(PACE Trial, etc.) Misleading medical research underpins disability cuts - Centre for Welfare Reform

[Dolphin]

http://www.centreforwelfarereform.org/news/misleading-mability-cuts/00270.html

Release: 14.04.2016

Misleading medical research underpins disability cuts
A new report from the Centre for Welfare Reform explains how a current scientific controversy relates to the debate surrounding welfare reform and cuts to disability benefits.

The 'biopsychosocial' model of disability has played an important role in shaping recent reforms to disability benefits, yet important claims about the value of biopsychosocial approaches have been founded upon evidence which was always potentially misleading, and can be shown to have been exaggerated and distorted in ways that further misrepresent the reality of living with ill health and disability.

The biopsychosocial model has been used to create new obligations for those suffering from common health problems, such as the responsibility to "recognize that the sick role is temporary, in the expectation of recovery." However it is not clear that these new obligations are reasonable. There is a danger that the belief that it is acceptable to encourage 'positive' views of ill health, disability and the efficacy of treatments have affected the design and reporting of medical research, encouraging unreasonable expectations of recovery.

A large and expensive assessment of biopsychosocial interventions, PACE, the only such trial to have received funding from the Department of Work and Pensions (DWP), provides a clear example of the problems which can affect academic research and distort our understanding of important issues. This report explains how problems with the design of this trial, and the presentation of its results, led to seriously misleading claims about patients' recovery rates.

In a Lancet commentary, reviewed and approved by the trial's researchers, patients were classed as having fulfilled a "strict criterion for recovery" even though the criterion used was in fact so loose that patients could have reported a worsening of all their symptoms and yet still have been classed as recovered.

Despite the problems identified with the presentation of results the trial's team continue to fight against releasing important data from this publicly funded research, with pre-specified primary outcomes remaining unreported. There have even been attempts to portray Freedom of Information requests about this trial as a form of harassment and stigmatise patients' concerns about the way in which the efficacy of potential treatments are being misrepresented to them.

With growing numbers of the international scientific community speaking out about the problems surrounding this trial, the Information Commissioner ruled that data which could correct many of the misleading claims made about the trial's results should be released. The trial's researchers and their institutions are appealing against this ruling, and an information tribunal is now due to take place on 20-22 April.

Dubious claims of biopsychosocial expertise have been used to serve the interests of influential institutions and individuals in government, medical research and the insurance industry, where concerns about money and reputation will inevitably compete with concerns about public health and patients' rights.

While there is a growing popular awareness of the problems with nonblinded or poorly controlled trials being used to make unjustified claims about the value of alternative medicine, there is also a widespread failure to acknowledge that more mainstream rehabilitative approaches can be built upon a similarly poor evidence base. Greater honesty about this is needed, especially as attempts to cut welfare spending lead politicians to turn to rehabilitation as a key part of their policies on disability, and as something which may become compulsory for those claiming disability benefits.

This report, written by George Faulkner, shows the need for more critical engagement with biopsychosocial medical research. There is a danger that the lives of millions of people have been damaged by judgments based upon inaccurate and misleading claims, shifting power away from those suffering with ill health and disability by presenting policies which reduce their options and income as benevolent and empowering interventions.

Further reading
There are several published articles already which draw attention to the serious flaws in this research. In particular:

PACE: The research that sparked a patient rebellion and challenged medicine http://www.stats.org/pace-research-sparked-patient-rebellion-challenged-medicine/

Results of the PACE follow-up study are uninterpretable http://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(15)00551-9/fulltext

An open letter to The Lancet, again http://www.virology.ws/2016/02/10/open-letter-lancet-again/

Comments
Dr Simon Duffy, Director of the Centre for Welfare Reform said:

Misleading medical research is particularly dangerous when politicians are looking to blame social problems on minority groups, as they have with disabled people. While it is encouraging that some of the academic community is beginning to challenge this problem, it is sad that so many continue to fight to protect their own interests, and we are particularly grateful to George Faulkner for carrying out this important research.

