Favorable language to ME in the FY 2016 House appropriations report; Congressional tweets of support for the #MillionsMissing Day of Action on Sept. 27, 2016, which called attention to the millions of Americans struck down by this disabling disease, the millions of dollars missing from ME research in the NIH budget, and the millions of doctors are uneducated or misinformed about the disease; and Pledged Congressional support for larger, more groundbreaking political actions in the near future, which will support ME patients and biomedical research.

In addition to these federal level efforts, ME advocates have been working at the local and state levels to educate, raise awareness, and promote actions to support ME patients — both with their elected officials and in their communities. #MEAction’s #MillionsMissing movement, which organized demonstrations in 12 U.S. cities and 13 cities abroad on Sept. 27, called attention to the shameful inaction and harmful practices toward ME patients by government health departments around the world.

Similarly, almost a dozen city governments across the United States — including Los Angeles and Phoenix, AZ — have now issued proclamations in honor of ME Awareness in their communities, again thanks to the hard work of very committed ME advocates.

Although the ME community has been bolstered by the encouraging response from Congress and their local representatives to these and other advocacy efforts, the U.S. Executive Branch response has been less heartening.

Recently, #MEAction in conjunction with other advocacy organizations and many individual advocates have also successfully lobbied Congressional members to achieve:

Representatives Eshoo and Lofgren received a reply to the letter they sponsored, which was signed by 53 other Congressional Representatives from across the country and from both sides of the aisle, asking Director Francis Collins to outline a concrete commitment to ME research and funding. That letter is reproduced below:

Department of Health & Human Services Public Health Service

National Institutes of Health

Bethesda, Maryland 20892

September 29, 2016

The Honorable Anna Eshoo

U.S. House of Representatives

Washington, D.C. 20515

Dear Representative Eshoo:

Thank you for your letter of September 9, 2016, concerning the National Institute of Health’s (NIH) plans to advance research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). We want to assure you that the NIH is committed to furthering research on this debilitating disease, and I am pleased to provide an overview of current initiatives and activities.

The complexity of ME/CFS and the need for an inter-disciplinary approach to better understand and develop treatments for this disease necessitate a trans-NIH approach that involves coordination among multiple NIH components. Because of this, the Trans-NIH ME/CFS Working Group is not housed within any Institute. While the National Institute of Neurological Disorders and Stroke (NINDS) helps organize and manage the Working Group under the leadership of NINDS Director Dr. Walter J. Koroshetz, it is a team effort among 23 Institutes, Centers, and Offices. The Working Group facilitates this coordination and meets regularly to discuss the best ways to foster ME/CFS research. As a first step toward encouraging ME/CFS research in the extramural community, the NIH has already funded seven supplements to existing awards focused on understanding the causes and mechanisms of ME/CFS. Awarded supplements will enable existing projects to expand the collection and analysis of ME/CFS patient samples to aid in biomarker identification and help identify potential therapeutic targets.

The NIH is preparing two Requests for Applications (RFAs) which will support ME/CFS collaborative research centers and a Data Management Coordinating Center. These RFAs will be released once they are finalized.

In order to make progress in ME/CFS research, collaboration among the NIH, the extramural community, and the ME/CFS community is essential, and we value the extensive comments generated by the RFI. The responses, which include input from individuals, patient advocacy organizations, researchers, and healthcare professionals can be viewed online via this site: https://www.nih.gov/mecfs/announcements. The Working Group is preparing a summary of the responses and will use the input to help guide future ME/CFS research and research training.

Plans are also proceeding for a clinical research study on ME/CFS that will be conducted at the NIH Clinical Center. This intramural study will explore the clinical and biological characteristics of ME/CFS following a probable infection to improve understanding of the disease’s cause and progression. We are finalizing the protocol and the informed consent forms, and healthy volunteers are being recruited to participate.

The goal is to admit the first set of healthy volunteers next month. Once techniques have been refined in studies of healthy volunteers, the protocol team will begin to bring individuals with ME/CFS to the NIH campus.

The NIH recently formed an ME/CFS Scientific Interest Group to provide a forum for researchers to discuss and disseminate clinical and scientific information about the disease. The Group seeks to foster new research collaborations across the NIH campus and is open to all intramural and extramural investigators interested in learning more about ME/CFS. The Scientific Interest Group is led by NINDS Clinical Director Dr. Avi Nath, who is also the principal investigator of the upcoming NIH intramural study on ME/CFS. The ME/CFS Scientific Interest Group has started a bimonthly seminar series with internal and outside experts and may include additional lectures, seminars, panel discussions, and other opportunities to facilitate discussion and collaboration.

We are hopeful that these new initiatives will support the efforts of the scientific experts who are working on this very challenging disorder, lead to an increase in the number of investigators who receive NIH grants to study ME/CFS in the future, and encourage rapid scientific progress and the development of new ways to diagnose and treat ME/CFS.

I am sending identical letters to your co-signatories.

Sincerely Yours,

Francis S. Collins, M.D., PhD.

Director

In addition to failing to specify a plan for each fiscal year as requested, the letter omits any indication of increased budget or expedited timeframe, which Director Collins publicly promised the community last year. It also contains no plan to ramp up applications/funding for investigator-initiated research, no RFAs for biomarkers and other key biological questions, no plan to fund hypothesis generation, and no plan to resolve key barriers impeding clinical trials or to progress clinical trials on drugs already being used successfully off-label. The projects that it does mention are mostly small, are mostly still unfunded, and were promised to the community a while ago.

It’s been roughly a year since Director Collins:

made the announcement that he would bolster ME/CFS research and reinvigorate the NIH’s work on ME/CFS; promised in an NPR interview to fund ME/CFS at a level “substantially greater than the current five or six million a year. We are going to ramp this up;” and requested in Science Insider that the ME/CFS community “Give us a chance to prove we’re serious, because we are.”

Director Collins’s response carefully makes no promises, outlining neither specific dollar amounts, nor timelines, nor specific activities the NIH plans to support in the following fiscal year. #MEAction representatives are working with the letter sponsors, Rep. Lofgren and Eshoo, on a response and will share more soon.

Note: multiple individual advocates contributed to this article!