Publications
APS Bulletin • Volume 13, Number 3, 2003
Articles
The Decade of Pain Control and Research
John D. Loeser, MD
Editor’s Note: Following is the transcript of the Decade of Pain Control and Research Special Lecture presented by Dr. Loeser at the APS Annual Meeting on March 20, 2003.
How did we get a Decade of Pain Control and Research? This wonderful 10-year epoch was the inspiration of Dr. Phillipp Lippe; he based it upon the concept of the Decade of the Brain, which had been successfully promulgated by the Society for Neurosciences and other professional organizations. This has not been a commonly utilized mechanism in Congress, and there was resistance to repeating the process after the Decade of the Brain. Dr. Lippe discussed his dream with several organizations and key people, but there was difficulty moving the idea forward through routine channels.
The Pain Care Coalition, a joint effort by the American Pain Society, the American Academy of Pain Medicine, and the American Headache Society, took up the cause. Michael Ashburn was able to enlist the help of Senator Orrin Hatch, the Chairman of the Senate Judiciary Committee, in whose purview such matters lie. Hatch attached the resolution creating the Decade of Pain Control and Research to a bill focused on crimes against women. It was accepted by the Conference Committee, passed in both Houses, and signed by President Clinton in November 2000 as HR2344. The part we celebrate today is known as Title VI, Section 1603. It reads, “The calendar decade beginning January 1, 2001, is designated as the “Decade of Pain Control and Research.”
The American Pain Society established a Task Force for Agendas for the Decade of Pain Control and Research. Four agendas were established: research, professional awareness, policy, and public awareness. Each agenda has a set of objectives with specific tasks to be accomplished. These were described on page 3 of the July/August 2002 APS Bulletin. I am sure there is one objective that interests every member of this Society, and I encourage each of you to take up that cause. Since I have played no role whatsoever in this marvelous accomplishment by individual members who care, I have been asked to deliver this keynote address.
We should ask ourselves what is going to happen if we do not seize this opportunity to make a difference in the remaining 9 years of our Decade. To assist in this process, I first will peer into the future, extrapolating from the current situations surrounding pain research and patient care and assuming that we will follow the pathways that have been established in the past decade or so. This process must start by a look back at the past 50 years, for we should remember Santayana, who said, “He who is ignorant of the lessons of history is destined to repeat them.” Then I will ask how could we have made a difference in the Decade of Pain Control and Research and improved the outcomes for our patients and the knowledge base for the generations of scientists and physicians who will follow us. Those who are concerned about caring for patients with pain and expanding our understanding of mechanisms and treatments must play a leadership role in shaping the future of research, clinical practice, and healthcare delivery. I will address all of these as well as problems with narcotics. First, I will look at research.
Research
In my professional lifetime, both the volume of pain research and its quality have dramatically expanded. When John Bonica began lobbying for pain research, there was almost no NIH-funded research on any aspect of pain. There were a few exceptional scientists who had made contributions, such as Henry Beecher, Ray Houde, and Bill Livingston, but nothing was organized. Scientists studied only normal animals and volunteer subjects who were trained to make discriminations based upon non-tissue-damaging stimuli. The idea that tissue damage or injury to the nervous system might alter the way that transmission of nociceptive information occurred or create abnormal impulse transmission when no noxious event had transpired was not in the collective consciousness. Indeed, when, in 1965, I first conducted physiological experiments on the dorsal horn neurons in cats who had had prior dorsal rhizotomies or spinal cord transactions, I was cautioned by the professor and chairman of physiology at the University of Washington, who was the author of the standard textbook of neurophysiology, that “no self-respecting scientist would ever study a damaged nervous system.” That viewpoint kept us from beginning to understand the mechanisms of chronic pains and those pains that were generated by nervous system injury. How silly such a viewpoint seems today, but we are always at peril that our successors will not look kindly upon our errors and inflexibilities.
Pharmaceutical and device manufacturing companies were not looking at new products in a systematic way. Opiates, aspirin, and acetaminophen were considered adequate. Their research budgets were relatively small, and major efforts were being put into the development of new antibiotics, but nothing similar was happening for analgesics. Experimental models for chronically painful conditions did not exist. The links between scientists and the corporations developing drugs and devices were few, and the public marketing efforts of these companies were limited. The companies did not often support meetings or journals.
