Despite its proven track record of success, and coverage by many federal and private third-party payers, spinal cord stimulation technology, the “pacemaker for pain,” still faces obstacles to acceptance that could leave many pain patients with no relief in sight. 

	In the face of decades of success in the use of spinal cord stimulation (SCS) to treat certain forms of neuropathic pain, new threats are emerging to the use of this technology, frustrating both patients with nowhere else to turn and the physicians who might be barred from giving patients what they need.

	Spinal cord stimulation—in layman’s terms a “pacemaker for pain”&mdash;has the coveted endorsement of the United Kingdom’s National Institute of Health and Clinical Excellence (NICE), one of the world’s foremost health technology assessment bodies. NICE said last fall that the implantable device “should be recommended as a treatment option for all chronic pain conditions of neuropathic origin.” In line with that assessment: Medicare, Medicaid, most private insurers, the military healthcare system, and 49 of 50 state workers’ compensation programs have covered this therapy for years.

	Susan Pleas-Kanarick needs no seal of approval from anyone. She has lived what so many others only know about SCS. While working as a medical equipment secretary in 1985, Pleas-Kanarick fell and injured her back. Immediately after surgery, Pleas-Kanarick, of Ferndale, WA, was denied rehabilitation coverage by the Department of Labor and Industries (L&I), the state agency that governs workers’ compensation for the state of Washington. Then, after falling again less than a year later, she kept working, even though the excruciating pain kept her from sitting for even brief periods. Visits to a series of specialist physicians resulted in a constantly modified medication regimen that provided little in the way of relief.

	Because L&I doctors said they found nothing wrong with Pleas-Kanarick, her claims for time lost were refused. Unable even to sleep, her life quickly devolved into a vicious cycle of constant pain and exhaustion. Eventually, fatigue forced her from her job. Over the years, Pleas- Kanarick kept trying one doctor after another. She turned to more medication, exercise, and cortisone injections. She even had metal plates bolted to her spine to stabilize her back. Still, nothing eased the pain.

	After suffering for six years, she learned about spinal cord stimulators. But L&I continued to say no to coverage. After another four years of anguish, her husband’s insurance stepped in and paid for the stimulator. She says the best day of her life was when that device was turned on. For the first time in years, the back pain was gone. L&I offered Pleas-Kanarick nothing to help her get back to work and live a normal life. But in a legal case against L&I, Pleas-Kanarick eventually won approval of her stimulator, the only treatment that worked for her. “This little unit continues to save my life from pain and medications,” she said. “This truly is a wonderful unit, which essentially gave me my life back. I am able to do all the physical activities that I want to try and can enjoy life to the fullest.” Despite Pleas-Kanarick’s triumph, L&I and others continue to stand in the way and block relief to countless others who suffer as she did. This obstruction comes despite the treatment’s proven success and despite the technological advancements that are making the device even more effective.

	Although Washington State is the exception and not the rule, 

 from the American College of Occupational and Environmental Medicine (ACOEM) could threaten patient access in other states. The ACOEM guidelines “fl y in the face of evidence-based medicine and threaten access by injured workers throughout the country,” says Joshua Prager, MD, MS, chairman of the 

 (NTAC), a consortium of stakeholders dedicated to promoting appropriate access to SCS and other neuromodulation therapies. The same ACOEM guidelines for pain disorders that find insufficient evidence to recommend SCS also do not recommend over one-half-of all pain-related tests and treatments, many of which are considered standard of care in the medical community.

	“ACOEM’s guidelines for the treatment of lower back pain, which recommend against the use of SCS, stand in total contrast to recent peer-reviewed studies including the UK’s NICE decision demonstrating the effectiveness of SCS for neuropathic pain,” adds Prager, who is also the director of the 

. Not only do these guidelines reach a conclusion that is out of step with Medicare, private payers, and peer-reviewed evidence, efforts are underway to make these guidelines "presumptively correct" by state workers’ comp programs around the country. That means that injured workers could very well end up at the bottom of a two-tier healthcare system. The NTAC and its members are working hard to ensure this doesn’t happen.

