Category: Invest in ME

Second DSM-5 public comment period closes 15 June: Final Call for Action

Second DSM-5 public comment period closes 15 June: Final Call for Action by UK patient orgs

This communication has been sent to the following organizations:

Action for M.E.; The ME Association; AYME; The Young ME Sufferers Trust; The 25% ME Group; RiME; Invest in ME; BRAME; ME Research UK; Mrs Sue Waddle

[Update: On June 1, Action for M.E. published a news item on DSM-5 confirming that it does intend to submit a response.]

Final Call for Action by UK patient organizations

Second DSM-5 public comment period closes 15 June

29 May 2011

The above organizations were alerted to this second public review period on 5 May, the day after revised criteria were posted on the American Psychiatric Association’s DSM-5 Development website.

To date, not one patient organization in the UK has confirmed to me that they intend to submit feedback, this year. Please take some time to review these proposals and prepare a submission or consider submitting a joint response with another UK patient organization.

The American Psychiatric Association (APA) DSM-5 Task Force is again accepting public comment on the latest proposals for the revision of DSM diagnostic criteria for psychiatric disorders.

The deadline for this second stakeholder feedback period is June 15 – less than three weeks away!

Is this a US specific issue?

No. UK and international input is required from patient organizations.

The DSM-5 “Somatic Symptom Disorders” Work Group has responsibility for the revision of the existing DSM-IV “Somatoform Disorders” categories. Two UK Professors of psychological medicine and research, Professor Michael Sharpe and Professor Francis Creed, are members of the Somatic Symptom Disorders Work Group.

The Diagnostic and Statistical Manual of Mental Disorders is the primary diagnostic system in the US for defining mental disorders and is used to varying extent in other countries. The next edition of the manual is scheduled for publication in 2013 and will inform health care providers and policy makers for many years to come. DSM-5 will shape international research, influence literature in the fields of psychiatry and psychosomatics and inform perceptions of patients’ medical needs throughout the world.

All UK patient organizations need to submit responses in this second review, even if they submitted last year. The latest key documents that expand on the proposals are attached for ease of reference. (Note: These documents have been revised several times since last year’s public review. Yellow highlighting has been applied by the Work Group to indicate edits and revisions between these latest versions and the texts as they had stood, earlier this year.)

What is being proposed?

The DSM-5 “Somatic Symptom Disorders” Work Group is recommending renaming the “Somatoform Disorders” section to “Somatic Symptom Disorders” and combining the existing categories – “Somatoform Disorders”, “Psychological Factors Affecting Medical Condition (PFAMC)” and possibly “Factitious Disorders”, into one group.

(“Somatic” means “bodily” or “of the body”.)

The Work Group also proposes combining “Somatization Disorder”, “Hypochondriasis”, “Undifferentiated Somatoform Disorder” and “Pain Disorder” under a new category entitled “Complex Somatic Symptom Disorder” (CSSD). There is also a “Simple or Abridged Somatic Symptom Disorder” (SSSD) and a proposal to rename “Conversion Disorder” to “Functional Neurological Disorder”.

If the various proposals of the Somatic Symptom Disorders Work Group were approved, there are considerable concerns that patients with a diagnosis of CFS, ME or PVFS, or awaiting diagnosis, would be vulnerable to the application of an additional “bolt-on” mental health diagnosis of a Somatic Symptom Disorder like “CSSD”, “SSSD” or “PFAMD”, or of misdiagnosis with a Somatic Symptom Disorder.

Because the APA and the WHO have a joint commitment to strive for harmonization between category names, glossary descriptions and criteria for DSM-5 and the corresponding categories in Chapter 5 of the forthcoming ICD-11, there could be implications for the revision of the “Somatoform Disorders” section of ICD-10 and therefore implications for UK patients – both adults and children.

Where can I find the full criteria for “CSSD”, “PFAMC” and other proposed categories?

Proposed criteria are set out on the DSM-5 Development site here: http://tinyurl.com/Somatic-Symptom-Disorders

The CSSD criteria are here: http://tinyurl.com/DSM-5-CSSD

There are two key PDF documents, “Disorders Descriptions” and “Rationale”, which expand on the Work Group’s proposals (attached for your convenience)

Disorders Description Key Document One: “Somatic Symptom Disorders”

Rationale Document Key Document Two: “Justification of Criteria — Somatic Symptoms”

Which patient groups might be hurt by these proposals?

The Chronic Fatigue Syndrome Advisory Committee (CFSAC) provides advice and recommendations to the US Secretary of Health and Human Services (HHS). On Day One of the May 10-11 CFSAC meeting, CFSAC Committee discussed the implications of these proposals for CFS, ME and Fibromyalgia patients as part of the agenda item around concerns for the proposed coding of CFS for the forthcoming ICD-10-CM.

If the Work Group’s proposals gain DSM Task Force approval, all medical diseases, whether “established general medical conditions or disorders”, like diabetes or heart disease, or conditions presenting with “somatic symptoms of unclear etiology” will have the potential for an additional diagnosis of a “somatic symptom disorder” – if the clinician considers that the patient’s response to their bodily symptoms and concerns about their health or the perception of their level of disability is “disproportionate”, or their coping styles, “maladaptive.”

But as discussed by CFSAC Committee members, patients with CFS, ME, Fibromyalgia and IBS (the so-called “Functional somatic syndromes”) may be especially vulnerable to the highly subjective criteria and difficult to measure concepts such as “disproportionate distress and disability”, “catastrophising”, “health-related anxiety” and “[appraising] bodily symptoms as unduly threatening, harmful, or troublesome.”

In a 2009 Editorial on the progress of the Work Group, the Work Group Chair wrote that by doing away with the “controversial concept of medically unexplained”, their proposed classification might diminish “the dichotomy, inherent in the ‘Somatoform’ section of DSM-IV, between disorders based on medically unexplained symptoms and patients with organic disease.” The conceptual framework the Work Group proposes:

“…will allow a diagnosis of somatic symptom disorder in addition to a general medical condition, whether the latter is a well-recognized organic disease or a functional somatic syndrome such as irritable bowel syndrome or chronic fatigue syndrome.”

In its latest proposals, the Work Group writes:

“…Having somatic symptoms of unclear etiology is not in itself sufficient to make this diagnosis. Some patients, for instance with irritable bowel syndrome or fibromyalgia would not necessarily qualify for a somatic symptom disorder diagnosis. Conversely, having somatic symptoms of an established disorder (e.g. diabetes) does not exclude these diagnoses if the criteria are otherwise met.”

“…The symptoms may or may not be associated with a known medical condition. Symptoms may be specific (such as localized pain) or relatively non-specific (e.g. fatigue). The symptoms sometimes represent normal bodily sensations (e.g., orthostatic dizziness), or discomfort that does not generally signify serious disease…”

“…Patients with this diagnosis tend to have very high levels of health-related anxiety. They appraise their bodily symptoms as unduly threatening, harmful, or troublesome and often fear the worst about their health. Even when there is evidence to the contrary, they still fear the medical seriousness of their symptoms. Health concerns may assume a central role in the individual’s life, becoming a feature of his/her identity and dominating interpersonal relationships.”

These proposals could result in misdiagnosis of a mental health disorder or the misapplication of an additional diagnosis of a mental health disorder in patients with CFS and ME. There may be considerable implications for these highly subjective criteria for the diagnoses assigned to patients, the provision of social care, the payment of employment, medical and disability insurance, the types of treatment and testing insurers and health care providers are prepared to fund, and the length of time for which insurers are prepared to pay out.

Dual-diagnosis of a “general medical condition” or a so-called “functional somatic syndrome” plus a “bolt-on” diagnosis of a “Somatic symptom disorder” may bring thousands more patients, potentially, under a mental health banner where they may be subject to inappropriate treatments, psychiatric services, antidepressants and behavioural therapies such as CBT, for the “modification of dysfunctional and maladaptive beliefs about symptoms and disease, and behavioral techniques to alter illness and sick role behaviors and promote more effective coping [with their somatic symptoms].”

Who should submit comment on these proposals?

All stakeholders are permitted to submit comment and the views of patients, carers, families and advocates are important.

But evidence-based submissions from the perspective of informed medical professionals – clinicians, psychiatrists, researchers, allied health professionals, lawyers and other professional end users are likely to have more influence. Patient organizations also need to submit comment.