This began to change in the late 1980s, and, by the end of the last decade, private industry was driving a major portion of the pain research efforts. Good scientists were leaving academia and working for drug and device companies, to no small degree due to the development of models of chronic pain that came from the NIH and academia. Money to support meetings, educational activities, and research shifted from the NIH and academia to private industry. Although the availability of such funds has certainly been useful, this has led to significant changes in what is being studied and talked about at meetings and published in journals. Indeed, it even generates journals devoted to topics of special interest to those who provide the funds. The mere fact of publication lends legitimacy to a new drug or treatment even if the quality of the research is poor. Several recent papers have shown that blinding is often a failure even in well-designed studies, and that patient and provider expectations are strong predictors of outcomes (Kalauokalani, Cherkin, Sherman, Koepsell, & Deyo, 2001; Turner, Jensen, Warms, & Cardenas, 2002).
There is nothing inherently wrong with corporate research and funding for education and research in academic centers. The problem is the selective nature of what gets funded and the risk that critical basic studies are not able to compete with targeted research. If we do not change this trend, the economic issues that drive corporate behavior will further skew research efforts and promote treatment modalities out of proportion to their actual efficacy. The big pharmaceutical companies now dominate clinical research. Most of the research is in multi-center, FDA-mandated, corporate-funded research on new products. Fundamental research with no obvious direct link to a marketable product will be even less popular. Many of the best minds will work for drug and device companies and not focus upon basic issues. We do live in a capitalist society, thank goodness, but we must remember that the definition of capitalism is that money motivates behavior. Getting a product to market and making a profit involves much more than the science that produced the drug. There is a growing literature on the misleading designs and reports of drug company-sponsored trials (Safer, 2002). Once a drug or device is FDA approved, there is little incentive to learn more about it. Off-label prescribing by physicians means that science can be abandoned and even more drugs or devices can be sold on the chance that something good might happen. It must be seen as bizarre that physicians can apply treatments, drugs, and operations to patients only on the hope that something of benefit to the patient will accrue. Journal supplements funded by drug and device manufacturers contain articles on off-label usages and permit the manufacturers to get around the FDA prohibition on advertising off-label drug or device applications. There is no mandatory recordkeeping, sharing of outcomes data, or standards for evaluating outcomes. Since open label trials usually have significantly better outcomes than prospective, randomized, double-blind trials, it must be the non-specific effects that are inherent in the doctor-patient or pill-patient relationship that provide for the apparent beneficial outcome from most of these off-label usages of drugs, devices, or therapies.
Unless we use the Decade of Pain Control and Research to change these trends, we will end up having sold out to the big guys. Those pain management strategies that do not involve new drugs or high technology will not be carefully examined and are likely not to receive adequate recognition and implementation. Somehow, we need to establish research priorities that are supported by major non- commercial funding agencies. We must also get the corporations to fund basic science and not just multicenter FDA-mandated trials. It has been alleged that drug companies provide one-third of the American Psychiatric Association’s budget, and I am certain that something similar to this is true about the major American specialty and pain organizations as well (Borenstein, 2000). Basic and clinical research will need expansion and the opportunity to follow investigator interest and not be targeted at specific drug or device issues. In the long run, both the research communities and drug and device companies will profit from such a broad research strategy.
We need to work for salary levels and working conditions in academia that are competitive. Academic healthcare providers cannot be pushed into generating revenue for their institutions rather than teaching and advancing science. Pain research must be given a visible position within academia. Laboratories devoted to pain research need to be established and funded. We really should push for departments or divisions of pain management that transcend any single department or even a single discipline. Particularly in the study of chronic pain, there is no particular relevance to anesthesiology and no reason to house pain management, other than post-operative pain, in that discipline.
Translational research is critically important if we are to take full advantage of this decade of progress in the world of pain. Things learned by the study of basic mechanisms in animals need to lead to developments in patient care. Interesting observations made in the laboratory or the clinic need exploitation to develop treatment strategies that will advance patient care. The research environment must provide feedback from the clinic to the laboratory. The Decade of Pain Control and Research has given us an opportunity to change the directions of research in the past 20 years. We need more study of the epidemiology of chronic pain, as well as the natural history of painful conditions. We need to push the NIH to devote more of its resources to the study of pain on all levels. We need to increase the training support for those who are considering careers in pain research. This type of action requires the efforts of more than a few key people. It must be on the agenda of every pain-related organization, both professional and public. Unrelieved pain affects more people than any specific disease; an NIH institute would certainly be appropriate. We need to become the squeaking wheel of research.