The report is available to read online and download as a pdf here:

http://bit.ly/expect-recovery http://bit.ly/expect-recovery

 

[Bob]

There's another webpage on their website, that introduces the full report...
http://www.centreforwelfarereform.org/library/type/pdfs/in-the-expectation-of-recovery.html

In the Expectation of Recovery
Author: George Faulkner

The attack by the UK Government on disability benefits has only just started to receive mainstream coverage in the wake of the resignation of Iain Duncan Smith. Until recently the Government found that it could reduce disability benefits by presenting its planned cuts as 'reforms' which would bring benefits, that included increasing employment levels and better health.

 

[Bob]

Full report.

PDF, here:
http://www.centreforwelfarereform.org/uploads/attachment/492/in-the-expectation-of-recovery.pdf

And viewable on scribd, here:
https://www.scribd.com/mobile/doc/308613502/In-the-Expectation-of-Recovery?skip_app_promo=true

 

[Bob]

https://twitter.com/i/web/status/720635223487213568

https://twitter.com/i/web/status/720636545187868672

https://twitter.com/i/web/status/720631126965035009

 

[TiredSam]

Fabulous. Especially as it's about the BPS model and benefits, ie a much wider focus than just ME patients, so more people may feel affected / concerned by it.

 

[Esther12]

Waited five years for criticism of the PACE trial to take off... now there's so much of it I can barely keep up.

 

[actup]

Additional insightful commentary by Ysabelle Stewart (I don't do twitter but find threads easy to read) on paper by George Faulkner.

https://twitter.com/i/web/status/720693380037132291

Following article explains UK government's complicity with disability insurers in long term plan to cut disability payments. Worth a read! http://www.newstatesman.com/politic...changes-government-doesnt-want-you-know-about

 

[actup]

Do go to actual twitter feed for all all of her comments on topic.

 

[JohnCB]

I read this through last night. It is about more than PACE. It does cover points about PACE that have been covered elsewhere but not in as much detail. I was a little disappointed that it did not give the credit due to ME campaigners, Tom Kindlon in particular, who did the initial analysis of PACE. Of course this work was done to make everyone aware of what has happened and so it is a good thing that it is getting further coverage.

What this report does do, and I think does well, is go into the wider background in which PACE is set. It does explain why PACE is such a difficult beast and why simply showing that the science is just plain wrong seems to have so little effect. PACE is presented here as an example, the prime example, of a political/medical process that is happening. Much of the report goes beyond what is covered in the studies we already know well. It is very useful, it is also very scary, from this point of view.

It is also good to see the work done by Tom, et al, getting wider coverage. It may be part of a process where the work done will get taken up by wider disabilty and political communities who perhaps still think that ME is about being rather tired. If ME/CFS is taken up as a banner in wider campaigns, it could make a huge change to general awareness.

I recommend taking a look at this report, perhaps even skipping the bits discussing PACE in particular and understanding the wider politics of the CBT and biopsychosocial movements. It does suggest there is some real skullduggery in the background and it would be very interesting if these issues are taken up by investigators who understand the political and medical worlds.

 

[Dolphin]

http://www.hetalternatief.org/CGT GET PACE Analyse Faulkner 2016 1331.htm

Faulkner:

PACE als voorbeeld van

hoe "hervormingen"

met het (bio)psychosociale model

"gerechtvaardigd" worden

In een uitgebreide analyse beschrijft George Faulkner hoe het (bio)psychosociale model gebruikt wordt als rechtvaardiging voor "politieke hervormingen" (lees: besparingen) en de invoering van "de omgekeerde bewijslast": patiënten kunnen beter worden, maar moeten wel willen.

Het boekwerkje gaat in op de claims die op basis van de PACE trial-studies gemaakt werden.



Aan de hand van een gedegen analyse van de cijfers en definities in studies en andere documenten toont Faulkner aan dat er van de claims van de auteurs weinig tot niets overblijft.



