Sunday, April 17, 2011

Margaret Williams: There are a staggering number of flaws in the PACE Trial article published in The Lancet

The Media and ME

by Margaret Williams, April 2011:

Ever since the foundation of the UK Science Media Centre in 1999 – whose purpose is to ensure that the media deliver only headline science stories that accord with Government policies – the reporting of the biomedical science surrounding ME/CFS has been noticeable by its absence. Instead, there has been a wealth of spin promoting the benefits and success of CBT and GET for every disorder imaginable, including ME/CFS.

In plain terms, the Science Media Centre presents only a one-sided view of the available information about ME/CFS, and direct contact with editors and health editors of broadsheet newspapers has revealed their policy of limiting their reporting of ME/CFS to what they receive from the Science Media Centre.

The fanfare of unlimited praise for the PACE Trial results at the press conference held at the Science Media Centre on 17th February 2011 is a case in point, with the media failing to use its critical faculties and regurgitating only what it had been spoon-fed.

There are a staggering number of flaws in the PACE Trial article published in The Lancet (Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Peter D White et al. The Lancet, 18 February 2011 doi:10.1016/S0140-6736(11)60096-2), not one of which was mentioned in the press conference.

These flaws and errors have been identified in a detailed complaint/statistical analysis sent by Professor Malcolm Hooper to The Lancet on 28th March 2011, upon which The Lancet has asked Professor Peter White to comment (a response with which Professor White has apparently not complied within the time allotted for its receipt by The Lancet).

It is understood that under the Elsevier complaints policy, Professor Hooper will be asked to respond to Professor White’s reply when it is received by The Lancet; it is also understood that the PACE Trial article was to be sent for re-review by different reviewers and statisticians whilst The Lancet was awaiting Professor White’s comments on Professor Hooper’s complaint.

Professor Hooper’s analysis will shortly be placed in the public domain; he had agreed with The Lancet to withhold his complaint from publication during the time allotted by The Lancet to Professor White to respond to it, but this agreed time limit has now expired.

There is one crucial point that should not be overlooked amidst the multitude of comments, spin, disquiet and anger surrounding the clearly contrived and exaggerated results of the PACE Trial, which is that if the PACE Trial Investigators had claimed to be studying the effect of CBT/GET on people with medically unexplained or idiosyncratic “fatigue”, few people would have objected.

What is fuelling the opprobrium is the fact that the PACE Trial Investigators insist that they have been studying those with “CFS/ME”, which is how they refer to the neuroimmune disorder ME/CFS.

The pressing question has to be how the Wessely School can be permitted to disregard the ever-increasing biomedical evidence-base on ME/CFS and to refuse – on no evidence whatever -- to accept the WHO classification of ME/CFS as a neurological disorder.

What can be done to halt the Wessely School’s anti-science activities and misinformation about ME/CFS which they propagate and disseminate with consummate skill? Since they will not budge from their beliefs, could they be right and the biomedical scientists be wrong? Not at all: the Wessely School is gravely mistaken about the nature of ME/CFS and about their ascription of its symptomatology to a somatoform disorder.

In 1978 (33 years ago), the BMJ published a summary of the symposium on ME held that year at The Royal Society of Medicine:



(BMJ 3rd June 1978)
“there was clear agreement that myalgic encephalomyelitis is a distinct nosological entity. Other terms used to describe the disease were rejected as unsatisfactory for various reasons: the cardinal, clinical features show that the disorder is an encephalomyelitis….Some authors have attempted to dismiss this disease as hysterical, but the evidence now makes such a tenet unacceptable….

The organic basis is clear – from the finding that The putative agent of ME/CFS can be transferred to monkeys , the detection of an increased urinary output of creatine, the persistent findings of abnormal lymphocytes in the peripheral blood of some patients, the presence of lymphocytes and increased protein concentration in the cerebrospinal fluid of occasional patients, and the neurological findings”

Apart from their close involvement with the medical and permanent health insurance industry and the unpalatable fact that their professional lives may be shown to have been spent in a null field of research (i.e.. trying to prove that ME/CFS is an aberrant illness belief), it remains a mystery as to why, as bona fide mental health researchers, the Wessely School so persistently refuse to engage with the extensive biomedical evidence-base that exists on ME/CFS.

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