Patient Care
Patient care is certainly the primary activity of the majority of our members. We come to this through different educational backgrounds and have different skills, attitudes, beliefs about how to provide care for those who suffer from pain. Few of us have the perspectives of more than one discipline or even medical specialty. We are all prisoners of our referral system and cannot know the universe of those who suffer from pain based upon our personal practice experience. We have the desire to use our skills to help our patients, and that is the primary motivator of those who provide health care, I hope. Yet, as one travels around this country, yet alone the planet we live on, there is tremendous variation in what care is provided for those who hurt. Some of this is due to resource availability, and I will address this later.
The biomedical model has been responsible for many improvements in modern medicine. It is, however, fatally flawed because it does not consider events outside the patient as relevant to disease in general or pain in particular. A biopsychosocial model at least identifies some of the extra-personal relevant factors. The failure to recognize the limitations of the biomedical model has led to a great divide in pain treatment. It also has led to tremendous healthcare expenditures whose utilities can be questioned. A dichotomous approach to chronic pain management has developed in the United States, typified as those who perform procedures and those who provide care for patients with pain. John Bonica had something to say about this 50 years ago when he wrote, “Perhaps the first and one of the most important principles in using nerve blocks is that the practitioner assume the responsibilities and discharge the obligations as a physician rather than act merely as a technician who is an expert in inserting needles...His behavior and attitude toward the patient must be that of a doctor who is particularly interested in the patient’s welfare, rather than that of one focusing his entire attention on the interruption of nervous pathways.”
This part of his message has been lost and a great schism has developed. It is fueled by the absence of outcomes data and by the golden rule in a capitalist society: He who has the gold makes the rules. The methods of paying for healthcare in our country do not reward all types of endeavor equally. Proceduralists and surgeons make more per unit of time than those who use exclusively cognitive skills. In addition, the change from an unfettered fee for service system to one in which fees are set by governmental and insurance agencies adds another point at which financial rewards are skewed toward interventions. Those who have been trained to provide comprehensive services feel pressured to do more procedures because of the potential for enhanced revenue generation. Those who only know how to do procedures find more and more patients who are willing to have these interventions. Institutions want to hire proceduralists who will generate significant revenue to enrich them.
Now, it has always intrigued me that a radiologist who undertakes imaging studies of chronic pain patients does not call himself a “pain radiologist”. Why then do we allow those who only perform injections to call themselves “pain specialists”? Procedures can certainly be of value in selected patients, but someone has to provide care and caring, and that person should be the only one labeled “pain manager” or “pain specialist.” This schism is perplexing to patients and to those who fund health care. This problem is derived from the fact that health care has never been driven by science or information on outcomes. Consider how we laugh at the 19th Century bleeders and purgers, yet both doctors and patients believed in these useless and sometimes harmful types of therapies. We need to realize that much of traditional health care is not based upon science any more than complementary and alternative medicine. It is just what we have done for a long time.
If we are to make health care for chronic pain relevant and effective, reduce unnecessary interventions and treatments, and deflect the rush toward complementary and alternative healthcare strategies, we must interrupt the current trends. We need to figure out how to present a comprehensive pain management plan that puts each type of healthcare intervention into a treatment algorithm. To do this, the first need is for outcomes studies to determine what happens to patients after different types of treatment. Such outcomes studies must include pain ratings, functional status including work, healthcare consumption, medication consumption, and management costs. Ironically, few perform and even fewer fund such studies. We need to call a halt to interventions without reasonable outcomes data. Treatments must be based upon characteristics of the patient— physical, psychological, and social. There is now ample data on multidisciplinary pain management, but very little on nerve blocks, facet injections, epidural steroids, spinal cord stimulators, or alternative and complementary health care (Turk, Loeser, & Monarch, 2002).
A revolution in pain management has occurred in the past 25 years. Not everyone has heard the message, but its key issues are obvious. Pain is no longer a by-product of disease. Pain is deserving of diagnosis and treatment. Those who care for patients with pain must do more that treat pain; they must care for and manage the patient with the pain. Chronic disease in general has been ignored by the biomedical imperative of the 20th Century; pain must be considered a major health problem.
