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Review of the Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk
By Chris Douglas
27 August 2010
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.
3. Service Provision Model
5. Conflicts of Interest
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?
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.
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.
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
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.
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):
– management structure
– 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
• 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.
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;
– 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
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.
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’
Chris Douglas is an ME sufferer and ex-corporate project manager.
© Chris Douglas 2010