Category: The Young ME Sufferers Trust

ME and CFS in Parliament: Term dates, APPG on ME and Lightning Process pilot study, Written Question, new EDM

ME and CFS in Parliament: Term dates, APPG on ME and Lightning Process pilot study in children, Written Question, new EDM


A compilation of Parliamentary related items

House of Commons Recess dates 2010-11 (Note: All recess dates are provisional)

House of Commons

State Opening: 25 May 2010

Conference Recess: House Rises: 16 September 2010 House Returns: 11 October 2010

Christmas Recess: House Rises: 21 December 2010 House Returns: 10 January 2011

Half term to be confirmed

Easter to be confirmed


The reconvened APPG on ME had been expected to hold a planning meeting in September. I cannot confirm whether and when a planning meeting took place.

Today, I have written to David Amess MP (Acting Chair, APPG on ME), Annette Brooke MP (Vice-Chair, APPG on ME), APPG on ME ME Association Secretariat and Jane Colby (The Young ME Sufferers Trust).

I have requested that the controversial issue of the Bath/Bristol Lightning Process pilot study in children (which for which ethics approval was obtained in September and for which the study protocol and related documents were published on 16 September) is going to be tabled for discussion at the first meeting of the APPG on ME, on whatever date this takes place. If this is not being tabled for discusion I have requested that it be added to the Agenda.

The following have been advised: Invest in ME; 25% ME Group; RiME, Sue Waddle (rep for ME Research UK) and BRAME.

I took the opportunity of thanking Annette Brooke, again, for raising this issue with Rt Hon Andrew Lansley, MP, Secretary of State for Health and also for tabling the Parliamentary Question for which a response was received from Paul Burstow, MP, Minister of State (Care Services), on 11 October.

I also thanked the ME Association and The Young ME Sufferers Trust for their very strong opposition statements, their joint press release and for their representations to the Department of Health and to the Chair of South West 2 Research Ethics Committee.

I will confirm whether this issue is being tabled for discussion at the next meeting of the APPG on ME, which is expected to be held in November but for which a date has yet to be confirmed.



An EDM (Early Day Motion) has been tabled by Ian Swales MP (LibDem Redcar). It is understood that this results out of lobbying by Jan Laverick and a family member.

EDM 778


Swales, Ian

That this House notes that despite the fact that the Department of Health now accepts myalgic encephalomyelitis (ME) as a genuine medical condition, diagnosis can still pose a problem because ME symptoms are similar to those present in a number of other medical conditions; recognises that one of the main obstacles to the adequate treatment of ME is the lack of knowledge and consensus about the disease; believes that funding and research must be focused on the bio-medical factors involved and not just simply managing the psychological symptoms; requests that the Government establishes an independent scientific committee to oversee ME research; and calls on the Government and the Medical Research Council to work with ME sufferers and bio-medical researchers in order to achieve a proper understanding of the condition’s challenges and unjust perceptions of the condition.

At 14 October, 18 MPs had signed up to the EDM. Follow its progres, here, where signatures of supporting MPs are listed:


Ian Swales MP maintains a Facebook page here: Ian Swales (Liberal Democrat) for Redcar on Facebook

What are Early Day Motions?

Early day motions (EDMs) are formal motions submitted for debate in the House of Commons. However, very few EDMs are actually debated. Instead, they are used for reasons such as publicising the views of individual MPs, drawing attention to specific events or campaigns, and demonstrating the extent of parliamentary support for a particular cause or point of view.

More information on the nature and purpose of EDMs, here, on the Parliament website


Contacting MPs

For contact details for MPs go to this page on the Parliament website:

or here on They Work for You:

Find out about your new MP/ MSPs/ MLAs

Read debates they’ve taken part in, see how they voted, sign up for an email alert, and more.

They Work for You links to:

The most recent Commons debates

The most recent Westminster Hall debates

The most recent Written Answers

The most recent Lords debates

The most recent Written Ministerial Statements


Written answers and statements, 13 October 2010 [2]

Written answers and statements
Hansard source (Citation: HC Deb, 13 October 2010, c347W)

Work Capability Assessment: Chronic Fatigue Syndrome

Margaret Curran (Labour, Glasgow West): To ask the Secretary of State for Work and Pensions whether the agency contracted to provide medical examinations as part of the Work Capability Assessment has been issued with specific guidance on the assessment of persons presenting a diagnosis of myalgic encephalomyelitis or chronic fatigue syndrome. [14304]

Chris Grayling (Minister of State for Employment): All health care professionals working for Atos Healthcare are required to read an evidence based protocol on chronic fatigue syndrome as part of their induction training. This was last updated in January 2010. In addition, all health care professionals are required to engage in a programme of continuing medical education which includes two modules on chronic fatigue syndrome. These were last updated in April 2009 and March 2010 respectively.

Related information

[1] “Unethical” Lightning Process pilot study in children receives ethics approval 

[2] Information on tabling Parliamentary Questions:

SMILE – Specialist Medical Intervention and Lightning Evaluation documents

SMILE – Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study – children [now aged 12 to 18] with CFS and ME)


See also previous ME agenda post:

“Unethical” Lightning Process pilot study in children receives ethics approval

Update: Key documents

3] SMILE Research Protocol

Open here: smprotv6final

29] Research Ethics  Application Form

Open here: recfrmrfs

University of Bristol website  

Source: Protocol document


SMILE – Specialist Medical Intervention and Lightning Evaluation

What is SMILE?

SMILE is a feasibility study to see whether it is possible to recruit young people into a study to compare specialist medical treatment with specialist medical treatment plus the Lightning Process for young people with chronic fatigue syndrome or ME (CFS/ME).

The study will also look at how we should measure outcomes and the health economic impact on the families of young people with CFS/ME.

Young people will be observed completing the questionnaires that we use to look at how unwell they are before they see us and what happens to them after an intervention. We will also talk to young people and their parents to understand what they think about the questionnaires and to determine the most acceptable and sensitive ones to use. This study is the first to work out which questionnaires we should be using to understand outcome in paediatric CFS/ME.

Frequently Asked Questions

Why is research in children needed?

Over 250 children a year already attend Lightning Process training. It is important that people know whether it is safe and effective or not. We need high quality research to answer these questions. If SMILE can recruit enough people to participate in the study then further research could look at whether it is helpful or not.

Should research be done in children before adults?

Children have the right to research particularly in illnesses which are different to adults. CFS/ME in children has a different outcome to adults and the treatment is different therefore research in adults cannot be extrapolated to children.

How will the safety of those involved in SMILE be monitored?

The safety and wellbeing of people involved in any research project, not just the SMILE project, is of the utmost importance. There is an Independent Advisory Group to oversee, and monitor this research. All participants will be carefully monitored and regularly reviewed in the specialist CFS/ME service. Young people taking part can opt out of the trial at any point.

How can we take part in the study?

Young people are eligible if they are between 12 and 18 years of age, have CFS/ME and are from the region covered by the Bath/Bristol specialist CFS/ME service. Young people are recruited at assessment so you will not be eligible if you have already been seen by the service.

What ethical review has SMILE received?

The study has been scrutinised by the South West 2 Research Ethics Committee whose role it is to ensure that research is safe and ethically sound. The ethics committee have looked in detail at the study design, and all associated documentation and suggested improvements to the readability and accessibility of the patient information leaflets and consent forms which have been adopted.

The SMILE study is compliant with Good Clinical Practice Guidelines, Research Governance Framework, Medical Research Council guidelines, Royal College of Paediatrics and Child Health guidelines for the conduct of trials and has been approved by an ethics committee.

Further information about this research project can be found in the following documents:

Smile Study Documents

[Ed: I have numbered these documents for ease of reference – they are not numbered on the University of  Bristol website.]

