Sign Guideline 98: Autism Spectrum Disorders

I was recently asked by Autism Rights if SIGN Guideline 98 had records of financial interests for all those involved in developing this national guideline. The answer is no. Along with 38 other separate guidelines, all operational today in NHS Scotland,  no records of financial conflicts of interest are available. These were destroyed by SIGN.

SIGN 98 - no register of interest

I raised my concerns about this in a letter that was published in the BMJ on the 6th January 2014: SIGN should be transparent about competing interests in all current guidelines

SIGN guidelines have changed in approach to transparency since I wrote and all newly published guidelines now have declarations of interest included in “supporting material”.

These declarations are available on-line such as this one for SIGN Guideline 131: Management of Schizophrenia. It is interesting to compare this with the considerably more thorough approach to declarations of interest as contained in the equivalent NICE guidelineCG178 Psychosis and schizophrenia in adults: treatment and management 

I recently re-visited the approach taken by SIGN to transparency. I did so as one NHS Board recently stated in writing that they consider my concern about this as “most unusual”.

I started this post with Autism Rights. I would like to conclude with them. In the two articles linked below Fiona Sinclair describes the struggle to make sense of changes in Scottish mental health legislation. Part of this considers the importance of transparency of financial interests in NHS Scotland.

My view is that Fiona Sinclair has provided us with important and informed summaries. I have thus urged MSPs, the Mental Welfare Commission, and third-sector organisations to consider the points that are raised within them.

(1) Autism and the madness of the Mental Health Act

(2) We should face up to the madness of the Scottish mental health system

Public consultation on a Sunshine Act for Scotland

As petitioner for a Sunshine Act I recently met with the Scottish Health Council regarding consultation with the public on my petition.

Since this meeting I have been reflecting on how the Scottish Health Council may go about such a consultation given the various options that we discussed. I have also sought confirmation as to whether the Scottish Government has allocated any resource for this public consultation.

I share the ambition of the Scottish Government that we seek views as widely as possible across Scotland given the importance of this petition.I think that it would be sensible for the Scottish Health Council to take a variety of interactive approaches and methods.

I am also aware that not everyone is online and so perhaps there is need to consider paper questionnaires which might also be sent to community interest groups.  Another approach would be through qualitative in-depth interviews, semi-structured, with individuals.  This should be with a mix of ages and backgrounds, and geographic areas. It would be sensible to include open-ended questions as well as more direct closed questions.

I wonder if the Scottish Health Council could also target focus groups already in existence and write to them, asking to visit and facilitate a discussion.

My petition has been considered 6 times now by a parliamentary committee and has generated a lot of evidence which has been carefully considered. I would wish, as petitioner, to see a proportionate input on public consultation. My view is that this is an important matter that may have significant consequences for the best possible approach to Scottish citizens requiring healthcare.

I do hope that the Scottish Health Council is given sufficient time and sufficient resources to undertake a meaningful public consultation.

The Scottish Government has repeated several times, that as the petitioner, I am virtually alone as a healthcare worker to have raised concerns about lack of transparency in NHS Scotland. I would strongly suggest that this may reflect the sort of NHS culture that Robert Francis has described in recent reports, where staff are fearful of the consequences of raising issues such as this.

Freedom to speak up

The Scottish health Council asked me if I would attempt a summary to explain the background to this petition and why it might matter to the individual. My first draft of this is below:

Peter-Sunshine,-Jan-2015

Sunshine Act: what is it and why might it matter to you?

In September 2013, Dr Peter J Gordon petitioned the Scottish Parliament to consider introducing a Sunshine Act for Scotland. The parliament has now considered this petition on 6 separate occasions and, having gathered much evidence, now wishes to seek the views of the Scottish public.

A Sunshine Act has been introduced in both France and America. The Act would make it necessary (a statutory requirement) for all healthcare workers and academics to declare any financial interests on a regular basis. These financial interests would be recorded in a single, searchable register that is fully open to the public.

