July 2017 – spoonseekerdotcom

Hillsborough Law – Shifting the Balance in Favour of Truth

The conversation on this You Tube ‘video’ took place on BBC Radio 4’s PM programme on 11th July 2017 when Andy Burnham, prompted by host Eddie Mair, proposed the adoption of a ‘Hillsborough law’ to shift the balance in the many instances where ordinary people bring genuine complaints but are dismissed and even denigrated by the establishment. He described the latter in terms of a cosy network of relationships between high ranking people in public bodies and the media. Burnham, a former Health Secretary and now Mayor of Greater Manchester, was speaking after the announcement of an inquiry into the massive blood contamination scandal which cost the lives of over 2400 people who received transfusions in the UK in the seventies till the nineties. He compared this to other scandals such as the Hillsborough disaster, in all of which the complaints of those involved and their families have been dismissed and ignored for decades.

I’m sure there are many other examples of such injustices. Hopefully the recent Grenfell Tower disaster will be dealt with more swiftly.

The conversation reminded me of an issue in which I am very much involved, that of ME (myalgic encephalomyelitis), also known – misleadingly- as CFS (chronic fatigue syndrome). This may seem like a trivial issue compared to the others I have mentioned, but therein lies the primary injustice. Unfortunately the term ‘chronic fatigue’ gives the impression of patients who are just ‘tired all the time’ so this is the view that many people have of this condition.

The truth is that the lives of people with ME are more severely impacted than those with a great many other illnesses including MS, HIV, and congestive heart failure. They suffer with a wide range of symptoms, far more than just fatigue. Even those who are ‘moderately affected’ are severely ill by any normal standards, while those termed ‘severely affected’ are often confined permanently to bed, in continuous pain, unable to sit up, tolerate light, or even communicate with their loved ones. To make matters worse, the sicker they become, the less medical attention they get. Doctors don’t understand the condition or know what to do, so they just stay away. Many people have died from ME, though this is rarely acknowledged by the authorities.

ME has been trivialised by the medical authorities for decades, notably by two British psychiatrists who studied an outbreak of the illness at the Royal Free Hospital in the fifties and concluded that it had been due to ‘hysteria’. The only ‘evidence’ they cited for this was that most of those affected had been female.

The misconception that ME is a mental health issue has persisted over the years, in part due to what has seemed to be the deliberate intention of those in authority. They have spread this confusion by adopting the trivialising name ‘chronic fatigue syndrome’ and also by using a wide range of mutually contradictory diagnostic definitions. Many of these are so vague that they include other, less serious, forms of chronic fatigue which therefore get lumped in together with ME. This has led to inappropriate ‘therapies’ such as GET (graded exercise therapy) and CBT (cognitive behavioural therapy) being recommended for ME.

CBT can be a helpful therapy to assist patients to live with a wide range of physical conditions but its most common use in CFS/ME is very different. It is used to convince patients that there is nothing physically wrong with them and that all they need to do is to slowly increase their level of activity (using GET) and they will recover. This approach may be moderately successful for some forms of chronic fatigue (such as that due to depression) but it is likely to be extremely damaging for ME. It flies in the face of research evidence which has revealed substantial physical abnormalities and an abnormal response to exercise. It also runs contrary to numerous patient surveys which report that GET makes many ME patients considerably worse, sometimes permanently so.

It is interesting to note that the PACE Trial, a large scale UK study which purported to illustrate the efficacy of CBT and GET for ME, was part funded by the DWP (Department of Work and Pensions) who are of course responsible for the payment of sickness benefits but are not normally involved in funding medical research. This draws attention to the fact that the governmental authorities have a vested interest in ‘proving’ ME to be a minor condition which responds well to short courses of relatively inexpensive ‘treatments ‘ like CBT and GET – even though this approach contradicts research evidence.

The PACE Trial itself has been a subject of substantial controversy, concerned patients having discovered a great many irregularities, the most astonishing of which was the change of patient entry criteria after the trial was started, thereby allowing patients to be ill enough to enter the trial, deteriorate during it, yet still be classed as ‘recovered’ at the end. This has naturally resulted in an upward distortion of the success rate.