Finally, caring for patients means more than applying technology. A revolution is needed to bring into focus the importance of knowing a patient as a human being and listening to his or her narrative (Charon, 2001). Patients do not belong to us, their care providers. They also are a spouse, a child, a parent, a member of a social group, an employee, a citizen, and many other things. To know a patient’s pain, one must first know the patient. This takes time and the ability to listen and to empathize. All these are not often found in proceduralists’ or primary care practitioners’ offices. It is not that I am opposed to interventions, for I earn my living as a neurosurgeon. I do recognize, however, that every needle has a sharp end that goes into the patient and a blunt end that is attached to a provider. And, every scalpel has a blade that encroaches upon the patient and a handle that attaches to a surgeon. Anyone who thinks that all the action occurs at the sharp end does not understand either health care or human behavior (Turner, 2001).
It is the suffering that is generated by chronic pain that brings patients to seek health care (Loeser, 2000). Suffering cannot be found on an image of the spine or an electro-diagnostic test. Events outside of the patient’s body are likely to be relevant and must be included in one’s patient assessment and treatment plan. The patient’s narrative serves as a link between the healthcare provider and the sufferer. A pain manager must spend the time to get to know the patient and listen to his or her story. The healing process for a patient with chronic pain usually involves those who surround the patient and not just a change in anatomy or pharmacology. Procedures may have utility, but someone had better prove this before we continue the present high-cost interventions that characterize pain treatment in this country. Mainstream medicine has often endorsed useless therapies; philosophers and writers have often seen their follies.
Healthcare providers underestimate the role of non-specific effects in determining treatment outcomes. In a sense, what we are doing to patients justifies what we really do for patients: listen to them, touch them, and offer advice and guidance and prognosis, giving back the feeling that they have control over their lives, and many other non-specific effects. This is why it is so hard to demonstrate outcomes that are specific to a treatment strategy. Providers need to learn more about what it is they really do to patients. The CAM frenzy is just another fad generated by dissatisfaction with allopathic physicians, practitioner revenue, and non-specific treatment effects. I welcome the attention to outcomes research in this arena, as well. The real problem is how to meld the needs for specific treatment effects with the needs for physicians and others as healers. The latter role is based upon interpersonal skills more than science. Patients clearly have needs for both, and pain research and management must incorporate both aspects of treatment. As eloquently written by Allan Basbaum, “Pain is not just a stimulus that is transmitted over specific pathways, but rather a complex perception, the nature of which depends not only on the intensity of the stimulus but on the situation in which it is experienced and, most importantly, on the affective or emotional state of the individual. Pain is to somatic stimulation as beauty is to a visual stimulus. It is a very subjective experience.”
Healthcare Delivery
We have no system of healthcare delivery in the United States, and we are not likely to achieve one in the next decade. The trend is quite clear; the majority do not want more taxes and health care already is 14% of the GNP; any change to make access to health care readily available for the 40 million who do not have any is likely to cost a lot of money. Although I am certainly not in favor of governmentally organized and sponsored health care, I am in favor of the concept that everyone living within our borders needs to have basic health care. This includes pain management, both acute and chronic. This is not the direction that health care is going in our country. To some degree, this stems from the traditional viewpoint of pain as a by-product of disease; if the disease is not covered, nor is the pain it causes. It also stems from the indifference that many healthcare providers have for someone else’s pain. Elaine Scary caught the essence of this in her book, The Body in Pain, in which she wrote, “To have pain is a certainty. To hear about pain is to have doubt.” Insurance companies try to spend as little money as possible, and pain management is often outside of what is funded. An interesting trend has recently appeared, however. Multidisciplinary pain management was commonly not funded because it was seen as too expensive and not proven. Now it is well studied and the outcomes are known. What was an alternative form of treatment is now mainline. The costs of interventional therapies are so high and unproven that insurance companies are beginning to look again at multidisciplinary pain management.
