Are the public being listened to?

This is a current Editorial in the BMJ:
Below are a few extracts from this editorial: In a similar vein to Carl Heneghan, I have outlined that there is a problem with the E in CME (Continuing Medical Education)

Sharing the BMJ Editors concerns about a failure of the Academy of Medical Sciences to take necessary action to ensure trust in science (EBM) and education (CME) this response was submitted:

“We could not agree more with Dr Tom Robinson in that we can only gain the trust of the public if we listen to them. One of us (Dr Peter J Gordon) raised a petition with the Scottish Parliament to consider a Sunshine Act for Scotland, and as part of this a consultation was undertaken with the Scottish public. The majority of those consulted agreed that it should be mandatory for all financial conflicts of interest to be declared on a public register. The Academy of Medical Sciences has gone no further than recommending the development of “frameworks for declaring and managing interests” . We would suggest that this will do nothing to restore the public’s trust.”

Dr Peter J Gordon and Dr Sian F Gordon

The Scottish Public: consulted on a Sunshine Act

The Scottish public were consulted on the need for a Sunshine Act for Scotland. Their response, in majority, was that this was necessary.

Almost a year-and-a-half on and the Scottish Government has provided no update to the Scottish people. This is disappointing given the Scottish Government’s assertion that “everyone matters” to them.

The lack of sunshine legislation in the British Isles is raised in this current BMJ News feature:

This response was submitted by Vagish Kumar L Shanbhag:

Your Parliament, Your Voice

The Commission on Parliamentary Reform published its Report on the Scottish Parliament this week. It is a most welcome review and one that has my full support.

The Editor of the Scotsman gave his view (21 June 2017):

Johann Lamont, MSP is quoted in the Scotsman of 21 June 2017:

My petition to the Scottish Parliament, PE1493, “A Sunshine Act for Scotland” was closed in early Spring of 2016. I was impressed by the organisation and the effort put into the wider consideration of my petition by all involved with the Public Petitions Committee.

A Public Consultation was carried out on my petition by the Scottish Health Council and this was published in March 2016. The public, in majority, agreed with the petition.

More than 15 months on since my petition was closed and the public have had no update from the Scottish Government. I wrote to the Scottish Parliament to ask that an update be requested from the Scottish Government but the short reply that they received lacked any substantial content. It has become familiar to many of those engaging with the Scottish Government to receive replies such as this that lack in transparency and openness.

The Scottish Parliament has told me that they can do no more and advised me to seek help from a constituency MSP. To me, this is like going backwards to the start.

I thus very much support the Review published by the Commission on Parliamentary Reform and hope that it will ensure that the public have a meaningful voice in helping the Scottish Parliament hold the Scottish Government to account.

Submission on PE1517: Polypropylene Mesh Medical Devices

Submission on PE1517 on Polypropylene Mesh Medical Devices

Made by Dr Peter J Gordon

Date of submission: 17th May 2017
Submission made in a personal capacity.

The Agenda for the Public Petitions Committee meeting of the 18th May 2017 includes a most helpful summary “Note by the Clerk” on PE1517: Polypropylene Mesh Medical Devices (Document PPC/S5/17/10/1). Having read this carefully, and in accordance with the first suggested “Action” (point 45, page 8), I would like to offer evidence. Before doing so I have listed below the most relevant sections of PPC/S5/17/10/1 in relation to the points of evidence that I wish to make.

In Annexe B of PPC/S5/17/10/1 the Interim and Final Conclusions of the Independent Review are listed side-by-side.

Conclusion 1, both Interim and Final, was that “Robust clinical governance must surround treatment”

Conclusion 3, both Interim and Final, was that “Informed consent is a fundamental principle underlying all healthcare”

In  Annexe C: Parliamentary Action (page 21 of PPC/S5/17/10/1) the Cabinet Minister for Health, Shona Robison answered question S5W-07749 by Neil Findlay, MSP on the 17 March 2017, by stating:

“Informed consent and shared decision making are expected prior to any procedure being carried out. The Chief Medical Officer goes into this in more detail in her Realistic Medicine report.”

