Saturday, June 25, 2016

Professor Hanson: further evidence against the ridiculous concept that ME/CFS is psychological


Professor Maureen Hanson: "our detection of a biological abnormality provides further evidence against the ridiculous concept that the disease is psychological in origin"

By Krishna Ramanujan, June 24, 2016, Cornell University:

  ksr32@cornell.edu

  Indicator of chronic fatigue syndrome found in gut bacteria

  In a study published June 23 in the journal Microbiome, the team describes how they correctly diagnosed myalgic encephalomyeletis/chronic fatigue syndrome (ME/CFS) in 83 percent of patients through stool samples and blood work, offering a noninvasive diagnosis and a step toward understanding the cause of the disease.

  “Our work demonstrates that the gut bacterial microbiome in ME/CFS patients isn’t normal, perhaps leading to gastrointestinal and inflammatory symptoms in victims of the disease,” said Maureen Hanson, the Liberty Hyde Bailey Professor in the Department of Molecular Biology and Genetics and the paper’s senior author.

  “Furthermore, our detection of a biological abnormality provides further evidence against the ridiculous concept that the disease is psychological in origin,”

  More @ cornell.edu

Friday, June 3, 2016

Ester Crawley given a million pounds to replicate FITNET's NULL effect


Ester Crawley given a million pounds to replicate FITNET's NULL effect

http://www.nets.nihr.ac.uk/projects/hta/14192109

Ester Crawley's Study will be based on the following Dutch study also called FITNET which ignored their own NULL effect just like the PACE trial did.




Because it's obviously more important to make sure that people who are severely ill do not get proper treatment and to make sure that their kingdom which is based on fake tan doesn't come tumbling down. The Sad State of Affair of greed and denial medicine ...

  Nijhof SL, Priesterbach LP, Uiterwaal CS, Bleijenberg G, Kimpen JL, van de Putte EM, Internet-based therapy for adolescents with chronic fatigue syndrome: long-term follow-up. Pediatrics. 2013 Jun;131(6):e1788-95. doi: 10.1542/peds.2012-2007. Epub 2013 May 13.

  ( Bleijenberg G aka the Dutch Peter D White or Simon Wessely and van de Putte EM aka the Dutch Ester Crawley)

  "Cognitive behavioral therapy (CBT) is known to be an effective treatment of adolescents with chronic fatigue syndrome (CFS), but its availability is limited." No it's not known to be effective but they want us to believe it is effective which is a totally different thing ... The reality is, as a recent review of the PACE trial showed, that CBT and GET are totally useless !!! But the BIG LIE must obviously continue ...

  "Fatigue in Teenagers on the Internet (FITNET), an Internet-based CBT program for adolescents with CFS, has been developed as an alternative to face-to-face CBT. Recently, its short-term effectiveness has been proven in a randomized clinical trial. Here we aimed to assess the long-term outcome of CFS in adolescents after FITNET treatment and after usual care."

  "Conclusion: The short-term effectiveness of Internet-based CBT on adolescent CFS is maintained at LTFU. At LTFU, usual care led to similar recovery rates, although these rates were achieved at a slower pace."

  "At LTFU, usual care led to similar recovery rates" aka as a NULL effect ...

  http://www.ncbi.nlm.nih.gov/pubmed/23669515

 

Tuesday, May 17, 2016

Unexpressed feelings towards lying psychiatrists? Then here is the reason why ...

Unexpressed feelings towards lying psychiatrists? Then here is the reason why ... If you have some unexpressed feelings towards lying psychiatrists like Simon Peasley, Pizza White, Michael Blushing and Trudies Itchyshoulder then here you can read why you have them ... Please make sure you have got a bucket ready otherwise you will need some urgent CeeBeeTea If you are really desperate then here is the link to the study http://psycnet.apa.org/psycinfo/2016-23898-001/

Wednesday, April 20, 2016

Great letter by Professor Hooper asking for retraction of the PACE trial 

Great letter by Professor Hooper asking for retraction of the PACE trial via meactionuk.org.uk, April 15, 2016:

  Dear Dr Horton,

  I write to call again for the retraction of the PACE study paper by White PD et al. (Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. "Lancet "2011;377:823-836).

  MORE @ meactionuk.org.uk

 

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

Tuesday, March 29, 2016

RIP Mr Cicero; German jazz singer Roger Cicero has died after being diagnosed with ME/CFS #PACEtrial #NOmorePsychiatricLIES


RIP Mr Cicero; German jazz singer Roger Cicero has died after being diagnosed with #MEcfs #PACEtrial #NOmorePsychiatricLIES

  dw.com, Mar 29, 2016:

  Germany's best-known jazz performer has died after being diagnosed with chronic fatigue syndrome. His career spanned almost 15 years, making him one of Germany's most beloved musical celebrities.

Friday, March 25, 2016

Thursday, March 24, 2016

#PACEtrial Psychiatry is much worse than #DiederikStapel psychology: Two great articles about the seriously flawed PACE trial

Two great articles about the seriously flawed PACE trial

  Editorial: On PACE by Trevor Butterworth, Mar 21, 2016: "And the thing about patients who either suffer from a rare disease, or a more common and inexplicable one as with ME/CFS, is that they are usually a formidable resource—a network of distributed experts who have sifted and weighed the scientific research with the kind of avidity you would expect, given that their lives depended on it. In pharmacology, rare disease patient groups are highly respected and are seen as partners in research rather than just subjects and consumers of studies."

  MORE @ stats.org

  AND

  PACE: The research that sparked a patient rebellion and challenged medicine by Professor Rebecca Goldin, Mar 21, 2016 :

  "The results from PACE (including these) have been published in prestigious journals and influenced public health recommendations around the world; and yet, unraveling this design and the characterization of the outcomes of the trial has left many people, including me, unsure this study has any scientific merit. How did the study go unchallenged for five years? And how could journalists have recognized the problems before reporting unqualified, but unjustified, good news?"

  MORE @ stats.org

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

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