01/09/19 Stefan Kertesz Program Century of Lies Date 9 January, 2019 Guest Stefan Kertesz This week on Century, we listen to a presentation by Stefan Kertesz, MD, from the UAB School of Medicine, at a workshop entitled Pain and Symptom Management for People with Serious Illness in the Context of the Opioid Epidemic. Audio file Copied to clipboard TRANSCRIPT TRANSCRIPT CENTURY OF LIES JANUARY 2, 2019 DEAN BECKER: The failure of drug war is glaringly obvious to judges, cops, wardens, prosecutors, and millions more now calling for decriminalization, legalization, the end of prohibition. Let us investigate the Century Of Lies. DOUG MCVAY: Hello, and welcome to Century of Lies. I'm your host Doug McVay, editor of DrugWarFacts.org. On November Twenty-Ninth, 2018, the National Academies of Sciences, Engineering, and Medicine's Roundtable on Quality Care for People with Serious Illness hosted a public workshop titled Pain and Symptom Management for People with Serious Illness in the Context of the Opioid Epidemic. The workshop aimed to explore the tension between efforts to address the use of opioids and the resulting impact on access to pain medications for people facing serious illness. The workshop will examine the unintended consequences of the responses to opioid prescribing, those consequences that are faced by patients, families, communities, and clinicians, and to consider the potential policy opportunities to address them. We're going to hear from one of those presentations. Stefan Kertesz, MD, is a professor in the Division of Preventive Medicine at the University of Alabama-Birmingham School of Medicine. STEFAN KERTESZ, MD: Hi. My name is Stefan Kertesz, and I'm really thankful for the opportunity to speak to you here today about a subject that is very important to me. I work at both the Birmingham VA Medical Center and the University of Alabama-Birmingham. Doctor Liebschutz was my fellowship director. I have some disclosures. I do not have any business with the pharmaceutical industry. In the past I have privately owned stock in Merck and Abbott, this was part of a portfolio that a broker purchased, and we sold it. My wife has her own stock and she has the same, it's a very small percentage of assets, she's not going to sell it. My opinions are not those of any federal agency or any of my employers. This talk includes learning from several people, and I wanted to credit them. This is a time of tragedy, and times of tragedy call for questions. When the final count is done for 2017, we expect there will probably be over 49,000 overdose deaths attributed to opioids. Among many parties implicated in how we got here are doctors. And, a need to do something about that risks up-ending the kind of questions that I tend to obsess about. These are: How do we know that what we think is right is right? Could what seems right be wrong? And, for whom might it not be right? I wish I could say I meditate these questions on only serious issues, but I actually think this when I'm walking through Target trying to figure out what to buy. But I will turn it to a more serious issue. The questions sort of come to light in a cartoon like this one, which we published in the journal Substance Abuse. I had it commissioned for the article, and in it, the doctor is seeing the patient surrounding by something to do with the CDC, and the DEA, and prescription drug monitoring, and newspaper headlines. The doctor says, too many people are dying. The situation's out of control. I kind of thought they were helping you, but I have to stop your Loritab pills. And the patient looks at the doctor hapless and says, what did I do? And right outside the window, there is some person injecting heroin in a graveyard full of syringes. And of course, the knowledgeable ones among you are going to say, but Stefan, it's not a complete separation between the room and what's outside the window, and of course, I know that, but this is what it feels like for patients today. A thesis: I hope we can agree that opioids are vastly over-prescribed. This caused harm. A systems level decline in opioid prescribing is desirable. My thesis, however, is that forced reductions are now highly incentivized and or mandated in those patients who've been on opioids long term, and this actually violates both ethical and evidentiary norms we traditionally apply to medical practice. The adverse consequences of this are evident, and better approaches are available to us. Here's what's next. I give a case example. I'll review policies, how they are in play and how they relate to the CDC guideline, and don't relate to the CDC guideline, and a comment as I was asked to provide on shortages in the inpatient environment. I'll then talk about some of the data regarding opioid tapers, and my policy suggestions. This patient is a real person, I had authorization to present, a veteran I took care of in the hospital. A 