The Scottish Government: “we are not aware”

This report, written by Marion Scott, was recently printed in the Sunday Mail:

Why paid, and to who (6-9-15)

The Cabinet Minister for Health, Wellbeing and Sport, is quoted as saying:

We are not aware

I was surprised by this Scottish Government statement.

Open and transparent from omphalos on Vimeo.

For the last four years, in research for my petition to the Scottish Parliament for a Sunshine Act, I have collected evidence and have shared this with the Scottish Government. This can all be read here.

Scottish Government Guidance (HDL 62), which is now 12 years old, is widely being ignored by NHS Health Boards across Scotland. There is no public transparency on how much of this £41 million went to Scottish doctors last year.

41 million

Whilst the Scottish Government are “not aware” it is reassuring that young folk of today, such as medical Students, are:

Educating future drs on industry pressures

Doctors loath to disclose their mental health issues

Doctors Loath to disclose their mental health issues (May 2015)

This report, from the BMJ, reminds me of when I attended the Scottish Parliament on the 6th January 2015. This was for a debate on mental health. I sat next to my friend Chrys Muirhead. Together we made up 2/3rds of the gallery who watched the debate from start to finish.

038

Following the debate I made this Hole Ousia post and sent it to a number of MSPs. A few replied, but this did not include Jamie Hepburn, MSP, whose ministerial role is to lead on mental health.

This blog-post is about stigma. It was obvious to me watching the parliamentary debate that it is not just doctors who may “loath to disclose their mental health issues”.

Not one MSP took the opportunity to talk of any personal mental health issues. They were however comfortable to describe mental health issues of  constituents or family members.

“We are being regulated to death”

Since Alexander McCall Smith recommended to me “A Pattern Language”, I have found myself spotting different patterns:051

This is a pattern about regulation as applied to the practice of medicine in the NHS. The pattern begins with this week’s BMJ:Defensive-medicine-16-Jan-2

Just before Christmas last year, the General Medical Council published the review into doctors’ suicides. Dr Marcus Bicknell wrote an article about this, which he titled:we are being regulated to death

I am not sure that I agree with Professor Terence Stephenson that the practice of defensive medicine is solely the consequence of litigation and that regulatory procedures play little part.

The study below, just published, has concluded: “Morbidity was greatest in cases involving the GMC. Most doctors reported practising defensively, including avoidance of procedures and high-risk patients. Many felt victimised as whistleblowers or reported bullying.”Impact-of-complaints-2015,-

The Chair of the General Medical Council said last week to the UK Parliament Health Committee:Untitled-1

Dr Christoph Lees and Dr Hilarie Williams have given their review of the current regulatory process. This is a well referenced article which is worth reading in its entirety:Lees & Williams, Jan 2015

A junior doctor recently wrote to the BMJ:reliant on policies and guidelines

The pattern that I have noted here is one of an approach to healthcare that appears to be ever more “regulated”, as described perfectly above. I believe that this is not the time to borrow military approaches in healthcare. The risk of this erosion of professionalism is that harm is caused to both patients and doctors.

Transparency in drug company payments to doctors

In a BMJ “briefing” Rebecca Coombes sums up the new UK system for public disclosure of payments from drug companies to doctors

Published the 2nd January 2015 in The BMJ, here follows the full article:

Transparency-in-drug-compan

I have met Andrew Powrie-Smith of the ABPI several times. He has made it a personal mission to improve transparency for the Pharmaceutical Industry and I applaud his efforts. My concern is that the medical profession may not yet quite agree with Powrie-Smith that transparency is a “societal expectation”. I say this as (1) the voluntary register Who pays this doctor? has not exactly been burdened with declarations, and (2) my research into Registers of interest for all staff employed in NHS Scotland has evidenced very poor compliance with Scottish Government Guidance (HDL 62).

The new database, set up by the ABPI, is a most positive development. We should however be aware that it only applies to the pharmaceutical industry and not other areas of commerce: such as device makers, nutritional supplements, digital technologies etc. It is my understanding that the ABPI Register also only applies to doctors. Do we not also need to consider academics, managers, commissioners, pharmacists, nurses, AHPs, charities all of whom could be paid to “educate” us about a specific condition and a product or test for this. Or to commission a service for it.

