A Doctor's Crusade Against Sharp Limits on Opioids for 'Legacy Patients'

About four years ago, Dr. Stefan Kertesz started hearing that patients who had been taking opioid painkillers for years were being taken off their medications. Sometimes it was an aggressive reduction they weren’t on board with, sometimes it was all at once. Clinicians told patients they no longer felt comfortable treating them.

Kertesz, a primary care physician who also specializes in addiction medicine, had not spent his career investigating long-term opioid use or chronic pain. But he grew concerned by the medical community’s efforts to regain control over prescribing patterns after years of lax distribution. Limiting prescriptions for new patients had clear benefits, he thought, but he wondered about the results of reductions among “legacy patients.” Their outcomes weren’t being tracked.

Now, Kertesz is a leading advocate against policies that call for aggressive reductions in long-term opioid prescriptions or have resulted in forced cutbacks. He argues that well-intentioned initiatives to avoid the mistakes of the past have introduced new problems. He’s warned that clinicians’ decisions are destabilizing patients’ lives and leaving them in pain — and in some cases could drive patients to obtain opioids illicitly or even take their lives.

“I think I’m particularly provoked by situations where harm is done in the name of helping,” Kertesz said. “What really gets me is when responsible parties say we will protect you, and then they call upon us to harm people.”

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It’s a case that Kertesz, 52, has tried to make with nuance and precision, bounded by an emphasis on the history of overprescribing and the benefits of tapering for patients for whom it works. But against a backdrop of tens of thousands of opioid overdose deaths each year and an ongoing reckoning about the roots of the opioid addiction crisis, it’s the dialectical equivalent of pinning the tail on a bucking bronco. Kertesz’s critics have questioned his motives. He’s heard he’s been called “the candyman.”

Dr. Stefan Kertesz a leading advocate against policies that call for aggressive reductions in long-term opioid prescriptions or have resulted in forced cutbacks. (University of Alabama at Birmingham)

“I am really worried that people like Stefan Kertesz, who is trying to champion ‘patient-centered care,’ in some ways are feeding into the same misleading messaging rolled out by Purdue [Pharma] and others that not to prescribe opioids is tantamount to torturing patients,” said Dr. Anna Lembke, the medical director of addiction medicine at Stanford.

The debate is playing out as doctors try to move beyond their days of overprescribing while responsibly treating chronic pain. It is also playing out in settings like Kertesz’s office here at a Veterans Affairs clinic, where a patient named Jerry Brown, a 63-year-old former boilermaker and carpenter, recently showed up.

Brown had a compressed spinal cord and severe neck pain. For more than a decade, dating back to before he started seeing Kertesz, he had been taking about 300 morphine milligram equivalents (MME) of opioids a day — a dosage equivalent to more than three times the level that clinicians should “avoid or carefully justify,” according to federal officials.

Kertesz and Brown tried a 10% dose reduction a few years ago. But Brown became volatile and less active and complained of revived pain, so Kertesz eased back.

Kertesz, who treats patients who are or have been homeless, told Brown that he had “incurred risk” with his dose. “Do you know that I wish you hadn’t had your doses increased?” he asked.

“Yes,” Brown replied.

They could try again to taper the dose to reduce that risk. But Brown had stable housing and activities to keep him busy — he helped his ex-wife out at her home and cleaned up after her Chihuahuas. He had anxiety and sometimes had trouble getting to the clinic because of transportation problems. But there was no evidence he had misused or sold his drugs, or misused other substances.

In this case, Kertesz’s takeaway was: “Leave well enough alone.”

Opioid prescribing has been declining since 2012, though levels remain higher than they were two decades ago. Today, depending on the estimate, anywhere from 8 million to 18 million Americans take opioids for chronic pain.

The interest in reducing their dosages is predicated in part on efforts to minimize patients’ risk of overdose and addiction. But there are other considerations. Enduring opioid use makes people more sensitive to pain, many experts believe. Opioid use has also been associated with anxiety, depression, and other health issues.

Plus, as people become dependent, the drugs might just be staving off symptoms of withdrawal that would come without another dose, rather than treating the original source of pain.

In short, experts say, long-term opioid use is not good medicine.

Kertesz, who is also a professor at the University of Alabama at Birmingham School of Medicine, agrees with all of that. But he believes that lowering dosages will hurt some patients who are leading functional lives on opioids, and that top-down strategies won’t protect them.

