Showing posts with label Health. Show all posts
Showing posts with label Health. Show all posts

Monday, October 14, 2019

Work Rehabilitation and Medical Retirement for ME/CFS Patients. A Review and Appraisal of Diagnostic Strategies


Open AccessReview

Work Rehabilitation and Medical Retirement for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Patients. A Review and Appraisal of Diagnostic Strategies


1
Family and Insurance Physician, 1096 HZ Amsterdam, The Netherlands
2
Independent Researcher, 49032 Osnabrück, Germany
*
Author to whom correspondence should be addressed.
Diagnostics 2019, 9(4), 124; https://doi.org/10.3390/diagnostics9040124
Received: 7 June 2019 / Revised: 11 September 2019 / Accepted: 13 September 2019 / Published: 20 September 2019
(This article belongs to the Special Issue Biomedical Insights that Inform the Diagnosis of ME/CFS)
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome leads to severe functional impairment and work disability in a considerable number of patients. The majority of patients who manage to continue or return to work, work part-time instead of full time in a physically less demanding job. The prognosis in terms of returning to work is poor if patients have been on long-term sick leave for more than two to three years. Being older and more ill when falling ill are associated with a worse employment outcome. Cognitive behavioural therapy and graded exercise therapy do not restore the ability to work. Consequently, many patients will eventually be medically retired depending on the requirements of the retirement policy, the progress that has been made since they have fallen ill in combination with the severity of their impairments compared to the sort of work they do or are offered to do. However, there is one thing that occupational health physicians and other doctors can do to try and prevent chronic and severe incapacity in the absence of effective treatments. Patients who are given a period of enforced rest from the onset, have the best prognosis. Moreover, those who work or go back to work should not be forced to do more than they can to try and prevent relapses, long-term sick leave and medical retirement. View Full-Text

Tuesday, August 14, 2018

Multidisciplinary rehabilitation treatment is not effective for ME/CFS : A review of the FatiGo trial

The FatiGo trial concluded that multidisciplinary rehabilitation treatment is more effective for chronic fatigue syndrome/myalgic encephalomyelitis in the long term than cognitive behaviour therapy and that multidisciplinary rehabilitation treatment is more cost-effective for fatigue and cognitive behaviour therapy for quality of life. However, FatiGo suffered from a number of serious methodological flaws. Moreover, it ignored the results of the activity metre, its only objective outcome. This jeopardizes the validity of FatiGo. Its analysis shows that there was no statistically significant difference between multidisciplinary rehabilitation treatment and cognitive behaviour therapy and neither are (cost-)effective. FatiGo’s claims of efficacy of multidisciplinary rehabilitation treatment and cognitive behaviour therapy for chronic fatigue syndrome/myalgic encephalomyelitis are misleading and not justified by their results.

Friday, November 25, 2016

Tuesday, November 8, 2016

Bogus FITNET trial is a GET trial in disguise being tested on children who don't have #MEcfs



Bogus FITNET trial is a GET trial in disguise being tested on children who don't have #MEcfs

FITNET trial is an unblinded trial (not a RCT) using subjective outcomes which uses their own "ME/CFS" criteria so that they can select patients who do not have the disease but then label them as if they do ...

Which is not surprising as Crawley, Bleijenberg and Knoop are involved who make Diederik Stapel look like an honest man. Pinocchio research from Britain and Holland. And the medical councils are still hibernating.

If you want to make yourself sick have a look at their protocol but make sure that you've got a bucket ready or better still ask your GP for an antiemetic before you read it. You will need it.



Tuesday, September 27, 2016

"You can't ignore me now" Naked Millions missing protest at Whitehall to demand better care for M.E patients



By Reya El-Salahi (@_Reya) 27 Sep 2016:
"You can't ignore me now" Naked protestor demands better support for M.E patients. Details on @LondonLive before 2pm #MillionsMissing https://t.co/o9SIbwSO1q (http://twitter.com/_Reya/status/780728125181353984?s=17)

Friday, April 8, 2016

Published, independent review of the PACE trial‏

The PACE Trial Invalidates the Use of Cognitive Behavioral and Graded Exercise Therapy in Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome: A Review


Corresponding author: Vink, Family Physician, Soerabaja Research Center, Amsterdam, The Netherlands
E-mail: markvink.md@outlook.com

Abstract
The main findings reported in the PACE trial were that cognitive behavioral therapy (CBT) and graded exercise therapy (GET) were moderately effective treatments for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), and fear avoidance beliefs constituted the strongest mediator of both therapies. These findings have been challenged by patients and, more recently, a number of top scientists, after public health expert Tuller, highlighted methodological problems in the trial. As a doctor who has been bedridden with severe ME for a long period, I analyzed the PACE trial and its follow-up articles from the perspectives of a doctor and a patient. During the PACE trial the eligibility criteria, both subjective primary outcomes, and most of the recovery criteria were altered, creating an overlap of the eligibility and recovery criteria; consequently, 13% of patients were considered “recovered,” with respect to 1 or 2 primary outcomes, as soon as they entered the trial. In addition, 46% of patients reported an increase in ME/CFS symptoms, 31% reported musculoskeletal and 19% reported neurological adverse events. Therefore the proportion negatively affected by CBT and GET would be between 46% and 96%, most likely estimated at 74%, as shown in a large survey recently conducted by the ME Association. Medication with such high rates of adverse events would be withdrawn with immediate effect. There was no difference in long-term outcomes between adaptive pacing therapy, CBT, GET and specialist medical care, and none of them were effective, invalidating the biopsychosocial model and use of CBT and GET for ME/CFS. The discovery that an increase in exercise tolerance did not lead to an increase in fitness means that an underlying physical problem prevented this; validates that ME/CFS is a physical disease and that none of the treatments studied addressed this issue.

