Signs of a federal/state shift in opioid punishment priorities
- On January 15, a partially redacted version of a Massachusetts state civil complaint revealed that several individuals in the Sackler family, owners of Purdue Pharma, are being sued for at least several hundred million dollars in compensation to the state and alleged victims.
Attorneys for Purdue and the Sackler family have fought in closed sessions in this case and others to hide hundreds of documents from public view and to keep hundreds of other documents from even being allowed into secret court records. On January 29, they lost on both counts, when the judge ruled that the entire, un-redacted complaint would be put on the public record, and the other documents had to be put on the docket.
The alleged personal involvement of Sackler family members in promoting Oxycontin had been detailed before in a New Yorker article and in articles in Orthopedics This Week.
The new information: that several Sackler family members are being sued individually, and details on Purdue’s alleged sales tactics. For example, the Massachusetts complaint says these Sackler family members directed actions which included:
- The sheer numbers: There were at least two months in which Purdue salespeople made more than 180,000 sales calls on physicians (each month, not in total)—with calls as often as daily to the biggest prescribers—to push Oxycontin. There were more than 100,000 such sales calls in each of many other months.
- That salespeople were allegedly ordered to tell physicians who were resisting prescribing Oxycontin, on the basis that patients were becoming addicted, that they were seeing only “pseudo addiction,” the only treatment for which was…higher doses of Oxycontin. The sales goal was allegedly to get every patient on the highest dose the company sold.
Several hundred of the documents made public in the January 29 Massachusetts court action are still confidential in a larger, ongoing multi-state federal lawsuit in Ohio, combining hundreds of individual lawsuits against about two dozen opioid manufacturers and distributors.
- On February 12, the FDA sent McKesson a Warning Letter which expresses strong, clear dissatisfaction with McKesson’s November 2018 response to a small number of 2016 reports from three McKesson wholesale customers who found that a very few bottles of what were supposed to be opioids contained other pills. The discoveries indicated that employees of McKesson may have been diverting opioids.
The fact that such a severe Warning Letter was sent to McKesson’s CEO John Hammergren seems to imply that FDA officials are furious over McKesson dawdling for more than two years, and failing to take required investigative steps.
- The opioid crisis is costing McKesson giant amounts of money. In a January 31 McKesson earnings call to investors recorded by Motley Fool Transcribing, the company’s executive VP and chief financial officer, Britt Vitalone, said, “For the third quarter, we recorded net opioid-related adjusted operating expense of $20 million and year to date, $81 million. For fiscal 2019, we continue to anticipate that opioid-related costs will exceed $100 million.”
The expense of the opioid crisis has hit McKesson’s bottom line—in a small (so far) but measurable way: “We now anticipate adjusted income from operations will decline in the low single digit year over year,” he said.
- Fentanyl manufacturer Insys Therapeutics has been targeted as well. U.S. Sen. Claire McCaskill, then the ranking minority member of U.S. Senate Homeland Security & Governmental Affairs Committee, filed a report October 17, 2018 titled, “Fueling an Epidemic, Report Four: Inside The Insys Strategy For Boosting Fentanyl Sales.”
“Insys Therapeutics, Inc., adopted and intensified sales and marketing techniques Purdue Pharma pioneered in the 1990s for OxyContin and applied them to Insys’ powerful fentanyl drug Subsys. Like Purdue, Insys aggressively used speakers’ programs—in which the company paid physicians to discuss Subsys with colleagues—and compensation programs for sales representatives to boost sales for Subsys… Insys also established several other sales and marketing practices that formed the core of its approach to boosting Subsys sales…”
