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Is There a Duty to Relieve Pain?
CHAPTER TWO
Is There a Duty to Relieve Pain? Mark D. Sullivan* and Jane Ballantynex, 1 *Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, United States x Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, United States 1 Corresponding author: E-mail: [email protected]
Contents 1. Introduction 1.1 Necessity 1.2 Expediency 2. What Do We Owe Patients With Chronic Pain? 2.1 A Diagnosis, a Cure 2.2 Pain Relief: No Pain, less Pain? 2.3 Pain Management: What Tools, What Goals? 2.4 Improved Function: What Kind, What Goals? 2.5 Improved Quality of Life: As Defined by Whom, and According to What Standard? 2.6 Pain as Innocent Suffering 2.7 Opioids as Pain-Specific Relief 3. Conclusion: What We Owe to Patients With Chronic Pain Acknowledgements References
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1. INTRODUCTION The foundations of medical ethics were laid out as early as the fifth century BC. Most famously, the Oath written by Hippocrates is sworn by new physicians in many countries to this day. Its fundamentals form the basis of medical ethics even where the oath is no longer formally sworn. In terms of provision of treatment, the key ethic principle is “I will use treatment to help the sick according to my ability and judgement, but never with a view to injury or wrong-doing” (Edelstein, 1943, p.56). Much later, in the 17th century, this was interpreted to mean “first do no harm”, although those exact words were not present in Hippocrates’ writing (Sokol, 2013). Nevertheless, the idea of not harming people through medical treatment has become increasingly central to medical ethics, as society has moved beyond the times when medicine could Developments in Neuroethics and Bioethics, Volume 1 ISSN 2589-2959 https://doi.org/10.1016/bs.dnb.2018.08.002
© 2018 Elsevier Inc. All rights reserved.
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palliate but not cure. Once medical treatments could cure and extend lifeda trend that accelerated rapidly after the discovery of antisepsis and anesthesia at the end of the 19th century that made complicated surgery survivabledthe relief of suffering, which had been so central to Hippocratic ethical practices, seemed overrun by the desire to cure, considered as the main route to relief of suffering. Pain relief per se was no longer the focus of medical treatment. At the same time, attitudes to opioid treatment of pain changed radically. Opioids had been a mainstay of medical treatment because there was not much else that could effectively treat pain and relieve many other distressing symptoms. Opioids could be bought at will from tradepeoples, pharmacies and doctors, to the limit of their cost and availability. At the beginning of the 20th century, in response to the post-Civil War laudanum and morphine epidemic, drug regulations were introduced into the United States and later into other Western democracies. People were no longer free to purchase opioids, the most powerful of analgesics, and use them for pain relief. Opioids could only be obtained through physicians, and physicians could lose their medical licences if they violated the spirit of the regulations. Not only were physicians afraid to prescribe opioids, they did not feel the need since they were focused more on disease control and less on palliation. By the latter part of the 20th century, pain, even pain at the end of life, was woefully undertreated. Correction was needed, and it was achieved through both necessity and expediency.
1.1 Necessity In 1985, the WHO (WHO) recognized that people were dying in unnecessary pain because drug regulations introduced at the beginning of the century had increased the stigma associated with opioid use. In response, the WHO published a simple protocol for treating pain at the end of life, usually associated with cancer (Ventafridda, Saita, Ripamonti, & De-Conno, 1985). This became known as the WHO stepladder. The model suggested initiating analgesia with simple analgesics, adding mild opioids when needed, and finally adding strong opioids, which could be titrated to effect. This simple model was very effective in validating opioid use at the end of life and in providing a roadmap that was useful to clinicians. Initiatives in individual countries were added to the WHO initiative to encourage better use of opioids at the end of life. In the US, one of the earliest attempts to produce evidence-based pain treatment guidelines was shepherded by the then Agency for Healthcare Policy Research (AHCPR), now the Agency for
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Healthcare Research and Quality (AHRQ), starting with acute pain guidelines (Carr, 1992), and two years later cancer pain guidelines (Jacox, Carr, & Payne, et al., 1994). Although these guidelines were broad-based, they provided strong support for the use of opioids for acute and cancer-related pain, and were mirrored by evidence-based pain treatment guidelines in other countries. Through these efforts, opioid use for short-lived pain was largely restored in the countries that had been affected by under-treatment of pain and underuse of opioids. Once this restoration of pain treatment had succeeded, the same advocates that had been successful in the realm of cancer pain treatment and opioid use for palliation turned their attention to chronic pain. They began to argue that suffering during chronic pain was as great as during cancer pain, and was equally deserving of opioid treatment (Portenoy & Foley, 1986). This argument had wide-reaching effects because it opened the door to the idea that opioids should be made available for the treatment of all severe pain, and that patients should have the right to receive opioids on demand (Joranson & Gilson, 1997). This movement coincided with changes in medical ethics from the tradition of paternalistic medicinedproducing good for the patient and protecting that patient from harmdto a philosophy of liberalism where public morality constrains and modifies medical ethics and the individual has autonomy and deserves protection of their civil liberties (Brennan, 1991; Veatch, 1981). Independent of pain treatment, the (Patient) Consumer Bill of Rights from the United States Advisory Commission on Consumer Protection and Quality in Healthcare (1998) emphasized that patients have the right to know their treatment options and to participate in decisions about their care. More specific to opioids and the promotion of the idea that they should be available for the treatment of any severe pain, statutes were written to protect physicians from censure if they were prescribed for the treatment of pain (Gilson & Joranson, 2002 Gilson, Maurer, & Joranson, 2005). The necessity to identify and treat pain crept into hospital mandates, and declarations from professional bodies stated the moral necessity to treat pain. For example, one intractable pain statute stated: Controlled substances and, in particular, narcotic analgesics, may be used in the treatment of pain experienced by a patient with a terminal illness or chronic disorder. These drugs have legitimate clinical use and the physician should not hesitate to prescribe, dispense, or administer them when they are indicated for a legitimate medical purpose. (Joranson & Gilson, 1997, as cited in; Ballantyne, 2007, p.134)
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Perhaps most significant was the declaration by the International Association for the Study of Pain (IASP), named the IASP Declaration of Montreal. This was not aimed at opioids per se, but at the idea that clinicians are morally bound to solicit and treat pain. The declaration states: .. recognizing the intrinsic dignity of all persons and that withholding of pain treatment is profoundly wrong, leading to unnecessary suffering which is harmful, we declare that the following human rights must be recognized throughout the world:
• The right of all people to have access to pain management without discrimination.