Note: some of the documents on this page are in PDF format. In order to view a PDF you will need Adobe Acrobat Reader

1] SMILE Information sheet for teenagers August 2010 [pdf (150kb)]

Open here: infoshtteensv4aug10

2] SMILE Information sheet for parents September 2010 [pdf (147kb)]

Open here: infoshtprntsv7sept10

3] SMILE Protocol Final July 2010 [pdf (170kb)]

Open here: smprotv6final

4] SMILE Under 16 assent to contact July 2010 [pdf (109kb)

Open here: u16asscv4july10

5] SMILE 16 to 18 consent to contact July 2010 [pdf (110kb)]

Open here: 16to18confinaljuly10

6] SMILE Parental consent to contact 10 May 2010 [pdf (111kb)]

Open here: parconsv310may10

7] SMILE Under 16 assent to study July 2010 [pdf (112kb)]

Open here: u16asscv4july10

8] SMILE 16 to 18 consent to study July 2010 [pdf (110kb)]

Open here:  16to18constjuly10final

9] SMILE Parental consent to study 10 May 2010 [pdf (113kb)]

Open here: parconssv310may10

10] SMILE teenager consent/assent to teenager interview August 2010 [pdf (110kb)]

Open here: tcontinvv5aug10

11] SMILE Parental consent to child interview 10 May 2010 [pdf (111kb)]

Open here: parconcinv10may10

12] SMILE Parental consent to parental interview 10 May 2010 [pdf (109kb)]

Open here: parconinvv310may10

13] SMILE Consent to record intervention for participants, parents and those delivering interventions July 2010 [pdf (110kb)]

Open here: conrecintjuly10final

14] SMILE Lightning process assessment form July 2010 [pdf (159kb)]

Open here: lipcassfrmv2july10

15] SMILE letter to GP 10 May 2010 [pdf (49kb)]

Open here: letgpv110may10

16] SMILE WPAI [pdf (135kb)]

Open here: wpai

17] SMILE Health resource use questionnaire 10 May 2010 [pdf (232kb)]

Open here: healthresuseq

18] SMILE SF-36 [pdf (165kb)]

Open here: smilesf36

19] SMILE Interview topic guide 10 May 10 [pdf (178kb)]

 Open here: topgdev210may10

Correspondence with Ethics Documents

20] Initial covering letter to NREC 20th May 2010 [pdf (75kb)]

Open here: covlet20may10

21] NREC Letter 14th June 2010 [pdf (108kb)]

Open here: let14jun

22] NREC Letter 19th July 2010 [pdf (272kb)]

Open here: let19july

23] Covering letter in reply to NREC 28th July 2010 [pdf (159kb)]

Open here: letrep28july

24] NREC Letter 13th August 2010 [pdf (72kb)]

Open here: let13aug

25] Letter re meeting notes in reply to NREC 19th August 2010 [pdf (45kb)]

Open here: letmetn19aug

26] Second covering letter reply to NREC 20th August 2010 [pdf (109kb)]

Open here: seclet20aug10

27] Letter in reply to NREC 13th September 2010 [pdf ( 80kb)]

Open here: let13sep

28] NREC Approval letter 14th September 2010 [pdf (213kb)]

Open here: applet14sep10

29] REC Form [pdf (353kb)]

Open here: recfrmrfs

New evidence that ME, CFS in children could be caused by a virus

A University of Dundee study on children has found further evidence that ME, or Chronic Fatigue Syndrome, could be caused by a virus. 


Additional reporting will be added to the top 

Media Coverage

Scottish Daily Record  |  Lachlan Mackinnon  | 8 September 2010

Chronic fatigue syndrome may be caused by virus, Scottish researchers find


Radio Scotland  |  Jane Colby  |  7 September 2010

Pick up around 11.00 in from start


WebMD Health News  |  Peter Russell  |  7 September 2010

Health news

Study links ME to virus
A small-scale investigation has found evidence that the debilitating illness could be caused by a virus

Reviewed by Dr Keith David Barnard


BBC News 7th September 2010: “Study shows ME/CFS ‘virus link’ found in children”  [Extracts already posted below]

BBC Health TV Report 7th September 2010: ME ‘could be caused by a virus’

BBC Radio 4 7th September 2010: Item on Today Programme

UKwired 7th Septemebr 2010: Study shows ME/CFS ‘virus link’ found in children


ME Research UK

Abstract and commentary also available on MERUK site

Comment by ME Research UK [note this commentary is heavy with links, please refer to site for links]

Illness in youngsters has a particular poignancy; the transformation of a bright, active child into one who is unable to go to school or play with friends is something that touches us all.

Estimates of the numbers of children affected by ME/CFS vary, but with prevalence figures of 60 to 70 cases per 100,000, it is likely that around 9,000 people under the age of 16 in the UK have this diagnosis. As the report to the Chief Medical Officer in 2002 made clear, this illness “represents a substantial problem in the young” and “potentially threatens physical, emotional, and intellectual development of children and young people, and can disrupt education and social and family life, at a particularly vulnerable time of life”.

The results of a previous study on quality of life in children with ME/CFS were recently published in Pediatrics by Dr Gwen Kennedy at the Vascular and Inflammatory Diseases Research Unit in the University of Dundee. In parallel with this work, Dr Kennedy and her colleague Dr Faisel Khan have been investigating biochemical and vascular abnormalities in children with the disease, and their results have just appeared in the US journal Archives of Pediatrics and Adolescent Medicine.

The Dundee group had previously reported a number of biochemical and vascular abnormalities in adults with ME/CFS. These mainly involve the immune and cardiovascular systems, and include an increase in the programmed death (apoptosis) of white blood cells, raised levels of oxidative stress which can damage blood vessels and other organs, increased markers of inflammation, and abnormalities in blood vessel function. All of these are potentially associated with a future risk for cardiovascular problems such as heart disease and stroke.

Drs Kennedy and Khan wanted to investigate whether these abnormalities were also present in children with ME/CFS, given the potential long-term consequences for cardiovascular risk. Risk factors such as high cholesterol and increased blood pressure, which are usually associated with adult diseases, have also been found in children and can progress into adulthood as hypercholesterolaemia and hypertension, so it is important that risks are identified as early in life as possible.

Twenty-five children with ME/CFS (all between the ages of 10 and 18 years) and 23 healthy children matched for age, gender and stage of puberty were recruited from throughout the UK. The diagnosis of ME/CFS had been made according to a revised version of the CDC-1994 case definition, and was confirmed by the researchers from a clinical examination.

A blood sample was taken from each child (using an anaesthetic cream to minimise their discomfort), and this was then subjected to a battery of tests in Dr Kennedy’s laboratory. The child’s blood pressure was measured, and then the pulse at their wrist was detected using a special pen-like probe applied lightly to the skin. This records the fluctuations in pressure as each pulse travels along the artery, and is exactly what you feel with your finger when you take your own pulse. This recording of the pulse is then analysed on a computer to give information on how flexible the artery is, which gives an indication of its health and function.

Overall, compared with healthy control children, the young people with ME/CFS had:

1.Higher levels of oxidative stress, manifested as elevated levels of isoprostanes
2.Reduced levels of vitamins C and E
3.A greater percentage of white blood cells undergoing apoptosis
4.A trend towards increased arterial stiffness, although this was not statistically significant

As Dr Kennedy points out, the increased oxidative stress may be due to a deficiency of antioxidants in the diet (such as vitamins C and E, found to be reduced in this study). However, she feels it is more likely to have been caused by white blood cells releasing an excessive amount of highly reactive free radicals, possibly from exercising muscle. This would tie in with the finding of increased white cell apoptosis, and Dr Kennedy has previously reported increased oxidative stress following exercise in adults with ME/CFS. She does emphasise, however, that more studies, perhaps including an assessment of diet, are needed to determine this mechanism.

