‘The medical untouchables’

The following is a recent opinion piece by Dr Des Spence published in the British Journal of General Practice.

I had been lined up to do the media interviews on BBC Scotland in relation to petition PE1651. However, on the day, due to changed travel arrangements, I was not available. Dr Des Spence was interviewed instead and did a better job than I could have done.

As an NHS doctor and specialist, I fully support this petition (PE1651) which calls on the Scottish parliament “to urge the Scottish Government to take action to appropriately recognise and effectively support individuals affected and harmed by prescribed drug dependence and withdrawal.”

I have submitted my response.

I feel it would be helpful to hear the views of the Chief Medical Officer for Scotland and in particular, how this matter might be considered as part of Realistic Medicine.

Three recent posts by me demonstrate the scale of competing financial interests in medical education in the UK. If you have a moment, you should have a look. Perhaps you might then share the worry that I have about this matter:

I have previously raised my own petition, PE1493, which the Scottish Public has supported. This was a petition for a Sunshine Act for Scotland, to make it mandatory for all financial conflicts of interest to be declared by healthcare professionals and academics.

My petition, supported by the public, had no support from “Realistic Medicine”. The public has had no update from the Scottish Government on my petition in 18 months. My view is that this is a shocking failure of governance and would seem to demonstrate a lack of respect for democracy.

Psychiatry without borders

This week the International Congress for the Royal College of Psychiatrists is taking place in Edinburgh. It is titled “Psychiatry without Borders”.

Given my concerns about the harms associated with over-medicalisation I decided to make a peaceful protest outside.

I was born in Edinburgh in 1967.

This was a home-made protest.

I have no associations with Critical Psychiatry, Anti-Psychiatry, Scientologists, the Citizens Commission on Human Rights.

I am simply a doctor who is interested in ethics.

I am of the view that critical thinking is an essential part of science.

I understand that biases come in all forms. However there is longstanding evidence that exposure to industry promotional activity can lead to doctors recommending worse treatments for patients.

Thank you to all who came to talk to me on the day. Particular thanks to Chrys Muirhead and her son Daniel for all their support

I waited the full day as I wanted to meet the Cabinet Minister for Health (Scottish Government) outside the International Congress. This was my experience:

More details about a Sunshine Act for Scotland can be found here and here.

The public consultation can be found here.

 

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 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.

 

Continuing Medical Education and its entanglement with the Pharmaceutical Industry

Yesterday I sent the e-mail (at the foot of this post) to Alex Neil, Cabinet Secretary for Health and Well-being for the Scottish Government. It should be self explanatory.

My timing of this letter is based on 8 separate areas. Areas that I hope present as close to a whole picture as I am best able to do:

(1) Freedom of Information (FOI) returns have now been received from all 22 Scottish NHS Boards on the subject of how they record payments to healthcare workers from the Pharmaceutical Industry and if these are open and transparent to all. The results are worse than disappointing.

The summary database is here: https://docs.google.com/spreadsheet/ccc?key=0ApF86-MCSbZzdGlVd2ZPYWhyN1ZUbkliNlFpTGxtMFE#gid=0

Full communication and register files (if available) are here: https://www.whatdotheyknow.com/user/peter_j_gordon/requests

(2) The USA, since five days ago, has a SUNSHINE ACT: look here and see what such statute-based transparency is beginning to reveal (that had previously been kept in the dark) http://projects.propublica.org/docdollars/

In case you think that this could not affect Scotland, well as just one example, Henry A. Nasrallah came to NHS Forth Valley and gave sponsored education on Risperdal in July 2009. He is in the top ten educators earning from the Pharmaceutical Industry with at least $647,341 changing hands.

(3) Scotland (and the UK) do NOT have a Sunshine Act. What we have is the Guidance on Joint-Working between NHS-Scotland and the Pharmaceutical Industry: A Common Understanding 2012 – Working Together For Patients. As guidance it was brought into effect in November 2012 and the Guidance was developed under the Chairmanship of Ian Mullen who was involved in this at the same time as he was Chairman of NHS Forth Valley. Despite this and the fullsome promises in the foreword by Ian Mullen, NHS Forth Valley has never had a functioning register of any joint-working other than the listed Interests of Board members. The FOI returns across all 22 NHS Scottish Boards have since evidenced that NHS Forth Valley, in this failing, was closer to the norm rather than the exception.

