An open AGM and some questions for Action for M.E. (Lightning Process)

An open AGM and some questions for Action for M.E. (Lightning Process)

Shortlink: http://wp.me/p5foE-36C

On Page 4 of the Autumn issue of Action for M.E.’s InterAction magazine, CEO, Sir Peter Spencer, announces changes to the way in which the organisation operates.

Sir Peter writes, “In another significant change, inspired by your Board wishing to create greater transparency and demonstrate their accountability, our Trustees have voted to invite members to attend Action for M.E.’s annual general meeting (AGM). The first opportunity is Thursday 21 October in London and an application form for attendance is enclosed with this magazine.

“Additionally, the Board will be introducing procedures that will give all our Supporting Members voting rights regarding the appointment of Trustees and the Chair from 2011.”

How this change of policy will operate in practice remains to be seen but I would like to thank those who have lobbied long and hard for years for the right to attend AGMs, for voting rights and the right to participate in what I hope will be a democratic trustee election process.

I maintain a membership of Action for M.E. not because I support their policies or the way in which they operate but because, as a site owner, I need to know what the organisation is involving itself in and with whom, and what its policies and positions are.

There is to be a question and answer session with the board members (the Trustees/Directors) at the AGM.

Were I to attend this first open AGM, scheduled for October, I would want to raise the following:

There has been considerable public and patient group opposition to the Lightning Process pilot study for children aged 8 to 18 proposed by the Royal National Hospital for Rheumatic Diseases NHS Foundation Trust, Bath (the “Min”) and the University of Bristol.

This pilot study, led by Dr Esther Crawley, with funding from the Linbury Trust and the Ashden Trust, is still pending approval by a South West Region Research Ethics Committee.

The application was submitted on 14 June. The REC meeting to consider the application took place on 8 July.

Although funding for the study had been secured last November and a press release published in early March, at 6 September, the study is said to be “still at the final stage of the ethics procedure”.

The ME Association and the Young ME Sufferers Trust issued a joint press release on 4 August, describing the proposed study as “unethical” and calling for it to be abandoned.

To date, no rigorous controlled trials have been undertaken using an adult patient cohort into the safety, acceptability, long and short-term effects of the application of the Lightning Process.

No rationale has been provided by the research team for piloting first with children and there has been virtually no information made available about the study design, objectives, interventions, criteria, recruitment process etc, for public scrutiny.

At the end of March, in response to a request for a position statement, Action for M.E. said it saw “no reason to oppose this pilot study.”

On 24 August, in response to a request that Action for M.E. set out what information it had used to inform its position on whether to support this study and what its understanding is of what the children in this proposed study would be exposed to, Sir Peter wrote:

“…Action for M.E. has not seen the research protocol for this proposal and has no detailed knowledge of the way in which this trial would be conducted if approved.”

They don’t know. They’ve bought into a pig in a poke.

Four days earlier, Action for M.E. had issued a second position statement in which the organisation wrote:

“As long as the ethics committee gives its approval, the charity supports proposals to investigate whether it is possible to set up a controlled trial to look at the Lightning Process and how it compares with current treatments for M.E./CFS in children.”

But how much does this South West Region REC actually know about the Lightning Process?

What information have the researchers placed before this committee?

With no robust data from RCTs into the application of Lightning Process in adults, how is the research team and the Research Ethics Committee considering this application in a position to determine that overall the likely benefits of this proposal outweigh any risks to child participants or that undergoing the training program would not be detrimental to their health and psychological well-being, as patients with ME and CFS?

So I should want to ask how Action for M.E. justifies sidestepping responsibility for safeguarding children as young as eight under these circumstances?

I’d also raise the following:

On Page 14 of this Autumn edition of InterAction, is a quarter page advertisement for the Phil Parker Lightning Process at the “Swallows Retreat”, in Henfield.

On Page 32, a quarter page ad for the “Rowan Centre” who until recently had been claiming on their website:

“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”

Their advertisement reads “We offer a training programme with on-going support to help people improve their symptoms. The teaching is based on neuroscience and cell biology and shows you how to affect your immune system using techniques derived from NLP processes, brain rehearsal and brief meditation techniques.”

On Page 22, a half page ad for The Lightning Process with Alastair Gibson.

In June, Mr Gibson’s “Withinspiration” Lightning Process company had been subject to an Advertising Standards Authority adjudication following a complaint about unsubstantiated claims [1].

In March, Mr Gibson (who in September will be offering Lightning Process sessions in Bristol) had identified himself on his website as “…one of the two practitioners working with the NHS and the young people in this exciting research study”.

I am sure there will be many questions raised at this Action for M.E. open AGM next month.

I append a copy of the article “New benefits for our members” by Sir Peter Spencer.

