Monday, 8 August 2016

Who is responsible?

Who takes responsibility when National Health Service guidelines cause medical harm?

It's a serious question.  Where does the buck stop?  


I am asking because, the National Institute of Clinical Excellence (NICE) guidelines for myalgic encephalomyelitis, ME, still recommend two controversial therapies: Graded Exercise Therapy (GET) and Cognitive Behaviour Therapy (CBT).

Actually NICE prefixes the name, ME, with "CFS" (chronic fatigue syndrome) - a shocking misnomer, that suggests patients are simply fatigued or tired.  This would appear to be an intentional attempt to belittle the disease.  It certainly doesn't indicate the potential for ME to become so severe that some patients exist in a living limbo of agonising immobility for years and even decades.

Yet General Practice doctors consult NICE guidelines, see the word "exercise" and regularly tell their ME patients to get out and starting exercising.

I too was given this advice at the start of my illness.  "Three short brisk walks a day", I was told.  It didn't work for me, and I doubt it would work for anyone with this debilitating disease.  Why would it?  One of the main problems with the disease is that exertion of any kind exacerbates all symptoms. Indeed, in my own case, trying to follow the advice I was given led only to increasing disability.

Patient groups and charities, are very aware of the problems with NICE guidelines and have often pointed out that both CBT and GET tend to do more harm than good.  The ME Association survey clearly shows that 74% of those doing GET say their symptoms are made worse.

Further, the now notorious PACE Trial which provides the so-called evidence base for GET and CBT, in fact only shows minor improvements for a small percentage of individuals.  Add to this, the fact that the methods used in the PACE trial, have been scientifically questioned, and that the authors are going to great lengths to resist releasing their data, and suddenly the evidence seems dubious.

Yet still patients are being subjected to this "exercise" paradigm.

So why is nothing changing?  Why does NICE cling to these harmful and questionable therapies?

What has happened to the medical maxim "first do no harm"?

And who is ultimately responsible for the harm being caused? 

I don't blame the doctors.  They refer to the guidelines and believe them to be the best medical information available.  They advise as they are advised.

Doctors also read media headlines, and sadly most ME news stories claim that people with ME just need to exercise and think positively in order to recover. It certainly seems like good common sense advice for the life-weary. Yet because ME has no clinically accepted biomarkers, it is easy for doctors to genuinely think the ME patients they see are just run-down. Or, conversely, to think that those who are just run-down might qualify as having the condition Chronic Fatigue Syndrome, which curiously the media always follow with the phrase "also known as ME".

One way and another, it is easy to see how confusion arises.

Yet for those who have the severely disabling, long-term, life-altering, debilitating disease of Myalgic Encephalomyelitis there can be no confusion: these patients know they have something very physically wrong with them. Any small extra thing a person with ME tries to attempt, results in flu-like payback, and potentially a ratcheting downwards of their long term health.  The disease is relentlessly cruel, stealing away the very essence of each sufferer's existence.

And for the most severely ill it seems there is little the NHS can offer.  Charities regularly get calls from concerned patients and their families, because home visits are denied, and trips to health centres or hospitals are too detrimental to the patient's well-being.

So it seems, severe ME patients are largely ignored by health services, and the NICE guidelines have few suggestions for patients reaching this state.  If patients are lucky, they given the equivalent of palliative care to ease their symptoms, but not much else.

Yet there are many anecdotal stories of Graded Exercise Therapy being the initial trigger that sent mild or moderately ill patients hurtling into the abyss of severe ME.  I cannot understand why these worrying stories, and the reports from the charities are being so blatantly ignored.

I ask again:  Who is responsible?  

