EDITORIAL For reprint orders, please contact: [email protected]
The war on drugs versus the war on pain: surviving two perfect storms
“Rogue physician prescribers and drug-seeking individuals who pose as pain patients are a distinct and insular minority of the population.” Ben A Rich* Images of the proverbial swinging pendulum abound in current discussions of the state of pain management. There are many who would have us believe that over the last 20 years we have gone, quite simply, from an epidemic of undertreated pain and its resultant public health problem of worldwide magnitude, to its polar opposite, an epidemic of overprescribing and, as a consequence, a major public health crisis of prescription drug abuse and overdose deaths, particularly in the USA. An alternative view, bleaker, but more consistent with existing data, is that we now have the worst of both worlds or, in contemporary parlance, the concurrence of two ‘perfect storms’, that is, a continuing epidemic of undertreated pain and, in some countries, such as the USA, a more recent epidemic of prescription drug abuse and overdose deaths. If this assessment is accurate, then an ethically and clinically sound public policy response will not discount or disfavor one crisis in order to obsessively focus upon the other. Rather, the overarching philosophy of an enlightened public health policy on pain management will strive to achieve balance between the dual and potentially, but not necessarily, conflicting goals of insuring effective pain relief for patients in need, while minimizing the risk
of prescription drug abuse, addiction, diversion or overdose. In the language of a recent WHO publication: “All countries have a dual obligation with regard to these medicines (controlled substances) based on legal, political, public health and moral grounds. The dual obligation is to ensure that these substances are available for medical purposes and to protect populations against abuse and dependence. Countries should aim at a policy that ultimately achieves both objectives, in other words, a balanced policy” [1]. Let us first endeavor to put to rest the simplistic notion that underprescribing of opioids could not persist in an era of escalating prescription drug abuse. The 2011 Institute of Medicine report, ‘Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research’, confirms in great depth and detail that undertreated pain remains a major problem [2]. Similarly, one of the seminal articles documenting that undertreatment of pain was a problem even for cancer patients appeared in 1994 [3]. In 2011, an article updating that much earlier study found that knowledge deficits and failure to follow existing pain management guidelines continue to be pervasive and problematic for cancer patients [4].
“...knowledge deficits and failure
to follow existing pain management guidelines continue to be pervasive and problematic for cancer patients.”
part of
*School of Medicine, University of California, Davis, CA, USA; [email protected]
10.2217/PMT.12.52 © 2012 Future Medicine Ltd
Pain Manage. (2012) 2(6), 523–526
ISSN 1758-1869
523
EDITORIAL Rich
“...chronic pain patients are stigmatized as being much more prone to addiction or abuse of prescription pain medications.”
524
At the international level, testimony to the continuing problem of undertreated pain appeared in the 2010 Declaration of Montreal, produced by the delegates to the International Pain Summit of the International Association for the Study of Pain. Among the findings of the summit are that pain of all types is inadequately treated, major knowledge deficits among healthcare professionals about pain and its relief persist, and chronic pain in particular is highly stigmatized [101]. Despite the weight and authority of the evidence above, a review of the recent reaction and response in the political and health policy arena in the USA has been anything but balanced. For example, a bill was introduced in the 112th Congress of the USA (2011–2012), actually a reintroduction of the bill from the previous Congress, with the title ‘Stop Oxy Abuse Act of 2011’. The legislation, if passed, would direct the Commissioner of the US FDA to take such action as may be necessary to modify the approval of any medication containing controlled release oxycodone (e.g., OxyContin®), so as to limit its approved use only to the relief of severe pain rather than, as previously, moderate-to-severe pain [102]. The bill was introduced by Congresswoman Mary Bono Mack, who asserted that the drug OxyContin, the primary target of the proposed legislation, “was intended to be prescribed only for severe pain as a way to help patients dealing with late-stage cancer and other severe illnesses” [103]. However, in 2002, the FDA Director of the Office of New Drugs testified before a committee of the US Senate that, in 1995, OxyContin had been approved for the treatment of moderate-to-severe chronic pain, and in continuing to exercise regulatory oversight the FDA’s goal was to “decrease misuse and abuse of this product while assuring that this drug is used properly and remains available for patients who suffer daily from chronic moderate-to-severe pain” [104]. At the state level, Washington has rushed to the forefront of policies and guidelines that maintain that responsible opioid prescribing for chronic pain patients requires consultation with a subspecialist in pain medicine for any patient who requires more than 120 mg/day of an opioid. This and other stringent constraints on the prescribing of opioids by nonspecialist physicians were implemented by legislative mandate in the form of rules promulgated by the Washington State Medical Quality Assurance Commission [105]. These regulations do not apply to prescribing for acute pain or pain associated with terminal illness. By
Pain Manage. (2012) 2(6)