Where can I read last year’s submissions?

Copies of international patient organization submissions for the first DSM-5 public and stakeholder review are collated on this page of my site, together with selected patient and advocate submissions:

DSM-5 Submissions to the 2010 review: http://wp.me/PKrrB-AQ

How to comment:

This is the last alert I shall be sending out. I hope all UK patient organisations will take this opportunity to submit their concerns.

Remember, the deadline is June 15.

Thank you.

Suzy Chapman
http://dxrevisionwatch.wordpress.com

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

Shortlink: http://wp.me/pKrrB-Qf

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

APPG on ME

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.

New EDM

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

MYALGIC ENCEPHALOMYELITIS
11.10.2010

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:

EDM 778 MYALGIC ENCEPHALOMYELITIS

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:

http://www.parliament.uk/mps-lords-and-offices/

or here on They Work for You: http://www.theyworkforyou.com/

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:
http://www.parliament.uk/documents/commons-information-office/p01.pdf

Text version: Review of Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk

Text version of Review of the Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk by Chris Douglas

Shortlink to this posting: http://wp.me/p5foE-34M

or http://tinyurl.com/ReviewIiMEProposalText

For the Word file of this document and related information go here:

Review of the Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk

TEXT VERSION

Review of the Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk

By Chris Douglas

27 August 2010

Introduction

In August 2010, Invest in ME (IiME) published a document titled: ‘A New Era in ME/CFS Research: An Opportunity for Major Progress in Diagnosis, Treatment and Research into Myalgic Encephalomyelitis’¹.

It is assumed that this document is a precursor to a more formal and detailed proposal that will be used to secure consultative input and financial commitment to the project.

The following review highlights specific areas in which the proposal could be strengthened if, in particular, it is to maximise commitment from potential financial donors.

1. Scope
2. Objectives
3. Service Provision Model
4. Funding
5. Conflicts of Interest

1. Scope

1.1. Geographic Scope

The scope of a proposal has direct bearing on project objectives and methodology and provides a framework within which the project can be assessed.

In the current proposal, it is unclear whether the Centre is aimed at servicing the Norfolk region only or the UK as a whole (which, presumably, would include Scotland and Northern Ireland). For example, there is reference to a “national centre of excellence for ME” whilst also discussing East Anglia as being a ‘region of opportunity’.

In particular, it is unclear whether there is a distinction in national and regional service provision between the separate clinical and research facilities detailed in the proposal (and located in Norfolk and Norwich University Hospitals, and the University of East Anglia/Norwich Research Park respectively).

If the clinical service is intended to be national, the following questions arise.

• Why has Norwich been selected as a location (given that it has poor logistical accessibility for the rest of the country)?
• Have other geographic locations and facilities been considered?
• If so, how has their suitability been assessed and by whom?

Page 2

For both a national and regional remit, the following questions arise for the clinical service.

• Why have Norfolk and Norwich University Hospitals (N&NUH) been selected to host the Centre’s clinical facility?
• What specific types and levels of expertise would N&NUH bring to the Centre?
• Does N&NUH health care staff have the capabilities and infrastructure to deliver the proposed service and, if not, how would this be addressed?
• Have other facilities been considered?
• If so, how has their suitability been assessed and by whom?

For a national and/or regional remit, the following questions arise for the research service.

• What is the rationale for selecting the University of East Anglia/Norwich Research Park (UEA/NRP) to run the Centre’s research programme?
• Has the UEA/NRP submitted a formal proposal for hosting the research programme?
• If so, who has assessed this and how has it been assessed?
• Have other research facilities been asked to submit proposals?
• If so, who has assessed these and how have they been assessed?

The distinction between a national and regional service is further confused by the assumption that the Centre’s ‘translational’ model can be achieved only where the clinical and research services share the same geographic location.

The rationale for this assumption is unclear and, indeed, is contrary to the existing health care provision framework in the UK which operates through a countrywide network of medical facilities within (or co-ordinated by) the National Health Service (NHS).

1.2. Disease Scope

The document uses the nomenclature ‘ME’ (myalgic encephalomyelitis) to describe the condition that it intends to cover although there are further associated illnesses that overlap with ME and, indeed, may actually be the same disease (e.g. fibromyalgia, atypical MS, atypical lupus).

In addition, the UK medical profession uses other terms to describe ME, including Post Viral Fatigue Syndrome (PVFS), Chronic Fatigue Syndrome (CFS) and even just chronic fatigue.

The UK medical profession also lacks clarity and consistency in disease definition and diagnosis, an issue which, as pointed out in the proposal, can lead to patients being diagnosed incorrectly (either as having ME when they do not or not having ME when they do).

To avoid the considerable confusion and inaccuracy of existing nomenclature, definition and diagnosis, it may be preferable to adopt the term ‘neuroimmune disease’, as used by the US Whittemore Peterson Institute (WPI) which the proposal states is a role model for the Centre.

Page 3

This may also avoid the potential confusion between the Centre of Excellence and existing NHS ME/CFS Centres (referred to in the proposal) which attract criticism for, amongst other things, their lack of biomedical intervention and focus on occupational and behavioural therapies.

In addition, this would provide a platform for further research into the human gammaretrovirus (HGRV) family which has been linked with ME and is the current focus of the WPI. The current proposal does not make reference to this retrovirus and this would seem an oversight given (a) the growing scientific interest in this area and (b) that donors to IiME’s Biomedical Research Fund approved support of the WPI’s UK study of HGRVs. It is also highly relevant for diagnostic purposes (a key focus of the proposal) given the likelihood that HGRVs will become, at very least, a biomarker for ME.

2. Objectives

Successful projects are underpinned by objectives which are specific, quantified, achievable and measurable.

The current proposal omits specific, quantified objectives or project ‘deliverables’, possibly because these are difficult to define given the lack of a precise scope.

Once the scope has been clarified, it may help to establish an overarching mission, a set of objectives and a timeline for implementation.

Given that this is a start-up project with a limited budget (see 4. Funding), it may be prudent to begin with a limited remit that can be met within a short lead-time and then used as a basis from which to develop more ambitious plans.

An example clinical mission would be: ‘To translate international biomedical research findings and therapies into clinical treatments for patients in Norfolk.’

Clinical objectives could include:

– to diagnose and treat x number of patients over time period y
– to deliver xx% improvement in patient health and well-being over time period y
– to train x number of N&NUH doctors in the diagnosis and treatment of ME over time period y

An example research mission would be: ‘To implement research programmes that complement and support those of the WPI.’

Research objectives could include:

– to complete x number of studies (by specified type) over time period y
– to replicate/validate findings of research study z
– to test the efficacy of treatments a, b and c over time period y

The proposal lists eleven project benefits and certain of these could be classed as deliverables (e.g. domiciliary services) but would require greater detail based on a

Page 4

quantified top line objective (e.g. diagnosis and treatment of a specified number of housebound patients pa).

All objectives would require an accompanying plan for delivery and methods of measurement and assessment.

3. Service Provision Model

In the absence of specific and robust objectives to use as a benchmark, it is difficult to assess the potential outcome efficacy of the proposed service model although questions about operational efficiency can be raised at this stage.

The diagram in figure 1 is a graphic representation of the service provision model described in the proposal. The shaded organisations are those which, combined, form the Centre of Excellence.

Fig 1. Overview of assumed service provision model

The proposal describes this as a “simple but effective structure”, although it could be argued that the model is, actually, quite complex given the number of stakeholders and communication pathways that are involved.

Page 5

In addition, four separate organisations and geographic locations constitute the Centre of Excellence itself, which makes it a concept rather than a single entity, and so conflicts with the proposal’s underlying theme of a closely integrated operation.

The responsibilities of each of the organisations within the Centre are unclear from the proposal, as are how they will inter-relate and how communication and control will be managed.

In particular, the proposal requires more detailed explanation of the roles of Norfolk PCT and N&NUH, not only in terms of how they may provide patient services regionally and/or nationally, but also in terms of their potential model for other PCTs and hospital trusts to follow, as well as their operation within the NICE (National Institute for Health and Clinical Excellence) guidelines for treating ME.

The proposal states that “a new commissioning director at Norfolk PCT…is supporting the steering group’s views”. It would be helpful to name the individual in question and also include their input in detail.

