‘It was odd being dead’

This is a fictional film. It is about a teddy bear, Dr Hale Bopp and a day of two halves. In the morning Dr Hale Bopp goes exploring in the Scottish Borders and he comes across the ruin of the Monteath mausoleum on Gersit Law. The oak door of the mausoleum has been breached and one can get inside and be with Monteath and the two angels that guard this forgotten statesman. Above him the dome has beautiful window stars to the universe beyond.

Dr Hale Bopp is a well-travelled bear and is constantly exploring, enjoying and reflecting upon the world in which he lives. The guid doctor has come to the view that life is complex, diverse and sometimes “messy”. He leaves the Monteath mausoleum with paws that were muddy and heads for a different afternoon. An afternoon of Appraisal to ensure that as a fictional bear and doctor that he is providing Good Medical Practice.

So that was the day of two halves. This film is about that.

Dr Hale Bopp is getting on a bit now and is at the end of his fictional medical career. One day soon he will retire from being a doctor but meantime he is of the view that his wanderings, philosophical and creative between the arts and sciences, has been nothing but to the benefit of the patients that he cares for.

Important note:
None of the words used in this film are those of the filmmaker. They are “borrowed” from C.P. Snow’s “Corridors of Power”; Evelyn Waugh’s “Decline and Fall”; and Jessie Burton’s novel “The Muse”.

‘It was odd being dead’ from omphalos on Vimeo.

Source material:
(1) Physicians of the future: Renaissance of Polymaths? By B F Piko and W E Stempsey. Published in The Journal of the Royal Society for the Promotion of Health. December 2002, 122(4), pp. 233-237
(2) Time to rethink on appraisal and revalidation for older doctors. By Dr Jonathan D Sleath. Letter published in the BMJ, 30 December 2016, BMJ2016;355:i6749
(3) Career Focus: Appraising Appraisal. Published in the BMJ 21st November 1988, BMJ1988;317:S2-7170
(4) Revalidation: What you need to know. Summary advice for Regulators. General medical Council.
(5) The Good Medical Practice Framework for Appraisal and Revalidation. General medical Council.
(6) Taking Revalidation Forward: Sir Keith Pearson’s Review of Medical Revalidation. January 2017.
(7) GMC response to Sir Keith Pearson’s report on Taking Revalidation Forward.

Music credits (under common license, thank you Dexter Britain):

(1) Perfect I am not – by Dexter Britain
(2) Telling stories – by Dexter Britain


Making science a reality

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

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

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

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

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

The full article can be accessed here from the BMJ:






Open and transparent from omphalos on Vimeo.

The Scottish Public Want Sunshine

There is a long standing joke about the lack of sunshine in Scotland.

Three years ago I began the process of raising a petition with the Scottish Parliament to urge the Scottish Government to introduce a Sunshine Act.

A Sunshine Act makes it a statutory requirement for all payments from commercial interests made to healthcare workers and academics to be declared publically. The metaphor is that sunshine brings full light. Both the United States of America and France have introduced a sunshine act.

The doctor in Gabriel García Marquez’   ‘Living to tell the tale’ says “Here I am not knowing how many of my patients have died by the Will of God and how many because of my medications”. Márquez often returns to the theme of medical ethics in his writings and reminds us that all interventions have the potential for benefit and harm.  In ‘No one writes to the Colonel’, “a man [who] came to town selling medicines with a snake around his neck”. Here Márquez is reminding us of the long history of the financial opportunities open to healthcare professionals.

As a junior doctor in around 2000, I was handed by a Consultant a several hundred page document entitled “Behavioural and Psychological Symptoms of dementia”. The Consultant told me “this is the way forward!” Some years on I came to realise that this document had been developed, funded and disseminated by the Pharmaceutical Industry whose first loyalty, as a business, is to its share-holders.