• The right of people in pain to acknowledgement of their pain and to be informed about how it can be assessed and managed.
• The right of all people with pain to have access to appropriate assessment and treatment of pain by adequately trained health care professionals (IASP, 2010)
1.2 Expediency At the end of the 20th century, there was not simply a moral initiative afoot regarding the necessity to treat pain. At the same time, the pharmaceutical industry became interested in promoting opioids for the treatment of more than just pain at the end of life, because newer extended release formulations of opioid medications were potentially profitable. Morphine had been used for centuries and was cheap to produce but carried a stigma because of its association with end-of-life care and was not particularly widely used or profitable. In contrast, the newer long-acting formulations of less familiar opioids such as oxycodone were ripe for promotion to those suffering and treating chronic pain, with chronic pain being much more widespread and long-lived than acute or end-of-life pain (VanZee, 2009). The disastrous effects of the promotional activities of the pharmaceutical industry on unfettered clinician prescribing are well documented (Kolodny et al., 2015). Although it is not possible to separate completely the effects of changes in clinical standards in pain management brought about by clinicians themselves from the effects of promotional activities by drug companies, there is no doubting what those promotional activities were, and that clinicians became involved in the marketing tactics. Pain patient advocacy groups, professional societies, the Joint Commission on Accreditation of Healthcare Organization (2001) pain standards and the Federations of State Medical Board’s model policy for opioid analgesics (West, et al., 1998), were
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dependent on funding from the pharmaceutical industry. Because some of the marketing was misleading and exaggerated the benefits while concealing the risks of opioids, the pharmaceutical industry and some individuals from the medical profession who had worked closely with the pharmaceutical industry, are now under intense scrutiny by politicians and lawyers (Parloff, 2018). This occurs most prominently in the US where overpromotion of opioids has led to an epidemic of opioid abuse and deaths (Paulozzi, Budnitz, & Xi, 2006; see also Kofi, Sud, & Buchman, this volume). Clinicians have been drawn into a legal and ethical quagmire because of misleading and in some cases, dishonest promotional activities. The fact that the pharmaceutical industry netted billions of dollars in profits from opioid sales, and passed some of those profits on to clinicians, does not help their cases now that they are under the microscope for their role in producing an opioid epidemic (Homeland Security and Governmental Affairs Committee, 2018). This is true of some individual physicians, and the professional societies that support them.
2. WHAT DO WE OWE PATIENTS WITH CHRONIC PAIN? If we examine this question systematically, it becomes clear that the answer is more complicated than it initially appears. There are a number of possible goals for care.
2.1 A Diagnosis, a Cure Patients with chronic pain very often present initially with the question: “what is causing my pain?”, and the request, “please fix the problem”. These are reasonable expectations of modern health care. These patients are quite frustrated when their requests for a diagnosis and a cure are turned aside by clinicians who can find no broken part or malfunctioning organ on physical exam or imaging tests. Patients are seduced easily by clinicians who point to bulging and degenerated discs on imaging tests as causes of back pain, despite the fact that many patients with no back pain have these findings (Carragee et al., 2006). The popular press still commonly includes advertisements promising rapid and easy diagnosis and cure of chronic pain. Nevertheless, the scientific literature supports the assertion that diagnosis and cure will not be possible for many of the most common forms of chronic pain such as back pain, neck pain, fibromyalgia, and chronic headache.
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2.2 Pain Relief: No Pain, less Pain? Once the patient has relinquished the search for a cure, the patient’s attention usually shifts to pain relief. If pain cannot be ended once and for all by removing its cause, can it be eliminated or reduced through medical treatment? Clinicians often caution patients with chronic pain that it is not possible to remove all their pain with current treatments. They try to get patients to accept less pain rather than no pain as their treatment goal. This is an important first step but it is inadequate. This is because this request for pain relief is often framed within some very specific assessment and treatment strategies. First, it is assumed that pain relief is provided through pain reduction. This pain reduction is assessed and quantified using the 0e10 numeric rating scale for pain intensity that is universally deployed throughout contemporary health care. Pain relief is commonly defined as a significant reduction in pain intensity, as either a percent reduction, such as 30% or reduction below a crucial threshold, below 4 on a 10-point scale (Veterans Health Administration, 2003). This approach to assess pain relief may be useful for acute pain in some circumstances, but its widespread use in chronic pain to assess need for treatment and response to treatment is flawed for multiple reasons. First, pain may be relieved through a change in its meaning rather than a change in intensity. For example, patients with cancer are often relieved when they learn their pain is due to treatment or concurrent illness, or anything other than progression of their cancer (Ersek & Ferrell, 1994). Second, it is now clear that what had been called the pain neuromatrix in the brain encodes pain salience and other attributes associated with pain in addition to pain intensity (Kucyi & Davis, 2015). The relevance of pain to the survival of the organism is the most important and valuable thing for the brain to monitor. This relevance is shaped by other threats and rewards for the organism and is not a direct product of the severity of injury or strength of nociception. If pain salience rather than pain intensity is the focus of our pain therapies, these therapies will look very different (Sullivan & Ballantyne, 2016).