We know that in one year £40 million was paid by the pharmaceutical industry to healthcare workers and academics in the UK. It is likely that approximately £4 million of this was paid to Scottish healthcare workers and academics. Payments most often relate to the provision of sponsored medical education in the forms of honoraria or for being Advisors to Pharmaceutical Boards. The amounts paid to individuals can be significant. One NHS Consultant said to me at an educational meeting “I was paid £3000 for this talk and I do not even prescribe the drug myself”.

The pharmaceutical industry, on average, spends twice as much on marketing activities as it does on innovation and developing new drugs.

Last year, BBC Panorama, did a programme “Who pays your doctor?” It was watched by 2 million viewers. Panorama argued that we expect far higher standards from our politicians than we do from healthcare workers. The concern is that if healthcare workers are “educated” by those whose first loyalty is to shareholders then scientific impartiality may suffer.

Current systems for declaring financial interests are failing in Scotland. No board in NHS Scotland has properly complied with the Scottish Government Guidance on transparency issued more than 12 years ago. Only a tiny proportion of the £4million known to be paid to healthcare workers by the pharmaceutical industry has been recorded in NHS Scotland registers.

Forty-four separate SIGN Guidelines, all currently in operation, have no records of the financial interests of those tasked to draw up the guidelines. This is concerning as these guidelines are generally followed by doctors to inform prescribing decisions for a wide range of medical conditions.

Each year healthcare workers have to ensure they have met professional requirements for continuing medical education. In at least two NHS Boards in Scotland, it is the case that medical education is entirely supported by sponsors such as the pharmaceutical industry. As an example, please see this 2014-15 register:

Education to healthcare workers is also provided through attendance at conferences. Most large conferences include “key opinion leaders” who may have been paid by industry to give their talk. Research for this petition has demonstrated that there is no consistent system for recording such financial conflicts of interest amongst the multiple different responsible bodies, such as the Royal Colleges and other professional bodies.

It has been argued that regulation, such as a Sunshine Act, might be an administrative burden and costly. However a single, central register (rather than multiple failing registers) has been found in the USA and France to be relatively simple to set up and administer. Furthermore a single register will cost significantly less than current multiple systems which all overlap and do not provide anywhere near full transparency.

The Association of the British Pharmaceutical Industry (ABPI) has set up a register of payments to begin next year. Unfortunately any individual can opt out of revealing any payments made to them. Given my research for this petition it is my certain view that the ABPI register will not ensure meaningful transparency and we will have no idea who received the £4million. As a patient you will have no idea if the doctor prescribing medication to you in NHS Scotland has received payments or been educated by those who have received payments.

Our collective healthcare needs to be based on scientific objectivity and such cannot be assured if we have no meaningful transparency. A Sunshine Act is the only way to ensure this.

 

Declarations by the Department of Psychiatry, Oxford University

I recently wrote to the Department of Psychiatry, Medical Sciences Division, University of Oxford asking where the declarations of interest for their staff could be accessed by the public. The University of Oxford treated my enquiry as a Freedom of Information request, although I was hoping for a link on their webpage to registers of interest for the current year and the two years before.

This reply arrived from the University of Oxford with an Excel attachment of the 2015 declarations:

UAS reply on declarations 2015

As it would seem that the Excel sheet of declarations is not available to the public through the University of Oxford website, the 2015 register is included below:

Department of Psychiatry - Oxford University - Declarations 2015

I would hope that the University of Oxford might consider making declarations of interest for all staff available to the public in the future.

Medical education and economies of influence

This reply to Dr McCartney’s recent editorial “Forever indebted to pharma – doctors must take control of our own education” was published yesterday in the BMJ rapid-responses. I felt it worth re-posting here on Hole Ousia. The author is Mark H Wilson, Bio-ethicist, Ontario, Canada:

Medical education and economies of influence

If anybody is inclined to think that this is “all in the past” it is worth looking at this up-to-date collection of invitations to pharma-sponsored medical education in the UK.

