Saturday, January 26, 2013

Countess fact-checks PDW and Sir Simon Wessely

 
 

Continuing Correspondence Between Countess of Mar and Professor Peter White and Professor Sir Simon Wessely

Professor Peter White has responded to the Countess of Mar's letter published in the "Independent on Sunday" of 13th January 2013 :

From: "Peter White"
To: "MAR, Countess"
Subject: RE: Letter to the Independent on Sunday

Dear Lady Mar,
As a matter of courtesy and for your information, I attach the link to an IoS wesbite posting from Sir Simon and myself, which was uploaded on Saturday.
Also for your information, I attach two of my most relevant papers that speak to the important role of infection as an immediate cause of CFS.
Yours sincerely,
Professor White

http://www.independent.co.uk/voices/letters/ios-letters-emails--online-postings-13-january-2013-8449260.html

"John Maddox Prize: We would like to correct several errors of fact in the letter published on this website by the Countess of Mar and others. These authors state that we "..have promoted an hypothesis that ME/CFS is due to an abnormal illness beliefs,.. " We have not; beliefs about an illness determine the ways people cope with it, but this has little to do with how the illness develops in the first place (its immediate cause), which our own research has shown can follow certain infections.

The correspondents also mention the PACE trial and state that "No data on recovery rates and positive outcomes have been released.." The results of positive (and negative) outcomes were published in the Lancet medical journal early in 2011. The results of recovery rates are due to be published in the medical journal Psychological Medicine within the next three weeks.

The authors state that "There has been no attempt by Professor White to correct the misapprehension in respected journals as well as the popular press that the PACE trial demonstrated recovery rates of between 30% and 40%." Again this is not the case; Prof White and colleagues published the following in the Lancet in May 2011: "It is important to clarify that our paper did not report on recovery; we will address this in a future publication."

The PACE trial has added to the now overwhelming scientific literature showing that two rehabilitative approaches of cognitive behaviour therapy and graded exercise therapy are moderately effective treatments of what is otherwise a chronic, debilitating and untreatable illness that blights patient's lives. This is good news that needs sharing. Professor Peter White Professor Sir Simon Wessely Queen Mary University London and King's College London"


Professor PD White
Professor of Psychological Medicine,
Centre for Psychiatry, Wolfson Institute of Preventive Medicine,
Barts and The London School of Medicine and Dentistry,
Queen Mary University of London.
Address: Psychological Medicine, St Bartholomew's Hospital, London, EC1A 7BE, UK.

Tel: (+44)(0)203 465 5696
Fax: (+44)(0)203 465 7082
p.d.white@qmul.ac.uk

http://bartscfs.eastlondon.nhs.uk

http://www.pacetrial.org


And the following is the Countess of Mar's response, sent on 25th January 2013:

From: "MAR, Countess"
To: "Peter White"
Subject: RE: Letter to the Independent on Sunday

Dear Professor White

Thank you for sending me a copy of the reply which you and Professor Sir Simon Wessely tells me was uploaded to the Independent on Sunday website on 19th January. I concede that I do not understand much of it, as semantics is no substitute for science.

We do not even know what disorder you are talking about because, whilst ethical approval and funding were granted on the basis that you would study CFS/ME and whilst the PACE trial documentation refers to CFS/ME (about which you stated in the PACE trial patient leaflet: "Chronic fatigue syndrome" is "also known as post-viral fatigue syndrome, myalgic encephalomyelitis (ME) or myalgic encephalomyelopathy (ME)….Medical authorities are not certain that CFS is exactly the same illness as ME, but until scientific evidence shows that they are different they have decided to treat CFS and ME as if they are one illness"), in March 2011 you confirmed to the editor of The Lancet: "The PACE trial paper…does not purport to be studying CFS/ME but CFS defined simply as a principal complaint of fatigue that is disabling".

I will address the points in your reply one by one: (1) that you have not promoted ME/CFS as abnormal illness behaviour; (2) that the PACE trial outcomes were published in The Lancet early in 2011; (3) that you did correct the mis-reporting in respected journals and the popular press that PACE demonstrated recovery rates of between 30% and 40% and (4) that the PACE trial has added to the overwhelming scientific literature showing that CBT and GET are moderately effective treatments, and that this is good news which needs sharing.

Your first point (that you have never claimed ME/CFS is an "abnormal illness belief")

You and Sir Simon state categorically that you have not promoted an hypothesis that ME/CFS is due to "abnormal illness beliefs".

Why, then, was CBT in the PACE trial (of which you were Chief Principal Investigator, with whom all responsibility ultimately rests) provided on the basis that "the symptoms and disability of CFS/ME are perpetuated predominantly by unhelpful illness beliefs (fears) and coping behaviours (avoidance)", whilst "GET was done on the basis of deconditioning and exercise intolerance theories of chronic fatigue syndrome. These theories assume that the syndrome is perpetuated by reversible physiological changes of deconditioning and avoidance of activity"?

Moreover, in your 2007 paper co-authored with Professors Bleijenberg and Knoop, you state: "The attitude of the therapist towards the treatment goals will affect the expectations and perceptions of the patient…If the therapist suggests that recovery is possible, the patient expectations are raised, which in turn may lead to a change in the perception of symptoms….For complete recovery, the perception of the patient also has to change. The patient has to perceive his fatigue and functioning as both normal and comparable to healthy people….A therapist delivering CBT can tell the patient that…full recovery is possible" (Psychother Psychosom 2007:76:171-176).

What else can this mean but that you regard ME/CFS, not as a pathological process resulting in chronic multi-system disease, but as a condition maintained by patients' abnormal illness beliefs which trap them in "self-perpetuating vicious circles of fatigue and disability"?

If it is the case that you both now accept this theory to be wrong (as your comment on the IoS website implies), this would be remarkable, because you have promoted and championed it for more than twenty years and the PACE trial interventions were based on that hypothesis. Therapists were trained to instruct participants that their symptoms do not result from physical disease, with the inescapable conclusion that ME/CFS is considered a non-disease. Indeed, the Therapists' Mannual on CBT taught therapists how to manage participants who believe they have a physical disease, how to persuade them that this is not the case, and how to dissuade them from seeking further medical attention.

Exactly what do you understand the nature of ME/CFS to be? Clearly, as you consistently disregard the biomedical evidence, including the fact that the MRC now states: "There is now preliminary evidence supporting the view that inflammatory mechanisms in the brain and spinal cord may underlie the pathophysiology of some severe disease CFS/ME phenotypes", you do not agree that it is a multi-system organic disorder and instead ascribe the protean symptomatology to psychiatric illness.

Because the issue of what kind of disorder you believe ME/CFS to be is so important, I remind you of the published views of all the PACE trial Principal Investigators (including your own) and of Sir Simon's views, since he directed and oversaw the PACE Clinical Trial Unit that was responsible for randomisation and database design.

Sir Simon wrote to me on 21st December 2012 and confirmed: "CFS is not classified as a somatisation disorder. Nor do I believe it should be". However, his published beliefs about the nature of ME/CFS do not accord with what he wrote to me, for example, his views are that "Functional somatic syndromes…include chronic fatigue syndrome" (Rev Bras Psiquiatr 2005:27:3) and that ME/CFS is "somatisation par excellence" (J Psychosom Res 1994:38:2:89-98).

You and your colleagues have flooded the literature with terms that you claim categorise ME/CFS, some of these being functional somatic syndrome; somatisation disorder; functional disorder; medically unexplained symptoms (MUS) and medically unexplained physical symptoms (MUPS).

The profusion of these terms to signify psychiatric conditions whose existence can neither be proven nor disproven illustrates a profound conceptual problem at the heart of liaison psychiatry.

There is no objective way to prove that a person has a functional somatic syndrome or somatisation disorder; it can only be claimed that no physical cause has so far been found, not that there is no physical cause (ie. one cannot prove a negative).

Using terms that are deliberately ambiguous, sometimes with the intention of concealing the clinician's belief that the patient has a mental illness, can only be damaging to the doctor-patient relationship.

In his 2012 JNNP paper (for which he designed the study and edited the manuscript -- The function of 'functional': a mixed methods investigation. JNNP: 16th January 2012) Sir Simon says that: "The term 'functional' …has increasingly come to mean 'hysterical'…(and) its ambiguity was seen as useful when engaging with patients…. 'Functional' is a common term for medically unexplained symptoms…It has retained popularity among neurologists as a medical term for conversion disorder….It can, for example, be used to mean a disturbance of bodily function or it can be used to denote conversion disorder, and by telling a patient they have a 'functional disorder' they may encourage them to contemplate the former meaning without being aware of the latter…allowing neurologists to use the same term to mean one thing to colleagues and another to patients".

Sir Simon explains that the forthcoming DSM V proposes to use the term "functional" as the official diagnostic term for medically unexplained neurological symptoms and that these are currently known as "conversion disorder", which is a somatisation disorder.

Sir Simon is known for his view that ME/CFS is now best described as MUS or MUPS and that MUPS is synonymous with somatisation disorder, where the cause of symptoms is mental in origin. MUPS is now used interchangeably with somatisation and functional somatic symptoms (Rosendal M, Fink P et al. Scandinavian Journal of Primary Health Care 2005: 21 (1): 3–10.)

On the one hand, Sir Simon states that he does not believe that CFS/ME should be classified as a somatisation disorder, however he has also written that it is a somatisation disorder.