2.3 Pain Management: What Tools, What Goals? The IASP Declaration of Montreal mentions the “right of all people have access to pain management without discrimination” (Cousins Lynch, 2011). Earlier versions of this Declaration mentioned a right pain relief, but this was changed since it is not possible to guarantee
to & to all
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patients pain relief (Cousins, Brennan, & Carr, 2004). A right for access to pain management is meant to be more flexible and accommodating of different types of pain problems and health care systems. However, it is not clear what “access to pain management” means and whether it captures what is most important to patients with chronic pain who are seeking care. At the most basic level, it is not clear what tools are included in this effort at pain management and what goals this effort aims at. We believe the intention of the Declaration is to provide more patients access to multidisciplinary pain care, but this is available to only a small fraction of patients with chronic pain coming from the most advanced economies and health systems. It is also not clear what goals this effort at pain management aims for: is the goal pain reduction, functional improvement, or a better quality of life? Who selects these goalsdpatients, providers, health systems, governments? The authors of the Declaration of Montreal have emphasized that they are not arguing for universal access to opioid therapy for chronic pain, but what concrete and feasible substitute should be provided is not clear (Cousins, 2012).
2.4 Improved Function: What Kind, What Goals? It has now become commonplace in the professional literature on chronic pain and in governmental policy on chronic pain to argue that the appropriate goal in chronic pain care is not reduced pain but improved function (Dworkin et al., 2008 Gewandter, et al., 2014). This is an improvement over a simple focus on pain reduction but leaves crucial questions unanswered. First, what kind of function is the goal? There are many possible kinds of patient function: physical function such as the ability to lift and climb stairs, social function such as the ability to relate to others, manage interpersonal conflicts, role function and the ability to meet expectations as a parent, spouse, a breadwinner, cognitive function and the ability to decide and remember, and emotional function including the ability to manage emotional distress and remain hopeful (Karayannis, Sturgeon, Chih-Kao, Cooley, & Mackey, 2017). Second, it is not clear that patients consider themselves as having functions (Savolaine & Granello, 2002). For example, my own kidneys have a function in my body, but I do not consider myself as having a function, except when considered as part of a larger whole like a family or a workplace. Persons have purposes rather than functions. These purposes are chosen by the persons themselves and are infinitely various (Gardner, et al., 2016).
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2.5 Improved Quality of Life: As Defined by Whom, and According to What Standard? A focus on function in chronic pain care, which usually means physical function, can be criticized as neglecting the aversive pain experience. Patients do not like pain at least partly because it feels bad (Navratilova & Porreca, 2014). This aversive experience affects a patient’s quality of life, as does any functional impairment produced by chronic pain. Quality of life is a more comprehensive and patient-centred goal for chronic pain care than functional status. Although it captures more of what is important to patients, it is more complex and difficult to achieve. Quality of life, even in those with chronic illness, is determined by many factors other than health and health care. For example, quality of life may be defined by quality of relationships and neighbourhood, level of income and education, and employment situation (Raggi, et al., 2016). If function and purpose vary greatly from patient to patient, quality of life and its determinants show even more variability among persons. Not only do the determinants of quality of life vary, the standards defining an adequate quality of life vary greatly. What would constitute an adequate quality of life in a low-income country where daily income averages a few dollars a day is very different from what might be considered an adequate quality of life in a high-income country. As we have moved through this list of possible goals for chronic pain care, we have moved from the simple to the complex and from the grossly incomplete to the more complete. The former is easier to operationalize but misdirect care in some important ways. The latter comes closer to the comprehensive goals we want but are difficult to operationalize and achieve through health care.
2.6 Pain as Innocent Suffering Clinicians tend to privilege pain as a form of physical suffering for which the patient is not responsible. On the model of acute pain and disease, patients usually consider chronic pain to be innocent suffering: “I did nothing to bring this on myself.” This stands in contrast to addiction, which may involve the voluntary ingestion of licit or illicit drugs. Chronic pain also stands in contrast to depression, which can include the taint of laziness and willful neglect of one’s duties and one’s self. Chronic pain also stands in contrast to stress, where some consider a lack of strength and resilience as an indicator of weakness.
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We must ask why, as a society, we speak of a right to pain relief but not a right to depression or anxiety or suffering relief. As authors, we propose that this is because pain is the most medical of aversive experiences, pointing toward injury or illness that could have befallen anyone. Pain is classically considered more urgent and more essential than nausea, dizziness, fatigue, dyspnea, or weakness. In the philosophy of the Enlightenment, for example, pain was used as a concept to cover all the aversive and unfortunate experiences in life. Jeremy Bentham, the father of the utilitarian approach to social policy, said: “[n]ature has placed mankind under the governance of two sovereign masters, pain and pleasure. It is for them alone to point out what we ought to do, as well as to determine what we shall do” (Bentham, 1789, p.1). Pain is the essence of misfortune and must be reduced.
