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Stifling distortions
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Tag Archives: harm
A tall, slightly stooping, gaunt figure
Dr Robert Hutchison died in 1960, seven years before I was born. However, his appearance as depicted in the portrait (above) reminds me of Roald Dahl. One of his closest friends and colleagues described him in this way:
Dr Robert Hutchison, like Roald Dahl, is recalled for his wonderful way with language. One of my favourite quotes – about the profession in which we have shared across centuries – is by Hutchison. I still find it extraordinary that he wrote this in 1897:
Robert Hutchison was born at Carlowrie Castle, Kirkliston, in 1871.
In the early 1990s I lived with Sian in Kirkliston, at Humbie farm cottages. I was then studying Landscape Architecture at the University of Aberdeen and Sian was completing her GP training in Livingston:
In 1893 Robert Hutchison graduated in Medicine and Surgery at the University of Edinburgh. Like me, he was a very young medical student, but unlike me he was far more promising.
Robert Hutchison delivered his first baby in 1894 at the Simpson Memorial Hospital Edinburgh. I was born in this same hospital 70 years later.
1897, aged just 26 years of age Robert Hutchison co-authored: Clinical Methods: A Guide to the Practical Study of Medicine:
This is still used and is now in its 23rd Edition!
Robert’s sister Isobel Wylie Hutchison was quite amazing. She was a poet, polyglot, painter, botanist and Arctic traveller. She could speak Italian, Gaelic, Greek, Hebrew, Danish, Icelandic, Greenlandic and some Inuit. Carlowrie remained a home for her to return to from travels, although the upkeep was hard and the castle did not have electricity until 1951. Isobel died at Carlowrie in 1982, aged 92.
I was delighted to see Dr Robert Hutchison quoted in a recent BMJ response by Dr Amr K H Gohar. This was in response to this BMJ Analysis:
Dr Gohar titled his response: Primum non nocere (first, do no harm). He summarised the potential harms from early detection which he said may include: overdiagnosis and overtreatment, false positive findings, additional invasive procedures, negative psychosocial consequences, and harmful effects on bodily function.
Dr Gohar confirmed his view [that]: “This does not mean that such early detection should be ignored but it means, as this article stresses, that early detection should be balanced. Critical assessment of early detection including early detection technologies and strategies in clinical practice is indispensable to avoid the persisting bias that early detection is only beneficial.”
This returned my thoughts to communications that I have had with Healthcare Improvement Scotland an NHS Board that is primarily guided by the American organisation: the Institute of Healthcare Improvement.
I have in Hole Ousia expressed my concerns about the approach taken to detection by Healthcare Improvement Scotland. My concerns have related to the lack of consideration of harms of “National Improvement” drives and the continued marginalisation of consent.
Robert Hutchison may have died seven years before I was born. But in 1897 he wrote words that I consider to be most prescient:
"From inability to let well alone; from too much zeal for the new and contempt for what is old; from putting knowledge before wisdom, science before art, and cleverness before common sense; from treating patients as cases; and from making the cure of the disease more grievous than the endurance of the same, Good Lord, deliver us."
Submission on PE1517: Polypropylene Mesh Medical Devices
Submission on PE1517 on Polypropylene Mesh Medical Devices Made by Dr Peter J Gordon Date of submission: 17th May 2017 Submission made in a personal capacity.
The Agenda for the Public Petitions Committee meeting of the 18th May 2017 includes a most helpful summary “Note by the Clerk” on PE1517: Polypropylene Mesh Medical Devices (Document PPC/S5/17/10/1). Having read this carefully, and in accordance with the first suggested “Action” (point 45, page 8), I would like to offer evidence. Before doing so I have listed below the most relevant sections of PPC/S5/17/10/1 in relation to the points of evidence that I wish to make.
In Annexe B of PPC/S5/17/10/1 the Interim and Final Conclusions of the Independent Review are listed side-by-side.
Conclusion 1, both Interim and Final, was that “Robust clinical governance must surround treatment”
Conclusion 3, both Interim and Final, was that “Informed consent is a fundamental principle underlying all healthcare”
In Annexe C: Parliamentary Action (page 21 of PPC/S5/17/10/1) the Cabinet Minister for Health, Shona Robison answered question S5W-07749 by Neil Findlay, MSP on the 17 March 2017, by stating:
“Informed consent and shared decision making are expected prior to any procedure being carried out. The Chief Medical Officer goes into this in more detail in her Realistic Medicine report.”