The position of a ‘clinical biomedical lead consultant’ is mentioned and also that candidates have been approached for this role, although their remit and responsibilities, selection and measurement criteria, and reporting structure are not explained. Similarly, it is unclear how the ‘GPs with special interest’ who support the lead consultant will be identified, enrolled, trained and funded.

The proposal recognises the critical importance of training health care staff (and also mentions ‘visiting experts’) although it is unclear who will be responsible for training the N&NUH staff, which staff will be trained and how training will be implemented and monitored.

Staff training will be paramount to the Centre’s success, particularly given the NHS’ current dearth of biomedical knowledge about ME and its inappropriate and, sometimes, harmful treatment options for the disease (as per the NICE guidelines, mentioned above). IiME needs to demonstrate that the NHS’ long established and entrenched misunderstanding of ME can be corrected, and swiftly, if the Centre is to gain the confidence of patients and commitment of financial donors.

With specific reference to IiME’s involvement in the project, the proposal would benefit from more detailed explanation of the following.

• For each of the three IiME entities (charity, limited company and steering group):

– role
– management structure
– governance
– overlap with the other two entities

• For the charity and steering group specifically:

– members and/or trustees (other than the two named in the proposal)
– how members/trustees are appointed
– who appoints members/trustees
– to whom members/trustees are accountable
– how members/trustees are monitored

Page 6

• For IiME Ltd specifically:

– when the company was/will be incorporated
– business classification and trading objectives
– share structure and ownership
– board members and responsibilities
– relationship with Norfolk PCT and N&NUH (given that the proposal refers to IiME Ltd supporting service commission by the former from the latter)

In addition, it would be helpful to understand how the Centre’s work might be integrated with that of other ME research organisations such as ME Research UK (currently funding a HGRV study in Sweden), the UK CFS Research Foundation (supporter of Dr Jonathon Kerr’s research for many years), as well as with its stated role model, the US WPI.

4. Funding

The proposal omits a top line funding requirement, a budget break-down and a cost-benefit analysis for the project.

Norwich local newspaper, EDP24, has stated: “Discussions will be going on over the next few months and once a decision has been made, funding will begin to the tune of £150,000 a year.”²

This amount seems low in the context of the proposed service provision model and particularly in comparison to the Center for Molecular Medicine (home of the WPI at the University of Nevada) which cost $77 million to establish.

The proposal states that funding for research would be “organised and provided by the charity and the UEA” although there is no further detail of how this would be supported nor who would fund the clinical element.

As a consequence, the following information remains to be confirmed.

• The estimated cost (overall and breakdown) of establishing and maintaining the Centre over a given time period (for example, five years).

• The share and source of funding to be provided by each of the organisations involved in the Centre.

• How the funds will be raised by each of the contributing organisations.

• Methods for monitoring expenditure, measuring outcomes and reporting to fund contributors.

• For those funds raised via IiME (the charity), whether donors will contribute to the Centre as a whole or to specific research and/or clinical projects.

• For IiME (the charity), the share of funding to be sourced via the following:

– general donations to the charity;
– profits from sale of IiME’s annual conference DVD;

Page 7

– donations to IiME’s Biomedical Research Fund;
– donations to a separate Centre specific fund.

• Whether, after completion of the WPI’s UK study, any residual monies in IiME’s Biomedical Research Fund will be transferred to the Centre or remain in the Fund for further research projects, and whether donors’ approval will be sought for either course of action (as per the precedent set when monies were reallocated from Dr Kerr’s withdrawn research to the WPI’s UK study).

5. Conflicts of Interest

Fund donors may wish to see further explanation for, and clarification of, the following potential conflicts of interest.

• Dr Ian Gibson’s involvement in this project will raise concerns with those who did not welcome his unofficial ‘Gibson Inquiry’ into ME (as referenced in the proposal) and the subsequent uncorrected ‘e-report’ which was published in October 2006³. There were significant criticisms of the way that Dr Gibson and his panel undertook this inquiry (which was a personal project and not a formal Parliamentary Inquiry or Report), such as the involvement of Lord Turnberg, a known supporter of cognitive behavioural therapy (CBT) and graded exercise therapy (GET), and the absence of proper consultation with the inquiry’s constituency of interest at all stages throughout the life of the project. Previously a Labour backbencher, Dr Gibson was barred from standing for the party in the 2010 general election following questions about his ministerial expenses.

• Dr Fiona Poland of UEA’s Institute of Health and Social Science Research is working in partnership with Action for ME (AfME) and a network of universities on part of a major ME research project sponsored by the Big Lottery Fund (i.e. reporting and developing early findings on the impact of the illness and available means of support). The association between UEA and AfME will raise concerns with a growing number of patients who openly criticise the latter’s role, agenda and efficacy, particularly in terms of its apparent unwillingness to support biomedical ME research and to challenge the psychosocial paradigm.

• The Norwich Research Park is a joint venture between the UEA, and amongst others, the Sainsbury Laboratory which, in turn, is supported by the UEA and the Gatsby Foundation. The Gatsby Foundation is one of a number of Sainsbury Family Charitable Trusts which share the same administrators and counsels. This includes the Linbury and Ashden Trusts which have provided funding for the RNHRD NHS FT, Bath (the ‘Min’) and the University of Bristol’s controversial trial of the Lightning Process on children and for which IiME has stated its public opposition.

• The Institute for Food Research (IFR) and The Genome Analysis Centre (TGAC) are institutes of the Biotechnology and Biological Sciences Research Council (BBSRC). The BBSRC grant-aids the John Innes Centre (based in Norwich Research Park) which hosts the Sainsbury Laboratory and the TGAC. BBSRC is one of seven Research Councils that work together as Research Councils UK (RCUK). It is funded from the Government’s Department for Business, Innovation

Page 8

and Skills (BIS). This is a complex organisational structure which makes it difficult to achieve transparency in funding governance and also to identify potential conflicts of interest.

• It is unclear from the proposal whether ME support groups in the Norfolk region (or nationally, if the scope is such) are involved in this project and the degree to which they have provided input and support. It is also unclear whether there has been any wide-scale patient consultation for this project or if any is planned in the future.

References

1 Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk August 2010
‘A New Era in ME/CFS Research: An Opportunity for Major Progress in Diagnosis, Treatment and Research into Myalgic Encephalomyelitis’

2 EDP24 “Norwich centre for ME sufferers planned” 03.08.10

3 THE ONE CLICK GROUP REPORT THE GIBSON ‘INQUIRY’ 17 January 2007

Chris Douglas is an ME sufferer and ex-corporate project manager.

douglas_chris@hotmail.co.uk

Review of Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk

Review of the Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk by Chris Douglas

Shortlink to this posting: http://wp.me/p5foE-33z

or http://tinyurl.com/ReviewIiMEProposal

At the 5th Invest in ME International ME/CFS Conference held in May, this year, a proposal was announced for the establishing of a “Centre of Excellence for ME” in Norfolk. To the best of my knowledge, Invest in ME had undertaken no national consultation with ME patients before drawing up its proposals.

Today I am publishing a review of Invest in ME’s proposal prepared by Chris Douglas.

A text version of this review is published in the next post.

Review of the Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk

By Chris Douglas

27 August 2010

Introduction

It is assumed that this document is a precursor to a more formal and detailed proposal that will be used to secure consultative input and financial commitment to the project.

The following review highlights specific areas in which the proposal could be strengthened if, in particular, it is to maximise commitment from potential financial donors.

Review of the Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk

Open Word document here: Norfolk Proposal Review 27.08.10

A text version of this Word document is published in the next post

Related information

Invest in ME

“Invest in ME is an independent UK charity campaigning for bio-medical research into Myalgic Encephalomyelitis (M.E.), as defined by WHO-ICD-10-G93.3.”

Invest in ME is constituted as a Trust, registered with the Charity Commission and run by a committee of three Trustees/Directors. Invest in ME is not a membership organisation. The organisation was founded in 2006 by carers and patients, Sue Waddle, Richard Simpson and Kathleen McCall (current chair). Ms Waddle has since stood down as a Trustee.

http://www.investinme.org/Research%20-%20ME%20Institute.htm

Invest in ME

A UK Centre for Biomedical Research into ME

Read the announcement here

The Research Proposal published by Invest in ME in July can be read here in PDF format:

Biomedical Research Institute Proposal July 2010

“A New Era in ME/CFS Research

“An Opportunity for Major Progress in Diagnosis, Treatment and Research into Myalgic Encephalomyelitis”

“A VISION FOR THE FUTURE

“Recent biomedical research and advances in knowledge and treatment regarding Myalgic Encephalomyelitis have brought more urgently needed awareness of this disease. In the East Anglian region of UK an opportunity now exists to bring real benefit to patients and establish a unique capability which will attract attention and recognition from across UK and Europe.”

