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’

Kindness

I resigned from NHS Forth Valley on the 6th June 2014. This was a very sad day for me as I had worked as a Consultant in older adults in Clackmannanshire for nearly 13 years. I hugely miss the people of Clackmannanshire and wish to reaffirm my sincere gratitude to the small team that I was very lucky to be part of.

What follows are some of the kind words that I received before and after I left NHS Forth Valley:003kindness014kindnessThe following message was from a nurse in training who showed exceptional promise:001kindnessFrom a carer:004kindnessFrom a carer:005kindness copyFrom a carer:006kindnessFrom a carer:007kindnessFeedback on my presentation for local CPD:030kindnessFrom a carer:008kindness 009kindnessFrom a member of staff in NHS Forth Valley:010kindnessFrom the Consultant Trainer of Junior doctors in psychiatry in NHS Forth Valley:031kindnessFrom a member of staff in NHS Forth Valley:011kindnessFrom the organiser of the Carers Support Group:1111From a GP who works in Clackmannanshire:013kindness1From a patient:033kindnessFrom a carer who, before I was involved, had significant concerns about the care given to her loved one in NHS Forth Valley:abcFrom a GP who works in Clackmannanshire:015kindnessFrom an NHS Forth Valley Consultant colleague in Psychiatry for Older Adults:016kindnessFrom a nurse:missedFrom a member of staff in NHS Forth Valley:020kindnessFrom a nurse:wwFrom a Healthcare Assistant:022kindnessFrom my secretary:principlesFrom a number of folk with lived experience::024kindnessFrom an ethicist:transparencyFrom a patient to NHS Forth Valley:026kindnessFrom a patient to NHS Forth Valley:027kindness028kindnessThe reference that was given to NHS Forth Valley before my Consultant interview in 2002:029kindness

NHS Boards are not following existing guidance

The Petitions Committee of the Scottish Parliament are to meet on Tuesday 27th January 2015 to give further consideration of my petition for a Sunshine Act, PE1493. I lodged this petition in September 2013. What follows below is the full transcript of a letter of update to the Committee:

Friday, 23rd January 2015

To: Sigrid Robinson
Assistant Clerk
Public Petitions Committee
The Scottish Parliament
petitions@scottish.parliament.uk

Dear Ms Robinson
Scottish Parliament Public Petition PE1493 on a Sunshine Act for Scotland

Thank you for informing me that my petition is to be considered by the Public Petitions Committee at its meeting on Tuesday 27th January 2015.

You suggested that I might like to make a short written submission for the meeting of the Committee informing me that this would be published online with the other evidence that the Committee have gathered for Petition PE1493.

Before I offer a brief summary, a year on almost to the day from my last written submission, I would like once again to thank the Committee, and supporting staff, for continuing to explore how the people of Scotland might benefit from a Sunshine Act.

I understand from your communication of the 20th January 2015 that the Committee, “despite numerous reminders,” has received no response from the Scottish Government. I am disappointed to hear this, particularly as the summary produced by the Scottish Government, in their letter of 17 April 2014, would appear to demonstrate wide failings in NHS Scotland’s Compliance with HDL (2003) 62. Given these failings, in December 2014 I contacted all 14 regional NHS Boards for further clarification and in the hope of progress. I have so far had reply from only 2 NHS Boards.

NHS Forth Valley and NHS Tayside now have a central register of interests for all staff. Both have now made these registers publicly accessible.

NHS Forth Valley: the current register includes the names of only 7 staff and all the other entries are by designation only. NHS Forth Valley’s register is therefore not complete in that it does not consistently identify individual staff. The Director of Education for NHS Forth Valley, confirmed last year in writing that he was “not aware” of HDL (2003) 62. The Director of Education also confirmed that Forth Valley’s “learning Centre” has no budget that pays for educational meetings”.

NHS Tayside: is the only other Health Board to reply to my recent request for an update and provided the public link to their Register. The register begins in 2011 and records 16 entries, and each without any identifying name. Ms McLeay, Chief Executive, stated in her reply of the 30th December 2014 “I agree that this public record of sponsorship is not complete and accurate at this point”.