PACE, in common with other research into ME/CFS by related researchers, contains a great many such defects, any one of which could have resulted in failure in a high school practical exam. Concerns have prompted more than forty eminent doctors and researchers who work in the field of ME/CFS to write to The Lancet, the journal which published the original PACE paper, calling for an independent review of the study.

A substantial critique of PACE’s many defects has been produced by the investigative journalist and public health lecturer David Tuller, who has also produced critiques of other studies by related researchers. A list of links to these articles can be found here. Building on the initial work of concerned patients, Tuller demonstrates glaring errors in these studies, yet the researchers and the supposedly reputable journals which publish them have responded to such criticisms with dismissive, unconvincing replies or else no response all.

As Andy Burnham suggested on the radio, there is a cosy network of people in authority who close ranks to defend each other against the criticisms of ordinary people. He mentioned politicians and the media but unfortunately – though it might damage the career of a politician like Burnham to suggest it – this is equally true of the medical profession. The PACE researchers seem to believe so strongly in their own preconceptions that they see nothing wrong in they or their colleagues ‘tweaking’ their studies to get the result that they believe to be the right one, and their friends in high places have such confidence in the integrity of their clubbable friends that they defend them without question, not feeling there is any requirement to take a look at the actual facts of the matter.

Part of their strategy – again as Burnham suggested – is to denigrate those who try to hold them to account. Patients had to fight hard to get vital data from PACE released under the Freedom of Information Act and met with vilification from the researchers for trying to do so. They were accused of making ‘vexatious’ requests for information, of ‘harassing’ the researchers, and even – in their attempts to unravel the complex sleights of hand that had been employed to get the researchers the results they wanted – of having ‘obsessive attention to detail’. At the FoA Tribunal which eventually ruled that the data should be released, patients were accused of presenting ‘a serious risk of violence to trial participants and researchers’ but this was deemed by the tribunal to be ‘grossly exaggerated’ and the ruling noted that the only evidence presented of such ‘violence’ was of one of the PACE researchers being heckled at a lecture.

Patients feel intense frustration that in spite of all the work done to expose the shortcomings of PACE and associated studies, they have not been retracted, and GET and CBT remain the recommended ‘therapies’ for ME/CFS in the U.K. Furthermore one of the PACE researchers’ associates – herself the source of numerous flawed and misleading papers on the condition – is now giving lectures in which she routinely vilifies the patients who question her research and accuses them of being ‘anti-science’. In view of the quality of the research in question, this is beyond irony.

Sadly, the cosy network even extends as far as some of the organisations which supposedly exist to further the interests of patients. The two main national organisations belong to a research committee whose Vice Chair gives the lectures mentioned in the previous paragraph and who seems to believe that severe ME in children is really ‘pervasive refusal syndrome’, a mental health condition for which no evidence exists. The use of this alternative diagnosis can lead to children being taken away from their parents and forcibly given a course of GET, even though this is not recommended for the severely affected and can result in severe disablement.

One of the patient organisations, Action for ME, has supported and enabled the PACE Trial itself, supposedly being involved to support the interests of patients yet singularly and spectacularly failing to do so. Increasingly, the patients whose financial contributions enable these organisations to exist are complaining about their actions and the company they keep – but sadly the cosy network described above seems to extend to their trustees and celebrity patrons, who themselves prefer to support those in authority rather than patients.

So yes, in the case of ME, we patients feel that the odds are stacked against us. A Hillsborough law would indeed be useful. As things stand, we ordinary patients seem to have very little power against the network of those with vested interests who believe that they and their friends must be right because of who they are. We have the truth on our side and we have the evidence to prove it – but that does not appear to be enough.

A quick PS: The national patient organisation I didn’t mention by name above is the ME Association. I would like to make plain that I have a great deal of respect for their work and that of their Medical Advisor Dr Charles Shepherd, who much of the time do a very good job of representing our interests. An example of this work is their recent petition to NICE regarding the decision not update the guidelines on ME/CFS (do consider signing if you haven’t already – this is important). However, MEA’s decision to stay in the CMRC and continue to work with those who malign patients and whose research contributes further misinformation about ME seems to me – and to many other patients – to be a serious error of judgement. They really should listen to the voice of informed patients.

PPS Sorry my first YouTube video isn’t exactly a multimedia extravaganza. It’s been a steep learning curve. Many thanks to Nigel B for helping me get as far as this.