implication, chronic pain patients are stigmatized as being much more prone to addiction or abuse of prescription pain medications. At the same time as these regulations were coming online, a number of clinics in Washington advised their chronic pain patients that they would no longer provide medications, which heretofore had been effective in, and in some instances essential to, managing their pain, thereby enabling them to maintain function and an acceptable quality of life [106]. Other states are watching the clinical and political sequelae of the Washington initiative and may well adopt similar mandatory regulatory constraints on the care of patients with chronic noncancer pain. The sense that we are marching backward in time in the management of chronic pain is further evidenced by an article recently published in a journal widely read by primary care physicians. Because of the risks of overdose, dependency and diversion, the author advocates that unless and until an objective measurement of pain can be developed, a new standard of care should be adopted requiring findings – by means of physical examination or diagnostic studies – of objective evidence of severe disease before opioid analgesics could be prescribed [5]. The elusive and unproductive search for lesions that would objectively validate a patient’s report of pain was ultimately abandoned as we came to understand that there are chronic pain syndromes that arise or persist in the absence of physical findings that would fully explain, and hence justify, the patient’s experience of pain. Ultimately and inevitably, pain of all types is a subjective experience and consequently in the parlance of one prominent pain medicine educator and practitioner, “pain is an untestable hypothesis” [6]. The rigid insistence upon concrete physical findings as a condition precedent to the prescribing of opioid analgesics for all patients with chronic pain will subject some individuals to unnecessary suffering and dysfunction far out of proportion to the risks of the medication. The final area of concern on which we should focus in this discussion is the recently launched investigation by the US Senate Finance Committee. Apparently responding to a series of articles from the online investigative journalism enterprise ProPublica entitled ‘Dollars for Docs’, the Finance Committee sent letters under the signature of Senators Baucus and Grassley to the manufacturers of some of the most widely prescribed opioid analgesics, and a number of organizations and individuals that have advocated for their use in the care of patients with
future science group
The war on drugs versus the war on pain: surviving two perfect storms pain. Included among the organizations receiving these letters were the American Pain Foundation (which has ceased operations), the American Academy of Pain Medicine and the American Pain Society (two of the most prominent organizations in the pain management field), the Pain and Policy Studies Group of the University of Wisconsin (A World Health Organization Collaborating Center for Pain for Pain Policy and Palliative Care), the Joint Commission (the major accrediting body for hospitals in the USA), the Federation of State Medical Boards and the Center for Practical Bioethics. The letters request payment information dating from 1997 to ten groups and eight individuals [107]. The implication of this investigation is that any support by the pharmaceutical industry of organizational or individual efforts to improve the care of patients with pain, even in the form of unrestricted grants, calls into question the need for or the legitimacy of the effort, regardless of the reputation or professional standing of the party involved. For example, in 1999 the Joint Commission published standards for the assessment and management of pain that all healthcare facilities would be required to meet by 2001 in order to secure or maintain accreditation [7]. Apparently thereafter, the Commission received financial support for the development of educational materials on pain management. Similarly, the inclusion of the Federation of State Medical Boards in the Finance Committee’s investigation was triggered by its widely distributed publication ‘Responsible Opioid Prescribing – A Clinician’s Guide’, which was an effort to provide more detailed guidance on how prescribing physicians might consistently follow its model policy for the Use of Controlled Substances for the Treatment of Pain [8]. The irony of the inclusion of organizations such as the Joint Commission and the Federation References 1
2
3
WHO. Ensuring Balance in National Policies on Controlled Substances – Guidance for Availability and Accessibility. WHO Press, Geneva, Switzerland (2011). Institute of Medicine. Relieving Pain in America: A Blueprint for Transforming Prevention Care, Education, and Research. The National Academies Press, Washington DC, USA (2011). Cleeland CS, Gonin R, Hatfield AK et al. Pain and its treatment in outpatients with
future science group
of State Medical Boards in the Finance Committee’s dragnet is that both had been widely praised for recognizing that widespread myths, misinformation, ignorance and fear had been at the root of the epidemic of undertreated pain in the USA [9]. By including pain management in the accreditation standards of the Joint Commission, and developing and disseminating a model policy that clearly stated that effective pain management was an essential element of quality patient care, there was increased optimism that clinicians would be educated and empowered to competently and compassionately address pain in their patients. With the convergence of these two perfect storms, the politics of pain management has become more contentious than ever before. As a society already terribly divided between liberal and conservative world views on a host of critical issues, the last thing we need is further polarization and demonizing of those who are genuinely seeking to serve all patients – those with severe pain of any type and those afflicted with substance abuse. Rogue physician prescribers and drug-seeking individuals who pose as pain patients are a distinct and insular minority of the population. Dealing appropriately and effectively with these malefactors need not and should not interfere with physicians seeking to care for patients with pain.