Media coverage

Great Yarmouth Mercury

Hopes for ME centre in Norfolk raised

31 August 2010

“…The independent charity will carry out the official campaigning for funding for the centre once a formal agreement is made.

“Now the charity has offered to send some of the UEA researchers to a biomedical research symposium in Australia at the end of the year.

“Mr Simpson said: “This would involve them discussing work with the top ME researchers and clinicians in this field from around the world.

“Discussions are under way, and we are really hopeful this will move things forward. The centre could change the lives of patients with ME. Early diagnosis is so important, and this centre would help establish that.’

“The charity is also planning to organise a conference in Norwich with the UEA and the Norfolk and Norwich University Hospital and is lining up discussions with the US Whittemore Peterson Institute, an institute for neuro-immune disease in Nevada that helps thousands of people with ME through research, scientific developments and treatment…”

———————

Norwich Evening News

Plans for world class Norfolk centre

Sarah Hall | 27 August 2010

———————

Environmental Illness Resource Blog

UK to get WPI Inspired Chronic Fatigue Syndrome Research and Treatment Centre

News – Chronic Fatigue Syndrome News

Matthew Hogg | 13 August 2010

———————

EDP24

Norwich centre for ME sufferers planned

Sarah Hall | 3 August 2010

25% ME Group position statement on Lightning Process pilot study in children 8 to 18

25% ME Group position statement on Lightning Process pilot study in children 8 to 18

Shortlink: http://wp.me/p5foE-31F

Today, the 25% ME Group has issued a position statement on the Dr Esther Crawley led RNHRD NHS FT Bath / University of Bristol proposed pilot study into the feasibility of recruiting to a randomised controlled trial (RCT)comparing the Lightning Process with specialist medical care.

The Medical Advisors to the 25% ME Group are Dr Byron Hyde (Canada) and former UK NHS paediatrician, Dr Nigel Speight.

Whilst I welcome the issuing of this statement, it should be noted that the press release announcing the pilot study was issued over five and a half months ago.

According to information provided by University of Bristol Information Rights Officer and their Director of Legal Sevices, information on the study and the research protocol is anticipated to be published on the University of Bristol website by the end of this month.

This suggests that ethics approval for the pilot study may now have been obtained.

It is not known whether the 25% ME Group has or intends to make representations to any individual, institutions, organisations or bodies.

The document is heavily formatted and I will be posting a copy of the text, later. In the meantime a Word version of the group’s statement can be opened here:

25% ME Group LP Research Position Statement 20.08.10

Scientific trial involving children and the Lightning Process is unethical, says joint statement issued by two national ME charities

Joint Press Release and statement issued today by the ME Association and The Young ME Sufferers Trust

Shortlink: http://wp.me/p5foE-2YW

Update @ 11 August

On 4 August, the ME Association released a list of recipients of the press release issued earlier that day jointly with the Young ME Sufferers Trust. The list is media recipients is appended beneath the press release.

ME agenda welcomes this very strong opposition statement from the ME Association and The Young ME Sufferers Trust. The iniative to liaise with Trading Standards is also welcomed.

The joint press release says:

“If any trial is to be held, it should first be on adults, who can give informed consent.”

My own position is that to undertake RCTs on any patient group would be giving credence to the Lightning Process as having potential as a treatment for ME and would also legitimise it, ethically, as a potential treatment. I would not want to see any RCTs into the application of the Lightning Process, whether undertaken with ME patients, MS patients or for any other medical disease, condition or syndrome.

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

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

From the ME Association

http://tinyurl.com/MEA-TYMESTrust-LP-Statement

Scientific trial involving children and the Lightning Process is unethical, says joint statement issued by two national ME charities

Wednesday, 04 August 2010 17:15

A plan to recruit children with ME/Chronic Fatigue Syndrome to a scientific trial comparing the efficacy of an unproven psychologically-based training programme with specialist medical care is “unethical”, say two of Britain’s leading ME/CFS charities – The ME Association and the Young ME Sufferers Trust.

In a joint statement issued today (4 August 2010), the two charities say:

We are issuing this joint statement due to widespread public concern, together with our own serious reservations, about a forthcoming study of the psychologically-based Lightning Process on children.

The pilot study, scheduled to start in September, will look at the feasibility of recruiting children aged eight to 18 with ME/CFS into a randomised controlled trial (RCT) comparing the Lightning Process with specialist medical care.

It is planned that over 90 children aged between eight and eighteen and their families will be involved in the study.

The Medical Research Council (MRC) produces specific guidelines for research involving vulnerable patient groups.

The document ‘MRC Medical Research Involving Children’ is quite clear on this issue. It poses the question: ‘Does the research need to be carried out with children?’ In answer, the MRC states: ‘Research involving children should only be carried out if it cannot feasibly be carried out on adults.’

The ME Association and The Young ME Sufferers Trust do not believe that it is ethically right to use children in trialling an unproven and controversial process such as the Lightning Process.

A survey of 4,217 people carried out by the ME Association on the management of ME/CFS found that over a fifth of those who had tried the Lightning Process were made worse (7.9% slightly worse,12.9% much worse). If any trial is to be held, it should first be on adults, who can give informed consent. No rigorous RCTs into the application of the Lightning Process have ever been undertaken.

Despite many years of scientific research there is still no single diagnostic test for ME/CFS, nor is there a curative treatment. The theory upon which the Lightning Process is based, together with its claim that the prolonged nature of the illness is caused by ‘the adrenaline, nor-adrenaline and cortisol loop’ is not scientifically proven. Moreover, the Advertising Standards Authority recently ruled that an advertisement in an internet sponsored link containing claims of its effectiveness by a Lightning Process practitioner should be removed. We understand that the practitioner will be involved in this study and we find this concerning.

The Trading Standards departments of two local authorities have also taken action over therapeutic claims by Lightning Process practitioners following referrals by Dr. Charles Shepherd of the ME Association. The Lightning Process calls itself a training programme, not a medical treatment, combining concepts from Neuro-Linguistic Programming, Life Coaching and Osteopathy. It claims to be effective for ME/CFS and psychological problems such as anxiety, stress, depression, guilt, low self esteem. Any evidence for this effectiveness on ME/CFS is purely anecdotal. ME has long been classified by the World Health Organisation as a neurological illness, not a psychological condition.

We cannot approve of a study involving children as young as eight when no rigorous trials have first been undertaken into the safety, acceptability, long and short-term effects of the application of this controversial and unregulated ‘process’ with adults.

Furthermore, we have serious concerns about the primary outcome measure, which is school attendance after six months. Children have a legal right to ‘suitable education’ for their particular needs, which may or may not include school attendance.

The statutory guidance ‘Access to Education for Children and Young People with Medical Needs’ explains that whilst it is desirable for children to be educated in school, other forms of education must be provided for those who need it. The Chief Medical Officer’s Working Group Report on CFS/ME (DOH 2002) stated that most children with ME will need education in their homes at some time, potentially for a considerable period. In 2009 the Education White Paper ‘Back on Track : A strategy for modernising alternative provision for young people’ included virtual education. Chapter 7, ‘Learning from the best and supporting innovation’, spoke of ‘e-learning and virtual provision, particularly for pupils who cannot attend school due to health needs.’ Accessible education is also provided for in disability discrimination law.

If school attendance is the primary outcome measure of this study, families involved may then feel pressurised into avoiding alternative forms of education which would benefit their children and to which they are legally entitled.

For all these reasons, it is our considered opinion that this study of the Lightning Process in children is unethical and should be abandoned.

NOTES TO EDITORS

References:

‘£164,000 awarded for new research into the treatment of a chronic childhood condition’.

