Rising stars: British Association of Psychopharmacology

I submitted a rapid response to the BMJ last September after viewing galleries of photographs of the British Association of Psychopharmacology (BAP) Summer Meeting of 2016. The BMJ did not publish my post. This year’s galleries of the British Association of Psychopharmacology (BAP) Summer Meeting have now been shared. This is an amended version of what I sent last summer:

I was recently shared the published photographs of the British Association of Psychopharmacology 2016 Summer Conference.

At this BAP conference, an accredited CPD conference, the rising stars are seen to mix with today’s key opinion leaders. We all welcome the sharing of experience between generations and I have repeatedly stated how important I believe this to be. Some of the BAP key opinion leaders have declared significant financial interests with the Pharmaceutical Industry.

Up-to-date declarations of BAP speakers can be viewed here

I support transparency.  I have understood that this can only ever be a means to an end.

Robert K Merton once insisted that science should be based not on interest but ‘disinterest’. Merton’s star rose long ago and he is now dead. I do hope that all generations of scientists might be able to see his ‘disinterested’ star, still in the sky that we all share.

 

Psychiatry Without Borders

The International Congress of the Royal College of Psychiatrists took place in Edinburgh, the city of my birth, between the 26 – 29 June 2017. This International Congress was called “Psychiatry Without Borders”.

As a psychiatrist who has worked in NHS Scotland for 25 years I made a peaceful protest outside the International Congress.

I have previously petitioned the Scottish Parliament to consider a Sunshine Act for Scotland which would make it mandatory for healthcare workers and academics to declare potential financial conflicts of interest on an open public register.

The pharmaceutical Industry has this year increased payments to healthcare workers and academics for ‘promotional activities’ –  from £109 million up to £116.5 million today.

The Association of the British Pharmaceutical Industry (ABPI) has, from 2015, established a voluntary disclosure system with searchable database. It remains the case that 65% of those who have received payments have opted out – and this accounts for 60% of the total payments (as reported in the British Medical Journal (BMJ 2017;357:j3195)

What follows here are the ABPI disclosures made by some of the speakers at the 2017 Royal College of Psychiatrists International Congress.

It is important to note that it is my understanding that no speaker 
was paid for giving presentations at this International Congress. 

These declarations relate simply to the voluntary declarations
for the years 2015 and 2016 respectively.

If you click on each declaration you will get a closer view.

In previous posts I have provided as much public transparency as there is currently available  relating to the potential financial conflicts of interest of those involved with the British Association of Psychopharmacology (BAP). This Association works closely with the Royal College of Psychiatrists in providing Continuing Medical Education.

A number of those involved in BAP have chosen not to declare on the ABPI Register. For this reason, I attach the declarations given along with the new BAP Guidelines for treating dementia as Professor John O’Brien was giving a talk about these guidelines at the 2017 International Congress:

A few personal thoughts:

Well done to those who have declared on the ABPI Register.

However, it remains the case that we cannot scientifically consider the scale of potential biases that financial incentives may bring to the prescribing of medications in the UK. This is because we have an incomplete dataset. This is surprising given that we do have longstanding evidence that exposure to industry promotional activity can lead to doctors recommending worse treatments for patients.

I would like to see the College, of which I am a member, support the public’s request for sunshine legislation.

 

 

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.

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.

 

Lurasidone – financial conflicts of interest

The launch in the UK of Lurisidone began in August 2014.


My previous post on Lurasidone (Latuda) which has now been marketed in the UK followed the financial interests of one of the authors of the “Special article” in the British Journal of Psychiatry.

Leslie Citrome

It has now crossed my mind, and here I must be very clear that I am speculating, that the British Journal of Psychiatry may have been paid to publish this “Special article”?

I have now looked at the details provided on Lutada to medical professionals by the makers SUNOVION

It is welcome that this new medication has fewer metabolic effects than currently available antipsychotics. It is worth reflecting that, when the “atypical” antipsychotics were first marketed, they were promoted as having fewer Extra-Pyramidal Side Effects (EPSEs) than existing antipsychotics. It later emerged that the atypical antipsychotics had considerable metabolic side-effects.

This is how Latuda is introduced:

lurasidone uk 3

Here are the “References” provided by its makers Sunovion. There are several key authors of studies cited along with “Latuda Summary of Product Characteristics”. I have previously covered Leslie Citrome. Another study author is well known as a Key Opinion Leader, Professor Stephen Stahl.

lurasidone references

I recently posted about Professor Stahl after he gave keynote addresses to this summer’s British Association of Psychopharmacology Conference.

Professor Stahl’s payments dwarf the $181000 dollars given to Dr Leslie Citrome by the makers of Lutada. Professor Stahl’s OVERALL payments by 15 Pharmaceutical companies amounts to $3.58 million.

Stephen Stahl

Evidence based medicine should include all evidence. This should include all financial conflicts of interest in those developing, researching and promoting new medications.

I do hope UK Psychiatrists are aware of all the evidence.

 

                     Update: January 2017

sunovion-lurasidone-marketing-nhs-20-dec-2016

I received the above message from my secretary with the e-mail below from SUNOVION attached:

From: Margo Hepple [mailto:Margo.Hepple@quintiles.com]
Sent: 20 December 2016
Subject: FW: Sunovion virtual appointment

Nice speaking with you and thank you for your help.

Please find below some detail of the appointment I would like to make with Gordon. I would like to offer an update in physical health in mental health with regard to our antipsychotic treatment.

Sunovion recognise the heavy schedules and workloads healthcare professionals have to manage. In order to offer greater flexibility and convenience for your interactions with Sunovion, we have created an online meeting environment which can be accessed at your convenience with the support of our dedicated remote meetings team.

We can now arrange for one of our remote representatives to provide you with useful information about Latuda©(lurasidone) for the treatment of adults with schizophrenia at a time that is absolutely convenient to you via a straightforward remote call. 

www.meetsunovion.co.uk  is an online meeting room where a remote Sunovion representative can provide up-to-date information about Latuda through an interactive platform to augment a simultaneous telephone conversation.

All you need is a computer with internet access, a phone line and a time to suit you , for an approximately 15 minute discussion.

With kind regards,
Margo Hepple
Sunovion Key Account Manager

I replied to my secretary that I do not see Pharmaceutical Representatives. My secretary was though already aware of this and that I had previously raised a petition with the Scottish Government to consider introducing a Sunshine Act for Scotland.

On the 20th December 2016 I wrote a shared e-mail to the Royal College of Psychiatrists, the British Association of Psychopharmacology (BAP) and the General Medical Council (GMC). I explained that I had just read the perspective of the out-going CEO of the Royal College of Psychiatrists in the December Psychiatric Bulletin.

03-vanessa-cameron-dec-2106

In my email of the 20th December 2016  I went on to express my concerns about conflation of marketing with “education” and  expressed my view that the ABPI voluntary register is anything but a “disinfectant”, rather that it gives a thin veneer of transparency.

I concluded: the risk is that rather than “realistic medicine” we have unrealistic medicine with over-medicalisation and associated harms on a wider scale. Inverse care then kicks in.

I asked politely if the Royal College of Psychiatrists, BAP or GMC were planning to do anything about this?

I only received a reply from the GMC. 

I reproduce this in full below:

From: General Medical Council
Sent: 20 January 2017
To: Peter J Gordon
Subject: RE: FW: Sunovion virtual appointment

Dear Dr Gordon,
Thank you for your email and sorry for the time it’s taken to respond.

As you know it’s our role to regulate the medical profession in the UK and as part of that role, we set the standards for the delivery of medical education and training. Although it is our role to regulate individual doctors, we do not have a role in regulating organisations and therefore cannot comment on any such policies to managing conflicts of interest.

We are clear in Good Medical Practice that ‘you must be honest in financial and commercial dealings with patients, employers, insurers and other organisations or individuals’ (paragraph 77) and ‘if faced with a conflict of interest, you must be open about the conflict, declaring your interest formally, and you should be prepared to exclude yourself from decision making’ (paragraph 79). We expand on this in our explanatory guidance Financial and commercial arrangements and conflicts of interest (2013) which includes principles on how to manage conflicts of interest should they arise in relation to making decisions about patient care and the commissioning of services.

I note your comments on the limitations of the Association of the British Pharmaceutical Industry (ABPI) register, however we see this as a start to creating a culture of openness and worked closely with them in promoting the database through a blog for doctors on our website. You may also be interested to know that in April 2016 we hosted a meeting bringing together key interest groups from across the UK to discuss issues around conflicts of interest. One theme which came out of this meeting was the need for greater transparency and how we can best support doctors in achieving this through guidance.

Amongst other work in this area, we are undertaking a review of the information contained on the medical register; part of this review considers whether a future register should include information on doctors’ interests.  We consulted on this in 2016 and are now reviewing all of the responses. We also continue to discuss conflicts with all of our key interest groups including via our inter-regulatory group meetings with other professional regulators to ensure that this remains a high priority and to enable us to share good practice across the health professions.

We continue to work with doctors to ensure they are reminded of their professional responsibility to avoid conflicts of interest wherever possible, and to declare any conflicts formally and as early as possible.