The Clerk, in point 7, (page 2 of PPC/S5/17/10/1) confirms that:

“The Scottish Government does not have the power to regulate what medical devices are licensed for use in the UK. The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medical devices in the UK”

The Clerk, in point 12 (page 3 of PPC/S5/17/10/1) includes quotations from the Preface of the Review’s Independent Report:

“We found some concerning features about how new techniques are introduced into routine practice”  and that

“We are aware that some of our conclusions have wider implications and see the need to embed this in patient Safety and Clinical Governance strands of the NHS”

Points of Evidence by Dr Peter J Gordon  (GMC number 3468861)

• HDL62:  the Scottish Government has acknowledged that this 
Guidance is not being followed by NHS Boards

• There have been media reports that NHS professionals working in 
Scotland, who are involved in educating NHS staff about Mesh
procedures, have been paid by commercial sectors who have 
financial interest in Mesh products. 

• PE1493, A Sunshine Act for Scotland, was closed in February 2016 

• A Public Consultation on PE1493 was undertaken by the Scottish 
Health Council. The Scottish  public, in majority, were of the view 
that it should be mandatory for  all financial payments made to 
healthcare workers and academics to be declared in a publically 
accessible form 

• No meaningful update has been provided by the Scottish Government 
since this Public Consultation was published more than a year ago.

• I  fully support the Chief Medical Officer’s “Realistic Medicine” 
initiative and I have suggested that Sunshine legislation should be 
considered an essential part of this development  

• I agree with the Independent Review that “robust clinical 
governance must surround treatment”. I am concerned that if the 
current situation continues, where “education” of health 
professionals may be significantly based on marketing, further 
examples of iatrogenic harm may occur in NHS Scotland.

• The Independent Review concluded that “informed consent is a 
fundamental principle underlying all healthcare”. If the advice 
given to patients is based on marketing, either partially or wholly, 
then informed consent may be denied patients. Further examples of 
Iatrogenic harm may then  unfortunately occur and healthcare 
in Scotland may risk being considered as  unrealistic 
rather than “realistic”.

 

Update, 22 May 2017:

Public Petitions Committee – Scottish Parliament: 18 May 2017 (click on image below to watch the full meeting)

The official report of the Public Petitions Committee of 18 May 2017

Sunday Post, 21 May 2017: ‘Probe to examine possible conflicts of interest in troubled mesh implant inquiry’

Making science a reality

It has been a long time since I last wrote on Hole Ousia about my activism for a science that strives for objectivity.

It is probably reasonable to suggest that no other in the British Isles has given more to this cause than I have.

I petitioned the Scottish Parliament to consider introducing a Sunshine Act for Scotland. Much evidence was gathered for this petition and this was then shared in a formal public consultation.

The Scottish public agreed, in majority, that payments from the pharmaceutical industry and device makers to healthcare professionals need to be declared on a mandatory basis. At the time, this landmark consultation was neither reported in the mainstream press nor the medical press. A year on the Scottish Government has provided no meaningful update.

It was thus with considerable interest that I read the following editorial in the current British Medical Journal:

The full article can be accessed here from the BMJ:






Open and transparent from omphalos on Vimeo.

The Scottish Public Want Sunshine

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.

 

Public Consultation on a Sunshine Act for Scotland: “The report cannot be shared”

I have previously expressed concerns about the process and validity of the public consultation on PE1493: A Sunshine Act for Scotland

The Scottish Health Council copied me into this communication of the 16th March 2016 to their staff:

“I understand that a few people who took part in the gathering views project on the development of a Register of Interests have asked local offices whether a report summarising their feedback is available yet.

By way of an update, the Scottish Health Council’s report was shared with the Scottish Government a few weeks after the final discussion group was held on 5 February. Since then and at its last meeting because of the election period, the Scottish Parliament’s Petitions Committee closed the Register of Interests petition. The Scottish Government has advised, however, that the Cabinet Secretary wishes to formally send our report to the Committee together with comments from the Scottish Government on the next steps. Essentially, we see this as a positive outcome and a demonstration of the impact of our report.

The Scottish Government will keep us informed about an appropriate timing for publishing the report on our website once it has been shared with the Committee. Whilst this is likely to be after the election period, until then the report cannot be shared further.   Please can local offices share this information with participants who may be seeking an update.”

I replied to the Scottish Health Council as follows:

"Many thanks for this update further to your last e-mail of the 
25th February 2016 when you informed that I would receive a copy 
of the report as soon as it was drafted.

I was disappointed that the Public Petitions committee chose to 
close my petition. As you are aware my petition sought a
Sunshine Act for Scotland however the committee have closed 
my petition “on the basis that the Scottish Government has 
committed to review the need for updated guidance on what 
the petition calls for”. 

My petition specifically asked for legislation because of the 
complete failure of previous guidance to be followed. 
As you know I was concerned that this failure was not 
communicated to those participating in the public consultation.

