Letter to Professor Watt of MRC

This letter from Professor Fiona Watt of the Medical Research Council in support of the PACE Trial appeared a few days ago in response to the Times article about the growing pressure on The Lancet concerning the trial:

CHRONIC FATIGUE

Sir, Further to your report “Call for review of ‘flawed’ ME research”(Aug 21), as funders of the Pace trial we reject the view that the scientific evidence provided by the trial for using cognitive behavioural theory and managed exercise in the treatment of chronic fatigue syndrome (also known as ME) was unsound. The Pace trial was funded following expert peer review, was overseen by an independent steering committee, and its published findings have also been independently peer-reviewed. Other research groups have drawn similar conclusions. Chronic fatigue syndrome/ME remains a priority for the Medical Research Council (MRC), and it is important that researchers are not discouraged from working on the disease because of concerns that they could be subject to the level of hostility that Pace researchers have experienced. Medical research can only flourish when there is mutual respect between all parties.

Professor Fiona Watt Executive chairwoman, Medical Research Council

There have been other responses from patients. Here is mine, which I decided to send directly to Prof Watt.

Maybe she will see it. Maybe she will read it. Maybe she will do as I ask! I’ve sent it anyhow. You don’t win the lottery if you don’t buy a ticket…

Dear Professor Watt,

Like many patients with M.E. I was surprised and disappointed by your letter to The Times wholeheartedly supporting the PACE trial. There are so many misconceptions in the letter that it is clear that you have not investigated this matter yourself but have – apparently- assumed that what the PACE authors tell you about it is correct and what patients tell you is not. I can only assume that this is because they are doctors and we are merely patients.

Yet you say in your letter that ‘medical research can only flourish when there is mutual respect between all parties’. I would certainly not disagree with that. Please then show patients the respect of being open to the possibility that what we (and indeed many distinguished researchers and other informed parties) say about PACE may actually be correct.

I am not asking you to take us at our word, but please look into the matter yourself instead of simply believing what you are told by the PACE authors and their friends. It will not take you long. I have provided a few references at the end of this letter which you will find useful. For the sake of the patients you say you wish to respect, please take the trouble to do this.

Thank you,

Useful references:

Rethinking the Treatment of Chronic Fatigue Syndrome – A Reanalysis and Evaluation of Findings from a Recent Major Trial of Graded Exercise and CBT by Wilshire et al. – Jan 2018 (A comprehensive re-evaluation of PACE following the release of data from the Freedom of Information Act Tribunal.)

Journal of Health Psychology Vol 22 No.9 Aug 2017 – A Special Issue on PACE. “On the basis of this Special Issue, readers can make up their own minds about the merits and demerits of the PACE Trial,” writes Editor David F Marks.

A letter to The Lancet signed by over a hundred scientists, clinicians, academics, MPs and other experts plus over sixty local, national, and international patient organisations, calling for an independent re-analysis of PACE and setting out the reasons why.

The August 2016 PACE Trial Freedom of Information Tribunal Judgement has useful information about so called hostility to PACE researchers, an unfounded allegation which your letter unfortunately perpetuates.

Two notes relating to this issue:

  • Allegations were made at the Tribunal by a representative of the PACE proponents that ME patients, described as ‘activists’ were ‘borderline sociopathic and psychopathic’ and posed ‘a serious threat of violence to trial participants and researchers’ but the Commissioner described these as ‘wild speculations’ which did the representative ‘no credit’ (see pages 22 and 36). PACE researcher Prof Chalder accepted that ‘there had been no threats made either to researchers or participants’ The Commissioner stated that the ‘assessment of activist behaviour was grossly exaggerated. The only actual evidence was that an individual at a seminar had heckled Prof Chalder.’ (see page 40)
  • Your letter also suggests that researchers might be ‘discouraged from working on the disease because of concerns that they could be subject to the level of hostility that PACE researchers have experienced’. The idea that researchers are being discouraged in this way is another often repeated misconception which seems to be intended to vilify patients. Working for the MRC, you will be fully aware of how little funding M.E. has received over the years. Nevertheless there is research going on worldwide, strongly supported by patients and often funded by them. (Many of these researchers are critical of PACE and have signed the letter to The Lancet requesting its independent reassessment – see above.) Patients do however object – in the form of letters such as this and other peaceful means – to the squandering of funds on poorly conducted research such as PACE, money which is desperately needed for high quality biomedical research into the condition.
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A Morass of MUS

As you are probably aware, here in the UK, NICE are currently engaged in the lengthy process of revising their guidelines for ME/CFS. The current guidelines recommend the use of GET (graded exercise therapy) and associated CBT (cognitive behavioural therapy), the latter being used in this case to persuade patients that GET is a good idea.

Patients have every right to be sceptical. Numerous patient surveys have shown that many report being made worse by GET. Many patients end up housebound or even bedbound as a result, sometimes permanently so. Research such as that by VanNess et al has provided evidence of why such exercise is harmful, while PACE, the most influential study purporting to support the use of GET, has been thoroughly debunked and discredited – most comprehensively by Wilshire et al. In the US, the recommendations for GET and CBT have been withdrawn in view of the latest information.

