INTRODUCTION
In this chapter, I lay out and criticize what I perceive as the dominant policy approach to pain, which centers on the opioid regulatory scheme. My criticisms do not necessarily arise from a fundamental disagreement with the objectives of this approach, but rather from the evidence that it has had little measurable impact on the undertreatment of pain in the U.S. I then provide a brief analysis, picking up on themes and arguments advanced in the first five chapters, of why the dominant policy approach is deficient.
In thinking about pain and its treatment, we see at least two major public health problems: prescription drug misuse and the undertreatment of pain. While this book has focused largely on the latter, there is no doubt that the former is an enormous problem, and the statistics are in their own way almost as staggering as those regarding the inequitable undertreatment of pain. According to the Center for Disease Control (CDC), drug overdose fatalities have increased annually for the last 11 consecutive years, from 16,849 deaths in 1999 to 38,329 in 2010. Sixty percent of these deaths involved pharmaceutical drugs, with 75 percent of pharmaceutical-related deaths resulting from opioids.
Yet my principal argument in this chapter, and indeed, in this book, is that these are in fact distinct public health problems. In the U.S., well-intentioned stakeholders have proceeded to conflate the problems, apparently believing that if we resolve our difficulties in managing the safe and effective utilization of opioid analgesics, we will substantially resolve our problems in treating pain. This is error. Both of these issues are serious public health problems, but they are not the same problem. We will not resolve the undertreatment of pain in the U.S. by striking the right balance in the management of opioid analgesics, regardless of whether that balance tilts in favor of liberalization or restriction of their availability. This chapter is devoted to explaining why this is so, and hence why I eschew an approach that focuses on opioids. Attention to both problems is certainly justified, but in this book, I am squarely focused on the undertreatment of pain.
At the outset, it is useful to lay out the state-of-the-art regarding the safety and efficacy of opioids for the treatment of pain. As there is reasonable evidence that long-term usage opioids for pain may be only marginally effective for a general population of pain sufferers, this undermines further the notion that liberalizing access to opioids will dramatically improve the undertreatment of pain.
Finally, I end the chapter by surveying some of the issues related to the meaning of opioids in American society. This general lack of an assessment of the meaning of opioids is an additional deficiency in the dominant policy approach. Even if I am mistaken and the opioid regulatory regime is critical to improving the treatment of pain, attempts to reshape and correct the policy scheme are unlikely to have significant impact if they are divorced from a deep understanding of the meaning of opioids. Although I do not provide such an analysis here because I ultimately remain unconvinced that such an approach is central to improving the undertreatment of pain in the U.S., I nevertheless close the chapter by sketching some features of what such an account might look like. This last segment of the chapter addresses some of the furor over the prosecution of opioid prescribers, which far and away generates the lionās share of the focus on the undertreatment of pain in the U.S. Such focus is unjustified, not because it is irrelevant to the culture of pain, but rather because it is unlikely to improve the undertreatment of pain in the U.S.
THE DOMINANT POLICY APPROACH TO PAIN: BALANCE IN OPIOID REGULATIONS
There is exactly one entity in the U.S. specifically devoted to pain policy that is expressly housed at an academic medical center: the Pain & Policy Studies Group (PPSG), affiliated with the University of Wisconsin Paul B. Carbone Cancer Center. For over 20 years, the PPSG has dominated academic and political discussions of pain policy in the U.S.
Since 1997, the PPSG has produced several editions of two documents whose influence on pain policy can barely be overstated. These documents are the āAchieving Balanceā reports, which include a āProgress Report Cardā and an āEvaluation Guideā containing profiles of each U.S. state and the federal government. The criteria for evaluation center on the government entityās compliance with the guiding principle of the PPSG, which is ābalanceā in regulation of opioid analgesics.3 āBalanceā is sought between the legitimate law enforcement aim of preventing the abuse and diversion of powerful narcotics like opioids, and the key role opioid analgesics play in the effective treatment of pain.4 As stated in the Introduction (this volume), it is perfectly appropriate to seek balance in public health policy of any kind, and the PPSG documents are valuable tools in this endeavor.
