Conflicts of interest and polypropylene Mesh implants

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.

Mesh implants and “fully informed consent”

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.

 

‘Robust clinical governance must surround treatment’

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.

Rising stars: British Association of Psychopharmacology

I submitted a rapid response to the BMJ last September after viewing galleries of photographs of the British Association of Psychopharmacology (BAP) Summer Meeting of 2016. The BMJ did not publish my post. This year’s galleries of the British Association of Psychopharmacology (BAP) Summer Meeting have now been shared. This is an amended version of what I sent last summer:

I was recently shared the published photographs of the British Association of Psychopharmacology 2016 Summer Conference.

At this BAP conference, an accredited CPD conference, the rising stars are seen to mix with today’s key opinion leaders. We all welcome the sharing of experience between generations and I have repeatedly stated how important I believe this to be. Some of the BAP key opinion leaders have declared significant financial interests with the Pharmaceutical Industry.

Up-to-date declarations of BAP speakers can be viewed here

I support transparency.  I have understood that this can only ever be a means to an end.

Robert K Merton once insisted that science should be based not on interest but ‘disinterest’. Merton’s star rose long ago and he is now dead. I do hope that all generations of scientists might be able to see his ‘disinterested’ star, still in the sky that we all share.

 

Unrealistic Medicine

This BMJ Editorial of the 30th June 2017 has had a number of responses:

The Editorial was a consideration of Academy of Medical Sciences report ‘Enhancing the use of scientific evidence to judge the potential harms and benefits of medicines’.

The President of the Academy of Medical Sciences and the Chair of the Report, Professor Sir John Tooke, has submitted this reply:

It is most welcome for Professor Sir John Tooke to set out his further thoughts but I found that what he said did not reassure me about the future of science and so submitted this response:

Unrealistic Medicine
Written by Peter, 15 July 2017
Submitted as BMJ Rapid Response.

The further thoughts of Professor Sir John Tooke, Chair of the Academy of Medical Sciences report ‘Enhancing the use of scientific evidence to judge the potential harms and benefits of medicines’ are most welcome.

Professor Sir John Tooke does not reassure me that an era of unrealistic medicine and the business of science will change anytime soon. Meantime the NHS is struggling across the United Kingdom and this may be in part due to the promotion of medical interventions whose evidence base lacks the objectivity that we all surely seek.

I would suggest that most of us fully understand the “reminder” from the Academy of Medical Sciences that potential conflicts of interest can come in all forms and not just financial. But like the public I share the view that we should start with potential financial conflicts of interest as evidence has determined that exposure to industry promotional activity can lead to doctors recommending worse treatments for patients  Godlee and Freer remind us that we expect this from our elected politicians and in other areas of public life.

The voluntary ABPI Register is not working. Its database is only a little more than half complete. This really does challenge the “E” in EBM.

The pharmaceutical Industry has, over the preceding year, increased payments to healthcare workers for “promotional activities” from £109 million to £116.5 million.  This is a major part of Industry budget. Furthermore, we do not know how much may be being paid by device makers and other forms of industry for promotion of their products.

It is welcome, but somewhat “after the bell has rung”, that Professor Sir John Tooke confirms that the Academy of Medical Sciences intends to “review” its approach to public transparency. But one wonders how many “houses” do we need to “get in order” to address this issue effectively? I find myself worrying that it could be like a game of Monopoly that never seems to end.

The most effective and cheapest way to address this matter would be Sunshine legislation. This would avoid multiple, overlapping and generally unsearchable databases of interests.

I would suggest that the reputation of science is at stake as is the balance between benefits and harms for us all

Roy Porter, who sadly died prematurely was considered as one of the United Kingdom’s finest historians of science and health. He ends “Madness: A Brief History “ with a teasing question: ‘Is folly jingling its bells again?’

 

Statements made by senior Psychiatrists working in the British Isles

“you are either abstinent or promiscuous when it comes to industry. Well you can see which side I am on”.

“For those of you who watch Panorama, I do not give my consent for you to film this”

“Who would have thought that Pharma Hospitality could cause excessive weight gain and type II diabetes? They kept that quiet”, I replied, ruefully patting my stomach.”

“this latest non-problem”

“it is time we all grew up”

 

Are the public being listened to?

This is a current Editorial in the BMJ:
Below are a few extracts from this editorial: In a similar vein to Carl Heneghan, I have outlined that there is a problem with the E in CME (Continuing Medical Education)

Sharing the BMJ Editors concerns about a failure of the Academy of Medical Sciences to take necessary action to ensure trust in science (EBM) and education (CME) this response was submitted:

“We could not agree more with Dr Tom Robinson in that we can only gain the trust of the public if we listen to them. One of us (Dr Peter J Gordon) raised a petition with the Scottish Parliament to consider a Sunshine Act for Scotland, and as part of this a consultation was undertaken with the Scottish public. The majority of those consulted agreed that it should be mandatory for all financial conflicts of interest to be declared on a public register. The Academy of Medical Sciences has gone no further than recommending the development of “frameworks for declaring and managing interests” . We would suggest that this will do nothing to restore the public’s trust.”

Dr Peter J Gordon and Dr Sian F Gordon

The Scottish Public: consulted on a Sunshine Act

The Scottish public were consulted on the need for a Sunshine Act for Scotland. Their response, in majority, was that this was necessary.

Almost a year-and-a-half on and the Scottish Government has provided no update to the Scottish people. This is disappointing given the Scottish Government’s assertion that “everyone matters” to them.

The lack of sunshine legislation in the British Isles is raised in this current BMJ News feature:

This response was submitted by Vagish Kumar L Shanbhag:

Psychiatry without borders

This week the International Congress for the Royal College of Psychiatrists is taking place in Edinburgh. It is titled “Psychiatry without Borders”.

