Swings amongst the Roundabouts

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Hillsborough Law – Shifting the Balance in Favour of Truth

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

Spotlight on GETSET Julie

Do GET Yourself

GETSET, the latest paper on graded exercise therapy by lead PACE investigator Peter White (et al), provides an excellent opportunity to probe into the nitty gritty of such a trial. The study required patients to administer their own GET so some of the details previously hidden by smoke and mirrors are laid bare in the explanatory booklet which served as the patients’ bible during the study.

Here are some quotes from the booklet (in blue) followed by my comments:

A GET programme will help you gradually improve your ability to undertake some of the physical activities that you have been unable to do since becoming unwell.’

The word ‘will’ seems optimistic here if we’re talking about ME. Though what illness are we talking about, I wonder? This guide refers to CFS/ME but the GETSET paper only mentions CFS. They need to be more specific about what they’re talking about.

However, a self-help guide such as this has not been officially tested so it is important that you check first with your GP or hospital specialist that a GET schedule is suitable for you. You should also continue to consult them regularly while undertaking your GET programme.’

Maybe they’re already wondering if that optimism of theirs was misplaced. This translates as ‘This therapy is totally, totally safe but make sure you tell some other doctors what you’re doing so we can blame it on them if it goes wrong.”

There may be a number of reasons why exercise did not work for you before. You may have started at too high a level of physical exercise, or increased the amount you did too quickly. You may have used an exercise that was too challenging for you now such as jogging, which you could do perfectly well before you became ill with CFS/ME.’

They seem to have forgotten the alternative explanation that it didn’t work because you may have ongoing pathology in your body – as illustrated by some of the biomedical research that got done with the small amount of money that wasn’t all wasted on nonsense like this.

‘The 2007 National Institute for Clinical Excellence (NICE) guidelines for the management of CFS/ME recommend GET as one of the most effective therapies for CFS/ME.’

But they’ve read a virology blog and may be having second thoughts. (Interesting that there’s no mention of the PACE trial here, by the way.)

‘After a period of illness most people find that they take some time to recover. During this recovery period we tend to avoid physical activity and rest more than usual. When we do less each day our body loses fitness and strength in a physical process called deconditioning. The result of deconditioning is that we become physically tired much sooner…’

‘The inability to function as before leads to frustration and an eventual lack of motivation for any physical activity. This starts a vicious cycle of avoiding activity and increased fatigue which then results in further deconditioning. The aim of GET is to break this cycle.’

That’s clear enough. They’re saying that CFS/ME is caused by deconditioning. This is a form of what they call ‘false ideation’. We think we’re ill but we’re not. So why does it say in the GETSET paper that ‘the relative efficacy of a behavioural intervention does not imply that chronic fatigue syndrome is caused by psychological factors’? This programme of treatment seems to be based on the supposition that it is caused by psychological factors. There seems to be incongruity at the very heart of the study. (Of course, there is plenty of evidence that ME is caused by some form of ongoing pathology rather than deconditioning. Is that why they’re fudging the issue?)

‘Regular physical activity is known to have considerable benefits: it improves the efficiency of the heart, lungs and circulation and generally helps the body to deal better with the demands of daily life.’

Unless of course some of the patients have ME. (I wonder if they’ve checked on that yet?)

‘It will be easier to keep exercising on a regular basis if you enjoy what you are doing. It could be an aerobic exercise such as walking, cycling, swimming; a home or gym based exercise programme; or just increasing things you do at home such as housework (e.g. vacuuming), gardening, or climbing stairs.’

I thought I read somewhere that research had shown aerobic exercise wasn’t good for people with ME. Or was that because they hadn’t chosen a type they enjoyed enough? If only I’d swum with dolphins instead of the vacuuming…

‘Your muscles can feel heavy after exercise, and you may feel physically tired. With CFS/ ME these feelings of physical tiredness can be more intense, but they will also help you sleep.’

Yes, as any person with ME will tell you, intense pain and exhaustion are just the thing for a good night’s sleep.

‘If you do have a setback, do not despair. They are relatively common in people with CFS/ME and you need to develop a plan to deal with them.’

You may find the longer this goes on, the more ‘relatively common’ your setbacks become. A good plan to deal with them may be to leave the trial.

‘If your setback is not CFS/ME related, in other words you have picked up an infection, you should reduce the amount of exercise you do, or even stop altogether for a short while, before returning to your GET programme. If your setback is CFS/ME related then you should try and continue exercising at your current level to the best of your ability.’

So if you get a cold, that could be serious so you need to stop for a while, but if it’s just ME, there’s no need to worry: just press on…

‘It is often incorrectly assumed that an increase in symptoms equals harm. It doesn’t.’

Glad we cleared that one up. This may explain why no harms were reported on the trial. Do they concede there’s a harm if somebody actually dies, I wonder?

