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

“A robust learning environment for healthcare professionals”

I have recently posted on the promotion of Lurasidone (Latuda) in the UK. This has raised concerns for me about transparency of conflicts of interest for some of the key doctors and academics involved with the research, development and promotion of this novel antipsychotic.

One of those who has most significant financial interests is Professor Stephen Stahl. In “partnership with” the British Association for Psychopharmacology he recently gave this “Expert Seminar” at the University of Bristol:

Expert Seminar Lurasidone Stahl 1

This “Expert Seminar” is introduced by Professor Stahl as follows:

Expert Seminar Lurasidone Stahl 2

And here is the Programme for this “robust learning environment” which is co-chaired by British Psychiatrist and Academic, Dr Hamish McAllister-Williams:

Expert Seminar Lurasidone Stahl 7

“Application” was made by Sunovion for CPD approval to the Federation of the Royal College of Physicians of the United Kingdom.

Expert Seminar Lurasidone Stahl 3

Summary:
This “robust learning environment for UK health professionals” has left me asking some questions:

  1. Were the healthcare professionals made aware that Professor Stahl has been paid over $3.5 million dollars since August 2013 by 15 Pharnmaceutical companies including SUNOVION?
  2. Can healthcare professionals and the public easily access Professor Stahl’s declaration of financial interests as required by the British Association for Psychopharmacology?
  3. What is the rationale of the Governance Panel for the British Association for Psychopharmacology in approving such “robust learning environments” for healthcare workers?
  4. Was this “Expert Seminar” approved for CPD by the Federation of the Royal College of Physicians of the United Kingdom?
  5. Where can the public find which healthcare workers received such “robust learning”?

Lurasidone – financial conflicts of interest

The launch in the UK of Lurisidone began in August 2014.

My previous post on Lurasidone (Latuda) which has now been marketed in the UK followed the financial interests of one of the authors of the “Special article” in the British Journal of Psychiatry.

Leslie Citrome

It has now crossed my mind, and here I must be very clear that I am speculating, that the British Journal of Psychiatry may have been paid to publish this “Special article”?

I have now looked at the details provided on Lutada to medical professionals by the makers SUNOVION

It is welcome that this new medication has fewer metabolic effects than currently available antipsychotics. It is worth reflecting that, when the “atypical” antipsychotics were first marketed, they were promoted as having fewer Extra-Pyramidal Side Effects (EPSEs) than existing antipsychotics. It later emerged that the atypical antipsychotics had considerable metabolic side-effects.

This is how Latuda is introduced:

lurasidone uk 3

Here are the “References” provided by its makers Sunovion. There are several key authors of studies cited along with “Latuda Summary of Product Characteristics”. I have previously covered Leslie Citrome. Another study author is well known as a Key Opinion Leader, Professor Stephen Stahl.

lurasidone references

I recently posted about Professor Stahl after he gave keynote addresses to this summer’s British Association of Psychopharmacology Conference.

Professor Stahl’s payments dwarf the $181000 dollars given to Dr Leslie Citrome by the makers of Lutada. Professor Stahl’s OVERALL payments by 15 Pharmaceutical companies amounts to $3.58 million.

Stephen Stahl

Evidence based medicine should include all evidence. This should include all financial conflicts of interest in those developing, researching and promoting new medications.

I do hope UK Psychiatrists are aware of all the evidence.

 

                     Update: January 2017

sunovion-lurasidone-marketing-nhs-20-dec-2016

I received the above message from my secretary with the e-mail below from SUNOVION attached:

From: Margo Hepple [mailto:Margo.Hepple@quintiles.com]
Sent: 20 December 2016
Subject: FW: Sunovion virtual appointment

Nice speaking with you and thank you for your help.

Please find below some detail of the appointment I would like to make with Gordon. I would like to offer an update in physical health in mental health with regard to our antipsychotic treatment.

Sunovion recognise the heavy schedules and workloads healthcare professionals have to manage. In order to offer greater flexibility and convenience for your interactions with Sunovion, we have created an online meeting environment which can be accessed at your convenience with the support of our dedicated remote meetings team.

We can now arrange for one of our remote representatives to provide you with useful information about Latuda©(lurasidone) for the treatment of adults with schizophrenia at a time that is absolutely convenient to you via a straightforward remote call. 

www.meetsunovion.co.uk  is an online meeting room where a remote Sunovion representative can provide up-to-date information about Latuda through an interactive platform to augment a simultaneous telephone conversation.

All you need is a computer with internet access, a phone line and a time to suit you , for an approximately 15 minute discussion.

With kind regards,
Margo Hepple
Sunovion Key Account Manager

I replied to my secretary that I do not see Pharmaceutical Representatives. My secretary was though already aware of this and that I had previously raised a petition with the Scottish Government to consider introducing a Sunshine Act for Scotland.

On the 20th December 2016 I wrote a shared e-mail to the Royal College of Psychiatrists, the British Association of Psychopharmacology (BAP) and the General Medical Council (GMC). I explained that I had just read the perspective of the out-going CEO of the Royal College of Psychiatrists in the December Psychiatric Bulletin.

03-vanessa-cameron-dec-2106

In my email of the 20th December 2016  I went on to express my concerns about conflation of marketing with “education” and  expressed my view that the ABPI voluntary register is anything but a “disinfectant”, rather that it gives a thin veneer of transparency.

I concluded: the risk is that rather than “realistic medicine” we have unrealistic medicine with over-medicalisation and associated harms on a wider scale. Inverse care then kicks in.

I asked politely if the Royal College of Psychiatrists, BAP or GMC were planning to do anything about this?

I only received a reply from the GMC. 

I reproduce this in full below:

From: General Medical Council
Sent: 20 January 2017
To: Peter J Gordon
Subject: RE: FW: Sunovion virtual appointment

Dear Dr Gordon,
Thank you for your email and sorry for the time it’s taken to respond.

As you know it’s our role to regulate the medical profession in the UK and as part of that role, we set the standards for the delivery of medical education and training. Although it is our role to regulate individual doctors, we do not have a role in regulating organisations and therefore cannot comment on any such policies to managing conflicts of interest.

We are clear in Good Medical Practice that ‘you must be honest in financial and commercial dealings with patients, employers, insurers and other organisations or individuals’ (paragraph 77) and ‘if faced with a conflict of interest, you must be open about the conflict, declaring your interest formally, and you should be prepared to exclude yourself from decision making’ (paragraph 79). We expand on this in our explanatory guidance Financial and commercial arrangements and conflicts of interest (2013) which includes principles on how to manage conflicts of interest should they arise in relation to making decisions about patient care and the commissioning of services.

I note your comments on the limitations of the Association of the British Pharmaceutical Industry (ABPI) register, however we see this as a start to creating a culture of openness and worked closely with them in promoting the database through a blog for doctors on our website. You may also be interested to know that in April 2016 we hosted a meeting bringing together key interest groups from across the UK to discuss issues around conflicts of interest. One theme which came out of this meeting was the need for greater transparency and how we can best support doctors in achieving this through guidance.

Amongst other work in this area, we are undertaking a review of the information contained on the medical register; part of this review considers whether a future register should include information on doctors’ interests.  We consulted on this in 2016 and are now reviewing all of the responses. We also continue to discuss conflicts with all of our key interest groups including via our inter-regulatory group meetings with other professional regulators to ensure that this remains a high priority and to enable us to share good practice across the health professions.

We continue to work with doctors to ensure they are reminded of their professional responsibility to avoid conflicts of interest wherever possible, and to declare any conflicts formally and as early as possible.

Kind regards
Caroline Strickland
Policy Officer, GMC

I replied to the GMC as follows, copying in the Royal College of 
Psychiatrists and the British Association of Psychopharmacologists:

20th January 2017

Dear Caroline Strickland,
I am very grateful for this reply on behalf of the GMC.

