Issues not considered in the ‘Edinburgh Consensus’

As an NHS doctor I was recently made aware of the “Edinburgh Consensus“. In this post I wish to explore issues that were not considered in the “Edinburgh Consensus”.

The Edinburgh Consensus made it clear that ethical considerations were “not applicable” :

The Nuffield Council on Bioethics may argue otherwise:

 

 

The “Edinburgh Consensus” was made up of experts in neurodegenerative disease. Not included were other academics involved in dementia research and prevention, such as Marcus Richie and Carol Brayne, who stated in a BMJ editorial that “In it’s most common late onset form, the term [Alzheimer’s disease] is unlikely to refer to a discrete neurological entity”:

Scotland has an important place in the study of brain ageing which has revealed astonishing complexity rather than simplicity:

 

 

One of the leading experts on neurodegeneration has confirmed research findings which have been left out of the “Edinburgh Consensus”:

 

 

Jesse Ballenger makes this cogent argument in his book “Self, Senility, and Alzheimer’s Disease in Modern America: A history”:

 

In 2014, Alzheimer Scotland supported the launch of the “Glasgow Declaration” which enshrined human rights to dementia assessment and care. This was an acknowledgement that individual rights and patient-centred care must come first, and like many I was delighted to support this:

 

The “Glasgow Declaration” has  been signed by 153 policy makers (including 84 MEPs) from 25 European countries along with 205 separate organisations:

 

I want to be very clear that I support research into dementia and into at-risk states for dementia. I also passionately support research into prevention. My concerns about the “Edinburgh Consensus” are related to scientific process which requires breadth of consideration and ethics. I share Dr Margaret McCartney’s concerns that Industry may be back again in the driving seat:

It is wonderful that Scotland is at the forefront of research into the prevention of dementia. It is vital however that we have full transparency of financial interests as research has shown that this can lead to the loss of scientific objectivity and result in harm:

I have long been concerned that we do not have sufficient transparency relating to potential financial competing interests. This does not just relate to the pharmaceutical industry: it relates to all commercial enterprises, such as imaging companies, service providers, device makers etc:

 

 

Professor Craig Ritchie who, alongside Serge Van der Geyten of Janssen Pharmaceutica, shares the Project Management of EPAD (European Prevention of Alzheimer’s Dementia Consortium) confirmed recently “the operationalisation of the Edinburgh Consensus which is on-going with NHS England and NHS Scotland.” EPAD has had full support of Alzheimer Scotland.

Dr Margaret McCartney in her book “The Patient Paradox” raised a difficult issue:


Scotland’s Chief Medical Officer, Professor Catherine Calderwood has launched this initiative, which I very much support:

 

This is also in accordance with the BMJ’s “Too much medicine campaign”. This is a recent response which expresses the potential for harm:

A fundamental concern that I have with the “Edinburgh Consensus” is its determination to re-designate all “at risk states” of dementia to “prodromal dementia” or “preclinical dementia” effectively stating that all cognitive impairment progresses to dementia. This does not match real world epidemiology.

The “Edinburgh Consensus” appears to be confusing prevention with early diagnosis. The “Edinburgh Consensus” wishes the  NHS to prepare to diagnose Alzheimer’s disease before dementia has developed. Yet research has established that of those aged 83 years at death, 1 in 2 had the post-mortem pathology of Alzheimer’s disease yet in life had no cognitive impairment whatsoever.

Whether deployed in the research or clinical setting it is vital that the issue of consent is given very careful consideration. The current lay understanding is that Alzheimer’s disease = dementia and the “Edinburgh Consensus” has not outlined how this important issue will be explained to patients, research recruits and the general public.

In NHS Scotland we have a recent example of what can go wrong if consent is not fully informed [the following statement was made recently in the Scottish Parliament by the Chief Medical Officer regarding the inquiry into polypropylene mesh implant devices]:

I have written a perspective relating to what I believe have been the harmful consequences of an incentivised target-based approach to the early diagnosis of dementia. A decade on and we are finding this across Scotland:

 

I passionately support research into the prevention of dementia. However I am of the view that by reclassifying all at-risk states as “prodromal dementia” or “preclinical dementia” we may cause great harm,  most significantly in the potential for a high rate of wrongful diagnoses of dementia. Furthermore, services which are already stretched beyond coping risk collapsing. This is what has been termed:

In conclusion:

For Scotland to take a leading role in dementia research it is important that any consensus includes not just the essential contribution of experts in neurodegeneration but also the equally necessary contributions of ethicists, epidemiologists, public health experts, clinicians, and, most importantly of all, potential patients themselves.