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Join Richard A. Lawhern, a patient advocate. We delve into the critical issues surrounding U.S. policy for the regulation of prescription opioid pain relievers and the challenges faced by clinicians managing chronic pain patients. Explore the controversial CDC guidelines, the impact on both patients and medical professionals, and the need for evidence-based policymaking in this contentious field.

Richard A. Lawhern is a patient advocate.

He discusses the KevinMD article, “Rethinking U.S. opioid policy.”

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Transcript

Kevin Pho: Hi, and welcome to the show. Subscribe at KevinMD.com/podcast and get CME for this episode by clicking on the CME link in the show notes. Today we welcome back Richard Lawhern. He’s a patient advocate. Today’s KevinMD article is titled “Rethinking U.S. opioid policy.” Richard, welcome back to the show.

Richard A. Lawhern: Thank you very much. I appreciate being invited.

Kevin Pho: So you’ve been on multiple times before. Go to KevinMD.com/podcast; in the upper right-hand corner there’s a search icon, and you can search for Richard’s name to hear his story. But today, let’s jump right into your most recent KevinMD article, “Rethinking U.S. opioid policy.” So how did this article come together?

Richard A. Lawhern: I started looking at the CDC guidelines on opioid prescribing that were published in October of 2022 and comparing them against the report of a group that was chartered when the guideline revision was announced. They were called the Opioid Workgroup, and they reported to the Board of Scientific Counselors, which is an advisory group of the National Center for Injury Prevention and Control, the authoring group that created the guidelines in the first place, in 2016, and then revised them. I traced the concerns voiced in the final report of the consulting group, in July of 2021, and tried to see how they might have affected the statement of 12 recommendations and the very large body of discussion and supporting material in the guidelines.

In doing that, I had to go back and redo some research I had done over the years on the incidence of what we call iatrogenic, or treatment-caused, opioid addiction in patients treated for pain. I began to see some glaring inconsistencies and concerns, and I put together a rather long treatise on the subject, doing the direct comparison. I shipped it to as many of the original participants in the Opioid Workgroup as I could find. There were about 18 of these people, drawn from a wide variety of backgrounds, many of them with subject matter expertise. I got back no commentaries on the details of the research I had done, and I was puzzled about why, and I kept pressing.

It turned out that when the members of the Opioid Workgroup signed up for service in this oversight role, each of them signed a nondisclosure agreement. We have to recognize that nondisclosure agreements do have a legitimate place at the stage where one is developing policy, before it’s published, because you have to protect people who are dealing with a controversial subject from external influence that might in some way be coercive, or from simply getting lost in a public argument that never goes anywhere. They have to arrive at some kind of conclusions. It’s useful in that context, but there is a downside hazard to this kind of process. What I learned was that several members of the workgroup believe that the nondisclosure agreements they signed are still binding today. That means they feel constrained, and I think I’m being fair here, from commenting on the process they went through to arrive at their concerns and recommendations.

Kevin Pho: Before getting into the behind-the-scenes story of how these new opioid guidelines came about, tell us the concerns you have with the 2022 update of the CDC opioid guidelines.

Richard A. Lawhern: Absolutely, Dr. Pho, and that’s why this whole process of trying to investigate is so important. I would represent to you, and to those who are tuned in and watching, that the CDC guidelines as published, and to some extent the workgroup report as it was published 16 months earlier, reflect two fundamental conceptual errors that essentially destroy the credibility of the guidelines outright. I’d like to name them and briefly discuss them.

First of all, the CDC guidelines have multiple mentions, in fact over 400 mentions, of the term “risk,” and they admonish clinicians that they should be analyzing and making a judgment on risks versus benefits for each individual patient they treat with opioids. That’s a pretty mundane idea when you think about it, except that there is no scientific methodology that allows a clinician to do it. In fact, no less an authority than the director of the National Institute on Drug Abuse, Dr. Nora Volkow, and one of her colleagues, Dr. McLellan, in the same month that the CDC guidelines were originally published in 2016, put out a landmark article in the New England Journal of Medicine called “Opioid Abuse in Chronic Pain: Misconceptions and Mitigation Strategies.” In that document, among other things, they lay out a concern that I’d like to quote: “Unlike tolerance and physical dependence, addiction is not a predictable result of opioid prescribing. Addiction occurs only in a small percentage of persons who are exposed to opioids, even among those with preexisting vulnerabilities.”