2.7 Opioids as Pain-Specific Relief Parallel and corollary to this innocent suffering of pain is a form of pain-specific relief, opioids. Physicians prescribe opioids to kill the pain and leave the person alone. As our patients often say to us, “don’t give me any of your mind-altering drugs, just take away my pain!” This assumes we can take away all of a patient’s pain and not alter who they are as a person. The implication is that chronic pain is not necessary or beneficial and should be removed however possible. This might sound like an extreme view, but echoes of this can be found in the medical literature. This occurred first with the treatment of pain at the end of life. As justifications for allowing patients to die in pain were considered invalid, the following argument was made: “[t]he proper dose of pain medication is the dose that is sufficient to relieve pain and suffering. To allow a patient to experience unbearable pain or suffering is unethical medical practice” (Wanzer, et al., 1989). This principle was gradually extended from end of life care, to cancer pain care, and then to chronic non-cancer pain care. It is echoed in the pleas of chronic pain patients to their prescribers: don’t you believe I am in pain? Don’t you think I deserve relief? Titrating opioid doses to a pain level may simultaneously reduce pain and make it harder for a patient to live his or her life by producing sedation or confusion or addiction. Pain reduction and quality of life reduction can both occur with opioid therapy. There is increasing recognition of this fact. For example, the new standards issued by The Joint Commission (2017) concerning management of pain within the hospital sets a new criterion of adequacy. These new standards state that the adequacy of pain relief
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should be determined in terms of adequacy of function. Zero pain is not the goal. Many of the ethical quandaries in pain management end up being quandaries directly related to opioid use. Since, through their respiratory depressant effects, opioids can hasten death, the issue of whether potentially lethal doses of opioids should be used to relieve suffering at the end of life presents challenging and continuing ethical debate. Although addiction issues may seem of a lesser magnitude than preservation of life, the fact that addiction destroys lives interferes significantly with the duty to treat pain. Because opioids are invaluable for the treatment of severe pain at the end of life, their use is conflated with the duty to treat non-cancer pain, yet their ability to destroy lives conflicts with that duty. This conflict in duty comes into sharp focus when considering the profit that can be made from selling or prescribing opioids. Trading in addictive substances is profitable for obvious reasons. Many laws and regulations have been instituted to control trade and usage of addictive substances so that it does not get out of hand or have a pervasive effect on society. While the pharmaceutical industry may have complied with the existing laws and with regulations, their role in the current North American epidemic of opioid-related morbidity and mortality is under scrutiny. The industry’s marketing tactics, which succeeded in grossing enormous profits, involved overplaying the ‘duty to treat pain’ card, and misleading prescribers and patients about the known limitations and risks of opioids (Homeland Security and Governmental Affairs Committee, 2018; Kolodny, et al., 2015 Parloff, 2018).
3. CONCLUSION: WHAT WE OWE TO PATIENTS WITH CHRONIC PAIN Our foremost duty to patients with chronic pain is not to simply reduce their pain intensity, but to improve their health. This consists of increasing the capacity of patients to be agents in their own lives (Sullivan, 2017). We seek to provide patients with the capability to move their lives forward again. This means the ability to pursue their passions in work or play. It means the ability to form and sustain relationships. It means the ability to carve one’s own environmental niche in the complex natural and social environment that is human society. When our most valuable analgesic erodes that ability, it is time to rethink what duty to relieve pain actually means.
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ACKNOWLEDGEMENTS Mark D. Sullivan has provided consultation to Aetna and Chrono Therapeutics, received research grants from Pfizer and Purdue Pharma L.P., and was an expert witness for the State of Washington. Jane Ballantyne does not report any conflicts of interest.
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Gilson, A. M., Maurer, M. A., & Joranson, D. E. (2005). State policy affecting pain management: Recent improvements and the positive impact of regulatory health policies. Health Policy, 74(2), 192e204. https://doi.org/10.1016/j.healthpol.2005.01.004. Homeland Security and Governmental Affairs Committee. (2018). Fueling an epidemic. Exposing the financial ties between opioid manufacturers and third party advocacy groups. (2018). US Senate and Homeland Security & Governmental Affairs Committee, Ranking Member’s Office. https://www.hsgac.senate.gov/imo/media/doc/ REPORT-Fueling an Epidemic-Exposing the Financial Ties Between Opioid Manufacturers and Third Party Advocacy Groups.pdf. accessed 4/11/2018. International Association for the Study of Pain. (2010). Declaration of Montreal: Declaration that access to pain management is a fundamental human right. http://www.iasp-pain.org/Content/ NavigationMenu/Advocacy/DeclarationofMontr233al/default.htm. Jacox, A., Carr, D. B., Payne, R., et al. (1994). Management of cancer pain: Clinical practice guideline. US Department of Health and Human Services, AHCPR Publication No. 94-0592 March 1994. Joint Commission. (2017). Joint commission enhances pain assessment and management requirements for accredited hospitals. Available at: https://www.jointcommission.org/assets/1/18/ Joint_Commission_Enhances_Pain_Assesment_and_Management_Requirements_ for_Accredited_Hospitals1.PDF. Joint Commission on Accreditation of Healthcare Organizations. (2001). Pain management standards. Effective January 1, 2001. Available at: http://www.jcaho.org/standard/. Joranson, D. E., & Gilson, A. M. (1997). State intractable pain policy: Current status. APS Bulletin, 7(2), 7e9. Karayannis, N. V., Sturgeon, J. A., Chih-Kao, M., Cooley, C., & Mackey, S. C. (2017). Pain interference and physical function demonstrate poor longitudinal association in people living with pain: A PROMIS investigation. Pain, 158(6), 1063e1068. Kolodny, A., Courtwright, D. T., Hwang, C. S., Kreiner, P., Eadie, J. L., Clark, T. W., & Alexander, G. C. (2015). The prescription opioid and heroin crisis: A public health approach to an epidemic of addiction. Annual Review of Public Health, 36, 559e574. Kucyi, A., & Davis, K. D. (2015). The dynamic pain connectome. Trends in Neuroscience, 38(2), 86e95. Navratilova, E., & Porreca, F. (2014). Reward and motivation in pain and pain relief. Nature Neuroscience, 17(10), 1304e1312. https://doi.org/10.1038/nn.3811. Parloff, R. (2018). Leading pain doctors face scores of opioid lawsuits. Opioid Watch. https:// opioidinstitute.org/2018/04/04/leading-pain-doctors-face-scores-of-opioid-lawsuits/ accessed 4/11/18. Paulozzi, L. J., Budnitz, D. S., & Xi, Y. (2006). Increasing deaths from opioid analgesics in the United States. Pharmacoepidemiology and Drug Safety, 15(9), 618e627. Portenoy, R. K., & Foley, K. M. (1986). Chronic use of opioid analgesics in non-malignant pain: Report of 38 cases. Pain, 25(2), 171e186. Raggi, A., Corso, B., Minicuci, N., Quintas, R., Sattin, D., De Torres, L., … Leonardi, M. (2016). Determinants of quality of life in ageing populations: Results from a crosssectional Study in Finland, Poland and Spain. PLoS One, 11(7). https://doi.org/ 10.1371/journal.pone.0159293. e0159293. Savolaine, J., & Granello, P. F. (2002). The function of meaning and purpose for individual wellness. Journal of Humanistic Counseling Education and Development, 41, 178e189. Sokol, D. (2013). ‘First do no harm’ revisited. Bmj: British Medical Journal, 347. Sullivan, M. D. (2017). The Patient As Agent of Health and Health Care. New York: Oxford University Press. Sullivan, M. D., & Ballantyne, J. C. (2016). Must we reduce pain intensity to treat chronic pain? Pain, 157(1), 65e69.
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Van Zee, A. (2009). The promotion and marketing of oxycontin: Commercial triumph, public health tragedy. American Jouranl of Public Health, 99(2), 221e227. Veatch, R. M. (1981). The theory of medical ethics. New York: Basic Books. Ventafridda, V., Saita, L., Ripamonti, C., & De Conno, F. (1985). WHO guidelines for the use of analgesics in cancer pain. International Journal of Tissue Reactions, 7(1), 93e96. Veterans Health Administration. (2003). Clinical practice guideline for the management of opioid therapy for chronic pain. Washington, DC: Department of Defense (Version 1.0). Wanzer, S. H., Federman, D. D., Adelstein, S. J., Cassel, C. K., Cassem, E. H., Cranford, R. E., … Cranford, R. E. (1989). The physician’s responsibility toward hopelessly ill patients. A second look. New England Journal of Medicine, 320(13), 844e849. West, J. E., Aronoff, G., Dahl, J., Johnson, S., Joranson, D. E., Koontz, W. W., … Toke, R. (1998). Model guidelines for the use of controlled substances for the treatment of pain. A policy document of the Federation of State Medical Boards of the United States Inc. Euless Texas: Federation of State Medical Boards of the United States Inc.
Is There a Duty to Relieve Pain? Mark D. Sullivan* and Jane Ballantynex, 1 *Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, United States x Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, United States 1 Corresponding author: E-mail: [email protected]
Contents 1. Introduction 1.1 Necessity 1.2 Expediency 2. What Do We Owe Patients With Chronic Pain? 2.1 A Diagnosis, a Cure 2.2 Pain Relief: No Pain, less Pain? 2.3 Pain Management: What Tools, What Goals? 2.4 Improved Function: What Kind, What Goals? 2.5 Improved Quality of Life: As Defined by Whom, and According to What Standard? 2.6 Pain as Innocent Suffering 2.7 Opioids as Pain-Specific Relief 3. Conclusion: What We Owe to Patients With Chronic Pain Acknowledgements References
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1. INTRODUCTION The foundations of medical ethics were laid out as early as the fifth century BC. Most famously, the Oath written by Hippocrates is sworn by new physicians in many countries to this day. Its fundamentals form the basis of medical ethics even where the oath is no longer formally sworn. In terms of provision of treatment, the key ethic principle is “I will use treatment to help the sick according to my ability and judgement, but never with a view to injury or wrong-doing” (Edelstein, 1943, p.56). Much later, in the 17th century, this was interpreted to mean “first do no harm”, although those exact words were not present in Hippocrates’ writing (Sokol, 2013). Nevertheless, the idea of not harming people through medical treatment has become increasingly central to medical ethics, as society has moved beyond the times when medicine could Developments in Neuroethics and Bioethics, Volume 1 ISSN 2589-2959 https://doi.org/10.1016/bs.dnb.2018.08.002
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palliate but not cure. Once medical treatments could cure and extend lifeda trend that accelerated rapidly after the discovery of antisepsis and anesthesia at the end of the 19th century that made complicated surgery survivabledthe relief of suffering, which had been so central to Hippocratic ethical practices, seemed overrun by the desire to cure, considered as the main route to relief of suffering. Pain relief per se was no longer the focus of medical treatment. At the same time, attitudes to opioid treatment of pain changed radically. Opioids had been a mainstay of medical treatment because there was not much else that could effectively treat pain and relieve many other distressing symptoms. Opioids could be bought at will from tradepeoples, pharmacies and doctors, to the limit of their cost and availability. At the beginning of the 20th century, in response to the post-Civil War laudanum and morphine epidemic, drug regulations were introduced into the United States and later into other Western democracies. People were no longer free to purchase opioids, the most powerful of analgesics, and use them for pain relief. Opioids could only be obtained through physicians, and physicians could lose their medical licences if they violated the spirit of the regulations. Not only were physicians afraid to prescribe opioids, they did not feel the need since they were focused more on disease control and less on palliation. By the latter part of the 20th century, pain, even pain at the end of life, was woefully undertreated. Correction was needed, and it was achieved through both necessity and expediency.