The Clerk, in point 7, (page 2 of PPC/S5/17/10/1) confirms that:
“The Scottish Government does not have the power to regulate what medical devices are licensed for use in the UK. The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medical devices in the UK”
The Clerk, in point 12 (page 3 of PPC/S5/17/10/1) includes quotations from the Preface of the Review’s Independent Report:
“We found some concerning features about how new techniques are introduced into routine practice” and that
“We are aware that some of our conclusions have wider implications and see the need to embed this in patient Safety and Clinical Governance strands of the NHS”
Points of Evidence by Dr Peter J Gordon (GMC number 3468861) • HDL62: the Scottish Government has acknowledged that this Guidance is not being followed by NHS Boards • There have been media reports that NHS professionals working in Scotland, who are involved in educating NHS staff about Mesh procedures, have been paid by commercial sectors who have financial interest in Mesh products. • PE1493, A Sunshine Act for Scotland, was closed in February 2016 • A Public Consultation on PE1493 was undertaken by the Scottish Health Council. The Scottish public, in majority, were of the view that it should be mandatory for all financial payments made to healthcare workers and academics to be declared in a publically accessible form • No meaningful update has been provided by the Scottish Government since this Public Consultation was published more than a year ago. • I fully support the Chief Medical Officer’s “Realistic Medicine” initiative and I have suggested that Sunshine legislation should be considered an essential part of this development • I agree with the Independent Review that “robust clinical governance must surround treatment”. I am concerned that if the current situation continues, where “education” of health professionals may be significantly based on marketing, further examples of iatrogenic harm may occur in NHS Scotland. • The Independent Review concluded that “informed consent is a fundamental principle underlying all healthcare”. If the advice given to patients is based on marketing, either partially or wholly, then informed consent may be denied patients. Further examples of Iatrogenic harm may then unfortunately occur and healthcare in Scotland may risk being considered as unrealistic rather than “realistic”.
Update, 22 May 2017:
Public Petitions Committee – Scottish Parliament: 18 May 2017 (click on image below to watch the full meeting)
The official report of the Public Petitions Committee of 18 May 2017
Sunday Post, 21 May 2017: ‘Probe to examine possible conflicts of interest in troubled mesh implant inquiry’
The objection to being stepped on
NHS Forth Valley – unable to offer reassurance
There were a number of reasons why I left NHS Forth Valley. One of those reasons was a concern that patients, often elderly, were being harmed through the misdiagnosis of dementia.
Shortly after I left I wrote to senior management seeking the following reassurance:
- that any patients that have been harmed are acknowledged and where appropriate supported in coming to terms with their mis-diagnosis,
- that practice in NHS Forth Valley now follows Scottish, UK and International guidelines on Dementia.
- that NHS Forth Valley has, as an organisation, reflected on this matter
Following a reminder I received a reply suggesting that examining comparative data would be helpful but would take some time:
Following another reminder I have now received what I take to be the final position of NHS Forth Valley on the matter. My understanding of this is that NHS Forth Valley cannot provide the reassurance that I was seeking:
I have sent the following letter to NHS Forth Valley which reiterates my ongoing concerns:
"I remain concerned about the potential for harm relating to the over-diagnosis of dementia. I understand that you are not in a position to reassure me on this in terms of patients referred to NHS Forth Valley. I would welcome it if this “could potentially be explored in the future.” I note and understand your general comments about reflection. The book “Intelligent Kindness” considers the importance of reflection not just at an individual level but also at an organisational one. I feel that it is now time to conclude our correspondence on this matter."
If anybody would wish to see the full context of the letters please contact me.
My lovely furry wolfskin coat
This is a film about inappropriate and unhelpful medicalisation and the lasting effects that this can have.
To be absolutely clear; this film refers to no living professionals.
My lovely furry Wolfskin coat from omphalos on Vimeo.
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”:
Update, 5th October 2016. The following was published on the front page of the Scotsman newspaper: "Mental health prescriptions hit ten-year high"
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.
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:
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.
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.
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
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.
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:
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".
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):
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
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:
In the references provided by Sunovion in this “promotional brochure” we have:
Sheldon Preskorn
who received nearly $112 in 2015 from the pharmaceutical industry:
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:
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?
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:
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)
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.
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.
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:
- BMJ Change paper “Don’t use antipsychotics routinely to treat agitation and aggression in people with dementia”. (November 2014)
Update, 5th October 2016. The following was published on the front page of the Scotsman newspaper: "Mental health prescriptions hit ten-year high"
The figures are from the Scottish Government and can be accessed here.
