My full reality: the interim delivery plan on ME/CFS was published by the Department of Health and Social Care (DHSC) on 9 August 2023. Consultation on the plan is now open to UK residents aged 13 and over, and will close on 4 October 2023.
The document was developed around three key themes: research, attitudes and education, and living with ME/CFS.
Within each of the themes, the report summarises issues and makes recommendations for improvements. ME Research UK’s response to the plan focuses on the research aspects.
While this plan provides a much-needed review of the global funding landscape for research into ME/CFS, it falls short in a number of areas, most significantly:
- The plan adds little new. The central issues facing biomedical research into ME/CFS are already well known, and have been for decades.
- There is no commitment to ring-fence dedicated funding for ME/CFS research, to reflect the disease’s prevalence and severity.
- There are no strategies to keep established researchers in the field and to help them build capacity, or to encourage early career researchers to specialise in ME/CFS research.
ME Research UK will continue to push for a commitment to more research funding when we respond to the interim delivery plan as part of the consultation process.
Aims of the interim delivery plan
The interim delivery plan has the distinct advantage of its remit spanning numerous government departments, including the Department of Works and Pension, the DHSC and, crucially, central funders of research – the NIHR and MRC – whose constructive involvement will be needed if the draft plan’s aim to improve the lives of those with ME/CFS is to be realised. The cross-departmental approach has the potential to improve the lives of all affected by ME/CFS, be it in education or healthcare settings, and in changing attitudes.
In the ministerial foreword, Helen Whately, Minister of State for Social Care, states that:
“With the right advice, care and adaptations provided by the NHS, social care, education, the welfare system and employers, I am confident that people with ME/CFS can be supported to manage their symptoms as effectively as possible, contribute more to our society and maximise their quality of life.”
While this may appear to be an aspirational quote, it places the emphasis on the need for people with ME/CFS to improve and contribute to society, whilst missing a hugely important opportunity to invest in high-quality biomedical research which aims to identify causes, alleviate symptoms, and eventually find a cure for ME/CFS.
Identifying the problems
The draft Plan lays out ‘Problem statements’ on research:
- There is low capacity and capability among the research community to respond to research needs in this area.
- Historically, there has been low awareness of the need and scope for research into ME/CFS across the health and care research landscape.
- There has been a relatively low amount of biomedical research funded on ME/CFS, compared with disease burden.
- There remains a lack of trust between different stakeholders, including a perception of bias, expressed by patient and carer groups, about prioritisation and the peer-review process when applied to ME/CFS research.
On a positive note, the draft plan reiterates the Government’s intention to increase and improve research into the disease and to “continue to support researchers to better understand ME/CFS”.
Priority is to be given to work understanding the disease process and into treatments. As part of the interim delivery plan, the UK Clinical Research Collaboration has established a two-year Research Working Group into ME/CFS. This group is tasked with providing evidence and insight for long-term action with a plan for “future actions and a sustainable legacy”.
Six rapid actions have been identified:
- The DHSC will support the Research Strategy subgroup to hold workshops with funders, academics, and people with ME/CFS on how to develop research questions to respond to the Priority Setting Partnership (PSP) Top Ten Plus priorities and initiate new clinical studies. This will help increase research funded in this area by bringing new and existing researchers to the field to discuss feasible, clear, and meaningful research applications.
- The DHSC will work with research funders to commission a landscaping review of national and international work underway in ME/CFS, map PSP research priorities against these and establish evidence gaps. This will enable researchers to target proposals at identified gaps and funders to consider which are most needed.
- The Medical Research Council (MRC) and the National Institute for Health and Care Research will raise awareness of research funding opportunities for researchers and highlight the PSP Top Ten Plus ME/CFS research priorities publicly and with decision making bodies. This will provide further guidance to researchers, including those new to the field, as to how to find and apply for funding in a competitive process. Raising awareness of the PSP Top Ten Plus will emphasise the value of those priorities to researchers, those involved in funding decisions, patients, and the public to enable high-quality applications to be prioritised for funding.
- As part of the Research Working Group, a charity and patient group collaboration will support funders to raise awareness of mechanisms for effective patient and public involvement and engagement (PPIE) in research, ensuring diversity across protected characteristics, geographical areas and severity and duration of disease. This will increase the co-production of research, ensure proposals are informed by personal experience, targeted to patient need, and increase competitiveness of proposals for funding.
- The DHSC will support the Research Working Group to develop case studies of research which show good practice, including effective PPIE. This will show exemplars to researchers and funders to improve the research application and review process.
