Transparency at the Top

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"

 

 

The lawn was white with doctors









For patients only

This is a film about leucotomies undertaken for mental illness in the United Kingdom.

This film is not about psychosurgery after 1970.

Were we asleep at the wheel?

At the beginning of June 2008 I sent an e-mail to Dr Leon Eisenberg, a former child psychiatrist, and a man of philosophy and science:
leon-eisenberg
Dr Eisenberg was then 89 years old and I wanted to convey how important his writings had been to me:mindlessness-and-brainlessness-in-psychiatry-1986
I did not expect a reply:
leon-eisenberg-to-peter-gordon-8-june-2016

A year later Leon Eisenberg died.

were-we-asleep-at-the-switch

After his death a memoir was discovered: which Eisenberg had named “Were We Asleep at the Switch?”.

Eisenberg suggested that a switch from ‘mind’ to ‘body’ has taken place in psychiatry as a discipline, which has led to overuse of medication.

He also argued that “monied interests” had been making de facto decisions on behalf of us all about the “science” of things that might affect us.

Eisenberg was worried that the overwhelming impact of economic considerations may have rendered, and might continue to render futile, the professional contributions of many brilliant, timely, and concerned working scientists.

leon-eisenberg-1987b

‘But the caption is wrong’

What follows is some of what mattered to me from a wonderful book:

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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: