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

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

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

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

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

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

I replied to the Scottish Health Council as follows:

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

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

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

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

 

Closed by the Scottish Parliament: a Sunshine Act

PE1493 closed

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

PPC 8 March 2016

I was naturally disappointed.

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

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

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

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

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

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

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

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

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

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

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

“There is stunned silence.”

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

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

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

 

What did you hope to achieve by submitting your petition?

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

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

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

 

How do you feel about the outcomes?

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

Grateful that this Petition has encouraged wider discussion.

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

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

In conclusion:

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

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

 

 

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 – 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.

 

 

 

A Friend of Liberty: Professor Walter Humes

Professor Walter Humes, writing in Scottish Review, 21st September 2015:

“For some time I have been copied into email exchanges concerning how complaints against public bodies are dealt with. I have no personal stake in any of the specific sources of concern (which include patient care in the NHS and responses by Police Scotland, the Scottish Government and the Crown Office and Procurator Fiscal Service (COPFS) to requests for formal investigations). I do, however, have a long-standing interest in issues of public accountability and am familiar with the various techniques used by bureaucratic organisations to avoid responsibility when things go wrong: these include silence, delay, evasion, buck-passing and attempts to discredit complainants.”

The Friends of Liberty from omphalos on Vimeo.

“Those who hold high office in public bodies are very adept at defending their own interests. They may claim to support openness and transparency but those principles are not always translated into practice. Bureaucratic Scotland often falls short of the democratic ideals which are said to underpin civic life”

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.