Transparency at the Top

Posted on June 25, 2017 by Snow-Leavis

I wrote “Transparency at the Top: British Psychiatry” in April 2015 but did not share it publically as I wanted to give the Royal College of Psychiatrists time to improve the governance of financial conflicts of interest. Over the last 2 years improvements have been made by the Royal College of Psychiatrists however the system in place is unsearchable, costly, and bureaucratic. It also does not help determine how much of the £340 million that the pharmaceutical industry pays each year for “promotional activities” goes to the “top” educators (key opinion leaders) in UK psychiatry.

Sir Professor Simon Wessely has been an outstanding President and has carefully listened to the concerns that I have kept raising on this issue. This week he hands over the Presidency of the Royal College of Psychiatrists to Wendy Burn.

Tomorrow, the International Congress: Psychiatry without Borders begins in Edinburgh. I will be protesting outside because I remain concerned about the considerable reach (to the many) of a handful of educators: “The Law of the Few”.

  Here follows my original transcript, dated 25 April 2015:

The Chief Executive of the GMC recently confirmed in the BMJ:

To ensure public transparency of financial payments to healthcare workers and academics both France and America have introduced a Sunshine Act. In the UK we do not have such statutory basis to transparency. Royal colleges rely on Guidance such as this guidance, CR148, by the Royal College of Psychiatrists*:

The Royal College of Psychiatrists Guidance, like The GMC, gives clear and unambiguous guidance*:

The Royal College of Psychiatrists has recently expressed that, in addition to such clear and unambiguous College guidance (CR148), that the Association of the British Pharmaceutical Industry (ABPI) “central platform” to be introduced in 2016, will ensure transparency that will “so avoid some of the criticisms of yesteryear”:

The ABPI “Central Register” has no statutory underpinning and any healthcare worker or academic can choose to opt out of revealing any financial payments made from industry.

It is perhaps then an opportune time to consider whether the Royal College of Psychiatrists is correct to express confidence that we may be able to “avoid some of the criticisms of yesteryear” in regards to transparency in regards to the relationship between industry and psychiatrists. To consider this, we might do well to look at some of the key College leads. So to start at the top this should include the current President of the Royal College of Psychiatrists. Such a consideration should also include the current Chair of the College Psychopharmacology Committee. To be properly representative of College leads, this consideration should also include a Psychiatrist who is today widely considered as a ‘key opinion leader’ in British psychiatry.

The only purpose of this consideration is to attempt to examine if our College leads are exemplars in transparency and to attempt to establish if they have followed College guidance CR148.

Sir Professor Simon Wessely was elected last year as President of the Royal College of Psychiatrists and took presidential office on the 26th June 2014. The week after his appointment, Professor Wessely was interviewed on BBC Radio 4 and, as part of this public broadcast, was part of a discussion with James Davies, University of Oxford:

This is an emphatic statement made publicly by the President of the Royal College of Psychiatrists.

In fact Wessely has been transparent about “Financial Disclosures” as given here following a co-authored review paper published in JAMA in 2014: “Dr Wessely has received financial support from Pierre Fabry Pharmaceuticals and from Eli Lilly and Co to attend academic meetings and for Speaking engagements.”

This full transparency helped Joel Kauffman consider the 2004 JAMA Editorial and this can be read in full here. But meantime, here is the relevant extract:

Those at the top of British psychiatry would appear to have a range of definitions of “transparency”? It is certainly very clear that Sir Professor Wessely does not have anywhere like the volume of working relationships with industry as some of the other current College leads. Last year Wessely gave the keynote lecture “Psychiatry under fire” at the following conference. This was not a sponsored talk as the programme makes clear. The Conference was organised by Professor Allan Young who confirms that the “objective” of this symposium is to provide “independent” education to help “achieve personal CPD objectives and in your everyday clinical practice”.

Professor Allan Young is also Chair of the Psychopharmacology Committee of the Royal College of Psychiatrists and his declarations are publicly available here where he confirms that he is paid for “lectures and Advisory Boards for all major pharmaceutical companies with drugs used in affective and related disorders”. Professor Allan Young may well be one of the most influential ‘key opinion leaders’ in British psychiatry. In this role, as a most influential educator Professor Allan Young has recently been considered here and here.

Also giving a talk at this 2014 “Latest Advances in Psychiatry Symposium” is Professor Guy Goodwin who is also considered to be a “key opinion leader” and who is undoubtedly one of those at the “top” of the hierarchy of British Psychiatry.