‘If you continue at the exercise level you are on now you may well find that you feel no worse, and after a short while you may actually feel better. Remember that although you may not feel like exercising during a CFS/ME related setback, by resting too much you can quickly lose the physical gains that you have made. Setbacks are a normal part of recovery and so it is important to remain as positive as possible. As you get stronger you will find that you have fewer setbacks and they are less severe and last a shorter time.’

Somewhere over the rainbow…

In the next post, I’ll move on to look at the focal figure of the GETSET Guide, Julie, who has already become an internet phenomenon…

 

Taking a Closer Look

Regular readers will know that I recently received a response from Professor Holgate to our 200-plus-signature email expressing concerns about the proposed MEGA study. “We are very appreciative of the enthusiasm being shown to pursue an exciting ‘omics-based research project in the field of M.E…” he said, with no mention of the various pressing concerns we raised in our email. You can read the whole of his message in this previous post.

It is a strange response indeed. It is like the shipping line which ran the Titanic writing to bereaved relatives to thank them for their interest in the general principle of oceanic travel. To carry the metaphor further, Professor Holgate is pleased to be in touch with us, but changes the subject whenever we mention icebergs.

I have now received a further response (addressing my response to his response), this one saying so little that I won’t bother printing it here, but once again referring us to the brand new MEGA website, which is indeed up and running at last.

If you’ve seen it, you were probably less than impressed. At first sight, it looks pretty much Continue reading “Taking a Closer Look”

The OMEGA Petition – Email to Professor Holgate

This email has been sent to Professor Holgate of MEGA. Many thanks to all those who signed. (Whoops! missed a few… Total signatures now updated to 221)

((Please note that we are not the organisers of the OMEGA petition.))

Dear Professor Holgate – We comprise a number of M.E. patients and carers, 218 in all. Please see our signatures at the end of this email..

We are writing because we notice your suggestion in your letter to Professor Jonathan Edwards that OMEGA (the petition opposing the MEGA study) has attracted so many signatures due to the support of Invest In ME. We are writing to assure you that we patients and carers are able to look at the evidence and make up our own minds on such issues.

Here are some of the grave concerns that we have about the MEGA study as it has been proposed. It seems likely that you have heard many of them before but in view of your professed perplexity about the OMEGA petition, we want to make sure you are aware of the issues. For the same reason, we are copying this to the other members of the MEGA team and to those you copied in to your letter to Professor Edwards. We are also sending a copy to Professor Edwards himself, and the email will be posted online at the Spoonseeker blog.

Our concerns about MEGA include the following:

Patients from the NHS CFS/ME clinics (apparently the intended source for MEGA) will not yield a representative sample of people with M.E. The reasons for this include:

  • Most severely affected patients cannot access the clinics and so will not be included in the study.
  • There will be an inevitable selection bias towards the mildly affected because
    • the clinics will tend to select such patients as those most likely to respond to the behavioural therapies on offer, and
    • the more severely affected patients will be more likely to reject such therapies – and hence the clinics – as inappropriate.
  • Other more severely affected patients will no longer be on the clinic’s system
    • either because they have not responded well to the therapies, dropped out, and not been followed up (as feedback suggests is often the case) or
    • they are among the long term sick who are no longer on the system because treatment is time-restricted

There has been a suggestion, following representations from patients, Continue reading “The OMEGA Petition – Email to Professor Holgate”

Letter to Dr Phil Hammond

Following last Saturday’s interview with Prof Esther Crawley on BBC Radio Bristol, I sent the following letter to Dr Phil Hammond who hosted the programme. I think it explains a large part of the reason why patients with M.E. have problems with Dr Crawley and why we don’t want her involved with the proposed MEGA study:

Dear Dr Hammond

Thank you for putting the concerns of ME/CFS patients to Prof Esther Crawley in your interview on Radio Bristol last Saturday. Unfortunately, as I have tried to explain as briefly as possible below, her responses were largely factually incorrect. I wonder if next time you have her on your programme, you could also invite the investigative journalist David Tuller whose original in-depth analysis brought the many and in some cases outrageous defects of the PACE Trial to wider attention. This led to numerous condemnations of PACE from eminent researchers in the field of ME/CFS. Here are just two of them:

Prof. Ronald Davis of Stanford University said: “I’m shocked that the Lancet published it…The PACE study has so many flaws and there are so many questions you’d want to ask about it that I don’t understand how it got through any kind of peer review.”

 Prof. Jonathan Edwards of University College London said: “It’s a mass of un-interpretability to me…All the issues with the trial are extremely worrying, making interpretation of the clinical significance of the findings more or less impossible.”

 PACE’s recommendations for the use of CBT and graded exercise therapy (GET) for ME/CFS have frequently been reported by the British media but the important work of Mr Tuller has been ignored, so grossly distorting the information which has been made available to the British public. It would be an invaluable service if your programme could help to redress this imbalance.

