 I now have the privilege of introducing Alexi Torqui. Alexi is an associate professor of medicine and associate division chief of general internal medicine and geriatrics at Indiana University. She's also director of the Daniel F. Evans Center for Spiritual and Religious Values in Healthcare and the fellowship director of the Fairbank Center for Medical Ethics. Dr. Torqui's research focuses on end-of-life care, patient communication, spiritual aspects of care and surrogate decision-making. She was the first person to describe and analyze the relationship between doctors and healthcare surrogates and her current research continues to focus on surrogate decision-making. In this case, for older adults with dementia, delirium or other forms of cognitive impairment. Dr. Torqui has also done work in medical education, designing and evaluating curricula regarding end-of-life care and clinical ethics for medical students, residents and fellows. Today, Dr. Torqui will speak on balancing the harms of pain and addiction. Please join me in welcoming Lexi. Thank you, Lainey. It's a pleasure to be here. This talk today is a little bit of a departure from some of the things I've addressed in the past years, but it's something I just can't seem to get my mind off of because of my own clinical practice and my encounter with patients. So I have no conflicts of interest. One of the greatest changes in the practice of medicine during my career has involved pain management, opiate prescribing and addiction. I trained in an era of a massive awareness campaign about pain and a resulting increase in opiate prescribing. It is now clear that this approach is one of the contributors to the national crisis of opiate addiction. The pendulum has swung from one side to the other. In this presentation, I will make the case that both the campaign to recognize and treat pain and the response to the opiate addiction crisis while well-intended have ignored some of the most important aspects of good patient care. This has left providers and frequent ethical dilemmas as they care for patients with pain and is resulting in continued suffering for patients. I will first describe the recent history of pain treatment and opiate use in the US. I'll point out some common ethical quandaries that physicians face and we'll end with some policy recommendations that I believe point us forward to healthier patients who have both better pain control and lower rates of abuse. In the book, Dreamland, author Sam Kinonis chronicles the story of the US opiate epidemic. He tells a compelling tale that weaves together several forces that led to the rise of the opiate addiction in the US and I'll walk you through some of them. As any of you who practiced in the 1980s and 90s remember, aggressive pharmaceutical advertising was clearly a daily fact of life. There was a barrage of pens, post-it notes, dinner and so-called advisory boards where physicians could be flown to exotic locations and paid thousands of dollars to be detailed by drug makers. Oxycontin was released into this milieu by Purdue Pharma in 1996 and was aggressively marketed to patients with chronic pain. There are approaches involved, some strategies that were perfectly legal at the time, including you see the fabulous swing CD here, things like Oxycontin, a step in the right direction. And there were also some times where they actually misrepresented evidence in ways that have led to criminal prosecution. Other medications, including MS-contin and hydrocodone products were also aggressively marketed. In the 1990s, there was a growing awareness of the burden of untreated pain. This concern grew into a movement. In 1996, the American Pain Society began a campaign naming pain as the fifth vital sign. The VA and the Joint Commission adopted this approach as well, physicians were encouraged to believe their patients' report of pain because it's a fundamentally subjective concept. There was also a growing belief that the risks of opiate addiction were overblown. This was based on incomplete evidence that few people questioned. At the same time that we were being encouraged to treat pain, visits were getting shorter and shorter and coverage for alternative therapies for pain, such as cognitive behavioral therapy and exercise interventions was limited. For me, practicing at that time in an urban hospital in Georgia, the resources were especially limited. So how did we respond to our patients' reports of pain with a prescription pad, which was quick and easy. With the freedom to prescribe opiates and many new addictive choices, clinics sprung up that did little but prescribed vast quantities of pain medication. Some of these were located in out-of-the-way storefronts. Physicians saw patients for as little as five minutes and then filled the prescription in on-site pharmacies. Some operations were cash only. There was little to no history or physical exam. That only did people come to supply their own addiction. They would bring others to the clinic in exchange for a cut of the pills to resell them on the street. Each of the three factors I've mentioned so far have contributed to substantial increases in prescribed opiates and contributed to one degree or another to a rise in addiction among patients who took the medications as prescribed and among others who used medications from friends or bought diverted pills on the street. This graph shows the increase in opiate prescriptions from 1991 to 2013. And at the right of the graph, you finally see the beginning of a decline in total prescription numbers. There was an even larger rise in the amount of opiate quantities of the amount of opiates prescribed. So