Professor Guy Goodwin featured centrally on the BBC Panorama programme in the following month. This programme was titled “who is paying your doctor” and Dr Goodwin came under considerable scrutiny. However it should be the case, that such scrutiny should include not just a single, individual “key opinion leader” but those like the Chair of Psychopharmacology Committee and the President of the Royal College of Psychiatrists. For patients to have trust in the medical profession it should be the case that such leads are exemplars when it comes to transparency of financial interests.

Following the Panorama programme in which Professor Guy Goodwin featured, the Head of Professor Goodwin’s University Department, had an article published in the BMJ where he expressed the view that the media harm caused by raising the subject of transparency “may outweigh any good”. An alternative view is given here. As a result, Dr David Healy, Director of the North Wales Department of Psychological Medicine offered a proposal to ensure wider consideration of transparency in British Psychiatry. This proposal for a “proper and open debate” was copied to a wide range of individuals including Professor Goodwin and had previously been discussed with Sir Simon Wessely. The correspondence can be read here .

As President of the Royal College of Psychiatrists, it is clear that speaking proportionally, most of the research Professor Wessely has been involved in has not involved working with the pharmaceutical Industry. Wessely is after all a professor of psychological medicine at the Institute of Psychiatry, King’s College London and head of its department of psychological medicine. Compared to some of the psychiatrist colleagues around him, and in particular “key opinion leaders” it is no doubt the case that Wessely has worked less with industry. However, it is not the case that he has “never worked with industry” as he emphatically stated on Radio just after becoming President of the Royal College of Psychiatrists.

In the past, Professor Wessely has helped prepare review articles through “educational grants” from the pharmaceutical industry. It perhaps may be argued that this is not “working” with industry. Though College guidance CR148 does seem to be much clearer in what it expects in terms of transparency. This was one such article involving Wessely and another one can be accessed here.

A few years before College Guidance CR148 was introduced, and long before Wessely was elected President of the Royal College of Psychiatrists, he gave his personal view on ‘working’ relationships with industry and insisted that it was “time we doctors grew up”. At the time, the BMJ published a range of views, and one of these has been included alongside Wessely’s to demonstrate this range. Professor Wessely’s personal view is now over a decade old and it would be helpful to know if his views have changed over this period of time.

Summary:
Is it the case that calling for transparency regarding financial payments may cause more harm than good? Some of those at the top of British psychiatry would appear to have put forward this view, arguing that such will damage public trust. Yet the GMC are clear what they expect of their professional group, namely doctors. Is it not time that we had an open public debate about this involving more than those just at the top?

*Since writing this CR148 was replaced in March 2017 by CR202

       Update of 11 June 2017: "The Law of the Few"

Continuing Medical “Education”

Posted on May 25, 2017 by Snow-Leavis

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

CPD is mandatory.

This Hole Ousia post considers CPD for UK psychiatrists.

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

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

This is the current Calendar:

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

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

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

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

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

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

There is currently a voluntary register (ABPI).

The BMJ reported this in March 2017:

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

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

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

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

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

‘Informed consent is a fundamental principle underlying all healthcare’

Posted on May 17, 2017 by Snow-Leavis

A recent Independent Review for NHS Scotland stated that: “Informed consent is a fundamental principle underlying all healthcare”

The Cabinet Secretary for Health and Sport, Shona Robison stated to the Scottish Parliament (17 March 2017): “Informed consent and shared decision making are expected prior to any procedure being carried out.”

On the 20th April 2017, I wrote to Healthcare Improvement Scotland 
about Patient consent in NHS Scotland:

I have just completed my annual Appraisal which is a General Medical Council requirement as part of 5 yearly Revalidation. As part of this I was informed by my Appraiser that I must comply with all the LearnPro modules which I have now done.

The following screenshot comes from the NHS Lothian mandatory LearnPro module on Capacity and Consent:

I apologise as the text is small, so I have reproduced verbatim what it states to me as an NHS Lothian employee:

“Consent is both a legal requirement and an ethical principle and requires to be obtained by healthcare professionals, prior to the start of any examination, treatment, therapy or episode of care.”

