Opioids: The Action Turns Away from Simply Punishing Physicians

Federal and state actions on opioids are turning away from simply targeting physicians, and there are even signs of a return to balance when it comes to prescribing.

In articles last summer, we chronicled the ways in which headlines about the opioid crisis led to blaming physicians, especially orthopedists, creating legal and regulatory pressures which led to extreme caution—too much caution, in the views of patient pain advocates—in prescribing opioids (“Orthopedists Due Major Blame for Opioid Crisis?” Part I, Part II).

Now, the legal and regulatory actions are massively targeting opioid manufacturers and distributors (see below). And a U.S. Senate hearing on February 12 offered a glimpse into changing federal attitudes toward prescribers:

It Takes a Patient

A woman named Cindy Steinberg made national TV news when she was brought in, lying on her back on a cot due to a permanently disabling, constantly painful 18-year-old injury, to testify about opioid prescribing and the crisis before the Senate Committee on Health, Education, Labor and Pensions.

Her plea: “Opioids are one treatment among many. They should not be a first-line treatment for chronic pain. Patients and providers should work together to carefully balance benefits and risks for each person. Nevertheless, for many pain sufferers, particularly those with severe pain, opioids can be a lifeline to lessening their pain,” she testified.

“In the near term, we can and must restore balance to opioid prescribing with de-politicized, rational and clear-eyed recognition of the risks and benefits of these medications,” she said. “In the long term, we must invest in the discovery of new, effective, and safer options for people living with pain.”

Ignoring the AMA!??

Two years ago, a year ago, even six months ago, the testimony receiving national news was all about opioid deaths and the epidemic. Voices urging balance, even that of the American Medical Association (AMA), weren’t being listened to.

The fact that she was called to testify in front of national television cameras, creating such a dramatic moment, is a sign of a shift in national political thinking about pain management policy and opioids, from targeting surgeons and other prescribers en masse to a more nuanced view of opioid prescribing and toward stepping up research on alternatives.

Along the same lines, in a little-noticed but telling action in January, when the National Institutes of Health’s Helping to End Addiction Long-Term (HEAL) research initiative announced the membership of a Multi-Disciplinary Working Group tasked to guide long-term federal research policy on new approaches to pain management, the group included pain researchers, a representative of a pain management advocacy group, and an AMA representative.

The composition of this advisory group is in sharp contrast to the way the Centers for Disease Control (CDC) went about choosing only opioid critics as advisors when it rushed into its now widely criticized, restrictive, one-size-fits-all 2016 guideline on prescribing opioids.

Signs of a federal/state shift in opioid punishment priorities

1. 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.

2. 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.

3. 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.

4. 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…”

Reports One and Two of “Fueling an Epidemic,” issued earlier in 2018, had documented that McKesson, Amerisource Bergen, and Cardinal Health had shipped 1.6 billion doses of opioids to Missouri alone from 2012 to 2017; at the peak, they sent 52 doses for every man, woman, child, and baby in the state in 2015. Report Three, in September 2018, said Insys employees used a variety of practices to deceive and game the Medicare prior authorization system for fentanyl.

5. The Food and Drug Administration (FDA) is trying to fix the obviously broken system for preventing massive diversion of opioids. On February 7, (FDA announced a pilot program to “inform the development of the enhanced electronic, interoperable track-and-trace system for industry set to go into effect in 2023 as part of the Drug Supply Chain Security Act.” This action underscores what the McCaskill report and many news stories have documented, that to date, the tracking system under this 2013 law has been massively outmaneuvered. By the 2023 deadline, opioids and other drugs are to be tracked down to the unit level, and FDA is considering the use of blockchain technologies to make it all work.

The common themes in items 1-5: that the states are clearly turning their attention toward seeking massive judgments or a national settlement against drug companies along the lines of the historic Tobacco Master Settlement Agreement to pay for their own costs in treating opioid abuse, and possibly also to compensate victims individually, and that the federal government—at least the FDA—is acknowledging that the worst problem has been diversion from distribution, not legitimate prescriptions.