"Adverse Impact on Research of the #PACETrial?" by Fred Friedberg, PhD. #MEcfs #CFS #MyalgicE #MyE #PwME #ME ---
The PACE Trial: New peer review commentaries
The July issue of the Journal of Health Psychology http://journals.sagepub.com/toc/hpqa/22/9 contained a series of mostly critical commentaries on the controversial PACE trial, a large randomized trial of behavioral interventions for ME/CFS that reported good success for graded exercise therapy (GET) and cognitive-behavior therapy as compared to control conditions. (Mary Dimmock also reports on this in the newsletter below.)
The critical commentaries focused on overstating the effectiveness of the PACE trial, the changing of criteria for improvement that favored better outcomes, conflicts of interest of the trial authors, and many other criticisms. The PACE trial authors defended themselves point by point in one of the articles. As these arguments have been aired many times in other forums (including our Association journal), I will simply refer interested readers to our journal http://www.tandfonline.com/toc/rftg20/5/1?nav=tocList& and the Journal of Health Psychology http://journals.sagepub.com/toc/hpqa/22/9 for further reading.
Adverse Impact on Research of the PACE Trial?
To me, the most misleading and damaging aspect of the PACE trial was contained in the subsequent reporting of “recovery” outcomes for a small minority of patients in the original trial. As a full restoration of health is rare in this illness, the publicity generated by the reporting of such inflated outcomes has led to the erroneous conclusion that simple behavioral interventions such as GET is all that these patients need. This can have the effect of delegitimizing the illness even more and may discourage biomedical research on ME/CFS.
We have one possible indication of this negative effect: I outlined above the roughly 50% decline in NIH grant applications on ME/CFS since 2010; Note that the PACE trial was published in 2011. Is this a coincidence or a possible negative impact of trial publicity lessening scientific interest in developing new grant proposals to study the illness? More generally, misleading reports that inflated the benefits of the PACE trial, which were widely cited in the mass media at the time, may have further undermined illness credibility with the research community. It’s impossible to make definitive conclusions about this, but the full and ongoing airing of the shortcomings of the PACE trial is certainly a welcome development.
Fred Friedberg, PhD
International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (IACFS/ME)
IACFS/ME President’s Letter
Volume 10, Issue 3 – August 2017