JAMA: Patients on Long-Term Opioids Often ‘Irrational’

By Pat Anson, PNN Editor

Do pain patients on long-term opioid therapy make irrational decisions? Is their mental capacity so diminished by opioids that they shouldn’t be involved in treatment decisions with their doctors?

The answer to both questions is often yes, according to a controversial new op/ed published in JAMA Internal Medicine. At issue is a recent update to the CDC’s opioid prescribing guideline, which calls for shared decision-making (SDM) when a prescriber considers tapering a patient or abruptly discontinuing their opioid treatment. The guideline was revised last year after reports of “serious harm” to patients caused by forced tapering.

“In situations where benefits and risks of continuing opioids are considered to be close, shared decision-making with patients is particularly important,” the 2022 guideline states.

But that advice about consulting with patients goes too far, according to the lead author of the JAMA op/ed, Mark Sullivan, MD, a professor of psychiatry at the University of Washington and a longtime board member of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.

“The value of SDM has been recognized for many years but also has its limitations, including where patients make irrational or short-sighted decisions,” Sullivan wrote. “Long-term opioid therapy induces a state of opioid dependence that compromises patients’ decisional capacity, specifically altering their perception of the value and necessity of the therapy; and although patients with chronic pain are not usually at imminent risk of death, they often can see no possibility of a satisfying life without a significant and immediate reduction in their pain.”

Sullivan and his two co-authors, Jeffrey Linder, MD, and Jason Doctor, PhD, have long been critical of opioid prescribing practices in the U.S. In their conflict of interest statements, Sullivan and Doctor disclose that they have worked for law firms involved in opioid litigation, a lucrative sideline for several PROP members.

Sullivan, Linder and Doctor call for more “structured” decision-making that includes the patient’s family and friends, “motivational interviewing” of patients about opioid risks and treatment goals, and education about non-drug alternatives such as yoga and meditation.

“We believe that a fully individualized, unstructured decision-making process will not be adequate to protect patients receiving long-term opioid therapy,” they wrote.

“In the case of opioid prescribing, and especially opioid tapering, working to persuade the patient is almost always the best clinical strategy. But there are circumstances where tapering should occur even if the patient objects.”

— Dr. Mark Sullivan

And what happens if a patient refuses to have their dose reduced? The op/ed doesn’t explicitly state it, but in an email to PNN, Sullivan said forced tapering would be acceptable in some situations.

“In the case of opioid prescribing, and especially opioid tapering, working to persuade the patient is almost always the best clinical strategy. But there are circumstances (opioid use disorder, diversion, serious medical risks) where tapering should occur even if the patient objects,” Sullivan wrote.

Opioid diversion by patients is actually rare. The DEA estimates that less than one percent of oxycodone (0.3%) and hydrocodone (0.42%) will be used by someone they were not intended for.

As for patients on opioids behaving “irrational,” Sullivan and his co-authors cite an op/ed published 33 years ago in The New England Journal of Medicine (NEJM). But that article doesn’t even discuss opioids or tapering, it’s about whether patients and doctors should collaborate in making decisions about end-of-life medical care.  It also makes an important disclaimer that “even the irrational choices of a competent patient must be respected if the patient cannot be persuaded to change them."

Sullivan rejects that approach to opioid treatment.

“We cite (the NEJM article) to demonstrate that SDM does not exclude or prevent irrational decisions,” he wrote in his email.  “You are right that we do not endorse the conclusion you cite, that patient’s irrational decisions must be respected.”

In a rebuttal to Sullivan’s op/ed also published in JAMA Internal Medicine, Mitchell Katz, MD, and Deborah Grady, MD, dispute the notion that a patient’s choices shouldn’t be respected.

“Primary care professionals generally highly value the inclusion of the patient’s perspective in decision-making, consistent with the principles of patient autonomy and self-determination, and are loathe to go against a patient’s wishes,” they wrote.

“As primary care professionals, we have found it helpful to tell patients that it is not recommended to take more than a specific threshold of opioids and that we do not want to prescribe something that is not recommended. However, that does not mean sticking to rigid cut points for dose and duration of opioid use, abandoning patients, or having them undergo too rapid a taper.”

Others questioned JAMA’s decision to publish Sullivan’s op/ed.

“While I recognize the editors’ legitimate intellectual interest in providing a forum for open discussion on the opioid policy space, I question their decision to publish an editorial that represents an ongoing call for broad, ill-defined reductions in opioid prescribing,” said Chad Kollas, MD, a palliative care specialist who rejects the idea that patients shouldn’t be involved in their healthcare choices.

