(Note this was first published on my 'PACE Complaint Documents' blog on 10 February 2016. I am placing here for ease of reference for others).
Summary of my specific concerns about PACE with annotated bibliography
This is a summary of my specific concerns about the PACE trial and its methodology, which differs to a degree to many of the other concerns currently being aired. This does not mean I do not share those other concerns. I do. but my own concerns here are more specific to other problems in PACE methodology, and provide additional fundamental reasons why the PACE trial methodology needs a critical review with a view to possible retraction. I actually believe all published PACE papers should be retracted because their 'findings' are unsafe: a consequence of the many methodological flaws of the trial. By 'unsafe' I mean both scientifically unsound and, actually more importantly, dangerous to patients.
It must be said that some of these concerns listed here have been present since at least 2004, and remain, borne out by newer evidence as it became available when the PACE trial paper was published. Others are newer concerns that arose as the paper was published and other flaws became evident.
The methodological and ethical problems I have identified are as follows:
1. Serious risks to clinical patient safety caused by unsound claims made about the efficacy of CBT and GET following the PACE trial;
2. Gross discrepancies between research and clinical cohorts, and how clinical patients (and the physiological dysfunction associated with them) appear to have been actively excluded from PACE and other research by the research group involved in PACE, which has, ironically, caused serious resulting risks to clinical patient safety in the UK in particular;
3. Related to the above, gross discrepancies in how various sets of patient criteria were used (and/or rejected), including but not limited to a changing of the London criteria by PACE authors from its original state, a set of criteria which was already controversial and problematic to start with for a number of reasons;
4. Failure of the PACE trial authors to acknowledge the range and depth of scientific literature documenting serious physiological dysfunction in patients given diagnoses of ME or CFS, and how CBT and GET approaches may endanger patients in this context;
5. The inclusion of major mental illnesses in the research cohort;
6. The distortion by PACE trial researchers of 'pacing' from an autonomous flexible management strategy for patients into a therapist led Graded Activity approach;
7. The post hoc dismissal of adverse outcomes as irrelevant to the trial, in direct contradiction to what is scientifically known about the physiological dysfunctions of people given diagnoses of Myalgic Encephalomyelitis or Chronic Fatigue Syndrome;
8. The instability of 'specialist medical care' as a treatment category, and the lack of any sound category of 'control' group.
ANNOTATED BIBLIOGRAPHY
1. Regarding my concerns about PACE's (and other projects') studied ignoring of the Canadian Guidelines:
http://bmj.bmjjournals.com/cgi/eletters/bmj.38301.587106.63v1
Also my response "Problems in the PACE Trial" (13 November 2007)
to the White et al paper "Protocol for the PACE trial":
https://bmcneurol.biomedcentral.com/articles/10.1186/1471-2377-7-6/comments
See also my complaint to the Lancet: http://pacedocuments.blogspot.co.uk/2011/04/complaint-to-editor-of-lancet-regarding.html
See also my book "Authors of our own Misfortune? The Problems with Psychogenic Explanations for Physical Illnesses" (2012) Market Rasen: The Village Digital Press, especially chapters 2, 4, and 6.
2. Regarding the problems of the London Criteria in particular:
Online exchange with Ellen Goudsmit following my response "Problems in the PACE Trial" (13 November 2007)
to the White et al paper "Protocol for the PACE trial":
https://bmcneurol.biomedcentral.com/articles/10.1186/1471-2377-7-6/comments
See also an online discussion on Phoenix Rising:
http://forums.phoenixrising.me/index.php?threads/pace-trial-and-the-criteria-for-m-e-used.10766/
See also my complaint to the Lancet: http://pacedocuments.blogspot.co.uk/2011/04/complaint-to-editor-of-lancet-regarding.html
3. Regarding the problems around criteria used generally:
http://bmj.bmjjournals.com/cgi/eletters/bmj.38301.587106.63v1
https://bmcneurol.biomedcentral.com/articles/10.1186/1471-2377-7-6/comments
http://forums.phoenixrising.me/index.php?threads/pace-trial-and-the-criteria-for-m-e-used.10766/
http://forums.phoenixrising.me/index.php?threads/pace-study-and-oxford-criteria.8880/
See also my complaint to the Lancet: http://pacedocuments.blogspot.co.uk/2011/04/complaint-to-editor-of-lancet-regarding.html
See also my book "Authors of our own Misfortune? The Problems with Psychogenic Explanations for Physical Illnesses" (2012) Market Rasen: The Village Digital Press, especially chapters 2, 4, and 6.
4. Regarding PACE and/or other research excluding ME patients (a neurological disease according to WHO ICD-10) with neurological dysfunction (and signs of physical illness) from research:
http://forums.phoenixrising.me/index.php?threads/pace-trial-and-the-criteria-for-m-e-used.10766/
http://forums.phoenixrising.me/index.php?threads/pace-study-and-oxford-criteria.8880/
http://forums.phoenixrising.me/index.php?threads%2Fpoll-swollen-lymph-nodes-did-you-have-these-before-getting-me-cfs-or-did-they-only-appear-after.9250%2F
See also: "RE: Authors Response" (Angela Kennedy replied to Anthony_Cleare on 13 Jan 2010 at 23:18 GMT)
http://www.plosone.org/annotation/listThread.action?root=1669
See also: Questions about 'CFS' and 'ICF' selection criteria of cohort' Response to Byrnes et al ('Expression in
Peripheral Blood Leukocytes in Monozygotic Twins Discordant for Chronic Fatigue: No Evidence of a
Biomarker' PLoS ONE 4(6): e5805 2009) 3 January 2011.
http://www.plosone.org/annotation/listThread.action?root=3801
See also: "'Cost-effectiveness' is irrelevant when safety has not even been addressed in the PACE trial 02 Aug 2012 at 11:35 GMT in response to McCrone et al "Adaptive Pacing, Cognitive Behaviour Therapy, Graded Exercise, and Specialist Medical Care for Chronic Fatigue Syndrome: A Cost-Effectiveness Analysis"
http://www.plosone.org/annotation/listThread.action?root=52481
See also my complaint to the Lancet: http://pacedocuments.blogspot.co.uk/2011/04/complaint-to-editor-of-lancet-regarding.html
See also my book "Authors of our own Misfortune? The Problems with Psychogenic Explanations for Physical Illnesses" (2012) Market Rasen: The Village Digital Press, especially chapters 2, 4, and 6.
5. Regarding claims to safety and efficacy:
http://www.plosone.org/annotation/listThread.action?root=52481
http://bmj.bmjjournals.com/cgi/eletters/bmj.38301.587106.63v1
See also my complaint to the Lancet: http://pacedocuments.blogspot.co.uk/2011/04/complaint-to-editor-of-lancet-regarding.html
See also my book "Authors of our own Misfortune? The Problems with Psychogenic Explanations for Physical Illnesses" (2012) Market Rasen: The Village Digital Press, especially chapters 2, 4, and 6.
6. Regarding the failure to address the biomedical evidence available detailing serious organic physiological dysfunction in patients who receive a 'CFS' or 'ME' diagnosis:
https://bmcneurol.biomedcentral.com/articles/10.1186/1471-2377-7-6/comments
See also my complaint to the Lancet: http://pacedocuments.blogspot.co.uk/2011/04/complaint-to-editor-of-lancet-
7. Other points:
https://bmcneurol.biomedcentral.com/articles/10.1186/1471-2377-7-6/comments
See also my complaint to the Lancet: http://pacedocuments.blogspot.co.uk/2011/04/complaint-to-editor-of-lancet-
See also my book "Authors of our own Misfortune? The Problems with Psychogenic Explanations for Physical Illnesses" (2012) Market Rasen: The Village Digital Press, especially chapters 2, 4, and 6.
Tuesday 11 October 2016
Wednesday 5 October 2016
Transcript of Liz Carr's speech at 2016 Labour Party Conference
Below is the transcript of a speech Liz Carr gave at the 2016 Labour Party Conference. The transcript was provided by Liz herself, and permission kindly given for people to share. I actually believe it will prove one of the most important speeches in history.
The speech can be listened to and watched here:
http://www.mirror.co.uk/news/uk-news/actress-liz-carr-stuns-audience-8911590#ICID=sharebar_facebook
"I won’t go on too much about the fact I’m on a BBC TV show called Silent witness - I only bring that up not in the name of my own ego but to go, we can't be Silent Witnesses, we actually have a moral responsibility to be activists and to give voice to those that don’t have voice and to give visibility to those that don’t have visibility. I’m a relatively privileged disabled person but still, at the moment, I’ve just had a care assessment. I’m at risk of my benefits being cut - my care assessment that got me here today, that paid for the personal assistance to get me here today. That’s happening to me. I can go to the press. I’ve got a profile. I’m white, I’m articulate and I’m educated. I have privilege and that’s happening to me. My social worker sat for 15 minutes at the beginning of my assessment and told me about the cuts to the Borough where I live and I had to stop her and say, ’this is unlawful - what you’re doing - I know it is because I know my rights’. But what if she goes to anybody else like that - and she does. She goes to other people’s houses and she sits there and she says, “you know we’ve got to make amends, we haven’t got enough money sooo… ”. That’s before she’s even looked at what people need. This is before she’s even said anything else other than ‘Oooh we’ve got lots of cuts’. How terrifying. How terrifying to older and ill and disabled people sitting there at home without the privilege that I have. So i can’t be a silent witness as much as I love that job, i have to be vocal. And I join with Disabled People Against Cuts, I join with other groups of disabled people but not just because of our issues, because this is hitting us all.
