‘Informed consent is a fundamental principle underlying all healthcare’

A recent Independent Review for NHS Scotland stated that: “Informed consent is a fundamental principle underlying all healthcare”

The Cabinet Secretary for Health and Sport, Shona Robison stated to the Scottish Parliament (17 March 2017): “Informed consent and shared decision making are expected prior to any procedure being carried out.”

On the 20th April 2017, I wrote to Healthcare Improvement Scotland 
about Patient consent in NHS Scotland:

I have just completed my annual Appraisal which is a General Medical Council requirement as part of 5 yearly Revalidation. As part of this I was informed by my Appraiser that I must comply with all the LearnPro modules which I have now done.

The following screenshot comes from the NHS Lothian mandatory LearnPro module on Capacity and Consent:

I apologise as the text is small, so I have reproduced verbatim what it states to me as an NHS Lothian employee:

“Consent is both a legal requirement and an ethical principle and requires to be obtained by healthcare professionals, prior to the start of any examination, treatment, therapy or episode of care.”

“In Scotland, everyone over the age of 16 is an adult. The law assumes that adults can make their own decisions and can sign legal documents, such as consent to medical treatment (in some circumstances this also can apply to children under the age of 16) provided they have the capacity. This means that they are able to understand what is involved in the proposed treatment, retain the information, be able to weigh up the information needed to make the decision and then communicate that decision. Treatment might be delivered in a hospital, clinic or in someone’s home.”

In years past I have written about consent for older adults in hospital in NHS Scotland:

Do we care enough about consent?

‘OPAC tools are working’

I am writing to Healthcare Improvement Scotland as I find myself confused.

Do I follow the mandatory requirements of my employers on consent? Or do I follow the National Improvement requirements of OPAC-HIS where consent is not required for assessments such as the 4AT assessment test? (formerly called “4AT screening tool”)

I know, from the re-drafted Care Standards, that Healthcare Improvement Scotland take consent very seriously.

I should state that I am writing in my own capacity and in my own time.

12 May 2017 - I sent this update to Healthcare Improvement Scotland:

Forgive me for this further correspondence but I felt that I should update you on the learning that I received as part of my attendance for Continuing Medical Education (CME) yesterday.

This CME event was for the Royal College of Psychiatrists in Scotland – Faculty of Old Age Psychiatry and was held in Falkirk.

At this event the Chair of Old Age Psychiatry for the Royal College of Psychiatry was giving a talk and when the time came for questions I asked about the wide use of haloperidol in older adults in hospitals in NHS Scotland. Dr Thompsell replied “evidence has found that Haloperidol actually worsens the outcome of delirium”.

Another lecturer at this meeting, who was giving a talk on her area of expertise: anti-psychotics and older adults, was Dr Suzanne Reeve. She replied: “Haloperidol does increase mortality in older people compared with other antipsychotics. That message has been out for a while but has not really got across.”

The next talk was entitled “Successes of Old Age Psychiatry Liaison team” and one of the slides shown had the headline “Compliance with 4AT”. The impressive “compliance” figures then followed. The dictionary definition of compliance is “the act of yielding”.

My concern here is for patient harm and indeed increased patient mortality. National Improvement work undertaken by HIS has been instrumental in increasing “compliance” with tools such as the 4AT and it is clear that no consent is deemed necessary. I have argued that this is not ethical as these tools are often the beginning of “pathways” and “protocols” that may result in the administration of haloperidol.

I am genuinely worried that National Improvement work undertaken by Healthcare Improvement Scotland has not properly considered ethics, available evidence and the potential for unforeseen consequences. You will understand that I am also nervous about writing this letter given the consequences for me when I first “spoke up” three years ago:

I would very much value your advice. I am not sure that I can work in a profession if it loses sight of Hippocrates and “first do no harm”.

This is the response from Healthcare Improvement Scotland,
dated 17th May 2017:

“Thank you for your letter of the 20th April and your letter of 12th May, in which you raise the interesting issue of taking consent in relation to cognitive screening.

I understand from staff involved in the inspections of older people’s care in hospital that taking of written consent prior to initial assessment for frailty is not routinely undertaken. Assessment at the point of admission, or where a change in a patient’s cognitive presentation is giving cause for concern, can alert staff to possible increased risk and enables planning of care for the patient. In these circumstances staff adopt a proportionate approach such as asking, for example, if they may ask some questions.

For absolute clarity though, as an employee of NHS Lothian, the requirements set out in the Board’s policies and mandatory training are those that you should follow.”

 

Submission on PE1517: Polypropylene Mesh Medical Devices

Submission on PE1517 on Polypropylene Mesh Medical Devices

Made by Dr Peter J Gordon

Date of submission: 17th May 2017
Submission made in a personal capacity.

The Agenda for the Public Petitions Committee meeting of the 18th May 2017 includes a most helpful summary “Note by the Clerk” on PE1517: Polypropylene Mesh Medical Devices (Document PPC/S5/17/10/1). Having read this carefully, and in accordance with the first suggested “Action” (point 45, page 8), I would like to offer evidence. Before doing so I have listed below the most relevant sections of PPC/S5/17/10/1 in relation to the points of evidence that I wish to make.

In Annexe B of PPC/S5/17/10/1 the Interim and Final Conclusions of the Independent Review are listed side-by-side.

Conclusion 1, both Interim and Final, was that “Robust clinical governance must surround treatment”

Conclusion 3, both Interim and Final, was that “Informed consent is a fundamental principle underlying all healthcare”

In  Annexe C: Parliamentary Action (page 21 of PPC/S5/17/10/1) the Cabinet Minister for Health, Shona Robison answered question S5W-07749 by Neil Findlay, MSP on the 17 March 2017, by stating:

“Informed consent and shared decision making are expected prior to any procedure being carried out. The Chief Medical Officer goes into this in more detail in her Realistic Medicine report.”

The Clerk, in point 7, (page 2 of PPC/S5/17/10/1) confirms that:

“The Scottish Government does not have the power to regulate what medical devices are licensed for use in the UK. The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medical devices in the UK”

The Clerk, in point 12 (page 3 of PPC/S5/17/10/1) includes quotations from the Preface of the Review’s Independent Report:

“We found some concerning features about how new techniques are introduced into routine practice”  and that

“We are aware that some of our conclusions have wider implications and see the need to embed this in patient Safety and Clinical Governance strands of the NHS”

Points of Evidence by Dr Peter J Gordon  (GMC number 3468861)

• HDL62:  the Scottish Government has acknowledged that this 
Guidance is not being followed by NHS Boards

• There have been media reports that NHS professionals working in 
Scotland, who are involved in educating NHS staff about Mesh
procedures, have been paid by commercial sectors who have 
financial interest in Mesh products. 