I could give a very long list indeed of doctors who are not following paragraph 77 of “Good Medical Practice”. The GMC risk being seen to have guidance that is widely not being followed. This would also constitute a lack of Probity as required for Appraisal and Revalidation.

Yet, if I reported a long-list (I have tried before) I find that I could not do so anonymously. The reality of such reporting would be that my professional life would be severely affected with outcomes such as bullying, isolation and mischaracterisation.

I note what you say about the ABPI Register but this Register gives the illusion of transparency, because, as you know, many doctors who are significantly paid by industry do not declare. These doctors may be the doctors who are “educating” the rest of the medical profession (CPD-approved) as required by the GMC and the Royal College of Psychiatrists and other colleges for “Good Professional Standing”.

When I retire I will release all the information I have and will be clear that neither the GMC nor Royal Colleges have taken effective action here. The risk of patient harm is very real and there are many evidenced examples of where marketeering as “education” has led to harmful and dangerous prescribing or other interventions.

I understand the GMC has no role in regulating organisations such as BAP. I am very concerned about the scale of “education” being marketed by this organisation. BAP no longer answer communications from me and the RCPsych did not answer my e-mail below.

Who is accountable for a situation where the ethics and objectivity of science is widely compromised? Who is accountable for harm that may result?

I would urge you to take more robust action than is currently the case.

The Scottish Government undertook a Public Consultation on this issue: the public in majority concluded that ALL payments to healthcare workers and academics should be openly declared, in full, on an open and searchable register. The public concluded that this had to be MANDATORY.

I am writing in a personal capacity and not in any way for my employers. I will take this communication to my Appraisal which is in March 2017.

I look forward to response from GMC, RCPsych and BAP.

Your sincerely, Dr Peter J Gordon

UPDATE (February 2017): UK-wide promotion of LURASIDONE:

envelope-latuda-promotion-sunovion-feb-2017
01-latuda-promotion-sunovion-feb-2017

Personal comment:

I would suggest that it would be more accurate, in terms of 
science, to describe antipsychotics (of any chemical formulation) 
as acting on brain chemistry, rather than "treating the mind".

02-latuda-promotion-sunovion-feb-201703-latuda-promotion-sunovion-feb-201704-latuda-promotion-sunovion-feb-201705-latuda-promotion-sunovion-feb-201706-latuda-promotion-sunovion-feb-201707-latuda-promotion-sunovion-feb-201708-latuda-promotion-sunovion-feb-2017

As you can see the REFERENCES provided in this “promotional brochure” are in small print and not so easy to read.

So here is an enlarged version that I have made from the original: in black and white (but the highlights matter):

references-latuda-promotion-sunovion-feb-2017

In the public domain are the most significant recent financial payments made to Stephen Stahl and Leslie Citrome from the pharmaceutical industry. Both of whom have been part of the promotion of Lurasidone in the UK

In the references provided by Sunovion in this “promotional brochure” we have:

                      Herbert Y Meltzer

herbert-y-meltzer-bio herbert-y-meltzer-declarations

In the references provided by Sunovion in this “promotional brochure” we have:

                      Gregor Mattingly

who has been paid $1.04 million from the Pharmaceutical Industry since 2013:

gregory-mattingly-1

In the references provided by Sunovion in this “promotional brochure” we have:

                     Sheldon Preskorn

who received nearly $112 in 2015 from the pharmaceutical industry:sheldon-preskorn-2

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.

 

 

British Association for Psychopharmacology Guidelines (BAP)

01BAP

The above Evidence-based guidelines for treating depressive disorders with antidepressants has recently been published.

The British Association for Psychopharmacology are an organisation highly regarded by my profession of psychiatry. 12% of their funds come directly from the Pharmaceutical Industry.

I have petitioned the Scottish Government to introduce a Sunshine Act. It is for this reason I am interested in transparency of financial conflicts of interest.