What must we pain specialists do to alter the trajectory of pain management within American health care? First, all physicians have a moral obligation to see to it that everyone in this country has access to basic health care. Second, whatever healthcare delivery system we work in, we must labor to have both acute and chronic pain management included within funding guidelines. The VA has done a good job in this respect. JCAHO has set standards for hospitals. We need to get private insurance and federal and state programs to mandate the provision of and the funding of pain management. We must, however, separate employment status from healthcare availability. All of this means that those of us who care must work on state and federal levels to reach our goals. This type of activity will be facilitated by achieving recognition for professional organizations focusing upon pain management and not linked to any one medical specialty. The discipline of pain management needs to establish itself as having one voice, one educational agenda, and one standard of care. Then we need to work to obtain recognition in the AMA, the ABMS, and in various governmental arenas. Then we need to yell, shout, scream, urge, cajole, manipulate—whatever it takes to get pain management on an equal footing with other aspects of health care.
Another wonderful book I recommend to those interested in pain is Ingenious Pain, authored by Andrew Miller. He writes, “All pain is real enough to those who have it; all stand equally in need of compassion.” I see an analogy with the Berlin Wall; it fell for moral reasons, and that must be the cornerstone of our campaign for pain. We must take our argument to the public and enlist its support, for it is their health care we are talking about. This is a moral issue, for only a corrupt society ignores pain and suffering.
Education
Everything depends on education. The public must be educated to demand adequate pain management services. Healthcare providers must learn the sciences basic to the diagnosis and treatment of pain and must learn effective and compassionate pain treatment strategies within each clinical specialty. The government-inspired myths about the risks of treating pain with narcotics must be challenged. Undergraduate medical education is particularly important for our quest, but it is very difficult to get curriculum time. Every residency must incorporate relevant aspects of pain management for its trainees’ education. CME courses on pain management need to be readily accessible. Some of you may know that the California legislature mandated 12 hours of CME on pain for every physician with a license in the state by 2006. Although mandatory government educational content is not the preferred mode of establishing educational programs, if that is the only way forward, it is better than ignorance and indifference. Every opportunity to introduce education about pain to every type of healthcare provider should be explored. This is particularly important for end-of-life care, where pain and suffering are usually the major issues (Cassell, 1999). There remains much ignorance among healthcare providers. This is a particular responsibility for those of us who are employed in academia and play a role in the training of clinicians. Our students must learn there is more to their training than learning the sciences basic to pain. Healthcare providers have existed since before the beginning of recorded history, yet almost all effective treatments as we know them have originated in the past 150 years.
Narcotics
I hope there is another reason I was selected to give this lecture, although I do not have the slightest piece of evidence to support such a delusion. Last year’s keynote speaker was Asa Hutchinson. I dreamed that I was selected because of the equal time doctrine that is required for those who wish to use the airways for radio and TV. I am opposed to most of what he said about narcotics and what he stands for in the attempt to constrain human behavior. I believe pain researchers and clinicians should reject the traditional and contemporary American method of dealing with socially problematic issues about substances that are inhaled, swallowed, or injected. If the misbehaving individual won’t just say no, then society will say no for him and to him. It is time that everyone recognize that prohibition creates crime and criminals and does not reduce the use of the substance of concern. It shifts funds flow from legitimate business and taxation by government to the support of large, international criminal organizations that respect none of our democratic traditions. Almost all those employed in the manufacture, distribution, and sales of alcohol have legitimate jobs and pay taxes.
More than one-half of those in jails in our country are incarcerated because of their drug use. In my state of 5 million people, there are more than 8,000 in jail for drug use at a cost to the taxpayers of $63 per day per person, or $184 million per year. The drug policies in our country are in large part responsible for many of the issues confronting pain management today. Our government has funded one campaign after another to frighten the public about narcotics, even when they are used for medicinal purposes. A recent federally funded TV ad seen while I watched the Superbowl suggested that marijuana leads to unwanted pregnancy! The ancient Greeks thought it was the East wind; I told my children a different story. What is legal to put into one’s mouth or nose is determined by social convention and not by medical science. Of course, there is a potential problem with the diversion of drugs intended for the relief of pain. If you think that is what the drug wars are all about, you do not know what is happening out there. The history of opiate use and its regulation is a mirror for health care. There are lessons to be learned from studying opiates and their use that can be applied to many other remedies and not just pain management. If you want to learn more about narcotics since the dawn of history, read the wonderful new book by Richard Davenport-Hines, The Pursuit of Oblivion. His conclusions seem rational to me, and his ability to make history talk to us is superb.
