The Scottish Public Want Sunshine

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.

 

“Bipolarisation”

This is a BMJ response written by me on the 8th June 2011.

Four years on and I remain just as concerned about the 
over-medicalisation of "mood disorders". 

None of my words take away from my understanding of the suffering 
that disturbances of mood may bring.
A reply by Dr Peter Gordon to the Frontline article 
‘Bad Medicine: bipolar II disorder’ 
and the responses it attracted

“We can eventually make quite a lot of sense of this habitat if we patiently put together the data from different angles. But if we insist that our own window is the only one worth looking through, we shall not get very far.” Mary Midgley[1]

John Brockman in his collection of scientific essays ‘Beyond the scientific revolution: The Third Culture’[2] made two key demands for his book, that given the stormy debate raised by the recent Frontline article ‘Bad Medicine: bipolar II disorder’ [3] need to be considered:

(1) that we need to tolerate scientific disagreement,

(2) that the role of the academic includes communicating

Nevertheless, it was not helpful for Dr Spence to state that ‘Modern psychiatry, for all its evidence, is merely an intellectual construct, neither fact nor science.’ Reality is after all chock full of constructs, and here Dr Spence forgets many strides made in mental health care, however imperfect the classification of such suffering continue to be.[4] Here, Professor Michael Rutter suggests we remember: Progress in science—clinical science and basic science—has to come from questioning the given wisdom of the day and doing so in a style that builds constructively to a better understanding. In other words, destructive criticism is rarely the way to go[5]

It is understandable that Academic Psychiatry responded to Dr Spence most defensively; less understandable was all-out personal attack. Hackles raised may have weakened reason and here the academic world of British psychiatry, as Dr Spence argues, continues to ignore our professional oath primum non nocere (above all do no harm). Many of the respondents to Des Spence belong to the academically distinguished cohort who in July 2008 sounded the alarm for British psychiatry to ‘wake up.’ Their call somehow managed to present an approach to suffering that – going by the correspondence – raised more concern than it did support.[6]

Awoken from omphalos on Vimeo.

Rather than getting embroiled in the well-rehearsed arguments over the status of Bipolar II, I wish to focus on the underlying theme of Dr Spence’s frontline. He returns primarily to the medicalization of today (here 450 words can never be sufficient) and he has established, through a series of critiques that his concern is not confined to mental health.  Readers today realise that debate on medicalization is not new, and that the view presented by Ivan Illich in 1975 that this is universally bad is an over-simplistic approach.[7] [8]

Medicalisation-today

What follows in this brief paper is an examination of antidepressant prescribing and where it sits today within a world that is beyond that described by Ivan Illich. To consider such it is crucial to gather all available evidence-base, but also not to dismiss a collective narrative less quantifiable. Medicine, in its evidence-base, should accept that numbers (that which is quantifiable) and words (the qualitative) are equal forms of measurement. It is disappointing that we need reminding of this essential evidence and that the individual story is increasingly lost in pursuit of ever greater denominators.

Last year 40 million prescriptions of antidepressants were issued in England and 4.5 million in Scotland. This is, in its own right is an evidence base that Dr Spence insists must not be ignored and that Professor Ian Reid insists must not be superficially analysed.

If we divide the total number of prescriptions of antidepressants issued in England[9] (40 million) and Scotland[10] (4.5 million) last year, by an average of five prescriptions per depressed, we have a crude approximate of 9 million on regular pharmacological treatment.[11] Of course the true estimate will be considerably lower as revealed by Moore and colleagues,[12] as antidepressants are appropriately prescribed for other symptoms of life: in particular low dose Amitriptyline which is used in both sleep disorder and neuropathic pain.

In what follows, I will present 9 reasons, one per million, open of course to debate, why mankind should not simply dismiss the ‘cod philosophy’[13] of Dr Spence.

First: ‘truth.’

This small, but powerful word was used repeatedly by respondents in their opposing argument to Dr Des Spence.[14] Truth as it relates to evidence-based medicine is the subject of this edition of the British Medical Journal.

Dr Philip J Cowen, Professor of Psychopharmacology at the University of Oxford, light-heartedly questioned if Dr Des Spence was real: suggesting he might be no more than an editorial construct. Here Professor Cowen linked any ‘Big Pharma’ notion with fantastical conspiracy.[15] Yet printed in the same edition of that British Medical Journal was the alternative take on ‘truth’ as given by Ray Moynihan: “With medical science so contaminated by conflicts of interest, what evidence can we trust?”[16]

Professor Cowen’s response, entitled ‘Constructionism,’ mentioned one competing interest: “I am one of the authors of the “Shorter Oxford Textbook of Psychiatry” which treats bipolar II disorders as if it were a medical condition.”  In May 2011 Professor Cowen wrote the lead Editorial in the British Journal of Psychiatry – ‘Has psychopharmacology got a future? in which he revealed more conflicts of interest than he chose to reveal in his reply to Dr Spence.[17] In this editorial Cowen described past British Medical Journal coverage on antidepressants as ‘deranged’[18] and warned today of the demise of pharmaceutical innovation. It is true that in 2011 two major pharmaceutical companies have announced cessation of research activity in the field of psychiatric drug development. However not all involved in neuro-pharmaceutics seem as concerned as Professor Cowen, and indeed some within the industry believe that declining innovation is a myth.[19] Professor Cowen entitled his response to Dr Spence’s frontline ‘constructionism’; however his editorial in the British Journal of Psychiatry[20] made no mention of unpublished evidence, which leaves him, and the editors of the British Journal of Psychiatry, open to the charge of communicating less than the whole truth. Two of the most frequently cited cases involving unpublished evidence relate to antidepressants: paroxetine and reboxetine. In the case of the latter, it was revealed recently that 74% of patient data had previously been unpublished: when this evidence was included the conclusion was rather different than that so marketed: “reboxetine is overall an ineffective and potentially harmful antidepressant”[21]

fair to conclude

In 2008, Dr Ben Goldacre published ‘Bad Science’[22] and it has since become a bestseller. Two chapters in this book are worth considering when it comes to debate on antidepressant prescribing. The first is ‘How the media promote the public misunderstanding of science.’ We are used to journalism that reduces the horrid reality of depressive illness: for example calling medication ‘happy pills’ or sufferers ‘pill poppers.’ Yet the chapter that follows is equally important, as in it Ben Goldacre suggests reasons “why clever people believe stupid things.”  In terms of evidence-based research he argues that we: ‘tend to seek out confirmatory information on any given hypothesis. ‘[23]

Dr Richard Smith, former Editor of the British Medical Journal departed office in 2003 with his own concern:  In his ‘goodbye’, Dr Smith warned of confounding marketing with medical education. This is not a new phenomenon, but in our generation cannot be dismissed, despite the good that many drugs have brought to life and greater longevity. In terms of Academic Psychiatry this subject was given careful consideration by Thomas A. Ban.[25]

Medical 203 from omphalos on Vimeo.

Second: what is health?
The central tenet of Des Spence’s argument is that too much of life is being ‘disordered’ and that this has consequences for us all. Some of the psychiatrists who responded to his frontline piece, accused him of either mind-body dualism or worse still ‘trivialising’ suffering. Anybody who has read the British Medical Journal[26], or any other journal for that matter over the last few years, cannot have failed to notice that boundaries of illness are moving: today we have pre-hypertension, cholesterolaemia, glycaemia etc.

25

As an old-age psychiatrist, I am obviously interested in research into Alzheimer’s pathology.[27] It appears to be emerging that this disease is not an ‘all-or-none’ entity: amyloids, neurofibrillary tangles and apoE alleles, are all now thought to be active components of normal neuroplastic processes. In other words, Alzheimer’s is not a disease (as so classically understood) but a physiological yet detrimental response to complex neuroplasticities. Ming Yi, from the Neuroscience Research Institute, Peking University, in consideration of this new understanding of Alzheimer’s pathology, suggests that we define health first, then diseases. Such a strategy will, Ming Yi so argues, reveal the ‘truth’ that most diseases appear in a dormant manner originating from a physiological continuum. Furthermore, Yi argues that this understanding not only provides a consensual framework for researchers, but should also benefit early diagnosis and intervention for patients. He goes on to suggest that such a ‘healthy’ framework might be a parallel to follow for mood disorders and their treatment.

