It's my pleasure to introduce Ken Follett. Dr. Follett received his bachelor's from Concordia College in Nebraska, and then went on to M.D. and Ph.D. from the University of Nebraska. He did his residency at the University of Iowa and then stayed on as staff, rapidly rising to professor of neurosurgery, and then moved back to Nebraska in 2005, where he's been the chair there for the past 13 years. He's past president of the American Academy of Pain Medicine. Many of us know him because he was the principal investigator on the VA cooperative study of the DBS on Parkinson's disease. And I think one of the really important contributions Ken has had to our field was he was involved in this 2012 report from the Institute of Medicine called Relieving Pain in America. This was at the height of opioid prescribing. It's actually come down a little bit if you look at the trends since 2012. But there's a recognition even then that the treatment of pain in this country has been fairly inadequate. A lot of the recommendations in that report, which is really worth reading, are really trying to go back and revive the biopsychosocial model of pain that John Lozier coined. So I can't think of a more appropriate recipient of this award. I'm very much looking forward to your talk about opioids in a world of hurt. Dr. Follett. Thank you, Jason. So it is truly an honor to be invited to join you today as the 2018 John Lozier Lecture. So I don't want to date John Lozier, but my very first interview for neurosurgery residency was at University of Washington, and the very first faculty member to interview me was John Lozier. And I looked up at him. I mean, I'm just a humble fourth-year student. Looked up at him as really the epitome of what a neurosurgeon could be. And I have to say, after all these years, I still hold Dr. Lozier in that same esteem. He's truly a remarkable individual, has done wonders for the world of pain neurosurgeons and our patients. Again, my thanks to the executive committee for this invitation. So I was invited to give an update on the work that sprang from the Institute of Medicine Committee on Relieving Pain in America and then the following national pain strategy. But then Bill Rosenberg tossed in, oh, by the way, why don't you do something about opioids too. So I wasn't able to get the whole title of the talk in your little program book. So this is the real title, Opioids in a World of Hurt, the IOM, the NPS, the CDC, the FDA, the NAS, and the Opioid Crisis. And I promise I will do all this in less than 30 minutes. So what I would like to do is give a really brief background on the Institute of Medicine Committee on Relieving Pain in America. And by the way, there was nothing special that got me appointed to the committee except that as they were looking to populate this group, they had a lot of people from the East Coast, the West Coast, they're thinking, well, we could use somebody from, like, the Midwest. And then they stumbled across my name and said, oh, my gosh, Omaha, plus he's a neurosurgeon. So I filled out the diversity requirement for the committee. So whirlwind background in the IOM committee, kind of where it came from, background and very brief update on the activities related to the National Pain Strategy. I'm going to touch on the opioid epidemic and then also touch on activities of the CDC, the FDA, and the National Academies of Science. And then I will briefly touch on the intersection between all these entities. So where did all this start? Well, it was back in 2008, actually, with Obamacare. And this was, I think, one of the hidden gems of Obamacare. One of the provisions of the Patient Protection and Affordable Care Act was that the secretary of the Department of Health and Human Services would enter an agreement with the IOM for activities that would increase the recognition of pain as a public health problem in the U.S. So the Institute of Medicine was tasked with conducting a study, and this comes from the charge, conducting a study to assess the state of the science regarding pain research, care, education, and make recommendations to advance the field. And I like this picture. This is Mitch McConnell on the floor of the Senate back when he was the Senate Minority Leader. He's got a stack of papers there that he says represent the regulations in Obamacare, and they were artfully wrapped in red tape. So the committee kicked off, met a number of times, had meetings in Washington, D.C., as well as some public meetings across the U.S., issued its findings, which you can get the book, you can get a downloadable version of the book online free of charge. Issued findings related to pain as a public health problem, care of people with pain, education challenges, and research findings, research challenges. And in total, the committee developed 16 recommendations. It assigned groups or entities that it felt would be responsible for each of those recommendations, along with broad timelines for when these recommendations should be implemented. But the key point is the Institute of Medicine committee emphasized pain as a public health challenge that could be amenable to population health-level interventions. And that'll be of some importance as we talk about intersection between IOM and the opioid challenge. So now I just want you to put that on hold for a minute, okay? Just hold those thoughts. Because the other thing that Obamacare did was it established this Interagency Pain Research Coordinating Committee, and that the specific mandate was that the Secretary, this is of Health and Human Services, shall establish the Interagency Pain Research Coordinating Committee to coordinate all efforts across HHS, as well as across all federal agencies that relate to pain research. So on behalf of Health and Human Services, the NIH established this Interagency Pain Research