“With the convergence of these two perfect storms, the politics of pain management has become more contentious than ever before.”
Financial & competing interests disclosure The author has received honoraria for consulting work from KOL, LLC within the last 3 years. From 2008 to 2010, he served on the Board of Directors of the American Pain Foundation. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript. metastatic cancer. N. Engl. J. Med. 330, 592–596 (1994).
4
EDITORIAL
Breuer B, Fleishman SB, Cruciani RA, Portenoy RK. Medical oncologists’ attitudes and practices in cancer pain management: a national survey. J. Clin. Oncol. 29, 4769–4775 (2011).
5
Zweifler JA. Objective evidence of severe disease: opioid use in chronic pain. Ann. Fam. Med. 10, 366–368 (2012).
6
Fishman SM. Opioid-based multi-modal care of patients with chronic pain: improving
effectiveness and mitigating risks. Pain Med. 10, S49–S52 (2009). 7
Berry PH, Dahl JL. The new JCAHO pain standards: implications for pain management nurses. Pain Manag. Nurs. 1, 3–12 (2000).
8
Fishman SM. Responsible Opioid Prescribing – A Clinician’s Guide. Waterford Life Sciences (2nd Edition). Washington DC, USA (2012).
9
Rich BA. An ethical analysis of the barriers to effective pain management. Camb. Q. Healthc. Ethics 9, 54–70 (2000).
www.futuremedicine.com
525
EDITORIAL Rich 103 Mack MB. Bipartisan coalition introduces
Websites 101 Declaration of Montreal (2010). International
Association for the Study of Pain, Seattle, WA, USA. www.iasppain.org/AM/Template. cfm?Section=Declaration_of_ MontrandNum233_al (Accessed 12 July 2012) 102 HR 1316. Stop Oxy Abuse Act of 2011.