• PE1493, A Sunshine Act for Scotland, was closed in February 2016 

• A Public Consultation on PE1493 was undertaken by the Scottish 
Health Council. The Scottish  public, in majority, were of the view 
that it should be mandatory for  all financial payments made to 
healthcare workers and academics to be declared in a publically 
accessible form 

• No meaningful update has been provided by the Scottish Government 
since this Public Consultation was published more than a year ago.

• I  fully support the Chief Medical Officer’s “Realistic Medicine” 
initiative and I have suggested that Sunshine legislation should be 
considered an essential part of this development  

• I agree with the Independent Review that “robust clinical 
governance must surround treatment”. I am concerned that if the 
current situation continues, where “education” of health 
professionals may be significantly based on marketing, further 
examples of iatrogenic harm may occur in NHS Scotland.

• The Independent Review concluded that “informed consent is a 
fundamental principle underlying all healthcare”. If the advice 
given to patients is based on marketing, either partially or wholly, 
then informed consent may be denied patients. Further examples of 
Iatrogenic harm may then  unfortunately occur and healthcare 
in Scotland may risk being considered as  unrealistic 
rather than “realistic”.

 

Update, 22 May 2017:

Public Petitions Committee – Scottish Parliament: 18 May 2017 (click on image below to watch the full meeting)

The official report of the Public Petitions Committee of 18 May 2017

Sunday Post, 21 May 2017: ‘Probe to examine possible conflicts of interest in troubled mesh implant inquiry’

Submission on PE01651: Prescribed drug dependence and withdrawal

As an NHS Psychiatrist who has worked in Scotland as a Consultant for over 15 years I want to offer my full support for this petition.

Recently at a Cross Party Group meeting held at the Scottish Parliament it was stated that “depression is under-recognised across all age groups” and that “maintenance treatment has a good risk-benefit ratio.” This was said without acknowledging that these statements cannot be made with absolute certainty.

I have found that my profession in Scotland seems to resist evidence of experience and at the same time prioritise the opinions of experts.

Potential for Expert Bias (one):
There is evidence that establishes that senior Scottish psychiatrists, who have provided expert input to Scottish Government strategies, and who have been involved in developing National prescribing guidelines, have had significant financially-based vested interests.

Potential for Expert Bias (two):
It is worth perhaps pointing out that Scottish Psychiatry has been traditionally orientated around biological determinants of mental health. Like myself, many academics have concluded that Scottish psychiatry lacks real-world, pluralistic breadth to the science of the mind and brain. Across the border, in England and Wales, the approach is far less reductionist. This includes the involvement of experts whose interests are not solely focussed on the bio-medical determinants of mental health.

I do prescribe psychiatric medications including antidepressants but I do not agree with the ‘experts’ that prescribing in Scotland is “conservative”. 1 in 7 Scots are now taking antidepressants.

Appropriate and informed prescribing is what we seek where there is open discussion about the potential benefits and potential harms of such treatments. This and an honest consideration that for many medications we cannot be certain of long-term effects.

                      Dr Peter J Gordon
                      GMC number 3468861

May it be granted the older you are

On the 26th of April 2016 I attended the Cross Party Group on Mental Health and Older People, Age and Ageing, held at the Scottish Parliament. The following is an  account of my experience of this meeting and some reflections on conversations that have followed it.

At the end of this post are included two papers that were submitted ahead of the Cross Party meeting: a paper by me entitled “May it be granted the older you are” and a paper by Mr Hunter Watson entitled “Psychoactive Medications”.

I have been to quite a number of Scottish Parliamentary Committee meetings but this was the first Cross Party Meeting that I have attended. How welcome it was to see such a good turn out with a packed committee room. I am inclined to conclude that this indicates how important it is that we value our older generation. It was however unfortunate that other parliamentary business meant that various parliamentarians had to absent themselves.

I was  keen to attend this meeting for a number of reasons. Having an interest in the Scottish Government’s “Ten Year Vision” for Mental Health I had attended one of its consultation events in Edinburgh and had also submitted a written response. There were  574  written responses in total, which again seems most encouraging.

Given that opportunities for anyone to raise discussion, at parliamentary level, about the Scottish Government’s ‘Ten Year Vision’ may not come along very often, I felt it was important, as the only NHS psychiatrist for older adults at this Cross Party meeting, to do my best to put forward the experiences of my patients.

I was very impressed that the convener, Sandra White, MSP made sure that as many voices as possible were heard at the meeting. I wrote to thank her for this.

I was particularly struck by the compelling and worrying testimonies of Rosemary Carter and Dianna Manson whose experiences as older adults with mental health issues remind us starkly how important it is that policy makers consider very carefully the consequences of visions set for the years ahead.

Rosemary Carter highlighted her experience of how the dominance of cognitive assessments in my profession has reduced capacity to care for those who have non-cognitive mental ill health. As a professional working in this area I share her concern and am of the view that Rosemary is far from alone in her experience. When the Dementia Strategies and Targets were first introduced in Scotland from 2010 onwards, it was my concern about this potential for inverse care, and for increased stigma associated with ageing, that led me to advocate publicly for a timely approach to the diagnosis of dementia. I did so at a time when this approach had no support whatsoever from policy makers, healthcare or the Mental Welfare Commission.

I thought that Angela Dias of “Action in Mind” spoke with clarity and genuine concern about what she termed “institutional discrimination” relating to older adults with mental health issues living in Scotland today.

Mr Hunter Watson’s concerns about human rights for older adults do, in my opinion, need to be carefully considered.

The Principal Medical Officer for Scotland, Dr John Mitchell, acknowledged several times the evidence that those with chronic mental health disorders die 15-20 years earlier than those who do not. He stated at this meeting that this is a “huge finding, a universal finding, a huge inequity”. Academics are increasingly of the view that one of the potential reasons for such early death has been the prescribing of psychiatric medications. This is why I mentioned a number of times at the meeting the widely gathered evidence (PE1493, Sunshine Act for Scotland) that the pharmaceutical industry continues to have a significant role in the “education” of Scottish doctors in the prescribing of psychiatric medications.