In view of all this, a disinterested bystander might be forgiven for assuming that withdrawal of support for CBT and GET will be close to a foregone conclusion when NICE eventually complete their review. Indeed, they might well agree with those patient groups who have asked NICE to remove the recommendation for these therapies from their guidelines at once before anyone else gets harmed.

As it happens, however, the latter request has not been successful and it’s anyone’s guess what will happen when the interminable review is finally completed in 2020 – though the smart punters would probably put their money on CBT and GET remaining in favour.

There’s a number of reasons for this.

  1. Though anyone who takes the trouble to look at the evidence will see that PACE has indeed been thoroughly debunked, the Trial’s authors have adopted the policy of pretending that no significant flaws have been uncovered and that everything will be fine if they keep on insisting they’ve done nothing wrong. Close to the heart of the British establishment as they are, this policy has served them pretty well so far and we can’t assume that NICE won’t be taken in too.
  2. If NICE withdraw their recommendation for CBT and GET, what therapies can they offer instead? There has been so little biomedical research in recent times – due in large part to the unhelpful influence of PACE itself – that no substantial advances in treatment seem likely to arrive in time for the completion of the review. So if NICE withdraw CBT and GET, they might leave doctors with nothing at all to offer – and doctors won’t like that.
  3. If CBT and GET are withdrawn, what will the poor old NHS CFS Clinics do? CBT and GET are their stock in trade. Without them, how could they survive? Will NICE want to trigger wholesale redundancies in the CFS industry? Probably not.

So the only sensible course of action from the point of view of patients is for NICE to withdraw their support for CBT and GET (preferably right away) but when you look at the self-interest of so many of the professionals involved, it’s a very different story.

On the other hand…

Taking a broader perspective, perhaps the closure of the CFS clinics wouldn’t be such a terrible blow for the pro-GET lobby after all. It may well be that they have Plan B in place already….

…Because whether by accident or design, the new MUS (medically unexplained symptoms) clinics which are being rolled out across the country in a major new initiative couldn’t have come at a better time for them. If NICE comes out against CBT and GET and the CFS clinics fail, then the MUS clinics will provide a natural place for their staff to go. It’ll be the same sort of work but with a much larger clientele. Up until now, they‘ve only had people with CFS to work on. Now the sky will be the limit.

MUS is a far more powerful dustbin diagnosis than CFS ever was. Even Esther Crawley couldn’t come up with figures to claim that people with CFS represent more than 2% of the population. With MUS, on the other hand, you are talking about a substantial proportion of the people who come through a doctor’s door.

According to the figures in ‘The Guidelines for Commissioners of Services for Patients with MUS (Feb 2017)’, up to 20% of people who go to see their GP really have MUS, while for secondary care, the proportion ranges from 39% for dentistry up to a staggering 66% for top-scoring gynaecology. Two things are especially worthy of notice here:

  1. Should it surprise us that gynaecology produced the highest proportion of patients believed to have MUS? (Not really. Women have suffered such prejudice for centuries of course. The ‘high attack rate in females compared with males’ among patients in the Royal Free outbreak was cited by Beard and McEvedy as part of their argument for labelling ME as ‘mass hysteria’ back in 1970 for instance ) and
  2. Those extraordinary figures for secondary care come from a 2001 study by – who would have guessed it? – S Wessely et al.

Before I go on, I should explain what MUS is in case you don’t know. The acronym stands for ‘medically unexplained symptoms’ which according to ‘The Guidelines for Commissioners of Services for Patients with MUS’ can be described as ‘bodily complaints for which adequate examination does not reveal sufficient explanatory structural or other specified pathology’. Or to put it another way, they are symptoms which don’t have an obvious physical explanation. Doctors don’t understand them and they don’t show up in tests. For people with ME, this will already sound eerily familiar.

The Royal College of Psychiatrists’ leaflet on MUS explains as follows:

‘When something in our body doesn’t feel right, there usually is a bodily or ‘physical’ cause –  stomach problems may be due to an infection, or palpitations may be due to a heart problem.

 ‘What if there is no physical explanation for your physical symptoms?  We can often understand and explain such symptoms when we look at how our thoughts, feelings and stresses can affect our bodies.

 ‘But – to say that a bodily symptom is not just physical is not the same as saying they are all in the mind. Medically unexplained symptoms aren’t “all in the mind”, but neither are they all in the body.  To understand them we have to think about how the mind and the body work together.’

But in spite of this ‘a bit in the mind and a bit in the body’ description, the suggested therapies turn out to be all psychological in nature: talking therapies and anti-depressants. Oh yes, and graded exercise. You may not find this surprising.