You are on record as disagreeing with Sir Simon and Professor Michael Sharpe (one of your PACE trial Principal Investigators) that there is only one functional somatic syndrome which incorporates ME/CFS together with irritable bowel syndrome, fibromyalgia and pre-menstrual syndrome (by including pre-menstrual syndrome, Wessely and Sharpe ignore the incidence of ME/CFS in males) (Lancet 1999:354:936-939); your view was that ME/CFS is an individual functional somatic syndrome (Brit J Psychiat 2004:185:95-96).

In 2009 you commented that Sharpe and Wessely believed: "functional disorders…include irritable bowel syndrome (and) CFS/ME. I have argued against this idea, suggesting that the commonality is abnormal illness behaviour, as seen in the process of somatisation" (Psychol Med 2009: 15 April: 1-9:PMID:19366500). Clearly you do promote the view that ME/CFS is abnormal illness behaviour.

You also contributed the chapter in Clinical Medicine (Kumar & Clark: 2005: pp1281 ff) where the entry for ME directs readers to the entry for CFS, which in turn directs readers to Section 21 (Psychological Medicine) where CFS/ME is listed under "Functional or Psychosomatic Disorders: Medically Unexplained Symptoms", in which you asserted that the psychiatric classification of these disorders is "somatoform disorder", which you state were previously known as " 'all in the mind', imaginary and malingering". In this chapter, you stated: " 'Functional' disorders are illnesses in which there is no obvious pathology or anatomical change in an organ…The psychiatric classification of these disorders would be somatoform disorders. Examples of functional disorders (include) fibromyalgia (and) chronic or post-viral fatigue syndromeaetiological factors include physical inactivity…. Perpetuating (maintaining) factors include avoidant behaviours (and) maladaptive illness beliefs".

In your presentation to The Royal College of Psychiatrists' Liaison Psychiatry Conference in March 2012 you asserted that ME/CFS is perpetuated by behavioural and psychological factors (ME or CFS: Belief or Science? slide 14). The irony of this is that the ME/CFS battleground represents your beliefs versus medical science.

In his presentation at the Foundation for Science and Technology event "The future strategy for the management of mental health in the UK" held at The Royal Society on 11th September 2012 Sir Simon repeated your own assertion in his presentation "Health in mind and body" ("CFS: what do we know?") that ME/CFS is "perpetuated by behavioural and psychological factors" and that there is "no evidence for chronic infection".

Your other PACE Principal Investigator, Professor Trudie Chalder, asserts that "Anorexia nervosa and chronic fatigue syndrome are classical psychosomatic disorders" (Advertisement for Research Worker, Institute of Psychiatry, 2007; Ref No: 07/R68).

What other neuroimmune disease is subjected to such relentless and unjustified dismissal by one particular group of mental health professionals? It is unsurprising therefore that you are seen to be attributing ME/CFS merely to wrong coping ability, in other words, you assume the person had a viral infection from which s/he would have recovered if s/he did not harbour aberrant illness beliefs, ie. no wrong illness beliefs, no ME/CFS.

You attached two of your own papers (1998 and 2001) that you say "speak to the important role of infection as an immediate cause of CFS" yet in your Lancet report you make no mention of the role of infection.

Why do you refuse to accept the evidence that it is the physical disease which limits activity? The evidence is convincing that ME/CFS is characterised by an inability to produce sufficient energy on demand (Canadian International Consensus Primer for Medical Practitioners, Carruthers B et al, 2012). Your own studies have not overturned that evidence, nor have they demonstrated that the well-recognised dysfunction of the central and autonomic nervous systems, the cardiovascular system, the musculature and the immune system are, as you propose in Kumar and Clark, merely secondary to inactivity ("Immune and endocrine abnormalities noted in CFS may be secondary to the inactivity").

From your own 2004 study on the effect of exercise on pro- and anti-inflammatory cytokines (JCFS 2004:12 (2):51-66) you know that the pro-inflammatory cytokine TNFa remains elevated three days after exercise in ME/CFS patients and that it can have deleterious effects on the central nervous system, TNF being a cytokine that is involved in systemic inflammation. In your article you said: "TNF-a is known to be a cause of acute sickness behaviour, characterised by reduced activity related to 'weakness, malaise, listlessness and inability to concentrate', symptoms also notable in CFS", yet you made no mention of it in the PACE trial literature or in your Lancet report.

Although your own previous studies have shown a link with one particular precipitating infection (EBV) and post-viral fatigue, the interventions you promote do not equate with management of a chronic infectious disease with a dysfunctional immune system and you treat ME/CFS as primarily a mental health problem.

With regard to Professor Sharpe's views about ME/CFS, they are very clear: he believes that ME is a "pseudo-diagnosis" (Occup Med 1997:47:217-227); he believes that people with ME who "refuse to be placed into and accept the stigma of mental illness remain the undeserving sick of our society and our health service" (ME. What do we know: real illness or all in the mind? Lecture given in October 1999 at University of Strathclyde; transcript available); his view is "that the issues around CFS/ME are the same as those surrounding the acceptance and management of (patients) who suffer conditions that are not dignified by the presence of what we call disease" (J Psychsom Res 2002:52:6:437-438) and that: "Factors such as immunological abnormalities are not of clinical value" (BMJ 2002:325:480-483); he believes that classifying ME/CFS as a somatisation disorder has "the most clinical utility" (Trends in Disability: UNUMProvident Report 2002) and he believes that: "Every medical specialty has its own syndrome of… 'functional' somatic symptoms….Fibromyalgia (and) chronic fatigue syndrome…are just some examples….Patients are assumed to have 'mental disease' " (Editorial: Somatoform Disorders: J Psychosom Res 2004:56:387-390).

In their chapter in "Somatoform Disorders", Volume 9, ed: Mario Maj et al 2005 (Chapter 5), Sharpe and Wessely assert: "The majority of patients with CFS…will fit the…criteria for…somatoform disorder".

In view of the above, what we said in our letter in the IoS (ie. that you promote the hypothesis that ME/CFS is due to abnormal illness beliefs) is justified and your denial is not supported by the published evidence.

Your second point (on "recovery" versus "positive outcomes")

You say that the PACE recovery rates are due to be published in Psychological Medicine within the next three weeks. Why, when these are the most important issue, has it taken two years over and above the published "positive outcomes" to provide the recovery figures? Such an exceptional delay gives rise to speculation that you are having difficulty in achieving the desired outcome.

Your Lancet report did not mention "recovery" but assumed that "reversal" of symptoms was possible; however, according to the PACE results, the condition is not reversible with your interventions and the only effect of CBT and GET was to change how participants filled in subjective questionnaires whilst offering no objective improvement in health.

I look forward to your forthcoming paper on recovery rates with considerable interest, given that in response to an FOIA request to Queen Mary University of London, Paul Smallcombe stated as recently as 1st November 2012: "The requested data relating to recovery rates and positive outcomes do not exist. That is to say that such analyses have not been done and there is no intention to do so. The reason for this is that the analysis strategy has changed from the original protocol". He went on to explain: "With regards to the recovery rates: the criteria threshold for measuring recovery in the Trial were changed in the light of more detailed consideration of previous published studies…and in the light of newly published work". This has been interpreted as meaning that you changed the threshold for recovery in light of the very poor results of the PACE trial's sibling trial (FINE), which used the same threshold that you had intended to use.

In your letter of March 2011 to the editor of The Lancet responding to Professor Hooper's formal complaint (which was sent to Margaret Williams by The Lancet), you wrote: "Future papers…are in preparation including reports of economic outcomes (and) different definitions of recovery and remission". Once again, your position is based on equivocal language. "Recovery" means recovery to full health, nothing less, but you obviously continue to believe that: "The percentage of recovered patients depended on the criteria used for recovery" (Psychother Psychosom 2007:76:171-176). You go into the meaning of standard deviations in relation to an alleged return to "normal" (universally interpreted as "recovery") whilst then admitting that your version of "normal" is not the same as normal health as interpreted by the average doctor. If a clinician treats a patient with CBT/GET, s/he will not be using standard deviations to measure a patient's recovery.

Reporting on "positive outcomes" is not the same as reporting on recovery rates: you and your co-authors Professors Bleijenberg and Knoop acknowledge that: "Improvement and not meeting research criteria for an illness are different from recovering" (ibid).

If the PACE trial is to be used as a guide for treatment, you need to explain in unambiguous terms what "recovery" mean -- ie. what percentage (and how many) of the 641 participants recovered as per the original protocol, which would be in line with the generally accepted meaning of recovery; what percentage (and how many) returned to gainful employment or study, as well as what percentage (and how many) no longer claimed sickness or insurance benefits as a direct result of the PACE interventions. Such outcomes were the intended purpose of the trial.

It is disturbing that you have re-defined your own definition of "recovery". According to your original protocol, "recovery" meant that a participant met all four of the following criteria: (i) a Chalder Fatigue scale score of 3 or less (ii) an SF-36 physical function score of 85 or above (iii) a CGI (Clinical Global Impression) score of 1 and (iv) the participant no longer met the Oxford criteria for CFS, the CDC criteria or your own version of the London criteria (which bore little resemblance to the original London (Ramsay) criteria, since there is no requirement for the presence of the cardinal feature of ME -- post-exertional exhaustion -- or of any neurological disturbance, thus lessening the distinction between true ME and "medically unexplained" fatigue, which is a somatisation disorder).

