More than a decade ago, Purdue Pharma pleaded guilty to marketing the powerful painkiller OxyContin in a way that illegally downplayed its addictiveness and abuse potential. This past October, the company again admitted criminal wrongdoing for misleading doctors, regulators and the public regarding the drug’s dangers.
Last Thursday’s congressional opioid hearing was the first time in years that the family behind Purdue, the Sacklers, would have a chance to take responsibility for it all. But instead of accepting blame for that reckless promotion, two of the family members, who appeared voluntarily under penalty of subpoena, did little more than murmur words of regret for the harmful commercial tactics that made their company’s lead product the poster child for the opioid crisis.
While both apologized, neither acknowledged personal (or familial) fault or error. It wasn’t for a lack of scathing questioning from the bipartisan committee’s bipartisan members, one of whom scolded the Sacklers for what he described as “plausible deniability” when called to account for the more than 400,000 Americans who, according to the Centers for Disease Control and Prevention, have died due to the opioid epidemic. Per the CDC, 230,000 of those deaths were tied to prescription opioids like OxyContin.
“There is nothing that I can find that I would have done differently based on what I believed and understood then, and I learned from management in the reports to the board,” said Dr. Kathe Sackler, who served on Purdue’s board for nearly 20 years. She was responding to questioning from Democratic Rep. Carolyn Maloney, chairwoman of the House Committee on Oversight and Reform.
Her cousin David Sackler, who served as a Purdue director for six years, also denied any personal responsibility for what Democratic Rep. Jamie Raskin called America’s opioid “nightmare” during his five minutes of questioning.
“Though I believe the full record, which has not been publicly released yet, will show that the family and the board acted legally and ethically, I take a deep moral responsibility for it, because our product OxyContin, despite our best intentions and efforts, has been associated with abuse and addiction,” said David Sackler.
Raskin countered this by responding, “Using the passive voice…implies that somehow you and your family were not aware of exactly what was taking place in the country.”
As the Department of Justice noted, the Sackler family exercised substantial oversight over Purdue management and, up until 2018, always held the majority of board seats at the company.
“So you as a family made decisions about all aspects of Purdue – marketing, budgets, financial distributions – didn’t you, as a family?” asked Democratic Rep. James Cooper.
“With the help of qualified outside directors and management,” David Sackler replied.
But the family had the board seats to do it, Cooper noted. Cooper also pressed Dr. Craig Landau, Purdue’s current CEO, about a report he wrote describing how Purdue operated with “the board of directors serving as de facto CEO.”
Moreover, Cooper added, outside consultants like McKinsey wrote as far back as 2008 that the board of Purdue was involved in all levels of company decision-making on a weekly basis. He cited passages from another McKinsey consultant’s report that “the [Sackler] brothers, who started the company, viewed all employees like the guys who trimmed the hedges: Employees should do exactly what’s asked of them and not say too much,” and “ss a manager, you get rewarded for pandering to the board.”
The grilling of the Sacklers followed the same committee’s release of a cache of documents showing the family “recklessly pushed [company execs] to flood the market with OxyContin to maximize their personal wealth,” even after Purdue settled with the Department of Justice in 2007 and paid $600 million in fines for misbranding the prescription painkiller.
Those revelations came on the heels of the opioid maker’s October plea deal and $8.3 billion settlement with the Justice Department, in which Purdue agreed to plead guilty to three felony criminal charges: lying to officials about a drug monitoring program and violating anti-kickback laws, both through its paid physician speaker program and by paying an electronic health records firm to influence prescribing.
The company’s speaker programs, which once paid doctors to spread the false narrative that OxyContin is a safer, less addictive option for HCPs treating pain in their patients, have been idle since 2017. That was also the year an OxyContin sales rep last visited a doctor’s office. (Landau stopped both practices after becoming CEO.)
Meanwhile, total national prescription opioid use has declined some 60% from the peak volume in 2011 after what is expected to be a year of double-digit decline in 2020, according to a report last week from IQVIA’s Institute for Human Data Science. The decrease is attributable to many measures taken over the past several years, from changes in clinical use, regulatory and reimbursement policies to progressively more restrictive legislation enacted since 2012, explained Murray Aitken, IQVIA SVP and executive director of the Institute.
Aitken said a pull-back in opioid promotion most certainly has contributed. “We’ve seen a sea change in the way in which prescription opioids are marketed. We’ve seen [opioid makers] dial back their efforts,” he observed. “At the same time, sensitivity to dependence by healthcare professionals has clearly risen dramatically. So put those together, and that’s a major factor.”
At the same time, the latest CDC data indicate deaths from drug abuse are ticking up again, even after a slight decline in 2018. “The big picture is that we continue to have a major opioid crisis in this country in terms of overdoses and deaths from opioid use,” Aitken added.
It strains credulity to think that the Sacklers may not have been more than a little involved in advocating the tactics that fueled that crisis. While individual members of the family have not been required to do so by the Justice Department, it would stand to reason – given that Purdue has twice admitted criminal wrongdoing – that the two Sacklers should have accepted some small measure of personal culpability.
“At least acknowledging that, either in your testimony or opening statement, would have been relevant, important and probably given you more credibility with me and the rest of the committee,” said Republican Rep. Kelly Armstrong.
Scoring a few points with the committee members, not to mention the families of all of the victims of the opioid crisis, is all the more important now that Purdue Pharma is in bankruptcy, with a settlement hanging in the balance. Some have observed that Purdue now lacks the assets to pay the full amount of the DOJ settlement, not to mention money to cover its liability in lawsuits from tens of thousands of opioid victims who have sued the company over its false marketing.
After the 2007 settlement, documents released as part of the bankruptcy proceedings show, family members began stashing away what would eventually amount to more than $10 billion of Purdue’s profits. This represented a “smart milking,” as one Sackler family member described it.
Several lawmakers suggested that some of the billions attributed to profits from OxyContin should be reclaimed by the federal government to compensate victims, and that Sackler family members should face criminal charges. Experts say neither seems likely. The DOJ settlement requires the family to forfeit just $225 million as part of a civil penalty separate from their company’s criminal plea.
Also as part of the settlement, Purdue is to be reorganized into a public benefit corporation, with profits from future opioid sales funding programs that address the opioid crisis. The prospect of the government going into partnership with Purdue, while the Sacklers managed to avoid guilt, didn’t sit well with committee members, who painted the family as “evil” and their behavior “sickening.”
“The responsible marketing of all medicines is something that manufacturers and their advisors need to take seriously, and understand the broader context in which they are operating,” said Aitken. “There seems abundant evidence that that was not the case with respect to these opioid medicines.”