Showing posts with label GUIDELINES. Show all posts
Showing posts with label GUIDELINES. Show all posts

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.

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

Monday, December 28, 2015

Thursday, July 23, 2015

Research shows graded exercise therapy causes exercise intolerance and makes things worse in ME/CFS

@ PubMed:

  Dyn Med. 2005 Oct 28;4:10. Time course of exercise induced alterations in daily activity in chronic fatigue syndrome. Black CD1, McCully KK.

  Author information  * 1Department of Kinesiology, The University of Georgia, Athens, GA, USA. blackcd@uga.edu

  Abstract
In a previous study we demonstrated that while people with CFS had lower daily activity levels than control subjects, they were able to increase daily activity via a daily walking program.

  We reanalyzed our data to determine the time course of activity changes during the walking program. Daily activity assessed via an accelometer worn at the hip was divided into sleep, active, and walking periods. Over the first 4-10 days of walking the subjects with CFS were able to reach the prescribed activity goals each day. After this time, walking and total activity counts decreased.

  Sedentary controls subjects were able to maintain their daily walking and total activity goals throughout the 4 weeks.

  Unlike our previous interpretation of the data, we feel this new analysis suggests that CFS patients may develop exercise intolerance as demonstrated by reduced total activity after 4-10 days.

  The inability to sustain target activity levels, associated with pronounced worsening of symptomology, suggests the subjects with CFS had reached their activity limit.

  FREE PMC article

 

Friday, July 10, 2015

My response to the medically unexplained nonsense from Professor Moss Morris



  Dear Professor Moss Morris,

  as a doctor who has been bedridden for more than a decade with ME/CFS, the result of a major Relapse caused by harmful graded exercise therapy, which breaches the do No Harm principle of the GMC, I'm always amazed that doctors and other medical professionals in this day and age of the computer, where you can read up on all the evidence sitting behind your computer using PubMed, totally ignore all the evidence that what they say is wrong. On the other hand I shouldn't be so surprised as in the first part of your post you write that you are from Kings College and that's where the top dog of Pinocchio psychiatry resides who has been deliberately ignoring clinical evidence for decades that what he says is wrong, to the detriment of people with severely disabling neuro immune diseases.

  In Good Medical Practice, duties of a doctor, the GMC makes it's perfectly perfectly clear that not keeping up to date with the current evidence is unacceptable, unfortunately that is what you and the Pinocchio Psychiatrists are doing when you ignore all the evidence that ME/CFS is a debilitating physical disease and call it a medically unexplained disease instead.

  What is medically unexplained is that people like yourself totally ignore evidence. Or as Dr Shepherd, the honorary medical adviser of the ME Association recently wrote: "Failure to keep up with the research on ME/CFS is 'inexcusable'" http://www.meassociation.org.uk/2015/06/failure-to-keep-up-with-the-research-on-mecfs-is-inexcusable-our-letter-to-the-times-8-june-2015/

  As professor Hooper wrote a few years ago when does ignoring evidence become serious professional misconduct ? It's clear that the Pinocchio Psychiatrists have crossed that line a long time ago. Please do keep in mind that evidence that something is psychosomatic or all in the mind, because that's basically what you say when you call a disease medically unexplained, does not exist.

  Or to use the words of exercise physiologist professor Keller: "Given what we have learned in the past eight years about this illness, it is intellectually embarrassing to suggest that ME is a psychological illness."

  A Danish study showed a few days ago that the quality of life for people with this disease is the worst when compared with 20 other diseases, including a number of cancers, chronic renal failure, ischaemic heart disease etc. This also makes it perfectly clear that the current "treatments", ie CBT and GET, are at best totally useless.

  It would be "nice" if you change your post in line with all the current evidence that ME/CFS is a debilitating physical disease, and not a psychological or psychiatric disease, as the prestigious American Institute the IOM recently concluded after an extensive review of the literature.

  Instead of ridiculing and belittling us with psychosomatic nonsense it's more than time that we get proper treatment so we get our health and independence back, can come off benefits and go back to work.

  For your information Prof Mella, a Norwegian oncologist and his team recently published their latest study which not only suggests that ME/CFS is an autoimmune disease but also shows that two thirds of responders to the cancer drug Rituximab, are still in remission at the 36-month follow-up.

  So not medically unexplained but a debilitating neuro immune disease. More than time that you and Kings College get up to date with the current evidence instead of ignoring it, which is inexcusable, breaches the GMC guidance and constitutes Bad Medical Practice.

  Kind regards,

  Dr Maik Speedy

 

  #     Exercise physiologist Prof Keller: "Given what we have learned in the past eight years about this illness, it is intellectually embarrassing to suggest that ME is a psychological illness."

  #     Professor Hooper: When does ignoring evidence by doctors become serious professional misconduct ?

  #     Prof Edward Shorter and the psychic epidemic of ignoring clinical evidence

  #     Evidence that a disease is psychosomatic doesn't exist

  #     Massachusetts Medical Society's NEJM Journal Watch: "There is still no cure, or even any reliably effective treatment, for CFS"

  #     Editorial in Jacobs Journal of Physiotherapy and Exercise: it is essential to protect ME patients against harm by exercise regimes

  #     Rituximab maintenance infusions leads to prolonged disease remission in ME/CFS

  #     Immunological Similarities between Cancer and Chronic Fatigue Syndrome

  #     Danish study finds patients with MEcfs have the lowest health-related quality of life of 21 conditions looked at which means / confirms that CBT and GET are at best totally useless 

 

Wednesday, June 17, 2015

P2P final report: the Oxford definition impairs progress, may cause harm and should be retired, just like the PACE trial that used them

@ Ann Intern Med., 16 June 2015:

  "Furthermore, the multiple case definitions for ME/CFS have hindered progress. In particular, continuing to use the Oxford definition may impair progress and cause harm. Therefore, for progress to occur, we recommend that this definition be retired; the ME/CFS community concur on a single case definition (even if it is not perfect); and patients, clinicians, and researchers agree on a definition for meaningful recovery."

Tuesday, June 16, 2015

Countess of Mar to Dr O'Sullivan: it is intellectually embarrassing to ignore all the evidence that ME/CFS is a serious neuro-immune disease

Countess of Mar response to Dr O'Sullivan.pdf

Countess of Mar to Suzanne O'Sullivan in response to the chapter about ME in 'It's All in Your Head: ....'.


Permission to Repost

(Header unable to copy)

Dr SuzanneO’Sullivan
NationalHospital for Neurology and Neurosurgery
33 QueenSquare
LONDON
WC1N 3BG

9 June 2015



Dear DrO’Sullivan

I write toyou as an Independent crossbench member of the House of Lords where I have been since 1975. I am a Deputy Speaker in the House. For more than 20 years I have represented the interests of people with ME/CFS and other MUPS. I am patron of several ME charities and Chairman of Forward-ME.