FULL article in Journal of Neurology and Neurobiology

Wednesday, February 10, 2016

The sickening hypocrisy of the PACE trial and it's Researchers


Feb 5th, 2016

Why the PACE researchers and their institutions affectation of concern for participants is particularly sickening hypocrisy


In 1990 Sir Iain Chalmers wrote in the Journal of the American Medical Association, “Failure to publish an adequate account of a well-designed clinical trial is a form of scientific misconduct that can lead those caring for patients to make inappropriate treatment decisions.”
(Iain Chalmers. JAMA. 1990 Mar 9;263(10): 1405-8.doi:10.1001/jama.1990.03440100121018)

It could be argued that any Clinical Trial which omits to publish the Primary Outcome Measures as declared and approved in the Protocol ‘is a form of scientific misconduct’; especially if tampering with the outcome measures skews the data and the skewed data is then spun in the media to further exaggerate the findings.

The Declaration of Helsinki states: “36. Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research.Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports.”

The World Health Organization (2004), A Practical Guide for Health Researchers states: “Writing the research protocol
“… once a protocol for the study has been developed and approved, and the study has started and progressed, it should be adhered to strictly and should not be changed. This is particularly important in multi-centre studies. Violations of the protocol can discredit the whole study…”
(http://whqlibdoc.who.int/emro/2004/9290213639.pdf)

The Research Councils UK Policy and Code of Conduct on the Governance of Good Research Conduct states:
“All research should be conducted to the highest levels of integrity, including appropriate research design and frameworks, to ensure that findings are robust and defensible. [] This code therefore concentrates on entirely unacceptable types of research conduct. Individuals involved in research must not commit any of the acts of
research misconduct specified in this code.”
“Falsification
This includes the inappropriate manipulation and/or selection of data, imagery and/or consents.”
“Misrepresentation, including: misrepresentation of data, for example suppression of relevant findings and/or data, or knowingly, recklessly or by gross negligence, presenting a flawed interpretation of data;”
(http://www.rcuk.ac.uk/documents/reviews/grc/goodresearchconductcode.pdf)

The Medical Research Council (MRC) Guidelines for Good Clinical Practice in Clinical Trials states: “2.5 Clinical trials should be scientifically sound and described in a clear detailed protocol.
2.6 A trial should be conducted in compliance with the protocol that has received prior Ethical Committee favourable opinion.”
(https://www.mrc.ac.uk/documents/pdf/good-clinical-practice-in-clinical-trials/)

Ben Goldacre remarked in The Guardian, “…in a trial, you might measure many things but you have to say which is the “primary outcome” before you start: you can’t change your mind about what you’re counting as your main outcome after you’ve finished and the results are in. It’s not just dodgy, it also messes with the statistics.”  Goldacre added, “You cannot change the rules after the game has started. You cannot even be seen to do that.”
(Ben Goldacre. Clinical trials and playing by the rules.  The Guardian, Saturday January 5, 2008)

Most of the £5 million that the PACE Trial has cost, came from public money allocated through the Medical Research Council (MRC); whose Guidelines for Good Research Practice (2005) state: “The MRC’s mission can only be fulfilled if the results of research are communicated effectively. The MRC therefore expects those it supports to play their part in disseminating balanced information on scientific advances and their potential implications for society to the health professionals and policy makers who will be involved in applying them, and to the wider public.”

Now let us see what our fine British Institutions say about the PACE Trial, starting with the MRC themselves.  The very institution which handed over millions of pounds of our money. Their website states:

“In 2011, the first findings from the PACE trial showed that CBT and GET benefit around 60 per cent of patients with CFS/ME”
(http://www.mrc.ac.uk/news/browse/two-effective-treatments-for-cfsme-are-also-cost-effective/)

Then there are Queen Mary University of London and Kings College London who both declare on their websites:
(http://www.qmul.ac.uk/media/news/items/smd/44140.html)
(http://www.kcl.ac.uk/newsevents/news/newsrecords/2011/02Feb/SafeandeffectivetreatmentsforCFSME.aspx)

“Two effective treatments benefit up to 60 per cent of patients with Chronic Fatigue Syndrome or Myalgic Encephalomyelitis”

The 60% figure claimed by these institutions is false.  Furthermore, the claim is in breach of the Declaration of Helsinki and every credible research guideline, including the MRC’s own.

This 60% figure is not just false information about ideas or about objects; it is false information about research participants.  It is not just disrespectful, it is an attack on their person and their autonomy.