- The DHSC will support the Research Working Group to engage with the initiatives to educate clinicians/practitioners about ME/CFS (for example, the Health Education England e-learning module to be developed on ME/CFS). This will ensure that researchers, researcher clinicians, and research funders are supported to engage with new educational resources on ME/CFS.
The information gleaned from the process has already begun to be implemented in that UKRI issued an updated Highlight Notice on ME/CFS in May 2023 (updated July 2023). This Notice narrates the work of DecodeME, the James Lind Alliance Priority Setting Partnership, and the Working Group, with the MRC stating it would “particularly welcome proposals within MRC remit that address one or more of the research areas identified by the ME/CFS Priority Setting Partnership for ME/CFS research”.
The interim delivery plan also asks researchers to ensure that research proposals consider how to:
- increase capacity in ME/CFS research,
- address the need for multidisciplinary teams to tackle the significant research challenges in this area, and
- involve persons living with ME/CFS in developing ME/CFS research proposals.
Overall, the draft plan helps ensure that the views of people with ME/CFS are central to the development of research priorities and in the design and conduct of research. This covers diversity issues as well as ensuring that all levels of severity of ME/CFS are considered.
Limitations of the interim delivery plan regarding research
While the plan does highlight critical issues for biomedical research into ME/CFS, it actually adds little new in the recommendations made. The central issues facing biomedical research into ME/CFS identified by the plan are actually well known, and have been for decades.
These issues were narrated in the ‘Inquiry into the status of CFS/M.E. and research into causes and treatment’ – the 2006 Gibson report – which cast a critical eye on progress made to that point in implementing the research recommendations of the 2002 ‘Report of the CFS/ME Working Group’ to the Chief Medical Officer.
The late Dr Gibson’s Report, like the current interim delivery plan process, received evidence in the form of documents, letters and oral submissions from major researchers in the field and from people with ME. It concluded that the UK “must invest massively in research into biomedical models of this illness”. It continues:
“This group believes that the MRC should be more open-minded in their evaluation of proposals for biomedical research into CFS/ME and that, in order to overcome the perception of bias in their decisions, they should assign at least an equivalent amount of funding (£11 million) [equating to over £26 million in 2023 pricing] to biomedical research as they have done to psychosocial research. It can no longer be left in a state of flux and these patients or potential patients should expect a resolution of the problems which only an intense research programme can help resolve. It is an illness whose time has certainly come.”
The above quote from the Gibson Report appeared under the heading of ‘The Immediate Future’. Seventeen years later and research into ME/CFS remains underfunded in terms of disease severity and prevalence.
A lack of central research funding
The six rapid actions identified are supporting and facilitating rather than commitments, and are to be delivered by others.
What is to be regretted, given the crucial role of government funders of research, is why there is no obvious or indeed oblique comment on how the (in)actions of central funders may have contributed to the problems being faced. There has after all been a Highlight Notice for ME/CFS since 2003 and the disease has been, according to the MRC “a high priority for MRC for several years”. Yet 20 years on …
Looking at the four problem statements identified, how many are caused by the lack of funding? How many researchers have chosen not to study ME/CFS due to the paucity of funding opportunities offered, or have abandoned their research after failing to achieve MRC backing?
It will also be noted that the Gibson Inquiry Report highlighted the role of the MRC and recommended specific actions, whereas the draft Plan, as well as the Government, lays the ‘blame’ firmly in the hands of researchers.
The interim delivery plan states that one of the reasons that there is a paucity of research into ME/CFS is that “there is low capacity and capability among the research community to respond to research needs in this area.” While there is undoubtedly a lack of awareness of ME/CFS amongst researchers – as there is across all sectors – the capability to conduct research into the disease is there; what is not there is dedicated funding to carry out high-quality biomedical research into ME/CFS and to encourage researchers into the field. This has undoubtedly led to issues with capacity.
However, the plan sets out no strategies to keep established researchers in the field, and to help them build capacity through multidisciplinary collaboration, and no dedicated funding to encourage early career researchers to specialise in ME/CFS research (such as PhD studentships or postdoctoral fellowships which, incidentally, ME Research UK provides). In addition, the 2022 APPG report on ME stated that there is a need to establish “centres for ME excellence”. The interim delivery plan makes no mention of these centres, or the process through which they would be founded or funded. For example, would it be down to the researchers to apply for centre for excellence status, such as the MRC Centres of Research Excellence (MRC CoRE) programme, or would the centres be established by the DHSC themselves. In fact, some of the issues identified are to be solved by researchers themselves according to the Highlight Notice.