I have read David Aaronovitch’s review of your book: “It’s all in Your Head – True Stories of Imaginary Illness” and I have listened to what you had to say on Radio 4’s Start the Week programme yesterday, though I have not read your book.Aaronovitch quotes you in the introduction to the chapter on ME as admitting that “to include ME/CFS in a book primarily concerned with the description of those suffering from psychosomatic illness is foolhardy to say the least.” He goes on to say that “This is because the reaction of many ME sufferers, their relatives and friends and the organisations that represent them, to the idea that the condition is psychosomatic – caused by the mind and not by a disease –is intensely hostile. I have experienced this hostility.” I assume the last sentence refers to him personally.

Sadly, both you and he are right about the hostility to the views you both promote, but you give the wrong reasons for that hostility. In recent years there have been a host of papers that demonstrate that ME/CFS is a disease as well as an illness.Firstly the Canadian Consensus document on ME/CFS, published in 2003, gave good guidelines for diagnosis and treatment of people with ME. This was followed by the more comprehensive Myalgic Encephalomyelitis - International Consensus Document published in 2011. More recently, the highly respected US Institute of Medicine in its report “Beyond Myalgic Encephalomyelitis/ Chronic fatigue Syndrome: Redefining the Illness” released on 10 February 2015, made clear that the primary message of the Committee’s report is that “ME/CFS is a serious, chronic, complex systemic disease that often can profoundly affect the lives of patients.”  Patients with the disease have always known this and are, understandably, deeply hurt and offended by the denigration they receive from some medical practitioners.

I admire the fact that you believe that people who suffer psychosomatic illnesses should be treated with compassion and understanding but I am equally disappointed that you appear to have failed dismally to keep abreast of current research into ME/CFS.  Had people like you in senior positions really tried to discover what is at the root of the symptoms suffered by the patients that you see more progress might have been made in the diagnosis and treatment of this dreadfully neglected disease.

For example,on 30 May this year in Metabolomics Armstrong et al wrote: “Metabolic profiling reveals anomalous energy metabolism andoxidative stress pathways in chronic fatigue patients.” Have you ever thought of metabolic profiling for your profoundly fatigued patients, I wonder? I do realise that there are vast numbers of papers of variable quality published each year, but I really do think that if one is professing an expertise in a particular disease or illness one should try to keep abreast of current research, don’t you?

You appear to be unaware that research shows that ME is an organic multi-system neuro-immune disorder with protean symptomology; some consider it likely to bean autoimmune disease with the target organ being the vascular endothelium.

For the avoidance of doubt, here are some facts that may have escaped you:

·        Since 2005 ME has been included in the UK National Framework for long-term neurological conditions.
·        On 30 January 2006 the then health Minister,Lord Warner, said on record: “There is only one World Health Organisation International Classification of Disease code for chronic fatigue syndrome/Myalgic encephalomyelitis, which is G93.3.” (HL3612)
·        On 2 June 2008 the Parliamentary Under-Secretary of State, Department of Health (Lord Darzi of Denham) stated: “My Lords, the Government accept the World Health Organisation’s classification of CFS/ME as a neurological condition ….MyLords, I have acknowledged that CFS/ME is a neurological condition.” (HLPQ:Health: Chronic Fatigue Syndrome/Myalgic Encephalomyelitis)
·        On 21 November 2011 Lord Freud, Minister fo rWelfare Reform, confirmed in a letter to me that the Department for Work and Pensions does not consider ME/CFS to be a mental disorder. The letter was unequivocal: “the Department of Health has indicated that they have ‘always relied on the definition set out by the World Health Organisation in its International Classification of Diseases (ICD)under the ICD code G93.3, subheading other disorders of the brain’. The DWP isin agreement with this view. Therefore, for the avoidance of doubt, I can be clear that the Department does not classify CFS/ME as a mental health disorder.”
·        The US National Institutes of Health, one of the world’s foremost medical research centres, convened a Pathways of Prevention working group which, in December 2014, published its draft Statement entitled“Advancing the Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome”.It is an important document as it signifies a major change in attitude towardsME/CFS. For example:
“Strong evidence indicates immunologic and inflammatory pathologies, neurotransmitter signalling disruption, microbiome perturbation, and metabolic or mitochondrial abnormalities in ME/CFS.
“This is not a psychological disease in aetiology.
“fMRI and imaging technologies should be further studied as diagnostic tools and as methods to better understand the neurologic dysfunction of ME/CFS.”

As a neurologist, I am sure you will find theseviews of interest.

Further research from the US posits that true ME(as distinct from the ubiquitous chronic “fatigue”) is indeed an autoimmune disorder: “Our results indicate a markedly disturbed immune signature in the cerebrospinal fluid of cases consistent with immune activation in the central nervous system, and a shift towards an allergic or T-helper type-2 pattern associated with autoimmunity….Profiles of ME/CFS subjects also differed from those of MS subjects, withME/CFS cases showing a markedly greater degree of central nervous system immuneactivation as compared with those with MS” (M Hornig et al: Molecular Psychiatry 31 March 2015: doi:10.1038/mp.2015.29)

The evidence is now so strong that ME/CFS is a serious multisystem neuro-immune disease that it becomes intellectually embarrassing for anyone to continue to consider it to be a psychosomatic disorder.  


I do hope that you will take my submission seriously and reconsider your belief thatME/CFS is a psychosomatic disorder.

I look forward to receiving your considered response.

Yours sincerely


Countess ofMar

Copy: DavidAaronovitch.

          Chatto and Windus – Lisa Gooding,Publicity.


Countess of Mar response to Dr O'Sullivan.pdf

Tuesday, April 28, 2015

The new diagnostic criteria for SEID are based upon important methodological shortcomings

@ informahealthcare.com, April 27, 2015:

A critical analysis of the proposal of the Institute of Medicine to replace Myalgic Encephalomyelitis and Chronic Fatigue Syndrome by a new diagnostic entity called Systemic Exertion Intolerance Disease Posted online on April 27, 2015. (doi:10.1185/03007995.2015.1045472) Frank NM Twisk ME-de-patiënten Foundation, The Netherlands Address for correspondence: Frank NM Twisk MBA BEd BEc, Zonnedauw 15, 1905 HB Limmen, The Netherlands. Tel. +31-72-505 4775; frank.twisk@hetnet.nl Abstract

 The Institute of Medicine (IOM) recently published their report in response to an assignment ‘to define diagnostic criteria for Myalgic Encephalomyelitis (ME)/chronic fatigue syndrome (CFS), to propose a process for reevaluation of these criteria in the future, and to consider whether a new name for this disease is warranted’. The basic preassumption of the IOM committee for the development of evidence-based diagnostic criteria for ME/CFS was that ME and CFS denote conditions with similar symptoms, hence ME/CFS.