“I could hardly get through the day” 

	Every day she wakes up, Kim Hansen is grateful for the stimulator that has pulsed in her lower back for the past four years and returned her to the golf course, the running path, and a productive work life.

	When Hansen’s pain first surfaced more than five years ago, doctors found and removed a lesion on her spine, a complication from spina bifida. But the tumor caused permanent damage that left her with “shooting sciatic pain” in her lower back and a left leg that often went numb. She tried everything: massage, acupuncture, cortisone shots, and addictive narcotics. “That’s exactly what I didn’t want,” says Hansen, referring to the Vicodin and Oxycodone that she had been taking. “I was praying to stay away from that medication and avoid that narcotic haze.”

	Nothing brought her the relief she needed. “I could hardly get through a day,” she said. “I had to just keep popping pills.” Finally, her doctor told her of a device, which she can adjust with a remote control, that just might work for her. But her first insurance provider refused to pay for SCS, saying it was “experimental.”

	“I didn’t realize that my insurance company could say no to something that would make me better,” said Hansen, who sells health insurance in northwestern Washington, the only state whose workers’ compensation program denies this treatment for injured workers. I thought I would be left to taking drugs all my life.”

	Fortunately, her employer switched insurers, and new provider Group Health approved the device. In an out-patient procedure, she had the stimulator attached externally and “in the first hour, I had at least 75 percent relief.” After a week, “I knew I wanted to do the [permanent] surgery” and have the device implanted. From that first day with the implant until now, Hansen estimates, “I have 80 percent coverage of my pain. What little I have left is completely manageable. I have no other form of pain management.”

	Now the wife and mother of an eight-year-old son is convinced she would never be able to have another child without the device, because it would leave her to rely on the narcotics she abhorred taking. “It was hard to believe,” said Hansen, who is expecting her second child this summer. “How was I missing out on this?”

Washington: A state in a state of denial 

	Many others in Washington State sidelined by back and leg pain have the right to ask why they are still missing out. Despite the clear benefits of SCS, the agency in charge of the workers’ compensation program has for more than a decade steadfastly refused to cover the device. Physicians, pain patients, and their advocates throughout the state are frustrated by this decision because the agency is not compelled to review a position that denies so many the same level of care given to Medicare recipients, military personnel and their families, and patients covered by commercial insurance.

	This refusal by L&I highlights the need for better awareness and advocacy. “A couple of decades ago, Washington State was a leader in pain management education and treatment,” says Joe Jasper, MD, a leading interventional pain physician practicing in Tacoma. “Now, Washington is one of the worst states in which to seek interventional pain care. Washington’s workers’ compensation program is a true outlier, clearly at odds with the standard of care for chronic pain in its refusal to allow coverage for neurostimulation, pain pumps, and several other procedures. I see many patients in my practice, including injured workers, who could benefit from SCS. Unfortunately, the workers’ compensation program denies them this option. It’s bad policy and bad health care.”

	Prager says the good news is that physician societies and patient advocates have never been better organized to educate policymakers and advocates to ensure appropriate access. “The days are probably over of simply knowing a therapy works and expecting that payers and policymakers will cover it,” Prager says. “We have to promote the best possible evidence at our disposal and advocate to ensure that patients have access to therapies, like SCS, in order to alleviate their pain and improve their quality of life.”

Eric Hauth is the executive director of the 

 (NTAC), a national coalition initiated by leading interventional medical professional societies to ensure appropriate access to neuromodulation therapies through advocacy, quality initiatives, and public education. The mission and purpose of NTAC is to promote appropriate patient access to neuromodulation therapies, implantable therapies that are vital in treating a range of debilitating, chronic conditions such as neuropathic pain, seizure disorders, and Parkinson’s disease. For more information, contact Eric Hauth at 651-278-4238 or 

Articles

Feature Articles

Despite its proven track record of success, the "pacemaker for pain," still faces obstacles to acceptance that could leave many pain patients with no relief in sight. 