“In Scotland, everyone over the age of 16 is an adult. The law assumes that adults can make their own decisions and can sign legal documents, such as consent to medical treatment (in some circumstances this also can apply to children under the age of 16) provided they have the capacity. This means that they are able to understand what is involved in the proposed treatment, retain the information, be able to weigh up the information needed to make the decision and then communicate that decision. Treatment might be delivered in a hospital, clinic or in someone’s home.”

In years past I have written about consent for older adults in hospital in NHS Scotland:

Do we care enough about consent?

‘OPAC tools are working’

I am writing to Healthcare Improvement Scotland as I find myself confused.

Do I follow the mandatory requirements of my employers on consent? Or do I follow the National Improvement requirements of OPAC-HIS where consent is not required for assessments such as the 4AT assessment test? (formerly called “4AT screening tool”)

I know, from the re-drafted Care Standards, that Healthcare Improvement Scotland take consent very seriously.

I should state that I am writing in my own capacity and in my own time.

12 May 2017 - I sent this update to Healthcare Improvement Scotland:

Forgive me for this further correspondence but I felt that I should update you on the learning that I received as part of my attendance for Continuing Medical Education (CME) yesterday.

This CME event was for the Royal College of Psychiatrists in Scotland – Faculty of Old Age Psychiatry and was held in Falkirk.

At this event the Chair of Old Age Psychiatry for the Royal College of Psychiatry was giving a talk and when the time came for questions I asked about the wide use of haloperidol in older adults in hospitals in NHS Scotland. Dr Thompsell replied “evidence has found that Haloperidol actually worsens the outcome of delirium”.

Another lecturer at this meeting, who was giving a talk on her area of expertise: anti-psychotics and older adults, was Dr Suzanne Reeve. She replied: “Haloperidol does increase mortality in older people compared with other antipsychotics. That message has been out for a while but has not really got across.”

The next talk was entitled “Successes of Old Age Psychiatry Liaison team” and one of the slides shown had the headline “Compliance with 4AT”. The impressive “compliance” figures then followed. The dictionary definition of compliance is “the act of yielding”.

My concern here is for patient harm and indeed increased patient mortality. National Improvement work undertaken by HIS has been instrumental in increasing “compliance” with tools such as the 4AT and it is clear that no consent is deemed necessary. I have argued that this is not ethical as these tools are often the beginning of “pathways” and “protocols” that may result in the administration of haloperidol.

I am genuinely worried that National Improvement work undertaken by Healthcare Improvement Scotland has not properly considered ethics, available evidence and the potential for unforeseen consequences. You will understand that I am also nervous about writing this letter given the consequences for me when I first “spoke up” three years ago:

I would very much value your advice. I am not sure that I can work in a profession if it loses sight of Hippocrates and “first do no harm”.

This is the response from Healthcare Improvement Scotland,
dated 17th May 2017:

“Thank you for your letter of the 20th April and your letter of 12th May, in which you raise the interesting issue of taking consent in relation to cognitive screening.

I understand from staff involved in the inspections of older people’s care in hospital that taking of written consent prior to initial assessment for frailty is not routinely undertaken. Assessment at the point of admission, or where a change in a patient’s cognitive presentation is giving cause for concern, can alert staff to possible increased risk and enables planning of care for the patient. In these circumstances staff adopt a proportionate approach such as asking, for example, if they may ask some questions.

For absolute clarity though, as an employee of NHS Lothian, the requirements set out in the Board’s policies and mandatory training are those that you should follow.”

‘It was odd being dead’

Posted on April 21, 2017 by Snow-Leavis

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

Posted on March 29, 2017 by Snow-Leavis

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

Posted on June 20, 2016 by Snow-Leavis

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

Posted on March 20, 2016 by Snow-Leavis

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:

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

Posted on October 7, 2015 by Snow-Leavis

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:

A letter to Professor Jason Leitch

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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:

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:

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 advice as National Clinical Director for NHS Scotland yet he is governed by a regulatory body that is not for general medicine.

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.

“This most unusual request”

Posted on June 16, 2015 by Snow-Leavis

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”.

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.

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.

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.

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.

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”.

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

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.

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.

Hole Ousia

The whole being: the cultures of science & arts together

Tag Archives: General Medical Council

Transparency at the Top

Continuing Medical “Education”

‘It was odd being dead’

Making science a reality

The Scottish Public Want Sunshine

A letter that the Scottish Parliament felt unable to publish

Lurasidone – financial conflicts of interest

A letter to Professor Jason Leitch

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“This most unusual request”