Coordinating Committee. And you can read the specific charge there. Develop a summary of pain care research supported by all federal agencies. Identify critical gaps in basic and clinical research on pain. Make recommendations on how best to disseminate information on pain care. And make recommendations on how to expand public-private partnerships to expand collaborative research. That was the mandate. So the people who really made this happen were Linda Porter, who is the Director of the Office of Pain Policy at NINDS, and Sean Mackey, who's Chief of the Division of Pain Medicine at Stanford. And those of you who are active in the general pain community will certainly recognize Dr. Mackey's name. He's had a lot of national press for some of his high-level research on love may be as good as morphine, and who needs Advil when you have love. A remarkable fellow. So those two were instrumental in making all this happen. So now you're going to look at this slide. Some of you guys are going to glaze over and say, well, this looks like the path of a steel ball as it randomly works its way down a pachinko machine. But this is actually the flow of events that led from the IOM to the National Pain Strategy. So we start up here, upper left. So the IOM recommendation, and this was a key recommendation, overarching recommendation, that DHHS should create a comprehensive population health-level strategy for pain prevention, treatment, management, and research. That is a huge charge. So that went to the then Assistant Secretary for HHS, who was Dr. Koh, who was trying to decide how to implement that recommendation. Well, he knew that the NINDS was already developing this Interagency Pain Research Coordinating Committee. So he went to NINDS, specifically to Linda Porter and Sean Mackey and said, hey, I want you to do this. And Sean, I've talked to him offline about this. He pushed back a little. He said, well, we're research people. We aren't the clinicians who should do this. And essentially, they were told either you do this or it won't happen. So they took that task on. They developed the National Pain Strategy Oversight Panel, which established workgroups in the six areas I've listed here, professional education, public education, service delivery and reimbursement, prevention and care, disparities, and population research. So each of those six workgroups got together and issued a draft of what would become the National Pain Strategy. That was released in spring of 2015. Now, remember that the Institute of Medicine recommendations, they were very broad, overarching, very high level. The National Pain Strategy represents the action plan for achieving the IOM recommendations. So for each of the six workgroup topics that I just mentioned, the committees established a statement of the problem they were tasked to study. They developed priority objectives with SMART objectives. They identified the stakeholders who were responsible. They established metrics by which success or failure would be gauged. And they established a specific time frame for completion of the deliverables. So again, this is the action plan for the pain strategy. This was released for public review and comment. One of the major collaborative efforts with respect to review and comment was the Pain Action Alliance to Implement a National Strategy, PAINS. This was a consortium of professional organizations, patient advocacy groups, and consumer groups. AANS and CNS were represented ably by Jason Schwalb and Bill Rosenberg, and certainly kudos to them for their participation in this project. That led ultimately to the release of the final version of the National Pain Strategy in 2016. And again, you can get this online as a free download. So 2016, spring of 2016. Well, at the same time, same time this was going on, 2013, 14, 15, 16, there was this tremendous surge in opioid-related deaths. And this is a graph from the CDC. You can see this big upswing somewhere around 2014. And as of 2016, more than 42,000 people were dying annually from opioid-related overdose deaths. And just for comparison, because I grew up through the Vietnam War era, 58,000 Americans died in total throughout the Vietnam conflict. So we're losing 42,000 per year now versus 58,000 in all of the Vietnam conflict. Huge number. And here are some eye-popping comments. These all come out of the CDC. Life expectancy, this was at the end of last year in the annual report. Life expectancy in the U.S. fell for the second year in a row in 2016, nudged down again by a surge in fatal opioid overdoses. So for perspective, the last single-year decline, not two-year, but single-year decline, 1993 in the AIDS epidemic, to find the most recent two-year decline in U.S. life expectancy, you have to go all the way back to 62, 63. Prior to that, the most recent decline, two-year, in the 1920s. This is rare. That's really eye-popping. Some other impressive statistics that were released. In 2015, 40% of U.S. adults were using prescription opioids or reported using prescription opioids. 