There is a long standing joke about the lack of sunshine in Scotland.
Three years ago I began the process of raising a petition with the Scottish Parliament to urge the Scottish Government to introduce a Sunshine Act.
A Sunshine Act makes it a statutory requirement for all payments from commercial interests made to healthcare workers and academics to be declared publically. The metaphor is that sunshine brings full light. Both the United States of America and France have introduced a sunshine act.
The doctor in Gabriel García Marquez’ ‘Living to tell the tale’ says “Here I am not knowing how many of my patients have died by the Will of God and how many because of my medications”. Márquez often returns to the theme of medical ethics in his writings and reminds us that all interventions have the potential for benefit and harm. In ‘No one writes to the Colonel’, “a man [who] came to town selling medicines with a snake around his neck”. Here Márquez is reminding us of the long history of the financial opportunities open to healthcare professionals.
As a junior doctor in around 2000, I was handed by a Consultant a several hundred page document entitled “Behavioural and Psychological Symptoms of dementia”. The Consultant told me “this is the way forward!” Some years on I came to realise that this document had been developed, funded and disseminated by the Pharmaceutical Industry whose first loyalty, as a business, is to its share-holders.
In the wake of the dissemination of this document, prescribing of antipsychotics, sedatives and antidepressants in Scotland has been rising year on year. This has been described as mass prescribing, and is often long-term. Yet the evidence to support such prescribing is poor.
There is much promotion of “partnership working” between industry and healthcare. Yet we must remember that these two partners have different aims, and it is the responsibility of healthcare workers to follow the ethical approaches central to their professions. For example, the General Medical Council is clear about what is expected of doctors in their code “Good Medical Practice”. The potential for conflicts of interest is recognised and doctors are advised “you must be open about the conflict, declaring your interest formally”.
Since 2003, Scottish Government guidance has been in place to allow the declaration of financial interests of NHS staff, to their employing health boards. As a result of my petition, the Scottish Government has confirmed that this guidance is not being followed.
One key area of concern is the continuing professional education of healthcare professionals, another requirement of professional bodies. In at least two Boards in NHS Scotland, continuing medical education relies entirely on the financial support of commercial interests.
National and international conferences may also form part of continuing professional education. Because of the Sunshine Act in the USA, we know that a key-note speaker at a recent UK conference has been paid more than £3 million dollars by the pharmaceutical industry since the Sunshine Act was introduced. There is currently no way of knowing the scale of any payment made to a UK speaker sharing the same platform.
My experience of trying to clarify if there is transparency about financial payments in Scotland has been revealing. I have encountered significant defensive reactions from individuals and organisations. There has long been a body of evidence that, for example, prescribing behaviour is influenced by commercial interests, yet doctors find it hard to accept this. This collective denial would suggest that the forthcoming (voluntary) ABPI Register is unlikely to work as many will regard it as not applying to them and will therefore opt out.
As part of their consideration of my petition, the Scottish Government commissioned a public consultation exercise on a need or not for a Sunshine Act. The majority of participants expressed their view that all financial payments should be declared on a single, central, searchable register and that this should be a mandatory requirement.
The forecast for Scotland looks good: sunshine.
What follows is a transcript of a letter that I have sent to the Scottish Parliament on my petition for a Sunshine Act for Scotland:
Scottish Parliament Public Petition PE1493 on a Sunshine Act for Scotland
Letter from the petitioner, Dr Peter J. Gordon, 20th November 2015
Dear Members of the Petition Committee,
I thought that it might be helpful to give you a brief summary on matters relating to my petition.
The Scottish Government has commissioned the Scottish Health Council to undertake consultation with the public. This is underway with ten separate discussion groups with somewhere less than 100 participants overall.
As petitioner I met with the Scottish Health Council in June and was asked to provide a summary to help in preparing information to act as the basis for the discussion among the participants. I was asked by the Scottish Government if I wanted to review the information that they had compiled but was confident that the Scottish Government would provide a balanced summary including the evidence that had been carefully compiled for this petition.
