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.

British Medical Journal, 24 January 2015

This week’s BMJ provides a useful overview of the thorny issue of seeking an earlier diagnosis in dementia. I have always argued that a push for “early” diagnosis, using what are in effect screening tools for cognitive impairment, carries with it risks of mis-diagnosis and over-diagnosis. I have found it very difficult to make my voice heard in raising these concerns about potential harm to patients. Several years down the line, following significant personal consequences of persistently arguing this point, I find that the UK National Screening Committee has come to exactly the same conclusion:

Evidence-for-screening-for-

In the section highlighted above the Committee identifies twice as many false-positive as genuine diagnoses of dementia using current tests.

Industry's-interest-in-deme

Dr McCartney raises one possible explanation of why the UK National Screening Committee’s advice regarding dementia, which is no different from its advice of 2010, was effectively ignored by governments, charities and healthcare professionals. My concerns about conflicts of interest influencing policy developments led me to petition the Scottish Government for a Sunshine Act.

Undiagnosing-dementia,-BMJ,

I have a continuing concern that the figures quoted by the UK National Screening Committee refer to people aged 65 years and over. A considerable proportion of the people that I see are over 80 years. Given the parabolic distribution of cognition with age it is possible that the rates of false-positive diagnosis could be higher in this age group.

Royal College of Psychiatry Debate: “This House supports the early detection of dementia”

Debate-as-set-out

This debate was part of  the Northern and Yorkshire Autumn Conference of the Royal College of Psychiatrists and was held in Durham, on Friday 26th September 2014.

The motion was worded as “This House supports the early detection of dementia”.

For the motion was Professor Clive Ballard. Below is the biography he supplied for the printed programme:

Prof Clive Ballard Bio 26-9-14

Against the motion was myself. Below is the biography that I supplied for the printed programme:

PJG bio 26-9-14

In what follows I will present the slides and the text of my spoken words that were given with each slide of my main argument. Opposing debaters were confined to a ten minute argument so unfortunately a vast subject like this has inevitably had to be reduced. In my argument I decided that it was most important to concentrate upon definitions, evidence and ethics.

Just before you read my presentation [as given on the day] I want to offer my sincere gratitude to Dr Tom Hughes, Academic Secretary (Northern & Yorkshire RCPsych) for being a perfect host and most balanced Chair. I also want to offer my thanks to Prof Clive Ballard for debating this difficult subject with me and for his professional and gentlemanly manner. Whilst we disagreed most significantly on this motion I am certain that Prof Ballard is of the same view as me that this is a complex matter and not one for a simplified approach. I also want to thank the RCPsych organisers: Eva Davison, Division Manager, and Leanne Lane, Divisional Administrator. Both Eva and Leanne were most helpful and the meeting was organised with most professional care.

My argument against the motion [as I presented it on the day]:

SLIDE 1:
I am grateful to have been invited here today to oppose the motion: that this House supports the Early Detection of Dementia.

My name is Dr Peter Gordon and I have worked over the last decade as a Consultant in Psychiatry for Older Adults in NHS Scotland. I have had a longstanding interest in the issues surrounding early diagnosis

I hope to explain to you why a timely approach to the diagnosis of dementia is preferable

slide-1

SLIDE 2:
It is perhaps important that we try and establish definitions for the key words in this motion.

Let us deal with DEMENTIA first. You will be familiar with internationally accepted definitions for dementia. The essential features being that this is a clinical syndrome that manifests with SIGNIFICANT cognitive and functional impairments across a RANGE of DOMAINS of assessment.

For the remainder of my ten minutes I am going to address what we mean by “EARLY” and then lastly consider what we mean by “DETECTION”.

slide-two

SLIDE 3:
It has been said that “Early Diagnosis is Everywhere”.

In 2012 The Westminster All-Party Parliamentary Group published its report: Unlocking Diagnosis. In this report the focus was that on EARLY diagnosis of dementia. The word timely was not used once.

02early

SLIDE 4:
Scotland’s National Dementia Strategy included the early diagnosis of dementia.

Dementia Strategy

SLIDE 5:
Instrumental to Strategy in Scotland was HEAT Target 4. All NHS Boards in Scotland set about ensuring that this early diagnosis target was reached.

HEAT-target-4-and-ealy-diag

SLIDE 6:
At meetings similar to this one today, around this time (2011 onwards), we were presented with new criteria for diagnosing “early Alzheimer’s disease”, including the use of biomarkers:

Wright copy

SLIDE 7:
The new Lexicon offering definitions for Alzheimer’s disease were quickly criticised. A report in the Lancet said of DUBOIS criteria: “but they proceed as if such biomarkers are already available. Moreover, the presence of biomarkers must not be confused with the disease itself. Thus, this new framework for Alzheimer’s disease might represent a Tower of Babel rather than a coherent Lexicon.” New Lexicon

SLIDE 8:
Since 1962 we have had 12, yes 12 different terminologies for mild cognitive impairment. No matter what we call it, we have not yet found a way of accurately predicting which of these people will go on to develop dementia: Pre-dementia2

SLIDE 9:
Continuing the theme of definitions. It has been suggested by some academics and clinicians that early diagnosis “is simply screening rebranded”.

