Following a number of FOI (freedom of information) requests, the results of a trial into chronic fatigue syndrome (CFS), sometimes known as myalgic encephalomyelitis (ME), have been called into question.
The initial results of a PACE trial carried out at Queen Mary University of London (QMUL) suggested that certain therapies for the treatment of CFS/ME were effective, with NICE (National Institute for Health and Care Excellence) deciding to recommend them as standard NHS treatment.
The PACE trial
The trial compared four therapies to determine how effective they were in the treatment of CFS. 641 people who had mild or moderate CFS took part in the trial, which excluded people with severe forms of the disease. The therapies investigated were APT (adaptive pacing therapy), CBT (cognitive behavioural therapy), GET (graded exercise therapy) and SMC (specialist medical care). Adaptive phase 1 clinical studies were not included in this trial, which simply compared the different treatment methods.
The cause of CFS is fiercely debated, with many patients and scientists believing that the disease has a biomedical or physical cause; however, the authors of this trial – which was funded by the Department for Work and Pensions (DWP) – embrace the theory that CFS is mainly due to psychological issues and could be cured if patients changed their thought processes and took more exercise.
Whilst clinical research organisations such as http://www.richmondpharmacology.com carry out successful trials that are peer reviewed and trustworthy, the New York Times reported that the published results of the PACE trial have damaged the public’s faith in science. It also states that medical professionals should stop recommending CBT and GET as effective treatments for the condition.
Freedom of information requests
The FOI request in March 2014 followed several earlier requests that had been unsuccessful. QMUL claimed that the costs involved in re-analysing the data were prohibitive; as a result, it was then asked for anonymised data so that it could be analysed by Aleem Mathees of Perth, Australia. This request that was initially denied on the grounds that it could not be anonymised enough to protect the participants’ identities.
Critics of the trial were portrayed by the researchers as obsessive, unstable and unreasonable; however, QMUL was eventually ordered to release the data after a FOI tribunal appeal and critics of the PACE trial have been vindicated.