The increased apoptosis (or programmed cell death) may be caused by a number of factors, including a persistent viral infection or toxic agent, or an abnormal immunological response. This finding is particularly intriguing given that many patients, including most children in this study, report that their disease started following a viral infection of some kind. At present, however, there is insufficient evidence to make a causal link between infection and increased apoptosis, though the finding is tantalising.

Although there were no other statistically significant changes in the children with ME/CFS, there was a clustering of markers such as arterial stiffness and cholesterol that showed small changes which may indicate the possibility of future cardiovascular risk. This type of clustering has been shown before in healthy children and in young people with diabetes. Although it should be stressed that children with ME/CFS are at no immediate risk of developing cardiovascular problems, we might expect these changes to become greater (closer to the adult pattern) as the children grow older and have been ill for longer.

Dr Kennedy and her team conclude their report by saying that the findings show that many children with ME/CFS “have an underlying, detectable abnormality in the behaviour of their immune cells, consistent with an activated inflammatory process”, and provide evidence of “a persistent or reactivating viral infection triggering apoptosis of white blood cells with an increased production of free radicals”.

It is important that these abnormalities have now been recognised in children with ME/CFS. To date, aside from symptomatic treatments, no specific therapy is available for children or adults with ME/CFS. Based on these and other biomedical findings in the disease, putative therapies could perhaps include both pharmacological and non-pharmacological strategies (to treat dysautonomia, for example), or antioxidant or antiviral interventions.

Co-funders of the study
ME Research UK funds biomedical research into ME/CFS with the aim of finding the cause of the illness and developing effective treatments. It funds the work of a growing number of scientists in the UK and worldwide, and to date has invested over £600,000 to support biomedical research. We are particularly grateful to the ME organisations which have provided larger donations to help us fund specific projects, details of which including some of the resulting scientific papers can be found on our research pages.

The Young ME Sufferers (Tymes) Trust, one of the major co-funders of the study at the University of Dundee, is the longest established national UK service for children and young people with ME and their families. A well-respected national charity, which recently won the Queen’s Award for Voluntary Service, its entire professional team give their time free of charge. It runs an Advice Line, provides access to ME experts for doctors, teachers and social workers, and produces a magazine for children, families and professionals. The Trust played a major role in producing the children’s section of the Department of Health Report on CFS/ME (2002). It promotes interactive virtual education for children with ME, and provides the Tymes Trustcard — a pass card for children in school, endorsed by the Association of School and College Leaders. More information on the Tymes Trust and its work can be obtained at its website.

Search ME, based in Rosyth, Fife, was founded in 2002. Its aims are to improve the lives of people with ME and to provide them with a voice on the Cross Party Group for ME in the Scottish Parliament. The charity has raised the bulk of its donations through organising Rock and Pop Concerts. Search ME became an early supporter of the study at the University of Dundee and helped fund the work carried out there. Members of the charity are very proud of the work carried out at Dundee and of all the people involved. Further information can be found on their website.

Tenovus Scotland has funded world class cancer research across the UK for over 40 years, providing a vital link by funding pilot studies which can attract further support from major funding bodies such as the Wellcome Trust, the MRC, Cancer Research UK, the British Heart Foundation and many others. Further information can be found at its website.


Vol. 164 No. 9, September 2010  |  Journal of Archives of  Pediatriatrics & Adolescent Medicine 

Biochemical and Vascular Aspects of Pediatric Chronic Fatigue Syndrome
Gwen Kennedy; Faisel Khan; Alexander Hill; Christine Underwood; Jill J. F. Belch
Arch Pediatr Adolesc Med. 2010;164(9):817-823.
ABSTRACT | FULL TEXT | PDF  [Free Abstract, Payment required for full paper] 


Biochemical and Vascular Aspects of Pediatric Chronic Fatigue Syndrome
Gwen Kennedy, PhD; Faisel Khan, PhD; Alexander Hill, PhD; Christine Underwood, MBBS; Jill J. F. Belch, MD 

Arch Pediatr Adolesc Med. 2010;164(9):817-823. doi:10.1001/archpediatrics.2010.157   

Objective To evaluate the biochemical and vascular aspects of pediatric chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). 

Design Cross-sectional clinical study. 

Setting Tayside, Scotland, United Kingdom. 

Participants Twenty-five children with CFS/ME and 23 healthy children recruited from throughout the United Kingdom. 

Interventions Participants underwent a full clinical examination to establish a diagnosis of CFS/ME and were asked to describe and score their CFS/ME symptoms. Biochemical markers were measured. Arterial wave reflection was estimated to assess systemic arterial stiffness. 

Main Outcome Measures Markers of oxidative stress and free radicals, C-reactive protein level, white blood cell apoptosis, and arterial wave reflection. 

Results Children with CFS/ME had increased oxidative stress compared with control individuals (isoprostanes: 252.30 vs 215.60 pg/mL, P = .007; vitamin C, mean [SD]: 0.84 [0.26] vs 1.15 [0.28] mg/dL, P < .001; vitamin E, 8.72 [2.39] vs 10.94 [3.46] µg/mL, P = .01) and increased white blood cell apoptosis (neutrophils: 53.7% vs 35.7%, P = .005; lymphocytes: 40.1% vs 24.6%, P = .009). Arterial stiffness variables did not differ significantly between groups (mean augmentation index, –0.57% vs –0.47%, P = .09); however, the derived variables significantly correlated with total (r = 0.543, P = .02) and low-density lipoprotein (r = 0.631, P = .004) cholesterol in patients with CFS/ME but not in controls. 

Conclusions Biomedical anomalies seen in adults with CFS/ME—increased oxidative stress and increased white blood cell apoptosis—can also be observed in children with clinically diagnosed CFS/ME compared with matched controls. Unlike in their adult counterparts, however, arterial stiffness remained within the reference range in these pediatric patients. 

Author Affiliations: Vascular and Inflammatory Diseases Research Unit, The Institute of Cardiovascular Research, Centre for Cardiovascular and Lung Biology, Division of Medical Sciences, Ninewells Hospital and Medical School, Dundee, Scotland, United Kingdom. 


Additional papers and Editorial in current edition: 

Adolescent Chronic Fatigue Syndrome: A Follow-up Study
Stefan M. van Geelen; Rob J. Bakker; Wietse Kuis; Elise M. van de Putte
Arch Pediatr Adolesc Med. 2010;164(9):810-814.
ABSTRACT | FULL TEXT | PDF  [Free Abstract, Payment required for full paper]


Adolescent Chronic Fatigue Syndrome
A Follow-up Study

Stefan M. van Geelen, MPhil; Rob J. Bakker, MD; Wietse Kuis, PhD, MD; Elise M. van de Putte, PhD, MD

Arch Pediatr Adolesc Med. 2010;164(9):810-814. doi:10.1001/archpediatrics.2010.145

Adolescent Chronic Fatigue Syndrome
A Follow-up Study

Stefan M. van Geelen, MPhil; Rob J. Bakker, MD; Wietse Kuis, PhD, MD; Elise M. van de Putte, PhD, MD

Arch Pediatr Adolesc Med. 2010;164(9):810-814. doi:10.1001/archpediatrics.2010.145

Objective To describe the symptomatic and educational long-term outcomes, health care use, and risk factors of nonrecovery in adolescent chronic fatigue syndrome (CFS).

Design Follow-up study.

Setting Academic pediatric hospital.

Participants Sixty adolescents with CFS.

Interventions Regular care.

Outcome Measures The Checklist Individual Strength, Child Health Questionnaire, and a general questionnaire regarding further symptoms, school attendance, work attendance, and treatment.