73 year old man with a history of kidney transplant, with chronic pain and polyarthritis since the early 1990s. Renal transplant in 2003. As customary for the time, he'd been on opioids since 2001 for this arthritis issue, which is always kind of vague. Doses had been escalated pretty aggressively to a range of 105 to 140 morphine milligram equivalents. That's the computation equivalent given to different drugs he was on through 2014. His dose was reduced in roughly thirty to sixty percent cuts without much reason documented in the chart, and he was down to 22.5 morphine milligram equivalents by mid-2017. He accepted all of this, by the way, he didn't protest or anything. He suffered a progressive loss of energy over several months, a sort of inability to organize himself and keep track of stuff, and in March 2017, he was admitted to my service with progressive renal failure, failure of the transplanted kidney. In fact, on review, he was the kind of person where maybe the argument for giving opioids should have been a more cautious one, because he did have some psychiatric history, he had prior alcohol use disorder until 1989, he had stopped drinking, and he, you know, on evaluation, we diuresed him, which is to say we took fluids off, got a renal biopsy. It showed acute and chronic rejection. Now the acute rejection component of that would have been prevented had he been able to keep up with the medicines intended to prevent the rejection of the transplanted kidney, but he kind of lost the ability to organize himself with the sort of mixture of pain and passivity. Dialysis restabilized him, we bumped up his oxycodone, contacted his doctor, and said, you know, you probably went too far. And within three weeks of his being out of the hospital, the dose was halved again. He was readmitted twice to the hospital the next six months, and in the final 24 hours of his life he was granted unlimited access to opioids, because we are caring and merciful healthcare system. Policy questions: Did this human being's opioid reduction count as entirely favorable in the metrics used by the National Committee for Quality Assurance, by CMS, by the Office of the Inspector General, which tells CMS they're not doing a good enough job, by the Congress, by the Veterans Administration, by the Department of Justice, and by all potential payers? The answer is yes. The second question is, was this man protected by his taper? I think we can agree that if the patient is dead, he was probably not protected. And that really gets to the heart of the matter. Where the metrics in play to reverse a very large and very serious crisis are neutral on the question of whether the patients live or die, and that's why I'm up here. Clinically, I want to give a word of clarification. This is not acute withdrawal. This is prolonged abstinence syndrome. It's really described in people with histories of opioid addiction. I don't think he qualified for that diagnosis, but it includes resurgent pain, dependence phenomena. With a nod to Chinua Achebe, things fall apart. He never qualified for the opioid use disorder Doctor Liebschutz so kindly laid out for us. Some patients really do feel better after slow opioid taper. They wake up, they feel good. Other outcomes that we do also see, anecdotally: churning of sedating medicines in an effort to prevent the opioids to go down; the adoption of ineffective procedures and injection and surgeries; medical deterioriation; loss of care relationships, and some people will turn to illicit substances or alcohol in an effort to resolve pain, or develop suicidal ideation. On our count currently there are about 50 suicides reported publicly in the news media or in social media in which we see mention of both pain and opiate reduction. I am not saying it's simple cause and effect, I'm just saying that's what we're seeing publicly reported, the kind of thing you should be investigating. I've reviewed two of these cases in depth, and they're very complicated. They're not simple stories. How is this happening? Why is this happening? You've heard Ms. Chaikin describe some of these policies as they affect her. I'm going to give you a sort of bird's eye review of a bunch of them at once. But I was required to do a side bar on parenteral opioid supply, and this is where I'm going to do it. Injectable opioids like hydromorphone -- sorry -- fentanyl, injectable morphine, and injectable dilaudid, have been in shortage in hospitals, so the inpatient care of acute pain has been an issue for the last two years. In April of 2018, according to the Academy of Health Systems Pharmacy, 86 percent of medical facilities reported shortages that they were dealing with, affected by a moderate to severe degree. This reflects -- this really reflects a manufacturing shortfall, probably because Pfizer took one company offline, and a very highly regulated supply chain, so