In the wake of the dissemination of this document, prescribing of antipsychotics, sedatives and antidepressants in Scotland has been rising year on year. This has been described as mass prescribing, and is often long-term. Yet the evidence to support such prescribing is poor.

There is much promotion of “partnership working” between industry and healthcare. Yet we must remember that these two partners have different aims, and it is the responsibility of healthcare workers to follow the ethical approaches central to their professions. For example, the General Medical Council is clear about what is expected of doctors in their code “Good Medical Practice”. The potential for conflicts of interest is recognised and doctors are advised “you must be open about the conflict, declaring your interest formally”.

Since 2003, Scottish Government guidance has been in place to allow the declaration of financial interests of NHS staff, to their employing health boards. As a result of my petition, the Scottish Government has confirmed that this guidance is not being followed.

One key area of concern is the continuing professional education of healthcare professionals, another requirement of professional bodies. In at least two Boards in NHS Scotland, continuing medical education relies entirely on the financial support of commercial interests.

National and international conferences may also form part of continuing professional education. Because of the Sunshine Act in the USA, we know that a key-note speaker at a recent UK conference has been paid more than £3 million dollars by the pharmaceutical industry since the Sunshine Act was introduced. There is currently no way of knowing the scale of any payment made to a UK speaker sharing the same platform.

My experience of trying to clarify if there is transparency about financial payments in Scotland has been revealing. I have encountered significant defensive reactions from individuals and organisations. There has long been a body of evidence that, for example, prescribing behaviour is influenced by commercial interests, yet doctors find it hard to accept this. This collective denial would suggest that the forthcoming (voluntary) ABPI Register is unlikely to work as many will regard it as not applying to them and will therefore opt out.

As part of their consideration of my petition, the Scottish Government commissioned a public consultation exercise on a need or not for a Sunshine Act. The majority of participants expressed their view that all financial payments should be declared on a single, central, searchable register and that this should be a mandatory requirement.

The forecast for Scotland looks good: sunshine.

 

A letter that the Scottish Parliament felt unable to publish

With careful thought, and backed with full supporting evidence,  I sent the following letter of the 2nd February 2016 to support my petition for a Sunshine Act for Scotland.

The Senior Clerk of the Parliamentary Committee was of the view that this letter did not comply with the Scottish Parliament’s policy on the treatment of written evidence. I was therefore asked to redact significant sections of the letter.

After considerable communications to and fro, I replied as per this e-mail of the 3rd March 2016:

I fully respect the right of the Scottish Parliament to determine 
what it publishes.

I feel very strongly that my letter without the highlighted text 
merely reiterates what I have already said, and fails to provide 
the evidence that I have repeatedly been asked for.

So my position is that I do not wish to amend my letter of the 
1st February on PE1493.

My petition has since been closed. I therefore have decided to publish my letter to the Scottish Parliament in full along with supporting evidence. I have had professional advice that what is contained in this letter is not defamatory as it is based on veritas and has full supporting evidence:

Dear Mr McMahon
Petition PE01493: A Sunshine Act for Scotland

I realise that the Committee must receive a great amount of correspondence however I hope that the committee might agree that what follows is extremely important when considering PE1493.

Since I last wrote to the committee I attended, for accredited continuing medical education, the Royal College of Psychiatrists in Scotland Winter Meeting held on the 29th January 2016. It is this that has compelled me to write this update as it demonstrates beyond doubt that lack of transparency around financial conflicts of interest remains a serious issue. An issue with implications for both patient safety and healthcare budgets. It also demonstrates that Government action is the only way to address this.

The full powerpoint presentations of this Accredited meeting for 
Continuing Professional Development can be accessed here - but only
for members of the Royal College of Psychiatrists. 

I am a member of the Royal College of Psychiatrists and I am of the 
view, as a scientist, that these lectures should be available to all 
and not just to members.