www.gpo.gov/fdsys/pkg/BILLS-112hr1316ih/ pdf/BILLS-112hr1316ih.pdf (Accessed 12 July 2012)
526
legislation to curb narcotic painkillers. http://bono.house.gov/news/documentsingle. aspx?DocumentID=233737 (Accessed 12 July 2012) 104 Statement by John K. Jenkins. OxyContin:
balancing risks and benefits. Senate Committee on Health, Education, Labor, and Pensions. www.fda.gov/NewsEvents/Testimony/ ucm115180.htm (Accessed 12 July 2012) 105 Washington Administrative Code §
246-919-450 to 246-919-86.3. http://apps.leg.wa.gov/WAC/default. aspx?dispo=true&cite=246–919 (Accessed 15 July 2012)
Pain Manage. (2012) 2(6)
106 Ornstein C, Weber T. American Pain
Foundation shuts down as senators launch investigation of prescription narcotics. ProPublica. www.propublica.org/article/senate-panelinvestigates-drug-company-ties-to-paingroups (Accessed 15 July 2012) 107 Murphy P. Washington state pain
management law will take effect soon. KUOW Broadcast News Transcript. www.kuow.org/program.php?id=23774 (Accessed 15 July 2012)
future science group
The war on drugs versus the war on pain: surviving two perfect storms
“Rogue physician prescribers and drug-seeking individuals who pose as pain patients are a distinct and insular minority of the population.” Ben A Rich* Images of the proverbial swinging pendulum abound in current discussions of the state of pain management. There are many who would have us believe that over the last 20 years we have gone, quite simply, from an epidemic of undertreated pain and its resultant public health problem of worldwide magnitude, to its polar opposite, an epidemic of overprescribing and, as a consequence, a major public health crisis of prescription drug abuse and overdose deaths, particularly in the USA. An alternative view, bleaker, but more consistent with existing data, is that we now have the worst of both worlds or, in contemporary parlance, the concurrence of two ‘perfect storms’, that is, a continuing epidemic of undertreated pain and, in some countries, such as the USA, a more recent epidemic of prescription drug abuse and overdose deaths. If this assessment is accurate, then an ethically and clinically sound public policy response will not discount or disfavor one crisis in order to obsessively focus upon the other. Rather, the overarching philosophy of an enlightened public health policy on pain management will strive to achieve balance between the dual and potentially, but not necessarily, conflicting goals of insuring effective pain relief for patients in need, while minimizing the risk
of prescription drug abuse, addiction, diversion or overdose. In the language of a recent WHO publication: “All countries have a dual obligation with regard to these medicines (controlled substances) based on legal, political, public health and moral grounds. The dual obligation is to ensure that these substances are available for medical purposes and to protect populations against abuse and dependence. Countries should aim at a policy that ultimately achieves both objectives, in other words, a balanced policy” [1]. Let us first endeavor to put to rest the simplistic notion that underprescribing of opioids could not persist in an era of escalating prescription drug abuse. The 2011 Institute of Medicine report, ‘Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research’, confirms in great depth and detail that undertreated pain remains a major problem [2]. Similarly, one of the seminal articles documenting that undertreatment of pain was a problem even for cancer patients appeared in 1994 [3]. In 2011, an article updating that much earlier study found that knowledge deficits and failure to follow existing pain management guidelines continue to be pervasive and problematic for cancer patients [4].
“...knowledge deficits and failure
to follow existing pain management guidelines continue to be pervasive and problematic for cancer patients.”
part of
*School of Medicine, University of California, Davis, CA, USA; [email protected]
10.2217/PMT.12.52 © 2012 Future Medicine Ltd
Pain Manage. (2012) 2(6), 523–526
ISSN 1758-1869
523
EDITORIAL Rich
“...chronic pain patients are stigmatized as being much more prone to addiction or abuse of prescription pain medications.”
524
At the international level, testimony to the continuing problem of undertreated pain appeared in the 2010 Declaration of Montreal, produced by the delegates to the International Pain Summit of the International Association for the Study of Pain. Among the findings of the summit are that pain of all types is inadequately treated, major knowledge deficits among healthcare professionals about pain and its relief persist, and chronic pain in particular is highly stigmatized [101]. Despite the weight and authority of the evidence above, a review of the recent reaction and response in the political and health policy arena in the USA has been anything but balanced. For example, a bill was introduced in the 112th Congress of the USA (2011–2012), actually a reintroduction of the bill from the previous Congress, with the title ‘Stop Oxy Abuse Act of 2011’. The legislation, if passed, would direct the Commissioner of the US FDA to take such action as may be necessary to modify the approval of any medication containing controlled release oxycodone (e.g., OxyContin®), so as to limit its approved use only to the relief of severe pain rather than, as previously, moderate-to-severe pain [102]. The bill was introduced by Congresswoman Mary Bono Mack, who asserted that the drug OxyContin, the primary target of the proposed legislation, “was intended to be prescribed only for severe pain as a way to help patients dealing with late-stage cancer and other severe illnesses” [103]. However, in 2002, the FDA Director of the Office of New Drugs testified before a committee of the US Senate that, in 1995, OxyContin had been approved for the treatment of moderate-to-severe chronic pain, and in continuing to exercise regulatory oversight the FDA’s goal was to “decrease misuse and abuse of this product while assuring that this drug is used properly and remains available for patients who suffer daily from chronic moderate-to-severe pain” [104]. At the state level, Washington has rushed to the forefront of policies and guidelines that maintain that responsible opioid prescribing for chronic pain patients requires consultation with a subspecialist in pain medicine for any patient who requires more than 120 mg/day of an opioid. This and other stringent constraints on the prescribing of opioids by nonspecialist physicians were implemented by legislative mandate in the form of rules promulgated by the Washington State Medical Quality Assurance Commission [105]. These regulations do not apply to prescribing for acute pain or pain associated with terminal illness. By