I first looked at MUS in my post ‘Medically Unexplained Assumptions’ a couple of years ago. You may find that post of interest. Back then, I was interested in delving into the origins of the medical profession’s attitude to ME. Little did I realise that MUS was about to come back into fashion on such an extraordinary scale.

Looking at the various documents about MUS that I have been collecting over recent months, I am struck by what a massive thing it appears to be. I have already written this post then scrapped it and started again several times over. I am anxious not to exaggerate or be alarmist yet it seems to me that unless I appear to do so, I am understating the challenge which MUS presents.

Those figures I quoted above from Wessely’s study give an idea of the extraordinary number of patients which the medical authorities seem to believe are affected by this mysterious entity MUS, yet when I turn to the NHS Choices website, I see they’re going even higher. They’re attributing ‘up to 45% of GP appointments and half of all new hospital visits’ to MUS. If the trend goes on, there will soon be more people with MUS than with what I shall call (for the want of anything better) ‘accredited illnesses’.

How do the authorities intend to deal with this burgeoning problem?

The ‘Guidelines for Commissioners’ booklet proposes a hospital MUS service as part of the solution. Apparently this will:

 ‘redirect patients from the emergency department, expedite discharges from medical and surgical wards, and offer effective interventions. These activities should help avoid unnecessary medical investigations and interventions, reduce length of hospital stays, and prevent frequent referrals and readmissions. Services must include psychological therapists who would provide evidence-based MUS interventions in a timely manner. The therapists would be sufficiently familiar with physical healthcare to be credible to patients – many of whom may not accept a psychological component to their physical symptoms and therefore the need for psychological therapy.’

So, in the future, it seems that your local hospital MUS service will be standing by at all times to whisk you away from the parts of the hospital where you might get medical assistance and take you somewhere nice and quiet where you can focus on the important business of working out which psychological therapy you need.  I’m afraid I do not find this reassuring.

Imagine a crowded A&E department on a Saturday night. Imagine the pressure to cut down waiting times and the shortage of hospital beds. The pressure on staff to dismiss a quota of patients as MUS and bundle them into a side room for CBT is going to be enormous. It’s certainly an easier option than finding something physically wrong and fixing them And indeed, will there be a fine to pay if they don’t don’t come up with the specified quota of MUS patients for the evening? A specified quota which, to take the figure from NHS Choices, would be no less than fifty per cent.

And what are we supposed to make of this bit: ‘the therapists would be sufficiently familiar with physical healthcare to be credible to patients’? Am I  wrong in getting the impression here that these psychotherapists are going to pretend to be doctors or something? What are they going to do: hang stethoscopes round their necks? Isn’t that illegal? At the very least, this seems to me to be an example of a national NHS document deliberately advising health professionals to mislead patients. Or am I being unfair?

Now, I can imagine why doctors might want to bear this MUS thing in mind for a small minority of their patients, but the guidelines seem to suggest it should be a primary consideration all the time. Look at this excerpt from another piece of advice for doctors, this time aimed at primary care. The Treatment of Medically Unexplained Symptoms in Primary Care – A Review of the Literature from ‘Mental Health in Family Medicine’ (2010) advises:

‘A quick and easy method for carrying out a mental state examination in primary care is the Look, Listen and Test schema. This schema utilises the observation and communication skills already possessed by GPs to enable the GP to develop a formulation by observing the patient’s behaviour and activities from the moment they enter the consultation room, by listening to and evaluating the content of the speech to identify underlying themes of depression, anxiety or paranoia, and by encouraging GPs to test severity by using questionnaires developed to evaluate mood and anxiety disorders. Once depression has been diagnosed, the GP should prescribe the standard dose of selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants (TCAs) available in their geographical area of practice.’

The reason for this assessment of mental health, of course, is that many  people with MUS are said to suffer with depression or anxiety. If the doctor can identify these problems, therefore, you’re well on your way to a MUS diagnosis. So while you’re talking about the abdominal pain you’re getting, your doctor is apparently sitting there trying to decide if you’re paranoid.

I can’t help wondering if it is really in the patient’s best interests to have the doctor’s attention deflected in this way? If a patient is  suffering say, in this case, abdominal pain, is it not sensible to focus on the abdomen, at least to start with?  Is there not  a danger that in their zeal to identify the 45% of their patients who have MUS, doctors may overlook some genuine physical illness?

I have other concerns about diagnosis- and about MUS in general – but I’ll save them till next time, I think. There’s plenty to go at I’m afraid. But for now I’d like to close this post by touching on an aspect of MUS which particularly concerns me.

The Guidelines for Commissioners identifies not only chronic fatigue syndrome but also myalgic encephalomyelitis as MUS conditions and patient advocates have quite rightly raised concerns about this, pointing out that ME has been recognised by the World Health Organisation as a neurological condition for a great many years. While I agree that this is important, I wonder if it is also overlooking the most important threat from MUS?