Touching a Nerve

	With an estimated 76.5 million Americans struggling with persistent chronic pain, there is no doubt that pain is woefully undertreated. An important part of the American Pain Foundation’s (APF) mission is to improve the quality of life of people with pain by advocating for the removal of barriers that impede access to effective pain management. The promotion of improved pain management practices is a critical part of this equation. APF, in partnership with key national pain experts, has identified core areas that must be addressed, including the integration of pain education in professional training, the advancement of balanced pain-related regulatory policies, and the promotion of open communication between healthcare providers and patients living with pain.

	As one of the most common reasons someone will seek medical care, pain is commonly reported as a primary chief complaint and frequently seen in the primary care practice setting. However, most healthcare professionals have not been trained in pain management, resulting in pain often being poorly assessed in most practice settings and looked upon as merely a symptom of other medical disorders. Marginalizing pain results in needless suffering and poor patient care outcomes. Untreated acute pain can lead to irreversible damage to the CNS; the disease of chronic pain evolves.

	Some providers refer those with pain complaints, no matter the cause, to a pain specialist. With approximately one pain specialist for every 21,000 patients, access to specialized pain management care is limited, forcing those in pain to either delay pain care, doctor shop in a desperate attempt to find care, or purchase medications from dubious sources.

	It is critical to have pain management training included in the core curriculums of schools of medicine to ensure that healthcare professionals have the skill set and resources to properly assess someone with pain and provide quality pain management. Providers must be prepared to understand how pain can influence all aspects of a person’s life and be able to recognize the signs of addictive disease or problematic behaviors without the fear that treating pain appropriately can cause or feed an addiction.

	In addition to improving professional education, universal regulatory policies need to be adopted. The perpetuation of myths and misconceptions about pain, its treatment, the obligation of medical ethics, and the medico-legal impact on practice fuels private and hospital practice policies. Physicians’ fears of being investigated or disciplined by state and federal regulatory agencies—particularly around the appropriate use of opioids to manage persistent chronic pain&mdash;have proven fertile ground for this dilemma. Physicians may feel that the need to protect their practice and livelihood takes precedence over the best interest of the person in pain; this significantly undermines the tenants of medical ethics and increases patient suffering.

	State medical boards’ regulatory processes are often confusing, which can restrict a practitioner’s ability to appropriately prescribe for pain management. Though in existence since 2002 as a guideline and established as a policy in 2004, the Federation of State Medical Boards Model Policy for the 

Use of Controlled Substances for the Treatment of Pain

 has yet to be adopted in all 50 states. Several state professional boards have used this policy as a cornerstone to develop a consensus document, yet integration into the practice setting has been hampered due to poor implementation strategies.

	How effective is the communication between the healthcare professional and the person with pain? In September of 2008, a nationwide survey found that a sizable gap exists between patients and healthcare professionals when it comes to understanding and discussing pain. Ineffective communication contributes to the complexity of pain care and leads to the under-treatment of pain. Personalized conversations about the pain experience and the impact on daily living are critical. Research has found that simply acknowledging a person’s pain can have profound therapeutic results.

	To address the communication gap, a group of leading pain management organizations have formed the 

. The purpose is to unite the perspectives of people with pain, caregivers, and healthcare providers and encourage them to "Talk, Listen and Act" to help improve overall pain care.

	As the 75 million baby boomers move toward retirement, the epidemic of chronic pain is expected to grow at an alarming rate, with the economic toll of pain exceeding more than $100 billion each year. The bottom line is that people in pain have a right to timely, effective care. The APF will continue its mission of improving the quality of life of people with pain by raising awareness, providing practical information, promoting research, and advocating to remove barriers and increase access to safe and effective pain management.

Will Rowe is Chief Executive Officer of the 

An important part of the American Pain Foundation's mission is to improve the quality of life of people with pain by advocating for the removal of barriers that impede access to effective pain management.

Improved Education, Consistent Policies, and Better Communication Are the Cornerstones of Effective Pain Management

Fibromyalgia is a chronic pain condition that affects millions of people. Advocates and patients have fought for years to raise awareness of fibromyalgia in the medical community and gain recognition for it as a legitimate illness. 

	More than 10 million Americans, approximately 80-90% of them women, have fibromyalgia. More than one-third of patients seen in rheumatology offices have fibromyalgia. The National Institutes of Health allocates millions of dollars for fibromyalgia research. The disorder is recognized by the Food and Drug Administration and the World Health Organization, as well as other prominent national and international organizations.

 about fibromyalgia read: “Drug Approved. Is Disease Real?” A February 8, 2009 

 on the marketing tactics employed by pharmaceutical companies that produce fibromyalgia treatments asked “whether it’s a real disease at all.” Even Fred Wolfe, the lead researcher on the 1990 American College of Rheumatology 

 article as having doubts. “Some of us in those days thought that we had actually identified a disease, which it clearly is not,” he said. “To make people ill, to give them an illness, was the wrong thing.”

	For decades, patients with fibromyalgia have fought the battle for recognition. They may go for years without receiving an accurate diagnosis, and when they finally are diagnosed with fibromyalgia—after visits to perhaps more than a dozen HCPs&mdash;they have to wrestle with a healthcare community, media, and a general public that question the very existence of the disease that causes chronic, all-over body pain, debilitating fatigue, and cognition problems, plus a number of other symptoms and overlapping comorbid conditions, including interstitial cystitis, migraine, and irritable bowel syndrome. Because studies haven’t identified the exact cause of fibromyalgia or generated definitive techniques for making a clinical diagnosis, it is still not accepted as a “real” disease.

	In a 2007 National Fibromyalgia Association 

 of physicians, 90% of respondents agreed that there is a need for more physician-oriented information about the condition, and 82% agreed that fibromyalgia is difficult to treat with currently available tools. Historically, other complex diseases have faced the same challenges, including multiple sclerosis, Parkinson’s disease, and Alzheimer’s disease. And perhaps it is the slowly evolving understanding of fibromyalgia that is partly to blame for the still-rampant lack of awareness of the disorder.

	Although this chronic widespread pain condition was christened “fibromyalgia syndrome” in the mid-1980s, it has been around for centuries. Our grandmothers were probably told they had rheumatism, and Elizabeth Barrett Browning was thought to suffer from the “vapors,” but their symptoms all point to fibromyalgia. At one time, inflammation was thought to be present in fibromyalgia, which helped to propagate it as an autoimmune illness; however, current research indicates that it’s a disorder of the central nervous system.

	In 1981, Muhammad Yunus, MD, and colleagues published their pivotal paper “

, and a new era of scientific thought began. Back then, fibromyalgia research money was unavailable, so investigators funneled leftover funds from other projects into small, often single-blinded studies. Because of the lack of funding, participant numbers were small and study designs were limited, resulting in researchers being chastised by their peers for their work being beneath most scientific standards.

	However, dedicated scientists continued to push forward. In 1990, the American College of Rheumatology (ACR) developed the criteria for the classification of fibromyalgia, consisting of a history of chronic widespread pain lasting longer than three months in all four quadrants of the body, coupled with an exaggerated response to 4kg of pressure at 11 of 18 tender points located at specific anatomical positions. Although the ACR criteria for the classification of fibromyalgia were developed specifically as a measurement tool for scientific research, they are now consistently used to diagnose fibromyalgia in clinical settings.

	In 1992, there were only about 200 published fibromyalgia papers, compared to more than 4,500 today. That is a tremendous increase in interest and attention, and yet fibromyalgia is still often seen as a sort of rheumatologic stepchild, less deserving of research funding than other health issues. In 2005, the NIH allocated $70 million for inflammatory bowel disease research and $26 million to study interstitial cystitis, an illness that affects just over 1 million Americans. The NIH granted $89 million to study lupus, a disease with an estimated patient population of between 1.5 and 2 million. These illnesses are comorbid conditions with fibromyalgia, and yet the 

 only $10 million for fibromyalgia research that same year.