Now there’s this sort of sense and certain press would have it that to be disabled today is all about blue badges and benefits and big loos isn’t it? That’s all it’s about. It’s a bit of a joke really. No and forgive me because I’m going to read this. For many people, being disabled in austerity Britain means being hated, it means being stigmatised, demonised as burdens, drains on the state, it means being labelled as fraudsters and work shy. It’s about being segregated and excluded and oppressed and discriminated against. It’s about being forgotten and derided and abused and sanctioned and attacked and killed and cut and rationed and reduced and starved and homeless and hungry and fearful and terrified and alone and isolated and abandoned and denied resources and silenced and rendered invisible and made to jump through hoops, to prove your worth, devalued, punished, subject to vicious attacks both by individuals and the state. It’s about being inhuman. It’s about being seen as useless eaters and the undeserving poor. That’s the reality for disabled people in today’s society.
And that’s not just about being disabled, that’s not just about us. We know that’s about every other oppressed group and every person who’s struggling to survive in austerity Britain. Forget words like reform and review - do you know what they mean? Rationing. As soon as you hear those words, that’s what it means - rationing. That’s what they’re trying to do. That’s what that social worker was doing to me, that is what she wants.
You know we are told, and I’ve heard this before, that work will set us free. Where have I heard that before? Sorry, but it needs to be said because to go to work, what do we do? Well let’s cut the benefits that people need by a third. Let’s do that with the ESA cuts, let’s do that. And let’s say you do have a chance of getting into employment - that’s employment where it’s accessible, or where employers aren’t actually scared to employ you because they don’t see being disabled as less than - which they normally do. So let’s say there’s no discrimination in employment and you actually get into employment, we then have cut to Access to Work which is the support to enable us to do our jobs so that’s been cut. So if we do get a job and we do get the support - and that’s quite unlikely - that’s great but do you have the social care to get you up in the morning or to pick you up from work or to cook you a hot meal to enable you to be in a state to do that job because that’s been cut. And how about your transport? Because Disability Living Allowance has been changed to the Personal Independence Payment and thousands and thousands of people have been miraculously cured. Hmmm, funny that? Is that rationing? Yes it fucking is. So lots of people now don’t have their own cars, they don’t have ways of getting from A to B. Getting a car on the Motability scheme isn’t a luxury - it’s a reality because most of the infrastructure in this country is not accessible unless you’re in the cities and even if it is, people still need bespoke transport for their bespoke needs. Right so now, let’s say we’ve got that job, we’ve got that social care and that’s a miracle if you get all that and you’ve got that transport. Did you get the education? Or did you get a segregated education that cared more about tossing bean bags and physio than doing the national curriculum and getting a decent education? And if you do get to higher education, what about the disabled student allowance / support grants that have also been cut? I mean, I could go on… it’s a miracle any of us get here. And I don’t mean in any religious sense, I mean because of the barriers that we are facing. But of course, it is absolutely true to say that work will set us free. Ummm yeah…
I guess I’m here today for all those who have died waiting for benefits to be reinstated, for those found fit for work months after their deaths, for those who have killed themselves because of fear of that pernicious brown envelope arriving through their letter box or the evil of the DWP or the unending shame of being part of our welfare state - because that’s what we’ve done, we’ve made it a thing of shame rather than a thing of support. We’ve made suicide a desirable alternative. Look, let's just cut out the middle man and legalise assisted suicide. Let’s give the state even more power over our life and death.
We are all collateral damage in the ideological war that this government is waging. And this is a war - make no mistake of it - and the strongest weapon that we have, in this room now is collectivism, solidarity and strength in numbers. This is not about pitting us against each other as we squabble over who is the hardest hit. This is the time for us to come together and to unite - all of us who are hit and hurt by austerity. We are stronger together and we are are all that we need in this room here and now. Thank you very much."
The speech can be listened to and watched here:
http://www.mirror.co.uk/news/uk-news/actress-liz-carr-stuns-audience-8911590#ICID=sharebar_facebook
"I won’t go on too much about the fact I’m on a BBC TV show called Silent witness - I only bring that up not in the name of my own ego but to go, we can't be Silent Witnesses, we actually have a moral responsibility to be activists and to give voice to those that don’t have voice and to give visibility to those that don’t have visibility. I’m a relatively privileged disabled person but still, at the moment, I’ve just had a care assessment. I’m at risk of my benefits being cut - my care assessment that got me here today, that paid for the personal assistance to get me here today. That’s happening to me. I can go to the press. I’ve got a profile. I’m white, I’m articulate and I’m educated. I have privilege and that’s happening to me. My social worker sat for 15 minutes at the beginning of my assessment and told me about the cuts to the Borough where I live and I had to stop her and say, ’this is unlawful - what you’re doing - I know it is because I know my rights’. But what if she goes to anybody else like that - and she does. She goes to other people’s houses and she sits there and she says, “you know we’ve got to make amends, we haven’t got enough money sooo… ”. That’s before she’s even looked at what people need. This is before she’s even said anything else other than ‘Oooh we’ve got lots of cuts’. How terrifying. How terrifying to older and ill and disabled people sitting there at home without the privilege that I have. So i can’t be a silent witness as much as I love that job, i have to be vocal. And I join with Disabled People Against Cuts, I join with other groups of disabled people but not just because of our issues, because this is hitting us all.
Now there’s this sort of sense and certain press would have it that to be disabled today is all about blue badges and benefits and big loos isn’t it? That’s all it’s about. It’s a bit of a joke really. No and forgive me because I’m going to read this. For many people, being disabled in austerity Britain means being hated, it means being stigmatised, demonised as burdens, drains on the state, it means being labelled as fraudsters and work shy. It’s about being segregated and excluded and oppressed and discriminated against. It’s about being forgotten and derided and abused and sanctioned and attacked and killed and cut and rationed and reduced and starved and homeless and hungry and fearful and terrified and alone and isolated and abandoned and denied resources and silenced and rendered invisible and made to jump through hoops, to prove your worth, devalued, punished, subject to vicious attacks both by individuals and the state. It’s about being inhuman. It’s about being seen as useless eaters and the undeserving poor. That’s the reality for disabled people in today’s society.
And that’s not just about being disabled, that’s not just about us. We know that’s about every other oppressed group and every person who’s struggling to survive in austerity Britain. Forget words like reform and review - do you know what they mean? Rationing. As soon as you hear those words, that’s what it means - rationing. That’s what they’re trying to do. That’s what that social worker was doing to me, that is what she wants.
You know we are told, and I’ve heard this before, that work will set us free. Where have I heard that before? Sorry, but it needs to be said because to go to work, what do we do? Well let’s cut the benefits that people need by a third. Let’s do that with the ESA cuts, let’s do that. And let’s say you do have a chance of getting into employment - that’s employment where it’s accessible, or where employers aren’t actually scared to employ you because they don’t see being disabled as less than - which they normally do. So let’s say there’s no discrimination in employment and you actually get into employment, we then have cut to Access to Work which is the support to enable us to do our jobs so that’s been cut. So if we do get a job and we do get the support - and that’s quite unlikely - that’s great but do you have the social care to get you up in the morning or to pick you up from work or to cook you a hot meal to enable you to be in a state to do that job because that’s been cut. And how about your transport? Because Disability Living Allowance has been changed to the Personal Independence Payment and thousands and thousands of people have been miraculously cured. Hmmm, funny that? Is that rationing? Yes it fucking is. So lots of people now don’t have their own cars, they don’t have ways of getting from A to B. Getting a car on the Motability scheme isn’t a luxury - it’s a reality because most of the infrastructure in this country is not accessible unless you’re in the cities and even if it is, people still need bespoke transport for their bespoke needs. Right so now, let’s say we’ve got that job, we’ve got that social care and that’s a miracle if you get all that and you’ve got that transport. Did you get the education? Or did you get a segregated education that cared more about tossing bean bags and physio than doing the national curriculum and getting a decent education? And if you do get to higher education, what about the disabled student allowance / support grants that have also been cut? I mean, I could go on… it’s a miracle any of us get here. And I don’t mean in any religious sense, I mean because of the barriers that we are facing. But of course, it is absolutely true to say that work will set us free. Ummm yeah…
I guess I’m here today for all those who have died waiting for benefits to be reinstated, for those found fit for work months after their deaths, for those who have killed themselves because of fear of that pernicious brown envelope arriving through their letter box or the evil of the DWP or the unending shame of being part of our welfare state - because that’s what we’ve done, we’ve made it a thing of shame rather than a thing of support. We’ve made suicide a desirable alternative. Look, let's just cut out the middle man and legalise assisted suicide. Let’s give the state even more power over our life and death.
We are all collateral damage in the ideological war that this government is waging. And this is a war - make no mistake of it - and the strongest weapon that we have, in this room now is collectivism, solidarity and strength in numbers. This is not about pitting us against each other as we squabble over who is the hardest hit. This is the time for us to come together and to unite - all of us who are hit and hurt by austerity. We are stronger together and we are are all that we need in this room here and now. Thank you very much."
