Published On October 2, 2015
TERESA SHAFFER’S chronic back pain began 25 years ago, after she gave birth to her third child. It was so severe that she could barely get out of bed, and so began a frustrating odyssey from one physician to another. Many were skeptical about her symptoms, and it took years before she got a definitive diagnosis—incurable, progressive osteoarthritis that had caused irreversible deterioration of the cartilage in her joints and the disks in her back. But with few effective treatment options and limited insurance coverage for physical therapy and psychological counseling, Shaffer, who lives in West Virginia, has mostly had to learn to live with pain. “It’s extremely frustrating, because medication alone isn’t enough—you need a whole toolbox of treatments,” Shaffer says.
Some 126 million American adults are in pain, according to the National Institutes of Health. And while other estimates suggest there may be as few as 25 million people with chronic pain, depending on how that is defined, the suffering is enormous, and attempts to get relief tend to be handled by physicians who have little training in managing pain and few effective tools.
Powerful painkillers are currently the most prevalent treatment option, and doctors wrote 259 million prescriptions for opioid pain medication in 2012—sufficient to give every adult in America a bottle of pills. Yet that solution may do more harm than good. Drug dependence and misuse are common, and prescription opioid overdoses now kill more Americans than car accidents do. This twist in the nation’s pain problem, perversely, has become the larger public health priority. New regulations limit how often and for how long opioids are prescribed, the FDA has mandated more research on the drugs’ effects, and drugmakers are under pressure to make “abuse deterrent” pills.
But the parent problem—finding ways to relieve patients’ pain—has seen less progress. Some experts contend that more comprehensive approaches to treating pain could help alleviate the problem of prescription drug misuse. “If we take better care of people with pain, it can only help with the oversubscribing of opioids,” says Linda Porter, a neuroscientist and program director for the National Institute of Neurological Disorders and Stroke.
To that end, Porter and scores of other national experts have joined together to devise a new federal initiative on pain. The panel is calling for a comprehensive approach that includes everything from a public awareness campaign to new research, improved therapies and better education for clinicians. Those objectives are part of the “National Pain Strategy,” the 72-page draft of an action plan that the U.S. Department of Health and Human Services (HHS) delivered last April. “Our goal is nothing short of transforming the culture in this country for assessing and managing pain,” says Sean Mackey, a physician and pain researcher at Stanford University Medical Center, who co-chaired the report.
Most people in the pain treatment community have lauded the report as a great step forward in their long quest to create a coherent, effective national policy. But whether that will really happen now remains uncertain. The biggest worry, says Gregory Terman, a professor at the University of Washington and president of the American Pain Society, who also contributed to the report, is that this effort will get lost amid the urgency of dealing with the opioid crisis.
“We don’t want this to be another federal report that gets published and shelved,” says contributor Christin Veasley, co-founder of the Chronic Pain Research Alliance, one of the 16 organizations that comprise the Consumer Pain Advocacy Task Force. The coalition includes representatives of constituencies for particular kinds of pain—the TMJ Association and the National Fibromyalgia & Chronic Pain Association—as well as other broader groups such as the Pain Action Alliance to Implement a National Strategy (PAINS). And while such wide-ranging support for a national policy on pain could ultimately help make it happen, it remains to be seen whether the broad cooperation that went into creating the draft report can be harnessed to put its recommendations into place.
PAIN IS ONE OF THE top reasons most people see their doctors. Lower back pain is the most prevalent, followed by severe headaches or migraine, and neck pain. Yet most physicians are poorly equipped to manage such problems, and a recent study of North American medical schools found that only four U.S. programs had required courses on pain.
Pain research, too, has lagged. Calls to add a pain institute at the National Institutes of Health led instead to expanding the role in 2003 of the NIH Pain Consortium, which had been established seven years earlier, to increase pain research, funding and collaboration. Today, the panel includes representatives from 17 NIH institutes and four centers. NIH funding for pain studies remains comparatively small, with $514 million estimated for 2016, far short of the $5.5 billion allocated to cancer research or the $1.2 billion for heart disease. “Investment right now is less than four dollars per American who is dealing with pain,” says Veasley, who herself has chronic pain caused by a car accident when she was a teenager.