“Trust is generally being eroded”

Last week I watched with much interest the 52nd Maudsley debate. The motion debated was: “This house believes that the use of long term psychiatric medications is causing more harm than good”.

52nd Maudsley debate

The Maudsley debate was covered in a head-to-head BMJ article.

Long-term-use-of-psychiatri

Given that I have petitioned the Scottish Government for a Sunshine Act I was interested in what this Maudsley Debate might say about our approach to transparency of financial conflicts of interest:

Transparency: hold the applause (British Psychiatry) from omphalos on Vimeo.

This particular aspect of the 52nd Maudsley Debate reminded me of a series of letters published in the BMJ a decade ago. It is interesting to consider what has, and what hasn’t changed, in the intervening ten years. The letters were in response to the following 2003 editorial:

No more free lunches (2003)

In a letter of response Dr K S Madhaven argued that “the market has us all in its grip”:

001 Madhaven

Whereas Professor Simon Wessely, in his letter of response, was of a view that “It is time we all grew up”:

001 Simon Wessely

Simon Wessely

Professor Wessely began his letter of 2003:

002 Simon Wessely

and continued:

005 Simon Wessely

It is interesting to reflect on changes that have occurred in the United Kingdom since 2003:

  1. Continuing Professional Development (CPD) has become a requirement of GMC Revalidation:
  2. the pharmaceutical industry now has to follow the ABPI code and healthcare professionals no longer receive branded products such as pens 
  3. “Sandwich lunches” (sponsored Continuing Medical Education – CME) remain core to continuing education. In NHS Scotland, at least two NHS Boards rely entirely on industry sponsorship to support the education of their staff
  4. It remains the case that, at any educational conference, neither the audience nor the public have any idea of how much speakers may have received from the pharmaceutical industry or commercial enterprises in the past three years. The proposed 2016 ABPI register is unlikely to help as any individual can opt out of disclosing payments received. Going by the experience in America, in some cases considerable sums may be routinely involved.

Professor Wessely, in 2003, was concerned about over-regulation, a concern that many of us, including myself have some sympathy with:

006-simon-wessely

Watching the Maudsley debate, in 2015, I was reminded of Professor Wessely’s 2003 fear that “trust [was] gradually being eroded” . It would seem to me that the audience of 2015 would agree with Professor Wessely that this may indeed have happened. However such erosion of trust would seem to be for exactly the opposite reason given by Professor Wessely. It would appear to be the lack of transparency rather than an “Orwellian world of prohibitions” that has contributed to this.

007-simon-wessely

Following the 52nd Maudsley Debate I have written to Professor Wessely, as President of the Royal College of Psychiatrists, to ask if the College might support a single, central, open, searchable database where all payments to healthcare workers, academics and researchers must be disclosed.

“Conservative prescribing”

This editorial, an opinion piece by Prof David Healy, was recently published in the BMJ. In this post I intend to explore the arguments made around whether “chemical imbalance” was ever part of standard medical teaching. I will also explore the suggestion, made by some experts that antidepressant prescribing in the western world is “conservative”.

024 Conservative Prescribing

Professor Healy’s editorial has attracted a number of replies. Here is one:

026 Conservative Prescribing

A psychiatrist in training gave his view that the above reply was “the cleverest” and then offered his own reply:

016 Conservative Prescribing

The psychiatrist in training then gave the following link to what he called: “the sensible reaction”:

019 Conservative Prescribing

I found that I agreed with the statement made in this “expert reaction” by the President of the Royal College of Psychiatrists:

018 Conservative Prescribing

However I found that I did not share the view of Professor David Taylor that the “idea that SSRIs correct an imbalance in the brain never really existed”:

017 Conservative Prescribing

In the 1990’s, as a psychiatrist in training, I followed the “Defeat Depression Campaign”. A central plank of this was the “chemical imbalance theory” involving serotonin. There was hardly an educational event that I went to where a “Stahl” neurotransmitter diagram was not displayed. Even up till 2007, I still found the Stahl diagrams appearing as part of my CME education:

029 Conservative Prescribing

In response to Professor Healy’s article on serotonin and depression it concerns me that experts such as Prof Philip J Cowen and Prof David Taylor are suggesting that the “chemical imbalance theory” always was “mythical”. I was there. It was a very real part of my “education” and often given by experts of the day.

