“The Law of the Few”

Malcolm Gladwell in his book ‘The Tipping Point’ describes what he terms “The Law of the Few”: namely that the influence of a few people can result in change in behaviour across a wider population.

This Hole Ousia post is about the education of psychiatrists and takes all its material from publically available sources. This post hopes to demonstrate the considerable reach (to the many) of a handful of educators.

This post follows on from the evidence that was gathered for my petition to the Scottish Parliament to consider introducing a Sunshine Act for Scotland. That petition closed 16 months ago following a consultation with the Scottish public who, in majority, asked that payments made to healthcare workers and academics be declared on a mandatory basis. I have argued the reasons why I am of the view that such mandatory declarations should be registered on a single, open, central, searchable, independent database.

Evidence has demonstrated that when a doctor has a financial “conflict of interest”, this can affect the treatment decisions they make, or recommend. There is longstanding evidence that exposure to industry promotional activity can lead to doctors recommending worse treatments for patients.

The post has come about following my invitations in the last month to Continuing Medical Education (CME) provided in my place of employment (NHS Scotland). I do not knowingly  attend sponsored medical education and so declined these two talks. The first was by Dr Peter Haddad (sponsored by Lundbeck) and the next one, just two weeks later, was by Professor McAllister Williams (sponsored by Lundbeck).

I am an ordinary psychiatrist working in a provincial NHS general hospital and to find such prominent individuals visiting our wee corner of Scotland left me to reflect upon the wide influence of a few key individuals.


The British Association for Psychopharmacology (BAP) describes itself as “a learned society and registered charity. It promotes research and education in Psychopharmacology and related areas, and brings together people in academia, health services, and industry.”

Professor Hamish McAllister-Williams is an Ex-Officio Member of BAP and is currently the BAP Director of Education.  Dr Peter Haddad, former Honorary General Secretary of BAP, has been involved over a number of years with BAP education providing articles and masterclasses.

Over the course of my career as a psychiatrist I have frequently heard colleagues say that BAP “is the place to go” for CME.  It is now a requirement for General Medical Council Appraisal and Revalidation to demonstrate with our College that we have participated in CME. Once this has been demonstrated the Royal College of Psychiatrists will issue a Certificate of “Good medical standing”.

As BAP Director of Education, Professor McAllister Williams recently shared this offer to trainee psychiatrists. Following the dissemination of this I took the opportunity to look more closely at the current BAP calendar for Continuing Medical Education. This again demonstrates the wide influence of a small number of individuals, some of whom would appear (within the limits of the current voluntary disclosure regime) to have potential financial conflicts of interest.

In the remaining part of this post I have included a few examples

As BAP Director of Education, Professor McAllister Williams chaired this BAP 2015 Summer Meeting: “Expert Seminar in Psychopharmacology”. The key-note speaker was Professor Stephen Stahl who many consider as one of the most influential key opinion leaders in world psychiatry.

In the USA, pharmaceutical and medical device companies are required by law to release details of their payments to doctors and teaching hospitals for promotional talks, research and consulting. This was the return for Professor Stahl at the time of his contribution to BAP as an educator of UK psychiatrists:

In the UK disclosure of payments is on a voluntary basis.

Professor David Nutt, former BAP President, has declared financial interests on the voluntary ABPI Register. Over the ABPI “disclosure period”, Professor Nutt has declared just short of £46,000 that he has received from Janssen-Cilag Ltd and Lundbeck Ltd.

There are strong links between BAP and the Royal College of Psychiatrists. The President Elect for BAP is Professor Allan Young.  Professor Allan Young is Chair of the Psychopharmacology Committee of the Royal College of Psychiatrists. Dr McAllister Williams, the BAP Director of Education is an appointed member of this Committee. Some years ago I wrote this post about the Royal College of Psychiatrists Psychopharmacology Committee.

Some years ago I put together this Hole Ousia post on Professor Allan Young and also this post. It is clear that Professor Allan Young remains a very active educator and opinion leader in the UK and beyond:

Professor Guy Goodwin was President of BAP between 2004 and 2005. In April 2014 he featured prominently on  BBC Panorama:

On the 40th anniversary of BAP, Professor Peter J Cowen was given the Lifetime Achievement award:

Professor Philip J Cowen featured in this post of Hole Ousia of some years back: All in the past? Well no. Definitely not.

Conclusion:
The recently retired CEO of the Royal College of Psychiatrists, Vanessa Cameron, who had been with the College for 36 years was interviewed for the Psychiatric Bulletin in December 2016. This was the view that she expressed:

Each time I reconsider this subject I do not find evidence to support this view. My worry is that the Royal College of Psychiatrists is being complacent in facilitating the education of the many by such a small group of individuals. The Law of the Few.

Footnote:

If you click on each invite below you will access what is available 
in the public domain regarding the educational activities of the 
recent speakers. I apologise if this is in any way an incomplete 
record.

