Government Regulation Created the Opioid Crisis
A federal jury in Cleveland yesterday concluded that three major pharmacy chains had contributed to a “public nuisance” in two Ohio counties caused by an oversupply of prescription opioids. The verdict, which represents the first time that retailers have been held legally liable for the “opioid crisis,” followed two recent rulings in which a California judge and the Oklahoma Supreme Court rejected similar claims against drug manufacturers.
These cases, along with thousands of other lawsuits by state and local governments that blame legal drug suppliers for opioid-related addiction and deaths, ask courts to focus on one link in a long causal chain. That chain includes decisions by state and federal regulators as well as actions by manufacturers, distributors, doctors, pharmacists, patients, black-market dealers who sell diverted pills, and nonmedical users who consume them.
In the Ohio case, Lake and Trumbull counties argued that the defendants—CVS, Walgreens, and Walmart—had ignored “red flags” indicating that some of the prescriptions they filled were medically inappropriate. The defendants argued that they had done nothing but fill seemingly legitimate prescriptions for legally approved medication written by licensed and regulated doctors. They emphasized the crucial roles that government agencies such as the Food and Drug Administration (FDA) and the Drug Enforcement Administration played in overseeing the distribution of prescription opioids, making them complicit in the supposed public nuisance described by the plaintiffs.
The government is likewise responsible for the harm caused by its ham-handed efforts to reduce opioid prescriptions, as illustrated by a recent case involving a Kentucky man, Brent Slone, who killed himself after his pain medication was suddenly slashed. His wife, CaSonya Richardson-Slone, sued Commonwealth Pain and Spine, which operated the clinic she blamed for denying her husband proper pain treatment. Last August, a Louisville jury awarded her and the couple’s daughter $7 million in damages. As STAT reporter Andrew Joseph’s thorough and illuminating account of the case shows, the situation that drove Slone to suicide is a predictable result of the government’s demonstrably counterproductive attempt to reduce opioid-related deaths by limiting access to pain medication.
In a 2011 car crash, Joseph reports, Slone suffered “a broken pelvis, a compressed spinal cord, and other injuries that caused chronic pain and put him in a wheelchair.” He was already taking opioids for pain relief in 2014, when he sought treatment at Commonwealth Pain and Spine. His daily dosage at the time was about 240 morphine milligram equivalents (MME), but it would eventually rise to a peak of 540 MME after a series of surgeries.
As Joseph notes, Slone’s treatment “coincided with campaigns to rectify opioid prescribing.” Responding to rising opioid-related deaths, regulators and legislators sought to discourage pain pill prescriptions across the board. In the effort to drive down consumption of opioid analgesics, chronic pain patients like Slone, who account for a disproportionate share of the total, were an obvious target.
Between 2010 and 2017, the number of opioid prescriptions per 100 Americans fell by 28 percent. During the same period, the rate of high-dose opioid prescriptions—defined as 90 MME or more per day—fell by 56 percent. In 2016, the Centers for Disease Control and Prevention (CDC) further encouraged the latter trend by publishing guidelines that were widely interpreted (misinterpreted, according to the CDC) as recommending that doctors stay below the arbitrary 90-MME cutoff.
Given the tremendous pressure on doctors to curtail the use of opioid analgesics, it would be surprising if all the dose reductions resulting from “campaigns to rectify opioid prescribing” were medically appropriate. Doctors had good reason to worry that they were risking their licenses and livelihoods if they defied the new conventional wisdom by maintaining patients on high doses of opioids, even if they had been taking them for years and the benefits seemed to outweigh the risks. Complaints about the consequences of the CDC’s guidelines, which included many reports of abrupt and drastic cutbacks in medication as well as outright denial of treatment, suggested that more than a few doctors sacrificed patient welfare to avoid unwanted attention.
While the benefits of long-term, high-dose opioid therapy are a contentious subject, Joseph notes, “experts and governmental guidelines agree that—with few exceptions—dose reductions need to go slowly, with patient buy-in.” But that is not what happened with Slone.
