We welcome guest blogger Dr. Stephen E. Nadeau, Senior Research Advisor, Alliance for the Treatment of Intractable Pain. Dr. Nadeau agreed to share his response to The Oregon Pain Guidance Clinical Advisory Group, Tapering Workgroup*. For more context, the Advisory group recently posted a set of guidelines for tapering opioid doses in patients with chronic nonmalignant pain who have been receiving long-term treatment with opioid analgesics. These recommendations were specifically designed to be utilized by clinicians throughout the state of Oregon and are available HERE. Of note, opioid tapering or abrupt cessation of opioids was covered on paindr.com in a previous post, If you are forced to stop opioids.
*The Workgroup and contributors include Jane Ballantyne, Roger Chou, Paul Coelho, Ruben Halperin, Andrew Kolodny, Anna Lembke, Jim Shames, Mark Stephens, and David Tauben.
Thank you, Dr. Nadeau, for your patient advocacy and response letter as it appears below.
Ballantyne and colleagues, in their recent article, “Tapering – Guidance and Tools” (https://www.oregonpainguidance.org/guideline/tapering/), make the implicit assumption that tapering of opioid regimens in patients with chronic nonmalignant pain is a desirable thing – this, despite the evidence that the cost of chronic pain to American society, based upon health care expenditures and cost of lost productivity, is $560-635 billion/year (1); the evidence from randomized controlled trials employing designs that replicate good clinical practice that opioids are highly effective in the treatment of nonmalignant pain (2-6); the evidence that this beneficial effect can be sustained for years (7-9); and the evidence that the annual case fatality rate associated with chronic opioid treatment of pain is 0.08% with dosage of <200 mg morphine equivalent/day (MMED) (10), 0.25%/year with dosage of >100 MMED (11), and 0.5%/year with dosage >400 MMED (10). The latter two case-fatality rates are quite comparable to the risks of fatal bleeding associated with use of rivaroxaban (0.2%/year) and warfarin (0.5%/year) in the prophylaxis of stroke due to atrial fibrillation (12). Given the extreme impact of chronic pain on a patient’s life, this small risk is likely to be acceptable to nearly all. Ballantyne et al. state “it is widely recognized that prolonged continuous high dose opioid pain treatment is neither effective nor safe for the majority of patients.” “Widely misperceived” would be more accurate, as these claims are not supported by scientific evidence.
The authors also seem to suggest that, because the CDC recommended an upper limit of 90 MMED (13), doses above this level must be fraught with unacceptable risk. This CDC recommendation ignores the case-fatality data presented above and it further makes the assumption that “one dose fits all.” Data from randomized controlled trials that have adequately titrated opioid dosage suggest 13-fold variability in dose requirements (2, 4), variability that can be attributed to differences in pain intensity, genetic differences in hepatic metabolism (14), and genetic differences in central nervous system nociceptive signal transduction (15).
The authors seem to further justify their tapering recommendations with the statement that “overdose rates continue to be high compared to historical standard.” No question, but it is critical to ask, “Why is this?” Despite draconian reductions in prescription opioid dosage, mortality from prescription opioids has remained static at about 17,000/year since 2012. However, deaths from illicit opioids, overwhelmingly heroin and illicit fentanyl in variable combinations, have risen from 7,000 in 2011 to approximately 30,000 in 2017 (CDC data). Richard Lawhern, PhD, has shown, using state by state data on CDC websites readily available to all, that the correlation between number of opioid prescriptions/100 persons and mortality rate is 0.05. The very idea that constraining prescription opioids in the clinic is somehow going to solve the still- growing crisis in the streets begs credulity.
I welcome the authors’ emphasis on balancing the risks of opioid treatment of chronic pain against its benefits. However, a judicious weighing of this balance must also take into account the overwhelming impact of chronic, inadequately-controlled pain on people’s lives. This reality must be fully appreciated, along with inter-individual variability in dose requirements, the modest risks of chronic opioid therapy, even in substantial dosage, and the patient’s vital input on the adequacy of pain control.
The most essential strategies for addressing the opioid overdose crisis and the CDC-manufactured chronic pain crisis are:
1) revise the CDC 2016 Guidelines so that they accurately reflect the scientific data;
2) release physicians to pursue unfettered good clinical practice in their management of patients in pain;
3) markedly enhance training of physicians in the management of chronic pain, including robust training in medical school and residencies and continuing education workshops (online courses will not suffice);
4) markedly increase the national resources dedicated to treatment of the opioid use disorder crisis in the streets (16).
As always, comments are welcomed with enthusiasm!
Stephen E. Nadeau, MD is a Professor of Neurology at the University of Florida College of Medicine and Associate Chief of Staff for Research at the Malcom Randall VA Medical Center in Gainesville, FL. He is a neurologist and a cognitive neuroscientist. He has devoted much of his clinical career since 1982 to the care of patients with chronic nonmalignant pain.
The contents of this manuscript do not represent the views of the United States Department of Veterans Affairs, the United States Government, or the University of Florida.
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