Spreading the Word

Dr Phil Hammond’s latest column in Private Eye is called ‘Trial on Trial’. You may remember he wrote quite a helpful column about ME just recently. This time he writes in response to criticism from a doctor who got in touch to say:

“Every illness has a physical, psychological and social component, and limiting diagnosis or treatment to only one aspect of someone’s illness is likely to lead to a much poorer outcome. This ‘triple diagnosis’ applies to any complaint you care to consider, although obviously in varying proportions. The one exception seems to be CFS/ME, where any suggestion that there might be a psychological or social component leads to criticism. That CBT is the only treatment which has repeatedly been shown to have any benefit is conveniently ignored.”

It does become tiresome having to deal with such ‘arguments’ time and time again. Once upon a time it was ‘yuppie flu’ that popped up in every article about ME. Now, at long last, that is slowly fading away. Yet now we have to deal with this endlessly repeated idea that ME patients have an unreasonable and unsubstantiated resistance to any suggestion that there might be a psychological component to our illness. People with cancer are happy enough to go for CBT, we are told. So what’s our objection?

Sigh. Look, a proportion of people with ME suffer with anxiety or depression due to having our illness, as is the case with any other chronic condition. Some receive CBT to help with this – and also to deal with other aspects of living with our condition, such as coming to terms with the fact that we are ill and the impact this has on our lives.

But CBT is classically used to ‘treat’ ME in a very different way: to try to convince us we’re no longer physically ill and that there is no physical barrier – other than a bit of deconditioning – to us slowly increasing our level of activity till we get back to normal. This was how CBT was applied in the PACE Trial, for instance, yet it is flying in the face of evidence of ongoing pathology and of abnormal response to exercise. It flies in the face of consistent reports from patients of being made to feel worse – sometimes for months or years and sometimes indefinitely – by taking exercise beyond our very limited level of energy.

So unfortunately ME is an exception. It is an exception in the way that CBT is all too often applied to it, and an exception too in this abnormal response to exercise. Put the two together and you get disaster: long-term deterioration and broken lives, with no one to turn to for help – or even apologies. This is why we object so strongly to the psychological label, not because (as is often suggested) we’re scared of the stigma of mental illness, but because it leads to the imposition of such inappropriate, potentially devastating so-called therapies.

Phil Hammond doesn’t make this particular argument in his response to the doctor who wrote in. Perhaps, as he works in Esther Crawley’s clinic, criticising the way CBT is used for ME would be a bit too close to home. But he makes a reasonable argument nonetheless, pointing out “it was doctors who initially dismissed a physical basis for CFS/ME, and as a consequence insufficient attention and resources have been given to doing large scale biological, nutritional, and genetic studies that might provide alternative treatments to the non-drug options currently on offer.”

Too right. It wasn’t patients who started labelling illnesses ‘physical’ or otherwise. It’s been foisted on us unbidden, but every time we try to point out that it’s been misapplied, we get told we’re obsessed with a false dichotomy.

And yes, the popularity (among the medical profession) of the misconceived and unsubstantiated psychogenic theory of ME has held back biological research for decades. For many patients, it has robbed us of any chance of getting well enough to return to normal life.

Dr Hammond also points out that patients are challenging the PACE Trial, the major study which purported to prove the efficacy of CBT and graded exercise therapy (GET). He says: “activists have had to fight to gain access to some of the data which they are re-analysing to find out if claims about the efficacy of CBT and GET have been overstated.” Hence the title of the piece presumably: ‘Trial on Trial’.

Which is all right as far as it goes, but as far as patients are concerned there is no ‘if’ about it. The show’s already over. The lady has already sung. Read David Tuller’s considerable collection of PACE analyses with an open mind and there can be little doubt where the truth lies. There are numerous irregularities in the study, some of them outrageous. Many of them should be enough to condemn the study all on their own, yet they form just a part of a well catalogued portfolio of bad practice.

Internationally, the word is getting around. The PACE  Trial is already being widely referenced as a prime example of bad science, and the ‘retiring’ of the Oxford diagnostic criteria (acknowledged by the US P2P report as being so broad that they include people who don’t have ME) means that the evidence of many studies which had seemed to suggest the effectiveness of CBT and GET (PACE among them) have now been dismissed by the US authorities. The Agency for Healthcare Research and Quality (AHRQ) has therefore concluded that there is now inadequate evidence to support the use of CBT (or GET) for ME.

So when that doctor who wrote in to Private Eye said: “that CBT is the only treatment which has repeatedly been shown to have any benefit (for ME) is conveniently ignored” he himself was ignoring the latest news from America – or as is more likely, he hadn’t read it in the first place, any more than he had read David Tuller’s demolition of the Dutch CBT studies, FITNET included.

ME patients have come a long way in unearthing the ills of the PACE Trial. Some have suffered deteriorating health because of their efforts to expose the shortcomings of those who were supposed to be helping them. If anyone checks the facts of the matter, the evidence to condemn PACE is already out there. So of course it is hard to forgive those journalists who continue to spout nonsense about ME patients just being lazy, but it is also frustrating to see the (now more common) pieces by well-meaning journalists who believe they are taking an even-handed approach, yet giving equal weight to both sides of the argument as though there were simply two opinions and the facts of the matter had yet to be proven.

These writers are perpetuating the current state of confusion because they can’t be bothered – or won’t find the time – to follow the links which patients have doubtless sent them and read the truth for themselves. Patients – and journalist David Tuller who has done so much to help us – are wondering how many times we have to explain the truth, how many more irregularities we have to expose – before what might be best described as ‘the establishment’ will take on board that PACE is a fallacy, CBT & GET are unproven, and ME patients have been not only mistreated but unfairly disparaged for protesting about it.

Dr Hammond has his own ideas about what it will take to get the message about PACE across. He says: “For the PACE researchers to accept (the) reanalysis would require it to be published in a credible, peer-reviewed journal with independent analysis that is free from bias.” I hope he will forgive me for a few moments while I split my sides laughing at that one. PACE itself was peer-reviewed and look what howlers got through that process. The jaw-hanging classic, of course, is that the entry and recovery criteria were set such that patients  could be ill enough to be accepted onto the trial, get worse, yet still be classed as ‘recovered’ at the end. That is a prime example of the nonsense that has been perpetrated but there are many more I could have selected – in PACE and in other studies which David Tuller has exposed, all of them sailing on a breeze through the supposedly ‘free from bias’ peer review process, presumably because the peer circles in a small country such as Britain are so tight knit that everyone knows everyone else and they can’t imagine their mates could possibly get things wrong -not even when patients later point it out to them, citing chapter and verse.

If PACE has proven one thing, it is that the peer review process is in need of some scrutiny itself. However, I understand that an article on the PACE reanalysis has indeed been submitted for publication and I hope that Dr Hammond is right and it will make a difference, at least among disinterested observers. If it doesn’t, then goodness knows what we’re supposed to do about it.

What is really needed, I guess, is for some high profile investigative journalist or broadcaster in the UK to take this issue on. ME patients in this country and throughout the world will be grateful if it can be done. There’s really quite a story to be told: not only about some very wobbly research but also about the (undue) influence of the Science Media Centre, the tendency of lazy journalists to simply repeat what they’re told instead of testing its validity, the shortcomings of peer review, the campaign to portray ME advocates as dangerous sociopaths and even assassins, the seeming inability of those in positions of power and privilege to submit their colleagues to due scrutiny etc etc… Some day it will probably be made into a feature film or a boxed set. All the ingredients are there. It would be a great story for Private Eye to take on, for instance.

Unless of course there’s a conflict of interest…

As for the PACE authors themselves, I doubt that anything will make a difference. They had clearly decided how the trial was going to turn out before they even started it, and I can’t see anything changing their views about it now, whether peer reviewed or otherwise. PACE was not a voyage of discovery. As the godfather of PACE, Sir Simon Wessely, inadvertently revealed, they always knew exactly where they wanted to get to. They simply made whatever adjustments they needed in order to get there. They live in a world where they are right, patients are wrong, and the facts can be changed to support that. I doubt they’re open to any kind of reason.

If you are reading this Dr Hammond – and I know you have found your way to my blog before – then I am grateful for the two articles you have written, but I wish you’d go on and finish the job. You called this latest article ‘Trial on Trial’ but in fact you only mentioned PACE in passing. There is so much more to be said. I really do believe that the whole issue of PACE – and ME in general – would be an excellent subject for a Private Eye expose.  Someone is going to make their mark on history – to say nothing of helping a lot of sick people – by writing it sometime, so it might as well be you. Then maybe you will be able to give up the day job… Which all in all might be for the best.

For your convenience, gathered below are some of the references you’ll need to look at for your article. A glance through previous posts on this blog might also be useful.

Links to David Tuller’s many articles on PACE. Trial by Error (in several parts) is the principal one. This list predates some recent articles, including the following:

Reanalysis by Matthees et al following release of data by Freedom of Information Tribunal

Overview of both reanalyses by Matthees et al and PACE authors

Professor Crawley’s FITNET Trial

FITNET continued including quotes from Crawley’s Radio Bristol interview

Dutch CBT Studies and Esther Crawley’s FITNET Poster

Sense about Statistics Editorial on PACE

Statistical critique of PACE Study Design by Rebecca Goldin

Pathways to Prevention ME/CFS Report

Institutes of Medicine ME/CFS Report

AHRQ Reanalysis of CBT and GET

Abnormal Response to Exercise:

Newton – Muscle Biopsies

VanNess – CPET Test

An Exploration of the Key Clinical Issues by ME Association – contains recent summary for doctors of research evidence regarding ME/CFS

ME Association Survey: Patient Experience of CBT and GET

PACE cited as example of bad science:

“…in no way do the study’s shortcomings rise to the level of fundamental errors of the kind he recently helped expose in the PACE trial…”

“The new analysis revealed what many suspected – that the interventions in the trial had little benefit.”

‘‘PACE trial is a fault line between the way we did medicine (secretive, clubbable) and the way we should do medicine (transparent, shared).’’

Note: Dr Nigel Speight left a comment in response to this post which mentions references for immunoglobulin treatment in ME/CFS. I can’t work out how to attach the documents to the comment but you can find the links here:

Immunoglobulin Treatments – University of York Review

Intravenous Gammaglobulin – Katherine Rowe