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WriteClick Editor’s Choice

Robert C. Griggs, MD

Editors’ Note: The topic of this week’s WriteClick is the American Academy of Neurology’s position paper on opioids for noncancer pain. Dr. Katz considers 2 potential contributing causes to the opioid overuse epidemic: pharmaceutical companies and hospitals with an eye on patient satisfaction scores. Dr. Swerdloff discusses pain as the fifth vital sign. Dr. Brass suggests adding “Patients placed on opiates should also be screened for sleepdisordered breathing” to the list of recommendations. Drs. Argoff et al. cite 4 additional studies claiming to demonstrate long-term benefits of opioid analgesic therapy. Author Franklin answers all points. —Megan Alcauskas, MD, and Robert C. Griggs, MD

OPIOIDS FOR CHRONIC NONCANCER PAIN: A POSITION PAPER OF THE AMERICAN ACADEMY OF NEUROLOGY

Jeffrey A. Katz, Columbia, SC: Franklin1 provided an excellent review on the opioid overuse epidemic. Considering the immensity of the topic, treatment within a single article may be impossible. The cause of this epidemic should have been considered in more detail. While the push by certain physicians and societies was noted, the influence of pharmaceutical companies was not mentioned. The marketing machine that helped drive the increased use of opioids for noncancer pain is controversial but cannot be disregarded. Similarly, the pressure by hospitals and health care organizations to chase the patient satisfaction metric is a contributor to the epidemic. I can attest that patient complaints about not receiving opioids influence a physician’s position in a hospital and a study has documented how chasing this metric can lead to increased mortality.2 Franklin and the American Academy of Neurology (AAN) should be credited for reviewing and taking a stance on this national problem but understanding the causes would help prevent recurrence. Marc A. Swerdloff, Fort Lauderdale, FL: Franklin’s position paper on opioids for noncancer pain1 highlights pain as the fifth vital sign. Escalating doses of opiates

place the other vital signs at risk (temperature, blood pressure, pulse, and respirations). While pain relief is the goal, it must be subordinate to the true vital signs. The results of this policy have been disastrous; the notion of pain as the fifth vital sign should be repudiated. Steven D. Brass, Davis, CA: I appreciate the position paper by Dr. Franklin1 on opioids for chronic noncancer pain. Several recommendations were listed in table 2 of what prescribers can do to safely and effectively use opioids. Both as a neurologist and as a physician practicing in sleep medicine, I felt compelled to mention one important recommendation that should have been included: screening patients for sleepdisordered breathing. Opiates may cause hypoxemia and hypoventilation through depression on the brainstem respiratory pathways and can lead to both obstructive and central sleep apnea.3 In a study of patients on methadone maintenance, 35.2% of subjects were diagnosed with obstructive sleep apnea and 14.1% of subjects were found to have central sleep apnea.4 Teichtahl et al.5 proposed that sleep apnea may play a role in unexplained increase in mortality in patients treated with chronic methadone. This finding has both serious patient safety issues and legal ramifications for the providers who prescribe opiates. Dr. Franklin should consider adding “Patients placed on opiates should also be screened for sleep-disordered breathing” to the list of recommendations. Charles E. Argoff, Albany; John Markman, Rochester, NY; Misha Backonja, Salt Lake City; Nathaniel Katz, Newton, MA: The AAN’s position paper on opioids for chronic noncancer pain misrepresented the evidence base for the efficacy of chronic opioid therapy.1 Adherence to standards for safe opioid prescribing must be strengthened and enforced. However, missing from this article is the equivalency or superiority of the evidence base for opioid therapy for chronic pain compared to tricyclic antidepressants, duloxetine, gabapentin, and pregabalin. Contrary to the statement that “there is no substantial evidence for maintenance of pain relief over longer periods of time,” there are actually multiple published studies demonstrating the long-term benefit of opioid analgesics.6–9 Neurology 84

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The author advocated a double standard by requiring functional improvement as an outcome for successful opioid treatment. No other medications prescribed by neurologists, such as those for epilepsy, are required to meet this standard. Should a person with severe chronic pain due to a disabling chronic neurologic condition now have opioids withheld because of lack of functional improvement even though effective pain relief and acceptable side effects have been achieved? The answer is obvious, yet this perspective is missing from the article. Misrepresenting opioid efficacy and erecting barriers to meaningful relief of chronic pain will not make these medications safer. Author Response: Gary M. Franklin, Seattle: We thank Dr. Katz for his thoughtful comments. Drug companies and their surrogates may have played a significant role in initiating and perpetuating the prescription opioid epidemic. There have been many investigative reports on this issue.10,11 In 2011, the Senate Finance Committee subpoenaed many of the surrogate organizations.12 Dr. Swerdloff rightly calls out “pain as the fifth vital sign” as another contributing factor. In a Veterans Health Administration study, the routine measurement of this sign was not associated with improved quality measures of pain management.13 Importantly, Dr. Brass points out the critical issue of the opioid effect on depressing central respiration, particularly in vulnerable patients, such as those with sleep-disordered breathing. It does seem possible that screening some at-risk patients for this problem could lead to appropriate reductions in opioid dose, prior to a catastrophic overdose event. One problem is that some pain leaders have advocated screening patients on high opioid doses for such risks as the principal method of risk reduction; this type of policy is not upstream enough, on a population basis, to have much impact on overall harm reduction. Drs. Argoff et al. state that the evidence base in the AAN position paper was misrepresented by not including 4 additional studies, cited in their response, purporting to demonstrate longer term efficacy. All 4 studies are uncontrolled case series, considered Class IV evidence in the AAN evidence-based methods process.14 Class IV studies are fraught with the highest risk of bias. For at least 2 of these studies, coauthors were employees of pharmaceutical companies. We were careful to point out the methods of monitoring patients on chronic opioids who may have some benefit. None of the studies cited by Argoff et al. offers more specific guidance as to who these patients may be; higher quality studies will be required to determine this. The most recent systematic review has shown no clear-cut evidence of longer term effectiveness.15 1504