Results Complete measurements were returned for 54 adolescents (90%). At initial assessment, their mean (SD) age was 16.0 (1.5) years and 20.4% were male. The mean follow-up duration was 2.2 years. At follow-up, the mean (SD) age was 18.2 (1.5) years; 28 adolescents (51.9%) had nearly complete improvement of symptoms but 26 (48.1%) did not experience improvement. Adolescents who attended school (n = 41) had missed an average of 33% of classes during the last month. The rest (n = 13) had worked an average of 38.7% of a full-time job during the last month. A total of 66.7% of subjects were treated by a physiotherapist, 38.9% were clinically treated in rehabilitation, 48.1% had received psychological support, and 53.7% had used alternative treatment.

Conclusions About half of the adolescents had recovered from CFS at follow-up. The other half was still severely fatigued and physically impaired. Health care use had been high, and school and work attendance were low. Older age at inclusion was a risk factor, and pain, poor mental health, self-esteem, and general health perception at outcome were associated with an unfavorable outcome. Future research should focus on customizing existing treatment and studying additional treatment options.

Author Affiliations: Department of Pediatrics, University Medical Center Utrecht, Utrecht, the Netherlands.

Postinfectious Fatigue in Adolescents and Physical Activity
Yue Huang, PhD; Ben Z. Katz, MD; Cynthia Mears, DO; Gary W. Kielhofner, DrPH; Renée Taylor, PhD

Arch Pediatr Adolesc Med. 2010;164(9):803-809.doi:10.1001/archpediatrics.2010.144



Objective To compare adolescents who do and do not recover from acute infectious mononucleosis in terms of fatigue severity and activity levels before, during, and in the 2 years following infection.

Design Prospective case-control study.

Setting The baseline and 12- and 24-month evaluations occurred in the subjects’ homes. The 6-month outpatient visit occurred at Children’s Memorial Hospital in Chicago, Illinois.

Participants  Three hundred one adolescents (aged 12-18 years) with acute infectious mononucleosis.

Main Exposures All participants were evaluated at baseline (during active infection). Six months following infection, 39 of them met criteria for chronic fatigue syndrome. These subjects were matched by sex and Tanner stage to 39 randomly selected screened-negative subjects. Both groups were reevaluated at 12- and 24-month follow-ups.

Outcome Measures Scores from the Fatigue Severity Scale and the Modifiable Activity Questionnaire.

Results  For both groups, physical activity levels declined and sleep increased as a result of having mononucleosis. Compared with their matched controls, adolescents with chronic fatigue syndrome reported significantly higher levels of fatigue at all points and spent significantly more time sleeping during the day 6 and 12 months following infection. The 2 groups did not differ significantly in terms of physical activity levels before, during, or after infection. There was a consistent trend for decreased physical activity in the chronic fatigue syndrome group.

Conclusions Adolescents with chronic fatigue syndrome appear to be pushing themselves in an attempt to maintain similar activity levels as their peers, but paying for it in terms of fatigue severity and an increased need for sleep, particularly during the day.

Author Affiliations: Department of Occupational Therapy, College of Applied Health Sciences, University of Illinois at Chicago (Drs Huang, Kielhofner, and Taylor); and Department of Pediatrics, Northwestern University Feinberg School of Medicine and Children’s Memorial Hospital (Drs Katz and Mears), Chicago, Illinois.

Editorial Vol. 164 No. 9, September 2010

Full Text

Chronic Fatigue Syndrome in Adolescence: Where to From Here?
Arch Pediatr Adolesc Med.2010; 164: 880-881. 

Extract Editorial [First 150 words]   

Chronic Fatigue Syndrome in Adolescence: Where to From Here?
Extract | Full Text 

Ute Vollmer-Conna, PhD 

Arch Pediatr Adolesc Med. 2010;164(9):880-881. doi:10.1001/archpediatrics.2010.149 

Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. 

Chronic fatigue syndrome (CFS) is a disabling disorder that poses a significant personal and economic burden for patients, their families, and the community. It is increasingly recognized that CFS is prevalent in children and adolescents.1-2 In the young, the disability associated with CFS can be exacerbated by the effect of the illness on emotional and social aspects of development including social learning, autonomy, a sense of self, a healthy body image, relationships, sexuality, and academic development.3 

After decades of hypothesis-driven research, the etiology and pathophysiology of CFS remains obscure, and curative therapies are not available. What have we learned from this poor outcome? For one, many now agree that the diagnostic label of CFS encompasses a heterogeneous group. This is supported by evidence from several studies (including one pediatric study2) showing that 3 to 5 distinct subclasses can be delineated from large, cross-sectional samples of individuals . . . [Full Text of this Article]  [Payment required] 


School of Psychiatry, University of New South Wales, Sydney, Australia 


BBC  |  BBC Scotland Health Correspondent  |  7 September 2010  

Study shows ME/CFS ‘virus link’ found in children 

By Eleanor Bradford 

A study on children has found further evidence that ME, or Chronic Fatigue Syndrome, could be caused by a virus. 

Scientists at the University of Dundee study found abnormalities in the white blood cells of children with ME/CFS, suggesting they had been fighting off infection… 

…In the study, funded by ME Research UK and The Young ME Sufferers (Tymes) Trust, 25 children aged between seven and 14 with ME/CFS were assessed, along with 23 children of a similar age in a control group. 

The report, published in the Archives of Paediatrics and Adolescent Medicine, said abnormalities were found in the blood of all the children with ME/CFS. 

The results were similar to those previously identified in adults with the condition. 

Samples taken from youngsters with ME/CFS contained higher than normal levels of free radicals – molecules that can damage cells, tissues and organs… 

Read full article here 


From Jane Colby  |  The Young ME Sufferers Trust  |  7 September 2010 


There should be quite a bit of coverage today of the new research in children, which The Young ME Sufferers Trust co-funded. I’ve done Radio 5 Live and BBC Northern Ireland radio so far.  BBC Wales coming up. Prof Jill Belch has done interviews about the science for a number of channels. 

I wasn’t able to say anything about this yesterday due to reporting restrictions. Will send out an Alert about the research later today. 

Jane Colby
Executive Director
The Young ME Sufferers Trust
PO Box 4347
Stock Ingatestone
Essex CM4 9TE
Tel 0845 003 9002

MEA statements: Review of NICE guideline CG53 and PACE Trial results

MEA statements: Review of NICE guideline CG53 and PACE Trial results [and BACME (British Association of CFS/ME) 2010 Conference Programme]


The British Association of CFS/ME (BACME) appears to have taken over some of the functions of the CFS/ME Clinical and Research Network and Collaborative (CCRNC). There is no website for BACME and very little information available about the role and operation of this organisation.

BACME is chaired by consultant paediatrician, Dr Esther Crawley (lead researcher, Lightning Process pilot study in children). Assistant Chair is Alison Wearden PhD, CPsychol (lead researcher, FINE Trial).

Related information from the News section of the ME Association website (which includes extracts from BACME’s Constitution for which I do not have access to a full copy):

Questions raised over training role of new body for ME/CFS professionals

‘Parliamentarians should examine role of new NHS training forum for ME/CFS’

1] ME Association statement: NICE Guideline on ME/CFS – 2010 review process (UK)

2] ME Association statement: PACE Trial results in October (UK)

ME Association statement: NICE Guideline on ME/CFS – 2010 review process (UK)

1 September 2010

Having been led to believe that the proposed review of the 2007 NICE guideline on ME/CFS would be starting in August 2010 The ME Association wrote to NICE to seek clarification in the absence of any official announcement being made during August.

We received the following reply on 24 August:

Thank you for contacting the National Institute for Health and Clinical Excellence (NICE).