Some of the expert authors involved in developing these guidelines have featured in Hole Ousia before, including:

Other authors of these guidelines are well known as “key opinion leaders”. Some were part of the Royal College of Psychiatrists International Congress, 2015 and their declarations can be found here

Transparency: hold the applause (British Psychiatry) from omphalos on Vimeo.

This post looks only at the level of transparency provided by BAP in these Guidelines. Most academics are of the view that full transparency of financial interests is necessary if we are to make recommendations that are “explicitly evidence-based”:

02BAP

I have written to Susan Chandler, Executive Officer for BAP, on a number of occasions over the last few years about BAP’s approach to declarations of interest:

03BAP

Professor Ian Reid was a former colleague of mine 
who is sadly missed.

Here is a copy of my last communication with BAP sent at the beginning of May 2015:

12BAP

I copied this to the General Medical Council. They did not reply.

This was the reply from the Executive Officer for BAP. I have received no further communications:

13BAP

Here is what BAP provides in these Guidelines. It is worth comparing the limited amount of information provided here with the much more comprehensive information provided by NICE guidelines.

04BAP

05BAP

In conclusion:
It is not possible to find out how much doctors like these Guideline authors have been paid.

The Academy of Medical Royal Colleges are of the view that all payments to individual doctors and academics should be mandatory.

10BAP

All in the past from omphalos on Vimeo.

Update, 5th October 2016. The following was published on the 
front page of the Scotsman newspaper: 

"Mental health prescriptions hit ten-year high"

prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-a prescriptions-for-mental-health-drugs-10-year-high-nhs-scotland-2016-b

The figures are from the Scottish Government and can be accessed here.

Latest Advances in Psychiatry

What follows is recent correspondence with the organisers of “Latest Advances in Psychiatry”. I can publicly share older correspondence if so wished. It is not dissimilar

From: Gordon, Peter J
Sent: 22 April 2015 11:14
To: ‘imayne@wiley.com
Subject: 14th Latest Advances in Psychiatry Symposium

Dear Izabela,
I hope you do not mind me writing. I seem to recall I contacted you before the previous LAP Symposium and you were very helpful. Though I recall only one of the sponsored talks had an identified speaker at the time we communicated and that was Professor N Farrier.

I have petitioned the Scottish Government for a Sunshine Act which if implemented would make declarations of financial interests a statutory requirement for healthcare workers and academics. I say this to explain my interest. I understand that conflicts of interest are part of life but argue that we should be fully transparent about financial conflicts of interest. I say this as an NHS doctor and psychiatrist of 20 years.

Recently I have been helping the Royal College of Psychiatrists improve transparency and the President Prof Sir Simon Wessely has been most helpful. Yet it still seems the case that College Guidance, CR148, issued 7 years ago is far from generally being followed, let alone governed over this time by the College.

I note the LAP Symposium held last month had three “satellite” symposia: one sponsored by LUNDBECK and two sponsored by SUNOVION.

I was wondering if the public can have open access to the financial basis of such sponsored symposia and where it is clarified who gave the sponsored talk and where publicly they made full declarations of interest as per CR148?

I would hope that declarations for all involved in LAP 13 and 14 have been made, are archived, and publicly available. This should include organisers and Chairman.

I do hope you can help direct me to the level of transparency that is enshrined by the Royal; College of Psychiatrists in CR148 and also, for doctors, the GMC “Good Medical Practice”.

Kind wishes
Dr Peter J Gordon
Bridge of Allan

Wiley reply

“Conservative prescribing”

This editorial, an opinion piece by Prof David Healy, was recently published in the BMJ. In this post I intend to explore the arguments made around whether “chemical imbalance” was ever part of standard medical teaching. I will also explore the suggestion, made by some experts that antidepressant prescribing in the western world is “conservative”.

