At the end of the corridor

 

Making science a reality

It has been a long time since I last wrote on Hole Ousia about my activism for a science that strives for objectivity.

It is probably reasonable to suggest that no other in the British Isles has given more to this cause than I have.

I petitioned the Scottish Parliament to consider introducing a Sunshine Act for Scotland. Much evidence was gathered for this petition and this was then shared in a formal public consultation.

The Scottish public agreed, in majority, that payments from the pharmaceutical industry and device makers to healthcare professionals need to be declared on a mandatory basis. At the time, this landmark consultation was neither reported in the mainstream press nor the medical press. A year on the Scottish Government has provided no meaningful update.

It was thus with considerable interest that I read the following editorial in the current British Medical Journal:

The full article can be accessed here from the BMJ:






Open and transparent from omphalos on Vimeo.

Courage to care













 

Reductionism – truly, madly, deeply

On Friday the 25th of November 2016 I gave a talk for the Scottish Philosophy and Psychiatry Special Interest Group.

My subject was “Improvement Science”.

The following is based on the slides and the four short films that I presented.

My talk was entitled:
001-improvement-science The meeting was held at the Golden Lion Hotel, Stirling:golden-lion-hotel-stirling-25-nov-2016-1golden-lion-hotel-stirling-25-nov-2016-2I started the day off:
002-improvement-scienceI gave these declarations:
003-improvement-science
I explained to the audience that like Dr Rev I M Jolly I can be overly pessimistic:


005-improvement-scienceThe dictionary definition of ‘Improvement’:
006-improvement-scienceThe dictionary definition of ‘Science’:
007-improvement-scienceMy concern is any pre-determinism to science:
008-improvement-scienceThe Health Foundation have considered Improvement Science: this is from 2011:
009-improvement-scienceMany different terms are used including “QI” for “Quality Improvement”:
010-improvement-scienceThis is where improvement science began, in Boston, Massachusetts:
011-improvement-scienceThe Founder of the Institute for Healthcare Improvement (IHI) was Don Berwick:
013-improvement-scienceThe first description of this movement in Britain goes back to 1992 by Dr Godlee:
014-improvement-scienceFifteen years later, Dr Godlee, Editor of the BMJ, said this:
015-improvement-scienceOnly last month the BMJ briefly interviewed Don Berwick:
016-improvement-scienceIHI describes improvement science as being based on a “simple, effective tool”:
017-improvement-scienceThis tool was developed from the work of an American engineer, W. A. Deming:
018-improvement-scienceThe “Model for Improvement” Tool [TM] is described by IHI as a “simple, yet powerful tool”:
019-improvement-scienceThe current President and CEO of IHI is Derek Feeley:
024-improvement-scienceUp until 2013, Derek Feeley was Chief Executive [Director General] for NHS Scotland:
021-improvement-scienceIn April 2013 Derek Feeley resigned from NHS Scotland:
022-improvement-science22nd February 2015 it was reported: “The astonishing and largely hidden influence of an American private healthcare giant at the heart of Scotland’s NHS”:
023-improvement-scienceDr Brian Robson, Executive Clinical Director for Healthcare Improvement Scotland [HIS] is an “IHI Fellow”:
dr-brian-robsonProfessor Jason Leitch, National Clinical Director for the Scottish Government is an “IHI Fellow”:
026-improvement-scienceMight we be facing the biggest change to healthcare in Scotland since the NHS began?nhs-scotland-1947 Improvement science is moving quickly and widely across Scotland:
027-improvement-scienceThis “Masterclass 1” for Board members cost  £146,837:
028-improvement-scienceAn NHS Board member commented after the Masterclass:
029-improvement-scienceHealthcare Improvement Scotland is one organisation with a very wide remit over NHS Scotland and it works closely with the Scottish Government:
031-improvement-scienceNine cohorts of Safety Fellows and National Improvers have so far been trained following IHI methodology:
032-improvement-scienceI was reminded of the current enthusiasm for improvement science when the Convener of a recent Scottish Parliament Committee meeting said of targets (another approach enthusiastically taken by NHS Scotland):033-improvement-scienceWhat is the place of ethics in Improvement Science?
034-improvement-scienceIn 2007 the Hastings Centre, USA, looked into this in some depth:
035-improvement-scienceThe Hastings Centre argue that Improvement science cannot ignore ethics:
036-improvement-scienceIn 2011 the Health Foundation, UK, produced this “Evidence Scan”:improvement-science-2011a2The Health Foundation commented that “improvement science is just emerging”:
037-improvement-science
The Evidence Scan found a “real paucity of evidence about the field of improvement science”:
038-improvement-scienceI would also suggest that there is a real paucity of philosophy about the field of improvement science:
039-improvement-scienceThe Health Foundation did find papers on the conceptual nature of Improvement Science but concluded that:
040-improvement-scienceMary Midgley is a philosopher now aged 95 years who is widely respected for her ethical considerations:
041-improvement-scienceChapter 7 of her book “Heart and Mind: The Varieties of Moral Experience” begins:
042-improvement-scienceMary Midgley is concerned about the overuse of reductionist tests in medicine stating that:
043-improvement-science
This film is about the potential consequences of inappropriate reductionism:

Leon Eisenberg has written many papers about this subject. He argues that reductionism should not be “abandoned” but that we must keep sight of where such an approach is scientifically useful and also where it is inappropriate:
045-improvement-scienceIn the Hastings Report, Margaret O’Kane asks:
046-improvement-scienceIn my view the answer to this question is YES. I am hopeful that the National Improvers recruited to NHS Scotland would agree:
047-improvement-scienceAs an NHS doctor I have seen unintentional harm brought about by National improvement work in Scotland. This related to a “Screening Tool” that was introduced across Scotland as part of this work. I found that the unintended consequences of the use of the following tool included implications for patients’ autonomy and the risk of over treatment:
048-improvement-scienceBoth the Hasting Group and the Health Foundation are of the view that improvement science cannot separate itself from the ethical requirements of research:
049-improvement-scienceThis article published in February 2016 argues that individual “rights transcend all aspects of Improvement science”
050-improvement-scienceThe following is a verbatim representation of a conversation held by National Improvers working in NHS Scotland:
051-improvement-scienceIn November 2016 Professor Joshi, also a psychiatrist outlined his concerns about reductionism in a published letter to the BMJ:
052-improvement-science
In this short film the mechanical language of healthcare improvers is considered:

Professor John Bruce was a Moral Philosopher in Edinburgh University in the 18th century. He built this temple, the “Temple of Decision”, in the grounds of his home by Falkland Palace so that he could consider his thesis:
054-improvement-scienceProfessor John Bruce did not succeed in his endeavour. His Temple however stood for many years:
055-improvement-scienceBut it eventually collapsed and his endeavour to “reduce the science of morals to the same certainty that attends other sciences” collapsed with it.
057-improvement-scienceAny search of Healthcare Improvement Scotland for “ethics” finds this result:
056-improvement-science
This film is about more up-to-date buildings – the enthusiasm for which was based on improvement science: The Red Road flats in Glasgow:

 

                         Post-script:

The following is an edited clip of the evidence given to the Scottish Parliament by Healthcare Improvement Scotland (HIS) on the 31st January 2017:

The full session can be watched here

The Official Report can be accessed here

Follow me

The First family of 6 Charlotte Square, Edinburgh was the Campbell family. A family whose wealth was made from the Brewing industry.

The Campbell family faced much tragedy. Above the family mausoleum in St Cuthbert’s, “Follow me” is inscribed.

Since 1966, the Campbell’s old home has been known as “Bute House” and is the official residence of Scotland’s First Minister.

This film is a plea for those elected Ministers gathering around the table in Bute House for the weekly Cabinet meeting to embrace Scottish intellectual pluralism. It is also a plea to recall all families of Scotland, however ordinary or extraordinary, and wherever their first home may have been.

Follow me from omphalos on Vimeo.

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.

 

A letter that the Scottish Parliament felt unable to publish

With careful thought, and backed with full supporting evidence,  I sent the following letter of the 2nd February 2016 to support my petition for a Sunshine Act for Scotland.

The Senior Clerk of the Parliamentary Committee was of the view that this letter did not comply with the Scottish Parliament’s policy on the treatment of written evidence. I was therefore asked to redact significant sections of the letter.

After considerable communications to and fro, I replied as per this e-mail of the 3rd March 2016:

I fully respect the right of the Scottish Parliament to determine 
what it publishes.

I feel very strongly that my letter without the highlighted text 
merely reiterates what I have already said, and fails to provide 
the evidence that I have repeatedly been asked for.

So my position is that I do not wish to amend my letter of the 
1st February on PE1493.