****

Useful References:

NICE guidelines for CFS/ME: 
http://www.nice.org.uk/guidance/cg53/chapter/1-recommendations

PACE Trial
: Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/fulltext 

Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome by Tom Kindlon http://www.ncf-net.org/library/Reporting%20of%20Harms.pdf

ME Association: Our CBT, GET and Pacing Report calls for major changes to therapies offered for ME/CFS | 29 May 2015 http://www.meassociation.org.uk/2015/05/23959/

David Tuller's articles on Virology Blog about the PACE Trial problems : Trial by Error: http://www.virology.ws/2015/10/21/trial-by-error-i/ and further articles on Virology Blog here: http://www.virology.ws/mecfs/

Valerie Eliot Smith has recorded events regarding refusal of PACE Trial researchers to share data: https://valerieeliotsmith.com/tag/pace-trial/

From Dr Mark Vink: The PACE Trial Invalidates the Use of Cognitive Behavioral and Graded Exercise Therapy in Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome: A review  http://www.sciforschenonline.org/journals/neurology/JNNB-2-124.php

Other posts on Just ME:

10 Things ME Patients Need NOW! March 2015
ME Awareness - Why NOT Exercise? May 2014
Graded Exercise Therapy? No Thank You! Sept 2015
The Use of Patient Blogs as a Care Resource
(My video presentation at Queens University Belfast) Sept 2015
Prof. VanNess on recent press reports Jan 2015

Thursday, 21 July 2016

Chronic Illness & "determination to recover"

The press love recovery stories where the long time ill - through sheer determination and will power - make themselves well again.  

These stories run with patient comments such as, "I was determined not to let this beat me." or "It was a very difficult journey, but I triumphed in the end."  The statements themselves are likely true, but the press will often imply that the tenacity of the patient was the major key to recovery.

So what about all the people that remain chronically, and often severely, ill?  Are they simply not determined enough to elicit their own recoveries?

Of course I understand the need for journalists to make the subject of their stories heroic, and therefore remarkable, but there must be other ways of doing this than implying that strength of character and determination alone are sufficient to overcome serious illness?

Actually this line of thinking is not just insulting to the patients who remain ill, but also to the many doctors and researchers involved in bringing effective treatments to patients.  Often the fact that a new drug, or change in treatment, coincided with the turning point in the patient's attitude is down played, and the reader is left supposing that any illness can be over come with good mental fortitude.

The message is subtle and repetitive.  It is also incredibly damaging.

Those who live with intractable chronic illnesses are often regaled with these popular recovery messages by friends and family.  Well meaning folk get convinced that recovery would be just around the corner if only the sufferer would just "think more positively" and "believe that recovery was possible"!

Worse however, is the way this concept affects attitudes wherever a chronically ill person goes!

The cynical "if only you'd try harder" attitude now seems to be the official line for benefits assessments.  The ongoing problems with Employment Support Allowance (ESA) and Personal Independence Payments (PIP) assessments being particularly problematical.

And here the media has influence again.

This time by vilifying patients by "catching them out" doing something they should not be capable of doing according to the benefits they receive.  In these articles journalists can be especially cruel, often using a photo captured in a single moment as their evidence, ignoring the fact that one single moment may not represent the real truth.

Gradually public opinion of the long-term ill and disabled changes.  The chronically ill are now labelled as either heros, or layabouts.  

Media heroes have their praises sung high.  In these stories the heroic individuals either: use their strength of will to recover from their condition; or they have a visible disability, manage to achieve something outstanding, and are described as an "inspiration to all".

Unfortunately, those who remain long term ill without much hope of recovery, and especially those who don't have immediately obvious disabilities, don't get hero treatment in the media.  Sadly it is then assumed they must fall into the category of "layabout".

This dichotomy might not be as a direct consequence of all those media spun recovery stories, but they do have influence.

Recovery stories where the patient is the hero, might appear to be applauding the character of the now smiling recovered individual, but I can't help thinking that the flip side of these stories - the implication that anyone could recover if their character was simply stronger - is unacceptable.

I'd love to see mainstream media stories focus more on the treatments themselves, and on how lives can be changed by them, than on the personal attributes and positive thinking of an individual.

Journalists - if you are reading this please consider that these stories, written with the best of intentions, are actually contributing to a bigger narrative - one that puts blame on all the chronically ill folk that don't recover.  This can also lead to less public sympathy and greater difficulty in finding funding for proper research into medical treatments.

