Dear Dr Gibson,
Further to your letter of 17th November 2005, please find herewith the submission of the Cross Party
Scottish Parliamentary Group on Myalgic Encephalomyelitis to the Group on Scientific Research into
Myalgic Encephalomyelitis (ME). Before presenting this submission, I should like to make two points
regarding its scope and context.
Firstly, the Cross Party Group is specifically on ME, though the Group acknowledges that patients
presenting with the distinctive clinical features relevant to ME are rarely given this diagnostic label
now. ‘Chronic fatigue syndrome’ (CFS) is the preferred term. However, the Group shares considerable
concern at the ‘unexplained fatigue’ perspective which has come to dominate, with official bodies in
the UK explicitly viewing CFS as implying chronic fatigue occurring in the absence of a medical root.
Both elements of this perspective are inappropriate to ME. Firstly, chronic fatigue is a symptom
common to many illnesses, and inadequate to describe what ME patients experience. Secondly, the
absence of a medical root cannot be assumed: indeed, there is a wealth of relevant evidence on this
matter, which the inquiry will no doubt consider in due course, and the World Health Organisation
classifies ME and CFS as neurological. The net impact of this confusion on patients has been and
remains significant, as the implications for healthcare and management for these two categories of
patients - i.e. ME and strictly defined CFS, as opposed to unexplained chronic fatigue - are quite
different. (The enclosed documents elucidate this issue.)
Secondly, it should be noted that, although this submission is from the Cross Party Scottish
Parliamentary Group on ME, the documents prepared are relevant to the setting south of the border. In
fact, the links between Scotland and England & Wales in respect of research into ME are substantial,
since the executive in Scotland has accepted the findings of the CMO’s Report, and has referred to the
MRC Research Strategy in respect of research funding.
I would also like to note that the Cross Party Scottish Parliamentary Group on Myalgic
Encephalomyelitis would be happy to provide a representative to give oral evidence to the inquiry,
should this be considered desirable.
The Cross Party Group on ME hereby submit the following to the inquiry:

‘What does the Chief Medical Officer’s Report recommend regarding research?’
A review of the CMO’s Report’s recommendations regarding research in the light of subsequent
developments, produced specifically for the Westminster inquiry. The relevant parts of the Report
are set out here, including some key points relevant to the wider role of research. This review also
highlights pointers to policy and practice stemming from or relating to research, especially those
elements of guidance contained in the Report which remain highly relevant yet appear to have been
neglected.
[Document 1]

The Medical Research Council Research’s ‘CFS/ME Research Strategy’
A commentary on the MRC’s ‘CFS/ME Research Strategy’ and related developments. This
document has been produced specifically for the Group on Scientific Research into Myalgic
Encephalomyelitis (ME) at Westminster.
[Document 2]

‘Which Interventions are Helpful to Patients with ‘CFS/ME’? - A Review of the Evidence’
This document reviews the evidence on interventions, as considered and assessed by the CMO’s
Working Group. This return to source information illustrates that official views concerning the
relevance and effectiveness of behavioural interventions require to be tempered. The paper also
presents some pertinent examples of research findings which challenge the view that graded
exercise or cognitive behavioural therapy (when aimed at increasing activity levels) may safely be
considered to be relevant and helpful. This paper was commissioned by the Cross Party Group on
ME, and was recently submitted to the Scottish Executive Health Department.
[Document 3]

Concerns Regarding Exercise
Following the publication of the report of the ‘CFS/ME Working Group’ to the English Chief
Medical Officer, the Cross Party Group on ME submitted a response to the Scottish Chief Medical
Officer, in which the Group expressed strong reservations concerning graded exercise. These
concerns were reiterated more recently, in a letter to the Deputy Health Minister, Lewis Macdonald
MSP, which was sent in advance of his visit to the Group’s November 2005 meeting, together with
the ‘Review of the Evidence’ document. As yet the questions raised in this letter, which are equally
relevant in England and Wales, remain unanswered. The text of both documents is presented here.
[Document 4]