Physicians who specialize in pain management need to play a leadership role in the struggle to rationalize this country’s concepts about controlling the ingestion of substances that can be deleterious to physical and mental well being. Look into the organization, Physicians’ Leadership on National Drug Policy. The utilization of opiates was mainly outside of medicine for the first 3,000 years of recorded use. It was forced into medicine by the attempt to curtail use in the early 20th Century in a project driven by the United States government. Then, the social strictures were applied to the medicinal usage of these drugs. We now find our ability to utilize opiates is impacted by the prohibitionist federal government. Most pain managers agree that opiates are the cornerstone of the management of moderate to severe pain.
Suffering from pain is a far more immoral event than ingestion of narcotics for non-medicinal purposes. Those who are responsible for the treatment of patients with pain must lead the fight to eliminate inaccurate information and threats to the public and to providers about using narcotics for the relief of pain. This I see as a moral obligation on our part, as the relief of suffering is the highest calling for a healthcare provider. I do not believe that every pain can be successfully treated with narcotics. Published reports seem to indicate about a 30% reduction in pain with narcotics. Is that adequate pain management? I see many problems with the shift towards more liberal use of narcotics for chronic pain, for these drugs are not a panacea. Pain is not simply a sign of narcotic deficiency. We do not, however, need to fill the public mind with propaganda and our jails with those who have not harmed another person. We should remain mindful of Voltaire’s gibe at physicians: “Doctors pour drugs, of which they know little, for diseases of which they know less, into patients—of which they know nothing.”
Conclusions
I have tried to assess where we are today in pain research and management, where we seem to be going, and what needs to be done to alter our course so that we can achieve meaningful goals in the Decade of Pain Control and Research. Pain management must be established as an essential component of health care. Treatment algorithms based upon outcomes studies must be established. Basic research needs to show us new ways of coping with tissue damage and injury to the nervous system.
There is a moral imperative to pain management that does not exist in many of the activities of modern healthcare delivery. It is our obligation to respond to this mandate and change the way our society deals with pain and suffering. We have a once-in-a-lifetime opportunity to gain access to the public, healthcare researchers and providers to advance the causes of the relief of pain and suffering. It will take planning, money, and, most importantly, individual efforts by those who care. I do not see how we can do any less for our patients. I would like to close with a message from the mathematician-philosopher, Bertrand Russell who went to the dentist with a toothache. “Where does it hurt?” the dentist asked. “In my mind,” the philosopher replied. “Does anyone think that a tooth or a back can hurt?”
I thank you for your attention and hope that you will use this wonderful meeting as the next step on your march for the Decade of Pain Control and Research.
References
Borenstein, D. (2000). Pharmaceutical companies. Psychiatric News, 35, 3.
Cassell, E. (1999). Diagnosing suffering: A perspective. Annals of Internal Medicine, 131, 531-534.
Charon, R. (2001). Narrative medicine. Journal of the American Medical Association, 286, 1987-1902.
Kalauokalani, D., Cherkin, D.C., Sherman, K.J., Koepsell, T.D., & Deyo, R. (2001). Lessons from a trial of acupuncture and massage for low back pain. Spine, 26, 1418-1424.
Loeser, J.D. (2000). Pain and suffering. Clinical Journal of Pain, 16, S2-6.
Safer, D.J. (2002). Design and reporting modifications in industry-sponsored comparative psychopharmacology trials. Journal of Nervous and Mental Disease, 190, 583-592.
Turk, D.C., Loeser, J.D., & Monarch, E.S. (2002). Chronic pain: Purposes and costs of interdisciplinary pain programs. The Economics of Neuroscience 4, 64-69.
Turner, J.A., Jensen, M.P., Warms C.A., & Cardenas, D.D. (2002). Blinding effectiveness and association of pretreatment expectations with pain improvement in a double-blind randomized controlled trial. Pain, 99, 91-99.
Turner, J.A. (2001). Nonspecific treatment effects. In J.D. Loeser (Ed.), Bonica’s management of pain, 3rd edition (pp. 1649–1656). Baltimore, MD: Lippincott Williams and Wilkins.
Dr. Loeser is professor of neurological surgery and anesthesiology at the University of Washington in Seattle.