My petition has since been closed. I therefore have decided to publish my letter to the Scottish Parliament in full along with supporting evidence. I have had professional advice that what is contained in this letter is not defamatory as it is based on veritas and has full supporting evidence:

Dear Mr McMahon
Petition PE01493: A Sunshine Act for Scotland

I realise that the Committee must receive a great amount of correspondence however I hope that the committee might agree that what follows is extremely important when considering PE1493.

Since I last wrote to the committee I attended, for accredited continuing medical education, the Royal College of Psychiatrists in Scotland Winter Meeting held on the 29th January 2016. It is this that has compelled me to write this update as it demonstrates beyond doubt that lack of transparency around financial conflicts of interest remains a serious issue. An issue with implications for both patient safety and healthcare budgets. It also demonstrates that Government action is the only way to address this.

The full powerpoint presentations of this Accredited meeting for 
Continuing Professional Development can be accessed here - but only
for members of the Royal College of Psychiatrists. 

I am a member of the Royal College of Psychiatrists and I am of the 
view, as a scientist, that these lectures should be available to all 
and not just to members.

One speaker highlighted the increase in prescribing costs in her health board area which was due to the high prescribing rate of a new antipsychotic injection, palperidone depot (XEPLION®). The next speaker demonstrated both the inferior effectiveness of this drug when compared to existing (far cheaper) depot medications and the perception amongst Scottish psychiatrists that it was more effective. Below you will see the flyer sent to mental health professionals in Scotland when this drug was launched:

002 Financial Conflicts of Interest, Scottish Psychiatry

I have highlighted one of the paid speakers, Dr Mark Taylor, because he also spoke at this week’s meeting where he reminded us that he was Chair of SIGN Guideline 131: The Management of Schizophrenia, which was published in March 2013.

At this week’s meeting Dr Taylor presented his declarations as follows: “Fees/hospitality: Lundbeck; Janssen, Otsuka; Roche; Sunovion”.

Dr Taylor commented on these declarations with the statement that “you are either abstinent or promiscuous when it comes to industry. Well you can see which side I am on”. Audience laughter followed.

The general question that arises is whether an influential professional such as a Chair of National Guidelines might earn more from the pharmaceutical industry than in his or her role as a healthcare professional? At present it is impossible for anyone to establish the scale of competing financial interests. To remind the committee the following avenues are not illuminating:

1. Royal College of Psychiatrists. This week’s meeting did not appear on the college database. In any case this database is neither searchable nor does it include specific details of payments and dates

2. NHS Boards. The committee has already established that, across Scotland, HDL62 is not being followed.

3. SIGN guidelines. The committee is aware of significant governance failings particularly in comparison with NICE which includes details of financial sums paid and associated dates.

4. Discussions with Senior Managers in NHS Scotland relating to the General Medical Council’s expected level of transparency has brought forth written responses describing my interest as “highly unusual” and “offensive and unprofessional”

5. The forthcoming ABPI register allows any professional to opt out of inclusion.

It is also worth repeating that the information provided to the public consultation on this petition failed to highlight most of the issues identified in points 1 to 5 above.

In terms of cost both to the public purse and the individual patient the Government’s stated wish for a “robust, transparent and proportionate” response would be fulfilled if a single, searchable, open register of financial conflicts of interest that has a statutory basis were to be introduced

Public Consultation on a Sunshine Act for Scotland: “The report cannot be shared”

I have previously expressed concerns about the process and validity of the public consultation on PE1493: A Sunshine Act for Scotland

The Scottish Health Council copied me into this communication of the 16th March 2016 to their staff:

“I understand that a few people who took part in the gathering views project on the development of a Register of Interests have asked local offices whether a report summarising their feedback is available yet.

By way of an update, the Scottish Health Council’s report was shared with the Scottish Government a few weeks after the final discussion group was held on 5 February. Since then and at its last meeting because of the election period, the Scottish Parliament’s Petitions Committee closed the Register of Interests petition. The Scottish Government has advised, however, that the Cabinet Secretary wishes to formally send our report to the Committee together with comments from the Scottish Government on the next steps. Essentially, we see this as a positive outcome and a demonstration of the impact of our report.

The Scottish Government will keep us informed about an appropriate timing for publishing the report on our website once it has been shared with the Committee. Whilst this is likely to be after the election period, until then the report cannot be shared further.   Please can local offices share this information with participants who may be seeking an update.”

I replied to the Scottish Health Council as follows:

"Many thanks for this update further to your last e-mail of the 
25th February 2016 when you informed that I would receive a copy 
of the report as soon as it was drafted.

