BACKGROUND
: Publications from the PACE trial reported that 22% of chronic fatigue syndrome patients recovered following graded exercise therapy (GET), and 22% following a specialised form of CBT. Only 7% recovered in a control, no-therapy group. These figures were based on a definition of recovery that differed markedly from that specified in the trial protocol.

PURPOSE: To evaluate whether these recovery claims are justified by the evidence.

METHODS: Drawing on relevant normative data and other research, we critically examine the researchers’ definition of recovery, and whether the late changes they made to this definition were justified. Finally, we calculate recovery rates based on the original protocol-specified definition.

RESULTS: None of the changes made to PACE recovery criteria were adequately justified. Further, the final definition was so lax that on some criteria, it was possible to score below the level required for trial entry, yet still be counted as ‘recovered’. When recovery was defined according to the original protocol, recovery rates in the GET and CBT groups were low and not significantly higher than in the control group (4%, 7% and 3%, respectively).

CONCLUSIONS: The claim that patients can recover as a result of CBT and GET is not justified by the data, and is highly misleading to clinicians and patients considering these treatments.

The £5m PACE trial was led by Professor Peter White of Queen Mary University London, which went to considerable lengths and a cost of some £200k of public funds to prevent release of the raw data required to conduct this reanalysis of the recovery claims.

Peter White retired from MEGA (The M.E./CFS Epidemiology and Genomics Alliance) a few days after they had posted their petition for support to obtain funding of their MEGA research proposals, “and will have an advisory role“.

MEGA applicant, Professor Esther Crawley, relies on the PACE trial for her current research, such as MAGENTA (dubbed the ‘PACE trial for kids‘) and FITNET (psycho-behavioural therapy via the internet for teenagers with ME/CFS).

Professor Stephen Holgate, Chair of the CFS/ME Research Collaborative,  is openly admiring of Deputy Chair, Esther Crawley’s, research.  He was quoted in recent media coverage of FITNET-NHS that more quality research such as this trial is needed.  He assembled the scientists to form MEGA.

The charity Action for ME played a key role in the PACE trial and represents the other charity members of the CFS/ME Research Collaborative on the MEGA group.  Patients are being told that it’s better to be inside the ‘big tent’ of the CMRC and have been urged to apply to join the MEGA Patient Advisory Group.

Our advice to MEGA is – disband.  We have no trust in the board of the CMRC or thus the MEGA project.   Now is the time for any serious biomedical researchers to cut loose and exit the CMRC tent to join the world-class UK biomedical research into ME/CFS being done right now outside.  There is still time to do this. You have not yet embedded yourself in this morass but time is running out as the deadline for funding application looms ever nearer.  At that point your reputation will forever be linked with the sham research that is PACE. Unless you put clear blue water between yourselves and the PACE trial, you are risking your own reputation and that of your university by association.

We are of the firm opinion that no-one involved in organising, steering, advising, or conducting research into ME/CFS, should be relying on, or continuing to defend, the conduct or outcomes of the PACE trial, hence our counter-petition ‘Opposing MEGA’ – http://www.change.org/p/opposing-mega-a-vote-of-no-confidence-in-mega-research-for-me-cfs

(please note that we are not affiliated in any way with the authors of the article published today on the reanalysis of the PACE trial recovery data, and our views on CMRC/MEGA do not reflect theirs). 

Further reading from our site –
Parliamentary Questions asked by MP Kelvin Hopkins

Shining A Light On The CMRC Setup (Minutes And Emails Obtained Under FOI)

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