Opioid Bogeymen: ACSH Advisor Takes Mayo Clinic to Task, for Its Pain Management Fairytale

This week, Red Lawhern, a long-time friend and writer for ACSH, wrote an article taking the Mayo Clinic and one of its clinicians to task for

“… promoting the outright fraudulent mythology that clinical treatment of pain employing opioids entails a high immediate risk of opioid addiction or mortality.”

I will let Red’s words speak for themselves, but I spent time reviewing the comments from Mayo and the study that underlie their thoughts. As with other studies with agendas, the factual dots are correct; it's just that the fabric woven to connect them is full of holes. 

The study published in the peer-reviewed Journal of Pain utilized data from the 2019 to 2020 National Health Interview Survey (NHIS) Longitudinal Cohort (NHIS-LC), an annual national survey of noninstitutionalized U.S. adult civilians. The incident, that is, the first use of opioids, included those participants who reported opioid use in 2020 but not in 2019. Participants were asked: “During the past 12 months, have you taken any opioid pain relievers prescribed by a doctor, dentist, or other health professional?” Those answering yes were asked if they had been given these prescriptions in the past 3 months. 

Of roughly 20,000 participants, 10,415 had completed the survey questions in 2019 and 2020, meeting the possible definition of incident, new onset use of opioids. Of that cohort, 395 (3.7%) were new users and the subject of their study. 

The researchers model the factors that “interact and influence the use of health services” to include:

• External environment – region of residence and categorization of urban vs. rural was the study’s surrogate
• Predisposing factors – the researchers use factors associated with prevalent opioid use: age, sex, race, graduation status, and Hispanic/Latino heritage.
• Enabling factors – Problems paying medical bills as a surrogate for household income and “better reflects the material conditions in which a person lives, and is considered a measure of financial stress.” The second factor was health insurance.
• Health need measures - were assessed by tracking sleep quality, anxiety, depression, recent pain in various body areas, chronic diseases (e.g., obesity, diabetes, heart issues), and disabilities related to mobility, self-care, work, and social participation. Healthcare use was measured by E.R. visits, overnight hospital stays, number of nonopioid pain treatments in the past 3 months, and how effective participants felt their pain treatments were.
• Personal health behaviors – smoking was the only variable collected by the survey. 

The researchers attempted to understand when in treatment opioids were first used by asking those who reported pain whether they had used any other treatments [1]. The number of treatments was incorporated into their model. The researchers indicate that their model predicts,

“health needs are the most direct cause of health service use, followed by enabling and predisposing factors. Therefore, we hypothesized that those with greater health care needs will be more likely to use prescription opioids after controlling for other variables in the socio-behavioral model.” [emphasis added]  

While they found a 1-year cumulative incidence of 4.1%, the incidence varied from a low of 1.2% who had not seen a physician or 1.7% without insurance to 10.2% who reported their pain treatment was not effective and 11.6% who had gone to the E.D. at least three times – which may well be another way of saying that their pain management was not effective. 

• Sex, race, Hispanic heritage, veteran status, insurance status, marital status, and smoking were not associated with increased risk. 
• Those with a high school education were 80% more likely to report opioid use than college graduates
• Those troubled with paying bills were 2.3 more likely to have an opioid prescription than those more financially secure.
• The highest risks for prescription opioid use were found in individuals 
  • With need: multiple painful conditions (2.3 fold), disabilities (2.6 fold), recent asthma (2.3 fold), frequent sleep issues (2.3 fold), and multiple chronic diseases (2.3 fold). 
  • Diagnosed with depression or anxiety showed an elevated risk for opioid use. 
  • With the increased use of health care: seeing a physician (3 fold), three or more E.D. visits (3.1 fold), overnight hospitalization (2.1 fold), three or more treatment modalities (1.9 fold), and those reporting that treatment was not effective (2.5 fold).

As it turned out, the most significant factor was healthcare needs. Full stop. 