Third: ticking all the boxes
In his reply to the frontline, Dr Ian M. Anderson, psychiatrist, questioned if we have become over-reliant on self-report measures such as questionnaires.[28] We must not forget that we are living in an age of patient empowerment. This is most welcome but depends crucially upon coherent public health education. Under the quality and outcomes framework, UK general practitioners are rewarded for using validated questionnaire measures of the severity of depression at the outset of treatment. While general practitioners are using the questionnaires in more than 90% of diagnosed cases, qualitative evidence suggests they doubt the validity of the measures and use their clinical judgment to decide about treatment regardless of patients’ questionnaire scores.[29] Professors Kendrick and Dowrick, in the only large scale study on the use of such self-report questionnaires concluded: “It should be emphasised that neither PHQ- 9 and HAD-D is an optimum measure of the severity of depression, and scores above the recommended cut-off values give only an indication that a particular patient is likely to have major depressive disorder.”

‘Incentivised care’, such as this, Chris van Weel, professor of general practice has argued is no substitute for professional judgment: “given the limited research, this is an area where general practitioners’ experience is well ahead of scientific evidence. Exploration of this experience could further improve the QOF process.”[30] In Scotland, the NHS supported campaign ‘doingwell’ launched itself upon the back of internet self-assessment by PHQ-9. Beyond Professor Van Weel, concern has been expressed more widely, including Professor Ian Reid of Aberdeen: “it maybe that QOF depression measures will simply have to be reconsidered if we wish to keep faith with the evidence base. For now, GPs should continue to exercise circumspection when interpreting depression severity measure scores.”[31]

qof2

Fourth: all that is classified.
As someone who is interested in the history of psychiatry there is one perennial conundrum that has presented itself every year since Johann Reil coined psychiatry[32]: the classification of mental suffering. Dr Spence has every right to remind us that we have not yet cracked this. Today it is necessary to follow Professor Craddock’s call for pragmatism. The search for biological markers will go on, and it is a cause that we should support, however there are many today who argue that whilst this is necessary for understanding it is not sufficient.[33] Today adding to a list for potential frames for classification are the adaptionists such as Randolph Nesse and his Evolutionary Medicine. In this subject it is helpful to read the range of intellectual arguments presented in the essays collected by John Brockman.[34]

In defending the construct of ‘Bipolar II disorder’ several correspondents returned to ICD and DSM classifications as if they were as determined as our genetic code. Here it is worth reporting what Dr Allen Frances, said in a recent interview about the delay in formulating DSM 5:  “There is no definition of a mental disorder. It’s bullshit. I mean, you just can’t define it.”[35] Dr Frances was the doctor who spear-headed the formulation of the previous version of DSM.

Fifth: necessary but not sufficient.
Evidence base is absolutely necessary for progressing our understanding but many of today’s intellectuals would argue that it is not sufficient. In addition we need intelligent kindness and to embrace the notion of hole ousia, relationships, real world, and the wisdom of the Scotttish physicist James Clerk Maxwell. Or as Edwin Morgan the poet put it: “holding hands amongst the atoms.”

With technological advance, it is understandable why mankind has chosen to view life through the paradigm of illness, when actually what we seek is health. Wholesome humanity must not today approach this back to front, or the result will bring harm.

One respondent suggested: “Dr Spence is right when he suggests that the diagnosis of bipolar II disorder is a real clinical issue. However, an over-diagnosis, whenever possible, doesn’t seem to carry the same negative consequences as an under-diagnosis.”[36] However, it is essential that we do consider the potential harm of over-diagnosis,[37] [38] [39] especially when the USA, our mental weather vane, statistically reveals that the incidence of major depression doubled in a decade from 1992 to 2002.[40]

redefine1

Sixth: stigma and the Hydra.
Every window views stigma differently. Education here is important, but surely such is not just for patients, but for us all? Stigma grow heads like the Hydra-monster, and it is not the simple case that giving a ‘diagnosis’ reduces stigma. Research in its beginning supports my ‘feeling’ that such is fallacy.[41]

Window Tax from omphalos on Vimeo.

Seventh: primum non nocere
Dr D.J Smith et al claim that up to 21% of primary care patients with depression in fact have unrecognised bipolar disorder, and the authors advise against inappropriate treatment by antidepressants in this significant minority as ‘antidepressants may trigger agitated, mixed or manic mood states.’[42] Other academics have replied stating that this research supports treatment for Bipolar II patients with atypical anti-psychotics such as Quetiapine and the anticonvulsant Lamotrigine.[43]. Such drugs, when appropriately used can reduce suffering, but equally we must consider the side-effects, and realisations of harm that only may appear many years later.[44]

poll

Eighth: Continuing medical education
Professor Nick Craddock, speaking for the 36 academics who asked our profession to ‘wake up’ reaffirmed a collective view: “we are not terribly interested in what is past.”[45]

The Royal College of Psychiatry has embraced the modern, multi-media techniques with its CME modules and podcasts, however look at the content. There is no history, except that of ancient lunacy laws. Where are the considerations of the changing classifications of mental illness, the social and cultural context of mental illness, philosophy[46], the language of science and indeed any ideological considerations beyond the medical model: holism, reductionism, ethics, philosophy, narrative medicine? They just are not there.

1a

Nine million prescribed:
As a citizen of Scotland who was started on an antidepressant during the 1990’s Defeat Depression Campaign, I shall conclude this piece by giving contrasting representations of this campaign as understood by a Professor in tertiary referrals and that of a doctor on the frontline:

Let us start with the former, Professor Reid of Aberdeen stated in one of his replies to Dr Spence: “the Defeat Depression Campaign went some way to improving antidepressant practice, by increasing the dose and duration of antidepressant prescription. This is what resulted in the much misunderstood increase in antidepressant prescriptions: not more people getting antidepressants, but those receiving them getting them – entirely within guideline recommendations.” With the dearth of long-term studies it is hard to see what evidence base the Defeat Depression Campaign based its recommended duration of treatment. Even today, recommended duration of treatment is still far from clear, and there is little clarity about withdrawing treatment.[47]

Professor Reid makes a further most important point: “Simply stating numbers of prescriptions, turns out not to be very informative, but entirely misleading. Indeed, this approach led the Scottish media (and the Government’s Information and Statistics Division) to over-estimate the proportion of the population taking antidepressants by a factor of 5.”  Professor Reid then goes on to state that “the quality of care has improved, and even suicide rates may have dropped as a consequence (of the Defeat Depression Campaign)” However, Melissa Raven and Jon Jureidini presented both epidemiological and philosophical argument why we cannot yet be certain that antidepressants have reduced suicide rates. [48]

In contrast, Dr Spence’s experience of the Defeat Depression Campaign: “you will note the large rises in depression diagnosis in the young, rising quickly in the mid nineties, sustained for 7 years and then declining rapidly in 2003. I worked through out this period and anecdotally will tell you what happened. We were berated for under-diagnosing depression and so treated patients. After 5-6 years it was patently obvious that this wasn’t the case and we were over prescribing medication. We lost faith. We had simply medicalised normal reactive behaviour and denied young patients the opportunity to develop coping skills. This is what happened, I was there.”

The truth of this prescriber’s experience is another which should not be ignored. This author has never had bipolar disorder but has suffered from depression and has been on paroxetine since the ‘Depeat Depression Campaign’:

Gilbert Farie revisited from omphalos on Vimeo.

