Purdue controversy skates past state’s drug monitoring
STAMFORD — Connecticut’s newly unredacted lawsuit against Purdue Pharma excoriates the owners and former executives of the OxyContin maker for allegedly fueling the opioid crisis. It does not lambast public officials.
As the Sackler family members who own Purdue have emerged as increasingly controversial figures in the debate about the epidemic of opioid abuse, the lawsuit and hundreds of other, similar complaints filed across the country do not suggest that government agencies bear responsibility as well. Instead, many medical professionals and legislators said they are confident in the state’s oversight of opioid prescribing.
“The state’s drug monitoring program is not designed to look at what pharmaceutical companies
are doing; it’s designed to show when prescriptions were issued to the pharmacies and filled,” said Dr. Jeff Gordon, a blood-andcancer specialist and former president of the Connecticut State Medical Society. “I think we’re going to have to rely on law enforcement mechanisms to see what any company does legally or illegally.”
Alleged negligence
A number of the lawsuit’s allegations focus on Purdue’s supervision of its drugs’ distribution.
Its owners and a number of former executives and board members monitored opioid sales from prescribers who were suspected of diversion and abuse, on a list code-named “Region Zero,” according to the complaint.
In 2010, the Purdue board allegedly was presented with the list, which included several Connecticut prescribers. The lawsuit does not name those prescribers.
The board was told that if Region Zero members stopped prescribing opioids, Purdue would lose almost 10 percent of its sales.
In response, the defendants allegedly decided to keep Region Zero prescribers a secret and never reported them to Connecticut authorities, even though they knew the dangers of diversion and abuse.
Meanwhile, company sales representatives made “numerous” sales calls to some of Connecticut’s Region Zero prescribers, according to the litigation.
Purdue has denied the allegations in the lawsuit, which it has described “part of a continuing effort to try these cases in the court of public opinion rather than the justice system.”
Tracking the prescriptions
The state tracks opioid prescribing through the Department of Consumer Protection’s Prescription Monitoring Program.
Opioid prescriptions statewide plunged by about 25 percent between 2015 and 2018, to approximately 1.96 million last year, according to DCP data.
“We know that these prescription decreases are only one indicator that we’re making progress in combatting the opioid crisis, but we’re pleased that the state is moving forward,” state Consumer Protection Commissioner Michelle Seagull said in a statement.
DCP’s oversight extends to Oxycodone Hydrochloride-type opioids, which include OxyContin — a group of pain drugs whose prescriptions in the state dropped 5 percent last year. The department does not keep prescribing tallies for individual brands.
“The big thing right now we’re trying to do is get good data out, in aggregate,” said Rodrick Marriott, DCP’s director of drug control. “Maybe at some point we may publish those things — prescribing amounts for brands — but we don’t have any immediate plans . ... The monitoring program isn’t going to tell us if a manufacturer is doing anything wrong necessarily, because if their prescriptions are being used frequently, then it could be the result of their drugs being effective.”
At the same time, legislators are not pushing for an overhaul of the system.
“Since the implementation of the (monitoring program) several years ago, it has provided the legislature with viable and important information,” said state Sen. Kevin Witkos, R-Canton, and a ranking GOP member of the General Law Committee, which oversees DCP. “This information has had the positive benefit of helping to further direct public policy based off of real-world data.”
Among related regulatory moves in recent years, the state enacted in 2015 a requirement for prescribers to check patient records in the monitoring program’s database for dosages for controlled substances, including opioids, lasting more than 72 hours.
In 2016, the state Legislature passed a measure that generally prohibited medical practitioners from writing opioid prescriptions for more than seven days, for first-time outpatient use.
“I don’t think any changes are needed with the monitoring program,” said Gordon, the former state Medical Society president. “I think it’s working well. And we use other resources, especially CT Health Link (a physician-led health information exchange), to get a full picture of what’s going on with our patients.”
At the same time, Connecticut still grapples with hundreds of opioid-related deaths each year.
The 948 opioid-involved fatalities in 2018 represented a 1 percent decline from 2017, but a 43 percent jump from 2015.
Litigation carries on
Some of the most substantive reinforcements to Connecticut’s response to the opioid crisis could emerge from the litigation — if the state receives major damages in a trial or settles.
In March, Purdue reached a $270 million settlement with Oklahoma.
The settlement terms call for nearly $200 million to fund the establishment of the National Center for Addiction Studies and Treatment at Oklahoma State University’s medical campus in Tulsa. Local governments would receive $12.5 million for opioid initiatives. In addition, Purdue would allot up to $60 million to cover litigation-related costs and fees.
“With the Oklahoma case, we saw the earmarking of most of the settlement money toward addiction treatment and research, and that’s a good thing,” said Richard Ausness, a professor of law at the University of Kentucky. “That didn’t really happen with the (1990s) tobacco settlement. Most of that money went into the general funds of the states and was never seen again.”
Connecticut Attorney General William Tong has reiterated his intent to take the case to trial, but the Sacklers have expressed their desire to avoid one.
Mary Jo White, an attorney for four of the Sackler defendants, has said that they would would prefer to settle and reach a “global resolution” of the pending litigation.
White represents three children of late Purdue co-founder Mortimer Sackler: Ilene Sackler Lefcourt, Kathe Sackler and Mortimer D.A. Sackler. Another client, Theresa Sackler, is his widow.
The four other Sackler defendants are Richard Sackler, son of the other late Purdue co-founder Raymond Sackler; Beverly Sackler, widow of Raymond Sackler; David Sackler, son of Richard Sackler; and Jonathan Sackler, son of Raymond Sackler.
Meanwhile, about 1,700 cities and counties’ lawsuits against Purdue and other pharmaceutical firms are proceeding through consolidated “multidistrict litigation” in federal court in Cleveland.
“The fact that there’s so much information that’s come out in the litigation about Purdue Pharma and other pharma companies is significant,” said Robert Bird, a professor of business law at the University of Connecticut. “This could be a prompt for state legislators in Connecticut and other states to take further action to help prevent these opioid tragedies from happening again.”