The historic chronic underfunding of ME/CFS research is well documented. The 2016 ÜberResearch report stated that ME/CFS research represented approximately 0.02% of all active awards given by mainstream funding agencies – including the MRC and Wellcome Trust. There is also an ongoing disparity in funding received between other illnesses. The ÜberResearch report stated that, although 250,000 people were estimated to have ME/CFS in the UK, Multiple Sclerosis (MS), which affects about 100,000 people, had received 20 times the funding.
While prevalence is only one aspect of a disease that affects the level of research funding, research also indicates that people with ME/CFS experience higher levels of functional impairment and lower levels of wellbeing, compared with conditions including depression, cancer and rheumatoid arthritis (RA). Despite this, the research spend per patient for ME/CFS between 2006 and 2015 was just £40 compared with £320 for those with RA and £800 for those with MS.
The 2016 ÜberResearch report also showed that research spend into psychosocial ME/CFS projects dwarfed that invested by the MRC into biomedical research. Even without research spending being increased to reflect historic underfunding, biomedical ME/CFS research has been an egregiously neglected and underfunded area. In fact, in 2022, the All-Party Parliamentary Group on ME called for Government research bodies to ensure that there is a parity of biomedical research funding between ME and other serious long-term conditions in its report, “Rethinking ME”. This call has not been taken up in the draft plan. The Gibson Inquiry report had called for this parity almost 2 decades before.
In addition, the level of funding into ME/CFS does not reflect the economic burden of the disease, and the interim delivery plan underestimates this burden. In the background of the plan, it is stated that “The 20/20 Health ‘Counting the cost’ report estimated that a weighted minimum cost to the UK of ME/CFS is £3.3 billion, using a cautious assumption of 0.4% prevalence.” This estimate is based on studies calculating costs for April 2014 to March 2015, estimates which are outdated by approximately eight years.
Although there are no more recent prevalence estimates of ME/CFS in the UK, it is clear that following the onset of COVID-19, the prevalence of ME/CFS is expected to increase. For example, on 21 April 2023, a hearing before the German Parliament’s Health Committee summarised that that around 1 to 2 percent of all people infected with SARS-CoV-2 (up to 20 percent of all long-COVID sufferers) will meet diagnostic criteria for ME/CFS after six months. It must therefore be assumed that the number of people affected by ME/CFS will almost double worldwide – in figures, this would correspond to 10 million new cases. In addition, evidence from the USA reports that before the onset of the COVID-19 pandemic, 1.5 million Americans were estimated to be affected by ME/CFS – costing the US economy an estimated $36 to 51 billion annually from 2020. The authors of this study estimated that due to COVID, the total ME/CFS prevalence numbers could rise to between 5 and 9 million and cost the US economy between $149 to 362 billion annually. If the minimum cost to the UK economy was £3.3 billion prior to the onset of the COVID-19 pandemic, it must be acknowledged that this will have dramatically increased, and any research strategies and funding allocated to biomedical research into ME/CFS must surely reflect this. Yet the plan is silent.
The priorities highlighted by the PSP process are highly commendable and cover areas of the utmost concern and, with the central involvement of people with ME, they must be the basis of research consideration. However, they will require to evolve into tractable research questions and this requires the input of researchers.
Further, the draft delivery plan process has not yet drawn on the opinions and experiences of the whole research realm, and must reach outwards to achieve its goals. It is to be hoped that cognisance is taken of a similar process being undertaken by the US’s NIH who have launched a NANDSC ME/CFS Research Roadmap Working Group whose members include a number of those involved in the draft delivery plan’s research subgroup. This group is more focused and specifically charged to “Assess current ME/CFS research activities and identify opportunities and gaps in ME/CFS research to identify targets for the development of treatments”.
Summary
Currently, the research elements of the interim delivery plan show a welcome level of commitment within the government to lay the foundations to advance research within the parameters it has already set even before the process began. However, the focus is actually on moulding researchers’ applications into a form and with content which the MRC direct they require to reach their standard for success. And it is for the research community to solve the issues which have grown over decades rather than even hinting at the role of the MRC in the past.
Unless there is a funding commitment, little may change in reality. The draft plan follows the narrative which directs that failures in ME/CFS research are due largely to researchers themselves.
What is urgently needed is reassurance that funds will be available to transform the research landscape, ensuring that biomedical research receives the same level of consideration as other research areas. And in order to increase capacity, there must be dedicated funding schemes, not only to retain highly regarded senior academics, but also to attract new and skilled researchers to the field of ME/CFS research.
This is the glaring omission in this interim delivery plan, and ME Research UK will continue to push for a commitment to more research funding when we respond as part of the consultation process.