The IOM committee recommends
1) that ME/CFS will be renamed “systemic exertion intolerance disease” (SEID); and that a new code should be assigned to SEID in the International Classification of Diseases (ICD), replacing the existing codes for ME (a neurological disease: G93.3) and CFS (“signs, symptoms, and abnormal clinical and laboratory findings, not elsewhere classified”: R53.82).

2) that a diagnosis SEID should be made if the new diagnostic criteria are met;

3) that the Department of Health and Human Services develops a toolkit appropriate for screening and diagnosing patients; and

4) that a multidisciplinary group re-examines the new diagnostic criteria when necessary.

This editorial reviews the working procedure of the IOM and two of the outcomes: the recommendation to introduce a new clinical entity (SEID) and new diagnostic criteria.

Based upon the contents of the report, and the arguments of the IOM, a search of PubMed and the archive of the Journal of Chronic Fatigue using the search terms ME (and old synonyms) and CFS, and a search of PubMed related to the five core symptoms of SEID was conducted.

Reviewing the working method and the recommendations, it is concluded that the new diagnostic criteria for SEID are based upon important methodological shortcomings and that the introduction of SEID to replace both ME and CFS has several profound negative consequences outweighing the advantages.

Keywords Myalgic Encephalomyelitis, chronic fatigue syndrome, systemic exertion intolerance disease, diagnosis, assessment, methodology

Friday, February 14, 2014

Are Myalgic Encephalomyelitis and chronic fatigue syndrome 2 different illnesses?

@ pubmed:
 2014 Feb 7. [Epub ahead of print]

Are Myalgic Encephalomyelitis and chronic fatigue syndrome different illnesses? A preliminary analysis.

Abstract

Considerable discussion has transpired regarding whether chronic fatigue syndrome is a distinct illness from Myalgic Encephalomyelitis. A prior study contrasted the Myalgic Encephalomyelitis International Consensus Criteria with the Fukuda and colleagues' chronic fatigue syndrome criteria and found that the Myalgic Encephalomyelitis International Consensus Criteria identified a subset of patients with greater functional impairment and physical, mental, and cognitive problems than the larger group who met Fukuda and colleagues' criteria. The current study analyzed two discrete data sets and found that the Myalgic Encephalomyelitis International Consensus Criteria identified more impaired individuals with more severe symptomatology.
PMID:
 
24510231
 
[PubMed - as supplied by publisher]

Wednesday, September 4, 2013

URGENT: ACT NOW To Stop ME Redefinition !

Posted by Liz Willow:
TELL HHS THAT YOU OPPOSE THE IOM CONTRACT – STOP THE PROPOSED IOM STUDY!

The US Department of Health & Human Services  is about to contract with the Institute of Medicine to "develop clinical diagnostic criteria for ME/CFS”.  This is extremely dangerous and must be stopped.


Why be concerned with this IOM initiative? The January 2013 IOM report on treatments for Gulf War Illness (GWI) redefined GWI as the non-specific chronic multisymptom illness (CMI) and recommended CBT, exercise and anti-depressants as treatments for severely ill and dying veterans with GWI. In addition, IOM is now conducting a study to “define a consensus case definition for chronic multisymptom illness (CMI) as it pertains to the 1990-91 Gulf War Veteran population.” This effort has come under fire by GWI advocates for failing to include sufficient expertise in Gulf War Illness on its panel.

If the current IOM initiative to define Gulf War Illness is any indication, the “ME/CFS” IOM initiative will use non-ME experts to “define” our disease and will likely result in a definition that is even worse than Fukuda – a vague, non-science based case definition that will set ME science and treatment back for decades.

The sample letter to HHS and the background section below provides more information on the dangers of this initiative and on the IOM initiatives on GWI.

Immediate Actions You Can Take to Stop This Contract:

Send an email every day to HHS voicing your strong opposition to this initiative as soon as possible but no later than by 5pm on Monday, September 9th. The email should go to HHS Secretary Kathleen Sebelius, Assistant Secretary Howard Koh, and the heads of all the CFSAC ex officio agencies.  The email addresses are provided below along with detailed instructions and a sample email that you can use if you wish.

Distribute this action alert to your advocacy networks and your family and friends, and urge them to send an email as well.

The above actions are initial steps to send a strong message to HHS that the ME advocacy community opposes this effort.  But we will not stop there - more actions are planned, including Congressional intervention.  Stay tuned for updates and additional actions you can take.  We can and must stop this destructive, anti-scientific initiative!

 If you have questions, please contact MEACTNOW@yahoo.com.
________________________________________________________________

Instructions for Emailing HHS:

1.If you are using the sample email provided below, copy the sample email into the body of an email message.

2. Add your name to the end of the letter.

3. Add the Subject Line “Stop the IOM Contract on “ME/CFS” Clinical Criteria”

4. Copy the following addresses into the ‘TO” and “CC” boxes
 TO:   Kathleen.Sebelius@hhs.gov
 CC:     howard.koh@hhs.gov; txf2@cdc.gov; Tomfrieden@cdc.gov;    Marilyn.Tavenner@cms.hhs.gov; margaret.hamburg@fda.hhs.gov; Mary.Wakefield@hrsa.hhs.gov; collinsf@mail.nih.gov; richard.kronick@hhs.gov; MEACTNOW@yahoo.com
The CC includes the following individuals:
HHS Assistant Secretary Howard Koh
AHRQ Director Richard Kronick
CDC Director Thomas Frieden
CMS Administrator Marilyn Tavenner
FDA Director Margaret Hamburg
HRSA Director Mary K. Wakefield
NIH Director Francis Collins
The Social Security administration is not included because the agency head’s email is not available yet. The email address MEACTNOW@yahoo.com is used to track the numbers of messages sent.

Sample Email - To be copied into the body of an email message.

Dear Secretary Sebelius,

I am writing to voice my strong opposition to the HHS proposal to contract with the Institute of Medicine (IOM) to develop “clinical diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome.” I am a member of the ME community and have witnessed firsthand the devastation of this disease. I am extremely concerned that this planned IOM initiative will gravely harm ME patients. Note that I am purposely using the term “ME” to distinguish the disease that has affected me from the overly broad “CFS”.