Pain Manage. (2012) 2(6)
implication, chronic pain patients are stigmatized as being much more prone to addiction or abuse of prescription pain medications. At the same time as these regulations were coming online, a number of clinics in Washington advised their chronic pain patients that they would no longer provide medications, which heretofore had been effective in, and in some instances essential to, managing their pain, thereby enabling them to maintain function and an acceptable quality of life [106]. Other states are watching the clinical and political sequelae of the Washington initiative and may well adopt similar mandatory regulatory constraints on the care of patients with chronic noncancer pain. The sense that we are marching backward in time in the management of chronic pain is further evidenced by an article recently published in a journal widely read by primary care physicians. Because of the risks of overdose, dependency and diversion, the author advocates that unless and until an objective measurement of pain can be developed, a new standard of care should be adopted requiring findings – by means of physical examination or diagnostic studies – of objective evidence of severe disease before opioid analgesics could be prescribed [5]. The elusive and unproductive search for lesions that would objectively validate a patient’s report of pain was ultimately abandoned as we came to understand that there are chronic pain syndromes that arise or persist in the absence of physical findings that would fully explain, and hence justify, the patient’s experience of pain. Ultimately and inevitably, pain of all types is a subjective experience and consequently in the parlance of one prominent pain medicine educator and practitioner, “pain is an untestable hypothesis” [6]. The rigid insistence upon concrete physical findings as a condition precedent to the prescribing of opioid analgesics for all patients with chronic pain will subject some individuals to unnecessary suffering and dysfunction far out of proportion to the risks of the medication. The final area of concern on which we should focus in this discussion is the recently launched investigation by the US Senate Finance Committee. Apparently responding to a series of articles from the online investigative journalism enterprise ProPublica entitled ‘Dollars for Docs’, the Finance Committee sent letters under the signature of Senators Baucus and Grassley to the manufacturers of some of the most widely prescribed opioid analgesics, and a number of organizations and individuals that have advocated for their use in the care of patients with
future science group
The war on drugs versus the war on pain: surviving two perfect storms pain. Included among the organizations receiving these letters were the American Pain Foundation (which has ceased operations), the American Academy of Pain Medicine and the American Pain Society (two of the most prominent organizations in the pain management field), the Pain and Policy Studies Group of the University of Wisconsin (A World Health Organization Collaborating Center for Pain for Pain Policy and Palliative Care), the Joint Commission (the major accrediting body for hospitals in the USA), the Federation of State Medical Boards and the Center for Practical Bioethics. The letters request payment information dating from 1997 to ten groups and eight individuals [107]. The implication of this investigation is that any support by the pharmaceutical industry of organizational or individual efforts to improve the care of patients with pain, even in the form of unrestricted grants, calls into question the need for or the legitimacy of the effort, regardless of the reputation or professional standing of the party involved. For example, in 1999 the Joint Commission published standards for the assessment and management of pain that all healthcare facilities would be required to meet by 2001 in order to secure or maintain accreditation [7]. Apparently thereafter, the Commission received financial support for the development of educational materials on pain management. Similarly, the inclusion of the Federation of State Medical Boards in the Finance Committee’s investigation was triggered by its widely distributed publication ‘Responsible Opioid Prescribing – A Clinician’s Guide’, which was an effort to provide more detailed guidance on how prescribing physicians might consistently follow its model policy for the Use of Controlled Substances for the Treatment of Pain [8]. The irony of the inclusion of organizations such as the Joint Commission and the Federation References 1
2
3
WHO. Ensuring Balance in National Policies on Controlled Substances – Guidance for Availability and Accessibility. WHO Press, Geneva, Switzerland (2011). Institute of Medicine. Relieving Pain in America: A Blueprint for Transforming Prevention Care, Education, and Research. The National Academies Press, Washington DC, USA (2011). Cleeland CS, Gonin R, Hatfield AK et al. Pain and its treatment in outpatients with
future science group
of State Medical Boards in the Finance Committee’s dragnet is that both had been widely praised for recognizing that widespread myths, misinformation, ignorance and fear had been at the root of the epidemic of undertreated pain in the USA [9]. By including pain management in the accreditation standards of the Joint Commission, and developing and disseminating a model policy that clearly stated that effective pain management was an essential element of quality patient care, there was increased optimism that clinicians would be educated and empowered to competently and compassionately address pain in their patients. With the convergence of these two perfect storms, the politics of pain management has become more contentious than ever before. As a society already terribly divided between liberal and conservative world views on a host of critical issues, the last thing we need is further polarization and demonizing of those who are genuinely seeking to serve all patients – those with severe pain of any type and those afflicted with substance abuse. Rogue physician prescribers and drug-seeking individuals who pose as pain patients are a distinct and insular minority of the population. Dealing appropriately and effectively with these malefactors need not and should not interfere with physicians seeking to care for patients with pain.
