SMART Policy Podcast
Podcast by the UT SMART Initiative. Host Jeremy Kourvelas speaks with experts from across the recovery ecosystem - representing healthcare, prevention, law enforcement and more - about local, state and federal drug policy to find out what is and isn't working to make this fight against addiction a little easier.
SMART Policy Podcast
The New CDC Guidelines: Correcting Past Mistakes
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Welcome to the Smart Policy Podcast, a production of the University of Tennessee's Institute for Public Service. Every month we'll give you in-depth interviews with a wide range of experts on substance use disorder and the overdose crisis, so that we can all have a better understanding of how we got here, how the state of Tennessee is fighting back, and what we might expect to see in the future. At the end of 2022, the CDC released new prescription guidelines for opioids, replacing their last set of guidelines from 2016. Excluding patients with cancer and other terminal illnesses, these guidelines strongly emphasize alternatives to opioids and urge extreme caution for physicians considering new opioid prescriptions, while also recommending how to appropriately care for chronic pain patients with long-term opioid treatment. Notably, however, is how the new guidelines answer the failures of the 2016 ones. According to the CDC, many laws, regulations, and policies were, quote, notably inconsistent and have gone well beyond its clinical recommendation, unquote.
SPEAKER_01It became used in some ways to sort of rule practice rather than guiding practice.
SPEAKER_00My guest today is Dr. Clay Jackson, a board-certified pain specialist from West Tennessee. He also serves on the state's opioid abatement council, which is tasked with ensuring the proper distribution of the opioid lawsuit money to programs fighting the overdose crisis.
SPEAKER_01Can we take a step back, Jeremy, and just look at um the reason that the CDC established their guideline? We often in in uh discussion refer to it as guidelines, but they actually named it a guideline. So uh maybe they thought of the whole document as one uh, you know, one guide to rule them all, if we could uh if we could paraphrase Tolkien. Um and and uh you know, obviously I'm being facetious there, but uh that humor may uh give us an insight into what actually happened. It it became used um in some ways uh to sort of rule practice rather than guiding practice. And I think that probably is the 40,000-foot view that we'd like to look at. Let's talk about how we got here. Um in the 1980s, uh maybe early 1990s, there was a thought in medicine that opioids should be used for basically two patient populations, immediate post-surgical or immediate post-trauma for acute pain. I think an ER with someone with a broken limb or post-abdominal surgery uh in the hospital or coming out of a same-day surgery center for a short period of time, think three to seven days. And then there was also this population of patients that I'm very familiar with through my work in palliative care and hospice. I was a hospice medical director for uh about a decade and a half. So many patients who are very near the end of life with pain relative to metastatic cancer or end stage uh COPD or emphysema, end-stage liver disease, these types of patients might be suffering pain and would require strong pain medication and think opioids in that space for relief. And until the 80s and 90s, it's kind of okay, that's that's who needs this medication. Then uh in the late 90s or early aughts, there was the idea that chronic non-malignant pain sufferers, osteoarthritis, rheumatoid arthritis, perhaps fibromyalgia, chronic low back pain uh patients might benefit from low-dose sustained release opioids. Now, as you're probably very well aware, and many of our listeners and colleagues today, this was not by accident associated with some pharmacologic advances in the uh pain management profession and industry of long-acting opioids, which were used. And but these drugs, when they became sort of loosed on the non-malignant pain population or the non-end-of-life population, uh skyrocketed in sales, popularity, and use by uh physicians and others in the primary care setting. And of course, this is what's known as the opioid epidemic, large-scale use of these opioids. And um, that peaked around 2012. If you look at the early teens in our century, you'll see that that's where per capita the most opioids were prescribed in the United States. It started to fall after that. CDC comes out in 2016 and says, you know what, still got too many opioids being prescribed. And they set some guidelines or limits that I think are apropos to our discussion. And basically, the way we the way we look at morphine power or opioid power is something called daily morphine equivalence or uh oral morphine equivalence, called OMEs. And so this is kind of like uh if if you're familiar with these