Furthermore, it would seem to me that such expertise is considered as sufficient in itself rather than including experience of taking SSRIs both short and long-term.

027 Conservative Prescribing

In his BMJ editorial Professor Healy gave this stark 2015 statistic:

012 Conservative Prescribing

It has been argued that this figure indicates over-diagnosis:

028 Conservative Prescribing

“Are antidepressant overprescribed”  was the question debated between Dr Des Spence and Professor Ian Reid  published in a BMJ Head-to-Head in January 2013.

Are antidepressants overprescribed, BMJ, 2013

A few years before this debate I gave a view on antidepressant prescribing from “my own window” which I submitted as a rapid-response in the BMJ. As I journey through life I often find my views change, but the view from the window I looked out from in 2011 seems still to be very much the same to me.

I was very sad when Professor Ian C Reid died last year, prematurely, as the result of cancer. I trained with Ian Reid in Aberdeen and he was an inspirational speaker and a most committed scientist. His loss is significant.

This research study was published in the British Journal of General Practice in September 2009:

020 Conservative Prescribing

The study gave a conclusion that I agreed with:

Conservatively

The study supported my view that GPs do not indiscriminately prescribe antidepressants. Here, I should be clear, I am talking about newly diagnosed depression, in a time more than a decade on from the likes of the “Defeat Depression Campaign”. However it remains true that access to psychological therapies, in NHS Scotland, remains a very real “challenge”.

Professor Ian Reid went on to say:

014 Conservative Prescribing

And gave his view that:

015 Conservative Prescribing

It is here I depart from sharing Ian Reid’s view. My view is that we need pluralistic evidence, rather than expert opinion alone, that chronic prescribing of antidepressants represents an “improvement in practice”.

The medical profession are generally of the view that long-term antidepressant prescribing is “appropriate” because it is likely that most individuals taking antidepressants have a “recurrent illness” and that such is often demonstrated when they stop taking their antidepressants.

011 Conservative Prescribing

The problem is that most studies into antidepressants, on which prescribing is based, have been short-term studies, often only 6 weeks. Without longer-term studies and the evidence of experience, we simply cannot be sure why so many individuals receive long-term antidepressant treatment.

004 Conservative Prescribing

In summary: It is certainly the case that antidepressants are widely prescribed in the Western world.  In my view we need to see more evidence that prescribing of antidepressants, particularly chronic prescribing, is “appropriate” and “conservative”.

Note to reader:
I am not a "Critical Psychiatrist" as I prescribe psychoactive 
medications including antidepressants. I try to do so only if 
indicated, and if this is the patient's preference. To prescribe 
"appropriately" I do my best to share the knowns and unknowns of 
antidepressant prescribing along with explaining potential harms 
and potential benefits. One potential unknown is the optimal 
duration of prescribing. Professor Reid's evidence would 
appear to demonstrate that long-term prescribing is common 
practice.

“All in the past”: well, no.

All in the past from omphalos on Vimeo.

Seven years ago this Editorial was published in the BMJ:KOL

Eleven years ago, all NHS Chief Executives in Scotland were asked to implement and govern this Scottish Government circular: HDL 62. This has not happened.HDL-62

The General Medical Council published nine years ago:  “Good Medical Practice”, which makes very clear:Annexe A, GMC

General Medical Council on conflicts of interest from omphalos on Vimeo.

