Looking Forward: Research Initiatives in 2012

By K. Kimberly McCleary, President & CEO

As a new year begins, we look ahead to research initiatives under way to help better define CFS, understand its biological underpinnings, discover biomarkers, identify objective diagnostics and determine better treatment approaches. There are many individual grantees at work, too. (Find links to reports on the Association’s grantees here: http://www.research1st.com/2011/11/28/accelerate/) This post is dedicated to institutionally or privately sponsored initiatives that were announced in 2011. Look for the green text for the next steps we expect to see this year.

The CFIDS Association of America

• The CFIDS Association of America issued a new Request for Applications (RFA) on Apr. 6, 2011, soliciting research proposals for studies that will advance diagnostics and treatments for CFS. The RFA was widely circulated in the research community and Letters of Intent were due on June 3, 2011. Full applications have been invited from 27 eligible investigators whose projects were responsive to the RFA and 26 were received by Sept. 30, 2011. Applications have been reviewed for scientific and strategic merit and funding decisions will be based on both evaluations. In 2012: Awards will be announced in the first quarter; investigators will meet and projects will commence as soon as all compliance and approval steps are completed.                 

• In March 2010, the Association established the SolveCFS BioBank, an integrated patient registry and biorepository that collects standardized medical information and biological samples from individuals diagnosed with CFS and control subjects. The SolveCFS BioBank is operated under the Genetic Alliance BioBank using its cooperative cost-sharing model that translates into a tightly controlled, comprehensive infrastructure to serve the dual functions of a patient registry and biorepository. The cooperative structure utilizes standardized protocols, allows for ethical re-contact of subjects and ensures robust privacy and security protections. Since securing institutional and ethical approval for the SolveCFS BioBank in March 2010, we have enrolled 449 CFS patients and controls, all of whom have consented to provide clinical information and donate biological samples. Through our first collaboration with an industry partner, we collected biological samples from 267 participants who met stringent enrollment criteria for this particular study. Testing of those samples has just been completed and the data is being analyzed and prepared for publication. This project not only adds important knowledge to the literature, but serves as a proof-of-concept for the SolveCFS BioBank structure and the ability to attract new partners to the study of CFS. In 2012: We will be expanding the BioBank, reviewing applications for BioBank samples and clinical data, and working with investigators to publish data from studies under way.

 

• One of the products of the projects funded in 2009–2010 is a knowledgebase generated from 250,000 articles about CFS and related areas of science (see http://bit.ly/vbG1K2). Dr. Bud Mishra’s team at New York University built this knowledgebase and the text mining tools that will enable us to use these assets. In 2012: We will continue to expand and refind the knowledgebase with new publication and will use the querying tools to develop a data-driven target list of biomarkers. We will then “shop” this list with academic centers and biotech companies to stimulate validation of these target biomarkers using samples from the BioBank or other clinical populations, accelerating the pace of moving from theoretical to practical applications for diagnostics and treatments. We will also explore other applications for the knowledgebase and querying tools.

For more information about the next phase of the Association’s research program, please see, “Looking to the Future.”

GOVERNMENT

United States

• The Institute of Medicine issued a consensus report on June 29, 2011 on the current state of pain research, care, and education with recommendations for an integrated strategy to address the human suffering and economic toll it takes. Two public meetings held on Nov. 22, 2010 and Jan. 4, 2011 were attended by representatives of the Chronic Pain Research Alliance (formerly the Overlapping Conditions Alliance) and testimony was presented based on recommendations included in the Alliance’s report issued in 2010, “Chronic Pain in Women: Neglect, Dismissal and Discrimination.” In early 2011, the committee sought public comment on barriers to pain care and groups that may not be adequately treated for pain. More than 2,000 individuals submitted comments, which helped shape the report in addition to extensive research. The report, “Relieving Pain in America: Transforming Prevention, Care, Education and Research,” includes recommendations for immediate and long-term corrective action. Watch the June 29 IOM press conference. In 2012: The U.S. Senate is considering holiding a hearing to examine the report’s recommendations and implementation steps.

 

• The National Institutes of Health (NIH) is sponsoring a second large study of XMRV/murine leukemia virus-like viruses. The study is being coordinated by Ian Lipkin, M.D., at Columbia University and funded by the National Institutes of Allergy and Infectious Diseases (NIAID). Six clinical sites will provide samples from well-characterized CFS patients and matched healthy controls. Coded samples will be tested under blinded conditions by investigators using their own assay methods and Dr. Lipkin will break the code. The laboratory investigators involved in the study include Dr. Judy Mikovits, Dr. Francis Ruscetti (National Cancer Institute), Dr. Shyh-Ching Lo (Food & Drug Administration) and Dr. Willam Switzer (Centers for Disease Control & Prevention). In 2012: Sample collection for this study will be completed and samples will be tested by the participating laboratories. Completion is expected in the first quarter of 2012.

