thinners, and drugs to treat mental health conditions all paid doctors substantially more than makers of opioids. In this highly competitive industry, it is hard to imagine drugmakers voluntarily changing marketing practices if it means giving an edge to a competitor. As such, lawmakers and regulators should focus on finding ways to align the interests of patients, physicians, and pharmaceutical companies.

Stakes raised

Criminally holding pharmaceutical executives responsible for fuelling the opioid crisis when their actions justify it has raised the stakes by a lot, according to a law professor who tracks opioid cases. The actions taken by INSYS executives were criminal and evil, but current marketing practices by drug sale representatives and pharmaceutical companies are perhaps even more concerning given that they are operating within the laws of the United States. With the human cost rising every day and the bipartisan support to confront the epidemic high, action should be taken to protect patients and remediate the conflict of interests in pharmaceutical marketing.