One speaker highlighted the increase in prescribing costs in her health board area which was due to the high prescribing rate of a new antipsychotic injection, palperidone depot (XEPLION®). The next speaker demonstrated both the inferior effectiveness of this drug when compared to existing (far cheaper) depot medications and the perception amongst Scottish psychiatrists that it was more effective. Below you will see the flyer sent to mental health professionals in Scotland when this drug was launched:

002 Financial Conflicts of Interest, Scottish Psychiatry

I have highlighted one of the paid speakers, Dr Mark Taylor, because he also spoke at this week’s meeting where he reminded us that he was Chair of SIGN Guideline 131: The Management of Schizophrenia, which was published in March 2013.

At this week’s meeting Dr Taylor presented his declarations as follows: “Fees/hospitality: Lundbeck; Janssen, Otsuka; Roche; Sunovion”.

Dr Taylor commented on these declarations with the statement that “you are either abstinent or promiscuous when it comes to industry. Well you can see which side I am on”. Audience laughter followed.

The general question that arises is whether an influential professional such as a Chair of National Guidelines might earn more from the pharmaceutical industry than in his or her role as a healthcare professional? At present it is impossible for anyone to establish the scale of competing financial interests. To remind the committee the following avenues are not illuminating:

1. Royal College of Psychiatrists. This week’s meeting did not appear on the college database. In any case this database is neither searchable nor does it include specific details of payments and dates

2. NHS Boards. The committee has already established that, across Scotland, HDL62 is not being followed.

3. SIGN guidelines. The committee is aware of significant governance failings particularly in comparison with NICE which includes details of financial sums paid and associated dates.

4. Discussions with Senior Managers in NHS Scotland relating to the General Medical Council’s expected level of transparency has brought forth written responses describing my interest as “highly unusual” and “offensive and unprofessional”

5. The forthcoming ABPI register allows any professional to opt out of inclusion.

It is also worth repeating that the information provided to the public consultation on this petition failed to highlight most of the issues identified in points 1 to 5 above.

In terms of cost both to the public purse and the individual patient the Government’s stated wish for a “robust, transparent and proportionate” response would be fulfilled if a single, searchable, open register of financial conflicts of interest that has a statutory basis were to be introduced

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

A letter to Professor Jason Leitch

Image

In this post I reply to Professor Jason Leitch, whose letter of the 2nd June 2015 on Haloperidol prescribing to Scotland’s elderly can be read here:

Jason Leitch Delirium

This is the link to my summary on Delirium Screening written March 2014 at the request of one of those involved with improvement work in delirium. I shared this with Healthcare Improvement Scotland, the Scottish Delirium Association and OPAC (Older People in Acute Care Improvement programme). I had no replies.

Recently this automated e-mail arrived:

Jason Leitch, unread letter deleted

I thus contacted Professor Leitch to clarify. This is the response I received:

e-mail: 25 September 2015 

Dr Gordon, I can assure you that not only did I receive and read 
your email of 8th June, I still have it. I noted its content and 
following our earlier correspondence didn’t feel it required a 
response. I also read our correspondence which you published 
on your blog. 

Professor Jason Leitch, National Clinical Director.

The following behind-the-scene communications were recently released as a result of a Data protection request. The communications indicate a tone of disdain for those who may write regularly to DG Health and Social care.

director-general-of-nhs-scotland-e-mail-to-jason-leitch-national-clinical-director-who-is-not-registered-with-the-gmc

I had asked if Professor Jason Leitch might confirm if he is registered with the General Medical Council. Again there is clear evidence of a most disparaging tone made by two of the most senior figures in the DG Health and Social care. One has to worry for other correspondents who write with legitimate concerns about patient wellbeing and safety.

communications-between-deputy-director-nhs-scotland-and-national-clinical-director-25-sept-2016

Professor Leitch chose not to answer my question about registration with the General Medical Council however he did kindly supply a most abbreviated CV which would indicate that he is not medically trained and qualified. Professor Leitch’s qualifications are in Dentistry and he is registered with the General Dental Council. This is important in that Professor Leitch gives as National Clinical Director for NHS Scotland is governed by a regulatory body that is not for general medicine.

national-clinical-director-and-director-general-25-sept-2016

 

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.

