BMJ: Pressure grows on Lancet to review “flawed” PACE trial

[Barry]

I've often wondered if in their clinics they might be defining CFS broadly and so treating a lot of people they say have CFS with CBT and GET and getting decent results, because a lot of those have idiopathic fatigue and/or undiagnosed depressive or anxiety disorders and actually benefit from CBT and GET.

Highly possible I would think. I suspect a lot of the practitioners misguidedly believe they are genuinely getting it right. I would think a great milestone one day will be for those folk to realise there is much more to it than meets their eyes.

I wonder what might be the best way to better educate such people. Overly scientific argument will lose many of them, and lose their interest. I met a very dedicated and compassionate ambulance man, but who had a very low opinion of ME and PwME - he effectively told me he thought PwME were trying it on; after a bit more talking I could see that even an ambulanceman could not comprehend an illness as invisible as mild/moderate ME. I think I convinced him a little, but it was clear although highly trained for what he does, it does not include the veracity of clinical trials, and even my very minor understanding of some of the science was lost on him. I wondered at the time if medical staff maybe browse journals during their breaks, and if there was anything could be targeted more to their mindset.

 

[Barry]

When one looks at the loose entry criteria for PACE and you look at the figures (the real ones, not the hyped), I think PACE demonstrated CBT & GET don't work very well for anyone.

The data showed it did not, the authors' published results said it did, and Michael Sharpe even the other day accused others of trying to suppress trial results they don't like.

 

[Sean]

New response entitled "No Differences at Long Term Follow-up", https://www.bmj.com/content/362/bmj.k3621/rr-8 - very short so I'm not quoting any of it here.

The long-term follow-up result should be placed at the centre of any discussion about PACE, and kept there. It is the main finding from PACE, that trumps all others from the study.

Once that is accepted, debate about the rest of it becomes secondary. (Not irrelevant, there is clearly a lot to learn from PACE about how not to run a clinical trial. But in terms of the basic findings, the LTFU is the main one.)

...ME/CFS affects levels of physical activity and employment. The PACE team are well aware of the latter from their insurance work, the NHS Plus document on employment they were all involved in, etc. Claiming success solely on subjective measures is less justified in this context.

Knowing of the problems with subjective measures, and how to control for them, seems a basic skill set for psycho-social clinicians and researchers. Supposedly senior world-leading experts certainly have no excuse for not knowing this stuff, and handling it properly.

Wessely & Chalder, et al, state unambiguously that increasing activity "...must ultimately be the aim of any treatment."

And that is certainly amendable to more objective measurements, such as actimeters, educational and employment participation, fitness and stamina tests, etc.

 

[Sly Saint]

The long-term follow-up result should be placed at the centre of any discussion about PACE

except they've changed their response to this and say it helps patients get over their 'current episode' (whatever that is!).

 

[adambeyoncelowe]

except they've changed their response to this and say it helps patients get over their 'current episode' (whatever that is!).

More rubbish. Again, how could this be measured? What's the point if it has to be repeated every time you crash? Doesn't that make it ridiculously expensive? The NHS would have to fork out multiple times a year for a treatment with no lasting benefit.

 

[TiredSam]

What's the point if it has to be repeated every time you crash? Doesn't that make it ridiculously expensive? The NHS would have to fork out multiple times a year for a treatment with no lasting benefit.

That could be the point - a million therapists on full-time contracts, training courses, "experts" being funded for further research ... exactly what they seem to be aiming for in other areas. All fits together nicely.

 

[Sly Saint]

What's the point if it has to be repeated every time you crash?

well, they wouldn't (at least not in Bristol)

"Exclusion criteria for the CFS/ME Service:

History of failed rehabilitation specific to CFS/ME (e.g. specialist CBT
programme) unless there are specific reasons to reconsider the role of
rehabilitation (please outline these in the referral)."

https://www.nbt.nhs.uk/sites/default/files/filedepot/incoming/Chronic Fatigue Syndrome-ME referral criteria.pdf

eta:
also on that form
"NB: we do not offer long-term counselling / support."
great

eta2:
Head of this service is Hazel O'Dowd, who AfME consult for their GP webinars.

 

[Trish]

"Exclusion criteria for the CFS/ME Service:
History of failed rehabilitation specific to CFS/ME (e.g. specialist CBT
programme) unless there are specific reasons to reconsider the role of
rehabilitation (please outline these in the referral)."

