Last week more than 100 healthcare professionals and pain care advocates signed a letter urging the Department of Health and Human Services to “prohibit or minimize rapid, forced opioid tapering in outpatients.”
Other pain doctors declined to sign, however, arguing that the letter’s language was alarmist, and that involuntary taper is sometimes required.
The letter (here or here) was drafted by Beth Darnall, PhD, a pain psychologist at Stanford Medical School. It addresses the plight of chronic pain patients who have been prescribed very high doses of opioids but who—whipsawed by rapid changes in medical consensus about the risks and benefits of such medication—are suddenly finding that they can no longer obtain their medications at such dosages. An estimated 18 million Americans are on long-term prescription opioid therapies.
If these patients are deprived of their medications too quickly, with insufficient medical and psychological support, they will suffer excruciating withdrawal symptoms. As a result, they “may seek relief from illicit (and inherently more dangerous) sources of opioids” or “become acutely suicidal,” the letter says.
In 2016, the Centers for Disease Control and Prevention published guidelines urging doctors to exercise great caution before escalating opioid doses above a certain level—the equivalent of 90mg of morphine per day. Many pain patients were on far higher doses when the guidelines came out. When those patients’ physicians retire, few doctors are willing to step into their shoes, continuing to prescribe opioids at such elevated levels. (The reasons why are disputed. They might feel that the medical risks outweigh the benefits; they might feel pressure from medical boards or the Drug Enforcement Administration; or they might fear civil liability, if the patient overdoses and dies.)
“Nonconsensual tapering policies are being enacted throughout the country … by prescribers and healthcare organizations, pharmacies, and insurance payors.”
Controversially, the Darnall letter asserts that “non-consensual tapering policies are being enacted throughout the country without careful systems that attend to patient safety.” These policies, it says, are being implemented by “prescribers and healthcare organizations, pharmacies, and insurance payors.”
“This is a large-scale humanitarian issue,” the letter states. “New and grave risks now exist because of forced opioid tapering: an alarming increase in reports of patient suffering and suicides within and outside of the Veterans Affairs Healthcare System in the U.S.”
“Policies are being implemented that may seem beneficial, but can confer additional suffering on the most vulnerable patients.”—Beth Darnall
“We’re imploring decisionmakers to think very carefully about unintended consequences,” says Darnall in an interview. “Policies are being implemented that may seem beneficial, but can confer additional suffering on the most vulnerable patients. . . . I don’t believe there should be collateral damage.”
Prominent signatories include Darnall’s colleague Sean Mackey, MD, PhD, who leads Stanford’s pain medicine division; addiction specialist Stefan Kertesz, MD, of the University of Alabama, an outspoken advocate for chronic pain patients; addiction psychiatrist, Yale University School of Medicine lecturer, and writer Sally Satel, MD; and the presidents and past-presidents of several pain medicine professional societies in the U.S., Canada, and Australia.
The letter has been accepted for publication as a commentary by Pain Medicine, according to Darnall.
Advocates for chronic pain patients have submitted similar letters in the past, including two authored by Kertesz protesting proposed policy changes by the Centers for Medicare and Medicaid Services and the National Commission on Quality Assurance.
But Darnall’s letter gained at least two new, notable signatories from the ranks of those who champion reductions in opioid prescribing—a group often assumed to be at loggerheads with the interests of chronic pain patients.
These include Darnall’s Stanford colleague, psychiatry professor Keith Humphreys, PhD, and David Juurlink, MD, PhD, a prominent Toronto clinical pharmacologist and researcher, who is also a board member of Physicians for Responsible Opioid Prescribing—an organization widely reviled by chronic pain patients.
Juurlink signed after being permitted to redline an earlier draft.
“Although [the final version] had some phrases I mightn’t have drafted myself,” Juurlink tells us in an email, “I thought the focus on discouraging rapid tapers was important enough to lend my voice to.”