Anyone with sincere concern for the welfare of PACE Trial participants, who was in a position to do so, would take steps to correct this false representation of participants as a matter of urgency.

The true figure for participants having a treatment affect in the PACE Trial is 15%.

The 15% figure can be calculated from the data published in the Lancet.  15% is even supported in a statement made by Professor Michael Sharpe*: “We have a number needed to treat; I think it's about seven to get a clinically important treatment benefit with CBT and GET.”  A ‘number needed to treat’ (NNT) of 7, correlates with only 15% of treated patients getting any benefit.
The whole point of doing a Controlled Clinical Trial is the ‘Control Group’.  Their results are subtracted from the treatment arms to give the true treatment effect.  15% is somewhat less than the 60% that is claimed by the MRC, KCL, QMUL; and reports in national and international media who were fed their information by the PACE Trial researchers and the Science Media Centre.
(*http://www.abc.net.au/radionational/programs/healthreport/comparison-of-treatments-for-chronic-fatigue/2993296)

The General Medical Council state in their Good Practice in Research Guide:
·      You must help to resolve uncertainties about the effects of treatments. (Paragraph 14f)
·      Research involving people directly or indirectly is vital in improving care and reducing uncertainty for patients now and in the future, and improving the health of the population as a whole. (Paragraph 70)
·      If you are involved in designing, organising or carrying out research, you must put the protection of participants’ interests first, act with honesty and integrity and follow the appropriate national research governance guidelines. (Paragraph 71)”

When researchers misrepresent data from trial participants, it exploits the trust and generosity of the volunteers and may involve them, most likely against their will and without their knowledge, in misleading other patients, the public and the medico-scientific communities.

Participants are entitled the protection of the Declaration of Helsinki.  Tampering with their data and misrepresenting it breaches their right to autonomy and nullifies Informed Consent.  For example, a PACE Trial participant whose outcome SF36PF score was 60 and Chalder Fatigue Scale score was 18 would evidently be suffering significant illness and restrictions.  How would they feel about researchers claiming that according to their new-fangled criteria, the participant’s health was ‘normal range’?  Did they consent to this?

An SF36PF score of 65 was considered bad enough to JOIN the PACE Trial – so participants could get 5 points WORSE but then be called ‘Normal Range’.  How is that showing respect to participants?

How might this misrepresentation impact on participant’s medical treatment or entitlement to state benefits?  What impact could it have on their trust of medical professionals and researchers?  How might it impact on their moral and social and religious values – that they have been used, exploited in a way that could harm the health and interests of their fellow patients and their families?

PACE Researchers and their institutions affect concern for participants as a ploy to refuse sharing the PACE Trial data; even though for 5 years they have misrepresented those same participant’s data.  It is a particularly sickening hypocrisy.

Peter Kemp MA

https://docs.google.com/document/d/1x5w52E63CZ2OrQ5c0x1rC3jm_dhw_5mi0sONeaWqmvU/edit

Tuesday, February 9, 2016

PACE trial's pseudo science‏

New Age "Science" or Pseudoscience: A Review of Mark Demitrack's and Susan Abbey's Chronic Fatigue Syndrome: An Integrative Approach to Evaluation and Treatment
by Maryann Spurgin, Ph.D.:

The basic thesis of Demitrack's and Abbey's book, Chronic Fatigue Syndrome: An Integrative Approach to Evaluation and Treatment, is that the condition is a post-infectious, but culture-specific, behavioral and interpretive disorder, or at least, it is a condition caused and perpetuated by behavior and interpretation. It occurs in patients who refuse to exercise because they misinterpret their symptoms as severe and as representative of damage to the body. The patients' belief system is responsible for their failure to recover, since it leads to deconditioning, the real source of the patients' debilitation.
According to this thesis, some 2 million people across the country, people whom the book theorizes were often of above-average intelligence before they got sick, developed a viral infection or some other bodily stressor and then, suddenly, their interpretation became skewed. Suddenly they began imagining that their symptoms continued beyond the acute, infectious stage and that those symptoms were severe. Such "attributions" and "cognitions" perpetuate the illness, as does the "attributional bias" of the physicians who take them seriously. The cure, according to the book, is Cognitive Behavioral Therapy, which alters the faulty cognitions and leads to new behaviors such as exercise. Exercise, according to the book, restores the patient to normal.
Elegant prose and cool, clinical language provide the book with an aura of scientific objectivity. Careful examination, however, reveals the book to contain more value-laden rhetoric than logic, more religion than science. Let's examine its authors' cognitions and attributions.
LOGICAL FALLACIES
The book's principle logical errors are (1) fallacy of Undistributed Middle, (2) self-contradictory statements, (3) circular reasoning, and (4) fallacies of division and composition. Let's examine the book's fallacious reasoning by Undistributed Middle. Suppose I made the following argument:
All cats have hair.
All dogs have hair.
Therefore, all cats are dogs. The absurdity of the argument is obvious, since cats are not dogs. It is fallacious to conclude that because two entities share some characteristics, they are the same entity and should be treated the same way. Demitrack employs this fallacious reasoning in his first full chapter, Chapter 4, where he discusses endocrinology and immunology. After an extensive discussion of immunological deficits in CFS, including reductions in Natural Killer (NK) cell function and number, evidence of T-cell activation, impaired cell-mediated immunity, reduced lymphocyte proliferative responses to in vitro mitogen stimulation, and more, Demitrack immediately informs the reader that some of the same immune aberrations appear in major depression, anorexia nervosa, bereavement, and psychological stress. The implied conclusion, of course, and the one the unsophisticated reader walks away with, is that CFS, too, is one of these latter states or something similar to one of these states. As an analogy, on Demitrack's reasoning, one might also conclude that AIDS, too, is not a viral infection or a primary immunological disease, but rather a mood state, since lowered NK cell function is seen in that disease as well. One might, following Demitrack's reasoning, proceed to treat AIDS with psychotropics rather than anti-virals. (The absurdity of doing so is obvious only because we now know it to be both viral and fatal, but prior to knowing this the absurdity is not so obvious.) It is likewise fallacious to conclude that because impaired immunity is a finding in both CFS and some psychiatric disorders, CFS is a psychiatric disorder.
The book artfully interprets the data with regard to endocrinology as well as immunology. Mark Demitrack is known for having compared cortisol levels in CFS patients with those of the melancholically depressed. While raised cortisol levels are a finding in depression, Demitrack discovered that CFS patients express lowered cortisol. Instead of interpreting this finding to mean that CFS patients were unlike depressed patients, Demitrack labors to find an interpretation that would again link CFS to depression: he proposes that there are other depressive states in which lowered cortisol is expressed.
At the same time, the book claims that depression is present in CFS, and that the therapist should assume it, even when the patient denies it and his or her actions do not support it. Indeed, the book goes so far as to say that if the therapist becomes depressed in talking to the patient, the patient is likely depressed. This is a highly subjective way of doing "science" and medicine. It raises this general question: just how vague can a science become without compromising its claim to being science at all? Psychological assessments are often ones that are based on the subjective opinions of the therapist ("I don't like you, therefore you're mental") often with no objective data. In this case, the data show the opposite of what Demitrack and Abbey were looking for, yet get reinterpreted into the old scheme. Where federal funding is concerned, it would appear that no amount of objective data that surfaces showing CFS to be distinct from depression and possibly indicative of viral chronicity and/or infectious or post-infectious neurodegeneration is sufficient to tear down long held subjective beliefs, cognitions, and attributions by federally associated researchers. Indeed, some beliefs just run too deep for reason.
Demitrack's treatise also falls prey to circular reasoning. On page 21, he states that "persistent Epstein Barr virus infection is almost certainly not tenable for most cases of the syndrome." This may be a true statement. But what about some of the cases? Earlier, he admitted that Epstein Barr virus can be a chronic infection and that there are documented cases of chronic Epstein Barr virus infection. Further, those cases meet the CDC case definition for CFS. Elsewhere in the book, Komaroff states that many of the viruses found and implicated in CFS (HHV-6, etc.) can also be chronic. Some of these are known to be serious infections. Yet despite Komaroff's focus on viral chronicity, Demitrack decides to exclude the chronically infected, whom he admits exist, from the CFS picture. He then goes on to exclude patients with any other objective signs of disease. On page 95, for example, he selects out of the definition of CFS those with neurological symptoms and signs. In discussing brain lesions detected by MRI, he urges us to adopt an alternative "interpretation" of this finding:
". . . Although most of the patients [showing MRI abnormalities] appeared to meet the subsequently published clinical criteria for chronic fatigue syndrome, the possibility that an alternative neurodegenerative disease was present in a subset of the group could not be excluded. Indeed, symptoms [were] not typical of most individuals with chronic fatigue syndrome . . . seizures, ataxia, paresis, . . ."
What might these "alternative neurodegenerative diseases" be? Demitrack doesn't say, nor does he tell the reader why he has decided not to focus on them. In short, Demitrack selects out of the definition of CFS anyone with chronic infection, neurological problems, and other objective signs of disease, only to draw the circular conclusion that CFS is neither a chronic infection nor a neurodegenerative disease (but instead a subjective belief system leading to faulty behavior). It is odd that the book accuses patients and their doctors of faulty cognitions when it would seem that, like Straus, Demitrack has failed to master the simple rules of elementary logic, and begs the question to "prove" his conclusions.