Press release issued by The Royal National Hospital for Rheumatic Diseases, which can be found at their press release page:

http://www.rnhrd.nhs.uk/index_sub_menus/news/news_menu.htm

Advertising Standards Authority ruling:

http://www.asa.org.uk/Complaints-and-ASA-action/Adjudications/2010/6/Withinspiration/TF_ADJ_48612.aspx

MEA and TYMES Trust 4 August 10 press release recipients

(NB: this may not be a comprehensive list)

The press release has gone out to

The Times news desk
David Rose, health reporter, The Times
The Independent news desk
Steve Connor, science editor, The Independent
Jeremy Laurence, health editor, The Independent
Sunday Times news desk
Daily Telegraph news desk
Sunday Telegraph news desk
The Lancet news desk
BMJ news desk
Daily Star, news desk
The Sun, news desk
Daily Mail, news desk
Daily Mail, health editor
Fergus Walsh, BBC health correspondent
Western Morning News, newsdesk
Bristol Evening Post, news desk
Western Daily Press, news desk
Buckingham Advertiser
Bucks Herald
You and Yours, Radio 4
Today programme, Radio 4
Panorama, BBC 1
Dispatches, C4
Disability Now
Evening Gazette Colchester
Channel 4 news
Breakfast, BBC 1
GMTV news desk
Randeep Ramesh, health reporter, The Guardian (Sarah Boseley is on holiday til August 9)
The Guardian, news desk
Osteopathy magazine
East Anglian Daily Times, news desk
Daily Express, news desk
Daily Express, health editor
Private Eye, news desk
Anna Winkles, health reporter, BBC Online
Press Association, health editor
All Together Now magazine
Bath Chronicle
News of the World
Tom Moore, health editor, Sky News, and his news desk.
Stacey Poole, the ME-aware health editor at Meridian, ITV station for south of England.
Emailed Times Ed Supplement, highlighting educational aspects of the release and suggesting they speak with Jane Colby.

Invest in ME Decline BACME Invitation

Invest in ME Decline BACME Invitation

Shortlink: http://wp.me/p5foE-2Z2

Invest in ME has issued a statement around its decision to decline an invitation to become a member of BACME (British Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis).

For Invest in ME’s position statement on the proposed Bath/Bristol pilot study 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 as young as eight, go here Invest in ME March 2010 Newsletter.

Invest in ME Decline BACME Invitation

Invest in ME recently received an invitation from the British Association for Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (BACME) inviting us to apply to become an executive member of that organisation.

BACME is chaired by consultant paediatrician Dr Esther Crawley – who was recently awarded a grant to do a clinical trial on the Lightning process (funded with £164,000 from the Linbury Trust and the Ashden Trust) – a business which assumes that no matter what is causing an ME patient’s illness it will help cure a patient from them.

With cases of people with ME being made worse from this business the recent Norwegian film by Paal Winsents (“Make Me Well”) illustrates the danger of people with no medical training attempting to treat a neurological illness such as ME. A telling quote from a LP practitioner in that film says it all –

“…. It does not matter how it started. Sometimes people had a bacterial infection, sometimes people had a viral infection. It does not matter how it started. The Lightning Process works equally well”.

Such uninformed, non-clinical and dangerous statements being used by people promoting businesses without any medical training, at a time when the need for more funding for biomedical research into ME and the evidence to support that funding requirement is overwhelming, is symptomatic of the problems on a non-strategic, non-biomedical approach to diagnosing and treating people with ME. Meanwhile ME patients and their families have to witness this absurd waste of money.

Dr. Crawley’s views on ME aren’t those of Invest in ME’s and we have serious concerns about her position as chair of an organisation such as this.

The Assistant Chair of BACME is Alison Wearden, who is Reader in Psychology at the University of Manchester, Chair Elect of British Psychological Society’s Division of Health Psychology and Associate Editor of British Journal of Health Psychology and whose studies include “Illness cognitions and diabetes – how the beliefs which patients hold about their diabetes impact on their attempts to manage it, their adjustment and well-being”. Wearden was head of the FINE trials (click here) – a waste of taxpayers’ money which resulted in nothing of value for people with ME.

BACME has a constitution to which members have to sign up. In this constitution, which BACME requires its members to support, it includes the following-

2.2 Objectives

2.2.1 To champion evidence-based approaches to the treatment of CFS/ME, such as those provided in the NICE guidelines

…

2.2.4 To support the delivery of services and to enable services to maintain standards of care in the treatment of CFS/ME as set out in the NICE guidelines

…

4. The Executive

4.1.4 The BACME Executive will invite no more than four people drawn from National UK CFS/ME organisations which explicitly support the aims and constitution of the organisation to sit on the Executive committee as either observers or members

Invest in ME rejected the NICE Guidelines and therefore cannot agree to endorse a constitution which lists among other things the above objectives.

Invest in ME endorse the critique set out by Twisk FNM, Maes M. in their review of CBT/GET in which they state

“So, it can be concluded that the efficacy claim for CBT/GET is false. But what is more important, is the fact that numerous studies support the thesis that exertion, and thus GET, can physically harm the majority of the ME/CFS patients.

This assertion is confirmed by the outcomes of two large patient surveys in the UK and Norway, and two smaller surveys in Scotland and the Netherlands.”

(A review on Cognitive Behavorial Therapy (CBT) and Graded Exercise Therapy (GET) in Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS): CBT/GET is not only ineffective and not evidence based, but also potentially harmful for many patients with ME/CFS. Neuro Endocrinol Lett. 2009 Aug 26;30(3):284-299.) click here

The NICE guidelines need complete revision* as their current version is far from evidence-based.

The NICE guidelines have been shown to be ineffectual, biased, unusable, with ME patients eventually taking NICE to a judicial review.

For an organisation to support NICE, and require members to abide by them, let alone “champion” them illustrates a flawed and damaging basis for any claim to represent people with ME and their families. Such an organisation is likely to continue to force a continuing approach of going round in circles, obfuscating the true requirements for ME patients and achieving little of real value for people with ME and their families.

With BACME maintaining its present structure, current chairman and constitution then Invest in ME will decline any offer to apply for membership of this organisation.

It would be unethical of Invest in ME to sign up to such a constitution and Invest in ME’s aim remains to find ways other than those set out in the NICE guidelines to treat patients diagnosed with ME according to the Canadian Clinical Consensus guidelines.

Further Reading: (links provided by Invest in ME)

Magical Medicine: How to Make a Disease Disappear – click here

Lightning Process – The Falsehood of Magical Medicine – IiME Newsletter March 2010 – click here

Can the MRC PACE Trial be justified? – click here

Wessely’s Way: Rhetoric or reason? – click here

Invest in ME – Communications with the UK Chief Medical Officer – click here

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: http://wp.me/p5foE-2W3 or http://tinyurl.com/LightningProcessPilotStudyPoll

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?

Advertising Standards Authority upholds complaint against Withinspiration (Lightning Process)

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

Shortlink: http://wp.me/p5foE-2Vt

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: http://tinyurl.com/LightningProcessPilotStudyPoll

An ASA Adjudication against “Withinspiration” came to my attention, today, via the Co-Cure mailing list:

ASA Adjudication on Withinspiration

Withinspiration

Date:
16 June 2010

Media:
Internet (sponsored search)

Sector:
Health and beauty

Number of complaints:
1

Complaint Ref:
123134

Ad
An internet sponsored link stated “Chronic Fatigue Recovery. End the cycle of ME/CFS: Get Well! with The Lightning Process”.

Issue
The complainant challenged whether the claim “Chronic Fatigue Recovery. End the cycle of ME/CFS” could be substantiated.

CAP Code
3.150.150.3

Response
Withinspiration said they had personal experiences of improvement in medical conditions, such as myalgic encephalomyelitis (M.E), as a result of using the lightning process. They argued that the lightning process, created by Phil Parker, had received a number of celebrity endorsements and positive press articles, which they believed were a testament to the effectiveness of the treatment. Although Withinspiration said they held no scientific evidence to support the claims, they said that trials were due to commence in 2010.

Assessment
Upheld

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.

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

Action
The ad must not appear again in its current form. We told Withinspiration to ensure they held substantiation before making similar efficacy claims for the lightning process

Adjudication of the ASA Council (Non-broadcast)

Bournemouth 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” in connection with the Dr Esther Crawley led pilot study. At 29 March, Mr Gibson’s website had carried this information:

http://www.withinspiration.co.uk/index.php

“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…”

http://www.withinspiration.co.uk/lightning_process_NHS_research.php

This statement no longer appears on his website. It is unclear whether Mr Gibson retains an involvement with this proposed pilot study.

RNHRD NHS FT Bath and University of Bristol pilot study

On 2 March, the Royal National Hospital for Rheumatic Diseases NHS Foundation Trust, also known as the Min, and the University of Bristol announced a research study looking into “interventions and treatment options for Chronic Fatigue Syndrome” [1].

Funding of £164,000 from the Linbury Trust and the Ashden Trust has been awarded to the research team led by Dr Esther Crawley, Consultant Paediatrician, Royal National Hospital for Rheumatic Diseases, Bath, the CFS Clinical Lead for Bath NHSFT and a Senior Lecturer, University of Bristol.

“The study will involve in depth interviews with the patients and their parents, and the primary outcome measure will be school attendance after six-months. It is hoped that over 90 children aged between eight and 18 and their families will be involved in the study. They will be recruited after assessment by the specialist team at the Min. The study will begin in September 2010.”

Press Release: Research study to investigate a chronic childhood condition

Open PDF here: Media Release – 2 March 2010

Open PDF media article here: Chronic fatigue syndrome study Mineral Water Hospital

Dr Esther Crawley

Dr Crawley, FRCPCH, PhD, is a Senior Lecturer at the University of Bristol, a Consultant Paediatrician and clinical lead for the Bath CFS service. Dr Crawley’s specialist CFS service for children and adolescents is reported to be the largest regional paediatric service in the UK and also provides services nationally.

Dr Crawley had been a member of the NICE CFS/ME Guideline Development Group and gives presentations around the NICE guideline CG53 and the CFS/ME Clinical and Research Network.

Dr Crawley had chaired the CFS/ME Clinical Research Network Collaborative (CCRNC), now reformed under the new name “BACME”, for which Dr Crawley continues as chair.

Dr Crawley is a member of the MRC’s “CFS/ME Expert Panel”.

In the last couple of years, Dr Crawley’s research team has been awarded considerable sums of funding for CFS studies and Chronic Fatigue studies in children – including a £873,579 NIHR Clinician Scientist Fellowship award, last year. She has also received funding from patient organisation, Action for M.E. (£49,650).

Grants awarded to Dr Crawley during 2007-09 here: http://www.bristol.ac.uk/ccah/grants/

The Lightning Process

The Lightning Process is controversial and untrialled. It is marketed by the Phil Parker organisation not as a therapy or a treatment but as a “training program” delivered by “instructors” or “practitioners” or “coaches”.

Instructors are trained and licensed by the Phil Parker organisation and are not accountable to any regulatory professional body. If individuals have complaints about a practitioner or about the Lightning Process, itself, which cannot be resolved directly with the practitioner or through the Phil Parker complaints procedure, their only recourse is Trading Standards.

Some practitioners may already be established therapists in CAM or psychotherapy fields but have trained with the Phil Parker organisation to also offer the Lightning Process to their clients. But many Lightning Process practitioners are individuals who have undergone the process for some condition or other, then paid to train with the Phil Parker organisation to become “Licensed Lightning Process Practitioners”, themselves, and will have had no previous background in therapies or life coaching.

In early 2007, the ME Association published their position on the Lightning Process which included the following statement:

“The Lightning Process is a new and very speculative form of treatment that has not been assessed in a proper clinical trial. So while we are providing information about it, it is not a form of treatment that we are able to endorse. We recommend caution when considering this approach.” [2]

In March 2007, Action for M.E. published an article featuring several negative patient experiences of undergoing the Lightning Process [3].

Data from two large patient surveys carried out by Action for M.E./AYME (published 2008) and by the ME Association (published May 2010) show similar levels of worsening of symptoms in CFS and ME patients following the three day “training program”, or of no improvement at all (AfME/AYME: Worse:16%, No change: 31%; MEA: Slightly worse 7.9%; Much worse 12.9%: No change: 34.7%) [4].

GOSH gives a platform to Phil Parker

At the July 2009 meeting of the Countess of Mar’s Forward-ME group, patient reps discussed their concerns that Phil Parker was being given a platform at a University College London workshop, held in conjunction with Great Ormond Street Hospital (GOSH), for medical and allied health professionals working with children and young people with ME and CFS at which Mr Parker would be promoting the Lightning Process [5].

CFS clinical lead and paediatrician, Dr Esther Crawley, who was presenting at this Forward-ME group meeting, was invited to participate in discussions around the GOSH workshop, the Lightning Process in general and its application in children, in particular. According to the minutes of the July meeting, Mary Jane Willows, CEO AYME, was tasked with approaching the workshop organisers to discuss ME patient organisation concerns. The outcome of this initiative was not recorded in the minutes of the next meeting of the Forward-ME group.

No RCTs

To date, no rigorous, randomised controlled trials into the safety, acceptability, short and long-term effects of the Lightning Process have been carried out in adults with ME and CFS. There is no reliable, independent published data on the safety of the application of the Lightning Process.

Patients and carers were astounded to learn, in early March, that a Bristol/Bath research team led by an NHS consultant paediatrician intends to undertake a pilot study to investigate whether it is possible to recruit children as young as eight with CFS and ME into an RCT comparing the Lightning Process with specialist medical care.

The press release, issued on 2 March, announced:

“The team will carry out a pilot project to investigate how to recruit to a randomised controlled trial looking at the Phil Parker Lightning Process® and specialist medical care. This will be the first study of its kind in this area, and the team hopes to establish a basis for a larger scale multicentre research project.”

The study has the involvement of Phil Parker and is expected to start in September 2010.

Research using vulnerable patient groups

The MRC produces specific guidelines for research involving children. The document MRC Medical Research Involving Children (Nov 2004, revised Aug 2007)” is clear:

“4.1 Does the research need to be carried out with children? Research involving children should only be carried out if it cannot feasibly be carried out on adults.” [6]

Not only is it feasible to carry out research into the application of the Lightning Process using adults with ME and CFS, many feel it is unethical not to do so first.

There are considerable concerns that an NHS paediatric CFS unit should be planning a study involving children as young as eight when no rigorous, RCTs have first been undertaken into the safety, acceptability, long and short-term effects of the application of this very controversial “process”.

Request for information under Freedom of Information Act

It is proving very difficult to obtain any information about the design, methods and objectives of this research study.

In response to a request for information under the Freedom of Information Act (fulfilled 17 June), the 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).

They are also withholding the names of the ethics committee(s) reviewing the application for ethics approval.

University of Bristol has confirmed that the study (for which the funding was secured last November) is still going through the ethics approval procedure.

All other information and documents requested is currently being denied [7].

Open PDF Request for information under FOI and responses: FOI – Lightning Study Chapman 17.06.10

To virtually all questions the response has been:

“This information is intended for future publication when the study protocol and other related documents are published online. It is therefore exempt from disclosure under section 22(1)(a) of the Freedom of Information Act.

“The study is currently going through the ethics approval procedure and this information is expected to be published around August / September 2010. We cannot see that there is any public interest in disclosing this information before that time.”

But it is a matter of considerable public interest that an NHS Trust seeks to use children as young as eight as guinea pigs. I am intending to request an internal review of the decision not to make available any information about the design and methods for this study, at this stage.

What does the Lightning Process involve?

The Lightning Process website describes the process as being derived from neuro linguistic programming (NLP), osteopathy and life-coaching [8].

One account included this description of the “process”:

Personal account of Lightning Process technique as applied to patient with ME

“I had an acute onset and went from a hardworking person to bedbound overnight. In a desperate attempt to recover I decided to try LP after reading stories of severely affected M.E. patients who had recovered. It all sounded so convincing and after a phone consultation with a LP coach I felt very positive I was doing the right thing. I borrowed the money from my parents, £880.00 as I had long lost my job, and went for it.

There were 3 other m.e. patients at the same course none of these people nor myself recovered. The course was over 3 days from 10am-2pm with a break at lunchtime for tea and biscuits. We were told not to discuss the content of the course with each other during the breaks. We learned the ‘affirmation’ and stood on the floor on paper circles with key words written on them.

Here is the big secret of what we had to say while standing on paper circles –

WHEN YOU FEEL A SYMPTOM
SHOUT- STOP! (stand on the paper STOP)
SAY- I HAVE A CHOICE ( stand on the paper CHOICE)
SAY- YOU CAN CHOOSE THE PIT OR THE LIFE YOU LOVE ( you then stand on the LIFE YOU LOVE circle)
SAY- I CHOOSE THE LIFE I LOVE
SAY- WELL DONE, YOU ARE A FANTASTIC GENIOUS, YOU ARE ON TRACK! I AM WITH YOU EVERY STEP OF THE
WAY (you are being your own coach here)
ASK YOURSELF – WHAT DO I WANT?
ANSWER YOURSELF- I WANT ENERGY AND HAPPYNESS LIKE (you say something that means energy etc. to you)
ASK YOURSELF- HOW WILL I GET THIS?
TELL YOURSELF- BY STOPPING EVERY NEGATIVE THOUGHT
EVERY NEGATIVE EMOTION
AND DOING THE LIGHTNING PROCESS.

There are a few more short affirmations and that’s it you are cured of M.E. We all DID leave on the third day full of hope and newly found confidence and told that no-matter how we felt in the future ALWAYS SAY WERE WERE CURED OR THE PROCESS WILL NOT WORK !!!! These coaches are very good at their job but I can assure you they can not cure you of M.E. Think about it PAPER CIRCLES AND AFFIRMATIONS. The four of us all were ‘high’ for a few weeks or months and did indeed do more than usual but sadly all relapsed.” [9]

The application process

Potential applicants for Lightning Process sessions must first complete an application form where they agree to undertake certain commitments and to sign up to certain beliefs, including that they are “ready” to benefit from the programme [10]. Practitioners may further “assess”, via a telephone interview, an applicant’s “readiness” to participate and benefit from the “process” but also “assess” whether the applicant has any previous or current medical or psychological conditions which would render them “unsuitable” for undertaking the “process”. Practitioners are not medically qualified.

Sample application form here: LP application form or here: http://www.changeworksforyou.com/applicationform.htm

Parents are expected to sign up to these beliefs and commitments on behalf of applicants under the age of 18, irrespective of whether the child or young person might be considered competent to understand the expectations of the practitioners delivering the courses or of understanding the implications of the “belief system” they are being asked to commit to and the tasks they will be expected to follow over the course of the three days of sessions and following completion of the sessions, which also includes a workbook through which affirmations are reinforced.

The patient experience – “living the life you love”

Lightning Process practitioners are charging from £560 to £880 for three sessions which may last 3 to 5 hours per day, held on three consecutive days, and usually in a group setting.

“Trainees” have reported that they are encouraged to ignore their symptoms of malaise and discomfort and at the end of the day’s session to undertake an activity which they would not normally undertake.

“Trainees” have reported that they were instructed to believe that they are “doing illness” not that they have illness. From one young woman’s personal account:

“The first thing was to take responsibility for our illness. I had to stop saying I had M.E. Instead I have to say I am ‘doing M.E’, I wasn’t tired, I was ‘doing tired and doing muscle aches’. The implication being if I am doing it I can stop doing it.” [9]

So “trainees” are expected to agree that they are “ready” to undertake and to benefit from the program when they sign up to it; that they will commit to understanding and carrying out the instructions properly and that they will work hard at putting the “process” into practice in order that they can “live the life they love”.

Is the burden of “failure” then placed on the patient and not on the ability of the “process”, itself, to “cure”, “resolve” or “substantially improve” whatever medical condition, psychological condition or “life-style issue” the process has been purchased for because the individual was not after all “ready” to undergo the “process”; or that they had not properly understood what was expected of them during the sessions; or that they had failed to carry out the instructions properly or that they had not worked had enough at putting the “process” into practice?

Here’s another account by a CFS patient who also reports on the experience of a “trainee” with Multiple Sclerosis and more accounts here [9].

A letter to the media, here, from a dissatisfied former “trainee”: Lightning process for ME didn’t work for me

No data

There are considerable concerns for the physiological and psychological impact of exposing young children and teenagers with CFS and ME to this type of program and some of these issues are raised within my FOI request, in questions 23 thru 26 a) to l). No responses were provided to any of these questions.

With no data from research into adults, how can the research team determine that overall the likely benefits of the research outweigh any risks to child participants or that undergoing the training program would not be detrimental to a child’s current health status and psychological well-being, as a patient diagnosed with CFS or ME?

Concerns raised include:

• there is no scientific evidence for the Lightning Process on which to base informed consent;
• children and their parents may not fully understand what is expected of them;
• children may feel pressured to conform to the beliefs of the practitioners or to say that they feel better in order to please the researchers and practitioners;
• children might feel pressured to get well and to make too rapid a return to school
• invalidation of the patients’ experience of illness and symptoms;
• the dangers of teaching a child to ignore and override sensations of illness and post exertional malaise;
• the program may be physiologically and psychologically damaging to the child and may impact negatively on the family dynamics if a child were unable to complete the program and withdrew early from the study, or if the child failed to gain benefit from the program, or experienced exacerbation of symptoms during or following the program, or were to experience significant set-back or relapse or if an apparent improvement or resolution of symptoms and disability proved to be short-lived.

With no data from RCTs on the safety and acceptability of the Lightning Process in adults with ME and CFS, how are parents able to give informed consent for their children to participate?

The University of Bristol would provide no rationale for undertaking a pilot study in children when rigorous, randomised controlled trials (RCTs)trials have yet to be undertaken and results published on the application of the Lightning Process in adults with CFS or ME.

There are also concerns that this pilot study in children might serve to legitimise referrals outside the NHS and influence potential future commissioning of the Lightning Process within NHS Trusts. There is evidence that some medical specialities are already referring patients to Lightning Process practitioners, for example, for chronic pain and for CFS, despite no rigorous RCTs having been undertaken into its safety and long-term effects and despite there being no regulatory professional body to protect these patients when accessing private sector providers.

As a clinician, Dr Crawley sees children and young people with a wide range of fatigue – from fatigue relating to other conditions, for example, following head injury, to chronic fatigue, Chronic Fatigue Syndrome and severe ME, where children may be bedbound [13] [14].

Because information is being withheld, it has not been possible to establish which research criteria are to be used. There are concerns that if improvement were shown in those mildly affected with fatigue that the process might be applied inappropriately to children with moderate to severe CFS and ME.

What else is the Lightning Process being used for?

Some Lightning Process practitioners are claiming success with patients with other diseases and conditions, like Multiple Sclerosis (MS), diabetes and some neurological diseases.

One Suffolk Lightning Process practitioner (The Rowan Centre) is currently making the following claims on its website:

http://www.simpsonandfawdry.com/lightning-process.html

What does the Lightning Process work for ?

“People using the Lightning Process™ have recovered from, or experienced significant improvement with the following issues and conditions

“ME, chronic fatigue syndrome, PVFS, adrenal fatigue
acute and chronic pain, back pain, fibromyalgia, rheumatoid arthritis, migraine, injury
PMT, perimenopausal symptoms and menopause
clinical depression, bipolar disorder, anxiety and panic attacks, OCD and PTSD
low self-esteem, confidence issues
hay fever, asthma and allergies
candida, interstitial cystitis, urinary infections, bladder and bowel problems
IBS, coeliac disease, crohns disease, food intolerances and allergies
blood pressure, cardiac arrhythmia, type 2 diabetes, restless leg syndrome, hyper / hypo thyroidism
insomnia and sleep disorders
autistic spectrum disorder, dyspraxia, ADHD
lymes disease, glandular fever, epstein barr virus
weight and food issues, anorexia and eating disorders
multiple sclerosis, cerebral palsy, parkinsonian tremor, motor neurone disease”

Timeline

Funding for the pilot had been secured by November, last year. £44,000 over three years (09/10, 10/11, 11/12) has been awarded by the Ashden Trust; £120,000 by the Linbury Trust.

An ethics committee decision is anticipated in August/September. The study is due to start in September.

Patient organisation positions

*AYME (Association of Young People with ME) has published no position statement, but in an article in the May 2010 edition of “LINK”, AYME describes the pilot as “an interesting piece of research”.

*Dr Esther Crawley is a Medical Consultant to AYME.

*Action for M.E. published this position statement on its Facebook Wall but not on its main website:

“Action for M.E. sees no reason to oppose this pilot study.

