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We delve into the complexities of opioid prescribing, pain management, and the opioid crisis with our guest, Richard A. Lawhern. As a patient advocate, Richard brings a unique perspective to the table. Join us as we discuss the discrepancies in data handling by organizations like the CDC, the implications of these discrepancies on public perception and policy decisions, and the role of patient advocacy in shaping discussions around pain management. Together, we’ll explore the nuances of this critical issue and uncover the truths behind the numbers.

Richard A. Lawhern is a patient advocate.

He discusses the KevinMD article, “Uncovering the real story behind opioid prescriptions and deaths.”

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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 “Uncovering the real story behind opioid prescriptions and deaths.” Richard, welcome back to the show.

Richard A. Lawhern: Thank you very much. I appreciate the chance to speak with you.

Kevin Pho: So Richard has been on multiple times talking about opioid prescribing and the opioid crisis. Go to KevinMD.com/podcast to hear his prior episodes and stories. So today let’s get to the most recent article on KevinMD, “Uncovering the real story behind opioid prescriptions and deaths.” For those who didn’t get a chance to read your article, what’s this one about?

Richard A. Lawhern: What I wanted to do was to look at the assertion that the CDC has been making for years concerning the sources of the so-called prescription opioid epidemic, quote unquote. That’s a phrase they’ve used often. And to answer the question, does the data support the assertion?

Because as a data analyst and a technologist of many years standing, my concern has been with an old phrase, that figures lie and liars figure. And unfortunately I’m afraid that phrase applies relatively well to the U.S. CDC in the positions they’ve taken with regard to the sources of the U.S. opioid crisis. In fact, another phrase that comes up, and that is mentioned in the article, is that if you torture the data for long enough you can make it say anything.

So I wanted to look at the data, and at multiple sources in the literature for the data, to understand, is there a real relationship between opioid prescribing and either addiction or opioid related overdose mortality? And I found, basically, that there is no such relationship, and that’s well illustrated in some charts that we’ll be dealing with shortly.

Kevin Pho: All right, so before we get into your perspective and your charts, just give a high-level version of what the CDC is asserting.

Richard A. Lawhern: What CDC has asserted, and this is in congressional testimony as well as in their public work, is that a major and ongoing driver of opioid addiction and mortality involving opioids in overdose has been overprescribing by doctors who have been careless, or who have been propagandized by big pharma. That assertion, when you test it carefully against the data that they actually published, doesn’t hold up.

And this is a real institutional issue, because it’s being built upon by the Veterans Administration, that is now pursuing a policy of no opioids to any patient for any reason. It’s also being pursued by the U.S. DEA, in what I regard, and what many clinicians regard, as an absolute witch hunt against doctors.

There’s an interesting article out just this morning, as a matter of fact, in a venue called Daily Remedy, that basically makes the case that DEA has deliberately and with malice ignored a Supreme Court decision that establishes criteria under which a doctor may be prosecuted for practicing outside the bounds of medicine. And again, revolving around the issue of the prescription of opioids for chronic pain.

Kevin Pho: All right, so you mentioned that you have some charts and data that refutes this claim.

Richard A. Lawhern: All right. I ran into a publication in, of all places, Twitter, some years ago, I think it was 2016 or 17, by a business analyst by the name of John Allen Tucker, and I want to give him full credit for the idea that eventually produced this chart.

What he had done was, he had asked some of the same questions that I was led to, which is, is there a relationship between opioid prescribing rates and rates of opioid related mortality? And he went back into the national cause of death database for the U.S. CDC, which is mounted through CDC WONDER, which is their database portal. And he did something that the CDC has not only never done before but has basically avoided like the plague. He tried to put the data on one chart.

And what he compared, and on this chart it would show up as the horizontal axis, is the number of prescriptions of opioids of specific kinds per 100 population. Now, this chart has a scale of 0 to 90, with a whole clump of data starting around 25 prescriptions per 100 and going as high as 80 or 100, and it’s for the year 2020.

On the vertical axis, though, he plotted deaths in which two categories of opioids are reported. And that doesn’t mean that these are necessarily the only deaths in which an opioid factors in, but these are the ones that are most closely related to prescriptions as such. Methadone is coded in the International Classification of Diseases, ICD-10, as T40.3, and synthetic or semisynthetic opioids other than methadone, which includes many prescription opioids, these are plotted as T40.4.

When you add the two of them up, you get something that very much violates the idea that on a state-by-state basis the rate of prescribing in any way drives the rate of overdose mortality. You get a shotgun blast. There is roughly a three and a half to one range of prescriptions per 100, but the range of opioid related deaths involving these two categories of prescription drugs is all the way from almost zero in some states to as high as 17 or so deaths per 100,000, which is not a huge number but it is definitely an interesting number.