To complicate matters even more, policy makers have drawn a distinction between “screening” and “case-finding”.057Iphigenia-copy

SLIDE 10:
The World Health Organisation has clear definitions of screening. Drs Wilson & Jungner defined screening through a set of ten criteria. This specifically applied not just to population screening, but also to case-finding, opportunistic and specific target groups.WHO2

SLIDE 11:
This is criterion number seven:

“The natural history of the condition, including development from latent to declared disease, should be adequately understoodWHO3

SLIDE 12:
A few years back, in the BMJ, Marcus Richards and Carol Brayne asked “what do we mean by Alzheimer’s disease?” This is a question that I would contend that we do need to consider how ever obvious it may sound, and in particular for our most elderly old.What do we really mean by AD

 SLIDE 13:
“In its most common late onset form, the term Alzheimer’s disease is unlikely to refer to a discrete neuro-pathological entity..”Richards-and-Brayne1

SLIDE 14:
“but to a diffuse clinical syndrome that represents the gradual accumulation of risk factors over the course of life” Richards-and-Brayne2

SLIDE 15:
Professor Carol Brayne’s Team are researching this area.CropperCapture[1]

SLIDE 16:
NEITHER the US Preventative Task Force NOR the UK National Screening Committee recommend cognitive screening as there is “insufficient evidence to assess the balance of benefits and harms” US statement on cognitive Screening March 2014

SLIDE 17:
The “intuitive and nearly religious belief that early diagnosis is a good thing has not gone away: government and charities now lobby to promote early signs of disease and to “educate” primary care doctors” 062Iphigenia

SLIDE 18:
My main concern is that “unlike in screening, the concept of early diagnosis generally has no intellectual framework, rigour, or systematic reviews” 058Iphigenia-copy

SLIDE 19:
Nearly all policy leads have justified “early detection” as case-finding.

There has indeed been much debate on what constitutes case-finding and what constitutes screening.

The main difference is that there is an internationally-agreed definition of screening with a specification of ten criteria which must be fulfilled before any policy can be recommended.

Screening thus considers the potential for harm whilst case-finding does not.Case-finding-and-Screening-

SLIDE 20:
This is the cover from the BMJ when they launched their too much medicine campaign.

There is certainly a risk that we might over-diagnose “early dementia” given remaining uncertainties about pathological basis for dementias.BMJ-on-overdiagnosis

SLIDE 21:
In the current BMJ Professor Illife states “subjective memory complaints are a poor predictor of dementia syndrome … a case finding method that misses most cases is an unusual choice.” case-finding-fudge-19-Sept-

SLIDE 22:
This has not stopped the Alzheimer Society in their push that Policy should be based on Case finding. Their Chief Executive goes further and has stated that “Case-finding is not screening”. Unfortunately this view is diametrically opposite to that of the World Health Organisation'case-finding is not screening' JH July2013

SLIDE 23:
This is the recent voice of one “old man”, J K Anand a retired doctor

“I want my doctors to treat me when I seek their help instead of wasting their time looking for abnormalities that they have neither the time nor the ability to alleviate” J K Annand on case finding 31 aug 2014

SLIDE 24:
Last year this paper was published in our Yellow Journal. It covered ethics.ethics1

SLIDE 25:
I would just like to highlight the following:

    • Risk of making a diagnosis too early or too late because of reasons related to differences in age- or gender-related disease frequencies
    • Risk of making inappropriate diagnoses related to varying definitions of mild cognitive impairmentspectrum

SLIDE 26:
In a 2011 study by the Preclinical AD Workgroup, it was found that “out of 126 cognitively INTACT people with mean age of 83.7 years at death” Nearly-1-in-2a

SLIDE 27:
“post-mortem found that 53 out of 126 or 43% had pathology of pre-clinical Alzheimer’s disease” Nearly-1-in-2b

SLIDE 28:
Thus the risk of over-diagnosis in our most elderly is very real. 1 in 2 of our cognitively unimpaired elders could be wrongly labelled with Alzheimer’s disease.The-diseased-other-2

SLIDE 29:
Research has actually been around for some time that confirms the risk of mis-diagnosis, for example PALMERS study, the Path-through-life study and this study, the 2007 InDDEx study which concluded:

“the overall rate of progression from mild cognitive impairment to Alzheimer’s dementia in this randomised clinical trial was much lower than predicted” Evidence4

SLIDE 30:
Published recently in the BMJ Open was this study looking at CSF biomarkers and MRI brain scans as potential biomarkers. They found that “after the administration of a brief test of memory, MRI or CSF does not substantially affect diagnostic accuracy for Alzheimer’s disease in patients with mild cognitive impairment” Richard-E,-Schmand-BA,-Eike

SLIDE 31:
Delayed diagnosis concerns me but the response to this should be to aim for a timely diagnosis. The risks with “early” detection are mis-diagnosis, over-diagnosis and ultimately the potential for services to be so stretched that those who most need help, those with dementia, are disadvantaged. This is known as inverse-care.2-July-2014-dementia

SLIDE 32:
This is my last slide. It is my view that a lot of care and support can be provided for those living with dementia and that you can live well with dementia. Let us care even if as yet we cannot cure. This is why I support timely diagnosis of dementia. The evidence and ethical base for “early detection” has not yet been made.Living-well-with-dementia

In my Next POST I will present some of the argument that Prof Ballard presented at this Debate in support of the motion. For that full argument I would suggest you contact dr ballard.