Ben Goldacre, writing about the Enhance trial of the cholesterol-lowering drug Simvastatin, stated: "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….But the people running the Enhance trial altered their chosen endpoint when the trial was over. They say they did so before they knew the results. That may be so, but it doesn't look good, and they've now had a very serious letter from a US congressional committee demanding to know why it was done….You cannot change the rules after the game has started. You cannot even be seen to do that" (The data belong to the people who gave it to you: The Guardian: 5th January 2008).

It can be surmised that few if any PACE participants met the requirement for "recovery" as originally specified, which is why you lowered the SF-36 physical function score by 25 points from 85 to 60.

To date, there has been considerable deviation from the normal scientific process, including the failure of the peer-review process to fulfil its duty as guardian of accuracy in the reporting of the results.

Your third point (that you did correct the mis-reporting of the PACE trial results)

You claim that your letter to The Lancet of 17th May 2011 was sufficient to correct the widespread misrepresentation of the success of the PACE trial interventions ("It is important to clarify that our paper did not report on recovery").

A number of things can be said about this. First, your Principal Investigators themselves contributed to the misrepresentation, including Professor Chalder's comment at the press conference on 17th February 2011 that: "twice as many people on graded exercise therapy and cognitive behaviour therapy got back to normal", which a reasonable person would understand to signify recovery, but "normal" as defined in the PACE Trial was in fact a level of health so low that a participant could be made worse by CBT and GET and still be classified as having "got back to normal".

Secondly, when other authors, such as Professors Bleijenberg and Knoop, and then Dr Esther Crawley, claimed (erroneously) in medical journals including The Lancet itself that CBT and GET had resulted in "recovery" rates of 30% - 40%, no action was taken to correct the record.

By contrast, when David Tuller, writing in The New York Times, criticised the case definition applied in the trial, within days you and Professors Chalder and Sharpe wrote directly to the paper to mount a defence.

Thus it is the case that when the misrepresentation was in your own favour, it was not corrected, but when comments that were factually correct but were not in your favour were reported, you immediately objected to them.

That you made no attempt at correcting the misinformation in The Lancet Comment by Bleijenberg and Knoop is not surprising, given that the Deputy Editor of The Lancet has confirmed that you approved it before publication: "The Comment in question was reviewed, as is our standard practice, by the authors of the accompanying PACE trial" (letter dated 22nd January 2013 from Dr Astrid James to the Press Complaints Commission).

The Deputy Editor goes on to state about my complaint to the Press Complaints Commission concerning the Comment: "We would like to reject this complaint in the strongest possible terms. We believe there are no inaccuracies….We have shared the complaint with Dr Bleijenberg and Dr Knoop and they stand by the content of their published Comment….They stand by their use of the term 'recovery'….We stand by our publication of the Comment by Dr Bleijemberg and Dr Knoop, and have found no inaccuracy that warrants a correction. We hope that our response is clear".

This is in stark contradiction to the email sent on 8th June 2011 by Zoe Mullan, Senior Editor at The Lancet, who confirmed about the Bleijenberg and Knoop Comment that it should be withdrawn: "Yes, I do think we should correct the Bleijenberg and Knoop Comment, since White et al explicitly state that recovery will be reported in a separate report. I will let you know when we have done this". Despite Zoe Mullan's assurance, it has not been corrected.

Such contradiction by The Lancet reflects badly on the editorial staff.

What you reported in The Lancet article was not "recovery" statistics but the number of participants who fell within your own (artificially low) definition of the "normal range" for fatigue and physical function.

In your letter published in The Lancet on 17th May 2011 you clarified that no recovery results had been published.

Why, then, did you approve publication of the Comment? That Comment said: "Both graded exercise therapy and cognitive behavioural therapy assume that recovery from chronic fatigue syndrome is possible and convey this hope more or less explicitly to patients….Have patients recovered after treatment? The answer depends on one's definition of recovery (quoting the paper you co-authored with Bleijenberg and Knoop: Psychother Psychosom 2007:76:171-176). PACE used a strict criterion for recovery: a score on both fatigue and physical function within the range of the mean plus (or minus) one standard deviation of a healthy person's score. In accordance with this criterion, the recovery rate of cognitive behavioural therapy and graded exercise therapy was about 30%....the PACE trial shows that recovery from chronic fatigue syndrome is possible".

Bleijenberg himself regards an SF-36 score of 65 as representing severe impairment (BMJ: 2005 January 1; 330: (7481):14), yet in the Comment he implicitly accepts a score of 60 (five points worse) to equate with "recovery".

As you approved the Comment before publication, was it not an omission on your part not to inform Bleijenberg and Knoop (and The Lancet) of their error?

The whole point is that PACE participants did not fulfil your "strict definition for recovery" (which you abandoned) and the SF-36 measure was not plus or minus one standard deviation of a healthy person's score; you yourself conceded in your letter to The Lancet that you used the mean of an English adult population (not a working age population as you claimed in your Lancet report). This distinction is important because an English adult population includes elderly people and individuals with chronic illness so your comparison for recovery was not, as Bleijenberg and Knoop state, relative to a healthy person's score. By not comparing with a healthy person's score (but with the average that included elderly and the chronically sick), you increased the likelihood that PACE participants' scores would reach your re-defined "normal range" on conclusion of the trial.

When your Lancet report mentioned one standard deviation, it was in relation to a marker by which improvement could be assessed. As mentioned, you accept that improvement is not the same as recovery and patients could have improved yet be far from "recovered". On what evidence, then, did Bleijenberg and Knoop claim "recovery" of "about 30%"?

This, according to the University of St Andrews, is false citation which may be construed as academic misconduct (University of St Andrews. 2013. Policy and governance. 6.1.2 Categories of academic misconduct. False Citation). False citation is the citing of a source for information when the source does not contain that information.

(http://www.st-andrews.ac.uk/staff/policy/tlac/academicmisconduct/academicmisconduct/).

As one of the UK's most respected medical statisticians, Professor Martin Bland, makes clear: "Potentially incorrect conclusions, based on faulty analysis, should not be allowed to remain in the literature to be cited uncritically by others" (BMJ: 19th February 2000:320:515-516).

No-one from the PACE trial team published a single thing that corrected the greatly exaggerated spin that flooded the media. Merely publishing a letter in The Lancet three months after the media frenzy of misreporting the results of the PACE trial is not sufficient. You, as Chief Principal Investigator, have a duty to at least try to ensure the accurate reporting of the trial results so that patients, clinicians and policy makers will not be influenced by misleading information.

Your fourth point (your claim that the PACE trial has added to the now overwhelming scientific literature about the efficacy of CBT and GET)

There is no body of "overwhelming scientific literature" that patients with ME/CFS benefit even moderately from CBT and/or GET. The only objective results of the PACE trial (ie. the six minute walking test) do not support such a claim. Indeed, Sir Simon is on record:

"It should be kept in mind that evidence from randomised controlled trials bears no guarantee for treatment success in routine practice. In fact, many CFS patients, in specialised treatment centres and the wider world, do not benefit from these interventions" (Huibers and Wessely. Psychological Medicine 2006:36:(7):895-900).

The very modest benefit in only some patients has been shown to last for only 6 -8 months: "the observed gains may be transient" (Long-term Outcome of Cognitive Behavioural Therapy versus Relaxation Therapy for Chronic Fatigue Syndrome: A 5-Year Follow-Up Study. Alicia Deale, Trudie Chalder, Simon Wessely et al. Am J Psychiat 2001:158:2038-2042).

This was confirmed by others: in 2003 it was reported at the 6th AACFS International Conference that Dr Daniel Clauw (who had studied 1,092 patients) found that at 3 months there were modest gains from CBT, but at follow-up at 6 and 12 months those modest gains were lost.

A Dutch report in February 2008 came to unambiguous conclusions about CBT for ME/CFS: the study "does not confirm the high success rates regularly claimed by research into the effectiveness of CBT for ME/CFS". It found no increase in employment rates, in educational training, engaging in sports, maintaining social contacts and doing household tasks. The majority reported substantial deterioration. Moreover, the length of the therapy did not affect the results. The authors' conclusion was: "Overall, CBT for ME/CFS does not improve patients' well-being. More patients report deterioration of their condition rather than improvement. Our conclusion is that the claims in scientific publications about the effectiveness of this therapy, based on trials in strictly controlled settings within universities, have been overstated and are therefore misleading" (Source: Medisch Contact, February 2008, ISBN: 978-90-812658-1-2, by Koolhaas MP, de Boorder H, van Hoof E. The Netherlands).

In January 2011, the result of a randomised controlled trial (and the PACE trial was not controlled) of the same interventions as those used in the PACE Trial came to very different conclusions at one year of follow-up: M Nunez et al. Clin Rheumatol doi 10.1007/s10067-010-1677-y). At 12 months, the interventions did not improve health-related quality of life scores, with worse SF-36 physical function and bodily pain scores in the intervention group.

In the six minute walking test at the end of the PACE trial, for those who had undergone GET the mean distance managed was 379 metres, representing a 67 metre increase from baseline after one year of therapy. The results were worse than results for those awaiting lung transplant (400 metres) or those in chronic heart failure (682 metres), and PACE participants were able to walk less distance during the 6 minute walking test than people with traumatic brain injury. After CBT or GET, PACE participants (average age 38 years) did not even achieve a six minute walking distance of 518 metres that is considered abnormally low for healthy people aged 50-85 years.

