by Myra Christopher, Director, PAINS Project
In July, the National Academies of Sciences (NAS) released a “consensus study report” titled Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Richard Bonnie, Professor of Medicine and Law at the University of Virginia, chaired the committee of eighteen. Their work was funded by a grant from the U.S. Food and Drug Administration (FDA) specifically for the purpose of helping the FDA to reassess the agency’s risk-benefit framework for opioid approval and monitoring. I encourage all those concerned about the tension between efforts to improve chronic pain care and to contain the opioid epidemic to download and read at least the thirteen-page summary, if not the full three-hundred plus page report.
The Preface of the report, written by the Bonnie begins, “Nature and human ingenuity have spawned a class of opioid drugs that alleviate pain and, not coincidentally, induce feelings of well-being. Unfortunately, overprescribing and misuse of these drugs pose serious risks to individuals who consume them and the population at large.”
The report is well-written and well-organized in two parts:
Part I: Pain Management and Research
Part II: Addressing the Opioid Epidemic
The committee appears to have attempted to do a balanced analysis and to make recommendations that will not unintendedly harm chronic pain patients. However, among the 21 recommendations made by the committee, only one is included in the Pain Management and Research Section:
Recommendation 3-1. Invest in research to better understand pain and opioid use disorder. Including but not limited to:
- Improving understanding of the neurobiology of pain
- Developing the evidence on promising pain treatment modalities and supporting the discovery of innovative treatments, including nonaddictive analgesics and nonpharmacologic approaches at the level of the individual patient; and
- Improving understanding of the intersection between pain and OUD (opioid use disorder), including the relationships among use and misuse of opioids, pain, emotional distress, and the brain reward pathway; vulnerability to and assessment of risk of OUD; and how to properly manage pain in individuals with and at risk for OUD.
Part II: Addressing the Opioid Epidemic, however, includes 20 recommendations. In fairness, some will without question help both patient populations, e.g., under “Strategies for Influencing Prescribing Practices,” Recommendation 5-3 is to “facilitate reimbursement for comprehensive pain management.” And under strategies for reducing Harm, Recommendation 5-10. Improve access to naloxone and safe injection equipment will also benefit chronic pain patients who may accidentally overdose on opioids they are prescribed.
The day the report was released, NAS hosted a webinar which I and many others listened in on. Presenters did a good job and tried to communicate clearly that they understood the importance of balancing these two public health issues. I was dismayed, however, that there was no mention of the National Pain Strategy during the webinar. Furthermore, review of the document revealed little more than a mention of the Institute of Medicine report, Relieving Pain in America or the National Pain Strategy. However, my concerns were somewhat assuaged by the statement of “Ethical Context” in the report’s introduction which revealed that the statement of task provided to committee members “directed the committee to make recommendations to the FDA and other policy makers that would properly balance the needs of pain patients and the (societal) need to address opioid misuse.”
Committee members did an excellent job of pinpointing the underlying tension that manifests itself at every turn as we try to advance better care for those living with chronic pain, i.e., as articulated by the committee, “one of the confounding features of the policy discourse on the regulation of opioids and opioid prescribing is that many physicians and patient advocates ground their arguments not in the aggregated balance of benefits and harms at the population level but in the patient-centered ethics of clinical medicine (ethics ‘at the bedside,’ so to speak).” The report acknowledges that the committee was “sensitive to the ethical tension between the population perspective of public health and the patient-centered perspective of clinical ethics.” Although they clearly state that their charge was to answer the question posed from a societal perspective, I am grateful that they concluded this section by acknowledging the importance of clinical ethics and challenging policy makers to be sensitive to the impact of alternative policies on public confidence in the healthcare system, including trust in the physician-patient relationship.
I couldn’t agree more and believe that the importance of addressing this underlying tension between the needs of the individual against the perceived needs of society is critical to resolving both these important public health issues. It is obvious that most of those making policy at the federal level have chosen to forgo the importance of balance. PAINS most recent policy and educational brief, Recognizing the Needs of Pain Patients in Substance Use Policy, makes this very clear.
I encourage those living with pain and those advocating on their behalf to speak out and to call out the imbalance that exists in current policy making, especially at the national level. We can no longer be silent.