“This most unusual request”

In August 2013 I read an article published in the BMJ which was entitled Three quarters of guideline panellists have ties to the drug industry”.

Majority-of-Guideline-panel

I have petitioned the Scottish parliament for a Sunshine Act. My petition seeks a single, searchable register of payments made to healthcare workers and academics. My petition has now been considered 6 times by a parliamentary committee. The committee would appear to be coming to the view that such a register would need to have statutory underpinning (just as they have in France and the USA). However, before any decision is made by parliament, the Scottish Government have asked for wider public consultation.

Update, March 2016: 
The public consultation concluded, by majority, that it should be 
mandatory for all financial transactions to be publically declared.

Peter-Sunshine,-Jan-2015

The Scottish Government and the Cabinet Secretary for Health, Wellbeing and Sport, have made comment “that apart from the petitioner” the issue of transparency has not been raised by other NHS healthcare professionals. This brings me to this blog-post which might explain why this has been the case.

we-can-find-no-record

In an entirely anonymised way I shall briefly present the narrative behind a senior healthcare professional who served as a key individual in a panel developing a national guideline. Unfortunately no records of financial interests for this guideline exist and so, as part of my research for a Sunshine Act, I wrote politely to this senior healthcare professional asking for the details of any financial conflicts of interest. I was grateful to receive responses but unfortunately found that they were uninformative and defensive. It was however clear from research publications that this individual had received payments from the pharmaceutical industry.

HDL-62

In Scotland, all NHS Chief Executives were written to by the Scottish Government in 2003 asking that they established registers of interests for all employees including GPs. However, across Scotland, for more than 12 years, this guidance has not been followed. In the hope that this senior healthcare worker had declared to his employers, I wrote to the Health Board involved. In doing so they breached my polite request for anonymity. I asked the Health Board if they could forward the evidence of this senior healthcare worker’s declaration to his employers, as expected in HDL 62 and also for GMC Annual Appraisal.

After many months, I received a reply from the NHS Board. This is the relevant section of the reply which confirms there are no entries for this senior healthcare worker who was involved in developing a national guideline which advises on prescribing.

One a

The NHS Board reply encouraged me to consider confidentiality of this senior healthcare worker but made no apology for my anonymity being broken.

The final paragraph of the NHS Board reply apologised for the time taken to look into this but asked me to “appreciate that this is a most unusual request”.

One b

The GMC does not consider it “unusual” to maintain transparency regarding financial conflicts of interest:

GMC on CoI

My experience for researching whether GMC guidance and extant NHS Scotland guidance on transparency have been followed has been most difficult. It has had negative consequences for me and I have felt as if I have been regarded as “unusual” to be concerned about transparency. Robert Francis in his two recent reviews relating to the NHS has talked of ‘a culture of fear’ where healthcare workers are fearful of the consequences of putting patients first. Perhaps then, this is why, other healthcare workers have not raised concerns about transparency of payments made by industry to colleagues.

Freedom to speak up

It would appear from this example that it is possible that authors of prescribing guidelines may have previously been paid by industry. As things stand there is reasonable chance, as a Scottish patient, that the medication you receive has been informed by such a process. And you will have no way of finding out if this is the case.

Update, September 2016:

SIGN 86, Management of patients with Dementia, has now been withdrawn, 
so is historical. 

I therefore feel that it is entirely reasonable to identify it.

sign-86-guideline-chair-dr-peter-connelly-guideline-now-withdrawn

sign-86-guideline-healthcare-improvement-scotland

 

“Unprofessional”

My view is that we all have conflicts of interest.

Science however cannot ignore financial conflicts of interest.