I oppose this proposal for the following reasons:

  • Two peer-reviewed consensus case definitions, developed by experts in this disease, already exist – the 2003 Canadian Consensus Criteria (CCC) and the 2011 ME International Consensus Criteria (ME-ICC), which used the CCC as its baseline. The CCC has been used both clinically and in research. Both are accompanied by clinical guidelines for medical practitioners, and are well regarded by patients, ME doctors, and ME researchers. Given that expertly defined and accepted consensus clinical criteria already exist, the proposed IOM contract wastes scarce taxpayer dollars and is unnecessary.
  • HHS has inexplicably refused to accept the CCC or the ME-ICC and even questions the hallmark symptoms of ME. Instead, it has promoted an overly broad view of the disease called “CFS”, which does not require the hallmark symptoms. This has confounded ME with depression, deconditioning and non-specific chronic fatigue, has severely impeded research, and is the direct cause of the medical skepticism and inappropriate or harmful treatment recommendations to which patients are subjected. 
  • IOM has only been involved in one other study to define a disease, the current effort for Gulf War Illness (GWI). Advocates and the Research Advisory Committee for GWI (RAC) have criticized the IOM report that redefined GWI as the overly broad chronic multisymptom illness (CMI). They further criticized the misguided focus on psychiatric issues and the failure to staff the IOM panel with GWI experts. Given this and IOM’s inaccurate characterization of CFS in the January 2013 IOM report on treatments for Gulf War Illness patients, we have no confidence that IOM is capable of producing a clinical consensus criteria that defines ME as described by CCC, ME-ICC and most importantly, the patients themselves.
  • Ironically, the claimed intent of the HHS-IOM initiative is to develop a consensus definition but this effort has been progressed in secret, apparently for many months and without consultation with key ME stakeholders. The timing of the announcement before a holiday weekend and the short response time indicate that HHS was not looking for input from the ME experts and ME community.
  • This IOM initiative does not reflect the October 2012 CFSAC recommendation on the development of a case definition for this disease and in fact is in direct contradiction to that recommendation.  CFSAC recommended that a clinical and research case definition be developed in unison, that the effort begin with the Canadian Consensus Criteria and, most importantly, that it be developed by disease experts only.
I strongly urge HHS to abandon its plan for this ill-advised, wasteful, and unscientific initiative.

Sincerely,
<Name>
________________________________________________________________


ADDITIONAL BACKGROUND FOR THE ME COMMUNITY

This section is intended to let you know why this is important.  It is not intended to be included in the letter to DHHS.



On August 27, the Department of Health and Human Services (HHS) announced a proposal to award a contract to the Institute of Medicine  (IOM) on a sole source basis to recommend consensus “clinical diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome.” Due to federal contracting rules, HHS has given other potential contractors until September 11, 2013 to inform HHS of their interest and capabilities before HHS moves forward with signing the contract with IOM.  It is likely that HHS will sign a contract with IOM immediately after the September 11 deadline. 

We have good reason to be extremely concerned that this IOM initiative will produce a definition that is as bad or even worse than Fukuda. The VA contracted the IOM to study Gulf War Illness (GWI). In January of 2013, the IOM issued a report, “Gulf War and Health: Treatment for Chronic Multisymptom Illness”. This report recharacterized GWI as chronic multisymptom Illness (CMI), defined “as the presence of a spectrum of chronic symptoms in at least two of six categories—fatigue, mood and cognition, musculoskeletal, gastrointestinal, respiratory, and neurologic—experienced for at least six months.” The creation of CMI muddied the patient cohort and in the words of Anthony Hardie, Gulf War vet, GWI patient and member of the VA Gulf War Research Steering Committee “defined [the disease] so broadly as to include nearly any human health condition.”

Chronic multisymptom illness is even broader than Fukuda and we know how Fukuda has buried ME.

GWI Advocates also charge that the IOM study and report obscured the science. In testimony in front of the House Committee on Veterans Affairs, Hardie further stated:
“The [IOM treatments] panel was charged by VA to conduct a literature review rather than to consult with knowledgeable medical practitioners experienced in treating ill Gulf War veterans.  And nearly all of the first presenters focused on "stress-as-cause", psychological, and psychosomatic issues – all debunked years ago.”
Not surprisingly, the IOM report recommended treatment guidelines that focused on anti-depressants, CBT and exercise. The IOM report even included a section on “CFS”, which included erroneous and outdated information and also listed CBT, exercise and anti-depressants as treatments.

Since then, the VA has contracted with IOM to constitute another IOM panel to “develop a consensus case definition for chronic multisymptom illness (CMI) as it pertains to the 1990-91 Gulf War Veteran population.” GWI advocates have criticized the composition of the panel and its inadequate expertise in Gulf War Illness. Jim Binns, chairman of the federal research advisory committee for GWI stated “the panel includes members that “represent discredited points of view” as well as psychosomatic and mental illness experts.”

Its important to note that Dr. Kenneth Shine, the previous president of IOM, has stated that he does not remember another time when IOM has been involved in defining a disease.

Reading about the IOM initiative for GWI is like reading a prequel to the planned IOM initiative for “ME/CFS”. It is not a leap to surmise that if the proposed IOM project goes forward, ME will be completely obliterated and be replaced with CFS as a subtype of chronic multisymptom illness.

Why is HHS spending the time, money and risk to come up with a new clinical criteria for ME - and the associated medical education material that will be required - when expertly developed consensus criteria and medical education already exist and are in use? Why is HHS using IOM, an organization whose single effort to define a disease has generated so much controversy with GWI advocates? What is the specific statement of work for this initiative? Will the panel be composed primarily of non-experts as was done with GWI? Why is HHS being so secretive? It appears that discussions with IOM regarding development of a case definition have been going on for months, yet HHS has not discussed the IOM initiative with ME clinicians and researchers, the members of CFSAC or the patient advocates
.
This initiative is dangerous and will hurt ME patients. We must oppose it.

=======================================================================
Additional Resources:

HHS Announcement of the Solicitation for “Study for Diagnostic Criteria for CFS” https://www.fbo.gov/index?s=opportunity&mode=form&tab=core&id=7fafc35816ee932dc44d6c319937b366&_cview=1
Forbes. “Inside the effort to define Gulf War Illness” 6/28/2013 http://www.forbes.com/sites/rebeccaruiz/2013/06/28/inside-the-effort-to-define-gulf-war-illness/
USA Today. “Gulf War illness advocates skeptical of institute panel. 6/26/2013 http://www.usatoday.com/story/nation/2013/06/26/veterans-institute-of-medicine-gulf-war-illness/2458745/
March 13, 2013 testimony by Anthony Hardie, Gulf War vet and member of the VA Gulf War Research Steering Committee, before the House Committee on Veterans Affairs, http://veterans.house.gov/witness-testimony/mr-anthony-hardie-0              
Video - http://www.youtube.com/watch?v=OuNJbPMfrYo
IOM Initiative to define Gulf War Illness: “Development of a Case Definition for Chronic Multisymptom Illness” http://www8.nationalacademies.org/cp/projectview.aspx?key=49546
91outcomes.Com collection of documents related to the IOM panel to define a consensus criteria for chronic multisymptom illness. Published by Anthony Hardie. http://www.91outcomes.com/2013/06/uploads-iom-gulf-war-chronic.html

Sunday, September 30, 2012

FDA: "ME/CFS is a serious or life threatening disease”

Voices from the Shadows, on September 29, 2012:
Dr Sandra Kweder MD, Deputy Director, CDER Office of New Drugs, stated  in response to Terry Gilmete

“ We consider your condition to be in the category of serious or life threatening diseases.

