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Join patient advocate Richard A. Lawhern as he challenges prevailing myths surrounding the opioid crisis. With insights from medical literature, he questions the link between opioid prescribing and toxicity, highlighting the need for evidence-based public health policies. Learn about the human toll of opioid restrictions and explore alternatives for severe chronic pain management.

Richard A. Lawhern is a patient advocate.

He discusses the KevinMD article, “Everything the government thinks it knows about the opioid crisis is wrong.”

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Transcript

Kevin Pho: Hi, and welcome to the show. Subscribe at KevinMD.com/podcast. 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. His KevinMD article is titled “Everything the government thinks it knows about the opioid crisis is wrong.” Richard, welcome back to the show.

Richard A. Lawhern: Thank you very much, Dr. Pho. I appreciate the invitation.

Kevin Pho: We’ll get into your article in a little bit, but for those who didn’t listen to our first episode together, just briefly share your story and journey.

Richard A. Lawhern: Well, I am a patient advocate. I’m not a clinician. However, my training is in technical analysis of data and research. I got into patient advocacy about 26 years ago, when my wife came down with what seemed at first to be some form of dental pain. It took us a year and six physicians to find out what was really going on, which was a rare form of facial neuropathic pain called trigeminal neuralgia.

I got active with the U.S. Trigeminal Neuralgia Association, which has since been rebranded as the Facial Pain Association, as basically a research analyst and writer for the material they wanted to present on the web. I generally got involved rather deeply in social media as a moderator for peer-to-peer support groups, patient support groups, and as a writer in the field of neuropathic pain.

About 12 or 15 years ago, I started hearing from patients who were having an increasingly hard time getting treatment with opioids for various forms of neurologically based pain, because not everybody responds to medications in quite the same way. I was gradually drawn into roles that involved understanding the medical literature and helping patients find authoritative information on a fairly wide range of medical disorders, authoritative information that we could really trace to sources.

Kevin Pho: Let’s talk about the KevinMD article that you chose today, “Everything the government thinks it knows about the opioid crisis is wrong.” So, a provocative title. Tell us, how did your article come together?

Richard A. Lawhern: Right, fine. Let me start with a story that I sometimes tell. Last year, in July, I was invited down to Florida to address a meeting of the Florida Society of Interventional Pain Physicians as a patient advocate. As part of a one-hour discussion with a little over 100 people, I asked a series of questions to help the audience get comfortable with itself and comfortable with me, primarily because I was focusing at that time on the circulating draft of the CDC opioid guidelines, which was still in draft in July of last year and was going to be published in October. I wanted to be sure the audience had had some exposure to it.

I asked questions about where people were coming from, and as the questions became a little more specific, the number of hands that went up in the audience started dropping. The last question that I asked was very germane, and it’s very germane to the venue that you operate as a podcast. I said, “How many of those in this room are board-certified in both addiction medicine and pain medicine?” Out of an audience of 100-plus, maybe four hands came up. But the final question was, “How many of you are also technically trained in the evaluation of trial protocols?” And only one hand went up.

I observed to the audience, “You realize, of course, that as clinicians, you are dependent on the goodwill and sense of proportion of those whose abstracts you’re reading, but whose substantive methods you don’t evaluate. And there is substantial concern in medical communities these days that the peer-review process isn’t helping you, because too much is being published that just doesn’t hold up under close scrutiny.”

I was there to talk with them about that, which is what led me in part to the article we’re talking about. When I say that most of what the U.S. government thinks it knows about opioid addiction and about medical opioids is wrong, I start from a theme that was probably first voiced by a journalist by the name of Johann Hari. He gave a TED Talk some years ago that has since been seen by about 20 million people. His theme was indeed that everything you think you know about, and this was in general terms, everything you think you know about opioids is wrong.