Surely however, the main issue with this new ABPI code is that it has no legal underpinning. Doctors can opt out of declaring any financial payments and they so they will not be named.

This is why I have petitioned the Scottish Government for a Sunshine Act (or clause). America has this legislation as do several other countries.

Opt-out

 

The GMC: “The differences between our guidance and a compulsory register”

This is the General Medical Council’s response to my Petition for a Sunshine Act to the Scottish Government:

PE1493/I

9 January 2014
To: petitions@scottish.parliament.uk
Andrew Howlett
Assistant Clerk
Public Petitions Committee
The Scottish Parliament

Dear Mr Howlett,
Scottish Parliament Public Petition PE1493 on a Sunshine Act for Scotland

Thank you for giving us the opportunity to submit our views on the proposed introduction of a ‘Sunshine Act’ for Scotland, creating a searchable record of all  payments (including payments in kind) to NHS Scotland healthcare workers from Industry and Commerce.

I have set out below how our guidance to doctors applies in this area, as well as some work that we will be taking forward which is relevant to the issues raised in the petition.

The status of GMC guidance
The standards we expect doctors to abide by are set out in our ethical guidance. Good medical practice and all its explanatory guidance, including that on Financial and commercial arrangements and conflicts of interest, describes what doctors must do when faced with a conflict of interest, including offers of payment or hospitality made by pharmaceutical or other healthcare companies.

Doctors must demonstrate, through the revalidation process, that they practise in line with the principles and values set out in our guidance. Serious or persistent failure to follow the guidance will put their registration at risk, because these are the standards they’ll be judged by if their fitness to practise is called into question.

The differences between our guidance and a compulsory register
Our guidance for doctors1 makes clear that they must be open and honest about  any financial and commercial interests, and they must not allow these to affect the  way they treat or care for patients. The guidance also sets out that doctors must  be open about any conflict, declaring interests formally, and should be prepared to  exclude themselves from decision-making.

This guidance on conflicts of interest is not limited to payments (including payments in kind) from Industry and Commerce as proposed in the Petition. Nor is  it restricted to doctors working in the NHS. Rather our guidance:

• applies to all doctors, regardless of their grade, specialty and whether they work in the NHS or the independent sector;

• relates to any conflict of interest, not just payments or payments in kind;

• says doctors must not accept any inducement, gift or hospitality that may affect or be seen to affectthe way they care for patients, ie it covers perceived, potential conflicts as well as those that are recognised and current.

Publishing research results
In the Official Report of 12 November 2013 Dr Gordon made reference to the failure to publish trial data. Our guidance on research1 makes clear that:

• we expect doctors to be open and honest about their research;

• financial interests must not affect completion of research;

• doctors should publish research results, including adverse findings, through peer review journals.

We also state that, as well as reporting adverse findings to the affected participants, and those responsible for their medical care, doctors must report adverse findings to the research ethics committee, and bodies – such as the Medicines and Healthcare products Regulatory Agency – responsible for protecting the public.

Fitness to practise cases relating to conflicts of interest
We can confirm that over the past seven years (since April 2006) over 200 (240) doctors were referred to us with allegations about conflicts of interest (from a total of over 25,000 cases). In 33 cases the doctors were referred to panel hearings. Of those doctors who were referred to panel hearings, 5 were erased, 6 suspended and 4 had conditions put on their licence. As at 21 November 2013, there were also a number of doctors (14) with open cases relating to conflict of interest allegations.

A compulsory register would require legislative change
We do not currently have any powers in the Medical Act 1983 to require doctors to disclose financial interests to us, and any scheme to publish details of doctor’s financial interests would need to be voluntary.

A change in legislation would be needed to establish a compulsory register of doctors’ interests. If this were not implemented across the UK simultaneously, it is not clear whether and how a change in legislation in Scotland – as proposed in this Petition – might impact on our regulation of doctors across all four UK countries. As it happens, in the light of a recent review of professional regulatory legislation undertaken by the Law Commission, we understand that a Bill is likely to be brought before the UK Parliament during the course of 2014 which would replace the 1983 Act with a new Act applicable to all the professional regulators.

Next steps
We recognise that there is scope for us to promote our guidance on good practice, to continue to raise awareness of it and do what we can to ensure compliance with it. Throughout 2014 we will continue to look for ways to embed the principles in doctors’ day to day practice.

