As published in the Journal of Medicine online.
Anyone who reads a newspaper these days has been exposed to the ongoing hysteria concerning a so-called (and largely fictitious) “epidemic” of deaths due to prescription opioid drugs. Nine months after the issuance of a highly restrictive CDC guideline, we are learning that the CDC writers group for the most part ignored the input of expert pain management specialists as they developed their guidelines on opioid prescription for chronic pain. Worse still, the consultants violated the CDC’s own research protocols, in what appears to have been an effort to bias the outcomes of their work against the use of prescription pain relievers – regardless of the reality that available medical evidence fails to justify such action .
In the meantime, tens of thousands of chronic pain patients have had proven and essential pain medications arbitrarily reduced or outright withdrawn by doctors afraid of being maliciously prosecuted by the US Drug Enforcement Administration for over-prescription. Doctors are leaving pain management, often “dumping” hundreds of their patients without referral. Some patients have committed suicide, unable to deal with the agony and disability that their own government has imposed on them. Others may follow.
An especially disturbing aspect of this policy debacle is that restrictions on prescription opioids have occurred in the absence of clearly effective alternatives for pain management or relief. This is despite a program of research mounted by the US Government including the Agency for Healthcare Research and Quality (AHRQ, within the US Department of Health and Human Services). Most recently, AHRQ has issued a public call for comment on a series of questions intended as a basis for analyzing available medical evidence pertaining to “noninvasive, non-pharmacological treatment” of five types of pain in adults:
- Chronic low back pain
- Chronic neck pain
- Osteoarthritis related pain
- Tension headache (excluding migraine)
The types of medical interventions discussed by AHRQ as potential treatments include “exercise (e.g. physical therapy (PT), supervised exercise, home exercise, group exercise), psychological therapies (e.g., cognitive behavioral therapy, acceptance and commitment therapy, biofeedback, relaxation training), physical modalities (e.g., traction, ultrasound, TENS, low level laser therapy, interferential therapy, superficial heat or cold, back or neck support, magnets) manual therapies (e.g., manipulation, massage) mindfulness and mind-body practices (e.g., meditation, mindfulness-based stress reduction, Yoga, Tai Chi, Qigong), acupuncture, and multidisciplinary/interdisciplinary rehabilitation” [Ref 2]. For each type of pain, three “sub-questions” are addressed:
1. What are the benefits and harms of noninvasive non-pharmacological therapies compared with sham treatment, no treatment, waitlist, attention control or usual care?
2. What are the benefits and harms of noninvasive non-pharmacological therapies compared with pharmacological therapy?
3. What are the benefits and harms of noninvasive non-pharmacological therapies compared with exercise? (for tension headache, “exercise” is replaced by “biofeedback”)
These questions are supplemented by one other general inquiry: “Do estimates of benefits and harms differ by age, sex or presence of co-morbidities (e.g. emotional or mood disorders)?”
I read these questions against a background of 20 years of active participation as the spouse and father of chronic pain patients. I am also a technically trained information miner and research analyst who daily interacts with hundreds of pain patients via social media. As a peer to peer support site moderator, healthcare writer and patient advocate, I have communicated with well over 15,000 people in pain, and heard their experience with just about all of the “noninvasive” techniques noted above.
Having myself commented at the AHRQ gateway, my fundamental question about this process is “Are you people SERIOUS?” If you had been talking with chronic pain patients themselves instead of your presumably educated colleagues, you would already understand the status of these so-called alternative therapies. Not to put too fine a point on this, but they seem to temporarily help fewer than half of those treated – and even smaller numbers when pain is sufficiently severe and sustained that opioid medication would even be considered as an option by a Board Certified specialist in pain management.
The AHRQ Draft Analytical Framework contains a number of obvious non-starter assumptions that should prompt its being thrown out and done over from scratch. Primary among these assumptions is the notion that opioid treatment of chronic pain is only temporarily effective and entails a high risk of patient addiction. I have read letters and postings from or talked with hundreds of patients who have used opioids at high stable doses for years, with strongly positive effect in maintaining the quality of their lives and no evidence of addiction behaviors. Just about any pain management specialist that you bother to consult will confirm this observation.
Just as bad is a fallacy in the present analytical framework— the apparent assumption that emotional or mood disorders may comprise a cause of chronic pain. While erudite papers are published by practitioners of so-called psychosomatic medicine, what I see is a much different picture from their optimism. I have never talked with a chronic pain patient in whom any form of Rational Cognitive Therapy has been effective against medically diagnosed pain.
Psychiatric professionals have little to offer beyond assistance with anxiety and stress control – and much to answer for in their too-often casual assumption that “the pain is all in your head.” Appearance of a mental health diagnosis in a patient record can literally be the kiss of death for ongoing medical assessment and effective treatment. Sometimes it is the kiss of death for the disregarded and isolated patient him/herself.
Several other factors are of concern in this framework. For instance, chronic neck pain and low back pain are not single medical entities. They are symptoms of multiple underlying disorders, sometimes neurological, sometimes neuropathic and not infrequently caused by treatment itself, particularly surgery. Medical treatment and patient response to treatment can vary significantly between individuals. Moreover, it is common for chronic pain patients to deal with multiple medical disorders which include forms of neuropathic pain — which AHRQ has chosen to exclude from its studies. Such complications will likely confound the extraction of convenient generalities concerning either primary therapies or alternative treatments.
My recommendation to the AHRQ is to withdraw the draft analytical framework and solicit the help of the American Academy of Pain Management in re-drafting it. Then advertise widely for participation in review by pain patients themselves and their doctors. As an old but often true cliche would have it, it can be very difficult to get where you want to go when you start out not knowing where you are. And you folks clearly don’t.