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’

Inspirational: the Chief Medical Officers for Scotland

The Chief Medical Officers for Scotland have been a huge inspiration to me.

I was delighted to hear, earlier this year, that Dr Catherine Calderwood had been appointed to this office to replace Harry Burns. My full support goes to Dr Calderwood in her appointment.

Last year I spoke at a Civic Trust event in Glasgow and was fortunate to follow Sir Harry Burns. His talk on “salutogenesis” accorded with all that Hole Ousia is about.

Salutogenesis from omphalos on Vimeo.

Kenneth Calman was the Chief Medical Officer before Harry Burns. No other Scottish doctor has inspired Hole Ousia writings more than Kenneth Calman.

001-Makars-&-Medicinersa 025 Makars & Mediciners

In my need to put patients first I have included the Director General for NHS Scotland in e-mails that I have considered important to patient safety and well-being. I admit to being persistent in this matter.

Communications sent but unanswered:
No response came from the office of the Director General for NHS Scotland. With this experience I eventually asked for a “read receipt”  (this is something I most rarely do) This appeared to establish that my communications were being received.  Following this, I reluctantly made a FOI request to the Scottish Government to ask why I had received no response to my communications. This was the reply:

Paul Gray 02

I cannot understand why the Director General did not re-direct my 
communications from outset.

My communications to the Director General were specifically about:

(1) Health and Social Care Integration

(2) Transparency in NHS Scotland

National conversation from omphalos on Vimeo.

the above film ends with the promise as made by 
the Director General for NHS Scotland

The consequence for me, as an NHS Consultant, for raising questions about patient safety:

Dr Catherine Calderwood, Chief Medical Officer

Footnote to the above e-mail:

I am not a "locum consultant". I am a substantive Consultant with 
NHS Lothian.

I agree with the Chief Medical Officer that my concerns relate to 
openness and accountability of the Scottish Government and 
especially its "advisors".

In my telephone conversation with the Chief Medical Officer, 
Dr Calderwood, I found that she never once asked about 
my wellbeing. Instead she seemed on guard, ill at ease:
almost as if she was hiding an ulterior motive 
for contacting my employers?

All I can say to anybody reading this: imagine the Chief Medical 
Officer for Scotland had expressed concerns about your 
mental "wellbeing"? 
How would you feel? 
How might your employers react? 
Might you feel that you had been re-defined? For better? Or for Worse?

My advice to the Scottish Government: do not be tempted, on the 
advice of your advisors, to so easily LABEL anybody for 
raising concerns. 

"See me".

First Minister Nov 2014

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