There’s no doubt that the opioid addiction crisis is a major health problem for our country. In the relatively short period of time (as far as public health issues go), the number of deaths and the amount of suffering caused by addiction to opioid drugs, both prescription and illicit, have skyrocketed. As Steve Novella pointed out, more than 11 million people abused prescription opioids in 2016. 42,000 Americans are dying every year from opioid overdose, 40% from prescription opioids, more than the 33,636 Americans who die from firearm injuries and the 37,133 who die from traffic accidents each year. Where there is a crisis, of course, there is also an opportunity. Unfortunately, in this case, the opportunity is being seized by purveyors of unscientific medicine and quackery who are arguing that their pseudoscience can address and alleviate the opioid addiction crisis. These boosters of “complementary and alternative medicine” or “integrative medicine” have successfully conflated in the minds of policymakers the term “nonpharmacologic treatment for pain” with the quackery they seek to “integrate” into conventional medicine, such as acupuncture, chiropractic, and the like. Quacks have been so successful at this that they’ve persuaded the Oregon Health authority to propose state Medicaid policy that could force taper patients on stable doses of opioids, persuaded the FDA to propose that doctors learn about chiropractic and acupuncture for chronic pain, infested Veterans Health with “integrative” quackery including naturopathy and acupuncture, and made headway in getting Medicaid to fund quackery. Now, the National Institutes of Health (NIH) is promoting an initiative to continue using the opioid crisis to promote the “integration” of quackery with medicine through its Helping to End Addiction Long-term InitiativeSM, or the NIH HEAL InitiativeSM, which was announced in 2018. Last week, the NIH announced the latest projects funded under the NIH HEAL Initiative.
We all recognize that part of the solution to the opioid addiction crisis will involve developing better nonpharmacologic treatments for pain, but those of us on the science-based medicine side want these treatments to be rooted in rigorous science showing that they are effective and safe, rather than ancient mysticism and deceptive appeals to placebo effects. Unfortunately, the National Center for Complementary and Integrative Medicine (NCCIH), that misbegotten center championed by quackery maven Sen. Tom Harkin, appears to have provided the blueprint for co-opting a real crisis in order to promote its mission of normalizing pseudoscience in medicine. Recall that in its 2016-2020 strategic plan, it explicitly invoked nonpharmacologic treatment of pain as part of its mission and proposed that the various quackeries that fall under the rubric of “integrative health” were part of the answer. True, it also proposed science-based nonpharmacologic treatments for pain, but that’s how “integration” works in “integrative medicine.” The pseudoscience and quackery are “integrated” into the science-based approaches, until patients (and even many doctors) can’t tell what is quackery and what is science-based, thus elevating quackery to be co-equal with science-based medicine.
NCCIH has a key role in this important large-scale research initiative. A major research emphasis for the Center over the past several years has been nondrug approaches for chronic pain. In fact, results of studies have shown that some mind and body approaches such as spinal manipulation, acupuncture, and yoga can help people manage their chronic pain symptoms and are recommended in clinical practice guidelines as first-line treatment for certain pain conditions. In addition, our experience coleading the NIH Health Care System Research Collaboratory has provided a “play book” of how to conduct pragmatic research and how to implement effective interventions in real world health care systems. This is important in our effort to improve clinical care for pain and OUD.
Because of course NCCIH is in it up to its ears in promoting pseudoscience throughout the entire NIH, and the NIH HEAL InitiativeSM is clearly its foot in the door. No wonder NCCIH Director Helene Langevin is so happy about NIH HEAL! I don’t have time today to go into depth regarding all the studies funded. (I might leave that as an exercise, either later in the week here or next week on my not-so-super-secret other blog.) However, I can’t help but note:
Among the NIH HEAL Initiative awards announced today are a combined $86.9 million over 6 years, pending the availability of funds, for initiatives that NCCIH is leading or coleading. This includes, Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM), Behavioral Research to Improve Medication Assisted Treatment (BRIM), and the NIH Back Pain Consortium (BACPAC) Research Program.
NIH HEAL Initiative research will develop non-addictive medications and nondrug treatments for pain and test new models of care in real-world settings. This includes a controlled trial of acupuncture under PRISM for chronic low-back pain in adults 65 years and older, and NIH is working with the Centers for Medicare & Medicaid Services (CMS). The results of this study will inform CMS coverage decisions. While some nondrug treatments of pain have been found to be effective, patients often do not have access to these treatments in their health care systems. The trials supported by the PRISM program will assess whether making these treatments directly available to patients with pain conditions improves their symptoms and ability to function.
Buried in Dr. Langevin’s post about NIH HEAL is the classic framing that advocates of CAM and “integrative” health use to put the cart before the horse, concluding that their “nonpharmacologic treatments for pain” are effective. For example, notice how Dr. Langevin states that “some nondrug treatments of pain have been found to be effective” right after mentioning the PRISM trial, which has a prominent acupuncture component. The implication is that acupuncture is effective for low back pain, although NCCIH doesn’t actually explicitly say that. Nonetheless, it goes on to justify the PRISM trial by asking whether “making these treatments directly available to patients with pain conditions improves their symptoms and ability to function,” with “these treatments” including acupuncture. Of course, acupuncture has never been shown to produce more than nonspecific effects for anything—and not for lack of trying by acupuncture advocates. It’s a theatrical placebo.
