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 letter that the Scottish Parliament felt unable to publish

With careful thought, and backed with full supporting evidence,  I sent the following letter of the 2nd February 2016 to support my petition for a Sunshine Act for Scotland.

The Senior Clerk of the Parliamentary Committee was of the view that this letter did not comply with the Scottish Parliament’s policy on the treatment of written evidence. I was therefore asked to redact significant sections of the letter.

After considerable communications to and fro, I replied as per this e-mail of the 3rd March 2016:

I fully respect the right of the Scottish Parliament to determine 
what it publishes.

I feel very strongly that my letter without the highlighted text 
merely reiterates what I have already said, and fails to provide 
the evidence that I have repeatedly been asked for.

So my position is that I do not wish to amend my letter of the 
1st February on PE1493.

My petition has since been closed. I therefore have decided to publish my letter to the Scottish Parliament in full along with supporting evidence. I have had professional advice that what is contained in this letter is not defamatory as it is based on veritas and has full supporting evidence:

Dear Mr McMahon
Petition PE01493: A Sunshine Act for Scotland

I realise that the Committee must receive a great amount of correspondence however I hope that the committee might agree that what follows is extremely important when considering PE1493.

Since I last wrote to the committee I attended, for accredited continuing medical education, the Royal College of Psychiatrists in Scotland Winter Meeting held on the 29th January 2016. It is this that has compelled me to write this update as it demonstrates beyond doubt that lack of transparency around financial conflicts of interest remains a serious issue. An issue with implications for both patient safety and healthcare budgets. It also demonstrates that Government action is the only way to address this.

The full powerpoint presentations of this Accredited meeting for 
Continuing Professional Development can be accessed here - but only
for members of the Royal College of Psychiatrists. 

I am a member of the Royal College of Psychiatrists and I am of the 
view, as a scientist, that these lectures should be available to all 
and not just to members.

One speaker highlighted the increase in prescribing costs in her health board area which was due to the high prescribing rate of a new antipsychotic injection, palperidone depot (XEPLION®). The next speaker demonstrated both the inferior effectiveness of this drug when compared to existing (far cheaper) depot medications and the perception amongst Scottish psychiatrists that it was more effective. Below you will see the flyer sent to mental health professionals in Scotland when this drug was launched:

002 Financial Conflicts of Interest, Scottish Psychiatry

I have highlighted one of the paid speakers, Dr Mark Taylor, because he also spoke at this week’s meeting where he reminded us that he was Chair of SIGN Guideline 131: The Management of Schizophrenia, which was published in March 2013.

At this week’s meeting Dr Taylor presented his declarations as follows: “Fees/hospitality: Lundbeck; Janssen, Otsuka; Roche; Sunovion”.

Dr Taylor commented on these declarations with the statement that “you are either abstinent or promiscuous when it comes to industry. Well you can see which side I am on”. Audience laughter followed.

The general question that arises is whether an influential professional such as a Chair of National Guidelines might earn more from the pharmaceutical industry than in his or her role as a healthcare professional? At present it is impossible for anyone to establish the scale of competing financial interests. To remind the committee the following avenues are not illuminating:

1. Royal College of Psychiatrists. This week’s meeting did not appear on the college database. In any case this database is neither searchable nor does it include specific details of payments and dates

2. NHS Boards. The committee has already established that, across Scotland, HDL62 is not being followed.

3. SIGN guidelines. The committee is aware of significant governance failings particularly in comparison with NICE which includes details of financial sums paid and associated dates.

4. Discussions with Senior Managers in NHS Scotland relating to the General Medical Council’s expected level of transparency has brought forth written responses describing my interest as “highly unusual” and “offensive and unprofessional”

5. The forthcoming ABPI register allows any professional to opt out of inclusion.

It is also worth repeating that the information provided to the public consultation on this petition failed to highlight most of the issues identified in points 1 to 5 above.

In terms of cost both to the public purse and the individual patient the Government’s stated wish for a “robust, transparent and proportionate” response would be fulfilled if a single, searchable, open register of financial conflicts of interest that has a statutory basis were to be introduced

Public Consultation on a Sunshine Act for Scotland: “The report cannot be shared”

I have previously expressed concerns about the process and validity of the public consultation on PE1493: A Sunshine Act for Scotland

The Scottish Health Council copied me into this communication of the 16th March 2016 to their staff:

“I understand that a few people who took part in the gathering views project on the development of a Register of Interests have asked local offices whether a report summarising their feedback is available yet.

By way of an update, the Scottish Health Council’s report was shared with the Scottish Government a few weeks after the final discussion group was held on 5 February. Since then and at its last meeting because of the election period, the Scottish Parliament’s Petitions Committee closed the Register of Interests petition. The Scottish Government has advised, however, that the Cabinet Secretary wishes to formally send our report to the Committee together with comments from the Scottish Government on the next steps. Essentially, we see this as a positive outcome and a demonstration of the impact of our report.