Dr Spence, reminds us that proportionality of understanding comes in words as well as numbers:, “The number of antidepressants prescribed by the NHS in the United Kingdom almost doubled during one decade. There is no evidence that our mental health has improved over this time and plenty to say it hasn’t. I do not celebrate the ever increasing consumption of antidepressants but mourn the poverty of our thinking.” This has been shown to be an argument we do not wish to hear; however it is essential that the humanities (given its classical name) must not be eliminated, and that biological research should never ignore the world we live in. Otherwise the stand-alone brain will fool us all.[49]

Conclusion: windows
It is our very need to ease suffering that brings great passion to debate. This is uniquely human, and a dimension that must never be reduced. Understanding requires that we must see the real world through more than our own window: today’s mental biologism is not enough – it is necessary but not sufficient. Equally quantitative evidence base is necessary but requires qualitative understanding. Here Professor Greenhalgh reminds us that medicine needs narrative more than we like to believe.[50] 

 


[1] Midgley, Mary. Notes. 2003, pp. 26-27.

[2] Brockman, John. Beyond the scientific revolution: The Third Culture. 1st Touchstone Ed edition. May 1996

[3] Spence, Des. Bad Medicine: bipolar II disorder. Frontline article. British Medical Journal. 4th May 2011. 342:d2767

[4] Ilangaratne, Jay. BMJ rapid-response. Condemning Psychiatry, Ideas Based Medicine, and Leading Questions Published 11th May 2011

[5] Rutter, Michael. Challenging psychiatry. Interviewed by Mathew Billingsley. BMJ Careers. 9th February 2011

[6] Craddock, Nick et al. Wake-up call for British psychiatry. The British Journal of Psychiatry, Jul 2008; 193: 6 – 9.

[7] Illich, Ivan Medical Nemesis. 1975

[8] Gordon, Peter J. Gilbert Farie Revisited. A reply to Reply to the Editorial: Has psychopharmacology got a future? May 2011. The British Journal of Psychiatry chose not to publish this.

[9] Population of England in 2010 approximately 51.5 million. Office for National statistics

[10] Population of Scotland in 2010 approximately 5.2 million. General Register Office of Scotland

[11] Hickey, Finlay. Lead Pharmacist Mid Highland CHP.  Kindly provided prescribing data on antidepressants for Scotland over the past 5 years.

[12] Moore, Michael, Kendrick, Tony et al. Explaining the rise in antidepressant prescribing: a descriptive study using the general practice research database. British Medical Journal. 15 October 2009. 10.1136/bmj.b3999

[13] Reid, Ian. BMJ Rapid response.  Practical considerations. Published 26 May 2011

[14] Reid, Ian.  BMJ Rapid response. Truth, not Beauty. Published 27 May 2011

[15] Cowen, Philip. BMJ Rapid response. Constructionism. Published 10 may 2011.”Indeed for some time the ontological status of Spence himself has been contested as a possible BMJ construct: a frontline, not to say “full time”, no nonsense, hard-headed, GP whose very appellation (Dispense) underlines the pervasive reach of big Pharma.”

[16] Moynihan, Ray. Reality Check: It’s time to rebuild the evidence base. British Medical Journal. 2011;342:doi:10.1136/bmj.d3004 (Published 25 May 2011)

[17] Cowen, Philip. Has psychopharmacology got a future?’ British Journal of Psychiatry. 198: 333-335. (Published May 2011)

[18] Cowen, Philip. Has psychopharmacology got a future?’ British Journal of Psychiatry. 198: 333-335. (Published May 2011)

[19] Schmid, Dennis & Schmid, Esther. Keynote review: Is declining innovation in the pharmaceutical industry a myth? DDT, Volume 10, Number 15 (published August 2005) “If you say something often enough, it must be true. Everyone knows that innovation is declining and is the source of all the woes of the pharmaceutical industry. But who has checked the facts?  The myth of the innovation deficit is exactly that – a myth”

[20] Cowen, Philip. Has psychopharmacology got a future?’ British Journal of Psychiatry. 198: 333-335. (Published May 2011)

[21] Wieseler, Beate et al. Finding studies on reboxetine: a tale of hide and seek. British Medical Journal 2010;341:doi:10.1136/bmj.c4942 (Published 12 October 2010)

[22] Goldacre, Ben. Bad Science. Fourth Estate (Oct 2008)

[23] Tallis, Raymond. Aping Mankind: Neuromania, Darwinitis and the misrepresentation of humanity. Acumen (published June 2011)

[24] Smith, Richard. Editorial: Medical journals and pharmaceutical companies: uneasy bedfellows British Medical Journal. 326 : 1202 (Published 29 May 2003)

[25] Ban, Thomas. Academic psychiatry and the pharmaceutical industry Progress. Neuro-Psychopharmacology & Biological Psychiatry 30 (2006) 429 – 441

[26] Godlee, Fiona. Who should define disease? British Medical Journal;342:doi:10.1136/bmj.d2974. Published 11 May 2011)

[27] Yi, Ming. BMJ Rapid response. Shall we define health first, then diseases? Neuroscience Research Institute, Peking. Published 13 May 2011

[28] Anderson, Ian. BMJ Rapid response: Bad medicine or bad mouthing? British Medical Journal. Published 10 May 2011: “Bipolar II disorder’s current celebrity fashion status feeds into this. But once again this is not confined to psychiatry, and every doctor has to deal with unexplained medical and psychological symptoms. The increasing “tick box” approach to medicine, at the expense of clinical judgement, can only weaken our ability to make a full assessment; this usually needs to incorporate third party information.”

[29] Dowrick, Christopher et al. Patients’ and doctors’ views on depression severity questionnaires incentivised in UK quality and outcomes framework: qualitative study. British Medical Journal. 338:b750 (Published 19 March 2009)

[30] Van Weel, Chris. Incentivised care is no substitute for professional judgment. British Medical Journal. 338:b934 (Published 19 March 2009)

[31] Reid, Ian & Cameron, Isobel. BMJ Rapid response: Depression severity measurement in primary care. Printed 11 April 2009

[32] Marneros, Andreas. Psychiatry’s 200th birthday. British Journal of Psychiatry. 10.1192/bjp.bp.108.051367 February 2008

[33] Tallis, Raymond. The Hand: A philosophical inquiry into
human being
(2003) I Am: A Philosophical Inquiry into First-Person Being (2004) The Knowing Animal: A Philosophical Inquiry into Knowledge and Truth (2005) Edinburgh University Press

[34] Brockman, John. Beyond the scientific revolution: The Third Culture. 1st Touchstone Ed edition. May 1996

[35] Greenberg, Gary. Inside the battle to define mental illness. Wired magazine. January 2011

[36] Sani, Gabriele et al. BMJ Rapid response: Bipolar II disorder: bad medicine or bad criticism? Published 31 May 2011

[37] Irwin, Charles et al. America’s adolescents: where have we been, where are we going? Journal of Adolescent Health, Volume 31, Issue 6, Supplement 1, December 2002, Pages 91-121

[38] Robin, A et al. Over-diagnosis and breast cancer screening. European Journal of Cancer Supplements, Volume 4, Issue 2, March 2006, Pages 6-9.

[39] Stephen Jones, J. Prostate Cancer: Are We Over-Diagnosing—or Under-Thinking? 

European Urology, Volume 53, Issue 1, January 2008, Pages 10-12

[40]   Compton, W. M et al. Changes in the prevalence of major depression and co-morbid substance use disorders in the United States between 1991-1992 and 2001-2002. American Journal of Psychiatry. 163(12):2141-7. Published December 2006

[41] B Rüscha, Nicolas et al. Biogenetic models of psychopathology, implicit guilt and mental illness stigma. Psychiatry Research 179 (May 2010)  328-323

[42] Smith, D. J. et al. Unrecognised bipolar disorder in primary care patients with depression. British Journal of Psychiatry. 10.1192/bjp.bp.110.083840. Published 3 February 2011

[43] Ferrier, Nicol et al. BMJ Rapid response: Bad medicine or bad practice. British Medical Journal. Published 12 May 2011

[44] Committee of Safety of Medicine. March 2004. In March 2004, the UK Committee of Safety of Medicines (CSM) informed clinicians that risperidone and olanzapine should not be used to treat behavioural and psychological symptoms of dementia (BPSD) because of increased risk of strokes with both drugs and increased risk of mortality with olanzapine.