The review date which you refer to is the date at which we plan to begin the review process. We are currently beginning to gather evidence and opinions to inform our review proposal. If there has been a large amount of new evidence produced since the original guidance was produced, the review proposal may be to conduct a full review, which can take over a year. On the other hand, if there has not been very much new evidence produced, we may propose to delay the review.

The review proposal will be posted on our website for consultation in the months following the ‘review date’ listed in the guidance. To be notified of additions to web pages relating to your area of interest, including review proposals, you may like to sign up for our web alert system. You can do this via the following page of our website:

I am sorry that I do not have any more definitive information at this stage.


Carla Springl

Communications Administrator (Enquiry Handling)
National Institute for Health and Clinical Excellence

Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United Kingdom


We also know that members of the original guideline development group have been asked for their opinion as to whether there is sufficient new evidence to justify a review at this time.

The important phrase here is large amount of new evidence produced since the original guidance was produced.

In NICE-speak this means results from randomised controlled trials into any aspect of management that have been published in reputable peer-reviewed medical journals since August 2007. The NICE guideline is primarily concerned with the clinical assessment and management of ME/CFS and does not get involved in coming to conclusions about causation – although NICE obviously has to take note of developments relating to causation, including the findings relating to XMRV and MLVs.

Having managed to fight off a Judicial Review of the ME/CFS guideline, NICE will be feeling confident that its guidance is sound and acceptable to both patients and doctors – a position which many patient support organisations, including the MEA, obviously strongly disagree with. And with very little in the way of new evidence being published in relation to the treatment of ME/CFS, and the fact that results from the PACE trial are fast approaching, it seems likely that NICE may decide to defer this review until later in the year, or even 2011, when they have this information – which could well strengthen their controversial recommendations regarding cognitive behaviour therapy (CBT) and graded exercise therapy (GET).

It should also be noted that NICE will not want to re-open the debate about existing evidence (ie results from clinical trials that were published up to the time of the 2007 guideline) – they want to look at new evidence.

The ME Association will obviously be challenging the current recommendations regarding the use of CBT and GET and to support out case we will be making use of the patient evidence (approx 4,500 respondents) from our 2010 Management Report – the largest ever survey of patient opinion ever carried out in the UK, probably in the world. This report can be accessed on-line here:

We are also consulting with various experts, including those with statistical knowledge, about how best to present our case to the review.

For information purposes the following explanation of how recommendations contained in a NICE guideline should be interpreted by clinicians when making decisions about patient management is worth noting. It clearly contradicts the mistaken view of some doctors that NICE guidelines are almost mandatory and as a result they are no longer able to exercise their clinical judgement where this is may not be entirely consistent with a guideline position.

NICE clinical guidelines are recommendations about the treatment and care of people with specific diseases and conditions in the NHS in England and Wales. Clinical guidelines represent the view of NICE, and are arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. However, the guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer, and informed by the summary of product characteristics of any drugs they are considering.

Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties.

With regards to technology appraisal guidance, this type of guidance contains recommendations on the use of new and existing medicines and treatments within the NHS. The NHS is legally obliged to fund and resource medicines and treatments recommended by NICE’s technology appraisals, usually within 3 months of guidance being published.

ME Association
1 September 2010


Ed: This BACME conference and AGM is being held in Milton Keynes on 13 and 14 October and is faciliated by AYME who have collaborated in CCRNC conferences.

Download PDFs for BACME Provisional Programme and Registration Form here:

BACME 2010 Conference Programme

BACME CFS ME CCRNC conference 2010 Registration Form


2] ME Association statement: PACE Trial results in October (UK)

3 September 2010

It is being reported today in Link magazine (issue 39, September 2010) that:

Data collected for the one year follow up of the PACE trial is currently being analysed in preparation for publication of the findings.

Professor Peter White of St Bartholomew’s Hospital, London will report on the most up-to-date progress and baseline data from the PACE trial to delegates at the British Association of CFS/ME (BACME) October conference.

The release of this PACE trial information may well have an effect on a decision by NICE as to when they commence a review of the 2007 Guideline on ME/CFS.

A statement and more information on the NICE Guideline review can be found in the September news section on the MEA website.

Information supplied by ME Association:


BACME CFS ME CCRNC conference 2010 Registration Form

BACME 2010 Conference Programme

Provisional Programme

British Association of CFS/ME (BACME)
2010 Conference

Draft Program – please note there may be changes before final program

Milton Keynes 13-14 October
Wednesday 13 October

9.30 -10.30  Registration and coffee

10.30-11.00  Opening Address:

Prof Stephen Holgate  MRC (Medical Research Council)  Clinical Professor of Immunopharmacology. 

“The time has at last arrived to strengthen research into CFS and ME”

11.00 – 12.00  Keynote Speaker: Professor Daniel J. Clauw MD Division of Rheumatology University Michigan

“Advances in Our Understanding of CFS and Overlapping Conditions”

12.00 – 1.30  Lunch Hot and Cold Buffett (preference to be booked)

1.30 -2.15  Dr Alison Wearden Reader in Psychology: FINE Trial

“Pragmatic rehabilitation for Chronic Fatigue Syndrome/ME”

2.15 – 3.00  Judith Harding:
The Role of Diet Management in CFS/ME

3.00 – 3.30  Comfort Break

3.30 – 5.00  Uni – professional Networking Groups.
To be facilitated please contact asp if you would like to request a specific group e.g physiotherapists, nurses, paediatricians

5.00 – 6.00  BACME AGM Chairperson: Gill Walsh
(for existing and new members)

7.30  Conference Dinner (to be pre-booked separately)

Thursday 14 October

9.00 Registration & Coffee

9.30 – 10.45  Workshop 1

10.45 – 11.15  Coffee & Comfort Break

11.15 – 12.30  Workshop 2

12.30 – 1.45
Lunch Hot and Cold Buffett (preference to be booked)

1.45 – 2.15  Poster Presentations – Organiser Gabrielle Murphy
Posters will be on display for the whole 2 days

2.15 – 2.45  Coffee & Comfort Break

2.45 – 3.30  Diane Cox & Heather Garry
Video Conferencing for delivery of CFS/ME Interventions at Home (Tele-rehabilitation)

3.30 – 4.30  Professor Peter White
St Bartholomew’s Hospital London

“PACE trial: so near yet so far”

(If outcome results are not yet published, Peter White will present the design, progress and baseline data from the trial)

4.30 – 5pm  Closing Address – To be announced


1. Working with the Severely Affected – Leeds Service

2. Mindfullness and ME –The Mindfull Approach to Chronic Illnesses Steve Johnson, Director of the Breathworks Foundation

3. Review of Literature and Clinical Implications on Sleep (please note this is not a workshop) Gabrielle Murphy & Alex Westcombe

4. To Be Announced

5. Research workshop – How to do research successfully when you are a busy clinician – Professor Peter White

6. Group work – Michelle Selby and Helen Chub


Additional information on selected presenters:


Gabrielle Murphy
Physician working in the Fatigue Service at the Royal Free Hospital and Clinical Lead. She also works in the Department of HIV medicine. Her interests include medically unexplained symptoms MUS). Also involved in local and national organisations promoting access to CFS/ME services and ongoing research.

