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Internal medicine and pediatric physician Charles LeBaron discusses his article “How the CDC’s opioid rules created a crisis for chronic pain patients.” Charles discusses the 2016 CDC opioid guideline, initially framed as a solution to over-prescription and overdose deaths, and critically examines its actual impact. He reveals how the guideline, despite being based on “low quality of evidence,” led to widespread restrictions on opioid prescriptions by states, federal agencies, insurance companies, and pharmacies. Charles highlights the severe, unintended consequences for chronic pain patients, including increased pain, worsened quality of life, and a rise in suicides and overdoses among those whose opioid dosages were reduced or discontinued. He also touches on the devastating impact on cancer patients experiencing undertreated pain and discusses criticisms from pain specialists and the damning report by Human Rights Watch, which characterized the de facto denial of pain relief as a potential human rights violation.

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Transcript

Kevin Pho: Hi, and welcome to the show. Subscribe at KevinMD.com/podcast. Today we welcome Charles LeBaron. He’s an internal medicine and pediatric physician and author of the book, Greed to Do Good: The Untold Story of CDC’s Disasters, War on Opioids. He has an excerpt from that book on KevinMD, and we’re going to talk about that today. Charles, welcome to the show.

Charles LeBaron: Thank you, Kevin.

Kevin Pho: OK, so just briefly share your story, and then tell us why you decided to share this excerpt on KevinMD.

Charles LeBaron: Well, as you know, Kevin, I think you and I both remember from medical school that they told us we learn more from our patients than from our books. What they didn’t add, which maybe they should have, is that you can discover for yourself that you often learn more by being a patient than even from your patients because it’s an enlightening experience to be at the other end of the stethoscope.

In my case, what was enlightening was that I was at the other end of severe pain. Unexpectedly, I developed staphylococcal septicemia and meningitis and collapsed a bunch of my vertebrae both in the neck and in the lower spine. Then, in the midst of fighting that off, I got disseminated shingles, which is an ulcerating condition affecting half of my body. So I developed a very intimate experience with what severe pain is like and what the obstacles are to getting relief from that severe pain.

I had discovered that the place where I’d worked, the CDC, had been prominent in basically creating obstacles for people in severe pain to get the medications they needed for relief. That was such an enlightening experience that I decided to write a book about it.

Kevin Pho: OK. So tell us the key messages you want readers to come away with after reading your book.

Charles LeBaron: Well, there are two things. One is that we’re in a paradoxical situation where we have had an explosion of overdoses. At the same time, we have great difficulty with people in pain getting appropriate pain relief. In some ways, it’s sort of a worst-case scenario because you would prefer exactly the opposite: low cases of overdoses and adequate pain relief.

The history on this is sort of peculiar in the sense that it represents a sequence of good intentions gone wrong. In the 1990s and early 2000s, it is well known there was a concern that pain was undertreated. A number of manufacturers of opioids decided this was a good, profit-making environment in which to work, so they promoted their pain relief, which was addictive—OxyContin and others. That became, in essence, so popular because of their promotion that we ended up with basically a prescription overdose environment where people were dying of prescription overdoses. Whereupon the CDC, my old employer, stepped in and came up with recommendations which were actually very, very severe on who should be getting opioid medications for pain relief.

The effect of that, in an environment where treatment of addiction was not widespread and alternatives to opioids were not freely available, in effect, created a large population of people who are opioid-dependent. They had no access to legal opioids. So, a group of entrepreneurs in Mexico, in Sinaloa and other locations, decided they could expand their market share from their traditional target population, heroin users, to this expanded group of folks who were opioid-dependent, thanks to opioid manufacturers, and began to promote fentanyl for widespread use.

In a sense, like prohibition, illegality became normalized. Fentanyl became a widespread drug of use. The difficulty is that the cartels don’t adhere to the same safety procedures and dosage that an FDA-approved opioid would typically have. So we had a massive explosion of overdoses as a result. Hence, we were placed in this paradoxical situation where there was an extreme limitation on prescription opioids for those who actually needed it. At the same time, there was widespread availability of very dangerous illicit opioids.

In a sense, we’re just now barely coming out of that paradoxical situation. That was basically what I was writing about in the book: that you can go wrong sometimes with the best intentions. You want to treat pain, and you create an opioid epidemic. Then you try and restrict that, and you create an overdose epidemic. In each case, you really need to be minding the store on what you’re doing, and that’s the substance, in essence, of what my book is.

Kevin Pho: Now, just so we’re clear, and for people who aren’t aware, what were some of the key points for the CDC’s guidelines? Just for those who aren’t familiar with them?

Charles LeBaron: Well, what they, with good intentions but in a misguidedly draconian fashion, wanted to do were three things, which are logical. One was to reduce the number of people who are getting opioids so that it’s restricted to people who really have severe, legitimate pain. But again, it’s a restriction which had some boomerang effects. Two was to restrict the level of dosage and the duration of dosage, and both of those had evidence behind them in the sense that people on high dosages for long periods of time are much more likely to end up in an addictive situation than those who are not.

So those three things—restriction of the people who could get the opioids, limitation of the total dosage, and limitation of the duration—were the three interventions that the CDC, in a sense, recommended. So again, well-intentioned, but they were implemented in such a restrictive and draconian way that, in effect, it created a mass withdrawal situation and then led to the entry of illicit opioids into the general population.