Okay, so all of the measures to move things through rapidly, all of the tools that we have here at FDA to try and expedite reviews or expedite development and work with companies to try and encourage them along that would apply to, you know, immediately life threatening cancer, as far as we’re concerned they apply to this condition.

This is a serious condition and I just want to make that clear. We consider it in the same category because there are no approved treatments for this condition and we understand how seriously and severely peoples’ lives are impacted by this disease – by this condition.” Read more>>  

FDA plans drug development to treat Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME/CFS)

Wednesday, January 25, 2012

Margaret Williams: The biopsychosocial model has no empirical foundation in relation to ME/CFS

More concerns about the current UK Welfare Reform

Margaret Williams 22nd January 2012:



Attention is drawn to a letter recently sent to two high-profile members of The House of Lords by Douglas Fraser, a former professional violinist but now severely affected by ME/CFS (http://www.meactionuk.org.uk/FraserToTGTandMM.htm ).

In it, Fraser sets out his concerns about a paper circulated by Lord (David) Freud, Parliamentary Under Secretary of State (Minister for Welfare Reform) to certain members of the House of Lords (this being “Models of Sickness and Disability” by Waddell G and Aylward M, whose track record on the alleged deviance of sick people -- those with ME/CFS being specifically targeted -- is documented in “Magical Medicine: how to make a disease disappear” by Professor Malcolm Hooper available at www.meactionuk.org.uk/magical-medicine.htm ).

David Freud’s history is interesting: he previously worked as a journalist for the Financial Times and then joined a leading UK investment bank (UBS investment banking), where he was on record as saying to his deputy: “If the rest of the country knew what we were being paid, there would be tumbrels on the streets and heads carried round on pikes”. In his city career he frequently got things seriously wrong.  As one reviewer of his book put it, Freud “will be remembered in the City as one of the key players in several of the most embarrassing and badly managed deals in investment banking”.  His revenue forecasts were, in his own words: “completely potty”; according to the Daily Telegraph, his financial plans for Euro Disney “went so goofy they almost wrecked his career” and on the Channel Tunnel Rail Link he got his sums wrong by £1.2 billion and had to be bailed out by the Government (www.variant.org.uk/events/Doc7Poverty/BankerBankies.pdf ).

Nonetheless, as the “To Banker from Bankies” 2009 report (which was supported and funded by Oxfam) states, in 2007 Freud was appointed as the key Government advisor on welfare reform by Labour’s John Hutton, having been commissioned to produce a report “Reducing Dependency, Increasing Opportunity” on the “Welfare to Work” programme.  This was despite the fact that, in his own words, Freud “didn’t know anything about welfare at all” (Daily Telegraph, 4th February 2008). Despite the great complexity of the welfare system, Freud researched and wrote his welfare “shake-up” plan in just three weeks. It recommended that the existing role of private firms (such as the French company Atos) in the Government’s “Welfare to Work” programme be dramatically increased; he acknowledged that there was no evidence to suggest that private contractors were any better than the Department for Work and Pensions, but he still concluded that it would be “economically rational” to pay them tens of thousands of pounds for every person they removed from benefits.

The Daily Telegraph subsequently reported that Freud himself had severed all ties with Labour Ministers and was joining the Conservatives’ Work and Pensions team “after being put forward for a peerage”.

In May 2010 the Coalition Prime Minister (David Cameron) appointed him to his current post as Minister for Welfare Reform.

On 17th January 2012 Hansard recorded that Lord Freud referred to the “Models of Sickness and Disability” document that he had handed round to some members of the House of Lords (http://www.publications.parliament.uk/pa/ld201212/ldhansrd/text/120117-0001.htm), this being the document which will apparently underpin the transition from Disabled Living Allowance (DLA) to the Personal Independence Payment (PIP) and from which document it is clear that the biopsychosocial construct now permeates medical assessments for state benefits (so it may come as no surprise that Professor Peter White is acknowledged as an advisor).

Lord Freud explained: “I am hopeful that PIP will do a better job than DLA….I shall now turn to the more technical aspects of this issue – that is, looking at what we are doing with the PIP and its assessment.  Is it a medical assessment…? It absolutely is not.

“…Our approach is – and this is rather a mouthful – akin to the biopsychosocial model…

“I sent round a rather interesting piece of analysis to many noble Lords in the Committee, called Models of Sickness and Disability, which showed the differences between the models, explaining the medical model, the reaction of the social model against the pure medical model and the synthesis of the biopsychosocial model. The summary of the biopsychosocial model in the analysis is that: ‘Sickness and disability are best overcome by an appropriate combination of healthcare, rehabilitation, personal effort and social/work adjustments’.  There is a coherent theory behind this assessment”.

There are about 170 references to “models” scattered throughout the 40 page document and Fraser points out that readers may get the impression when it comes to the “biopsychosocial model” that a rigorous and scientific approach has been taken, yet it may be argued that there is no coherent theory whatsoever behind that “model”.

Fraser draws attention to the authors’ footnotes, which are rife with selective referencing and contain misquotations from and misrepresentations of the (not easily available) cited source.

In one instance the authors seem to infer (from their cited source) that it has been shown to be perfectly legitimate to proceed directly from biopsychosocial theory (or the “conceptual model”) to biopsychosocial practice and policy, when the cited author in fact concluded that the biopsychosocial model is “hardly a theory” and “certainly not a model”.

The central arguments surrounding issues of bias and confounding in relation to the biopsychosocial model that are exposed within the cited source are not -- as they should have been -- made known by Waddell and Aylward.

Notably, the impression from the footnotes is that it was Professor Peter White who provided “classic” examples on “how the biopsychosocial model is not an aetiological model of disease, and (how) arguments about whether the cause of a particular disease is biological or psychosocial obscure the main issue”, when in reality it was George Davey-Smith, Professor of Clinical Epidemiology at the University of Bristol who urged caution and who carried the torch for intellectual integrity: it was he who showed that bias can generate spurious findings and that when interventional studies to examine the efficacy of a psychosocial approach have been used, the results have been disappointing, and he who pointed out that cholera was attributed to “moral” factors and that peptic ulcer was attributed to stress before the appliance of science (Proof Positive?  Eileen Marshall & Margaret Williams, 30th August 2005 http://www.meactionuk.org.uk/PROOF_POSITIVE.htm ).

According to Waddell and Aylward (and White), both these examples are of “specific diseases of doubtful relevance to common health problems” and they are dismissed because they appear to threaten the biopsychosocial philosophy, which Waddell and Aylward claim applies to “any illness”.

However, when one examines Waddell and Aylward’s claim of supporting evidence for the biopsychosocial model in the management of low back pain (“extensive scientific evidence that the biopsychosocial model provides the best framework for the modern management of low back pain”), one finds from the latest Cochrane meta-analysis examining the results of behavioural interventions for low back pain that: “the risk of bias of the trials included in this review was generally high” and, in relation to the addition of behavioural therapy to in-patient rehabilitation over the longer term, that: “there was only low or very low quality evidence, which was based on the results of only two or three small trials” (Behavioural treatment for chronic low-back pain; 7 JUL 2010.  The Cochrane Collaboration.  http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD002014.pub3/full ).

