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.

 

Lurasidone – “Special Article”

I noticed this “Special Article” published in the October edition of the British Journal of Psychiatry. It details a novel antipsychotic medication called Lurasidone  (trade name Latuda):

Lurasidone, Oct 2015

I would anticipate that this is the start of a programme to educate psychiatrists in the UK on this new drug.

I note from the ProPublica Searchable database that one of the authors of this “Special Article” has received payments from the drug’s manufacturers as below:

Leslie Citrome

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.

 

 

“All in the past”: well, no.

All in the past from omphalos on Vimeo.

Seven years ago this Editorial was published in the BMJ:KOL

Eleven years ago, all NHS Chief Executives in Scotland were asked to implement and govern this Scottish Government circular: HDL 62. This has not happened.HDL-62

The General Medical Council published nine years ago:  “Good Medical Practice”, which makes very clear:Annexe A, GMC

General Medical Council on conflicts of interest from omphalos on Vimeo.

Seven years ago the Royal College of Psychiatrists issued its own guidance, CR148:CR148 says (3)

Given these multiple levels of failing in governance, and in the pursuit of scientific objectivity, I have petitioned the Scottish Government to consider implementing a Sunshine Act. The research behind this can be accessed here.

I am employed as an NHS psychiatrist and have been an NHS Consultant for 13 years.

Over this time, the key opinion leaders in UK psychiatry (though I have never met) have become known to me.

Continuing Medical Education invites (generally “CME-accredited”) come to my NHS e-mail address on a weekly basis.

As an NHS employee I have had regular invites to attend “CME-accredited” conferences that include educational talks by distinguished speakers such as:

  • Professor Allan Young
  • Professor Peter Passmore
  • Professor Guy Goodwin
  • Professor Philip J Cowen
  • Professor David Nutt
  • Professor J Chick
  • Professor David Taylor (pharmacist)
  • Professor Clive Ballard
  • Professor Nick Fox

It is the case that (in 2015) we still have no way of knowing how much may be paid to any individual to educate professionals like myself

The ABPI “central platform”, which will be operational next year, allows individuals to “opt out” of revealing any payments.

Dr McCartney has long argued that the medical profession should take the lead on transparency. I agree.

009b

The Royal College of Psychiatrists guidance CR148 has not been followed since it was introduced seven years ago. The updated system (following my dogged persistence) still fails to require details of monetary exchange or for specific dates of (any such) payments.

The USA have introduced a Sunshine Act and so in recent years, drug companies have started releasing details of the payments they make to doctors and other health professionals for promotional talks, research and consulting:

CropperCapture[1]

Over a decade ago, I noted this letter of reply by Professor Philip J Cowen. A reply that troubled me.

Cowen, P J - Constructionism 24-5-2011Professor Philip J Cowen

A straightforward internet search would indicate that Professor Cowen has followed extant guidance regarding transparency. Here follows some of the material on Professor Cowen to be found in the public domain:Cowen, P. J,CINP, 2016 Cowen, P J - 3-3-2014 Cowen, P J - 17-11-2014 Cowen, P J - 19-5-2011  Cowen, P J - 2011 2011, RCSPsych Int CongressCowen, P J - 2014 b Cowen, P J - 2014 Cowen, P J - 2015 Cowen, P J - April 2014 Cowen, P J - April, 2012 Cowen, P J - Aug 2010 Cowen, P J - Aug 2013 Cowen, P J - Dec 2012 Cowen, P J - ECNP Cowen, P J - Jan 2015 Cowen, P J - May 2012 Cowen, P J - Nov 2012 Cowen, P J - Nov 2012b Cowen, P J - Nov 2013From “Our own window” published in BMJ rapid responses:Soft rebuttal, 2001

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

Continuing Medical Education and its entanglement with the Pharmaceutical Industry

Yesterday I sent the e-mail (at the foot of this post) to Alex Neil, Cabinet Secretary for Health and Well-being for the Scottish Government. It should be self explanatory.

My timing of this letter is based on 8 separate areas. Areas that I hope present as close to a whole picture as I am best able to do:

(1) Freedom of Information (FOI) returns have now been received from all 22 Scottish NHS Boards on the subject of how they record payments to healthcare workers from the Pharmaceutical Industry and if these are open and transparent to all. The results are worse than disappointing.

The summary database is here: https://docs.google.com/spreadsheet/ccc?key=0ApF86-MCSbZzdGlVd2ZPYWhyN1ZUbkliNlFpTGxtMFE#gid=0

Full communication and register files (if available) are here: https://www.whatdotheyknow.com/user/peter_j_gordon/requests

(2) The USA, since five days ago, has a SUNSHINE ACT: look here and see what such statute-based transparency is beginning to reveal (that had previously been kept in the dark) http://projects.propublica.org/docdollars/

In case you think that this could not affect Scotland, well as just one example, Henry A. Nasrallah came to NHS Forth Valley and gave sponsored education on Risperdal in July 2009. He is in the top ten educators earning from the Pharmaceutical Industry with at least $647,341 changing hands.

