Looking at the Evidence

As you may know, a few days ago the Journal of Health Psychology published a very important special issue critiquing in depth the controversial, deeply flawed PACE Trial, a study which purported to provide evidence for the use of graded exercise and a very specific type of CBT in the treatment of ME (myalgic encephalomyelitis, also known – misleadingly – as chronic fatigue syndrome or CFS). Congratulations to the journal’s editor Prof David F Marks for taking the trouble to inform himself about the true situation regarding ME. He is one of very few scientists and health professionals who despite having no personal or pre-existing professional interest in the condition has made the effort to look at the facts and realise that – unlikely as it may seem to many – the PACE Trial and similar ‘research’ into ME by those with a fixed biopsychosocial mindset really is every bit as flawed, misleading and potentially damaging as patients have been claiming for years. Dr David Tuller, Prof James Coyne, and Prof Jonathan Edwards are other rare free thinkers who have not been afraid to get informed and challenge the status quo – or to put it another way, to point out that the emperor is naked because that is what he is.

By contrast, those who persist in defending PACE give the impression that they have simply taken the word of the PACE investigators rather than study the actual evidence. Prof Malcolm Macleod, who was trotted out by the Science Media Centre as an ‘expert’ in response to the special issue, seemed only aware of one of PACE’s many flaws and seemed to base his defence of the study chiefly on the ‘doubtful provenance’ of some of its critics. It is another example of people being judged on the basis of who they are, rather than what they say or where the truth lies.

As for Prof George Davey Smith, who left the JHP’s editorial board in protest at the PACE-related special issue, he seemed to positively gloat about his ignorance of ME at last year’s CMRC conference, this in spite of his involvement with the much vaunted though controversial MEGA study, and even referred to it as CSF rather than CFS, apparently mixing up chronic fatigue syndrome with cerebrospinal fluid.

Speaking on Twitter, David F Marks described his disappointment that George Davey Smith did not ‘offer a pro-PACE commentary instead of leaving in a huff’. He (Marks) has offered to debate with PACE supporters in a public forum at any time. I don’t suppose he’ll get any takers. That would put them to the trouble of actually sitting down and informing themselves of the true situation.

Marks, meanwhile, has studied the facts and has drawn his own conclusion. He says: ‘“The many wrongs committed by psychiatry and medicine to the ME/CFS community can only be righted when the Pace trial is ultimately seen for what it is: a disgraceful confidence trick to reduce patient compensation payments and benefits.’ To which I would add: ‘also an exercise to try to protect the reputations of a small number of health professionals who have built their illustrious careers on the back of an unproven ‘biopsychosocial hypothesis’.

Meanwhile the proponents of PACE continue to take the cream of the research money here in the UK, so inhibiting much-needed biomedical progress; unsuspecting patients are given potentially damaging courses of graded exercise; and the number of parents threatened with ME-related child custody proceedings appears to be spiralling upwards, all this fuelled by the unproven biopsychosocial hypothesis.

As The Times article reported with great relish, James Coyne allegedly called the departing Davey-Smith ‘a disgusting old fart neoliberal hypocrite’. This may seem a little harsh but if language like that helps to get the truth about PACE in the newspapers, then so be it as far as I am concerned. And in view of the human suffering which underlies the farce that is PACE, perhaps such language is restrained.

Note: David Tuller’s response to the Science Media Centre’s ‘expert comments’ on the JHP special issue is here.

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Spreading the Word

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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? Continue reading “Spreading the Word”

Letter to Dr Phil Hammond

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: Continue reading “Letter to Dr Phil Hammond”

White In Denial

We’ve had to put up with decades of nonsense about ME in the press but today’s Guardian article by Peter White of the PACE Trial has to be the worst I’ve seen. It wasn’t easy to leave a comment on the article while shaking with anger but I did my best. Here’s what I wrote. I’m pleased to say that many others were making powerful points at he same time.

Following the recent release of data from Peter White’s PACE trial (by order of a Freedom of Information tribunal, £250,000 having been spent in attempting to stop it) PACE has finally been revealed as the travesty of the truth it always has been. Rather than give the appropriate heartfelt apology, however, Prof White continues in denial.

The blog to which he disparagingly refers was written by patients who have used energy they can ill afford to spend in a David-and-Goliath struggle to reveal the truth about this reprehensible study. With the aid of expert statisticians they have not distorted the figures, as Prof White implies. What they have done is to use the newly released data to analyse the results in line with the trial’s original protocol, which White and his fellow authors originally declared they would use but then changed their minds as it didn’t give them the outcomes they wanted. They never gave a satisfactory explanation for this change but it now seems pretty obvious why it happened. The newly reanalysed results show that GET and CBT are of no more use than a placebo. They are worthless for ME/CFS, but White and his associates refuse to admit it as they have built their life’s work on these therapies. Therapies which, moreover, have been shown to be harmful for patients with ME/CFS in numerous surveys. Patients have ended up housebound or bedbound for years on end because of the efforts of White & Co, but still they refuse to admit they have done anything wrong.

This change of protocol was only the tip of the iceberg in terms of the study’s shortcomings. The Criteria used to select subjects for the study included patients with other fatigue conditions; the numerous changes in protocol meant that patients could be ill enough to join the study, deteriorate during it, yet still be classed as ‘recovered’ at the end; objective outcome measures which actually measured patients’ abilities were abandoned in favour of questionnaires; conflicts of interest on the part of the investigators were not disclosed to study participants, the list goes on and on…. In years to come, PACE will be used as an example of how NOT to conduct a research study.

 

P.S. The most complete analysis of the many shortcomings of the PACE trial is by David Tuller. The article, Trial By Error,  is in several parts. There are links to all of them here. If you just read the summary though, at the opening of part one, that tells you a lot.

The Light of Day

After long opposition (and substantial expense) from the trial investigators and Queen Mary University of London, data from the £5m publicly funded PACE Trial, which studied graded exercise (GET) and CBT therapies for ME/CFS, has finally been released under the Freedom of Information Act. ME patients Alem Matthees, Tom Kindlon and Carly Maryhew, with the support of two prominent US statisticians, have reanalysed the data according to the original trial protocol and illustrated that the recovery results were exaggerated by a factor of four due to unexplained protocol changes. The revised results were in fact statistically insignificant. This means that , in spite of what the investigators claimed, the trial provided no proof that GET and CBT help people with ME/CFS to recover.

Though those who have studied the trial have long suspected that the results as originally presented were grossly misleading, it is still a “gosh- wow” moment to actually witness the proof of this. One is tempted to ask “How did they think they would get away with what appears to be such a deliberate attempt to mislead?”

The answer appears to be that they calculated quite cleverly: they almost did get away with it. The professional reputation of the investigators had led many prominent people to assume that they must be in the right, and that the ME patients who have been fighting to expose the truth (whom the PACE investigators branded as a fairly small, but highly organised, very vocal and very damaging group of individuals’) were unreliable obsessives, eager to discredit the trial simply because its conclusions did not agree with their own beliefs about ME. (In actual fact, the attempt to besmirch the patients in this way appears to have been a classic case of ‘projection’, the investigators having apparently twisted the figures to fit their own mistaken beliefs about the condition.)

Even now, it seems likely that they will stick to the strategy of claiming that black is white and relying on their reputations to Continue reading “The Light of Day”

Out of the Blue

Well, I seem to have gone into PEM at the moment – due to too much blogging amongst other things. Fortunately I have a post for ME Awareness Month which I prepared earlier. In it, I have tried to describe how it can feel to be suddenly stricken down with this devastating condition. Please take a few minutes to read it, especially if you know very little about ME. It is not an easy illness to understand unless you have it yourself or are close to someone who does – and even then it can be bewildering. I have tried to open a small window on the experience of trying to adjust to this unwelcome visitor. (And if you’ve been wondering what PEM is, you’re about to find out…)

One day you start feeling ill. You don’t think very much about it at first. It’s just a bug and bugs go away, don’t they? But at the end of a week you’re not feeling any better. You wonder how long this is going to take. You’re getting a bit alarmed.

At the end of a fortnight, you’re positively worried. You have to phone work yet again to tell them you’re still not well. There’s a growing pressure to explain yourself but you’re just as baffled as everyone else. Your body’s supposed to repair itself, so why’s it not happening?

You also have to explain yourself to your family. They want to know when you’ll be well again. There are things to do that you can’t put on hold forever. Could you give them some idea of when you’ll be up to speed again? This illness of yours is getting inconvenient.

So you go to the doctor, hoping that he will know, but he doesn’t seem to have any more idea than you do. He gives you a sick note but even that seems grudging. Even he seems to think you ought to be fixing yourself by now. But isn’t that his job?

You try to start doing more – but the more you do, the worse you feel. You’re weak and in pain and something feels poisoned inside you. You’re starting to think that something is seriously wrong. Continue reading “Out of the Blue”

Closing the Door on Freedom

OK, here’s my take on the Freedom of Information Refusal Notice which came out a couple of days ago, not to be confused with the Tribunal outcome which (as I write) is expected imminently. Apologies for the fact that it’s about twice as long as it should be but I now have brain fog so I don’t have the intellect to edit it down! If you manage to read it, I hope you find it of interest. Me, I’m going to get some sleep….

The latest PACE Trial Freedom of Information Refusal Notice causes particular concern, not only for the PACE Trial and its implications for the future prospects of people with ME/CFS, but also for the Freedom of Information Act itself – and even for freedom of speech. The Notice incorporates twelve pages of repetitive arguments from QMUL (Queen Mary University of London, home of the PACE Trial) and three pages of what seem to me to be concise and clearly argued response from ‘the complainant’ (i.e. the guy who has made the request for information). Unfortunately, the Commissioner then goes on to reject the latter in favour of the former, apparently believing every word that QMUL have told him, i.e. that patients have launched a concerted campaign to discredit the PACE Trial by submitting a burdensome number of FOI requests in the desperate hope of finding something wrong with it and in the meantime bringing Lead PACE Investigator Prof Peter White and his staff to their knees under the resultant administrative load so that they aren’t able to do any more of their vital research. Or something like that. Their evidence is not so much a linear argument as a trip several times round the houses in the hope that if they say the same things often enough, some of them will eventually convince the Commissioner. Unfortunately, this strategy appears to have been successful.

The information the complainant requested relates to the data from the step test, an objective outcome measure which went unreported in the original PACE report but appeared in the form of a small scale graph in an appendix to one of the follow up studies. Continue reading “Closing the Door on Freedom”

Make Sure We Speak

After a difficult few weeks in the world of ME advocacy, it’s been really heartening to see the new critique of the PACE trial and accompanying editorial on the Sense About Science USA/ American Statistical Association website. After 7000 words of searing analysis, Rebecca Goldin concludes that the flaws in the study design “were enough to doom its results from the start”, while Trevor Butterworth’s editorial pronounces “a terminal prognosis” on the study. As far as patients are concerned, this demise cannot come too soon – and it remains to be seen if the British media, who have uncritically lauded the study on so many occasions, will consider this latest development to be worth reporting.

Nevertheless, it is encouraging for patients to receive such clear validation of what we have been saying for so long from such a reliable source. It has to be another important step in the right direction.

Trevor Butterworth writes: “David Tuller may not get a Pulitzer Prize for investigating PACE trial on a blog; but his service to—and we do not exaggerate—millions of sufferers around the world make it hard for us to think of another work of journalism so deserving of commendation.” Patients – including those who produced the initial critiques which first attracted Tuller to the issue – will heartily agree with that analysis, likewise with Butterworth’s acknowledgement of the important contribution of Julie Rehmeyer in drawing attention to the flaws of the trial. Let us hope their work pays off very soon and the study is deservedly retracted. Lead PACE investigator Peter White still has his finger in the dam but sweat is breaking out on his forehead. He must be wondering how much longer he can hold back the torrent of truth. Continue reading “Make Sure We Speak”

Heat of Battle

In my previous post relating to the controversy surrounding the NIH study, I wrote that disagreements were only to be expected. I still stick by those words, yet I – like many – have looked on in some distress since then as angry reactions have escalated to a potentially catastrophic extent, threatening a very serious setback in our battle to expose the PACE trial and win recognition for the true nature of ME.

I myself do not believe that anything any patient has said about the NIH study has been more outrageous than the NIH’s own decision to appoint Dr Walitt as study director. When you put this in the context of the promises made about the study after all the years of neglect and betrayal it is scarcely surprising that some patients have got very angry or that bitter disputes have arisen about how best to respond.

But we must not lose sight of what we hope to achieve. David Tuller and Professor James Coyne have built on years of painstaking work by patients to put us in reach of finally exposing the slick tricks of the PACE trial. It will be tragic if we lose that chance because of a few angry exchanges in the heat of battle.

I think we need to accept that Professor Coyne is the way he is. He fights hard and says what he thinks in no uncertain terms. That’s what makes him such a fearsome opponent for those who are ranged against us. But if we ask a lion to fight for us, we can’t be surprised if he roars in our direction from time to time. If that weren’t his essential nature, he wouldn’t have taken on this battle of ours which nobody else would touch. He has been willing to stand up for truth on our behalf. We need his support and he deserves ours in turn.

No one deserves to have been upset over this. All that anyone was trying to do was to speak up in whatever way seemed appropriate to them to achieve our common goal of true recognition, research and treatments for this devastating, misunderstood, neglected condition. Continue reading “Heat of Battle”

Keep Watching

‘Somatoform disorders’ have reared their heads in the ME-related news recently. First there was the announcement that one of the control groups for the upcoming and eagerly anticipated US National Institutes of Health (NIH) study of post-infectious CFS would be people with ‘functional movement disorder’, a strange choice which has made a lot of ME patients feel uneasy. The NIH explained: “Functional Movement Disorder was chosen to contrast post-infectious ME/CFS patients with a very well-studied group of patients with clear psychological illness with neurological presentation.”

But why not compare us with, say, AIDS or MS patients, people have asked? Why choose these ‘functional’ patients? It is difficult to avoid the suspicion that the NIH may be secretly looking for similarities rather than contrasts between people with ME/CFS  and those with this so-called ‘functional’ disorder. And if such similarities are found, what then?

There is, after all, no proof that any condition is ‘functional’ or ‘somatoform’ or ‘psychogenic’ or whatever you want to call it – as Doctor Speedy explains here. These diagnoses are based entirely on the opinion – and in many cases, as we shall see, the presumption – of the doctor. When it comes to such so-called ‘psychogenic’ conditions, otherwise known as ‘medically unexplained symptoms’, evidence-based medicine seems to go out of the window.

So these poor people with movement disorders may have conditions which are no more ‘psychogenic’ than ME is, yet according to the NIH they have ‘clear psychological illness’. So if we have similarities with such patients, what does that mean for us in the eyes of the NIH?

Perhaps I am being unduly suspicious here. There is plenty that seems to be good about the NIH study. It is large scale, it is studying post-infectious CFS (i.e. patients whose CFS started with an infection) and there is going to be a particular focus on the cardinal symptom of post exertional malaise. Continue reading “Keep Watching”