We need a Renaissance of Generalists

I aspire to be a generalist.

We live between the microscope and the telescope. I am of the view that the art and science of being a doctor requires such necessary width of focus.

Bettina Piko argued in 2002 that we need a “renaissance of polymaths”. It saddens me to consider that the western world, in the time since, has encouraged, and supported, the greater development of specialisms.

This post is about General Practice. My wife Sian has been a GP for more than 25 years.

This week the Royal College of General Practitioners has accused the Scottish Government of “longstanding under funding” of General Practice.

1 in 4 GP practices have a vacancy in Scotland.

I found myself part of a conversation about the current and future state of General Practice on the Stephen Jardine programme, Radio Scotland, on the 14th July 2017:

Are the public being listened to?

This is a current Editorial in the BMJ:
Below are a few extracts from this editorial: In a similar vein to Carl Heneghan, I have outlined that there is a problem with the E in CME (Continuing Medical Education)

Sharing the BMJ Editors concerns about a failure of the Academy of Medical Sciences to take necessary action to ensure trust in science (EBM) and education (CME) this response was submitted:

“We could not agree more with Dr Tom Robinson in that we can only gain the trust of the public if we listen to them. One of us (Dr Peter J Gordon) raised a petition with the Scottish Parliament to consider a Sunshine Act for Scotland, and as part of this a consultation was undertaken with the Scottish public. The majority of those consulted agreed that it should be mandatory for all financial conflicts of interest to be declared on a public register. The Academy of Medical Sciences has gone no further than recommending the development of “frameworks for declaring and managing interests” . We would suggest that this will do nothing to restore the public’s trust.”

Dr Peter J Gordon and Dr Sian F Gordon

The Scottish Public: consulted on a Sunshine Act

The Scottish public were consulted on the need for a Sunshine Act for Scotland. Their response, in majority, was that this was necessary.

Almost a year-and-a-half on and the Scottish Government has provided no update to the Scottish people. This is disappointing given the Scottish Government’s assertion that “everyone matters” to them.

The lack of sunshine legislation in the British Isles is raised in this current BMJ News feature:

This response was submitted by Vagish Kumar L Shanbhag:

Submission on PE1517: Polypropylene Mesh Medical Devices

Submission on PE1517 on Polypropylene Mesh Medical Devices

Made by Dr Peter J Gordon

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

Update, 22 May 2017:

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

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

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

Submission on PE01651: Prescribed drug dependence and withdrawal

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

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

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

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

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

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

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

                      Dr Peter J Gordon
                      GMC number 3468861

Making science a reality

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

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

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

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

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

The full article can be accessed here from the BMJ:






Open and transparent from omphalos on Vimeo.

“The shadowy mandarin class deserves greater scrutiny”

This was a recent post by Walter Humes for the Scottish Review. 

I read this as a personal view about the civil service in Scotland 
(and not just about the governance of the NHS) so I (presume) 
that I am safe to share Professor Hume's view without worrying 
about any potential consequences for me as an NHS employee 
working in Scotland

Wednesday 14th October
I wonder how many SR readers would recognise one or more of the following names: Leslie Evans; Paul Johnston; Alyson Stafford; Graeme Dickson; Paul Gray; Sarah Davidson; Ken Thomson. They all hold important positions which enable them to influence decisions about the future direction of Scottish society. Leslie Evans is the most senior civil servant in Scotland, with the title of permanent secretary. The others head different directorates within the Scottish Government (Learning and Justice; Finance; Enterprise, Environment and Innovation; Health and Social Care; Communities; Strategy and External Affairs). They are called directors-general, a title that manages to carry both bureaucratic and military associations. Brief biographies of each can be found on the Scottish Government website.

Notwithstanding all the talk about openness in public administration, civil servants continue to prefer to remain in the background. They play down the power that they exercise, colluding with politicians in maintaining the fiction that it is always the latter who determine policy, the former merely advising and supporting. One of the most important ways in which senior civil servants can shape events is through their capacity to influence public discourse. They draft minutes, reports, consultation documents and policy statements. The skilful use of language can serve as a form of intellectual control.

The shadowy work of the mandarin class deserves to be subject to greater scrutiny than it normally receives. I offer this as a topic which the recently formed group of investigative journalists in Scotland – called The Ferret – might wish to pursue. They see their role as ‘sniffing up the trouser leg of power’. Sounds good to me.