As was made clear when it was announced, the research at this stage is simply a pilot designed to see if it would be possible to set up a trial that can independently assess the Lightning process against specialised medical care.

It is a fact that many parents are already taking their children to LP practitioners and so there are urgent questions that need to be addressed in order to assure the safety of those children. Dr Crawley’s initiative aspires to find a way of answering some of those questions.”

*Sir Peter Spencer, CEO of Bristol based, Action for M.E., is a non-executive director of the Royal National Hospital for Rheumatic Diseases, Bath – Dr Esther Crawley’s employer.

ME Association: No position statement issued

The Young ME Sufferers Trust: No position statement issued

The 25% ME Group: No position statement issued

Invest in ME published a position statement in its March/April 2010 Newsletter:

Lightning Process – The Falsehood of Magical Medicine

“…Not only is this a waste of scarce resources but children aged 8-18 are to be used to perform this study. There are many stories of the damage this series of courses can do to patients – a business enterprise which is unregulated, has no valid research into the “theory” behind it which really warrants funding of it (certainly not in preference to the funding of biomedical research into ME) and for which anyone can seemingly attend a few courses and set up a business, with no medical training…

…If this training programme really needs research then why not start with adults who can give informed consent – and why not test it on a well known patient group with clear biomarkers such as diabetics or MS patients to see if these patients stop “doing” diabetes or MS after three days of training. Why are ME patients always the target for therapy businesses? If there is funding available for research into ME then why not direct it to biomedical research…”

Full statement here: http://www.investinme.org/IIME%20Newsletter%20Mar%2010.htm

Discussion:

There are a number of current threads on Lightning Process, in general, and this pilot study in particular on Phoenix Rising Forums:

April 2010 “Dr Frivoldi, MD” blog article by Cort Johnson

http://www.forums.aboutmecfs.org/blog.php?b=364

Article: An MD on the Lightning Process

http://www.forums.aboutmecfs.org/showthread.php?4687-Article-An-MD-on-the-Lightning-Process

Lightning Process to be Evaluated in Research Study on Children

http://www.forums.aboutmecfs.org/showthread.php?3538-Lightning-Process-to-be-Evaluated-in-Research-Study-on-Children

My son & i are giving the lightning process a go on this week

http://www.forums.aboutmecfs.org/showthread.php?3827-My-son-amp-i-are-giving-the-lightning-process-a-go-on-this-week

See also:

Action for M.E. 2007 article:

http://www.afme.org.uk/res/img/resources/IA%2059%20lightning%20process.pdf

The March 2007 edition of Action for M.E.’s magazine InterAction published this article:

InterAction 59 March 2007

LP: the light at the end of the tunnel or just another flash in the pan?

“The Lightning Process (LP) has attracted national press coverage but alongside the hype and talk of miraculous recovery, InterAction received reports of relapse and failure, and decided to find out more.”

References:

[1] Press Release, University of Bristol, 2 March 2010:
http://www.bristol.ac.uk/news/2010/6866.html
Media article: Chronic fatigue syndrome study Mineral Water Hospital

[2] ME Association position statement on Lightning Process, February 2007

[3] Action for M.E. article on Lightning Process, InterAction magazine, March 2007:
http://www.afme.org.uk/res/img/resources/IA%2059%20lightning%20process.pdf

[4] Patient Survey 2008, Action for M.E. and AYME:
http://www.afme.org.uk/res/img/resources/Survey%20Summary%20Report%202008.pdf

Patient Survey May 2010, ME Association:
http://www.meassociation.org.uk/images/stories/2010_survey_report_lo-res.pdf

[5] Minutes, Forward-ME meeting, House of Lords, 8 July 2009:
http://www.forward-me.org.uk/8th%20July%202009.htm

[6] MRC Guidelines Medical Research Involving Children (Nov 2004, revised Aug 2007):
http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002430

[7] Request for information under FOI and FOI Office responses:
FOI – Lightning Study Chapman 17.06.10

[8] Lightning Process website
http://www.lightningprocess.com/

[9] LP Doesn’t Work for ME: Personal accounts from LP “trainees”:
http://www.sayer.abel.co.uk/LP.html

Letter: Lightning process for ME didn’t work for me:
http://www.thisisnorthdevon.co.uk/news/Lightning-process-didn-t-work/article-613394-detail/article.html

Personal account of Lightning Process technique as applied to patient with ME:
http://www.forums.aboutmecfs.org/showthread.php?4687-Article-An-MD-on-the-Lightning-Process&p=77679&viewfull=1#post77679

Personal account of Lightning Process as applied to patients with ME and MS:
http://forums.randi.org/showpost.php?p=4293368&postcount=1

[10] Sample Lightning Process application form:
http://www.changeworksforyou.com/applicationform.htm

[11] ASA adjudication against “Withinspiration”, June 2010:
http://www.asa.org.uk/Complaints-and-ASA-action/Adjudications/2010/6/Withinspiration/TF_ADJ_48612.aspx

[12] Withinspiration “NHS and Lightning Process research collaboration”:
http://www.withinspiration.co.uk/lightning_process_NHS_research.php

[13] Radio 4 Case Notes: Dr Crawley on CFS clinic approach, November 2007
http://www.bbc.co.uk/radio4/science/casenotes_tr_20071106.shtml

[14] RNHRD Bath Chronic Fatigue Syndrome/ME Service for Children & Young People
http://www.rnhrd.nhs.uk/departments/chronic_fatigue_syndrome_children.htm

Summary ME Association Board of Trustees meetings 14, 15 June 2010

Summary of ME Association Board of Trustees meetings 14 and 15 June 2010

Shortlink: http://wp.me/p5foE-2Ua

ME Association | 17 June 2010

This is a summary of key points to emerge from two meetings of The ME Association Board of Trustees.

These meetings took place at our Head Office in Buckingham on Monday afternoon, June 14th and on Tuesday morning, June 15th 2010.

This is a summary of the Board meetings – not the official minutes.

The order of subjects below is not necessarily in the order that they were discussed.

MEA website: http://www.meassociation.org.uk

PRESENT

Trustees:

Ewan Dale (ED) – Honorary Treasurer
Mark Douglas (MD)
Neil Riley (NR) – Chairman
Charles Shepherd (CS) – Honorary Medical Adviser
Barbara Stafford (BS) – Vice Chairman

MEA Officials:

Gill Briody (GB) – Company Secretary
Tony Britton (TB) – Publicity Manager

Apologies:

Rick Osman (RO)
Janet Thomas (JT)

FINANCES, ADMINISTRATION, PREMISES AND STAFF

ED updated trustees on the current financial situation. This was followed by a discussion on the monthly management accounts for the period up to the end of April 2010. There has been a drop in some areas of income during the past few months when compared to the same period in 2009 – unrestricted donations and bank interest in particular. As a result, general expenditure is currently running slightly ahead of unrestricted income.

However, income from fundraising has shown a significant and welcome increase over the same period in 2009 and in order to cope with the increased demand on fundraising support services it was decided to create a new part-time post to deal with fundraising administration with immediate effect. Details about this new post will be placed on the MEA website when trustees have agreed the job description.

There has also been a significant increase over the past twelve months in the ring fenced funding held by the Ramsay Research Fund for research purposes.

Trustees once again reviewed the current ‘best buys’ for interest-gaining options in relation to money kept in the business and Ramsay Research Fund deposit accounts.

The new computer equipment for Head Office staff is now fully installed and working in a satisfactory manner. GB reported that a few minor problems have still to be resolved.

Trustees discussed some possible changes to The MEA Memorandum and Articles of Association to take account of expected new charity legislation.

Trustees passed on best wishes to Lucy Kingham, at Head Office, who will be taking maternity leave in October.

FORWARD PLANNING

Trustees held a further discussion on the future growth of the MEA. This work includes looking at areas of priority for expansion of the services we already provide and new services that we would like to provide if/when the financial situation allows us to do so. Continue reading “Summary ME Association Board of Trustees meetings 14, 15 June 2010” →

Final Call for Action by UK patient organizations

Second DSM-5 public comment period closes 15 June

Is this a US specific issue?

What is being proposed?

Where can I find the full criteria for “CSSD”, “PFAMC” and other proposed categories?

Which patient groups might be hurt by these proposals?

Who should submit comment on these proposals?

Where can I read last year’s submissions?

How to comment:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this: