Michael E. Schatman

The damage done by the war on opioids: the pendulum has swung too far

In the United States, patterns of opioid use for the management of pain have drastically changed over the past 30 years. In the 1980s, the American pain medicine landscape was characterized by opiophobia, the fear to prescribe opioids. Around the turn of the millennium, however, we witnessed a fairly rapid shift to opiophilia, or the “overprescribing” of opioids. The ubiquitous undertreatment of pain was the catalyst for clinicians and pain societies to successfully lobby for increased use of opioids for all pain types, including non-cancer pain. The approval of new standards for pain management incorporating pain as the “fifth vital sign” by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)1 seemingly fueled this increase in opioid prescription. From 1991–2009, prescriptions for opioid analgesics tripled, with emergency department visits related to non-medical use of prescription opioid overdoses doubling from 2005–2009.2 In 2010, accidental overdose deaths associated with opioids increased for the eleventh consecutive year, highlighting the drastic shift in opioid use.3 The figurative pendulum began to swing toward opiophobia following the publication of data that demonstrated that the risk of addiction associated with chronic opioid use was likely underestimated.4 Guidelines for the use of controlled substances released by the Federation of State Medical Boards of the US in 1998 reflected this change in attitude.5 At present, there is a general consensus that opioids are over-prescribed and education among health care providers is sorely lacking, with considerable debate on how to appropriately address the issue not yet resulting in a balance between treating legitimate pain patients, and mitigating abuse, overdoses, and related deaths. In this environment, physicians and non-physician prescribers, health systems, regulatory agencies, and insurers are seeking tangible targets for intervention.

Cannabis in Pain Treatment: Clinical and Research Considerations

UNLABELLED Cannabinoids show promise as therapeutic agents, particularly as analgesics, but their development and clinical use has been complicated by recognition of their botanical source, cannabis, as a substance of misuse. Although research into endogenous cannabinoid systems and potential cannabinoid pharmaceuticals is slowly increasing, there has been intense societal interest in making herbal (plant) cannabis available for medicinal use; 23 U.S. States and all Canadian provinces currently permit use in some clinical contexts. Whether or not individual professionals support the clinical use of herbal cannabis, all clinicians will encounter patients who elect to use it and therefore need to be prepared to advise them on cannabis-related clinical issues despite limited evidence to guide care. Expanded research on cannabis is needed to better determine the individual and public health effects of increasing use of herbal cannabis and to advance understanding of the pharmaceutical potential of cannabinoids as medications. This article reviews clinical, research, and policy issues related to herbal cannabis to support clinicians in thoughtfully advising and caring for patients who use cannabis, and it examines obstacles and opportunities to expand research on the health effects of herbal cannabis and cannabinoids. PERSPECTIVE Herbal cannabis is increasingly available for clinical use in the United States despite continuing controversies over its efficacy and safety. This article explores important considerations in the use of plant Cannabis to better prepare clinicians to care for patients who use it, and identifies needed directions for research.

Challenges and Opportunities in Pain Management Disparities Research: Implications for Clinical Practice, Advocacy, and Policy

UNLABELLED Due to high profile initiatives at the national level, awareness of inadequate pain care affecting many groups in our society has never been greater. Nevertheless, increased awareness of pain disparities and the initiatives to address these disparities have yielded only modest progress, most notably in the form of growing appreciation that pain disparities likely result from multiple factors, including biological, psychological, environmental, health system, and cultural factors. Much less progress has been made in developing interventions that target these multiple determinants to reduce pain management disparities. In this paper we discuss key ethical and methodological challenges that undermine our capacity to investigate and develop meaningful interventions to improve pain outcomes among vulnerable populations. Key challenges in the areas of research engagement, recruitment, design, and measurement are discussed from both scientific and normative standpoints. Specific opportunities within emerging research paradigms to improve designs and measures are also discussed. Finally, we conclude with identifying potential synergies between the pain management disparities research agenda and the broader areas of clinical practice, advocacy, and policy that could help to move the field forward. PERSPECTIVE Researchers studying disparities in pain care face a number of ethical and methodological challenges that must be addressed to advance the field towards eliminating disparities. We discuss these ethical and methodological challenges and propose opportunities for paradigmatic revisions in areas of research engagement, design, measurement, advocacy, and policy.

Autonomy vs Paternalism in the Emergency Department: The Potential Deleterious Impact of Patient Satisfaction Surveys

Patient satisfaction surveys, such as Press Ganey, are flawed metrics for the emergency department setting and also in broader pain medicine. National experts discuss the pitfalls of applying such measures in pain care, and the potential unintended negative consequences to patients and providers alike. Evaluators, administrators, and payers are challenged to understand the limitations of Press Ganey and patient satisfactions in pain treatment, and the field is challenged to develop meaningful and valid metrics for best practices and competencies.