Director General for NHS Scotland

I have found it impossible to communicate directly with the Director General for NHS Scotland.

The Director General for NHS Scotland does not reply to e-mails sent to him unless you follow this advice from his office:

Paul Gray 02

Please note: The above includes only the first paragraph of the
Deputy Director's letter of the 15 October 2015.

It is essential to note that the Director General had repeated opportunities to make it clear to me that this was the process of communication to be followed. Unfortunately this never happened.

My advice to the Scottish Public is to carefully follow the advice as given by the Deputy Director, Colin Brown. Otherwise you may risk being considered “unwell”, as I have been,  for contacting the Director General through his, openly available Scottish Government, e-mail address.

Paul Gray, PAG1962, Year of Listening, NHS Scotland

Mr Paul Gray, the Director General for NHS Scotland: 
Year of Listening, 2016: "I've taken time to listen"

Over the last 8 months I felt it would not be constructive to attempt to communicate with the Office of the Director General of NHS Scotland.  However, following the EU Referendum the Director General wrote a letter to all NHS Scotland staff in which he stated “I greatly value the contribution of every member of staff in NHS Scotland”. Given that this had not been my experience, I wrote to dghsc@gov.scot expressing this reality which has led me to consider early retirement and asking: “I would be interested in your thoughts and if you have any words of support for me.”

I received the following reply (reproduced here exactly as it was sent):

paul-gray-director-general-chief-executive-1-july-2016

Below: an audio recording of a contribution I made to a 
BBC Radio Scotland discussion on retirement:

My communications in the past to the Director General related to my endeavour to put patients first, specifically in the areas of an ethical approach to the diagnosis of dementia and relating to my petition for a Sunshine Act. The lack of support I received in return is strikingly at odds with the following statement made by the Director General on the Scottish Health Council film below:

“We worry about transfer of power, transfer of responsibility. As far as I am concerned, the more power that patients have, the better. The more power that individuals have, the better. Because they are best placed to decide on what works for them.

To be frank, there is very clear evidence that if people feel powerless their wellbeing is greatly reduced.

If people feel that they have a degree of power, a degree of autonomy that actually helps their wellbeing. So to suggest that it involves something that relates to a loss of power on the part of the service provider, in order for the service user to gain, I think is quite wrong.

I think the service user, the patient, the carer, can have as much power as they are able to exercise without causing any loss or harm to the service provider whatsoever. Indeed I think it is greatly to the benefit of service providers to have powerful voices, powerful patients, and powerful service users, who are able to help us understand what works for them.”

Our Voice: support from senior leaders. 
Published by the Scottish Health Council

Perhaps the following explains why this admirable rhetoric does not seem to play out in practice:

Whistleblowing in NHS Scotland from omphalos on Vimeo.

In Dumfries and Galloway Health: Opinions & ideas, the Director General for NHS Scotland had published in July 2015: “Leadership in a rewarding, complex and demanding world”. The article is worth reading in full but here is one quote:

paul-gray-nhs-scotland-scottish-government-1

This was the response of the Deputy Director as shared with the Director General when I shared my experience of the NHS initiative “Everyone matters”:

deputy-director-to-director-of-nhs-scotland-hes-another-of-our-regular-correspondents

This report in the National describes the Director General’s approach to whistleblowing, an approach that would seem to address only selected recommendations of Sir Robert Francis:

No if yer a whistleblower it's no

all-nhs-workers-should-have-the-confidence-to-speak-up-without-fear-pag1962-paul-gray-chief-executiveThe above interview was published in the Herald on the 26th September 2016.

nhs-staff-too-scared-to-speak-out-paul-gray-chief-executive-pag1962

first-steps-towards-a-more-open-nhs-scotland-paul-gray-herald-chief-executive

In the month before the Director General shared his views with the Herald he had sent the following communication. I acknowledge that I have been persistent but would maintain that this was because of the lack of any substantive responses from his Department. This sort of behind the scenes approach by those in a genuine position of power highlights the very culture that Mr Gray needs to address.  I share the conclusions of the Editor of the Herald that “public statements of intent are not enough”.

from-the-director-general-nhs-scotland-15-aug-2016

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: