One of the main themes of this petition is genuine transparency

What follows is a transcript of a letter that I have sent to the 
Scottish Parliament on my petition for a Sunshine Act for Scotland:

Scottish Parliament Public Petition PE1493 on a Sunshine Act for Scotland

Letter from the petitioner, Dr Peter J. Gordon, 20th November 2015

Dear Members of the Petition Committee,
I thought that it might be helpful to give you a brief summary on matters relating to my petition.

The Scottish Government has commissioned the Scottish Health Council to undertake consultation with the public. This is underway with ten separate discussion groups with somewhere less than 100 participants overall.

Scottish Government and Scottish Health Council (HIS)

As petitioner I met with the Scottish Health Council in June and was asked to provide a summary to help in preparing information to act as the basis for the discussion among the participants. I was asked by the Scottish Government if I wanted to review the information that they had compiled but was confident that the Scottish Government would provide a balanced summary including the evidence that had been carefully compiled for this petition.

Having now seen the “information” provided by the Scottish Government, that forms the basis of the consultations, I now feel that I was naïve to have been so trusting.

This petition would not have been raised, nor indeed considered by the committee, had it not been for the following evidence, evidence which has not been provided to the discussion groups:

  1. 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.
  2. The pharmaceutical industry, on average, spends twice as much on marketing activities as it does on innovation and developing new drugs. If healthcare workers are “educated” by those whose first loyalty is to shareholders then scientific impartiality may suffer. 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.
  3. At least forty 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.
  4. 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.

As petitioner my overwhelming concern is that by presenting unbalanced information the Scottish Government has arranged consultations which will lack in validity. One of the main themes of this petition is genuine transparency. I am therefore also disappointed to note that the authors of the information provided are not identified.

I realise that the consultation process is well under way but felt it important to present to the committee the significant concerns which I have.

 

 

I no longer feel safe

I have reluctantly decided that I am no longer going to write any posts about NHS Scotland on Hole Ousia. I will however still continue to discuss health and wellbeing in the context of the “two cultures”.

My reason is that I no longer feel safe to speak out individually as an employee of NHS Scotland.

I will continue to advocate for transparency and accountability.

I feel very lucky to be a doctor. The NHS is so important to me. I have so many wonderful colleagues and I never cease to learn from the Scottish folk that I try to help when in a time of need.

I will always try my best to put patients first. That is the way I am. I do not agree with those who suggest that such a determination might be considered as a sign of illness.

Dr Peter J. Gordon

The Friends of Liberty from omphalos on Vimeo.

A Friend of Liberty: Professor Walter Humes

Professor Walter Humes, writing in Scottish Review, 21st September 2015:

“For some time I have been copied into email exchanges concerning how complaints against public bodies are dealt with. I have no personal stake in any of the specific sources of concern (which include patient care in the NHS and responses by Police Scotland, the Scottish Government and the Crown Office and Procurator Fiscal Service (COPFS) to requests for formal investigations). I do, however, have a long-standing interest in issues of public accountability and am familiar with the various techniques used by bureaucratic organisations to avoid responsibility when things go wrong: these include silence, delay, evasion, buck-passing and attempts to discredit complainants.”

The Friends of Liberty from omphalos on Vimeo.

“Those who hold high office in public bodies are very adept at defending their own interests. They may claim to support openness and transparency but those principles are not always translated into practice. Bureaucratic Scotland often falls short of the democratic ideals which are said to underpin civic life”

Stephen Stahl: $3,581,159 in payments from Pharma

In my last post I considered the level of transparency provided by the British Association for Psychopharmacology (BAP) in relation to its recently published Guidelines on prescribing for depressive disorders.

This post, will very briefly look at the programme for the recent 2015 Summer Meeting and specifically the issue of transparency:

07BAP

If you download the programme and then type “declaration” into text search you get zero responses.

The programme does list these sponsors:

08BAP

I noticed that Stephen Stahl was giving several keynote educational talks on day one of this conference for the British Association for Psychopharmacology (BAP). Stephen Stahl is a world-wide “key opinion leader” who has his home in California.

09BAP

In America all payments to individual doctors and academics must be provided for the public. This being a statutory requirement of a Sunshine Act. All payments can be established by typing into a searchable database called dollars for docs.

Here is the return, as at the time for writing, for Dr Stephen Stahl:

Stephen Stahl

In the United Kingdom the public have no way of establishing if or how much individual British doctors or academics may have been paid by the pharmaceutical industry or by other commercial companies. When these individuals are involved in educating the healthcare profession or drawing up guidelines this situation needs to change. And soon.

 

 

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.

 

“This most unusual request”

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

Majority-of-Guideline-panel

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

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

Peter-Sunshine,-Jan-2015

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

we-can-find-no-record

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

HDL-62

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

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

One a

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

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

One b

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

GMC on CoI

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

Freedom to speak up

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

Update, September 2016:

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

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

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

sign-86-guideline-healthcare-improvement-scotland