medications, percocet may have one power, morphine may have one power, dilauded may have one power. And so this is a way of just sort of equalizing or standardizing the opioid power. And they said, you know what? 50 morphine equivalents is is is pretty much a yellow light, and 90 morphine equivalents is is a red light. Now, these were based on they were based on data that above these levels you start to see some overdose risk go up. And so I I do not criticize the the CEC for in 2016 for setting those elements of concern. Uh now, incidentally, in Tennessee, we set those levels of concern higher. We set the sort of yellow light at 90 and the red light at 120. So we were a little more generous in opioids, recognizing that there were many patients that were on high levels of opioids in their in their their current care. And the CDC set these sort of uh stop points and and caution points at terms of how much you should prescribe for a patient. But the very first line of the CDC guideline said it was for primary care clinicians, not subspecialists, and it was to exempt cancer pain and hospice and palliative patients. The same three exemptions that we had in Tennessee. I will tell you, Jeremy, that unfortunately from 2016 up until the new guideline just dropped in 2022, in that six-year period, I don't think many people at all took the CDC first sentence seriously, that this is for primary care people treating chronic non-malignant pain. This guideline, and and permit me, I'm just going to be very free with my opinion here. And this is my opinion. This guideline became weaponized by third-party payers and to some extent by state and federal regulatory agencies to say, hey, if you are prescribing above 50 or 90 in your practice, then you're not doing good practice. Insurance companies refuse to pay for medications without a prior approval if they were above those limits, even if a patient had been stable for many years. I have to tell you, I do not believe that was the intent of the CDC at the time. Regardless of how you feel about the COVID-19 pandemic and the CDC and the politicization of government entities, at that time, I believe that the CDC had good intentions. I will tell you that there are many of us in the pain management care space. We had some grave concerns that that the CDC might be overstepping here with uh a draconian guideline that might set arbitrary limits on patient care. Subsequently, um, I think that's been shown to be true. What's happened, Jeremy, is that uh since 2012, prescriptions have decreased across the board in America on the order of you know 30, 40 percent, depends on which study, which patient population you look at. Actually, I think that's a good thing. I think we were prescribing too many opioids. And when I say we, I just mean the medical community in the United States. I think there were patients who were getting not only too many patients getting opioids, but patients getting it too long and for too much. So I think there was a correction in order. What my concern is, is that I think the guideline, as I said, was utilized inappropriately by third-party payers and people who were not doing direct patient care to just across the board deny care, saying this is above this number. What the CDC has done, and and listen, I'm critical of the 2016 guideline and and particularly how how it was formed and then how it was used. I'm not critical of the intent, but I will tell you that I applaud the CDC. I am a huge fan that they came back and revised their guideline and said, guys, uh, we need to do more individualized patient care. The new CDC guideline is basically a 100-page document that says individualized care, individualized care, individualized care, individualized care. It says over and over and over and over, here are the here are these these principles that you need to incorporate in care, but you need to be very concerned that you don't just say, you know, what's one size fits all, and that, you know, above, you know, at 50, you're okay, and at 51, you're not, in terms of opioid equivalence. And I think that's exactly the right approach. And so um I'm very encouraged that the CDC has taken a step uh in the last three years, and again, not to be political, but we've all heard follow the science, follow the science, follow the science. Well, I will tell you, as an aspiring member of the scientific community, one of the hallmarks of scientists uh uh of scientists is saying is being able to say, I was wrong. We were wrong, or hey, we were mostly right, but here's a few things we need to improve on. Science, by definition, is an incremental approach to attempting to understand truth and recognizing that as humans, particularly in controversial topics, we don't have a complete grasp on that at any any one time. If someone is telling you we know the truth, this is the truth, it's incontrovertible, I would say you're probably not dealing with science as much as you're dealing with