Coping Better With Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Cognitive Behaviour Therapy for CFS/ME

Alex Westcombe
North Bristol NHS Clinical Psychologist

Michelle Selby
OT lead Dorset CFS Service (formerly “The Wareham Clinic”); Clinical Co-ordinator, Southampton CFS/ME Clinic

Dr Helen Chubb
Senior Registrar, Whitchurch Hospital
Chronic Fatigue Syndrome – personality and attributional style of patients in comparison to healthy controls and depressed individuals: Helen. L. Chubb; Irene Jones; Janice Hillier; Christopher Moyle; Stephanie Sadler; Tanya Cole; Kate Redman; Anne Farmer
DOI: 10.1080/09638239917274 Journal of Mental Health, Volume 8, Issue 4 August 1999 , pages 351 – 359

Lightning Process: further statement from ME Association and Young ME Sufferers Trust

Lightning Process: further statement from ME Association and Young ME Sufferers Trust


Lightning Process: further statement from ME Association and Young ME Sufferers Trust

Wednesday, 01 September 2010 09:08

On 4 August 2010 The ME Association and The Young ME Sufferers Trust (Tymes Trust) issued a joint statement that expressed a number of concerns about the proposal to carry out a feasibility study, involving children and adolescents with ME/CFS, into the use of the Lightning Process.

The statement can be read here.

We also sent a copy of this statement to the Department of Health with a request that it should be forwarded to the ethics committee that will be examining this proposal. This is because we believe the ethics committee should be aware of widespread concerns being expressed by people with ME/CFS about the trial. Our statement also contained information about an adjudication from the Advertising Standards Authority and interventions by several trading standards officials – both in relation to therapeutic claims being made for the Lightning Process which we believe the ethics committees must be aware of when reviewing this proposal.

The Department of Health have refused to forward this information to the ethics committee on the grounds that

“We expect research ethics committees to consider all the relevant evidence, but they have to be seen do so objectively and impartially and to arrive at their decisions independently if they are to command public confidence and the credibility of all the stakeholders concerned. For this reason, it would be inappropriate, as well as potentially counterproductive, expressly to bring your joint statement to the attention of the research ethics committee reviewing the proposal for this project..”

We profoundly disagree with the DoH’s reasoning, which we consider carries serious implications for the integrity of the scientific process. Whether or not an ethics committee membership is confidential, it should still be possible for essential evidence to be supplied to them. How else can the public be assured that an ethics committee has all the relevant evidence to consider before reaching its decision?

The two charities are unable to forward this statement direct because the identity and location of the relevant ethics committee is not in the public domain.

We are now considering what further action to take.


Update on ethics approval: Dr Esther Crawley Bath/Bristol Lightning Process pilot study for children 8 to 18

Update on ethics approval for the Dr Esther Crawley led RNHRD NHS FT Bath/University of Bristol Lightning Process pilot study for children aged 8 to 18


For background to this issue see ME agenda 5 July report:

Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)

For joint ME charity opposition statement and press release see:

Joint Press Release and statement: ME Association and The Young ME Sufferers Trust

I was advised by the University of Bristol Director of Legal Services on 17 August that

“The Information Rights Officer has been assured by the leader of this project that the information requested will be published on the University’s website by the end of this month. The published information will include the research protocol and related material, including information about the ethics approval process.”

“May I therefore suggest that you await publication of the information and then come back to the Information Rights Officer if there are any aspects of your original request which you consider have not been fulfilled through publication.”

On 26 August, I was advised by the University’s Information Rights Officer that:

“The study is at the final stage of the ethics proposal. The information will be published regardless.”


On 3 August, I had submitted a request for information to the National Research Ethics Service (NRES) under the Freedom of Information Act around the application for ethics approval and application timeline.

This was fulfilled yesterday, 27 August.

I received the following responses provided by the FOI Manager, NHS South West. Responses are highlighted in blue:

27 August 2010

Royal National Hospital for Rheumatic Diseases NHS Foundation Trust and the University of Bristol

Funders: £164,000 awarded by Linbury Trust and the Ashden Trust

Lead researcher: Dr Esther Crawley, Consultant Paediatrician, Royal National Hospital for Rheumatic Diseases, Bath, Senior Lecturer, University of Bristol.

Study: Pilot project to investigate how to recruit to a randomised controlled trial looking at the Phil Parker Lightning Process and specialist medical care in CFS/ME in children. Project to incorporate study on health economic cost of CFS/ME in children.

Ethics Approval:

1] Any reference numbers attached to the application for ethics approval: 10/H0206/32

2] Names of Research Ethics Committee(s) responsible for reviewing application: [A South West region Research Ethics Committee is identified]

Status of application for ethics approval:

3] Date application received: 14 June 2010

Has a Research Ethics Committee already met to consider this application? Yes

On what date did this meeting take place? 08 July 2010

Was an unfavourable ethical opinion or a favourable ethical opinion given? A decision is awaited on the ethical opinion.

If an unfavourable opinion, has the applicant re-submitted, submitted modifications or appealed, and on what date were these received? Not applicable

Were any clarifications requested? This information is exempt under Section 22 of the Act (information intended for future publication) as it will be published by the University of Bristol in the foreseeable future.

Was a modified application submitted to a different REC and if so, which REC? No

If an appeal was submitted was the application reviewed by a different REC and if so, which REC? Not applicable

What was the outcome of any re-submission, modification or appeal and on what date was the Principal Investigator/lead researcher applicant notified of the outcome? Not applicable

If a favourable opinion, on what date was the Principal Investigator/lead researcher/applicant notified? Not applicable

If the application has yet to be considered, which Research Ethics Committee is responsible for considering this application and on what date is the committee expected to meet to consider the application? Not applicable

By what date is the Principal Investigator/lead researcher/applicant expected to be notified of the opinion? This date is not yet known.

Please provide copies of applications for research ethics approval for the study, including any accompanying documentation that forms part of the application, for example, questionnaires, interview protocol.

Please provide copies of any ethical opinions already handed down, with any requests for resubmissions, modifications, requests for clarifications.

This information is exempted under Section 22 (information intended for future publication) as the University of Bristol plans to publish this information in the foreseeable future.  

I am advised that I have the right to complain about this response by reference to the complaints procedure of the South West Strategic Health Authority in which case I should write to the Chief Executive at NHS South West, South West House, Blackbrook Park Avenue, Taunton, Somerset TA1 2PX. That if I remain dissatisfied with the decision of the Authority following my complaint, I may write to the Information Commissioner, whose address is:
Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF.


Related information:

REC Application flowchart

 REC Application Researcher Training Pack

 FOI request 16 May 2010 to University of Bristol, fulfilled 17 June

Background to this issue

ME Association and The Young ME Sufferers Trust joint Press Release, 4 August 10

Archive for all Lightning Process posts on ME agenda

Lightning Process pilot: Update and response from Research Governance Manager, DoH

Lightning Process pilot for children with CFS and ME aged 8 to 18: Update and a response from Research Governance Manager, Department of Health


For background to this issue see ME agenda 5 July report:

Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)

For joint ME charity statement and press release see:

Joint Press Release and statement: ME Association and The Young ME Sufferers Trust


It’s now five and a half months since the RNHRD NHS FT Bath/University of Bristol announced its intention to undertake a pilot study looking into the application of the Lightning Process in children aged 8 to 18. The press release issued 2 March can be read here:  Press Release, a media article here: Media article.

Joint charity press release

On 4 August, the ME Association and The Young ME Sufferers Trust issued a joint statement and press release strongly opposing the pilot study and calling for it to be abandoned. Their joint press release can be read here.

The press release was issued too late for inclusion in the ME Association’s Autumn issue of ME Essential. But the magazine does include a write up, on Page 4, of the Advertising Standards Authority (ASA) adjudication against Lightning Process company “Withinspiration”.

ASA adjudication against Lightning Process company

In June, the ASA upheld a complaint against an advertisement in which unsubstantiated claims had been made about the efficacy of the Lightning Process for CFS and ME.

Read the full ASA adjudication against “Withinspiration” here

Alastair Gibson, the Lightning Process practitioner associated with the company, had let it be known in March that he was one of two Lightning Process practitioners involved with this controversial NHS study. This information no longer appears on the “Withinspiration” website and the current status of his involvement in this pilot study is unknown.

