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’

A Sunshine Act for Scotland (parliamentary update)

007 (2)My petition was further considered by this parliamentary committee on the 31st March 2015. What follows is the full transcript:001John Pentland, MSP002HDL-62Angus MacDonald, MSP 003Jackson Carlaw, MSP 004John Wilson,  MSP 005 006 007 008 009009b003 (2) 005 (2)

Open and transparent from omphalos on Vimeo.

“appropriate” and “correct” concerns in NHS Scotland

After sending an update of my petition for a Sunshine Act to the Chief Executive Officer of NHS Forth Valley I received this reply. Whilst I was employed by NHS Forth Valley I raised concerns that HDL 62, the Scottish Government Circular sent to all Chief Executives in NHS Scotland, was not being followed.

Jane-Grant,-NHS-Forth-Valle

Two aspects of this letter from the Chief Executive Officer for NHS Forth Valley are worth further consideration:

(1) Transparency:

When I was an employee of NHS Forth Valley I was formally written to by Dr Rhona Morrison, Associate Medical Director. In this letter from the Associate Medical Director, which was both unsigned and undated, I was described as “unprofessional” and “offensive” for raising concerns that NHS Forth Valley was not following extant Scottish Government guidance on transparency regarding declarations of interest.

This letter confirmed that I would be “invited” to  an “informal” meeting by the Associate Medical Director’s immediate peers.

My experience of this “informal” meeting was that my character, reputation and probity were robustly questioned by the Medical Director, Dr Peter Murdoch, and the General Manager, Mrs Kathy O’Neill. This meeting was not minuted. This meeting left me distressed.

A number of weeks after this meeting I resigned from NHS Forth Valley. On my resignation I had this  feedback from those who I had cared for and worked with

(2) Freedom to Speak Up:

The Chief Executive Officer reinforces in her letter the “importance of a culture of openness and candour”. However, Jane Grant, the Chief Executive Officer for NHS Forth Valley then goes on to give qualifications: that any concerns raised should be “appropriate” and “correct”.

Whistleblowing in NHS Scotland from omphalos on Vimeo.

To conclude: it appears to me that there are still significant barriers to raising concerns in NHS Scotland. If you click on the image below you can read the full review by Sir Robert Francis. I have selected one particular recommendation which I think will require a different mindset to that suggested in the letter from Jane Grant, Chief Executive Officer for NHS Forth Valley:

Freedom05002

Update: November 2016:
On the 22 March 2016 the following petition was lodged by 
Pete Gregson with the Scottish Parliament: PE01605: Whistleblowing 
in the NHS - a safer way to report mismanagement and bullying.

On the 24th November 2016 the Public Petitions Committee considered 
all the submissions requested as part of evidence gathering. 
This included a letter from the Chief Executive Officer for 
NHS Forth Valley. This letter was commented on in particular 
by Angus MacDonald, MSP:

pe1605-nhs-scotland-whistlblowing-jane-grant-nhs-forth-valley