For decades, those in the myalgic encephalomyelitis-chronic fatigue syndrome (ME-CFS) community have faced an uphill battle, getting the government, and the medical community in general, to take their condition seriously.
for one, has heeded that call. The program director of epilepsy at the NIH's National Institute of Neurological Disorders and Stroke (NINDS), gave the keynote presentation at the International Association of Chronic Fatigue Syndrome Myalgic Encephalomyelitis () biennial conference in Fort Lauderdale, Fla. She announced NIH plans to request applications for a consortium to facilitate a collaborative approach to researching the illness.
Earlier this year, Whittemore discussed the idea of a consortium during a .
"I think it's going to take an army of really good researchers to solve this problem ... It can't be individual groups working in isolation. So what we'd like to do is to form a consortium really of investigators who are working hand in step," she stated.
Whittemore also announced that investment in the disease would rise to $15 million in 2017, which is double the estimated spending for the disease in 2016, according to Science.
In February 2015, the Institute of Medicine (now the National Academies of the Sciences, Engineering and Medicine) published a report that was viewed as a turning point for ME-CFS patients. The report stated that ME-CFS is a debilitating multi-systemic medical illness -- not a psychiatric disorder as some -- and established streamlined diagnostic criteria for it.
A second report developed out of the "" led by an NIH working group, focused on expanding research to improve treatment for ME-CFS patients, and also helped to "wake up" the medical community to the seriousness of the illness.
In March 2016, NIH director, announced the agency's first-ever ME-CFS study, which will evaluate whether post-infection ME-CFS is triggered by a viral illness that leads to immune-mediated brain dysfunction. The study is set to include 100 participants, 40 of whom have ME-CFS.
And in May, the NIH pledged to supplement ongoing projects with the potential for crossover into ME-CFS. It solicited feedback from the community regarding research strategies and priorities.
The patient community continues to lobby for attention and investment. In May, ME-CFS advocates in seven U.S. cities and around the globe participated in the "Millions Missing" protest, demanding increased scientific research and stronger accountability from government. Another challenge they say must be overcome is "."
In an email interview with MedPage Today, Whittemore discussed the current state of research for ME-CFS, the lessons learned from other disease models, and the challenge of attracting young investigators to study the disease. The interview was facilitated through an NIH press representative; it has been edited for clarity.
MPT: What did you learn at the IACFS/ME conference?
Whittemore: My main takeaways from the conference are:
- There are now several potential mechanisms and hypotheses for the etiologies and pathophysiology of ME-CFS that need to be expanded, replicated, and further explored.
- We need more young investigators in ME-CFS research who will develop a pipeline of researchers to continue to explore new avenues in ME-CFS research.
- It will be difficult to develop a case definition until we have objective measures for ME-CFS. It is likely that there are subtypes of the disease, and it is this heterogeneity that makes developing one case definition so difficult.
- Discussion and collaboration between U.S. investigators, and investigators around the world, at international meetings such [IACFS/ME] will help coordinate efforts to bring the best scientists to the table to do research.
At the conference, the Trans-NIH ME/CFS Working Group and the CDC launched the Common Data Elements project. How will such a database enhance research?
Whittemore: The initiative at NINDS strives to facilitate research of the highest quality, yet streamline clinical trials data collection in neurological studies by developing common data elements that can be used in clinical studies -- and clinical trials -- for specific diseases and across neurological diseases.
Representatives from the Department of Defense and the Department of Veterans Affairs attended an IACFS/ME pre-conference that focused on Gulf War syndrome. Is a collaboration with these agencies possible?
Whittemore: Discussions with the VA and DOD about individuals with ME-CFS who are being treated and how their treatment is handled may elucidate ways to advance ME-CFS research.
How do you see the disease models used for Gulf War syndrome and multiple sclerosis influencing ME-CFS research?
Whittemore: Each of these diseases are likely to have different, but overlapping, measures of biological and molecular function, so it will be important to be able to compare measures in these different groups. Having Common Data Elements for MS and developing them for ME-CFS should help facilitate comparisons across studies.
A suggested that ME-CFS could represent "an evolutionarily conserved, genetically regulated, hypometabolic state." The study authors stated that the disease may be a body's way of responding to threat, so instead of fighting, it "hibernates." What do you make of this hypothesis?
Whittemore: It is an interesting hypothesis that needs further research to determine any possible role in the disease.
Has there been any significant progress in the diagnostic criteria for ME-CFS?
Whittemore: We are hopeful that new research that will provide objective measures of biological function in individuals with ME-CFS will lead to faster and better ways in which to diagnose the disease.
What progress has been made on the Pathway to Prevention Workshop's recommendations?
Whittemore: A summary from the follow-up meeting will be released in the near future. The Federal Partners are already moving forward with several of the collaborations that were discussed, including the Common Data Elements project that will be supported by NINDS and the CDC, with involvement from the FDA and other agencies.
Has there been increased interest from drug companies in developing ME-CFS treatments, now that NIH-supported research, and other privately funded studies, are getting more attention? There's been talk of repurposing older drugs, and combining compounds to try to identify possible treatments, which may not require FDA approval. Does NIH plan to support research in this area?
Whittemore: NIH supports basic, translational and clinical research, including clinical trials through peer-reviewed grant mechanisms. Researchers who would like to develop new treatments for ME-CFS, including repurposing of old drugs and/or combining compounds, are welcome to submit grant applications to NIH. They should certainly discuss their plans for their grant application with the program staff at the appropriate NIH [branch] to help to clarify NIH policies and procedures.
How can the medical community attract young investigators to study ME-CFS?
Whittemore: Young investigators are the pipeline for ongoing, rigorous scientific research on ME-CFS. There are , and we encourage young investigators to submit applications. This will also require that there are senior scientists doing research on ME-CFS who can train and support these young investigators, so NIH will be working to expand the community of ME-CFS researchers through new [] and investigator-initiated grants.
Many of the sickest patients with ME-CFS are bed- or home-bound. How can telemedicine be used to reach these patients?
Whittemore: More research is needed on individuals with ME-CFS who are house- or bed-bound. The severity of their disease makes it difficult for them to participate in research studies, but telemedicine may be an approach through which they can become involved in clinical research. We encourage researchers to take advantage of new technology to explore potential methods of including severely ill patients in their studies.
How do you anticipate the next administration will impact the NIH's progress on accelerating research in this area?
Whittemore: NIH has a long history of bipartisan support, and stands ready to work with the new Administration to improve people's health and reduce the burden of disease through biomedical research.
Can you share any more details about the consortium?
Whittemore: Information will be contained in the RFAs that will be released in December. The funding that will be available will also be released in the RFAs.