In the PACE trial report, you concede that only about 30% were helped "moderately". However, this figure taken in isolation is misleading as 15% of participants who received standard medical care also achieved the same outcome, meaning that only 15% of participants gained benefit from the addition of CBT or GET. This means that 85% of participants gained no additional benefits from CBT/GET over and above standard medical care, even though you re-defined a "positive outcome" and set the bar at an exceptionally low level.

On the participant-rated CGI (clinical global impression) of change in overall health, 60% of the GET group reported negative or minimal change after 52 weeks and 58% of the CBT group reported negative or minimal change after 52 weeks. By any standards, that is not a successful outcome.

In his broadcast on 18th April 2011 on Australian radio, Professor Sharpe said: "We have a number needed to treat; I think it's about seven to get a clinically important treatment benefit with CBT and GET" (ie. seven patients had to be treated to find one who benefitted). Your results show that only one in seven of those who were only "moderately" affected gained only a "moderate" benefit. That is a woeful result.

However, the real world efficacy is lower even than this because severely affected and housebound patients were excluded from your trial.

Professor Sharpe further stated about the PACE trial: "What this trial isn't able to answer is how much better are these treatments than really not having very much treatment at all".

This is very different from the exaggerated spin of "recovery" that was fed to the international media, including the figure of about 30% recovery in The Lancet Comment by Bleijenberg & Knoop, not forgetting the even more inflated but insupportable figure of 40% recovery claimed by Dr Esther Crawley (Esther Crawley et al, BMC Health Services Research 2011, 15th September: 11:217 doi:10.1186/1472-6963-11-217), one of your 26 co-signatories to the IoS letter supporting the award of the John Maddox prize to Sir Simon.

In the light of this evidence, for you and Sir Simon to claim that the PACE trial adds to the "overwhelming scientific literature" of the efficacy of CBT and GET appears at best misguided.

I find your position not only incomprehensible, but also inconsistent with what you have written elsewhere, and very much at odds with the reality of the disease.

I look forward to receiving your considered response.

Yours sincerely,

The Countess of Mar

California Foundation for Independent Living

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Chronic Illness and Loss of Friendship

If you think you're alone because all your friends abandoned you when you became ill -- you're not.  Here's just one article on the subject:
 
 
If anyone knows of any research/studies about this, please feel free to put a link to them in the comments.
 
 

America's Biggest Cover-Up: 50 More Things Everyone Should Know

America's Biggest Cover-Up: 50 More Things Everyone Should Know About The Chronic Fatigue Syndrome Epidemic And Its Link To AIDS

by Neenyah Ostrom


Chapter 46:

"An Experimental Drug That Appears Promising For CFS And AIDS Is Being Evaluated By The FDA

In February 1993, the Food and Drug Administration's Anti-Viral Drug Advisory Committee met to consider the merits of an experimental drug, AMPLIGEN, that appears to have promise for treating CFS (and, in earlier trials, AIDS). So far, no drug has been approved for the treatment of CFS by the FDA.

AMPLIGEN appears to correct a defect in a very important natural anti-viral pathway. When this pathway isn't working properly, viruses aren't attacked by the body's natural defenses. In CFS patients, as in AIDS patients, this anti-viral pathway is defective; furthermore, Ampligen appears to correct the defect in both sets of patients.

... Dr. Peterson told the FDA that, although Ampligen "appears to have great potential in this disease process, it has been bogged down in a corporate and bureaucratic quagmire, and yet the disability and anguish of the patients and treating physicians remains unaddressed." …

Similar testimony from other patients, or their families if they were too impaired to deliver or prepare testimony themselves, was also presented to the FDA committee.

The FDA, however, has yet to grant approval to Ampligen or any other drug to treat CFS."
 
 
 
And, here we are 20 years later, and still neither Ampligen, nor any other drug, is specifically FDA-approved for CFS.

Friday, January 25, 2013

10th anniversary California Disability Capitol Action Day -- May 22, 2013

If you want to get involved, contact Ted@CFILC.org
 
This is the largest cross-disability event nationwide, with over 2000 people attending last year.  Let's get all our CFS/fibro support groups and national associations in the loop, and see how many more we can add this year!
 
You can lobby the legislators if you like, but it's a unity day rather than a policy day, with a Resource Fair, displays and exhibits.
 
The most important goal is to bring the disabled community together.  If we're all sitting on the front lawn of the State Capitol in our matching T-shirts, the legislators will see us as a huge group, rather than a few from this disease, a few from that condition.  We're a big voting bloc and we need to let them know!
 
At this time, we need a theme/slogan and ideas for displays and exhibits.  If you have any ideas, e-mail them to Ted@CFILC.org
 
You can also contact Ted if you want to be added to the mailing list and/or be notified of meetings.  You don't have to live in Sacramento to "attend" the DCAD meetings -- there were a dozen people all around the state who were on conference call.  Ted runs a tight ship, when he says the meeting will be one hour, he means one hour.
 
This event is open to all disabilities, so if you have friends who are in other support groups, pass the word, and ask them to pass the word to their national organizations, too.
 
* * *
 

Ampligen update from Klimas

http://www.newswise.com/articles/chronic-fatigue-syndrome-patients-need-an-effective-therapeutic

Chronic Fatigue Syndrome Patients Need an Effective Therapeutic

Released: 1/24/2013 4:00 PM EST
Source Newsroom: Nova Southeastern University
(more news from this source)

Newswise — Ampligen, the first drug ever seeking approval to treat
chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), recently
hit another roadblock with the U.S. Food and Drug Administration
(FDA). In its long quest to treat 1 million Americans suffering from
this debilitating illness, the FDA advisory panel did not recommend
the drug to be sold on the market, largely because CFS/ME doesn't have
clear biomarkers such as blood tests to define patients who most
likely to respond to the drug. Data from clinical trials of Ampligen
has not convinced the FDA so far.

The real loser is not Ampligen, but CFS/ME patients whose daily suffering continues to be unabated. CFS/ME feels like you've been run
over by a truck – pain, inflammation, utter exhaustion and trouble
concentrating.

I have been caring for patients with CFS/ME for 26 years now. It's
heartbreaking seeing them struggle and suffer from this serious
illness that has been trivialized by science and society. One of the
early controversies quickly disproven suggested that CFS/ME is a form
of depression. This led to enduring public policies that allowed
insurance companies to limit coverage to CFS/ME to either mental
health or exercise therapy, neither get to the root cause of CFS/ME.

CFS/ME researchers, including myself, have seen major advances in our
understanding of the biology of CFS/ME. It seems to resemble an
illness we know how to treat like multiple sclerosis (MS), chronic
viral diseases and autoimmune diseases.

Around since the late 1980s, this drug is not new to science and
medicine. Two phase 3 clinical studies have been completed. The data
shows that a subgroup of CFS/ME patients showed marked improvement,
even recovery on the drug.

Yet, that's not enough evidence for the FDA advisory committee to
approve because they would like to see a conclusive biomarker. As a
physician, I could live with this decision if I had other effective
therapies to treat my CFS/ME patients. But I do not.
Moreover, it defies common logic in used in drug approval for other
complex immune mediated diseases.

Take for example, MS: Its earliest approved treatments had opposite
immune effects. One interferon increased immune activity and a second
interferon quieted immune activity. In the studies that led to
approval, MS drugs, like Ampligen, had about a 40 percent success
rate.

Clinical research for these early MS drugs produced no biomarkers
other than a patient's successful response to therapy, such as the
case of Ampligen. The biomarker the FDA relied on for approval of MS
--- seeing if the lesions in a patient's brain decreased -- had no
correlation to the patient's improvement.

Why would the FDA approve MS drugs before there were concrete biomarkers to determine success? The answer is simple. The advisory panel saw MS as a serious disease that required interventions ASAP, and were willing to accept that clinicians would better understand where to use the first drugs with more experience using them. Now there are seven approved drugs for MS that have significantly improved quality of life for patients. But they are not willing to use the same logic for Ampligen.

Because CFS/ME patients are stilling waiting for their first
therapeutic, Nova Southeastern University (NSU) in Fort Lauderdale,
Fla. has brought on board a nationally renowned group of experts to
form the NSU College of Osteopathic Medicine Institute for Neuro
Immune Medicine, which will open in February. These doctors and
scientists will conduct basic research using genomics to help further
develop drugs to treat this disease, while they treat patients. They
are also doing clinical testing for Ampligen.

With or without a biomarker, the FDA should recognize the seriousness
of CFS/ME and approve Ampligen, and open the door for other targeted
therapies now.

Nancy Klimas, M.D., one of the world's leading researchers and
clinicians in chronic fatigue syndrome/myalgic encepahalomyelitis
(CFS/ME), is the director of the Nova Southeastern University's
College of Osteopathic Medicine Institute for Neuro Immune Medicine

Thursday, January 24, 2013

Morgellons: A hidden epidemic or mass hysteria?

 

Has he mentioned these thoughts to his doctor?

"No, because talking about things like that adds a mental angle – supports the prognosis of DOP. And it's absolutely a physical condition. I mean, look!"

 

 

Sounds familiar?