If there was a relationship in which prescribing dominated the subject, prescribing as such dominated opioid related deaths, what we should see is a line with a slope that increases with the number of prescriptions per 100 population, and it should rise from something on the order of two deaths per 100,000 to something on the order of maybe 14 deaths per 100,000, if there was really a relationship. And by the way, the data should be clumped tightly around that line if there’s a strong correlation.

But what we actually get is what’s on this chart, and for those who are not seeing the chart, we get something that looks like a shotgun blast with a trend line that is almost flat. And what I note is that if prescribing is a major driver of opioid related mortality, that can’t happen. You have to see a line where there’s correlation, and strong correlation, if you’re going to make that case.

Kevin Pho: Let’s go on to the next chart and look at another dimension of this, if we can.

Richard A. Lawhern: It turns out that I’m certainly not the only one to investigate the contributions of opioids to accidental deaths. There was a paper published by Hawre Jalal and his colleagues in the journal Science in September of 2018, in which what they found, really, by analyzing every opioid overdose related death in a period of 26 years, was that he was able to describe the net curve, and that’s on the right side of this chart. The net curve of opioid mortality rates in accidental deaths from 1980 to 2016. And that curve tracks very closely with an exponential curve in which individual opioid and nonopioid agents contribute in a very much shifting balance.

Now, in the left side of this chart, the message is that prescription opioids are only one of eight contributing factors in drug related deaths of all kinds. If you look, for instance, at one of the lines that is specific to prescription opioids, the estimated mortality rate per 100,000 varies from something on the order of seven tenths, 0.7 per 100,000, to something on the order of, in 2016, about 3.5 per 100,000. For those of us who think in percents, that’s 0.035 percent. That’s a very small number, when mortality rate itself varies from something on the order of one mortality per 100,000 population up to as high, in 2016, as 17 per 100,000. These are fairly small numbers.

Now, here’s another footnote to this chart. This material was cited in a conference that was presented by the DEA Division of Diversion Control in December 2019, to an audience of clinicians who were taking a course from DEA to renew their licenses to prescribe. So DEA has known about this data for the last four years, and they continue to persecute physicians in a witch hunt, at least I believe it’s a witch hunt because it’s unfounded, where they know that prescription opioids are only a minor contribution to the overall accidental curve, and they are overshadowed, particularly by non-prescription illegal drugs, and this mostly means counterfeit fentanyl.

They also know there are major uncertainties, because there is a fair fraction of this exponential curve that is attributed to unspecified drugs or unspecified narcotics. About a quarter of all deaths over this period are attributable to, if you will, an uncertain designation, where the doctor said, I think there’s an opioid operating here, I’m not sure which one it is, or, there’s some drug that was involved but we weren’t able to figure out which one it was.

Now, with that said, let’s go to the third chart that we have in this series. CDC basically had their hide nailed to a wall in 2018, when they discovered, much to their unhappiness, that the attribution of causes of death had improperly associated deaths by illegal fentanyl with deaths by prescription fentanyl. And they changed the rules on how they account for deaths in cause of death reports from clinicians all across the country. When they did that, the number of deaths attributed to prescription drugs dropped by half.

Now, think about the significance of that. Those drugs that we’ve been calling prescription drugs, and that the CDC has been saying this is the cause of our opioid epidemic, were misreported for 20 years. And when the numbers were corrected to attribute properly, then we got an answer where prescription drugs were vastly less important than had been previously considered.

CDC has never admitted to it explicitly, but what they have done is tried to do a better job of reporting. So they’ve built something that’s called the State Unintentional Drug Overdose Reporting System, which is called SUDORS.

In 2022, which is the most recent year that we have data for, there were 51,435 deaths in which some drug was reported as a cause of death. And what they did was, they went back and did fine grain analysis on which drugs were involved.

Of those drugs, about 82 percent of all deaths that involve a drug of any kind that’s accidental involve at least one opioid, and 57 percent involved at least one stimulant, and it’s often cocaine or meth. Illegally made fentanyls were the most commonly involved opioids in this. So accidental drugs involving any opioids are about 81 percent, illegally made fentanyls are involved in 75 percent, and there’s overlap between these two categories. Heroin is down something in the range of, if I’m recalling right, 5 percent. Prescription opioids are showing up at around 12 percent. And we go through this story from one end to the other.

