With Apologies to Lennon and McCartney, All We Need is Data: Opioid Concerns in Pediatrics.
I t is abundantly clear that there is a problem with people dying from opioid overdoses. One can debate whether this is an "opioid epidemic" or a "polypharmacy overdose epidemic,"1 but at this point the issue is not only of clinical or public health concern, it is highly charged politically. Many in both the professional and lay press assert that too much attention has been paid to treating pain and that physicians are too liberal in their prescribing of opioids,2 5 resulting in legislative efforts, for example, to reign in such practices. A major problem in this discussion is lack of data. We do not understand the precise relationship between physician prescribing and diversion and misuse. For example, in the past few years, as prescribing has decreased and long acting opioid formulations have been made more tamper resistant, deaths from heroin and synthetic opioids have skyrocketed. And if there is a gap in data pertaining to adults, there is a chasm when it comes to children and adolescents.6 In the absence of reliable data, the consequence is that people often make public statements and try to guide policy based on what we may politely call intuition or conjecture. For example, in a letter to then Acting Commissioner Ostroff after the Food and Drug Administration approved OxyContin for 11 to 16 year olds, Senator Joe Manchin (DWV) asserted, "An 11 year old's brain has another 14 years before it is fully developed. We have years of evidence that shows that drug use at an early age makes a child more likely to abuse drugs later in life. You have ignored all of this. Instead, under your new guidance, we are literally poisoning our children's brains and setting them up for future drug abuse."7 An example of how such bias and lack of data may ill affect large swaths of the population comes from California assemblywoman Burke (D Marina Del Rey) who in 2018 sponsored AB 2741, limiting opioid prescriptions for minors. She stated, "Forty percent of all opioid overdose deaths involve a prescription and over 120,000 addicts are under the age of 21. This is an insidious crisis which compels us to take action. I'm proud to join my colleagues as we work towards bi partisan, comprehensive solutions that will protect families from tragedies."8 Although these "data" would appear to justify the actions, the National Vital Statistics System reports drug poisoning deaths to be negligible in the 0 to 14 year age group (often not even included in the graphs) rising in the 15 to 24 year age group, and skyrocketing in the 25 to 34 year age group. National Institute of Drug Abuse tells us that 12th graders' misuse of Vicodin has "dropped dramatically" in the past 5 years. Data from the Monitoring the Future study show that eighth and tenth graders are not using narcotics other than heroin; 12th graders' use is at pre 1974 levels.9,10 What seems intuitively obvious to Assemblywoman Burke will instead lead to the suffering of children.11 Daniel Carr summarized the issue by offering a novel metric, "Number Needed to Under Treat," posing the question, "How many people need to suffer in needless pain in order to prevent a single individual from becoming addicted to opioids?"12 We will add that when the sufferer is an innocent child, the weight of that calculation potentially is even greater. Consequently, we offer a special section in the Clinical Journal of Pain in an effort to provide and update about what we do know on some key issues in prescribing opioids to the pediatric population to treat pain, as well as to highlight the critical gaps. As we edited these papers, it was with a specific mindset that is important to define. We are not advocates for opioid use, per se. We recognize the potential lethality of these drugs, which has become increasingly apparent with misuse and abuse. However, we unwaveringly support the adequate prevention and treatment of pain and suffering in the young, both for humane reasons and to reduce the risk of challenging pain responses over the course of development.13 We argue for balance the responsible treatment of pain is just as critical as addressing irresponsible prescribing of opioids that may be adding to the current crisis. We begin with a pro versus con discussion of including opioids in the treatment armamentarium for pain in children. Krane lays out key elements of the debate by initially looking at the arguments for and against the use of opioids to treat pain. In the end, he recognizes that there is indeed therapeutic benefit that cannot be matched by other agents at this time. By prescribing the drugs as safely as possible, we go in recognizing the limitations, minimize the risks, but ultimately rely on these medications for their analgesic effects. On the flip side, Anderson highlights that the risks of opioids are unacceptably high and that the medical community has become far too lax about attending to those risks. He argues that for both acute and chronic pain, effective alternatives are available that present fewer untoward side effects and negative consequences. With that as background, several substantive reviews appear. Finkel and Pukish provide background on the molecular biology of opioid analgesia in order to facilitate their more targeted use for analgesia, but also consideration for tolerance, dependence, and hyperalgesia. Kopecky focuses on aspects of physiological development that are determinants From the *Departments of Anesthesiology, Perioperative and Pain Medicine, and Pediatrics, Stanford University, Stanford, CA; and +Departments of Anesthesiology and Psychiatry, University of Washington, Seattle, WA. The authors declare no conflict of interest. Reprints: Elliot J. Krane, MD, Department of Anesthesiology, 300 Pasteur Drive, Stanford, CA 94305 (e mail: ekrane@stanford.edu) Copyright (c) 2019 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/AJP.0000000000000699 SPECIAL TOPIC SERIES ON OPIOID THERAPEUTICS AND CONCERNS IN PEDIATRICS
The Clinical journal of pain