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:
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.
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.]
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.
Debunking the PACE Trial:
- If you only read one piece on the PACE trial, make it this magnificent one by Julie Rehmeyer for Stat News: Bad science misled millions with chronic fatigue syndrome. Here’s how we fought back
- The debunking – brilliant and thorough re-analysis on the new PACE trial data following the FOI request: Virology Blog – No ‘Recovery’ in PACE trial, new analysis finds
- Excellent piece including debunking of PACE trial, by Nathalie Wright for the Guardian (also covering #MillionsMissing protests) – ME affects four times as many women as men. Is that why we’re still disbelieved?
- James Le Fanu on PACE trial cover-up for The Telegraph – Wellbeing Column
- And one science piece (as opposed to opinion piece) – YAY! – from The Times – Exercise and Therapy Cure for ME patients is ’seriously flawed’ – Tom Whipple
- What did the judge say about the FOI request for data the PACE authors fought so hard against releasing? George Faulkner for Centre of Welfare Reform – goes through judgement in detail. Major Breakthrough On Pace Trial
- Excellent points made by Simon McGrath in BMJ blogs – ‘PACE trial shows why medicine needs patients to scrutinise studies about their health’
- Millions Missing Protests – round up by Erica Verrillo of all the cities involved and media coverage: Milliions Missing Day of Protest Draws Attention to ME/CFS sufferers all round the globe:
On Esther Crawley and FITNET
- The only balanced article on this news story – by Janet Eastham for The Times: ‘I got ME and thought: ‘This is the end” – The Times 2 Nov 2016
- Link to Esther Crawley’s previous studies (which include a study – as yet not written-up) on the Lightning Process ® ‘SMILE’.
- (For reference – older articles) Neurology Letters – Twisk and Maes on CBT and GET in ME/CFS are not only ineffective but harmful for patients. and Tom Kindlon’s paper on The Reported Harms Associated with Graded Exercise Therapy
- New, good study from Leonard Jason et al – do ME patients die earlier than normal? If so, what causes their death? Spoiler: yes, ME patients do die earlier than normal – but more study is needed as the sample size was small. See more here.
- ME as Hibernation? Cort Johnson on Naviaux’s ‘hibernation’ study – The Core Problem in Chronic Fatigue Syndrome Identified? Naviaux’s Metabolomics Study Breaks Fresh Ground
- Robert Naviaux’s original paper for PNAS on Metabolomics in CFS/ME
- Telegraph Covering Naviaux’s study – Scientists find signature of Chronic Fatigue Syndrome in blood which suggests disease is the body going into hibernation
- Cort Johnson on Maureen Hansen’s follow-up to Naviaux’s study – some findings in common – Hanson’s Metabolomics ME/CFS Study Validates Naviaux’s Core Finding
Three brilliant pieces by Miriam E Tucker for well-respected medical journal Medscape:
- Miriam E Tucker – Medscape – Postexertion ‘Crash,’ not Fatigue per se, Marks Syndrome
- Miriam E Tucker – Medscape – Biomarker Research Advances in ‘Chronic Fatigue Syndrome’
- Miriam E Tucker – Medscape – (on Fluge and Mella) Immune-Modulating Agents Eyed for ‘Chronic Fatigue Syndrome’
- Really helpful letter explaining some of the concerns about Esther Crawley’s FITNET trial – Formal Complaint from the Countess of Mar to BBC Director General about coverage of the FITNET story 13 Nov 2016
- Letter from lawyer and scholar Steven Lubert, exposing the problems of the PACE trial and Simon Wessely’s attempts to shut down and shame critics. It’s a good’un. An Open Letter to Dr. Simon Wessely, Defender of the PACE Study
PHEW. Thanks for reading thus far. Anything else I missed? Anything need correcting? Let me know. Thanks for listening.
Want to do more?
- Petition 1 – Sign here .
- Petition 2 – Sign here .
- Sign up to receive ME Action’s newsletter to keep in touch with further protests/petitions.
- Consider giving – even a small donation – to Invest in ME’s B-cell/Rituximab trial, ME Research UK – investigating possible biomarkers, or Ron Davis’ research into the severely affected – End ME/CFS
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.