The Root of the Problem That Current Opioid Lawsuits Missed

On Thursday, May 2, five defendants from the Insys Therapeutics pharmaceutics company were found guilty of racketeering in Boston. The federal jury returned its verdict 15 days after deliberation began, but eventually convicted founder John Kapoor as well as four co-defendants from Insys. US attorney Andrew E. Lelling called the win “landmark prosecution that vindicated the public’s interest in staunching the flow of Opioids into our homes and streets”. Yet, after 11.5 million people reported misusing prescription Opioids in 2016 and over 47,600 people died using Opioids in 2017, the winning state attorneys general miss the true, persistent criminal behind the addiction crisis: inadequate legislation of pharmaceutical marketing.

The federal Massachusetts suit comes to a close as several other Epidemic-initiated cases across the country have come to life or, similarly, wrapped up with guilty verdicts. The first felony drug trafficking charges were filed against distributor Rochester Drug Cooperative in April. Purdue Pharma (the OxyContin® manufacturers) and certain Sackler family members are also being sued by the Massachusetts attorneys general. Some Purdue executives had already pleaded guilty in 2007. Regardless, the company was ordered to pay a $270 million settlement to Oklahoma in March.

I think that this will send a message to other prosecutors that, look, these are cases that can be brought. If you have the evidence and you can put it before a jury, there’s hope you hold those criminally responsible.

Michael Canty
former federal prosecutor, 2019

The charges Kapoor and his co-defendants received can result in up to 20 years of prison time. During the 10-week trial, prosecutors presented evidence against Insys that included bribing doctors to prescribe the wildly addictive Fentanyl spray, Subsys®, setting up a fake call center to pose as doctors office employees, and lying to insurance companies to get them to cover the drug’s high costs (prices for Subsys rise as doses increase and can cost thousands per month).

Bringing Legislative Changes to the Pharmaceutical Industry

Yet, according to legal experts like Leo Betelsky, “a lot of what pharmaceutical companies did in the context of the Opioid crisis that we are dealing with now was not, in fact, illegal.”

This is because most marketing practices remain unregulated, leaving corporations to choose between “ethical” and “unethical” campaigns and business methods. For instance, doctors cannot be bribed into writing a prescription, but they can receive payment as part of a promotional partnership with a company. Likewise, doctors aren’t allowed to lie about a patient’s diagnosis, but they can prescribe medication intended to treat other diseases as long as the doctor believes it properly addresses the patient’s symptoms – known as off-label prescribing. These practices have not only allowed doctors to write millions of fraudulent prescriptions, it has let bad characters across the pharmaceutical industry thrive.

As such, Betelsky believes the litany of Opioid lawsuits have missed the root of the issue that permitted the crisis to swell to record-breaking rates of addiction and death in the first place. Too, the country’s lack of regulation in the medical industry empowers companies more concerned with profits than patient health to flourish while overdoses continue. Annual sales of its Opioids made Insys a “darling of Wall Street” with over $300 million annually in profits.

Speaking to NPR, Betelsky said, “We need to think much more deeply about how we regulate the pharmaceutical industry and how we prevent these kinds of practices from occurring in the first place.”

In the US, Fentanyl encounters doubled between 2014 and 2015 to 13,882 cases. The drug is up to 100 times more powerful than Morphine and 50 times as potent as Heroin. In marketing their spray-version of the drug, two Insys sales representatives made a rap video in 2015 and presented it at a company conference. The rap focused mainly on “titration”, or the process of increasing medication dosage among patients.

I love titrations, and it’s not a problem. I got new patients, and I got a lot of them.

Insys sales representatives
Subsys rap video, 2015