It’s important to note the name for which the NIH HEAL Initiative PRISM is supposedly an acronym: Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing. This is not rigorous science. PRISM will fund “pragmatic” and “implementation” studies? What does that mean? Obviously, implementation studies look at how to implement or roll out a treatment in a study population, which is, of course, putting the cart before the horse with acupuncture and these “nonpharmacologic treatments for pain.” “Pragmatic” studies are generally not randomized, or, if they are, they are unblinded.
In general, pragmatic studies are studies done after rigorous randomized, double-blind trials have demonstrated a treatment to be effective and safe in order to determine their real world effectiveness. The reason is that, not infrequently, treatments that are shown to be efficacious in rigorous randomized clinical trials turn out to be less “effective” in the real work. There are several reasons for this. One is that clinical trials are very rigorous in their inclusion and exclusion criteria; this is to minimize variability in the study population, thus minimizing “noise” in the outcome results as much as possible. Once a treatment makes it out “into the wild,” so to speak, inevitably it’s used in patients who wouldn’t have been eligible for the clinical trial and as a result might be less effective. Then, of course, there are other reasons why apparent effectiveness can decline “in the wild.” Patients are observed carefully in clinical trials, less so in real clinical practice. High levels of compliance can be achieved in clinical trials (albeit not without difficulty and sometimes elaborate measures); out in the real world, patients much more frequently forget to take their medicines. Also, in the case of procedure-based treatments, in a clinical trial there are quality measures and training to make sure that the doctors doing the procedures are skilled at it. Diffusion of that skill into the community can take time, and naturally there will be a much more variable level of skill among a larger number of doctors that could impact results and adverse reactions.
Doing a pragmatic trials like this ones to be funded under NIH HEAL and PRISM is, again, putting the cart before the horse, particularly the acupuncture studies. Acupuncturists love pragmatic trials because there is no control for placebo effects, allowing them to claim that a trial shows that acupuncture “works.” I learned that from Steve Novella, who taught me how pragmatic studies are perfect for promoting a worthless treatment. Basically, a pragmatic trial will always show an effect for a subjective outcome like pain. It’s true that there are reasons to do pragmatic trials on treatments that have been shown to be efficacious in randomized trials. I’ve listed some above, but there are others, such as to answer pragmatic questions, such as: If primary care doctors prescribe a daily aspirin to all patients who should be getting it what is the ultimate effect on public health? Note the similarity to the “pragmatic question” being asked by PRISM: Will making acupuncture and other “nonpharmacologic treatments for pain” available to patients with chronic pain reduce opioid use? Of course, it could, but because at the same time there are other forces operating to force doctors to prescribe and patients to use less opioid drugs. It’s quite possible that making acupuncture more widely available could decrease opioid use and prescribing at the cost of increased pain.
Here are examples of pragmatic trials under PRISM:
- Testing the use of decision support tools embedded in electronic health records to help patients and clinicians choose nondrug pain care after surgery and to improve patients’ role in managing their chronic pain
- Determining whether physical therapy (PT) plus transcutaneous electrical nerve stimulation in women with fibromyalgia is more effective than PT alone at community PT clinics
- Evaluating the effectiveness of incorporating a sustainable and billable mindfulness-based stress-reduction program into a primary care treatment for chronic low back pain
- Employing primary spine practitioners, such as chiropractors and physical therapists, as first-line providers of nondrug care for low back pain
- Conducting a clinical trial in older adults (aged 65 years or older) with chronic low back pain to evaluate whether acupuncture is effective in this patient population
The first example might not be so bad if only actual science-based “nondrug pain care” modalities are included. (What are the odds of that? Slim and none.) The second example is not blinded, and it’s hard to see a justification for it. The third example might be acceptable, as stress reduction is helpful, although “mindfulness” is basically poorly designed and very much oversold. The fourth one irritates me, because I hate how it assumes that chiropractors and physical therapists are essentially interchangeable and equivalent. Although there can be a disturbing amount of woo embraced by some physical therapists, most physical therapists use science-based practice, and the entire profession is not in itself based on pseudoscience, as chiropractic is. As I like to say, chiropractors are just poorly trained physical therapists with delusions of grandeur, who love to go beyond spinal manipulation and embrace all manner of quackery in addition to spinal manipulation. Of course, the last example is just what I was talking about above, a worthless pragmatic trial of a treatment that has never been convincingly shown to be anything more than a theatrical placebo.
Sadly, through NIH HEAL, the NIH is wasting close to $1 billion on this sort of stuff. Sure, some of it will be worthwhile, because it’s not all “integrative” quackery. But a lot of it is, meaning that a lot of this money will be squandered instead of being invested in research that might actually produce new science-based nonpharmacological treatments for pain. Thus NCCIH triumphs through NIH HEAL.