Sunday 22 May 2016
Statement by Angela Kennedy and Stevie Kennedy from August 2009 regarding Judicial Review of NICE guidelines on 'CFS/ME'
**This statement was distributed by me and my daughter Stevie on 1 August 2009 in response to certain comments being made about the Judicial Review of the NICE Guidelines for 'CFS/ME'. The statement has been altered only slightly to take account of my daughter's correct name, at her request. Otherwise it is the exact same statement made in 2009.**
CLARIFICATION BY ANGELA AND STEVIE KENNEDY
In light of recent events and suggestions made elsewhere about both of us, we would like to clarify, collectively, the following:
In 2005, Stevie, after receiving a ‘CFS/ME’ diagnosis in 2001/2002, was subsequently given a ‘borreliosis’ diagnosis, following test results. As anyone with any knowledge of the problems facing people diagnosed with ‘CFS/ME’, or ‘Lyme’, or ‘borreliosis’ will understand, the political situation is not as simple as being diagnosed with one or another. A useful account, for the layperson, of the rank confusion and contestation surrounding ‘Lyme’, ‘borreliosis’ and ‘CFS’ diagnoses is given in Pamela Weintraub’s book “Cure Unknown: Inside the Lyme Epidemic”, with a foreword by Hilary Johnson, author of “Osler`s Web”. It should be noted that many people, initially diagnosed with ‘CFS/ME’, have subsequently received a diagnosis of ‘borreliosis’ or ‘Lyme’, or other condition or disease.
Stevie remains severely physiologically impaired by her condition, though there have been small improvements due to certain treatments and a proper diagnosis of a cardiac/neurological condition. We would both like to go on record and say, specifically, that none of this improvement has been as a result of NHS policy or ‘care’. Our collective position remains that the NICE guidelines are inappropriate and dangerous.
In 2007, Stevie attempted to bring, independently from any other party, a Judicial Review against NICE in respect of their Guidelines for ‘CFS/ME’. Because of the other, apparently partially funded, cases being brought at the same time, Stevie could not secure Legal Aid and therefore unfortunately could not proceed. Situations such as these are apparently quite common and neither of us hold anyone ‘responsible’ for Stevie’s failure to secure Legal Aid.
Another clarification we need to make is that we had no knowledge of the Short/Fraser case until it was first announced publicly, although it is clear they had knowledge of Stevie’s case as her solicitors were mentioned by Professor Malcolm Hooper in his statement. Although we kept the One Click group informed of Stevie’s intention to bring a JR action, we were not given any information by them, and therefore had no knowledge of the One Click JR case apart from that made public by them.
We are both keen to see accuracy prevail, because we believe there are important advocacy lessons that might be learned from a careful analysis of what has happened. For this reason we may have cause to clarify any further issues raise by public comments made by supporters of the Short/Fraser or the One Click JR action.
Due to family problems at the time, Angela was unable to continue campaigning with the One Click Group. Since April 2006, the trajectory of campaigning that One Click has subsequently taken is therefore not that of Angela’s own, although Angela is aware that some of her work was used by One Click in the response to the NICE guidelines (for example, her “Summary of the Psychiatric Paradigm of ME/CFS” document), subsequent to her having discontinued her association with them. Angela has no problem with her previous work on either NICE or the psychiatric paradigm being used by other advocates, and is happy that this work has been of use to people.
Since leaving One Click in 2006, Angela continues to work in advocacy for people suffering because of ‘psychogenic’ explanations for their illness. For example, she co-initiated a campaign to ensure the APPG on ME were made fully aware of the objections many in the ME/CFS community have to the ‘psycho-social’ approach adopted by most of the ‘CFS/ME’ clinics. This was done in support of other advocates who had been highlighting this problem. In 2008 she, with another advocate, tackled the ongoing misrepresentation of the ME/CFS community that was taking place on Wikipedia, an unfortunate result of unsubstantiated allegations, made in the Gibson Report, about members of the ‘CFS/ME’ community ‘harassing’ a Professor. As a result of their attempts to protect the ME/CFS community from such unsubstantiated allegations being incorporated into the Wikipedia article on Simon Wessely, Angela was herself defamed on Wikipedia, and, falsely implicated as being involved in “personally harassing” Professor Wessely. More information on this subject can be found here in the public-archived dedicated Yahoo Group APK-Papers.
Angela continues to advocate for people adversely affected by the scientific and logical flaws in ‘psychogenic’ explanations for illness. She is currently working on an academic project which she hopes will benefit the ME/CFS, Lyme and other patient communities, a project supported by Stevie. Both continue to support the work of other patient advocates whenever possible.
We both hope that the above clarifies our respective positions.
ANGELA KENNEDY
STEVIE KENNEDY
1 August 2009
Thursday 21 April 2016
Exchange with member of 'Phoenix Rising' in 2012 regarding erasure of my work on PACE.
I reproduce here my side (two emails) of an exchange with a member of Phoenix Rising CFS forum from 2012, after a group had published 'an analysis' (though intially 'the analysis') of PACE. I warned them in advance (in 2012) that I would be publishing my own emails to them. However I have redacted their name to preserve anonymity. I believe this exchange demonstrates some key issues around how my work in the area of PACE and on psychogenic explanations for M.E. and other impairments (including the 'biopsychosocial model') has been subject to academic and other forms of erasure* for some time, sadly.
*My grateful thanks to Curls McBobbins (@zaranosaur on Twitter) who has very sagely and succinctly reminded me that "academic erasure is a thing", and the higher risk of it happening to already marginalised academics (as I do indeed consider myself, for various reasons of which some readers will be aware). I'd been struggling to articulate what has been happening to me: her wise words have helped more than she might know.
3 May 2012:
Dear - ,
I am writing because you did invite comments on the above document.
What I am about to write may discomfit you, and I would first like to say I am not intending to write in any hostility, although the points I make here will be necessarily critical.
I should say immediately in the interests of transparency that I have done quite a lot of work over the years on the way psychiatrists have EXCLUDED people with neurological deficits (associated with the neurological illness myalgic encephalomyelitis) from their research cohorts. I have also been a vocal and analytical critic of the PACE trial since its inception. I did try and explain the issues about the criteria to others on the threads about the PACE trial that evolved on Phoenix Rising, but with the honourable exception of one person, was largely ignored.
I am highly concerned that this document may be promoted, especially on PR, as a comprehensive overview of the issues around the PACE trial, when it is nothing of the sort (I note with dismay you claim to have 'done the analysis' - my italics). This would be to the immense detriment to the ME community, and to those of us (even non-ME but supporters like myself) who have worked extremely hard on identifying key problems with PACE since before the trial started in 2004, and the issues we have rightly raised. By claiming or implying it is definitive, you have dismissed serious key issues around PACE that have enormous adverse implications for ME sufferers and their safety, a key point I have raised in my complaint to the Lancet, and which I publicised on the relevant threads on PR.
One major problem with this is the lack of references to the work of others on PACE. There are a number of references I can give you. Just three are here from myself and from Jane Bryant of the One Click Group (when I was working with her), but these are not exhaustive, either of our respective works or of other people:
http://www.theoneclickgroup.co.uk/documents/PACE/BREAKDOWN%20OF%20ISSUES.pdf
http://www.theoneclickgroup.co.uk/documents/PACE/THE%20PACE%20REPORT.pdf
http://www.theoneclickgroup.co.uk/documents/PACE/THE%20PACE%20TRIAL%20IDENTIFIER%20.pdf
I also cannot see references either to my own complaint correspondence, nor Malcolm Hooper's extensive work in this area. At the very least you should have provided a bibliography of the work others have done, especially as your document implies this is a definitive analysis. Obviously this implication is not correct. If you acknowledge it is not then you need to publicise that, and a bibliography is the best way to do this.
One key area in which any implication this is a definitive analysis is particularly problematic is around the issue of the criteria used in PACE. Your document leaves out key issues and is discrepant in some places:
1. A key problem is that my frequently stated point that the Oxford Criteria allowed EXCLUSION of the 38% of clinic attendees possibly BECAUSE they have Myalgic Encephalomyelitis (and neurological deficits associated with such), has been ignored. I did try and explain this at some length to people on the PR threads, and show why this is a possibility that needs exploring by scientists (I'm presuming your document is intended to raise at least some scientific interest in the concerns raised by the ME community and its supporters?) but was largely ignored or dismissed.
2. You have also here - incorrectly - discussed FUKUDA, when in fact the PACE trial used REEVES et al 2003 (different to Reeves 2005), which is actually MORE EXPLICITLY EXCLUSIONARY than Fukuda, although it does look like White et al CHANGED their criteria to Reeves et al 2003 FROM Fukuda at some point in the trial. Though it should also be noted Fukuda and London were NOT EVEN INCLUDED in the PACE Trial Identifier leaked by ONE CLICK in 2004, and appear to have been added in response to criticisms about ignoring the Canadian Criteria - which myself and Jane Bryant raised publicly, as you will see from the above links.
3. You have also not addressed the discrepancies about the LONDON criteria - or that White et all used a 'version' of 'London' of their own making, that excluded people with signs of neurological deficits. In fact, you have not even discussed the discrepancies about the London criteria, period, even before White et al bastardized it to suit themselves.