Kind regards
Caroline Strickland
Policy Officer, GMC

I replied to the GMC as follows, copying in the Royal College of 
Psychiatrists and the British Association of Psychopharmacologists:

20th January 2017

Dear Caroline Strickland,
I am very grateful for this reply on behalf of the GMC.

I could give a very long list indeed of doctors who are not following paragraph 77 of “Good Medical Practice”. The GMC risk being seen to have guidance that is widely not being followed. This would also constitute a lack of Probity as required for Appraisal and Revalidation.

Yet, if I reported a long-list (I have tried before) I find that I could not do so anonymously. The reality of such reporting would be that my professional life would be severely affected with outcomes such as bullying, isolation and mischaracterisation.

I note what you say about the ABPI Register but this Register gives the illusion of transparency, because, as you know, many doctors who are significantly paid by industry do not declare. These doctors may be the doctors who are “educating” the rest of the medical profession (CPD-approved) as required by the GMC and the Royal College of Psychiatrists and other colleges for “Good Professional Standing”.

When I retire I will release all the information I have and will be clear that neither the GMC nor Royal Colleges have taken effective action here. The risk of patient harm is very real and there are many evidenced examples of where marketeering as “education” has led to harmful and dangerous prescribing or other interventions.

I understand the GMC has no role in regulating organisations such as BAP. I am very concerned about the scale of “education” being marketed by this organisation. BAP no longer answer communications from me and the RCPsych did not answer my e-mail below.

Who is accountable for a situation where the ethics and objectivity of science is widely compromised? Who is accountable for harm that may result?

I would urge you to take more robust action than is currently the case.

The Scottish Government undertook a Public Consultation on this issue: the public in majority concluded that ALL payments to healthcare workers and academics should be openly declared, in full, on an open and searchable register. The public concluded that this had to be MANDATORY.

I am writing in a personal capacity and not in any way for my employers. I will take this communication to my Appraisal which is in March 2017.

I look forward to response from GMC, RCPsych and BAP.

Your sincerely, Dr Peter J Gordon

UPDATE (February 2017): UK-wide promotion of LURASIDONE:

envelope-latuda-promotion-sunovion-feb-2017
01-latuda-promotion-sunovion-feb-2017

Personal comment:

I would suggest that it would be more accurate, in terms of 
science, to describe antipsychotics (of any chemical formulation) 
as acting on brain chemistry, rather than "treating the mind".

02-latuda-promotion-sunovion-feb-201703-latuda-promotion-sunovion-feb-201704-latuda-promotion-sunovion-feb-201705-latuda-promotion-sunovion-feb-201706-latuda-promotion-sunovion-feb-201707-latuda-promotion-sunovion-feb-201708-latuda-promotion-sunovion-feb-2017

As you can see the REFERENCES provided in this “promotional brochure” are in small print and not so easy to read.

So here is an enlarged version that I have made from the original: in black and white (but the highlights matter):

references-latuda-promotion-sunovion-feb-2017

In the public domain are the most significant recent financial payments made to Stephen Stahl and Leslie Citrome from the pharmaceutical industry. Both of whom have been part of the promotion of Lurasidone in the UK

In the references provided by Sunovion in this “promotional brochure” we have:

                      Herbert Y Meltzer

herbert-y-meltzer-bio herbert-y-meltzer-declarations

In the references provided by Sunovion in this “promotional brochure” we have:

                      Gregor Mattingly

who has been paid $1.04 million from the Pharmaceutical Industry since 2013:

gregory-mattingly-1

In the references provided by Sunovion in this “promotional brochure” we have:

                     Sheldon Preskorn

who received nearly $112 in 2015 from the pharmaceutical industry:sheldon-preskorn-2

Update: June 2017

Promotion in PROGRESS in Neurology and Psychiatry (“supplement”) by Dr Lars Hansen, Consultant Psychiatrist and Honorary Senior lecturer, Southampton University:


Steve Chaplin is cited as “medical writer” of the case notes. The following article of March 2013 “GMC: more detailed advice on good practice in prescribing” appears to be by him:

Latest Advances in Psychiatry

What follows is recent correspondence with the organisers of “Latest Advances in Psychiatry”. I can publicly share older correspondence if so wished. It is not dissimilar

From: Gordon, Peter J
Sent: 22 April 2015 11:14
To: ‘imayne@wiley.com
Subject: 14th Latest Advances in Psychiatry Symposium

Dear Izabela,
I hope you do not mind me writing. I seem to recall I contacted you before the previous LAP Symposium and you were very helpful. Though I recall only one of the sponsored talks had an identified speaker at the time we communicated and that was Professor N Farrier.

I have petitioned the Scottish Government for a Sunshine Act which if implemented would make declarations of financial interests a statutory requirement for healthcare workers and academics. I say this to explain my interest. I understand that conflicts of interest are part of life but argue that we should be fully transparent about financial conflicts of interest. I say this as an NHS doctor and psychiatrist of 20 years.