Even those perhaps puzzling factors like education gain more meaning through the lens of need. For example, what is the likelihood that someone with less than a college education is working in a manual labor job with an enhanced chance of injury? Data from the National Bureau of Labor Statistics reports that those with a high school education have “injury rates 62 percent to 105 percent higher than those with some postsecondary education.” A review of sleep disorders and chronic pain found: 

“In the general community, approximately 20% of the people living with chronic pain report at least one symptom of insomnia compared to only 7.4% in those without chronic pain. Within the healthcare system, as many as 90% of the patients attending a pain management centre for treatment also report at least one sleep complaint, and more than 65% of these patients would identify themselves as “‘poor sleepers.’”

So, while the findings are objective, there is a classic chicken-egg problem when deciding whether sleep disturbances and financial frailty are the cause or result of the medical need driving individuals to use opiates. I was a bit puzzled by the association of asthma with opioid use, but in this instance, the researchers identified a more plausible causal relationship  

“[the] possibly due to use of codeine-containing antitussive syrup to suppress coughing during asthma attacks. This is consistent with state-level E.R. and national ambulatory care data showing that respiratory diagnoses were among the most common diagnoses where opioids were prescribed, with codeine-containing syrup being the most frequently used.”

That there is an underlying belief that opioids are “bad” is found in these two quite contradictory statements. The general principle of care is that in fashioning specific care, one begins with the most effective and least harmful alternative – that has been the rationale behind ending the opioid-first approach to pain. Here is what the researchers write,

“Our study examined additional characteristics such as pain management approaches and their perceived effectiveness, both of which were strongly associated with incident opioid use. Combined, these data are consistent with best-practice guidelines, in that patients and providers may turn to prescription opioids when other less-aggressive approaches fail. Moreover, participants with multiple disabilities and comorbidities were more likely to exhibit incident prescription opioid use, aligning with evidence highlighting the association between pain and the burden of disabilities and comorbidities.” [emphasis added]

But in their conclusion, they write,

“Our data suggest that some participants are using opioids as a first-line or early-resort analgesic, instead of following various best-practice guidelines that recommend nonpharmacologic modalities, over-the-counter medications, and other nonopioid analgesics as initial treatment for pain.” [emphasis added]

Which is it? The researchers note that increasing use of pain treatments is associated with a greater incidence of opioid use. But that would be consistent with best practices – where opioids are reserved when other treatments fail. And there is no data at all as to when and the order in which treatments were initiated. This conclusion that best-practice guidelines are not followed has no basis in the data they had available or presented. I spent a lot of time looking for that data in their paper, but it just wasn’t presented. I can understand, maybe, how this got past peer review, but the lead author repeats this unfounded statement in the article meant for the general public posted by Mayo Clinic. 

"One of the things that we noticed is that people are still utilizing opioids as an early resort or first line treatment, before trying nonopioid treatments first, which goes against best practice guidelines in healthcare," says anesthesiologist Ryan D'Souza, M.D., lead author of the study.”

As with much of today’s research, this study is based on a nationally conducted survey that is not specifically designed to answer the researchers' questions but is validated and already collected. Rather than torture the data to give the conclusions desired, the researchers water-board their narrative to confess that evil opioids are still being misused and putting patients at risk. But as with most water-board confessions, at some point, the narrative will say anything to stop being further tormented. 

Ultimately, Mayo’s research seems less about uncovering the truth than reinforcing a foregone conclusion. Despite data that points to complex social and medical factors driving opioid prescriptions, Mayo's narrative clings to the simplistic "opioids bad, alternatives good" mantra, leaving out the nuance that makes healthcare solutions work. Red Lawhern shines a light on this selective storytelling; I urge you to read his opinion.

[1] The list included “physical therapy, rehabilitative therapy, occupational therapy, spinal manipulation or chiropractic care, cognitive behavioral therapy, self-management program or workshop, peer-support groups, yoga or tai-chi, massage, meditation, guided imagery or other relaxation techniques, and “other” approaches for pain management.”

Source: Nationally Representative Rates of Incident Prescription Opioid Use Among United States Adults and Selected Subpopulations: Longitudinal Cohort Study From the National Health Interview Survey, 2019 to 2020 Journal of Pain DOI: 10.1016/j.jpain.2024.104665