In the future, will it matter whether ME is designated MUS or not?  Will it matter whether NICE recommend CBT and GET for ME or not? As more is discovered about ME and the imposition of psychological therapies is made more difficult by the growing weight of evidence against them, will the diagnosis ME – and even CFS – become too troublesome for the powers that be to use any more? Far better, perhaps, from their point of view, to shift new patients off into the vague morass of the ‘MUS’ label, where CBT, GET, and other psychological therapies can be used without fear of interference from those who insist on researching the truth of our condition.

 

 

 

How Many Times Must a Story Be Told…?

Sorry I’ve not been blogging recently. I put the blog to one side to concentrate on another project but I didn’t realise how long it would take. Needing to take breaks every five minutes to replenish my brain when I’m writing doesn’t make for speedy progress. Today, however, it has been May 12, ME Awareness Day, and I managed to share a link to Robert Saunders’ excellent ME-related version of Dylan’s ‘Blowing in the Wind’ on my (mainly non-ME specific) Facebook page. I read what I’d written to introduce the piece again just now and decided it was worth sharing it here too. If you’re involved in the ME world in some way, you’ve probably come across Robert’s splendid video already, but if not then do please take five minutes to listen – and maybe to share it with others.

Here (for a change) is the non-Facebook version of Robert’s introduction to the video.

Even if you think you know something about ME, some of the quotes used in the video may surprise you:

‘I split my clinical time between ME/CFS and HIV and I can tell you if I had to choose between the two illnesses, I’d rather have HIV.’ – Dr Nancy Klimas, Director, Institute of Neuro Immune Medicine, NSU.

‘People with ME are more disabled and have a lower quality of life than people with most other chronic illnesses including heart disease and multiple sclerosis.’

‘When the full details of the PACE Trial become known, it will be considered one of the biggest medical scandals if the 21st century.’ Carole Monaghan, UK MP

The PACE Trial spent £5m of UK taxpayers’ money and purported to illustrate the effectiveness of graded exercise therapy for ME. However, it was eventually discovered to be so full of flaws that it is now being taught in some university courses as an example of how not to do research. In spite of this, PACE is still highly influential worldwide, including here in the UK, its researchers being so embedded in the higher echelons of the medical establishment that mere facts seem to do nothing to damage their ‘credibility’ in the eyes of their peers.

Time and again, the faults and subterfuge which lie behind PACE have been laid bare, first by patients – many working from their sick beds – and more recently by commentators such as Dr David Tuller who have taken the trouble to look at the evidence and understand that the trial, and the biopsychosocial theory which underlies it, need to be exposed as the sham that they are. Time and again, the argument is won, and the PACE researchers are left mumbling the same excuses which didn’t hold water the last time around, yet to change the consensus view of the illness appears to take decades rather than years. Press coverage is slowly improving but the PACE researchers have a powerful lobbying group, the Science Media Centre, on their side, and though journalists are often well meaning, their idea of balance seems to be to present both sides of the argument, irrespective of where the truth may lie. The equivalent of most articles about ME would be a feature on the shape of the planet which gave equal time and weight to the views of the Flat Earth Society.

As the song puts it:

How many times must an idea fail

Before it is seen to be flawed?

How many flaws can a Trial embrace

Before it is seen as a fraud?

So the process of exposing the truth is an arduous one and of course people with ME have little energy to spare. We fight the illness as best we can but it is a cruel truth that we also have to fight an intransigent medical establishment. Thank goodness for those few healthy people who are willing to help us.

The slow process of getting to the truth has to go on. Graded exercise as promoted by PACE is very dangerous for people with ME. It can – and does – leave patients bedbound, sometimes permanently so. Not only that but the persistent presence of the biopsychosocial lobby means that most research money, especially here in the UK, goes into various ‘rehabilitation’ research programs such as PACE rather than into much needed biomedical research.

Of the 14 million people worldwide estimated to have ME, about 25% are housebound or bedbound, many as a result of graded exercise programs. Many of these severely affected can’t tolerate light so they spend their lives in darkened rooms. Some are not even well enough to talk to those close to them, so they Iive lives of total isolation.

The photos in the video illustrate the worlds of a solitary room in which many such people must live. When the song talks of people screaming in the dark then, it is not exaggeration – except that in reality the scream will most likely be a silent one.

Thanks for listening and reading. Please help by sharing this. Thanks, too, to Robert Saunders and all involved in making this powerful video.

How many times must a story be told

Before you will see what is true?

Further reading:

David Tuller’s initial analysis of PACE. Just reading the summary gives you a good understanding of the scale of the ‘errors’ involved:

Out of the Blue: an account of what it can be like to go down with ME – and a few useful links (from the Spoonseeker blog):

 

Feedback to Dr Hoenderkamp

First, a brief word of apology: I hadn’t realised what a difficult process it would be to embed a load of tweets into this blog. WordPress protested in various ways at this indignity but I thought I had overcome them. The post looks fine on our desktop PC and my smartphone. So far so good. I hope it’s the same for you. But then I discovered that if I follow a link from a tweet onto a tablet, a whole load of duplicate tweets which I had battled hard to suppress suddenly appear out of nowhere. If this happens to you, please press or click or whatever it is these days on the title of the blog. ie Spoonseekerdotcom That should make it ok. If you then want to leave a comment – or look at the comments – press or click on the title of this particular post, ‘Feedback to Dr H’. You should then have access to the comments without the duplicate tweets returning (I hope!) If you get any other problems with the post, please let me know and I’ll try to help if I’m up to it. Grr. I’m not going to try a post like this again in a hurry – and please don’t ask about the PEM.