We can find no record

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

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

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

Annexe A, GMCHDL-62CR148 cover

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

Royal College of Psychiatrists: relationships with pharmaceutical and other commercial organisations

In response to my letter to the Royal College of Psychiatrists regarding relationships with pharmaceutical and other commercial organisations I received this e-mail from Professor Nick Craddock, Treasurer of the Royal College of Psychiatrists:

From: Nicholas Craddock
Sent: 13 March 2015 15:17

Dr Gordon
Thank you for your letter of 15th February concerning the revision of CR148 “Good Psychiatric Practice: Relationships with pharmaceutical and other commercial relationships”. The current report along with all other College reports is available on the College’s website.

This report has been reviewed initially by the Committee on Professional Practice and Ethics. Their draft has been sent for comment to the Psychopharmacology Committee and to representatives from the Academic Faculty including myself. The document will then be further revised in the light of comments received before being finally approved by the Policy and Public Affairs Committee. If you would like to submit any written comments perhaps you could send these to the Chair of the Policy and Public Affairs Committee as soon as possible.

The declarations of interests for speakers at the forthcoming International Congress will appear on the Congress App which is available to all delegates. If you are not able to come to Birmingham I can arrange for this to be sent to you. Declarations are currently being collected.

The declarations of interests for speakers at the Old Age Conference will be available to all conference delegates. I can also make these available to you if you are not intending to attend this conference.

Yours sincerely
Nick Craddock

Professor Nick Craddock
Treasurer
Royal College of Psychiatrists
21 Prescot Street
London E1 8BB

Here is the reply I have sent to the Royal College of Psychiatrists dated 14th March 2015:

Dear Professor Craddock
Thank you very much for your e-mail of the 13th March 2015 which is most helpful. It is particularly welcome to hear that, in terms of the forthcoming CPD-approved Royal College of Psychiatrists Conference that “the declarations of interests for speakers at the forthcoming International Congress will  appear on the Congress App which is available to all delegates.”  As I am not coming to this conference I would be most grateful to accept your offer to arrange for this to be sent to me.

Forefront 2015

I would also like to accept this further offer: “the declarations of interests for speakers at the Old Age Conference will be available to all conference delegates.  I can also make these available to you if you are not intending to attend this conference.”

Old Age March 2015 RCPsych

I remain of the view, as articulated in my letter of the 14th February 2015, that The College should have no more difficulty in having a tab on the homepage of these Conferences with declarations of all involved than they do in having a tab on the homepage for “Exhibition opportunities.”

exhibition-opportunities

I am also most grateful to be appraised about the process and timescale of the revision of CR148 “Good Psychiatric Practice: Relationships with pharmaceutical and other commercial relationships” which was first approved in January 2008. I note that CR148 contained a “due for review: 2011”.

CR148 cover

You have invited me to make comments on this revision to CR148 and to forward these “as soon as possible” to the Chair of the Policy and Public Affairs Committee. I hope this letter will suffice and I will forward it to the Acting Head of Policy as you suggest. I have not been party to any of the considerations to date and for this reason I would like to comment on the existing guidance, CR148, issued January 2008.

The research that I have undertaken across the UK over the last few years, in preparation for advocating a Sunshine Act to the Scottish Parliament, has led me to conclude that this guidance is not being fully followed.

CR148 principles

The “principles” of CR148 have a basis on “transparency” and “full declaration of relationships with commercial organisations”.  When I was a speaker at the RCPsych Autumn Conference in Durham I was the only speaker to declare my interests in the programme.  At the Conference itself, Professor Clive Ballard, one of the other speakers, did not declare any interests at all. Another speaker, Professor Allan Young, a key Opinion Leader in Affective disorders, appeared to belittle transparency regarding the need to declare financial  interests. There was no declaration of his extensive financial interests in the programme.

debate-as-set-out (2)

This leads me to my FIRST QUESTION in relation to the proposed revisions of CR148: What consequences will there be for an individual who does not follow the guidance?