 

 

Wednesday, January 23, 2013

A patient speaks



This was written by my dear friend May Tucker, who suffers from lupus.  It's a good look inside the mind of a patient.

https://www.facebook.com/pages/PAIN-or-PAVEMENT/286154544735938?ref=stream
 
BALD vs. BALD--My Blood Curls

Foreword: This blog ought to make you laugh with a tinge of worry, but laugh first, by all means!!

Found all my nice hats from about 20 years ago--first time I balded. I marvel at my wisdom and the care that I have taken to keep them boxed up and clean. O, let's not forget that human hair wig!! Summer comes will I don the piece, of course. Winter is the perfect time to lose 70% of my hair--cold and hats go together.

My lupus is raging in spite of the raise of all disease-modifying RXs. My lab studies read like a death sentence. ...
 
OK, enough grumbling. This flare came out of no where, well, technically it came from my own body. Yet I am wracking my brain as to what could have precipitated this wild orgy of my blood cells--without even informing, let alone asking for my permission to carry on like this.

...
 
I was asked if I am depressed yesterday. I asked back, "What is NOT depressed?" I received no answer. The sense of forlornness and extreme concern and fear surpass depression as most with severe lupus patients would understand. No, I am not going to kill myself on purpose BUT, I can't speak intrinsically for my blood chemistry at the moment. I hope you all see the irony.

Some well-intentioned "shrinks", sorry, did I just write shrinks? I guess I mean shrinks. Some of them analyze that auto-immune diseases is the manifestation that the individual DOES NOT like herself on a subconscious level and that's the reason her body goes hog-wild and destroys her in spite of herself. If you are one of these shrinks, I might seriously consider getting a gun and take good care of you! Others friends and family members suggest that we, somehow, are doing something or not doing something to come to this point. Well, as much as a peace advocate, I WILL use that gun. Those friends who tell me that I look great and wish me to get WELL soon--I WILL shrink you myself. I will never be well in the true sense of wellness. I may be stable, at best. Not to forget the well-intentioned self-proclaimed nutritionists and the know-it-alls, please do not tell me to eat 2 pounds of blueberries/whatever a day or I will live in your house and occupy your personal bathroom facilities, indefinitely. Those who cry--STOP it. I mean it. Suck it up--I do. All them "I worry about you's"--you can zip it up as well. You don't know the meaning of worry, trust me. Ones who avoids me after knowing I am sick. You are good--keep avoiding me until you get shrunk. The contradictors, please go to medical school, after you get in, specialize in rheumatology, finish your residency, see patients and research for about 20 years, then come back and I will have tea and biscuits waiting for you.

The friends who want to help in tangible ways: look into my soul via my eyes--do you see the same person as you have always seen in me? If so, let's have a great time in our dialogue--from weather to religion, to election, to family, to cultures, to philosophies, to faith, to love, to peace, to war, to science, to music, to fashion, to money, to God, to Satan, to evolution, to creationism, to books, to movies, to laundry, to house-keeping, to bargain-hunting, to money-making tips, to money-saving tips, to trip-planning, to gardening, to personal affairs, to tombstone epitaphs, to church, to gossip, to vanity, to shopping online, to shopping off line, to old friends, to Facebook, to Youtubing, to children, to siblings, to relatives, to parents, to fights, to laughter, to everything, and of course, to hair-styles. By being a true friend, you have just lightened the load immensely. Please try to be this kind of friends to all people who suffer alone and often in silence as our world does not validate invisible illnesses.

My blood curls just a bit when I think all the hassle I might wreck upon my immediate family if I were to depart. So for that reason alone, I shall try to be merciful to my husband, my sons and my brothers. I will stick around and blog! And you had better read it and respond, as true friends do. Shalom.

P.S. I am certainly preaching to the choir if you have read thus far!!! Hahahaha!
 
 
 

Name Change

Panel recommends changing name of common disorder in women
<http://links.govdelivery.com:80/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTMwMTIzLjE0NzI0ODIxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDEzMDEyMy4xNDcyNDgyMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MzY0NTk0JmVtYWlsaWQ9ZGVib0B0aWFjLm5ldCZ1c2VyaWQ9ZGVib0B0aWFjLm5ldCZmbD0mZXh0cmE9TXVsdGl2YXJpYXRlSWQ9JiYm&&&102&&&http://www.nih.gov/news/health/jan2013/od-23.htm>
01/23/2013 08:13 AM EST

An independent panel convened by the National Institutes of Health has
concluded that the name of a common hormone disorder in women,
polycystic ovary syndrome (PCOS), causes confusion and is a barrier to
research progress and effective patient care.

/*Gee whillikers, I know another disease that sure could benefit by a
name change. Surely "Chronic Fatigue Syndrome" is the paradigm exemplar
of crucifixion by linguistic folly. Who would have imagined that this
episode of cruel and careless word-smithery could cause so much
unnecessary death and destruction? Who would have imagined that the
banal word fatigue could turn into an instrument of sabotage and the
ruination of lives?*/
* * *
Thanks, Deb!
 
The CDC agreed to study the matter [of a name change] but later announced
that the adoption of a new name is premature. In a catch-22, the present name
trivializes the illness, thereby discouraging the research funding needed to
uncover the pathophysiology of the disorder, which would help determine a more
accurate name. -- Katrina Berne
 
The name "Chronic Fatigue Syndrome" was selected by a small group of politically motivated scientists. Their deliberate intention was to obfuscate the nature of the disease by placing it in the realm of the psychiatric rather than the organic. The harm they have caused is surely one of the great tragedies of medicine. –– Hillary J. Johnson
 
The name of an illness has a profound impact upon those who suffer from it, upon how the uninformed perceive it, and upon medical research and treatment.–– John Herd

How To Crowdfund Your Project

 
 
Perhaps for some of those research projects that patients would like done and government won't fund, we should try crowdfunding?  Someone with the skills make a video and let's get it viral!

Correlation is not causation

Note: The research definition for CFS excludes bipolar disorder, however in the real world many diseases coexist, but it doesn't necessarily then mean they are related. One could also do a study to determine the hair color of children most often abused and then compare that to the hair color of patients with disease and conclude that hair color is linked to patterns of abuse and subsequent illnesses. One could then conclude that hair dye would nip the problem in the bud. Correlation is not causation.

However there is some research showing that abuse may affect the immune
system which could make people more vulnerable to certain diseases. In this
study, as in any study of this type, there is the possibility of recall
bias. As well in this case the authors specifically singled out the
illnesses most often considered by some psychiatrists to have psychosomatic
elements.


J Affect Disord. <http://www.ncbi.nlm.nih.gov/pubmed/23337654#> 2013 Jan
18. pii: S0165-0327(12)00773-2. doi: 10.1016/j.jad.2012.11.020. [Epub ahead
of print]

Role of childhood adversity in the development of medical
co-morbiditiesassociated with bipolar disorder.

Post RM, Altshuler LL, Leverich GS, Frye MA, Suppes T, McElroy SL, Keck PE
Jr, Nolen WA, Kupka RW, Grunze H, Rowe M.
Source

Bipolar Collaborative Network, 5415 West Cedar Lane Suite 201B, Bethesda,
MD 20814, USA. Electronic address: robert.post@speakeasy.net.
AbstractOBJECTIVE:

A role for childhood adversity in the development of numerous medical
conditions in adults has been described in the general population, but has
not been examined in patients with bipolar disorder who have multiple
medical comorbidities which contribute to their premature mortality.
METHODS:

More than 900 outpatients (average age 41) with bipolar disorder completed
questionnaires that included information about the occurrence of verbal,
physical, or sexual abuse in childhood and whether their parents had a mood
or substance abuse disorder, or a history of suicidality. These factors
were combined to form a total childhood adversity score, which was then
related to one or more of 30 medical conditions patients rated as present
or absent.
RESULTS:

The child adversity score was significantly related to the total number of
medical comorbidities a patient had (p<.001), as well as to 11 specific
medical conditions that could be modeled in a logistic regression (p<.03).
These included: asthma, arthritis, allergies, chronic fatigue syndrome,
chronic menstrual irregularities, fibromyalgia, head injury (without loss
of consciousness), hypertension, hypotension, irritable bowel syndrome, and
migraine headaches.
LIMITATIONS:

The contribution of parental diagnosis to childhood adversity is highly
inferential.
CONCLUSIONS:

These data link childhood adversity to the later occurrence of multiple
medical conditions in adult outpatients with bipolar disorder.

Recognition of these relationships and early treatment intervention may
help avert a more severe course of not only bipolar disorder but also of
its prominent medical comorbidities and their combined adverse effects on
patients'health, wellbeing, and longevity.


Copyright © 2012 Elsevier B.V. All rights reserved.

Professor Martin Pall's Response to Wessely et al. on MCS

*Permission to repost.*

In December, the "Journal of the Royal Society of Medicine" published an
article titled "Taking refuge from modernity: 21st century hermits"
authored by I Boyd, G J Rubin and S Wessely (see abstract below)

In response, Professor Martin Pall submitted the following letter to the
editor but it was rejected.

Here is Professor Pall's letter:


*Taking refuge from modernity: 21st century travesty?*

Wessely and colleagues argue that multiple chemical sensitivity (MCS) and
electromagnetic field (EMF) hypersensitivity (EHS) are simply contemporary
ways that allow people to isolate themselves from society, arguing that
these are not true sensitivities to chemicals or EMFs1.