I should make it quite clear that this is not me being 'huffy' because I've been ignored. My ego is not bruised. But I am frustrated that the key issues I've raised, which are vital to an effective critique of PACE, have been ignored, and the adverse effects that will have on advocacy on this issue and protection of the patient community from the adverse effects of PACE and its promotion. One of the biggest problems this community faces is when people refuse to acknowledge or co-operate with knowledgable others in the community, for reasons of petty prickliness, pomposity, sometimes sexism or classism, or whatever. Even when I've had disagreements with people, if there are areas we can work together, or if someone is being treated unfairly, I will still co-operate and support wherever possible, because cutting one's nose off to spite one's face is not conducive to good advocacy strategy. People should have been working together on this - and I was one of those whose concerns and knowledge (and indeed, even my own complaint to the Lancet) have been largely ignored on the Phoenix Rising forums. While the problems of internet interaction is one thing (and there are a lot of problems in this area on the Phoenix Rising forums), it does not excuse the lack of attention to these important issues that I have raised here.
I hope that you will take my honest and reasonable concerns here on board in the spirit they have been sent, refrain from shooting the messenger, and seek instead to present a bibliography of the work others have done in this area, and publicly acknowledge, in the document itself, that your own analysis in this document is inevitably not comprehensive or definitive, because of the work named others have done. I can provide you with a reasonably wide comprehensive bibliography with links (though even this may not be exhaustive). I would also suggest you remove the term 'the analysis' and replace it with 'an analysis'.
Please do not hesitate to contact me if you need any further clarification. I should let you know I am publicising this email. you have my permission to share this email with others, but I ask it be done so in its entirety, so any part of it is not at risk of being taken out of context.
Best wishes
Angela
-----------------------
14 Mary 2012:
Thank you very much for your reply. I am also very flattered that you have indirectly described me as one of the 'heavyweights' with regard to the knowledge base on PACE - although I note you've referred to me as a 'them', which confused me somewhat at first.
However, I am not reassured by your response for a number of reasons:
1. The issue around the criteria is crucial, because you have ignored the way four criteria (Oxford, a bastardised 'London', the Reeves et al 2003 change to Fukuda, and the NICE criteria) excluded ME patients from the PACE trial, and the various discrepancies around those criteria. Anyone reading your document would believe Oxford were the only criteria used in PACE, and that the excluded 38% DO NOT represent ME patients, when this cannot be said to be the case. At the very least you should be seeking to correct this, because anyone reading your document will not be getting the correct information and may take further action (including advocacy) based on inaccurate information. Currently any psychiatrist wishing to poo-poo your objection to Oxford would be able to do so very easily, because of your lack of accuracy or clarity about the way the various criteria (Oxford, a bastardised 'London', the Reeves et al 2003 change to Fukuda, and the NICE criteria) were used to exclude patients from the research. You also fail to mention Reeves 2003, a crucial 'clarifier' to Fukuda, and the various changes to criteria that were made throughout the PACE trial (at least as important as changes to outcome measures). The lack of clarification on the criteria issue also renders your discussion about the pre-excluded 38% of patients, and the patients included, somewhat confusing.
2. Your 'primary conclusions' are actually wide ranging and authoritative sounding, but you are making claims based on incomplete evidence, particularly in the section on criteria. That is your choice, but in doing so you are doing a disservice to the community itself, other advocates, and any scientists or other parties coming across your work but who are not aware of the key analysis carried out elsewhere. If you had focused on the smaller area of the outcome measures, where your thread was most productive, and acknowledged there were other key issues being looked at elsewhere, I would not have seen this paper as a problem. As you have made wide-ranging conclusions without acknowledging they should not be considered as definitive, readers not aware of the prior work of others will erroneously believe that these are the only crucial points about PACE, when they are not. They are merely SOME points about PACE (and some of them are not quite correct).
3. At the very least, you should be acknowledging that there is other analytical work being done on PACE by people like myself and Professor Hooper (and mention our respective complaints), if you are determined not to provide a short bibliography of our work. This would allow the reader to understand that your 'middle ground' is not definitive, and will prevent any misapprehension on this issue.
Nevertheless, your decision not to include any bibliography is highly problematic, because the vast majority of discussion about the criteria was actually carried out by myself on the large thread and some other related threads on PR. If this were an academic paper, you would be dangerously close to plagiarism, and to prevent this you would be required to give a bibliography of others work on the subject, especially as you claim to have known about them in advance (as your compliment about the 'heavyweights' implies).
4. I am concerned that, however modestly you regard your document, it will be presented on Phoenix Rising as a definitive analysis of PACE, to the exclusion of vital points made elsewhere by myself and Professor Hooper. PR has become extremely self-promoting, and I can see this problem occurring. I cannot see how you can reassure me otherwise, frankly.
5. I do acknowledge you may not be aware of this, but, it is important that you understand that I was being heavily moderated and also subject to various bans over on PR after protesting against mistreatment of me by others, or defending myself against them after not being protected by moderators. At one point I was falsely accused of threatening the Royal Family. While the problems of PR are neither here nor there as far as you are concerned, and I am certainly not seeking any sympathy from yourself, you should be made aware that I had no awareness that you had proposed any such project. Today is the first time I have been made aware of it. In any case, by not including or acknowledging my work which was actually on this thread (and others), you have ignored it. It was also striking how little people engaged with me on the criteria issue during my time on that thread, when it was clear I had some very specific information that I was imparting to people.
6. I have to say that I did not know that you have been involved in any major critiques of PACE. This would be because you have not made them public? Could you perhaps enlighten me as to which critiques you have been involved in? I feel that this comment of yours is somewhat accusatory. I could not be aware of anything you have been involved in if you did not make it public. I have traditionally shared my work on PACE with the ME community, and indeed shared my work on my complaint, and updates, on your thread, and others, until I was banned from PR.
7. I am glad that you acknowledge that we need to find a way to show why the psychogenic model of ME is incorrect. I don't understand why that would 'bother' you though. I thoroughly agree a multi-pronged approach is needed, but this is EXACTLY why I have needed to write to you about the problems of your document. A multi-pronged approach needs to be done in such a way that others' approaches - where on the 'same side' - are not damaged. If you do not acknowledge the limitations of your report, it will NOT 'engender further interest' very well at all, but could instead proscribe it. This means that key work, that can be used to ultimately show why the psychogenic model is flawed, could be prevented from seeing the light of day following the problems of PACE, because people have been misled into believing that your incomplete (and on the issue of criteria, currently not correct) report is complete and definitive. When I say misled, I do not mean deliberately. I believe that the high potential of your document to mislead people (because I unfortunately do believe this is the case) is because of error only.
However, it really needs more than the changing of one word to correct these problems. A short disclaimer about this not being definitive and complete, and perhaps a short mention of others' work (Hoopers, my own, as just two examples, and where they differ to yours) would not be hard to do, if a short bibliography of links is impossible. This will not in any way compromise your intention to be 'accessible', but will point to the necessarily deeper analyses which are vital tools, as you acknowledge, in the work dismantling the problems caused by PACE and the psychogenic model of ME. I also presume that your desire to be 'more accessible' would not mean you were prepared to be inaccurate, and therefore you understand the need to correct the inaccuracies in your document around the criteria used in the PACE study.
There is much more that I could write about my concerns about your claims to have achieved certain things. But it is really not my intention to attack your paper, or damage any specific points that fall within the remit that you and your colleagues on that thread have undertaken, and that you wish to take ownership of. Not at all. My concern is to ensure you have not damaged the work of others in this field (and that includes my work), which, so far, your document is in danger of doing. A small amount of work will rectify that, as I have shown.
If you cannot see your way to doing this, I will need to point out the problems wherever I see this document being touted as a definitive analysis of the PACE trial, unfortunately. Feel free to reply to me 'officially', but please bear in mind that, as I have no 'right of reply' on Phoenix Rising, I will have to publicise any objections I may have (such as those above) in other places, and explain that I have no 'right of reply' on PR.
I am hoping that you will have some understanding of the importance of what I have endeavoured to explain to you, and that my specific concerns are reasonable, and will take the small amount of work needed to rectify these problems. If I had my way I would re-write the whole way you have described the criteria issue. However I realise this is unlikely to be acceptable.
Best wishes
Angela
*My grateful thanks to Curls McBobbins (@zaranosaur on Twitter) who has very sagely and succinctly reminded me that "academic erasure is a thing", and the higher risk of it happening to already marginalised academics (as I do indeed consider myself, for various reasons of which some readers will be aware). I'd been struggling to articulate what has been happening to me: her wise words have helped more than she might know.
3 May 2012:
Dear - ,
I am writing because you did invite comments on the above document.
What I am about to write may discomfit you, and I would first like to say I am not intending to write in any hostility, although the points I make here will be necessarily critical.
I should say immediately in the interests of transparency that I have done quite a lot of work over the years on the way psychiatrists have EXCLUDED people with neurological deficits (associated with the neurological illness myalgic encephalomyelitis) from their research cohorts. I have also been a vocal and analytical critic of the PACE trial since its inception. I did try and explain the issues about the criteria to others on the threads about the PACE trial that evolved on Phoenix Rising, but with the honourable exception of one person, was largely ignored.
I am highly concerned that this document may be promoted, especially on PR, as a comprehensive overview of the issues around the PACE trial, when it is nothing of the sort (I note with dismay you claim to have 'done the analysis' - my italics). This would be to the immense detriment to the ME community, and to those of us (even non-ME but supporters like myself) who have worked extremely hard on identifying key problems with PACE since before the trial started in 2004, and the issues we have rightly raised. By claiming or implying it is definitive, you have dismissed serious key issues around PACE that have enormous adverse implications for ME sufferers and their safety, a key point I have raised in my complaint to the Lancet, and which I publicised on the relevant threads on PR.
