Stifling distortions












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“Packaging up old myths”

Last week the Association of the British Pharmaceutical Industry (ABPI) held its Annual Conference:Annual Conference 2015The Pharmaceutical Industry are concerned about an “affordability conundrum”:Affordability conundrum1The affordability conundrumThis BBC Report from November 2014: “Pharmaceutical Industry gets high on fat profits” documented that:Pharmaceutical industry gets high on fat profits (2b)There will be many companies around the world who would like to be dealing with this kind of “affordability conundrum”.

Another area of concern to the industry was discussed at the 2015 ABPI Conference:Aileen Thompson 2aileen_thompsonThe closing session of the 2015 ABPI Conference was focused on the reputation of the pharmaceutical industry:  Industry as a credible partner A panel discussion was part of this:      Sponsored by concentraI wonder if the panel considered this:Pharmaceutical industry gets high on fat profits (3)Andrew McConaghie of PharmaPhorum recorded this passage:wrong1 wrong2 wrong3My view is that if the Pharmaceutical industry are concerned about their reputation then they should avoid such obvious scapegoating. Dr Goldacre has been and continues to be a world pioneer for scientific objectivity and it does the “reputation” of the British Pharmaceutical industry no credit to distort his work in this way.

Here is the view of the World Health Organisation:Pharmaceutical industry gets high on fat profits (4)

“A mark of exceptional impact”

On the 26th March 2015, following a previous post by Hole Ousia, the Royal College of Psychiatrists stated that it “‏is committed to our Conflicts of Interest policy.” principles-of-rcpsychThis policy advises that:cr148-guidance1and that:cr148-guidance3Dr Ben Goldacre in his book “Bad Pharma” suggested that:008This is advice I have tried to follow, but have found that it is much harder than I realised. Ben Goldacre also gave this advice:007I have written to the Royal College of Psychiatrists for a number of years now as I have concerns that extant College Guidance is not being followed. Recently the President of the Royal College of Psychiatrists reassured me that “our team are on the case”. 

Here are the twenty members of the Organising Committee for the forthcoming International Congress in Birmingham. The linked biographies demonstrate that 19 out of 20 have so far not provided any declarations of interest.  At the same time there appears to have been no difficulty in offering sponsorship opportunities in advance of the conference.Organising Committtee International congress 2015Here is the view of the Editor of the BMJ this time last year. A year on and it appears that there is still a need to hold the applause.002Through research for my petition to the Scottish Government for a Sunshine Act I have collected evidence that fully supports Dr McCartney’s claim that, one way or another, “doctors’ education is paid for almost exclusively by industry”012Dr Ben Goldacre is of the same view.KONICA MINOLTA DIGITAL CAMERAThis is the Royal College of Psychiatrists response to the Association of the British Pharmaceutical Industry (ABPI) “Central Platform” which intends to set up a central, open-access register of payments. However any healthcare worker or academic can simply opt out of disclosing any payments on this registeravoid some ofIn recent social media correspondence with the President of the Royal College of Psychiatrists, Dr Ben Goldacre‏ made a series of comments:

“Surely the problem here is the College calling this a problem of the past while failing to implement basic COI transparency? It’s such a dull ancient thing to have to gripe about.”

“I’m surprised that the declarations that have been made aren’t publicly posted?”

“I am very concerned about the reputational consequences for the profession of casual false reassurance on these issues.”

“I really wish the Royal College of Psychiatrists would show some leadership and do Conflict of Interest declaration properly. Not hard, happy to help. It’s unnecessary and embarrassing to be resistant on this issue, we need to be seen to be clean by our patients.”

The President of the Royal College of Psychiatrists replied: “Give us a break Ben. We are chasing and everyone speaking will do so with a full COI. Which will largely be empty”006Unless we have transparency it is impossible for any of us to know who might be paid to educate us. We know in one year that the pharmaceutical Industry paid £40 million to healthcare workers in the UK.

Last year at a Royal College of Psychiatrists Conference, one speaker was Professor Allan Young. Professor Young’s declarations can be accessed from the webpage of the Psychopharmacology Committee of which he is currently chair.Prof Allan Young, ChairBelow is Professor Young’s “bio” as an organiser for the International Congress. As is the case for 95% of the organising committee, this does not yet include the declarations above:Prof Allan Young as organiser of RCPsych Conf

This is a post that I never wanted to write. I should not have had to. This is a governance issue. It is the Royal College of Psychiatrists who should be ensuring that their policy CR148 is being followed.

We need our College to lead on transparency otherwise we risk a dark “mark” which may be “exceptionally” difficult to rub off.

Continuing Medical Education and its entanglement with the Pharmaceutical Industry

Yesterday I sent the e-mail (at the foot of this post) to Alex Neil, Cabinet Secretary for Health and Well-being for the Scottish Government. It should be self explanatory.

My timing of this letter is based on 8 separate areas. Areas that I hope present as close to a whole picture as I am best able to do:

(1) Freedom of Information (FOI) returns have now been received from all 22 Scottish NHS Boards on the subject of how they record payments to healthcare workers from the Pharmaceutical Industry and if these are open and transparent to all. The results are worse than disappointing.

The summary database is here: https://docs.google.com/spreadsheet/ccc?key=0ApF86-MCSbZzdGlVd2ZPYWhyN1ZUbkliNlFpTGxtMFE#gid=0

Full communication and register files (if available) are here: https://www.whatdotheyknow.com/user/peter_j_gordon/requests

(2) The USA, since five days ago, has a SUNSHINE ACT: look here and see what such statute-based transparency is beginning to reveal (that had previously been kept in the dark) http://projects.propublica.org/docdollars/

In case you think that this could not affect Scotland, well as just one example, Henry A. Nasrallah came to NHS Forth Valley and gave sponsored education on Risperdal in July 2009. He is in the top ten educators earning from the Pharmaceutical Industry with at least $647,341 changing hands.

(3) Scotland (and the UK) do NOT have a Sunshine Act. What we have is the Guidance on Joint-Working between NHS-Scotland and the Pharmaceutical Industry: A Common Understanding 2012 – Working Together For Patients. As guidance it was brought into effect in November 2012 and the Guidance was developed under the Chairmanship of Ian Mullen who was involved in this at the same time as he was Chairman of NHS Forth Valley. Despite this and the fullsome promises in the foreword by Ian Mullen, NHS Forth Valley has never had a functioning register of any joint-working other than the listed Interests of Board members. The FOI returns across all 22 NHS Scottish Boards have since evidenced that NHS Forth Valley, in this failing, was closer to the norm rather than the exception.

A common Understanding

(4) There is also the UK-wide ABPI Code (The Association of the British Pharmaceutical Industry): latest version is here: “The Code of Practice for the Pharmaceutical Industry Second 2012 Edition”  http://www.abpi.org.uk/our-work/library/guidelines/Pages/code-2012.aspx

The ABPI code was reported in the BMJ on its launch in an article by Clare Dyer entitled “Collaboration with drug industry won’t affect clinical decisions, says new guideline”

ABPI promoted

This report of the new ABPI code stirred a vigorous response in BMJ rapid-responses: http://www.bmj.com/content/344/bmj.e2489?tab=responses

One of these responses was subsequently published 24 April 2012 as a letter entitled: “Guidance offers little in the way of ethics or transparency” It was written by Rogers, Zutlevics, Raven & Jureidini:

ABPI Guidance - one response

The above article as per original publication may not be very clear so I have re-pasted the body of the text here (highlights are mine)

deeply-disappointing

In February 2013 the Lancet withdrew its support of document on collaboration between doctors and drug industry http://www.bmj.com/content/346/bmj.f770 I will reprint some of the text here:

Falling-out-with-Pharma

(5)  I have been collecting over the last 3 months all details of Pharmaceutical Sponsored Education that comes my way. I do not see Pharmaceutical Reps and so this will most likely be urepresentative sample of the wider picture. Have a look and form your own opinion:http://pinterest.com/peterjgordon/pharmaceutical-sponsored-medical-education/

Pharmaceutical Sponsored Education

(6) Last year £40 million was paid in total to healthcare workers in the UK from the Pharmaceutical Industry. Whatever proportion went to Scotland, it certainly is not represented in what few returns have been made by doctors to their NHS Boards. So much for transparency. And what then of the ‘probity’ section all doctors sign as part of mandatory GMC regulations for Appraisal and Revalidation?