Tweeting this quote, which happened to catch my attention on Facebook, recently provoked a flurry of activity on my Twitter feed when the medical writer and broadcaster Dr Renee Hoenderkamp took exception to it as follows:

It was not my intention – or, I think, that of the person who made the remark on Facebook – to criticise all GPs, and it does not seem to me now, in the cold light of day, that anyone carefully reading my tweet should get that impression. I argued as follows:

Dr Hoenderkamp retorted:

And so on:

Patient Advocate Dr Claudia Gillberg also contested Dr Hoenderkamp’s interpretation of the original tweet:

If you are reading this, Dr Hoenderkamp (and I shall be inviting you to take a look) I hope you will agree that a pattern is emerging here: that by and large, to judge by these tweets, people with ME/CFS do not consider their GPs (or other GPs they have consulted) to be well informed about the condition. The tweets that came flowing in that afternoon told between them a very consistent story. There are many more of them below. These were just the tweets which came in from the ME patients who happened to be on Twitter that afternoon. Had I put out further tweets to ask for more, I think we could soon have got into triple figures and beyond. Even the tiny minority of patients who eventually managed to find an informed doctor recount how many others they tried before they ‘struck lucky’.

Of course, this only amounts to anecdotal evidence, but the results seem to me to be too consistent to ignore. What is more, I believe a poll among GPs would give a similar result. Here, tweeted by Joan McParland, are some comments from a questionnaire circulated among medical students after viewing the recent film ‘Unrest’ about ME. It is clear that they were surprised by how little they found they knew about the condition and baffled why this should be the case when so many people are so fundamentally affected.

NI students 1
NI students 2

It is good that Dr Hoenderkamp, unlike these students, feels she has been trained in ME but many patients tweeted to register their concern about what she might have been taught. Here are some of their comments on this issue:

A good way to find out more about the reasons why the PACE Trial (which claimed to provide evidence for the use of CBT and GET for ME/CFS) is now widely judged to have been discredited is to read Trial by Error, a detailed expose of the trial by pubic health lecturer and journalist Dr David Tuller. The first installment (of many) can be found here, though simply reading the summary will go a great way towards explaining why it has led to over a hundred eminent scientists and researchers writing an open letter to The Lancet calling for an independant review of the study and why CBT and GET are no longer the recommended treatments for ME/CFS in the USA.

The Journal of Heath Psychology special issue on the PACE Trial is also well worth a read and is available as a free download.

Moving on from PACE, the film Unrest, which has already been mentioned, is a powerful window into the world of severe ME, a chance to connect with some of those 25% of patients most severely affected, most of whom are long term bedbound, spending their lives confined to a single room and usually with little or no medical help. I have been drawing attention to the fact that doctors don’t understand ME but their understanding of severe ME is unfortunately so much worse. This must be the only condition where the sicker you get, the less attention you get from doctors. Most of them have absolutely no idea how severe the illness can become and no idea what to do about it if they see it. Again, I am not getting at doctors here. The problem is most of them aren’t taught about it so what can they do?

Unrest mainly skirts clear of PACE and other such controversy but it does not shirk away from sharing the raw experience of the illness. It has won numerous awards and can be viewed on Netflix.

Also recommended above are the purple booklet from the ME Association, which is a guide to the latest ME/CFS research written for doctors, and researcher Prof Jose Montoya’s question and answer session on ME, which appears in Paul Watton’s tweet above. There are many more such sources of information which could be mentioned but these few which I and others have suggested are a useful introduction to understanding the true nature of the condition, an essential antidote to the misinformation about ME/CFS which is all too abundant.

There is lots of opportunity for informed doctors to spread the word about the reality of ME/CFS. In his tweet above, Paul suggested you should do a video blog about it. A great time to do this would be in May/June when most of the eminent biophysical ME researchers come to Britain for the annual Invest in ME conference. I am sure they will be eager to talk about their latest research and ME in general.

Before returning to the many tweets of 27th January, here’s a particularly powerful – and upsetting – one from ‘motherofaliens’ which came in only the other day. Dr Keith Geraghty’s tweet, which led to it, is also very relevant of course:

Sadly – and shamefully – children are amongst those with ME who suffer most from the attitude of doctors. At least one prominent paediatrician does not recognise the existence of severe ME in children. Instead, the parents are blamed for the child’s condition and all too often are threatened with court proceedings. Only the efforts of Jane Colby of Tymes Trust and the paediatrician Dr Nigel Speight prevent such children being taken into care. Tymes Trust have dealt with over 150 such cases already and the problem seems to be escalating.