So what they are saying, basically, is that we know we can predict risk in large populations, but there was no consensus in 2016, and I might add there still is no consensus, on how one might extrapolate from those demographic studies to help a clinician actually assess the risks in any individual. What that really means is that there is no consensus on whether clinicians can comply with the guidance the guidelines have provided them. There is enormous contention over that issue, and clinicians are being driven out of practice and persecuted out of practice because of it. So this is a very germane issue.

Effectively, clinicians are being presented with a Hobson’s choice. If they withhold opioids because they believe a given patient may possibly be at risk for addiction, in effect they guarantee harm to that patient from untreated or undertreated pain. However, if they prescribe at levels that exceed the relatively modest recommendations of the CDC guidelines, both the original in ’16 and the update in ’22, if they prescribe at effective levels, they can be persecuted out of practice and imprisoned, and that is in fact happening on a large scale. So what we’ve got in the guidelines is a conundrum, if you want to call it that. It’s a basic conflict. The conflict says you have to assess risks and benefits, but there’s no methodology for you to do that, so we’re going to leave you on your own. If the guidelines had acknowledged that conundrum, they couldn’t have been published, because they would have become moot.

Now, there is a second major methodological error that both the guideline writers and the workgroup participants were aware of, because you can trace it in the documents. There’s a 25-year history in the medical literature examining the way opioids are metabolized in the liver. This can be made pretty complicated, but for your non-clinician listeners, I’ll try to simplify. Basically, six key enzymes in the liver break down opioids, and almost all other drugs, into component sub-elements, or products, as they’re called, that can cross the blood-brain barrier and have an effect in the brain, on pain and on many other disorders. It turns out that there is wide variation in the genetics of individuals, and that creates a very wide range in minimum effective dose levels and a very wide range in potential side effects of dosing. The range has been estimated, in work that I shared as a co-author with Dr. Stephen Nadeau, at 15 to 1. There are some patients who can do fairly well on low doses. There are some, and they are rare, who are actually almost allergic to opioids; that’s observed in clinical practice, and it’s well established. And there are some who can take enough opioid analgesic by prescription to knock over a horse and hold a perfectly cogent conversation with you throughout the brief period of time those opioids remain in their bloodstream. Doses that are intended to last for four hours may pass through the bloodstream of a hypermetabolizer in 20 minutes.

Now, here’s the rub. The literature is out there. It is only vaguely acknowledged in one footnote to one table in the CDC guidelines, and it is mentioned only in the charter, which is an appendix to the workgroup report. But obviously both groups were aware that there is a genomic, or genetic, component that significantly impacts the way opioids need to be prescribed and can be prescribed. I’m going to offer a surmise. It’s a surmise that’s grounded in a great deal of research, but it’s one I want to see publicly explored, in a conversation that the workgroup members need to have without restriction.

Kevin Pho: Now tell me, since you represent the patient advocate community, what was the reaction of patients when they saw the revision of the guidelines?

Richard A. Lawhern: Horror. Absolute horror. Patients are aware, and they’ve been made aware by multiple publications, in places like the New York Times and the Washington Post and a number of other places, that doctors are leaving practice all over America in pain management, and that clinics are refusing to accept new patients, because pain management clinics want to protect themselves from possible legal repercussions. And they are force-tapering patients off their existing dosage levels. Doctors and pharmacists are refusing to treat pain with the most effective clinical techniques, proven safe, that are now available, because they’re afraid of being persecuted.

Kevin Pho: Now tell me, specifically with the 2022 update to the guidelines, what about them is causing doctors to rapidly taper prescriptions?

