Improvement science and consent: a failure of NHS Governance

I am an employee of NHS Lothian and have been ‘sign posted’ to the “New Capacity and Consent intranet page: important information for all staff.”

This is a screenshot taken on Friday 2nd June 2017:

The Capacity and Consent intranet page begins by reminding all NHS Lothian staff of the ‘Obtaining Consent’ Policy (2014):

The NHS Lothian ‘Obtaining Consent’ Policy (2014) informs staff that “failure to secure consent may constitute assault under common law in Scotland”.

All NHS Lothian staff are also reminded that “acquiescence when a patient does not know what the intervention entails, or is unaware that he or she can refuse, is not consent”.

Two years ago I wrote about national improvement work undertaken by Healthcare Improvement Scotland for older people in hospital in NHS Scotland and my concern that “compliance” had replaced consent.

Given my experience that the guidance from my employers (NHS Lothian) on consent and the explicit requirements of “compliance” mandated by Healthcare Improvement Scotland seem to go in opposite directions, I wrote seeking further guidance. I have had this reply from Healthcare Improvement Scotland.

In conclusion: I would suggest that a failure of NHS Governance in Scotland has led to a confusion about the rights of older people to give consent.

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’

“Trust is generally being eroded”

Last week I watched with much interest the 52nd Maudsley debate. The motion debated was: “This house believes that the use of long term psychiatric medications is causing more harm than good”.

52nd Maudsley debate

The Maudsley debate was covered in a head-to-head BMJ article.

Long-term-use-of-psychiatri

Given that I have petitioned the Scottish Government for a Sunshine Act I was interested in what this Maudsley Debate might say about our approach to transparency of financial conflicts of interest:

Transparency: hold the applause (British Psychiatry) from omphalos on Vimeo.

This particular aspect of the 52nd Maudsley Debate reminded me of a series of letters published in the BMJ a decade ago. It is interesting to consider what has, and what hasn’t changed, in the intervening ten years. The letters were in response to the following 2003 editorial:

No more free lunches (2003)

In a letter of response Dr K S Madhaven argued that “the market has us all in its grip”:

001 Madhaven

Whereas Professor Simon Wessely, in his letter of response, was of a view that “It is time we all grew up”:

001 Simon Wessely

Simon Wessely

Professor Wessely began his letter of 2003:

002 Simon Wessely

and continued:

005 Simon Wessely

It is interesting to reflect on changes that have occurred in the United Kingdom since 2003:

  1. Continuing Professional Development (CPD) has become a requirement of GMC Revalidation:
  2. the pharmaceutical industry now has to follow the ABPI code and healthcare professionals no longer receive branded products such as pens 
  3. “Sandwich lunches” (sponsored Continuing Medical Education – CME) remain core to continuing education. In NHS Scotland, at least two NHS Boards rely entirely on industry sponsorship to support the education of their staff
  4. It remains the case that, at any educational conference, neither the audience nor the public have any idea of how much speakers may have received from the pharmaceutical industry or commercial enterprises in the past three years. The proposed 2016 ABPI register is unlikely to help as any individual can opt out of disclosing payments received. Going by the experience in America, in some cases considerable sums may be routinely involved.

Professor Wessely, in 2003, was concerned about over-regulation, a concern that many of us, including myself have some sympathy with:

006-simon-wessely

Watching the Maudsley debate, in 2015, I was reminded of Professor Wessely’s 2003 fear that “trust [was] gradually being eroded” . It would seem to me that the audience of 2015 would agree with Professor Wessely that this may indeed have happened. However such erosion of trust would seem to be for exactly the opposite reason given by Professor Wessely. It would appear to be the lack of transparency rather than an “Orwellian world of prohibitions” that has contributed to this.

007-simon-wessely

Following the 52nd Maudsley Debate I have written to Professor Wessely, as President of the Royal College of Psychiatrists, to ask if the College might support a single, central, open, searchable database where all payments to healthcare workers, academics and researchers must be disclosed.

Sponsored medical education: another Scottish NHS Board

Those who have followed my posts on Hole Ousia will know that I have petitioned the Scottish Parliament for a Sunshine Act. As an NHS doctor working in Scotland I was recently invited to this educational meeting. I thought it might be useful to use this as an example of the current situation for continuing medical education as I have encountered it in Scotland.

Passmore, 26-2-2015, NHS Lothian

Although this flyer does not make clear, this educational meeting is sponsored by the Pharmaceutical industry. Professor Peter Passmore has been described as a “key opinion leader” in medical education both in the UK and internationally.

This list of declarations for Professor Peter Passmore is from 2008 as given to the Journal of the Royal College of Physicians in Edinburgh.

Geriatric-Medical-Symposium2

I do my best to avoid sponsored medical education but I do try to attend meetings organised by the Royal College of Psychiatrists. For the Autumn 2011 Faculty Meeting I had suggested to the organisers that we might debate “early diagnosis of dementia” . I offered to take one side of the argument. However the organisers chose instead to invite Professor Peter Passmore.