Having now seen the “information” provided by the Scottish Government, that forms the basis of the consultations, I now feel that I was naïve to have been so trusting.
This petition would not have been raised, nor indeed considered by the committee, had it not been for the following evidence, evidence which has not been provided to the discussion groups:
- Current systems for declaring financial interests are failing in Scotland. No board in NHS Scotland has properly complied with the Scottish Government Guidance on transparency issued more than 12 years ago.
- The pharmaceutical industry, on average, spends twice as much on marketing activities as it does on innovation and developing new drugs. If healthcare workers are “educated” by those whose first loyalty is to shareholders then scientific impartiality may suffer. Each year healthcare workers have to ensure they have met professional requirements for continuing medical education. In at least two NHS Boards in Scotland, it is the case that medical education is entirely supported by sponsors such as the pharmaceutical industry.
- At least forty separate SIGN Guidelines, all currently in operation, have no records of the financial interests of those tasked to draw up the guidelines. This is concerning as these guidelines are generally followed by doctors to inform prescribing decisions for a wide range of medical conditions.
- A single, central register (rather than multiple failing registers) has been found in the USA and France to be relatively simple to set up and administer.
As petitioner my overwhelming concern is that by presenting unbalanced information the Scottish Government has arranged consultations which will lack in validity. One of the main themes of this petition is genuine transparency. I am therefore also disappointed to note that the authors of the information provided are not identified.
I realise that the consultation process is well under way but felt it important to present to the committee the significant concerns which I have.
I have found it impossible to communicate directly with the Director General for NHS Scotland.
The Director General for NHS Scotland does not reply to e-mails sent to him unless you follow this advice from his office:
Please note: The above includes only the first paragraph of the Deputy Director's letter of the 15 October 2015.
It is essential to note that the Director General had repeated opportunities to make it clear to me that this was the process of communication to be followed. Unfortunately this never happened.
My advice to the Scottish Public is to carefully follow the advice as given by the Deputy Director, Colin Brown. Otherwise you may risk being considered “unwell”, as I have been, for contacting the Director General through his, openly available Scottish Government, e-mail address.
Mr Paul Gray, the Director General for NHS Scotland: Year of Listening, 2016: "I've taken time to listen"
Over the last 8 months I felt it would not be constructive to attempt to communicate with the Office of the Director General of NHS Scotland. However, following the EU Referendum the Director General wrote a letter to all NHS Scotland staff in which he stated “I greatly value the contribution of every member of staff in NHS Scotland”. Given that this had not been my experience, I wrote to email@example.com expressing this reality which has led me to consider early retirement and asking: “I would be interested in your thoughts and if you have any words of support for me.”
I received the following reply (reproduced here exactly as it was sent):
Below: an audio recording of a contribution I made to a BBC Radio Scotland discussion on retirement:
My communications in the past to the Director General related to my endeavour to put patients first, specifically in the areas of an ethical approach to the diagnosis of dementia and relating to my petition for a Sunshine Act. The lack of support I received in return is strikingly at odds with the following statement made by the Director General on the Scottish Health Council film below:
“We worry about transfer of power, transfer of responsibility. As far as I am concerned, the more power that patients have, the better. The more power that individuals have, the better. Because they are best placed to decide on what works for them.
To be frank, there is very clear evidence that if people feel powerless their wellbeing is greatly reduced.
If people feel that they have a degree of power, a degree of autonomy that actually helps their wellbeing. So to suggest that it involves something that relates to a loss of power on the part of the service provider, in order for the service user to gain, I think is quite wrong.
I think the service user, the patient, the carer, can have as much power as they are able to exercise without causing any loss or harm to the service provider whatsoever. Indeed I think it is greatly to the benefit of service providers to have powerful voices, powerful patients, and powerful service users, who are able to help us understand what works for them.”