An overview of coverage contained in the document ‘Myalgic Encephalomyelitis/Chronic
Fatigue Syndrome: Clinical Working Case Definition, Diagnostic and Treatment Protocols’.
This paper, written by BM Carruthers et al., was published in the Journal of Chronic Fatigue
Syndrome Volume 11, Number 1, 2003. The full document is commended to the inquiry. The
enclosed contents list indicates range and scope of coverage.
[Document 5]

‘Developments following the publication of ‘A Report of the CFS/ME Working Group’ to
the Chief Medical Officer (England & Wales)’
Soon after publication of ‘A Report of the CFS/ME Working Group’ to the English Chief Medical
Officer (CMO), a debate was held in the Scottish Parliament on the need for the allocation of
government funds to relevant research. More recently, a second debate took place (June 2005).
Remarkably little appears to have changed in the intervening years. This document sets out key
issues, as reflected in these debates. It has been produced specifically for the Group on Scientific
Research into Myalgic Encephalomyelitis at Westminster.
[Document 6]

‘What is Happening to ME? - The Distinguishing Features of Myalgic Encephalomyelitis
and their Relationship to Current Diagnostic Practice.’
This short paper sets out the distinctive clinical profile which is unique to ME, notes some of the
misconceptions about this illness, and sums up the current diagnostic mess and it’s implications. It
comprises edited extracts from a briefing paper for MSPs, produced in consultation with the Cross
Party Group on ME, February 2005.
[Document 7]
Key Issues
In drawing together this material for submission, the Cross Party Group on ME has become aware that,
if the inquiry is to assess the impact of the present situation with regard to research in meaningful
terms, then it is not enough just to look at what research has been conducted.
A great deal of relevant research evidence exists – from before and after the publication of the CMO’s
Report. Plausible hypotheses as to possible underlying causes have emerged from both the observed
pattern of illness and the wide range of physical abnormalities identified in the course of research,
which have been documented for some time. Granted, this information has not yet been drawn together
to produce an inclusive and conclusive picture of the reasons behind the onset and persistence of illness
in each and every case; with case definition drawn very broadly, this is not surprising, and the possible
need for subgrouping is one issue which the Cross Party Group would expect to be brought to the
attention of the inquiry. At a minimum, however, we appear to have at present some very strong clues
as to what is going on. This information is highly relevant if we are to move towards treatment (as
opposed to management) approaches.
Of fundamental importance, however, is the way the various strands of research have been interpreted
– in particular, official views as to their significance. Related, and equally important, is the relationship
between evidence and practice.

1
BIOMEDICAL RESEARCH STUDIES: Advances have without doubt been made in biomedical
research in the period since the publication of the CMO’s Report, but indications are that
knowledge and awareness of the relevant research findings and their significance remains
negligible.

This is of particular concern with regard to key groups such as medical
practitioners and students, benefits agency assessors, social services and
education department staff. If service providers are unaware of the relevant
biomedical research findings, then this research has no practical import and no
bearing on the lives of patients.

A wide range of relevant research exists: as such it is unrealistic to expect each
member of staff among the relevant service providers to appraise themselves
‘from scratch’. Fortunately this is unnecessary: in the year following the
publication of the CMO’s report, an authoritative paper was published
following input from invited world leaders in the research and clinical
management of ME/CFS patients.1 This paper gives a succinct research review
in addition to valuable guidance on management and care (Document 5 enclosed
lists coverage). Unfortunately, the vast majority of relevant practitioners,
including medical practitioners with a specific interest in this condition, appear
to remain unaware of the contents and implications of this paper.