1.1 Necessity In 1985, the WHO (WHO) recognized that people were dying in unnecessary pain because drug regulations introduced at the beginning of the century had increased the stigma associated with opioid use. In response, the WHO published a simple protocol for treating pain at the end of life, usually associated with cancer (Ventafridda, Saita, Ripamonti, & De-Conno, 1985). This became known as the WHO stepladder. The model suggested initiating analgesia with simple analgesics, adding mild opioids when needed, and finally adding strong opioids, which could be titrated to effect. This simple model was very effective in validating opioid use at the end of life and in providing a roadmap that was useful to clinicians. Initiatives in individual countries were added to the WHO initiative to encourage better use of opioids at the end of life. In the US, one of the earliest attempts to produce evidence-based pain treatment guidelines was shepherded by the then Agency for Healthcare Policy Research (AHCPR), now the Agency for
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Healthcare Research and Quality (AHRQ), starting with acute pain guidelines (Carr, 1992), and two years later cancer pain guidelines (Jacox, Carr, & Payne, et al., 1994). Although these guidelines were broad-based, they provided strong support for the use of opioids for acute and cancer-related pain, and were mirrored by evidence-based pain treatment guidelines in other countries. Through these efforts, opioid use for short-lived pain was largely restored in the countries that had been affected by under-treatment of pain and underuse of opioids. Once this restoration of pain treatment had succeeded, the same advocates that had been successful in the realm of cancer pain treatment and opioid use for palliation turned their attention to chronic pain. They began to argue that suffering during chronic pain was as great as during cancer pain, and was equally deserving of opioid treatment (Portenoy & Foley, 1986). This argument had wide-reaching effects because it opened the door to the idea that opioids should be made available for the treatment of all severe pain, and that patients should have the right to receive opioids on demand (Joranson & Gilson, 1997). This movement coincided with changes in medical ethics from the tradition of paternalistic medicinedproducing good for the patient and protecting that patient from harmdto a philosophy of liberalism where public morality constrains and modifies medical ethics and the individual has autonomy and deserves protection of their civil liberties (Brennan, 1991; Veatch, 1981). Independent of pain treatment, the (Patient) Consumer Bill of Rights from the United States Advisory Commission on Consumer Protection and Quality in Healthcare (1998) emphasized that patients have the right to know their treatment options and to participate in decisions about their care. More specific to opioids and the promotion of the idea that they should be available for the treatment of any severe pain, statutes were written to protect physicians from censure if they were prescribed for the treatment of pain (Gilson & Joranson, 2002 Gilson, Maurer, & Joranson, 2005). The necessity to identify and treat pain crept into hospital mandates, and declarations from professional bodies stated the moral necessity to treat pain. For example, one intractable pain statute stated: Controlled substances and, in particular, narcotic analgesics, may be used in the treatment of pain experienced by a patient with a terminal illness or chronic disorder. These drugs have legitimate clinical use and the physician should not hesitate to prescribe, dispense, or administer them when they are indicated for a legitimate medical purpose. (Joranson & Gilson, 1997, as cited in; Ballantyne, 2007, p.134)
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Perhaps most significant was the declaration by the International Association for the Study of Pain (IASP), named the IASP Declaration of Montreal. This was not aimed at opioids per se, but at the idea that clinicians are morally bound to solicit and treat pain. The declaration states: .. recognizing the intrinsic dignity of all persons and that withholding of pain treatment is profoundly wrong, leading to unnecessary suffering which is harmful, we declare that the following human rights must be recognized throughout the world:
• The right of all people to have access to pain management without discrimination.
• The right of people in pain to acknowledgement of their pain and to be informed about how it can be assessed and managed.
• The right of all people with pain to have access to appropriate assessment and treatment of pain by adequately trained health care professionals (IASP, 2010)
1.2 Expediency At the end of the 20th century, there was not simply a moral initiative afoot regarding the necessity to treat pain. At the same time, the pharmaceutical industry became interested in promoting opioids for the treatment of more than just pain at the end of life, because newer extended release formulations of opioid medications were potentially profitable. Morphine had been used for centuries and was cheap to produce but carried a stigma because of its association with end-of-life care and was not particularly widely used or profitable. In contrast, the newer long-acting formulations of less familiar opioids such as oxycodone were ripe for promotion to those suffering and treating chronic pain, with chronic pain being much more widespread and long-lived than acute or end-of-life pain (VanZee, 2009). The disastrous effects of the promotional activities of the pharmaceutical industry on unfettered clinician prescribing are well documented (Kolodny et al., 2015). Although it is not possible to separate completely the effects of changes in clinical standards in pain management brought about by clinicians themselves from the effects of promotional activities by drug companies, there is no doubting what those promotional activities were, and that clinicians became involved in the marketing tactics. Pain patient advocacy groups, professional societies, the Joint Commission on Accreditation of Healthcare Organization (2001) pain standards and the Federations of State Medical Board’s model policy for opioid analgesics (West, et al., 1998), were
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dependent on funding from the pharmaceutical industry. Because some of the marketing was misleading and exaggerated the benefits while concealing the risks of opioids, the pharmaceutical industry and some individuals from the medical profession who had worked closely with the pharmaceutical industry, are now under intense scrutiny by politicians and lawyers (Parloff, 2018). This occurs most prominently in the US where overpromotion of opioids has led to an epidemic of opioid abuse and deaths (Paulozzi, Budnitz, & Xi, 2006; see also Kofi, Sud, & Buchman, this volume). Clinicians have been drawn into a legal and ethical quagmire because of misleading and in some cases, dishonest promotional activities. The fact that the pharmaceutical industry netted billions of dollars in profits from opioid sales, and passed some of those profits on to clinicians, does not help their cases now that they are under the microscope for their role in producing an opioid epidemic (Homeland Security and Governmental Affairs Committee, 2018). This is true of some individual physicians, and the professional societies that support them.
2. WHAT DO WE OWE PATIENTS WITH CHRONIC PAIN? If we examine this question systematically, it becomes clear that the answer is more complicated than it initially appears. There are a number of possible goals for care.
2.1 A Diagnosis, a Cure Patients with chronic pain very often present initially with the question: “what is causing my pain?”, and the request, “please fix the problem”. These are reasonable expectations of modern health care. These patients are quite frustrated when their requests for a diagnosis and a cure are turned aside by clinicians who can find no broken part or malfunctioning organ on physical exam or imaging tests. Patients are seduced easily by clinicians who point to bulging and degenerated discs on imaging tests as causes of back pain, despite the fact that many patients with no back pain have these findings (Carragee et al., 2006). The popular press still commonly includes advertisements promising rapid and easy diagnosis and cure of chronic pain. Nevertheless, the scientific literature supports the assertion that diagnosis and cure will not be possible for many of the most common forms of chronic pain such as back pain, neck pain, fibromyalgia, and chronic headache.
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2.2 Pain Relief: No Pain, less Pain? Once the patient has relinquished the search for a cure, the patient’s attention usually shifts to pain relief. If pain cannot be ended once and for all by removing its cause, can it be eliminated or reduced through medical treatment? Clinicians often caution patients with chronic pain that it is not possible to remove all their pain with current treatments. They try to get patients to accept less pain rather than no pain as their treatment goal. This is an important first step but it is inadequate. This is because this request for pain relief is often framed within some very specific assessment and treatment strategies. First, it is assumed that pain relief is provided through pain reduction. This pain reduction is assessed and quantified using the 0e10 numeric rating scale for pain intensity that is universally deployed throughout contemporary health care. Pain relief is commonly defined as a significant reduction in pain intensity, as either a percent reduction, such as 30% or reduction below a crucial threshold, below 4 on a 10-point scale (Veterans Health Administration, 2003). This approach to assess pain relief may be useful for acute pain in some circumstances, but its widespread use in chronic pain to assess need for treatment and response to treatment is flawed for multiple reasons. First, pain may be relieved through a change in its meaning rather than a change in intensity. For example, patients with cancer are often relieved when they learn their pain is due to treatment or concurrent illness, or anything other than progression of their cancer (Ersek & Ferrell, 1994). Second, it is now clear that what had been called the pain neuromatrix in the brain encodes pain salience and other attributes associated with pain in addition to pain intensity (Kucyi & Davis, 2015). The relevance of pain to the survival of the organism is the most important and valuable thing for the brain to monitor. This relevance is shaped by other threats and rewards for the organism and is not a direct product of the severity of injury or strength of nociception. If pain salience rather than pain intensity is the focus of our pain therapies, these therapies will look very different (Sullivan & Ballantyne, 2016).
2.3 Pain Management: What Tools, What Goals? The IASP Declaration of Montreal mentions the “right of all people have access to pain management without discrimination” (Cousins Lynch, 2011). Earlier versions of this Declaration mentioned a right pain relief, but this was changed since it is not possible to guarantee
to & to all
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patients pain relief (Cousins, Brennan, & Carr, 2004). A right for access to pain management is meant to be more flexible and accommodating of different types of pain problems and health care systems. However, it is not clear what “access to pain management” means and whether it captures what is most important to patients with chronic pain who are seeking care. At the most basic level, it is not clear what tools are included in this effort at pain management and what goals this effort aims at. We believe the intention of the Declaration is to provide more patients access to multidisciplinary pain care, but this is available to only a small fraction of patients with chronic pain coming from the most advanced economies and health systems. It is also not clear what goals this effort at pain management aims for: is the goal pain reduction, functional improvement, or a better quality of life? Who selects these goalsdpatients, providers, health systems, governments? The authors of the Declaration of Montreal have emphasized that they are not arguing for universal access to opioid therapy for chronic pain, but what concrete and feasible substitute should be provided is not clear (Cousins, 2012).
2.4 Improved Function: What Kind, What Goals? It has now become commonplace in the professional literature on chronic pain and in governmental policy on chronic pain to argue that the appropriate goal in chronic pain care is not reduced pain but improved function (Dworkin et al., 2008 Gewandter, et al., 2014). This is an improvement over a simple focus on pain reduction but leaves crucial questions unanswered. First, what kind of function is the goal? There are many possible kinds of patient function: physical function such as the ability to lift and climb stairs, social function such as the ability to relate to others, manage interpersonal conflicts, role function and the ability to meet expectations as a parent, spouse, a breadwinner, cognitive function and the ability to decide and remember, and emotional function including the ability to manage emotional distress and remain hopeful (Karayannis, Sturgeon, Chih-Kao, Cooley, & Mackey, 2017). Second, it is not clear that patients consider themselves as having functions (Savolaine & Granello, 2002). For example, my own kidneys have a function in my body, but I do not consider myself as having a function, except when considered as part of a larger whole like a family or a workplace. Persons have purposes rather than functions. These purposes are chosen by the persons themselves and are infinitely various (Gardner, et al., 2016).
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2.5 Improved Quality of Life: As Defined by Whom, and According to What Standard? A focus on function in chronic pain care, which usually means physical function, can be criticized as neglecting the aversive pain experience. Patients do not like pain at least partly because it feels bad (Navratilova & Porreca, 2014). This aversive experience affects a patient’s quality of life, as does any functional impairment produced by chronic pain. Quality of life is a more comprehensive and patient-centred goal for chronic pain care than functional status. Although it captures more of what is important to patients, it is more complex and difficult to achieve. Quality of life, even in those with chronic illness, is determined by many factors other than health and health care. For example, quality of life may be defined by quality of relationships and neighbourhood, level of income and education, and employment situation (Raggi, et al., 2016). If function and purpose vary greatly from patient to patient, quality of life and its determinants show even more variability among persons. Not only do the determinants of quality of life vary, the standards defining an adequate quality of life vary greatly. What would constitute an adequate quality of life in a low-income country where daily income averages a few dollars a day is very different from what might be considered an adequate quality of life in a high-income country. As we have moved through this list of possible goals for chronic pain care, we have moved from the simple to the complex and from the grossly incomplete to the more complete. The former is easier to operationalize but misdirect care in some important ways. The latter comes closer to the comprehensive goals we want but are difficult to operationalize and achieve through health care.
2.6 Pain as Innocent Suffering Clinicians tend to privilege pain as a form of physical suffering for which the patient is not responsible. On the model of acute pain and disease, patients usually consider chronic pain to be innocent suffering: “I did nothing to bring this on myself.” This stands in contrast to addiction, which may involve the voluntary ingestion of licit or illicit drugs. Chronic pain also stands in contrast to depression, which can include the taint of laziness and willful neglect of one’s duties and one’s self. Chronic pain also stands in contrast to stress, where some consider a lack of strength and resilience as an indicator of weakness.