I thought the presentation by Dr David Christmas was most interesting and share his concern that there is an imbalance in research studies across the age ranges. I raised a number of questions with Dr Christmas because he works as a “super-specialist” and so deals with a very select group of patients.

At the Cross Party meeting Dr Christmas stated that “depression is under-recognised across all age groups” and that “maintenance treatment has a good risk-benefit ratio.” He did so without acknowledging that these statements cannot be made with absolute certainty.

I have attended a wide range of GMC-required Continuing Medical Education (CME) and so over the years have found that I have attended a number of educational talks given by Dr David Christmas. He always carefully talks through his declarations of interest which for at least the last five years do not  include any financial interests other than his employment with NHS Tayside as the Clinical lead of the Advanced Intervention Service.

Dr Christmas is a member of the Psychopharmacology Committee of the Royal College of Psychiatrists. The Chair of this most influential committee (in terms of the prescribing of psychiatric drugs) is Professor Allan Young, a “key opinion leader”. Professor Allan Young declares his extensive financial interests as follows: “Paid lectures and Advisory Boards for all major pharmaceutical companies with drugs used in affective and related disorders” . A similar key opinion leader, Professor Stephen Stahl, gave a keynote talk at the British Association of Psychopharmacology in 2015. As he is American, and they have a Sunshine Act, it is possible to establish Professor Stahl’s earnings from promoting psychiatric drugs. When last looked at, this was more than $3.5 million dollars. In the absence of a similar Sunshine Act in the UK we cannot establish the scale of payments made in the UK.

Dr Christmas has given educational lectures alongside Dr Hamish McAllister-Williams who is also a member of the Psychopharmacology Committee of the Royal College of Psychiatrists (RCPsych), and who was appointed in 2012 as Director of Education for the British Association of Psychopharmacogy (BAP).

Dr McAllister-Williams declares a wide range of financial interests with the Pharmaceutical Industry. Dr McAllister Williams is “a major contributor” to the RCPsych and BAP Continuing Professional Development programme.

It was with this knowledge, of the influential position that Dr Christmas has in terms of the education of UK psychiatrists, that after the Cross Party Meeting I wrote to ask Dr Christmas to ask if he might support a Sunshine Act for Scotland?  At the meeting Dr Christmas took time to carefully address other biases (which I share his concern about) but did not do the same for the financial biases that may affect the advice given by key opinion leaders. The same potential exists for research itself.

In my correspondence with Dr Christmas I  reminded him that I prescribe both antidepressants and antipsychotics but explain to patients that the best evidence we have is generally based on short-term studies and that all interventions (including psychological interventions) can have both benefits and harms.

I have  confirmed with Dr Christmas that I share his determination to seek science that is as objective as possible and that this means that I realise that biases do indeed come in all forms and not just financial. I simply argue that science should be based on transparency or it ceases to be science. My view is that it is not necessarily a bad thing if doctors are paid for their time and expertise working outwith the NHS. For example, working for NICE, or giving expert views to court. However, when a doctor has a financial “conflict of interest”, this can affect the treatment decisions they make, or recommend. These conflicts cannot be entirely avoided, and in many cases they are entirely reasonable. However, it is important that information is available on which companies have paid a doctor, so that colleagues and patients can decide for themselves what they think. For example, there is longstanding evidence that exposure to industry promotional activity can lead to doctors recommending worse treatments for patients.

I have also discussed with Dr Christmas the view that proportionality of understanding should come in words as well as numbers and  that the quantitative and qualitative require ‘parity of esteem’.

In summary, I thought the Cross party meeting on Mental Health, Ageing and Older People was an excellent opportunity for a range of voices to share their thoughts and experiences. Such involvement is to be commended and I hope that both my profession and policy makers of all sorts may agree.

Dr Peter J. Gordon

(writing in my own time)

GMC registration: 3468861

Member of the Royal College of Psychiatrists: number 12351

I have worked in NHS Scotland for over 25 years and I am employed 
with NHS Lothian as a Consultant in Psychiatry for Older Adults. 
As well as being a doctor and scientist, I am a philosopher, 
ethicist, and artist.

 

‘May it be granted the older you are’

Prepared to share with the Cross Party Group on Older People, Age and Ageing ahead of the meeting on the 26th April 2017

In this summary I will present original articles, reports and writing. I wish to keep my words spare.

William H. Thomas said this in 2004 in his book “What are Old People For?”:

On the 1724 ruin of Mavisbank (considered as Scotland’s finest ruined building) and carved on the sculpture “The Ageing Stone” by Dr Peter J. Gordon:

May you grow old either never or late,
and that you experience earthly changes late.
May what the numerous ages erode be restored intact,
may it be granted that the older you are,
the more beautiful you may shine.

[Dr Peter J Gordon was formerly a Trustee of Mavisbank House, Loanhead, Edinburgh.]

Ballatt and Campling in their acclaimed book (2011) “Intelligent Kindness” offered this concern about current approaches to healthcare:

I have argued in a number of publications that prevailing approaches in medicine, and particularly a primary focus on biomedicine may risk this outcome for our older generation:

The Scottish Government and Alzheimer Scotland had this recent four-page spread in a National newspaper:

The Scottish Government has indeed made progress with dementia care but we should be wary of repeated statements made by them that this is “world leading”.

Barak Obama, when President of the United States, said:

Scotland is a relatively small country and this may be one reason why biomedical determinism has prevailed without challenge. This approach to mental wellbeing has its place. I have reasoned in a number of publications, that unless philosophy is irrelevant, then biomedicine should not be the only determinant to wellbeing.

Owen Jones, in his 2014 book “The Establishment” insisted:

Personally I have very much valued the views and writings of individuals like Mr Hunter Watson and Mrs Chrys Muirhead. It disappoints me to have witnessed the ways that those in genuine positions of power have sometimes treated them. Simply because their views may not be shared.

Prescribing of psychotropic medications (of all types) has been rising year-on-year in Scotland for the last decade (ISD figures, Scottish Government). Rising in all age groups: including our children and our older generation. Reporting on this on the 5th October 2016, The Scotsman had as its front-page headline “Prescriptions for mental health drugs at 10-year high”.