In an editorial accompanying this paper, it is noted that “the clinician should
not be confused that fatigue (or myalgia or the other symptoms that occur with
increased frequency with fatigue) is an entity in its own right but is a common
Carruthers, B et al. (2003): Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome: Clinical Working Case Definition,
Diagnostic and Treatment Protocols in the Journal of Chronic Fatigue Syndrome, Vol. 11 [1] 2003, pp7-115. List of
contents enclosed.
symptom of underlying disease”.2 General awareness and acceptance of this
one key sentence would constitute a major step forward.

CURRRENT PRACTICE: In present practice, a ‘nothing physically wrong’ label is not unusual.
Alternatively, patients arecommonly viewed as having physiological problems which are a
consequence of inactivity.

The latter perspective bedevils the CMO’s report recommendations, made in
the absence of an appraisal of the relevant biomedical research evidence. It is
explicit in the subsequent MRC Research Strategy document.

The net result of this situation is that, in the case of patients with ME,
perceptions are out of touch with reality while laying claim to being ‘evidencebased’. This reflects the influence of research on behavioural interventions
aimed at medically unexplained chronic fatigue.

As such, greater awareness of the distinctive defining features of what used to
be referred to in medical circles as ME and refinements to diagnostic practice
are crucial if patient care is to be improved (see enclosure, Document 7).

BEHAVIOURAL RESEARCH STUDIES: Research studies concerning behavioural
interventions - i.e. graded exercise/activity, and cognitive behavioural therapy aimed at
encouraging patients to engage in same - are explicitly underpinned by assumptions that patients’
ongoing illness presentation results from inactivity and consequent deconditioning, possibly
following an earlier period of (possibly viral) illness. It is widely perceived that the findings of
such research studies conclusively demonstrate that these interventions are appropriate - and
possibly even curative - for all patients currently presenting with a diagnosis of ‘chronic fatigue
syndrome’ (CFS). This will include those with the unique and distinctive clinical presentation
formerly referred to in medical circles as myalgic encephalomyelitis (ME). Concern at this
perspective led to the production of the ‘Evidence Review’ paper for the Cross Party Group (copy
enclosed: Document 3), which highlights implications for practice if harm to such patients is to be
avoided.

The relevant research papers are clearly aimed at dealing with the problems
faced by patients with unexplained chronic fatigue.3 The use of broad ‘Oxford’
fatigue criteria to recruit research subjects is of crucial significance in this
context. Yet the MRC, in the research strategy developed subsequent to
publication of CMO’s Report, explicitly advocate use of such broad criteria. In
the absence of an investigation into the features of subgroups, this is unhelpful.

It is notable that physiological research evidence exists which challenges the
perspective that exercise is relevant and beneficial: indeed, some such evidence
would indicate that exercise is, on the contrary, inappropriate and possibly
harmful to certain patients. This evidence is not new: it was available at the
2
Editorial: Chronic Fatigue Syndrome Guidelines De Meirleir, K and McGregor N, in the Journal of Chronic Fatigue
Syndrome, Vol. 11 [1] 2003, pp1-6. The above quote is from page 2-3.
3
‘Chronic fatigue syndrome’ (CFS) is the term currently favoured in medical and other official circles, and is used to
encompass a broad range of clinical presentations. Notably, it has come to be erroneously confused with chronic fatigue
occurring in the absence of a medical basis. This despite that fact that unexplained fatigue is listed as a mental and
behavioural disorder in the World Health Organisation International Classification of Diseases (ICD) 10, section F48.0. On
the other hand, ME and CFS are classified as neurological (section G93.3). No illness or condition may appear in more than
one category.
time when the CMO’s Working Group was deliberating. The Working Group
Report, in recommending graded exercise as “potentially beneficial in
modifying the illness”,4 apparently took no cognisance of such evidence. The
Cross Party Group on ME formally expressed concern at the advocacy of
graded exercise in the CMO’s Report, and has reiterated these concerns more
recently (see Document 4, enclosed). Physiological evidence contra-indicating
exercise has continued to accrue in the four years since the report was
published.