“With the convergence of these two perfect storms, the politics of pain management has become more contentious than ever before.”
Financial & competing interests disclosure The author has received honoraria for consulting work from KOL, LLC within the last 3 years. From 2008 to 2010, he served on the Board of Directors of the American Pain Foundation. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript. metastatic cancer. N. Engl. J. Med. 330, 592–596 (1994).
4
EDITORIAL
Breuer B, Fleishman SB, Cruciani RA, Portenoy RK. Medical oncologists’ attitudes and practices in cancer pain management: a national survey. J. Clin. Oncol. 29, 4769–4775 (2011).
5
Zweifler JA. Objective evidence of severe disease: opioid use in chronic pain. Ann. Fam. Med. 10, 366–368 (2012).
6
Fishman SM. Opioid-based multi-modal care of patients with chronic pain: improving
effectiveness and mitigating risks. Pain Med. 10, S49–S52 (2009). 7
Berry PH, Dahl JL. The new JCAHO pain standards: implications for pain management nurses. Pain Manag. Nurs. 1, 3–12 (2000).
8
Fishman SM. Responsible Opioid Prescribing – A Clinician’s Guide. Waterford Life Sciences (2nd Edition). Washington DC, USA (2012).
9
Rich BA. An ethical analysis of the barriers to effective pain management. Camb. Q. Healthc. Ethics 9, 54–70 (2000).
www.futuremedicine.com
525
EDITORIAL Rich 103 Mack MB. Bipartisan coalition introduces
Websites 101 Declaration of Montreal (2010). International
Association for the Study of Pain, Seattle, WA, USA. www.iasppain.org/AM/Template. cfm?Section=Declaration_of_ MontrandNum233_al (Accessed 12 July 2012) 102 HR 1316. Stop Oxy Abuse Act of 2011.
www.gpo.gov/fdsys/pkg/BILLS-112hr1316ih/ pdf/BILLS-112hr1316ih.pdf (Accessed 12 July 2012)
526
legislation to curb narcotic painkillers. http://bono.house.gov/news/documentsingle. aspx?DocumentID=233737 (Accessed 12 July 2012) 104 Statement by John K. Jenkins. OxyContin:
balancing risks and benefits. Senate Committee on Health, Education, Labor, and Pensions. www.fda.gov/NewsEvents/Testimony/ ucm115180.htm (Accessed 12 July 2012) 105 Washington Administrative Code §
246-919-450 to 246-919-86.3. http://apps.leg.wa.gov/WAC/default. aspx?dispo=true&cite=246–919 (Accessed 15 July 2012)
Pain Manage. (2012) 2(6)
106 Ornstein C, Weber T. American Pain
Foundation shuts down as senators launch investigation of prescription narcotics. ProPublica. www.propublica.org/article/senate-panelinvestigates-drug-company-ties-to-paingroups (Accessed 15 July 2012) 107 Murphy P. Washington state pain
management law will take effect soon. KUOW Broadcast News Transcript. www.kuow.org/program.php?id=23774 (Accessed 15 July 2012)
future science group