scientism, which is actually the religious or political worship of the concept of the enlightenment that humans can understand anything at all times, just given enough power and enough data. Um, I disagree with that philosophically, I disagree with it existentially. And so I think incremental improvements and admitting when we're wrong is incredibly valuable. Let me give you an example of how we were wrong in Tennessee. In 2012, when we convened the chronic pain guidelines, we were looking at continued growth and overdose deaths in Tennessee. And we saw that it tracked pound for pound, if you will, both curves of overdose deaths and opioid prescriptions we're tracking. Now, your entry-level high school statistics teacher will tell you correlation is not causality. Just because two things track together doesn't mean they're causing each other. There are many confounding factors. We all knew that sitting around the room, but just practically, we thought if we lower prescriptions, we will lower over OS test. It may take a few years, but we'll sort of I'm using air quotes here for those of you listening, flush out the system of high opioid prescriptions and we'll see opioid deaths come down. Jeremy, uh, with in all sincerity and with a deep and abiding sadness, I have to report to you that we were absolutely wrong. We weren't wrong to lower prescriptions. And I will tell you that we um wanted to do it judiciously. We our goal was to have high single-digit or low double-digit reductions in opioid prescriptions year upon year. Eight to 12%, you know, and and I'm using those as example numbers. We didn't set it as a hard goal, but you know, why didn't you want a hundred percent reduction in one year or 50% reduction? Because we didn't want to leave patients hanging. If they had been on four Percocets a day and you say, That's it, that's all, you get no more. We didn't want patients to be opioid refugees, right? Roaming around the state looking for someone to treat them, or worse, going to um take illicit substances because they were seeking to avoid withdrawal. Of course, this is exactly what happened. We did see a lot of that, Jeremy, unfortunately. And what no one on our committee could have anticipated is that there would be an exponential growth in the use of illicit substances in the United States. Heroin came back with a vengeance. We think of it as a 20th century drug, but it made a 20th, 21st century comeback uh through established channels of um international cartels. And then uh that's about uh in you know, 2013, 14, we start to see those deaths rise with heroin. And then in 2016, 17 or so, we see the fentanyl epidemic explode. Now, this is not the fentanyl patches or the IV fentanyl that are used. Uh, fentanyl patches are used for chronic pain. Uh this FDA-approved product, very safe when used as directed IV fentanyl, very safe in the hospital setting with used uh mostly by anesthesia staff, sometimes by EUR staff. But, you know, this illicit fentanyl that we see, these were chemically altered compounds that mostly originated out of China, many times by legal pharmaceutical companies above ground, you know, brick and mortar, glass and steel buildings that were constructing these molecules and they change the nitrogen here, they change a CO2 atom there, and just make it slightly different from a drug that was on patent. And many of these fentanyl analogues, as we call them, were much, much more powerful. Fentanyl itself is about a hundred times more powerful than morphine, so it's already uh a quite a powerful compound. Now we see these fentanyl analogs, which are sometimes used in veterinary medicine. You know, think elephants and rhinos, you know, extremely powerful medications. Um, and to call the medications is charitable. These are these actually they're just they're drugs. And um it really overwhelmed our interdiction system. China was willing, uh, some of the some of the the players here in China were willing to ship it to your door to the dark web. And uh a brick-sized amount of this altered fentanyl could be enough to sell illicit substances to an entire block of people for six months. Uh, it was um incredibly difficult for our law enforcement officials to prevent this material from coming in in in usable quantities uh just because of the size factor. You know, if you're if you're if you're trafficking cocaine, there's a physical problem, there's a space problem. You can take a small amount of fentanyl and and and hide it in a vehicle crossing the border. And um, you know, again, incredibly profitable for these illicit manufacturers, incredibly profitable for illicit traffickers, uh, incredibly addictive medication uh or or substances for those who have substance use disorder and lethal because a tiny amount can kill a person. When you when you clean out an area where there's a fentanyl press where they're making fake pills, um, it requires hazmat. Uh it takes 60 to 70,000 to do a cleanup job because