Dr Fred Friedberg, IACFS/ME President comments:

In a significant development regarding the controversial PACE trial, the largest and most influential behavioral treatment trial of CFS/ME to date, a recent open letter to the editor of the Lancet was published by a distinguished group of scientists (Davis, Edwards, Jason, Levin, Racaniello and Reingold, 2015).

The letter re-examined the reported fatigue and physical function outcomes in the trial article and also pointed out potential conflicts of interest. The letter requested an independent expert-conducted re-analysis of PACE trial data.

The letter raised significant concerns about how ‘recovery’ was defined, pointing out that recovery criteria for improved fatigue and physical functioning were so broad that many patients with impairments or no improvement were still classified as ‘recovered.’ The use of the recovery term in my view is appropriate only for those who have experienced full or near full restoration of health. Yet the data from the PACE trial did not empirically confirm such restoration for those ‘recovered’ individuals, nor did the study report on how many patients actually viewed themselves as recovered.

The terms ‘recovery’ and ‘cure’ should be carefully considered when applied to chronic illnesses. Certainly measurable improvement occurs in ME/CFS but the notion of full recovery is a much more ambitious construct for which we need proof not only from instruments, but from talking to the patients themselves.

Source: IACFS/ME Newsletter, Volume 8, Issue 3 • December 2015: Distinguished scientists address the PACE trial