Sterker nog, zoals onder meer Mark Vink (arts/ME-de-patiënt) en ondergetekende onderbouwden: de PACE-trial uitkomsten laten zien dat CGT en GET niet effectief zijn en mogelijk zelfs schadelijk.



Voor de PACE trial-analyse van Faulkner, klik op onderstaande afbeelding:

 

[Tom Kindlon]

I read this through last night. It is about more than PACE. It does cover points about PACE that have been covered elsewhere but not in as much detail. I was a little disappointed that it did not give the credit due to ME campaigners, Tom Kindlon in particular, who did the initial analysis of PACE. Of course this work was done to make everyone aware of what has happened and so it is a good thing that it is getting further coverage.

What this report does do, and I think does well, is go into the wider background in which PACE is set. It does explain why PACE is such a difficult beast and why simply showing that the science is just plain wrong seems to have so little effect. PACE is presented here as an example, the prime example, of a political/medical process that is happening. Much of the report goes beyond what is covered in the studies we already know well. It is very useful, it is also very scary, from this point of view.

It is also good to see the work done by Tom, et al, getting wider coverage. It may be part of a process where the work done will get taken up by wider disabilty and political communities who perhaps still think that ME is about being rather tired. If ME/CFS is taken up as a banner in wider campaigns, it could make a huge change to general awareness.

I recommend taking a look at this report, perhaps even skipping the bits discussing PACE in particular and understanding the wider politics of the CBT and biopsychosocial movements. It does suggest there is some real skullduggery in the background and it would be very interesting if these issues are taken up by investigators who understand the political and medical worlds.

Thanks.
I have received quite a fair amount of credit/mentions in the last 6 months or so between David Tuller's articles, comments by James Coyne, etc. which is nice and means I don't worry so much in other situations.

Three of my pieces are included in the references so I do get acknowledged in a way.

I'm very glad George Faulkner has gone to the trouble of writing such a piece which must have involved a lot of time and effort. He has explored angles that I have not written formally about.

 

[Dolphin]

There's another webpage on their website, that introduces the full report...
http://www.centreforwelfarereform.org/library/type/pdfs/in-the-expectation-of-recovery.html

In the Expectation of Recovery
Author: George Faulkner

The attack by the UK Government on disability benefits has only just started to receive mainstream coverage in the wake of the resignation of Iain Duncan Smith. Until recently the Government found that it could reduce disability benefits by presenting its planned cuts as 'reforms' which would bring benefits, that included increasing employment levels and better health.

The Government's strategy for promoting its reforms seemed to rely heavily on a combination of prejudice and wishful thinking. On the one hand it implied that many of those not working were 'skivers' - people who could work - but who chose not to. On the other hand the Government relied on research which seemed to support the biopsychosocial model of disability - a model which could be taken to imply that illness or disability was at least partially the result of the attitudes held by sick or disabled people themselves. Although the language of the biopsychosocial model is clinical, there is a severe danger that, in the wrong hands, it can be used to support ugly prejudices.

The evidence used to support the biopsychosocial model is often weak, or misleadingly presented; however in 2006 the DWP funded a group of academics to begin the PACE trial which the Wolfson Institute of Preventative Medicine describes as:

"This large-scale trial is the first in the world to test and compare the effectiveness of four of the main treatments currently available for people suffering from chronic fatigue syndrome (CFS), also known as myalgic encephalomyelitis (ME)."

Results from this trial were first published in 2011 and were presented as an exciting success for biopsychosocial interventions. Since then the Government has gone on to use the biopsychosocial model, and the theories underpinning it, to suport its general approach to benefits and welfare reform. For instance, in 2012 Lord Freud defend the 'reform' of Disability Living Allowance in the House of Lords by saying:

"...we have gone for the biopsychosocial model. That model has now garnered very significant academic support, as those noble Lords to whom I sent that very interesting piece of research will recognise."