NHS Lothian: I have had no reply to my recent communication on HDL (2003) 62. The situation as recorded in FOI reply from NHS Lothian dated 6th May 2013 stated: “There are no other [apart from Board members] centrally held registers available within NHS Lothian and any such register would not necessarily identify payments to staff”.

NHS Greater Glasgow: I have had no reply to my recent communication on HDL (2003) 62. Following my original FOI request (before I lodged this petition in September 2013) NHS Greater Glasgow attached a register that covered 5 years and had entries for 27 separate employees. NHS greater Glasgow is the largest health board in the United Kingdom, serving 1.2 million people and employing 38,000 staff. This NHS Greater Glasgow register for “all staff” is not available to the public.

NHS Ayrshire and Arran: have promised to reply to my recent communication on HDL (2003) 62 stating that “turnaround times are proving challenging”.  NHS Ayrshire and Arran stated in June 2013 “discussions are ongoing to create a register to encompass the whole organisation … we are in the process of updating our Model Publication Scheme to include this register which will be published on our public website.” I can today find no such register (other than for Board Members only) for NHS Ayrshire and Arran.

NHS Lanarkshire: I have had no reply to my recent communication on HDL (2003) 62. However previously (15th May 2014) Dr Iain Wallace, the Medical Director for NHS Lanarkshire, wrote to me stating: “I can advise that it is not the intention of NHS Lanarkshire to publish a register of interests for all staff”.

NHS Grampian: I have had no reply to my recent communication on HDL (2003) 62. However in relation to my original FOI request, I was informed in July 2013: “…no such register is maintained and therefore a copy is unable to be provided to you….In all of the circumstances therefore, NHS Grampian is unable to provide a register to meet your requirements.”

From the 6 other regional NHS Boards I have had no reply to my recent communication on HDL (2003) 62. I have not made further contact with the 7 special NHS Boards since my original FOI request. My understanding however is that HDL (2003) 62 applies equally to the special boards.

To remind the Committee, here is the relevant section of HDL(2003) 62:

HDL-62

On the 17th May 2014 the Herald reported: “The Health Secretary has 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.”

SUMMARY:

  1. HDL (2003) 62 was issued 12th December 2003. It is more than a decade old. It asked Chief Executives to “establish a register of interest for all NHS employees and Primary Care Contractors.”
  1. The Scottish Government summary of the 17th April 2014 demonstrated widespread failure to comply with HDL(2003) 62. The updated evidence I have managed to gain indicates reasons to be more rather than less concerned.
  1. I have found no evidence, in any register of any sort, of declarations from “Primary Care Contractors”.

The Committee may recall that before I had submitted oral evidence for the petition the Association of the British Pharmaceutical Industry (ABPI) submitted a letter to the Committee. The ABPI plan to develop what they term a “Central Platform”: from the 1st July 2016 the intention is to collect and record data of individual payments to healthcare practitioners and record these on an open database. It is important to note that healthcare practitioners will be able to opt-out if they do not wish payments to be disclosed.

The General Medical Council (GMC), in reply to the Petition Committee confirmed that a “compulsory register would require legislative change.” This week the GMC sent this reminder to medical practitioners:

GMC Jan 2015 CoI

Despite reminders, NHS Boards are not following existing guidance. This strategy has failed for more than ten years. The disappointingly slow response of the Scottish Government to communication from the Committee only highlights the failure of the current approach. This strengthens my view that a new law would be a better way of focusing minds on a matter that may be having a significant impact on Scotland’s health. I would remind the Committee that I was first prompted to look into this when considering the widespread, off-label over-prescription of antipsychotic medications for Scotland’s elderly people. My experience was that the Pharmaceutical Industry financially supported the “education” of healthcare practitioners in this approach.

I hope this update is of some assistance to the Committee ahead of the 27th January 2015.  I wish to say that I am very grateful to the Committee members, and supporting staff, for all your help.

