Office of Research on Women's Health (ORWH)
Frequently Asked Questions – Trans-NIH ME/CFS Working Group
What is Chronic Fatigue Syndrome?
Chronic Fatigue Syndrome, sometimes referred to as Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), is an illness that causes extreme fatigue that is not alleviated by rest, which limits a person’s ability to carry out activities of daily life. Characteristic symptoms of ME/CFS include fatigue for six months or more, muscle pain, memory problems, headaches, pain in joints, sleep disturbance, sore throat and tender lymph nodes. Many symptoms of ME/CFS overlap with other illnesses. ME/CFS affects women more often than men. There are many sources of information on ME/CFS symptoms, causes, and treatments, for example, Medline Plus (http://www.nlm.nih.gov/medlineplus/chronicfatiguesyndrome.html), PubMed Health (http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0002224/), and the Women’s Health information center (http://womenshealth.gov/publications/our-publications/fact-sheet/chronic-fatigue-syndrome.cfm), in addition to information that may be available from your healthcare professional.
What type of research is being conducted on the diagnosis, cause, underlying mechanisms, and potential treatments for ME/CFS?
Resources from government, non-profit, and for-profit organizations are being placed into research on the cause(s) and treatment(s) for ME/CFS. The National Institutes of Health (NIH), an operating division within the U.S. Department of Health and Human Services, is a leading supporter of research on ME/CFS. The types of research being conducted by NIH to determine the cause, underlying mechanism(s) and potential treatments for ME/CFS include, for example, basic research on tissues, cells and molecules from human subjects affected with the illness, research on the pattern of ME/CFS across multiple geographic locations to determine the prevalence of the illness, and research to test hypotheses about specific treatments for ME/CFS in affected patients and controls. Taken together, the outcome from all these types of research serves as a foundation of knowledge about various aspects of the illness that physicians and researchers can use to develop more effective treatments to help affected individuals.
How does NIH interact with other organizations to facilitate information exchange about ME/CFS?
The U.S. Department of Health and Human Services, Office of the Secretary, provides advice and recommendations to the Secretary of Health and Human Services via the Assistant Secretary of Health on issues related to ME/CFS. This is accomplished through coordination of the activities of the Chronic Fatigue Syndrome Advisory Committee (http://www.hhs.gov/advcomcfs/). The CFSAC serves as a focal point for the exchange of information about the current state of knowledge and research about ME/CFS, the impact and implications of current and proposed diagnosis and treatments for ME/CFS, and the development and implementation of programs to inform the public, health care professionals and the academic and research communities about ME/CFS advances, and partnering to improve the quality of life of affected individuals. The Chair of the Trans-NIH ME/CFS Working Group is the NIH ex officio member of the CFSAC and disseminates information about NIH activities and research related to ME/CFS to the committee.
How does NIH coordinate the research on ME/CFS?
At NIH, the research and activities related to ME/CFS are coordinated through the Trans-NIH Mylagic Encephalomyelits/Chronic Fatigue Syndrome Research Working Group. The Office of Research on Women’s Health (ORWH), located within the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), serves as the lead for this Trans-NIH working group.
What is the Trans-NIH Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Research Working Group?
The Trans-NIH ME/CFS Working Group is a group of individuals from the various NIH Institutes, Centers and Offices (ICOs) who are interested in facilitating and promoting ME/CFS research at NIH. Serving on a Trans-NIH group, they serve as conduits between the WG and their own ICO leadership with regard to information on ME/CFS. The WG also communicates relevant activities and research on ME/CFS directly to the NIH leadership through DPCPSI. Working together, the WG identifies cross-cutting areas of research, and confronts challenges faced by multiple ICOs working on ME/CFS. The WG does not have a budget, and does not have authority to fund research projects directly.
What areas of research does the NIH support on or related to ME/CFS?
NIH supports investigators who are working to find a cause, diagnosis and treatment for ME/CFS. These projects include studies of immune system function, pathophysiology, neuropathology, and vascular dysfunction. NIH also supports conferences and workshops that help connect investigators in the numerous scientific disciplines involved in ME/CFS research.
Where is there a complete listing of all types of research NIH funds, including ME/CFS?
A user friendly website, called RePORTER, can quickly give you information about funded projects at the NIH. Go to: http://projectreporter.nih.gov/reporter.cfm. This site allows detailed searches of amount of funds provided for research by location (e.g., domestic by state or district, or foreign), by category (e.g., ME/CFS, stroke, headache), by year, or any string of search terms. The level of detail available to the user includes an overview of a specific project, the NIH institute or center funding the project, the name of the researcher awarded the funds, and links to publications and media coverage of the published project outcome.
Where is information about clinical trials supported by NIH?
The NIH has developed a comprehensive website for the public to search for information pertaining to clinical trials. The following link has detailed information about clinical trials: http://www.nih.gov/health/clinicaltrials/index.htm. At this site, clinical trials can be searched for by disease area, geographical location of clinical trials, and whether clinical trials are currently recruiting volunteers. Clinical trials recruit healthy subjects and subjects with specific conditions; everyone can make a contribution to medical research by participating in a clinical trial! To look for specific clinical trials, use the following link to view all clinical trials nationwide: http://clinicaltrials.gov/.
Does the NIH support clinical trials for ME/CFS treatments?
NIH continues to support clinical trials on ME/CFS. Scientists and clinicians who have the expertise to conduct treatment interventions should contact NIH ICs as early as possible to learn more about the application process for clinical trials research. NIH ICs typically consider support for clinical trials on a case-by-case basis. Clinical trials are complex, costly projects that must be judged by peer review for scientific merit and institutional review boards for clinical safety.
What happened to the research on xenotropic murine leukemia virus-related virus (XMRV) and murine leukemia virus (MLV)? Will the NIH be supporting more research on retroviruses?
NIH has been supporting research on retroviruses for many years, and will continue to fund research that seeks to understand the role that viruses, including retroviruses, play in the etiology of a variety of human diseases. Since 2009, there has been an increase in interest in studies related to XMRV/MLV biology and ME/CFS and prostate cancer. Applications for research in this area will be judged by peer-review of the science proposed and the potential benefits to public health of the research outcomes. Applications that score highly during peer review will be funded based on scientific merit.
What is the status of the NIAID-supported “Multi-Center Blinded Analysis of XMRV/MLV in Chronic Fatigue Syndrome” study, led by Dr. Ian Lipkin?
This laboratory-based study is ongoing and is designed to rigorously evaluate whether the presence of XMRV/MLV nucleic acids or antibodies in the blood is associated with CFS. Researchers, working with clinicians in six regions across the United States, will compare blood and plasma samples from patients diagnosed with CFS to samples from healthy people who have not been diagnosed with CFS and who are matched to the CFS patients by age, sex, and geography. The results from this study have been published in the journal, mBio and are available at the following link: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3448165/pdf/mBio.00266-12.pdf.