I was honored to be chosen to write an authoritative review on MCS, by
three eminent toxicologists (the editors2). It was clear that they thought
that MCS was a disease of toxic exposure. Why else ask for such a paper?
Among the papers that convincingly show that are studies of
Schnakenberg3,4, showing that four polymorphic genes involved in the
metabolism of chemicals implicated in MCS had highly significant roles in
determining MCS susceptibility
(p<10-15 for all four occurring by chance!).
These followed studies by McKeown-Eyssen, implicating three such chemical
metabolism genes and by Haley implicating one such gene. In all, seven such genes were implicated, all having roles in chemical metabolism. How can all this be true if chemicals have nothing to do with MCS? Wessely has no answers1.

The seven classes of MCS-implicated chemicals act to produce elevated NMDA
activity2. Six other types of evidence suggest NMDA elevation has roles in
MCS2,5 ; one of these involves two genetic polymorphism studies, both
showing that alleles of the CCK-B receptor gene that produce an elevated
NMDA response are associated with increased MCS susceptibility.

There are many other studies showing real physiology in MCS, including 25
studies on objectively measurable changes in response to chemical exposure,
where MCS patients differ from normals. 24 of these are completely
incompatible with psychological interpretations2. Many human studies and 38
animal model studies show physiological changes with apparent causal
roles2. Shouldn't Wessely inform readers of the vast evidence that argues against his hypothesis?

Reference 2 is 50 pages, containing 427 citations. Letters limited to 300
words, 5 citations.

Martin L. Pall, Professor Emeritus of Biochemistry and Basic Medical
Sciences, Washington State University, 638 NE 41st Ave., Portland, OR
97232-3312 USA; Email: martin_pall@wsu.edu

Competing interests: none declared.

References

1. Boyd I, Rubin GJ, Wessely S. Taking refuge from modernity: 21st century
hermits. J R Soc Med 2012:105:523-529.
2. Pall ML. Multiple chemical sensitivity: toxicological questions and
mechanisms. In: Bryan Ballantyne, Timothy C. Marrs, Tore Syversen, editors.
General and Applied Toxicology, 3rd Edition. London: John Wiley and Sons,
Ltd., 2009 p. 2303-2352.
3. Schnakenberg E, Fabig KR, Stanula M, et al. A cross-sectional study of
self-reported chemical-related sensitivity is associated with gene variants
of drug metabolizing enzymes. Environ Health 2007;6:6 .
4. Müller KE, Schnakenberg E. Die Bedeutung de Glukuronidierung bei
unweltmedizinischen Erkrankungen am Beirspeil der
UDP-Glukuronosyltransferase 1A1. Umwelt-Medizin-Gesellschaft
2008;21:295-300.
5. Pall ML. NMDA sensitization and stimulation by peroxynitrite, nitric
oxide and organic solvents as the mechanism of chemical sensitivity in
multiple chemical sensitivity. FASEB J 2002;16:1407-1417.

....................................................


http://jrsm.rsmjournals.com/gca?gca=jrsm%3B105%2F12%2F523&submit=Get+All+Checked+Abstracts

*Abstract *

*Review:*
I Boyd, GJ Rubin, and S Wessely

*Taking refuge from modernity: 21st century hermits *
J R Soc Med December 2012 105:523—529; doi:10.1258/jrsm.2012.120060

Idiopathic environmental intolerances, such as 'multiple chemical
sensitivity' and 'electrosensitivity,' can drastically affect the quality
of life of those affected.
A proportion of severely affected patients
remove themselves from modern society, to live in isolation away from the
purported causal agent of their ill health. This is not a new phenomenon;
reports of hermits extend back to the 3rd century AD. We conducted a
literature review of case reports relating to ancient hermits and modern
day reclusion resulting from idiopathic environmental intolerance, in order
to explore whether there are similarities between these two groups and
whether the symptoms of these 'illnesses of modernity' are simply a
present-day way of reaching the end-point of reclusion. Whilst there were
some differences between the cases, recurring themes in ancient and modern
cases included: dissatisfaction with society, a compulsion to flee, reports
of a constant struggle and a feeling of fighting against the establishment.
The similarities which exist between the modern-day cases and the
historical hermits may provide some insight into the extreme behaviours
exhibited by this population. The desire to retreat from society in order
to escape from harm has existed for many centuries, but in different
guises.

Diagnostic and Treatment Resources Online (Dr. Lerner)

Diagnostic and Treatment Resource Guide for Myalgic
Encephalomyelitis/Chronic Fatigue Syndrome Available Online

BEVERLY HILLS, MI – March 20, 2012 New diagnostic and treatment
resources for Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome
(ME/CFS) physicians and patients are now available online to the
public. ME/CFS, a poorly understood illness affects as many as 4
million people in the US alone, by CDC estimates, with a quarter
disabled by it. ME/CFS affects more Americans than AIDS, lung cancer
and breast cancer combined, yet has few available treatment options or
resources for patients and even fewer research dollars available to
scientists. Dr. A Martin Lerner, esteemed infectious disease
specialist and researcher of the Treatment Center for CFS in Beverly
Hills, MI, has made available online a video presentation
http://bit.ly/GNGcV3 i.e.
http://www.treatmentcenterforcfs.com/video/2011-prt1.html of his
diagnostic and treatment protocol, a digital file http://bit.ly/GH6OIO
i.e. http://www.treatmentcenterforcfs.com/video/documents/Dr.AMLerner-PrimeronMECFS.pdf
of the corresponding document presented and a stand-alone treatment
resource guide for ME/CFS http://bit.ly/GJ2ev1 i.e.
http://www.treatmentcenterforcfs.com/video/documents/MECFSTreatmentResourceGuideforPractitioners.pdf
. They are all found on his website, at
http://treatmentcenterforcfs.com/video .

When asked why he produced a video and supplemental documents around
his ME/CFS protocol, Lerner responded, "I decided to record the
diagnosis and treatment of ME/CFS with its science, for both
physicians and patients. There was a need for information that was
easy for both communities to follow, clearly outlined for educational
and implemental use."

Lerner himself was at one time plagued by ME/CFS. He was his own first
patient. Since then, he has seen hundreds of stricken patients. Over
the decades, and through much research, he has created the protocol
used today - involving the treatment of Epstein Barr Virus,
Cytomegalovirus, and Human Herpesvirus 6 singularly or in combination
through the use of antiviral pharmaceuticals. In recent years there
has been increasing talk of his protocol success, in large part due to
the publication of his most recent case study. He published the
successful results of 142 ME/CFS patients over the course of treatment
lasting as long as 6 years.

A lack of available ME/CFS literate physicians available to ME/CFS
patients is universally known within this tight knit community. It is
therefore commonly understood, these patients take on the role of
educating their doctors on their own illness. It came to the attention
of the Treatment Center for CFS that patients have been printing out
Lerner's published research and case reviews; bringing these as
resources for their doctor appointments, asking their doctor to follow
the Lerner protocol. Lerner's most recently shared set of diagnostic
and treatment resources is a nod to this practice. It is one more set
of resources the patient can share with their treating physician and
the treating physician can add to their diagnostic and treatment
arsenal.

Tracy Waechter, former medical professional, climber, and community
volunteer now housebound with ME/CFS shared, "I am fortunate to have a
local physician who supports the diagnosis of ME/CFS. He isn't one to
try much outside of the box, but (he) is interested in research-based
medicine. I recently presented him with Dr. Lerner's excellent
research on the use of antivirals. I greatly appreciate and admire
physicians like Dr. Lerner who dedicate themselves to this underserved
patient population, and provide patients like me treatment options."

Another common concern in the ME/CFS community is regarding the safety
of patients. Antiviral drugs commonly used, while when managed closely
have been found to be quite safe, must be monitored. Sharing these
diagnostic and protocol guidelines provided another opportunity to
remind the treating physicians and their patients just how important
it is to closely monitor the treatment process.

Diagnostic and Treatment Resource Guide for ME/CFS – Page 2


"Close management by the responsible physician is absolutely
necessary. When following the protocol, they must NOT allow for
abnormalities that can occur, in liver and kidney levels for example,
as highlighted in my research and guidelines," says Lerner. "But with
much care, the results are life-saving, and regularly return ME/CFS
patients to a more normal life."

It is with this hope for all ME/CFS patients, that Dr. Lerner
continues his work. At 82-years-young, Lerner continues to see
patients five-days-a-week, and to publish groundbreaking science. Most
recently his work could be seen in a poster presentation at the annual
International Association for CFS/ME Conference in Ottawa, Canada.

When asked what's next, Lerner replied, "Our research work continues!
All of the work in the video has been confirmed by its repeated
replication over the past few years." He then changed gears a bit, to
say, "I am hopeful, for the sake of the patients as well as future
research, that the science of ME/CFS can soon be accepted to join the
total body of our scientific understanding of viral infection."

The ME/CFS patient and physician community share his enthusiasm and
hope. In the meantime, because of Lerner's commitment to sharing his
findings, they have a few more diagnostic and treatment resources at
their fingertips.


About Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome(ME/CFS), also
called Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS),
Myalgic Encephalomyelitis (ME) or Chronic Fatigue Syndrome (CFS),
affects as many as 4 million people in the US alone, by CDC estimates,
with a quarter disabled. It affects more Americans than AIDS, lung
cancer and breast cancer combined. Research by the National Chronic
Fatigue foundation found CFS sufferers average age of death to be as
much as 20 years premature to the average American. It is a
multisymptom disease, affecting the cardiovascular, immune and central
nervous system. The most publicized symptom of the disease is the
crippling fatigue, with most patients bed-ridden for all but a few
short minutes or hours per day. To the naked eye these patients may
look healthy, due to the "invisible" nature of the symptoms, many
times causing confusion regarding its legitimacy.


About Dr. A. Martin Lerner

Dr. A. Martin Lerner founded the Treatment Center for Chronic Fatigue
Syndrome in Beverly Hills, Michigan. An Infectious Diseases specialist
who was at one time plagued by ME/CFS, he has committed the past 25
years to the diagnosis and treatment of CFS for patients around the
world. In the past 50 years Dr. Lerner has written over 200
peer-reviewed publications spanning many areas of infectious diseases
and virology.




Dr. A. Martin Lerner Treatment Center for CFS
Mailing Address: 32804 Pierce Road, Beverly Hills, MI 48025
tel +1 248.540.9866 fax +1 248.540.0139 www.treatmentcenterforcfs.com

Double-blind Ampligen research

Note: Rintatolimod is more commonly known as Ampligen.

-----------------------------------------------------------------

fulltext is available at-
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0031334

A Double-Blind, Placebo-Controlled, Randomized, Clinical Trial of the
TLR-3 Agonist Rintatolimod in Severe Cases of Chronic Fatigue Syndrome
David R. Strayer1*, William A. Carter1, Bruce C. Stouch2, Staci R.
Stevens3, Lucinda Bateman4, Paul J. Cimoch5, Charles W. Lapp6, Daniel
L. Peterson7, the Chronic Fatigue Syndrome AMP-516 Study Group**,
William M. Mitchell8*

1 Hemispherx Biopharma, Inc., Philadelphia, Pennsylvania, United
States of America, 2 BCS Consulting, Philadelphia, Pennsylvania,
United States of America, 3 University of the Pacific, Stockton,
California, United States of America, 4 Fatigue Consultation Clinic,
Salt Lake City, Utah, United States of America, 5 Center for Special
Immunology, Fountain Valley, California, United States of America, 6
Hunter-Hopkins Center, Charlotte, North Carolina, United States of
America, 7 Sierra Internal Medicine Associates, Incline Village,
Nevada, United States of America, 8 Vanderbilt University School of
Medicine, Nashville, Tennessee, United States of America
** For a list of the members of Chronic Fatigue Syndrome AMP-516
Clinical Study Group please see Table S2.


Abstract

Background
Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a
severely debilitating disease of unknown pathogenesis consisting of a
variety of symptoms including severe fatigue. The objective of the
study was to examine the efficacy and safety of a TLR-3 agonist,
rintatolimod (Poly I: C12U), in patients with debilitating CFS/ME.

Methods and Findings
A Phase III prospective, double-blind, randomized, placebo-controlled
trial comparing twice weekly IV rintatolimod versus placebo was
conducted in 234 subjects with long-standing, debilitating CFS/ME at
12 sites. The primary endpoint was the intra-patient change from
baseline at Week 40 in exercise tolerance (ET). Secondary endpoints
included concomitant drug usage, the Karnofsky Performance Score
(KPS), Activities of Daily Living (ADL), and Vitality Score (SF 36).
Subjects receiving rintatolimod for 40 weeks improved intra-patient
placebo-adjusted ET 21.3% (p = 0.047) from baseline in an
intention-to-treat analysis. Correction for subjects with reduced
dosing compliance increased placebo-adjusted ET improvement to 28% (p
= 0.022). The improvement observed represents approximately twice the
minimum considered medically significant by regulatory agencies. The
rintatolimod cohort vs. placebo also reduced dependence on drugs
commonly used by patients in an attempt to alleviate the symptoms of
CFS/ME (p = 0.048). Placebo subjects crossed-over to receive
rintatolimod demonstrated an intra-patient improvement in ET
performance at 24 weeks of 39% (p = 0.04). Rintatolimod at 400 mg
twice weekly was generally well-tolerated.

Conclusions/Significance
Rintatolimod produced objective improvement in ET and a reduction in
CFS/ME related concomitant medication usage as well as other secondary outcomes.


Trial Registration
ClinicalTrials.gov NCT00215800

Is CFIDS related to AIDS?

"A disturbing announcement was made at the July 1992 international AIDS
conference held in Amsterdam: Several people with symptoms of AIDS, but who had no evidence of infection with either HIV-1 or HIV-2 (the viruses generally believed, at the time, to cause AIDS), had been identified by the U.S. CDC.

A few weeks later…Newsweek made an even more shocking announcement: that CFS researcher Dr. Paul Cheney had in his practice 20 CFS patients who had the same immune system deficiencies as the non-HIV AIDS cases revealed at the Amsterdam conference."

Source: http://www.fms-help.com/aids.htm

More on non-HIV AIDS (ICL):
http://www.autoimmune.com/Non-HIVAIDSGen.html
http://www.cfsstraighttalk.blogspot.com

Revolutionizing Research

http://www.pacific.edu/About-Pacific/Newsroom/PFL-Feature.html

University of the Pacific

SCIENCE AND TECHNOLOGY

Hope for the Weary

Internationally recognized research conducted by
faculty and students in the Pacific Fatigue
Laboratory is giving hope to those with debilitating
illnesses.

Linda DuBois

Feb 17, 2012

The Pacific Fatigue Lab (PFL) is a research, clinical and
teaching laboratory that studies fatigue-related illnesses
such as Chronic Fatigue Syndrome/Myalgic
Encephalomyelitis (CFS/ME). Founded in 2007, PFL is
operated through the Department of Sport Sciences.

CFS/ME is an incurable, debilitating illness that is difficult to
diagnose. At PFL, individuals with CFS/ME - often
dismissed as malingering or depressed by family members,
insurance companies and even physicians - are receiving
objective, clinical validation that they indeed have a
disabling illness, important for both psychological and
practical reasons.

Revolutionizing the Field of CFS/ME Research

PFL provides a comprehensive disability evaluation that
measures heart, lung and sympathetic nervous system
function, metabolic function and cognitive processing time.
Testing includes an 8-12 minute exercise stress test.
However, a difference in Pacific's testing protocol is that
patients are also re-tested the next day. This factor has
revolutionized CFS/ME research.

*Those with CFS/ME are the only patients who score
significantly worse the second day,* says Staci Stevens
'91, '97, PFL founding executive director. Research has
proved that, regardless of health level, a person will score
about the same on both days when taking a stress test two
days in a row. *CFS/ME patients do not recover normally
from physical exertion.*
From test results PFL researchers provide an extensive
evaluation to help the patient manage their illness and to
educate physicians and attorneys. For some, it is a
financial lifesaver; helping them obtain disability benefits
they were previously denied. Each patient also receives an
heart-rate monitor to help them manage exertion levels and
prevent a flare-up.

PFL is the only place that offers this comprehensive service,
and only two centers have implemented its exercise testing,
one at Ithaca College in New York and one at a university in
the Netherlands. Consequently, the lab has drawn patients
from as far as Chile and Japan. This includes people with
illnesses other than CFS/ME, such as HIV, multiple
sclerosis and cancer, who increasingly must prove they are
unable to work.

*We do have a reputation that goes beyond the United
States, which is quite unique for a small institution like
this,* says Christopher Snell, sport sciences professor and
PFL scientific director. Stevens and Snell have both served
on the U.S. Department of Health and Human Services
Chronic Fatigue Syndrome Advisory Committee, which
Snell has chaired for the past three years.

Students Gaining Real-World Experience

Both undergraduate and graduate students are involved
through every aspect of the research and testing process.
Students work with patients, review medical history,
measure height, weight and blood pressure, conduct the lab
testing, and compile the results into a report.

Many of the students have presented their research at major
conferences. Larson recently presented his research at the
International Association of CFS/ME (IACFS/ME)
conference (http://www.iacfsme.org/). Graduate Harnoor
Singh '07 has presented research at the American College
of Sports Medicine (http://www.acsm.org/) conference and
was named Student Researcher of the Year at the
IACFS/ME annual meeting.

Singh and Larson agree their experiences in the Pacific
Fatigue Lab are invaluable preparation for their future in
health-related careers. Singh, now in medical school, was
particularly affected by clients' frustration at being
repeatedly dismissed by doctors. He says it has taught him
the importance of listening and being sensitive to patients.






Highly praised video "Biomarkers for ME/CFS" available for FREE download

The highly praised video "Biomarkers for ME/CFS" is now available for FREE
downloading.

In the video Dr. Kenneth J. Friedman discusses the development of biomarkers
for ME/CFS. Particularly, brain imaging, bio-chemistry and exercise testing
may be downloaded from the cfsKnowledgeCenter Facebook page at:



http://www.facebook.com/video/video.php?v=3116650328444&saved


Kenneth Friedman, Ph.D., is a member of the Board of Directors of the
IACFS/ME, Associate Professor of Pharmacology and Physiology, New Jersey
Medical School (retired) and a member of the Board of Advisors of
cfsKnowledgeCenter.