The health insurance industry: perpetuating the opioid crisis through policies of cost-containment and profitability

Disclosure Over the past year, MES has served on advisory boards for Mallinckrodt and Zogenix, and on the speakers’ bureau of Mallinckrodt. Over the past year, LRW has consulted or received research grants from AstraZeneca, BioDelivery Sciences International, CVS Caremark, Depomed, Egalet, Grunenthal USA, Inspirion Pharmaceuticals, Insys Therapeutics, Jazz Pharmaceuticals, Kaleo, Mallinckrodt, Nektar, Nevro, Orexo, Proove Biosciences, Signature Therapeutics, Synchrony Healthcare, Teva, and Travena.

A practical and ethical solution to the opioid scheduling conundrum

Abuse-deterrent formulations (ADFs) of opioids have been in existence since the 1970s,1 with abuse-deterrent mechanisms including physical barriers (eg, barriers to crushing), chemical additives such as opioid antagonists or irritants, and prodrugs that require conversion of the medication into their active forms in the gastrointestinal tract.2 A recent systematic review and meta-analysis3 found no difference between ADFs and non-ADFs in terms of efficacy or adverse events including nausea, vomiting, dizziness, headache, somnolence, constipation, and pruritus. Notably, the efficacy of ADFs in preventing abuse is not yet established, and therefore the authors could only comment on their “potential … to deter or resist some of the common forms of tampering associated with opioid misuse and abuse”. While Turk et al2 have elucidated the complexity of producing high-quality research on the efficacy of ADFs to reduce opioid abuse, recent data are encouraging. For example, since Purdue Pharma’s (Stamford, CT, USA) voluntary reformulation of OxyContin® to an ADF in 2010, abuse of the medication has decreased significantly.4–6 As a specific example, National Poison Data System statistics indicated a 36% reduction in abuse exposure for OxyContin following ADF reformulation. Meanwhile, researchers for Purdue Pharma found an increase in abuse exposure for other single-entity oxycodone products and a 42% increase in abuse exposure for heroin during the same time frame.7 Although OxyContin has been the most investigated abuse deterrent formulation, ADFs of other opioids have demonstrated promise in preliminary investigations.8,9

The American chronic pain crisis and the media: about time to get it right?

On November 23, 2015, the venerable Wall Street Journal published an article entitled “New Help for Back Pain”.1 In this article, the author wrote of “an innovative approach to help patients cope and heal called functional restoration”, suggesting that it helps avoid costly diagnostic tests, surgery and other expensive treatments, and the risks of problems potentially associated with opioid analgesics. While the author’s claims regarding interdisciplinary chronic pain management’s potential benefits are accurate, as is so often the case, the media’s inability to comprehend the “big picture” of the American crisis in pain medicine has resulted in yet another much-read yet highly biased and misinformative article that ultimately serves to exacerbate the difficulties with which our patients, and the system that they attempt to navigate, are faced. The author, Ms Landro, refers to interdisciplinary programs as “innovative”. This is inaccurate and befuddling, as interdisciplinary chronic pain management programs have been in existence for over half a century.2 In the 1970s, such programs were described as “medicine’s new growth industry”,3 with an estimated 1,000 such programs in the US around the turn of the millennium.4 Through empirical investigations and meta-analyses, these programs were found to not only be clinically effective in terms of functional restoration and relief of psychological symptoms, but cost-effective as well.5 On an anecdotal level, I witnessed the “miracles” that these programs performed, as I developed and ran an interdisciplinary pain program for 16 years. Tragically, the profit-driven American health care insurance industry decided that these programs were “too expensive”, irrespective of their aforementioned empirically-established cost-efficiency. At first, insurers attempted to reduce their costs by “carving out” services from programs. A typical interdisciplinary program would include physician management, psychological services, nursing, physical and occupational therapy, biofeedback, and vocational counseling.6 Despite the great success of these treatment programs, the insurance industry arbitrarily began to exclude payment for certain services, clearly without an empirical basis for doing so. For example, the program described in the recent Wall Street Journal article,1 according to the author, involves a “staff including a doctor, occupational and physical therapists, and a nurse practitioner”, with other crucial services not provided. Research by Gatchel et al7 has indicated that these “carve-out” programs obtain results significantly inferior to those obtained by comprehensive interdisciplinary programs. Thus, when the author reports that the cost of such a program is approximately US

On the Transformation of the “Profession” of Pain Medicine to the “Business” of Pain Medicine: An Introduction to a Special Series