So what we’ve got is clear evidence that although prescription drugs are being detected and reported by county coroners and county medical examiners, in 2022 they are simply not driving the opioid crisis. When you do similar charts to this one, you get pretty much the same answers that go all the way back to 2010, when pill mills were pretty much eliminated by the crackdowns that involved prescription drug monitoring programs.

Basically, the point I’m trying to make from the data is that prescription opioids prescribed by a doctor in an ongoing doctor patient relationship have never, ever, ever been the major factor that is driving our opioid crisis. They just aren’t there that visibly. They do contribute at the margins.

But in studies done by places like the Commonwealth of Massachusetts, this is back some distance now, 2013, 2014, it’s been discovered and confirmed by other sources that when a drug overdose death involving an opioid occurs, up to six different agents are found, including alcohol. Some of the drugs that are reported as unintentional are no doubt suicides, but others are very most definitely accidental, because they are the result of people unwisely using multiple agents, either in an effort to control pain, that’s fairly frequent now, or simply because they are addicted to multiple opioids.

Kevin Pho: So if you were to present this data to the CDC, can you speculate what their response would be? How would they push back against that?

Richard A. Lawhern: The CDC has been running from this data for years, in my view. Now, realize there’s a certain degree of opinion here, and I want to be fair about this. CDC has been transmitting a message that basically ignores the data that they’ve collected, and their CDC guidelines ignored it as well.

As a matter of fact, they went so far in their guidelines as to say that they knew that non-invasive, non-opioid interventions in pain are preferred over opioids. Now, that is an outright lie. There is no trials data that demonstrates that, but that’s the assertion they made.

The other thing they did in their guidelines, that in my view and in the view of many clinicians makes those guidelines fatally flawed, was that they totally ignored the reality that there’s a natural wide range in opioid dose for the minimum effective dose in individuals, and that range is genetically determined. It’s something on the order of 15 to 1. But the medical literature on opioids does not account for that natural range in trials of opioid and other pain relieving analgesics. The entire medical literature on the effectiveness of opioids and their safety basically needs to be burned to the ground and thrown out.

CDC knew that, because there’s a 20 year history in the clinical literature, and it’s even vaguely referenced in one place in the CDC guidelines of 2016 and 2022. They knew that this wide range is not reflected in any of the work that they relied upon to develop their recommendations for treatment. So what we’ve got is a CDC guideline that’s based on mythology.

Kevin Pho: Tell us now, with the data, what do you anticipate the next steps to be?

Richard A. Lawhern: The next steps that we’re probably going to have to go through, because CDC doesn’t really want to hear the answer, is, I’m now developing what is called a national campaign to protect people in pain. We have a speaker bureau of about 12 or 14 very qualified clinicians. We are speaking to as many legislators in the House and Senate as we can. And as a matter of fact, I’ll be involved this afternoon in one session with the health care legislative aide of a representative, someone who sits on the House health subcommittee, or subcommittee on health, sorry.

What we’re basically saying is, we’ve got to translate this information into actionable legislation. We are lobbying for the health subcommittee to have public hearings and to invite patients and their doctors to those hearings, somewhat in the same manner as was done about two years ago by a different committee of Congress. And from that session we hope to develop definitive legislation that forces major revision of the Controlled Substances Act of 1970, and that protects clinicians from persecution by DEA and state agencies that have bought into the mythology that CDC has been preaching.

This is already something that’s been taken as an initiative in six states. Six states have in fact passed legislation that protects doctors from being censured or sanctioned for simply prescribing opioids in a professional manner, under controls. This is a trend that is beginning to develop and is going to become broader all the time.

Because right now, because of DEA and other actions, some of them by state medical boards that should have known better, the evidence is that about half of all community clinics in the U.S. are refusing to accept new patients for pain management. It’s gotten that bad. And doctors are denying pain management to patients in hospice, of all places, because they’re afraid of being censured. And surgeries are being postponed. We’ve got a problem here that is fundamental, that we have to solve with legislation, because CDC is not going to listen.

Kevin Pho: We’re talking to Richard Lawhern. He’s a patient advocate. Today’s KevinMD article is “Uncovering the real story behind opioid prescriptions and deaths.” Richard, last question. Can you briefly share your take-home messages to the KevinMD audience?

Richard A. Lawhern: My take-home message is that patients and clinicians are now actively lobbying for changes in public law that will recognize the reality that opioid medications, when used in the treatment of pain in an ongoing relationship, are inherently safe and effective. And we need to implement that as a major change in the public conversation concerning the opioid crisis.

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

Richard A. Lawhern: Thank you very much, Dr. Pho.