So, in 2015, when the Centers for Disease Control and Prevention proposed prescribing guidelines for primary care clinicians treating chronic pain, Kertesz grew nervous.

The guidelines, a set of measured recommendations finalized in March 2016, suggested clinicians try other therapies for pain before moving to opioids and prescribe only the lowest effective dose and duration of the drugs. (The guidelines do not apply to end-of-life or cancer care.) For patients on high doses, the guidelines said, “If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids.”

“Our day-to-day practice aligns with nearly all principles laid out in the guideline,” Kertesz wrote in a comment he submitted on the draft. But he cautioned the voluntary recommendations could be implemented too stringently by others.

“This is a guideline like no other … its guidance will affect the immediate well-being of millions of Americans with chronic pain,” he wrote.

After the release of the guidelines, Kertesz started seeing ripple effects. In early 2017, federal officials unveiled a Medicare proposal that would have blocked prescriptions higher than 90 MME without a special review. Around the same time, the National Committee for Quality Assurance considered docking clinicians’ scores if they had patients on high doses for long periods.

Kertesz, other experts, and some medical societies protested such proposals, contending they invoked the CDC guidelines while violating them.

The prescription medicine OxyContin is displayed. (Darren McCollester/Getty Images)

“Most of us wish to see an evolution toward fewer opioid starts and fewer patients at high doses,” Kertesz and colleagues wrote in response to the NCQA plan. “The proposed NCQA measure indulges no such subtleties.”

The discussion overall has been hindered by limited research, including evidence for the benefits of forced tapering. But as of October 2018, 33 states had codified some prescription limits into law. Pharmacies and insurers capped prescriptions at 90 MME. Law enforcement agencies warned high prescribers.

Some initiatives have focused on avoiding “new starts,” not on tapering legacy patients. But Kertesz and other advocates argued the pressure of all the policies and warnings inculcated an anxiety around prescribing.

Chronic pain patients were seen as legally risky and medically complicated, so they had trouble finding providers.

Kertesz and his allies raised their concerns in the popular and academic presses and at conferences, building momentum over the years. They collected anecdotes from patients who said they had been harmed in some way by dose reductions or involuntary tapers.

“It is imperative that healthcare professionals and administrators realize that the Guideline does not endorse mandated involuntary dose reduction or discontinuation,” read a March letter co-authored by Kertesz calling on the CDC to reiterate its recommendations were not binding. The letter continued: “Patients have endured not only unnecessary suffering, but some have turned to suicide or illicit substance use.”

More than 300 patient advocates and experts, including three former White House drug czars, signed it.

Kertesz sees his advocacy work as an extension of several throughlines in his career. For one, he has patients who have been on opioids for years, and he knows the stress clinicians face when renewing a high-dose prescription. He also has a history of arguing for causes that stretches back to writing op-eds for his high school newspaper in Silicon Valley.

But his willingness to take on what he sees as injustices does not mean he feels self-assured about doing so.

“Every single bit of it involves ambivalence and driving myself crazy,” he said. “Like, am I making a mistake? Am I going to blow up my career?”

When Kertesz thinks, he leans forward and pulls his hair back. His obsessive streak extends to both his career and his personal life. (He’s become a fencing fanatic, having taken up the sport less than six years ago.) When he talks about medicine, he pauses mid-conversation to point out whether his statements are based on randomized trials or his own inference. He can appear scatterbrained and is working with a coach to become more structured.

“He’s not like a heroic figure on a horse. He’s more like a neurotic figure on a horse,” said Dr. Saul Weiner of the University of Illinois at Chicago, who became friends with Kertesz while working at a hospital in Gabon during medical school.

Having tenure has made Kertesz more comfortable being outspoken. And he feels he may have more credibility than other physicians to make this specific case. He is a primary care physician who cares for people who are homeless and, beyond some former stock ownership, has no ties to drug companies, as opposed to a pain specialist who received research funding from them. (Kertesz noted that he recently packed his own PB&J for a conference, the implication being he’ll avoid even a pharma-funded sandwich spread.)