My petition was based on principles of transparency on an issue 
that affects us all. I am very disappointed that the process 
has also seemed to lack openness and that the petitioner and 
indeed the public will only see the contents of the consultation 
well after those in positions of power."

 

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.

 

 

Director General for NHS Scotland

I have found it impossible to communicate directly with the Director General for NHS Scotland.

The Director General for NHS Scotland does not reply to e-mails sent to him unless you follow this advice from his office:

Paul Gray 02

Please note: The above includes only the first paragraph of the
Deputy Director's letter of the 15 October 2015.

It is essential to note that the Director General had repeated opportunities to make it clear to me that this was the process of communication to be followed. Unfortunately this never happened.

My advice to the Scottish Public is to carefully follow the advice as given by the Deputy Director, Colin Brown. Otherwise you may risk being considered “unwell”, as I have been,  for contacting the Director General through his, openly available Scottish Government, e-mail address.

Paul Gray, PAG1962, Year of Listening, NHS Scotland

Mr Paul Gray, the Director General for NHS Scotland: 
Year of Listening, 2016: "I've taken time to listen"

Over the last 8 months I felt it would not be constructive to attempt to communicate with the Office of the Director General of NHS Scotland.  However, following the EU Referendum the Director General wrote a letter to all NHS Scotland staff in which he stated “I greatly value the contribution of every member of staff in NHS Scotland”. Given that this had not been my experience, I wrote to dghsc@gov.scot expressing this reality which has led me to consider early retirement and asking: “I would be interested in your thoughts and if you have any words of support for me.”

I received the following reply (reproduced here exactly as it was sent):

paul-gray-director-general-chief-executive-1-july-2016

Below: an audio recording of a contribution I made to a 
BBC Radio Scotland discussion on retirement:

My communications in the past to the Director General related to my endeavour to put patients first, specifically in the areas of an ethical approach to the diagnosis of dementia and relating to my petition for a Sunshine Act. The lack of support I received in return is strikingly at odds with the following statement made by the Director General on the Scottish Health Council film below:

“We worry about transfer of power, transfer of responsibility. As far as I am concerned, the more power that patients have, the better. The more power that individuals have, the better. Because they are best placed to decide on what works for them.

To be frank, there is very clear evidence that if people feel powerless their wellbeing is greatly reduced.

If people feel that they have a degree of power, a degree of autonomy that actually helps their wellbeing. So to suggest that it involves something that relates to a loss of power on the part of the service provider, in order for the service user to gain, I think is quite wrong.

I think the service user, the patient, the carer, can have as much power as they are able to exercise without causing any loss or harm to the service provider whatsoever. Indeed I think it is greatly to the benefit of service providers to have powerful voices, powerful patients, and powerful service users, who are able to help us understand what works for them.”

Our Voice: support from senior leaders. 
Published by the Scottish Health Council

Perhaps the following explains why this admirable rhetoric does not seem to play out in practice:

Whistleblowing in NHS Scotland from omphalos on Vimeo.

In Dumfries and Galloway Health: Opinions & ideas, the Director General for NHS Scotland had published in July 2015: “Leadership in a rewarding, complex and demanding world”. The article is worth reading in full but here is one quote:

paul-gray-nhs-scotland-scottish-government-1

This was the response of the Deputy Director as shared with the Director General when I shared my experience of the NHS initiative “Everyone matters”:

deputy-director-to-director-of-nhs-scotland-hes-another-of-our-regular-correspondents

This report in the National describes the Director General’s approach to whistleblowing, an approach that would seem to address only selected recommendations of Sir Robert Francis:

No if yer a whistleblower it's no

all-nhs-workers-should-have-the-confidence-to-speak-up-without-fear-pag1962-paul-gray-chief-executiveThe above interview was published in the Herald on the 26th September 2016.

nhs-staff-too-scared-to-speak-out-paul-gray-chief-executive-pag1962

first-steps-towards-a-more-open-nhs-scotland-paul-gray-herald-chief-executive

In the month before the Director General shared his views with the Herald he had sent the following communication. I acknowledge that I have been persistent but would maintain that this was because of the lack of any substantive responses from his Department. This sort of behind the scenes approach by those in a genuine position of power highlights the very culture that Mr Gray needs to address.  I share the conclusions of the Editor of the Herald that “public statements of intent are not enough”.

from-the-director-general-nhs-scotland-15-aug-2016

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.