[45] Craddock, Nick et al. Wake up call: Response from authors. Published 19 Oct 2008

[46] Nagel, Thomas. The view from nowhere.“Philosophy is the childhood of the intellect, and a culture that tries to skip it will never grow up.” Published 1989. OxfordUniversity Press

[47] Burton et al. Newly initiated antidepressant treatment in Scotland. Evidence into Practice. 2010

[48] Isacsson, Göran, & Rich, Charles (For) Jureidini, Jon & Raven, Melissa (Against). IN DEBATE: The increased use of antidepressants has contributed to the worldwide reduction in suicide The British Journal of Psychiatry (2010) 196: 429-433.

[49] Tallis, Raymond. Aping Mankind: Neuromania, Darwinitis and the misrepresentation of humanity. Acumen (published June 2011)

[50] Greenhalgh, Trisha. Soft Rebuttal. Rapid Response British Medical Journal. 31st Dec 2004.

Tony Delamothe: ‘The “truth,” if and when it emerges, will be thanks to the positivist philosophy that underpins quantitative research.’

Trisha Greenhalgh: Is this a declaration of Tony Delamothe’s personal bias or an indication of the BMJ’s editorial position? If the latter, I challenge the BMJ’s Editor to make a formal statement to the effect that:

“Qualitative research is considered by the BMJ to be inherently lower quality than quantitative research. Authors seeking to publish qualitative research should doff their caps accordingly and strive to ensure that their submissions are philosophically nihilist, atheoretical and present a single, unambiguous truth with narrow confidence intervals. Co-authorship with professors of epidemiology will substantially increase the chances of acceptance of qualitative papers.”

 

Stephen Stahl: $3,581,159 in payments from Pharma

In my last post I considered the level of transparency provided by the British Association for Psychopharmacology (BAP) in relation to its recently published Guidelines on prescribing for depressive disorders.

This post, will very briefly look at the programme for the recent 2015 Summer Meeting and specifically the issue of transparency:

07BAP

If you download the programme and then type “declaration” into text search you get zero responses.

The programme does list these sponsors:

08BAP

I noticed that Stephen Stahl was giving several keynote educational talks on day one of this conference for the British Association for Psychopharmacology (BAP). Stephen Stahl is a world-wide “key opinion leader” who has his home in California.

09BAP

In America all payments to individual doctors and academics must be provided for the public. This being a statutory requirement of a Sunshine Act. All payments can be established by typing into a searchable database called dollars for docs.

Here is the return, as at the time for writing, for Dr Stephen Stahl:

Stephen Stahl

In the United Kingdom the public have no way of establishing if or how much individual British doctors or academics may have been paid by the pharmaceutical industry or by other commercial companies. When these individuals are involved in educating the healthcare profession or drawing up guidelines this situation needs to change. And soon.

 

 

SIGN guidelines: transparency and objectivity

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):

003 SIGN

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:

The Herald 31 Jan 2014

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

From the Chair of SIGN, 26 February 2014:004 SIGN

My reply:005 SIGN

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.

44 guidelines without record of COI (20 Nov 2013)

January 2014: Sufficiently concerned about this, my wife and I wrote to the British Medical Journal:SIGN guidelines transparency

This was the response by SIGN:SIGNs reply to Gordon & Gordon

The subject of transparency of financial conflicts of interest for those involved in developing guidelines has featured in science journals across the world:three quarters

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].

010

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.

009

How guidelines can fail us.Sept 2014 BMJ Editor

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]:

SIGN Council Meeting, 4th November 2013:SIGN Nov 2013

SIGN Council Meeting, 5th March 2014:SIGN March 2014

SIGN Council Meeting, 28th May 2014:SIGN May 2014

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”:

SIGN 98 - no register of interestBipolar disorder chronic kidney disease GI bleeding Head and Neck cancer obesity Parkinson's disease  Stroke or TIA

Royal College of Psychiatrists and conflicts of interest

The Chief Executive of the General Medical Council (GMC) recently confirmed, in response to a recent BMJ article, that it “takes very seriously the issue of conflicts of interest”:start-with-GMC

We know that in the course of a year, in the United Kingdom:40 million

Currently, it is almost impossible to find out anything other than the overall figure.

NHS registers of interest are not functioning. Yet doctors are asked to sign this at annual Appraisal:Probity-statement-SOAR-ApprAll Appraisals are then scrutinised by senior NHS managers to be “signed off”:

The BMJ make this charge:failure of regulation

However should we be asking if our Royal Colleges are also failing?

For several years I have written to the Royal College of Psychiatrists about conflicts of interest. This post is based on the latest correspondence which was prompted by the recent announcement of this International Conference:

change-my-practice

The Co-chairs give this welcome note:welcome-by-co-chairs

It is almost certain that a significant proportion of the £40 million goes to: KOLs2

The Conference organisers have made it clear of the “exhibition opportunities” provided at this event:exhibition-opportunities

What is less clear is whether the speakers or those involved in workshops or seminars have any conflicts of interest.

This is why I have written to:Board-RCPsych

My most recent letter to the above, copied to the Chief Executive of the GMC, asks for transparency ahead of the Conference in this important area:Craddock-letter

 

 

 

 

 

 

Healthcare Improvement Scotland – Register of Interests

29 May 2013

Dear Healthcare Improvement Scotland,
Hospital Boards are reportedly meant to keep a register of payments  from pharmaceutical companies (and other relevant companies) to  staff, in case of conflicts of interest [1]. I am requesting a copy  of the register for this Board – which I would hope includes  details of all relevant payments to staff and any related potential  conflicts of interest. If it would be possible to have this  information in an appropriate structured data format – for example,  a CSV file – this would be helpful. If this Board does not have a  complete register, I would request: the release of the information  on this topic that the Board does hold; and an explanation of why  the Board does not hold a complete register.

I am aware that some would view data on pharmaceutical funding as  personal data for those staff receiving the funding. Even if some  of the information on this register may be classed as personal data  (although this is contestable – for example, in some sectors of  academia information re funding sources is made public as a matter  of course) it would be covered by paragraph 6 of Schedule 2 of the  Data Protection Act. The release of these data is “necessary for  the purposes of legitimate interests pursued by the data controller  or by the third party or parties to whom the data are disclosed”  [2]. Spurling et al’s systematic review of how information from  pharmaceutical companies impacts physicians’ prescribing reported  that, of the studies included which looked at total promotional  investment, three “found that total promotional investment was  positively associated with prescribing frequency…Two…found both  positive results and no association…One study did not detect an  association” [3]. There is thus a legitimate interest in releasing  this register: the available research suggests that it is plausible  that payments received influence how public money is spent and the  type of care provided to members of the public.

For the reasons given above, there is a strong public interest in  releasing this information. While “requests for the personal data  of a third party are exempt under section 40(2) of the Freedom of  Information Act…if disclosure would contravene section 10 of the  Data Protection Act, the right to prevent processing likely to  cause damage or distress” [2], I would argue that, even if some of  those named in these documents feel that their release would cause  them damage or distress, this is outweighed by the significant  public interest served by releasing these data.

Yours Faithfully,
Dr Peter J. Gordon

[1] http://www.guardian.co.uk/society/2013/a
[2] http://www.justice.gov.uk/downloads/info
[3] http://www.plosmedicine.org/article/info

————

From: Healthcare Improvement Scotland

29 May 2013

Dear Dr Gordon
Further to your freedom of information request of today 29 May (below), this has been logged and is being processed.