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We must ask why, as a society, we speak of a right to pain relief but not a right to depression or anxiety or suffering relief. As authors, we propose that this is because pain is the most medical of aversive experiences, pointing toward injury or illness that could have befallen anyone. Pain is classically considered more urgent and more essential than nausea, dizziness, fatigue, dyspnea, or weakness. In the philosophy of the Enlightenment, for example, pain was used as a concept to cover all the aversive and unfortunate experiences in life. Jeremy Bentham, the father of the utilitarian approach to social policy, said: “[n]ature has placed mankind under the governance of two sovereign masters, pain and pleasure. It is for them alone to point out what we ought to do, as well as to determine what we shall do” (Bentham, 1789, p.1). Pain is the essence of misfortune and must be reduced.
2.7 Opioids as Pain-Specific Relief Parallel and corollary to this innocent suffering of pain is a form of pain-specific relief, opioids. Physicians prescribe opioids to kill the pain and leave the person alone. As our patients often say to us, “don’t give me any of your mind-altering drugs, just take away my pain!” This assumes we can take away all of a patient’s pain and not alter who they are as a person. The implication is that chronic pain is not necessary or beneficial and should be removed however possible. This might sound like an extreme view, but echoes of this can be found in the medical literature. This occurred first with the treatment of pain at the end of life. As justifications for allowing patients to die in pain were considered invalid, the following argument was made: “[t]he proper dose of pain medication is the dose that is sufficient to relieve pain and suffering. To allow a patient to experience unbearable pain or suffering is unethical medical practice” (Wanzer, et al., 1989). This principle was gradually extended from end of life care, to cancer pain care, and then to chronic non-cancer pain care. It is echoed in the pleas of chronic pain patients to their prescribers: don’t you believe I am in pain? Don’t you think I deserve relief? Titrating opioid doses to a pain level may simultaneously reduce pain and make it harder for a patient to live his or her life by producing sedation or confusion or addiction. Pain reduction and quality of life reduction can both occur with opioid therapy. There is increasing recognition of this fact. For example, the new standards issued by The Joint Commission (2017) concerning management of pain within the hospital sets a new criterion of adequacy. These new standards state that the adequacy of pain relief
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should be determined in terms of adequacy of function. Zero pain is not the goal. Many of the ethical quandaries in pain management end up being quandaries directly related to opioid use. Since, through their respiratory depressant effects, opioids can hasten death, the issue of whether potentially lethal doses of opioids should be used to relieve suffering at the end of life presents challenging and continuing ethical debate. Although addiction issues may seem of a lesser magnitude than preservation of life, the fact that addiction destroys lives interferes significantly with the duty to treat pain. Because opioids are invaluable for the treatment of severe pain at the end of life, their use is conflated with the duty to treat non-cancer pain, yet their ability to destroy lives conflicts with that duty. This conflict in duty comes into sharp focus when considering the profit that can be made from selling or prescribing opioids. Trading in addictive substances is profitable for obvious reasons. Many laws and regulations have been instituted to control trade and usage of addictive substances so that it does not get out of hand or have a pervasive effect on society. While the pharmaceutical industry may have complied with the existing laws and with regulations, their role in the current North American epidemic of opioid-related morbidity and mortality is under scrutiny. The industry’s marketing tactics, which succeeded in grossing enormous profits, involved overplaying the ‘duty to treat pain’ card, and misleading prescribers and patients about the known limitations and risks of opioids (Homeland Security and Governmental Affairs Committee, 2018; Kolodny, et al., 2015 Parloff, 2018).
3. CONCLUSION: WHAT WE OWE TO PATIENTS WITH CHRONIC PAIN Our foremost duty to patients with chronic pain is not to simply reduce their pain intensity, but to improve their health. This consists of increasing the capacity of patients to be agents in their own lives (Sullivan, 2017). We seek to provide patients with the capability to move their lives forward again. This means the ability to pursue their passions in work or play. It means the ability to form and sustain relationships. It means the ability to carve one’s own environmental niche in the complex natural and social environment that is human society. When our most valuable analgesic erodes that ability, it is time to rethink what duty to relieve pain actually means.
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ACKNOWLEDGEMENTS Mark D. Sullivan has provided consultation to Aetna and Chrono Therapeutics, received research grants from Pfizer and Purdue Pharma L.P., and was an expert witness for the State of Washington. Jane Ballantyne does not report any conflicts of interest.
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Van Zee, A. (2009). The promotion and marketing of oxycontin: Commercial triumph, public health tragedy. American Jouranl of Public Health, 99(2), 221e227. Veatch, R. M. (1981). The theory of medical ethics. New York: Basic Books. Ventafridda, V., Saita, L., Ripamonti, C., & De Conno, F. (1985). WHO guidelines for the use of analgesics in cancer pain. International Journal of Tissue Reactions, 7(1), 93e96. Veterans Health Administration. (2003). Clinical practice guideline for the management of opioid therapy for chronic pain. Washington, DC: Department of Defense (Version 1.0). Wanzer, S. H., Federman, D. D., Adelstein, S. J., Cassel, C. K., Cassem, E. H., Cranford, R. E., … Cranford, R. E. (1989). The physician’s responsibility toward hopelessly ill patients. A second look. New England Journal of Medicine, 320(13), 844e849. West, J. E., Aronoff, G., Dahl, J., Johnson, S., Joranson, D. E., Koontz, W. W., … Toke, R. (1998). Model guidelines for the use of controlled substances for the treatment of pain. A policy document of the Federation of State Medical Boards of the United States Inc. Euless Texas: Federation of State Medical Boards of the United States Inc.