If you have read this far, Dr Hoenderkamp, thank you for doing so, and perhaps you are starting to understand the reasons for our concern. I shall end with some more tweets received in response to yours of 27th January. I hope I have included enough to give you an idea of the numbers who have had a similar experience. There were more tweets I could have included but embedding them in my blog is proving to be an arduous business, and I too have ME..

And finally, here is Dr Carolyn Wilshire, responding to Dr Hoenderkamp’s original tweet:

Have You Been Harmed by PACE?

Dr Sarah Myhill has written a comprehensive letter of complaint to the General Medical Council about the conduct of the authors of the PACE Trial. You can find the full text here. This is a courageous letter which states very publicly and unequivocally what a great many patients have been saying for some time: that in the way they have conducted the Trial, the PACE authors are guilty of fraud.

Dr Myhill is asking for patients who have been harmed by the Trial to support her by sharing their experience with the GMC using a template letter which can find it in a Word document here. Please try to find the time and energy to do this if your health allows. Dr Myhill is taking on a lot in trying to help patients in this way. I believe she deserves the support of us all in return.

Craig Robinson, from Dr Myhill’s team, explains in more detail as follows:

*** DR MYHILL HAS COMPLAINED TO THE GMC ABOUT THE PACE AUTHORS ***

*** SHE WANTS YOUR HELP ***

**PLEASE DO COPY YOUR LETTER OF SUPPORT TO cr648@hotmail.co.uk – if you feel comfortable with doing so**

PLEASE SHARE THIS POST AS WIDELY AS POSSIBLE. THIS COMPLAINT IS IN THE PUBLIC DOMAIN.

The GMC is the UK doctor’s regulatory authority – the General Medical Council. Patient support is sought from all patients who feel they have been harmed by PACE. You do not have to be a UK citizen.

PACE is the study ‘Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. (2011)’, published in The Lancet.

SEVEN other medical doctors are supporting this complaint but wish to remain anonymous – they are concerned about the impact of such “whistle-blowing” on their future careers within and without the NHS.

The complaint is one of Fraud, namely:
–fraud by false representation
–fraud by failing to disclose information
–fraud by abuse of position

There are also numerous breaches of:
–GMC Guidance on Good Medical Practice
–GMC Guidance on Good Practice in Research
–GMC Guidance on Consent to Research

Dr Myhill is asking for your help.

Please read the letter of complaint and also the ‘PACE patient support letter‘.

HELPING DR MYHILL

We want people who have been harmed by PACE to write in support of this complaint. You are free to use the PACE patient support template letter. You could have been harmed in any of these ways and possibly others too (please see further notes about this further down the post) :

• suffered damage (including physical, mental or emotional distress) as a result of CBT.
• suffered damage (including physical mental or emotional distress) as a result of GET.
• been denied disability benefits because the physical nature of your disease has not been properly recognised and/or you have been told you have a psychological condition.
• have been denied industrial compensation for your disease because the physical nature of your disease has not been properly recognised and/or you have been told you have a psychological condition.
• have been denied referral or funding for referral to a physician specialising in the biomedical approach to treating CFS/ME.

You do NOT have to have been diagnosed or have fallen ill with CFS/ME after PACE was published [March 2011] to support this complaint.

So, for example if you were diagnosed/fell ill in 1980, but have recently been refused benefits as a result of PACE [for example, for not engaging in CBT or because your illness was considered psychological) or maybe you have suffered mental distress as a result of PACE (for example, benefit applications were more stressful because your illness was considered psychological) then you CAN support this complaint. It will help our case to have as many support letters as possible.

If you feel you have even the smallest ‘case’ for inclusion then please do submit a letter of support – it is incumbent on the GMC to prove that you have not been so affected, not for you to prove that you have!

Please do email if you are in doubt or need help phrasing why you have been harmed by PACE. Please be patient – we will respond as quickly as possible. See the hotmail email address below.

Just put your reasons for supporting this complaint in the relevant section in the PACE patient support letter and fill in any other portions that need filling in [all marked in red] and then:

1–email it to TStephenson@gmc-uk.org – Sir Terence Stephenson is the Chair of the GMC

2–if you can, please send your letter by post too, here is the address –
Sir Terence Stephenson
General Medical Council
Fitness to Practise Directorate
3 Hardman Street
Manchester, M3 3AW.

3—if you feel comfortable with doing so, please can you copy your letter of support to Dr Myhill at cr648@hotmail.co.uk [in the past the GMC have denied receiving letters of support and having physical copies to collate and send to them has been a very powerful tool]

GENERAL COMMENTS

We cannot engage in a running commentary on progress but will give updates as and when possible and necessary.

We know that GMC employees or people who report to the GMC are members of the Dr Myhill groups and so we do have to be circumspect.

You may feel that the letter of complaint could be improved – good!