Under the Freedom of Information (Scotland) Act 2002 [FOISA], we must respond within 20 working days – at latest by close of Wednesday 26 June.

Please do not hesitate to contact me if you would like an update on progress.

Yours sincerely
Patrick Maitland-Cullen.

Health Information Scientist (Freedom of Information Officer)
Healthcare Improvement Scotland Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB

The Healthcare Environment Inspectorate, Scottish Health Council, Scottish Health Technologies Group, Scottish Intercollegiate Guidelines Network and the Scottish Medicines Consortium are part of Healthcare Improvement Scotland.

 

Alex-Neil-on-Reg-of-Interes

——
From: Maitland-Cullen Patrick
Healthcare Improvement Scotland

20 June 2013

Enclosures:

  • Board Members Register of Interests 2013 2014 v 0.4.pdf
  • Register of gifts and hospitality 13 14.pdf
  • Employee Code of Conduct updated.pdf  2
  • FOI Letter 389.pdf

Dear Dr Gordon
Further to your freedom of information request of 29 May, please find our response letter attached together with supporting files.

Please do not hesitate to contact me if you require further information.

Yours sincerely
Patrick Maitland-Cullen.

——–
From: Peter J Gordon

25 June 2013

Dear HEALTHCARE IMPROVEMENT SCOTLAND,
Thank you for your most helpful response, attachments and links.

For ease of Public access I will append your reply of 20 June 2013  below. Based on your returns, I have some further questions which I will ask through a separate e-mail.

Yours sincerely,
Peter J Gordon

All Healthcare Improvement Scotland staff:
There is a nil return on staff receiving payment from a pharmaceutical company. This return includes staff working in both the Scottish Intercollegiate Guidelines Network(SIGN), and Scottish Medicines Consortium (SMC).

Please find attached the register for financial year 2013 to 2014:

Register of gifts and hospitality.pdf

Please also find our employee code of conduct attached. Section 35  sets out the conditions on accepting additional employment:

Employee Code of Conduct (updated).pdf

www.healthcareimprovementscotland.org

Board members’ register of interests

Please find attached for information the register of interests for  financial year 2013 to 2014. The register includes senior staff members, and it should be noted that for this group there is no  pharmaceutical company-related return:

Board register 2013 to 2014.pdf

This information is also available online, along with the Board  members’ code of conduct, at:
www.healthcareimprovementscotland.org/ab

———-
From: Peter J Gordon

25 June 2013

Dear HEALTHCARE IMPROVEMENT SCOTLAND,
Your responses to FOI indicate that your “Employee Code of Conduct”  “version 1.0” was written as recently as 25 March 2013 and only  approved by your Policy Sub-Group on 22 May 2013. It says this was  based on NHS QIS Code of Conduct.

(1) Under FOI could you provide for the public the QIS Code of  Conduct and explain from what date it was followed? One assumes well before the Scottish Government Guidance was published on Hospitality, Payments and potential COI involving any NHS staff?

(2) Can you provide the Hospitality Registers for the QIS Code of Conduct?

(3) You have zero returns as this policy has only just been implemented. Is this correct?

(4) You are confirming under FOI that none of your NHS employees for HEALTHCARE IMPROVEMENT SCOTLAND have received NO payments from Pharmaceutical Industry or Pharmaceutical Sponsored Education? It is very important that we are clear with the public on this, as given longstanding roles of Scottish Intercollegiate Guidelines Network (SIGN), and Scottish Medicines Consortium (SMC).

For this reason I am requesting an Internal Review.

Yours sincerely,
Peter J Gordon

—————

From: Maitland-Cullen Patrick
Healthcare Improvement Scotland

5 July 2013

Dear Dr Gordon
Please accept my apologies for the delay in acknowledging your freedom of information request and review request.

Both requests are being processed. Under the Freedom of Information (Scotland) Act 2002 [FOISA], we must respond within 20 working days – at latest by close of Tuesday 23 July.

Please do not hesitate to contact me if you would like an update on progress.

Yours sincerely
Patrick Maitland-Cullen.

——————————————————————————–
22 July 2013
Healthcare Improvement Scotland

Dear Dr GordonFurther to your request for review of freedom of information response 389,  please find the decision set out in the attached letter.
Review Letter FOI 389.pdf 286K DownloadView as HTML

The response to your accompanying questions, our reference FOI 401, is  being finalised. The deadline for our response is close of tomorrow.

Please do not hesitate to contact me if you require further information.

Yours sincerely
Patrick Maitland-Cullen.

——-

From: Peter J Gordon
22 July 2013

Dear Patrick Maitland-Cullen
HEALTHCARE IMPROVEMENT SCOTLAND,

I will post your reply below for ease of public access.

Yours sincerely,
Peter J Gordon

———–

Enquiries to: S Twaddle
Healthcare Improvement Scotland

Dear Dr Gordon
Pharma payments – review of FOI 389

Further to your email of 25 June appealing against this organisation’s response to your freedom of information (FOI)  request, a review was held on Friday 12 July.

On 20 June we responded as follows:

‘All Healthcare Improvement Scotland staff: There is a nil return on staff receiving payment from a pharmaceutical company. This return includes staff working in both the Scottish Intercollegiate Guidelines Network (SIGN), and Scottish Medicines Consortium (SMC).

Please find attached the register for financial year 2013 to 2014… [ ]

Please also find our employee code of conduct attached. Section 35 sets out the conditions on accepting additional employment…

Board members’ register of interests

Review request

Your email of 26 June said:  “You are confirming under FOI that none of your NHS employees for HEALTHCARE IMPROVEMENT SCOTLAND have received NO payments from  Pharmaceutical Industry or Pharmaceutical Sponsored Education? It  is very important that we are clear with the public on this, as  given longstanding roles of Scottish Intercollegiate Guidelines  Network (SIGN), and Scottish Medicines Consortium (SMC). For this  reason I am requesting an Internal Review.’

On Friday 19 July I reviewed the information relating to the request, Scottish Information Commissioner guidance, information from the Healthcare Improvement Scotland FOI officer, together with  our comments, following the process set out in our FOI policy.

Review decision
The response of 20 June included the corporate register of hospitality for financial year 2013 to 2014, covering all  Healthcare Im provement Scotland staff, and gave a nil return on  payments to staff from pharmaceutical companies.

I can confirm there is a nil return for Healthcare Improvement Scotland staff recording payment from a pharmaceutical company during financial year 2013 to 2014. All HIS employed staff working in SIGN and the Scottish Health Technologies Group (SHTG), and HIS-employed health economists who work with SMC make an additional annual declaration of any competing interests. These declarations of interest include information on any payments to the individual and their close relatives

These staff groups also had a nil return on payments from pharmaceutical firms for financial years 2011 to 2012 and 2012 to 2013.

The hospitality register for financial year 2012 to 2013 records a nil return for staff payment by a pharmaceutical company. The sources of hospitality and gifts value in that year were: Kalvar  County Council, Sweden (£155); BMJ Group (Euros 50); Institute for  Healthcare Improvement (£30); South Korean academic delegation  (£60); and Marketing Scotland £30.99).

The hospitality register for financial year 2011 to 2012 records a nil return for staff payment by a pharmaceutical company. The  sources of hospitality and gifts in that year were: Finnish  guideline developers (£20); Communications supplier (£5); HAA  design (£10); Conscia (£400 – prize won in open draw at annual  national NHS Scotland conference).

Your questions which accompanied the review request are being processed by the Finance unit as freedom of information request 401.

Please don’t hesitate to contact me if you would like to discuss  any aspect of this

response.
Yours sincerely

Dr Sara Twaddle
Head of Evidence & Technologies
Director of SIGN (reviewer)

——-
From: Peter J Gordon
22 July 2013

Dear HEALTHCARE IMPROVEMENT SCOTLAND,
Many thanks for yiour further reply.

