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.
Sunday, 25 October 2015
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.
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.
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.
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).