A draft document issued by the National Institutes of Health (NIH) in advance of an upcoming workshop on myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) has provoked strong opposition from the patient advocate community and some experts, who say the systematic literature review does not reflect the reality of the illness.
In the case of ME/CFS, whose very name is the subject of debate, the literature is not only incomplete and underdeveloped but, patient advocates and some experts say, is also flawed by the use of multiple case
definitions in studies, resulting in heterogeneous patient populations. This, they believe, has led to erroneous study results, notably in the controversial 2011
PACE (Pacing, graded Activity, and Cognitive behavior therapy: a randomized Evaluation) trial, which concluded that graded exercise treatment (GET) and cognitive and behavioral therapy are effective treatments.
"It's hard to identify research needs if you haven't articulated the current situation. I don't think they have done that," Kenneth J. Friedman, PhD, told
Medscape Medical News. Dr Freidman is a coauthor of the International Association for CFS/ME's 2012 "
ME/CFS: A Primer for Clinical Practitioners" and a former associate professor of pharmacology and physiology, New Jersey Medical School in Newark.
Dr Friedman and others also question whether ME/CFS should even have been included in the P2P process, which involves a "jury model," in which a panel of nonexperts will hear expert "testimony" during the December workshop and will produce another draft document immediately thereafter.
"When this [P2P] announcement came out, I said it's a fool's mission. It is so not appropriate for ME/CFS on so many levels," Dr Friedman said.