024 Conservative Prescribing

Professor Healy’s editorial has attracted a number of replies. Here is one:

026 Conservative Prescribing

A psychiatrist in training gave his view that the above reply was “the cleverest” and then offered his own reply:

016 Conservative Prescribing

The psychiatrist in training then gave the following link to what he called: “the sensible reaction”:

019 Conservative Prescribing

I found that I agreed with the statement made in this “expert reaction” by the President of the Royal College of Psychiatrists:

018 Conservative Prescribing

However I found that I did not share the view of Professor David Taylor that the “idea that SSRIs correct an imbalance in the brain never really existed”:

017 Conservative Prescribing

In the 1990’s, as a psychiatrist in training, I followed the “Defeat Depression Campaign”. A central plank of this was the “chemical imbalance theory” involving serotonin. There was hardly an educational event that I went to where a “Stahl” neurotransmitter diagram was not displayed. Even up till 2007, I still found the Stahl diagrams appearing as part of my CME education:

029 Conservative Prescribing

In response to Professor Healy’s article on serotonin and depression it concerns me that experts such as Prof Philip J Cowen and Prof David Taylor are suggesting that the “chemical imbalance theory” always was “mythical”. I was there. It was a very real part of my “education” and often given by experts of the day.

Furthermore, it would seem to me that such expertise is considered as sufficient in itself rather than including experience of taking SSRIs both short and long-term.

027 Conservative Prescribing

In his BMJ editorial Professor Healy gave this stark 2015 statistic:

012 Conservative Prescribing

It has been argued that this figure indicates over-diagnosis:

028 Conservative Prescribing

“Are antidepressant overprescribed”  was the question debated between Dr Des Spence and Professor Ian Reid  published in a BMJ Head-to-Head in January 2013.

Are antidepressants overprescribed, BMJ, 2013

A few years before this debate I gave a view on antidepressant prescribing from “my own window” which I submitted as a rapid-response in the BMJ. As I journey through life I often find my views change, but the view from the window I looked out from in 2011 seems still to be very much the same to me.

I was very sad when Professor Ian C Reid died last year, prematurely, as the result of cancer. I trained with Ian Reid in Aberdeen and he was an inspirational speaker and a most committed scientist. His loss is significant.

This research study was published in the British Journal of General Practice in September 2009:

020 Conservative Prescribing

The study gave a conclusion that I agreed with:

Conservatively

The study supported my view that GPs do not indiscriminately prescribe antidepressants. Here, I should be clear, I am talking about newly diagnosed depression, in a time more than a decade on from the likes of the “Defeat Depression Campaign”. However it remains true that access to psychological therapies, in NHS Scotland, remains a very real “challenge”.

Professor Ian Reid went on to say:

014 Conservative Prescribing

And gave his view that:

015 Conservative Prescribing

It is here I depart from sharing Ian Reid’s view. My view is that we need pluralistic evidence, rather than expert opinion alone, that chronic prescribing of antidepressants represents an “improvement in practice”.

The medical profession are generally of the view that long-term antidepressant prescribing is “appropriate” because it is likely that most individuals taking antidepressants have a “recurrent illness” and that such is often demonstrated when they stop taking their antidepressants.

011 Conservative Prescribing

The problem is that most studies into antidepressants, on which prescribing is based, have been short-term studies, often only 6 weeks. Without longer-term studies and the evidence of experience, we simply cannot be sure why so many individuals receive long-term antidepressant treatment.

004 Conservative Prescribing

In summary: It is certainly the case that antidepressants are widely prescribed in the Western world.  In my view we need to see more evidence that prescribing of antidepressants, particularly chronic prescribing, is “appropriate” and “conservative”.

Note to reader:
I am not a "Critical Psychiatrist" as I prescribe psychoactive 
medications including antidepressants. I try to do so only if 
indicated, and if this is the patient's preference. To prescribe 
"appropriately" I do my best to share the knowns and unknowns of 
antidepressant prescribing along with explaining potential harms 
and potential benefits. One potential unknown is the optimal 
duration of prescribing. Professor Reid's evidence would 
appear to demonstrate that long-term prescribing is common 
practice.