Many of us are determined to recover.  That determination is of course fantastic. It gives us strength  to see through difficult treatments, or to campaign for change. And I've no doubt some positive thinking can help with coping with a restricted lifestyle.  However, please, let's be realistic about the place of "determination" in effective healing.

Thank you.



Sunday, 26 June 2016

ME Mortality

I have written before about the "living death" of very severe ME, and of patients clinging to life, desperately hoping for medical progress to rescue them. Sadly, some patients don't survive long enough. 


In the last weeks I have heard of the untimely deaths of five ME patients: 

Jodi Bassett, 
Louise Ramage, 
Pat Blankenship,
Tink Bastion and 
Linda Hayes Burke.  

I knew none of these ladies in real life, but their deaths nonetheless feel like a punch in the gut. 

Theirs are not the only ME deaths I've encountered either. The online ME community often morns losses from its ranks, but these five deaths, occurring in such quick succession, highlight a sensitive issue - ME mortality.

So why, knowing ME deaths occur, is ME research is still so agonizingly slow?  

Why is it still hampered by such a significant lack of government funding world over?  

Certainly, noises are being made by government bodies about future funding, but patients sense a complete lack of urgency, when it comes to seeking answers through biomedical research. 

It seems the pounds and dollars are slow to appear for the types of studies we need. 

Another question: Why do we still have publications in respectable journals that describe ME as a condition where mind-over-matter types of therapies are effective?  

Do deaths not indicate something more serious?  

There is a saying that events can become "just another statistic", but what if those statistics are never collected?  

Are the deaths of ME patients recorded? If not, why not?

The frustration that shows in my writing today is, I know, felt by many.  

I hope awareness of the urgent needs of Severe ME patients will one day be exposed.  I hope the outrage our community feels at the untimely deaths of patients like Jodi, Louise, Pat, Tink and Linda, will grow to become a public outrage.  

I hope many more who are not affected by ME will start to ask questions about our situation.

In the mean time, those of us remaining, and still able to campaign, must do all we can to bring ME to the attention of medical professionals and key health decision makers - where ever we are - world over. 

I'm doing what I can.

**********

Post Script: Brought to my attention in comments:
And a post by Jennifer Spotila on Mortality
http://www.occupycfs.com/2014/07/07/mecfs-mortality/

And from Leela - two more patients:
"Sally. I reviewed the ME/CFS Memorial Page and found that 2 other ME patients, that I didn't know, Sarah Ellis and Pam Carmichel, died in May along with Pat. So that is 7 that we know of in the last 2 months. And how many are unrecorded? "  -  Seven patients in such a short time, it is almost too much to take in. :(

Via a Twitter comment:
Causes of Death Among Patients With Chronic Fatigue Syndrome (2006)
LEONARD A. JASON, KARINA CORRADI, SARA GRESS, SARAH WILLIAMS, and SUSAN TORRES-HARDING. DePaul University, Chicago, Illinois, USA

And finally a link to my post "Living Death Disease":  http://sallyjustme.blogspot.co.uk/2014/08/living-death.html


Wednesday, 15 June 2016

The Question of Sleep! (& N:Rem tablets)

Unrefreshing sleep is a symptom of ME, and of many other long term conditions. Indeed, the topic of night-time hours (and of making them as comfortable and restorative as possible) is one that is often debated online.

Luckily for me, I was in the right place at the right time and was offered a free trial of these N:rem foam mattress toppers, in exchange for an honest review of them on my blog.

Disclosure notice: "I have been given this product as part of a product review through the Chronic Illness Bloggers (http://chronicillnessbloggers.com/chronic-illness-bloggers/) network. Although the product was a gift, all opinions in this review remain my own and I was in no way influenced by the company. "

Background: I had seen these mattress toppers mentioned generally favourably on various FaceBook groups, and so I understood that they worked on the principle of giving different parts of our body more or less support according to individual need. This seemed so sensible and simple, that I knew I had to give them a go.

The N:rem website can be seen here: https://nremsleepsystem.co.uk/ and the toppers viewed here: https://nremsleepsystem.co.uk/topper/

Before my month's trial, I found I could mostly sleep through the wee small hours of the night provided I went to bed an hour after midnight and then rose before seven o’clock.  Trying to stay  in bed longer did not produce more sleep - yet I also knew I needed more sleep than this short window provided. Part of my problem, I think, was discomfort making me restless. (I have been attending a chiropractor for many years to keep my back "right"!)

The trial N:Rem system consists of 5 tablets of foam, of differing densities, that can be placed over your existing mattress.  The idea is to re-arrange these tablets so that the softest ones are beneath pressure points that cause you bother, and the firmer ones are then placed to give more support to less tender areas.

On receiving the huge delivery box from the N:rem people, I immediately placed them over my mattress according to one of the patterns in the accompanying literature. I then snuggled down enthusiastically for the first night.

Sadly, that first arrangement did nothing good for my sleep whatsoever! The firmest tablet was WAY too firm for my liking.  I pulled it out and relegated it to the bottom of my bed, where my even my feet rarely reach!

Re-arranging the tablets over the next couple of nights helped me fine-tune an arrangement that suited my personal needs, and remarkably as the month of the trial progressed, I found that I was starting to sleep on longer each morning. Then I discovered that I could also head to bed earlier, and still sleep right through the small hours of the night.

The scientist in me says that this result might not be entirely due to the mattress toppers - that maybe some other factor was at play?

However, the part of me that just happens to like sleeping well, won the internal debate with the logical argument that - I was mighty pleased to get the toppers back again, after I lent them to a friend for a couple of nights!

So the end result is that I really do like this system.  However I have one very small suggestion for improvement.  I think it would be nice to have the option of a narrower piece so that I could place a small slightly firmer strip just about my waist level.

Overall Conclusion:  Thumbs Up! 

And, I’m seriously tempted to get one of their full mattress options in the near future.

****

PS I probably shouldn’t admit this - but when I took the trial on, and heard that I could keep the tablets after the trial, I remember thinking that if I really didn’t like them, that at least they would make good dogs beds!  Well I’m sorry Finn, but you lost out chum!



Saturday, 11 June 2016

Chasing Competent Care conference report



Hope 4 ME & Fibro Northern Ireland ran an ambitious and exciting conference on Monday 6th June in The Stormont Hotel, Belfast. The conference, “Chasing Competent Care” delivered a strong message calling for change to the currently inadequate care situation for ME and fibromyalgia patients in Northern Ireland.

Chairperson, Martina Marks opened the meeting, welcomed everyone and thanked the Big Lottery Fund for their sponsorship of the event. Her welcome was followed by an empassioned plea from Joan McParland, the founder and treasurer of Hope 4 ME & Fibro NI, to have medical professionals take patients’ symptoms seriously. Joan explained that she had been ill, and operating at less than 30% of her normal capacity, since 1999. In that time no effective treatments had been offered, and one consultant had even suggested she was simply reading too much into her symptoms and that she should see a psychiatrist!

Joan thanked the many volunteers and family members who made the event possible, and also the medical professionals and MLAs in the audience for taking time to attend.

Sally Burch, another charity trustee, then pointed out that ME (myalgic encephalomyelitis) and fibromyalgia are both disorders recognised by the World Health Organisation. She then explained that the most severely affected by ME could be left bed-bound, tube fed and lying in darkened rooms for weeks, months and years! She further described the severely debilitating nature of fibromyalgia and how the invisible pain that sufferers endure can have devastating life consequences. Sally outlined the symptom overlap between these conditions and suggested that biomarker development and medical research was now urgently required.