It is false that seizures, ataxia, and paresis are uncommon in CFS. They are only uncommon if one defines them as not being part of the CFS pathology. Why in Demitrack's treatise do the more seriously ill drop out of the discussion? Why would he want to exclude the more serious cases from study? Couldn't more be learned from them? The only plausible answer is that learning is simply not a goal here. The seriously ill are excluded from study because they testify against the behavioral hypothesis.
The authors of the book also take to contradicting themselves. For example, the book states that persons with preexisting psychiatric conditions undergo prolonged recovery or fail to recover from viral infections more frequently than persons without such conditions. Empirical studies in psychology have indeed shown that persons with, say, depression, or even persons whose mother died in their childhood and hence are predisposed to pessimism, do develop all forms of illness (cancer, infections, etc.) more frequently than persons without a pessimistic outlook. Yet it is one thing to say that some psychiatric states contribute to prolonged recovery or failed recovery from viral infections or render individuals more susceptible to infections. It is quite another to say -- contradicting oneself -- that having failed to recover from a viral infection they do not have a viral infection. This contradiction occurs repeatedly throughout the book.
Of course, given that the DSM-IV tends to pathologize and clinicize the entire range of human behavior and experience -- everything from clumsiness (315.4) and snobbery (301.7) to snoring (780.59) and coffee drinking (305.90) are mental disorders according to the DSM-IV -- one can easily use the manual to justify a claim that any group had preexisting psychiatric disease. Thus, the view that "most" CFS patients had preexisting psychiatric disorder is highly subjective.
The two chapters in the book on CBT -- one by Simon Wessely and one by Michael Sharpe -- offer a discussion of patients in a tone of profound hostility, misogyny, and disrespect. Patients don't relapse with exertion, Sharpe states, nor does their condition deteriorate following exertion -- that's only an "interpretation." He suggests that the therapist review with the patient the "evidence" for the belief that post-exertional symptoms signify disease progression. The patient should "generate more benign explanations of [symptom] exacerbation," he says, and "regard the symptoms as positive evidence of an effective challenge to the pathophysiology of the illness" (p. 254).
Like Demitrack, Sharpe seems to hold that personal psychology determines reality. If I think I'm well, I am. A benign explanation of the symptoms, simply, makes them benign. Perhaps Sharpe could cure all diseases by applying this simple reasoning: cancer is only cancer if you think it is, likewise with AIDS, and so on. Indeed, perhaps if Sharpe thinks he can fly he won't be squashed when leaping from tall buildings. At the same time, Sharpe seems to hold that symptom exacerbation -- e.g., increased pain, weakness, flu symptoms, blurred vision, hot/cold chills, shaking chills, fainting, vertigo, parasthesias, night sweats, neuropathies, numbness, paralysis, tachycardias, cardiac arrhythmias, and dementia -- are a positive sign, something the editors and contributors of the book also hold. Again, perhaps they could expand their thesis for other diseases: positive signs are what increase arthritis symptoms, increase an AIDS patient's viral load, exacerbate the symptoms of lupus, and so forth. If one follows the reasoning of the book to its logical conclusions, one might seriously begin to question not only the cognitions of its authors but perhaps even their sanity.
Despite his suggestion of reviewing the "evidence" for the belief that symptoms are severe and represent disease progression, Sharpe himself (and the book in general) selectively ignores well-published data showing that exertion is harmful in CFS, data showing exercise-induced neuroendocrine deficits, oxygen deficits, cardiac ischemia and other cardiac involvement, worsened SPECT, IQ drops, etc. (by Cheney, Natelson, Simpson, Lerner, and others). Nor does Sharpe offer studies that confirm his cognition that the patient is misinterpreting his or her symptoms as more severe than they are.
Finally, it is difficult to overlook the striking similarity of Straus's and Demitrack's thesis to the simplistic New Age models of disease that currently saturate the popular media. Demitrack dresses the model in sophisticated prose and seemingly scientific language, but the core thesis is the same: believe yourself well, and you will be. Or, as Demitrack puts it, "the formulation of alternate [i.e., non-infectious] models of disease . . . is imperative to favorable outcome." He suggests that "observer bias" was responsible for the infectious model of the disease in past epidemics, and sees himself as quite unbiased in the view that it's all a matter of how you think -- personal beliefs determine reality: "Greater functional impairment was associated with factors such as the patient's belief in a viral cause [and] . . . the limiting of exercise." It never occurs to the authors that those who think they have a viral infection may actually have one, or that the functional impairment and exercise limitations may be a result of (not a cause of) severe, systemic disease. For them, it is the belief in viral causality that impairs recovery: ". . . the profound disability of CFS may lie in the cognitions of those afflicted" (p. 227). In fact, the book seems to suffer from a philosophical confusion of fact and concept: "Chronic fatigue syndrome is an illness that is formed . . . by the complex context in which it is diagnosed . . ." Demitrack states, in one of his many moments of a dishonest and underhanded version of philosophical idealism. While it may be true that the concept of CFS is formed by diagnostic contexts -- diseases themselves are entities that occur quite independently of conceptual contexts, however close or far away we are from a conceptual grasp of those diseases. This is a point that is lost on -- or perhaps deliberately obscured by -- Demitrack and his contributors. This conceptual confusion also occurs repeatedly in Straus's work (who once stated that the wave of chronic mononucleosis that swept across the U.S. in the 1980's resulted from physicians' misinterpretation of laboratory tests).
The book discourages the search for causes as "futile." It ignores or dismisses all serious attempts to understand the syndrome and offers false information to physicians, dismissing all data that disconfirm its behavioral thesis. Physicians who believe their patients are portrayed as enablers who perpetuate the disease and who themselves have "attributional bias" (the authors are, of course, bias free, as is anyone who adopts the behavioral thesis).
Demitrack, Straus, Abbey, Wessely, and Sharpe are surely and most certainly right that there are behaviors that perpetuate CFS. Unfortunately, they are the very behaviors that these authors recommend. This is a dangerous book that will perpetuate misconceptions at best and, at worst, cause harm. My concern is for children who will suffer abuse at the hands of physicians as a result of this book. Chronic Fatigue Syndrome: An Integrative Approach to Evaluation and Treatment is not a serious, scientific attempt to understand a disease that has crippled adults and children across the country. Instead, it is a poorly reasoned, conceptually confused, biased piece of rhetoric and trendy New Age religion. The authors state that the patients' belief that their disease is a catastrophe is a "mind trap" and a "cognitive error." Perhaps if Demitrack and Abbey had mastered a few elementary rules of logic, they would have fallen into fewer mind traps and cognitive errors of their own.
Maryann Spurgin holds a Ph.D. in philosophy and taught philosophy prior to developing M.E. Her review of Hillary Johnson's Olser's Web appeared in The Nation in 1996.