Aware of Professor Passmore’s extensive promotion of drugs I chose not to go.Nov-2011-Forth-Valley-Educa

At this time, 2011, Scottish psychiatrists were invited to a number of educational meetings where Professor Passmore was widely promoting Memantine (EBIXA).

Just recently, the Scottish Parliament have recommended that a Register of lobbying of parliamentarians should be established. The following is an example from 2011:

push-for-the-latest-dementi

In 2013, Professor Passmore was promoting SOUVENAID, a nutritional supplement for “early Alzheimer’s disease”:

Dementia-2013

By being paid to give educational meetings for CPD approved conferences and meetings Professor Passmore is by no means departing from accepted practice.

KOLs2

Whilst I was doing my research on NHS “hospitality registers” I wrote to Professor Passmore asking where he recorded his financial interests? I got this reply from NUTRICIA:

Letter-Nutricia-june-2013

The Association of the British Pharmaceutical Industry (ABPI) are currently introducing a register of payments to individual doctors: “The central platform”. Doctors can choose to opt-out from disclosing any payments received from industry.

My interest is in transparency about such financial conflicts of interest and in particular public transparency. This is why I have petitioned the Scottish Government for a Sunshine Act:

Peter's-Sunshine-Act,-Janua

Returning to the start of this post and the invitation to attend this latest sponsored medical education, I wrote to the organisers and had this reply from the Associate Director of Medical Education:

“All of our clinical association meetings are sponsored, if they were not we simply would not be able to provide these educational meetings as we have no budget for either the catering or the travel expenses of our speakers. We have moved away from sponsorship of teaching at foundation level, but for these hospital wide meetings, at which we are keen to attract speakers from out with Lothian, this is not possible at present.”

051

Those who follow my blog posts may recall that since Alexander McCall Smith’s recommendation to me of “A Pattern Landscape” I have been exploring patterns. Here I am reminded of NHS Forth Valley who are another NHS Board in Scotland who have no money to support medical education.

I am one of many scientists who has concerns that continuing medical education in Scotland is being funded by vested interests.

 

 

 

 

NHS Lothian – Register for all staff

As petitioner for the Sunshine Act I undertook Freedom of Information Requests to all 22 NHS Boards in Scotland to establish if Boards had  Registers of Interest for ALL staff. The findings revealed that most Boards did not.

HDL-62

The above guidance, HDL 62, was issued by the Scottish Government in 2003:

“Chief Executives are asked to establish a register of interest for all NHS employees and Primary Care contractors”. 

NHS Lothian has  NO Register of Interests for all staff. This was confirmed in this Freedom of Information reply dated 6th May 2013:

May2013

The former Cabinet Minister for Health & Wellbeing, Alex Neil, referring to HDL 62 “made it clear” the responsibilities enshrined in it to all Health Boards since it was issued in 2003 (this in the letter below, dated 31st October 2013):

Alex-Neil-on-Reg-of-Interes

This week Professor David Taylor is giving an “educational” talk to NHS Lothian. The Continuing Professional Development (“CPD”) talk he gave earlier this year to NHS Forth Valley was on the basis of a paid honorarium. It was sponsored by the Pharmaceutical Company Janssen. As NHS Lothian have NO Register of Interests this financially sponsored education will have no formal record. It is important to note that Professor David Taylor may be talking about his “prescribing guidelines”.

The British Medical Journal have recently covered this issue (19th July 2014):

BMJ-cover-19-July-2014---me

The Editor of the Sunday Herald shares the concerns of the British Medical Journal:

Herald-Editorial18-May-2014

It's-time-patients-knew-Mgt

NHS Lothian – Register of Interests

6 July 2013

I must advise that information in relation to NHS Lothian’s Register of Interest for Board Members and the Gift and Hospitality Register is available via the following link:-

http://www.nhslothian.scot.nhs.uk/OurOrganisation/BoardCommittees/LothianNHSBoard/BoardMembers/Pages/default.aspx

There are no other centrally held registers held within NHS Lothian and any such register would necessarily identify the payments to staff.  Normal practice would be to declare the interest, not the financial amount.  If someone received payments through secondary employment, we would not have that info.

Ideally any transactions should be on a firm footing directly between the Board and the company.  The appropriateness of the relationship should be considered before it is pursued.

With the exception of HDL (2003) 62, which can be found via the following link:- http://intranet.lothian.scot.nhs.uk/NHSLothian/Corporate/Policies/NHSLothianStandingOrdersPack/Applying%20Principles%20of%20Good%20Business%20Conduct/Guidance%20-%20HDL%20200362.pdf), and Board Members register, we do not maintain a standing register of interests for all employees.  Employees are meant to declare relevant interests as and when required, and then it will be recorded and considered accordingly.

Yours sincerely
Alan Boyter
Director of Human Resources and Organisational Development
NHS Lothian

Cc: Chief Executive

Full correspondence here: https://www.whatdotheyknow.com/request/register_of_payments_from_pharma_160#outgoing-278490

Our Secretary for Health and Wellbeing on this matter:

Alex-Neil-on-Reg-of-Interes