Our Voice: support from senior leaders. Published by the Scottish Health Council
Perhaps the following explains why this admirable rhetoric does not seem to play out in practice:
In Dumfries and Galloway Health: Opinions & ideas, the Director General for NHS Scotland had published in July 2015: “Leadership in a rewarding, complex and demanding world”. The article is worth reading in full but here is one quote:
This was the response of the Deputy Director as shared with the Director General when I shared my experience of the NHS initiative “Everyone matters”:
The above interview was published in the Herald on the 26th September 2016.
In the month before the Director General shared his views with the Herald he had sent the following communication. I acknowledge that I have been persistent but would maintain that this was because of the lack of any substantive responses from his Department. This sort of behind the scenes approach by those in a genuine position of power highlights the very culture that Mr Gray needs to address. I share the conclusions of the Editor of the Herald that “public statements of intent are not enough”.
This report, written by Marion Scott, was recently printed in the Sunday Mail:
The Cabinet Minister for Health, Wellbeing and Sport, is quoted as saying:
I was surprised by this Scottish Government statement.
For the last four years, in research for my petition to the Scottish Parliament for a Sunshine Act, I have collected evidence and have shared this with the Scottish Government. This can all be read here.
Scottish Government Guidance (HDL 62), which is now 12 years old, is widely being ignored by NHS Health Boards across Scotland. There is no public transparency on how much of this £41 million went to Scottish doctors last year.
Whilst the Scottish Government are “not aware” it is reassuring that young folk of today, such as medical Students, are:
The above Evidence-based guidelines for treating depressive disorders with antidepressants has recently been published.
The British Association for Psychopharmacology are an organisation highly regarded by my profession of psychiatry. 12% of their funds come directly from the Pharmaceutical Industry.
I have petitioned the Scottish Government to introduce a Sunshine Act. It is for this reason I am interested in transparency of financial conflicts of interest.
Some of the expert authors involved in developing these guidelines have featured in Hole Ousia before, including:
- Prof Allan H Young: here, here, here and here
- Professor David Taylor: here
- Professor Philip J Cowen: here
Other authors of these guidelines are well known as “key opinion leaders”. Some were part of the Royal College of Psychiatrists International Congress, 2015 and their declarations can be found here
This post looks only at the level of transparency provided by BAP in these Guidelines. Most academics are of the view that full transparency of financial interests is necessary if we are to make recommendations that are “explicitly evidence-based”:
I have written to Susan Chandler, Executive Officer for BAP, on a number of occasions over the last few years about BAP’s approach to declarations of interest:
Professor Ian Reid was a former colleague of mine who is sadly missed.
Here is a copy of my last communication with BAP sent at the beginning of May 2015:
I copied this to the General Medical Council. They did not reply.
This was the reply from the Executive Officer for BAP. I have received no further communications:
Here is what BAP provides in these Guidelines. It is worth comparing the limited amount of information provided here with the much more comprehensive information provided by NICE guidelines.
It is not possible to find out how much doctors like these Guideline authors have been paid.
The Academy of Medical Royal Colleges are of the view that all payments to individual doctors and academics should be mandatory.
Update, 5th October 2016. The following was published on the front page of the Scotsman newspaper: "Mental health prescriptions hit ten-year high"
The figures are from the Scottish Government and can be accessed here.
It has been a good while since I last wrote about SIGN Guidelines. In fact my last communication to SIGN was the following e-mail (of over a year-and-a- half ago):
I was concerned at that time that SIGN guidelines lacked in necessary governance regarding financial conflicts of interest.
Those that know me understand that I have an interest in ethics. That interest in itself does not make me more “ethical” than any other. I am however passionate about science. If science seeks to be objective we must insist on transparency. This is why I raised a petition for a Sunshine Act with the Scottish Parliament:
A year-and-a-half-on, whilst some improvements have been made by SIGN, my view is that these improvements are very far from sufficient. In terms of providing transparency of potential financial conflicts of interest my personal view is that SIGN compares poorly to the level of transparency provided by NICE (England and Wales).