£40 million

(7) An area of legitimate concern must relate to academics and doctors that have been termed as “Key Opinion leaders” and whose joint-working with the Pharmaceutical Industry can be considerable . I must confess that I had not been especially aware of this until the recent UK-wide discussion on dementia diagnosis was raised in leading journals. I have always advocated for the timely, personalised and holistic diagnosis of dementia pointing out that considerable harms may be associated with the prevailing imperative of ‘early diagnosis’. I was a lead in this debate before just about any other. I was thus concerned when the Key Opinion Leaders in dementia in their reply to the Open letter that I had joined with Grassroots Doctors on this subject http://grassrootsgp.org/category/dementia-screening/  made no declarations of interest. Not one. I knew this was incorrect.

Grassroots GP

Dr Martin Brunet in The Binscome Doctor Blog, as one of the Grassroot doctors made the same observation: http://binscombe.net/blog/?p=639

“Our letter was initially published as a rapid response, where it triggered a reply from an eminent group of doctors who declared that they had no competing interests. The letter was subsequently published as an Observation article, and a further reply came from many of the same authors, several of whom decided on this occasion to declare interests, including financial support from pharmaceutical companies and appointments related to the field of dementia. These conflicts are not wrong in themselves, and do not invalidate their comments, but neither are they unimportant, nor did they arise in the intervening three-month period between the letters. What changed? A prick of the conscience? A word from the editor? Or perhaps the fact that the BMJ tightened its wording about conflicts of interests in January 2013 – between the two submissions.

CropperCapture[2]

Even a robust policy on this matter is insufficient, however. The BMJ has very clear guidance on what should be declared, but there is very little the editors can do when proper declarations are not made – with retraction of the article being their most draconian punishment. Retraction may have repercussions in the scientific community, but it is rarely reported on in mainstream media.”

Since this time I have collected the declarations made by all the Key Opinion Leaders, at least those of whom I am most aware that educate us on dementia, whether it be in  practice, prescribing or policy. My absolute determination is to look at this as a group and thus I would wish no doctor to be singled out. This is not about reputations, or simply conflicts of interest, it is about transparency and that goal that we surely all share: the quest for scientific objectivity.

Why I no longer consult for drug companies https://vimeo.com/72517101/settings

This film carries some of the words by Dr Peter J. Whitehouse in a paper that he wrote called “Why I no longer consult for drug companies” published in Culture, Medicine and Psychiatry, March 2008, Volume 32, Issue 1, pp 4-10

http://link.springer.com/article/10.1007%2Fs11013-007-9075-x#page-1

I wish to thank Dr Whitehouse for allowing me to use his words in this film.

I have made this film as I share Dr Whitehouse’s concern about the entanglement of pharmaceutical marketing/health industries with continuing medical education. I also share concern that when it comes to the Key opinion leaders in dementia that the talk of “transparency” is only talk. Last year £40 million was paid by Pharma to healthcare workers in the UK. Research into Scottish NHS Hospitality Registers evidences that payments from Pharmaceutical Industry are consistently not being declared in Registers (if indeed there is a functioning NHS register!) We are in the dark about this. Unlike USA we have no ‘Sunshine Act.’ The UK has a meaningless, one-sided, code called the ABPI code.

Why I no longer

89% of British Medical journal readers (999 out of 1128), in a poll of April 2013, agreed that drug companies should publish the names of doctors to whom they make donations. That is a striking consensus.

Donations poll

The Pinterest Board on Key Opinion Leaders in Dementia is here: http://pinterest.com/peterjgordon/opinion-leaders-in-dementia/ I was going to write about this but, for so many reasons, I find this very difficult. I am particularly concerned that I am simply a doctor, not an investigator (and do not wish to be). I hope that all readers of this realise that my only determination is to be fair to all, to follow evidence, ethics, professionalism and the humanity that I hope I have within me.

Key Opinion Leaders 'educating' us

(8) Before finishing this post with a copy of the e-mail that I sent to Alex Neil, Cabinet Secretary for Health and Well-being for the Scottish Government. I would like to post a couple of ‘slides’ that I have made from the current BMJ and the article “Everything you need to know about the Sunshine Act” (intended  for the USA readership) http://www.bmj.com/content/347/bmj.f4704

Sunshine-03

Sunshine-06

And finally some advice from Dr Ben Goldacre aimed at his fellow professionals. This is also in the form of a film that I have made called: “What Can You Do” (thank you to Dr Goldacre for agreeing to allow me to use the text from his book Bad Pharma) https://vimeo.com/68919466

Dr-Ben-Goldacre's-advice

Bad pharma 5

From: Gordon Peter (NHS FORTH VALLEY)
Sent: 07 August 2013 20:15
To: alex.neil.msp@scottish.parliament.uk
Subject:ADULT ADHD ACADEMY – sponsored education

7th August 2013.

