Trial By Error: Will MAGENTA’s Null Results Finally End Professor Crawley’s Long ‘Reign of Error’?

By David Tuller, DrPH

For years, Professor Esther Crawley, the University of Bristol’s methodologically and ethically challenged ME/CFS investigator, has hoovered up millions of pounds from public and private funders to support her misbegotten research. She achieved this success as a grant magnet despite abundant and easily available evidence that she was violating core principles of scientific research.

Now, perhaps, the disastrous results of a much-ballyhooed study“Graded exercise therapy compared to activity management for paediatric chronic fatigue syndrome/myalgic encephalomyelitis: pragmatic randomized controlled trial”–could help end her long “reign of error.” If so, her dominant impact on the treatment of British kids with the disease will hopefully dwindle or disappear altogether, along with her undeserved reputation as an authoritative and credible voice in this domain. The sooner that comes to pass, the better for families throughout the realm.

It must be said that this new article, in the European Journal of Pediatrics, represents something of a change for Professor Crawley—she and her colleagues report that the trial, nicknamed MAGENTA, yielded null results for the primary outcome of self-reported physical function at six months. Given that leading members of the GET/CBT ideological brigades, like Professor Crawley, long ago adopted a Trumpian strategy toward evidence and truth, this unvarnished acknowledgement that their much-touted treatment approach has proven useless is, frankly, surprising.

In MAGENTA, 123 participants were offered GET and 118 were offered an intervention called “activity management” (AM). In the paper’s explanation, the latter sounds like GET-lite. However, it is also described as a form of “pacing”—which is odd, because AM as described, with a focus on gradually increasing activity, does not conform to the understanding of pacing widely shared by patients. One question about the study is why Professor Crawley believed any difference in outcomes between these two similar-sounding interventions would be detectable.

Maybe things woulda been sorta-kinda okay for Professor Crawley and her team if participants in either arm had, you know, gotten better. But that’s not what happened. “There was no evidence that GET was more effective or cost-effective than AM in this setting, with very limited improvement in either study group evident by the 6-month or 12-month assessment points,” notes the abstract. Oops! Overall, the results for the secondary outcomes—including actigraphy, an objective measure of movement–were similarly disappointing.

Professor Crawley undoubtedly understands that everything she produces these days will come under more rigorous scrutiny in the post-publication period than it has received from the incompetent and cheerleading peer-reviewers and journal editors who have routinely approved her nonsense. She presumably knows, for example, that she cannot present a trial as prospective if more than half the participants were recruited before registration. When she pulled that stunt in her 2017 report about the Lightning Process trial, it led to a 3,000-word correction and a 1,000-word editor’s note offering a pathetic rationale for republishing the original findings.

Professor Crawley also likely knows that related professional stumbles—such as, for example, accusing me in lectures of “libellous blogging” and then refusing to respond to requests for evidence, or informing me at a public presentation that Bristol had sent me a “cease-and-desist” letter when no such letter had been sent–have further tarnished her reputation. At that time, Bristol’s administration did not distinguish itself in this matter. The university behaved as if we were in a Sopranos episode, engaging in thuggish threats to my employment in the form of complaints to Berkeley’s chancellor about my “behaviour.” Berkeley determined these complaints were meritless, and ignored them.

Who knows what Bristol’s legal department really thinks about Professor Crawley’s antics? Presumably they, and she, hope to avoid further high-profile pratfalls. Maybe that accounts for the unexpected display of honesty in this latest paper.

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Long delay from trial to publication

Now I don’t give Professor Crawley much or any credit here for integrity. Had there been a way to make these stinky findings smell like lavender or disappear completely, I imagine it would have been found. In any event, the record does not suggest any particular sense of urgency with regard to publication. The trial recruited participants from 2015 to 2018, but the draft wasn’t submitted to the European Journal of Pediatrics until October of 2023. That’s an extremely long time for a team of investigators to spend analyzing data and writing up results.

What was going on all that time? Were earlier drafts rejected elsewhere because they presented doctored data or because no journals were interested in publishing null findings? Or did Professor Crawley just want to prevent the bad news from becoming public as long as conceivably possible? She must have known these results would be an enormous embarrassment for her and the entire GET/CBT paradigm. This debacle certainly aligns with the 2021 ME/CFS guidelines from the UK’s National Institute for Health and Care Excellence, which rescinded the agency’s prior recommendation for GET.

