What you need to know

1 in 7 Scots are on an antidepressant. Some Scottish academics have argued that this is “appropriate prescribing” for “recurrent” and “chronic” conditions.

Antipsychotic prescribing, in all age-groups, has risen year-on-year since the Scottish Government started measuring such prescribing. Last week NHS Scotland was struggling to source one such antipsychotic, namely haloperidol. Intramuscular haloperidol may not be available for 14 months. I do not know if this is a supply or demand issue, however this medication is being most extensively used in NHS hospitals in Scotland despite generally being prescribed “off-label”.

With this in mind I present a pattern that emerged from reading the current British Medical Journal alongside my weekend newspapers.  Here is what they both suggested that “you need to know”:

All the other children are on it, 21 Nov 2015, Guardian Andrew Lansley, Roche 20 Nov 2013 Disney and McDonald's staple, 21 Nov 2015, Guardian Generation meds, 21 Nov 2015, Guardian Long term effects on oor children, Guardian, 21 Nov 2015 Now you are my friend, Nov 21, 2015, Guardian Pharmacological mission creep, BMJ, 20 Nov 2015 What you need to know, Bmj, 21 Nov 2015

Update, 5th October 2016. The following was published on the 
front page of the Scotsman newspaper: 

"Mental health prescriptions hit ten-year high"

prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-a prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-b

The figures are from the Scottish Government and can be accessed here.

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:

“Authenticity”: The British Journal of Psychiatry

I have always enjoyed the 100 word summary in the British Journal of Psychiatry, even if I may be troubled by matters made simpler than they really are!

In the current edition of the British Journal of Psychiatry, September 2015, the 100 words try to summarise “Authenticity:

Authenticity, Br J Psychiatry Sept 2015

Recently I made a film about the history of the cover of the Journal of my College: By yellow lights tormented. In doing so I reviewed the archive of the Journal stemming back the full 22 years that I have been working as an NHS psychiatrist. In only one edition did I find that the adverts of those sponsoring the journal had been included in the archive. This concerned me.

By yellow lights tormented from omphalos on Vimeo.

In the current edition of the British Journal of psychiatry there are three full page adverts, all for medical treatments for ADHD. I wonder if they will be included in the archive?

Elvanse Adult, Br J psych Sept 2015 Matoride XL, B J Psych 2015 Medikinet XL B J Psych Sept 2015

However we choose to summarise “authenticity” I very much agree that it matters.

Footnote:  I would like my profession to fully distance itself 
from marketing. This should happen now and without further ado.

Haloperidol prescribing to Scotland’s elders

In a previous post the FOI returns on Haloperidol prescribing in NHS Scotland were shared.  This followed on from my consideration of a BMJ report regarding the scale and potential harms of  such “off-label” prescribing to our elderly in hospital.

Since that time I have had a response from Professor Jason Leitch, National Clinical Director, Healthcare Quality, Scottish Government:

Letter from Prof Leitch

Today I have sent this reply to Professor Leitch:

To: Professor J. Leitch,
National Clinical Director, Healthcare Quality,
Healthcare Quality and Strategy Directorate
Planning and Quality Division
St Andrew’s House,
Regent Road,
Edinburgh EH1 3DG

8th June 2015

Dear Professor Leitch,
I was most grateful to receive your letter of reply dated 2nd June 2015.

I thought it best to reply to you to clarify the focus of my concerns. I wish to try and keep my reply short and focussed on the points you raise.

Point ONE:
You state that the Scottish Clinical Advisor for Dementia informed you that the “off-label use of Haloperidol for dementia is not especially unusual”. This would seem to diverge from  this BMJ change page made by NHS England’s National Clinical Director for Dementia, Professor Alastair Burns (I attach the full paper)

Dont use

You cite SIGN 86 guidelines on Dementia. These guidelines were issued 9 years ago when it was stated that “they will be considered for review in three years.” SIGN 86 is specifically for dementia and not delirium. The SIGN website indicates that there is no current plan to update SIGN 86 nor to introduce a Guideline on Delirium:

SIGN 86 was criticised in this research: Knűppel H, Mertz M, Schmidhuber M, Neitzke G, Strech D (2013) Inclusion of Ethical Issues in Dementia Guidelines: A Thematic Text Analysis. PLoS Med 10(8): e1001498. doi:10.1371/journal.pmed.1001498. I find it disappointing that an outdated and flawed guideline is still the basis for prescribing in dementia.

Ethical issues

Point TWO:
Haloperidol prescribing is part of the “Comprehensive Delirium pathway” introduced across NHS Scotland by the Scottish Delirium Association (SDA) and Healthcare Improvement Scotland (OPAC). You will be aware of this as I note that you are giving the key-note talk this week at the conference: Transforming delirium care in the real world”. Over a year ago the Secretary of the Scottish Delirium Association asked me to summarise my views on delirium improvements happening in Scotland. I did so and shared these with the SDA and with OPAC. I am disappointed to note that no reply has been forthcoming. I attach this summary for you with this letter.