Dear Cabinet Secretary for Health and Well-being,
Scotland’s 22 NHS Boards have now all replied to Freedom Of Information (FOI) enquiries regarding financial payments from Pharmaceutical Industry to NHS staff.

The results are most dismal. Have a look yourself

Summary database here: https://docs.google.com/spreadsheet/ccc?key=0ApF86-MCSbZzdGlVd2ZPYWhyN1ZUbkliNlFpTGxtMFE#gid=0 (any errors in summary will be mine)

Full communication here: https://www.whatdotheyknow.com/user/peter_j_gordon/requests

Could Scotland not lead here? Why can we not have full transparency on this in Scotland? A Sunshine Act. Like they now have in USA?

Like many others I am primarily concerned about science and objectivity (please see the views of Robert Merton in the slide below which are certainly not out of date)

Last year £40 million across the UK went to doctors (healthcare workers) . . . not much of this is showing up in returns given to Scottish NHS Boards (that is if the NHS Board has a Register.)

If Conflicts of Interest are not a worry to all, this lack of transparency on the part of doctors, most certainly is. Currently Consultants like myself have to Revalidate and as part of this and annual Appraisal we sign a section on ‘probity’.

Please do reply to this concern. I am grateful.

Yours sincerely,
Dr Peter J. Gordon

Consultant Psychiatrist for Older Adults,
 Clackmannan Community Healthcare Centre,
 Hallpark road,
 Sauchie.
 FK10 3JQ

Changing-system-of-producin

The text on this slide on SCIENTIFIC OBJECTIVITY and what MERTON CORRECTLY FEARED may happen, is from the book “Genes, Cells and Brains” by Hilary & Steven Rose

Truth of an industry and the transparency of a profession

GlaxoSmithKline is fined record $3bn in US, published 3 July 2012, as:BMJ2012;345:e4568

http://www.bmj.com/content/345/bmj.e4568

Reply by Dr Peter J Gordon as rapid-response to the BMJ, 10th July 2012: http://www.bmj.com/content/345/bmj.e4568/rr/593464

£3 billion

Truth of an industry and the transparency of a profession
I am not a campaigner against the pharmaceutical industry and support pharmaceutical innovation and development. However I am shocked by the 212 exhibits now available for all to see following the whistleblower lawsuit against GlaxoSmithKline, for which the company has pled guilty and agreed to pay $3bn in penalties for unlawful promotion of prescription drugs and failure to report safety data[1]. The Chairman of GSK has admitted ‘regret’ but has offered no apology.

Let us consider TRUTH and the pharmaceutical industry. Here we must mull over: ‘misleading’ journal articles; the deliberate concealment of negative trial results; the illegal promotion of off-label uses of drugs; and the culture of promotion that makes profit the prime consideration.

Now let us consider TRANSPARENCY. Here we need to ask: Do the public have open access to hospitality registers and where is the General Medical Council support of this? Do the public know how entangled our continuing medical education is with the pharmaceutical Industry? Can we be reassured by Richard Thompson chair of the Ethical Standards in Health and Life Sciences Group given their recent controversial guideline to ‘promote collaboration between doctors and the pharmaceutical industry’?[2] Can we agree with them that the pharmaceutical industry plays a ‘valid and important role in the provision of medical education’? Are we reassured by Stephen Whitehead, Chief Executive of Association of the British Pharmaceutical Industry that the ‘Drug industry takes great care to be a responsible healthcare partner’?[3] And finally are our leading medical journals transparent when it comes to reprint sales that are so strongly associated with pharmaceutical funding?[4]

I would urge readers to look at the 212 exhibits presented for this law-suit and to ask a final question: does our continuing medical education need the pharmaceutical industry?

fair to conclude

My short film on this: A series of exhibits: https://vimeo.com/45512456


[1] BMJ2012;345:e4568 GlaxoSmithKline is fined record $3bn in US. Published 3 July 2012

[2] BMJ2012;344:e3371 Guidance on collaboration with drug industry Towards greater transparency in the life sciences. Published 15 May 2012

[3] BMJ2011;343:d6695 Drug industry takes great care to be responsible healthcare partner Published 26 October 2011

[4] Medical journals: a gaggle of golden geese Blog by Richard Smith. 3 July 2012. by BMJ Group