as you see here, the amount of opiates prescribed per person was three times higher in 2015 than in 1999 in MMEs or morphine milligram equivalents. This graph shows the concomitant rise in opiate prescriptions and overdose deaths. Now I know that associations, temporal or otherwise, do not prove cause and effect, but they are a piece of evidence for it. And I think the evidence here is really quite striking. An additional force that contributed to the opiate epidemic is the widespread availability of heroin, particularly in mid-sized cities and rural areas where it was not previously available. Beginning in the 1980s, a distribution for black tar heroin spread across the country. This heroin was distributed and sold by individuals from a small area in Western Mexico. They developed a system that has been compared to fast food chains or pizza delivery. Customers would reach a dealer on a cell phone or pager and would set up a meeting place in a parking lot or other location. The dealers carried small amounts of heroin, were generally nonviolent or involved in gang crime, and rarely used the drug themselves. They didn't dilute the heroin or cheat their customers. So the first customers were those who were already addicted to heroin who liked the convenience and the quality of black tar. Over time, however, their customer base grew to include pill users who realized that the heroin was substantially cheaper than pills like Oxycontin. The result of these forces has been a vast increase in the number of Americans who die each year from overdose and other complications of abuse. As this slide shows, the rise in heroin-related overdose deaths has increased by 286% from 2002 to 2013. Recently, solutions are emerging to some of these problems. Pill mills have been shut down and physicians who run them have been imprisoned. Organizations have moved away from the notion that pain is the fifth vital sign. Efforts are underway, perhaps, with limited success to take down the highly successful networks of black tar heroin dealers in America. Family and advocacy organizations are speaking out about addiction, seeking to remove the stigma and increase support for addiction treatment, including treatments as alternatives to prison time. States have imposed regulations on opiate prescribing, which include required databases to track all prescriptions received by a patient, limits on doses and pill amounts in most circumstances, mandatory treatment agreements, or pain contracts in urine drug testing. But the wild pendulum swing from the pain revolution to the opiate crisis has left physicians in ethical binds when treating patients. I'll share two cases that I'm familiar with to illustrate this. So here's the first one. This is pretty close to someone I treated, a 62-year-old man with lung cancer who comes to see his palliative care doctor. She prescribes morphine for pain. At the next visit, the physician reviews the medical record and finds that the patient was admitted to the hospital from jail after he was arrested for trading the morphine for heroin. He now returns out of medication and complaining of severe chest pain at the site of his tumor. His doctor offers him admission to drug rehabilitation, but is unable to find a program that will take a patient without insurance. He now reports 10 out of 10 pain and begs for morphine. What should the physician do? Should the patient walk out of the clinic with no pain medication because he clearly abuses it? The patient has both a legitimate need for pain treatment and an addiction problem. An essential piece of the puzzle is that treatment for opiate addictions must be expanded. There've been some successes in communities that have refocused resources from prisons to treatment facilities, but for individuals who are not in the criminal justice system, access to treatment and coverage of treatment must be greatly improved. Here's a second case. A 59-year-old man with chronic degenerative disc disease in his low back who works as a carpenter comes to see a new primary care doctor. For the past three years, he uses ibuprofen during the day and takes two hydrocodone acetaminophen at night. He feels he's doing well with his pain regimen. He drinks alcohol socially once a week. The primary care doctor said she will not continue prescribing the hydrocodone because it is addictive and dangerous. She also notes that there are many burdens and documentation requirements that are unrealistic given how many patients she has to see in a day. She tries to refer him to a pain specialist, but the health system doesn't have one. He says, I'm doing really well now. I can handle the pain during the day. I can make it if I can come home at night and have some relief. I can sleep well, sometimes have sex with my spouse. I am not addicted. The PCP feels terrible that she has so little to offer him, but she has five more patients to see by the end of the day, so she concludes the visit. States have passed laws and regulations on opiate prescribing that make it highly burdensome to write prescriptions. These administrative burdens may exempt situations in which opiates are clearly appropriate, such as palliative care, advanced cancer, and hospice, but they do not address many other situations in which opiates may be appropriate. In my outpatient palliative care practice, we regularly receive referrals from primary care physicians who simply do not have time to treat chronic pain in their 15-minute office visits. They would have to write electronic opiate prescriptions using two login procedures, do a treatment agreement, check the controlled substances registry, and fill out a slew of