Recently I have been helping the Royal College of Psychiatrists improve transparency and the President Prof Sir Simon Wessely has been most helpful. Yet it still seems the case that College Guidance, CR148, issued 7 years ago is far from generally being followed, let alone governed over this time by the College.

I note the LAP Symposium held last month had three “satellite” symposia: one sponsored by LUNDBECK and two sponsored by SUNOVION.

I was wondering if the public can have open access to the financial basis of such sponsored symposia and where it is clarified who gave the sponsored talk and where publicly they made full declarations of interest as per CR148?

I would hope that declarations for all involved in LAP 13 and 14 have been made, are archived, and publicly available. This should include organisers and Chairman.

I do hope you can help direct me to the level of transparency that is enshrined by the Royal; College of Psychiatrists in CR148 and also, for doctors, the GMC “Good Medical Practice”.

Kind wishes
Dr Peter J Gordon
Bridge of Allan

Wiley reply

“Unprofessional”

My view is that we all have conflicts of interest.

Science however cannot ignore financial conflicts of interest.

We can find no record

The above was a recent statement by the Scottish Government in response to my petition for a Sunshine Act.

This statement by the Scottish Government reminded me of why so many of my healthcare colleagues would choose not to express any concern about lack of transparency

My experience in asking, as fairly and politely as I can, about the governance of: Good Medical Practice” (General Medical Council); NHS Scotland (HDL62) and Royal College of Psychiatrists (CR148) has met with calls of being “unprofessional”.

Annexe A, GMCHDL-62CR148 cover

It was disappointing how many colleagues used the term “unprofessional” when asked about governance of the declarations of financial conflicts of interest.

Ethics, a doctor and his hairt-beat

I had several envelopes like this delivered through my letter-box.

Immediately recognisable, even before opening, I felt my heart (‘hairt’ in Scottish) beat much faster.

I shall try and explain why.

hairt-beat

This is another pattern that I wish to present.

Alexander McCall Smith, as an admirer of my films, wrote to me about our shared interest in patterns. He recommended this book “A pattern language” which has inspired some of my recent posts:

026

The envelopes from NHS Forth Valley to my home address were always from Senior Managers and nearly always officially reminded me of “Good Medical Practice” as issued by the General Medical Council.

Here is an example from a letter from the Medical Director of NHS Forth Valley, Dr Peter Murdoch, to me dated 21st May 2014. It was part of a wider letter .  The letter made references to my “behaviour”. The letter summoned me to an “informal” meeting with the Medical Director and General Manager for NHS Forth Valley:

21-may-2014

When I was off sick, due to work stress, the Locum Consultant who covered for me, had the following experience:

annoyed & demanding

The Locum Consultant concluded that this demonstrated:

disregard

This was the Locum Consultant’s experience of the Medical Director, Dr Peter Murdoch. There was no action taken here.

three

I have many interests: interests which remind me how little I know. One of my interests is in ethics.

In my 13 years with NHS Forth Valley my ethical interests were in three broad areas.

In my time with NHS Forth Valley there was no forum to discuss ethics.

The FIRST was:Timely-can-we-do-better

It is fully accurate to say that not one of my consultant medical colleagues in NHS Forth Valley shared my advocacy for a timely approach to the diagnosis of dementia. Today it is the basis to the diagnosis of dementia across Europe

The SECOND was:
transparency1

I share the view of most ethicists and many in academia that education and research should be free of marketing. Free of any distortion created by financial incentives. I have petitioned for a Sunshine Act (or clause) for Scotland. I believe that a central, open-access register would be straightforward and not at all costly to set up.

The THIRD was:
consent

My view is that we need to consider more fully the importance of consent. Any intervention, be it a test, or a “tool”, or a treatment can have potential benefits and potential harms. These need to be shared as best as we can.

The Former Cabinet Minister for Health and Wellbeing, October 2014:

Neil-12-Oct-14

This week, the General Medical Council published:

CropperCapture[1]

This report confirmed that 54% of those doctors who committed suicide had been referred by their employers.

One response to this GMC investigation remarked:

“There is a parallel with whistleblowing here. The stress of the situation caused mental health difficulties and the person concerned is therefore dismissed as being unwell. Which comes first?”

My experience in raising ethical considerations, and thus trying to put patients first, was very difficult indeed.

I do hope other healthcare professionals, if they raise genuine concerns, will not face what I have faced for raising ethical considerations.

I see a pattern here. So did a senior NHS doctor who wrote to me recently:

“No wonder NHS doctors live in fear when threatened with the GMC for raising ethical concerns in the workplace.”