A common Understanding

(4) There is also the UK-wide ABPI Code (The Association of the British Pharmaceutical Industry): latest version is here: “The Code of Practice for the Pharmaceutical Industry Second 2012 Edition”  http://www.abpi.org.uk/our-work/library/guidelines/Pages/code-2012.aspx

The ABPI code was reported in the BMJ on its launch in an article by Clare Dyer entitled “Collaboration with drug industry won’t affect clinical decisions, says new guideline”

ABPI promoted

This report of the new ABPI code stirred a vigorous response in BMJ rapid-responses: http://www.bmj.com/content/344/bmj.e2489?tab=responses

One of these responses was subsequently published 24 April 2012 as a letter entitled: “Guidance offers little in the way of ethics or transparency” It was written by Rogers, Zutlevics, Raven & Jureidini:

ABPI Guidance - one response

The above article as per original publication may not be very clear so I have re-pasted the body of the text here (highlights are mine)

deeply-disappointing

In February 2013 the Lancet withdrew its support of document on collaboration between doctors and drug industry http://www.bmj.com/content/346/bmj.f770 I will reprint some of the text here:

Falling-out-with-Pharma

(5)  I have been collecting over the last 3 months all details of Pharmaceutical Sponsored Education that comes my way. I do not see Pharmaceutical Reps and so this will most likely be urepresentative sample of the wider picture. Have a look and form your own opinion:http://pinterest.com/peterjgordon/pharmaceutical-sponsored-medical-education/

Pharmaceutical Sponsored Education

(6) Last year £40 million was paid in total to healthcare workers in the UK from the Pharmaceutical Industry. Whatever proportion went to Scotland, it certainly is not represented in what few returns have been made by doctors to their NHS Boards. So much for transparency. And what then of the ‘probity’ section all doctors sign as part of mandatory GMC regulations for Appraisal and Revalidation?

£40 million

(7) An area of legitimate concern must relate to academics and doctors that have been termed as “Key Opinion leaders” and whose joint-working with the Pharmaceutical Industry can be considerable . I must confess that I had not been especially aware of this until the recent UK-wide discussion on dementia diagnosis was raised in leading journals. I have always advocated for the timely, personalised and holistic diagnosis of dementia pointing out that considerable harms may be associated with the prevailing imperative of ‘early diagnosis’. I was a lead in this debate before just about any other. I was thus concerned when the Key Opinion Leaders in dementia in their reply to the Open letter that I had joined with Grassroots Doctors on this subject http://grassrootsgp.org/category/dementia-screening/  made no declarations of interest. Not one. I knew this was incorrect.

Grassroots GP

Dr Martin Brunet in The Binscome Doctor Blog, as one of the Grassroot doctors made the same observation: http://binscombe.net/blog/?p=639

“Our letter was initially published as a rapid response, where it triggered a reply from an eminent group of doctors who declared that they had no competing interests. The letter was subsequently published as an Observation article, and a further reply came from many of the same authors, several of whom decided on this occasion to declare interests, including financial support from pharmaceutical companies and appointments related to the field of dementia. These conflicts are not wrong in themselves, and do not invalidate their comments, but neither are they unimportant, nor did they arise in the intervening three-month period between the letters. What changed? A prick of the conscience? A word from the editor? Or perhaps the fact that the BMJ tightened its wording about conflicts of interests in January 2013 – between the two submissions.

CropperCapture[2]

Even a robust policy on this matter is insufficient, however. The BMJ has very clear guidance on what should be declared, but there is very little the editors can do when proper declarations are not made – with retraction of the article being their most draconian punishment. Retraction may have repercussions in the scientific community, but it is rarely reported on in mainstream media.”

Since this time I have collected the declarations made by all the Key Opinion Leaders, at least those of whom I am most aware that educate us on dementia, whether it be in  practice, prescribing or policy. My absolute determination is to look at this as a group and thus I would wish no doctor to be singled out. This is not about reputations, or simply conflicts of interest, it is about transparency and that goal that we surely all share: the quest for scientific objectivity.