 References

[1] ASA adjudication against “Withinspiration”, June 2010

[2] Background to this Lightning Process pilot issue

———————–

InterAction 73 Autumn 2010

New benefits for our members

Action for M.E. is transforming how it operates so that we can reach more people with M.E. and work more effectively on your behalf. Sir Peter Spencer explains.

We really do appreciate the expertise that people with M.E. share with us. Over the past three years we have greatly increased our efforts to consult so that we can better represent your views on a wide range of important matters. However, Action for M.E. can still do more to empower members to become an even stronger collective catalyst for change.

Today, the most efficient and cost-effective way of reaching more people with M.E. is through the internet. That’s why we are creating an entirely new website, the Online M.E. Centre.

As well as multi-media communication channels, new members-only forums will be available as safe havens, where people with M.E. can reach others who understand exactly what they’re going through. We know that 50% of people with M.E. are not in contact with anyone else with the illness. We have ample evidence that putting people in touch can really help them face and share the distressing problems of isolation caused by loss of social contact and not being understood by family and friends.

Membership

From September this year, anyone renewing or joining Action for M.E. for the first time will be able to choose the features and benefits they want from their membership package. You can join or renew online, by telephone or by post.

There will also be greater flexibility by giving members a personal choice about how much they feel able to contribute through their membership donation, either by a monthly direct debit or on an annual or lifelong basis. Exceptionally, those facing extreme financial hardship may be eligible for a payment waiver. The sustainability of our new membership arrangements will be made possible through the generosity of those more fortunate who are willing to give more to enable the most vulnerable to remain part of our movement; an essential point that I want to re-emphasise.

We greatly value you as members mainly for your presence and for contributing your expertise and moral support. You are much more than a vital source of revenue. The higher our numbers grow, the stronger our voice and the greater our credibility and authority in lobbying the Government for action.

Some of our supporters do not have M.E. themselves. Many of these provide extremely generous financial donations and free expertise because they care so much about those who have the illness. We need much larger numbers of all types of member and, because all members are essentially supporting our charity, we’ve adopted the term ‘Supporting Member’ to describe all categories of personal membership. Professional membership for individuals and organisations will also be available, allowing better access to relevant information about how to support people with M.E.

AGM and trustees

In another significant change, inspired by your Board wishing to create greater transparency and demonstrate their accountability, our Trustees have voted to invite members to attend Action for M.E.’s annual general meeting (AGM). The first opportunity is Thursday 21 October in London and an application form for attendance is enclosed with this magazine.

Additionally, the Board will be introducing procedures that will give all our Supporting Members voting rights regarding the appointment of Trustees and the Chair from 2011.

This is a crucial and exciting year for Action for M.E. I hope you agree that the developments I’ve described will ensure that we continue to meet your high expectations.

I know that many people with M.E. do not use the internet. So want to reassure you: Action for M.E. will of course continue to provide printed information through InterAction and our information booklets. We will also be providing enhanced telephone support line services from October.

Source: InterAction 73 Autumn 2010 http://www.afme.org.uk

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?

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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.

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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

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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.

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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

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• 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;

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– 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

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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

© Chris Douglas 2010

ME Association now registered as “ME Society”

ME Association now registered as “The ME Society”

In February, this year, I sought clarification from the ME Association Board of Trustees around their recent use of the wording “Welcome to The ME Association, sometimes known as The ME Society.” on their website and “Also known as The ME Society…” on their ME Association on MySpace site.

I note, today, that the wording on the Home Page of the ME Association’s website has been changed yet again and now reads:

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

“Welcome to The ME Association, also registered as The ME Society.”

 

Charity Commission website entry at 21 September 2009:

http://www.charity-commission.gov.uk/ShowCharity/RegisterOfCharities/CharityFramework.aspx?RegisteredCharityNumber=801279&SubsidiaryNumber=0

801279 –
THE MYALGIC ENCEPHALOPATHY ASSOCIATION LIMITED

Other names
MYALGIC ENCEPHALOMYELITIS ASSOCIATION (Old Name )
THE MYALGIC ENCEPHALOMYELITIS ASSOCIATION (Old Name )
THE MYALGIC ENCEPHALOPATHY ASSOCIATION (Old Name )
THE ME SOCIETY (Working Name )
THE ME ASSOCIATION (Working Name )

—————-

I am not aware of any announcement having been made by the ME Association about the formal adoption of this organisation working name nor the rationale behind it.  There would not appear to be any reference in the summaries of the Association’s board meetings to any decision being taken to register “The ME Society” as a Working Name with the Charity Commission or to the ratification of a decision taken between board meetings.

Once again, this appears to be an issue that the Board did not want (or did not consider) it needed to be transparent about. But ME Association members have a right to be informed about such changes and the rationale behind them and some of them might also have expected to have been consulted.