 

• The NIH Clinical Center is undertaking a study of CFS patients, especially those who have been tested for XMRV with either positive or negative results. The NIH Clinical Center is the nation’s largest hospital devoted exclusively to clinical research. Teams of researchers, including collaborators at academic institutions, translate scientific observations and laboratory discoveries into new approaches for diagnosing, treating and preventing disease. The study has completed enrollment and testing of samples is currently being completed. In 2012: Results will be submitted for publication.

 

•  On Nov. 18, 2011, the NIH issued two new funding opportunity announcements for investigator-initiated applications listed below. Many other funding opportunity announcements of possible relevance to CFS research are listed in the NIH Guide. Enter the keyword search term or a co-morbid condition and then click the Search button. In 2012: The first receipt date for new application is Feb. 24, 2012.
  • Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Etiology, Diagnosis, Pathophysiology, and Treatment (R01)
    (PAR-12-032)
    Standard R01 receipt dates apply; next receipt date for new applications is Feb. 24, 2012.
    A call for R01 applications that propose innovative, interdisciplinary research to examine the etiology, diagnosis, pathophysiology and treatment of ME/CFS in diverse groups and across the lifespan.
  • Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Etiology, Diagnosis, Pathophysiology, and Treatment (R21)
    (PAR-12-033)
    Standard R21 receipt dates apply; next receipt date for new applications is Feb. 24, 2012.
    A call for R21 applications (exploratory/developmental research) that propose innovative, interdisciplinary research to examine the etiology, diagnosis, pathophysiology, and treatment of ME/CFS in diverse groups and across the lifespan.

 

• The Department of Defense’s Congressionally Directed Medical Research Program (CDMRP) included CFS in its priority topics for the first time in FY11. The CFIDS Association advocated for its inclusion during the FY11 federal funding cycle. This recognition gave researchers another potential source of funding, although applications still must successfully pass peer review. Interested investigators were required to submit pre-applications by May 25, 2011. Applications are now under review. In 2012: New funding awards will be announced.

 

• On Oct. 3, 2011, the U.S. Centers for Disease Control & Prevention (CDC) announced access to its large data set from the Wichita clinical study of CFS. The data sets were collected during a two-day in-hospital clinical assessment study conducted from December 2002 to July 2003 in Wichita, KS (referred to as Wichita Clinical Study). The study enrolled 227 people and classified them into five study groups. CFS patients were classified using the 1994 case definition (Fukuda et al., Annals of Internal Medicine). There are 32 data sets including demographic, clinical, laboratory, medication usage, cytokines, endocrine, sleep, single nucleotide polymorphism and gene expression data. For more information about the methods by which data was collected and the specific data sets, please visit http://www.cdc.gov/cfs/programs/wichita-data-access/index.html. In 2012: Data will be available to investigators for their studies.

 

• The CDC has entered into contracts with three physician groups: Dr. Benjamin Natelson (Beth Israel, NY); Dr. Nancy Klimas (Miami, FL); and a consortium formed by Drs. Andy Kogelnik (Open Medicine Institute, Calif.), Daniel Peterson (Sierra Internal Medicine, Nev.), Lucinda Bateman (Fatigue Consultation Clinic, Utah), Charles Lapp (Hunter-Hopkins Center, NC) and Richard Podell (NJ). These physicians will provide CDC with clinical expertise from physicians caring for patients with CFS from multiple clinical practices and will obtain standardized clinical, functional and epidemiologic data to ascertain the extent of heterogeneity within and between clinical practices.   These contract awards were made in response to a May 2011 solicitation and were announced during the CDC’s agency update at the Nov. 9, 2011 meeting of the CFS Advisory Committee. In 2012: This group will be working to identify a standardized approach to definition use in clinical diagnosis and management of CFS and improve standardization, integration and sharing of CFS data to benefit research.

Other Countries

• In the early spring of 2011, British Columbia’s Ministry of Health announced funding of $2 million for a clinical and research study that will help patients with a variety of complex chronic diseases, such as chronic Lyme disease, fibromyalgia and CFS, with screening, diagnosis and treatment. On Dec. 1, 2011, the Provincial Health Services announced that the new clinic will be housed at the British Columbia Women’s Hospital and Health Center. An opening date has not yet been set, but several regional patient groups are involved in the planning. The Vancouver Sun reported about the new clinic on Dec. 6. In 2012: The clinic will open and begin accepting new patients.

 

• On Oct. 19, 2011 results of a double-blind placebo-controlled phase II clinical trial of rituximab were published in PLoS ONE. The study was small, with just 15 CFS patients in each arm, but it showed promising results. 67 percent of the patients treated with rituximab, a monoclonal antibody, showed improvement after two infusions given two weeks apart, compared to 12 percent of those who received placebo. Rituximab is approved for use in certain cancers and rheumatoid arthritis. It is one of manufacturer Roche/Genentech’s “blockbuster” drugs. The study attracted attention from media around the world and resulted in an apology from Norway’s Directorate of Health for the poor care that patients with CFS have received in the country’s health care system. In 2012: With funding from the Norwegian government and other sources, two additional open-label phase II studies are now under way and the team at Haukeland Hospital in Bergen (Norway) is working with other centers to design a larger phase III study.

 

•  On Dec. 21, 2011, the Medical Research Council (UK) announced awards totaling $2.5 million (USD) for five new projects to investigate the mechanisms and underlying biological processes involved in CFS/ME. Topics to be covered in the new projects include: a search for the biological “fingerprint” of fatigue in Sjögren’s patients (Newcastle Univ.); autonomic dysfunction and related cognitive impairment in CFS (Newcastle Univ.); aberrant mitochondrial dysfunction (Liverpool Univ.); restoration of slow wave sleep (Imperial College); and interferon-A treatment of hepatitis C as an immunological model for CFS (King’s College). In 2012: Studies will get under way.

ACADEMIC

• In March 2011, Stanford University launched a Chronic Fatigue Initiative dedicated to studying infection-associated chronic illnesses, including CFS. Under Dr. Jose Montoya’s leadership, the center will provide clinical care and already has several research projects under way.

 

• Nova Southeastern University (NSU) announced on Dec. 12, 2011 that Dr. Nancy Klimas would join its faculty to launch the Institute for Neuro Immune Medicine within its College of Osteopathic Medicine. Dr. Klimas’ move from the University of Miami comes after 27 years of service, but she saw an opportunity to combine her clinical and research interests under one roof. “It will be a place to coordinate cutting edge thinking and research, train new practitioners, and offer the highest quality clinical care for a hugely underserved population. I am thrilled to partner with NSU in this giant step forward in the field of CFS/ME care and research.” In 2012: Dr. Klimas’ private practice will be brought under the NSA umbrella and her research team will establish its projects at NSU.

 

OTHER PRIVATE

• On Mar. 31, 2011, the UK’s ME Association announced that its Ramsay Fund will support new research into the role of transcription factors (complicated proteins that act at a cellular level as a key part of the body’s initial defensive response to harmful stimuli) in ME/CFS. In 2012: The study is expected to be completed.

 

• An international panel of 26 researchers, physicians and teaching faculty has published new criteria for myalgic encephalomyelitis (ME) in the Journal of Internal Medicine ahead of print on July 20, 2011. The panel recommends use of the term ME and the new criteria as a replacement for CFS in research and clinical settings. The criteria propose one compulsory feature — post-exertional neuroimmune exhaustion (PENE) — plus seven symptoms from three subdivided symptom clusters: neurological, immunological and energy production/transport impairments, summarized here. In 2012: The authors are working on Physicians Guidelines and an International Consensus Symptom Scale. 

 

• The Chronic Fatigue Initiative, launched Sept. 15, 2011, will provide $10 million from the Hutchins Family Foundation to support research and clinical experts at the world’s leading research institutions. The multi-faceted program will begin by funding projects at Columbia University on pathogen discovery and an epidemiology project at the Harvard School of Public Health. The CFI’s mission is closely aligned with the CFIDS Association’s and the two organizations’ approaches are highly complementary. In 2012: Samples collected for the XMRV/MLV “Lipkin” study will be evaluated by Lipkin’s team at Columbia’s Center for Infection and Immunity will be tested for known and novel pathogens using high-throughput molecular techniques.

 

• Dr. Daniel Peterson, one of the early pioneers in CFS care and research, has established a new research foundation, Simmaron Research, to make use of his 25 years of experience and an extensive biorepository of biological samples collected from well-characterized patients. The foundation lists two current collaborations with Bond University in Australia and Wisconsin Viral Research. On Dec. 8, 2011, the Mason Foundation (Australia) announced a four-year, $831,037 award to Bond University and its U.S. collaborators. In 2012: The study will be ongoing.

 

• A new CFS research and clinical care initiative is getting under way at Mt. Sinai Hospital in New York under the leadership of Dr. Derek Enlander. There has been no formal announcement by the institution yet; a patient meeting held on Nov. 20, 2011 involved Dr. Eric Schadt and Dr. Miriam Merad of Mt. Sinai and promised more extensive collaborations with other researchers and institutions. The effort has been launched with a $1 million gift made by one of Dr. Enlander’s patients. In 2012: More details about the nature and scope of studies to be performed. 

 

• The Whittemore Peterson Institute continues its research program under the direction of Dr. Vincent Lombardi. In 2011: They mainain an NIH RO1 award and have secured a grant from the Department of Defense’s Congressionally Directed Medical Research Program for the pathophysiology of CFS.

 What did we miss?

K. Kimberly McCleary has served as the Association’s chief staff executive since 1991.

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