that there's not that much elasticity to make up the problems when there are shortfalls. And the effects are nicely profiled in an article in the New England Journal of Medicine that I would refer you to. But they include swapping products and formulations; daily deliberations between pharmacists, nurses, and doctors, which leads to sometimes medical errors; and then doctors who get frustrated turf the care to a small cadre of experienced palliative pain doctors to sort of handle them, which Doctor Bruera described as very stressful. And I think that's sort of worth knowing. It is going to get better, but that's kind of the system we're in. It's not directly caused by the supply chain, as mandated by DEA, but that's just part of the picture. Okeh. What does the CDC guideline say? Because this is the authority that's invoked in these policies that are in play. Shortest summary ever: Try to reduce the tendency to start opioids. They're not routinely superior to other treatments for chronic pain, even though for some people they are the thing that matters. Evaluate the risks and benefits of that decision very, very carefully, because these drugs are deeply problematic and induce a lot of challenges. Go for the lowest effective dose. And interestingly, what do they say for patients already on opioids? Evaluate the harm to that patient versus the benefit; make an individualized decision; no dose target; no mandated reduction. They couldn't reach consensus on that, so they don't recommend it. The evidence quality was generally low for the items in this guideline, but it's a reasonable consensus of experts. We're in the era of prescription control as a major component of our response to crisis, as you would expect, with Congresspeople and others, everyone hearing about the crisis affecting people. Tightened production. There are state restrictions in terms of laws regulating duration or dose. Quality indicators typically based on the pill dose or the count, and they're used by everybody. Payers effectively impose, without necessarily writing it, a non-consensual taper or discontinuation. Pharmacies invoke their own liability. We just heard the story of the pharmacist screaming in the store, and their corresponding responsibility, which is a legal term that does apply to pharmacists to reject. What do they reject? The prescription, or the prescriber, or the patient? And I'll give examples of those. And physicians operate under fear of investigation, and also a certain degree of shaming from their fellow doctors for prescribing. DOUG MCVAY: We're listening to a presentation by Doctor Stefan Kertesz. It was delivered on November 29, 2018, at the National Academy of Sciences, Engineering, and Medicine, at a workshop entitled Pain and Symptom Management for People with Serious Illness in the Context of the Opioid Epidemic. We'll hear the rest of that in just a moment. You're listening to Century of Lies. I'm your host Doug McVay, editor of DrugWarFacts.org. A few quick announcements, things that are coming up later this year. First of all, of course, NIDA is holding its annual National Drug and Alcohol Facts Week January 22 through 27. You can get information about that at teens.drugabuse.gov. National Drug and Alcohol Fact Week is NIDA's annual propaganda exercise that targets young people, middle schools, high schools, even some colleges. Drug and alcohol facts. You may have heard this already, but it's worth repeating: the fact is that should read "Alcohol and Other Drugs." The kind of stupid, pointless, and hypocritical distinction that our society draws between alcohol on the one hand and "drugs" on the other is nothing but self-defeating. Alcohol is a drug. These stupid legalistic definitions are not helping anyone. They don't serve any useful purpose. All they do is confuse people. Alcohol is a drug. It shouldn't be a big deal. National Alcohol and Other Drugs Facts Week. A couple more words than they currently use, but it would be correct. There are a number of good questions that people should be asking NIDA. Why is it our government refuses to support harm reduction projects like syringe exchange, like supervised injection facilities, like heroin assisted treatment? Proven harm reduction interventions that other nations use successfully. Why don't we? We know that treatment with methadone, with buprenorphine, and with heroin, can help people who have an opioid use disorder to maintain, to live a healthy life, and to eventually get the help they need. Why is it then that we make it so tough for people to be on methadone treatment? Why do we have set up so many hurdles? Why when it comes to recovery do we set so many stumbling blocks in the way of people? When we talk about stigma and how stigma creates more trouble, why then do we turn around and criminalize the use and possession of some drugs? Stigma. Criminalization. These are questions