Journal of IiME Volume 9 Issue 1 secured established positions as advisors on “CFS/ME” to UK Departments of State, including the Department of Health and the Department for Work and Pensions, and also to bodies such as the Medical Research Council (MRC) and NICE (the National Institute for Health and Care Excellence), it is their behavioural modification interventions (ie. “brain-washing”) that prevail throughout the NHS, with the risk of serious iatrogenic harm to patients with ME/CFS. Many informed observers believe that within the next ten years this situation will be seen for what it is – a truly appalling medical scandal of astounding proportions, but it is a scandal that (via the auspices of the Science Media Centre and the UK media) many UK luminaries, have condoned without question, (http://www.sciencemediacentre.org/film/); (http://www.meactionuk.org.uk/The-SMC-andits-campaign-against-MECFS.htm). The “evidence” of the “behavioural” camp The PACE trial (Pacing, Activity, and Cognitive behavioural therapy, a randomised Evaluation) is by far the most contentious clinical research study conducted in the field in the last ten years. Conceived and executed by psychiatrists Professors Peter White and Michael Sharpe, assisted by a behaviour therapist, Professor Trudie Chalder, it was funded by the MRC, the Scottish Chief Scientist’s Office, the Department of Health and the Department for Work and Pensions. The PACE Trial is the only clinical trial that the DWP has ever funded and it did so because it was assured that cognitive “restructuring” would successfully remove people with ME/CFS from claiming State benefits. Recruiting began in 2004 and finished in November 2008. Problems with the PACE trial were legion, a particular one being that CBT and GET participants (but not those in other arms of the trial) were instructed to ignore their symptoms. May 2015 Such advice has previously been described as “dangerous” in a Witness Statement for the High Court (http://www.meactionuk.org.uk/Statements-ofConcern-for-High-Court.htm). After the trial had started the Principal Investigators abandoned the protocol-defined thresholds for fatigue and physical function required for a "positive outcome" and "recovery" and replaced them with far less demanding criteria. These changes were such that it became possible to leave the trial with greater fatigue and worsened physical function and still meet the newly-defined thresholds of “the normal range” (this is not the same as normal health, but the media was encouraged to report it as synonymous with “recovery”). The recalculation and construction of “the normal range” allowed the claim that participants had “recovered”: “This study confirms that recovery from CFS is possible and that CBT and GET are the therapies most likely to lead to recovery” (PD White et al: Psychological Medicine: 2013: doi:10.1017/S0033291713000020). ●● ● “Numerous FOIA requests for the raw data (which does not belong to the Investigators but to UK taxpayers) to be released have been refused on entirely spurious grounds” ●● ● The Investigators initially claimed that the PACE trial was to study “CFS/ME” but after publication in The Lancet of selective results in February 2011, the Chief Principal Investigator (Professor Peter White) wrote to the editor in March 2011 saying that the PACE trial “does not purport to be studying CFS/ME but CFS simply defined as a principal complaint of fatigue”. This was a cause for concern, because funding and ethical approval had been sought and obtained on the basis that the Investigators would be studying “CFS/ME”, not “fatigue”. The PACE trial cost UK taxpayers over £5 million and, despite desperate and increasingly ludicrous attempts to proclaim its success, it is widely acknowledged to have failed (http://www.bmj.com/content/350/bmj.h227/rapi Invest in ME (Charity Nr. 1114035) www.investinme.org Page 18 of 57
19 Publizr Home