(3) Scotland (and the UK) do NOT have a Sunshine Act. What we have is the Guidance on Joint-Working between NHS-Scotland and the Pharmaceutical Industry: A Common Understanding 2012 – Working Together For Patients. As guidance it was brought into effect in November 2012 and the Guidance was developed under the Chairmanship of Ian Mullen who was involved in this at the same time as he was Chairman of NHS Forth Valley. Despite this and the fullsome promises in the foreword by Ian Mullen, NHS Forth Valley has never had a functioning register of any joint-working other than the listed Interests of Board members. The FOI returns across all 22 NHS Scottish Boards have since evidenced that NHS Forth Valley, in this failing, was closer to the norm rather than the exception.

A common Understanding

(4) There is also the UK-wide ABPI Code (The Association of the British Pharmaceutical Industry): latest version is here: “The Code of Practice for the Pharmaceutical Industry Second 2012 Edition”  http://www.abpi.org.uk/our-work/library/guidelines/Pages/code-2012.aspx

The ABPI code was reported in the BMJ on its launch in an article by Clare Dyer entitled “Collaboration with drug industry won’t affect clinical decisions, says new guideline”

ABPI promoted

This report of the new ABPI code stirred a vigorous response in BMJ rapid-responses: http://www.bmj.com/content/344/bmj.e2489?tab=responses

One of these responses was subsequently published 24 April 2012 as a letter entitled: “Guidance offers little in the way of ethics or transparency” It was written by Rogers, Zutlevics, Raven & Jureidini:

ABPI Guidance - one response

The above article as per original publication may not be very clear so I have re-pasted the body of the text here (highlights are mine)

deeply-disappointing

In February 2013 the Lancet withdrew its support of document on collaboration between doctors and drug industry http://www.bmj.com/content/346/bmj.f770 I will reprint some of the text here:

Falling-out-with-Pharma

(5)  I have been collecting over the last 3 months all details of Pharmaceutical Sponsored Education that comes my way. I do not see Pharmaceutical Reps and so this will most likely be urepresentative sample of the wider picture. Have a look and form your own opinion:http://pinterest.com/peterjgordon/pharmaceutical-sponsored-medical-education/

Pharmaceutical Sponsored Education

(6) Last year £40 million was paid in total to healthcare workers in the UK from the Pharmaceutical Industry. Whatever proportion went to Scotland, it certainly is not represented in what few returns have been made by doctors to their NHS Boards. So much for transparency. And what then of the ‘probity’ section all doctors sign as part of mandatory GMC regulations for Appraisal and Revalidation?

£40 million

(7) An area of legitimate concern must relate to academics and doctors that have been termed as “Key Opinion leaders” and whose joint-working with the Pharmaceutical Industry can be considerable . I must confess that I had not been especially aware of this until the recent UK-wide discussion on dementia diagnosis was raised in leading journals. I have always advocated for the timely, personalised and holistic diagnosis of dementia pointing out that considerable harms may be associated with the prevailing imperative of ‘early diagnosis’. I was a lead in this debate before just about any other. I was thus concerned when the Key Opinion Leaders in dementia in their reply to the Open letter that I had joined with Grassroots Doctors on this subject http://grassrootsgp.org/category/dementia-screening/  made no declarations of interest. Not one. I knew this was incorrect.

Grassroots GP

Dr Martin Brunet in The Binscome Doctor Blog, as one of the Grassroot doctors made the same observation: http://binscombe.net/blog/?p=639

“Our letter was initially published as a rapid response, where it triggered a reply from an eminent group of doctors who declared that they had no competing interests. The letter was subsequently published as an Observation article, and a further reply came from many of the same authors, several of whom decided on this occasion to declare interests, including financial support from pharmaceutical companies and appointments related to the field of dementia. These conflicts are not wrong in themselves, and do not invalidate their comments, but neither are they unimportant, nor did they arise in the intervening three-month period between the letters. What changed? A prick of the conscience? A word from the editor? Or perhaps the fact that the BMJ tightened its wording about conflicts of interests in January 2013 – between the two submissions.

CropperCapture[2]

Even a robust policy on this matter is insufficient, however. The BMJ has very clear guidance on what should be declared, but there is very little the editors can do when proper declarations are not made – with retraction of the article being their most draconian punishment. Retraction may have repercussions in the scientific community, but it is rarely reported on in mainstream media.”