One major problem with this is the lack of references to the work of others on PACE. There are a number of references I can give you. Just three are here from myself and from Jane Bryant of the One Click Group (when I was working with her), but these are not exhaustive, either of our respective works or of other people:
http://www.theoneclickgroup.co.uk/documents/PACE/BREAKDOWN%20OF%20ISSUES.pdf
http://www.theoneclickgroup.co.uk/documents/PACE/THE%20PACE%20REPORT.pdf
http://www.theoneclickgroup.co.uk/documents/PACE/THE%20PACE%20TRIAL%20IDENTIFIER%20.pdf
I also cannot see references either to my own complaint correspondence, nor Malcolm Hooper's extensive work in this area. At the very least you should have provided a bibliography of the work others have done, especially as your document implies this is a definitive analysis. Obviously this implication is not correct. If you acknowledge it is not then you need to publicise that, and a bibliography is the best way to do this.
One key area in which any implication this is a definitive analysis is particularly problematic is around the issue of the criteria used in PACE. Your document leaves out key issues and is discrepant in some places:
1. A key problem is that my frequently stated point that the Oxford Criteria allowed EXCLUSION of the 38% of clinic attendees possibly BECAUSE they have Myalgic Encephalomyelitis (and neurological deficits associated with such), has been ignored. I did try and explain this at some length to people on the PR threads, and show why this is a possibility that needs exploring by scientists (I'm presuming your document is intended to raise at least some scientific interest in the concerns raised by the ME community and its supporters?) but was largely ignored or dismissed.
2. You have also here - incorrectly - discussed FUKUDA, when in fact the PACE trial used REEVES et al 2003 (different to Reeves 2005), which is actually MORE EXPLICITLY EXCLUSIONARY than Fukuda, although it does look like White et al CHANGED their criteria to Reeves et al 2003 FROM Fukuda at some point in the trial. Though it should also be noted Fukuda and London were NOT EVEN INCLUDED in the PACE Trial Identifier leaked by ONE CLICK in 2004, and appear to have been added in response to criticisms about ignoring the Canadian Criteria - which myself and Jane Bryant raised publicly, as you will see from the above links.
3. You have also not addressed the discrepancies about the LONDON criteria - or that White et all used a 'version' of 'London' of their own making, that excluded people with signs of neurological deficits. In fact, you have not even discussed the discrepancies about the London criteria, period, even before White et al bastardized it to suit themselves.
I should make it quite clear that this is not me being 'huffy' because I've been ignored. My ego is not bruised. But I am frustrated that the key issues I've raised, which are vital to an effective critique of PACE, have been ignored, and the adverse effects that will have on advocacy on this issue and protection of the patient community from the adverse effects of PACE and its promotion. One of the biggest problems this community faces is when people refuse to acknowledge or co-operate with knowledgable others in the community, for reasons of petty prickliness, pomposity, sometimes sexism or classism, or whatever. Even when I've had disagreements with people, if there are areas we can work together, or if someone is being treated unfairly, I will still co-operate and support wherever possible, because cutting one's nose off to spite one's face is not conducive to good advocacy strategy. People should have been working together on this - and I was one of those whose concerns and knowledge (and indeed, even my own complaint to the Lancet) have been largely ignored on the Phoenix Rising forums. While the problems of internet interaction is one thing (and there are a lot of problems in this area on the Phoenix Rising forums), it does not excuse the lack of attention to these important issues that I have raised here.
I hope that you will take my honest and reasonable concerns here on board in the spirit they have been sent, refrain from shooting the messenger, and seek instead to present a bibliography of the work others have done in this area, and publicly acknowledge, in the document itself, that your own analysis in this document is inevitably not comprehensive or definitive, because of the work named others have done. I can provide you with a reasonably wide comprehensive bibliography with links (though even this may not be exhaustive). I would also suggest you remove the term 'the analysis' and replace it with 'an analysis'.
Please do not hesitate to contact me if you need any further clarification. I should let you know I am publicising this email. you have my permission to share this email with others, but I ask it be done so in its entirety, so any part of it is not at risk of being taken out of context.
Best wishes
Angela
-----------------------
14 Mary 2012:
Thank you very much for your reply. I am also very flattered that you have indirectly described me as one of the 'heavyweights' with regard to the knowledge base on PACE - although I note you've referred to me as a 'them', which confused me somewhat at first.
However, I am not reassured by your response for a number of reasons:
1. The issue around the criteria is crucial, because you have ignored the way four criteria (Oxford, a bastardised 'London', the Reeves et al 2003 change to Fukuda, and the NICE criteria) excluded ME patients from the PACE trial, and the various discrepancies around those criteria. Anyone reading your document would believe Oxford were the only criteria used in PACE, and that the excluded 38% DO NOT represent ME patients, when this cannot be said to be the case. At the very least you should be seeking to correct this, because anyone reading your document will not be getting the correct information and may take further action (including advocacy) based on inaccurate information. Currently any psychiatrist wishing to poo-poo your objection to Oxford would be able to do so very easily, because of your lack of accuracy or clarity about the way the various criteria (Oxford, a bastardised 'London', the Reeves et al 2003 change to Fukuda, and the NICE criteria) were used to exclude patients from the research. You also fail to mention Reeves 2003, a crucial 'clarifier' to Fukuda, and the various changes to criteria that were made throughout the PACE trial (at least as important as changes to outcome measures). The lack of clarification on the criteria issue also renders your discussion about the pre-excluded 38% of patients, and the patients included, somewhat confusing.
2. Your 'primary conclusions' are actually wide ranging and authoritative sounding, but you are making claims based on incomplete evidence, particularly in the section on criteria. That is your choice, but in doing so you are doing a disservice to the community itself, other advocates, and any scientists or other parties coming across your work but who are not aware of the key analysis carried out elsewhere. If you had focused on the smaller area of the outcome measures, where your thread was most productive, and acknowledged there were other key issues being looked at elsewhere, I would not have seen this paper as a problem. As you have made wide-ranging conclusions without acknowledging they should not be considered as definitive, readers not aware of the prior work of others will erroneously believe that these are the only crucial points about PACE, when they are not. They are merely SOME points about PACE (and some of them are not quite correct).
3. At the very least, you should be acknowledging that there is other analytical work being done on PACE by people like myself and Professor Hooper (and mention our respective complaints), if you are determined not to provide a short bibliography of our work. This would allow the reader to understand that your 'middle ground' is not definitive, and will prevent any misapprehension on this issue.
Nevertheless, your decision not to include any bibliography is highly problematic, because the vast majority of discussion about the criteria was actually carried out by myself on the large thread and some other related threads on PR. If this were an academic paper, you would be dangerously close to plagiarism, and to prevent this you would be required to give a bibliography of others work on the subject, especially as you claim to have known about them in advance (as your compliment about the 'heavyweights' implies).
4. I am concerned that, however modestly you regard your document, it will be presented on Phoenix Rising as a definitive analysis of PACE, to the exclusion of vital points made elsewhere by myself and Professor Hooper. PR has become extremely self-promoting, and I can see this problem occurring. I cannot see how you can reassure me otherwise, frankly.
5. I do acknowledge you may not be aware of this, but, it is important that you understand that I was being heavily moderated and also subject to various bans over on PR after protesting against mistreatment of me by others, or defending myself against them after not being protected by moderators. At one point I was falsely accused of threatening the Royal Family. While the problems of PR are neither here nor there as far as you are concerned, and I am certainly not seeking any sympathy from yourself, you should be made aware that I had no awareness that you had proposed any such project. Today is the first time I have been made aware of it. In any case, by not including or acknowledging my work which was actually on this thread (and others), you have ignored it. It was also striking how little people engaged with me on the criteria issue during my time on that thread, when it was clear I had some very specific information that I was imparting to people.
6. I have to say that I did not know that you have been involved in any major critiques of PACE. This would be because you have not made them public? Could you perhaps enlighten me as to which critiques you have been involved in? I feel that this comment of yours is somewhat accusatory. I could not be aware of anything you have been involved in if you did not make it public. I have traditionally shared my work on PACE with the ME community, and indeed shared my work on my complaint, and updates, on your thread, and others, until I was banned from PR.
7. I am glad that you acknowledge that we need to find a way to show why the psychogenic model of ME is incorrect. I don't understand why that would 'bother' you though. I thoroughly agree a multi-pronged approach is needed, but this is EXACTLY why I have needed to write to you about the problems of your document. A multi-pronged approach needs to be done in such a way that others' approaches - where on the 'same side' - are not damaged. If you do not acknowledge the limitations of your report, it will NOT 'engender further interest' very well at all, but could instead proscribe it. This means that key work, that can be used to ultimately show why the psychogenic model is flawed, could be prevented from seeing the light of day following the problems of PACE, because people have been misled into believing that your incomplete (and on the issue of criteria, currently not correct) report is complete and definitive. When I say misled, I do not mean deliberately. I believe that the high potential of your document to mislead people (because I unfortunately do believe this is the case) is because of error only.