forms. We see these patients once, but then we send them back to their PCP since almost none of them actually have a life-threatening illness. Then insurance companies add other barriers. In our practice, our palliative care nurses spend a great deal of time each day obtaining prior approvals on opiate medications for a range of diseases for patients nearing the end of life. So instead of doing the things they should be doing, counseling patients providing psychosocial support or doing advanced care planning, they sit on the phone and on their computers, convincing insurers that a patient needs a higher dose, more pills, or a medication to which they are not allergic. I want to talk now about high-quality approaches to pain management. The CDC's current guidelines take us a balanced approach to opiates that supports cautious use and combines their use with other recommended therapies. There are three main principles. The first is that non-pharmacologic therapy and non-opioid therapies are preferred for chronic pain, but opiates may be considered in certain circumstances. Second, clinicians should establish treatment goals for pain and function. I think function is especially important here and monitor response. And finally, clinicians should discuss risks, benefits, and patient and clinician responsibilities for monitoring therapy. I think these are pretty sensible. So now let's look more closely at some of these alternatives or complementary therapies. A recent study in JAMA by Aaron Krebsen colleagues compared opiate and non-opiate approaches to chronic back and knee pain. Regarding their primary outcome function, they found that opiate medications were no better than non-opiate medications. Regarding pain, there were significant differences with opiates outperforming non-opiates, although they noted that on the scales they use, this differences were probably not clinically meaningful. This means that for fairly healthy older adults with chronic musculoskeletal pain, non-opiate approaches are the way to go. For these patients, the move away from opiates is the right approach. The complexity is that many patients that I see, and I'm certain that many of you see, are not like these patients. They have bad kidneys and can't take non-steroidal medicines like Advil and Ibuprofen. They are old and become cognitively impaired with amipramine and gabapentin. So for these patients, opiates might be part of the pain control solution. A second important approach is high-quality pain management. So this randomized trial by Kurt Krenke and others tested a nurse delivered in-person and telephone intervention for patients with concomitant depression and pain. They treated the depression first and then worked on the pain. They found significant improvements in both pain and depression with the intervention, suggesting that high-quality follow-up can improve quality of life. And here you see the results for pain with improvements in both interference and severity. Another extremely important opportunity is the use of non-pharmacologic interventions. A recent really fantastic VA review identified several interventions that are relatively low-cost and effective. These include cognitive behavioral therapy, exercise and movement therapies like Tai Chi, and manual therapies like manipulation and acupuncture. These relatively low-cost, low-tech interventions are rarely implemented because they are poorly reimbursed. So using non-opiate medications and non-pharmacologic approaches are effective ways to reduce pain and reduce needless suffering for patients. An ethical approach to pain management will include these elements. So now to conclude, I think there are three recommendations that will be important going forward to providing high-quality and ethical pain management. First, policy, law, and medical practice must concurrently address pain control and opiate addiction. Swinging back and forth between the two causes is harming our patients. Second, non-opiate approaches to pain should be widely implemented, including pharmacologic and non-pharmacologic approaches, and they need to be paid for. Third, treatment options for addiction must be expanded and availability and covered by insurance or free. So persons with addictions who are ready to quit can find the resources they need. Failure to address these twin problems of pain and addiction will continue to cause substantial suffering due to untreated pain. Also, because people with pain and emotional suffering will continue to seek relief, our current policies will be unlikely to reduce abuse and diversion in the illegal sale of heroin and prescription drugs. Thank you. Well, relative certainly to addiction treatment, I think relative to the harm in lost work hours, productivity, other societal costs of not treating pain and addiction. So I agree that if we're going to do a cost analysis, we have to do a broad view of the aspects of costs that we're considering. I would say saving one addiction would be a low-cost intervention. Rick Kodish from Cleveland, thank you for that very nice talk, something that's certainly been on my mind too. I wanted to know if you have looked into or seen much about sickle cell disease specifically in this problem as a clinician who cares for kids with sickle cell. I have concern that it's obviously vasoclusive pain crisis is a bad problem and opiates work, and I haven't seen much about this issue that you raise in terms of the tension between the policy issues for that specific population. Yeah, I have to say that I'm not specifically expert in that area. I do know, I mean, again, when I was trained, people said that sickle cell patients