Transparency at the Top

I wrote “Transparency at the Top: British Psychiatry” in April 2015 but did not share it publically as I wanted to give the Royal College of Psychiatrists time to improve the governance of financial conflicts of interest. Over the last 2 years improvements have been made by the Royal College of Psychiatrists however the system in place is unsearchable, costly, and bureaucratic. It also does not help determine how much of the £340 million that the pharmaceutical industry pays each year for “promotional activities” goes to the “top” educators (key opinion leaders) in UK psychiatry.

Sir Professor Simon Wessely has been an outstanding President and has carefully listened to the concerns that I have kept raising on this issue. This week he hands over the Presidency of the Royal College of Psychiatrists to Wendy Burn.

Tomorrow, the International Congress: Psychiatry without Borders begins in Edinburgh. I will be protesting outside because I remain concerned about the considerable reach (to the many) of a handful of educators: “The Law of the Few”.

  Here follows my original transcript, dated 25 April 2015:

The Chief Executive of the GMC recently confirmed in the BMJ:

To ensure public transparency of financial payments to healthcare workers and academics both France and America have introduced a Sunshine Act. In the UK we do not have such statutory basis to transparency. Royal colleges rely on Guidance such as this guidance, CR148, by the Royal College of Psychiatrists*:

The Royal College of Psychiatrists Guidance, like The GMC, gives clear and unambiguous guidance*:

The Royal College of Psychiatrists has recently expressed that, in addition to such clear and unambiguous College guidance (CR148), that the Association of the British Pharmaceutical Industry (ABPI) “central platform” to be introduced in 2016, will ensure transparency that will “so avoid some of the criticisms of yesteryear”:

The ABPI “Central Register” has no statutory underpinning and any healthcare worker or academic can choose to opt out of revealing any financial payments made from industry.

It is perhaps then an opportune time to consider whether the Royal College of Psychiatrists is correct to express confidence that we may be able to “avoid some of the criticisms of yesteryear” in regards to transparency in regards to the relationship between industry and psychiatrists. To consider this, we might do well to look at some of the key College leads. So to start at the top this should include the current President of the Royal College of Psychiatrists. Such a consideration should also include the current Chair of the College Psychopharmacology Committee. To be properly representative of College leads, this consideration should also include a Psychiatrist who is today widely considered as a ‘key opinion leader’ in British psychiatry.

The only purpose of this consideration is to attempt to examine if our College leads are exemplars in transparency and to attempt to establish if they have followed College guidance CR148.

Sir Professor Simon Wessely was elected last year as President of the Royal College of Psychiatrists and took presidential office on the 26th June 2014. The week after his appointment, Professor Wessely was interviewed on BBC Radio 4 and, as part of this public broadcast, was part of a discussion with James Davies, University of Oxford:

This is an emphatic statement made publicly by the President of the Royal College of Psychiatrists.

In fact Wessely has been transparent about “Financial Disclosures” as given here following a co-authored review paper published in JAMA in 2014: “Dr Wessely has received financial support from Pierre Fabry Pharmaceuticals and from Eli Lilly and Co to attend academic meetings and for Speaking engagements.”

This full transparency helped Joel Kauffman consider the 2004 JAMA Editorial and this can be read in full here. But meantime, here is the relevant extract:

Those at the top of British psychiatry would appear to have a range of definitions of “transparency”? It is certainly very clear that Sir Professor Wessely does not have anywhere like the volume of working relationships with industry as some of the other current College leads. Last year Wessely gave the keynote lecture “Psychiatry under fire” at the following conference. This was not a sponsored talk as the programme makes clear. The Conference was organised by Professor Allan Young who confirms that the “objective” of this symposium is to provide “independent” education to help “achieve personal CPD objectives and in your everyday clinical practice”.