In 2016, the same year the CDC issued its controversial advice, Slone “started traveling to California for advanced wound care,” because his wheelchair had “caused pressure sores that resulted in bone infections.” After a series of surgeries in 2017 that included skin grafts, Slone spent several weeks at a nursing facility in La Jolla, and “his daily opioid intake increased from 240 MME to above 400 MME, occasionally reaching 540 MME.” He was discharged with a prescription at the latter level.
When Slone returned to Kentucky in August 2017, one of his doctors at the pain clinic initially wrote him a 540-MME-per-day “bridge” prescription. But at an appointment about a week later, Slone’s dosage was suddenly reduced by 56 percent, to 240 MME per day. Exactly why that happened is a matter of dispute.
“The defense framed Slone’s reduction as intentional,” Joseph writes. “The higher dose of 540 MME reflected what Slone was on for acute pain following surgery, at a time when he was closely monitored at inpatient facilities. Such a dose would not be safe for him out in the world. They were simply moving him back to his chronic pain baseline dose, and claimed he would not experience withdrawal because 240 MME was still supplying a sufficient opioid amount.”
By contrast, Hans Poppe, Richardson-Slone’s lawyer, “pointed to testimony indicating that a nurse inadvertently slashed Slone’s dose to his prior one—perhaps because she copied over information from his chart from months earlier—and that the doctors didn’t catch the error.” At the trial, Poppe described the change as a clear case of “patient abandonment,” and the jury evidently agreed.
Whether the sharp drop in Slone’s dosage was deliberate or accidental, it certainly seems inconsistent with recommendations that doctors who decide to “taper” patients begin with a reduction of about 10 percent. “This is the problem that we see,” Beth Darnall, a psychologist who directs the Stanford Pain Relief Innovations Lab, told Joseph. “There is this rush, almost a panic, to decrease doses rapidly under the guise of patient safety, but the irony is these rapid changes expose patients to greater risk.”
Stefan Kertesz, a University of Alabama at Birmingham pain and addiction specialist, agreed “it was a dose change that people would not be expected to tolerate.” It is fair to say that Slone, who killed himself a few weeks after his dose was cut, did not find it tolerable.
Kertesz, who is researching suicides following abrupt tapering, helped organize a 2019 letter from hundreds of experts who were alarmed by the practice. In response, then–CDC Director Robert Redfield emphasized that the agency “does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm.” He said the CDC recommends that clinicians “work with patients to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy.” It “also recommends that the plan be based on the patient’s goals and concerns and that tapering be slow enough to minimize opioid withdrawal, e.g., 10 percent a week or 10 percent a month for patients who have been on high-dose opioids for years.”
In a “safety announcement” issued the same day, the FDA said it had “received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased.” It warned that the consequences “include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.”
The CDC is in the process of revising its opioid prescribing advice. “Some policies and practices citing the guideline went beyond its recommendations and were inconsistent with its guidance,” Deborah Dowell, who co-authored the guidelines, said at a meeting in July. “For example, the guideline does not support abrupt tapering or sudden discontinuation of opioids, but we heard many reports of it being inappropriately cited to justify suddenly cutting off opioids.”
The harm to patients is not the only cost of restrictions on pain medication. As of last year, the overall opioid prescribing rate had fallen by 48 percent since 2012. During the same period, opioid-related deaths more than tripled. Last year about 83 percent of those deaths involved illicit fentanyl.
“U.S. opioid prescribing has plummeted in the past decade,” Joseph notes, “even as the overdose crisis has reached record heights due to an explosion of illicit fentanyl.” That is hardly a coincidence, since the crackdown on legally produced opioids has driven nonmedical users toward black-market substitutes that are far more dangerous because their potency is inconsistent and unpredictable.
Which brings us back to the lawsuit against CVS, Walgreens, and Walmart. To make their case, the counties that sued the pharmacy chains had to show that the public nuisance they alleged was ongoing. “The counties’ lawyers successfully argued that when the supply receded, patients who were addicted to the pills had turned to heroin and illegal fentanyl,” The New York Times reports. “That result was a foreseeable, direct descendant of the floods of prescription opioid pills, the lawyers said.”
It is a mistake to describe all of those opioid users as “patients,” which implies that the drugs typically were prescribed for them and that they became addicted as a result of pain treatment, something that happens much less often than commonly thought. But the Times is right that restricting the supply of legally produced opioids had predictably lethal effects.