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’
What follows below are several extracts from Socialism and Hope by Neil Findlay, MSP.
If you wish to purchase this book please do so through socialismandhope.com as this means a greater donation goes to good causes.
According to the Sunday Post of the 23rd September 2017, the former Health Minister for the Scottish Government, Alex Neil, MSP, is:
“urging the Scottish Government to stage a summit bringing together experts from around the world as the scandal of women left badly injured by the propylene implants escalates”
I am interested in the Mesh implant scandal because of my petition to the Scottish Parliament which sought consideration of a Sunshine Act for Scotland.
On the 17th May 2017 I submitted a summary as part of further consideration of on PE1517: Polypropylene Mesh Medical Devices.
Mr Neil’s call for an international summit has cross-party support in the Scottish Parliament. He also has the backing of East Renfrewshire MP, Paul Masterton, Conservative, who is campaigning at Westminster.Paul Masterton MP states:
The Interim and Final Independent Reviews on the use of Mesh implants concluded that “robust clinical governance must surround treatment”. I have argued that for this to happen the Scottish Government need to listen to the people.
Since my last post on PE1571, Polypropylene Mesh Medical Devices, there has been further consideration of this petition, with evidence given by Dr Wael Agur and the petitioners Elaine Holmes and Olive McIlroy:
What follows are some of my reflections on the parliamentary committee session of the 28th September 2017:
Before the committee began I suggested to interested colleagues:
“The petition on Mesh implants will start taking further evidence today. This could potentially be a watershed moment for the Scottish Government’s Department of Health?”
Dr Agur was extremely good in giving evidence. He came across to me as open, genuine, careful, scientific and reflective. Dr Agur disabuses the stereotypical notion that surgeons struggle to combine pragmatism with philosophy.
Dr Agur was entirely open about his declarations. Here he is an exemplar.
However I retain the concern that manufacturers may have had a greater share in “shared decision making” on Mesh surgery than we are currently able to determine?
The Mesh survivors spoke incredibly well, and thankfully more openly and candidly than any of those in the systems of power that surround us.
The cross-party questions to Dr Agur and the petitioners explored the issues extremely well.
I have no idea what will happen from here on – but I support all the recommendations of this Parliamentary committee.
I dislike over-simplified summaries and yet I now offer one:
We should be especially open to the consideration of what might constitute “fully informed consent”. I do hope the Chief Medical Officer follows through on Realistic Medicine including the potential for science to be distorted, and patients harmed, by vested interests.
The above statement was part of a longer statement made by the Chief Medical Officer for Scotland in giving evidence on PE1571 on the 18th May 2017.
The following is a shared consideration of the potential for conflicts of interest to have had a significant role in the harm caused to Scottish women by Mesh implants. This is taken directly from the official report of this Scottish Parliament evidence session.
I commend Neil Findlay, MSP for raising this important issue with and Dr Agur for his considered responses.
I would also hope that the Review of the “independent review” that Professor Britton is undertaking will consider the issue of conflicts of interest specifically.
The evidence gathered for PE1493, A Sunshine Act for Scotland, established that NHS Scotland governance is failing here and that NHS Boards have routinely ignored the guidance offered.
PE1493 closed a year and a half ago, after a public consultation exercise under taken by The Scottish Health Council. The majority of those consulted were of the view that there should be a public register open to all and that it should be mandatory for all healthcare staff and academics to declare all competing financial interests.
The following is an account of the experience of the petitioners, Elaine Holmes and Olive McIlroy as members of the “Independent Review” into Polypropylene Mesh implants. This is taken directly from the official report of the Scottish Parliament evidence session of 28 September 2017.
A senior Scottish figure once gave me advice that it is very important to be perceived as “credible”.
I was thinking about this advice recently when the convener of the Parliamentary Committee considering polypropylene Mesh implants concluded:
It is not surprising, therefore, that those who have experienced harm from healthcare may feel that they are not being listened to.
In the same week another example featured in a week long series of articles in the Herald: “A Bitter Pill”. On a background of ever increasing prescribing of antidepressants it appears that my profession is still struggling to accept the value of people’s experience (which may not always be positive) and can respond defensively:
One responder has already articulated my feeling about this:
My understanding is that this series in the Herald arose, at least partly, because of a petition to the Scottish Parliament which seeks consideration of prescribed drug dependence and withdrawal.
One of the explanations for the rising prescribing of antidepressants is that people are often taking them for many years. Another way of looking at this is that people are not stopping these drugs. It is still the case that we really do not understand why this may be and we are not going to understand this until we listen to the experience of those taking these medications.
Experience is evidence and I find it incredible that we do not listen carefully enough to it.
This post is based on the following Scottish Parliamentary debate which took place on the 5th December 2017. In this post I have highlighted cross-party considerations relating to fully informed consent. One of the aims of the original petition, Polypropylene Mesh Medical Devices, PE1517 was to call on the Scottish Parliament to urge the Scottish Government to:
“introduce fully informed consent with uniformity throughout Scotland’s Health Boards”.
Johann Lamont, MSP, stated:
Johann Lamont went on to state:
Jackson Carlaw, MSP made the comparison between this Mesh scandal and that of Thalidomide, a prescribed medication:
Jackson Carlaw, cited Brenda O’Hara, MP who like Johann Lamont expressed determination that this should never be allowed to happen again:
Neil Findlay, MSP, has steadfastly supported the Mesh survivors from the outset. He began by expressing very serious concerns about financial conflicts of interest and the medical profession:
Neil Findlay, MSP, continued:
Currently there is no regulatory requirement for healthcare workers to declare financial interests. In NHS Scotland there exists Guidance (HDL62) but this guidance is being routinely ignored by NHS Boards. This was why I raised petition PE1493, A Sunshine Act for Scotland.
This was the first point raised by the former Health Secretary, Alex Neil, MSP:
The Scottish Public share this view. This was established almost two years ago through a public consultation undertaken by the Scottish Health Council.
An open-access, central register where all healthcare workers are required to declare financial interests would provide a fuller basis for informed consent.
The Scottish public agree with David Torrance, MSP. There is longstanding evidence that exposure to industry promotional activity can lead to doctors recommending worse treatments for patients.
Michelle Ballantyne, MSP has come to this conclusion:
The evidence gathered for PE1493 (A Sunshine Act for Scotland) came to the same conclusion.
Anas Sarwar, MSP, gave one of the closing speeches and stated that:
SUMMARY:
The Mesh survivors were deprived of fully informed consent and as a result dreadful harm resulted.
This parliamentary debate demonstrates that there is full cross-party agreement that, in order to prevent future harm, action has to be taken to ensure that consent is fully informed.
Without transparency of financial conflicts of interests, fully informed consent cannot be ensured. The Scottish public came to this conclusion almost two years ago in a consultation arranged by the Scottish Government.