However, there are significant limitations to the PPSG approach. The first major problem is the unstated assumption that achieving balance in opioid policy is the primary means of improving the undertreatment of pain in the U.S. The reason this assumption is problematic is because a focus on opioid policy leaves opaque the role that social and cultural beliefs, attitudes, and practices regarding the meaning of pain play in its undertreatment. The example I provided in the Introduction (this volume) noted the tendency of elderly persons in the U.S. to underreport their pain, which is a significant barrier to effective treatment.5 There is little reason to believe that achieving balance in the opioid regulatory scheme will remedy this problem.
Second, a focus on opioid policy inevitably centers on the opioid prescriber, which in the U.S., is exclusively the physician. This is a serious problem because common attitudes, practices, and beliefs about the meaning of pain are part of a cultural frame shared by pain sufferers, caregivers, and nonphysician health care providers (of which elderly populations tending to underreport their pain is an excellent example). Focus simply on the prescribers obscures the larger contexts that deeply influence practices and beliefs towards pain and its treatment. Thus, for example, pain sufferers frequently join physicians in the attempt to objectify their own pain, self-stigmatize, and doubt the pain talk of fellow pain sufferers.
Third, the efforts to achieve balance in the opioid regulatory scheme typically do not explain or account for the reasons why opioid policy has historically been and remains unbalanced in the U.S.6 That is, to reconfigure opioid policies in ways that come closer to an ideal state of balance, it seems important to tailor these efforts to address the root causes that have driven the imbalance in opioid policy. Policy that is not so tailored is unlikely to have the practical effect intended or hoped for, and is in my view a central reason why the best efforts of the PPSG and its allies do not seem to have had the expected and hoped-for impact as of the current date. C. Stratton Hill, Jr., a retired cancer physician and pain specialist who has been advocating for improved pain treatment for over three decades, maintains that an approach that focuses almost exclusively on tweaking the regulatory scheme is simply doing what was tried over 30 years ago, with little success.7
Why does the PPSGās approach to pain policy focuses almost exclusively on the opioid regulatory regime? On one level, the answer is obvious: for centuries if not millennia, opioids have been a frontline therapy for the effective treatment of many kinds of pain. Yet other factors likely contribute, and do so in important ways. For example, Richard deGrandpre coined the phrase ābehavioral pharmacologismā to refer to the American tendency to see health problems primarily if not exclusively in context of pharmaceuticals.8 That this behavior is encouraged by the pharmaceutical industry is also beyond dispute. In context of pain, this operates to shape policy discourse at the highest levels, such that even well-intentioned groups like the PPSG tend to see the problem of and potential solutions to the undertreatment of pain primarily in terms of the availability of pharmaceutical drugs.9
There is little question that opioids remain relevant for treating pain today, but an increasing body of evidence suggests that the efficacy of opioid analgesics for different kinds of pain is uncertain at best. If this evidence is legitimate, it obviously suggests a fourth reason for contending that an undue policy focus on opioid regulation is unlikely to substantially improve the undertreatment of pain: opioids themselves, however important, are not even the clinical answer to the undertreatment of pain. Examining this evidence briefly is important to thinking about the strengths and weaknesses of the ābalanceā approach.
EVIDENCE RELATED TO THE USE OF OPIOIDS IN TREATING PAIN
The present state of the art regarding the use of opioids for treating pain is in flux. There is little question both that opioids remain an important therapy and that the total volume of opioid dispensation has increased dramatically over the last two decades. Such an increase has coincided with a dramatic increase in the total number of fatalities attributed to prescription drugs, and although there are likely myriad reasons for the latter, it strains credulity to deny any causal connection between the liberalization of the opioid regime and the significant increase in deaths and other adverse drug events. Given the significant public health risks, there is reason for demanding significant evidence of clinical benefit for the utilization of such opioids.
Yet Deshpande et al. observe that despite the fact that the use of opioids ā¦ remain[s] a controversial issue in the management of chronic non-cancer pain, and chronic [low-back pain] in particular, there is a steadily growing trend toward prescribing opioids for the management of [chronic non-cancer pain]. Market data indicate that since 2000, long- and short-acting opioids experienced a 26.5 percent and 39 percent compounded annual growth rate, respectively.10
The controversy over the extent of the efficacy of opioids for chronic nonmalignant pain seems to have grown concomitant to its usage.11 In their systematic review of the efficacy of opioids in improving pain or function in persons with chronic low-back pain,...