BIOMEDICAL RESEARCH FUNDING: Government funding for biomedical research into ME,
whether through the Medical Research Council (MRC) or the Chief Scientist’s Office (CSO) in
Scotland, continues to be low to non-existent. Members of the Scottish Parliament have voiced
support for Scottish Executive funding for such research, which is of international significance, in
the course of parliamentary debates (see enclosed: Document 6) and through the Cross Party Group
on ME.

BEHAVIOURAL RESEARCH FUNDING: Government funding for research adopting a
‘biopsychosocial’ perspective, on the other hand, has been considerable: primarily studies on
behavioural interventions, as discussed above. Notably, the multi-million pound PACE5 trials
have been funded by the MRC, the Scottish Chief Scientist’s Office, and the Department of Work
and Pensions. Similarly, the FINE6 intervention study, aimed at severely affected sufferers, is
MRC funded.

The CMO’s Report, in discussing cognitive behavioural therapy, graded
exercise, and pacing, recognised some of the limitations of the research in the
area of behavioural interventions, and consequently made some
recommendations for further research in this area. This field of research has
subsequently attracted high levels of UK government and Scottish Executive
funding. This cannot, however, be said of the range of research priorities
identified by the Working Group in the section of the Report specifically
headed ‘Recommendations of the Working Group’ (see enclosed: Document 1).

However, this reflects priorities for research as set out in the MRC’s research
strategy, developed following publication of the CMO’s Report. This strategy
clearly defines the problem as chronic fatigue (i.e. a symptom, not an illness)
occurring in the absence of a medical basis, making comparisons between this
condition and medically unexplained low back pain. It explicitly endorses the
perspective that patients are suffering from deconditioning caused by inactivity
(see enclosure: document 2). Job advertisements for posts relating to the PACE
trial also make this ‘medically unexplained fatigue’ perspective explicit.

OTHER PATHS TO KNOWLEDGE: Finally, scientific research, important though it is, is not
the only way to find out about an illness and the way it impacts on patients. Investigations in a
4
A Report of the CFS/ME Working Group: Report to the Chief Medical Officer of an Independent Working Group. London: Department
of Health, 2002, page 45.
5
6
Pacing, Activity and Cognitive behaviour therapy: a randomised Evaluation.
Fatigue Intervention by Nurses Evaluation
clinical setting would help clarify what is wrong with the specific patient. Recording how patients
respond to various treatments and interventions in a clinical setting is critically important too.
In the light of these factors, the following quote - from a paper presented by Byron Marshall Hyde
M.D., an eminent authority on M.E., to the Nightingale Research Foundation – is highly pertinent:
“All definition of epidemic or infectious illness must be based upon persistent clinical
examination of the afflicted patient, an understanding and exploration of the
environmental factors producing that illness, and pathophysiological examination of
tissue from those patients.” 7
This approach has been and remains notably absent in respect of patients presenting with a diagnosis of
‘chronic fatigue syndrome’.
At the ‘Second World Congress on ME/CFS and related disorders’, held in Brussels in September
1999, Dr Daniel Peterson, a Diplomate of the American Board of Internal Medicine, who first
identified CFIDS8 during an outbreak in Incline Village, Nevada, in 1984,9 said that he was amazed at
the misconceptions that existed about ‘ME/CFS’; he said that ten years ago, he believed that ‘ME/CFS’
would be resolved by science; he had now changed his mind and believed it could only be resolved by
politics. The Cross Party Scottish Parliamentary Group on Myalgic Encephalomyelitis (ME) would like
to conclude by expressing the hope that the inquiry being conducted by the Group on Scientific
Research into Myalgic Encephalomyelitis at Westminster will prove to be a first step towards such a
resolution.
7
New South Wales, February 1998. See http://www.nightingale.ca/ICaustralia2.html.
Chronic Fatigue and Immune Dysfunction Syndrome (the term used in the US).
9
Journal of Chronic Fatigue Syndrome 1995: 1:3-4: pages 123-125.
8