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Fibromyalgia - An NIH Perspective: Interview with Stephen Katz, M.D., PH.D.

  [ 266 votes ]   [ Discuss This Article ]
www.ProHealth.com • September 27, 2002


Editor's Note: Reprinted with permission from Fibromyalgia Frontiers, Vol. 8, #3, Summer 2000, the official quarterly publication of the National Fibromyalgia Partnership. Website: www.fmpartnership.org.

The lion's share of the fibromyalgia (FM) research supported by the federal government is funded by the National Institutes of Health (NIH) -- in particular, the NIH National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). It is our great privilege to share with you below an interview with NIAMS Director Stephen Katz, M.D., Ph.D., which was recently conducted by Tamara Liller, editor of Fibromyalgia Frontiers (the official publication of the Fibromyalgia Association of Greater Washington).

TL: Please tell our readers about your background before you became Director of the NIH National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

Dr. Katz: I am a dermatologist and an immunologist and during my 26 years in the intramural program (on the Bethesda campus of the NIH), I have focused my work on developing a better understanding of the skin immune system as both a target of destruction and as a vehicle to carry out the various important functions subserved by the skin. In addition to serving as the Director of the NIAMS for the past 5 years, I have served as Dermatology Branch Chief in the National Cancer Institute for over 23 years. The reason I accepted the position of Institute Director of NIAMS was the tremendous challenge and rare opportunity it afforded to have an impact on so many diseases in which I have had a long-time interest. I was also excited by the tremendous research challenges of the many chronic and disabling diseases under the aegis of the Institute.

TL: Fibromyalgia, like several other medical conditions under the NIAMS umbrella, affects females disproportionately. There is also some general pain research suggesting that women experience pain differently than men (i.e., have different pain thresholds, different responses to medications, etc.). How can medical research, particularly that sponsored by the NIAMS, address gender issues relating to chronic conditions like FM?

Dr. Katz: Many of the diseases and conditions within the mandate of the NIAMS disproportionately affect women, including fibromyalgia, lupus, rheumatoid arthritis, and osteoporosis, so we have a keen interest in these gender issues in our research. In fibromyalgia, for example, we already support a number of grants specifically addressing female aspects of the disorder, including the effects of estrogen on pain perception, emphasizing how the menstrual cycle relates to stress, pain thresholds, and other symptoms.

On a broader level, NIAMS has heartily embraced the NIH-wide mandate to include women (and minorities) in clinical studies, and has collaborated closely with the NIH Office of Research on Women's Health in projects involving both research and training.

TL: Despite all of the new fibromyalgia research that has taken place during the last decade, there is still relatively little accurate information available about the true prevalence of FM in the general population (i.e., estimates range from 5 to 10 million). In addition, there are still no FDA-approved drugs for the treatment of FM. In what ways can NIAMS foster research in these areas?

Dr. Katz: In 1998, the National Arthritis Data Workgroup published, "Estimates of the Prevalence of Arthritis and Selected Musculoskeletal Disorders in the United States" (Arthritis and Rheumatism 41: 778-99). Fibromyalgia was added as a new section to this report that was previously published in 1989, and the authors note that a number of factors complicate the diagnosis and classification of fibromyalgia. The numbers cited in this paper are that approximately 3.7 million people age 18 and older in the United States have fibromyalgia. Prevalence is lower in men than in women, and prevalence increases with age.*

With regard to your question on the development of new drugs for fibromyalgia, this will involve the participation of government agencies like the NIH to support the research, as well as private industry to develop, test, and market effective drugs. As to the role of the NIAMS, we are working to improve the understanding of fibromyalgia--the reality is that our understanding of any disease will come from the interplay of many disciplines and many scientific approaches.

We must continue to support basic research to uncover the fundamental mechanisms of disease as well as develop good animal models of disease; we must have clinical studies to improve our diagnostic and therapeutic approaches; we must support clinical trials to determine therapeutic efficacy; we must have epidemiologic studies to understand the way a disease affects the entire population; and ultimately, we must devise preventive strategies whenever possible. No one of these is more important than the others, but when their findings are put together, the puzzle becomes much better understood.

*Editor's Note: The National Arthritis Workgroup was formed by the NIAMS in 1986 to form a single source of data on the prevalence and socioeconomic impact of rheumatic disorders. It is comprised of epidemiological experts from governmental agencies (the NIH, CDC, etc.) and academe. In the "fibromyalgia” portion of the article to which Dr. Katz refers, the Workgroup relied on data obtained from available FM prevalence studies conducted between 1989-1995. The authors noted the difficulties inherent in the diagnosis and classification of FM and in comparing studies conducted both before and after the institution of the 1990 Official ACR criteria for FM. In their introduction to the article, they stated: "The data in this report should be viewed as conservative estimates with varying degrees of precision depending on the disease and the data source used".

TL: Fibromyalgia is a complex medical condition which is often difficult to diagnose and treat. Although awareness of this condition has improved greatly in recent years, particularly in areas where there are major medical centers, there are still many parts of the country where relatively little is known about FM and its diagnosis and management. In addition, very little is available in the way of formal training to medical students and other health professionals who wish to learn about FM. What efforts does the NIAMS make to disseminate information to patients and the medical professionals who treat them, particularly in the less technologically sophisticated regions of the U.S.? How can professional training be encouraged for FM?

Dr. Katz: I have said many times that research is of limited value if the results never get to patients and their doctors. That's why we have developed such a large, multifaceted public information program, including: (1) publications on diseases, (2) an information clearinghouse, and (3) a website, automated fax line, and a line for the hearing-impaired. The newest addition to our information arsenal, however, is our free phone line, 1-877/22-NIAMS, which anyone can use in either English or Spanish to order a pamphlet and find out more about research, disease, or resources available for health problems. We are committed to disseminating results widely and to targeting particularly vulnerable communities.

We are also very proactive in our information efforts, letting the public and the scientific community know about our research advances through press releases and interviews, frequent communication with voluntary and professional groups, an active exhibit program, and presentations at meetings and conferences.

Telling people about diseases and research is important, but we also need to actively engage the research community in studying all aspects of fibromyalgia. This means building a pipeline of researchers who can conduct patient studies, translating basic research to clinical application, and enhancing the communication between patients and researchers. NIAMS, like virtually all of the institutes and offices at the NIH, has made a commitment to increase training of clinical investigators who can work with basic scientists and use their knowledge to improve public health. I'm happy to say that the Institute is participating in several new award mechanisms to increase clinical research training and career development.

In addition, I believe that we need to broaden the field of participation in research. By this I mean, we need to increase the interactions between government, academic health centers, pharmaceutical industries, and managed care corporations. In the new era in which we are operating, each of these players provides a vital dimension and we need to ensure that they all keep the lines of communication open.

TL: Compared to many other diseases/medical conditions, fibromyalgia is relatively "young" in terms of the amount of research that has been performed and the number of researchers currently in the field. Based on your considerable experience at the National Institutes of Health, what general suggestions can you offer the research community in terms of its future development?

Dr. Katz: First, there are various strategies that we have used to encourage research on fibromyalgia. I do not have to tell anyone reading this newsletter how challenging fibromyalgia is for physicians and other health care providers and their patients. There are many unanswered medical questions and we have worked to close those gaps in several ways.

Our Institute has offered scientific workshops, like the multi-disciplinary workshop supported by the NIAMS and four other NIH components that was held in July 1996. This workshop put a definite spotlight on specific aspects of fibromyalgia, and we all learned more about the basic science of chronic pain, neuroendocrinology, circadian rhythm, and sleep disorders associated with fibromyalgia. This seminal meeting identified research needs and opportunities--gaps in our understanding of fibromyalgia.

The participation of both basic and clinical scientists in this workshop was critically important. In fact, some of the scientists who attended this meeting had never even heard of fibromyalgia. But they brought their expertise in some fundamental issues that we need to understand. In addition, representatives of fibromyalgia support groups and their advocates also participated. We were very grateful for their support and interest and their commitment to advancing research and education on fibromyalgia.

Now, as patients, you want to know what we did with the results and recommendations generated by this workshop. The answer is: we undertook a number of initiatives. We partnered with other NIH components, building on the bridges established and enhanced at this meeting, and issued solicitations for research on particular aspects of fibromyalgia, aspects that challenge daily life for many of you.

One of these areas is the sleep problems associated with fibromyalgia. In addition, we joined with our colleagues in the National Institute of Allergy and Infectious Diseases in issuing a program announcement to look at the pathophysiology of chronic fatigue syndrome, especially as it may relate to fibromyalgia.

These initiatives added to the foundation already in place, including the research grants that were supported as a result of the Request for Applications that we issued in 1994. In addition, we now fund other research grants that are studying key aspects of fibromyalgia, including:

? Research into the role of behavioral factors in fibromyalgia,

? An evaluation of actual and perceived physical, cardiovascular, and musculoskeletal phenomena related to fibromyalgia, and

? An examination of factors related to health care usage, education, and social support among fibromyalgia patients.

The final example of how we have worked to stimulate research in areas of need is the recent teaming that the NIAMS undertook with a number of other NIH components in issuing a Request for Applications in fibromyalgia. As a result, in 1999 we began 15 new fibromyalgia research studies that are being funded by NIAMS and three other NIH components--the National Institute of Neurological Disorders and Stroke, the National Institute of Dental and Craniofacial Research, and the NIH Office of Research on Women's Health. The awards include both basic and clinical research studies on fibromyalgia.

These new projects will enhance the current portfolio of research on fibromyalgia and hold promise for improved understanding and treatment of this clinically challenging disorder. We intend to expand the research base and to capitalize on the new knowledge that derives from these investments.

I would note that, while institute directors have some tools for tweaking the system, the reality is that the vast majority of what the NIH supports is investigator-initiated. Smart people from around the country figure out a rich variety of approaches to basic and clinical research questions, and the NIH funds them to pursue their visions. This is truly the NIH at its best.

I am convinced that the greatest research progress is realized from supporting a broad spectrum of research. What this means is that we support basic research in the laboratory, animal models, clinical research involving patients, clinical trials and a diverse range of studies, including outcomes studies as well as research in epidemiology and prevention.

If you think of the understanding of disease as a puzzle, each research study fills in a bit more of the puzzle until we begin to see it taking shape. We cannot develop improved diagnostic methods or effective treatments with fewer side effects or pursue prevention strategies until we understand the disease process better. That comes from funding a broad array of studies and putting the findings together to solve the puzzle of a disease like fibromyalgia.

Finally, I think it might be useful to provide a brief description of the major areas of research opportunity and need in fibromyalgia:

Development of improved diagnostic and treatment strategies:

? New imaging technologies could be used in fibromyalgia, for example to establish correlation of brain function and pain perception;

? The correlation between brain function and stress and other responses to pain stimuli needs to be established;

? Potentially provide a surrogate for fibromyalgia/other stress related pain syndromes; and

? Potentially provide a surrogate for treatment responses and patient subset identification.

New approaches could identify genetic factors:

? Genetic factors are likely to influence pain perception and pain mechanisms;

? Genetic factors may be related to observed sex differences in pain perception;

? Studies of genetic factors related to disease severity may reveal potential pathogenic mechanisms; and

? Genetically manipulated animal models of sleep and pain may reveal pathways important in fibromyalgia.

The effects of sex and gender in pain perception and disease chronicity:

? Evidence suggests that women may have lower thresholds than men for painful sensory stimuli;

? The mechanisms underlying the sex differences in these responses are not known;

? Sex hormones may be involved in the physiologic stress response system; and

? Estrogens may inhibit stress response.

These are just some of the research needs and opportunities that we have identified and are pursuing in fibromyalgia studies.

TL: There has recently been great dismay and concern among patients with chronic fatigue syndrome (CFS) as well as patients with fibromyalgia (some of whom also have CFS) about the Centers for Disease Control's alleged misuse of research funds earmarked for CFS research. What safeguards does the NIAMS have which ensure the proper use of research funding earmarked for fibromyalgia research?

Dr. Katz: The question of responsible stewardship of the public funds that the NIH receives to support and conduct first-rate research is an extremely important one--particularly in an era of growing agency budgets and heightened public expectations. Typically, the NIH, including the NIAMS, does not receive a specific dollar earmark for fibromyalgia or other priority areas. Rather, the Congress appropriates an overall budget level for each Institute and then trusts that those in charge of overseeing these funds will allocate them in a responsible fashion. Most of the NIH's funds are distributed as research grants and contracts through a competitive process of peer review. This process seeks to support investigations that are of the highest scientific quality.

At the NIAMS, as at other NIH Institutes, a priority setting process is in place--and is constantly being refined--that takes into account a number of factors, including scientific opportunities, public health needs, Congressional interest, and patient concerns, among other considerations. The NIAMS consistently seeks public input as we define and develop our research initiatives. We do this through our Advisory Council, planning meetings, scientific conferences, and several other activities. These efforts often result in new solicitations for research in targeted areas, such as the 1998 Request for Applications (RFA) for basic and clinical research on fibromyalgia. The NIH was very pleased with the response we received to this announcement, and indeed, we have devoted twice the dollar amount originally anticipated in support of related research proposals.