A large proportion of that portfolio remains in basic research, and though strides have been made in understanding the biological, cognitive and psychological underpinnings of pain, many gaps persist, particularly in translating effective treatments from research into practice. “The core issue really is the lack of productive and coordinated translational research over the past five decades, which has resulted in pain management overwhelmingly relying on opioid analgesics,” says Jianren Mao, vice chair for research and chief of pain medicine in the Department of Anesthesia, Critical Care and Pain Medicine at Massachusetts General Hospital.
The law with the greatest impact on pain management is the 1970 Controlled Substances Act, which, among other provisions, holds practitioners legally responsible for the proper prescribing and dispensing of opioids. But during the 45 years since it became law, advocates have repeatedly attempted to make pain itself a public health priority. The Pain Care Coalition, for example, formed by the American Academy of Pain Medicine, the American Headache Society and the American Pain Society in the late 1990s, succeeded in having the first 10 years of the new century designated the Decade of Pain Control and Research. That occasioned considerable academic and clinical work and resulted in an explosion of new treatment guidelines for physicians. But the only national legislation was the initial congressional proclamation. And while several versions of proposed legislation known as the National Pain Care Policy Act have been debated over the years, it wasn’t until 2009 that a Senate committee voted unanimously to include provisions for increased pain research and education in the Affordable Care Act, signed into law in 2010.
The law required HHS to enlist the IOM for a broad analysis of the issues surrounding pain and to recommend improvements. And in 2011, the IOM released a seminal 382-page report, “Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education and Research.” Most health care professionals, medical societies and advocacy groups applauded the report’s findings and recommendations. “Everyone believed that when the IOM report came out, that would help to generate a better understanding of the impact of long-term pain and things would start happening,” says Penney Cowan, founder and chief executive officer of the American Chronic Pain Association, who also contributed to this year’s draft strategy. But amid the overwhelming demands of budget sequestration and implementing the ACA, pain policy became a lower priority.
The IOM report called on HHS to create a comprehensive strategy for pain prevention, treatment and research by the end of 2012. But by late summer of that year, despite repeated meetings between pain policy advocates and HHS officials, nothing had happened. HHS generally reviews but is not legally required to adhere to IOM recommendations. Finally, physician Howard Koh, then assistant secretary for health of HHS, met with a newly formed 12-member NIH panel—the Interagency Pain Research Coordinating Committee, or IPRCC—and requested that the panel take on the responsibility of drafting a national pain strategy, thereby optimizing how the federal government funds pain research. Stanford’s Sean Mackey, a founding member of the IPRCC, complained that the panel was a research group and didn’t have the resources or expertise to enact such an important, far-reaching strategic plan. But Koh responded that if the IPRCC didn’t come up with a plan, “it wouldn’t happen for years,” Mackey says.
By early 2014, Mackey and Porter had the wheels turning, assembling 80 pain experts from within the government as well as from academic centers and advocacy groups to draft the document. Six working groups broke off to address specific pain issues. Members of each group were asked to agree on three or four specific objectives—“achievable goals, nothing pie-in-the-sky,” says James Rathmell, chief of anesthesia at Brigham and Women’s Hospital in Boston, who served as co-chair of the 15-member working group that addressed professional education and training. It took months of back-and-forth before the group could agree on the content for its section.
“We couldn’t start with, ‘We need to retrain everyone in the health care profession and provide education across the continuum,’” he says. Instead, the group ultimately called for establishing core competencies for education, certification and licensing—which would aim in part to incorporate particular skills and knowledge about pain into the accreditation requirements for physicians and other care providers.
The document expressly frames many objectives as “biopsychosocial,” calling for biological, psychological and social factors to be addressed in pain treatment. And the report frequently points to a need for more and better data and research. It emphasizes using tools such as electronic health records and new online pain registries to learn more about how pain is treated. Other goals of the National Pain Strategy are to develop self-management programs for patients, a national public awareness campaign, and better reimbursement models that would reward coordinated, comprehensive pain care.
The draft policy is ambitious and brings together far-flung constituencies in the pain community that not only helped draft the report but are also charged with implementing the steps it outlines. And its release in April was greeted with mostly positive reviews. “I think everyone agrees it’s a nice start, a nice road map,” says Bob Twillman, a psychologist and executive director for the American Academy of Pain Management. Still, a comment letter to HHS from Twillman’s group highlighted areas of concern. The letter suggested, among other things, that it might be more cost-effective for the push for public awareness of pain issues to come directly from providers rather than through an expensive national campaign, and it criticized the report for neglecting to discuss pain experienced by children and adolescents.
