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Congressional Justification Narrative
February 2008 (historical)
Authorizing Legislation: Section 301 and title IV of the Public Health Service Act, as amended.
|FY 2007 Actual||FY 2008 Enacted||FY 2009 Estimate||Increase or Decrease|
This document provides justification for the Fiscal Year (FY) 2009 activities of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), including NIH/AIDS activities. Details of the FY 2009 HIV/AIDS activities are in the "Office of AIDS Research (OAR)" Section of the Overview. Details on the Common Fund are located in the Overview, Volume One. Program funds are allocated as follows: Competitive Grants/Cooperative Agreements; Contracts; Direct Federal/Intramural and Other. The NIAMS is the lead Institute for the Patient-Reported Outcomes Measurement Information System (PROMIS) initiative supported through the NIH Common Fund.
The NIAMS supports a broad range of research, training, and information dissemination activities related to arthritis, musculoskeletal, and skin diseases. Some are rare disorders, but many are very common. All have a major influence on the quality of people's lives. Diseases addressed by NIAMS affect individuals of all ages, of all racial and ethnic backgrounds, and across all economic strata; many disproportionately affect women and minorities.
Over the years, NIAMS-funded research teams have made significant progress on uncovering the causes of many disorders of the bones, muscles, joints, and skin. Most recently, many of these efforts have been possible only because of technological advances, such as those that allow investigators to manage large volumes of data produced by genome-wide association studies or through new imaging technologies.
In September 2007, the NIAMS released findings from a study of the success of postdoctoral research trainees who received support through the Institute's extramural research training and career development awards program. Like other NIH training and career development activities, the NIAMS program is intended to help ensure that a diverse and highly trained workforce is available to assume leadership roles related to biomedical and behavioral research. Results of this study were discussed by the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council, and the Institute is currently assessing how best to implement recommendations from this report.
A key ingredient in research success is translation of laboratory insights to patient care, and the application of subsequent observations to new laboratory investigations that further improve public health. In this vein, NIAMS launched its Centers of Research Translation (CORT) program and awarded its first round of grants in FY 2006. In FY 2007, the Institute funded a second set of awards, for a total of seven centers addressing conditions such as lupus, orthopaedic trauma, psoriasis, scleroderma, and a genetic form of rickets (a childhood disorder characterized by a softening and weakening of bones). The Centers, which run through FY 2011 or 2012, unite basic and clinical scientists in a way that helps convert research discoveries into new drugs, treatments and diagnostics.
Progress also continues on the Osteoarthritis Initiative (OAI), a large, long-term investment that will expedite the pace of scientific studies and help enable the development of new and improved treatments for patients to preempt disease progression and preserve normal function. Under the leadership of the NIAMS and with support from numerous NIH components and private-sector sponsors, the OAI is creating a publicly available scientific resource to identify and evaluate biomarkers of osteoarthritis for use in clinical research. By the end of FY 2007, more than 600 researchers from 41 countries had registered to access OAI data, and 555 clinical datasets had been downloaded for analysis.
To reach members of underserved populations who are affected by the diseases NIAMS studies, the NIAMS has developed a series of easy-to-read fact sheets on a variety of health topics. Many have been translated into a Spanish-language series called "Esenciales," while others are being published in Chinese. To facilitate dissemination to patients and their health care providers, the NIAMS bundled these materials on a CD-ROM that it is distributing through its Information Clearinghouse, at professional society meetings, and at community health fairs. In FY 2007, the Institute also developed an interactive Web tool, "Check Up On Your Bones," to help people identify the most common red flags that put their bones at risk and give pointers on how to make bones stronger and healthier. Information provided through the tool is relevant for both men and women, and for people of diverse races and ethnicities. The Web tool is an example of personalized medicine allowing the identification of disease risk on an individual, patient-by-patient basis.
Recognizing that the scale and complexity of today's biomedical research problems demand that scientists move beyond their individual disciplines and explore new organizational models for team science, the NIAMS initiated a new research supplement in FY 2008 to promote interdisciplinary partnerships. The first round of awards will be made for collaborations that bridge specific research topics: autoimmunity and gender/sex factors; autoimmunity or developmental biology and systems biology; soft tissue biology and imaging technologies; and tissue engineering and developmental biology or immunology. Despite having common interests and needs, the fields selected for this pilot program do not have a long history of interactions. However, a modest incentive in the form of a research supplement could stimulate new scientific advances beyond what individual laboratories could attain in the absence of the partnership. If the initial round of supplements generates productive collaborations, the NIAMS may reissue this funding opportunity with a broader scientific scope in the future.
The NIAMS is also pursuing efforts to encourage the use of data from genome-wide association studies (GWAS) that would advance arthritis, musculoskeletal, and skin diseases research. These analytic studies will build on currently-supported projects, including activities being funded through the Genetic Association Information Network (GAIN). Information garnered from such activities could help to predict the potential for disease in a patient before symptoms occur. In addition, the Institute is sponsoring a roundtable discussion on GWAS in the spring of 2008 to develop a better understanding of the various epidemiological resources that are available to the research community, and how the Institute can best leverage these resources and related tools for future studies.
Building on a Memorandum of Understanding that the NIAMS spearheaded in FY 2007 on behalf of the NIH in partnership with the National Aeronautics and Space Administration (NASA), the NIAMS will lead a trans-NIH effort to encourage biomedical researchers to develop projects that could be conducted in the microgravity environment of the International Space Station (ISS). The ISS provides a unique setting where researchers can explore fundamental questions about human health issues, including how the body heals itself, fights infection or develops diseases such as osteoporosis. When the ISS is fully operational in 2011, the U.S. segment will have laboratory space, data processing capabilities, and crew time available for experiments such as those that could be designed by the biomedical research community.
FY 2009 JUSTIFICATION BY ACTIVITY DETAIL
Program Descriptions and Accomplishments
Arthritis and Rheumatic Diseases:
The goals of this program are to advance high-quality basic, translational, and clinical biomedical and biopsychosocial research to treat, cure, and prevent arthritis and rheumatic diseases. It utilizes new insights in the fields of genetics, genomics, proteomics, and imaging. The NIAMS is committed to pursuing new opportunities that identify risk factors for these disorders, to enhance disease prediction, and advance prevention strategies.
In FY 2007, the NIH released "The Future Directions of Lupus Research," a scientific planning document that identifies the opportunities, priorities, and needs in lupus research. Future implementation strategies for the plan were discussed at the November 2007 meeting of the Lupus Federal Working Group, which is led by the NIAMS to coordinate Federal efforts in lupus research and education. In addition, the Institute held a scientific roundtable in February 2007 to examine gender and sex factors in inflammation and immune-mediated diseases.
The 2009 budget estimate for the Arthritis and Rheumatic Diseases program is $135,103,000, a decrease of $202,000 or 0.15 percent from the FY 2008 Consolidated Appropriations Act. NIAMS plans for FY 2009 include a continued emphasis on the development and validation of biomarkers related to autoimmune diseases, particularly through participation in a public-private partnership fostering development of systemic lupus erythematosus biomarkers. The Institute will also support studies to further illuminate the role of genetics in various autoimmune disorders. In addition, it anticipates increased focus on innovative therapies for rare rheumatic diseases, such as juvenile idiopathic arthritis, and developing research approaches to better understand chronic musculoskeletal pain in children with arthritis and other diseases. Adaptive clinical trial design will be explored with national thought leaders, to build efficiency in studying interventions in complex, heterogeneous diseases, such as rheumatoid arthritis and systemic lupus erythematosus, and rare diseases.
Musculoskeletal Biology and Diseases:
The program focuses on understanding the fundamental biology of tissues that constitute the musculoskeletal system, and on translating and applying this knowledge to a variety of diseases and conditions including osteoarthritis. It studies the causes and treatment of acute and chronic injuries -- including carpal tunnel syndrome, repetitive stress injury, and low back pain. The program supports the development of new technologies, such as methods for imaging bone and cartilage to improve the diagnosis and treatment of skeletal disorders, or to facilitate repair of damage caused by trauma to otherwise healthy musculoskeletal tissue.
In FY 2007, the NIAMS formally reorganized its musculoskeletal biology and diseases portfolio to place additional emphasis on musculoskeletal development, tissue engineering, and regenerative medicine (see portrait). Other activities of note included a scientific roundtable to examine opportunities in musculoskeletal injury and trauma, and a session at the Institute's annual scientific planning retreat focused on soft tissue imaging techniques.