Wednesday, February 3, 2016

Research by Chalder et al. shows why the trick of using the Oxford criteria in the PACE trial did not work

Research by Chalder et al. shows why the trick of using the Oxford criteria ( so that patients could be included who do not have the disease, ie including patients with depression and other psychiatric disorders and not ME/CFS) in the ME/CFS PACE trial did not improve outcomes ie did not work

@ BMJ:

Research
Facilitated physical activity as a treatment for depressed adults: randomised controlled trial BMJ 2012; 344 doi: http://dx.doi.org/10.1136/bmj.e2758 (Published 06 June 2012) Cite this as: BMJ 2012;344:e2758 * Melanie Chalder, research fellow1 , * Nicola J Wiles, senior lecturer1 , * John Campbell, professor2 , * Sandra P Hollinghurst, senior lecturer1 , * Anne M Haase, senior lecturer3 , * Adrian H Taylor, professor4 , * Kenneth R Fox, professor3 , * Ceire Costelloe, research associate1 , * Aidan Searle, research associate1 , * Helen Baxter, research associate1 , * Rachel Winder, associate research fellow2 , * Christine Wright, associate research fellow2 , * Katrina M Turner, lecturer1 , * Michael Calnan, professor5 , * Deborah A Lawlor, professor1 , * Tim J Peters, professor6 , * Deborah J Sharp, professor1 , * Alan A Montgomery, reader1 , * Glyn Lewis, professor1 Author affiliations *
Correspondence to: M Chaldermelanie.chalder@bristol.ac.uk *

Accepted 22 March 2012

 Abstract
Objective To investigate the effectiveness of facilitated physical activity as an adjunctive treatment for adults with depression presenting in primary care.

 Design
Pragmatic, multicentre, two arm parallel randomised controlled trial. Setting General practices in Bristol and Exeter. Participants 361 adults aged 18-69 who had recently consulted their general practitioner with symptoms of depression. All those randomised had a diagnosis of an episode of depression as assessed by the clinical interview schedule-revised and a Beck depression inventory score of 14 or more.

Interventions
In addition to usual care, intervention participants were offered up to three face to face sessions and 10 telephone calls with a trained physical activity facilitator over eight months. The intervention was based on theory and aimed to provide individually tailored support and encouragement to engage in physical activity.

 Main outcome measures
The primary outcome was self reported symptoms of depression, assessed with the Beck depression inventory at four months post-randomisation. Secondary outcomes included use of antidepressants and physical activity at the four, eight, and 12 month follow-up points, and symptoms of depression at eight and 12 month follow-up.

 Results
There was no evidence that participants offered the physical activity intervention reported improvement in mood by the four month follow-up point compared with those in the usual care group; adjusted between group difference in mean Beck depression inventory score −0.54 (95% confidence interval −3.06 to 1.99; P=0.68). Similarly, there was no evidence that the intervention group reported a change in mood by the eight and 12 month follow-up points. Nor was there evidence that the intervention reduced antidepressant use compared with usual care (adjusted odds ratio 0.63, 95% confidence interval 0.19 to 2.06; P=0.44) over the duration of the trial. However, participants allocated to the intervention group reported more physical activity during the follow-up period than those allocated to the usual care group (adjusted odds ratio 2.27, 95% confidence interval 1.32 to 3.89; P=0.003).

 Conclusions
The addition of a facilitated physical activity intervention to usual care did not improve depression outcome or reduce use of antidepressants compared with usual care alone.

Trial registration Current Controlled Trials ISRCTN16900744

Friday, December 25, 2015

Prof Gelman: More on the PACE (chronic fatigue syndrome study) scandal

Posted by Prof Gelman on 25 December 2015:


Last week we reported on the push to get the data released from that controversial PACE study on chronic fatigue syndrome.
Julie Rehmeyer points to a news article with background on the story:
Patients rapidly discovered serious scientific problems with the 2011 Lancet paper. Despite these errors, the study, known as the PACE trial, went on to inform recommendations from such influential bodies as the Centers for Disease Control and Prevention, the Mayo Clinic, and the British National Health Service. . . .
But just days before the new study was released, on Oct. 21, the San Francisco journalist David Tuller published a major investigation exposing deep methodological flaws in the entire PACE trial that put its validity in serious doubt.
And this time, the new study has been met with intense criticism from outside the world of patients and advocates. On Friday, six researchers, including prominent scientists such as virologist Vincent Racaniello of Columbia University and geneticist Ronald Davis of Stanford University, released an open letter to the Lancet demanding an independent review of the PACE trial.
“The whole study is unbelievably amateur,” says Jonathan Edwards, a biomedical researcher at University College London who signed the letter. “The trial is useless.”
Rehmeyer reports on a lag between the scientific community and medical practice:
The PACE trial has exerted a strong influence on American physicians: If you ask your doctor about CFS, odds are good you’ll hear that cognitive behavioral therapy (the flavor of psychotherapy used in the trial) and exercise are the only proven treatments for CFS.
The American scientific research community, on the other hand, has rejected the psychiatric model that PACE epitomizes and is instead looking for physiological explanations for the disease.


MORE @ andrewgelman.com

PS: Andrew Gelman is a professor of statistics and political science and director of the Applied Statistics Center at Columbia University.



Wednesday, December 23, 2015

Just when you think it can't get worse, more shocking PACE trial revelations‏


From Margaret Williams : further details about PACE Trial data security. Permission to repost.

"Two points merit further consideration: (i) the matter of guaranteed confidential storage of PACE trial data and (ii) the Principal Investigators’ undeclared conflict of interest until after the consent forms were signed by participants.

The PACE trial Protocol published in BMC Neurology on 8 March 2007 was an abridged version
but, as noted by Alem Matthees, the Full Protocol (226 pages) states on page 110:
“Your GP and any other doctors you are consulting will be told you are joining our study. And occasionally, other researchers will need to see your notes so they can audit the quality of our work. An audit might be run by one of the universities helping with our study or hospital regulatory authorities, or by one of the organisations funding our study” http://www.meactionuk.org.uk/FULL-Protocol-SEARCHABLE-version.pdf

What Matthees did not mention was the fact that one of the organisations funding the study was the UK Department for Work and Pensions (DWP). How many participants looked at the funding bodies before signing the consent forms and realising to what they were giving their consent?
Quite how “confidentiality” could be guaranteed if the DWP had access to the data has never been explained, especially as ME/CFS is known to be a targeted disorder for the withdrawal of state benefits, with patients being harassed by the DWP who required a 60-page form to be completed because the DWP menacingly informed such patients: “We have reason to believe that you are capable of work”.
If the PACE trial therapists and Investigators deemed a participant “recovered” enough to resume work, then might that participant quickly discover that the DWP stopped paying benefit? The PACE Trial has been described as a “Trojan horse” for the DWP.
Regarding the secure storage of data, the Full Protocol is unambiguous:
“Will you keep my details confidential?”
“Yes. All your details and all recordings will be kept strictly confidential and held in a locked filing cabinet or on a secure computer. People on our research team will only see your records if they need to for the research”.
The DWP was not involved in research but still had participants’ signed permission to access their records/data.

From the outset, recordings were not kept in a locked filing cabinet: some were stolen and thus lost to review (see previous post on 19th December 2015: https://jcoynester.wordpress.com/2015/12/18/kings-college-london-stalls-some-more-reiterating-refusal-to-release-the-pace-trial-data/#comment-1375
 ).

The Consent Form 1 for baseline assessment which participants were required to sign was clear:

“3. I understand that any of my medical notes may be looked at by responsible individuals from either the trial or regulatory authorities where it is relevant to my taking part in research.

4. I give permission for these individuals to have access to my records.
…

14. I understand that information collected about me for the trial, including my personal details, a copy of this consent form and all of the questionnaires I complete for the trial, will be held securely by the local trial staff and at the PACE trial centre at Queen Mary, University of London. I give permission for this to happen”.
The PACE PIs obtained participants’ consent on the promise of keeping trial data secure, yet they had made no provision to do any such thing.
When the PACE Trial had been running for two years, the Participants’ newsletter (Issue 1, June 2006) reaffirmed that the trial data was safe: “The information is being entered onto a large and secure database, designed and maintained by an independent clinical trial unit at King’s College, London”. This was provided for participants even though the PIs knew that trial data had already been stolen (see previous post #‎comment
-1375).

In relation to the PIs’ undeclared conflict of interest, one of the pre-trial assessments was at Baseline Visit 1; this set out to collect personal data that seems to have little bearing on a clinical trial but could be of value to the DWP and the permanent health insurance industry because the collected data included not only the customary demographic details, date of birth, age, sex, ethnicity, marital or partner status, years of education, occupation (the latter would obviously afford information about a participant’s earnings) but also very detailed questions about participants’ permanent health insurance payments, for example, questions on page 172 ff of the Full Protocol included the following:
“Do you currently receive income protection benefit (income protection or total and permanent disability)?”
“ If yes, how much annually do you receive? £”
“If the participant chooses not to give an answer, please use the prompt card to show income brackets, and record the letter [an alphabetical letter designating an income bracket] that corresponds to the participant's income”.