"NB: we do not offer long-term counselling / support."

''We'll make you worse then we'll abandon you''.
or ''We'll make you worse, but we don't want to hear about it, it might upset us and mess up our success statistics.''
or ''We'll make you worse, but we don't want you anywhere near our new crop of victims.''

How terribly nice and caring...

 

[adambeyoncelowe]

well, they wouldn't (at least not in Bristol)

"Exclusion criteria for the CFS/ME Service:

History of failed rehabilitation specific to CFS/ME (e.g. specialist CBT
programme) unless there are specific reasons to reconsider the role of
rehabilitation (please outline these in the referral)."

https://www.nbt.nhs.uk/sites/default/files/filedepot/incoming/Chronic Fatigue Syndrome-ME referral criteria.pdf

eta:
also on that form
"NB: we do not offer long-term counselling / support."
great

eta2:
Head of this service is Hazel O'Dowd, who AfME consult for their GP webinars.

@Action for M.E. How do you feel about this?

It's interesting that failed CBT/GET has to be listed as an exclusion criteria. That must mean they're aware of a significant enough number of such patients that they would be a burden on the service. It's almost as if those treatments don't work!

 

[Robert 1973]

I've often wondered if in their clinics they might be defining CFS broadly and so treating a lot of people they say have CFS with CBT and GET and getting decent results, because a lot of those have idiopathic fatigue and/or undiagnosed depressive or anxiety disorders and actually benefit from CBT and GET.

I used to assume that was the case. I used to assume that there must be some people being diagnosed with ME/CFS who had something very different to me which responded well to CBT/GET. How else could all these apparently intelligent people be so convinced of the effectiveness of their treatments? But the more evidence I have examined – including your own work – the less convinced I have become that CBT/GET works for anyone diagnosed with ME/CFS, however broadly it is defined. Some people get better anyway, and if they happen to be given CBT, GET, homeopathy or snake oil at the time they start to improve, both the patient and those administering the treatment may believe that it has been effective.

A different question is whether there could be people diagnosed with ME/CFS whose illnesses are perpetuated by unhelpful beliefs who do not respond positively to CBT or GET – possibly because their unhelpful beliefs are too deeply ingrained. If that were the case, they would presumably be suffering from some form of psychosis, which, as far as I understand, implies some form of abnormal pathology. But if abnormal pathology is resulting in restricted function which does not respond to talking therapies, what is the need for, or purpose of, talking about unhelpful beliefs? How can the unhelpful beliefs concept be useful or falsified? One might as well say that the abnormal pathology is sending undetectable signals to aliens in another universe who are sending undetectable signals back to the patients which causes them not to be able to function properly. Perhaps this is what is happening in MS, Parkinson’s or any any other illness.

If we assume that surrounding patients with magic crystals will block the signals to the aliens and reverse the illness we could do a trial. We could recruit patients by explaining, without caveat, that the treatment is highly effective, and we could explain to participants in the treatment arm that the crystals only work if you think positively and stop telling people that you feel unwell. The control group could be told that we’re really sorry they weren’t lucky enough to get the really effective new crystal treatment that they were hoping for when they signed up and that sadly there is nothing more we can do for them at the moment. Then we ask them all if they feel any better – and make sure we don’t measure anything objective.

 

[Tom Kindlon]

 

[Guest 102]

I've often wondered if in their clinics they might be defining CFS broadly and so treating a lot of people they say have CFS with CBT and GET and getting decent results, because a lot of those have idiopathic fatigue and/or undiagnosed depressive or anxiety disorders and actually benefit from CBT and GET.

