I thought that it might be helpful to share a timeline of communications between myself and researchers in dementia in Scotland. The timeline stretches back almost two years. I want to thank all of those who have kindly engaged with me, particularly Dr Tom Russ, Professor John Starr and Professor Craig Ritchie.
4 May 2016
NHS Consultants were written to about Dementia Research in Scotland. I wrote to Professor Craig Ritchie asking if we might meet up. Unfortunately this meeting did not transpire.
“My questions would be around issues such as definitions, ethics, transparency and so forth.”
15 May 2016
I wrote to Professor Craig Ritchie, Professor John Starr and Professor Peter Connelly:
“I was wondering if all those involved in dementia research might consider declaring any financial interests on the SDCRN or EPAD website. Alternatively, doctors can declare on this voluntary site: Who pays this doctor“
15 May 2016
I submitted a response to this Analysis in the BMJ. This paper was introduced with this statement:
“Providing information to enable informed choices about healthcare sounds immediately appealing to most of us. But Minna Johansson and colleagues argue that preventive medicine and expanding disease definitions have changed the ethical premises of informed choice and our good intentions may inadvertently advance overmedicalisation.”
Recruitment for dementia research – BMJ rapid-response by Dr Peter J Gordon (15th May 2016)
This analysis paper struck a chord with my recent experience regarding the recruitment drive for dementia research. There is a focus on this area, perhaps amongst other reasons influenced by International Dementia Summits and the intervention of our own Prime Minister .
Research into the pathologies of dementias is undoubtedly very important. As a professional involved in the care of those currently living with dementia, I also want to see research into ways of helping individuals to live well with dementia.
The authors’ identification of five areas of difficulty in “informed choice” has crystallised for me the issues that concern me about the recruitment process for dementia research.
The pathological basis of Alzheimer’s disease (considered as the leading cause of dementia and therefore the focus of most research) is far from certain and the worldwide research community is recognising this with a shift of focus towards understanding the risk factors involved in dementia. Judging from the contents of the information leaflets I have seen, researchers have found it difficult to convey this uncertainty and to clarify the difference between risk and disease to potential trial participants. The concern I have is that research looking at preventive strategies may be confused by participants as investigating cures for established disease.
There are also longstanding problems, across medicine, of research criteria being adopted in a clinical environment before their clinical utility has been established . Again my concern is that this is not being adequately communicated to potential trial participants. This also applies to the community of healthcare professionals who are being asked to support research.
The research and clinical communities need to work together to ensure that we take account of the above challenges and to direct our inevitably scarce resources proportionately.
27 May 2016
I shared the above BMJ submission with Professor John Starr, who replied:
“If an ethics committee is happy with such material, no individual is in any position to suggest that they are in some way better informed.”
3 December 2017
Professor Craig Ritchie wrote to NHS Consultants in Scotland, he began:
“We have a broad programme of research in EPAD to look at the impact of disclosure of risk status in people with preclinical or prodromal dementia (previously referred to as MCI).”
Professor Ritchie went on to say that this research work was to support “the operationalisation of the Edinburgh Consensus which is ongoing with NHS England and NHS Scotland.”
Professor Ritchie shared a recently published paper based upon the “Edinburgh Consensus” and went on to confirm that “We plan a full day meeting to follow up on the Edinburgh Consensus in Edinburgh on 26th June hosted by Alistair Burns, Martin Rossor and me. This will be a multi-stakeholder meeting supported also by RCPsych and ARUK, Alzheimer’s Scotland and Alzheimer’s Society”
12 December 2017
I wrote this personal perspective on the “Edinburgh consensus”
12 December 2017
I shared my perspective (above) with some of the authors of the “Edinburgh consensus” and asked two associated questions:
(1) My question is straightforward how do you diagnose preclinical and prodromal Alzheimer’s disease accurately? Otherwise the risk is that there will be a significant false positive rate
(2) Is the Glasgow Declaration redundant?
I also said:
(a) As to the Edinburgh Consensus many of those (but certainly not all) involved work/have worked extensively with the pharmaceutical industry. I note that the Consensus was not sponsored, but it appears to be a consensus of dementia specialists only. No ethicists. No epidemiologists. No sociologists. No medical humanities etc.
(b) Just to be clear I passionately support research into at-risk states of dementia but in my view I cannot honour the Hippocratic oath I took by diagnosing all “at-risk states” as Dementia.