TL: Despite the large number of medical conditions which the NIAMS addresses through its intramural and extramural research programs and considering the burden of illness which arthritis as well as musculoskeletal and skin diseases impose on the U.S. population, many people do not realize that the NIAMS is a relatively new institute and is comparatively small compared to other NIH institutes in terms of its size and budget. Can members of the public and medical professionals champion the NIAMS' cause on Capitol Hill, in the office of the Director of the NIH, etc.?

Dr. Katz: We often describe the NIAMS as an Institute that studies conditions which are common, chronic, costly and debilitating. Diseases in our mission areas cut across the life span and affect every ethnic group. Some of these disorders, such as fibromyalgia, rheumatoid arthritis, and systemic lupus erythematosus, affect individuals in the prime of their lives. Furthermore, as the U.S. population ages--and the baby boomers move into their retirement years--we are likely to see greater numbers of Americans touched by conditions such as osteoarthritis and osteoporosis.

Clearly, the NIAMS deals with diseases that exact a heavy physical, emotional and financial toll and that compromise the quality of people's lives. We have been extremely fortunate in the past few years as the Congress has pursued its goal of doubling the NIH's budget by 2003. This effort has been successful, at least in part, because legislators and voters alike have recognized the value of NIH's work and realize that everyone is touched by disease and disability somehow, whether directly or through a loved one. Clearly, the Congress and the Executive Branch of the government are learning from the public that medical research is a priority. One of the major benefits of the most recent budget increases has been the opportunity to invest in high quality clinical research and training that bring breakthroughs at the research bench to the bedside of affected patients.

This is both an NIH priority and an area of emphasis at the NIAMS. We will continue to be committed to this type of translational research, in addition to efforts to disseminate the results of studies we support to the public and health care practitioners. As our budget grows, our responsibility to communicate new knowledge expands as well.

The NIH is able to pose the research questions it does and support the varied research approaches it takes because of the many blessings we enjoy in this country: the freedom to explore ... to follow the scientific leads and clues; the training in our colleges and universities; an enthusiastic public, including the valuable voluntary groups that are dedicated to improving the health of patients with fibromyalgia and other conditions; and a supportive Congress that provides the appropriations annually for us to pursue research opportunities and improve public health.

Conclusion

I want to share with you my optimism about progress in fibromyalgia. A number of forces are converging that lead me to this view. Biomedical research in general is at a very exciting crossroads. We are witnesses to stunning developments in molecular medicine, genetics, and biotechnology. Advances in one area are shown to have previously unrecognized links to other areas of science.

Now, a word about my vision for the future in research on fibromyalgia, and the areas of study I hope we will see:

? I would hope that we will see an increased number of investigator-initiated research proposals being generated in this area. This category of applications is, of course, the backbone of the NIH--the foundation of every institute's research grant portfolio.

? We intend to continue to work with other institutes at the NIH and other federal agencies to stimulate collaborative activities in research on fibromyalgia.

? We will continue to encourage other scientists in related fields to focus their expertise on fibromyalgia.

? We will continue to encourage interactions among researchers in all the diverse disciplines relevant to fibromyalgia to sustain the multi-disciplinary approach that we are convinced holds the greatest promise.

In the five years that I have been the Director of the NIAMS, I have benefited greatly from the opportunity to meet and strategize with many dedicated scientists, clinicians, and patients. The members of the fibromyalgia community are certainly outstanding examples of that. They bring a commitment and a drive and a passion to their advocacy, and I applaud them for that. During the last few years I have met with many affected patients and advocates for fibromyalgia research, often in small group meetings, and have been enlightened as they shared their perspectives.

This interview also gives me the opportunity to thank you, Tammy, for your many contributions: as a tireless and effective advocate for people with fibromyalgia, as a dedicated and respected member of our NIAMS Advisory Council, and as a thoughtful contributor to many activities and programs at the NIAMS. I have relied on your sound judgment, your vision, and your advice on many occasions.

I also want to thank you for giving me this chance to bring you an update on research on fibromyalgia. I always appreciate opportunities to continue the dialogue that has been established with patient and advocacy groups for fibromyalgia. We pursue knowledge to improve our understanding of the causes, diagnosis, and treatment of fibromyalgia to make your daily lives better. We have a very clear and strong focus at the NIAMS and improved health is that focus.

The thought I want to leave you with is that medical research has made a tremendous difference in the lives of all Americans--both in longevity and in quality of life, and I am very excited and optimistic about the new studies on the horizon.

To receive information on fibromyalgia and other health conditions from the NIAMS:
Phone: 877/22-NIAMS (toll free) • Fax: 301/881-2731 (Fast Facts system) Website: www.nih.gov/niams



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