Such seeming sleight of hand by Waddell and Aylward in seriously misleading a Government Minister and members of the House of Lords is to be deplored.

When it comes to ME/CFS, over 20 renowned international experts on ME/CFS have provided written statements of concern effectively stating that cognitive behavioural therapy and graded exercise therapy used to support the alleged existence of the “biopsychosocial model” do not work for people with ME/CFS (Magical Medicine pp 88-92).

Furthermore, numerous trials have shown that not only is the “biopsychosocial model” unsuccessful in the management of ME/CFS but that the model itself is not evidence-based and it may be actively harmful:

(i)              the evidence that behavioural modification techniques have no role in the management of ME/CFS is already significant and has been confirmed by a study in Spain, which found that in ME/CFS patients, the two interventions used to justify the biopsychosocial model (CBT and GET) did not improve HRQL (health-related quality of life) scores at 12 months post-intervention and in fact resulted in worse physical function and bodily pain scores in the intervention group (Nunez M et al; Health-related quality of life in patients with chronic fatigue syndrome: group cognitive behavioural therapy and graded exercise versus usual treatment. A randomised controlled trial with 1 year follow-up. Clin Rheumatol 2011, Jan 15: Epub ahead of print)

(ii)            “Notwithstanding the medical pathogenesis of ME/CFS, the (bio)psychosocial model is adopted by many governmental organizations and medical professionals to legitimize the combination of Cognitive Behavioral Therapy (CBT) and Graded Exercise Therapy (GET) for ME/CFS…. Justified by this model CBT and GET aim at eliminating presumed psychogenic and socially induced maintaining factors and reversing deconditioning, respectively. In this review we invalidate the (bio)psychosocial model for ME/CFS and demonstrate that the success claim for CBT/GET to treat ME/CFS is unjust. CBT/ GET is not only hardly more effective than non-interventions or standard medical care, but many patients report that the therapy had affected them adversely, the majority of them even reporting substantial deterioration…. We conclude that it is unethical to treat patients with ME/CFS with ineffective, non-evidence-based and potentially harmful ‘rehabilitation therapies’ such as CBT/GET” (A Review on Cognitive Behavioural Therapy (CBT) and Graded Exercise Therapy (GET) in Myalgic Encephalomyelitis (ME) / Chronic Fatigue Syndrome (CFS). Neuroendocrinol Lett 2009:30(3):284-299)

(iii)          The Wessely School’s much-vaunted FINE (Fatigue Intervention by Nurses Evaluation) Trial could not by any standards be judged to have been successful: the results showed that “pragmatic rehabilitation” (PR, based on CBT/GET) was minimally effective in reducing fatigue and improving sleep only whilst participants were engaged in the programme and that there was no statistically significant effect at follow-up. Furthermore, pragmatic rehabilitation had no statistically significant effect on physical functioning; equally, its effect on depression had diminished at follow-up. Moreover the other intervention being tested (“supportive listening” or SL) had no effect in reducing fatigue, improving physical functioning, sleep or depression (AJ Wearden et al; BMC Medicine 2006, 4:9 doi:10.1186/1741-7015-4-9

(iv)          Equally, the widely acclaimed but statistically unsustainable PACE Trial cannot be said to have been successful since, uniquely, ratings that would qualify a potential participant as sufficiently impaired to enter the trial were considered  “within the normal range” when recorded on completion of the trial and no recovery statistics have been published by the Chief Principal Investigator, Professor Peter White (Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. PD White et al. Lancet 2011 Mar 5;377(9768):823-36).

It has not been possible to determine Lord Freud’s awareness of the need to distinguish biomedical science from biopsychosocial ideology before he formulates Government policies that will have a profoundly detrimental impact on sick and frightened people whose means of survival is threatened if their state support is withdrawn.

The term “biopsychosocial model” is used almost exclusively by Wessely School psychiatrists to refer to disorders that they continue to regard as psychosomatic (especially ME/CFS) and it is not used by other disciplines. For example, cardiologists do not refer to patients as having a “biopsychosocial” disorder and oncologists do not refer to cancer as a “biopsychosocial” disorder, nor do they claim that their patients must be coerced back to work by the withdrawal of their state benefits because it is patients’ aberrant belief that they are physically sick which maintains their disease.

The use of such a term can be seen as a linguistic misdirection by these psychiatrists, allowing them to conceal their belief that ME/CFS is not a physical disease but an aberrant state of mind maintained by psychological and behavioural factors (ie. the psychosocial components of “biopsychosocial”).  The only “bio” in their “biopsychosocial model” is their reluctant concession that ME/CFS is sometimes preceded by a self-limiting viral infection (and, despite the overwhelming international evidence to the contrary, they insist it is maintained by psychosocial elements that do not result from any organic pathology).

As Fraser states: “As the tortured arguments continue, one suspects that the authors (Waddell and Aylward) are keenly trying to ensure something is kept out of public view….Had Lord Freud said ‘We have not gone for the medical model; we have gone for the psychosomatic model’, I do not think that members of the House would have been impressed for a moment”.

Informed readers of “Models of Sickness and Disability” might wonder why something that has been repeatedly shown not to be a successful model is being promoted by a UK Government.

As Fraser points out, an explanation may be found from a 2005 issue of “Decision Makers’ Exchange” (DME), the monthly newsletter for DLA and Attendance Allowance decision makers: “Confirmation that Medical Services (ie. the DWP) have adopted the Biopsychosocial Model for assessing not just claims based on incapacity for work but also DLA and AA came in the July edition of Decision Makers’ Exchange…An item explained that Medical Services have recently introduced a change in the way that they assess a customer’s disabilities and the effect it has on their lives.  The Biopsychosocial Model aims to address how a person’s disability has an effect on that individual’s life”.  The newsletter features an article by Mansel Aylward, former Chief Scientist at the DWP, entitled “Professor Aylward endorses the Biopsychosocial Model of Disability….Conditions for which there is limited or no recognised pathological basis, such as chronic fatigue, fibromyalgia…feature regularly in disability assessments for state benefits….The Biopsychosocial Model is the answer to the disability analyst’s plight”.

Fraser then quotes from an Atos Origin Medical Services meeting in 2004 which sets out just how the dogma that underpins the “biopsychosocial model” is being authoritatively promulgated, and he notes “the convenient fictions and lack of logic those responsible would…refuse to tolerate if applied to their own family and friends”.

The Atos Origin 2004 Conference report is explicit: “Psychosocial factors…are at least as important as physical factors in the onset and maintenance of these conditions.  Patients can make a number of ‘secondary gains’ with these unexplained illnesses, such as…turning a socially unacceptable disability into a more acceptable ‘organic’ disability caused by injury or disease beyond their control. They can blame their failures on the illness; elicit care, sympathy and concern from family and friends; avoid work or even sex; and there are financial rewards associated with disability.