Since this time I have collected the declarations made by all the Key Opinion Leaders, at least those of whom I am most aware that educate us on dementia, whether it be in  practice, prescribing or policy. My absolute determination is to look at this as a group and thus I would wish no doctor to be singled out. This is not about reputations, or simply conflicts of interest, it is about transparency and that goal that we surely all share: the quest for scientific objectivity.

Why I no longer consult for drug companies https://vimeo.com/72517101/settings

This film carries some of the words by Dr Peter J. Whitehouse in a paper that he wrote called “Why I no longer consult for drug companies” published in Culture, Medicine and Psychiatry, March 2008, Volume 32, Issue 1, pp 4-10

http://link.springer.com/article/10.1007%2Fs11013-007-9075-x#page-1

I wish to thank Dr Whitehouse for allowing me to use his words in this film.

I have made this film as I share Dr Whitehouse’s concern about the entanglement of pharmaceutical marketing/health industries with continuing medical education. I also share concern that when it comes to the Key opinion leaders in dementia that the talk of “transparency” is only talk. Last year £40 million was paid by Pharma to healthcare workers in the UK. Research into Scottish NHS Hospitality Registers evidences that payments from Pharmaceutical Industry are consistently not being declared in Registers (if indeed there is a functioning NHS register!) We are in the dark about this. Unlike USA we have no ‘Sunshine Act.’ The UK has a meaningless, one-sided, code called the ABPI code.

Why I no longer

89% of British Medical journal readers (999 out of 1128), in a poll of April 2013, agreed that drug companies should publish the names of doctors to whom they make donations. That is a striking consensus.

Donations poll

The Pinterest Board on Key Opinion Leaders in Dementia is here: http://pinterest.com/peterjgordon/opinion-leaders-in-dementia/ I was going to write about this but, for so many reasons, I find this very difficult. I am particularly concerned that I am simply a doctor, not an investigator (and do not wish to be). I hope that all readers of this realise that my only determination is to be fair to all, to follow evidence, ethics, professionalism and the humanity that I hope I have within me.

Key Opinion Leaders 'educating' us

(8) Before finishing this post with a copy of the e-mail that I sent to Alex Neil, Cabinet Secretary for Health and Well-being for the Scottish Government. I would like to post a couple of ‘slides’ that I have made from the current BMJ and the article “Everything you need to know about the Sunshine Act” (intended  for the USA readership) http://www.bmj.com/content/347/bmj.f4704

Sunshine-03

Sunshine-06

And finally some advice from Dr Ben Goldacre aimed at his fellow professionals. This is also in the form of a film that I have made called: “What Can You Do” (thank you to Dr Goldacre for agreeing to allow me to use the text from his book Bad Pharma) https://vimeo.com/68919466

Dr-Ben-Goldacre's-advice

Bad pharma 5

From: Gordon Peter (NHS FORTH VALLEY)
Sent: 07 August 2013 20:15
To: alex.neil.msp@scottish.parliament.uk
Subject:ADULT ADHD ACADEMY – sponsored education

7th August 2013.

Dear Cabinet Secretary for Health and Well-being,
Scotland’s 22 NHS Boards have now all replied to Freedom Of Information (FOI) enquiries regarding financial payments from Pharmaceutical Industry to NHS staff.

The results are most dismal. Have a look yourself

Summary database here: https://docs.google.com/spreadsheet/ccc?key=0ApF86-MCSbZzdGlVd2ZPYWhyN1ZUbkliNlFpTGxtMFE#gid=0 (any errors in summary will be mine)

Full communication here: https://www.whatdotheyknow.com/user/peter_j_gordon/requests

Could Scotland not lead here? Why can we not have full transparency on this in Scotland? A Sunshine Act. Like they now have in USA?

Like many others I am primarily concerned about science and objectivity (please see the views of Robert Merton in the slide below which are certainly not out of date)

Last year £40 million across the UK went to doctors (healthcare workers) . . . not much of this is showing up in returns given to Scottish NHS Boards (that is if the NHS Board has a Register.)

If Conflicts of Interest are not a worry to all, this lack of transparency on the part of doctors, most certainly is. Currently Consultants like myself have to Revalidate and as part of this and annual Appraisal we sign a section on ‘probity’.

Please do reply to this concern. I am grateful.

Yours sincerely,
Dr Peter J. Gordon

Consultant Psychiatrist for Older Adults,
 Clackmannan Community Healthcare Centre,
 Hallpark road,
 Sauchie.
 FK10 3JQ

Changing-system-of-producin

The text on this slide on SCIENTIFIC OBJECTIVITY and what MERTON CORRECTLY FEARED may happen, is from the book “Genes, Cells and Brains” by Hilary & Steven Rose