Tuesday, February 16, 2016

Nice explanation of PACE trial nonsense and Wessely psychiatry

Nice explanation of PACEtrial nonsense and Wessely psychiatry by @dwbarlow: "If the only tool you have is a hammer you tend to see every problem as a nail"

Saturday, February 13, 2016

Dr Esther Crawley acknowledges in the MAGENTA protocol that ME/CFS patients will not benefit from graded exercise therapy


The MAGENTA trial aka the PACEtrial for children involves "Children between 8 and 17 years old who have been diagnosed with CFS/ME." So they will be experimenting and using their unethical and harmful treatment on 8 year olds ...

"The aim of this study is to find out how successful and cost-effective GET is ... in children" with ME/CFS.
We do know that subjective outcomes are not reliable so what does the magenta trial use?  "The children and their parents are then interviewed in order to judge how well the treatment is working." So no objective measures are used as usual ... However the principal investigator of this trial also writes that "What are the possible benefits and risks of participating? Participants will not benefit directly from taking part in the study" which means that children with ME/CFS who are getting treated with GET will not benefit from it ... Why waste a million £££ on it if she already knows that the treatment doesn't work ?? If you don't know the answer to that question just read on or scroll down ...

Furthermore GET causes severe relapses if patients do have ME/CFS unless the diagnosis is wrong or people are in remission which happens in 5 to 7% but even they have to be careful with exercise therapy. So if you subject people with ME/CFS to exercise therapy you are basically torturing patients. Yet what do they write in the protocol? "it may prove enjoyable contributing to the research. There are no risks of participating in the study."
So if you acknowledge that the treatment doesn't work like the principal investigator Dr Esther Crawley is doing in the protocol then you are basically wasting shedloads of money to make sure that people with this debilitating neuroimmune disease do not get proper treatment; shameful doctoring as usual from the denial Brigade who have been ignoring evidence for decades. And according to medical boards doctors should not ignore evidence which goes against the duties of a doctor ... Which means that the denial Brigade should be suspended or struck off ...
You can read the delightful protocol here: http://www.isrctn.com/ISRCTN23962803

Thursday, February 11, 2016

"I’m tired of having to counter the same propaganda ad nauseum."

"I’m exhausted by the politics and the endless endless lies and spin. I’m tired of having to counter the same propaganda ad nauseum." YES that sounds like the denial psychiatrists Simon Wessely, Peter White, Michael Sharpe, Trudie Chalder and their PACEtrial propaganda but as a matter of fact it's from the juniordoctorblog explaining why they strike.

Just posted this on Action for ME Facebook site to get behind the PACE trial data sharing

Well guys it's pretty simple you take a big black marker and you anonimise the data; when patients signed the consent form to take part in the trial they consented for the data to be released in an anonymous way to independent researchers etc; if however some patients change their mind you just exclude their data from release. It's that simple. And as you probably know patients can withdraw their consent at anytime. It's time that you as Action for ME take a stand against the BAD PACE trial "science" which is hurting hundreds of thousand people worldwide.

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

Tuesday, February 2, 2016

PACE and geocentrism -- both on the wrong side of science



  By ELLA Peregrine:

  Recently, David Tuller, James Coyne, Vincent Racaniello, and some other non-invested scientists and writers have been looking more carefully into the claims and relative lack of transparency of the UK’s expensive and influential PACE trial. Those interested in the question of data sharing in research have been drawn in, because of the ongoing refusals by PACE researchers of requests for de-identified data to analyze. Last week quite a stir was raised when Nature published an argument for avoiding data sharing in which patients and scientists questioning the claims made by PACE authors were equated with tobacco industry supporters and climate change deniers. Although the editorial was not written by a member of the research group responsible for PACE, there are traceable connections between the authors.

  Following their ongoing (and previously very effective) narrative of victimization and infallibility, the PACE defenders have made a quantum leap in their willingness to twist reality to serve their purposes. Climate change deniers and tobacco control opposition are funded by the deep pockets of industries under threat from emerging science, and represent the status quo of money and power in their respective fields. White, Chalder, Wessley and company have much more in common with climate change deniers (aka the fossil fuel industry) financially, culturally, and politically, than with the scientists desperately trying to illuminate an emergent and critical threat to life and health.

  The PACE group has been buttressing up their version of reality for years, against substantive and copious emerging science showing that their stance is at best ineffective and at worst, extremely harmful. This has been done largely through unsubstantiated claims of being attacked or harassed, and never with purely objective findings. Their contention is that ME and/or CFS, (whichever disease they’re claiming to study at the time) are caused by “false illness beliefs” – that these diseases are primarily treatable with exercise and psychological training to ignore physical symptoms.

  Further, their research outcomes are used to cement policy and public belief that prevents insurers, other researchers, the government, physicians and family members of the sick from looking beyond the psychological for etiology, treatment, or support. These claims and the way they are backed up by the medical, political, and insurance-industry establishment are causing untold suffering and costing patients their lives.

  This idea that patients and scientists who question the strength and legitimacy of the PACE claims are somehow like the tobacco industry, though, it just had to be addressed. Finally, the appropriate analogy arose. This group of psychologists, without any actual proof that “false illness beliefs” can even be the cause of the disease called ME or CFS, they are like the Catholic Church in the time of Gallileo. They just “know” (believe!) that they’re right, and they’ve been telling everyone who will listen this same story for years, insistently, without even an iota of credible reflection on evidence to counter their belief. What's even more important, public policy is based on their “facts” – which are unassailable so long as they can keep those data hidden.

  Ironically, despite their self-identification as scientists, they are behaving like the power structure of the church – trying to silence or excommunicate anyone who crosses them, and hiding evidence that their claim of divine knowledge may in fact be incorrect. But the church didn’t stand alone, and neither does this group. The government, the media, the insurance industry – all collude in this story-telling, this clinging to an incorrect belief in the face of mounting scientific (biomedical, not psychological) evidence.

  If PACE has to be retracted, so will many other papers. A knighthood may be rescinded; high-paying insurance industry consulting fees may be lost. Expensive medical research will have to be funded, insurance companies and social support networks will have to acknowledge that the disability is legitimate, and patients will have to be treated with the respect and care that sufferers of diseases like cancer and MS receive. Their defensive clinging is to power, status, and money, not to truth. If they wanted truth, they’d release the data.

  Eventually, as with Galileo, science will win. The question now is, how long will patients be left on the rack of medical neglect due to this rampant anti-science belief, and how many more will die, before the unscientific claims of PACE will be torn down?

We know the earth isn't the center of the solar system, and we know that exercise doesn’t cure people with ME. It’s just a matter of time before the power structure lets go of the second false belief.

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