Continue reading “Hillsborough Law – Shifting the Balance in Favour of Truth”

Spotlight on GETSET Julie

This follows on from my previous post on Prof Peter White’s new GETSET study: Do GET Yourself…

GETSET Julie illo

The star of the GETSET guide is ‘Julie’, a (presumably) fictitious patient who valiantly adjusts her activity diary to ‘stabilise’ her schedule so that she is doing a similar amount of activity every day. Julie has already become a favourite with online patients who are impressed with her remarkable level of activity for someone with CFS/ME. She now has her own Twitter account and according to her profile picture wears a Wonder Woman suit.

This is scarcely surprising, as before commencing therapy she was working five days a week, walking to work and back two or three times a week, attending a weekly yoga class, and going out with friends on Thursday and Saturday evenings. In spite of all of which, she sought medical help for CFS/ME.

I suppose we have to assume she is a typical patient of Prof White’s. Why, after all, would he choose to use a diary from an untypical patient? So once again we are left wondering what illness we are dealing with here?

Julie’s attempt to stabilise her diary is also interesting. From my experience of my own local NHS clinic, which used to be one of the better ones, setting a baseline level of activity for their own rather more patient-driven strategy usually entailed cutting back considerably on the total level of activity, partly by lowering standards on things like housework.

By contrast, the remarkable Julie was able to stabilise her week’s activity by fitting in an extra hour-long study period, trebling her hour-long reading sessions from two to six, introducing three hours of housework (which she had previously neglected entirely), spending an hour phoning round her friends (again previously neglected), going out for Sunday lunch, and even cramming in five extra hours of TV – all this at the same time as keeping up her two nights out a week, her yoga class and her thirty-five hours at work – though the latter now included three ten minute rest periods a day (so it’s good to see some pacing going on).

Presumably work were ok with these rests, though it does stand out as a possible example of the clinics expecting more cooperation from employers then they’re actually prepared to give. Nevertheless it is quite a feat, this ‘stabilisation’ of Julie’s; you have to wonder how she does it. Has she overturned the laws of mathematics?

Not quite, though the answer is Wonder Woman-like enough. She does it by taking twenty-one hours less sleep a week.

That’s right. You heard it. Twenty-one hours less sleep. That’s the equivalent of three hours less a night. All that neglecting housework was obviously making her dozy. Now she’s stabilised and doing all the extra stuff in an orderly manner, she no longer needs so much sleep.

And how long does this massive change take her: adding in three hours of housework, extra study and reading, extra time for friends, plus cutting out twenty-one hours of sleep etc etc? The guide warns ‘it may take a week or longer’.

Well, Rome wasn’t built in a day, but I suspect Prof White might have wanted it finished by the weekend.

On top of all this, Julie has to add in some stretches, and then some favourite exercise (on top of the three hours of housework she’s just introduced) and then increase the amount of exercise by ‘no more than’ 20% a week.

The guide advises:

You may find that at the beginning of a week when you have increased your exercise time that you experience some stiffness or fatigue. Do not worry – this is a normal response to increased activity. If you continue with your exercise, and do not cut back or add any other physical activities, your body will adapt.

Thank goodness for those adaptable bodies of ours. We’d be in a pickle without them, wouldn’t we?

Seriously, though, the more you read this stuff, the more you think they must be talking about something other than ME. Yes, many of us struggled on at work for ages, dragging ourselves around, but we didn’t manage two nights out a week and a yoga class as well. And if we stabilised to what we could readily cope with every week, we wouldn’t be adding in extra studying and housework thank you very much.

It seems obvious that this plan was not written by someone with ME, nor by someone who had ever listened to anyone with ME (not really listened). Even the grading of the different activities (into high, moderate, and low level activities and rest/sleep) is a nonsense.

OK, walking, shopping and yoga are classed as high, which is accurate enough; but working itself is classed as moderate, as is housework (which any ME patient knows is strenuous exercise). Showering is classed as low level, but this is also strenuous and can be a landmark activity. For many people with ME, it is all they can do in a day. Talking with friends on the phone can also be strenuous in its way. It is not ‘low level’ for most of us.

So are they really dealing with ME or with other forms of chronic fatigue?