There is another, much more grounded and much more scientifically grounded narrative here, by economist Anne Case and Nobel Prize winner Angus Deaton, in their book “Deaths of Despair and the Future of Capitalism.” These are very credible sources, and what they have to say, basically, is that the nature of our opioid epidemic has been fundamentally misdefined, because it is not caused by exposure to medical opioids, or indeed by any supply-based parameter. It is caused by the social determinants of health, which have resulted in increasing desperation among large bodies of people who are basically facing 50 years of wage stagnation, the hollowing out of both rural and inner-city communities, the destruction of families, and the increasing wealth inequality in the U.S. These are all very large-picture issues.

But what they had to say, basically, is that people get to be vulnerable to the appeal of distractions like opioids, street opioids specifically, not medically prescribed ones, because they’re desperate, because they’ve run out of options. It’s a crisis in hopelessness, not in opioids. It’s been misdefined.

Now, with that in mind, I have been digging for much of the last 10 years on research around the whole idea of what really is involved in causing our opioid epidemic. What I come up with is very much grounded in data that is published by the U.S. CDC, SAMHSA, the National Institutes of Health, and a number of other places. What that data tells us is that for at least the last 13 years, there has been no substantive relationship between rates of opioid prescribing and rates of either hospitalizations or opioid-involved overdose deaths. There is no statistically interesting relationship. In fact, the correlations are exactly in the opposite direction. And of course, we remember the old remark that correlation is not cause, but a lot of people who are writing in this field these days forget that.

Bottom line here: When you do state-by-state simple linear regression for roughly the last 15 years between rates of prescribing, or any analog for them, notably the volume of opioid sales, and rates of either hospitalizations or opioid-involved overdose deaths, and that means an opioid of some kind will be involved, not always a medical opioid, and not always as the primary cause, if you look at that connection, what you find out is that the correlation has been inverse since 2012. Opioid-related deaths have tripled in the same period. You can’t get that result in the statistics for any medical model that proposes opioid prescribing as even a significant cause of hospitalizations or death. It can’t happen. And yet the entire policy discussion is ignoring that.

Kevin Pho: Why do you think that point has been ignored by the public health community?

Richard A. Lawhern: Well, now that’s going to get us into an area where I have to point out some hard truths. The point is being ignored because it basically reveals that the U.S. CDC developed its guidelines around a political agenda, and, you know, it’s like, “Damn the torpedoes, full speed ahead. We’re not going to accept any other answer.”

I would say, and I realize I’m being something of a redhead with his little remaining hair on fire when I say this, that the U.S. CDC knew there was no relationship, ignored it, and deliberately attempted to sidestep it, because in order to acknowledge it, they would have to acknowledge publicly that what they had produced was fraudulent. By that, I realize there’s an accusation here, and I’m not making it casually. The U.S. CDC knew perfectly well that the statistics didn’t support them, and they ignored the statistics. That we can prove.

In that regard, the writing of Dr. Chad Kollas is very important, and he has some work that’s fairly recently out, again during the same cycle of public comment on the updated CDC guidelines. What’s basically happening here is that there’s a lot of money involved in chasing the idea that the big pharma companies did it to us by over-prescribing and by encouraging over-prescribing. But over-prescribing didn’t produce this crisis. I realize that this, again, is an evidence-based position, but it’s a position that many people, even in medicine, are having a really hard time accepting, because what it means is we’ve not only done it wrong, we’ve destroyed tens of thousands of lives and imprisoned physicians because it’s wrong.

Kevin Pho: Tell us some of the ramifications of the misinterpretations of this data.

Richard A. Lawhern: Sure, let’s do that. Let’s take an example from the 2016 guideline. Basically, what the CDC claimed was that there is reason not to prescribe opioids over 90 morphine equivalents per day. That term is used very widely in CDC 2016, and it’s also used multiple times in CDC 2022. However, there is no consensus on how you measure or model MMED, and large numbers of clinicians, including the leadership of the American Medical Association, have explicitly labeled MMED as junk science. But it occurs throughout the CDC guidelines.

