Following last Saturday’s interview with Prof Esther Crawley on BBC Radio Bristol, I sent the following letter to Dr Phil Hammond who hosted the programme. I think it explains a large part of the reason why patients with M.E. have problems with Dr Crawley and why we don’t want her involved with the proposed MEGA study:
Dear Dr Hammond
Thank you for putting the concerns of ME/CFS patients to Prof Esther Crawley in your interview on Radio Bristol last Saturday. Unfortunately, as I have tried to explain as briefly as possible below, her responses were largely factually incorrect. I wonder if next time you have her on your programme, you could also invite the investigative journalist David Tuller whose original in-depth analysis brought the many and in some cases outrageous defects of the PACE Trial to wider attention. This led to numerous condemnations of PACE from eminent researchers in the field of ME/CFS. Here are just two of them:
Prof. Ronald Davis of Stanford University said: “I’m shocked that the Lancet published it…The PACE study has so many flaws and there are so many questions you’d want to ask about it that I don’t understand how it got through any kind of peer review.”
Prof. Jonathan Edwards of University College London said: “It’s a mass of un-interpretability to me…All the issues with the trial are extremely worrying, making interpretation of the clinical significance of the findings more or less impossible.”
PACE’s recommendations for the use of CBT and graded exercise therapy (GET) for ME/CFS have frequently been reported by the British media but the important work of Mr Tuller has been ignored, so grossly distorting the information which has been made available to the British public. It would be an invaluable service if your programme could help to redress this imbalance.
When asked about the recent PACE reanalysis on your programme, Prof Crawley replied as follows:
“The re-analysers first did the reanalysis based on what the authors originally said they were going to do. That reanalysis is entirely consistent with the original results. Then they did the reanalysis using a different definition of recovery that was very much harder to reach and the trial just wasn’t big enough to show a difference and they didn’t show a difference.”
This is incorrect. What actually happened was that the PACE authors stated their original definitions of recovery in their protocol but then used different definitions of recovery in their published study. What the re-analysers did was to re-analyse the data in accordance with the recovery definitions in the original protocol i.e. the way the PACE authors originally said they would do it. They found that the results so calculated revealed no statistically significant benefit for CBT or GET. They also showed that the results using the amended recovery definition (and published in the PACE study) had shown benefits approx four times higher. The PACE authors appeared to have changed the definition after completion of the study so that they achieved the results they wanted.
This was only one of innumerable flaws in the study. Even the Oxford criteria which were used to enlist patients onto PACE have now been ‘retired’ by the medical authorities in America because they are known to include patients with other fatigue conditions. Accordingly, CBT and GET are no longer recommended treatments for ME/CFS in the US. Once you discard the studies which used the erroneous Oxford criteria, the evidence to support their use no longer exists.
Prof Crawley also said on your programme that patients had misunderstood the FITNET study in the Netherlands. She said that there was no difference between the two arms of the study at long-term follow-up because most of the patients in the ‘standard care’ arm had decided to also try FITNET once the original six month study had come to an end. In actual fact, if you read the publication, you will see that less than half of ‘standard care’ patients (32 out of 67) later tried FITNET, so this does not explain the outcome after all.
In spite of all this, Prof Crawley still claimed on your programme that there is good evidence for the use of GET and CBT and that PACE is a ‘great, great trial’. Even from the examples I have given above, it should be obvious that this is not the case. There are many more issues with PACE I could have cited. Most of them appear in David Tuller’s critique. It is a long read but a brief look at the summary (near the start) will tell you a lot.
Prof Crawley also said on your programme that patients were trying to stop her doing biomedical research into ME/CFS (the so-called MEGA study). In actual fact, patients do want such research. It’s just that some of us don’t want Prof Crawley involved because we are concerned about i) her continuing support of the now discredited PACE trial and the biospychosocial model it purports to support and ii) at risk of being impolite, the slapdash way she does science.
I expect you are aware of her ‘CFS at Age 16’ study which used data from the ‘Children of the Nineties’ project to assess the prevalence of ME/CFS in 16-year-olds. This is where she gets the ‘1 in 50’ figure she uses, but it is based on questionnaires about fatigue filled in by the children and their parents with no medical examination or any attempt to exclude other conditions which might be causing the fatigue. Neither is there any requirement for the cardinal symptom of post-exertional malaise. As someone who regularly diagnoses ME/CFS, you must know how much skill this requires and how inadequate for diagnosis is the method I’ve just described. Prof Crawley basically selected children with generic fatigue but called it ME/CFS and now presents the (grossly inflated) results as definitive figures.
And have you read the protocol for her forthcoming FITNET study? For that, she seems to be using a subtly altered version of the NICE diagnostic guidelines. These are intended for clinical rather than research purposes and even then apparently many of the NHS clinics don’t use them because they are far too broad and pick up many people who don’t have ME/CFS. Yet for FITNET, Prof Crawley is using even broader criteria. As I say, she has subtly altered the NICE criteria so that they require as the core symptom ongoing ‘fatigue’ rather than ‘post-exertional malaise and/or fatigue (typically delayed, for example by at least 24 hours, with slow recovery over several days)’ as is stated by NICE. So once again we have a broader description of the illness.
To be perfectly candid, it seems to me that Prof Crawley’s research, rather than helping us understand ME/CFS, is simply spreading further confusion by the unnecessary use of a series of heterogeneous, unduly broad descriptions, all of which she then declares to relate to the same condition.
The long and the short of it is that there is M.E. and there are other conditions causing fatigue. Some of the latter (such as depression) may well respond to GET and associated CBT. Judging from her diagnostic criteria, I even suspect that some of Prof Crawley’s so-called ‘M.E.’ patients may be otherwise healthy teenagers who have got into the habit of sleeping in too late in the mornings – but once again they will be helped by the GET/CBT. So it’s great that she is helping all these people, some of whom have very distressing conditions. But she (and the PACE proponents in general) are making no proper attempt to distinguish between these and the patients who have genuine M.E. and are likely to be harmed by CBT/GET, often to the extent of it causing severe long term, even permanent, disability. There is increasing research evidence to illustrate that such patients have an abnormal physical response to exercise, so demonstrating the physical reality of PEM (see examples from Newton and Van Ness). It is vital that children – and indeed adults – with this condition are spared the imposition of the inappropriate therapies GET and CBT which can condemn them to a life of extreme disability. Many of us patients are doing all we can to put a stop to what it seems to us amounts to abuse, and which is all the more distressing when applied to children. We should appreciate anything which you and your programme could do to help us in this battle. All we are interested in is bringing out the truth. A discussion between Prof Crawley and David Tuller might serve as an important first step toward this.
Thank you for reading…
P.S. By contrast to the Crawley-dominated Radio Bristol show, there was a very good feature on M.E. last Monday on BBC Radio Scotland, with contributions from Dr Shepherd of the ME Association and from patients, some of them very powerful indeed. Thanks go to Radio Scotland and to Kaye Adams who hosted the show. It is quite long but it is well worth a listen. The M.E. feature starts about 1-40 in and continues after the news.