Darnall also sought signatures from PROP’s executive director and president, addiction psychiatrist Andrew Kolodny, MD, and pain medicine doctor Jane Ballantyne, MD, respectively. They circulated the letter to the organization’s 19-member board, but none, besides Juurlink, signed. (Four board members shared with me their objections. Some excerpts are appended to this article.)
“[Darnall’s letter] addresses a real problem,” Kolodny acknowledges in an interview, which he calls “the problem of legacy patients.” By that he means patients prescribed opioids in the past for conditions that science now shows are actually worsened by those drugs.
“What I don’t like is that [the letter] gives credence to a false narrative of government overreaction that’s resulting in policies all over the country forcing patients to come off opioids too rapidly, resulting in people committing suicide or using fentanyl or heroin.”
“ ‘Forced’ sounds like a bad word. But if the risks outweigh the benefits, you have no choice. Doctors are not vending machines.”—Andrew Kolodny
Kolodny also maintains that involuntary taper is sometimes appropriate, given the harms and risks of high-dose opioid therapy. (High-dose opioid therapy can cause severe constipation, depression, lethargy, cognitive decline, hormone imbalance, cardiac problems, breathing problems, increased pain, falls, car accidents, overdose, and death.)
“ ‘Forced’ sounds like a bad word,” Kolodny says. “But if the risks outweigh the benefits, you have no choice. Doctors are not vending machines.” (Kolodny co-heads the Opioid Policy Research Collaborative at Brandeis University.)
The letter was sent to the chief medical officer of HHS, Vanila Singh, MD, on Sept. 24, just before a two-day meeting of the HHS chronic pain task force. This week, Darnall gave a Congressional briefing and spoke with the FDA on related issues.
The letter concludes by asking that the agency take four actions:
“Not every single patient on earth should go through taper,” says Darnall in an interview. “That’s just common sense. We need exceptions. Patients need to be protected.”
The following PROP board members agreed to share their concerns with the letter. Here are some excerpts:
Mark Sullivan, MD (pain medicine doctor and psychiatrist at the University of Washington, who has published research on opioid tapering): “Voluntary and supported taper is always best. But the boundary between voluntary and involuntary tapers can be quite fluid in practice. Some of the highest risk patients really need to be pushed toward taper. Patients with diversion or [opioid use disorder] need to be forced to taper or switch to [buprenorphine, an addiction treatment medication].”
Anna Lembke, MD (addiction psychiatrist at Stanford Medical School, who is currently leading a free, online continuing medical education seminar on opioid tapering): “I’m a strong advocate of slow, compassionate, patient-centered opioid tapers …. But I also believe these tapers need to occur even if patients don’t want them, i.e. in some cases, they need to be ‘forced’. … Data show the large majority of high dose legacy patients will not voluntarily engage in tapering.”
Stephen Gelfand, MD (rheumatology consultant, Myrtle Beach, S.C.): “Certainly the avoidance of forced tapering in most … is indicated. But there is also a significant percentage of these patients who actually have the disease of addiction and need addiction treatment services including medication-assisted therapy [MAT] such as buprenorphine. The problem here is the difficulty in identifying these patients, who are often in denial, and/or their doctors are often reluctant to make the diagnosis of addiction or unaware of its possibility. … In view of the above, we also need to have victim advocates who have survived and overcome the scourges of addiction as the result of opioid overprescribing to sit on these patient advisory boards at every level of decision-making.”
Danesh Mazloomdoost, MD (anesthesiologist and doctor of regenerative medicine): “The wording [of the letter] feeds into a catastrophic vocabulary prevalent among chronic pain patients. … I regularly see patients who feel abandoned by their providers because of a sudden arrest in the opioids they had been prescribed for years. These patients have the impression that regulations, addiction, and physician fears of prosecution are the primary motivators for this radical change. They are entirely unaware of the scientific foundation that guides these changes …. It sets up an adversarial relationship with every clinician thereafter and further stigmatizes opioid use disorder and alternatives to opioid management. I would strongly urge a more objective letter outlining the need for clinician guidance on … (1) how to effectively converse with patients about the long-term detrimental effect of opioids and the need for tapering, and (2) methodological guidance on tapering.”