Kathe and David Sackler recently faced questions from a House committee about the role of Purdue Pharma and the Sackler family in the ongoing opioid epidemic in the U.S. This was one of the rare times that members of the infamous Sackler family directly testified in public, under oath, in a congressional investigation where they refused to apologize for their role and insisted that their conduct was legal and ethical
“We don’t agree on a lot on this committee in a bipartisan way, but I think our opinion of Purdue Pharma, and the actions of your family, we all agree are sickening,” said James Comer, R_KY 1st) the highest-ranking Republican.
Democrat Chairwoman Rep. Carolyn B. Maloney (NY_1st) called the Sackler family group “the Bernie Madoff of medicine.”
Overdosage of prescription pain killers such as OxyContin and their illicit analogs like heroin and fentanyl have killed thousands of Americans; the number is estimated to reach 1 million by the end of 2020. Families and communities continue to be ravaged by the epidemic and thousands of dependent patients face a protracted battle against addiction.
As a physician in the U.S. healthcare system, I have insight into the opioid epidemic, its origin, and its impact on our society. I often feel persuaded to use potent opioid analgesics for uncomplicated procedures at the behest of patients who have a long-standing history of opioid use and who show little response to non-opioid pain killers.
Over the last few decades, opioid manufacturers like Purdue have worked with a web of other entities including researchers, attorneys, advocacy groups, lobbyists, and consultancy firms to increase drug sales; these actions to maximize monetary gains have led to the loss of numerous lives.
Doctors and patients have been misled about the addiction potential of OxyContin. The chairman of the board of Purdue Pharma, Steve Miller, recently plead guilty to conspiracy to defraud the United States and to violate the Food, Drug, and Cosmetic Act, and conspiracy to violate the Federal Anti-Kickback Statute.
This was the culmination of the efforts by several prosecutors to bring Purdue to justice for its relentless tactics to increase the sales of opioids. Despite the admission of guilt, the existing legal framework makes it is exceedingly difficult to hold executives from drug companies individually accountable.
Attorneys often tend to utilize provisions like the deferred-prosecution agreement or non-prosecution agreement to evade prison time for any of the employees. Such agreements allow drug makers to pay a fine and implement reforms to prevent future fraud.
These fines, though hefty, are far outweighed by the earnings generated by sales of the drug in question and thus aren’t enough to change the conduct of the drug companies.
In 2012, for instance, GlaxoSmithKline was fined $1 billion for criminal charges involving Paxil, Wellbutrin, and Avandia; the fine however was less than 5% of the $26.9 billion in earnings the company made through these drugs.
Pfizer is yet another example of the inadequacy of such agreements. The company entered its first non-prosecution agreement in 2004 but continued its fraudulent practices and entered four other such agreements between 2007 and 2018. Not a single executive from Pfizer was charged despite repeated fraudulent schemes.
Such recidivism by pharmaceutical companies is the reason drug makers are compared to the mafia and the cartel. In the recent congressional hearing, Rep. Peter Welch, (D-VT) invoked El Chapo to compare the behavior of the Sacklers. Similar comparisons have been made by legal scholars demanding the drug makers be prosecuted under the provisions of the Racketeering Influenced and Corrupt Organizations Act (RICO) of 1970.
Prior to the enactment of RICO, legal barriers made it nearly impossible to indict the high-ranking members of the Mafia. The higher-ups would shield themselves by delegating crime and decision-making authority down the hierarchy.
The 1970 Act allowed the government to prosecute the entire criminal enterprise and its members by holding each individual accountable for the conduct of others in the organization. It imposed the same punishment on all members regardless of their rank and mandated a forfeiture of assets. The most famous RICO indictments came under the Mafia Commission Trial that involved the heads of New York’s Five Families and essentially dismantled organized crime.
Prosecutors can circumvent hurdles in the prosecution of opioid makers by using RICO, as the conduct of opioid makers like Purdue often fulfills the criteria to apply the provisions of the act. The provisions for applying RICO include the involvement of the individuals in the functioning of the enterprise, working together to advance sales, admission by a member to predicate frauds, and an impact on commerce.
Last year, in an exceedingly unusual landmark case, a jury found Insys Therapeutics founder and its executives guilty of contributing to the nation’s opioid epidemic. They were convicted on racketeering charges for conspiring to fuel the sale of their opioid painkiller, Subsys.
Based on the Insys precedent, a strong case can be made for the wider application of RICO against opioid makers like Purdue. This will allow the government to impose sentences based on the amount of drug prescribed and profits generated from such conduct.
It would also deter other drug makers and their proxies from using fraudulent monetization tactics. RICO will mandate a forfeiture of assets gained from such illegal activity, including executive bonuses and stock compensation. The forfeiture would in turn pave a path to easier compensation of victims and their families.
A multipronged approach is clearly needed to fight the opioid epidemic including retraining of practitioners, resetting of patient expectations, prescription monitoring, and availability of resources to combat addiction and overdose.
However, none of these measures will induce a behavior change in drug makers; RICO will. The families of the victims and our communities demand that we hold opioid makers accountable. RICO will deliver.
Dr. Sumeet Dua is a practicing radiologist at the Rush University Medical Center in Chicago specializing in both oncological and non-oncological aspects of imaging. He is a Public Voices Fellow through The OpEd Project.