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

The fragility of knowledge in psychiatry

As an NHS Psychiatrist I am hoping to be able to attend this conference.

Oct 2015

As an NHS Consultant, to fulfil the requirements necessary for Appraisal and for 5 year Revalidation, I must gain sufficient CPD points [Continuing Professional Development].

I was Revalidated in 2013.

This Conference has a wonderfully varied agenda, including “Plenary 1: The Fragility of knowledge in Psychiatry” by Edward Shorter:

Untitled-1

After several years of polite persistence on my part, my College has finally introduced a public register of declarations of interest.

This is welcome progress, but what still concerns me is that the public, from registers like this, have no idea how much a doctor/academic/speaker may have been paid at any time, for any reason, by commercially vested interests.

I will continue to argue, however unpopular it may make me, that we need full transparency. And not any fudge.

NHS Scotland: “Advisory Board Medics admit they were paid”

Last year, across the UK, healthcare workers received £41 million from the Pharmaceutical Industry. In Scotland we have no idea to whom this was paid and why.

This report by Marion Scott is based on her research and asks if we have full transparency regarding financial payments that may have been made to those developing national guidelines for NHS Scotland:

A hard pill to swallow 13 Sept 2015

This image file is not easy to read so I have included the html file below:

A hard pill to swallow 13 Sept 2015b

If you are interested in the evidence I have gathered for my petition to the Scottish Parliament for a Sunshine Act, this can be read here.

Open and transparent from omphalos on Vimeo.