The 2009 budget estimate for the Musculoskeletal Biology and Diseases program is $90,732,000, a decrease of $136,000 or 0.15 percent from the FY 2008 Consolidated Appropriations Act. Program plans for FY 2009 include activities building on a scientific discussion of connective tissue biology that the Institute intends to have with members of the research and lay communities later in FY 2008. Basic and translational research on repair mechanisms of tendons, ligaments, and their interfaces with bone and muscle could lead not only to interventions that will stimulate healing after accidental injury or surgical insult, but also to strategies for engineering functional tissue replacements that could be used when connective tissue is damaged beyond repair. The Program also will continue to lead the Osteoarthritis Initiative (OAI). Developed with support from numerous NIH components and private-sector sponsors, the OAI is building a publicly available scientific resource for identification and evaluation of biomarkers of joint deterioration that can be used in clinical research. All data and resources developed through the OAI are publicly available for scientific investigation; by the end of FY 2007, more than 600 researchers from 41 countries had registered to access OAI data, and 555 clinical datasets had been downloaded.
Bone Biology and Diseases:
The program covers a broad spectrum of research designed to better understand genetic and cellular mechanisms involved in the build-up and break down of bone. It studies regulation of bone remodeling; bone formation, bone resorption, and mineralization; and effects of hormones, growth factors, and cytokines on bone cells. It supports several large epidemiologic cohorts for characterization of the natural history of osteoporosis, and for identification of genetic and environmental risk factors that contribute to bone disease.
In FY 2007, the NIAMS began a formal evaluation of its bone genetics portfolio to identify resources that, if combined, could provide sufficient statistical power for genome-wide association studies related to bone mass and fracture risk. t also organized three meetings of the Federal Working Group on Bone Diseases, which provides a forum for NIH components and other government agencies to share information on bone-related research
The 2009 budget estimate for the Bone Biology and Diseases program is $66,104,000, a decrease of $100,000 or 0.15 percent from the FY 2008 Consolidated Appropriations Act. Program plans for FY 2009 include continued support of two epidemiologic studies of fracture risk in women and men-the Study of Osteoporotic Fractures (SOF) and Osteoporotic Fractures in Men study (Mr. OS). In addition to providing valuable information about the medical and demographic characteristics that are associated with low bone mass and potential fracture risk, the long-term studies most recently have linked a popular class of antidepressant drugs (serotonin reuptake inhibitors) with an increased risk of broken bones in older people. They also have made a major contribution to the body of evidence suggesting that anyone over 50 years of age who is being treated for a broken bone should be tested for osteoporosis. Basic and translational research efforts may assess the role of vitamin D in reducing fracture risk. Efforts to address genetic and biochemical factors influencing bone mass and fracture risk in humans also will be implemented upon completion of an evaluation of research resources that could be used by NIH-funded investigators.
Muscle Biology and Diseases:
The program supports a wide range of basic, translational, and clinical research projects in skeletal muscle biology and diseases. It focuses on fundamental biology of muscle development, physiology, and muscle imaging. Its overarching objective is to advance the understanding of, and, ultimately, prevent and treat the muscular dystrophies, inflammatory myopathies, muscle ion channel diseases, and muscle disorders such as disuse atrophy and age-related loss of muscle mass.
Program activities in FY 2007 included participation in a Request for Applications for the Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers and other solicitations to encourage translational research on muscular dystrophies. Staff also convened a small group of researchers for a one-day discussion of how best to evaluate potential therapies for muscle diseases that soon will be ready for clinical testing.
The 2009 budget estimate for the Muscle Biology and Diseases program is $73,125,000, a decrease of $110,000 or 0.15 percent from the FY 2008 Consolidated Appropriations Act. Program plans for FY 2009 include continued funding for the Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers awarded in FY 2005 and expected in FY 2008. In addition to these Centers, we will continue to fund basic, translational and clinical research studies of myotonic, Duchenne/Becker, facioscapulohumeral and other muscular dystrophies. Other subjects of interest to the NIAMS that may be pursued through the Muscle Biology and Diseases program in FY 2009 include non-dystrophic skeletal muscle diseases such as channelopathies, inflammatory and mitochondrial myopathies as well as muscle wasting resulting from disuse or systemic diseases. We will continue our support of studies exploring the causes of muscle diseases and promising treatment strategies such as cell or gene therapy, therapeutic proteins or small molecule drugs.
Skin Biology and Diseases:
This program supports a broad portfolio of basic, translational, and clinical research in skin, including work on the developmental and molecular biology of skin, the study of skin as an immune organ, and the genetics of skin diseases. The Institute is pursuing opportunities in developing artificial skin, and imaging technologies for diagnosis and tracking progression of skin diseases.
In FY 2007, the NIAMS sponsored a scientific roundtable centered on psoriasis, psoriatic arthritis, and rheumatoid arthritis. Attendees examined the most promising opportunities and critical needs, as seen by the research community. In September 2007, the Institute held a meeting focused on the genetic components of psoriasis to discuss collaborative efforts in identifying the disease's susceptibility genes.
The 2009 budget estimate for the Skin Biology and Diseases program is $66,676,000, a decrease of $101,000 or 0.15 percent from the FY 2008 Consolidated Appropriations Act. NIAMS plans for FY 2009 include continued support for studies focused on the biology and treatment of chronic wounds, to better understand the molecular mechanisms underlying this process with the goal of finding ways to accelerate wound healing and to improve patient outcomes. In addition, the budget estimate anticipates an enhanced emphasis on the genetic factors that contribute to skin diseases such as psoriasis, building on current projects supported by NIAMS and through the Genetic Association Information Network (GAIN). The program will develop additional areas in skin biology to complement its expertise in keratinocyte biology and diseases, and skin immunobiology and immune diseases.
Intramural Research Program:
The mission of this program is to conduct innovative basic, translational, and clinical research relevant to the health concerns of the Institute, and to provide training for investigators interested in related careers. The program conducts clinical studies on the genetics, etiology, pathogenesis, and treatment of a variety of rheumatic, autoimmune, inflammatory, joint, skin, and muscle diseases.
Over the past year, the program has added clinical staff with expertise in pediatric rheumatology, an area that will continue to be a high priority for the Institute. The program is also benefiting from a new, state-of-the-art gene sequencing system which will support gene expression studies with greater efficiency, lower cost, and increased accuracy than earlier technologies. In addition, this program participates in the new multidisciplinary, trans-NIH Immunology and Inflammation Research Initiative, which will bring together scientists from several NIH institutes who are using common approaches to study multiple disease systems (see portrait).
The 2009 budget estimate for the Intramural Research Program is $52,629,000, an increase of $778,000 or 1.5 percent from the FY 2008 Consolidated Appropriations Act. NIAMS plans for FY 2009 include an enhanced focus on translational research, in order to facilitate patient-oriented studies in the areas of arthritis, musculoskeletal, and skin diseases, including their genetic, inflammatory, and immune mechanisms. The Institute will enhance its expertise in pediatric rheumatic and musculoskeletal diseases; key recruitments in these areas are currently underway. NIAMS will continue its commitment to multidisciplinary training of rheumatology research fellows, including interactions with other NIH intramural training programs with common scientific interests, to strengthen the pipeline of highly qualified physician-scientists in this field. The Institute's intramural research program anticipates building upon its recent ground-breaking, collaborative studies in 2007, to uncover more information on the genetic underpinnings of chronic, autoimmune, inflammatory diseases.
Research Management and Support (RMS):
NIAMS' RMS supports the scientific, administrative management, and information technology expenses associated with day-to-day operations. It supports long-term investments in the research enterprise, including the review and financial management of applications for grants and contracts, and dissemination of research results to the American public. In FY 2007, the Institute managed more than 1,261 research grants and centers, as well as 57 research and development contracts and 319 individual and institutional research training grants. NIAMS supports 450 clinical research studies, including 68 clinical trials.
In FY 2007, the NIAMS launched a new public Web site to enhance usability by patients, health care providers, researchers, and the American public. Rigorous reviews by internal and external users were conducted in order to ensure that information was relevant and clearly presented. A unique component of the Web site is a searchable image gallery containing photos and illustrations for use by the public. Items in the gallery are accompanied by abstracts describing each image (see portrait).
The 2009 budget estimate for RMS is $24,711,000, an increase of $365,000 or 1.5 percent from the FY 2008 Consolidated Appropriations Act. NIAMS plans for FY 2009 include activities in support of NIH-wide efforts to enhance the peer review system. The NIAMS will undertake an institute-wide assessment of information technology applications in order to examine functionality and maximize the utilization of available resources. Finally, the Institute will continue to sponsor roundtable discussions and a scientific retreat with extramural investigators and lay representatives to inform the research priority-setting and strategic planning process.