Professor Allan Young is also Chair of the Psychopharmacology Committee of the Royal College of Psychiatrists and his declarations are publicly available here where he confirms that he is paid for “lectures and Advisory Boards for all major pharmaceutical companies with drugs used in affective and related disorders”. Professor Allan Young may well be one of the most influential ‘key opinion leaders’ in British psychiatry. In this role, as a most influential educator Professor Allan Young has recently been considered here and here.

Also giving a talk at this 2014 “Latest Advances in Psychiatry Symposium” is Professor Guy Goodwin who is also considered to be a “key opinion leader” and who is undoubtedly one of those at the “top” of the hierarchy of British Psychiatry.

Professor Guy Goodwin featured centrally on the BBC Panorama programme in the following month. This programme was titled “who is paying your doctor” and Dr Goodwin came under considerable scrutiny. However it should be the case, that such scrutiny should include not just a single, individual “key opinion leader” but those like the Chair of Psychopharmacology Committee and the President of the Royal College of Psychiatrists. For patients to have trust in the medical profession it should be the case that such leads are exemplars when it comes to transparency of financial interests.

Following the Panorama programme in which Professor Guy Goodwin featured, the Head of Professor Goodwin’s University Department, had an article published in the BMJ where he expressed the view that the media harm caused by raising the subject of transparency “may outweigh any good”. An alternative view is given here. As a result, Dr David Healy, Director of the North Wales Department of Psychological Medicine offered a proposal to ensure wider consideration of transparency in British Psychiatry. This proposal for a “proper and open debate” was copied to a wide range of individuals including Professor Goodwin and had previously been discussed with Sir Simon Wessely. The correspondence can be read here .

As President of the Royal College of Psychiatrists, it is clear that speaking proportionally, most of the research Professor Wessely has been involved in has not involved working with the pharmaceutical Industry. Wessely is after all a professor of psychological medicine at the Institute of Psychiatry, King’s College London and head of its department of psychological medicine. Compared to some of the psychiatrist colleagues around him, and in particular “key opinion leaders” it is no doubt the case that Wessely has worked less with industry. However, it is not the case that he has “never worked with industry” as he emphatically stated on Radio just after becoming President of the Royal College of Psychiatrists.

In the past, Professor Wessely has helped prepare review articles through “educational grants” from the pharmaceutical industry. It perhaps may be argued that this is not “working” with industry. Though College guidance CR148 does seem to be much clearer in what it expects in terms of transparency. This was one such article involving Wessely and another one can be accessed here.

A few years before College Guidance CR148 was introduced, and long before Wessely was elected President of the Royal College of Psychiatrists, he gave his personal view on ‘working’ relationships with industry and insisted that it was “time we doctors grew up”. At the time, the BMJ published a range of views, and one of these has been included alongside Wessely’s to demonstrate this range. Professor Wessely’s personal view is now over a decade old and it would be helpful to know if his views have changed over this period of time.

Summary:
Is it the case that calling for transparency regarding financial payments may cause more harm than good? Some of those at the top of British psychiatry would appear to have put forward this view, arguing that such will damage public trust. Yet the GMC are clear what they expect of their professional group, namely doctors. Is it not time that we had an open public debate about this involving more than those just at the top?

*Since writing this CR148 was replaced in March 2017 by CR202

       Update of 11 June 2017: "The Law of the Few"

 

 

The lawn was white with doctors









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.

Were we asleep at the wheel?

At the beginning of June 2008 I sent an e-mail to Dr Leon Eisenberg, a former child psychiatrist, and a man of philosophy and science:
leon-eisenberg
Dr Eisenberg was then 89 years old and I wanted to convey how important his writings had been to me:mindlessness-and-brainlessness-in-psychiatry-1986
I did not expect a reply:
leon-eisenberg-to-peter-gordon-8-june-2016

A year later Leon Eisenberg died.

were-we-asleep-at-the-switch

After his death a memoir was discovered: which Eisenberg had named “Were We Asleep at the Switch?”.

Eisenberg suggested that a switch from ‘mind’ to ‘body’ has taken place in psychiatry as a discipline, which has led to overuse of medication.