The NICE criteria were used for the study. These were never intended for use in research and are unduly inclusive, as with Fukuda. They are only a little better than the much derided Oxford criteria. They require fatigue with (arguably) post exertional malaise but unless this is carefully defined, it can gather in all and sundry. Many other typical ME symptoms are mentioned in the NICE definition but only one of them is required. So we could be talking about a sample of patients most of whom do not have ME but some other form of chronic fatigue: a whole brigade of Julie’s.

This may indeed be the case because one of the exclusion criteria for the trial is ‘contraindications to exercise’, So really any patients with genuine ME should have been excluded from the sample. Research such as that by Prof Mark VanNess has shown that we have an abnormal response to exercise, while the US Institutes of Medicine suggested that ME should be renamed Systemic Exertion Intolerance Disease to describe the condition in terms of this essential characteristic. So ‘contraindications to exercise’ should certainly apply to us.

Indeed, patients have long suspected that many people with genuine ME have been excluded from exercise therapy trials (and also, incidentally, from NHS clinics) because it was clear they were too ill to respond well to the ‘treatment’ on offer. The trouble is such trials are nevertheless presented as relating to CFS/ME – or even just to ME – so that what may work for generic chronic fatigue is assumed to also work for what is an entirely different, much more serious, condition.

None of what I’m saying here is exactly groundbreaking and if I don’t get to the end of this soon one or two of you (Julie excepted of course) may be nodding off. But what I have less often heard discussed is the question of why proponents of the deconditioning (aka biopsychosocial or bps) theory do not simply accept that their ideas don’t apply to everyone?

If patients with fatigue due to depression, for instance, respond well to GET and CBT, then why not try to specifically identify such patients instead of dragging ME patients into it too? The researchers might then improve on what are quite frankly pretty mediocre results even with all the sleights of hand with the figures; they would stop getting hassle from us; and patients with ME could be finally left alone to get the rest we need. It seems to me that this would be win-win situation.

From time to time the bps researchers do this in a half-hearted way. They’ve been known to say that their research only applies to CFS, not to ME, for instance – and here in the GETSET paper, reference is only made to CFS, not to ME. But there is no consistency. The GETSET patients’ guide – in contrast to the paper – refers to CFS/ME, and when the two are conflated by reporters in the media, Prof White and his colleagues rarely if ever correct it.

So why do they insist on muddling us all together? Can they just not bear to lose us as their patients? Or could it be that they need us in some other way? Could it be that they need the presence of ME patients to make their theories appear to stand up?

Take deconditioning for instance. If you look at Julie with her five day working week, her walks, her yoga, her nights out twice a week etc, how can it be that she is deconditioned? Surely she does so much that she can’t be… But if she isn’t deconditioned, then how – according to the bps theory – can she be ill?

Maybe the researchers need the presence of some really ill people (who look like they might be deconditioned) to lend their theory some credence, to make it seem like they know what they’re talking about? Because Julie may benefit from the ‘therapy’ but she doesn’t fit the theory any better than we do.

Hmm, just thinking aloud really that last bit and it’s not really up to us patients to make sense of it all, more to point out where things don’t add up. So it may be worth summarising the blatant incongruities I’ve encountered while going through the GETSET guide one more time:

How can they claim there’s no implication that the condition is ‘caused by psychological factors’ when the treatment is based on deconditioning due to false ideation?

How can the treatment be relevant to ME if patients with contraindications to exercise are supposed to be excluded?

The GETSET paper talks about CFS and the guide about CFS/ME. Why the discrepancy?

How can a supposedly typical patient like Julie be deconditioned when she’s been working five days a week, attended yoga class, gone for walks, and had evenings out twice a week?

On top of which there are additional problems with the trial which I haven’t gone into here. These read a bit like the bps researchers’ greatest hits. They include:

No significant improvement in physical functioning reported.
Addition of a new primary outcome measure after the trial had started.
All outcome measures were subjective and self-reported.

And, this being bps, there’s more as well of course. You can take a look at a detailed critique of the study from Dr Charles Shepherd of the ME Association here.

Right, Julie, it’s time for your yoga class now…

(Julie’s ‘before and after’ schedules can be found on pages 10 and 11 of the GETSET Guide.)

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