Kertesz and Saul Weiner working at a hospital in Gabon in the early 1990s. (Saul Weiner)

But other leaders of Health Professionals for Patients in Pain, the group that wrote the March letter calling on the CDC to clarify its guidelines, have projects that are supported by drug companies. They disclose as much on the group’s site, but it’s left the group exposed to the criticism that it’s not wholly removed from the pharmaceutical industry.

Kertesz “certainly is very close to people who are being paid by opioid manufacturers,” said Dr. Adriane Fugh-Berman of Georgetown University, who studies the pharma industry’s influence on medicine. “He’s certainly worked with people who have close ties to opioid manufacturers.”

Kertesz said that because of the industry’s history of opioid promotion, such criticisms need to be part of the discussion.

Fugh-Berman is among the experts who have challenged Kertesz’s most alarming claim: that pain patients are being driven to suicide. They argue advocates are relying on anecdotes more suited to a political candidate’s barnstorming of Iowa than the kind of scientific evidence needed to substantiate claims of a new epidemic. Establishing cause and effect in suicide is complex, and studies have shown an association between opioid use and suicide.

“Where is your evidence of documented suicides from people who are tapered?” Fugh-Berman asked Kertesz following a presentation at a conference last year.

Kertesz replied that he had reviewed medical records from people who had died by suicide after an opioid reduction. He added a caveat: “You have three things that are potentially simultaneously associated with harm: Pain itself. Opioid dependence, the dependence itself. And the event, however we wish to interpret it clinically — as resurgent pain or untreated opioid dependence — in patients who are having opioids taken away.”

Kertesz is now trying to secure funding to study such suicides.

Fugh-Berman and Kertesz are often cast as representatives of two fundamentally opposed camps. (Indeed, Stanford’s Lembke and Kertesz are slated to square off in a “spicy debate” at an upcoming medical conference.)

Such a framing elides what they agree on. Kertesz emphasizes that opioids were massively overprescribed, that the patients he’s worried about should have never been on these doses, and that many patients will be better off after tapering. Lembke stresses that tapers need to go slowly and that patients should be monitored closely during the process — never pushed out of care.

But they disagree on exactly how to go about lowering prescribing and the proportion of patients who can be tapered without compromising quality of life.

Lembke argues that top-down policies are required to counter all the incentives clinicians have to keep patients on opioids. She has called for medical centers to establish teams that can guide patients through the process. She also said that some patients should be switched to buprenorphine — an opioid addiction medication that eases withdrawal symptoms — even if they do not meet the diagnosis of opioid use disorder.

“To leave them at those doses because it’s too hard, that’s not OK,” she said.

Lembke noted that prescription policies typically include exceptions for some patients to remain on high-dose opioids.

“There are rare instances where I would agree that maybe the most judicious path is ‘leave well enough alone,’” she said. “But that would be where the patient has to commute four hours to get to my clinic, they have no social support, they have no family, they have no psychological or emotional resources to help them do this hard thing which really from a medical perspective they need to do.”

Kertesz takes a different view. He supports doctors who encourage tapers, and he has spoken about tapering a patient off her medications against her wishes in one case. But he believes those are choices for clinicians to make, and that overarching policies will lead to mismanaged care.

Backing mandatory limits, he said, “assumes that what’s going to happen at the systems level will reflect the best clinician.”

Last month, the authors of the CDC guidelines published a paper that said “some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations.” They called out “hard limits and abrupt tapering of drug dosages” that their guidance did not endorse.

It was what Kertesz and his colleagues had been asking for. But now, they face the more difficult task of ensuring every group that overshot the CDC guidelines corrects course.

The national attention Kertesz has received for his efforts felt far removed from the room where he was seeing his patients earlier this month. One was in the midst of a taper experiment, from 40 MME to 35 MME a day. But there was also talk of blood pressure medications and cancer screenings — primary care basics.

Then there was Byron, 47. He asked that his last name not be used, but Kertesz and the staff at the clinic called him their Jonah. He had been swallowed up by his addiction and maybe should have died, but here he was, like God had some plan for him.

Byron was staying at a recovery home, but he felt listless without the rush of drugs or living on the street, he told Kertesz. Kertesz bumped up his buprenorphine dose, but the existential anguish was a harder problem to address.

“At any given moment, any one of us feels unsure about who to be or what to do or how to do it,” Kertesz told him.

“You have extra burdens, but you’re not alone,” he continued. “Everyone has times when they don’t have clarity.”

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This story was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.

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