He also argued that “monied interests” had been making de facto decisions on behalf of us all about the “science” of things that might affect us.

Eisenberg was worried that the overwhelming impact of economic considerations may have rendered, and might continue to render futile, the professional contributions of many brilliant, timely, and concerned working scientists.

leon-eisenberg-1987b

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

What you need to know

1 in 7 Scots are on an antidepressant. Some Scottish academics have argued that this is “appropriate prescribing” for “recurrent” and “chronic” conditions.

Antipsychotic prescribing, in all age-groups, has risen year-on-year since the Scottish Government started measuring such prescribing. Last week NHS Scotland was struggling to source one such antipsychotic, namely haloperidol. Intramuscular haloperidol may not be available for 14 months. I do not know if this is a supply or demand issue, however this medication is being most extensively used in NHS hospitals in Scotland despite generally being prescribed “off-label”.

With this in mind I present a pattern that emerged from reading the current British Medical Journal alongside my weekend newspapers.  Here is what they both suggested that “you need to know”:

All the other children are on it, 21 Nov 2015, Guardian Andrew Lansley, Roche 20 Nov 2013 Disney and McDonald's staple, 21 Nov 2015, Guardian Generation meds, 21 Nov 2015, Guardian Long term effects on oor children, Guardian, 21 Nov 2015 Now you are my friend, Nov 21, 2015, Guardian Pharmacological mission creep, BMJ, 20 Nov 2015 What you need to know, Bmj, 21 Nov 2015

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.

One of the main themes of this petition is genuine transparency

What follows is a transcript of a letter that I have sent to the 
Scottish Parliament on my petition for a Sunshine Act for Scotland:

Scottish Parliament Public Petition PE1493 on a Sunshine Act for Scotland

Letter from the petitioner, Dr Peter J. Gordon, 20th November 2015

Dear Members of the Petition Committee,
I thought that it might be helpful to give you a brief summary on matters relating to my petition.

The Scottish Government has commissioned the Scottish Health Council to undertake consultation with the public. This is underway with ten separate discussion groups with somewhere less than 100 participants overall.

Scottish Government and Scottish Health Council (HIS)

As petitioner I met with the Scottish Health Council in June and was asked to provide a summary to help in preparing information to act as the basis for the discussion among the participants. I was asked by the Scottish Government if I wanted to review the information that they had compiled but was confident that the Scottish Government would provide a balanced summary including the evidence that had been carefully compiled for this petition.

Having now seen the “information” provided by the Scottish Government, that forms the basis of the consultations, I now feel that I was naïve to have been so trusting.

This petition would not have been raised, nor indeed considered by the committee, had it not been for the following evidence, evidence which has not been provided to the discussion groups:

  1. Current systems for declaring financial interests are failing in Scotland. No board in NHS Scotland has properly complied with the Scottish Government Guidance on transparency issued more than 12 years ago.
  2. The pharmaceutical industry, on average, spends twice as much on marketing activities as it does on innovation and developing new drugs. If healthcare workers are “educated” by those whose first loyalty is to shareholders then scientific impartiality may suffer. Each year healthcare workers have to ensure they have met professional requirements for continuing medical education. In at least two NHS Boards in Scotland, it is the case that medical education is entirely supported by sponsors such as the pharmaceutical industry.
  3. At least forty separate SIGN Guidelines, all currently in operation, have no records of the financial interests of those tasked to draw up the guidelines. This is concerning as these guidelines are generally followed by doctors to inform prescribing decisions for a wide range of medical conditions.
  4. A single, central register (rather than multiple failing registers) has been found in the USA and France to be relatively simple to set up and administer.

As petitioner my overwhelming concern is that by presenting unbalanced information the Scottish Government has arranged consultations which will lack in validity. One of the main themes of this petition is genuine transparency. I am therefore also disappointed to note that the authors of the information provided are not identified.

I realise that the consultation process is well under way but felt it important to present to the committee the significant concerns which I have.

 

 

“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 – “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