Transforming delirium care in the real world

Conclusion:
It is welcome to hear that the Scottish Government are taking actions here. It is the case, by Scottish Government figures, that antipsychotic prescribing is increasing year-on-year in NHS Scotland. I seek improved care for individuals with delirium and dementia. I am concerned that current approaches, along with staff shortages and increased demands on staff time, are making it more rather than less likely that our elders may receive antipsychotic medication that can result in significant harms.

Yours sincerely,
Dr Peter J. Gordon

Included with letter:

Update, 5th October 2016. The following was published on the 
front page of the Scotsman newspaper: 

"Mental health prescriptions hit ten-year high"

prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-a prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-b

The figures are from the Scottish Government and can be accessed here.

Do we care enough about consent?

This leaflet is widely available to patients in NHS Scotland including in the waiting room outside my consulting room: 039

Its first page defines consent as follows:038

This is the front page of the current BMJ:021

It is reporting on a legal ruling which has implications for consent as summarised by the editor:051052 053 054

Previously Sokol has said:013

I have had a longstanding interest in consent:015

Consideration of patient consent goes back to the earliest days of the NHS (and indeed before):032

I have previously highlighted how this difficult area becomes even more complex when we are considering cognitive screening:014

Scotland led the way with an incentivised target-based approach to the “early diagnosis” of dementia. The following is from one of the earliest expert meetings:First Dementia Strategy Meeting

A few years later the Scottish Government were sharing widely league tables:002

The Scottish Government commended its own approach to the Westminster Government:How to improvegeoff-huggins4 Geoff Huggins3

It was this robust approach that led me to consider whether the consent to assessment of the individual patient might be significantly affected by an external target. It was at this stage I contacted the National Clinical Leads for dementia, specifically highlighting my concerns about consent:Dementia Leads1

The Scottish Lead for Dementia replied:Dementia Leads2

I was delighted to attend this Conference in Glasgow which culminated in the signing of a rights-based approach to dementia:034044

At this Conference, the Chief Executive of the Mental Welfare Commission gave an address. Mr Colin McKay reminded us that for any individual deemed to lack capacity certain principles should apply. This includes having one’s own wishes listened to:
020

The previous Chief Executive of the Mental Welfare Commission offered his personal view on consent to examination. For many reasons I believe that cognitive screening is a very different activity to measuring blood pressure:056

I have also been in conversation with parliamentarians regarding consent to cognitive screening. In my letter to Dr Simpson, MSP, I highlighted the following points:

  • my concerns are specifically about obtaining consent to cognitive screening
  • Cognitive screening does not fulfill World Health Organisation criteria (Wilson & Jungner)
  • the UK National Screening Committee do not advise screening for cognitive impairment

Richard Simpson2

This is the view of the former Cabinet Minister for Health & Wellbeing:At liberty

I have also asked the UK’s leading Dementia charities about consent:042

I have recently written to Alzheimer Scotland about their current campaign: “Lets talk about dementia”. Disappointingly this appears to have back-tracked from the Glasgow Declaration and is advocating early rather than timely diagnosis. The “difficult conversation” as suggested by Alzheimer Scotland appears to me to trivialize consent:033

I have also had a number of “difficult conversations” when trying to raise issues of consent:Dr Brian Robson

One of the many reasons why this matters is that cognitive screening is not risk-free. 046047

Off-label anti-psychotic prescribing has increased year-on-year in the elderly across Scotland.

It is my view that those promoting improvement methodologies in NHS Scotland are currently not taking consent sufficiently seriously. It appears that I am not alone in having found these conversations “difficult”:061

The following post was about improvement work in the elderly on the Ayrshire Health blog. The full post and all responses to it can be read here:Flying without wings1

I submitted a reply which outlined my considerations about obtaining consent for cognitive screening. In response to my considerations, the Associate Nurse Director of Mental Health Services in NHS Ayrshire and Arran and Chair of the Mental Health Nursing Forum Scotland, appeared to remain unsure of the basis of my concerns:Flying without wings2

Professor June Andrews, Director of the Dementia Services Development Centre offered the following advice:June Andrews3

A service user shared my concerns about patient consent and raised the matter with the Ethics Committee of the Royal College of Psychiatrists:    John Sawkins

Over a decade ago, NHS Scotland published this Expert Group report:Adding life to years, 2002 aAdding life to years, 2002 cAgeism in NHS Scotlandc

This blog post asks if we care enough about consent? My view is that the principle of patient consent should be a fundamental right for all ages. It is the case that consent is a complex area but this is not a good enough reason for marginalising it. I would argue strongly that wider discussion particularly involving all of our elders is long overdue.

