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’

The ABPI “Guidance”

Petition PE1493 advocating that Scotland introduce a Sunshine Act was presented to the Public Petition Committee of the Scottish Government on 12th Novemeber 2013:

Evidence presented here: http://www.scottish.parliament.uk/parliamentarybusiness/28862.aspx?r=8630&mode=pdf
Film of evidence presented on PE1493: https://vimeo.com/79379949

The Association of the British Pharmaceutical Industry (ABPI) wrote to the Petition Committee of the Scottish Government two weeks in advance of the petition’s presentation (I gather this is unusual). The ABPI letter of the 29 Oct 2013 was written by Andrew Powrie-Smith, Director ABPI Scotland: http://www.scottish.parliament.uk/S4_PublicPetitionsCommittee/General%20Documents/PE1493_A_ABPI_29.10.13.pdf

My response to ABPI Scotland, by e-mail, is below.

Meantime, it might be worth considering the reasons why the lancet withdrew its support of the ABPI Guidance in February of this year.

Falling-out-with-pharma---L

From: Gordon Peter (NHS FORTH VALLEY)
Sent: 01 November 2013 07:30
To: @abpi.org.uk
Subject: Public Petition PE01493

1 November 2013.

Dear Keith,
Andrew Howlett, Assistant Clerk, Public Petitions Committee forwarded to me the letter of the 29th October 2013 sent by Andrew Powrie-Smith regarding the above petition lodged by myself.

This was a most helpful letter.

I would be interested to meet up and to learn more of the EFPIA Code and the Disclosure Code. It would be most helpful to know how such would be practically implemented in Scotland. I can also appraise ABPI on what the FOI returns have evidenced to be happening in NHS Scotland. There is also the issue of non-NHS academics who are key-opinion leaders and researchers, often affiliated to Universities where currently very little, if anything is recorded in terms of conflicts of interest.

My view is that the GMC should have a role in developing an open, searchable database and that such could fit in within a statutory Act like a Sunshine Act. You will understand then that I am looking at this matter from both sides: where the medical profession has equal responsibility to that of the Pharmaceutical Industry.

I would also be interested, if it is possible, to attend the multi-stakeholder event planned for this autumn.

Evidence based research tells us that there are harmful consequences of an approach where the Pharmaceutical industry spends twice as much on marketing as on innovation and development. There are so many examples, over generations that one could cite: Reboxetine, Seroxat, Vioxx etc etc. Stephen Whitehead has kept assuring that such “is all in the past”. For balance, I would argue that ABPI’s Director, Andrew Powrie-Smith should have mentioned the repeated and well-established evidence of harm associated with marketing in the first part of paragraph two of his letter of 29 October 2013. Collectively we have an ethical duty of “primum non plus nocere quam succurrere” (first do no net harm).

My secretary can be contacted below and best days for tend to be Friday afternoons.

Kind wishes,
Peter Gordon

A SUNSHINE ACT for Scotland

This is an exact transcript of a submission made 23rd August 2013 to the Public Petitions Committee of the Scottish Parliament: http://www.scottish.parliament.uk/parliamentarybusiness/CurrentCommittees/29869.aspx

1. Name of petitioner:
Dr Peter J. Gordon

2. Petition title
A Sunshine Act for Scotland: payments (including payments in kind) to NHS Scotland healthcare workers from Industry and Commerce

3. Petition text 
Calling on the Scottish Parliament to urge the Scottish Government to implement a SUNSHINE ACT that will make it mandatory that all payments, gifts and hospitality from the manufacturers of drugs, nutritional supplements, medical devices and healthcare technology to NHS Scotland healthcare workers are reported, logged and kept on a publicly-open database.

This database should also include all sponsored education of healthcare workers and managers and should quantify the sums of money (or cash equivalent of payments in kind) involved.

The Scottish Government could lead the way in the UK on this issue.

4. Action taken to resolve issues of concern before submitting the petition
Concerns about the over-prescribing of antipsychotic drugs in the elderly led me to consider possible explanations for this behaviour by doctors. I was also aware of a powerful marketing campaign including a series of national meetings led by key opinion leaders promoting the use of another drug, Memantine, for the management of behavioural and psychological issues in dementia. This led me to examine the current systems in place to make clear any potential conflicts of interest.

Two years of enquiry with my local NHS regarding any register of outside interests were eventually answered to reveal that no such register had ever existed.

This led me to write to all 22 of Scotland’s NHS Boards under Freedom of Information legislation and the results show that many of the Boards have no policy in place and in those that do the information recorded is very patchy and generally not available to the public.

The FOI returns can be viewed at: https://www.whatdotheyknow.com/user/peter_j_gordon/requests

I have prepared a summary database: due to the heterogeneity of the returns this is a rough guide at best: https://docs.google.com/spreadsheet/ccc?key=0ApF86-MCSbZzdGlVd2ZPYWhyN1ZUbkliNlFpTGxtMFE#gid=0

5. Petition background information
In January 2013 I wrote to the Scottish Government seeking clarification of regulations in this area. I received a reply which directed me to A Common Understanding 2012 – Working Together For patients: Guidance on Joint-Working between NHS-Scotland and the Pharmaceutical Industry. This document specifically excludes research, procurement and sponsorship. The reader is directed to NHS Circular MEL (1994) 48 Standards of Business Conduct For NHS Staff (which is now nearly 20 years old and written before devolution) and to the ABPI Code of Practice for the Pharmaceutical Industry: http://www.abpi.org.uk/our-work/library/guidelines/Pages/code-2012.aspx

The ABPI Code has been roundly criticised: Guidance on collaboration with drug industry offers little in the way of ethics or transparency. BMJ2012;344:e2910 http://www.bmj.com/content/344/bmj.e2910

Lancet withdraws its support of document on collaboration between doctors and drug industry. BMJ2013;346:f770 http://www.bmj.com/content/346/bmj.f770

The technique of pharmaceutical companies using Key Opinion Leaders (KOL) is well recognised: Drug marketing: Key opinion leaders: independent experts or drug representatives in disguise? BMJ2008;336:1402 http://www.bmj.com/content/336/7658/1402

Guidelines have become an integral part of medical practice but it is not always clear what influences might lie behind their formation: Three quarters of guideline panellists have ties to the drug industry. BMJ2013;347:f4998 http://www.bmj.com/content/347/bmj.f499

The United States of America have just enacted a Sunshine Act: http://www.ama-assn.org/ama/pub/advocacy/topics/sunshine-act-and-physician-financial-transparency-reports.page

As I understand it both Australia and France are in the process of developing a Sunshine Act.

6. Do you wish your petition to be hosted on the Parliament’s website as an e-petition?

YES

7. Closing date for e-petition

8. Comments to stimulate on-line discussion

Conflicts of interests feature daily in the news and in many different fields. Healthcare should not believe itself immune from these.

Date …23rd August 2013

Completed forms should be returned to—

The Clerk to the Public Petitions Committee
The Scottish Parliament
Edinburgh, EH99 1SP
petitions@scottish.parliament.uk