5% misused them. 1% had use disorders. This is a key point for the next slide I want to show. Of those using heroin, the vast majority started with a prescription drug. So here's the graphical representation. So for every one prescription or illicit opioid death in 2015, there were 18 people using heroin, 62 who had a substance use disorder involving prescription opioids, 400 people who misused prescription opioids, 3,000 people who used prescription opioids. So the US government is now looking at this number up here, the number of deaths per year from opioid overdose. So what's the easiest, the most simplistic way to reduce this number? Well, you get rid of the base. You just cut opioids. And that's exactly what happened. So the solution to this problem is simply, let's cut the supply. And we've seen action at federal and state levels, as well as at the private commercial levels. So federally, the CDC issued guidelines telling us as practitioners and patients, avoid opioids. It set upper limits on reasonable daily doses of opioid. The DEA reduced the national supply. In 2017, the national supply was down approximately 10% or 12%. And last November, the DEA announced that it intended to cut the supply of Schedule II opioids by 20% in 2018. Now, I don't know how things are in your shops. But I will tell you, in my institution, in the last few months, we have at times struggled to get hydromorphone fentanyl for use in the perioperative setting. So even though the DEA was warned there would likely be an undersupply if they cut the national supply, it's here. And it's on us. The FDA developed specific strategies for reducing supply. At the state level, we've seen regulations that limit prescriptions to three days or seven days. Maximum doses have been set, after which patients must be referred to a pain specialist. Prescription oversight programs have been developed, such as prescription drug monitoring programs. And payers are getting in the act. They're limiting scripts for new opioids to three or seven days. They've increased requirements for providers. So this, I thought, was interesting. I did what, for me, was kind of a difficult ulnar nerve transposition. A guy, big, beefy, Nebraskan, his arms looked like small animals. So it was a fairly extensive dissection. And my PA gave him, like, 10 hydrocodone or something for post-op pain control. A week later, we got in the mail this box from the workers' comp carrier, a urine drug testing kit, with a request that we bring the patient into clinic and we do this urine drug screen. And the interesting thing to me is, you can't read it from back there, but this lists about 50 different drugs. And the workers' comp carrier had already checked about 40 that were to be screened. With every illicit drug I'd heard of, some I hadn't heard of, I mean, meth, PCP, ecstasy, heroin, cocaine, it was clear they were on a fishing expedition to get this guy off their rolls. So anyway, one more hurdle we had to jump through. And just also as an aside, for those of you who should run into this, so the way my PA addressed this when he got this in his mailbox, he called the workers' comp carrier, the rep, and said, by the way, I got your request that we schedule this fellow for a clinic visit. And I got your order for the urine drug testing. Can I have your medical license number? And of course, they said, well, what do you mean? He said, well, you're ordering medical tests. I'm assuming you have a medical license. And they didn't, and that was actually the last we heard of that. So what's the problem with all this? Well, the problem is that nothing, whether pharmaceutical or non-pharmaceutical, is being offered to replace the opioid that's being withdrawn. We know as pain practitioners that not all patients achieve pain relief with non-opioid analgesics or with non-pharmacologic therapies. There is a distinct lack of novel agents, and there is a lack of coverage for non-pharmacological therapies. So in essence, the rugs are being pulled out from under our patients. There is nothing there to soften the blow when they fall. So what is the intersection of the IOM, the National Pain Strategy, and the opioid epidemic? Well, actually, it's pretty clean, because they don't really intersect. They may brush up against each other tangentially, but they don't really talk to each other. So the IOM, as I mentioned earlier, they really looked at pain from the population health level. They did not make recommendations about specific treatments. They did issue a couple of recommendations that, again, brush up against this issue tangentially. Recommendation 3.5 was that reimbursement policies be revised to foster coordinated and evidence-based pain care. This includes non-opioid and non-pharmacologic therapies. And recommendation 5.2 was, and this went to the FDA, was that the process for developing new agents for pain care be improved. So that's the closest the IOM got to addressing the opioid issue. So what about the National Pain Strategy in opioids? Well, I spoke with Sean Mackey for clarification, because the report doesn't say anything about opioids. He said, well, the reason that their monograph doesn't say much about opioids is they flat out tried to stay away from it. They did not want the bigger issue of the need for good pain care to be subsumed by the opioid issue and all the emotional baggage that gets attached to that. And I will tell you that even when the IOM came out with its report, even suggesting that opioids may have a role, that's all they said, there was a lot of backlash. There were people in public and professional organizations who claimed the IOM committee members were in the pockets of Big Pharma and so on. So the National Pain Strategy work group tried to stay very clean. Now, they did make a couple of recommendations that he unbrushed tangentially up against the issue of the opioid epidemic. In the public education and communication component, they recommended implementation of an educational campaign that encourages safe medication use, especially opioids. That was the only recommendation out of all of them in their work that touched on opioids directly. In the professional education and training work group, recommendation has been made that the NIH establish centers of excellence in pain education, which would help teach practitioners the best ways to manage pain, which would include appropriate prescribing of opioids. To the credit of the NIH, they funded nine of these centers so far. And then finally, in the service delivery and reimbursement work group, recommendation was made that came out of this sense that non-pharmacologic therapies