“Doing damage in delirium the hazards of antipsychotic treatment in elderly people”

This paper was published in the Lancet in late last year. It is a two page article that is worth reading in full. All screenshots below are from this paper:001

The authors commented that002

The authors were of the view that003

Scottish Government figures confirm that prescribing of antipsychotics is rising in our elderly. It thus seems important to consider why this may be. The authors continue:004

There is always the risk in times of austerity, and when staffing levels are not ideal, that:005

The authors state:006

The promotion of off-label use of antipsychotic medication was instrumental in my petition to the Scottish parliament for a Sunshine Act:007

The authors continue:

008

But what does the evidence have to say? The authors state:009

The authors continue:011

The authors ask:012

The authors conclude with Dr William Osler:013

I am also of the view that there is a risk that “brief screening tools” may result in “pathways” being followed that, despite good intentions, lead to greater prescribing of antipsychotics in our elderly. I am aware that currently “brief screening tools” are being promoted in Scottish NHS hospitals.

I wish to conclude with one recent example of many: an elderly woman, with terminal cancer returned to her GP after a recent period in hospital. She asked her GP “But why am I on this anti-schizophrenic drug?”

Update, 5th October 2016. The following was published on the 
front page of the Scotsman newspaper: 

"Mental health prescriptions hit ten-year high"

prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-a prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-b

The figures are from the Scottish Government and can be accessed here.

Reply from Scottish Government

Geoff Huggins,
Head of Mental Health at The Scottish Government,
Directorate for Health and Social Care Integration Mental Health and Protection of Rights Division

T: 0131-244 3749
geoff.huggins@scotland.gsi.gov.uk

26 September 2013

Dear Peter
I said I would write to you with a summary of our meeting on 19 September.

This was a wide-ranging meeting although the initial focus of your engagement over recent months has been on dementia.

We covered your concerns on what you see as the risks around over-diagnosis of dementia and the over-medicalization of memory loss in old age. As discussed the Scottish Government’s shift of emphasis from early to timely diagnosis is quite a subtle and nuanced one reflecting the balance of clinical and other opinion in favour of the latter. The essential principles – reflected in our strategic focus on post-diagnostic support embodied in the HEAT target – are that, as you know, people benefit from an accurate and timely diagnosis and there can be significant advantages in getting the diagnosis at the stage of the illness (early on) when they can get optimum benefit from post-diagnostic support to adjust to the diagnosis (both psychologically and practically), connect better and navigate through services and plan for and make active and informed decisions on future care.  We recognise that there are some challenges around early diagnosis in that diagnosing some dementias are difficult in the early stages.

You also shared some concerns you have about the potential ethical issues around diagnosis and the roll-out of post-diagnostic support in areas such as consent and confidentiality. More broadly you are strongly of the view, as we are, that responding to memory loss and dementia should be informed by a holistic, person-centred and human rights-based approach. This is exactly the approach taken in developing and implementing not only the post-diagnostic HEAT target – which adopts a comprehensive, person-centred model, supported by the roll-out of national training and awareness not only to front-line staff but also to operational and strategic managers – but also the dementia standards and the Promoting Excellence framework.

In dementia and other areas you expressed your on-going concerns about the risk, as you see it, of disproportionate influence of pharmaceutical companies in inculcating and sustaining a clinical culture where there are risks of over-diagnosis and where drug treatments are over-prescribed. You argue that greater transparency is needed regarding the relationships between such companies and individual clinicians and practices.

We had some discussion on the prescribing of anti-depressants. I explained that although our national target on reducing anti-depressant prescribing had been superseded on our target on increasing access to psychological therapies as a main lever for change and improvement, implementing the anti-depressant target in Scotland had been an immensely valuable process and helped us learn more about the issues involved than many other parts of the world.

We have good evidence of the appropriateness of clinical practice in this area. The study “ Newly initiated anti-depressant treatment in Scotland: a database study” (Christopher Burton & Colin Simpson, Centre for Population Health Sciences, University of Edinburgh) found that their “data suggest better adherence to treatment [in Scotland] than in three recent reports using comparable routine care data from England, Spain and the USA” . In addition, John Gillies, the Royal College of General Practitioners Chair has said:  “As the stigma attached to mental health has declined, more patients raise problems such as depression with their GPs. There is good evidence that GPs assess and treat depression appropriately. Good prescribing practice often means treating patients at a therapeutic dose for longer to avoid a recurrence. This explains much of the rise in prescribing”.

Our over-riding principles are that people with mental illness should expect the same standard of care as people with physical illness and should receive medication if they need it. While we ensure those who need medication continue to receive it, we are also committed to improving access to alternatives, such as psychological therapies, that increase choice and best accommodate patient preference.

Thank you for taking the time to meet with me.  Please let me know if at any time you wish to or have the time to get involved in or contribute to dementia work streams being taken forward as part of implementing the 2013-16  strategy. I know you have already contributed your views on our work with stakeholders to develop a national commitment to reduce the prescribing of inappropriate psychoactive medications in the treatment of dementia.

Yours sincerely

Geoff Huggins sig

GEOFF HUGGINS