Kevin Pho: I’ve had a lot of physicians and patient advocates saying what you’re saying about how draconian the CDC’s guidelines were and how they led to this epidemic of overdoses and illicit substances. So, you are in Atlanta, and obviously, the CDC is your former employer. You have some inside knowledge, so I’m sure that they heard some of these criticisms. What was their response to some of these criticisms?

Charles LeBaron: Well, I would like to say that the CDC, I think in many cases, we follow Winston Churchill’s old dictum that no matter how beautiful the strategy, you should occasionally consult the result. There was no dishonor in coming up with that logical limitation of opioids in a context where they were massively overprescribed. But you have to examine the unexpected adverse effects and then say what you need to do about it. In retrospect, and it should have been in prospect as well, the CDC should have recognized that if you severely limit opioid access for people who are dependent on it, then they’re going to seek it elsewhere. When you have a doubling of the number of fatal overdoses within 24 months of implementing an intervention, you should really reconsider the intervention, take a look at it, and say what we should modify and how we should not.

Unfortunately, the CDC had a tendency in this situation to kind of stick to its guns and not modify. If I were to give them an excuse, which I don’t really, I could understand the notion behind this restriction was that it was going to take a while for the benefits to become apparent, that we’re basically preventing people from initiating opioid use and it’s going to take years to see that. So on that premise, they sort of stuck to their guns.

The problem was more and more and more people were dying. We’re not talking about just being unhappy but actually dying. Overdoses reached a level where the deaths were more frequent each year than guns and automobile accidents combined. They are more than every single cancer. They’re the number one killer of adults between the ages of 18 and 45. So when you have a situation where there’s that level of mortality, you really need to haul back a little bit. Unfortunately, it took them roughly about five years to haul back, and only in 2022 did they come up with more appropriate prescription guidelines.

Kevin Pho: So what are the changes that they made to their original 2016 guidelines, and are the changes still in effect today? What modifications did they make?

Charles LeBaron: Yes, they made modifications. 2022 is when the relaxed, or more appropriate, guidelines were put into effect. In essence, they said these are not strict guidelines. You can go up on the dosage, and you can widen the number of people for whom it is available.

The implementation problem was that the folks who had decided to follow the guidelines—which were basically insurance companies, pharmacy benefit managers, Medicaid, Medicare—all these folks had already embedded the original guidelines into their practices and their restrictions. So it wasn’t enough for the CDC to just come up with, “OK, we’re having more appropriate guidelines.” It really needed to, in a sense, go on a campaign to make sure that the more appropriate guidelines reached the implementation stage rather than just being a piece of paper that was sent out. So even today, that problem continues, despite the fact that the CDC has improved its guidance on paper.

Kevin Pho: So on a more practical level, inside the exam room, this is an issue that physicians across the country deal with many, many times per day: the issue of chronic pain, opioid dependence, and possible overdose due to exposure to illicit substances. Do you have any practical tips that you could share with these clinicians who may be listening to you today and experiencing this type of encounter several times on a daily basis?

Charles LeBaron: Well, clinical practice right now is certainly placed in a dilemma because the original draconian guidelines are still, in effect. Physicians have actually been put in jail—that sounds strange—but for exceeding those guidelines. The dilemma continues, but what I would say is that the opportunities to push up against those restrictions are much more available than they used to be. The DEA, for instance, while it monitors opioid use on the part of physicians, no longer basically assumes that going over those guidelines is going to be inherently a criminal event.

And so, for people in pain, I think they need to advocate for themselves, which is a difficult thing. I spent a long time in the ICU, and it’s hard to advocate for yourself when you’re in the ICU. But I think for most physicians who are going to be dealing with severe chronic pain, it’s going to be on an outpatient basis, and there needs to be that interactive, cooperative interaction between the patient and the physician.

The second thing that physicians should keep in mind is that one of the recommendations, and this is quite correct, is that anyone who’s on high doses of opioids or extended doses of opioids should also have the antidote, Narcan, available to them. That’s available actually over the counter as a nasal spray. It’s also available by prescription, and even though the over-the-counter version is easier to obtain, the reason you might write a prescription from your physician is that there’s no reimbursement for the patient when they buy an over-the-counter version, whereas when they buy a prescription, most of the insurance companies will pay for it. So it sounds strange to recommend a physician make a prescription for an over-the-counter drug, but that helps the patient have that around.

That being said, the proportion of patients who actually die of prescription opioids now is very, very low compared to illicit opioids. But it’s also true that folks who are on prescription opioids are at greater risk to get illicit opioids if their prescription isn’t adequate for their needs. And so having the Narcan, the naloxone, around in some fashion can be a lifesaver.

Kevin Pho: We’re talking to Charles LeBaron. He’s an internal medicine and pediatric physician. Today’s KevinMD article is, “How do the CDC’s opioid rules create a crisis for chronic pain patients?” Charles, let’s end with some take-home messages that you would like to leave with the KevinMD audience.

Charles LeBaron: Well, I think there are two issues that are important. I come from a public health background more than a clinical background, so when I look at the situation, I see a tragedy of good intentions gone wrong. The Winston Churchill dictum of looking at the results is the most important take-home for us public health folks. For the clinical folks, I think it’s very important to recognize that severe pain can be treated safely, but it needs to be treated by prescription opioids, and we shouldn’t let the cartels be America’s pharmacists. We clinicians should be treating it, and adequately.

Kevin Pho: Charles, thank you so much for sharing your perspective and insight, and thanks again for coming on the show.

Charles LeBaron: Thanks, Kevin.