I note that you have remain to answer the following:

“Your responses to FOI indicate that your “Employee Code of Conduct – version 1.0″ was written as recently as 25 March 2013 and only  approved by your Policy Sub-Group on 22 May 2013. It says this was  based on NHS QIS Code of Conduct.Under FOI could you provide for  the public the QIS Code of Conduct and explain from what date it  was followed? One assumes well before the Scottish Government  Guidance was published on Hospitality, Payments and potential COI  involving any NHS staff?”

Can you also confirm in writing that none of those involved and employed by you in preparation of SIGN guidelines (Scottish Intercollegiate Guidelines Network) and Scottish Medicines Consortium (SMC) have had in any time, 3 years before publication of said guidelines, had ANY conflict of interest. As it stands the understanding is that this is the case.

Yours sincerely,
Peter J Gordon

——-
From: Maitland-Cullen Patrick
Healthcare Improvement Scotland

23 July 2013

    • FOI Letter 401.pdf  229K
    • Table1GiftsHospitality.pdf
    • NHS QIS Code of Conduct October 2004.pdf

Dear Dr Gordon
Further to your freedom of information request emailed on 25 June, please  find our response letter attached.

—–
New FOI request – our ref. 406

In your email of 22 July, you wrote:
Can you also confirm in writing that none of those involved and employed by you in preparation of SIGN guidelines (Scottish Intercollegiate Guidelines Network) and Scottish Medicines Consortium (SMC) have had in any time, 3 years before publication of said guidelines, had ANY conflict of interest. As it stands the understanding is that this is the case.””

I understand that Dr Twaddle’s review letter sent to you yesterday  confirmed that this was the case for financial years 2011-2012, and 2012-2013.

I should be grateful if you would clarify that you are looking for  confirmation of a similar nil return for NHS QIS staff working for SIGN  and SMC in financial year 201-2011?

I look forward to hearing from you.

Yours sincerely
Patrick Maitland-Cullen.

——————

The full communication with Healthcare Improvement Scotland including all provided attachments and files: https://www.whatdotheyknow.com/request/register_of_payments_from_pharma_177#incoming-411986

NHS Forth Valley – Register of Interests

NHS Forth Valley was the first of Scotland’s 22 NHS Boards that I approached about Register of Interests for all staff employed by NHS Forth Valley – as per HDL (2003) 62.

I first wrote to NHS Forth Valley on the 17th May 2011. This is now two-and-a-half years ago. There was no reply so I wrote again. But still no reply. I then contacted appropriate Line managers. I include the bulk of this communication below.

As of 10th November 2013, NHS Forth Valley do not have a register of interests for their employees. The Registers that exist are for Board members only. they can be accessed here: http://www.nhsforthvalley.com/about-us/board-matters/code-of-conduct

The 2013 NHS Forth Valley Board members Register (as of 10 Nov 2013):

CropperCapture[1]

You will see from the communication below that NHS Forth Valley are currently reviewing their policy in this area. I have asked to be kept updated but have had no further information supplied to me as yet.

Alex Neil, Cabinet Secretary for Health and Wellbeing on this matter:

Alex-Neil-on-Reg-of-Interes

————-
Sent: 17 May 2011 14:00 T
o: King Florence (NHS FORTH VALLEY – FK8 1DX)
Cc: O’Neill Kathy (NHS Forth Valley)
Subject: Hospitality et al Pharma Hospitality and funding of courses:

17th May 2011.

Dear Florence,
I take it all these declarations are published annually and open for all to see?

What about doctors who go out every week, or indeed twice-a-week, for lunch with drug-reps? Those £25 would add up, but not as much, dare I suggest, as the prescribing influence.

It is necessary for us all that continuing medical education is not driven by industry. Psychiatry here, as per the very latest article in the British Medical Journal, has been most vulnerable. Medicalisation: A new deal on disease definition by Ray Moynihan. BMJ 2011;342:doi:10.1136/bmj.d2548 (Published 3 May 2011)

I look forward to hearing your answer to my open question.

Kind wishes,
Peter Gordon

————-
From: Peter J Gordon
8 May 2013

Dear Forth Valley NHS Board,
Recently under FOI Request, you kindly provided  documents/spreadsheets regarding the FOI enquiry about: Register of payments from pharmaceutical companies to staff.

To seek absolute consistency of request – to all 13 Scottish NHS  Boards – I am using this online-process and so wanted to forward  the FOI request that I have sent to other 12 Scottish NHS Boards for you to review.

This is NOT a further FOI request, it is simply to ask if you could  upload all the NHS Forth Valley Hospitality Register spreadsheets that you provided to me for open public access through this page.

I shall also attach correspondence between myself and NHS Forth  valley on this matter by a separate post.

I am sorry for the inconvenience,

Yours faithfully
Peter Gordon

————

The updated letter is this
:

8 May 2013

Dear Forth Valley NHS Board,
Hospital Boards are reportedly meant to keep a register of payments from pharmaceutical companies (and other relevant companies) to  staff, in case of conflicts of interest [1]. I am requesting a copy  of the register for this Board – which I would hope includes  details of all relevant payments to staff and any related potential  conflicts of interest. If it would be possible to have this  information in an appropriate structured data format – for example,  a CSV file – this would be helpful. If this Board does not have a  complete register, I would request: the release of the information  on this topic that the Board does hold; and an explanation of why  the Board does not hold a complete register.

I am aware that some would view data on pharmaceutical funding as  personal data for those staff receiving the funding. Even if some  of the information on this register may be classed as personal data  (although this is contestable – for example, in some sectors of  academia information re funding sources is made public as a matter  of course) it would be covered by paragraph 6 of Schedule 2 of the  Data Protection Act. The release of these data is “necessary for  the purposes of legitimate interests pursued by the data controller  or by the third party or parties to whom the data are disclosed”  [2]. Spurling et al’s systematic review of how information from  pharmaceutical companies impacts physicians’ prescribing reported  that, of the studies included which looked at total promotional  investment, three “found that total promotional investment was  positively associated with prescribing frequency…Two…found both  positive results and no association…One study did not detect an  association” [3]. There is thus a legitimate interest in releasing  this register: the available research suggests that it is plausible  that payments received influence how public money is spent and the  type of care provided to members of the public.

For the reasons given above, there is a strong public interest in  releasing this information. While “requests for the personal data  of a third party are exempt under section 40(2) of the Freedom of  Information Act…if disclosure would contravene section 10 of the  Data Protection Act, the right to prevent processing likely to  cause damage or distress” [2], I would argue that, even if some of  those named in these documents feel that their release would cause  them damage or distress, this is outweighed by the significant  public interest served by releasing these data.

Yours Faithfully,
Dr Peter J. Gordon

[1] http://www.guardian.co.uk/society/2013/a
[2] http://www.justice.gov.uk/downloads/info
[3] http://www.plosmedicine.org/article/info

———-

From: Peter J Gordon
8 May 2013

This is the previous correspondence between myself and NHS Forth  Valley on Hospitality Registers:

To Chief Executive, NHS Forth Valley;
From: Gordon Peter (NHS FORTH VALLEY)  S
ent: 13 February 2013 18:05  To: Mackenzie Fiona (NHS FORTH VALLEY)
Subject: NHS Forth Valley Hospitality Register

13th February 2013

Dear Professor Mackenzie,
Would it be possible for us to discuss NHS Forth Valley’s  Hospitality Register? I understand from our General Manager for NHS Forth Valley that it has never been functional. It has taken me two  years of polite enquiry to establish this.

I am most grateful.