“Do you currently receive a private medical / retirement pension?”
“If yes, how much weekly do you receive? £
OR
If yes, how much monthly do you receive? £
OR
If yes, how much annually do you receive? £”

“If the participant chooses not to give an answer, please use the prompt card to show income brackets, and record the (alphabetical) letter that corresponds to the participant's income”.

“In the past six months, have you received any one-off payments from income protection or insurance schemes as a result of your health?”

Such specific questions have no clinical relevance but would be of interest to the Chief PI of the PACE trial in his dual role as the re-insurer Swiss Re’s Chief Medical Officer.
As detailed by David Tuller, participants could not give fully informed consent because the PIs’ Iong-standing involvement with the permanent health insurance industry was never disclosed to them. Indeed, it appears that this significant conflict of interest was not initially disclosed even to the Trial Steering Committee: at the meeting on 22nd April 2004, all members present were asked to declare any conflict of interest. It was minuted that no financial conflicts of interest were declared and it was agreed that no-one present had any other substantial or material conflict relevant to their work on the PACE Trial. Amongst those present were Professors Peter White, Michael Sharpe and Trudie Chalder, all of whom worked for the permanent insurance industry. There was a brief mention of paid consultancy work done by the PIs in the BMC Neurology version of the Protocol, which was long after signed consent forms had been obtained."


Saturday, December 19, 2015

Principal investigators of PACE and FINE trial were involved in writing Cochrane review protocol to review their own trials ...


King's College wrote to professor James Coyne that they did release PACE trial data for the Cochrane review (by Larun et al.).

What they forgot to mention is that the three principal investigators of the PACE trial, just like the principal investigator of the FINE trial, it's sister trial, were involved in writing the protocol for the Cochrane review of their own trials ...
(http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD011040/full)

And the principal investigator of the FINE trial, was also part of the PACE trial group
Trial Steering Committee ...

 That in essence is Cochrane's impartiality ...


Saturday, December 12, 2015

Vexatiousness, a Multisymptom Affective Disorder, aka M.A.D.

Abstract
Vexatiousness, a Multisymptom Affective Disorder, also known as M.A.D., is a disabling disorder of unknown cause, highly prevalent in a subgroup of British Psychiatrists. It's symptoms do not remit with rest, are made worse by requests for unreleased data from the PACE trial and there are a number of ways to define the condition. A few examples of the different triggering factors and manifestations of the disorder are mentioned below but it's important to realize that they can all be part of the same disorder.



The most common triggering factors of vexatiousness are:
Any request to release data, because according to research policies, data is supposed to be kept and stored safely for 10 years. Kept is from the verb to keep, which means you keep it yourself and you do not release it. Furthermore it's not in the public interest to find out that patients are right and psychiatrists are wrong for the umpteenth time in medical history

Assuming that the PACE trial is a mediating factor to please insurance companies some of the principal investigators work for

Not understanding that being ill or disabled is a form of recovery

Being interested in the full data of the subjective and objective outcomes of the PACE trial

Assuming that the CBT psychiatrists suffer from a severe case of evidence phobia driven by secondary gains

Trying to use a deconditioner, developed in Oxford to rigorous specifications, to recover from your exercise phobia and when it doesn't work ask for release of data from the PACE trial

Several meta-analyses of CBT and GET indicate moderate benefits for the affected psychiatrist from these treatments. Recovery from Vexatiousness without treatment is reported to be uncommon as a systematic review found that only 7% recovered over time but measurement of recovery could involve many domains and within the trial context these include reading requests for data release and measuring how the psychiatrists respond to it.

In this context it is important to note that many psychiatrists who are suffering from this disorder experience a request for release of data as a death threat.

Common symptoms of Vexatiousness include being afraid of patients who are bedridden and dependent on others, hysterical responses to normal questions, peer-review allergy, medically unexplained ignoring of evidence, and panic attacks when release of PACE trial data is mentioned.

Specialist doctors and therapists worked with affected psychiatrists to help monitor activity and symptoms, aiming to improve quality of life and create the best conditions for remission.

All requests for release of data were medically assessed by the affected psychiatrists who used the structured clinical denial form in accordance with the intent of the Oxford criteria to make sure that every request could be classed as vexatious.

The Dr Speedy Multicentre Research Ethics Committee ( DSMREC 93.3 ) approved the study. As with any trial conducted by Dr Speedy, thanks to his hypersensitivity to light he is already masked which is very practical in a randomized controlled trial even though psychiatrists might class this as a form of secondary gains.

All requesters were given an answer to deny their request consistent with vested interest psychiatry, as presently recommended by the principal authors of the PACE trial and Queen Mary from London. This is an important addition because other Queen Mary's who value transparency of research and science might well have another opinion on this matter.

The clinical global impression cumulative hierarchy of request denial was applied combined with the resulting odds ratios and 100% confidence intervals adjusted for the stratification variables to make sure that no request slipped through the net.

Both self-report and objective measures were used, and both were found to mediate the denial to release data, lending credence to the definitions of vexatiousness as mentioned above.

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