NIH Announces New Efforts to Advance ME/CFS Research

October 29, 2015

nihThe National Institutes of Health announced today that it is taking two major steps to advance research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. NIH has assigned the National Institute of Neurological Disorders and Stroke (NINDS) as the lead of a multi-institute ME/CFS research effort and a re-invigorated Trans-NIH ME/CFS Research Working Group. NIH also is launching a research protocol at the NIH Clinical Center to intensely study individuals with ME/CFS. The move is a landmark one for ME/CFS, which has previously been housed in the Office of Research on Women’s Health and did not receive the attention or funds that a disease with its burden merits.

“Of the many mysterious human illnesses that science has yet to unravel, ME/CFS has proven to be one of the most challenging,” said NIH Director Francis S. Collins, M.D., Ph.D. “I am hopeful that renewed research focus will lead us toward identifying the cause of this perplexing and debilitating disease so that new prevention and treatment strategies can be developed.”

NINDS Director Walter J. Koroshetz, M.D., called Solve ME/CFS Initiative President Carol Head personally to tell her the good news and express his enthusiasm for trying to move the science forward on the disease. Head and Solve ME/CFS Initiative Research Director Zaher Nahle, MPA, PhD, met with Koroshetz and other NIH officials when they were in Washington, D.C., Oct. 6.

NIH’s direction on the disease is being guided by the February 2015 Institute of Medicine report and the NIH-sponsored Pathways to Prevention report, which included recommendations for research strategies.

Because the pathology of ME/CFS remains unknown and there is no test to diagnose the disease, studies to date have used different criteria for diagnosis, which has limited the ability to compare results across studies. Additionally, many of the published studies are based on small study populations and have not been replicated.

To remedy the situation, NIH will design a clinical study in the NIH Clinical Center with plans to enroll individuals who developed fatigue following a rapid onset of symptoms suggestive of an acute infection. The study will involve researchers from NINDS, the National Institute of Allergy and Infectious Diseases, the National Institute of Nursing Research and the National Heart, Lung and Blood Institute. The primary objective of the study is to explore the clinical and biological characteristics of ME/CFS following a probable infection to improve understanding of the disease’s cause and progression.

NIH will also be considering additional ways to support ME/CFS research in the extramural research community. Since the root cause of ME/CFS is unknown and the manifestations of the disorder cut across the science interests of multiple NIH institutes and centers, a trans-NIH working group is needed to support that plan. NINDS Director Walter Koroshetz will chair the Working Group along with Vicky Holets Whittemore, Ph.D., the NIH representative to the U.S. Department of Health and Human Services’ Chronic Fatigue Syndrome Advisory Committee, on which Solve ME/CFS Initiative President Carol Head serves. One goal of the group will be to explore how new technologies might shed light on what causes ME/CFS. The Working Group includes representation from 23 NIH institutes, centers and offices.

“This is a landmark day for the millions of patients suffering with this dreadful disease and a giant step forward in our drive to make ME/CFS understood, diagnosable and treatable,” said Carol Head.