 

Continuing Medical “Education”

To be revalidated by the General Medical Council all UK doctors have to evidence participation in Continuing Medical Education (CME). This is based upon an accredited system of Continuing Professional Development (CPD).

CPD is mandatory.

This Hole Ousia post considers CPD for UK psychiatrists.

This week I was included in a circular e-mail that ‘sign-posted’ this free CPD educational opportunity for trainee psychiatrists. I was asked to share this with trainees.

BAP is acronym for the British Association of Psychopharmacology. I frequently hear colleagues describe it as “the place to go to” for CPD.

This is the current Calendar:

I have written on a number of occasions over the last few years to BAP about transparency of financial conflicts of interest:

BAP have now significantly improved on transparency and each speaker now has a link to any declared financial interests. This is available to professionals and public alike.

The declarations however give no details of amounts paid for any particular service.

BAP educational events are regularly advertised in the British Journal of Psychiatry

The Chief Executive of the Royal College of Psychiatrists recently offered this reassurance (Psychiatric Bulletin, December 2016):

Last year £340 million was paid by the Pharmaceutical Industry to UK healthcare workers for “promotional activities”.

There is currently a voluntary register (ABPI).

The BMJ reported this in March 2017:

As it stands, professionals, patients and public alike can have no clear understanding of where this £340 million went to in the UK for “promotional activities”.

However we do have evidence that promotional activity can lead to doctors recommending worse treatments for patients.

Returning to the Continuing Professional Development (CPD) calendar that the British Association of Psychopharmacology (BAP) is currently providing. It took me a full day to go through the declarations. These follow below, in alphabetical order of  educator:





In summary it is encouraging to see these declarations of financial interests for BAP educators. This is a group of professionals who have a position of significant influence over the prescribing patterns of current and future psychiatrists. This means that even those doctors who regard themselves as not being subject to conflicts of interest may be indirectly influenced.

It is my concern that this potential influence is not always recognised by colleagues attending CPD in good faith and this is my reason for compiling this post.

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.

“A robust learning environment for healthcare professionals”

I have recently posted on the promotion of Lurasidone (Latuda) in the UK. This has raised concerns for me about transparency of conflicts of interest for some of the key doctors and academics involved with the research, development and promotion of this novel antipsychotic.

One of those who has most significant financial interests is Professor Stephen Stahl. In “partnership with” the British Association for Psychopharmacology he recently gave this “Expert Seminar” at the University of Bristol:

Expert Seminar Lurasidone Stahl 1

This “Expert Seminar” is introduced by Professor Stahl as follows:

Expert Seminar Lurasidone Stahl 2

And here is the Programme for this “robust learning environment” which is co-chaired by British Psychiatrist and Academic, Dr Hamish McAllister-Williams:

Expert Seminar Lurasidone Stahl 7

“Application” was made by Sunovion for CPD approval to the Federation of the Royal College of Physicians of the United Kingdom.

Expert Seminar Lurasidone Stahl 3

Summary:
This “robust learning environment for UK health professionals” has left me asking some questions:

  1. Were the healthcare professionals made aware that Professor Stahl has been paid over $3.5 million dollars since August 2013 by 15 Pharnmaceutical companies including SUNOVION?
  2. Can healthcare professionals and the public easily access Professor Stahl’s declaration of financial interests as required by the British Association for Psychopharmacology?
  3. What is the rationale of the Governance Panel for the British Association for Psychopharmacology in approving such “robust learning environments” for healthcare workers?
  4. Was this “Expert Seminar” approved for CPD by the Federation of the Royal College of Physicians of the United Kingdom?
  5. Where can the public find which healthcare workers received such “robust learning”?

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:

Stephen Stahl: $3,581,159 in payments from Pharma

In my last post I considered the level of transparency provided by the British Association for Psychopharmacology (BAP) in relation to its recently published Guidelines on prescribing for depressive disorders.

This post, will very briefly look at the programme for the recent 2015 Summer Meeting and specifically the issue of transparency:

07BAP

If you download the programme and then type “declaration” into text search you get zero responses.

The programme does list these sponsors:

08BAP

I noticed that Stephen Stahl was giving several keynote educational talks on day one of this conference for the British Association for Psychopharmacology (BAP). Stephen Stahl is a world-wide “key opinion leader” who has his home in California.

09BAP

In America all payments to individual doctors and academics must be provided for the public. This being a statutory requirement of a Sunshine Act. All payments can be established by typing into a searchable database called dollars for docs.

Here is the return, as at the time for writing, for Dr Stephen Stahl:

Stephen Stahl

In the United Kingdom the public have no way of establishing if or how much individual British doctors or academics may have been paid by the pharmaceutical industry or by other commercial companies. When these individuals are involved in educating the healthcare profession or drawing up guidelines this situation needs to change. And soon.