This is still an Esther Crawley study, however, so something has to be wrong. Indeed, the conclusion manages to sneak in the unjustified suggestion that the “lack of improvement in physical function may be explained by the low intensity of therapy sessions.” In this context, “low intensity” appears to mean that participants attended fewer sessions than initially expected. The authors believed that participants in both arms would likely seek between eight and 12 sessions. As it turns out, the mean number of sessions in the GET and AM arms were, respectively, 3.9 and 4.6.

It seems that the participants did not find the sessions as useful as anticipated. The authors provide no evidence to indicate that greater intensity—that is, more sessions—would have produced signs of improvement. The mention of “low intensity” as a possible explanatory factor is perhaps a subtle appeal for yet more funding to explore ways to encourage participants to increase the number of sessions. Granting any further funding to Professor Crawley for this or any other research would certainly be unwise, but UK funding bodies have shown repeatedly that they are stupid enough to do just that.

This study shared an unusual feature with the Professor Crawley’s fraudulent Lightning Process study. In both, Professor Crawley conducted a feasibility study and then folded those participants into a full-fledged trial while changing outcome measures at that point in time. It is hard to understand why anyone would consider this to be an acceptable way to conduct a trial; it is disturbing that any ethical review board would approve it.

The point of a feasibility trial, if there is one, is to test the feasibility of conducting a full-scale trial. Based on the data received, you then select outcomes and conduct a completely separate and larger trial. You don’t get to wave a wand and somehow transform your feasibility trial participants into full trial subjects while selecting your final outcome measures at half-way through. Has anyone ever done such a thing besides Professor Crawley?

In the Lightning Process study, she and her colleagues pretended they hadn’t done what they did; the trial report, as a result, was concocted of lies. It was a flagrant example of research misconduct, so I found BMJ’s decision not to retract the paper an astonishing abrogation of responsibility. Nonetheless, such an episode would be mortifying for any investigator, even in the absence of a retraction, and it made Professor Crawley and her colleagues look like fraudsters.

I assume Professor Crawley might have been inclined to engage in similar shenanigans with the MAGENTA trial report if that previous effort hadn’t been exposed. Instead of lying about the study’s peculiar feasibility-trial-into-full-trial design, they acknowledge it and concede that it is a limitation. Here’s what they write:

“Whilst we registered MAGENTA before starting recruitment during the feasibility phase, we did not confirm the primary outcome measure until the first full trial protocol…; we recognise this invites the accusation that we used the data collected during the feasibility phase to select the primary outcome.”

Well, yes, exactly. Why shouldn’t it invite that accusation? And why didn’t the authors pre-designate their outcome measures in the first place? I mean, a key aspect of a well-designed clinical trials is that you declare what you’re studying before you start. If you start by collecting data, it is understandable that you would be accused of using feasibility trial data to select the primary outcome. Indeed, the accusation would have been entirely appropriate and necessary had MAGENTA’s primary outcome produced anything other than null results.

As it is, this unacceptable study design ensured that the many hundreds of thousands of pounds spent would be a waste no matter what the results. Someone at the funding agency, the UK’s National Institute for Health and Care Research, should answer for the perplexing decision to fork over money for such ridiculousness.

5 thoughts on “Trial By Error: Will MAGENTA’s Null Results Finally End Professor Crawley’s Long ‘Reign of Error’?”

  1. Peter Trewhitt

    As well as ending the metaphorical ‘reign of error’ let’s hope we also see a final end to the literal ‘reign of terror’ for families who have been subjected to child protection procedures because they refused GET due to the harm it caused their children. Though we have only recently seen a severely ill young adult with ME threatened with sectioning by a British hospital for refusing GET and requesting PEG feeding. So it is still not fully safe for children or adults with ME to engage with the UK ‘health system’.

    Good too that these results also offer no succour to those British clinicians who, as with the misnamed ‘activity management’ arm of this study, try to sneak GET past its prohibition in the current NICE ME/CFS guidelines by seeking to disguise it as pacing. Pacing as understood by patients and by the current NICE guidelines is definitely not a treatment, but rather a restriction and balancing of activity to avoid the harms caused by over exertion, which for the very severely effected could include having a conversation or being in a brightly light room. Any form of ‘pacing up’ is GET by another name.

  2. If my son’s experience under Crawley is anything to go by, the low level of sessions attended is because young people with ME simply cannot sustain the level of engagment her protocols demand – indeed they get worse through trying! She set my son back years.