There is no doubt that these Wessely-inspired CFS clinics are seeing patients who have idiopathic chronic fatigue and not ‘classic’ ME, as I know it, the criteria are so loose, really anyone can be diagnosed with CFS, it is a dustbin diagnosis. Having attended an informal meeting of the Lothian Clinic when it opened a few years ago - there is only one CFS clinic in Scotland - and I think BACME were involved in the pilot - and having listened to the staff describe the clinic it was clear as day they were seeing a broad spectrum of patients. Indeed, this is the same clinic that caused harm to @Emsho

 

[adambeyoncelowe]

There is no doubt that these Wessely-inspired CFS clinics are seeing patients who have idiopathic chronic fatigue and not ‘classic’ ME, as I know it, the criteria are so loose, really anyone can be diagnosed with CFS, it is a dustbin diagnosis. Having attended an informal meeting of the Lothian Clinic when it opened a few years ago - there is only one CFS clinic in Scotland - and I think BACME were involved in the pilot - and having listened to the staff describe the clinic it was clear as day they were seeing a broad spectrum of patients. Indeed, this is the same clinic that caused harm to @Emsho

The psychiatrist at Liverpool also gave me this impression. They're not just seeing ME patients, but a large number of psychiatric patients. But given how they assume everything is due to psychiatric causes, one has to doubt even that.

 

[EzzieD]

Wonderful to see that Dr Kerr is back in the UK and in the ME field again.

 

[Guest 102]

The psychiatrist at Liverpool also gave me this impression. They're not just seeing ME patients, but a large number of psychiatric patients. But given how they assume everything is due to psychiatric causes, one has to doubt even that.

I know I bang on about this all the time but the conflation of ME and chronic fatigue is very much at the root of what has gone wrong since late eighties. It has been a deliberate disappearing of ME, a reframing as fatigue and voila we have the mess we are in. And the medical establishment still stumbling on defending PACE. Meanwhile, our lives disrupted & diminished in ways most people will never understand, even others with chronic illness. It truly is a medical scandal, but whenever we pointed this out we were beaten over the heads with the cudgel of ‘stop stigmatising mental illness’. I am just so very weary and I honestly expect there may be no cure/great advances for ME in my lifetime. I mean thirty-five years have passed since my own diagnosis and nothing.

 

[chrisb]

There is no doubt that these Wessely-inspired CFS clinics are seeing patients who have idiopathic chronic fatigue and not ‘classic’ ME, as I know it, the criteria are so loose, really anyone can be diagnosed with CFS, it is a dustbin diagnosis

Interestingly, well I found it interesting, I came across this classification from 1990 in
Leading Arficle

The chronic fatigue syndrome: a return to common sense
A.M. Denman
Division of Immunological Medicine, Clinical Research Centre and Northwick Park Hospital, WatfordRoad, Harrow, Middlesex HAI 3UJ, UK.

pmj.bmj.com/content/postgradmedj/66/777/499.full.pdf

Once patients with obvious underlying diseases have been identified, four major categories remain.

The first includes patients with an initial illness resembling an acute virus infection in whom fatigue is accompanied by consistent disease features, notably myalgia, headaches, lymphadenopathy and low grade fever.

Patients in the second category have similar chronic symptoms, but they have no history of any obvious precipitating infection. A high incidence of concomitant atopic disorders may prove to be a useful diagnostic point.'

The third group comprises patients in whom chronic fatigue, sometimes accompanied by myalgia, is a consistent complaint but who lack the other symptoms suggesting an infective aetiology.

Finally, there are patients in whom there is a strong suspicion that fatigue reflects stress or other emotional problems but who will not admit to them. However, there are usually other pointers to this aetiology, such as the long duration of the fatigue with no hint of remission and co-existing complaints of great variability.

It still looks to be a useful grouping. He rather spoiled the effect by going on to advocate GET, but it is hard to be sure what was meant by that.

 

[adambeyoncelowe]

Interestingly, well I found it interesting, I came across this classification from 1990 in
Leading Arficle

The chronic fatigue syndrome: a return to common sense
A.M. Denman
Division of Immunological Medicine, Clinical Research Centre and Northwick Park Hospital, WatfordRoad, Harrow, Middlesex HAI 3UJ, UK.

pmj.bmj.com/content/postgradmedj/66/777/499.full.pdf

Once patients with obvious underlying diseases have been identified, four major categories remain.

The first includes patients with an initial illness resembling an acute virus infection in whom fatigue is accompanied by consistent disease features, notably myalgia, headaches, lymphadenopathy and low grade fever.

Patients in the second category have similar chronic symptoms, but they have no history of any obvious precipitating infection. A high incidence of concomitant atopic disorders may prove to be a useful diagnostic point.'

The third group comprises patients in whom chronic fatigue, sometimes accompanied by myalgia, is a consistent complaint but who lack the other symptoms suggesting an infective aetiology.

Finally, there are patients in whom there is a strong suspicion that fatigue reflects stress or other emotional problems but who will not admit to them. However, there are usually other pointers to this aetiology, such as the long duration of the fatigue with no hint of remission and co-existing complaints of great variability.

It still looks to be a useful grouping. He rather spoiled the effect by going on to advocate GET, but it is hard to be sure what was meant by that.

I dunno. That last characterisation worries me. Perhaps patients 'won't admit' to psychiatric problems because they don't have them? In my experience, those whose fatigue is caused by psychiatric problems are quite happy to embrace that causality and say so. Hence why those who claim to be cured by LP, Gupta, etc, also talk a lot about 'stress'.

 

[Keela Too]

Just a thought. Folk have been saying that Pharma trial regulations are incredibly thorough.

Would a Pharma body be a useful, respected, arbitrator in judging PACE (and similar) trials?

Sure the BPSers will say their trials can’t be judged to the same criteria as Pharma trials. Yet, despite obvious difficulties with blinding and so on, there seem to be so many features of a fair test that PACE wilfully ignored.

 

[EzzieD]

I know I bang on about this all the time but the conflation of ME and chronic fatigue is very much at the root of what has gone wrong since late eighties. It has been a deliberate disappearing of ME, a reframing as fatigue and voila we have the mess we are in. And the medical establishment still stumbling on defending PACE. Meanwhile, our lives disrupted & diminished in ways most people will never understand, even others with chronic illness. It truly is a medical scandal, but whenever we pointed this out we were beaten over the heads with the cudgel of ‘stop stigmatising mental illness’. I am just so very weary and I honestly expect there may be no cure/great advances for ME in my lifetime. I mean thirty-five years have passed since my own diagnosis and nothing.

Spot-on. As someone who acquired ME in 1983 defined by Ramsay's description back before 'CFS' was invented, and taken seriously as a physical illness by the doctors who did believe it was 'real' (some didn't, but many did), I hear you 100%. As well as Ramsay ME, so many unfortunate people with other varying fatigue-related diseases have been swept under this 'CFS' umbrella since then, that it will indeed now be hard to sort everyone out into sub-groups. It's a mess, and one that was invented by some self-serving folks in order to 'disappear' a condition that I guess they thought was short-lived and would just go away. Unfortunately, it hasn't.

 

[Suffolkres]

Wonderful to see that Dr Kerr is back in the UK and in the ME field again.

Indeed yes. I was astonished to learn this yesterday AND that he is in Suffolk!! Can we make Suffolk an a area of "excellence" and fulfill Dr Terry Mitchell's dream of replacing his post with Jonathan and another?

https://www.careerscene.com/search/result/10048/biomedical-scientist

Public Health England current operates four Specialist Microbiology Services laboratories in the East of England (EofE) Group, Addenbrooke’s Hospital in Cambridge, West Suffolk Hospital in Bury St Edmunds, Ipswich Hospital and Colchester Hospital. A process is underway to consolidate the work of these centres to the laboratories in Cambridge and Ipswich. This post is being recruited out of Ipswich but you will be required to work at West Suffolk until the work is transferred to the Ipswich hub.

The Microbiology laboratory in Bury St Edmunds is sited at West Suffolk Hospital and is currently part of the PHE East of England region laboratory service. The laboratory currently provides services to the local Trust and the surrounding district, and is accredited with CPA. All EofE PHE sites have teaching, research and epidemiological interests through their links to the PHE hub laboratories at Cambridge and Ipswich. The department undertakes a wide range of routine microbiological investigations with automation supporting the delivery of the service, including BactAlert, IQ Sprint, VITEK 2, Probetec, Vidas and T4 analysers.

The Microbiology laboratory at Ipswich Hospital is one of the Hub laboratories for the Eastern Regional Laboratory for Public Health England currently providing services to Ipswich Hospital, the surrounding district and other NHS Laboratories.

In the future Ipswich will be providing services to both Colchester and West Suffolk Hospitals. It has active research and epidemiological interest with its link to the other PHE Eastern Hub Laboratory at Cambridge.
The laboratory is accredited with CPA with strong teaching interests. Set on the outskirts of the County Town of Suffolk Ipswich Hospital is one of the largest District General Hospitals in the UK. Ipswich pathology is closely associated with leading educational providers including the University of Essex.