Why I no longer consult for drug companies https://vimeo.com/72517101/settings

This film carries some of the words by Dr Peter J. Whitehouse in a paper that he wrote called “Why I no longer consult for drug companies” published in Culture, Medicine and Psychiatry, March 2008, Volume 32, Issue 1, pp 4-10

http://link.springer.com/article/10.1007%2Fs11013-007-9075-x#page-1

I wish to thank Dr Whitehouse for allowing me to use his words in this film.

I have made this film as I share Dr Whitehouse’s concern about the entanglement of pharmaceutical marketing/health industries with continuing medical education. I also share concern that when it comes to the Key opinion leaders in dementia that the talk of “transparency” is only talk. Last year £40 million was paid by Pharma to healthcare workers in the UK. Research into Scottish NHS Hospitality Registers evidences that payments from Pharmaceutical Industry are consistently not being declared in Registers (if indeed there is a functioning NHS register!) We are in the dark about this. Unlike USA we have no ‘Sunshine Act.’ The UK has a meaningless, one-sided, code called the ABPI code.

Why I no longer

89% of British Medical journal readers (999 out of 1128), in a poll of April 2013, agreed that drug companies should publish the names of doctors to whom they make donations. That is a striking consensus.

Donations poll

The Pinterest Board on Key Opinion Leaders in Dementia is here: http://pinterest.com/peterjgordon/opinion-leaders-in-dementia/ I was going to write about this but, for so many reasons, I find this very difficult. I am particularly concerned that I am simply a doctor, not an investigator (and do not wish to be). I hope that all readers of this realise that my only determination is to be fair to all, to follow evidence, ethics, professionalism and the humanity that I hope I have within me.

Key Opinion Leaders 'educating' us

(8) Before finishing this post with a copy of the e-mail that I sent to Alex Neil, Cabinet Secretary for Health and Well-being for the Scottish Government. I would like to post a couple of ‘slides’ that I have made from the current BMJ and the article “Everything you need to know about the Sunshine Act” (intended  for the USA readership) http://www.bmj.com/content/347/bmj.f4704

Sunshine-03

Sunshine-06

And finally some advice from Dr Ben Goldacre aimed at his fellow professionals. This is also in the form of a film that I have made called: “What Can You Do” (thank you to Dr Goldacre for agreeing to allow me to use the text from his book Bad Pharma) https://vimeo.com/68919466

Dr-Ben-Goldacre's-advice

Bad pharma 5

From: Gordon Peter (NHS FORTH VALLEY)
Sent: 07 August 2013 20:15
To: alex.neil.msp@scottish.parliament.uk
Subject:ADULT ADHD ACADEMY – sponsored education

7th August 2013.

Dear Cabinet Secretary for Health and Well-being,
Scotland’s 22 NHS Boards have now all replied to Freedom Of Information (FOI) enquiries regarding financial payments from Pharmaceutical Industry to NHS staff.

The results are most dismal. Have a look yourself

Summary database here: https://docs.google.com/spreadsheet/ccc?key=0ApF86-MCSbZzdGlVd2ZPYWhyN1ZUbkliNlFpTGxtMFE#gid=0 (any errors in summary will be mine)

Full communication here: https://www.whatdotheyknow.com/user/peter_j_gordon/requests

Could Scotland not lead here? Why can we not have full transparency on this in Scotland? A Sunshine Act. Like they now have in USA?

Like many others I am primarily concerned about science and objectivity (please see the views of Robert Merton in the slide below which are certainly not out of date)

Last year £40 million across the UK went to doctors (healthcare workers) . . . not much of this is showing up in returns given to Scottish NHS Boards (that is if the NHS Board has a Register.)

If Conflicts of Interest are not a worry to all, this lack of transparency on the part of doctors, most certainly is. Currently Consultants like myself have to Revalidate and as part of this and annual Appraisal we sign a section on ‘probity’.

Please do reply to this concern. I am grateful.

Yours sincerely,
Dr Peter J. Gordon

Consultant Psychiatrist for Older Adults,
 Clackmannan Community Healthcare Centre,
 Hallpark road,
 Sauchie.
 FK10 3JQ

Changing-system-of-producin

The text on this slide on SCIENTIFIC OBJECTIVITY and what MERTON CORRECTLY FEARED may happen, is from the book “Genes, Cells and Brains” by Hilary & Steven Rose