But it was the draft’s stance on opioids that drew the most flak. The report endorsed these drugs as an essential component of pain treatment for some patients, although it did note that insufficient research data exist to identify those at risk for addiction and other adverse effects. A call for a national education campaign “encouraging safe medication use, especially in opioid use, among patients with pain” prompted a letter from Physicians for Responsible Opioid Prescribing, or PROP, asking that the notion of “safe use” be struck, among other modifications. “The National Pain Strategy is skirting the opioid issue, which is really the core of what’s wrong with pain management in this country,” says Jane Ballantyne, a physician and president of PROP. “There is no evidence that the long-term use of opioids is safe, effective or cost- effective for chronic pain conditions.”
HHS received fewer than 800 comments on the draft report by its May 20 deadline. Teresa Shaffer, active in several online forums, has urged the hundreds of fellow sufferers she communicates with every week to weigh in with their support and criticism of the draft, as she did, both in comments to HHS and by contacting their congressional representatives. “If people living with pain don’t advocate for themselves, how can we expect someone else to do it for us?” she says. According to panel co-chair Linda Porter at the NIH, a revised final version should be out this fall.
WHAT WILL HAPPEN after the final report is issued? Some supporters are concerned that it’s not yet clear which government entity will be responsible for beginning to implement policy changes. “We want to know who will be accountable, and what the next step is,” says Mackey. HHS is a logical candidate, but Howard Koh and Story Landis, former director of the National Institute of Neurological Disorders and Stroke and another champion of pain reform, have both left the agency. Porter insists that HHS officials are “enthusiastic” about the draft and that she expects the strategy to be rolled out from within the agency. David Thomas, a program officer at the National Institute on Drug Abuse and another contributor to the report, agrees. “The strategy is different than other government reports,” he says. “We have identified who is going to do what, crafted in such a way that the government and outside groups are given some direct action.”
But others are taking nothing for granted and stress the importance of implementing the full range of the report’s recommendations. “The National Pain Strategy isn’t going anywhere without a coordinated comprehensive advocacy movement around it,” says Christin Veasley of the Chronic Pain Research Alliance. “We don’t want to see just bits and pieces of it adopted and implemented.” Veasley’s group and others are calling for HHS to develop a federal oversight body to lead an implementation effort and set aside money for a launch so that the final draft can be translated into public policy solutions.
Advocates, meanwhile, are mailing and meeting with key members of Congress, including those on the House and Senate appropriations committees, to discuss the potential need for legislation and calling for additional federal dollars to fund the strategy’s many objectives. But those haven’t been easy discussions, Veasley says. “Given all the attention to the opioid crisis, the majority of legislators are unaware of the issues of chronic pain, and there’s a lot of misinformation about what that is, and how chronic pain relates to prescription drug abuse,” she says.
Some groups are also concerned that time may be short. Since the draft came out as part of the Affordable Care Act, there are worries that if a policy doesn’t get rolling by the next presidential election, it might never go anywhere.
Advocacy groups, such as the Pain Action Alliance to Implement a National Strategy (PAINS) are also tapping sources outside the government for pain funding and support. Those include academic groups, policy organizations and industry as well as private foundations, which could help underwrite pilot projects for integrated pain delivery as well as a public awareness and education campaign. But there’s a long lead time with those grant-making groups, and it’s likely to be 2018 before there’s any infusion of private dollars.
Stanford’s Sean Mackey says the magnitude of devising and implementing a national policy on pain will require a sustained effort. “It’s going to be up to all of us—legislators, regulators, insurance companies, patient advocacy groups, medical, nursing and dental schools, professional associations, foundations—to come together and enact these goals,” he says. “But there’s a great opportunity here.”
“National Pain Strategy: A Comprehensive Population Health-Level Strategy for Pain,” U.S. Department of Health and Human Services, April 2015. A panel of 80 experts outlines the stakeholders, goals and next steps for more coherent and effective management of pain.
“Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research,” Institute of Medicine, June 2011. The study mandated by the Affordable Care Act outlines the need for population-level solutions to pain.
ConsumerPainAdvocacy.org A coalition of 16 consumer organizations working to raise awareness of pain is monitoring the progress of the National Pain Strategy draft.
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