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.

A Sunshine Act for Scotland

I cannot promise sunshine (who can) but here is a pattern that appears in the daylight of my today.

Hole Ousia found new direction after Alexander McCall Smith recommended “A Pattern Landscape”

051

This post is based on the recent considerations (27th January 2015) by the Petitions Committee on my petition for a  “Sunshine Act”

Kenny Macaskill, MSP gave this response to my petition:

Kenny MacAskill & Jackson Carlaw: A Sunshine Act for Scotland from omphalos on Vimeo.

Kenny Macaskill states to the Petitions Committee: “we have got to give them some opportunity” [Scottish Government]  … “I don’t think that can be done quickly as it is quite complex”. HDL-62

HDL (2003) 62 was issued 13 years ago. It was addressed to every NHS chief executive in Scotland.

Kenny MacAskill states that “it does seem to me [for there to be] a willingness to look into this”

Evidence reveals that such “willingness” has been largely ignored by NHS Boards since HDL (2003) 62 was issued more than a decade ago.

Jackson Carlaw, MSP: “can I say how I am delighted to agree with Mr MacAskill”

Appreciating this evidence, John Wilson, MSP, gave this “note of discordance” to the Committee:

A Sunshine Act: John Wilson, MSP from omphalos on Vimeo.

20th January 2015: “Despite numerous reminders, no response has been received from the Scottish Government. In light of this and concerns raised in your correspondence with the Committee’s clerking team, it is advisable for you to direct your concerns directly to the Public Petitions Committee by way of a short written submission that will be published online and circulated for the Committee’s meeting on 27 January 2015”

I sent this reply three days later. I could not do any more.

The basis of my petition, it occurs to me, may risk being lost in procedure:

Prescribed Harm from omphalos on Vimeo.

HDL (2003) 62 made it clear who was accountable. Alex Neil, former Cabinet Minister (17 May 2014) “asked officials to urgently investigate why some NHS boards have not put in place registers as covered by the 2003 circular. Alex Neil believes the guidance is clear that this action should have been taken, and we are looking for clarification on why some boards have not acted.”

My investigations have demonstrated that this financial basis to “medical education” is largely hidden in NHS Scotland. This despite General Medical Council guidance.

Accountability is passed like a parcel.