17,000, she is reporting on the cost of a truncated “carve-out” rather than a considerably more expensive and effective full comprehensive program. Interestingly, most of the research supporting the cost-efficiency of interdisciplinary chronic pain management was conducted prior to the days of “carve-outs”.8 Reducing costs by bastardizing services was not sufficient for the health insurance industry, however. In the early years of this millennium, insurers began to simply refuse to cover these programs altogether,9–13 choosing to follow the “business ethic” of cost-containment and profitability while denying any fiduciary obligation to their enrollees. Although the main “culprit” in the demise of interdisciplinary pain management in the US was the insurance industry, it has also been noted that the hospital industry should shoulder some of the blame; hospitals shut down their pain clinics not necessarily because they were losing money, but rather because they were generating insufficient profits.14 The tone of Ms Landro’s Wall Street Journal article1 suggests that interdisciplinary programs are an “option” for patients with chronic back pain, when, in fact, access in most states is not a possibility. In a 2012 study on international perspectives on interdisciplinary chronic pain management,15 I noted that from over 1,000 programs in the US in 1999, the number of programs had dropped to approximately 90 (outside of the military and the Veterans’ Administration). Not surprisingly, results of the study indicated that while the number of interdisciplinary programs in the US has been decreasing precipitously, the number of treatment facilities in industrialized nations with National Health Services had increased dramatically during the prior decade. The same was true of the Veterans’ Administration and the military in the US, as these entities (like National Health Services) “own” their enrollees pain care for life and accordingly have chosen to follow the evidence basis and provide the most effective, cost-efficient, and compassionate possible treatment. Unfortunately, Ms Landro’s article is not the only example of the American print media’s misinformation potentially causing harm to the already vulnerable population of patients with chronic pain. In a recent article in the Journal of Pain Research,16 my colleagues and I elucidated the detrimental impact of the media in our society’s “war on opioids” – which has essentially represented an attack on those who manufacture, prescribe, or rely upon opioid analgesics in order to manage their chronic pain. Our expression of concern regarding the deleterious impact of the media’s often biased and disingenuous behavior was certainly not the only one of its type expressed.17–20 Although negative stories regarding opioids in the print media have been empirically determined to affect physicians’ prescribing patterns,21 there is no evidence that negative print media characterizationshave had any impact on the real problem around opioids – ie, a lack of adequate risk mitigation practices among physicians. The media has happily published myriad stories regarding prescription opioid-related abuse, diversion, overdose, and deaths, yet is seemingly unwilling to write stories regarding the millions of Americans with chronic pain whose qualities of life are actually enhanced through their appropriate utilization of opioid analgesics. “If it bleeds, it leads” has clearly become media’s mantra regarding pain management, resulting in the desire to sell print trumping its broader societal responsibility to disseminate accurate, unbiased, and balanced information. I grew up in the era of Woodward and Bernstein, when the media was composed of individuals who we considered heroes – ie, journalists willing to take personal risks to disseminate accurate and unbiased information that the American people deserved to understand. During the days of the Watergate scandal, the US was clearly facing great crisis. Today, with the Institute of Medicine report22 indicating that approximately 100 million Americans suffer from chronic pain, we are experiencing another type of crisis. Given the moral deterioration of pain medicine in our country,11,23,24 this crisis has only become amplified. Accordingly, is it not time for the media to step up to the plate, and consider writing legitimate stories that may actually help patients with pain – and assist those of us who are trying our best to aid them?

The MEDD myth: the impact of pseudoscience on pain research and prescribing-guideline development.

Over recent years, considerable concern has been expressed regarding the quality of pain treatment in the United States; the deterioration of which has led to the discipline as being described as in a state of “crisis”[1–3]. Our current treatment of pain is not particularly effective, resulting in a lack of improvement of quality of life among treated pain sufferers—irrespective of the increasing number and costs of treatments that are being received [4]. A number of theorists [5–8] have suggested that much of this crisis can be explained by the deepening and widening schism between the various stakeholders involved in pain care, with these stakeholders including patients, pain care professionals, hospitals, third-party payers, employers, industry (defined broadly), pain educators and societies, legislatures, and various government agencies. Hamaty [9] has described todays physician as a “lesser professional,” a “reluctant entrepreneur,” part of an immoral society. While some in the pain community maintain hope that broad health care reform will result in an improvement in the quality of care provided to patients with pain [10], the scope and impact of these efforts are still of unknown quantities [11]. Medicine as a profession , including pain medicine, has evolved in myriad ways over the past century. Some have dated medical professionalism back to the Hippocratic era [12], while others in the Renaissance, when the notion of a social obligation to treat the sick developed [13]. However, it was not until the mid-19th century that the American Medical Association (AMA) developed the first national set of ethical and practice standards [14], and one can accordingly identify 1847 as the birth date of the profession of medicine in the United States. Physicians are obligated to adhere to the (updated) AMA ethical standards, just as nurses, psychologists, physical therapists, …

Upscheduling of Hydrocodone: Convenience and Access vs Patient Safety Measures

With the opioid-misuse and -abuse problem on the rise, pain practitioners and lawmakers are scrambling for strategies to help mitigate opioid risks. Approaches include opioid-treatment agreements, urine drug testing, prescription-monitoring programs, assorted validated risk-assessment tools for abuse/misuse and opioid-induced respiratory depression (OIRD), biopsychosocial support, and other strategies.1–3 Nonopioid pain therapies should be considered and maximized prior to initiating opioid treatment; however, in some cases opioids are the optimal choice for both noncancer and cancer-related pain syndromes.4