12 December 2017
I received a kind reply from Dr Tom Russ:
“As you know, EPAD and many other dementia prevention initiatives are based around personalising dementia risk profiles to help an individual reduce their own risk – through lifestyle modification, medication, or anything else. The distinction between Alzheimer’s disease which develops in the brain decades before Alzheimer’s dementia has been becoming increasingly clear in recent years from a variety of sources of information – pathological, epidemiological, and from neuroimaging. I think the possibility of individuals being empowered to reduce their own risk is very exciting and fits in very well with Alzheimer Scotland’s model of citizenship.”
Dr Russ also confirmed: “You’ll have seen from the conflict of interest statements that no drug company was involved in any way with the Edinburgh Consensus.”
13 December 2017
I submitted a response to the BMJ after reading this published letter by Dr Mike Devine, NHS Psychiatrist for Older Adults in Barking and Deagenham:
I share Dr Devine’s professional approach to patient-centred diagnosis of dementia .
This approach was enshrined in the Glasgow Declaration of 2014, which has been signed by 153 policy makers (including 84 MEPs) from 25 European countries along with 205 separate organisations.
The same day that I was reading Dr Devine’s letter I was sent a communication about the “Edinburgh Consensus”. I was not aware of the Edinburgh Consensus until I received this communication which confirmed “the operationalisation of the Edinburgh Consensus which is on-going with NHS England and NHS Scotland.” I have practised in NHS Scotland for 25 years, I am a specialist in dementia, and I was born In Edinburgh.
The “Edinburgh Consensus” provides this context: “This commentary discusses the implications of disease-modifying treatments for Alzheimer’s disease which seem likely to appear in the next few years and results from a meeting of British experts in neurodegenerative diseases in Edinburgh. The availability of such treatments would help change public and professional attitudes and accelerate engagement with the prodromal and preclinical populations who might benefit from them. However, this would require an updated understanding of Alzheimer’s disease, namely the important distinction between Alzheimer’s disease and Alzheimer’s dementia”.
I worry about the potential for harm in conflating risk with disease, especially when understandings are still very much in development. The potential for over-medicalization and inverse care cannot be ignored.
Have we here further examples of divides? Between Glasgow, and its Declaration, and Edinburgh and its Consensus?
I fully support research into at-risk states for dementia. However I am concerned that this “consensus”, which has been approved by the Faculty of Old Age Psychiatry of the Royal College of Psychiatrists and the Association of British Neurologists, may not have sought to listen to any other voices than their own.
13 December 2017
I wrote to Professor Craig Ritchie and Dr Tom Russ:
“Please can you share all of the ICJME declarations for all of those involved in the Edinburgh Consensus”
15 December 2017
I gave the response (below) to the following blog: The Edinburgh Consensus: a useful opportunity for self-reflection
“I support research into at-risk states of dementia and am fully, totally, and completely behind prevention.
My understanding is that the “Edinburgh Consensus” is now being “operationalised” in NHS England and NHS Scotland. This worries me as the Edinburgh Consensus has determined that mild cognitive impairment should now be classified as “preclinical dementia” or “prodromal dementia”. Thus determining, over and above any individual consultation, that all cognitive impairment progresses to dementia. This does not match real world epidemiology.
Prof Clive Ballard stated in the Lancet “the paradigmatic brain pathology of Alzheimer’s disease – plaques and tangles – is only a post-mortem finding of limited explanatory value in the expression of dementia in the population.”
Yet the Edinburgh Consensus has determined that the NHS is now to diagnose Alzheimer’s disease. The Consensus does not explain how this can be done accurately in the clinical setting.
In Scotland we already have inverse care as a result of the incentivised target for the early diagnosis of dementia. Somewhere in the region of 50% of those diagnosed for dementia are on waiting lists for post-diagnostic support.
I fully support EPAD research (research into prevention) but in my opinion, with current state of knowledge, it could be most harmful to introduce research criteria into the clinical setting.
The knowledge of pathology is developing thanks to good folk like Prof Ritchie and this is revealing the most complex interaction between the person, our organic brain, and living through time. The pathologies remain poorly understood and seem to be far more complex than the 1907 starting point.