However, it really needs more than the changing of one word to correct these problems. A short disclaimer about this not being definitive and complete, and perhaps a short mention of others' work (Hoopers, my own, as just two examples, and where they differ to yours) would not be hard to do, if a short bibliography of links is impossible. This will not in any way compromise your intention to be 'accessible', but will point to the necessarily deeper analyses which are vital tools, as you acknowledge, in the work dismantling the problems caused by PACE and the psychogenic model of ME. I also presume that your desire to be 'more accessible' would not mean you were prepared to be inaccurate, and therefore you understand the need to correct the inaccuracies in your document around the criteria used in the PACE study.
There is much more that I could write about my concerns about your claims to have achieved certain things. But it is really not my intention to attack your paper, or damage any specific points that fall within the remit that you and your colleagues on that thread have undertaken, and that you wish to take ownership of. Not at all. My concern is to ensure you have not damaged the work of others in this field (and that includes my work), which, so far, your document is in danger of doing. A small amount of work will rectify that, as I have shown.
If you cannot see your way to doing this, I will need to point out the problems wherever I see this document being touted as a definitive analysis of the PACE trial, unfortunately. Feel free to reply to me 'officially', but please bear in mind that, as I have no 'right of reply' on Phoenix Rising, I will have to publicise any objections I may have (such as those above) in other places, and explain that I have no 'right of reply' on PR.
I am hoping that you will have some understanding of the importance of what I have endeavoured to explain to you, and that my specific concerns are reasonable, and will take the small amount of work needed to rectify these problems. If I had my way I would re-write the whole way you have described the criteria issue. However I realise this is unlikely to be acceptable.
Best wishes
Angela
Sunday 3 January 2016
Bob Findley Williams on disabled people and 'Godwin's Law'
Disabled academic and activist Bob Williams-Findlay said this earlier on today, in the wake of Matthew Parris's rationale for legalising assisted suicide. The issue is actually much bigger than assisted suicide. Parris's, and others', comments on the Radio 4 programme hosted by Jane Campbell yesterday, and comments elsewhere (The Times Newspaper) illustrate only too clearly why Bob's words below are so apposite:
"May I take this opportunity to thank Matthew Parris for being candid enough to articulate so clearly the Thatcherite ideological position on those of us with impairments. It is rare to read in print how people like Parris see people who in their eyes contribute little to society and therefore should expect to receive little in return.
Why I'm thanking Parris is because I can now say 'up yours', to all those who accused people like me of scaremongering or resorting to Godwin's Law. The position disabled people find themselves in today in the UK of 2016 is almost identical to that of disabled people in the 1920s within the Weimar Republic - their very right to exist and be supported to live rather than encouraged to die is now under debate. This isn't bloody scaremongering, this is reality."
** Same Difference have kindly shared the Parris article here: http://samedifference1.com/2016/01/02/matthew-parris-responds-to-jane-campbell-today-interview/
"May I take this opportunity to thank Matthew Parris for being candid enough to articulate so clearly the Thatcherite ideological position on those of us with impairments. It is rare to read in print how people like Parris see people who in their eyes contribute little to society and therefore should expect to receive little in return.
Why I'm thanking Parris is because I can now say 'up yours', to all those who accused people like me of scaremongering or resorting to Godwin's Law. The position disabled people find themselves in today in the UK of 2016 is almost identical to that of disabled people in the 1920s within the Weimar Republic - their very right to exist and be supported to live rather than encouraged to die is now under debate. This isn't bloody scaremongering, this is reality."
** Same Difference have kindly shared the Parris article here: http://samedifference1.com/2016/01/02/matthew-parris-responds-to-jane-campbell-today-interview/
Sunday 25 October 2015
Statement regarding the series of articles by David Tuller on the 'Virology' blog about the PACE Trial
I have worked since 2004 on identifying and publicising the serious substantive flaws in the PACE trial, as well as other flaws in psychogenic explanations of ME (and where ME is called 'CFS). I have produced a large amount of work on the subject, contributing to below the line comments in medical and scientific journals, and detailing my copious findings in my book "Authors of our Own Misfortune? The Problems with Psychogenic Explanations for Physical Illnesses" (published in 2012). I have also officially and publicly complained about the problems of the PACE trial, both at the beginning of the trial in 2004, and after its publication by the Lancet in 2011. I was therefore dismayed to see my own contributions, but more importantly my substantive findings, ignored in the series of three articles on PACE recently written by journalist David Tuller.
Not only were my findings ignored, so were those apparently of Professor Emeritus Malcolm Hooper, another major contributor to the flaws of the PACE trial. At the same time, there are some points made by Dr Tuller that appear to have originated from work undertaken elsewhere, including the One Click Group from 2004 onwards, and myself, that are not acknowledged as such by him. Neither Hooper's nor my own substantive complaints to Lancet and elsewhere, and the worrying responses, were acknowledged either in the Tuller series. I am not in any position to speak for Professor Hooper at all, and am not doing so here. I do not know his feelings on the matter. Nevertheless, I believe that there are key findings by him and his team, and grave problems in the way he has been treated for daring to bring these findings to official and public attention, that should also have been related in Tuller's series. Doctor Tuller was made aware of one of my own key findings, and my book, by me. I also offered further information. However he did not respond to the initial information at all once he had received it. Nevertheless, if he had, as he implies he did, performed a thorough literature search on advocacy critiques of the PACE trial, he would have become aware of the key work undertaken by myself, the One Click Group, and the Hooper team, as just three examples. A Google search will result in a large number of links to work detailing my own and others work on PACE, and the key, substantive criticisms we have made, above and beyond the outcome measures issue.
The issue of the outcome measures is important in itself, but nevertheless only forms part of the methodological, ontological and ethical problems of the PACE trial. Flawed methodology and ethical problems dogged the trial from the very beginning. There are enough major flaws and problems within the methodology to render the PACE trial and its resulting literature unsound enough to be retracted. However, Tuller's unfortunate failure to acknowledge some of those key flaws, as found by people like but not limited to myself, weakens what is actually otherwise a strong case for retraction of papers emanating from the PACE trial. It also strikes key events and work from the history of the PACE trial, thus rendering his account incoherent. That his series is being implied as a definitive deconstruction of the PACE trial, and as if Tuller himself had undertaken such a thing, also poses a massive risk to advocacy efforts to expose the many, key flaws of and dangers to patients caused by the PACE trial, which have grave implications for patient safety beyond the issues of the outcome measures.
For my own part, some major problems I have highlighted publicly and which are highly relevant to any discussion claiming to be explaining "the PACE trial: deconstructed" (Tuller's words), include but are not limited to:
1. Serious risks to clinical patient safety caused by unsound claims made about the efficacy of CBT and GET following the PACE trial;
2. Gross discrepancies between research and clinical cohorts, and how clinical patients (and the physiological dysfunction associated with them) appear to have been actively excluded from PACE and other research by the research group involved in PACE, which has, ironically, caused serious resulting risks to clinical patient safety in the UK in particular;
3. Related to the above, gross discrepancies in how various sets of patient criteria were used (and/or rejected), including but not limited to a changing of the London criteria by PACE authors from its original state, a set of criteria which was already controversial and problematic to start with for a number of reasons;
4. Failure of the PACE trial authors to acknowledge the range and depth of scientific literature documenting serious physiological dysfunction in patients given diagnoses of ME or CFS, and how CBT and GET approaches may endanger patients in this context;
5. The inclusion of major mental illnesses in the research cohort;
6. The distortion by PACE trial researchers of 'pacing' from an autonomous flexible management strategy for patients into a therapist led Graded Activity approach;
7. The post hoc dismissal of adverse outcomes as irrelevant to the trial, in direct contradiction to what is scientifically known about the physiological dysfunctions of people given diagnoses of Myalgic Encephalomyelitis or Chronic Fatigue Syndrome ;
8. The instability of 'specialist medical care' as a treatment category, and the lack of any sound category of 'control' group.
Other issues highlighted by other advocates include but are not limited to key conflicts of interest of the PACE trial researchers, and the strange role of the Department of Work and Pensions in funding the PACE trial and the ideological basis of that funding. This in particular is a serious ethical issue, especially in light of subsequent UK state policy toward disabled people, and the proposed use of CBT and coercive 'treatments' in this policy, to the point the UK government is now being investigated by the United Nations for its treatment of disabled people. The problems of the PACE trial are many and complex, which is why it presents such a danger to patient safety, and why a careful, methodical consideration and acknowledgement, by scientists, of all of its flaws, is desperately needed, with a view to urgent retraction of the original paper at least, and preferably all papers emanating from the PACE trial.
Over the years I have worked very hard to find scientists willing to consider carefully the copious evidence I and others have collected about the flaws in the PACE trial, so far without success. There is not even a way to enforce the 'Declaration of Helsinki', it appears. At one point I had a surreal email conversation with the Lancet Ombudsman about his own conflict of interest, where I was left wondering if I had actually conjured up the idea of conflicts of interest myself, perhaps in a fevered dream. The PACE trial and its methodological and ethical flaws provide an exemplar of how principles of science can be corrupted by ideology and power structures within science, a human practice, itself.