  3. Thank you David. I am a continuing victim of the Crawley ‘CFS/ME Clinic’ as it was called when I attended at the end of 2011, the year of publication of the PACE trial. Those of us in the adult service of the clinic were introduced to her at the beginning of our course.

    What MAGENTA describes sounds remarkably similar to the ‘treatment’ I received in their adult service. It is their combination of Adaptive Pacing Therapy and CBT as per the PACE manuals – GET lite as you suggest. The clinic called their version of APT “Activity” management as far back as 2011, and possibly earlier than that. We were given activity homework, even back then, despite the fact that many of us were still trying to work at the same time. The switching of types of activity from cognitive to physical to social described in the MAGENTA trial, is the same thing I was taught, along with keeping a diary of activity and establishing a baseline.

    However, PACE style APT and CBT conflict with each other which, presumably, is why they were in different arms of the PACE trial. APT (i.e., increase activity as symptoms allow and patient is able; together with patient collaboration which is limited to exactly what activity your individual homework will consist of. Whereas, CBT is teaching you to ignore your symptoms as they are not stemming from a biological illness, it’s fear and deconditioning. It’s mightily confusing I can tell you, especially when you’re that ill. Your body is telling you it’s really not able, but your now indoctrinated mind (I think they call it retraining your brain) is telling you to ignore it, all of which is reinforced weekly in the nicest possible way by the therapists. I mean to say, why would they lie to you? It should be noted that by the time you arrive at the clinic stage with ME, generally your social life has been given up, the daily chores such as cleaning, cooking, shopping have all taken a massive hit, you can’t follow a whole tv programme, and if you’re lucky enough to still be desperately clinging on to your job, it’s because you need to earn the money to live! It is more often than not the last bastion of ‘activity’ which you are clinging to. Then comes riding to your rescue the NHS! Hurray! What do they do? Immediately coerce you into agreeing to try to do more ‘activity’. Although the force or threat they use is couched in terms of, you want to get better don’t you? Ironically, they teach you how to say ‘no’ to doing something when you don’t have the energy without offending a family member or friend, but try saying no to them and you’re met with phrases such you’re not applying the things we’ve taught you or you should be able to do this by now. It’s insidious.

    However, I suspended my disbelief about the lack of common sense in what they were saying, putting it down to my cognitive difficulties in understanding the science bit, and because I wanted to get better. We all did. Afterall, what could go wrong? We were advised in the group sessions that ‘recent research’ confirmed that more than 50% improved with this treatment, and I certainly wouldn’t get worse, IF I applied myself fully to the treatment.

    Accordingly, having suspended my disbelief, I did as I was told (today I think she calls this process ‘Acceptance and Commitment’) for the 2hr a week sessions during the 6 week group course I attended in person. The clinic confirmed a CFS/ME diagnosis of mild/moderate as I was still struggling to work on reduced hours at the end of 2011 when I began the course.

    There were 12 in the group; 3 men and the rest women of all ages. We all struggled to get through the 6 weeks, and a couple dropped out. None of us thought our health had improved. The fact that I was getting progressively worse throughout the course was ignored, even though I was needing to use a walking aid in the last couple of weeks and I was not backwards in telling them. I was not the only one.

    48hrs after end of the course, I collapsed for the third time in 3 years. However this was by far the worst. Previously I was able to return to work eventually. However, this time, after a diagnosis of CFS/ME and a full course of NHS treatment I was immediately completely bedbound for the whole of 2012. From then ’til now, I have been permanently 80-90% housebound with severe ME – never having been able to return to a working life or any kind of quality family life.

    This is an example of how activity management works in the ‘social’ category of activity in Crawley’s clinic. At least how it did in 2011.

    What do you miss in your social life? Meeting friends for a coffee and chat. OK, for your homework why not try a phone call for half an hour to keep in touch, ‘live your values’ is the phrase they use. It’s about achieving a work life balance. However, let’s ignore the fact that you’ve seriously struggled to get two hours of your job done that day. Clearly a priority. Obviously you have a whole week in which to slot this extra activity in but of course, you relapse after only achieving 20 mins chatting and spend the rest of the week recovering just in time for the next 2hr course appointment. Did you manage to achieve your phone call they ask? Yes, but I couldn’t work the next day! That will improve, they say. Remember what we told you about expecting a slight worsening of symptoms Hey presto, you’re sucked into doing exactly the same thing next week and so it progressively and cummulatively worsens until, in my case – collapse and you’ve lost your job. Yes you answer on your final SF36 questionnaire, I do feel better about being so sick, because I expect to be sick, you said it would happen. You’re not so depressed about the many losses in your life as a result of it. You have accepted your new state of being. That is not an improvement in physical ability and it is certainly not recovery.

    Literally 48hrs after completing the questionnaire, I collapsed and was on my back for 12 months. I was too ill to complete the six month follow up treatment questionnaire. I think the phrase is that I was ‘lost to follow up’. Had it been recorded I would definitely have been listed as harmed.

    Now, when you work at a job, most of the time you pretty much know what you’re doing. You’re not learning new things every day.BUT at school children are learning new things almost every day! This is far more cognitively challenging than trying to do a day’s work for an adult. It will be utterly exhausting for them. This is never highlighted. I had to replace my microwave last year. This time I bought the most basic model I could find on the market, and my carer had to show me how to work it as I couldn’t understand the written instructions. I still don’t know how to change the time on the clock or work the timer or defroster. I just use the 30 second button, repeatedly. I used to travel the UK teaching groups of lawyers to use specialist computer software.

    After 2012, I decided to thoroughly research everything about CFS/ME I could find including discovering the NICE Guidelines 2007, and like thousands of others before me, shockingly discovered what had really been happening to this illness group for decades. It wasn’t until after becoming bedbound by treatment that I discovered my collapse after 24/48 of finishing the activity (the course) was a classic symptom, and that something called PEM was to be avoided at all costs for these very reasons. Far too late.

    3 months after finishing the course of treatment, I purchased a book titled “Severe ME/CFS: A Guide to Living” by Emily Collingridge as I had need of it thanks to the NHS. A week later on 18th March 2012 Emily died. The 12th anniversary of her death is in 8 days time. My husband ‘and I were in complete shock – afterall, no-one died from ME. The experts said I could recover. Yet here I was reading of three deaths in this article which begins:

    “How many young people have to die before ‘chronic fatigue syndrome’ merits properly funded biomedical research?”

    https://www.theguardian.com/commentisfree/2012/mar/30/me-emily-collingridge-chronic-fatigue-syndrome

    I promptly purchased a copy of the film ‘Voices from the Shadows’ referred to in the article. The film was made in 2011. I wish I’d seen it before going anywhere near the clinic. At least I would have been able to give informed consent.

    I decided to adopt Pacing as defined and utilized by the ME community members, which was when my illness more or less stabilized albeit at a very much lower level of functioning. I am able to get out of bed most days for part of the day. I have no friends left to chat to even for 5 mins.

    I reach state retirement age in 16 days time. At the end of 2012 I was denied ill-health retirement from my job as an external ‘medical expert’ engaged by my employers reported that it was not a ‘permanent’ disability. Self evidently, in my case they were wrong.

    At my most vulnerable point in life, I had been forced to listen to and trust the wrong experts! It was the first time in my life I learned to deeply distrust large sections of the medical profession. That has never left me. The psychological and relationship damage in addition to the physical harm their treatment did is profound and long lasting. The clinic knew I was disabled by the treatment as they happily prepared their own supporting letter for me to obtain FULL disability benefits from the DWP which I received without any further assessment or difficulty.

    I was a grown adult, but these poor children and their families. When you find out the truth, it’s too late the harm is done, but in their case they are blackmailed into compliance for fear of criminal charges of FII. Like Munchausen syndrome by proxy before it, the names may change over the years but the stories remain horrifically the same.

    If the children in MAGENTA weren’t even getting past 4.6 weeks before dropping out how could she possibly describe it as “low intensity”? By that stage on my course I was already having to use walking aids for the first time, and a couple of adults had dropped out. I note that the MAGENTA protocol was aiming for 8 to 12 weeks treatment duration. Where is she plucking these timescales from? What evidence existed that this length of treatment may succeed? It’s as if the FINE trial hadn’t taken place.

    I read it as the clinic realising from years of previous patient courses, that 6 weeks doesn’t cure and at least in some cases further seriously disables, so just increase the duration and see if that works. If true, what kind of dystopian hell is this! Where are they parking their ethics as they go about business as usual gambling with childrens’ lives and traumatising parents? Is their moral compass so smashed to pieces that they happily live with the knowledge of the destroyed lives and relationships their ‘gold standard’ treatment for adults leaves in it’s wake? The tone of the MAGENTA paper is a marked departure from her previous papers, but I agree with you, the “low intensity” comment leaves an opening for further funding opportunities.

    Apologies for the length and muddle of this comment but my brain is burning at the moment. I felt I had to try and explain how Crawley does not seem to have changed her treatment much, at least up until 2018/19 when she began this trial. If anything it’s a combination of two of the PACE trial arms. When looked at this way, unless I’m missing something significant which is highly possible, MAGENTA confirms the reanalysis of the PACE trial data and MAGENTA was long after your 2015 Trial by Error expose. This is despite her making protestations in defence to complaints about the MAGENTA trial before it officially began at the time that treatment of children was necessarily different to the treatment adults received, as children responded differently or something along those lines. It certainly doesn’t seem to be that different from what the adult service delivered, which she oversaw in 2011, and which I received.

    So once again David, thank you for everything you do to shine light into the darkness.

  4. It’s funny how researchers can conduct themselves like this. They might be pretending to believe their own lies but It’s patently obvious there agenda is to enrich themselves at the expense of the very people they are pretending to be helping. This is not just damaging in that they are promoting an unfounded belief we are doing this to ourselves, that we don’t deserve any sympathy or respect. It actually puts a target on our back that says “kick me”. Being psychologist, understanding human nature the way they do they almost certainly have to know this.

  5. Kelly McKeown

    Your words make me giggle but let’s face it the least Esther Crawley deserves!! Plus, when they come after your credibility with false claims – you know you’re going something right!

    As a severe sufferer myself, the drive and determination of the ME community has in all honesty, kept me going……. HOPE and thank you so much from all of us x please keep up the eloquent insults it really cheers us up!

    I’m launching my own ME quest, a lot of organisations are noticing the gap but it’s still in its infancy and I’m hoping we can all unite for the children of this terrible disease.

    In 2019 my daughter became severely unwell- we were so so so incredibly lucky, we had what millions of families don’t have – a dedicated Paediatrician/Team who refused to rest until everything else was ruled out.

    It took 4 years, even that’s considered lightning fast however covid hit, consultant referral time etc etc

    We finally ended up at Alder Hey Children’s Hospital UK – Chronic Pain Team ME Specialist- oh my nerves, which side of The Pace Trail is this team ……. happy to report ‘the patients side’!!

    The nurse actually gave me a hug when I mentioned The Pace Trail – so many parents and schools think the answer is to push push push….. but the stars have aligned for my daughter, she had a mum and no matter how severe my illness was- I knew what she needed. I was backed up and supported completely by Alder Hey Hospital and we came up with a plan.

    Oh how rare that is, up until this point her school were ok, but they rejected all medical assessments, refused to communicate or listen to reason. They FABRICATED a meeting between all educational officials including Local Authority and came to tell me all support has been withdrawn.

    My daughter was assessed as being able to attend school 6hrs per week, home learning and as she was in GCSE exam year it wasn’t medically possible to study the full curriculum- my daughter was heartbroken x

    The school rejected this, the outcome of the fabricated meeting was that Gracie must attend school full time, including PE multiple times a week.

    I sat and explained the horrors of the past and the horrors of what will become of my daughter if I listened to a word they said – then the threats came, of what will happen if I don’t police involvement, social services, educational welfare – the safeguarding officer was elated to relay this, do your worst I said – it will be a learning opportunity for them.

    How many parents would of forced their children into school? You see even on the rare occasions that the new NICE guidelines are enforced within the NHS, you have a dedicated ME Specialist, a Physiotherapist and a Paediatric Occupational Therapist all experienced in paediatric ME and Chronic Illness……. It’s not enough, sadly it’s not enough!

    My daughters medical team and GP all had to step in to safeguard my family against the school and this one particular Safeguarding Officer whom I’m sure she’s related to Crawley, or at least ‘selective reading’ on old Pace Trail propaganda x

    Yes we need to rid the ME research world of Crawley et al and yes we need to ensure proper care is there within our NHS but the policy in place for our children in education is not enough- it’s just not enough.

    The unnecessary nightmare re paediatric ME In education needs to end – not many families at all are as lucky as mine xxx

    Ps Gracie did outstanding in her exams, she had 20% attendance across 4yrs of high school, no support from them – she self taught herself and passed with flying colours, never been so proud in my life x

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