Another example in the guidelines is that both versions of the guidelines proclaim loudly that non-opioid, and indeed non-pharmacological, pain treatment is, quote unquote, “preferable” to opioids in common practice, both for general practitioners and for specialists. But when you get into the references that supposedly justify that position, and you look for the details, which is what I did with help from a couple of clinicians, what you discover is that all of this relies on reports published by the Agency for Healthcare Research and Quality, AHRQ, and particularly by or involving one author. His name is Dr. Roger Chou.

The outcome of the review was that out of about 5,000 trials of non-opioid therapies of various types, just over 200 of them managed to pass rigorous quality criteria. In other words, they were sufficiently well grounded that they could be regarded as pretty serious research in the field. When you look at those 200-plus, I think it’s 218 trials, over 150 of them list the medical evidence that supports them, or the medical trials data that supports them, as weak: “Evidence weak.” They also show you that the improvement in pain levels is generally not more than two levels on a scale of 10.

They do not ever, in any of that literature, do a direct comparison between opioid pain relief and non-opioid pain relief. It isn’t there. It’s not in any of those trials. And yet CDC claims the use of non-pharmacological techniques is, quote unquote, “preferable.” By no stretch of a vivid imagination can that assertion be held as truth. It’s an outright misrepresentation of what the literature actually says.

That’s only one of several examples. Here’s another one that’s much, much more important. We’ve known for 20 years that individual patients respond differently to medications because of their genetics. There’s a whole process of breakdown for primary opioids and other medications in the liver, and it turns out that there’s a series of six enzymes that the liver uses in accomplishing the metabolic breakdown of opioids and many other meds. However, we know that there are at least two different modes of response that don’t fit the typical. One is people who are very resistant to opioids, who have a very poor metabolism for them. And others, and this is recognized in FDA publications, are hyper-metabolizers. We have people running around in large numbers who literally can take enough opioids to knock over a horse, look at you, hold a cogent conversation, and basically not even notice.

But none of the trials literature on pain reflects that kind of comparison. And yet what we get is an assertion by CDC that, oh gosh, oh gee, there are so few long-term trials that we really can’t consider that opioids have proven their effectiveness. That’s disingenuous; it’s fundamentally disingenuous. Because what we’ve got is long-term trials that run into the fact that large parts of the trial population may be either over-responders or under-responders that are not accounted for, and the protocols are not designed to address them.

So what we have is a misattribution of ineffectiveness, very clearly so in 2016 and to some degree in 2022, where the CDC writers basically tried to make a politically determined case. And they ignored the fact that the literature they were examining doesn’t in any way address the genetic effects on pain medication metabolism. In fact, when you go and read through the full document issued as an updated document, the term “genetics” occurs once in 2022. Just once, and it’s peripheral. And yet what we’ve got is a trials literature that doesn’t account for the fact that large numbers of the population don’t respond the way the writers of that document assume they should respond.

Kevin Pho: We’re talking to Richard Lawhern. He’s a patient advocate. His KevinMD article is titled “Everything the government thinks it knows about the opioid crisis is wrong.” Richard, tell us about the path forward. What do you think should happen next? And maybe you could wrap up with some take-home messages.

Richard A. Lawhern: Sure. What I think should happen next is that the U.S. Congress should hold hearings and then pass legislation to remove the U.S. CDC from all policy-making roles with regard to the practice of pain management. That is not a trivial ask; I realize that. But the bottom line is that they’ve had two chances at that, and they messed it up royally both times. And potentially, they messed it up as a consequence of a political agenda that does not reflect the science of treatment for pain management, and that should not affect regulation, but is indeed very negatively affecting patients.

That would be my sum-up on the article. And I think the article is also worth a good read, because it’s deeply referenced, and I certainly want to promote that outcome.

Kevin Pho: Richard, thank you so much for sharing your time and insight. Thanks again for coming back on the show.