Pain psychologist Beth Darnall, Ph.D., has embarked on a study to examine how behavioral modification tools and greater individual control could effectively help patients taper off of opioids.
In March 2016, the Centers for Disease Control and Prevention (CDC) issued a set of guidelines that would — or so the agency hoped — help doctors across the US as they dealt with the country’s growing opioid crisis. Aimed at primary care physicians, the report reminded practitioners about the dangers of opioid-based pain medications, urging them to be prudent about prescribing such drugs.
Patients should be clearly informed about the risk, the CDC said; other types of drugs should be considered first. And, if doctors did give patients opioids, they should be extra-judicious about prescribing dosages greater than or equal to 50 MME per day.
At the time, of course, concern about opioids was approaching something of a fever pitch in this country. In 2012, physicians wrote nearly 259 million prescriptions for opioid pain relievers. This was enough, the CDC noted, that every adult in US could have their own bottle. More disturbing, between 1999 and 2014, more than 165,000 people across the country had died from opioid pain medication. The message boomeranging around the country was clear: Opioids are dangerous. Opioids are deadly. Opioids should be avoided.
Which is why, perhaps, it wasn’t necessarily surprising that the CDC’s guidelines were widely and wildly misinterpreted and misapplied by doctors and health organizations. That recommendation to think carefully before prescribing doses over 50 MME? To some physicians it became a strict line in the sand. Not only did they refuse to increase dosages beyond that, but they insisted that patients who’d been taking larger amounts of opioids — sometimes for years without any issues — reduce their intake. Other doctors insisted patients get off opioids all together.
The result has been what some might call the second opioid crisis. It’s one in which many of the millions of chronic pain sufferers have suddenly been forced off of medications that had helped make their discomfort and lives manageable. The consequences, in some instances, have been catastrophic, with research showing that forced tapering of opioid meds can lead not only to the return of pain, but also to a rise in depression, suicidal ideation and suicide itself.
“In an attempt to quote-unquote protect patients in the United States, what we’ve seen is the enactment of practices and policies that are actually harmful to patients,” says Beth Darnall, Ph.D., director of the Stanford Pain Relief Innovations Lab and an associate professor. “People who were taking opioids for 20 years with no problems are suddenly being told, ‘Oh, you can’t have them anymore. We have to take you off of opioids.’ For the majority of people there’s minimal-to-no justification for that practice.”
A Key Study
Darnall has spent much of her career focusing on how behavioral medicine can help patients battle chronic pain, developing techniques that help people deal with pain without medication. But in recent years, she’s taken on an additional, somewhat ironic role: outspoken advocate against the forced tapering of opioid medications. She’s testified before Congress and the FDA. She was one of the authors of an international stakeholder letter, published in the journal Pain Medicine, arguing against forced opioid tapering. And she worked with the CDC to clarify its 2016 opioid guidelines, clarifying its message on dosages.
Perhaps most significantly, Darnall is the principal investigator behind the EMPOWER study, a patient-centered, four-state research effort focused on voluntary opioid tapering and behavioral modification techniques for pain. EMPOWER stands for Effective Management of Pain and Opioid-Free Ways to Enhance Relief. Backed by $9 million in funding from the Patient-Centered Outcomes Research Institute (PCORI), the study hypothesizes that giving patients greater control and the right coping tools can be effective in lowering opioid usage and managing pain overall.
“EMPOWER is an incredibly important study that has broad national policy implications, as well as broad implications for students,” says Sean Mackey, MD, Ph.D., chief of the Stanford pain medicine division. “It meets multiple needs at one time, which is uncommon these days.”
Darnall is well aware of the stakes of the study, not only for patients, but for the country’s longstanding, too-often misguided war on pain. “There are patients who have killed themselves because they’ve been taken off opioids,” she says. She pauses, then adds: “Essentially, it’s a form of torture for people.”
An Understanding of Pain and the Opioid Problem
Growing up in New Mexico, Darnall suffered chronic pain in the form of persistent stomach issues, of which the cause was never pinpointed. The pain went away by the time she was in her 30s. It wasn’t — at least not consciously — her motivation for becoming a pain psychologist, but she believes it has made her more effective at her job.
“I wouldn’t wish chronic pain on anybody, but it was a gift for me in so far as I can now translate that into an understanding of what’s needed for some patients and how to best help them,” she says.
Her interest in studying pain came during graduate school at the University of Colorado and a post-doc fellowship at Johns Hopkins University. In both situations, she saw VA patients trying to cope with major medical complications like burns and amputations; common to all was a need for pain management.
“It’s a field people avoid because they don’t think they can help,” she says. “But I found I enjoyed working with this population in that I wasn’t afraid of suffering.”