Yours sincerely,
Dr Peter J. Gordon

Full correspondence on NHS Registers of Interest can be followed here

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The above post is by Chrys Muirhead. It can be accessed here. I have also re-posted it below:

Sunshine Act for Scotland Petition Goes Before Parliament a 3rd Time

January 23, 2015

In Scotland petitions are a direct way for people to raise national issues with their Parliament, a request for action.  Dr Peter J Gordon, consultant psychiatrist, first lodged a petition on the Scottish Parliament website, PE01493: A Sunshine Act for Scotland, 29 September 2013:

“Calling on the Scottish Parliament to urge the Scottish Government to introduce a Sunshine Act for Scotland, creating a searchable record of all payments (including payments in kind) to NHS Scotland healthcare workers from Industry and Commerce.”

Peter J Gordon is a man of many parts: a qualified doctor and landscape architect, husband and father, a family man whose interests include philosophy, sociology, ethics, evidence-based medicine, neuroscience, horticulture, sculpture, poetry, local history,  photography and film-making.  He writes on Hole Ousia (whole being) and has 269 films, at the latest count, on Omphalos.

spshotsunshineactpetOn 12 November 2013 the Public Petitions Committee at parliament took evidence from Dr Gordon in respect of his Sunshine Act for Scotland petition.  (See video, 25 minutes in)  Here is part of my comment on the video, now disabled but on my Google+ profile:

“The points about the marketing potential of education versus scientific objectivity demonstrate the need for regulation of drug industry payments, or in kind rewards, made to or received by health care professionals.  To hear the figure of £40million gifted by drug companies to UK health workers and about £4million of that going to Scottish workers is quite astonishing.”

— Herald Scotland article 13 November 2013: ‘Doctor calls for drug payments register‘.

In addition to petitioning Scottish Parliament, Dr Gordon has been diligently raising Freedom of Information requests in respect of Registers of Interests in every Scottish health board area.  Scottish Government brought out a directive, NHS Circular HDL (2003) 62, instructing health boards to set up Registers of Interest so that staff could declare payments from pharmaceutical companies.  For the sake of transparency.  The health boards have not been complying with this government call to action.

Herald Scotland article 17 May 2014: ‘Urgent review as nearly half of health boards ignore pharma disclosure rule‘ and quote “The Health Secretary has 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.”

HeraldEditorial18may14On 18 May 2014 the Herald Scotland Editor gave his support for the Sunshine Act petition and greater transparency, saying “Simply hoping that NHS Boards enforce existing guidance is a strategy that has failed for more than ten years.  A new law would be a better way of focusing minds on this important matter.”

Nearly a year to the day after Dr Gordon gave his evidence, on 11 November 2014, his Sunshine Act petition was considered by the Public Petitions Committee at its meeting in the Robert Burns Room of Scottish Parliament.  I was there to hear the proceedings, punctuated by a Remembrance Day commemoration in the Garden Lobby of parliament at 11am, and then at around 12 noon the topic came up.  It took two minutes mention of contacting Scottish Government to ask about the NHS Circular HDL (2003) 62 (Registers of Interest) progress.  My thoughts?  Swingball.  Pass the buck.  See blog post I wrote following the meeting.

On Monday this week a notification arrived to say that Dr Peter Gordon’s petition will be considered, again, by the Public Petitions Committee on 27 January 2015 in the Robert Burns Room of Scottish Parliament.  Meeting starts at 10am and the agenda item containing the Sunshine Act should start at around 11.15am, subject to change.  I have booked a ticket and plan to observe the proceedings from the Public Gallery.  Live broadcasts can be viewed at this link.  Videos after the event here plus links to business papers and reports.

I am hoping this time around in the Rabbie Burns room for more than 2 minutes worth of talk and no direct action.  A Sunshine Act for Scotland makes sense economically and ethically.  Doctors in their drug prescribing should be free from conflicts of interests.  The pharmaceutical industry is primarily a money making concern.  Patients deserve to know that their medical treatment is for them and not for profit.

“While Europe’s eye is fix’d on mighty things,
The fate of Empires and the fall of Kings;
While quacks of State must each produce his plan,
And even children lisp the Rights of Man;
Amid this mighty fuss just let me mention,
The Rights of Woman merit some attention.”

— Robert Burns, The Rights of Woman, 1792