a few grains of this fentanyl can kill you. So in the old days, you know, there's experimentation with drugs. People, people use, you know, it's common in high school and college for people to experiment. Uh I'm not here to justify or or argue for or against legalization of marijuana, et cetera. But certainly marijuana use uh has become pop even more popular than it used to be. There are those who experiment with drugs. And in the old days, you know, if you take one of somebody else's percocet, that's dangerous, it's illegal. But, you know, the level of danger with fentanyl is so much higher because you don't know what you're getting. And so these illicit uh traffickers now they they make pills that look like a percocet, an oxycodone, uh a legitimate medical uh uh pill or tablet, but it's cut with fentanyl. And these these drugs are manufactured in the salad mixers, and it is there's no quantification of them. The manufacturing process by these cartels is is without quality control. Um, you're talking kitchen mixers and and vats of of drugs that are then dried and pressed, and um, so it's so, so dangerous. I do not mean to minimize the dangers of of casual drug use or illicit drug use before, but now you have a molecule that is a hundred to a thousand times more potent. And so literally one dose at a party can kill a person. And it's not just okay, well, I'm gonna take opioids. Fentanyl is now used to cut a lot of other substances, such as cocaine. It's it's used to pack a power punch for marijuana. Uh, there are many other drugs, uh, methamphetamines. Yeah, that's the big one. Yeah, where fentanyl is being laced. And so if you if you look at toxicology reports from Tennesseans that are dying from overdoses, people rarely overdose and die from one substance now. It's often a a mix or a recipe that's found in their bloodstream after an overdose. Uh, and they may have only taken one pill or one tablet or a handful out of one bowl at a party or something, but it had a lot of different substances in it because what they were sold is not what they thought they were getting. And so harm reduction becomes important. But you know what? I actually think, Jeremy, we're gonna go back to the 80s. I think we're gonna wheel out Nancy Reagan's uh campaign again and just say no. Abstinence education is gonna be important for youth because whereas in in 1980, if someone took a drug, yes, they're headed down a dangerous path, but they'll probably live to choose that path or not choose that path. 2022, you're a high school senior and you decide after the prom that you're gonna take you know something out of the so-called Skittles bowl, you know, with the different colored pills that everybody's contributed, you may die that night. So it's a real, it's a real paradox because the the politization politicization of these topics has trended more toward individual freedom and less toward societal control. And yet, pharmacologically, the risk of that freedom are much, much higher. Uh, unless you're buying obviously from a legalized dispensary or uh uh you know a some type of regulated program.
SPEAKER_00The necessity of regulation is definitely a uh a big part of this. That's one of the reasons why I'm um worried about the lack of regulation in the Delta VIII market, because with these aerosol uh vape pens, we're uh seeing a lot of heavy metals, silicon, things like that showing up in it. I mean, who it's for all intents or purposes, it's plausible that that Delta um that excuse me, that fentanyl could be found in some of these as well.
SPEAKER_01Oh yes, I oh yes. When we're talking about um synthetic cannabinoids or so-called you know marijuana-like products that hit the THC receptor in the body or the CBD receptor in the body, the what we call the endocannabinoid system, you know, you have plant products that are basically put out and dried, and then manufacturers may spray stuff over them to give it an extra kick. And that spray might include fit nil. So again, if it if there's not regulation of these products, I mean it can I just say it this way if you're buying something from a gas station and putting it in your body as a a so-called medicinal product, buyer beware. You know, a a lot of these a lot of these products are um, you know, they're they're technically legal because one molecule's been changed, but you just don't have an idea of what's in it. And so um, you know, our old friend the FDA may turn out to be may turn out to be a safe harbor that, you know, if you're taking something that's FDA regulated, at least you know what's in it. And and again, we there's controversy about how drugs get approved and how they don't get approved and biases and potential conflicts of interest, but at least there's some idea of what you're taking.
SPEAKER_00True. Uh but unfortunately we also have to uh deal with the reality that the FDA uh was a contributor to prescription misuse uh with the expedited approval of produced products.
SPEAKER_01Well, I think I think that's one way to look at it. Um, I I think that the FDA saw an unmet need. Now we can talk about biases and et cetera. And again, this gets to what were the intentions and then what was the outcome. I think, you know, I I don't necessarily fault the FDA for approval. I think that the data that was brought to the FDA was was highly selective. I think the company and and multiple companies didn't take seriously some of the outcomes that they were seeing. The sales tactics after the drug was on the market, we have to take a hard look at where people were were potentially minimizing the adverse events and they were accentuating the positive uh events. And then ultimately, you know, you also have to look at prescribers. You know, we we as prescribers, just because something's approved doesn't mean it's for every patient. And so if we're looking to point the finger at the the opioid problem, well, uh, what about patients? Uh, what did they ask for? What were their tactics of asking for it? What about prescribers? What about, you know, what about manufacturers that were shipping loads of drugs into one town uh and per capita the the the use was very, very high, but people were making a profit. And so a lot of questions weren't asked. Uh so there's you know, there's regulatory questions to be asked, there's prescriptive uh questions to be asked, there's there's patient questions to be asked, there's sales practice questions to be asked. I I think this is something that we can we can learn from, you know, but uh not the first time this has happened in America. Uh remember that cocaine and and morphine were being sold over the counter uh in the late late late 1800s and early 1900s. And heroin and cough syrup, yeah. Yes, heroin was in cough syrup. Remember that the reason, the reason that a proactive FDA actually exists is because an eastern Tennessee pharmacy company produced a cough syrup that had basically antifreeze in it. Company sold a lot of this, and a lot of children died in this country from renal failure. Uh so that's you know that happened in the 1930s. Look it up. They also saved us from thalidomide. There you have it. There's a lot of blame to go around. I'd like to flip that, Jeremy, and say there's a lot of learning to go around. And the more honest conversations that we have like this as a society about how we approach the treatment of complex problems, the better off we'll be because it's not the last time we'll face this where something that has therapeutic potential may be abused. I, for one, don't want to see marketing at a strip mall be what the public has to rely upon. I I want sound scientific voices, I want public consensus, I want uh um, you know, reasoned debate to to to guide the way society approaches some of these newer products. And so, you know, we could spend a lot of time in the review mirror about the opioid epidemic, but if we're gonna do that, I'm more interested in learning than I am in blame because uh, meanwhile, while we're looking in the review mirror, there's some things that are coming up on our windshield pretty fast. And those are two of the products that I would mention, ketamine and and um the psychedelic substances that um you know are being used across the country right now, and um they have tremendous promise, but they also have uh some serious concerns.
SPEAKER_00So coming back to a round of the 2022 guidelines, uh, like you said, individual, the word individual and individualized care appears more than two dozen times. Uh, there is a huge emphasis on non-opioid treatment as the preferred safe uh uh route to start with. And in fact, I think one of the things they say let's see here. Um so here are some of the conditions that they found that uh non-steroidal anti-inflammatory, so your neuroxins, your ibuprofen, et cetera, were uh the same or better for uh than opioids for um pretty much most common acute pain conditions, and this includes low back pain, neck pain, uh other musculoskeletal injuries, sprains, strains, tendinitis bursitis, pains related to minor surgeries, you know, dental extractions, but in general also dental pain, kidney stone pain, headaches, and this includes episodic migraine. Uh that's that's a long list. That is an extraordinarily long list of things that uh NCIDs have outperformed opioids on. Um I was wondering what what do you think about that in terms of its impact with these recommendations?
