September – Zaher Letter

zaher-letter

Dear Friends,

The decision by the U.S. government’s Agency for Health Research Quality (AHRQ) to downgrade its recommendation on the usefulness of Cognitive Behavioral Therapy (CBT) and Graded Exercise Therapy (GET) in ME/CFS is a significant and consequential development. It is virtually unprecedented for AHRQ to change a recommendation.  Coming in the form of an Addendum to the published 2014 AHRQ ME/CFS Evidence Review after a methodical reanalysis of CBT/GET ME/CFS literature, this development was triggered by unrelenting requests from the patient community.

AHRQ is the federal agency entrusted with evaluating the quality of research in the United States.

AHRQ worked with investigators to reanalyze data, filtering out the inherent selection bias favorable toward CBT/GET (namely, the Oxford case definition), examining instead, and separately, published papers with more disease-appropriate selection criteria (i.e., those using definitions relevant to ME/CFS). There was also a re-assessment of the limited number of CBT studies, this time not in conjunction with other forms of therapies (e.g., counseling) so that the effect of CBT would be evaluated on its own merit.

Following this more appropriate analysis, no benefit at all for GET (or insufficient evidence of effectiveness, as it was described by AHRQ) was found on measurable outcomes like function, fatigue, quality of life, employment, and overall symptom improvement. CBT was also found to be inefficient or barely significant when not in conjunction with other forms of therapies. Insightful pieces have been written on this topic by Jenny Spotila and Mary Dimmock and Cort Johnson with more details. Here, we  briefly highlight this development as the first official lowering of the “credit rating” of CBT/GET in ME/CFS by a federal agency.

While this process is highly nuanced—and more needs to be done by AHRQ—what is noteworthy is that this decision establishes a precedent. The precedent for rectifying misinformation should not be underestimated in a climate of increased pressure toward the standardization of policies on common data elements for clinical evaluation and other forms of cooperation across government agencies. As such, it is unthinkable that such a precedent from the federal authority that sets the standards on health research quality may go unnoticed, especially among agencies that—like AHRQ—are unified under the oversight of the Department of Health and Human Services. We have seen an increase in inter- (and intra-) agency coordination on ME/CFS. This AHRQ Amendment is now part of the historical record that must incentivize other government officials to examine, revise, qualify, or purge any information inconsistent with current, up-to-date information, or that is not supported by real, vetted data.

In addition to being the federal agency entrusted with evaluating the quality of research in the United States, AHRQ also belongs to the group of agencies that commissioned the Institute of Medicine (IOM) report on ME/CFS, released in February 2015. As such, the conclusions rendered here should be taken as part of a continuum central to the issues of refining clinical diagnosis criteria for the disease and disseminating medical information—both topics clearly emphasized in the IOM report.

Additionally, the August 16 decision by the United Kingdom’s First-tier Tribunal ordering the release of the PACE trial data and last week’s approval by Queen Mary University of London to release this information—after considerable resistance—are all positive indicators that the domino effect of accountability is now in motion.

Undoubtedly, these new developments are all important steps toward refining the narrative about ME/CFS. It is understandably very challenging for public health officials to dismiss peer-reviewed publications without cause, and this type of targeted refutation of questionable decision data helps in that regard. It also signals to researchers that a re-analysis of data could be forthcoming anytime, and therefore great attention must be placed on study design and inclusion criteria.

In retrospect, this whole exercise with AHRQ (and PACE) underscores the old adage “garbage in, garbage out.” Lumping together studies with fundamentally different inputs, poor designs, or incorrect premises is like comparing apples and oranges. The distinction being that this is not a display of healthy fruit but rather poisonous “junk science” that has confounded the peer-reviewed literature on ME/CFS for decades, contributing to the stigmatization of this disease.

Yours,

Zaher Nahle, PhD, MPA
Vice President for Research and Scientific Programs
Solve ME/CFS Initiative