that NIDA needs to be answering. These are questions people need to be asking. Well, NIDA's chat day is January 24. The misnamed National Drug and Alcohol Facts Week is January 22 through 27. On social media, you'll find the hashtags #NDAFW and #DrugFacts. Coming up March 29 through 31, it's the Global Students for Sensible Drug Policy Conference, #SSDP2019. That's going to be held in Rosemont, Illinois, at the Crown Plaza Chicago-O'Hare Hotel and Conference Center, right there in Chicago. It ought to thaw out by March, and it will be a great time. Folks want more information about that, to register, then go to conference.ssdp.org. Always a tremendous time, a great conference, a lot of terrific people. It is one of those must-attend events each year. Coming up April 11, 12, and 13, it's the Thirteenth National Clinical Conference on Cannabis Therapeutics, hosted by Patients Out of Time. This year it will be held in Tampa, Florida. You can find more information at the Patients Out of Time website, which is PatientsOutOfTime.org. And, I must, for full disclosure, mention that I do social media and web work for Patients Out of Time. There are some great conferences and other events throughout the year. I'll make it to as many as I can. I encourage you to attend as much as you can. Sometimes, some of these sessions get webcast live. It's a terrific opportunity to learn. It's a great opportunity to network, if you can get to one of these things. There are sometimes scholarships available, if you find funding is a difficulty. Heck, sometimes they need people to volunteer as well, and that's another great way to get into these conferences and to learn, and to network with the people attending. Now, let's get back to that presentation. Again, we're hearing portions of a roundtable that was entitled Pain and Symptom Management for People with Serious Illness in the Context of the Opioid Epidemic. It was held by the National Academies of Sciences, Engineering, and Medicine's Roundtable on Quality Care for People with Serious Illness on November 29, 2018. We're listening to a presentation by one of the speakers, Doctor Stefan Kertesz. Doctor Kertesz is a professor in the Division of Preventive Medicine at the UAB School of Medicine. STEFAN KERTESZ, MD: A single prescription is now subject to multiple high stakes and often conflicting imperatives. So it's very difficult to manage. About six examples here, different levels of the health system. This is a letter from a medical practice to patients, 2018. CMS has implemented a new law, HB21, with a max of 90 morphine milligram equivalents. I want to highlight that mis-citation of authority: HB21 is a Florida state law. CMS doesn't implement state law. But, mis-citations of authorities are common, both in the medical chart and in the letters that patients receive. I have read, in charts I review, "because of VA, CDC, DEA, I am tapering opioids." I don't know what they're referring to, but that's what people are putting in the chart. We will taper you by ten percent a week, i.e. we have to get this done by January. Most patients have less pain when they're on lower doses. I think I know what they're referring to in terms of an observational correlational dataset that might have shown that, but I'm not sure. And the offers here were group support or psychologist, cannabidiol, or switching to buprenorphine. In some of these letters, it says you can have procedures done at our facility to help you with your pain. Okeh. Walmart to a prescriber, it cites legal corresponding responsibility, which pharmacies really have. "In reviewing your controlled substance prescribing patterns and other factors, we have determined that we will not be able to continue filling your controlled substance prescriptions." We don't know what metric was used. These are not open to review or finding out what the criteria were. This is just a letter that effectively blackballs the doctor forever, and their patients, from that pharmacy if controlled substances are involved. I assume doses were involved, somehow involving CDC guideline. I have no idea though, and a lot of these letters have been coming out around the time that Walmart and other pharmacies were named as plaintiffs in combined multi-district litigation, so this looks like a liability control activity. Okeh. Private pharmacy to a patient: "We now require the following documentation." Think of a pharmacist scrutinizing these records. The medical records, for example, they'd like to see an MRI, x-ray, doctor's notes, a recent urine drug test positive for the opioid prescribed. This liability reduction exercise, this is a private pharmacy, positions the pharmacist as the assessor of pain care quality, in order to protect their liabilities. Okeh. Insurer to patient, I think it's either Humana or Aetna, I don't remember which one. Okeh, they're denying coverage at over 90 [milligram morphine equivalents]. We just heard that. "Our decision to deny coverage is unchanged. Our decision does not reflect any view about the appropriateness of this medication. Only you and your provider can make decisions about your care. But your plan covers up to 90, and not more." This effectively mandates the dose reduction that the CDC guideline did not endorse. Finally, we have a state Medicaid program that has been entertaining, and may not enact, an opioid plan to take all patients off opioids short of those with cancer. In 2018, they require that no back disorders be treated with opioids, and that all patients on them be taken off. Their proposal for 2019 has been taper to zero for all. That is under review and discussion at this point, and I do not know if that is going to be the final policy. But it again shows you the same kind of crowding. Now, just to pile in, same basic phenomenon, we're just going to shift federal departments here. This is a letter, reported in the Atlanta Journal-Constitution, from the US Attorneys in Atlanta to the top thirty prescribers in the Atlanta area. They identified the doctors from prescribing opioids in greater quantities or doses than their peers. Sound familiar? The Department of Justice has not determined if the doctors have broken the law. This is part of an initiative by the US Department of Justice to reduce opioid prescriptions by one third over the next three years. Will the threat of prison reduce prescribing? Probably. But these are all entities operating on the same basic metrics and invoking typically the same basic authorities, which is that CDC guideline, and the payoff for this is this: This kind of headline signals good citizenship for the insurer, or for any agency. Look at the reduction we've achieved. I hope you notice we've not talked about patient outcomes here at all, just doses. Opioid prescribing has been falling. All prescriptions, high dose, it's going down, quite a bit since 2012. Interestingly, when you look at overdoses that don't involve heroin and fentanyl, and just include the typically prescribed type of opioid, and I'm looking at the dotted line here. These are from CDC National Vital Statistics data. Minus the blip in 2011, it's kind of a rock solid number of about ninety-five hundred to 10,000 such overdoses a year in which the possibly prescribed opioid is found. The high dose prescribing rate obviously has sunk. And this to me signals that we may not be pushing on the right string in order to get the result we want. The policy conundrum, as I'll summarize: agencies have prioritized opioid counts as the indicators of quality, safety, good faith, and professionalism. Most invoke the CDC guideline in doing so, but inaccurately. Opioid counts are the de facto standards for legal risk. The patient who receives any long standing prescription, but especially those at high dose, are now a liability to all concerned. And what do professionals normally do with liabilities? You get rid of them. There is a case to be made that taper, with or without the consent of the patient, is helpful to some individuals. I'm on Youtube describing a non-consensual taper, and it worked out very, very well for the patient. But science on institutionally mandated taper requires discussion. The policy has moved ahead of the science. Crucially, the mandating agencies here do not measure, and they are not accountable, for any patient outcomes, including mortality tied to their plans. And I wish I could sugarcoat this, but I really can't. It's not just that I hear from patients, or that I see my peers taking patients off and having chaotic results. But there's another layer to this, which is that I'm frequently party to communications from doctors to their supervisors in health systems, saying, we are upset by the patients who we have traumatized. We are upset by the patient who attempted suicide due to what we did. We're upset by the patients who have killed themselves due to what we did. In healthcare, the normal response to a catastrophic event is root cause analysis, remediation, investigation, and the offer of support. On these deaths, those responses are conspicuously lacking. The response I normally see by email is, that's unfortunate. Maybe you need more training. I don't see follow up. I don't see investigation. And I don't see a surge of resources to prevent catastrophic events, and this is a real departure from the normal way we practice healthcare. Where's the data supporting the mandates? And I have two minutes and ten seconds. The first thing to understand is that an overview of the literature suggests that for voluntary patients, a significant percentage actually achieve good results with opioid taper, so we -- it's not, like, all bad. It's a good thing, for a lot of people. The limitation's we just don't have studies on the kind of mandated affair that we're watching