The other four videos in the series with Dr. Friedman may be accessed at:
http://www.me-cfscommunity.com

Tuesday, January 22, 2013

Relationships between Researchers and CFS patients

On the one hand, we have researchers who claim to have received death threats from CFS patients, and on the other hand, we have researchers like Dr. Judy Mikovits whom patients will defend to the death.
 
Instead of blaming the patients, those researchers who've received death threats should look in the mirror.
 
The researchers we dislike are those who ignore all the scientific evidence to tout their own baseless theories that we're just lazy and crazy.  The researchers we admire are those who look for -- and find -- more scientific evidence (which the other band of researchers choose to ignore).
 
 

A Howl of Desperation for those who Cannot Howl

http://blogs.suntimes.com/foreignc/2012/02/life-in-the-shadows.html

Our far-flung correspondents

A howl of desperation for those who cannot howl
Uploaded by Roger Ebert on February 10, 2012 3:38 PM

Scott Jordan Harris in the UK


There is a shot in "Voices from the Shadows" that shows a man in his
twenties lying forlornly in bed. Like the rest of the documentary, it
exists to illustrate the miserable effects of the illness Myalgic
Encephalomyelitis, or ME, which is often unhelpfully called Chronic
Fatigue Syndrome.

There is a detail in the shot that haunts me. The man has a beard, of
a length and thickness unusual, and unsuitable, for someone his age.
He has the beard because he is unable to stand up long enough to shave
and because having his parents, or a nurse, sit and shave him as he
lays in bed is messy, uncomfortable and undignified. Every morning he
thinks about shaving but his reserves of energy are so limited that he
has to choose between being able to go to the bathroom because he
wants to shave or, later in the day, being able to go to the bathroom
because he needs to go to the bathroom.

He could shave instead of telling his carers what he feels able to eat
that day, or instead of eating it, but that's not a sensible idea. He
could shave instead of speaking to the friend who will visit him for
ten minutes in the afternoon, but he hasn't spoken to anybody besides
his parents and his doctors in two months, and he really wants to talk
to that friend. He could shave instead of counting out and swallowing
the painkillers he needs to roll over in bed without wincing but ...
well, that's just crazy talk. Besides, you need light to shave, and
electric light gives him migraines and blurs his vision. Every day,
this pattern recurs. Although shaving is always on the list of things
he wants to do, it never makes it to the top. And so the beard grows.

None of this is discussed in "Voices from the Shadows" - the man is
unnamed and his beard is unmentioned - but I know about it because I
have the same beard. I have the same beard because I have the same
illness and, apart from three years of remission in my teens, I have
had it since I was 11. I'll be 30 this year. I always hope to get
better. I never expect to.

As a child, I was an inexhaustible over-achiever and what, in America,
is called a straight A student. At 10, I was an assistant karate
instructor and on course to be one of the youngest black belts in
Britain. At 11, I had a routine inoculation - a common catalyst for ME
- alongside the rest of my school classmates. I was never
inexhaustible again. Eighteen hours later, I couldn't lift my arms. My
skin erupted in a rash. Daylight burned my eyes. My migraine made me
cry. My dad thought I had measles. I wish he had been right.

I couldn't go back to school for a year. My childhood stopped, and I
measured time by counting down the intervals between doses of
painkillers. A couple of doctors, and several teachers, didn't believe
I was ill. I learned a new term, one whispered to my mother and father
when doctors thought I couldn't hear, or couldn't understand:
'school-phobic'. If it hadn't been for my combative parents, my
saintly GP and my fast mouth, I would have been referred to a
psychiatrist, or reported to a truant officer.

Eventually, I recovered. I went to high school, and tried to reclaim
the time I'd lost. I was captain of the debating team, the rugby team
and the athletics team. I was on the basketball team and the swimming
team and the cricket team. I wrote the school play. I was champion
athlete on sports day two years running. I played rugby for the town
and the county and the local club, sometimes four times a week and
twice a day.

And then I started to feel ill again. A few months later I was back in
bed, trying not to throw up the little food I could keep down,
exhausted by the effort of cleaning my teeth, and as completely
reliant upon my parents as I would have been if I'd become
quadriplegic. I stayed that way for years. Once, when I was sick of
being 16 years old and unable to take a damn shower by myself, I tried
to take one while my parents were out. My legs buckled and I had to
lie on the bathroom floor. I was there for two hours. I was never well
enough to finish high school. Again, there were doctors who thought I
wasn't really ill. There still are.

I'm in a better situation than most of the ME-sufferers in "Voices
from the Shadows." For one thing, my symptoms are not as severe as
they used to be and I am able to work a little from my bed. (I'm a
film critic. Or at least as much of a film critic as one can be
without ever really getting to the cinema.) For another thing, I'm
still alive.

"Voices from the Shadows" does not just document the effects of ME: it
documents the abuse of those who have it by doctors who fail to
recognize it is a physical condition and treat it instead as a mental
illness. The World Health Organization has defined ME as what it is -
a neurological disorder - since 1969. Especially in Britain, but
elsewhere too, sufferers born more than twenty years later are still
being treated as malingerers.

Of the patients profiled in "Voices from the Shadows," two stand out.
One is Sophia Mirza and the other is Lynn Gilderdale, whose face -
pretty and pale, and somehow serene despite struggling not to grimace
with pain - is one of the film's unshakable images. I knew Lynn
Gilderdale. I didn't know her well, but then it wasn't easy to know
her well. She could barely move, and the idea of her leaving the house
was laughable. She had 48 Facebook friends and I was one of them. We
exchanged occasional emails. I took longer to reply to hers than I
should have. I didn't realize the opportunity to know her would be so
brief.

Lynn's agony was incessant: her ME tortured her with an intensity that
shocked me. Before I knew her, Lynn's body had been damaged by doctors
who thought she was at worst lazy and at best mentally ill. She never
recovered, and her life worsened day on day. In early December 2008, a
friend told me that Lynn was dead, and that her mother had been
arrested for murder. Lynn's illness had become insurmountable and, one
night, she attempted to overdose on morphine but didn't have the
strength or co-ordination to do it. Walking in on her, Lynn's mother -
in a supreme act of maternal love - assisted with the overdose. An
autopsy revealed that Lynn's spine was severely diseased. Her illness
had been purely physical.

The film doesn't describe the circumstances of Lynn's death, and
offers no opinion on assisted suicide. (The endorsement of the actions
of Lynn's mother implicit here is mine and not its.) This is neither
bravery nor cowardice on the part of the film-makers: it is an astute
decision made to ensure the debate about this film does not became a
debate about assisted suicide. "Voices from the Shadows" is not about
the tragic circumstances of Lynn Gilerdale's death: it is about the
tragic circumstances of her life.

Sophia Mirza's ME was similar to Lynn's, and far worse than mine. As a
girl, Sophia was bright and beautiful and lively - and then she
developed ME, and suddenly she was none of these. But her doctors
didn't believe that such a change could be due to physical causes and
so they insisted she simply didn't want to be well. In the most
excruciating sequence in Voices from the Shadows, we hear the
recording Sophia secretly made when those doctors, accompanied by
police officers, forced their way into her home and took her to a
secure mental institution. There, like other patients profiled in the
film, she would no doubt have been forced to exercise - to prove to
her that there was no physical reason why she could not. (Exercise
only worsens the symptoms of ME; nevertheless, it is still prescribed
as a treatment.)

But she was too ill even for that. The stress of being committed to a
mental hospital when she had no mental illness, of being fed food she
couldn't eat, of not being allowed to sleep when she needed to, and of
being treated at all times as if she was physically healthy, made her
symptoms deteriorate to such an extent that a judge eventually ruled
she should be allowed home. She never recovered and, two years later,
she died. Sophia Mirza was bullied to death by medical professionals
who ought to have helped her; no criminal charges have been brought
against them. An autopsy revealed that Sophia's spine was severely
diseased. Her illness had been purely physical.

"Visions from the Shadows" isn't technically or artistically
impressive. It isn't the bold new work of a brave new film-maker. It
is a howl of desperation from co-directors Natalie Boulton and Josh
Biggs - the mother and brother of a young woman with ME - on behalf of
those who cannot howl themselves. Much of it consists simply of people
sitting and talking about ME. What makes this invaluable is that the
things they say are seldom said. Or rather, they are seldom listened
to.

No documentary has ever devastated me like "Voices from the Shadows."
Unless you are an ME-sufferer, it's unlikely to have quite such a
powerful effect on you - and I am glad of that. I couldn't in good
conscience urge people to see a film that would do to them what
"Voices from the Shadows" did to me.

Although "Voices" joined "The Artist" and "Albert Nobbs" in winning a
prize at 2011's Mill Valley Film Festival, it has no theatrical
distribution deal. Boulton and Biggs sell European DVDs of the film
through their website; outside Europe, it is streaming for $2.99 from
MUBI.com. http://mubi.com/films/voices-from-the-shadows

I can't be impartial about this film, and I can't conclude my review
of it - if this is a review of it - with the customary, balanced
summation of why you should, or should not, try to see it. But I can,
with total sincerity, say this: if I could make everyone in the world
see just one film, this would be the film I'd choose. It's my film of
the year. It'll be my film of the decade.

As a critic, I spend my life hoping to find films that will be speak
to me. "Voices in the Shadows" goes beyond that. It is a film that
speaks for me. And I want you to hear it.