Lined up, to the side of the speakers’ podium, was a haunting display of over 200 pairs of empty shoes. These were part of the global ‪#‎MillionsMissing‬ campaign. Each pair of shoes carried a tag with the name of a patient unable to participate in their active lives due to ME and/or fibromyalgia. During the conference many attendees took time to read the comments on the tags and to consider the magnitude of the devastation caused by these largely forgotten and ignored conditions.



First speaker up was Dr Joe McVeigh, who outlined the problems with exercise and fibromyalgia. He explained that whilst exercise is important for maintaining health, that it must be conducted at a level manageable for each individual patient. He called this the “Goldilocks approach”, and explained that at no time should attempted exercise cause a patient to relapse.

Professor Malcolm Hooper next gave a strong talk berating the inadequacies and misleading conclusions of the PACE Trial. At one point, he suggested that the PACE Trial was potentially fraudulent and told us that he had once even said as much in The House of Lords. This elicited a spontaneous round of applause from the audience. Feelings run high amongst patients on the PACE trial, mostly because it has been used to support the NHS recommended therapies of Cognitive Behaviour Therapy (CBT) and Graded Exercise Therapy (GET), both of which have been demonstrated to cause harm in patient surveys.


Professor Hooper questioned the motives of the PACE trial authors in promoting results that carry such marginal benefits and such great potential risks. He recommended that patients reference Dr Mark Vink’s paper, “The PACE Trial Invalidates the Use of Cognitive Behavioral and Graded Exercise Therapy in Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome: A Review”, any time they were asked to undertake these therapies.

After this lively and well received talk, the conference paused for a comfort break. The weather was uncharacteristically balmy for Northern Ireland, and some of the audience sat outside in the evening sun as they contemplated the issues raised.

Natalie Boulton, carer to her daughter who has severe ME, spoke next. She opened by showing a clip from the video “Voices from the Shadows”, that gave the audience a disturbing insight into the annihilation caused by very severe ME. Natalie told us she had recently followed up with some of the patients from the video and found many of them had worsened, and that both Emily Collingridge and Lyn Gilderdale had since died. She spoke of the horror of the treatments doled out by psychiatrists who believed patients to be faking their illness. Hers was a genuinely moving and sobering talk.

Next Professor Mady Hornig from Columbia University, USA, gave a detailed and highly informative account of her work towards developing blood biomarkers. She explained how immunity and gut microbiota can be linked to the brain, its functioning and mood. She talked about the epigenetic changes that can occur in the microbiome during a person’s lifetime and the link to serotonin production. She also talked about measuring blood molecules such as cytokines before and after an exercise challenge in ME patients, and comparing these changes to healthy controls. These cytokines being the most promising as potential biomarkers. Although much of what she described cannot be simply summarised, the audience was left with a strong feeling that Professor Hornig is now working determinedly to solve the biochemical riddles produced by ME.

Dr Pamela Bell then took the podium to talk about the problem with pain. Dr Bell has worked extensively in the field of pain, and is now chair of the Pain Alliance Northern Ireland. She emphasised the widespread nature of chronic pain and its disabling effects, noting that once pain becomes chronic it no longer serves a useful purpose in the body. She recognised the difficulties with effectively treating ongoing pain and explained that different types of pain needed different drug types to alleviate symptoms.

The final speaker of the evening was Louise Skelly from the Patient and Client Council of Northern Ireland. She spoke of her frustration at trying to bring about change to the current impasse with Health and Social Care Board in Northern Ireland regarding the care on offer for ME and fibromyalgia patients. She spoke of her determination to follow through with the campaign to improve the situation, and of the great need of these neglected patient cohorts.

Martina Marks then brought the conference to a close. Overall the atmosphere of the evening was one of both frustration, and of optimism. Frustration that change seems to be taking so long to happen and for the injustices that have occurred along the way, but also optimism that things are starting to gain momentum towards real medical advances for the future.

