Journal of IiME Volume 1 Issue 2 www.investinme.org The PACE TRIALS (continued) thought about, attempting to compile such a list. Similarly, I do not possess, and have never possessed, a list of vitriolic articles and websites, so I cannot provide these”. Also in his letter of 7th November 2006, Dr Johnson simultaneously did “not know when CFS/ME became controversial or why” but nevertheless proffered his speculation that “controversy sometimes arises when the evidence base is slender as many views and ideas can be put forward without any means of resolving them. The publication of a large number of research papers in the medical literature, some of poor quality or based on small samples only leads to further confusion”. This is an interesting piece of conjecture, given that the post of Statistician Clinical Trials Unit (CTU) Division of Psychological Medicine Ref No: 06/A09 is described as the “Johnson_Wessely_Job” (07/07/2006) at the The Institute of Psychiatry where: “The team works under the direction of Professor Simon Wessely, the Unit Director. The team is supported by the regular input of a Unit Management Group from within the Institute of Psychiatry. The statisticians within the Unit also have regular supervision meetings with Dr Tony Johnson from the MRC Clinical Trials Unit. The post holder will be directly responsible to the CTU Manager (Caroline Murphy), supervised by the CTU Statistician (Rebecca Walwyn) and will be under the overall direction of the Head of Department, Professor Simon Wessely”. Against the evidence that mixing study populations is inadvisable, the PACE trial is mixing at least three different groups of patients. As no satisfactory response had been received to a perfectly valid request for further clarification (i.e. the names of individuals involved with the PACE trial who, Johnson believed, would, without his own “vital” intervention, be unable to maintain the requisite “neutrality” which he was able to ensure through his “familial involvement” with one of the charities), the ME/CFS sufferer wrote again with the same request. Over five months after that request, Dr Johnson sent a further letter dated 2nd April 2007 in which he wrote: “The issues that you raise here are complicated. First it is important to realise that there is a substantial range of opinion among clinicians about the relative merits of some treatments”. Johnson’s reply was a five-page masterpiece of confabulation but still did not answer the question asked. Instead, amongst other diversions, he wrote at length about SSMC (standardised specialist medical care) for those with ME/CFS as part of the PACE trial, causing another ME/CFS sufferer to ask: “What is the accepted definition of standardised specialist medical care (SSMC) for those with ME/CFS? In order to achieve an accurate assessment of the PACE trial outcomes, there must be a definition of standardised Invest in ME Charity Nr 1114035 ‘in designing the trial we had to guess the outcomes and our guesses (were) mostly based on published studies”.. specialist medical care, so what is this definition and where is it accessible? (It is a matter of record that there isn't one). Tony Johnson accepts that an early design for the current PACE trial did not include an SSMC group but he seems to have expediently overlooked the reality that there is no SSMC for those with ME/CFS, as Catherine Rye made plain in 1996 about the Sharpe et al paper of the Oxford trial of CBT/GET: ‘I am a sufferer and participated in the Oxford trial. There are facts about the trial that throw into doubt how successful it is. It is stated that patients in the control group received standard medical care. I was in that group but I received nothing’ ” (Independent, 30th March 1996, page 16). The same ME/CFS sufferer also asked: “What is Tony Johnson’s statistical rationale for deliberately mixing patient cohorts in the PACE trial? Against the evidence that mixing study populations is inadvisable, the PACE trial is mixing at least three different groups of patients. “Fibromyalgia patients are included in the Principal Investigator’s own selection of those with “CFS/ME” for the MRC PACE trial, as well as those with other states of chronic fatigue, including psychiatric states, yet all three categories are taxonomically different and are classified differently by the WHO. Fibromyalgia is classified at ICD-10 M79.0; ME/CFS is classified at ICD-10 G93.3 and other fatigue states are classified at ICD-10 F48.0. “In a reply dated 15th April 2005 to Neil Brown, Simon Burden of the MRC wrote: ‘When researchers put together a proposal they are required to define the population they are studying’. Why does this basic requirement not apply to the PACE trial and how will the outright abandonment of this MRC principle affect Johnson’s statistical analysis of the PACE trial? “How does this accord with what Simon Burden asserted was the MRC’s requirement for ‘the high scientific standard required for funding’? “Johnson acknowledges in his reply (on page 4) that: ‘It is important to realise that there is a substantial range of opinion among clinicians about the relative merits of some treatments’. Indeed, this is so. What, then, is his statistical explanation for the MRC’s undue reliance on the ill-founded beliefs of Wessely School psychiatrists, given the large body of undisputed published evidence that their beliefs about the nature of ME/CFS are simply wrong? Johnson states in his reply: ‘in designing the trial we had to guess the outcomes and our guesses (were) mostly based on published studies”. For what statistical (continued on page 55) Page 54/72
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