Annette Leibing in an Editorial in Cult Med Psychiatry explored the origins of the widely used label/acronym “BPSD”:

One of the consequences of this has been the very wide practice of prescribing ‘off-label’ of antipsychotics in Scotland to those living with dementia. Unfortunately this wide practice has always lacked evidence for the “appropriateness” of such prescribing:

Promotion of “off-label” use of drugs is still widespread practice in the UK and, if anything, has become more embedded since the introduction of GMC required ‘Continuing Medical Education’ (CME):

The above was the concern of the Royal College of psychiatrists in 2005 (twelve years ago). However the Royal College of Psychiatrists has stated recently that this is “now a thing of the past” and that psychiatry is “puritanical” in its relationship with the pharmaceutical industry. Unfortunately real-world evidence does not support this statement (see the wide-ranging evidence gathered for ‘A Sunshine Act for Scotland’ )

Dr Catherine Calderwood, Scotland’s Chief Medical Officer is to be commended for her initiative Realistic Medicine. I have presented the reasons to the Scottish Government why a Sunshine Act for Scotland must be a necessary part of this.

[For instance: If we had a Sunshine Act perhaps the MESH scandal and so much harm might have been avoided.]

Dr Margaret McCartney, Glasgow GP, author, BMJ columnist has outlined the harmful consequences of Industry being in the driving seat. One aspect of this is ‘inverse care’. More than two years on since Dr McCartney wrote this and we find that no NHS Board area in Scotland is achieving more than 54% of the “guaranteed” Post-Diagnostic Support:

More than two years ago this “Change Paper” was published in the British Medical Journal. Professor Burns is the National Clinical Director for Dementia in NHS England and Wales:

In response, I submitted this published rapid-response to the British Medical Journal:

I welcome this “change page”. [1]

The authors describe the routine prescription, off-label, of 
antipsychotics to our most vulnerable elderly. At a recent 
international conference one presentation referred to the estimate 
that “2/3rds of current UK prescriptions for antipsychotics in 
people with dementia are inappropriate”.[2] These reports remind us 
that those living with dementia are often considered to lack 
“capacity” and their voice is easily lost.

My previous correspondence to the BMJ has demonstrated my view that 
our profession should not be “educated” by commerce or industry. 
[3]

In 1999, as a doctor in training, I was handed a document by my 
trainer. This I was told was “the way forward”. The document had an 
acronym: “BPSD”. I had not heard of “BPSD”. I learned that this 
acronym stood for “Behavioural and Psychological Symptoms 
in Dementia”.I accepted it with little thought. The comprehensive 
BPSD document was produced by Pharma: though at the time, and for 
almost a decade thereafter, I was not aware of this fact.

I am aware that a number of NHS guidelines are in existence for the 
treatment of “BPSD”. [4] Haloperidol, in lowest possible dose, is 
generally the drug recommended. My concerns over prescribing of 
antipsychotic drugs like Haloperidol in a frail elderly population, 
led me to raise a petition for a “Sunshine Act” with the Scottish 
Government. [5]

It has been my experience that marketing activity by the 
pharmaceutical industry, and also “education” by key opinion 
leaders paid for by the pharmaceutical industry, have in the past 
encouraged the off-label use of antipsychotic drugs. Until we 
acknowledge this mechanism, we risk losing the opportunity to 
minimise the harm of such an approach.

References 1-5

Four months later this research was published:

It should be noted that antipsychotics also can cause side-effects (morbidity) as well as increasing risk of mortality. Such side effects include: parkinsonism, sedation, mental dulling, excess salivation, weight gain, cardiac disturbances and hormonal dysregulation. This is why, as an NHS doctor for older adults, I use antipsychotics as sparingly as I can and generally when all other options have reasonably been tried. If I do prescribe antipsychotics I try to do so for as short a period as possible.

The SIGN 86National Clinical Guideline” on “Management of patients with Dementia” was published in 2006. A review of national guidelines on dementia, published in 2013, established that this was found to be almost the worst national guideline for dementia in the world (certainly in terms of consideration of ethics)

I have written about my concerns that financially vested interests may have played a significant part in the development of SIGN Guideline 86 on Dementia:

Last year Sign 86 Guideline was withdrawn. There has been no replacement – despite the promise made within SIGN 86 – to have it reconsidered by 2011.

The following slides consider failures of governance for National Guidelines such as SIGN:

One of my interests is in ethics. I share the ethicists’ view that we all may suffer if our shared determination scientific objectivity is compromised for vested reasons. It was this consideration that led me (in 2013) to petition the Scottish Parliament to consider introducing a Sunshine Act for Scotland:

My petition was closed in February 2016 after wide gathering of evidence and a Public Consultation.

The public consultation revealed that the Scottish public support the petition and that in majority they would like to see all payments made to doctors, healthcare workers and academics to be publically declared on an open, central register.

More than a year on since this consultation was concluded and the public has had no meaningful update from the Scottish Government.

In the Observer newspaper of 1st October 2016 an Editorial our older generation ended:

I also want to end by celebrating the real value of our older generations.

This was a rapid response to the British Medical Journal by myself that was published 2nd September 2015

The contributions of those “retired” often prove invaluable:

Yesterday I was at a consultation event held by Healthcare 
Improvement Scotland which sought wider views on a proposed 
national approach to “Scrutiny” of health and social care in 
Scotland (1). At the meeting I met a number of individuals who had 
been designated “retired” on their name badge. I was not surprised 
to find that during the course of the consultation event, the 
contributions of those “retired” proved to be invaluable.


Returning home on the train I thought about this a little more. 
Names like J K Anand, L Sam Lewis and Susanne Stevens, all regular 
submitters to the BMJ rapid responses came into my mind. All 
describe themselves as “retired” and one happily calls himself 
“an old man”. The contributions by retired folk have always struck 
me as having a different quality to those by people who are still 
employees of today’s NHS. In “retirement” there may be a greater 
freedom to ask questions of prevailing approaches. Our older 
generation also has great experience which should be considered 
as “evidence” in itself.


Yet in my job as a doctor for older adults, I see the world around 
me as seeming to do its best to reduce our elders. The language 
used in discussing our elders commonly denotes some sort of loss. 
For example the “guru” of Healthcare Improvement Don Berwick talks 
about the “Silver Tsunami”. Other healthcare leaders talk of 
“epidemics” and “challenges”, implying that our elders are a burden 
to younger generations. To address these “challenges” the 
healthcare improvers, it seems to me, are devising shortcuts. 
Today these are often termed “tools” and may be part of “toolkits”. 
I have even heard healthcare improvers discussing the need to 
“invent” a “tool” for patient centredness. I think our elders, 
or those “retired”, might consider this to be particularly 
ridiculous.