Yours sincerely,
Peter Gordon

——————-

From: NHS FORTH VALLEY
Sent: 18 February 2013 14:52
To: Gordon Peter (NHS FORTH VALLEY)
Subject: FW: NHS Forth Valley Hospitality Register

Dear Dr Gordon,
Professor Mackenzie has asked me to reply to your query below.  There is in fact a functioning Hospitality Register that can be found at the below link. We are in the process of updating the  Business Conduct Policy and aim to re-launch this throughout the  organisation and through our General Manager structure which will  draw further attention to individuals responsibilities around the  Register. In addition there is also a Register held at Board level  for senior staff to document any hospitality. The Board members  declarations of interest are on the website and also note any gifts  or hospitality.

I hope this is helpful and if your require any more information  please do not hesitate to contact me.

Kind Regards
Head of Performance

———-

From: Gordon Peter (NHS FORTH VALLEY)
Sent: 21 February 2013 07:56
To: NHS FORTH VALLEY
Subject: NHS Forth Valley Hospitality Register

Dear NHS Forth Valley
I am sorry to trouble you again but I think I am confused about the  NHS Forth Valley Register.

After looking at the page you sent http://www.nhsforthvalley.com/about-us/b…  and opening up the link to the 2011 to the “Hospitality Register  2010/2011′ I am left wondering if this Register only applies to the NHS Board? Certainly it is listed under the overall framework for “Board Matters” and the only clinician (who is also a Manager) that is listed is Dr Allan Bridges.

I attach screenshot to make sure we are on the same page.

NHS Forth Valley General manager, Mrs Kathy O’Neill, wrote to me on the 27th December 2012 (see e-mail below) stating “there is no central hospitality register” for NHS Forth Valley.

I have perhaps not been clear enough, and if so I apologise: what I  am interested in, under FOI request if necessary is: if there is a  functioning central register for all NHS Forth Valley employees  (not just Board Members). My interest, as said, is actually nationwide and is based on the repeated assertions by the  Pharmaceutical Industry (I can provide the International Journal  references if you wish) that state that “collaboration” between the  NHS and the Pharmaceutical Industry on matters of “education” and  financial support are “transparent”.

In Forth Valley over many years, and continuing to this day, I have  been aware of

  • Pharmaceutical sponsored educational events for NHS Forth Valley  healthcare professionals;
  • Professionals talking of significant “honoraria” payments given  in return for “educational talks” at meetings set-up and sponsored  by the Pharmaceutical Industry
  • and on an on-going basis the payment and hospitality provided to  NHS Forth Valley Healthcare practitioners by the Pharmaceutical  Industry to attend International Conferences.

I am writing then to ask if your statement of the 18th February:  “There is in fact a functioning Hospitality Register that can be found at the above link” is correct and that it is open to all staff employed in NHS Forth Valley as per extant NHS Forth Valley  Business Conduct Policy?

I am very grateful for your help and apologise for my confusion.

Yours sincerely,
Dr Peter J. Gordon

————-

From: NHS FORTH VALLEY
Sent: 22 February 2013 11:05
To: Gordon Peter (NHS FORTH VALLEY)
Subject: RE: NHS Forth Valley Hospitality Register

Dear Dr Gordon,
I have put your queries into the FOI system to ensure we respond to  your actual issues. I hope this will be helpful in getting to the  bottom of this.

Kind Regards
Head of Performance
NHS Forth Valley
Carseview House

———–
From: Gordon Peter (NHS FORTH VALLEY)
Sent: 22 February 2013 11:15
To: NHS FORTH VALLEY
Subject: RE: NHS Forth Valley Hospitality Register

Dear NHS Forth Valley,
Many thanks. I am grateful for your help and kind assistance.

Peter Gordon

———-

Medical Directorate
Information Governance Department,
CSD,
Colquhoun Street
Stirling,
FK7 7PX

NHS Forth Valley  Date: 22 April 2013
Our Ref: 0001095 Review

Dear Dr Gordon,
Re : Request for Review Under the Freedom of Information [Scotland] Act 2002
I would initially say that while you have asked for a review under  the Freedom of information (Scotland) Act 2002, technically this is  not a review but rather additional questions in relation to your  primary request.

The other clarification I would like to make is that there is more than one process that you refer to within your correspondence and  this may be a cause for confusion.

The Register of Interests is a process that the Board members go through and rests within the Code of Conduct for Board members  (2003). There is a process relating to the organisation and  pharmaceutical companies, both are currently separate from the  Hospitality Register process which is part of the Policy on Standards of Personal Business Conduct (2007) and relates to all staff.

1. To see the hospitality register, extant as you confirm under FOI  0001095, for all the years it has functioned, {assume this goes  back to a time before I enquired in May 2011.

Response:
The only hospitality registers we have available are for the  following years 20l0-2011, 2011-2012 & 2012-2013 with the current  ersion on the website being 20l1-20l2: http://www.nhsforthvalley.com/_documents

I have enclosed a copy of these registers for ease.

This is the only information we have received from staff through the Policy on Standards of Personal Business Conduct 2007. This  policy is for all staff.

The Policy on Standards of Personal Business Conduct 2007 is available via the staff intranet under Financial Operating  Procedure 20 —I have enclosed a copy of this for your information.

2. Can NHS Forth Valley confirm they have followed the Scottish  Government Guidance to Boards (Working together for patients) which  “expects al Scottish NHS Boards to have publically-open and functioning Hospitality Registers to include hospitality from industry honoraria paid to staff and sponsorship of continuing medical education.”

Response:
I can confirm The Policy on Standards of Personal Business Conduct 2007, as stated in our initial response is currently undergoing extensive review and will be reissued to staff. This review will  take on board changes in legislation e.g. Bribery Act 2010,  Pharmacy procedures, the guidance contained in Work Together for  Patients — A Common Understanding which you reference and was  published in November 2012 and any other appropriate changes.

NHS Forth Valley has published the hospitality register for the  year 201l-2012 on the public website and will continue to do so.

I hope this information can be of assistance to you.

Please do not hesitate to get in touch if you require any further assistance.

———–
From: Gordon Peter (NHS FORTH VALLEY)
Sent: 24 April 2013 11:31
Subject: advice  24th April 2013.

To Kinburn Castle,
St Andrews,
Fife.

Dear Scottish Information Commissioner,
I enclose the reply I had from the Head of Clinical Governance for NHS Forth Valley after seeking clarification under FOI law about  Forth Valley NHS staff and any collaboration with  industry/commerce. I wanted to establish if such was declared and  openly registered: including any financial, hospitality or gift  transactions.

I also attach the extant NHS Forth Valley ‘Hospitality Registers’ as open to public: http://www.nhsforthvalley.com/_documents

NHS Forth Valley’s ‘Policy on Standards of Personal Business  Conduct 2007’ can be sourced as per letter from Deidre Coyle  (copied below).  It has taken me two years to get this far. It has not been easy.

You will note that NHS Forth Valley ‘Hospitality Register’ is for NHS BOARD members only.  There is NO record of ANY collaboration between NHS FV healthcare  workers and outside Industry/commerce. None. Not one record of  sponsored meetings, sponsored attendance to courses, honoraria  received or any other ‘collaboration’.

I am very concerned about this lack of transparency.

I am writing to ask your advice. I would like to put all this information together with all letters and databases supplied on  open access on the Intranet: to create a coherent, open and  balanced record of where we are now on this important matter. I  write to ask if there are any reasons why I should not do this?  I have copied our Health Minister into this as the Scottish  Government Guidance to Boards (Working together for patients)  “expects al Scottish NHS Boards to have publically-open and functioning Hospitality Registers to include hospitality from industry honoraria paid to staff and sponsorship of continuing medical education.”

I would also recommend you read NHS Forth Valley’s ‘Policy on Standards of Personal Business Conduct’ a policy that has existed  since 2007 (6 years ago). It is clear that this policy has not been followed.

Vulnerable patients deserve, at minimum, clarity and openness about  any ‘collaboration’ otherwise we cannot even attempt to distinguish ‘medical education’ from ‘marketing’.