Doctor Tuller should have carefully worked to ensure the relevant history of the PACE trial, and all the major substantive concerns made by advocates, were adequately aired in his series, and that the various 'experts' he cites were made fully aware of them. Indeed, he had a ethical duty to the M.E. community to ensure this. In its current state, this series of articles is seriously incomplete at best, and has in effect stricken valid criticisms off the public agenda, which is likely to have a devastating effect on the prospects for safety and fair treatment of an already beleaguered, stigmatised and ignored patient community. I believe at the very least Doctor Tuller has an ethical duty to amend his series to reflect the fact that people such as (but not limited to) myself, Jane Bryant of the One Click Group, and Malcolm Hooper have found major methodological and ethical problems in the PACE trial and made official complaints about them (some even before the trial got underway, as well as post-publication), even if Tuller is unable to discuss or summarise these himself, whatever his reasons. But it would frankly be more useful if he also undertook in the future to consider, understand and wherever possible support the findings of other advocates, if he believes that the issue of PACE and its problems are now important to him.
Not only were my findings ignored, so were those apparently of Professor Emeritus Malcolm Hooper, another major contributor to the flaws of the PACE trial. At the same time, there are some points made by Dr Tuller that appear to have originated from work undertaken elsewhere, including the One Click Group from 2004 onwards, and myself, that are not acknowledged as such by him. Neither Hooper's nor my own substantive complaints to Lancet and elsewhere, and the worrying responses, were acknowledged either in the Tuller series. I am not in any position to speak for Professor Hooper at all, and am not doing so here. I do not know his feelings on the matter. Nevertheless, I believe that there are key findings by him and his team, and grave problems in the way he has been treated for daring to bring these findings to official and public attention, that should also have been related in Tuller's series. Doctor Tuller was made aware of one of my own key findings, and my book, by me. I also offered further information. However he did not respond to the initial information at all once he had received it. Nevertheless, if he had, as he implies he did, performed a thorough literature search on advocacy critiques of the PACE trial, he would have become aware of the key work undertaken by myself, the One Click Group, and the Hooper team, as just three examples. A Google search will result in a large number of links to work detailing my own and others work on PACE, and the key, substantive criticisms we have made, above and beyond the outcome measures issue.
The issue of the outcome measures is important in itself, but nevertheless only forms part of the methodological, ontological and ethical problems of the PACE trial. Flawed methodology and ethical problems dogged the trial from the very beginning. There are enough major flaws and problems within the methodology to render the PACE trial and its resulting literature unsound enough to be retracted. However, Tuller's unfortunate failure to acknowledge some of those key flaws, as found by people like but not limited to myself, weakens what is actually otherwise a strong case for retraction of papers emanating from the PACE trial. It also strikes key events and work from the history of the PACE trial, thus rendering his account incoherent. That his series is being implied as a definitive deconstruction of the PACE trial, and as if Tuller himself had undertaken such a thing, also poses a massive risk to advocacy efforts to expose the many, key flaws of and dangers to patients caused by the PACE trial, which have grave implications for patient safety beyond the issues of the outcome measures.
For my own part, some major problems I have highlighted publicly and which are highly relevant to any discussion claiming to be explaining "the PACE trial: deconstructed" (Tuller's words), include but are not limited to:
1. Serious risks to clinical patient safety caused by unsound claims made about the efficacy of CBT and GET following the PACE trial;
2. Gross discrepancies between research and clinical cohorts, and how clinical patients (and the physiological dysfunction associated with them) appear to have been actively excluded from PACE and other research by the research group involved in PACE, which has, ironically, caused serious resulting risks to clinical patient safety in the UK in particular;
3. Related to the above, gross discrepancies in how various sets of patient criteria were used (and/or rejected), including but not limited to a changing of the London criteria by PACE authors from its original state, a set of criteria which was already controversial and problematic to start with for a number of reasons;
4. Failure of the PACE trial authors to acknowledge the range and depth of scientific literature documenting serious physiological dysfunction in patients given diagnoses of ME or CFS, and how CBT and GET approaches may endanger patients in this context;
5. The inclusion of major mental illnesses in the research cohort;
6. The distortion by PACE trial researchers of 'pacing' from an autonomous flexible management strategy for patients into a therapist led Graded Activity approach;
7. The post hoc dismissal of adverse outcomes as irrelevant to the trial, in direct contradiction to what is scientifically known about the physiological dysfunctions of people given diagnoses of Myalgic Encephalomyelitis or Chronic Fatigue Syndrome ;
8. The instability of 'specialist medical care' as a treatment category, and the lack of any sound category of 'control' group.
Other issues highlighted by other advocates include but are not limited to key conflicts of interest of the PACE trial researchers, and the strange role of the Department of Work and Pensions in funding the PACE trial and the ideological basis of that funding. This in particular is a serious ethical issue, especially in light of subsequent UK state policy toward disabled people, and the proposed use of CBT and coercive 'treatments' in this policy, to the point the UK government is now being investigated by the United Nations for its treatment of disabled people. The problems of the PACE trial are many and complex, which is why it presents such a danger to patient safety, and why a careful, methodical consideration and acknowledgement, by scientists, of all of its flaws, is desperately needed, with a view to urgent retraction of the original paper at least, and preferably all papers emanating from the PACE trial.
Over the years I have worked very hard to find scientists willing to consider carefully the copious evidence I and others have collected about the flaws in the PACE trial, so far without success. There is not even a way to enforce the 'Declaration of Helsinki', it appears. At one point I had a surreal email conversation with the Lancet Ombudsman about his own conflict of interest, where I was left wondering if I had actually conjured up the idea of conflicts of interest myself, perhaps in a fevered dream. The PACE trial and its methodological and ethical flaws provide an exemplar of how principles of science can be corrupted by ideology and power structures within science, a human practice, itself.
Doctor Tuller should have carefully worked to ensure the relevant history of the PACE trial, and all the major substantive concerns made by advocates, were adequately aired in his series, and that the various 'experts' he cites were made fully aware of them. Indeed, he had a ethical duty to the M.E. community to ensure this. In its current state, this series of articles is seriously incomplete at best, and has in effect stricken valid criticisms off the public agenda, which is likely to have a devastating effect on the prospects for safety and fair treatment of an already beleaguered, stigmatised and ignored patient community. I believe at the very least Doctor Tuller has an ethical duty to amend his series to reflect the fact that people such as (but not limited to) myself, Jane Bryant of the One Click Group, and Malcolm Hooper have found major methodological and ethical problems in the PACE trial and made official complaints about them (some even before the trial got underway, as well as post-publication), even if Tuller is unable to discuss or summarise these himself, whatever his reasons. But it would frankly be more useful if he also undertook in the future to consider, understand and wherever possible support the findings of other advocates, if he believes that the issue of PACE and its problems are now important to him.
Friday 11 September 2015
Submission to the Department of Work and Pensions' Independent review into the impact of employment on employment outcomes of drug or alcohol addiction, and obesity: Call for Evidence July 2015.
**** I have just emailed this submission to the DWP, in response to their 'Call for Evidence' (deadline is today at 5 pm). Please note formatting changed (font etc.) to publish on this blog. ****
Submission to the Department of Work and Pensions' Independent review into the impact of employment on employment outcomes of drug or alcohol addiction, and obesity: Call for Evidence July 2015.
By Angela Kennedy, 11 September, 2015.
INTRODUCTION
I am making here a submission to Professor Carol Black's Call for Evidence in the Independent review into the impact of employment on employment outcomes of drug or alcohol addiction, and obesity.(1) I am writing in the following capacity:
1. As an independent academic researcher in the following areas: Sociology of science, health and medicine; social constructions of various kinds of 'deviance' (including within state policy), social constructions of 'obesity' and their effects on the lived experiences of individuals; disability denial within state and medical discourses and policies; flaws in medical reasoning in diagnosing psychogenic explanations for physical impairments. My book on the last subject was published in 2012. (2)
2. A woman of bigger size due to lifelong thyroid disease, who has other impairments and who, if my situation is considered through a social model of disability, (3, 4, 5) is disabled by others' prejudice towards me because of my impairments, and others' failure to accommodate my needs as a person with impairments.
I will be addressing specifically the call for evidence specifically related to 'obesity' in this submission. However, it is possible that my comments here can also be applied to the issue of 'addiction', or, more specifically, how people suffering with addiction are at risk from some of the beliefs exhibited in the Call for Evidence itself.
This submission has unfortunately been produced under difficult circumstances due to personal and family circumstances out of my control. It is therefore more truncated than it would have been under normal circumstances. Nevertheless it points to other literature and considerations which need to be included in the 'Review'. I am willing to be contacted for further information if necessary.
KEY ERRORS IN REASONING IN THE REVIEW ITSELF
The 'Call for Evidence' itself exhibits a number of key errors in reasoning.
1. The Introduction to the Call for Evidence, in the first paragraph, claims that conditions such as obesity are 'potentially treatable'. By the third paragraph (under 'terms of reference), the conditions are deemed 'treatable', and this continues throughout the review. This is a major leap of assumption that is not warranted by the evidence available about 'obesity', its multiple potential causes, and the various medical and political 'treatments' proposed. It therefore forms a major error of reasoning that has potentially disastrous effects on how people deemed 'obese' are to be treated by the DWP.
2. The Call for Evidence demonstrates an inherent ideological belief system held by its authors that, again, is not supported by the evidence available. The claims below are particularly problematic:
"...[obesity] can have profoundly damaging impacts on individuals and their families, and significant costs for the taxpayer and the economy. The government believes that not enough is being done to ensure people get medical help for such long-term, treatable issues or specialist employment support - even though one or more of these conditions may be the primary reason for being out of work."
