PACE trial debunked, #millionsmissing, Esther Crawley and FITNET – an ME news round-up

pace-trial-millionsmissing-esther-crawley-fitnet-me-news-round-up

There has been so much ME news over the past few months – the PACE trial scandal, #MillionsMissing protests all over the world, and Esther Crawley’s proposed research splashed all over the papers as a ‘breakthrough’, that I thought I’d do a summary.

I’ve tried to keep it as short as I can – here’s a round-up:

Good news

1) Judge rules against Goliath (PACE Trial) in favour of David (ME patient Alem Matthees). The appeal court ordered PACE trial authors to comply to a patient’s Freedom of Information (FOI) Request. The PACE trial was hailed as the biggest and most reliable study into effective treatment of ME, comparing Graded Exercise Therapy and Cognitive Behavioural Therapy against Standard Medical Care or ‘Pacing’ (doing what you can). Despite the PACE trial spending more than £200K on a legal fight to keep their data hidden, patient Alem Mathees won his appeal. The judge took a dim view of the PACE trial authors’ claims of harassment as an excuse not to release data, when under cross-examination it transpired that their version of dangerous and violent harassment turned out to be a heckler at a lecture. This led to:

2) PACE trial debunked. The FOI data revealed the PACE authors changed their protocol to massively inflate their results, in order to make Graded Exercise and CBT look like better therapies for ME/CFS. Under their original protocol, ‘improvement’ from CBT/GET was just 10% more than control, and ‘recovery’ rates were null – not the 60% improvement rate and 20% recovery rate they claimed. More scientists weighed in to disparage  and expose the PACE trial. There was muted coverage in the press, but a few dents were made in the scientific press.

3) #MillionsMissing Protests happen all round the world on 27 September. The protests, organised by #MEAction.net garnered media attention, and The Guardian published this excellent piece by patient-journalist Nathalie Wright. Many individuals who saw the protests said they hadn’t realised how severe ME was, and were supportive of our cause as a result.

4) ME as hibernation state? Robert Naviaux just published a groundbreaking study looking at metabolomics as a possible biomarker for ME, which also showed ME patents to be in a hibernation, body-shut-down state. Someone else published a study right after him confirming that ME patients have abnormal metabolomics. Meanwhile, Ron Davis, Director of the Stanford Genome Technology centre has seen in the metabolomics a new possibility for treatment, and is currently using that knowledge to treat his extremely-sick son, Whitney Dafoe. It’s early days, but these interventions seem to be enabling Whitney’s body to digest food better and put some weight on his skeletal frame. This is a really promising area of study, and could ultimately produce the holy grail of a biomarker for ME.

5) Dr Nigel Speight completely cleared and restrictions removed. Nigel Speight is probably the best paediatric doctor we have in the UK for ME, and he does not advocated Graded Exercise Therapy as treatment. There was a clash of opinion for treatment in one complex case, and because of this Nigel was banned, by the GMC, from treating children for ME (though not banned from medicine entirely). At the hearing, Nigel Speight was cleared of all wrongdoing and is back advising ME patients again. It seems as though he was the victim of a witch hunt, because he discourages Graded Exercise.

6) Karina Hansen is FREE!! If you remember me talking about Karina Hansen, the ME patient in Denmark who was (wrongly) sectioned, and put in a treatment centre that made her severe ME even worse. She was told she could leave at any time (but of course she couldn’t walk…) In the centre, her phone was taken away and her parents weren’t allowed to visit, despite being cleared of any potential abuse, and she was appointed a state legal guardian who made health decisions for her, to keep her in there. It’s been 3.5 years, but finally she is free and at home, though substantially traumatised and her health worse. A sympathetic physio made all the difference. Read Valerie Elliot Smith’s helpful update here.

7) Invest in ME have raised £500,00 for a Rituximab and B-Cell study, in partnership with Fluge, who did the original breakthrough Rituximab study with severe ME patients in Norway. Some extremely severe ME patients were fully recovered after Rituximab (a cancer drug), though they are still dependent on the drug for their continued health. As other Rituximab studies seem to be stalling, this one could be really important. They are an excellent but small charity who need more funds – you can donate here. 