Kind wishes,
Peter Gordon

————

From: Gordon Peter
Sent: 25 April 2013 12:44
To: NHS FORTH VALLEY
Subject: FW: Enquiry: information request to NHS Forth Valley

Could you read this over and give guidance on NHS FV and copyright?

I would like to place all communication on-line.

My over-arching view is that the population of Forth Valley deserve  transparency about this matter, noting that NHS Forth Valley has NO  record of collaboration (be it financial or of any other form) with  Industry/commerce outside NHS.

Aye Peter Gordon

——–
From: [email address]
Sent: 25 April 2013 12:21
To: Gordon Peter (NHS FORTH VALLEY)
Subject: Enquiry: information request to NHS Forth Valley

Dear Dr Gordon
Enquiry: information request to NHS Forth Valley

Thank you for your enquiry dated 24 April 2013.

In your email you ask for advice on putting information relating to  your on-going communications with NHS Forth Valley (NHSFV)on the  internet and whether there are any reason why you should not do  this.

Generally speaking I do not see any issues with you deciding to  publish the correspondence between yourself and the authority that  has been created as a consequence of the request you made to NHSFV.  Indeed there is a website called WhatDoTheyKnow where details such  correspondence is available to the public to look at. You may find  this of interest to look at and as such please see the following  link for reference: https://www.whatdotheyknow.com/

The one thing I would draw to your attention in relation to making  available information you have gathered as a consequence of your requests, is that information released under FOI legislation is  still subject to copyright rules. With this in mind I would suggest  that you clarify NHSFV’s copyright arrangements, including what’s  called third party copyright, where the information supplied by in  this case NHSFV does not actually hold the copyright. This is a  specialist area and I would suggest that after clarifying the  authority’s position you might want to look at the fair dealing  provisions, which refer to this. For reference I have provided a  link to the UK Copyright Service http://www.copyrightservice.co.uk/copyri

With respect to FOI legislation itself please see the following  link to the Commissioner’s guidance booklet “Your right to know”, which provides an overview of the processes involved in FOI and how  to progress matters to the Commissioner if this becomes necessary

I hope the above is useful, however should you have any queries  please feel free to contact me.

Yours sincerely
Freedom of Information Officer
(Policy and Information)

The Office of the Scottish Information Commissioner
Kinburn Castle
Doubledykes Road
St Andrews
Fife  KY16 9DS

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Sent: 02 May 2013 08:23
To: Gordon Peter (NHS FORTH VALLEY)
Subject: RE: Enquiry: information request to NHS Forth Valley

Hi Peter,
Apologies for the delay in getting back to you but I have been out  of the office and like everyone else I have an e-mail backlog.

Thank you for your recent enquiry regarding NHS Forth Valley and copyright.

I have no issue with you publishing what we have provided to you so far through the Freedom of Information Act.

The Board does have copyright in the material it has published, but as it is publically available you can link to it.

We have not provided you with any information that is not the copyright of NHSFV.

It may be prudent in future to seek legal advice about the content of anything you choose to publish as this cannot be approved for you by the Board.

Hope this helps
Kind regards

Head of Information GovernanceLink to this

———–

From: NHS FORTH VALLEY  Sent: 10 May 2013 15:21
To: Gordon Peter (NHS FORTH VALLEY)
Subject: Hospitality Registers

Hi Peter,
I have arranged today for all three registers that we supplied to  be placed on the NHS Forth Valley public website.

They can be found at the link below – http://www.nhsforthvalley.com/about-us/b

I hope this is what you were looking for.

Kind regards
Head of Information Governance

(Please note: comment by Peter Gordon the link provided above is NOT to Central Hospitality Registers for all NHS staff employed by NHS Forth Valley. These are Registers of Interests of BOARD members only)

——–
Communication with NHS Forth Valley here: https://www.whatdotheyknow.com/request/register_of_payments_from_pharma_166#outgoing-273345

A summary database of all FOI returns from Scotland’s 22 NHS Boards: 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

Greater Glasgow NHS – Register of Interests

5 June 2013
Greater Glasgow NHS

Dear Mr Gordon
Thank you for your request for information received on 8 May 2013 by NHS Greater Glasgow and Clyde relating to register of payments from pharmaceutical companies to staff as described in your email below.

We are treating your request under our procedures for responding to requests for information under the Freedom of Information (Scotland) Act 2002.

I can confirm that NHS Greater Glasgow & Clyde holds information as described by you.

As a general principle where decisions are being taken about medicines that could be influenced by a personal or non-personal interest then declarations of interest are made and appropriate action taken in terms of non-participation or actual participation in the discussions, however, the information is not necessarily routinely collated. Individual staff members are expected to record such information in the on-line register.

The medicines advisory structures tend to have a more formal collation of interests from members:

  • Members of the medicines advisory structures complete a standard declaration of interest proforma.
  • At each meeting those attending are required to declare interests when relevant to agenda items.
  • Participants in Clinical Guideline Development Groups make a declaration of interest, noted on the documentation, but not routinely collated.
  • Applicants and panel members for each Individual Patient Treatment Request make declaration of interest.

I am able to provide the information you have requested and the following is attached:-

  • Icon 1  – Extract from NHSGGC Code of Conduct for Staff on-line register
  • Icon 2 –  Sample of declaration of interest proforma
  • Icon 3 – Area Drugs and Therapeutics Committee and Associated Sub
  • Committees [Some declarations have still to be received]
  • Icon 4 – Pharmacy and Prescribing Support Unit Executive Group
  • Icon 5 – FOI requirement for review
  • Icon 6 – Review Form.

Yours sincerely
Elizabeth Watt

Secretariat Department
J B Russell House
Gartnavel Royal Hospital

Full communication with Greater Glasgow NHS is here (including attached Excel spreadsheets): https://www.whatdotheyknow.com/request/register_of_payments_from_pharma_157#incoming-396416

Summary spreadsheet of all FOI returns here (due to the heterogeneity of the returns this is a rough guide at best): https://docs.google.com/spreadsheet/ccc?key=0ApF86-MCSbZzdGlVd2ZPYWhyN1ZUbkliNlFpTGxtMFE&pli=1#gid=0

Alex Neil, Cabinet Secretary for Health and Wellbeing considers this matter:

Alex-Neil-on-Reg-of-Interes

Dumfries and Galloway NHS – Register of Interests

Dumfries and Galloway NHS

31 May 2013

“Attached are a redacted Gifts and Hospital Register and Pharmaceutical Interests for 2008, 2009, 2011 and 2012. There is no pharmaceutical interests register for 2010”

Chief Executive’s Office
Freedom of Information
Mid North Crichton Hall
Bankend Road
Dumfries
DG1 4TG

After some further communication, Dumfries and Galloway NHS, supplied on the 28 June 2013 the above registers free of redacted names of employees.

Dumfries and Galloway NHS Registers and all communications with Dumfries and Galloway NHS can be accessed here: https://www.whatdotheyknow.com/request/register_of_payments_from_pharma_155#outgoing-283202

Note: NHS Dumfies & Galloway Register for 2008 is unspecified: “Lilly. Astra Zeneca, Lundbeck, Janssen-Cilag, BMS, Pfizer, Wyeth and Servier – Sponsorship for various meetings” and “Lilly, Astra Zeneca Cilag- occasional honoraria for lecturing, meetings, consultancy and sponsorship to educational events/meetings”

NHS Dumfies & Galloway Register for 2009 is unspecified: 19 departments listed and multiple Pharmaceutical Companies involved

For summary of Registers (due to the heterogeneity of the returns from across Scotland) this is a rough guide at best:: https://docs.google.com/spreadsheet/ccc?key=0ApF86-MCSbZzdGlVd2ZPYWhyN1ZUbkliNlFpTGxtMFE&pli=1#gid=0

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