Given my concerns about the harms associated with over-medicalisation I decided to make a peaceful protest outside.

I was born in Edinburgh in 1967.

This was a home-made protest.

I have no associations with Critical Psychiatry, Anti-Psychiatry, Scientologists, the Citizens Commission on Human Rights.

I am simply a doctor who is interested in ethics.

I am of the view that critical thinking is an essential part of science.

I understand that biases come in all forms. However there is longstanding evidence that exposure to industry promotional activity can lead to doctors recommending worse treatments for patients.

Thank you to all who came to talk to me on the day. Particular thanks to Chrys Muirhead and her son Daniel for all their support

I waited the full day as I wanted to meet the Cabinet Minister for Health (Scottish Government) outside the International Congress. This was my experience:

More details about a Sunshine Act for Scotland can be found here and here.

The public consultation can be found here.

 

“The Law of the Few”

Malcolm Gladwell in his book ‘The Tipping Point’ describes what he terms “The Law of the Few”: namely that the influence of a few people can result in change in behaviour across a wider population.

This Hole Ousia post is about the education of psychiatrists and takes all its material from publically available sources. This post hopes to demonstrate the considerable reach (to the many) of a handful of educators.

This post follows on from the evidence that was gathered for my petition to the Scottish Parliament to consider introducing a Sunshine Act for Scotland. That petition closed 16 months ago following a consultation with the Scottish public who, in majority, asked that payments made to healthcare workers and academics be declared on a mandatory basis. I have argued the reasons why I am of the view that such mandatory declarations should be registered on a single, open, central, searchable, independent database.

Evidence has demonstrated that when a doctor has a financial “conflict of interest”, this can affect the treatment decisions they make, or recommend. There is longstanding evidence that exposure to industry promotional activity can lead to doctors recommending worse treatments for patients.

The post has come about following my invitations in the last month to Continuing Medical Education (CME) provided in my place of employment (NHS Scotland). I do not knowingly  attend sponsored medical education and so declined these two talks. The first was by Dr Peter Haddad (sponsored by Lundbeck) and the next one, just two weeks later, was by Professor McAllister Williams (sponsored by Lundbeck).

I am an ordinary psychiatrist working in a provincial NHS general hospital and to find such prominent individuals visiting our wee corner of Scotland left me to reflect upon the wide influence of a few key individuals.


The British Association for Psychopharmacology (BAP) describes itself as “a learned society and registered charity. It promotes research and education in Psychopharmacology and related areas, and brings together people in academia, health services, and industry.”

Professor Hamish McAllister-Williams is an Ex-Officio Member of BAP and is currently the BAP Director of Education.  Dr Peter Haddad, former Honorary General Secretary of BAP, has been involved over a number of years with BAP education providing articles and masterclasses.

Over the course of my career as a psychiatrist I have frequently heard colleagues say that BAP “is the place to go” for CME.  It is now a requirement for General Medical Council Appraisal and Revalidation to demonstrate with our College that we have participated in CME. Once this has been demonstrated the Royal College of Psychiatrists will issue a Certificate of “Good medical standing”.

As BAP Director of Education, Professor McAllister Williams recently shared this offer to trainee psychiatrists. Following the dissemination of this I took the opportunity to look more closely at the current BAP calendar for Continuing Medical Education. This again demonstrates the wide influence of a small number of individuals, some of whom would appear (within the limits of the current voluntary disclosure regime) to have potential financial conflicts of interest.

In the remaining part of this post I have included a few examples

As BAP Director of Education, Professor McAllister Williams chaired this BAP 2015 Summer Meeting: “Expert Seminar in Psychopharmacology”. The key-note speaker was Professor Stephen Stahl who many consider as one of the most influential key opinion leaders in world psychiatry.

In the USA, pharmaceutical and medical device companies are required by law to release details of their payments to doctors and teaching hospitals for promotional talks, research and consulting. This was the return for Professor Stahl at the time of his contribution to BAP as an educator of UK psychiatrists:

In the UK disclosure of payments is on a voluntary basis.

Professor David Nutt, former BAP President, has declared financial interests on the voluntary ABPI Register. Over the ABPI “disclosure period”, Professor Nutt has declared just short of £46,000 that he has received from Janssen-Cilag Ltd and Lundbeck Ltd.

There are strong links between BAP and the Royal College of Psychiatrists. The President Elect for BAP is Professor Allan Young.  Professor Allan Young is Chair of the Psychopharmacology Committee of the Royal College of Psychiatrists. Dr McAllister Williams, the BAP Director of Education is an appointed member of this Committee. Some years ago I wrote this post about the Royal College of Psychiatrists Psychopharmacology Committee.

Some years ago I put together this Hole Ousia post on Professor Allan Young and also this post. It is clear that Professor Allan Young remains a very active educator and opinion leader in the UK and beyond:

Professor Guy Goodwin was President of BAP between 2004 and 2005. In April 2014 he featured prominently on  BBC Panorama:

On the 40th anniversary of BAP, Professor Peter J Cowen was given the Lifetime Achievement award:

Professor Philip J Cowen featured in this post of Hole Ousia of some years back: All in the past? Well no. Definitely not.

Conclusion:
The recently retired CEO of the Royal College of Psychiatrists, Vanessa Cameron, who had been with the College for 36 years was interviewed for the Psychiatric Bulletin in December 2016. This was the view that she expressed:

Each time I reconsider this subject I do not find evidence to support this view. My worry is that the Royal College of Psychiatrists is being complacent in facilitating the education of the many by such a small group of individuals. The Law of the Few.

Footnote:

If you click on each invite below you will access what is available 
in the public domain regarding the educational activities of the 
recent speakers. I apologise if this is in any way an incomplete 
record.