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Significant Breakthrough for ME/CFS at the NIH

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Reprinted with the kind permission of The SolveCFS Chronicle, Winter 2015.
On Oct. 29, the National Institutes of Health announced that it is taking several major steps to advance research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. NIH is launching a research project at the NIH Clinical Center to intensely study individuals with ME/CFS and will also be funding external research on the disease to a degree that will be “substantially greater” than our disease has received in the past, according to NIH Director Dr. Francis S. Collins.

Additionally, NIH announced that the leadership role for ME/CFS research, which was assigned to the Office of Research on Women’s Health, has now been assigned to the National Institute of Neurological Disorders and Stroke (NINDS). NINDS will lead a multi-institute ME/CFS research effort and a re-invigorated Trans-NIH ME/CFS Research Working Group. This move marks a very positive elevation of the status of our disease within NIH. NINDS Director Dr. Walter Koroshetz will chair the Working Group, along with Vicky Holets Whittemore, PhD, the NIH representative to the U.S. Department of Health and Human Services’ Chronic Fatigue Syndrome Advisory Committee (CFSAC), on which Solve ME/CFS Initiative President Carol Head serves.

After the announcement, we followed up with Vicky Whittemore on a number of questions raised by this exciting news, which has brought renewed hope, and cautious optimism, to our community.
Q: What would you attribute as the most significant catalyst for these changes?

A: The release of the Institute of Medicine report and the NIH Pathways to Prevention conference and report on ME/CFS came together to elevate the discussion about ME/CFS at NIH.

Q: What does NIH hope to achieve with the changes?

A: The NIH hopes to stimulate and support meritorious research on ME/CFS that will lead to an understanding of the pathophysiology (causes) of ME/CFS, to the development of effective treatments and eventually to identify ways in which ME/CFS can be prevented. The Trans-NIH Working Group will initially be guided by the IOM and P2P reports in their discussions about potential new initiatives and research priorities, as well as input from the community.

Q: Our understanding is that these changes have come from the top down—Dr. Collins himself. Is that true?

A: Dr. Collins discussed these changes with the Institute Directors and has been encouraging and very supportive of the changes that have been made.

Q: What is the significance of the Trans-NIH Working Group?

A: The fact that the root cause and the driving pathobiology behind ME/CFS are unknown argues persuasively for a trans-NIH approach to research on this disease. The Trans-NIH Working Group on ME/CFS will engage multiple Institutes and Centers at NIH to support research on ME/CFS. NINDS will take the initial lead in chairing and staffing the Trans-NIH Working Group, but all of the relevant Institutes, Offices and Centers will continue to be involved and participate in supporting research.

Q: How will ME/CFS be factored into NIH’s five-year strategic plan?

A: In order to advance its mission and fulfill a request from Congress, NIH is developing a five-year NIH-wide Strategic Plan to outline a vision for biomedical research that will pursue fundamental knowledge about the nature and behavior of living systems and apply that knowledge to extend healthy life and reduce illness and disability. NIH senior leadership and staff from all 27 Institutes, Centers and Offices (ICOs), with input from the Advisory Committee to the Director of NIH, have developed a framework for the Strategic Plan. As the number of disorders in the NIH portfolio is extensive, the strategic plan could not address specific diseases but lays out the general framework for research at NIH.

You can see more about the framework at:  www.nih.gov/about-nih/nih-strategic-plan.

We expect that the process will include discussion about research priority areas whether or not they are housed in a specific institute.

Q: Will there be money allocated specifically to ME/CFS?

A: NIH does not allocate funds for research on specific diseases except as is legislated by Congress (i.e., for HIV/AIDS, Alzheimer’s disease and Autism).

Q: While we know that NINDS will be taking the lead, will the National Institutes of Allergy and Infectious Diseases (NIAID) also play a major role?

A: As noted, the ME/CFS Trans-NIH Working Group will coordinate research at NIH. Yes, NIAID will continue to play a critical role in ME/CFS research since the disorder commonly occurs following an infectious illness and there are interesting data that suggest that abnormalities in the immune system play a role.

Q: What is the nature and composition of the reinvigorated Trans-NIH Working Group?

A: The Trans-NIH ME/CFS Working Group will be made up of representatives from 23 Institutes, Offices or Centers at the NIH. You can visit the NIH website to view the interests and activities that take place in each of these Institutes, Centers and Offices at: www.nih.gov.
Q: Our understanding is that leadership of the Trans-NIH Working Group for ME/CFS will rotate among institutes. Is this correct? If so, for how long will each institute chair the working group before the chair rotates? Will Dr. Koroshetz or yourself be chairing the working group?

A: The details for rotation of the leadership of the Trans-NIH Working Group have not been determined. Initially, Dr. Koroshetz will be chairing the Working Group with my assistance.

Q: Regarding the new ME/CFS clinical trial at the NIH, the understanding is that it is focused on the immunity aspect of the disease. Why was that the only focus chosen and/or is that part of a multi-step plan? Will this be expanded, for instance, by studying other fields implicated in ME/CFS or developing similar clinical trial protocols?

A: The study participants will be those that are within five years of the onset of ME/CFS following an infectious illness. It was decided to focus on this population as a way to reduce the heterogeneity between the individuals in the study. The protocol will include many studies to determine changes in the immune system, as well as other systems. Other details about the number of patients and duration of the study will be announced as soon as they become available.

Q: What will be the process for patient recruitment and involvement for this trial?

A: As with other studies conducted in the NIH Clinical Center, the study participants will be recruited through the website www.clinicaltrials.gov and through the NIH Clinical Center Patient Recruitment and Public Liaison Office.

Q: What is the post-trial process and how will the NIH follow up on these sorts of trials from precedence?

A: The study results will be reported both through the website www.clincaltrials.gov as well as published in scientific journals. Follow-up studies and/or clinical trials of treatment will depend on the results of the study.

Q: Is there coordination with other international counterparts on this issue?

A: It will be important going forward to expand our communication with international counterparts so that common protocols can be launched in larger numbers of individuals with ME/CFS worldwide.

Q: Are there any details on an upcoming RFA (Request for Applications) for ME/CFS? What might the timeframe be and how much money might be attached to them?

A: No, there are no details at this time. The Trans-NIH Working Group will discuss future initiatives at an upcoming meeting.

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