We will also assess conflicts of interest and the practicality of keeping a list of doctors’ interests attached to the Register. Through our Corporate Strategy for 2014-2017 we are committing to considering if there are any changes that we could make to the medical register to make it as relevant, accessible and useful as possible. This review will provide a timely opportunity to address this important matter.

We would welcome information about the progress of this Petition and would be glad to offer a meeting if that would be helpful.

Yours sincerely
Paul Buckley

Director of Strategy & Communication

Annex A: Extracts from GMC guidance

Annexe A, GMC

The GMC say “If you are in doubt about whether there is a conflict of interest, act as though there is. “

I sent the letter below to the GMC after reading their Guidance on declarations of interest:

CropperCapture[1]

From: Gordon Peter (NHSFORTHVALLEY)
Sent: 27 November 2013 13:09
To: standards@gmc-uk.org
Subject: Declarations of Interest and doctors

27th November 2013,

Dear GMC,
Each year I sign my annual appraisal form, including the probity section, to confirm that I have followed my NHS Board policy on conflicts of interest. I have never had any such declarations to make so I have always signed with probity: https://holeousia.wordpress.com/declarationof-interests/

However FOI research to all 22 Scottish NHS Boards has demonstrated that Boards universally lack – either with no policy, or no register, and not infrequently without both:

https://holeousia.wordpress.com/category/medical-writings/pharmaceutical-industry-and-medical-education/nhs-hospitality-registers/

So my question is:

How many doctors are signing off annual appraisal but have not registered COI with their NHS Board or Trust? And thus have the GMC had any reports of doctors who have not declared COI?

In terms of “regulating doctors, ensuring good medical practice” this surely is a legitimate and very real concern. Last year £40 million was paid by Pharmaceutical industry to healthcare workers for Continuing Medical “Education” and recent reports have evidenced that up to 3/4s of Guideline Panellists have “ties to industry”

I would be grateful for your thoughts on this.

Yours sincerely,
 Peter Gordon

GMC

On the 14th January 2014, I had this most helpful reply from the GMC:

From: GMC
Sent: 14 January 2014 14:59
To: Gordon Peter (NHS FORTH VALLEY)
Subject: RE: FOI query

Our ref: F13/5915/EH

Dear Dr Gordon
Thank you for your email below. Our Standards Team forwarded your email to us to look into whether we could provide the information you request. I apologise for the delay in responding to you.

I’m afraid we don’t hold the necessary data to be able to tell you how many doctors are signing off annual appraisal but have not registered conflicts of interest with their NHS Board or Trust. However, in relation to whether the GMC have had any reports of doctors who have not declared conflicts of interest more generally, we can provide some information which I hope will be helpful.

When we investigate a case against a doctor we record some information concerning the allegations made in an electronically searchable way. We also record a very brief description of the allegations made in a ‘free text’ field.

We have looked at cases opened since 2007 (the first full year for which we have this facility) for those with allegations falling within the following groups – ‘fail to declare interests’, ‘interests affect patient care’, ‘undeclared interest – other’, ‘undeclared interest in home’ and ‘undeclared interest in hospital’. We have located 201 cases opened since 2007, relating to 199 doctors, where there is an allegation falling within any of these categories.

However, we cannot extract the specific figure you require from this search. I have therefore used the ‘allegation description’ field to assist in identifying any cases where a Health Board/Trust alleges a failure to declare a conflict of interest to them, as per your email. I have located six such cases. I should stress that this figure results from a limited manual search of the description field and not a review of all information held on all 201 cases.

Of these six cases, two are on-going, one was closed with advice and the remaining three were heard by a Fitness to Practise Panel.

I should explain at this point that as allegation categories are selected by the Investigation Officer when we begin to investigate a case, it often happens that, if the doctor is referred to a hearing, they are not referred on the basis of all allegations originally recorded. For example, allegations may not progress to this stage due to a lack of evidence.

Therefore, of the three cases heard by a panel, in only one case was an allegation concerning non-declaration of a conflict of interest to the Trust considered by the Panel. I have attached the public minutes for your information.

I hope this is helpful. If you have any concerns regarding the handling of this request please contact Julian Graves, Information Access Manager, at jgraves@gmc-uk.org.

Kind regards
Redacted

Information Access Officer
Tel no: 0161 923 6314