Unfortunately it turns out that the research that Lord Freud refers to is often deeply flawed. In this detailed report, George Faulkner explains what went wrong and the lessons we should learn. While campaigners continue to demand that the full trial results be published, what is already clear is that the results were manipulated to give a much greater appearance of success than should have been claimed. It is also worrying that some of those involved are closely connected to private insurance companies, such as, Unum, which seems to be lobbying Government to promote private health insurance, instead of our public social security system.

Growing numbers of the international scientific community have begun to express concerns about the research central to this report, for instance, recent discussion includes:

PACE: The research that sparked a patient rebellion and challenged medicine http://www.stats.org/pace-research-sparked-patient-rebellion-challenged-medicine/

Results of the PACE follow-up study are uninterpretable http://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(15)00551-9/fulltext

An open letter to The Lancet, again http://www.virology.ws/2016/02/10/open-letter-lancet-again/

George Faulkner's powerful report usefully describes many of problems with the PACE research and explores its impact in relation to debates about welfare reform.

 

[medfeb]

What this report does do, and I think does well, is go into the wider background in which PACE is set. It does explain why PACE is such a difficult beast and why simply showing that the science is just plain wrong seems to have so little effect.... I recommend taking a look at this report, perhaps even skipping the bits discussing PACE in particular and understanding the wider politics of the CBT and biopsychosocial movements.

Agree - these parts are well worth reading.

 

[Luther Blissett]

A nice companion piece from the more sociological side is;

Illness as ‘Deviance’, Work as Glittering Salvation and the ‘Psyching-up’ of the Medical Model: Strategies for Getting The Sick ‘Back To Work’.

http://blacktrianglecampaign.org/20...strategies-for-getting-the-sick-back-to-work/

A double standard is observable within the BPS lobby’s argument against the legitimacy of ‘symptom-defined illnesses’(such as IBS, stress and back conditions). The medical establishment is asserted to have allowed the growth of ‘syndromes’, which they construct as having less validity than ‘diseases’, counterpoised as having a solid pathological basis.

It is strongly ironic, then, that they do not hold psychology to the same criticism, since its epistemology is practically founded on the creation of labels around sets of observed behaviours.

One initial area of illness which has been exposed to the notion of the ‘medically unexplained’ is that of conditions of the lower back, symptomatically presenting as an individual’s subjective experiencing of pain, and therefore incapacity, in that region, without, it is asserted, any detectable underlying physical pathology.

A leading figure from within the BPS lobby in this topic is Gordon Waddell, whose publications, notably his ‘Back Pain Revolution’ (2004), have become key sources in the referencing of ‘medically unexplained symptoms’. Revealingly, his work is referenced over fifty times within the aforementioned ‘Malingering’ book. Of note in this regard is Waddells’ attempt to distance his work, specifically his diagnostic tool, ‘Waddells’ Signs’, which has acquired a reputation for use in discrediting litigants in industrial negligence cases (Gelman and Brazin, 2000; Personal Injury News, 2008) from any notion that it intends to prove malingering. The fact that this disclaimer is reported within the book on malingering itself lends a certain irony to the situation.

Recent developments in medical technology (University of Aberdeen, 2000) have highlighted the limitations of conventional MRI in detecting the physical causes of musculoskeletal conditions, a category that takes centre stage among the BPS lobby’s ‘medically unexplained’ disorders.

Under conventional, non-weight-bearing MRI “the conditions under which symptoms arise are often not reproduced” due to the patient lying down. (Group Health, 2010). New ‘weight-bearing’ i.e. upright MRI technology is proving to have a superior capacity in more accurately identifying the pathologies behind these conditions.

 

[Freddy]

Simply brilliant! And putting all our experiences in a larger context.

But I can't help laughing, is the following part of the article not the best irony ever?