Seven years ago the Royal College of Psychiatrists issued its own guidance, CR148:CR148 says (3)

Given these multiple levels of failing in governance, and in the pursuit of scientific objectivity, I have petitioned the Scottish Government to consider implementing a Sunshine Act. The research behind this can be accessed here.

I am employed as an NHS psychiatrist and have been an NHS Consultant for 13 years.

Over this time, the key opinion leaders in UK psychiatry (though I have never met) have become known to me.

Continuing Medical Education invites (generally “CME-accredited”) come to my NHS e-mail address on a weekly basis.

As an NHS employee I have had regular invites to attend “CME-accredited” conferences that include educational talks by distinguished speakers such as:

  • Professor Allan Young
  • Professor Peter Passmore
  • Professor Guy Goodwin
  • Professor Philip J Cowen
  • Professor David Nutt
  • Professor J Chick
  • Professor David Taylor (pharmacist)
  • Professor Clive Ballard
  • Professor Nick Fox

It is the case that (in 2015) we still have no way of knowing how much may be paid to any individual to educate professionals like myself

The ABPI “central platform”, which will be operational next year, allows individuals to “opt out” of revealing any payments.

Dr McCartney has long argued that the medical profession should take the lead on transparency. I agree.

009b

The Royal College of Psychiatrists guidance CR148 has not been followed since it was introduced seven years ago. The updated system (following my dogged persistence) still fails to require details of monetary exchange or for specific dates of (any such) payments.

The USA have introduced a Sunshine Act and so in recent years, drug companies have started releasing details of the payments they make to doctors and other health professionals for promotional talks, research and consulting:

CropperCapture[1]

Over a decade ago, I noted this letter of reply by Professor Philip J Cowen. A reply that troubled me.

Cowen, P J - Constructionism 24-5-2011Professor Philip J Cowen

A straightforward internet search would indicate that Professor Cowen has followed extant guidance regarding transparency. Here follows some of the material on Professor Cowen to be found in the public domain:Cowen, P. J,CINP, 2016 Cowen, P J - 3-3-2014 Cowen, P J - 17-11-2014 Cowen, P J - 19-5-2011  Cowen, P J - 2011 2011, RCSPsych Int CongressCowen, P J - 2014 b Cowen, P J - 2014 Cowen, P J - 2015 Cowen, P J - April 2014 Cowen, P J - April, 2012 Cowen, P J - Aug 2010 Cowen, P J - Aug 2013 Cowen, P J - Dec 2012 Cowen, P J - ECNP Cowen, P J - Jan 2015 Cowen, P J - May 2012 Cowen, P J - Nov 2012 Cowen, P J - Nov 2012b Cowen, P J - Nov 2013From “Our own window” published in BMJ rapid responses:Soft rebuttal, 2001

“Packaging up old myths”

Last week the Association of the British Pharmaceutical Industry (ABPI) held its Annual Conference:Annual Conference 2015The Pharmaceutical Industry are concerned about an “affordability conundrum”:Affordability conundrum1The affordability conundrumThis BBC Report from November 2014: “Pharmaceutical Industry gets high on fat profits” documented that:Pharmaceutical industry gets high on fat profits (2b)There will be many companies around the world who would like to be dealing with this kind of “affordability conundrum”.

Another area of concern to the industry was discussed at the 2015 ABPI Conference:Aileen Thompson 2aileen_thompsonThe closing session of the 2015 ABPI Conference was focused on the reputation of the pharmaceutical industry:  Industry as a credible partner A panel discussion was part of this:      Sponsored by concentraI wonder if the panel considered this:Pharmaceutical industry gets high on fat profits (3)Andrew McConaghie of PharmaPhorum recorded this passage:wrong1 wrong2 wrong3My view is that if the Pharmaceutical industry are concerned about their reputation then they should avoid such obvious scapegoating. Dr Goldacre has been and continues to be a world pioneer for scientific objectivity and it does the “reputation” of the British Pharmaceutical industry no credit to distort his work in this way.