I really do not think that this “Alzheimerisation” is helping us live well. It is not realistic medicine. It simplifies, generates great fear, and marginalises what we have learned about the normal ageing brain. Most of the patients I see are in their 80s and have complexities of all sorts that would seem to indicate that neurodegeneration (as understood today) is not the whole story.
I realise that this comment will probably not go down well but I do worry about the influence of the pharmaceutical industry and commercial enterprises for imaging and neuropsychology. I am fully aware that there was no pharmaceutical sponsorship of the “Edinburgh Consensus”. However it is the case that a significant number of the authors have financial relationships with commercial enterprises who have an interest in this area.”
21 December 2017
I published this summary on Hole Ousia: Issues not considered in the ‘Edinburgh consensus’
22 December 2017
To Springer Nature’s Global Open Research Support Team
I would be grateful if you could send me copies of the full and original declarations for all the authors involved with: The Edinburgh Consensus: Preparing for the advent of disease modifying therapies for Alzheimer’s disease. I am concerned about potential inconsistencies. I am researching as part of evidence for A Sunshine Act for Scotland.
22 December 2017
From: Springer Nature’s Global Open Research Support Team
Thank you for submitting your query. A member of our Global Open Research Support team will be in touch as soon as possible to assist you (Case number 00772745).
27 December 2017
I published this summary on Hole Ousia: Industry is back in the driving seat
2 January 2018
Professor Craig Ritchie wrote to me and kindly said “Your summaries are excellent.”
6 January 2018
Having read an open letter sent to the BMJ by the CEO of the Association of the British Pharmaceutical Industry, I submitted a response which outlined some of the ethical and pragmatic issues that can arise in relation to partnerships with the commercial sector and healthcare, including research.
8 January 2018
The Royal College of Psychiatrists confirmed:
“There was no wider consultation of Faculty members on the Edinburgh Consensus. This was not considered necessary as the meeting was not to generate evidence-based guidelines, nor to develop RCPsych policy, nor to develop a College Report. There was no discussion with the wider College.”
The Royal College of Psychiatrists confirmed that the Glasgow Declaration “is an important Declaration but the focus of the statement [Edinburgh Consensus] was far narrower than the Declaration”
The Royal College of Psychiatrists confirmed that its ethical committee was “not consulted” on the Edinburgh Consensus
The Royal College of Psychiatrists confirmed, in reference to the Edinburgh Consensus: “We have no reason to doubt the accuracy or completeness of those declarations.”
9 January 2018
I reminded the Royal College of Psychiatrists of this statement published in a letter to the BMJ by Professor Alistair Burns and co authors, 21 March 2013:
“The issue of the terminology of early or timely diagnosis of dementia is important. Most people now agree that “timely” is a better way of describing what is trying to be achieved – it suggests a person centred approach, does not tie the diagnosis to any particular disease stage . . . “
10 January 2018
I received this from Professor Craig Ritchie:
“Over the weekend I noted that my ICJME form for the paper was not available. I have send this to the journal editor toady and would hope that this is will be attached soon for public review as I value greatly the chance for full disclosure of interests as a critical part of scientific collaboration. This was an oversight on my part – as you know I am usually incredibly diligent on these matters and on this occasion fell short of the high standard I set myself.”
12 January 2018
Professor Ritchie later sent this communication: “I will forward this e-mail to my co-authors for them to complete their ICJME declarations.”
13 January 2018
Pfizer has pulled out of all research into brain neurodegeneration. The reason given was that research has revealed astonishing complexity and a poorer correlation with “paradigmatic pathology” than ever previously considered.
16 January 2018
As neither the Royal College of Psychiatrists nor the National Clinical Director for Dementia and Older Peoples’ Mental Health, NHS England could advise me on this matter, I have written to these three organisations involved in governance seeking their advice: GMC, The Prescription Medicines Code of Practice Authority (PMCPA) and ABPI.
18 January 2018
The PMCPA and ABPI confirm that they can neither advise nor help as the ABPI code does not cover this issue.
20 January 2018
There has been no further responses from Springer Nature’s Global Open Research Support Team, since their acknowledgment of the 22 December last year (Case number 00772745).
Without the benefit of ICJME declarations the following has been put together from material in the public domain. Declarations of competing interests – the “Edinburgh Consensus”
23 January 2018
Professor Craig Ritchie kindly sent me all of the ICJME declarations. They can be accessed here.