BIRMINGHAM, Ala. — 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.

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“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.”

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.”

“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.”

Dr. Stefan Kertesz
Kertesz examines Jerry Brown, 63. Brown has been on high-dose opioids for over a decade. Tamika Moore for STAT

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.

“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.

Dr. Stefan Kertesz
Kertesz and licensed practical nurse Amber Carthen examine Byron, 47. Tamika Moore for STAT

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.)

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.”

Saul and Stefan in Gabon
Kertesz and Saul Weiner working at a hospital in Gabon in the early 1990s. Courtesy Saul Weiner

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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  • I have been on pain meds since the 90’s and my Dr cut me off all my narcotic meds because I had no way to specialists for other problems I have. My blood pressure is 182/117 is this legal?

  • Anna Lembke is a member of the Kolodny anti-opioid zealotry group PROP who wrote the CDC Opioid Rx Guidelines and has lost all credibility a long time ago. Pain and suffering are really of no consequence to her and her fellow “pain is all in your head” believers. She should be apologizing but there’s no money for that.

  • Re” “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.” Dr. Anna Lembke

    That is an appeal to extremes logical fallacy. With those words, Anna Lembke destroyed any credibility as a medical practitioner.

    The reality is that the “opioid crisis” and demonization of honest physicians and chronic pain patients is leaving chronic pain patients bereft of effective care, suggestions for ineffective palliatives and wishful thinking, and driven to the ultimate escape.

    https://www.painnewsnetwork.org/stories/2017/5/20/an-epidemic-of-undertreated-chronic-pain

    https://www.jabfm.org/content/jabfp/14/3/211.full.pdf

    https://www.medscape.com/viewarticle/745776

    https://medium.com/@ThomasKlineMD/opioidcrisis-pain-related-suicides-associated-with-forced-tapers-c68c79ecf84d

    • Anna Lembke is a member of the Kolodny anti-opioid zealotry group PROP who wrote the CDC Opioid Rx Guidelines and has lost all credibility a long time ago. Pain and suffering are really of no consequence to her and her fellow “pain is all in your head” believers. She should be apologizing but there’s no money for that.

  • I know of people who chose suicide because they were taken off cold turkey. Dr said you won’t die, you will just feel like it! I have been there they took me off my opioids and put me on buefenorphine. I have tryed to taper off of 2 pills a day, but I can’t function without the meds. I hope I never have to go through that again. Good luck to everyone who is out there helping all of us.

  • People who have been successfully prescribed opioids that have enabled them to become productive members of society have been victims of this opioid reduction. The motivations for all this opioid reduction is highly suspect and is not reducing illicit drug use!

    • I know of people who chose suicide because they were taken off cold turkey. Dr said you won’t die, you will just feel like it! I have been there they took me off my opioids and put me on buefenorphine. I have tryed to taper off of 2 pills a day, but I can’t function without the meds. I hope I never have to go through that again. Good luck to everyone who is out there helping all of us.

  • I’m a 60 year old female who has been taking moderate amounts of Percocet 75% mme for over 10 years now. I have a genetic predisposition for degenerative disc disease. It’s gone back to my great grandma, who I never knew out of a wheelchair. My dad had it and so do four of my siblings. I’ve had two surgeries on my lower back and recently had an X-ray of my cervical spine ,which showed I now have severe stenosis in my cervical spine, along with other issues. My husband and myself bought a retirement home in a very small rural town in northern Ca. The nearest doctor is in a town not much bigger than ours, but it does have medical facilities. Although they are not the same level of care I’m used to,I really have no choice at this point. I recently went in to see the PA that has been treating me and was told that they are going start tapering me off them. I wS floored, as I have no history of misuse or any other reason,other than they say it’s the new regulations. It was my fault because at our last appointment,which I might add is every 28 days,I had asked if I could possibly be bumped up one tablet a day due to the pain I’ve been having in my neck, which causes more pain in my right arm along with numbness in my fingers. It’s gotten to the point that I can’t hold a coffee cup with my right hand. Big mistake on my part,now they want to take me off them all together,even though I’ve never asked for an increase or early refill. It’s just the tip of my medical problems though. I’ve had cancer on three separate occasions. The first was a malignant mole on my leg, which metastasized to my lymph nodes in my left groin. That led to a horrible treatment of high dose intravenous interferon which is like being poisoned 5 times a week for 5 hours a day. I thought that would kill me before the cancer would. After that I had kidney cancer as well,where they had to remove half of my left kidney. Luckily it wasn’t melanoma it was renal cancer. But I have to live with the thought that at anytime the melanoma could return. My oncologist told me things like stress,just to name a few can cause it to flair up again. I’m beside myself with this doctor taking my pain medicine away from me. Which as you can imagine has my stress at an all time high. They don’t want to listen to me as I’ve pled my case. They have an agenda to stop prescribing pain medicines to patients even though they know they are in need. I don’t know what to do. I’m so afraid of what is to come. I feel I was misinformed when they took my on as a patient a year ago that they were not going to change my current medication. Yesterday he said he could refer me to a pain management clinic, two hours away but first I have to have a nerve test or they won’t see me. I called the clinic and they said that wasn’t a prerequisite but if the PA thought I needed one then I should have it. But he lied to me when he said they had to have it or I wouldn’t be seen. All they said they needed was a referral and my records. I asked if he was going to make another appointment for me to see him ,if I couldn’t get all the test done and for the pain management clinic to see me, before the 28 days of medicine that I have runs out? But he wouldn’t make another appointment for me. I feel as if he’s abandoning me…what do I do if I can’t get treatment at the pain management clinic? I’ll be without all my medicine. I have done nothing but cry all day and on very little sleep. What do I do? I feel so helpless and hopeless in this matter. I don’t deserve this. All I want is to be able to live what’s left of my life in peace and have my pain controlled. I haven’t even given out all of my medical problems it’s all I could do to get this out. Thank you anyone who might have a solution.

  • I became disabled in 2001 from a disease that came out of nowhere. I acquired small nerve fiber peripheral neuropathy in feet, legs, hands and arms and into some of my internal organs like my bladder and bowels and the cause was never found. I suffer from a variety of pain such as burning, stinging, numbness, stabbing, aching pain every minute of every day of my life. Went from working in middle management in financial field to unable to walk. Was in wheelchair for almost a year due to loss of feet and leg function. Took ten months to get a diagnosis, got spinal cord stimulator implant in 2002 to help block leg pain. It helps but doesn’t cure the pain, only dulls about 40%. But enough to be able through PT to regain leg use. I was put on high levels of morphine in 2004 and oxycodone for breakthrough pain in 2012. Over a period of time my pain doctor changed my meds to find a combination that helped and that was finally done through 90mg morphine and 90mg of oxycodone per day. I was on these for 12 years until my pain doctor shut down his practice on December 31,2018. I got a letter after they closed. I then tried my family doctor and he said his hands were tied and he couldn’t prescribe anything to me. I ended up at the ER because coming off such high doses was not only dangerous but painful. I got three days of percocet and told to come back until I could get a new pain doctor and to go into rehab for medical detox which I refused. I started into severe withdraw and went back to ER every five days until the third time they said they couldn’t prescribe anything else and my only option was rehab. I went home and continued my withdraws that were absolutely awful but I did it at the age of 58. It took two months for my body to fully adjust to no pain medication. I finally got into a new pain doctor who also will not prescribe me anything other than 1 mg of suboxone per day, which is used to help people detox but I was two months past that and he tells me the 1 mg of opiate in it is all I need for pain. I was told years ago that I should have been bed bound from my disease, but I have fought against that but now without proper pain control I am almost bed bound and may end up in a nursing home which will cost Medicare a lot more than it cost to buy a couple prescriptions a month. I was never mentally addicted to my medications and thus don’t have a craving for them. I was physically dependent on them but now live in excruciating pain unable to do much and have no one to care for me as my husband died 5 years ago from pancreatic cancer. These laws have affected people who should never have been affected. I am in fear that the suicide rate will increase among cpp. The lawmakers have no idea of the chronic pain we all suffer from and until they are in our shoes they will never understand.

  • I was a chronic pain patient for fifteen years before this fake “opioid crisis” hit. I have osteoarthritis in my back, and have had disc replacement surgery that left me in more pain than before surgery. I got so frustrated and hurt by the lack of care and concern for my pain problem, that I just decided to get into a methadone program hoping it would help with the pain and yes, withdrawal symptoms associated with unethical standards of doctors rightfully scared to prescribe the drugs I needed, and need to have as close to a normal life as possible.
    I predicted that these guidelines and procedures of rapid tapering,and just cutting patients off cold turkey, while inhumane, would only drive cpp to go the rout of seeking out dangerous street drugs. Many people who, on their high horse, are making all these restrictions for people who have been doing just fine on their dose of opiates have never been in chronic pain. Pain makes every second of every minute of every hour of every day incomprehensibly torturous for us. Then we have to wake up and deal with it again. Its not fair when there is medicine out there that will help us get back to living lives with at least some purpose! Forget about how hard it is for our loved ones to go through this with us. Talk about guilt on top of pain! Anyway, I dont paint anymore, and I’m an artist. I dont do photography, cook, dance or do anything that made me a whole person when I was on the correct amount of pain medicine. I wish there were more doctors like the one in this article! Dont doctors take an oath to “Do No Harm” ? I understand it’s atricky path and hard to deal with patients in pain but. Lets not throw out the baby with the bathwater! It does so much more harm than good.

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