...For instance, in 2012 Lord Freud defend the 'reform' of Disability Living Allowance in the House of Lords by saying:
"...we have gone for the biopsychosocial model. That model has now garnered very significant academic support, as those noble Lords to whom I sent that very interesting piece of research will recognise."

Unfortunately it turns out that the research that Lord Freud refers to is often deeply flawed. ...

Freud, mhh, I think I know this name...
No joke, it's the great-grandson of good old Sigmund! That made my day!

 

[Bob]

I've now read quite a chunk of this report, and... wow, wow, wow, wow, wow... this is an exceptional project...

It's an impressive report; it's well argued, and its exceptionally well researched, and meticulously referenced. And the author creates a seamless narrative while citing a large number of sources.

It focuses especially on the corruption surrounding the biopsychosocial model, in a political, historical and academic context. And I've learned quite a lot from it. It illuminated (with a broad context) quite a number of issues that we often talk about, and I found myself saying "aha", "aha", "aha", throughout the text as I recognised behaviours and as the wider context explained much of the behaviour of the psychiatric lobby to me. I found it quite an eye opener. The wider context makes it all seem even more corrupt than I had imagined!

It raises all sorts of issues relating to: the issue of non-blind trials and subjective outcomes; the biopsychosocial model; bad research practices; false/misleading research results; withholding data; misleading media reporting, etc.; and how PACE relates to these issues. It discusses how the research evidence base for the biopsychosocial model can't be relied upon, because the research is flawed, but that the academic establishment requires it to be artificially propped up because e.g. careers rely on it. To do this, it says that patients are belittled, denigrated and targeted in a campaign to undermine them. It uses PACE as an example for all of these discussions.

And it discusses the implications of false research outcomes, for patients, social security, the welfare state, the insurance industry and privatization of welfare benefits. It implicates PACE and associated conflicts of interest. And it does so in the context of a history and paradigm of the biopsychosocial model and politics.

It mentions and references many recent events, such as the FOI tribunal and the latest sympathetic blogs that have been written about PACE.

It's very interesting and it's clearly written so it's easy to read.. but if you're not up to tackling the full report, it's worth having a quick read of the one-paragraph "About the Author" and "Acknowledgements" at the very beginning. And read the forward and summary if you're feeling more adventurous. The list of references is also interesting.


Full report:
http://www.centreforwelfarereform.org/uploads/attachment/492/in-the-expectation-of-recovery.pdf

The report is introduced, here:
http://www.centreforwelfarereform.org/library/type/pdfs/in-the-expectation-of-recovery.html

With a press release, here:
http://www.centreforwelfarereform.org/news/misleading-mability-cuts/00270.html

 

[worldbackwards]

Duffy's hawking this in the HuffPo as well:
http://www.huffingtonpost.co.uk/dr-simon-duffy/the-misleading-research-a_b_9726490.html

I think we've finally found a consistent media ally!

 

[Bob]

Duffy's hawking this in the HuffPo as well:
http://www.huffingtonpost.co.uk/dr-simon-duffy/the-misleading-research-a_b_9726490.html

I think we've finally found a consistent media ally!

That's great!

For anyone who doesn't know, Dr Simon Duffy is the director of The Centre for Welfare Reform; the organisation which published the above report.

 

[Esther12]

From HuffPo:

it turns out that because the standard for 'recovery' was lowered after the research began you could even get worse and still be counted as having 'recovered' (see figure).

This is for the 'recovery' claims in the Bleijenberg and Knoop Lancet commentary, not ones made by the PACE researchers. I think it's probably still okay to say this though. A short piece like this aimed at a general readership could never go into all the details of the different recovery claims.

 

[Bob]

...it turns out that because the standard for 'recovery' was lowered after the research began you could even get worse and still be counted as having 'recovered' (see figure).

This is for the 'recovery' claims in the Bleijenberg and Knoop Lancet commentary, not ones made by the PACE researchers.

I think it applies to the recovery paper as well, Esther. e.g. A patient with an SF-36-PF score of 60 could be classed as 'recovered'.