Richard A. Lawhern: Doctors basically are very risk-averse. Doctors read the guidelines, and they say, “Well, yeah, I’ve got to estimate risks versus benefits.” But the guidelines also say that there’s a point of diminishing returns, above a dose of, let us say, 50 or perhaps 90 MME, in the effectiveness of opioids. But there’s no reference; in fact, there are no specific references from the literature that identify where this estimate, or this advocacy, comes from. The guidelines never refer to a specific place we can go and check that says, “Yeah, here’s the evidence that there’s a threshold of diminishing returns that you shouldn’t go above.” So the doctors consult their lawyers, and their lawyers say, “It ain’t worth it, guys. These people are going to come get you no matter what. The DEA is going to persecute you out of practice and put you in prison if they can, if you prescribe any opioid to any patient for any reason at any dose.” Now, obviously I’m being emphatic here, but I have talked with doctors who have phrased the issue in exactly this way. Doctors are being intimidated, and the ones who aren’t intimidated are being forced by hospitals and others to stop prescribing opioids.

I’ve talked with more than one patient who, when they went in to visit their dying spouses in the hospital, were told, “No, I can’t prescribe opioids, because it might compromise my license.” In fact, I published this in an article in Reason magazine. I was told that by a lady out in California whose husband died of a brain tumor. She was with him, watching him cry in agony for the last three months of his life in a hospital room, and the doctors wouldn’t prescribe opioids. They prescribed Tylenol, which is a little bit like going after a forest fire with a squirt gun. So this is a general problem, not an exception. It is affecting literally millions of patients and thousands of clinicians, and the CDC guidelines are at fault.

Kevin Pho: What do you suggest that health care professionals do with the current guidelines?

Richard A. Lawhern: Ignore them, because there are major alternatives to the CDC that are far more balanced in their approach to this issue.

Kevin Pho: Like what? What are some examples?

Richard A. Lawhern: Well, some examples: The Federation of State Medical Boards has released, and recently updated, guidelines. The World Health Organization ladder of pain management was published originally in 1984. It is taught in medical schools, it has been validated by extensive clinical experience, and it provides a framework within which one may reasonably set up an orderly process for deciding which patients need opioids, for what reasons, and then prescribing at a level that’s effective for them.

The standard, not recognized by the CDC but recognized by many other clinicians, is this: If you believe that opioids are clinically indicated for a patient, because you’ve tried a few other things and decided, “Yeah, we don’t see much help from anything else,” then start low, titrate up slowly, monitor for side effects, and diagnose and aggressively treat the side effects. If you don’t get a good answer with one opioid, then taper it down and titrate up another opioid with a different mechanism of action, perhaps a different targeting, or a drug cocktail. Document what you do along the way, and verify the patient reports by doing intelligent but non-punitive urine testing, and blood testing where necessary.

Likewise, although the World Health Organization doesn’t mention it explicitly, there’s increasing evidence that genomic testing for the enzyme activities in the liver can provide significant guidance on why a patient is not responding well to opioids, or to a particular class of them. That’s well established in clinical practice. Practically any doctor who has had experience in this field will see, and has seen, patients who thrive on doses not of 50 MME but of three grams a day. Three thousand is not all that uncommon. It’s not extremely common, let’s not misrepresent that, but I’ve heard that statement made by clinicians in medical board meetings, in California particularly; that’s the source of that particular observation.

So the bottom line is: Document what you’re doing, and communicate with and educate your patients and their resident caregivers, because you have to protect the patient from the possibility of being oversedated. You don’t want somebody having a respiratory arrest. And make clear that the patient reports are important, that they’re heard and that they’re trusted, because without a sound clinician-patient relationship, nothing good can happen.

Kevin Pho: We understand that. We’re talking to Richard Lawhern, a patient advocate. Today’s KevinMD article is titled “Rethinking U.S. opioid policy.” Richard, tell us some of the take-home messages that you want to leave with the KevinMD audience.

Richard A. Lawhern: The take-home messages I would offer: Talk to your doctor. Tell him he can’t use the CDC guidelines, because they’re scientifically flawed and known to be. And write, or better yet phone, your legislators and demand that they take legislative action to remove the CDC guidelines as a de facto standard. Anyone who wants to reach me can do so; I am about as visible as a highway flare in a Google search, and several of my articles include my email address. Likewise, reach out to other patients on social media and realize that you’re not alone. You’re not fighting this fight alone. You have other advocates, and I am by no means the only one.

Kevin Pho: Richard, thanks again for coming back on the show and sharing your time and insight.

Richard A. Lawhern: Thank you, Dr. Pho. It’s greatly appreciated, and patients will bless you for making this whole issue visible.