would never get addicted. That was clearly untrue. So again, in any chronic disease that causes severe pain, I think a balanced approach is the most appropriate. I think we can do risk assessments on our patients. There is growing evidence of patients who are at high risk for addiction, but I think a multimodal approach is definitely a value. But I'm not familiar with cutting edge researcher if there's enough research on patients with sickle cell. Do you know anything about the pharmacogenomics in terms of addiction risk? Pharmacogenomics of what? When you talk about trying to assess our patients for risk of opioid addiction, is there a hope that there will be some genomic assessment of that risk that'll help to nuance it? Yeah, whoa, mic drop. I think that there is hope for that for the future. I think right now it's widely clinically available or more about psychosocial risk factors, although I think pharmacologic risk factors would be important and valuable. Hi, September Williams. I've now been around long enough to have learned a lot about addiction communities and sort of self-help groups, Al-Anon and different places. There's a phrase that always comes up in those communities, which is no think. That when people are addicted, they do things and there's no think. And it occurred to me that the no think principle really applied to what happened when we recognized that people who were dying of diseases that were painful should actually get pain medicine. And then we allowed as a group of professionals and as people who listened to pharmacology entities and as people who were almost simultaneously relinquishing control of primary care doctors or family doctors from their patients and transferring it to piecemeal. We had this bright moment of about 10 years where family medicine was the continuity of care and then the gatekeeper concept came in. So when I think about this stuff, I think about where the no think started and how you can back off of it. So this idea that palliative care is the same thing as chronic pain. So if you could give me a no think point in history or in the history of your own career, I'm just curious, because that's where I see the no think part happened. It's where I just described it. What do you think is the no think? Well, that's interesting. I mean, I think for me in my own training, the pain is the fifth vital sign was the one. I mean, it was, I think, I mean, of course then, now people call everything the fifth vital sign they're supposed to screen for 15 things and they're each the fifth vital sign. You know, I think it's highly problematic to come up with a problem without coming up with a solution. It's very, I mean, I think that was part of the problem as we were told and I certainly believed it as a resident. Believe your patient's report of pain, you ask about their pain. This is epidemic of untreated pain, but we're not gonna give you any tools that are new to deal with it. And I think addressing one side without the other that would be a great definition for it as no think. And then I have just one quick follow up. You know, I know acupuncture is covered in the Affordable Care Act, but I'm wondering how many people are aware that clinicians can use and prescribe other alternative therapies in many states if their license allows them to prescribe. And are you aware of that and do you use that as an alternative? I think issues of prescribing and coverage certainly vary. I mean, I think, for example, within the VA, things like acupuncture, chiropractic are widely available. For many patients, some of those things are not available. For example, Medicaid in my state covers very little of those kinds of things. So it is varied locally. I hope the expansion of coverage is something that we see in the Affordable Care Act. That's wonderful. It was buried in there. Jennifer Hartlin came back out of retirement to make sure that people knew it was aware that they were aware of it. Good to know. Yeah, thank you very much. Oh, should we take one more? All right, last question. Oh, thank you so much. My name is Hannah. I'm an internist. I really appreciated your talk, learning about how your experience as a resident sort of informed your thoughts about everything. I definitely trained at a time which is current where the opioid crisis is literally talked about all the time. And your case number one really struck me that you mentioned about the patient with pain related to his malignancy who also had an opioid use disorder. And I think there really is a role for things like suboxone and methadone for patients like that, as opposed to completely writing them off as people who don't merit opioids for their chronic pain, because that patient, from my perspective, was not being appropriately treated for his opioid use disorder. So I guess that's more of a comment. And I'm curious what role you think MAT medication assisted therapy has in palliation for patients like that. Great. I think it has an important role. I mean, I do believe that MAT is an important part of the solution, which is medication assisted treatment for addiction. I think patients like that ought to be treated within a treatment, within an opiate addiction treatment program. So for example, I can't prescribe suboxone at all. I could prescribe methadone. I could certainly do that because I can say it's for his pain, but it actually is for his pain and addiction. And so we need more providers who are both able to prescribe medication addicted therapy and second of all, people who are both palliative care expert, have both palliative care and medication assisted therapy expertise. Yeah. Thank you. Thank you very much.