(reprinted with permission)
Twelve U.S. ME/CFS organizations have called on the Centers for Disease Control and Prevention (CDC) and Agency for Health Research & Quality (AHRQ) calling on them to investigate the PACE trial concerns outlined by David Tuller and then take the steps needed to protect patients. The letter to Director Thomas Frieden of the CDC and Director Dr. Richard Kronick of the AHRQ can be found here.
You can add your voice by signing this accompanying petition. While the petition is directed to the CDC and AHRQ, their response will affect other countries as well, so we encourage people from all countries to sign.
Recently, journalist David Tuller, DrPH, published an investigative report outlining serious concerns with the conduct, analyses, and results of U.K.’s £5 million PACE trial for chronic fatigue syndrome. PACE investigated the efficacy of cognitive behavioral therapy (CBT) and graded exercise therapy (GET)
Since then, other researchers and journalists have voiced their own concerns with the fundamental problems in the trial. Most recently, Julie Rehmeyer wrote an excellent overview of the situation in Slate Magazine and six researchers called on The Lancet to “seek an independent re-analysis of the individual-level PACE trial data.”
The PACE treatment approach is based on the theory that the debility of ME/CFS is caused by presumed deconditioning, which is the result of patients’ belief that they have an organic disease and that activity will harm them. CBT and GET is claimed to lead to improvement and even “recovery” by reversing patients’ “illness beliefs,” “fear of activity,” and deconditioning.
PACE is hugely influential in how patients are treated in the media, by society, and especially in medical practice. In the U.S., many ME/CFS clinical guidelines, including those of the Centers for Disease Control and Prevention (CDC), recommend CBT and GET, based in part on the PACE trial. This is true even in medical education and clinical guidelines published since the 2015 Institute of Medicine (IOM) report. The IOM report makes it clear that the problem is not deconditioning. It states that the hallmark of the disease is a systemic intolerance to exertion, which would be exacerbated by PACE’s treatments.
The impact of PACE is also seen in scientific evidence reviews. In 2014, the U.S. Agency for Healthcare Research and Quality (AHRQ, part of HHS) recommended CBT and GET, based in part on PACE, which it ranked as a “good” study. This is significant because the AHRQ Evidence Review can be used to support CBT and GET recommendations in future journal articles and in the clinical guidelines of any country. This evidence review already has been used for this purpose in at least one U.S. clinical guideline.
Even aside from concerns with the conduct of PACE, the AHRQ Evidence Review recommendation for CBT and GET for all ME/CFS patients is questionable since the review itself acknowledged that PACE’s Oxford definition was overly broad and could include patients who do not have ME/CFS. NIH’s 2015 Pathways to Prevention report felt this problem was so serious that it called for the Oxford definition to be retired.
Continuing to use PACE and similar Oxford definition studies to support treatment recommendations for all ME/CFS patients is an issue of grave concern because it confuses doctors on the nature of the disease and results in medical treatment that can harm patients.