There are four main problems with this statement:
(a)The claim that somehow obese people cause 'significant costs for the taxpayer and the economy'.
(b) The assumption that obesity itself can somehow "have profoundly damaging impacts on individuals and their families".
(c) The assumption that there is suitable medical 'help' actually available to the vast majority of people deemed 'obese' to 'cure' them of 'obesity', or indeed, that the government would even be committed to implementing some of the possible effective 'cures' that might be available.
(d) The assumption that obesity is, often enough to warrant intervention, a verifiable 'primary' cause of unemployment.
These claims are unsafe for a variety of reasons, only some of which are delineated here. Firstly, ALL people cause ''significant costs for the taxpayer and the economy', as this is the nature of state policy (i.e. the UK is a democracy with a welfare state that enables people to attend school, claim child benefit, pensions and obtain health care). Obese people are also tax-payers, and the vast majority of obese people appear to be working. The idea that obese people singularly cost the taxpayer a large amount, over other groups of people, exhibits an ideological and incoherent train of reasoning, not supported by the empirical evidence available.
Secondly, the 'damaging effects' of 'obesity' appear to be related to prejudice against fat people and the effects of this. Prejudice against fat people is embedded in UK and other cultures at all levels, including state and medical. (6, 7, 8) Prejudice against people deemed obese is often referred to colloquially as 'the last safe prejudice'. Applying a social model of disability (3, 4, 5) to obesity, it becomes clear that the ill-treatment of people deemed 'obese' causes damaging effects. Yet it is actually very difficult - and sometimes impossible - to establish any clear 'damaging effects' from the physical condition of obesity itself. (6, 8) Mortality and morbidity rates do not soundly establish such, for example. (6, 8) Even the notion that obesity is 'harmful' per se is open to challenge. For example, research appears to show that often higher weights are 'protective' against certain cancers and other illnesses (if the logic of the research is followed), and obese people do not actually live shorter lives per se. (6, 8) Ironically, the figures quoted in the Call for Evidence itself actually show, proportionally, a rather small amount of people claiming benefit due to 'obesity', if one actually considers the amount of people of working age deemed obese, and yet NOT claiming benefits. The notion that obesity is a verifiable 'primary' cause of unemployment is untenable. This may appear counter-intuitive a situation to consider, but I would argue that this is because of the ideologically informed prejudice against fat people, which has permeated even scientific research and state and medical policy. This has caused many unsound assertions and fallacious reasoning to be made on inadequate evidence within the literature.
Thirdly, as will be demonstrated in this submission, the idea that the government would actually be committed to 'curing' obesity, or intervening to improve quality of life chances, including opportunities to work, for people deemed 'obese', is currently not supported by the evidence available. The 'Review' that the government has asked Professor Black to produce appears merely a measure to support punitive, prejudicial state policy akin to racism and disableism, in line with copious other recent attacks on vulnerable people, such as disabled people and those in poverty.
THE IDEOLOGY OF BLAME WITHIN GOVERNMENT DISCOURSE
'Obesity', as a research subject and domain of knowledge is still very much incomplete. It is also subject to various errors of reasoning in academic, scientific and lay discourses, including political. (6, 8) Potential causes of 'obesity' are varied and multiple, and still not fully elucidated. Yet most often the focus of state and medical intervention or attention is to blame the victim and treat them as psychologically deviant, as greedy and/or lazy. But actual and potential actual causes of obesity include (though are not limited to):
1. Physical dysfunction such as but not limited to thyroid disease: especially as these conditions are often inadequately treated, or misdiagnosed.
2. Conflicting advice around nutrition from state and medical agencies. For example, it is now known that diets higher in protein but lower in carbohydrates can help maintain a lower weight.
3. Lack of access to high protein, low carbohydrate foods because of poverty (foods with carbohydrates are the cheapest and most accessible)
4. Loading of carbohydrates in the process of food product manufacture.
5. A possible genetic propensity towards bigger size, though this may not be necessarily harmful (other animals appear to experience this, for example).
6. Overeating due to psychological problems related to serious adversity, including but not limited to experiences of being denied food as a simple and justified need, or as a form of comfort in extreme adversity, such as suffering sexual and other abuse.
If the government, and those of the medical establishment who support government ideology, were actually seriously committed to making life opportunities better for obese people, including in order to keep them in work, or help them get work, they would be approaching the issue from a different standpoint, i.e. that of a social justice framework, and producing key policies based on that. Policies might include but not be limited to, for example:
1. Offering liposuction and other related surgery, through the National Health Service, rather than just bariatric surgery. Liposuction appears to have no less of a 'success' rate than bariatric surgery, and appears not to have as the risks of iatrogenic injury, including fatality, as bariatric surgery. (8)
2. Legislating against abuse of fat people and discrimination, especially but not exclusively in the area of work and workplaces, similar to other equalities legislation related to race and disability.
3. Promoting positive body images of fat people in all aspects of culture.
4. Designing public spaces and travel systems that all disabled people can access, including people deemed obese. This may include ensuring chairs are suitably sturdy as an inherent feature of design, for just one example.
6. Funding adequate research into thyroid and other metabolic dysfunction.
7. Immediately medically investigating treating physical impairment as it arises in people deemed 'obese' (e.g. knee problems, arthritis), and not blaming the person for being both fat and active (wear and tear on the body indicates a person is active, whatever their size) and assuming being 'obese' is the primary cause of an impairment.
8. Offering supportive, non-coercive psychotherapy, such as non-directive counselling (rather than coercive forms of cognitive behavioural therapy, which fails to address causes of any underlying distress, but instead demands regimented behaviour that appears untenable).
9. Ensuring people deemed obese, like other people, are not suffering poverty and deprivation, so that they have the economic ability to make healthier food choices.
10. Changing food production practices to reduce amount of unnecessary carbohydrates in food.
11. Ensuring advice about food choices is sound, coherent and based on empirical adequacy.
However, sadly, the evidence available indicates that the government intends to adopt a punitive, victim-blaming approach, instead of the above, far more reasonable, measures. This seems to be in keeping with their treatment of disabled people, unemployed people, and people in poverty, and seems part of a neoliberal ideological worldview also shared by previous UK governments since the late 1970's, including 'Labour' governments. In this way a politics of resentment is being engendered, with already actual disastrous effects, but potentially even more disastrous effects, occurring, leading to a break-up of social cohesion and increasing social exclusion. The results of such implementation of a politics of resentment on human societies are likely to be catastrophic in many ways, too profound and wide-ranging to be discussed here, but which do need to be considered urgently at the level of public discourse.
'TREATMENT' AS COERCION
Treatment of people who are poor, disabled, and unemployed, has become extremely punitive and coercive. Depriving vulnerable people of the actual means of survival has become government policy, particularly in the form of 'sanctions'. Copious evidence of the harms related to this measure are available. Coercive psychological interventions as state policy are also being explored by the government.
In the case of obesity, the only 'treatments' currently offered on the NHS are cognitive behavioural therapy, and bariatric surgery. If the 'logic' of sanctions and coercive demands to undergo treatment are followed, people deemed 'obese' may be forced to undergo surgery, and surgery with a high risk of fatality and further morbidity and failure rate. They will therefore be undergoing coercion, by the state, into putting their lives at risk and having surgery they would not otherwise accept. Or they may be coerced into undertaking psychological intervention that may not be right for them and that they would otherwise not accept. This is a fundamental abuse of state power, and that this is implied as reasonable within Professor Black's Call for Evidence should be causing profound concern to all people who wish to maintain the UK as a social democracy, rather than allowing it to disintegrate into a totalitarian state containing elements of fascist ideology.
CONCLUSION
In conclusion, the ideas exhibited in Professor Black's Call for Evidence, and in the government's quotes reported in the media, are extremely unsound and dangerous, and should be abandoned. If the government and their supporters, including some medical doctors, are serious about improving conditions for people deemed 'obese', the above measures I have alluded to would have positive outcomes, instead. But, unfortunately, it remains to be seen whether this is actually the current government's intent.
NOTES
1. DWP Independent review into the impact of employment on employment outcomes of drug or alcohol addiction, and obesity: Call for Evidence July 2015.
2. Kennedy, A. Authors of our own Misfortune? The Problems with Psychogenic Explanations for Physical Illnesses (2012) Market Rasen, Village Digital Press.
3. Scope 'The social model of disability: What is it and why is it important to us?' http://www.scope.org.uk/about-us/our-brand/social-model-of-disability (Last accessed 15 September 2015).
4. Thomas, P. Gradwell, L. Markham, N. 'Defining Impairment within the Social Model of Disability' GMCDP Coalition Magazine July 1997.
5. Crow, L. 'Including All of Our Lives: Renewing the Social Model of Disability' in
Morris, J (Ed) (1996) Encounters with Strangers: Feminism and Disability, Women's Press, London
6. Gard, M. Wright, J. (2005) The Obesity Epidemic: Science, Morality and Ideology London: Routledge.
7. Bovey, S. The Forbidden Body: Why Being Fat is Not a Sin (1994) Pandora, London.
8. Sandy Swarcz, 'Junkfood Science' Blog contains many resources on the empirical evidence available around 'obesity' (including bariatric surgery), and critiques of where fallacies of reasoning occur in policy and science around 'obesity': http://junkfoodscience.blogspot.co.uk/ (Last accessed 11 September 2015).
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