So I would like to say three cheers for the “retired” folk. 
To discourse they bring wisdom, to the prevailing methodologies 
they are more willing to ask critical questions, and when it comes 
to cutting through to what matters, being true to oneself, 
our elders are superior to many, if not most, policy makers.

References 1 and 2


 

Mr Hunter Watson also submitted a paper ahead of the Cross Party Meeting on Mental Health and Older People, Age and Ageing. It is included below:

In the report entitled “Remember, I’m still me” psychoactive medication is described as “medicines used to treat behavioural symptoms, like agitation, verbal and physical aggression, wandering and not sleeping”. From this description it seems clear that psychoactive medication is regarded by some as medication which can be used as chemical restraint rather than for the purpose for which it was developed.

That report, which was published in April 2009, was based upon what was found when the Care Commission and the Mental Welfare Commission made joint visits to a sample of 30 care homes in Scotland. The authors observed that “While we saw some examples of good practice, our findings reveal that overall, care in Scotland’s care homes needs to improve significantly in order to meet the needs of people with dementia who live in them”.

The report also noted that “Although most staff were aware of different types of therapies recommended for caring for people with dementia, they told us they were not using them or encouraging them to be used as they did not feel their knowledge was sufficient and they did not have enough time.”

In May 2014 there was published a report entitled “Dignity and respect: dementia continuing care visits”. This report was based upon what the Mental Welfare Commission found when it visited 52 NHS units providing longer-term care for people with dementia. Among its findings were the following:

84% of people were on at least one psychotropic medication 
(i.e. psychoactive medication) with 30% on three or more, 
in many cases without evidence of regular reviews

175 people (52%) were taking anxiolytic medication, mainly 
Diazepam or Lorazepam, with 65 of the 175 (37%) receiving this 
on a regular basis. This level of use is disturbing and is much 
higher than the level of use we found in Remember, I'm still me 
where only 19% of people with dementia in care homes were 
prescribed anxiolytic medication. The British National Formularly 
(BNF) states "Anxiolytic medication should be limited to the 
lowest possible dose for the shortest possible time".

166 people (45%) were taking antipsychotic medication. While this 
may be helpful in relieving symptoms such as hallucinations, 
delusions, agitation or aggression, there are known risks for 
people with dementia. All antipsychotic medications increase 
the risk of stroke and death, many can impair mobility and 
increase the risk of falls.


Although people with dementia in NHS care may present with more 
challenging and complex problems than people with dementia in other 
care settings, staff skills and knowledge and staff numbers should 
be better. We were concerned at the high usage of antipsychotic 
medication often in combination with anxiolytics or sedative 
antidepressants.

In October 2016 there was issued a National Statistics Publication for Scotland entitled “Medicines used in Mental Health”. It provided statistics for the years 2005/06 to 2015/16. Among the facts contained therein are the following:

All NHS Boards show increased prescribing of antipsychotic drugs 
since 2009/10.

The total number of prescription items dispensed for psychoses and 
related disorders increased between 2014/15 and 2015/16 ...  
This follows a gradual increase over the last ten years. 

The majority of the drugs used in the treatment of psychoses and 
related disorders are antipsychotic drugs.

In June 2010 there was published a document entitled Scotland’s National Dementia Strategy”. This document made clear that the Scottish Government was committed to “ensuring that people receiving care in all settings get access to treatment and support that is appropriate with a particular focus on reducing the inappropriate use of psychoactive medication …”

In May 2013 there was published a document entitled “Scotland’s National Dementia Strategy: 2013 – 16”. In this document it was stated that “The first Dementia Strategy identified that a key driver to ensure care and treatment is always safe, effective and appropriate is working with partners to reduce the inappropriate prescribing of psychoactive medication for people with dementia”. In order to try to achieve this goal an expert working group was asked “To agree and recommend a national commitment on the prescribing of psychoactive medications (excluding cognitive enhancers), as part of ensuring that such  medication is used only where there must be a likelihood of benefit to the person with dementia and where there is no appropriate alternative”.

In a 1998 edition of the International Journal of Geriatric Psychiatry (No 13) there appeared an article entitled “Medication Use in Nursing Homes for Elderly People”. In the summary it was stated “Residents of nursing and residential homes are often prescribed medication for physical and mental ill-health with resultant polypharmacy and the possibility of iatrogenic disorders. (Disorders caused by medication.) Sometimes drugs are prescribed inappropriately and a number of studies have highlighted the overuse of psychotropic drugs. Legislation in the USA has been effective in controlling their use in that neuroleptic prescriptions (i.e. antipsychotic prescriptions) for the treatment of behavioural disturbances have been significantly reduced and non-pharmacological  strategies aimed at ameliorating behavioural disturbances have been proposed.”

In the editorial of the BMJ of 1 April 2006 it was stated, with reference to an article entitled “Managing challenging behaviour in dementia”, that “… the behaviour of staff … may play a central role in the manifestation of challenging behaviours in patients … a new culture of dementia care should focus on meeting individual patient’s needs rather than on restraint.”

On 3 June 2011 I was sent from the USA a copy of an article entitled “The wrong drugs in nursing homes. Too many antipsychotics” The article was written by Daniel Levinson, the inspector general in the Department of Health and Human Services. Within that article it is stated that “Researchers found that 88 percent of the time, these drugs (antipsychotics) were prescribed for elderly people with dementia. This is precisely the population that faces an increased risk of death when using this class of drugs, according to the FDA.The report didn’t investigate why patients with dementia are prescribed antipsychotic drugs so often. But a series of lawsuits and settlements that my office helped to bring about suggests that many pharmaceutical companies have improperly promoted these drugs to doctors and nursing homes for many years.”

Observations and recommendations:

The production of dementia strategies has been ineffective in 
reducing the prescribing of life-threatening antipsychotic drugs 
to people with dementia in care homes and hospitals. The Scottish 
Government should, therefore, agree that, as recommended by the 
Mental Welfare Commission, there be a wide review of mental health 
and incapacity legislation when the place of learning disability 
and autism in current mental health legislation is reviewed. 
When carrying out that review full account should be taken of 
the Convention on the Rights of Persons with Disabilities.

Guidelines should be produced for the use of antipsychotics and 
otherpsychoactive drugs for people with dementia. 