	Fibromyalgia is still not included in most medical school curricula, and practicing physicians for the most part remain unaware of the latest developments in fibromyalgia research, including studies that show fMRIs and SPECT scans reveal subtle but important changes in patients’ brains in response to a pain stimulus compared to healthy subjects. Studies have also revealed neurochemical abnormalities in fibromyalgia patients, including lower than normal levels of dopamine and serotonin and higher levels of substance P. Three medications approved by the FDA—pregabalin, duloxetine, and milnacipran&mdash;are making a positive impact on fibromyalgia symptoms in some patients. Nevertheless, the public and many members of the medical community are still questioning fibromyalgia as a legitimate diagnosis. It is time for more research, more continuing medical education, and a better understanding of how fibromyalgia affects the quality of life of millions of people.

 (NFA), is a perfect example of a typical patient struggling with fibromyalgia. In 1988, she was a successful businesswoman running a marketing company in California. Her life radically changed when she woke up during endometriosis surgery. Later in the recovery room, she sensed something had changed and her body felt different. After being in bed for almost three years—losing the business in the process&mdash;and visiting more than 30 healthcare professionals, she was finally diagnosed with fibromyalgia. While still bedridden, she connected with an online friend who also had fibromyalgia, Karen Lee Richards, and together they launched the National Fibromyalgia Awareness Campaign.

	In the beginning, she thought it would take only a couple years to alert the public and medical community about fibromyalgia and the life-altering devastation the disorder can cause its victims. Now, more than 12 years later—even with FDA-approved medications, more than 4,500 published scientific articles, and multimedia campaigns&mdash;the challenges to raise awareness remain.

	In addition to providing patient education programs, a major part of the NFA’s efforts to raise awareness of fibromyalgia involves creating and promoting educational initiatives for physicians and other healthcare professionals. Last year, the NFA partnered with California State University, Fullerton and others in securing a UniHealth Foundation grant to develop a free eight module online 

 as part of the Fibromyalgia Assessment, Management and Education (FAME) project. In September 2008, the NFA launched an online 

 for healthcare professionals; currently, the organization is developing more than eight CME programs, including one in partnership with the Johns Hopkins University School of Medicine and the Johns Hopkins University School of Nursing.

	The NFA and other organizations striving to empower patients and raise awareness of fibromyalgia rely on the assistance of physicians and researchers who are willing to share their expertise, and on the cooperation of patients who are willing to speak out and share their experiences. Much progress has been made in the past decade in improving our understanding of fibromyalgia, yet so much remains to be done. Physicians and other healthcare providers can help by learning more about diagnosing and treating fibromyalgia through the FAME project and other CME programs; ensuring they follow and properly administer the ACR diagnostic criteria; and gaining a better understanding of the benefits and limitations of FDA-approved fibromyalgia medications (these drugs work on only about 30% of patients, but sometimes they can be used together or with other medications for even better outcomes). A multidisciplinary program utilizing medication, an appropriate exercise program, and other treatment modalities is optimum for patient treatment.

	It is time for fibromyalgia to be recognized as a legitimate condition that can have a devastating effect not only on patients’ quality of life, but also on the lives of their families, loved ones, and employers. Healthcare providers must invest the same amount of time in learning about the latest research on fibromyalgia diagnosis and treatment as they do with any other illness. Offering respect for their fibromyalgia patients, who are dealing with a life-altering, chronic illness, is the right and honorable thing to do.

Rae Marie Gleason is executive director of the National Fibromyalgia Association, headquartered in Anaheim, CA. For more information, call 714.921.0150 or visit 

Cover Story

Advocates and patients have fought for years to raise awareness of fibromyalgia in the medical community and gain recognition for it as a legitimate illness.

March/April 2009

Touching a Nerve

Improved Education, Consistent Policies, and Better Communication Are the Cornerstones of Effective Pain Management

Invisible No Longer: Fibromyalgia and the Struggle for Recognition