just aren't reimbursed. So a study has been initiated in which the coverage policies related to pharmaceutical and non-pharmaceutical pain care strategies are being reviewed at three major carriers, California Medicaid, Anthem, and CVS Caremark, which most of you should know is a major national pharmacy management firm. The report of this pilot study should be out sometime this year, so stay tuned. I think that may actually go somewhere. Well, so you had the IOM, you had the NPS doing their thing through 2014, 15, 16. Opioid epidemic hit. Well, so it turns out the CDC had also started looking at taking action 2015, 2016. Came up with their guideline for prescribing opioid, which I've touched on already. Really sets maximum reasonable doses for opioid and encourage us and our patients to not use them. But this was done in a method process that was fully independent of what the national pain strategy work groups were doing. Well, the FDA's getting its fingers in the mix, too. At about the same time, 2015, 2015, they developed what they called their opioid action plan. One of the items in this plan was that the National Academies of Sciences would establish an ad hoc committee to advise the FDA on developing a framework for opioid review, approval, and monitoring. Now, to their credit, they did acknowledge the need for balance between treating our patients and yet paying attention to the broader issues of the opioid misuse epidemic. So in response to their request, the National Academies convened a work group. So this National Academies of Medicine is the new name for the Institute of Medicine. So this is the same general group of people. So that group assembled this Committee on Pain Management and Regulatory Strategies. They issued their report just last July. Again, it's available online, free of charge. And I'll give you just the key excerpts from that here. So the NAS issued 19 recommendations. And they were lumped into these three categories, trends in opioid use and harm, opioid approval and monitoring by the FDA, and then the third group, strategies for addressing the opioid epidemic. And I'll just point out to you, if you look down the recommendations there, other than the last one, strategies for reducing harm, they're all about reducing supply and demand. So just straightforward, strategies for restricting supplies. You just cut the number of pills that can be produced each year. Strategies for influencing prescriber practices, so strategies for getting you and me to simply write fewer opioid scripts. And strategies for reducing demand, in part, public education campaigns. And again, another recommendation that harkens all the way back to the IOM recommendation about the need for coverage of non-pharmacologic therapies. One of the recommendations is that reimbursement be facilitated for comprehensive pain management. Again, non-opioid, non-pharmacologic. So here was the intersection of the IOM, the National Pain Strategy, and the opioid epidemic. Pretty clean. They kind of brushed against each other a little bit. And here's the picture for the intersection of the IOM, the NPS, the CDC, the FDA, the NAS, and the opioid epidemic. And this illustrates that each of these activities, each of these entities, has worked more or less independent of the others. They have different goals. So the policies and strategies that have been developed, they don't necessarily intersect. They don't interconnect. They don't go in the same direction. And in many regards, they're just on totally different planes. So it really, it's created relative chaos in the pain care community right now. So I want to go all the way back to the Institute of Medicine Committee on Pain, Relieving Pain in America. Their most important finding, 1-1, addressing the nation's enormous burden of pain will require a cultural transformation in the way pain is understood, assessed, and treated. The committee felt strongly that this is how we would advance pain care in the United States. So the committee issued its report. The goal was this cultural transformation that would move us away from the status quo. The national pain strategy was seen as the vehicle that would take us to this cultural transformation. What's happened, though, is now we've got major federal agencies, FDA, CDC, Medicare, DEA, and a plethora of professional organizations, private organizations, commercial interests, all getting their fingers in the mix of the opioid crisis and pain care. And the challenge, frankly, my problem in speaking to you today is I can't tell you which of these are going to be facilitators that will move us toward that cultural transformation, which are going to be distractors that keep us on the path to status quo, or even worse. So this is going to play out. I think over the next two or three years, we're going to see the dust settle. And I think within three to five years, we're going to have a much better sense for where pain care is going to be in the long term. I am optimistic, if nothing else, that the attention to the opioid epidemic is going to promote reimbursement for non-pharmacologic pain care strategies, which so many of our patients need. It harkens back to the biopsychosocial model. We can't fix everything with a medical intervention. These patients need something else. Most insurance companies don't pay for that something else. So I think that this may all push carriers to really let us look at pain and treat it as a biopsychosocial model. And all I can really say is, stay tuned. We'll see how this plays out over the next handful of years. So thanks again for the invitation to meet with you this afternoon. And stay tuned, because we have some really interesting talks coming up right after this. Thank you.

opioid epidemic

non-opioid treatments

non-pharmacologic treatments

coordination

pain care

reimbursement