The Scottish Government will keep us informed about an appropriate timing for publishing the report on our website once it has been shared with the Committee. Whilst this is likely to be after the election period, until then the report cannot be shared further.   Please can local offices share this information with participants who may be seeking an update.”

I replied to the Scottish Health Council as follows:

"Many thanks for this update further to your last e-mail of the 
25th February 2016 when you informed that I would receive a copy 
of the report as soon as it was drafted.

I was disappointed that the Public Petitions committee chose to 
close my petition. As you are aware my petition sought a
Sunshine Act for Scotland however the committee have closed 
my petition “on the basis that the Scottish Government has 
committed to review the need for updated guidance on what 
the petition calls for”. 

My petition specifically asked for legislation because of the 
complete failure of previous guidance to be followed. 
As you know I was concerned that this failure was not 
communicated to those participating in the public consultation.

My petition was based on principles of transparency on an issue 
that affects us all. I am very disappointed that the process 
has also seemed to lack openness and that the petitioner and 
indeed the public will only see the contents of the consultation 
well after those in positions of power."

 

Closed by the Scottish Parliament: a Sunshine Act

PE1493 closed

My petition was closed on the 8th March 2016, after the following consideration by the Public Petition’s Committee:

PPC 8 March 2016

I was naturally disappointed.

I was invited by the Scottish Parliament to give feedback. This is what I said:

Thinking about the process that your petition went through, 
how fairly do you think your petition was dealt with?

Firstly I am impressed with how well organised and structured the PPC is. There are many petitions (a growing number?) and without the Clerks I cannot imagine that the committee members and Convener would manage to cope.

Secondly I am impressed that the PPC meetings are all recorded and archived both by Parliamentary TV and full verbatim Minutes. This is most commendable

My petition PE1493 was not fairly managed. The reasons are as follows:

(1) Apart from the initial opportunity to present my petition and engage directly with the committee there were no further opportunities to directly engage with the committee

(2) This lack of direct engagement deprives the public of consideration of the further evidence and correspondence collected by the PPC. Not once were any of the responses to PE1493 discussed publically in any detail by the PPC.

(3) Following my initial presentation of PE1493, all PPC meetings considering my petition were very short indeed. Many of them under a minute and the most common outcome was “the PPC will write to the Scottish Government”

(4) A huge amount of responsibility falls the way of the Senior Clerk and the Clerk’s team. Given this, and that this is a Committee for the public, who have elected the MSPs on the committee, it would seem important for the committee to acknowledge this. It would be helpful to set out clearly the qualifications and responsibilities of the Clerk and the line-management system, and system of appeal for any petitioner or member of public. Otherwise the PPC risks being considered undemocratic.

(5) As Petitioner for PE1493, in being asked to provide evidence from Scotland, to substantiate the request to consider legislation for healthcare workers and academics to declare financial conflicts of interest, I found myself in an impossible position. For example one piece of evidence, with full supporting material (film and the RCPsych approved power-point presentations of the academics) was refused publication by the PPC. In fact the PPC members, to my knowledge, never saw the letter. The decision not to publish was made by the Clerk based on Parliamentary Guidelines. I fully respect the right of the Scottish Parliament to determine what it publishes. However I feel very strongly that without this evidence (repeatedly asked for by the PPC, Scottish Government, and the Cabinet Minister for Health) that PE1493 could not be properly and meaningfully considered.

(6) PE1493 was closed. This was the deliberation of that decision of the PPC of 8th March 2016:

“There is stunned silence.”

Closure of my petition for a Sunshine Act for Scotland was then “minded” for closure by one of the members repeating what had been recorded by the Clerk in the papers for the meeting, that being:

“PE1493 by Peter John Gordon on a Sunshine Act for Scotland. To close the petition, under Rule 15.7, on the basis that the Scottish Government has committed to review the need for updated guidance on what the petition calls for and is consulting on the issue to gather views on what format it should take.”

My petition specifically asked for legislation because of the complete failure of previous guidance to be followed.

 

What did you hope to achieve by submitting your petition?

For a Sunshine Act to be introduced. For Scotland to lead the way in the UK.

To reduce harm caused by bias introduced into science by financial vested interests.

To address over-medicalisation and harmful misdirection of finite resources.

 

How do you feel about the outcomes?

Proud that I was brave enough and had sufficient stamina to pursue this petition.

Grateful that this Petition has encouraged wider discussion.

Disappointed at the skewed “Public Consultation” which deliberately chose not to explain to the consultees that existing Scottish Government Guidance has failed across our nation for more than 13 years. The information provided to the Consultees was drawn up by the Scottish Government.

Disappointed that PE1493 was closed without further opportunity to consider the evidence gathered and that it was closed based on the misunderstanding that PE1493 “called for updated guidance”

In conclusion:

The Scottish Parliament could have done more to hold the Scottish Government to account.

“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