Millions Missing protest London img_6054

Millions Missing Protest, London

Bad news:

1) The NIH in America haven’t yet delivered on funding for ME/CFS research, despite promising they would. Jennie Spotila is holding them to account.

2) The UK government continue to award ME/CFS research grants pretty much exclusively to psychiatrists investigating CBT and Graded Exercise Treatment. Esther Crawley is awarded a feasibility study for MAGENTA, a ‘PACE trial for kids’ (this time with no objective tests to measure improvement, just evaluation by questionnaire), and FITNET, which is an online CBT course for teenagers. Worryingly, parents in the MAGENTA study have been told there are no risks to CBT or Graded Exercise Therapy for kids with ME, and are not told of the dangers.

3) Esther Crawley releases misleading Press Release about CBT treatment for ME – and the press print it unquestioningly. Before Crawley has even embarked upon her FITNET study it’s been heralded as a possible breakthrough treatment, with a possible cure/improvement rate of 60%, citing a 2012 study in The Netherlands. It’s hard to understand why bigger studies in the US from biomedical viewpoints are pointedly ignored in the UK press, while psychiatric studies have significantly more airtime. Just like PACE trial, the 2012 study from the Netherlands showed no difference, long-term, between the patients who used FITNET as therapy and those who did nothing.

[Updated: for the sake of balance it’s worth pointing out that the Netherlands study seems to indicate people using FITNET improve more quickly than those who had standard health care. Yet in a survey amongst ME sufferers in the Netherlands, like the UK, the majority reported that CBT and Graded Exercise of this kind made them worse, not better. Why the discrepancy? CBT and GET really do seem to help some people with a CFS diagnosis, but it’s worrying that a study like this could ignore the wider field that reports harm from CBT and GET. After the PACE trial, which initially seemed to suggest that Graded Exercise and CBT improved 60% of sufferers, and then turned out to be wildly exaggerated, I’d want to make sure this Netherlands study and Esther Crawley’s studies were thoroughly scrutinised. Children are already pressured to go back to school earlier than they should, and become much sicker as a result – and studies like this could potentially make that situation worse.]

millions missing protest img_6048

FITNET – a breakthrough study with CBT? Debunking some myths about the Esther Crawley story:

1) She’s published breakthrough research? Actually, she hasn’t even STARTED the research. Yet she’s claiming, based on an older study in the Netherlands, published in 2012, that it could successfully treat (which most people hear as ‘cure’) 60% of ME patients. This pushes at some major ethical boundaries – you’re not supposed to claim success for a trial before you’ve started it, in case it biases patients. This is especially important when the evaluation of the study depends on a patient survey of self-reported improvement or decline.

2) Her research is a brand new method of treatment? It’s not. It’s the same old CBT/Graded Exercise program that every other research trial paid for by the UK government is researching right now, just delivered by the internet. There have been £millions poured into trials like PACE, and this is just another one.

3) She’s treating it as a physical illness, not a behavioural disorder? Unlikely. In interviews about FITNET she was keen to say it was a ‘real’ problem, and that it was focusing on biology – for example, sorting out sleep patterns. Surely this is a good thing? Getting good sleep patterns established is useful in ME – but it’s not CBT. Most GPs could give that advice. And it would concern me if ‘getting good sleep patterns’ meant restricting sleep for ME patients, because some need to sleep a lot, especially in the early stages. From first glances, the protocol seems to focus on increasing activity (like Graded Exercise), and ignoring your symptoms.

4) All the mother’s fault? Should you enrol your child on the FITNET or MAGENTA studies? This didn’t go reported in the press, but it’s a potential alarm bell for the FITNET study. It may well be fine, but  there are a few things that combine that make me a little concerned for the parents of the children in the trial. This is my train of thought.

a) In the Netherlands study that inspired the FITNET trial at least one third didn’t respond to the treatment. Why? Rather than blame the therapy, the Netherlands follow-up study placed the blame on ‘anxious mothers’ who focused too much on ‘bodily symptoms.’ (Of course, another way to interpret this is that the kid kept getting sicker in the trial, and the mother was increasingly anxious as the child got worse. Anxiety is only harmful if the situation doesn’t warrant it – it’s not clear from the study that the anxiety was unfounded.)

b) Esther Crawley has previously published a study about the role of mothers in children with fatigue syndromes, associating a mother’s depression with the chance of a child getting ME, and advising ’family-based therapy’ as a result. It is noteworthy that there is a small MS study that suggested that trauma in childhood made it more likely you would develop MS – but (quite rightly) no one is suggesting family therapy for patients with MS as a cure for MS.

c) Crawley has written elsewhere that it is likely that some with an ME diagnosis have ‘Pervasive Refusal Syndrome’, and to consider this as an alternative diagnosis when the ME is severe. As a paediatrician* she has the power to change the diagnosis. This could possibly be true for a tiny minority, but Karina Hansen (diagnosed with by a psychiatrist as having Pervasive Refusal Syndrome, although her specialist diagnosed M.E.), Sophia Mirza and other severe sufferers’ stories of being falsely sectioned raise concerns about the legitimacy of relabelling someone with ME – particularly someone with severe ME that doesn’t respond to treatment – as having a somatisation (‘psycho-somatic’) disorder.

This all makes me wonder what happens to patients who don’t respond to Crawley’s version of CBT and Graded Exercise. Are they left alone? Are they rediagnosed with PRS? Is ‘Munchausen’s by proxy’ (where the child is not ill, but the parent treats them as though they were) suspected? Sadly some doctors do just that, and the TYMES Trust represent cases where children are (falsely) assumed to be victims of abuse (see False Accusations of Child Abuse in Cases of Childhood Myalgic Encephalomyelitis.) It is worth bearing in mind that of the 115 cases taken on by TYMES trust, 100% of the parents were cleared of wrongdoing. Likewise, Karina Hansen’s parents were investigated – and no evidence of abuse was found. It is worrying that for parents who don’t have the resources to fight the system, their kids could be taken away simply because severe ME isn’t recognised as a condition.

For the FITNET trial, they specifically mention that they’re training the parents and children separately. There may well be legitimate reasons for this, but it greatly concerns me that a mother who is anxious about her child getting sicker could be labelled as the cause of their child’s illness. This is not what ME is – and yet there are cases every year in the UK where social services attempt to take the children away, assuming abuse or psychiatric disorder, simply because social workers and medics don’t understand how disabling ME can be. So although the FITNET and MAGENTA studies may not be making the same conclusions about parental involvement, and may have entirely different reasons for the parental therapy, whatever that entails, it does raise some questions for me that I would want answered before enrolling my child on such a study.

Meanwhile, patients continue to report harm from CBT and especially Graded Exercise Therapy. The increasing pile of biomedical research showing ME patients’  abnormal physiological responses to exercise backs up patients’ experiences.

Some ME patients DO improve through Graded Exercise or CBT (see here for why that may be), but there are so many who get worse from it that it is still a significant risk to try it. I’m very concerned that the parents of these research trials won’t have been told of these risks.

***

Sometimes it feels like PACE is a gorgon which grows another three heads when you cut one off. The good news? Esther Crawley, who previously enthusiastically endorsed the PACE trial, is now distancing herself from it a little. This indicates that the power of PACE is crumbling in the scientific community, though it will take a while to trickle down to the ME community and wider press.

Overall, there has been more good news than bad, and it feels like the advances in the biomedical research into ME are rapidly gaining. There is much to be thankful for. I’m especially grateful for every ally who supports people with ME and wants to discover more about the illness, and would encourage everyone to sign up to join #MEAction network, who fight for better treatment and research for those with ME.

A final favour

Please would you sign two petitions, right now?

  • Sign the petition(s) (one for UK, one for the rest of the world) to stop Graded Exercise Therapy trials for ME patients (Why? so many trials of these kinds have already been done, they rely on subjective questionnaires for evaluations, so not accurate results, and they’re sucking up all the research grants. The massive PACE trial is a recent example of how to waste £5million) Sign here 
  • Sign the petition to halt Esther Crawley’s MAGENTA study on children with ME (which promotes Graded Exercise Therapy without warning the parents of the significant dangers of it – especially in light of debunked PACE trial.). Sign here 
  • Also – Sign up to receive ME Action’s newsletter and be the first to know about other protests or petitions.

Sean MacEntee 5144379598_c6373ec0f6_z

Helpful links

Debunking the PACE Trial:

#MillionsMissing

On Esther Crawley and FITNET

Research News

Three brilliant pieces by Miriam E Tucker for well-respected medical journal Medscape:

Magnificent Letters

PHEW. Thanks for reading thus far. Anything else I missed? Anything need correcting? Let me know. Thanks for listening.

Want to do more? 

And extra points if you share this with your friends 🙂 Thank you.

*this piece originally stated that Esther Crawley is a psychiatrist, which she is not. Thanks for the corrections. However, I have heard that she can (and does) change the diagnosis from ME to PRS in some severe patients.

, ,

17 Responses to PACE trial debunked, #millionsmissing, Esther Crawley and FITNET – an ME news round-up

  1. Jenny Munns 21st November, 2016 at 3:10 am #

    Hello Tanya. I’ve been following your blogs for some time and grateful for the insights and information you share.

    There has been some recent good scientific research on ME/CFS being done in Australia at Griffith University – Gold Coast Campus. In case you’ve not heard of the research being done here, I’ve enclosed a link to the Research Unit and the recent results.

    https://www.griffith.edu.au/health/national-centre-neuroimmunology-emerging-diseases

    Being the arty type myself rather than scientific, I showed a research scientist in my family who was very impressed with this ME/CFS research unit.

    We live in hope for a cure and in the meantime respect for the challenges we face with this difficult illness.

    PS I’m working through your booklist. Just finished Arcadia.

    • Tanya 20th February, 2017 at 4:36 pm #

      Thank you So much for this lovely note! Sorry it’s taken so long to reply. This research does indeed look encouraging! I’m just waiting for the tipping point when this psychiatry nonsense can finally be put to bed. Also – very excited to see you’re working through my book recommendations! Would love to hear what you thought of Arcadia – it’s a brain-stretcher, for sure!

  2. Sally Anfilogoff 19th November, 2016 at 10:07 am #

    Tanya, great round up and a few things I’d not seen before so thank you. But one correction: Crawley isn’t a psychiatrist. She’s a consultant paediatrician. That’s why it’s odd that she makes determinations about mental health when she doesn’t have more than basic training.

    Biography

    Dr Esther Crawley, is a Reader in Child Health at the University of Bristol and a Consultant Paediatrician with a special interest in CFS/ME. She is the clinical lead for Bath specialist CFS/ME service for children based at the Royal National Hospital for Rheumatic Diseases in Bath which currently provides assessment and treatment for over 200 children and young people each year.

    Dr Crawley completed her medical training in Oxford, and then worked in Birmingham and Liverpool before doing her PhD at University College London and Great Ormond Street Hospital. Esther then moved to Bristol and Bath and set up the paediatric CFS/ME service. She is a medical advisor to the Association of young people with ME and the Kent and Sussex ME Society and was Chair of the British Association for CFS/ME (BACME, 2007-2010). She set up the Royal College of Paediatrics and Child Health special interest group for CFS/ME, was on the guideline development group for the NICE guidelines published in August 2007 and the MRC CFS/ME expert working group (2009-2010).

    .

    • Tanya 20th November, 2016 at 10:31 am #

      Thank you, Sally! Really helpful – have corrected.

  3. leelaplay 19th November, 2016 at 2:55 am #

    Great overview Tanya. 2 other things to include I think
    1. the Countess of Mar’s Formal Compaint to the BBC regarding their biased churnalism on Esther Crawley talking about her proposed study ie manufactured news; study hasn’t even started. In it she reports “. Professor Esther Crawley is currently under investigation by the GMC for negligent management of a young person with the condition in which she alleges to be an expert, this management being exactly the same as that which is to be used in her FITNET study so strongly promoted by the BBC. ” http://www.margaretwilliams.me/2016/bbc-complaint-mar-nov16.pdf
    2. The IACFSME conference and all the great science coming out of it.

    • Tanya 20th November, 2016 at 10:30 am #

      Thank you!
      Re no. 1 – I think I did mention that already – the link is under ‘magnificent letters’
      And yes! IACFSME conference is doing some great things! I haven’t followed that conference closely, so can’t really comment on all the latest science, but yes, definitely encouraging.

  4. weyland 19th November, 2016 at 2:12 am #

    The situation in the UK is as appalling as it has ever been. The recent revelations of how much control Esther Crawley actually has over things in the UK is concerning to put it mildly. Perhaps others have been aware of this for longer, but it was shocking to me. I thought she was just some kooky nobody that was doing that quack lightning process trial, but with the information that Keith Geraghty came forward with, it appears that Crawley is in direct control of which researchers will be allowed to join the CMRC collaborative via her position as co-chair and Holgate’s deference to her. This is extremely shady given that she has already received the lion’s share of ME research money in the past several years. Now she can help funnel even more money towards her institution. How this isn’t seen as a massive conflict of interest is beyond me.

    Not only that, but we’ve recently seen that she has just as much power to do damage to us via the media as Wessely, White, Chalder, and Sharpe, perhaps even more so. Someone has also been engaging in some very dirty harassment and silencing tactics, such as the fraudulent reporting of Nigel Speight to the GMC, and also the harassment of Keith Geraghty via vexatious complaints to his institution. Crawley hasn’t been proven to be the source of either of these, but she or someone in her camp is the best guess.

    I now view Crawley as the absolute biggest threat to the biomedical understanding of ME in the UK and perhaps even abroad. With the recent voting in of conservative governments in the UK and US, I see some very dark times ahead for disabled people with ME and other chronic illnesses.

    • Tanya 20th November, 2016 at 10:28 am #

      I definitely agree that I’ve been disappointed by the way she’s spoken of patients with ME in the media, creating the impression that anyone who disagrees with her methods are violent and/or crazy. And Esther Crawley does seem to be emerging as someone with increasing power in the UK M.E. medical scene.

      It’s sad that all the power and money right now resides with those who are emphasising psychiatric treatments – but although it’s slow, I am encouraged by the increasing discoveries across the world about physiological abnormalities in ME, and the potential causes that could lead to potential treatments. Having world-renowned researchers on the case like Dr Ian Lipkin, and Dr Ron Davis is tremendously encouraging, and there seem to be lots of avenues to explore. It feels like the temperature is beginning to heat up, and there’s increasing pressure on the US government to be different. With all the recent upheavals in politics, I think it is going to be dark for a while ahead, but I can just about see some light at the end of it all.

      Thanks for taking the time to read and comment.

  5. Dan 18th November, 2016 at 5:00 pm #

    Thank you for putting this together. Very much appreciate having one place to go for all the latest news.

    • Tanya 20th November, 2016 at 10:21 am #

      Thanks for taking the time to thank me! It means a lot

  6. Bill Clayton 18th November, 2016 at 2:52 pm #

    Hi Tanya. A brilliant gathering of ME news to round the week off. I hope you don’t mind, but I’ve added a little of it to me ME website, but then linked back to here so that people will come to your site to read it all. To see what I’m talking about, visit: http://www.York-ME-Community.org. Thanks.

    • Tanya 20th November, 2016 at 10:21 am #

      Thank you! And of course – absolutely fine to do what you’ve done, and thanks so much for checking with me – that’s good of you. Have a good day!

  7. Alison Whale 18th November, 2016 at 9:51 am #

    Hi Tanya. Great round up thank you. In awe that your brain can think and write so lucidly and follow all this!
    Under Bad News point 2 end of first paragraph I think you need to remove the ‘not’ for it to make sense. (Or the ‘no’ later on. With both its a double negative) and means parents are told of risks.

    ‘Worryingly, parents in the MAGENTA study have not been told there are no risks to CBT or Graded Exercise Therapy for kids with ME, and are not told of the dangers.’

    • Tanya 20th November, 2016 at 10:20 am #

      Thank you! This thing took me weeks to write and was so long and complicated that I completely missed errors – very grateful to everyone for being my (late) editors, otherwise I’d be stuck!

Trackbacks/Pingbacks

  1. A Great Round Up Of ME News By Tanya Marlow – The York ME Community - 18th November, 2016

    […] Link to Tanya’s site […]

Leave a Reply

Please send me my free ebook and updates