When asked about the recent PACE reanalysis on your programme, Prof Crawley replied as follows: Continue reading “Letter to Dr Phil Hammond”

More on MEGA

Following on from their original email and Professor Holgate’s response, Leeds ME Network have sent a further email to Prof Holgate of CMRC about concerns regarding the proposed MEGA project:

Many thanks for your swift response to my previous email regarding the MEGA study and for passing our concerns on to those who are preparing the bid for funding…

It is heartening to hear from your email that the inclusion of very severe patients is under discussion by the MEGA team. I notice, however, that you mention ‘financial limitations’ in this context. The reaction of other patients with whom I have shared this issue echoes my own: that severely affected patients should be the priority. People with ME/CFS in general are offered little in the way of treatment but most of the severely affected are abandoned entirely by doctors. They are left to lie in darkened rooms, often unable even to sit up in bed or converse with their loved ones, and without any prospect of medical intervention. I’m sure you know all this. Though I cannot claim to have taken a scientific sample of opinion, the overwhelming impression I get from patients is that if there are financial constraints regarding MEGA then these should apply to the overall number of samples taken rather than be focussed on the severely affected, who are the ones most in need of help. I am reminded of Prof Ron Davis’ observation that data from severely affected patients is the most important ‘because their biology would show the greatest differences compared with healthy controls’. It seems incongruous to be envisaging such an enormous study yet even at this stage, while the grant submission is still being prepared, to be talking about insufficient money for full inclusion in the study of those most in need of help.

A further issue regarding patient selection occurred to me while reading through the ‘questions and answers’ update on the MEGA petition website:

The update says: “The only way to do this is to recruit patients through NHS clinics throughout England.”

As I described in my previous email, taking patients from the clinics alone would produce a sample of patients biased towards the less severely affected. Continue reading “More on MEGA”

Making the Most of MEGA

In an earlier post, I published an email from Leeds ME Network to Sonya Chowdhury, CEO of Action for ME, expressing reservations about the presence of Profs White and Crawley on the team of the proposed MEGA biomedical research project. Here is the latest update from Leeds ME Network:

In response to our letter to Sonya Chowdhury, we have just received what appears to be a standard letter referring to the latest updates on the MEGA petition page at Change.org. Leeds ME Network have now responded in turn with the following email, slight variations of which will be sent to Ms Chowdhury; Stephen Holgate the CMRC Chair; Dr Charles Shepherd at ME Association; and ME Research UK. Our email follows:

We are grateful to the MEGA team for letting us know about the proposed CFS/ME biomedical research project. We believe it is very important that this study goes ahead but in view of some of the less than helpful research which has taken place in the past (in particular, of course, we are thinking of the PACE trial) we hope you will understand why we patients are keen to voice our concerns about the proposal.

1) The impression has been given that patients for the study group will all be drawn from the NHS Clinics. It seems clear that such a sample would be heavily biased towards less severely affected patients and that the sample would therefore be unrepresentative of the total patient population.

The reasons for this are as follows: Continue reading “Making the Most of MEGA”

A Broader Picture

The last draft post I wrote about the MEGA petition was superseded by events before I finished it, so I’ll try and crack on with this one before the same thing happens again. Of course ‘cracking on’ in ME terms is still kind of slow but I’ll see if I can break the tortoise barrier.

So, what’s happened recently?

Well, we’ve been told that Peter White is retiring from research and will only be an ‘advisor’ to MEGA from now on. This perspective appears to be endorsed by the latest list of MEGA personnel, which no longer includes him. I can only give a muted ‘hurrah’ to this one. Advice is dangerous stuff and you can still do a lot of damage with it. His PACE Trial is swiftly becoming a watchword for bad science (see here, here, and here). Is he really the sort of ME ‘expert’ that either we patients or the MEGA team want around to guide this latest project?

It really is astonishing that MEGA apparently do still want him around after all he has done, and that they clearly expect patients to put up with it. It seems to me that if a passing Martian was given a brief course in English and the full facts, then even he (or she) would swiftly understand why we don’t want Prof White anywhere near this project. Why do the MEGA team not get this?

People with ME have  been left on the scrapheap for decades. I myself have been ill for over thirty years. That’s over half my life. I have no children because of it. I lost my job. My life is very limited. Yet I am one of the relatively lucky ones. I can sit and tap at this keyboard – as long as I take plenty of rests to fend off the shoulder and eye pain and overall exhaustion. There are plenty of others who have to spend all their lives in bed, who can’t stand the light, who can’t even talk to their loved ones. We’ve all heard about Whitney Defoe whose birthday it recently was. He is not alone in his suffering. The vast majority of the severely ill are left to fend for themselves as best they can. Rarely do doctors come near them and they wouldn’t know what to do if they did.

And all this time, all these decades, so little research has been done, in large part because of the fairy story dreamed up by the PACE researchers and their associates: the fairy story that Continue reading “A Broader Picture”