“Errantly embracing a lower evidentiary standard for medical decision-making capacity creates an unacceptable risk for harm to patients with pain by violating their rights of medical autonomy and self-determination.”

Opioids were once commonly prescribed in the U.S. for both acute and chronic pain, but those days are long over. Opioid prescribing has been cut in half, to levels not seen since the 1990’s. And many patients today have trouble just getting their prescriptions filled at pharmacies due to opioid shortages.

Despite that, fatal overdoses have climbed to record levels, with illicit fentanyl and other street drugs involved in the vast majority of drug deaths, not prescription opioids.

Kolodny Returns as PROP President

By Pat Anson, PNN Editor

After an eight-year hiatus, much of it spent testifying as a paid expert witness in opioid litigation trials, Andrew Kolodny, MD, has been reappointed as president of Physicians for Responsible Opioid Prescribing (PROP), the anti-opioid activist group that he founded. Kolodny succeeds Dr. Jane Ballantyne, who remains with the organization as VP for Clinical Affairs.

“I am delighted to serve in this role again, especially at a time when the need for more cautious opioid prescribing in the United States and abroad is becoming increasingly clear to clinicians, policymakers and the public,” Kolodny said in a press release.

Kolodny served as PROP’s first president from 2010 until 2014, when he was Chief Medical Officer at Phoenix House, a nationwide chain of addiction treatment centers. He is currently the Medical Director of Opioid Policy Research at Brandeis University.

Although Kolodny is a psychiatrist with a background in addiction treatment and lacks expertise in pain management, he has played a prominent role in reducing the use of opioids to treat pain. He lobbied Congress and federal health agencies for years to limit opioid prescribing, and is often quoted making sensational anti-opioid comments in the media, calling them “heroin pills” or saying that over-the counter drugs like ibuprofen “are as effective and in some cases more effective than opioids.”   

He stopped talking to this reporter years ago, saying he doesn’t like my questions and hasn’t had “a good experience” answering them.

Paid Expert Witness

Kolodny’s reinstatement as PROP’s president comes at a time when many opioid litigation cases are wrapping up against drug manufacturers and distributors, resulting in multi-billion dollar settlements with states, cities and counties. The plaintiff law firms who filed and pursued those cases stand to make billions of dollars themselves in contingency fees.

Kolodny was a paid expert witness or consultant for at least four of those law firms (Motley Rice, Nix Patterson, Cohen Milstein and Scott & Scott), making as much as $500,000 when he testified at a rate of $725 an hour in Oklahoma’s lawsuit against Johnson & Johnson.

That case, which resulted in a $425 million verdict against the drug maker, was overturned last year by Oklahoma’s Supreme Court, which ruled that J&J was not the “public nuisance” that Kolodny and the state attorney general portrayed it to be.  

A similar ruling was made by a California judge, who said opioid manufacturers did not use deceptive marketing and were not liable for the state’s opioid crisis. Dr. Anna Lembke, a Stanford psychiatrist and PROP board member, testified as a paid witness for plaintiffs in that case, but Judge Peter Wilson said her testimony about opioid addiction was unreliable.

DR. ANDREW KOLODNY

Court records show that Lembke was paid up to $800 an hour for her testimony in a New York opioid litigation case.

Public records also show that Kolodny was hired as an “expert consultant” by at least one state. In 2020, he signed a contract with the New York State Department of Financial Services to provide “consultation on medical issues and trends regarding the prescription of opioids” at a rate of $600 an hour. In one invoice, Kolodny billed the state $1,500 for making two phone calls. The maximum amount to be paid to Kolodny was later set at $174,999.

In addition to Kolodny and Lembke, at least five other PROP board members have testified as paid expert witnesses or consultants in opioid litigation: Ballantyne, Dr. Danesh Mazloomdoost, Dr. Adriane Fugh-Berman, Dr. Mark Sullivan and Dr. David Juurlink. Mazloomdoost was paid a rate of $850 an hour for his testimony.

PROP members have failed on repeated occasions to disclose these business relationships, but when questions were raised about them, they filed revised conflict of interest statements — without providing details on who they worked for or the amount they were paid.

PROP itself has not been transparent about its finances. PROP is not a public charity and has never filed a tax return. It takes advantage of a loophole in IRS law by having the Steve Rummler Hope Foundation as its “fiscal sponsor,” which allows donors to make tax-deductible donations anonymously.

PROP says it does not accept funding from “pharmaceutical companies and other life sciences corporations.” Kat Marriott, PROP’s Executive Director, did not respond to an email asking if the organization accepted money from law firms, medical device makers, drug testing companies or other industries that have profited from the opioid crisis.  