Here is the view of the World Health Organisation:Pharmaceutical industry gets high on fat profits (4)

Sunshine Act for Scotland: transparency, independence and accountability

Mrs Chrys Muirhead, writer and carer, has submitted this response to the BMJ:Transparency, independance & accounatbility - Chry

This was in reply to this “no holds barred” piece in the BMJ by Dr Margaret McCartney:009b

“PULSE Live is heading to Scotland”: the Corn Exchange

My wife is a GP working in NHS Scotland and was recently invited to the “PULSE LIVE 2015″ educational conference to be held in Edinburgh on the 19 May 2015:Pulse Live 1

This educational conference is to be held in Edinburgh’s Italianate and historical CORN EXCHANGE. General Practitioners can register for a free place and 7 CPD hours are accredited:Pulse Live 2

In my earlier career I trained as a Landscape Architect at Edinburgh University and was awarded the Scottish Chapter prize. This will explain to you why old buildings and designed landscapes interest me. The Corn Exchange was where traders brought grain to sell. It was a place of barter: where goods were exchanged for money:Former corn exchange

With this in mind it is worth looking at the PULSE LIVE 2015 programme and noting that a significant number of the educational talks are sponsored by the pharmaceutical industry or other commercial enterprises. The speakers are mostly from NHS Scotland and it is fair to reasonably conclude that they will receive honoraria for giving their talks:Dr Douglas Elder, Bayer HealthCare, 2015 Dr Paul Newman, Johnson & Johnson, 2015 Dr Richard Watson, Lundbeck, 2015 Dr Tom Fardon, Pfizer, 2015 LUTS, 2015, Pulse Live, Astellas

My interest in this area relates to my wish to consider the ethics of medical practice. In this instance, my interest is in public transparency of any financial transactions between healthcare workers/academics and wider commerce.

I should make it very clear: I understand that conflicts of interest are part of life.

Over a few years I have collected the invites to NHS doctors to attend pharmaceutical sponsored education. These invites are collected here and demonstrate that financial sponsorship by the pharmaceutical industry (or commercial enterprises), as included in PULSE Live 2015, is generally the norm. Dr McCartney has considered this in her BMJ Column of last week: Forever indebted to pharma—doctors must take control of our own education:009b

My petition to the Scottish Government for A Sunshine Act is a request that transparency surrounding (non NHS) financial payments made to all those involved in healthcare (including academics and all those involved in medical education) to be a requirement by statute. In terms of the United Kingdom, I have suggested that Scotland might lead the way on this. America and France have introduced a Sunshine Act.

Open and transparent from omphalos on Vimeo.

NHS Scotland has failed (in my view, most miserably) to follow Scottish Government guidance HDL 62. This Government Circular was issued to all NHS Scotland Chief Executives over a decade ago. The Scottish Government has, since my petition which was based on my research, accepted widespread failure across NHS Scotland to follow HDL 62.

HDL-62

The Cabinet Secretary for Health, Wellbeing and Sport, Shona Robison MSP, wrote recently to the Convener of the Scottish Parliament Petitions Committee. Shona Robison, 24-4-2015

The Cabinet Secretary for Health, Wellbeing and Sport, asks for a “broader view” on an issue that the Scottish Government agree is “important”. The Cabinet Minister will be attending PULSE Live 2015 for the “Big Interview”:Pulse Live, Cabinet Minister for Health, May 2015

Perhaps the Cabinet Secretary for Health, Wellbeing and Sport, will look upwards to the roof of the Corn Exchange which is celebrated for its “massive single-span”. Sponsored Medical Education also celebrates a massive span across NHS Scotland. Please do not be fooled into thinking that this, like the Corn Exchange and the bartering it once housed, may be a thing of the past.Former corn exchange

So go on, if you dare, be like me and shout about this from the roof-top! If we reach for the sunshine perhaps we might all be a little healthier. Sunshine on Leith!0094638392057_600