“…if a patient believes their illness was caused by a virus and there’s nothing they can do about it, their prognosis is not likely to be positive.  But if the patient believes…that the symptoms won’t last long and they have control over them, then the prognosis will be better….  We need patients to understand their situation, so they are more likely to go back to work”  (http://www.meactionuk.org.uk/AtosConference2004.pdf).

Fraser concludes in his letter: “Given the combined forces of what appears as an unseen (and) corporate-generated self-serving attitude (tacitly approved by “Models of Sickness and Disability” authors as perfectly moral) in the guise of the…psychosomatic model…promoting the prejudice of…pop-psychology directed at vulnerable and relatively powerless others…and a profit-driven foreign company…it is unsurprising that so many of the bad decisions they help facilitate are overturned on closer examination at costly appeals.  It would of course, be much cheaper in the long run to adopt some of the higher standards of appeal tribunals in the first place”.

This non-evidence-based but pervasive biopsychosocial ideology is now being foisted on the unsuspecting people of Australia and New Zealand, because in May 2010 Aylward wrote a report for the Australasian Faculty of Occupational and Environmental Health (Realising the Health Benefits of Work: A Position Paper. Professor Sir Mansel Aylward CB; Director: Centre for Psychosocial Research and Disability Research, Cardiff University (the Centre being funded by the health insurance company UNUM Provident).  In it, Aylward asserts:

“Fundamental Precepts:
Main determinants of health and illness depend more upon lifestyle, socio-cultural environment and psychological (personal) factors than they do on biological status and conventional healthcare
Work: most effective means to improve well-being of individuals, their families and their communities
Objective: rigorously tackling an individual’s obstacles to a life in work.

“Making the distinction: definitions and usage:
Disease: objective, medically diagnosed pathology
Illness: subjective feeling of being unwell
Sickness: social status accorded to the ill person by society

In that report Aylward claims that largely subjective complaints (such as ME/CFS) are often associated with psychosocial issues, not with pathology, and that “bio-psycho-social factors” may aggravate and perpetuate disability and that they may also act as obstacles to recovery and barriers to return to work. He refers to the UK Government’s “Pathways to Work” initiative, with its mandatory work-focused interviews for sick people and the use of CBT to change people’s alleged misperceptions about their health; his message is: “Barriers to recovery and return to (retention in) work are primarily personal, psychological and social rather than health-related ‘medical problems’ and that “Perceptions lie at the ‘heart’ of the problem”.

His report provides guidance on “ Engaging and Exploiting Stakeholders”, which he says must include
changing the beliefs and attitudes of politicians, civil servants, health professionals, employers etc and changing the present culture about health and well-being in order to deliver “visible hard outcomes”.

Even more disturbingly, Aylward’s report asserts that there must be new roles for health professionals, who must no longer permit their patients to believe that they are incapable of work if they have a disease but must instead propel them back into work even if they do have a legitimate medical disease.  In the UK, there are recorded accounts of people with cancer being forced back to work and of a cancer sufferer dying whilst awaiting an appeal against a refusal of benefits by Atos.

Unsurprisingly, since he has invested so much into the promulgation of it, despite the accumulating evidence to the contrary, Aylward claims that the biopsychosocial principles of management are evidence-based, when the “biopsychosocial model” can be readily shown to have no empirical foundation, particularly in relation to ME/CFS.

It has nevertheless been used to justify beliefs and policies, for example, in his letter to the two members of the House of Lords, Douglas Fraser quotes the following:

"Benefits and Work has seen one recent medical report in which a DWP doctor explicitly stated that he had used the Biopsychosocial model. The claimant has Chronic Fatigue Syndrome and was seeking renewal of an award of the middle rate of the care component and the higher rate of the mobility component. His condition had deteriorated since his last award over two and a half years ago. The doctor who visited him recorded that: ‘There are few significant findings other than subjective tenderness and stiffness. But the customer is clearly living the life of a disabled person and I have applied the Biopsychosocial model’. The doctor then stated, without explaining how the conclusion had been reached, that the claimant’s condition was just 40% physical and ‘60% psychosocial’…. This allowed the decision maker to conclude that the claimant’s award of higher rate mobility was no longer appropriate as the primary reason for his virtual inability to walk was psychosocial rather than physical".

The specific numbers given (40/60 split) provided a superficial appearance of scientific objectivity to cover what was in fact no more than a highly-prejudiced guess, because such things cannot be measured or quantified, but they achieved the required outcome (which was to strip this person of his benefits and for which the company to which the DWP has delegated its medical assessments would receive a handsome financial reward).

It is, of course, imperative to seek out and remove from state benefits the cheats and idle lead-swingers, but it is even more imperative to take appropriate medical care of the sick, yet what underpins current Government welfare reform is the un-evidenced conviction that work is always good for people, no matter how ill they may be.

Commenting on a response to her article “Illness as Deviance, Work as Glittering Salvation and the ‘Psyching-up’ of the Medical Model: Strategies for Getting the Sick ‘Back to Work’ ” (http://www.democraticgreensocialist.org/wordpress/?page_id=1716), Gill Thorburn says: “I was appalled to discover what they have been doing to the ME community for so many years.  Its nothing short of legitimised abuse.  The one discouraging thing I’ve experienced in all my research so far has been discovering for how many years how much authentic evidence has been simply disregarded by those in power in favour of this spurious psychological approach.  Some of the accounts on the net are simply heartbreaking, and it beggars belief that these people should have been allowed to continue with their ‘methods’ and ‘theories’.  As someone pointed out recently, they ‘intervene’ in peoples’ lives with impunity, disregarding their negative effects, for which they are never held to account”.

A UK Government is democratically elected to look after the best interests of the nation and of its citizens, not to abuse and persecute the sick in favour of foreign corporate profits by imposing the “biopsychosocial model” that is promoted by UK psychiatrists who have vested financial interests in such a “model” because they work for the health insurance industry, whose profits benefit from its use.


See also: Another cracker from the CBT school of denial: “The bastards don’t want to get better”…

See also: Harvard Medical School: EEG spectral coherence data distinguish chronic fatigue syndrome patients from healthy controls and depressed patients 

See also: The putative agent of ME/CFS can be transferred to monkeys 
See also: Almost 5% of ME/CFS patients contracted ME/CFS from a blood transfusion

See also: Cerebrospinal fluid profiles can differentiate between Lyme disease, ME/CFS and healthy controls

See also: The main characteristic of ME is an abnormally delayed muscle recovery after doing trivial things, if you don't have that, you don't have ME
See also: GET (graded exercise therapy) is torture for ME patients and directly contravenes the do NO Harm principle of the GMC

See also: I never imagined my sister would die from ME

Wednesday, January 18, 2012

David Tuller: It’s not rocket science to figure out that The PACE study included people who are depressed and don’t have CFS

Posted by Julie Rehmeyer on January 18th, 2012:

When I wrote that first story about the PACE study, I’d been focusing primarily on XMRV, not CFS more generally. I didn’t understand the problem with case definitions [a set of criteria for what symptoms should be required for a person to be diagnosed with CFS], and there was a context of controversy that wasn’t part of my awareness at the time. I wrote that story in a couple hours on deadline. It wasn’t until afterward that I realized that this wasn’t the piece I would have written had I known more about it.