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None of the other medications cited by Argoff et al. has been associated with a similar epidemic of morbidity and mortality, or with a large segment of patients with underappreciated but severe dependence and addiction from which they may never recover. We may be substantially undercounting addiction, as the classic definitions of addiction may not be completely relevant to those receiving prescribed opioids for chronic pain.16 As to whether function should be measured along with pain, we pointed out that both guidelines for clinical research17 and recent state policies support the ongoing measurement of pain and function to determine if there is clinically meaningful improvement from use of chronic opioids. © 2015 American Academy of Neurology 1.

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Franklin GM. Opioids for chronic noncancer pain: a position paper of the American Academy of Neurology. Neurology 2014;83:1277–1284. Fenton JJ, Jerant AF, Bertakis KD, et al. The cost of satisfaction: a national study of patient satisfaction, health care utilization, expenditures, and mortality. Arch Intern Med 2012;172:405–411. Farney RJ, Walker JM, Cloward TV, Rhondeau S. Sleepdisordered breathing associated with long-term opioid therapy. Chest 2003;123:632–639. Sharkey KM, Kurth ME, Anderson BJ, Corso RP, Millman RP, Stein MD. Obstructive sleep apnea is more common than central sleep apnea in methadone maintenance patients with subjective sleep complaints. Drug Alcohol Depend 2010;108:77–83. Teichtahl H, Promdromidis A, Miller B, Cherry G, Kronborg I. Sleep-disordered breathing in stable methadone programme patients: a pilot program. Addiction 2001;96:395–403. Wallace M, Thipphawong J. Open-label study on the long-term efficacy, safety and impact on quality of life of OROS hydromorphone ER in patients with chronic low back pain. Pain Med 2010;11:1477–1488. McIlwain H, Ahdieh H. Safety, tolerability, and effectiveness of oxymorphone extended release for moderate to severe osteoarthritis pain: a one-year study. Am J Ther 2005;12:106–112. Portenoy RK, Farrar JT, Backonja MM. Long-term use of controlled-release oxycodone for non-cancer pain: results of a 3-year registry study. Clin J Pain 2007;23: 287–299. Sandner-Kiesling A, Leyendecker P, Hopp M, et al. Longterm efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of noncancer chronic pain. Int J Clin Pract 2010;64:763–774. Meier B. In guilty plea, oxycontin maker to pay $600 million. New York Times May 10, 2007. Available at: http://www.nytimes.com/2007/05/10/business/11drug-web. html?_r51&. Accessed January 19, 2015. Fauber J. UW a force in pain growth: research group receiving millions from pharmaceutical firms helped liberalize use of opioids. Milwaukee Journal Sentinel April 2, 2011. Available at: http://www.jsonline.com/watchdog/ watchdogreports/119130114.html. Accessed January 19, 2015.

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Ornstein C, Weber T. Senate panel investigates drug companies’ ties to pain groups. Washington Post May 8, 2012. Available at: http://www.washingtonpost.com/national/ health-science/senate-panel- investigates-drug-companies-tiesto-pain- groups/2012/05/08/gIQA2X4qBU_story.html? hpid5z4. Accessed January 19, 2015. Mularski RA, White-Chu F, Overbay D, et al. Measuring pain as the 5th vital sign does not improve quality of pain management. J Gen Intern Med 2006;21:607–612. Gronseth GS, Woodroffe LM, Getchius TSD. Clinical practice guideline process manual. Am Acad Neurol 2011. Available at: http://tools.aan.com/globals/axon/ assets/9023.pdf. Accessed January 19, 2015.

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Reuben DB, Alvanzo AAH, Ashikaga T, et al. National Institutes of Health Pathways to Prevention workshop: the role of opioids in the treatment of chronic pain. Ann Intern Med 2015;162:295–300. Ballantyne JC, Stannard C. New addiction criteria: diagnostic challenges persist in treating pain with opioids: International Association for the Study of Pain. Pain Clin Updates 2013;21: 1–7. Available at: http://iasp.files.cms-plus.com/FileDownloads/ PCU_21-5_web.pdf. Accessed January 19, 2015. Dworkin RH, Turk DC, Wyrwich KW, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain 2008;9:105–121.

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Author disclosures are available upon request ([email protected]). Neurology 84

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Opioids for chronic noncancer pain: A position paper of the American Academy of Neurology Jeffrey A. Katz, Marc A. Swerdloff, Steven D. Brass, et al. Neurology 2015;84;1503-1505 DOI 10.1212/WNL.0000000000001485 This information is current as of April 6, 2015 Updated Information & Services

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Neurology ® is the official journal of the American Academy of Neurology. Published continuously since 1951, it is now a weekly with 48 issues per year. Copyright © 2015 American Academy of Neurology. All rights reserved. Print ISSN: 0028-3878. Online ISSN: 1526-632X.

Opioids for chronic noncancer pain: A position paper of the American Academy of Neurology.

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