I was disappointed that the Public Petitions committee chose to 
close my petition. As you are aware my petition sought a
Sunshine Act for Scotland however the committee have closed 
my petition “on the basis that the Scottish Government has 
committed to review the need for updated guidance on what 
the petition calls for”. 

My petition specifically asked for legislation because of the 
complete failure of previous guidance to be followed. 
As you know I was concerned that this failure was not 
communicated to those participating in the public consultation.

My petition was based on principles of transparency on an issue 
that affects us all. I am very disappointed that the process 
has also seemed to lack openness and that the petitioner and 
indeed the public will only see the contents of the consultation 
well after those in positions of power."

 

Closed by the Scottish Parliament: a Sunshine Act

PE1493 closed

My petition was closed on the 8th March 2016, after the following consideration by the Public Petition’s Committee:

PPC 8 March 2016

I was naturally disappointed.

I was invited by the Scottish Parliament to give feedback. This is what I said:

Thinking about the process that your petition went through, 
how fairly do you think your petition was dealt with?

Firstly I am impressed with how well organised and structured the PPC is. There are many petitions (a growing number?) and without the Clerks I cannot imagine that the committee members and Convener would manage to cope.

Secondly I am impressed that the PPC meetings are all recorded and archived both by Parliamentary TV and full verbatim Minutes. This is most commendable

My petition PE1493 was not fairly managed. The reasons are as follows:

(1) Apart from the initial opportunity to present my petition and engage directly with the committee there were no further opportunities to directly engage with the committee

(2) This lack of direct engagement deprives the public of consideration of the further evidence and correspondence collected by the PPC. Not once were any of the responses to PE1493 discussed publically in any detail by the PPC.

(3) Following my initial presentation of PE1493, all PPC meetings considering my petition were very short indeed. Many of them under a minute and the most common outcome was “the PPC will write to the Scottish Government”

(4) A huge amount of responsibility falls the way of the Senior Clerk and the Clerk’s team. Given this, and that this is a Committee for the public, who have elected the MSPs on the committee, it would seem important for the committee to acknowledge this. It would be helpful to set out clearly the qualifications and responsibilities of the Clerk and the line-management system, and system of appeal for any petitioner or member of public. Otherwise the PPC risks being considered undemocratic.

(5) As Petitioner for PE1493, in being asked to provide evidence from Scotland, to substantiate the request to consider legislation for healthcare workers and academics to declare financial conflicts of interest, I found myself in an impossible position. For example one piece of evidence, with full supporting material (film and the RCPsych approved power-point presentations of the academics) was refused publication by the PPC. In fact the PPC members, to my knowledge, never saw the letter. The decision not to publish was made by the Clerk based on Parliamentary Guidelines. I fully respect the right of the Scottish Parliament to determine what it publishes. However I feel very strongly that without this evidence (repeatedly asked for by the PPC, Scottish Government, and the Cabinet Minister for Health) that PE1493 could not be properly and meaningfully considered.

(6) PE1493 was closed. This was the deliberation of that decision of the PPC of 8th March 2016:

“There is stunned silence.”

Closure of my petition for a Sunshine Act for Scotland was then “minded” for closure by one of the members repeating what had been recorded by the Clerk in the papers for the meeting, that being:

“PE1493 by Peter John Gordon on a Sunshine Act for Scotland. To close the petition, under Rule 15.7, on the basis that the Scottish Government has committed to review the need for updated guidance on what the petition calls for and is consulting on the issue to gather views on what format it should take.”

My petition specifically asked for legislation because of the complete failure of previous guidance to be followed.

 

What did you hope to achieve by submitting your petition?

For a Sunshine Act to be introduced. For Scotland to lead the way in the UK.

To reduce harm caused by bias introduced into science by financial vested interests.

To address over-medicalisation and harmful misdirection of finite resources.

 

How do you feel about the outcomes?

Proud that I was brave enough and had sufficient stamina to pursue this petition.

Grateful that this Petition has encouraged wider discussion.

Disappointed at the skewed “Public Consultation” which deliberately chose not to explain to the consultees that existing Scottish Government Guidance has failed across our nation for more than 13 years. The information provided to the Consultees was drawn up by the Scottish Government.

Disappointed that PE1493 was closed without further opportunity to consider the evidence gathered and that it was closed based on the misunderstanding that PE1493 “called for updated guidance”

In conclusion:

The Scottish Parliament could have done more to hold the Scottish Government to account.