CR148 guidance

CR148 states “psychiatrists should avoid accepting inducements that might compromise the independence of their professional judgement and practice”. We know from ABPI figures that in a calendar year at least £40 million has been paid to UK health professionals by the pharmaceutical industry.

40 million

The ABPI have recently introduced a “Central Platform” which will form a central register of individual financial payments to healthcare workers. This will not start reporting till 2016. However the main problem with this register is that individual healthcare workers can opt-out of disclosing payments. Given that the Royal College of Psychiatry is not alone in having struggled to govern its own existing guidance, it is reasonable to have concern that this ABPI “Central Platform” will share such difficulties.

Thus, my SECOND QUESTION: What role, if any, will the ABPI “Central Platform” have in the revised CR148?

CR148 Registers of members interests

The research I have undertaken in NHS Scotland has confirmed that local registers are generally not being maintained and are generally not open to the public.

The Scottish Government has confirmed that the guidance issued on this in 2003, HDL 62, has not been followed. HDL 62 asked the following of Chief Executives:

HDL-62

At annual appraisal all doctors are asked to sign a Probity statement similar to the screenshot below. In this, each doctor confirms that he or she has followed paragraphs 56-76 of Good Medical Practice and complied with local mechanisms of declaring interests. In Scotland, I have evidence that in terms of “transparency” that there are widespread discrepancies here and I fear that public trust in our profession may suffer if we do not take action.

Probity statement SOAR Appraisal (Jan 2014)

To conclude, my view is that the simplest, most effective, consistent and evidence-based way to ensure transparency regarding financial conflicts of interest would be to have UK legislation that seeks a central, single, open, searchable register that is updated on a regular basis and which is tied to professional accountability and GMC governance. Ideally this would include not just psychiatrists, but pharmacists, academics, allied health professionals and indeed charities. My final question then is what discussions have taken place between the Royal College of Psychiatrists and the GMC on revisions to CR148

Yours sincerely

Peter signature
Dr Peter J. Gordon

Copied to:

  1. Professor Sir Simon Wessely, President Royal College of Psychiatrists, 21 Prescot Street, London, E1 8BB
  2. Vanessa Cameron, Chief Executive, Royal College of Psychiatrists, 21 Prescot Street, London, E1 8BB
  3. Chris Fitch, Acting Head of Policy, Royal College of Psychiatrists, 21 Prescot Street, London, E1 8BB
  4. Niall Dickson, Chief Executive and Registrar, GMC, Regent’s Place, 350 Euston Road, London NW1 3JN.

Royal College of Psychiatrists and conflicts of interest

The Chief Executive of the General Medical Council (GMC) recently confirmed, in response to a recent BMJ article, that it “takes very seriously the issue of conflicts of interest”:start-with-GMC

We know that in the course of a year, in the United Kingdom:40 million

Currently, it is almost impossible to find out anything other than the overall figure.

NHS registers of interest are not functioning. Yet doctors are asked to sign this at annual Appraisal:Probity-statement-SOAR-ApprAll Appraisals are then scrutinised by senior NHS managers to be “signed off”:

The BMJ make this charge:failure of regulation

However should we be asking if our Royal Colleges are also failing?

For several years I have written to the Royal College of Psychiatrists about conflicts of interest. This post is based on the latest correspondence which was prompted by the recent announcement of this International Conference:

change-my-practice

The Co-chairs give this welcome note:welcome-by-co-chairs

It is almost certain that a significant proportion of the £40 million goes to: KOLs2

The Conference organisers have made it clear of the “exhibition opportunities” provided at this event:exhibition-opportunities

What is less clear is whether the speakers or those involved in workshops or seminars have any conflicts of interest.

This is why I have written to:Board-RCPsych

My most recent letter to the above, copied to the Chief Executive of the GMC, asks for transparency ahead of the Conference in this important area:Craddock-letter