These guidelines should take full account of the recommendations in 
the British National Formularly. 

Note should be taken of the fact that the guidelines in SIGN 86 
have now been withdrawn since they became out of date.

New National Care Standards for Care Homes for Older People 
should be produced. These new standards should not suggest 
that medication could be used as restraint in response to 
"restless or agitated behaviour" as do the existing care standards. 
This suggestion positively encourages care home staff to request 
that a doctor prescribes an antipsychotic for a resident whose 
behaviour is perceived as challenging. Unfortunately some doctors 
are too ready to accede to such a request and do not properly 
consider whether the known risks outweigh the potential benefits 
nor attempt to obtain the informed consent of the patient. 
There seems to be an incorrect assumption by some that care home 
residents, especially those with dementia, would be incapable of 
passing the recognised test of capacity to make a treatment decision.

New regulations should specify that doctors must take due account 
of prescribing guidelines when they prescribe antipsychotics to 
care home residents and also that they must give a written 
explanation of any decision to do this. The care inspectorate 
should confirm that due account has been taken of prescribing 
guidelines and also that acceptable written explanations have been 
provided. The regulations should specify sanctions which could be 
taken against care homes in which there has been evidence of an
excessive and inappropriate use of antipsychotics or other 
psychoactive drugs

It should be recognised that in Scotland, as in the USA, 
pharmaceutical companies could have been improperly making payments 
when marketing their psychoactive drugs as suitable for use in the 
treatment of care home residents and others. 

The Scottish Government, therefore, should make it mandatory for 
doctors, healthcare workers and academics to disclose publicly all 
payments from the pharmaceutical industry. 

Peter Gordon, a consultant in old age psychiatry, submitted 
petition PE1493 to the Petitions Committee in the hope that it 
would lead to the Scottish Government agreeing to enact the 
necessary legislation which he suggested could be named the 
Sunshine Act. However, in an email dated 14 April 2017 sent to 
the Minister for Mental Health and others he stated 
"A year on and there has been no meaningful public update 
from the Scottish Government on PE1493 and a Sunshine Act".

The Scottish Government should give serious consideration to 
Peter Gordon's proposal.

Caring for elderly people with dementia is a demanding task but the 
care homes which have the responsibility for their care are 
commonly under-staffed and under-funded. Such homes are unable to 
pay staff sufficient to ensure that they do not leave for better 
paid and less demanding work elsewhere, such as in a supermarket. 
The consequence is that in some care homes there is a high turnover 
and hence a lack of properly trained staff. In these circumstances 
it is not surprising that care homes resort to the use of 
psychoactive medication when residents present problems.

It should be recognised that in order to ensure that people with 
dementia are properly cared for more resources must be devoted to 
social care and that, if necessary, taxes should be raised to 
achieve this.

Making science a reality

It has been a long time since I last wrote on Hole Ousia about my activism for a science that strives for objectivity.

It is probably reasonable to suggest that no other in the British Isles has given more to this cause than I have.

I petitioned the Scottish Parliament to consider introducing a Sunshine Act for Scotland. Much evidence was gathered for this petition and this was then shared in a formal public consultation.

The Scottish public agreed, in majority, that payments from the pharmaceutical industry and device makers to healthcare professionals need to be declared on a mandatory basis. At the time, this landmark consultation was neither reported in the mainstream press nor the medical press. A year on the Scottish Government has provided no meaningful update.

It was thus with considerable interest that I read the following editorial in the current British Medical Journal:

The full article can be accessed here from the BMJ:






Open and transparent from omphalos on Vimeo.

Courage to care













 

Reductionism – truly, madly, deeply

On Friday the 25th of November 2016 I gave a talk for the Scottish Philosophy and Psychiatry Special Interest Group.

My subject was “Improvement Science”.

The following is based on the slides and the four short films that I presented.

My talk was entitled:
001-improvement-science The meeting was held at the Golden Lion Hotel, Stirling:golden-lion-hotel-stirling-25-nov-2016-1golden-lion-hotel-stirling-25-nov-2016-2I started the day off:
002-improvement-scienceI gave these declarations:
003-improvement-science
I explained to the audience that like Dr Rev I M Jolly I can be overly pessimistic:


005-improvement-scienceThe dictionary definition of ‘Improvement’:
006-improvement-scienceThe dictionary definition of ‘Science’:
007-improvement-scienceMy concern is any pre-determinism to science:
008-improvement-scienceThe Health Foundation have considered Improvement Science: this is from 2011:
009-improvement-scienceMany different terms are used including “QI” for “Quality Improvement”:
010-improvement-scienceThis is where improvement science began, in Boston, Massachusetts:
011-improvement-scienceThe Founder of the Institute for Healthcare Improvement (IHI) was Don Berwick:
013-improvement-scienceThe first description of this movement in Britain goes back to 1992 by Dr Godlee:
014-improvement-scienceFifteen years later, Dr Godlee, Editor of the BMJ, said this:
015-improvement-scienceOnly last month the BMJ briefly interviewed Don Berwick:
016-improvement-scienceIHI describes improvement science as being based on a “simple, effective tool”:
017-improvement-scienceThis tool was developed from the work of an American engineer, W. A. Deming:
018-improvement-scienceThe “Model for Improvement” Tool [TM] is described by IHI as a “simple, yet powerful tool”:
019-improvement-scienceThe current President and CEO of IHI is Derek Feeley:
024-improvement-scienceUp until 2013, Derek Feeley was Chief Executive [Director General] for NHS Scotland:
021-improvement-scienceIn April 2013 Derek Feeley resigned from NHS Scotland:
022-improvement-science22nd February 2015 it was reported: “The astonishing and largely hidden influence of an American private healthcare giant at the heart of Scotland’s NHS”:
023-improvement-scienceDr Brian Robson, Executive Clinical Director for Healthcare Improvement Scotland [HIS] is an “IHI Fellow”:
dr-brian-robsonProfessor Jason Leitch, National Clinical Director for the Scottish Government is an “IHI Fellow”:
026-improvement-scienceMight we be facing the biggest change to healthcare in Scotland since the NHS began?nhs-scotland-1947 Improvement science is moving quickly and widely across Scotland:
027-improvement-scienceThis “Masterclass 1” for Board members cost  £146,837:
028-improvement-scienceAn NHS Board member commented after the Masterclass:
029-improvement-scienceHealthcare Improvement Scotland is one organisation with a very wide remit over NHS Scotland and it works closely with the Scottish Government:
031-improvement-scienceNine cohorts of Safety Fellows and National Improvers have so far been trained following IHI methodology:
032-improvement-scienceI was reminded of the current enthusiasm for improvement science when the Convener of a recent Scottish Parliament Committee meeting said of targets (another approach enthusiastically taken by NHS Scotland):033-improvement-scienceWhat is the place of ethics in Improvement Science?
034-improvement-scienceIn 2007 the Hastings Centre, USA, looked into this in some depth:
035-improvement-scienceThe Hastings Centre argue that Improvement science cannot ignore ethics:
036-improvement-scienceIn 2011 the Health Foundation, UK, produced this “Evidence Scan”:improvement-science-2011a2The Health Foundation commented that “improvement science is just emerging”:
037-improvement-science
The Evidence Scan found a “real paucity of evidence about the field of improvement science”:
038-improvement-scienceI would also suggest that there is a real paucity of philosophy about the field of improvement science:
039-improvement-scienceThe Health Foundation did find papers on the conceptual nature of Improvement Science but concluded that:
040-improvement-scienceMary Midgley is a philosopher now aged 95 years who is widely respected for her ethical considerations:
041-improvement-scienceChapter 7 of her book “Heart and Mind: The Varieties of Moral Experience” begins:
042-improvement-scienceMary Midgley is concerned about the overuse of reductionist tests in medicine stating that:
043-improvement-science
This film is about the potential consequences of inappropriate reductionism:

Leon Eisenberg has written many papers about this subject. He argues that reductionism should not be “abandoned” but that we must keep sight of where such an approach is scientifically useful and also where it is inappropriate:
045-improvement-scienceIn the Hastings Report, Margaret O’Kane asks:
046-improvement-scienceIn my view the answer to this question is YES. I am hopeful that the National Improvers recruited to NHS Scotland would agree:
047-improvement-scienceAs an NHS doctor I have seen unintentional harm brought about by National improvement work in Scotland. This related to a “Screening Tool” that was introduced across Scotland as part of this work. I found that the unintended consequences of the use of the following tool included implications for patients’ autonomy and the risk of over treatment:
048-improvement-scienceBoth the Hasting Group and the Health Foundation are of the view that improvement science cannot separate itself from the ethical requirements of research:
049-improvement-scienceThis article published in February 2016 argues that individual “rights transcend all aspects of Improvement science”
050-improvement-scienceThe following is a verbatim representation of a conversation held by National Improvers working in NHS Scotland:
051-improvement-scienceIn November 2016 Professor Joshi, also a psychiatrist outlined his concerns about reductionism in a published letter to the BMJ:
052-improvement-science
In this short film the mechanical language of healthcare improvers is considered:

Professor John Bruce was a Moral Philosopher in Edinburgh University in the 18th century. He built this temple, the “Temple of Decision”, in the grounds of his home by Falkland Palace so that he could consider his thesis:
054-improvement-scienceProfessor John Bruce did not succeed in his endeavour. His Temple however stood for many years:
055-improvement-scienceBut it eventually collapsed and his endeavour to “reduce the science of morals to the same certainty that attends other sciences” collapsed with it.
057-improvement-scienceAny search of Healthcare Improvement Scotland for “ethics” finds this result:
056-improvement-science
This film is about more up-to-date buildings – the enthusiasm for which was based on improvement science: The Red Road flats in Glasgow:

 

                         Post-script:

The following is an edited clip of the evidence given to the Scottish Parliament by Healthcare Improvement Scotland (HIS) on the 31st January 2017:

The full session can be watched here

The Official Report can be accessed here

The Scottish Public Want Sunshine

There is a long standing joke about the lack of sunshine in Scotland.

Three years ago I began the process of raising a petition with the Scottish Parliament to urge the Scottish Government to introduce a Sunshine Act.

A Sunshine Act makes it a statutory requirement for all payments from commercial interests made to healthcare workers and academics to be declared publically. The metaphor is that sunshine brings full light. Both the United States of America and France have introduced a sunshine act.

The doctor in Gabriel García Marquez’   ‘Living to tell the tale’ says “Here I am not knowing how many of my patients have died by the Will of God and how many because of my medications”. Márquez often returns to the theme of medical ethics in his writings and reminds us that all interventions have the potential for benefit and harm.  In ‘No one writes to the Colonel’, “a man [who] came to town selling medicines with a snake around his neck”. Here Márquez is reminding us of the long history of the financial opportunities open to healthcare professionals.

As a junior doctor in around 2000, I was handed by a Consultant a several hundred page document entitled “Behavioural and Psychological Symptoms of dementia”. The Consultant told me “this is the way forward!” Some years on I came to realise that this document had been developed, funded and disseminated by the Pharmaceutical Industry whose first loyalty, as a business, is to its share-holders.

In the wake of the dissemination of this document, prescribing of antipsychotics, sedatives and antidepressants in Scotland has been rising year on year. This has been described as mass prescribing, and is often long-term. Yet the evidence to support such prescribing is poor.

There is much promotion of “partnership working” between industry and healthcare. Yet we must remember that these two partners have different aims, and it is the responsibility of healthcare workers to follow the ethical approaches central to their professions. For example, the General Medical Council is clear about what is expected of doctors in their code “Good Medical Practice”. The potential for conflicts of interest is recognised and doctors are advised “you must be open about the conflict, declaring your interest formally”.

Since 2003, Scottish Government guidance has been in place to allow the declaration of financial interests of NHS staff, to their employing health boards. As a result of my petition, the Scottish Government has confirmed that this guidance is not being followed.

One key area of concern is the continuing professional education of healthcare professionals, another requirement of professional bodies. In at least two Boards in NHS Scotland, continuing medical education relies entirely on the financial support of commercial interests.

National and international conferences may also form part of continuing professional education. Because of the Sunshine Act in the USA, we know that a key-note speaker at a recent UK conference has been paid more than £3 million dollars by the pharmaceutical industry since the Sunshine Act was introduced. There is currently no way of knowing the scale of any payment made to a UK speaker sharing the same platform.

My experience of trying to clarify if there is transparency about financial payments in Scotland has been revealing. I have encountered significant defensive reactions from individuals and organisations. There has long been a body of evidence that, for example, prescribing behaviour is influenced by commercial interests, yet doctors find it hard to accept this. This collective denial would suggest that the forthcoming (voluntary) ABPI Register is unlikely to work as many will regard it as not applying to them and will therefore opt out.

As part of their consideration of my petition, the Scottish Government commissioned a public consultation exercise on a need or not for a Sunshine Act. The majority of participants expressed their view that all financial payments should be declared on a single, central, searchable register and that this should be a mandatory requirement.

The forecast for Scotland looks good: sunshine.

 

A letter that the Scottish Parliament felt unable to publish

With careful thought, and backed with full supporting evidence,  I sent the following letter of the 2nd February 2016 to support my petition for a Sunshine Act for Scotland.

The Senior Clerk of the Parliamentary Committee was of the view that this letter did not comply with the Scottish Parliament’s policy on the treatment of written evidence. I was therefore asked to redact significant sections of the letter.

After considerable communications to and fro, I replied as per this e-mail of the 3rd March 2016:

I fully respect the right of the Scottish Parliament to determine 
what it publishes.

I feel very strongly that my letter without the highlighted text 
merely reiterates what I have already said, and fails to provide 
the evidence that I have repeatedly been asked for.

So my position is that I do not wish to amend my letter of the 
1st February on PE1493.

My petition has since been closed. I therefore have decided to publish my letter to the Scottish Parliament in full along with supporting evidence. I have had professional advice that what is contained in this letter is not defamatory as it is based on veritas and has full supporting evidence:

Dear Mr McMahon
Petition PE01493: A Sunshine Act for Scotland

I realise that the Committee must receive a great amount of correspondence however I hope that the committee might agree that what follows is extremely important when considering PE1493.

Since I last wrote to the committee I attended, for accredited continuing medical education, the Royal College of Psychiatrists in Scotland Winter Meeting held on the 29th January 2016. It is this that has compelled me to write this update as it demonstrates beyond doubt that lack of transparency around financial conflicts of interest remains a serious issue. An issue with implications for both patient safety and healthcare budgets. It also demonstrates that Government action is the only way to address this.

The full powerpoint presentations of this Accredited meeting for 
Continuing Professional Development can be accessed here - but only
for members of the Royal College of Psychiatrists. 

I am a member of the Royal College of Psychiatrists and I am of the 
view, as a scientist, that these lectures should be available to all 
and not just to members.

One speaker highlighted the increase in prescribing costs in her health board area which was due to the high prescribing rate of a new antipsychotic injection, palperidone depot (XEPLION®). The next speaker demonstrated both the inferior effectiveness of this drug when compared to existing (far cheaper) depot medications and the perception amongst Scottish psychiatrists that it was more effective. Below you will see the flyer sent to mental health professionals in Scotland when this drug was launched:

002 Financial Conflicts of Interest, Scottish Psychiatry

I have highlighted one of the paid speakers, Dr Mark Taylor, because he also spoke at this week’s meeting where he reminded us that he was Chair of SIGN Guideline 131: The Management of Schizophrenia, which was published in March 2013.

At this week’s meeting Dr Taylor presented his declarations as follows: “Fees/hospitality: Lundbeck; Janssen, Otsuka; Roche; Sunovion”.

Dr Taylor commented on these declarations with the statement that “you are either abstinent or promiscuous when it comes to industry. Well you can see which side I am on”. Audience laughter followed.

The general question that arises is whether an influential professional such as a Chair of National Guidelines might earn more from the pharmaceutical industry than in his or her role as a healthcare professional? At present it is impossible for anyone to establish the scale of competing financial interests. To remind the committee the following avenues are not illuminating:

1. Royal College of Psychiatrists. This week’s meeting did not appear on the college database. In any case this database is neither searchable nor does it include specific details of payments and dates

2. NHS Boards. The committee has already established that, across Scotland, HDL62 is not being followed.

3. SIGN guidelines. The committee is aware of significant governance failings particularly in comparison with NICE which includes details of financial sums paid and associated dates.

4. Discussions with Senior Managers in NHS Scotland relating to the General Medical Council’s expected level of transparency has brought forth written responses describing my interest as “highly unusual” and “offensive and unprofessional”

5. The forthcoming ABPI register allows any professional to opt out of inclusion.

It is also worth repeating that the information provided to the public consultation on this petition failed to highlight most of the issues identified in points 1 to 5 above.

In terms of cost both to the public purse and the individual patient the Government’s stated wish for a “robust, transparent and proportionate” response would be fulfilled if a single, searchable, open register of financial conflicts of interest that has a statutory basis were to be introduced

Public Consultation on a Sunshine Act for Scotland: “The report cannot be shared”

I have previously expressed concerns about the process and validity of the public consultation on PE1493: A Sunshine Act for Scotland

The Scottish Health Council copied me into this communication of the 16th March 2016 to their staff:

“I understand that a few people who took part in the gathering views project on the development of a Register of Interests have asked local offices whether a report summarising their feedback is available yet.

By way of an update, the Scottish Health Council’s report was shared with the Scottish Government a few weeks after the final discussion group was held on 5 February. Since then and at its last meeting because of the election period, the Scottish Parliament’s Petitions Committee closed the Register of Interests petition. The Scottish Government has advised, however, that the Cabinet Secretary wishes to formally send our report to the Committee together with comments from the Scottish Government on the next steps. Essentially, we see this as a positive outcome and a demonstration of the impact of our report.

The Scottish Government will keep us informed about an appropriate timing for publishing the report on our website once it has been shared with the Committee. Whilst this is likely to be after the election period, until then the report cannot be shared further.   Please can local offices share this information with participants who may be seeking an update.”

I replied to the Scottish Health Council as follows:

"Many thanks for this update further to your last e-mail of the 
25th February 2016 when you informed that I would receive a copy 
of the report as soon as it was drafted.

I was disappointed that the Public Petitions committee chose to 
close my petition. As you are aware my petition sought a
Sunshine Act for Scotland however the committee have closed 
my petition “on the basis that the Scottish Government has 
committed to review the need for updated guidance on what 
the petition calls for”. 

My petition specifically asked for legislation because of the 
complete failure of previous guidance to be followed. 
As you know I was concerned that this failure was not 
communicated to those participating in the public consultation.

My petition was based on principles of transparency on an issue 
that affects us all. I am very disappointed that the process 
has also seemed to lack openness and that the petitioner and 
indeed the public will only see the contents of the consultation 
well after those in positions of power."