SIGN Guidelines (those that have declarations of interest):
There is no detail in any of the current declarations. So we cannot know how much Dr X, Independent expert Y, or Academic Z might have been paid in the last 3 years. There seems to be little standardisation of what is collected by SIGN. No specific dates of payments are given, and very rarely are there any actual details of payment.
So a year-and-a-half on, as a professional who wishes to be guided by evidence-based science, I remain concerned about the level of public transparency provided by SIGN in terms of declaration of financial conflicts of interest.
If paid: the public should know exactly how much Dr X, Independent expert Y, or Academic Z was reimbursed for working with industry.
In my view such payments should have no “three year window”. Every payment should be there, for all to see, for all time.
Last year, in the UK £41 million was paid by the pharmaceutical industry to the likes of “X, Y and Z.”
My personal view is that SIGN governance still does not provide sufficient transparency to inform us how much X,Y, or Z, might have have received from industry.
What follows is an update since a year-and-a-half ago. It is another “pattern” of a sort:
Apart from my communications to, and and the replies from SIGN, all the material in this post has been openly sourced and is in the public domain
The origin of my concern (November 2013):
44 separate SIGN guidelines in operation across Scotland but with no record of declarations of interest.
My original inquiry was borne of a specific guideline that is still in operation today. It is 6 years beyond the date SIGN scheduled for its review. We will never know if there may have been financial conflicts of interest in those, including the Chair, tasked with drawing up and publishing this still operational SIGN guidance.
In Scotland, I have provided evidence to the Scottish Parliament that NHS Boards have not been following, for more than a decade, Scottish Government Guidance that was first issued to all NHS staff (HDL 62) in December 2003
The Scottish Government Guidance of 2003 made it clear that this was a responsibility of every Chief Executive in NHS Scotland.
Alex Neil, former Cabinet Minister for Health wrote to me to reconfirm that all Chief Executives were expected to follow this Scottish Government Guidance [letter dated 31st October 2013].
Last year, in the UK, £41 million was paid by industry to healthcare workers. This aggregate sum does not seem to include the academics and independent experts who may also “educate” NHS healthcare workers at CPD accredited conferences [CPD is a GMC requirement]. All payments, beyond the aggregate, are thus completely hidden.
The ABPI voluntary reregister (to begin next year) will continue to allow such hiding.
What follows is taken from the minutes of SIGN Council since I first raised concern with SIGN about its governance of this matter [all highlighting is mine]:
The following screenshots, all from today, 3rd September 2015, are a brief, ad hoc selection of the current operational SIGN guidelines, that have no surviving record of any potential financial conflicts of interest for any of those involved in developing each individual guideline.
If you want to see more: type into GOOGLE “SIGN Guidelines” and next to this “declarations”:
The following paper was recently sent to me by Professor Tim Stokes.
It is an excellent summary of the situation in New Zealand. A good deal of my Scottish forebears emigrated to New Zealand in the 19th century. It encourages me, as a petitioner for a Sunshine Act for Scotland, that doctors and academics of New Zealand want to see full public transparency regarding all industry payments.
All the evidence collected for the Scottish petition can be viewed here
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”.
The Maudsley debate was covered in a head-to-head BMJ article.
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:
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:
In a letter of response Dr K S Madhaven argued that “the market has us all in its grip”:
Whereas Professor Simon Wessely, in his letter of response, was of a view that “It is time we all grew up”:
Professor Wessely began his letter of 2003:
It is interesting to reflect on changes that have occurred in the United Kingdom since 2003:
- Continuing Professional Development (CPD) has become a requirement of GMC Revalidation:
- the pharmaceutical industry now has to follow the ABPI code and healthcare professionals no longer receive branded products such as pens
- “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
- 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:
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.
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.