(Update: This story contains several updates relating to PROP members working as paid expert witnesses and consultants in opioid litigation cases. )

Do Prescription Opioids Increase Social Pain and Isolation?

By Pat Anson, PNN Editor

Long-term use of opioid medication may increase social isolation, anxiety and depression for chronic pain patients, according to psychiatric and pain management experts at the University of Washington School Medicine.

In an op/ed recently published in Annals of Family Medicine, Drs. Mark Sullivan and Jane Ballantyne say opioid medication numbs the physical and emotional pain of patients, but interferes with the human need for social connections.

“Their social and emotional functioning is messed up under a wet blanket of opioids,” Sullivan said in a UW Medicine press release.

Sullivan and Ballantyne are board members of Physicians for Responsible Opioid Prescribing (PROP), an influential anti-opioid activist group. Ballantyne, who is president of PROP, was a member of the “Core Expert Group” that advised the CDC during the drafting of its controversial 2016 opioid guideline. She has retired as a professor of pain medicine at the university, while Sullivan remains active as a professor of psychiatry.

In their op/ed, Sullivan and Ballantyne say it is wrong to assume that chronic pain arises solely from tissue damage caused by trauma or disease. They cite neuroimaging studies that found emotional and physical pain are processed in the same parts of the human brain.  While prescription opioids may lessen physical pain, they interfere with the production of endorphins – opioid-like hormones that help us feel better emotionally.

“Many of the patients who use opioid medications long term for the treatment of chronic pain have both physical and social pain,” they wrote. “Rather than helping the pain for which the opioid was originally sought, persistent opioid use may be chasing the pain in a circular manner, diminishing natural rewards from normal sources of pleasure, and increasing social isolation.

“To make matters worse, the people who need and want opioids the most, and who choose to use them over the long term, tend to be those with the most complex forms of chronic pain, containing both physical and social elements. We have called this process ‘adverse selection’ because these are also the people who are also at the greatest risk for continuous or escalating opioid use, and the development of complex dependence.”

Sullivan and Ballantyne say doctors need to recognize that when patients have both physical and social pain, long-term opioid therapy is “more likely to harm than help.”

“We believe that short-term opioid therapy, lasting no more than a month or so, will and should remain a common tool in clinical practice. But long-term opioid therapy that lasts months and perhaps years should be a rare occurrence because it does not treat chronic pain well, it impairs human social and emotional function, and can lead to opioid dependence or addiction,” they wrote.

Angry and Depressed Patients

It’s not the first time Sullivan and Ballantyne have weighed in on the moods and temperament of chronic pain patients. In a 2018 interview with Pain Research Forum, for example, Ballantyne said patients often have “psychiatric comorbidities” and become “very angry” at anyone who suggests they shouldn’t be on opioids.

“I’ve never seen an angry patient who is not taking opiates. It’s people on opiates who are angry because they’re frightened, desperate, and need to stay on them. And I don’t blame them because it is very difficult to come off of opiates,” she said.

In a 2017 interview with The Atlantic, Sullivan said depression and anxiety heighten physical pain and fuel the need for opioids. “People have distress — their life is not working, they’re not sleeping, they’re not functioning,” Sullivan said, “and they want something to make all that better.”

JANE BALLANTYNE MARK SULLIVAN

In a controversial 2015 commentary they co-authored in the New England Journal of Medicine, Sullivan and Ballantyne said chronic pain patients should learn to accept pain and get on with their lives, and that relieving pain intensity should not be the primary focus of doctors. The article infuriated both patients and physicians, including dozens who left bitter comments.

“Great job. I will be going into the coffin business thanks to these believers that people should suck it up. How NEJM even recognizes these people as doctors and not quacks is beyond me,” wrote a family practice physician.

“I take just enough narcotic pain meds to cut the edge off of my pain to be coherent enough to love my wife and respond to your constant misinformation,” wrote a patient.

Ballantyne and Sullivan’s op/ed in Annals of Family Medicine has yet to produce a similar response, either pro or con. The article was submitted to the journal over a year ago, but is only being published now.

Ballantyne disclosed in her conflict-of-interest statement that she has been a paid consultant in opioid litigation lawsuits, while Sullivan disclosed that he provided expert testimony for the states of Maryland and Missouri.

Other PROP board members have also found a lucrative sideline testifying in lawsuits. The organization is currently conducting a fundraiser to hire a new Executive Director to “take PROP's work to the next level.”