cost of chronic pain to American society, based upon health care expenditures and cost of lost productivity, is $560-635 billion/year

Response to Oregon’s Tapering Guidance and Tools

www.paindr.com/%ef%bb%bfresponse-to-oregons-tapering-guidance-and-tools/

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.

Disclaimer:
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.

References

1. Institute of Medicine. Relieving
Pain in America: a Blueprint for Transforming Prevention, Care, Education, and
Research. Washington, DC: National Academies Press; 2011.

2. Hale ME, Ahdieh H, Ma T, Rauck
R, Oxymorphone ER Study Group 1. Efficacy and safety of OPANA ER (oxymorphone
extended release) for relief of moderate to severe low back pain in
opioid-experienced patients: a 12-week, randomized, double-blind,
placebo-controlled study. Journal of Pain. 2007;8:175-84.

3. Hale ME, Dvergsten C, Gimbel J.
Efficacy and safety of oxymorphone extended release in chronic low back pain:
results of a randomized, double-blind, placebo- and active-controlled phase III
study. Journal of Pain. 2005;6:21-8.

4. Katz N, Rauck R, Ahdieh H,
Gerritsen van der Hoop R, Kerwin R, Podolsky G. A 12-week, randomized,
placebo-controlled trial assessing the safety and efficacy of oxymorphone
extended release for opioid-naive patients with chronic low back pain. Current
Medical Research and Opinion. 2007;23:117-28.

5. Rauck RL, Nalamachu S, Wild JE,
Walker GW, Robinson CY, Davis CS, et al. Single-entity hydrocodone
extended-release capsules in opioid-tolerant subjects with moderate-to-severe
chronic low back pain: a randomized double-blind, placebo-controlled study.
Pain Medicine. 2014;15:975-85.

6. Katz N, Kopecky EA, O’Connor M,
Brown RH, Fleming AB. A phase 3, multicenter, randomized, double-blind,
placebo-controlled, safety, tolerability, and efficacy study of Xtampza ER in
patients with moderate-to-severe chronic low back pain. Pain. 2015;156:2458-67.

7. Milligan K, Lanteri-Minet M,
Borchert K, Helmers H, Donald R, Kress H-G, et al. Evaluation of long-term
efficacy and safety of transdermal fentanyl in the treatment of chronic
noncancer pain. Journal of Pain. 2001;2:197-204.

8. Mystakidou K, Parpa E, Tsilika
E, Mavromati A, Smyrniotis V, Georgaki S, et al. Long-term management of
noncancer pain with transdermal therapeutic system-fentanyl. Journal of Pain.
2003;4:298-306.

9. Roth SH, Fleischmann RM, Burch
FX, Dietz F, Bockow B, Rapoport RJ, et al. Around-the-clock, controlled-release
oxycodone therapy for osteoarthritis-related pain. Archives of Internal
Medicine. 2000;160:853-60.

10. Gomes T, Juurlink DN, Dhalla
IA, Mailis-Gagnon A, Paterson JM, Mamdani MM. Trends in opioid use and dosing
among socio-economically disadvantaged patients. Open Medicine. 2011;5:13-22.

11. Bohnert ASB, Valenstein M, Bair
MJ, Ganoczy D, McCarthy JF, Ilgen MA, et al. Association between opioid prescribing
patterns and opioid overdose-related deaths. Journal of the American Medical
Association. 2011;305:1315-21.

12. Patel MR, Mahaffey KW, Garg J,
Pan G, Singer DE, Hacke W, et al. Rivaroxaban versus warfarin in nonvalvular
atrial fibrillation. New England Journal of Medicine. 2011;365:883-91.

13. Dowell D, Haegerich T, Chou R. CDC Guideline
for prescribing opioids for chronic pain — United States, 2016. Morbidity and
Mortality Weekly Report. 2016;65:1-49.

14. Agarwal D, Udoji MA, Trescot A.
Genetic testing for opioid pain management. Pain Therapy. 2017;6:93-105.

15. Galvan A, Skorpen F, Klepstad
P, Knudsen A, Fladvad T, Falvella FS, et al. Multiple loci modulate opioid
therapy response for cancer pain. Clinical Cancer Research. 2011;17:4581-97.

16. Winkelman TNA, Chang VW,
Binswanger IA. Health, polysubstance use, and criminal justice involvement
among adults with varying levels of opioid use. JAMA Network Open. 2018. DOI:
10.1001/jamanetworkopen.2018.0558

17.
Richard A Lawhern, Ph.D. and John Alan Tucker, Ph.D. “Analysis of US Opioid
Mortality and ER Visit Data”, May 15, 2018, available at
http://face-facts.org/atip/analysis-of-cdc-wonder-rx-and-er-data-v1-4-may-2018-2/

3 Responses

  1. I have the dire misfortune to live in Oregon & have been fighting the sadistic bigots & zealots of the Church of Opiophobia here for what seems like a very, very long time. The only problem with this outstanding article is that (1) the members of the Task Farce will never read it, & (2) even if they did read it, it would make no difference whatsoever. They have repeatedly proven that they have less than no interest in facts or evidence. They ignore, twist, & mangle evidence that does exist, & more commonly they outright lie –just make up crap, and basing their extremist, draconian proposal on BELIEFS, not evidence, like Ballentyn’s insistence upon conflating dependence & addiction. I absolutely guarantee that anyone who knows anything about real addicts & addiction knows that there is a gulf between that & simple physical dependence as wide as the Milky Way. They just want the difference to disappear so they can send all the CPPs to their addiction treatment centers (kolodny & ballentyne) & to acupuncturists & chiropractors & suchlike –several of the Task Farce members are acupuncturists & chiropractors & suchlike, a fact which I’m sure is purely coincidental. Riiiiiight. They get to make policies that destroy people they’ve clearly stated in public meetings are lesser beings unworthy of decent care AND line their own pockets while doing it. How nice for them.

  2. If chronic pain patients cost the American economy more than half a trillion dollars a year, then what does the drug addict cost our society? Let’s add up those costs, for which I have never seen the full figures, but remember we must account for these issues: lost productivity (most have never held a job), unemployment costs, food stamp costs, Medicare and Medicaid (since most are on the government’s back), hospital costs for ER and admissions, treatment center costs (medications, appointments with providers and counseling, drug testing — despite the fact that these people fail to adhere to treatment plans and fail drug tests repeatedly, they still get their “medications” while abusing illegal drugs!), law enforcement costs (patrols, arrests, jailed while waiting trial), court time (typically just to be sent to the same failed treatment centers who keep making money off the addict because the government thinks that throwing more money at the problem is going to solve it — typical stupid politician thinking, but as long as their are lining the pockets of their certain friends and contributors, all is good), and more. I am sure that the costs is more than double what chronic pain patients cost!

  3. Thank you Dr. Stephen Nadeau. You’ve been a Godsend to countless CPP folks with your informed and articulate communication skills.
    I may some day cite your perspectives to a jury as they are factual and comprehensive. On point summary with direction forward.
    Thank you for your time.

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