Chonic Pain Conference
Chronic Somatic Syndromes Consortium
Introduction: For many years, researchers have studied conditions such as fibromyalgia, irritable bowel syndrome (IBS), chronic fatigue syndrome (CFS), temporomandibular joint disorder (TMJD), somatoform disorders, Gulf War Illnesses, and related entities as independent illnesses. Our early findings indicated substantial overlap in symptoms and similar underlying neurophysiology such that more recent research has been enlightening in exploring their commonalities. Today, the aggregate scientific knowledge regarding this spectrum of illness is now finally mature enough to allow us to say that there are common, understood, mechanisms that underlie all of these disparately-labeled entities. Similarly, there is a core set of drug and non-drug treatments that improve symptoms and function in this spectrum of illness. However, this message is not “getting out”. This is in large part because there is no credible scientific entity that has “accepted ownership” of this entire spectrum of illness.
Ordinarily, “ownership” of an illness is associated with the physicians and scientists from the discipline most closely aligned with the illness under consideration. But this spectrum of illness affects the entire body. A very common illness that needs no specialized procedures or treatments would ordinarily be the responsibility of primary care physicians, but most of these health care providers are not aware of the latest findings regarding mechanisms or treatment of this spectrum of illness, and as such they do not feel “equipped” to take on this challenge. Similarly, no group of sub-specialists now (reluctantly) caring for the spectrum of illness that affects “their region of the body” wants to take a larger role in caring for the entirety of these patients. Our research group at Michigan would like to take the initial steps toward creating an academic consortium of scientists who are committed to performing ongoing research in these illnesses and who are interested in developing structured diagnostic guidance and education for peer clinicians and the lay community.
The purpose of this organization is to accomplish several objectives:
- To explore the need for development of evidence-based and expert consensus guidelines regarding the most effective treatments in this spectrum of illness. At present, such guidelines are sporadically developed for individual conditions within this continuum (e.g., for fibromyalgia, or IBS), but generally not for the entire spectrum of illnesses. The few such guidelines that are for individuals with multiple somatic symptoms are, arguably, too reliant on the “somatoform” view of the world, and do not recommend use of some of the newer drugs that likely would be effective in patients with multiple somatic symptoms. Given the prevalence of these illnesses in the population, e.g. 2-4% for fibromyalgia, the need for appropriate guidelines for clinicians is paramount. As such, we will explore the need for improved guidance in these illnesses.
- To explore the need for development of diagnostic criteria for this spectrum of illness that would encompass the entirety of the illness and be applicable in a primary care setting. At present, nearly all of these conditions are defined based on historical perspectives, usually of a single subspecialty. As such, with the exception of somatoform disorders, none of the definitions encompass the entirety of this spectrum of illness, yet there is growing evidence that many individuals with these different labels have the same underlying condition. Moreover, many of the illnesses within this spectrum have set a “high bar” for diagnosis (e.g., fibromyalgia and CFS), yet there are data suggesting that individuals with earlier or milder forms of the same symptoms (e.g., chronic widespread pain and chronic idiopathic fatigue) may respond to the same treatments. Further, existing criteria for some illnesses, like fibromyalgia, are for research diagnostic purposes and do not translate well in clinical practice. Finally, it is possible if not likely that initiating treatment earlier in the course of these conditions might prevent the development of psychological, behavioral, and cognitive consequences that make individuals refractory to simpler and more effective interventions. Thus, there is a need for new diagnostic criteria that encompass the entirety of this spectrum of illness and that could readily be applied in a primary care setting.
- To facilitate inter-disciplinary and multicenter research in this field. Opportunities exist for making tremendous additional insights into this spectrum of illness, especially using research methods such as genomics and proteomics. For example, we could develop and implement standardized, multicenter phenotyping protocols that could capture the entire range of symptoms and findings seen in these illnesses, rather than study them as individual entities as we typically do now. In addition, this group would be well positioned to design, lead and perform multicenter clinical trials examining new treatments in this spectrum of illness, especially those studying multimodal treatments that might not be initiated or funded solely by industry or government agencies. These studies could focus on patients with multiple somatic symptoms rather than just the musculoskeletal, GI, facial, or other manifestations that typically make up individuals meeting current sub-specialty-based diagnostic criteria.
- To explore the need for development of the content for physician education programs in this spectrum of illness. As mentioned earlier in this summary, this spectrum of illnesses is quite common and needs no specialized procedures or treatments; however, most of the health care providers who treat these patients are not aware of the latest findings regarding mechanisms or treatments and, as such, do not feel “equipped” to take on this challenge. In addition, the pharmaceutical industry will soon spend millions of dollars on educating health care providers regarding this spectrum of illness (detailed below). This consortium could likely agree on a unified, coherent message regarding the underlying cause(s) for this spectrum of illness, as well as the most effective drug and non-drug treatments.
There already are some organizations that are advocating for many of the conditions within this spectrum; do we need another? We would argue that no current organization has the structure or leadership necessary to carry out the objectives put forth at the beginning of this document. The science-related organizations that exist currently often focus narrowly on one aspect of the illness or on a small collection of viewpoints regarding the patients and their care, rather than developing a larger, evidence-based stance that encompasses the entirety of the illness, treatments and patients. In some of the disorders within this spectrum, there are very good patient advocacy groups that have attempted to serve many or all of the patients with this spectrum of illness; however, patient-run organizations are not optimal for playing a leadership role in guiding science and expert opinion in these areas. The ideal organization, such as the consortium we are proposing, should be led by experienced scientific researchers and clinicians from academic and federal institutions, with additional representation from interested pharmaceutical companies.
We recognize an unprecedented opportunity to create such an entity. Within the next few years there will be at least 3 – 4 FDA-approved drugs specifically for fibromyalgia in the US, and these drugs will likely be approved worldwide for this indication shortly thereafter. This will represent the first time that drugs have been approved expressly for one of the conditions acknowledged within this spectrum (notwithstanding the IBS drugs, which have arguably targeted motility much more than pain or other overlapping somatic symptoms seen in these conditions). In aggregate, the pharmaceutical companies that are developing and testing these drugs have a common goal of educating both healthcare providers and patients about these conditions. Soon, nearly all pharmaceutical companies will be entering this realm of marketing drugs as a package that includes supplemental education.
Not unlike when fluoxetine and the subsequent SSRIs were first approved to treat depression, we have an opportunity to convey a consistent and concise message regarding what is known about the biology of these illnesses, why these drugs work, and how drug and non-drug therapies could be optimally combined to treat individuals with this spectrum of illness. An independent academic entity such as this consortium is well positioned to explore the pros and cons of existing education programs and, ultimately, develop educational information or programs that would be useful for clinicians who are treating these illnesses. This information could be easily translated into patient-friendly education and could also be used by researchers who continue to study these illnesses.
Conclusion: This consortium has strong potential to become the driving force behind finally legitimizing these conditions, and at the same time assessing the need for improving existing diagnostic and treatment paradigms that make sense and work for health care providers treating theses illnesses. In a few years, our efforts, in aggregate, could be responsible for improving the lives of millions of individuals struggling with these illnesses worldwide.