SPEAKER_01Individualized patient care. Uh, you just gave a long list of where NSAIDs may uh have non-inferiority or even superiority in some clinical conditions. Let me give you a long list of patients who can't take NSAIDs, chronic chronic kidney disease patients, patients with a history of gastric ulcers, bleeding, uh, patients who are on other blood thinners, uh, with a history of stroke, et cetera. So we have a number of patients that we cannot use NSAIDs for, and typically we use opioids for those patients. And so, yes, you need a panoply of pharma, you know, of pharmaceutical agents, you need a pharmacopia, you need a variety of classes that you can treat um that are analgesic classes. But you know, some patients can't tolerate opioids and some patients can't tolerate NSAIDs. You know, we all you got is a hammer, the whole world's a nail. We need a vice grip, we need a channel lock, we need a screwdriver, you know, we do lots of different tools to help patients. Let's back up a minute and let's just forget pills. How about massage for low back pain? Does your insurance company pay for that? Probably not. What's what it this is a fight that we fought vociferously in the teens as the Academy of Integrated Pain Management. And oh, by the way, we lost uh big time uh because insurance companies said acupuncture is a new and investigative treatment. Now it's been out for 5,000 years, but I suppose that new, you know, new new and investigational. So CMS came out, you know, the three initials that runs Medicare came out with a guideline on chronic pain and some of the the CAM, the complementary and alternative therapies that were useful. And uh, so there's you know, there's a very detailed set of data around this. And so insurance benefit managers really have no excuse for denying payment for these uh interventions, except it's just expensive. Pills, once they go off patent, are dirt cheap. We can manufacture millions of pills for pennies on the dollar. A therapy where a human has to touch or intervene with another human, like massage therapy, acupuncture, surgery, et cetera, et cetera, much more expensive. And so we find that uh there's a bias against these uh non-pharmacologic interventions. Now, that bias is not entirely monetary. It's not entirely monetary because insurance companies will pay for a ton, a ton of epidural blocks, uh, lumbar injections, you know, so-called procedures. Now, these cost thousands of dollars, whereas drugs cost, you know, hundreds of dollars, tens of dollars uh per per month of therapy. You can get a lot of massages for what you can get one epidural block from. And people criticize the data on opioids, but let's look at the data, the long-term data on injections for low back pain. Not that great. So, what we see is there's there tends to be a bias in third-party payers toward uh pills rather than high touch uh procedures. And then there's a bias of allopathic procedures over uh complementary procedures. So, you know, injections and surgery over massage or acupuncture, et cetera. And hey, acupuncture doesn't work for everything. Surgery doesn't work for everything. You know, let's look at everything based on evidence. Can we just leave our biases at the door and look at whether it works? Let's do quality of life surveys, let's do pain intensity scores, let's do functionality scores, and let's see and let's just make the comparisons. And if it turns out you need to put, you know, uh metal studs in people's ears and uh, you know, auricular therapy, if you need to, if you need to do injections, if you need to prescribe opioids, if it's inSAIDS, you know, let's compare apples to apples, oranges to oranges, and let's get a fruit basket of things at work. But I think as we continue that search for better chemistry, let's return to a search for for better humanity. Let's return to a search for a better understanding with people. Kafka, uh, in his book, The Country Doctor, he's got a scene of a of a parish priest who's folding his vestments in an empty church, and there's a line outside the the country doctor's practice. And Kafka's telling line is to write prescriptions is easy. To come to an understanding with people is hard. And I think that one line encapsulates what the opioid epidemic is really all about. These are complex problems, they're chronic problems. They start before kindergarten with adverse childhood experiences, as you well know, that set people up for inflammatory diseases and set them up for chronic pain and set them up for mental health issues. And lo and behold, when you take simple solutions and try to push them into spaces of complex problems, garbage in, garbage out, it doesn't work well. I think we will recover from the opioid epidemic. What the next challenges of medicine will look like, you know, how we'll negotiate it, you know, I can't give you those technical answers, but I will tell you if commercialism absolutely drives practice, or if regulation absolutely drives practice, we'll fail, if paternalism is all that we have, or if individual consumerism and patient autonomy is all that we have, will fail. But if we will take a judicious approach, recognizing that we're all limited people and none of us has all the answers. Over time, I do have hope that we will correct. I will say that as Americans, we tend to do a great job of pushing the pendulum way over here and then way over there, and it it takes us a long time. But um I'm I'm hoping for a centrist medical practice that takes seriously patient experiences, that takes seriously pharmacologic advances, and takes seriously clinician uh judgment uh to push people toward a better outcome and lead them to a better and preferred future.
SPEAKER_00For more episodes on in-depth discussions on Tennessee policies related to substance use disorder by a range of local experts. Please subscribe to us wherever you get podcasts and visit our website at smart.tenesse.edu. I'm Jeremy Corvillis. Thank you for listening and see you next month.