As the hall emptied, the lines of lonely shoes from the #MillionsMissing campaign were gathered up, their labels still attached, and some-one was heard to say: “These are the folk we do all this for - they will not be left forgotten any longer.”
*****************

PS Edit to add copy of the letter we wrote to all attendees:



6th June 2016

Dear “Chasing Competent Care” conference attendee,

We are delighted that you have taken an interest in the currently unacceptable care situation for ME & fibromyalgia patients in Northern Ireland.

A large part of the problem is that diagnosis is difficult without accepted biomarkers, and, that there are no specialist consultant physicians in Northern Ireland to whom GPs can refer patients.

Misdiagnosis is known to be a problem in the UK1, and based on patient stories misrepresentation of these illnesses as mental health problems is prevalent.

Furthermore the NICE recommended treatments of Graded Exercise Therapy (GET) and Cognitive Behaviour Therapy (CBT) that are offered for ME, are now being widely questioned, and patient reports demonstrate clear harms from GET2,3.

CBT and GET are based on the biopsychosocial premise that patients are no longer physically ill. The “PACE trial” 4 that purports to provide evidence to support these therapies is now coming under considerable scientific scrutiny5. Suspiciously, the PACE trial researchers are also refusing to share the data that would validate their claims6.

The Health and Social Care Board in Northern Ireland is currently intending to roll out a Condition Management Programme (CMP) run solely by occupational therapists without the support of a medical consultant-led clinic.

The HSCB lead commissioner for ME and Fibromyalgia services has confirmed that this CMP was initially based on the PACE trial methods. It is now clear that CBT and GET show no long term treatment benefit7, and as mentioned earlier harm from GET is widely reported2,3. The current staff of the CMP pilot are doing their utmost to help patients within their remit but they lack the support of a consultant physician with specialist biomedical knowledge.

It is time for change! Can you help us? Perhaps you could alert health service providers to the difficulties faced by ME and fibromyalgia patients? Or write to the new Health Minister to appeal for change?

The display of empty shoes at the side of the hall is part of the #MillionsMissing worldwide campaign8 orchestrated by MEAction.net. The shoes represent those who are unable to participate in normal life because of devastating long-term illness.

We urgently need the support of healthy advocates and sympathetic medical professionals so we can change the current apathy towards the plight of these patients.

Hope 4 ME & Fibro Northern Ireland9 is a registered charity run by patient volunteers. We support the scientific view that myalgic encephalomyelitis (ME) and fibromyalgia are a physical disorders, and that scientific biomedical research is our best hope towards their understanding. Thank you for taking an interest.

We hope you will help spread our message of concern. 

Best wishes,

Trustees and Committee of Hope 4 ME & Fibro Northern Ireland

References:

1. The Newcastle NHS Chronic Fatigue Syndrome Service: Not all fatigue is the same. Newton JL, Mabillard H Scott A Spickett G (2010) http://www.ncbi.nlm.nih.gov/pubmed/21132135

2. Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Tom Kindlon http://www.ncf-net.org/library/Reporting%20of%20Harms.pdf

3. ME Association: Our CBT, GET and Pacing Report calls for major changes to therapies offered for ME/CFS | 29 May 2015 http://www.meassociation.org.uk/2015/05/23959/

4. PACE Trial: Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/fulltext 5. Virology Blog: Trial by Error: http://www.virology.ws/2015/10/21/trial-by-error-i/ and further articles on Virology Blog here: http://www.virology.ws/mecfs/

6. Valerie Eliot Smith has recorded events regarding refusal of PACE Trial researchers to share data: https://valerieeliotsmith.com/tag/pace-trial/


7. The PACE Trial Invalidates the Use of Cognitive Behavioral and Graded Exercise Therapy in Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome: A review  http://www.sciforschenonline.org/journals/neurology/JNNB-2-124.php

8. #MillionsMissing A global day of protest for ME and CFS: http://millionsmissing.meaction.net/ with Belfast details here: http://millionsmissing.meaction.net/locations/united-kingdom/belfast/

9. Hope 4 ME & Fibro NI website: http://www.hope4mefibroni.btck.co.uk/ and Facebook announcements page: https://www.facebook.com/Hope4MEFibro/