Darnall’s focus on opioids began in earnest a decade and a half ago when she was at Oregon Health and Science University. Patients began asking for her help to get off the powerful pain drugs. It ultimately prompted Darnall to write two books for patients on pain relief and to develop non-pharmacological tools that are scalable and low-cost. “Empowered Relief” is a two-hour class, led by trained clinicians across the country, that gives patients skills to cope with pain, while “My Surgical Success” is a free, online behavioral medicine treatment for pain and opioid reduction.
Darnall certainly doesn’t deny the existence, or the extent, of the opioid crisis that emerged in the US in the first decade of the century. “I’m the last person to tell you there has not been a problem with overprescribing, because there really and truly was,” she says. “We saw it in the early 2000s, all the way up to 2012. There was too much opioid prescribing.”
Experts have identified many reasons for overprescribing, from cultural and market forces to the pain-as-the-fifth-vital-sign movement of the mid-1990s. The latter asked physicians to pay more attention to patients’ pain levels and some say it led to overprescribing opioids.
But lost in the talk about opioids has been the nuance. For starters, Darnall believes, the average person has an incorrect understanding of what’s caused so many opioid-related deaths over the years. She believes they’ve conflated the spike in prescriptions with the even greater spike in illicit use of opioids, including the flow of fentanyl and cheap heroin into the country.
“Illicit use of prescription opioids, illicit fentanyl and heroin were conflated in the death rates,” she says. “Medically prescribed opioids were not the source of the spike in death rates — illicit drugs were.”
Also lost in the backlash is the fact that, while opioids can be addictive and dangerous for some people, for others they can be lifesaving. Opioids can allow the latter to manage their pain while leading productive lives, and this is why forced tapering by doctors can be problematic.
Indeed, even the suggestion that they’ll have to forgo their medication is enough to create in some patients deep fear and anxiety that high levels of pain will return — the nocebo response. That, in turn, can activate the central nervous system, which only leads to more pain.
“We run the risk of amplifying people’s pain right at the moment we’re actually reducing their prescriptions,” Darnall says. “It’s a recipe for the medical system to increase health risks in patients rather than reduce them.”
That distress can set off negative effects, including depression, suicide and ironically even a heightened possibility of overdose.
“The medical literature has revealed that opioid dose changes in either direction — up or down — confers health risks,” Darnall says. “These data refute the notion that forcing people to lower doses is safer for them.”
Reducing opioid doses is a very delicate matter. It’s not stopping an antibiotic. It’s not stopping aspirin.”
Mackey says the culture’s extreme response to the opioid epidemic reminds him of a quote from literary critic and journalist H.L. Mencken: “There is always a solution to every human problem — neat, simple, and wrong.”
Adds Mackey, “What people have come up with as a solution to the opioid problem is, well, we’ll just take everybody off opioids. The problem is we’ve got no guidance on how to do it, let alone whether it’s correct to do it or not.”
Treating the Whole Person
Darnall believes at the heart of the country’s difficulty in dealing with pain is its ever-present instinct to reach for a one-size-fits-all approach. For a decade it was to put everyone on opioids; now it’s to take everyone off of them. The complex, shaded truth, she says, is that the right solution depends on the patient.
The animating idea behind Darnall’s EMPOWER study is that, rather than being taken off opioids by their doctors, patients should exert significant control over the process. That’s why patients choose to be a part of the study; it’s also why there are no pre-set targets when it comes to dosage reduction. Partnering with a physician, each patient controls the pace of their opioid taper and is free to slow or, even pause, the process if the effects become too negative. The goal is simply to get to the lowest dosage possible over one year’s time.
EMPOWER was launched in 2018 and will ultimately enroll 865 patients in a clinical trial. New patients will be accepted until 2022, and the study, which has been slowed by COVID-19, will be completed in 2024.
Patients are randomly placed in one of three groups: one that receives eight weeks of cognitive behavioral therapy while tapering; another that takes part in peer-led support groups on chronic pain self-management for six weeks while tapering; and a third that simply tapers without behavioral modification support.
Darnall hopes to demonstrate that the pain management techniques allow patients to lower their opioid doses more effectively while keeping their pain levels low and improving quality of life. As she puts it, “We want to help people live better, do more, be more active.”
More broadly, Darnall would like to see an overhaul in the way the medical community deals with pain. More and better physician training could help — she notes veterinarians receive more hours of training in pain than physicians do. Another help would be an understanding of the fact that treating pain is far more complicated than just giving a patient a pill — or taking one away.
“We need to treat the whole person,” she says. “It’s our failure to do that that led us to overprescribing opioids. And it’s also led to a reductive approach and simply wanting to rip away all those opioid prescriptions. In which case we are willfully inflicting suffering on humans who are not prepared to manage the complexities of that. Nor should they be subjected to it.”
This article originally appeared in the 2020-2021 issue of Stanford Anesthesia magazine.