I will say, though, that my story was better than most of the others on it, which for the most part didn’t have any caveats.

What dissatisfied you about the story?

I was driving home when it appeared, and by the time I got home I had half a dozen emails about the piece. I realized that I hadn’t focused on the issue of the case definition. I’ve been a public health student and I teach reporting about public health [at the University of California-Berkeley Graduate School of Journalism and School of Public Health’s new concurrent Master of Public Health/Master of Journalism program]. In the first semester, all public health students have to take epidemiology, and one of the things they learn is that if you’re doing research, you have to have a good case definition so that you know which patients have the illness and which don’t. The PACE study’s definition of CFS is six months of unexplained fatigue — period. It’s not rocket science to figure out that that’s likely to include people who are depressed and don’t have CFS. Fatigue is a common symptom of depression, but people with CFS have some symptoms that are not typical of depression.
It was really because of that that I ended up writing a second story, a month or so later, about case definition in CFS. I tried to put it in a larger context — that this issue had been fought over for years, and the PACE trial was the latest variation on it.

What made you want to write an even more in-depth piece, explaining the history of CFS research and relating that to the recent XMRV mess?

Writing the case definition story led me to start looking into the Centers for Disease Control’s role in defining the disease. I found that in 2005, the CDC created a new way of defining the illness. Using that framework, the agency calculated that the prevalence of CFS was four times what everyone else thought it was, and ten times their own previous estimate. But if four to ten times as many people now have it, obviously something is really wrong with your case definition, before or after. William Reeves was head of the CDC’s research program for CFS for two decades, and two years ago, they moved Reeves aside. They never publicly said why, as far as I could tell. Furthermore, in the 1990s, the CDC spent funds allocated for CFS research on other projects, then lied to Congress about it.

I think all of this is really important for understanding why patients can be so suspicious and paranoid. In most of the coverage, the XMRV situation was decontextualized from the experience of patients and history of the illness, although Amy Dockser Marcus did some terrific reporting in the Wall Street Journal about the back story. But no one had really focused in depth on the case definition problem and the CDC’s role in perpetuating that problem.

I didn’t want to write a rant. I wanted to write, “This is what happened with the epidemiology, and this is why the situation is so screwed up.” I wanted something that patients felt represented some of the frustration they’d experienced in the past 20 years.

Did you think of the story as an advocacy piece?

No. I’m not a patient. I didn’t want to write it as an advocate for people with CFS. I wrote it because there was an undertold story. I understood that it was something that would likely be useful to the patient community; to the extent that that’s the case, that’s great. My goal is to tell a story that’s interesting, and one that I think is important. Obviously I do think that the CDC has not done what people expected it to do in this case. I think of writing this piece as being a proper watchdog of a government agency in an area that hasn’t gotten much attention.

Read more>>


See also: World exclusive: Prof Wessely admits in the BMJ that there were no ME/CFS patients in the ME/CFS PACE trial
See also: PACE trial results are out: ME is caused by an oncogenic virus
See also: Cerebrospinal fluid profiles can differentiate between Lyme disease, ME/CFS and healthy controls
See also: The main characteristic of ME is an abnormally delayed muscle recovery after doing trivial things, if you don't have that, you don't have ME
See also: Operation Mincemeat aka the PACE trial, a thrilling true story of deceit and survival

Wednesday, December 28, 2011

Another cracker from the CBT school of denial: “The bastards don’t want to get better”…


This delightful quote by the way is from page 18, if you're interested, that is.

If you still fancy reading this report, which denies the existence of almost 5000 research papers showing that ME is a physical disease, which was obviously funded by the Medical Research Council, which we all know likes to waste shed loads of money on silly CBT and dangerous GET, but which is so sad and not even beautifully written, that I would advise you to get some anti-sickness tablets from your doctor first before you sit down and puke all over this delightful document.  

The bastards don’t want to get better.pdf

PS: this report is so sad and badly researched that the so-called researchers don't even know that ME means Myalgic Encephalomyelitis and not myalgic encephalitis




PS 2: thanks to HP who spotted this very professional remark in this paper, which wasted more than 1 million taxpayers pounds on a therapy which doesn't work for ME, which we have known for decades

See also: Harvard Medical School: EEG spectral coherence data distinguish chronic fatigue syndrome patients from healthy controls and depressed patients 
See also: The putative agent of ME/CFS can be transferred to monkeys 
See also: Almost 5% of ME/CFS patients contracted ME/CFS from a blood transfusion
See also: Cerebrospinal fluid profiles can differentiate between Lyme disease, ME/CFS and healthy controls
See also: The main characteristic of ME is an abnormally delayed muscle recovery after doing trivial things, if you don't have that, you don't have ME

See also: GET (graded exercise therapy) is torture for ME patients and directly contravenes the do NO Harm principle of the GMC
See also: Harvard Medical School: EEG spectral coherence data distinguish chronic fatigue syndrome patients from healthy controls and depressed patients
See also: Dr. Hilary Jones, When you say, "ME is controversial", did you check that with Alison, Annabel and Sophia? Now, I'm sure you didn't, because all three died of ME. Yes you read that right, …

Tuesday, November 15, 2011

NHS Scotland recommends to diagnose ME with the Canadian Criteria and separate it from CFS

By Christine: The Scottish government commissioned the Scottish Public Health Network to undertake an assessment of services for those with ME and CFS. The end result is that ME be separated from CFS, with ME sufferers being diagnosed using the Canadian Consensus Criteria and those with CFS diagnosed using the NICE Guidelines. This is what ME advocates have screamed out for and is a major shift within the government-medical establishment.

Care Needs for those Experiencing ME-CFS, lead author Phil Mackie, ScotPHN Lead Consultant and Senior Specialist in Public Health, NHS Lothian.
Scottish Public Health Network Recommendations.pdf


See also: Harvard Medical School: EEG spectral coherence data distinguish chronic fatigue syndrome patients from healthy controls and depressed patients 
See also: The putative agent of ME/CFS can be transferred to monkeys 
See also: Almost 5% of ME/CFS patients contracted ME/CFS from a blood transfusion
See also: Cerebrospinal fluid profiles can differentiate between Lyme disease, ME/CFS and healthy controls
See also: The main characteristic of ME is an abnormally delayed muscle recovery after doing trivial things, if you don't have that, you don't have ME 
See also: GET (graded exercise therapy) is torture for ME patients and directly contravenes the do NO Harm principle of the GMC

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