right now, with insufficient data on suicidality in particular. Tapering for prescription opioid use disorder? Not highly effective, although it still can be helpful for people in long term pain and dependence. We do have descriptions, correlational, not proof of cause and effect, correlational descriptions of suicidal ideation for some people after taper, as I've seen. No study has shown that dose reduction is actually protective, safety wise, even voluntary. Four preliminary studies presented at scientific meetings or briefed to the FDA in the last year all signal concerns that the outcomes are not consistently good from discontinuation or taper. All retrospective and observational, none prove cause and effect. All will require peer review and robust debate. But that's a signal of concern, too. This is data from a patient survey, 3,155 patients. The kinds of things that they report, and this is not representative, it's people through the web: being discharged from primary care, being discharged from pain management, losing pain care, increasing hopelessness, 53 percent told I need to accept services I do not want in order to get services I need, that's the classic I'll inject your back if you want to continue to receive those opioids from my clinic. A better approach, I suggest, is to focus on the patients who require the care, rather than the management of their pills. There are many factors associated with high dose opioid receipt. They're not always people with a single disease. In the literature, it's a compendium of serious medical and psychological and substance use disorder related morbidities that are highly correlated with the receipt of high dose opioids. We can care for these conditions, and they are predictive of the very adverse outcomes that we want to prevent, overdose and suicide, at least in VA data. My recommendations, and I'll be done, systems level correctives. No patient is safe if no doctor can assume their care. We have to reverse metrics, policies, legal threats, that jeopardize the protection of legacy patients on opioids, nearly all of these policies violate the CDC guideline while invoking the CDC's authority. Any entity using metrics based on prescriptions must collect patient outcomes. Are patients dead or alive? They currently don't measure that. Continuous care or loss of care. Hospitalized or not. They must report outcomes publicly and be held accountable. Are you enacting health policy with no patient outcomes measurement and no accountability? Dare I remind you that's how we got into this mess in the first place? We're just going to make a single score, the pain score, go down. Don't worry, there will be no downside to this approach. We got there this way, so let's not make the same mistake backwards. This is a time of tragedy, it's a time for choosing. We professionals are implicated in creating this tragedy. Regulators are as well. We're under the gun. So are our patients. And I ask the very same questions that I posed at the start: How do we know that what we think is right is right? And I thank you for your attention. DOUG MCVAY: That was a presentation by Doctor Stefan Kertesz. He's a professor at the Division of Preventive Medicine at the University of Alabama-Birmingham's School of Medicine. He was speaking on November 29 at a public workshop entitled Pain and Symptom Management for People with Serious Illness in the Context of the Opioid Epidemic. That workshop was sponsored by the National Academies of Sciences, Engineering, and Medicine's Roundtable on Quality Care for People with Serious Illness. And that's it for this week. I want to thank you for joining us. You have been listening to Century of Lies. We're a production of the Drug Truth Network for the Pacifica Foundation Radio Network, on the web at DrugTruth.net. I’m your host Doug McVay, editor of DrugWarFacts.org. The executive producer of the Drug Truth Network is Dean Becker. Drug Truth Network programs, including this show, Century of Lies, as well as the flagship show of the Drug Truth Network, Cultural Baggage, and of course our daily 420 Drug War News segments, are all available by podcast. The URLs to subscribe are on the network home page at DrugTruth.net. The Drug Truth Network has a Facebook page, please give it a like. Drug War Facts is on Facebook too, give its page a like and share it with friends. Remember: Knowledge is power. You can follow me on Twitter, I'm @DougMcVay and of course also @DrugPolicyFacts. We'll be back in a week with thirty more minutes of news and information about drug policy reform and the failed war on drugs. For now, for the Drug Truth Network, this is Doug McVay saying so long. So long! For the Drug Truth Network, this is Doug McVay asking you to examine our policy of drug prohibition: the century of lies. Drug Truth Network programs archived at the James A. Baker III Institute for Public Policy.