In 15 years of dealing with the GMC, and other regulatory bodies, one thing above all has become clear: these regulatory investigations are like a game of chess. A marathon not a sprint. You have to plan 6 moves in advance…

Essentially, we are saying – trust us! Between us we have won 30 GMC cases as defendants and numerous cases across many regulatory bodies as complainants.

Thank you.

Here’s Craig again with an update:

N.B. The harm done to you does NOT have to fall within the 5 broad categories listed in the template letter. ANY harm or ANY DISTRESS caused by PACE is ”enough”. See as follows for an example of how another patient has put it in her great letter:

  • I have suffered mental distress as a result of PACE. For example, benefit applications, and assessments were more stressful because my illness was considered psychological
  • Visits to doctors, and consultants, and NHS emergency departments are more stressful because my illness is considered psychological.
  • I am denied treatment because my illness is considered psychological
  • I am accused of wasting time, and lying, and treated with contempt and suspicion because my illness is considered psychological
  • My word and experience is dismissed because my illness is considered psychological, and I am labelled as ‘mentally ill’.
  • I am labelled as a delusional patient because of negative connotations implied by doctors and NHS staff.
  • It appears all my other health issues, and concerns are now considered psychological, and therefore dismissed as imaginary
  • I experienced extreme trauma, HARM & LOSS because my illness was considered psychological
  • I was targeted, and harmed after complaining, because my illness was considered psychological
  • I am denied compensation for my disease because the physical nature of it has not been properly recognised and/or told I have a psychological condition
  • It is my belief PACE WAS AT THE ROOT OF THESE PROBLEMS

A (Second) Letter to Dr Phil Hammond

Dear Dr Hammond – I was very pleased to hear about your vision for the way ahead regarding CFS on your 25 October BBC Radio Bristol show with Jennifer Brea (available on listen again at 2-21)

You said: “I remember when HIV first hit in the 80s in the UK … it was the patients themselves who learnt all the research and became very assertive and demanded the best care… I see that same movement happening with chronic fatigue. We need to unite people across the globe and use their wisdom and experience to get better research and that’s the route to an optimistic future, I think.”
I very much agree that this is the way ahead. We patients are doing our best to move things along this path. Unfortunately “becoming assertive” in the way that has been so successful for HIV campaigners is being interpreted by some health professionals as ‘harassment’. I’m glad you do not share this view. We are not trying to be difficult for the sake of it. All we are trying to do is to help uncover the truth about this illness which devastates so many patients’ lives.
With this in mind, I wonder if you have the time to answer a few questions which arose from your interview with Jennifer Brea. You were kind enough to respond when I wrote to you about a year ago and any response you can make again now would be very much appreciated.
1) You mentioned to Jennifer that some of your young patients improve when they have graded exercise therapy at your clinic. When you responded to me last year, however, you said that ‘the mainstay of treatment ( at the clinic) is activity management’. Which of these do you actually use at the clinic? Or is it both?
2) You were also telling Jennifer that when you do graded exercise therapy, you cut back on the amount your patients are doing. I wonder if your approach is the same as that described in the Magenta protocol, where patients start on a baseline level which is the same as the median amount which is currently being achieved each week. The total level therefore remains the same but there is more consistency in the amount of exercise day to day. Once this baseline level has been achieved every day for 1 to 2 weeks, then according to Magenta, participants are advised to increase exercise by 10 to 20% a week. This means that any cutback in exercise is not substantial (really more a smoothing out than an actual reduction) and does not seem to last very long. Is this indeed what you do in the clinic? In which case, the overall emphasis seems really to be more about increasing the level of exercise rather than cutting back. Or do you do things another way? If so, why do you not use the same regime as Magenta?
3) Jennifer remarked that the regime in your clinic as you described it to her seemed very like pacing, but the Magenta advice to increase by 10 to 20% a week seems much less flexible than that. Even if the increase is not rigidly imposed, the therapist – and inevitably the patient – will feel under pressure to deliver it. The most crucial issue is: what happens if symptoms start getting worse? Are patients encouraged to cut back on exercise or to carry on regardless? The Magenta protocol doesn’t seem to say what the advice will be but the PACE protocol is clearly in favour of carrying on as far as possible in spite of worsening symptoms. Is this the advice given in your clinic I wonder? If so, then it certainly isn’t like pacing. And if otherwise, what is the advice given?
I’m sorry if these questions seem fussy and pedantic but it seems to me that a lot of the problem in understanding CFS is that so many factors are not precisely defined. From a short conversation, it can seem like a graded exercise program is very similar to pacing but the devil is in the detail. Similarly, so many researchers have made the mistake of assuming that patients diagnosed with different diagnostic criteria all have the same condition.
As you said in the interview: “we’ve noticed there are some kids who do improve when they have graded exercise therapy and cognitive behavioural therapy – and some who don’t, which suggests… either we’re dealing with different conditions or chronic fatigue syndrome is a variety of different things.” As Jennifer put it (with your agreement): “we have to make sure we are treating the right patients with the right treatments.” This is true not least because the wrong treatment can lead to long term disability.
So I couldn’t agree more that we need to distinguish between the different types of patients, but we’re not going to do this as long as we keep on using a dogs breakfast of different criteria to identify patients, frequently conflating ME/CFS with generic chronic fatigue and even making up new variations as we go along. I’m afraid that a prime example of the latter appeared in the original protocol for FITNET-NHS, which – for no very good reason – proposed using a version of the NICE criteria which did not require the presence of post-exertional malaise. I understand that this has now been scrapped but why on earth was it thought to be a good idea in the first place? Unless we start describing patients precisely and consistently, we will never get anywhere.
You mentioned that some of your patients do not respond well to graded exercise and it would be interesting to see if such patients fit the Canadian criteria rather than Fukuda or NICE. You also showed great interest when Jennifer described the use of the VO2 Max test to try to make sense of patient response to exercise. You even suggested collaboration. Would it not be possible to make that happen? It is indeed important to distinguish between the different types of patients so why are you not using some of these (what seem to me to be) obvious strategies to help you do so?
I think it is great that you are helping so many children who respond well to your therapies but you acknowledge that many do not and I can only agree that there is a very great need to distinguish between them, not least for the sake of those who you describe as having severe symptoms for a long time. As you say ‘that is where most of the attention needs to go’. Once again, I can only agree. I applaud what is obviously your heartfelt desire to help such children. As a concerned and assertive patient, I urge you to do whatever you can to bring that about.

 

Looking at the Evidence

As you may know, a few days ago the Journal of Health Psychology published a very important special issue critiquing in depth the controversial, deeply flawed PACE Trial, a study which purported to provide evidence for the use of graded exercise and a very specific type of CBT in the treatment of ME (myalgic encephalomyelitis, also known – misleadingly – as chronic fatigue syndrome or CFS). Congratulations to the journal’s editor Prof David F Marks for taking the trouble to inform himself about the true situation regarding ME. He is one of very few scientists and health professionals who despite having no personal or pre-existing professional interest in the condition has made the effort to look at the facts and realise that – unlikely as it may seem to many – the PACE Trial and similar ‘research’ into ME by those with a fixed biopsychosocial mindset really is every bit as flawed, misleading and potentially damaging as patients have been claiming for years. Dr David Tuller, Prof James Coyne, and Prof Jonathan Edwards are other rare free thinkers who have not been afraid to get informed and challenge the status quo – or to put it another way, to point out that the emperor is naked because that is what he is.

By contrast, those who persist in defending PACE give the impression that they have simply taken the word of the PACE investigators rather than study the actual evidence. Prof Malcolm Macleod, who was trotted out by the Science Media Centre as an ‘expert’ in response to the special issue, seemed only aware of one of PACE’s many flaws and seemed to base his defence of the study chiefly on the ‘doubtful provenance’ of some of its critics. It is another example of people being judged on the basis of who they are, rather than what they say or where the truth lies.

As for Prof George Davey Smith, who left the JHP’s editorial board in protest at the PACE-related special issue, he seemed to positively gloat about his ignorance of ME at last year’s CMRC conference, this in spite of his involvement with the much vaunted though controversial MEGA study, and even referred to it as CSF rather than CFS, apparently mixing up chronic fatigue syndrome with cerebrospinal fluid.

Speaking on Twitter, David F Marks described his disappointment that George Davey Smith did not ‘offer a pro-PACE commentary instead of leaving in a huff’. He (Marks) has offered to debate with PACE supporters in a public forum at any time. I don’t suppose he’ll get any takers. That would put them to the trouble of actually sitting down and informing themselves of the true situation.

Marks, meanwhile, has studied the facts and has drawn his own conclusion. He says: ‘“The many wrongs committed by psychiatry and medicine to the ME/CFS community can only be righted when the Pace trial is ultimately seen for what it is: a disgraceful confidence trick to reduce patient compensation payments and benefits.’ To which I would add: ‘also an exercise to try to protect the reputations of a small number of health professionals who have built their illustrious careers on the back of an unproven ‘biopsychosocial hypothesis’.

Meanwhile the proponents of PACE continue to take the cream of the research money here in the UK, so inhibiting much-needed biomedical progress; unsuspecting patients are given potentially damaging courses of graded exercise; and the number of parents threatened with ME-related child custody proceedings appears to be spiralling upwards, all this fuelled by the unproven biopsychosocial hypothesis.

As The Times article reported with great relish, James Coyne allegedly called the departing Davey-Smith ‘a disgusting old fart neoliberal hypocrite’. This may seem a little harsh but if language like that helps to get the truth about PACE in the newspapers, then so be it as far as I am concerned. And in view of the human suffering which underlies the farce that is PACE, perhaps such language is restrained.

Note: David Tuller’s response to the Science Media Centre’s ‘expert comments’ on the JHP special issue is here.