25% ME Group position

On 11 August, Simon Lawrence, Chair of the 25% ME Group Management Committee, confirmed that the 25% Group is intending to issue a position statement shortly and that my concerns and documents sent to them have now been passed on to their medical advisors, Dr Byron Hyde, Canada, and Dr Nigel Speight (former NHS paediatrician with a special interest in ME in children).

Requests for information under the Freedom of Information Act

On 22 July, I submitted a formal request to the University of Bristol’s Director of Legal Services for an internal review of their decision to withhold nearly all information around the study under FOIA Clause 22(1)(a). A response is due on or before 19 August. My request for an internal review can be read here.

On 3 August, I submitted a request for information to the National Research Ethics Service (NRES). This is due for fulfilment on or before 31 August. Questions submitted under FOIA around the application for ethics approval and the application timeline can be read here.

Responses from parliamentarians and government departments

In July, I approached my MP, Annette Brooke (Lib Dem, Mid Dorset and North Poole), for her involvement with this issue. (Mrs Brooke is the MP who gave the adjournment debate speech on ME before Parliament dissolved prior to the election and is now Vice-chair of the recently reformed APPG on ME.)

On 31 July, I received a copy of a paper letter from the Parliamentary Office of Annette Brooke to the Rt Hon Andrew Lansley MP, Secretary of State for Health, Department of Health, dated 29 July. Mrs Brooke has requested that the Secretary of State for Health look into this matter. A response is pending.

I also raised my concerns with the Countess of Mar, Lord Clement-Jones and Earl Freddie Howe, all three being Patrons to the Young ME Sufferers Trust. Earl Howe is the Parliamentary Under-Secretary of State for Quality.

My communication was forwarded by Earl Howe to Matthew Harpur, Department of Health.  Mr Harpur forwarded it to Bill Davidson, Research Governance Manager, Department of Health, who has responded on behalf of Earl Howe.

Response from  Bill Davidson, Research Governance Manager, Department of Health on behalf of the Parliamentary Under-Secretary of State for Quality:

30 July 2010

Thank you for your e-mail of 16th July to the Parliamentary Under-Secretary of State for Quality regarding a research project involving the “Lightning Process” in 8- to 18-year-olds with myalgic encephalomyelitis. Earl Howe has asked me to reply.

You are quite right that new treatments should be compared with current standards to see which is better. You are also right that this comparison should be made in appropriate participant groups.

New treatments are not generally tried out first in children before there is evidence of their safety and efficacy in adults, but sometimes it is appropriate to do so. It is a matter for a research ethics committee to be assured that the evidence supports the extension of the new treatment to children.

We require the decisions of research ethics committees to be independent and free from bias and particular stakeholder interests. It would therefore be inappropriate to have a mechanism through which particular stakeholders might seek to affect a research ethics committee’s decision. We require research ethics committees that become aware of a possible breach of good practice in research to inform the relevant authorities so that they can take appropriate action.

Our National Research Ethics Service publishes lay summaries of the research approved by research ethics committees. It is normal practice for researchers also to put details of interventional studies on an open-access register, before the first participant is recruited, unless there is very good reason for delaying disclosure.

I note that the outcome of the research ethics committee review of the proposal for this project has not yet been reached. I expect it will, in accordance with Department of Health policy, come to a decision that takes account of all the ethical issues, including the appropriateness of the proposed participant group.

Yours sincerely,

Bill Davidson
Research Governance Manager
Department of Health
Quarry House
Quarry Hill
Leeds LS2 7UE
Tel: 0113 254 6184 / 07900 164755
Fax: 0113 254 6174

Child Experimentation on the NHS; a new article on MESHARE

Child Experimentation on the NHS; a new article on MESHARE


From Peter Kemp

9 August 2010

This article and several others about the proposal to test the lightning process on children are now available on MESHARE for group newsletters.

Peter Kemp 

Child Experimentation on the NHS

On 2nd March, 2010, the Royal National Hospital for Rheumatic Diseases announced that £164,000 had been awarded for a trial using the ‘lightning process’ (LP) on children with CFS (1). This move has been condemned as  unethical’ by the ME Association and Tymes Trust, leading UK charities (2).

Needless to say, lightning process practitioners are getting in on the act – with this announcement blandished on the front page of the first 3 LP websites I looked at last week. And why not – after all it does appear that the NHS is giving credence to this expensive alternative therapy.

The proposed research puts parents in a very awkward position when it comes to deciding whether to consent to their sick child participating. Parents may have been exposed to the hard-sell type websites that promote LP and a parent’s own vulnerability due to concern for their child with CFS would almost certainly affect their judgement. Could they deprive their child of a chance to get treatment that might restore their health?

Yet a parent that consents would be choosing a highly experimental treatment for their child, delivered in a way that fails to meet established ethical standards.

The researchers themselves are in a very awkward position. Any medical professional that cooperates with the research would be in breach of ethical codes governing such research. The General Medical Council (GMC) rules are unequivocal: “Children or young peopl should be involved in research only when research on adults cannot provide the same benefits” (3). The Declaration of Helsinki also remarks on using vulnerable groups who are deemed ‘incompetent’ to give informed consent for research – i.e. children:

“For a potential research subject who is incompetent, the physician must seek informed consent from the legally authorized representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the population represented by the potential subject, the research cannot instead be performed with competent persons, and the research entails only minimal risk and minimal burden.” (4).

And the Royal College of Paediatrics (RPC) states: “Research with children should be undertaken only if work with adults is clearly not feasible.” (5)

So why choose children for lightning process research?

Among several possible reasons for choosing to experiment on children with the LP might be the fact that children are impressionable. They can be controlled and manipulated more easily than adults. As the RCP remarks: “Many children are vulnerable, easily bewildered and frightened, and unable to express their needs or defend their interests.” (5)

This appears to be something that could be taken advantage of. As Marshall and Williams note from a discussion in 2005 which included several Wessely school theorists:

“At this point, Trudie Chalder made a truly disturbing contribution: “Rather than start with the physicians, which might be quite a difficult task, we could make a start with youngsters in schools. My experience is that they are much easier to educate. The only barrier is the parents. Once we have the child on our side we are in a very good position”.” (6)

Removing the ‘barrier’ of at least some parents to permit experimentation with LP on children, might not be a very difficult task. Parents on a low income for whom the cost of LP would be prohibitive might leap at a chance to save around £700 by getting the treatment for their child for free. Parents on higher incomes might choose to play it safe and wait until the trial results come out. Then if the results look good and the risks seem low, they may then choose to purchase LP for their child.

This means that financial inducement could be acting on those who choose participation. This is because the research is proposing to give a commercial product free of charge. The RCP (5) state: “For consent to be freely given researchers must: offer families no financial inducement”.

As the lightning process might be described simplistically as ‘thought control’, children are probably the group most likely to be easily and profoundly affected. They are also the group who could suffer the longest lasting negative effects if things go wrong; as the RCP point out (5):

“Children are unique as a research group for many reasons. They are the only people, in British law, on whose behalf other individuals may consent to medical procedures. Many children are vulnerable, easily bewildered and frightened, and unable to express their needs or defend their interests. Potentially with many decades ahead of them, they are likely to experience, in their development and education, the most lasting benefits or harms from research.”

In the same dialogue reported by Marshall and Williams (above); Professor Malmgren made a spookily prophetic suggestion:

“Helge Malmgren, Professor of Theoretical Philosophy, Goteborg University, Sweden, said: “Considering that so many people go to alternative and complementary medicine practitioners, perhaps we should not only confront alternative medicine, but also try to make alliances. In particular, we could try this with practitioners who use brands of alternative medicine that we think have some plausibility”.” (6)

Is this what is happening?

Peter Kemp
Aug 2010


(1) Royal National Hospital for Rheumatic Diseases. £164,000 awarded for new research into the treatment of a chronic childhood condition. 2nd March 2010. Media Release. [Online]. Available at: 
Accessed Aug 6th 2010.

(2) ME Association and Tymes Trust. Study involving children and the Lightning Process is unethical, says joint charity statement. [Online]. Available at: . Accessed Aug 5th 2010.

(3) General Medical Council. 0-18 years: guidance for all doctors. [Online]. Available at: . Accessed Aug 5th 2010.

(4) The World Health Organization. Declaration of Helsinki 2008. [Online]. Available at: . Accessed Aug 5th 2010.

(5) Royal College of Paediatrics, Child Health: Ethics Advisory Committee; and PROFESSOR SIR DAVID HULL. Guidelines for the ethical conduct of medical research involving children. Archives of Disease in Childhood. 2000;82;177-182. [Online]. Available at: . Accessed Aug 5th 2010.

(6) Eileen Marshall, Margaret Williams. PROOF POSITIVE? 30th August, 2005. [Online]. Available at: . Accessed Aug 5th 2010.

Ed: Context for quote (6)


Re: Appropriate treatments for M.E., 10 August 2007

From: Douglas Fraser, M.E. sufferer, London
To: Sir Peter Spencer, Chief Executive Officer, Action for ME.


However an example of how PACE trialists Chalder, Deary and Gerada-Wessely use information offered them in good faith by members of the public and recycle this against other members of the public, can be observed in an IoP video produced by Satrorious, Goldberg and Gask, during which they practise their contrived art of outsmarting members of the public, a technique apparently requiring ‘role playing’ because ‘it’s only by rehearsing the skills that you need that you’ll be able to use them when faced with the real situation’.

This video was originally titled: ‘Maudsley videos: The treatment of chronic fatigue (“ME”) in primary care – Dr Tylee interviews Dr Trudy Chalder of the Maudsley Hospital. The package demonstrates how not to get into arguments with the patient, how to form a therapeutic alliance with them, and how to carry out a plan of treatment aimed at the restoration of normal function’, and was recently put online in March 2006 at :

Encouraging Chalder, Deary, Gerada-Wessely, Deale and the others involved in this self-promotional video, and without a flicker of doubt about their unscientific methods, ignorance of human behaviour, armchair speculation about others, dangerous advice to GPs, specious reasoning and contrived explanations of M.E., Andre Tylee gives voice very expicitly to what they project throughout this performance in terms of their obvious collective contempt at the ‘stupidity’ of M.E. sufferers, with the familiar excuse over failure: it’s these ‘chronic fatigue syndrome patients [that] are difficult’. Chillingly, one of this group of social determinists, naively unaware of the dark lessons of social engineering from the past, recently voiced her ambitions that (Chalder T in PD White 2005): “Rather than start with the physicians, which might be quite a difficult task, we could make a start with youngsters in schools. My experience is that they are much easier to educate and to treat. The only barrier is the parents. Once we have the child or older youngster on our side we are in a very good position. They take up the messages up very quickly.”

Is it ethical to undertake a pilot looking at feasibility of recruiting children 8 to 18 with CFS and ME into an RCT comparing Lightning Process and specialist medical care when no rigorous RCTs into the application of LP in adults have been undertaken?

Shortlink:  or

Update @ 5 August

Poll now closed

Thank you to everyone who registered their opinion.

For background to this issue see ME agenda Post 5 July 2010:

Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)  

Poll: Is it ethical to undertake a pilot study looking at the feasibility of recruiting children aged 8 to 18 with CFS and ME into a randomised controlled trial (RCT) comparing the Lightning Process and specialist medical care when no rigorous RCTs into the application of the Lightning Process in adults with CFS and ME have been undertaken?


ME Association: Advertising Standards Authority upholds a complaint against a Lightning Process practitioner

ME Association: Advertising Standards Authority upholds a complaint against a Lightning Process practitioner


Update @ 7 July

Phil Parker’s Lightning Process site at is down this morning and the Lightning Process pages of his site are also unavailable.


Read ASA Adjudication on Withinspiration or for full text see previous post

Today, the ME Association reported on the ASA adjudication.

From the News pages of the ME Association

Tuesday, 06 July 2010

ASA Ruling 

A complaint that an internet sponsored link carried an unsubstantiated claim that the Lightning Process can make people with ME/CFS well again has been upheld by the Advertising Standards Authority (ASA).

In a decision announced on 16 June 2010, the ASA ordered the company “Withinspiration” to drop an advertisement which claimed: “Chronic Fatigue Recovery. End the cycle of ME/CFS: Get Well! with The Lightning Process.”

The ASA ruling says: “The ad must not appear again in its current form. We told Withinspiration to ensure they held substantiation before making similar efficacy claiming for the lighting process [sic]”.

The complainant wasn’t named in the ruling but the ASA said the company had told them that they had personal experiences of improvement in medical conditions such as ME, as a result of using The Lightning Process. The process had received a number of celebrity endorsements and positive press reaction, which were testament to its effectiveness.

Although Withinspiration said they held no scientific evidence to support the claims, they said that trials were due to begin in 2010.

 Upholding the claim, the ASA wrote:

“The ad breached CAP Code clauses 3.1 (Substantiation), and 50.1 (Health and beauty products and therapies).”

“The ASA understood that the lightning process was a three-day course that sought to teach individuals a range of techniques, such as life coaching and neuro-linguistic programming skills, to improve physical and mental well being, particularly amongst those with chronic fatigue syndrome (CFS) or ME.

“We were concerned that Withinspiration did not hold robust evidence to support their claims that the lightning process was an effective treatment for CFS or ME. We therefore reminded them of their obligations under the CAP Code to hold appropriate evidence to substantiate claims prior to publication. Because we had not seen any evidence to demonstrate the efficacy of the lightning process for treating the advertised conditions, we concluded that the claims had not been proven and were therefore misleading.”

◦ No similar claims appear on the Withinspiration website today. The site promotes the work of Alastair Gibson – “one of the most experienced international advanced Lighting Process practitioners”. It gives a contact phone number for the Bournemouth area.

Ed: Note that Lightning Process instructor/trainer/coach, Alastair Gibson, had already identified himself, on his Withinspiration website, as “one of the two practitioners working with the NHS and the young people” in the Dr Esther Crawley led pilot study.

At 29 March, Mr Gibson’s website had carried this information:

“Breaking News – NHS and Lightning Process research collaboration.

“A new pilot study involving the Lightning Process and the NHS has been awarded £164,000 for research into the treatment of CFS/ME in children and adolescents. Alastair Gibson is one of the two practitioners working with the NHS and the young people in this exciting research study. Find out more…”

This statement no longer appears on his website. It is unclear whether Mr Gibson retains an involvement with the proposed pilot study, announced by the Royal National Hospital for Rheumatic Diseases NHS Foundation Trust and University of Bristol in March.

In response to a request for information under FOIA, University of Bristol Information Office is withholding the names of Lightning Process practitioners who have an involvement with the study under Clause 22(1)(a) of the Freedom of Information Act.

The study, scheduled to start in September, is still going through the ethics approval procedure.  Funding for the pilot had been secured in November 2009.

The names of the ethics committee(s) reviewing the application are also being withheld by University of Bristol. 


Related material:

Press Release issued 2 March 2010: Research study to investigate a chronic childhood condition

For background to this issue see ME agenda 5 July report:

Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)


Poll: Do you think it is ethical to undertake a pilot study looking at the feasibility of recruiting children aged 8 to 18 with CFS and ME into a randomised controlled trial (RCT) comparing Lightning Process and specialist medical care when no rigorous RCTs into the application of LP in adults have been undertaken?

Register your opinion here: