Further PACE findings and a biased Australian interview

Yesterday the medical journal PlosOne published findings from the PACE trial, a trial of various treatment options for “Chronic Fatigue Syndrome” which was published to great derision from the patient community last year. The original study found that Cognitive Behaviour Therapy (CBT) and Graded Exercise Therapy (GET) benefited about 60% of “patients with “CFS/ME for whom fatigue was the main symptom”. According to a Medical Research Council press release issued yesterday:

The latest study, published in the journal PLOS ONE, compared the cost-effectiveness of each treatment after one year against the criteria used by the NHS watchdog NICE. The researchers looked at the total cost of each course of treatment to the NHS and to wider society through patients requiring time off work and informal care from friends and relatives.

Specialist medical care was the cheapest option in terms of absolute cost to provide, but when the benefit of treatment on quality of life was taken into account, CBT became the most cost-effective option (likelihood of 62.7 per cent). There was a 26.8 per cent likelihood that GET was the most cost effective, while the likelihood for APT and standard care alone were 2.6 and 7.9 per cent, respectively.

CBT and GET were found to be even more cost-effective when the “benefits to wider society”, such as reduced care costs, were taken into account.

The publication prompted an interview on Australian ABC radio with Michael Sharpe, professor of psychological medicine at the University of Edinburgh who was one of the main authors of the PACE trial, and with Richard Horton, the editor of the Lancet which published the original study. The station did not invite any representative of any patient organisation to participate, despite the fact that this is a dispute between a group of scientists and the patient community, and despite the criticisms made of the patient community made by the two men interviewed. The same bias was seen in the coverage of the “ME death threats” controversy that happened a year ago, in which Simon Wessely and a few of his associates were allowed to make accusations against the patient organisations and advocates while the latter were allowed very limited opportunities to respond.

Sharpe explained it thus:

Yes, well this was the part of the controversy that we set out to address. The treatments for which there was some evidence were cognitive behavioural treatments, which is basically a talking treatment, which aims to help people be able to gradually increase activity by addressing concerns they have about doing that. The second treatment is called graded exercise therapy, which again tries to help people working with them to gradually increase their activity but does it very much in an exercise treatment-based way.

Then there was another treatment, for which there really wasn’t much evidence but a lot of support, which was called pacing and we evaluated in this trial the adaptive pacing therapy. And that has a rather different philosophy, which is helping the patient to manage whatever energy they have in the most effective way. And if they find they are able to do more, that’s terrific, but not to really push them or encourage them to try and up the amount they’re able to do.

Regarding pacing, he says:

Firstly, before we say pacing, adaptive pacing therapy, had no effect, it didn’t improve patients’ fatigue or what they could do compared with medical care. But the patients who received it were as satisfied with it as the patients who received CBT and GET, and that was a high level of satisfaction. So I think it is doing something for people; it’s just not improving fatigue and physical functioning. Between CBT and GET there are nuances of different measures: for example, one of the outcomes we did was how far the person could walk in a six-minute period, and the people who had the exercise therapy did a bit better at that; the people who had the CBT did a bit better at being less depressed.

Pacing is nowhere claimed to be a cure for ME. It is a means of managing one’s energy so as to avoid doing too much activity and making the symptoms worse. This is a fundamental part of managing not only ME but also a range of other chronic illnesses. Patients do, of course, want to do as much as they are able and nobody is suggesting that anyone simply lie in bed all the time when they do not have to — that is tedious enough at the best of times but if you have ME and feel terribly ill and are in pain, you will need something to distract you from it. He says CBT is intended to “address concerns” patients have about increasing their activity levels, but if their concerns are based on real experience of their symptoms getting drastically worse after exertion, no amount of talk therapy is going to change that basic fact. Although there are other factors that can lead to a worsening of symptoms in ME, such as infections, pacing makes sure that the affected person does not make their own condition worse.

The problem is that, like so many other studies into “CFS”, that very few of the patients in this study are likely to have had ME. This is not only because the criteria are notoriously broad, concentrating on fatigue, a symptom of numerous conditions both physical and psychological, but also because intolerance to exercise is a fundamental criteria for diagnosing classic ME: Melvin Ramsay, who identified the disease in the 1960s, noted “a unique form of muscle fatiguability whereby, even after a minor degree of physical effort, 3, 4, 5 days or longer elapse before full muscle power is restored” and described this as “virtually a sheet-anchor in the diagnosis of Myalgic Encephalomyelitis [without which] a diagnosis should not be made”. So, someone put through a course of graded exercise who had ME would have experienced this somewhere on the course, and if none of the subjects who were put through GET as part of this trial experienced this post-exertional symptom, it stands to reason that they did not have classic ME. People whose symptoms do match classic ME would likely have been advised not to participate.

Both Sharpe and Horton refer to the existence of a small but very vocal group of patient advocates who opposed the study: Sharpe alleged:

There is, parallel to that, a very vociferous series of websites and so on. It’s not really the same world as the ordinary patient coming to the clinic. They have been quite hostile in many ways to the findings of the trial and unfortunately also to the people who’ve undertaken the trial and collaborated with the trial … I think it’s well known, it’s not uncommon in this field and it isn’t by any means restricted to this trial or to us, but people who produce findings which are not the findings that are desired receive unpleasant emails and vilification on the internet and so on.

And from Horton:

Richard Horton: The accusations that are being made about them is that they have behaved unethically, breached international standards of ethics, and indeed in a few examples allegations have been made to professional authorities, the General Medical Council here in the UK, about the work of these scientists, on the basis of the flimsiest and most unfair allegations. And indeed the study cost 4-million pounds to undertake but the allegations and the freedom of information requests and the legal fees that have been wrapped up over the years because of these vexatious claims has added another 750,000 pounds of taxpayers’ money to the conduct of this study.

Norman Swan (interviewer): Yet patients’ groups were involved, engaged in the study all the way through.

Richard Horton: Indeed, and I think this is where one sees a real fracture in the patient community. One is seeing a very substantial number of patients very willing to engage in this study, desperate to get good evidence on which to base their future treatment. But one sees a fairly small, but highly organised, very vocal and very damaging group of individuals who have, I would say, actually hijacked this agenda and distorted the debate so that it actually harms the overwhelming majority of patients.

My own observation of the ME community for the past two and a half years since I got involved following the Gilderdale case is that the patient community overwhelmingly opposes GET because they and their friends have found it harmful, and everyone knows of someone who has been harmed by it or simply by pushing themselves too hard. They are not simply a bunch of internet activists who sit behind computer screens writing angry letters to scientists; some of them actually are scientists, or have close connections to the people who were involved in treating ME long before Wessely and other psychologisers came on the scene in the 1980s. The vast majority of the ME patient groups that exist opposed the PACE trial; only one group supported it after publication, the so-called Association of Young people with ME (AYME) (I say so-called because the name suggests a democratic organisation run by delegates on behalf of its members, which AYME is not) whose policies are heavily influenced by the same people who produced this study. (Horton refers to a “43-page diatribe” impugning the ethics of the study; this refers to this complaint by Prof. Malcolm Hooper.)

As is so often the case, the media have picked up on the press release and essentially rewritten it without much criticism and without asking any patient groups except Action for ME (examples: BBC News, the Independent). The BBC article notes that CFS is “also known as ME” when ME means something else entirely and is used to refer to a specific disease with a much more precise set of criteria than used in recruiting patients for this study. The emphasis on the effectiveness of the treatments in terms of cost is somewhat distasteful, since the aim of medicine is to improve health for its own sake, not to save money, and the emphasis on cost puts patients at risk in a climate where there is financial pressure on health and social services and patients in many parts of the country cannot rely on finding doctors who recognise ME. The study is highly unethical and any extension of it to children and severely affected patients would be even more so; there are also some highly effective advocates who are not irrational fanatics and could put the patients’ case if any news organisation wanted it.

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