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 carry the day. Just before the release of the data, the investigators put out a revised analysis (according to the original protocol) of the improvements reported by patients in the trial, which when compared to the originals showed that these had been exaggerated by a factor of three in the published paper. In spite of this glaring difference, which rendered the results – once again – statistically insignificant, the investigators announced that these outcomes were ‘very similar’ to the results reported in the original paper.

More recently, in response to the reanalysis by Matthees et al, Sir Simon Wessely, president of the UK Royal College of Psychiatrists, who might be regarded as the godfather of PACE, told statistician and ME patient Julie Rehmeyer that his reaction was “OK folks, nothing to see here. move along please.” So it seems like they are indeed going to keep on pretending there’s nothing wrong and hope that no one important notices. His choice of words (“nothing to see, move along please”) seems chillingly pertinent to this strategy. They are indeed hoping that if they say there’s nothing to see, people will see nothing. What we need is for those in authority to stop and look for long enough to notice that these emperors have no clothes – and to act on the implications of that.

Because there are very important implications. As Metthees et al put it: ‘pending a comprehensive review or audit of trial data, it seems prudent that the published trial results should be treated as potentially unsound, as well as the medical texts, review articles, and public policies based on those results.’

The NICE guidelines currently recommend the use of GET and CBT for people with ME (other than the severely affected). They predate the PACE Trial but nevertheless PACE is seen as the most substantial pillar of evidence supporting their use. There is therefore now a good case for their immediate suspension and review, especially as patient surveys and substantial anecdotal evidence indicate that GET in particular can cause substantial harm to patients. The US Agency for Healthcare Research and Quality (AHRQ) has already adjusted its advice, accepting that ‘there is insubstantial evidence for the effectiveness of GET’ and little for CBT. It is high time the NICE guidelines here in Britain were also put on hold.

The same goes for the MAGENTA Trial, which is effectively a PACE Trial for children. Always controversial, there is surely now no excuse for proceeding with this trial which will subject the young participants to a treatment which patient experience suggests is likely to cause long term harm. The trial seems especially outrageous and unnecessary when there is such substantial anecdotal evidence that children (unlike adults) stand a very good chance of full recovery when they are simply allowed to build back their strength at their own rate.

ME patients, with the help of David Tuller and others, have done a remarkable job in the ‘David and Goliath’ battle to expose the truth about PACE. We owe all those involved a debt of thanks. Now it is time for those in authority to open their eyes to what has occurred and take action. An independent, comprehensive review of PACE is certainly needed, not least to ascertain whether it was an appropriate use of public money. Until that happens, we all have to carry on putting the word out there. It has taken so long but we are starting to get it across…

#MillionsMissing

Who and what are the #MillionsMissing because of ME?

There are Millions Missing from employment

Millions Missing from relationships

Millions Missing from parenthood

Millions Missing from friends & relatives

Millions Missing from activities they love

Millions Missing from the world beyond a bedroom

Millions Missing from the world beyond a house

Millions Missing from the lives they should be leading because of ME

 

There are Millions of health professionals Missing knowledge of ME

There are Millions Missing from biomedical research funding for ME

Millions of patients are Missing correct diagnosis of ME

Millions of patients are Missing effective treatment for ME

Millions of patients are Missing any kind of medical attention

How many Millions more must be Missing before there is understanding?

How many Millions more must be Missing before there is treatment?

How many Millions more lives must be lost in waiting for there to be progress in fighting ME?

 

ME (myalgic encephalomyelitis – also known by the rather misleading name of chronic fatigue syndrome) is classified by the World Health Organisation as a neurological condition. The 2015 US Institute of Medicine Report concluded that it is ‘serious, complex, chronic, systemic disease’.

 

Some places to find out more about ME:

ME Association – patient support (UK)

Tymes Trust – support for young patients with ME (UK)

ME Research UK – biomedical research

#MEAction Net – has info on today’s #MillionsMissing demonstrations worldwide

You can also search for #MillionsMissing on Twitter

 

Thank you for reading

A Few Notes on GETSET

The latest GET study by Prof Peter White et al is entitled Graded Exercise Therapy guided Self-help Treatment (GETSET) for patients with chronic fatigue Syndrome: a randomised controlled trial in secondary care. This trial apparently aimed to assess the efficacy and safety of Guided Exercise Self-help (GES). At the time of writing, an abstract only is available and this has been discussed on the Phoenix Rising forum. Russell Fleming summarised some of the discussion in a useful series of tweets and I asked his permission to share them here, not least because tweets are such ephemeral things and can be hard to access for future reference.

Russell frequently tweets extremely useful summaries of new research papers and notable ME-related events and is well worth following if you don’t already do so. Follow him @Firestormmer

Here are Russell’s notes on GETSET. (Whatever you think of the research, you have to admire the acronyms, though someone on Phoenix Rising suggested that GETSHT might be more appropriate.) Over to Russell:

From the discussion on Phoenix Rising and without anyone seeing the full paper, there already appears to be some issues with this trial. Quelle surprise you might think. Let me try to summarise the concerns:

1.The Chalder fatigue scale outcome was added after the trial started.

2. The NICE criteria were used to recruit but from selected secondary care centres – we don’t yet know which ones but can probably guess.

3. Only after the trial was an attempt made to allocate patients to other criteria and only Fukuda and Oxford – e.g. no mandatory PEM

4. The trial ran for only 12 weeks – which might be a fair representation of secondary care – but may not be long enough.

5. The improvements are ‘tiny’ e.g. A CFQ 6.3 point improvement means patients marked one question one step better than at baseline.

6. They also only list “adjusted” scores, so unadjusted scores probably show no improvement.

7. Serious adverse events were recorded in each arm (1% GET, 2% SMC) but we don’t know what their definition was from the abstract.

8. The pre-specified outcome measure (SF36) recorded only small effect size, so they switched to Chalder post-hoc for a better result.

9. The end-date for the trial was extended and more patients recruited while the trial was underway. This would affect outcome measures.

10. There’s mention in the Phoenix Rising discussion of a 1 year outcome measure (Chalder) but I can’t see the results in the abstract.

11. “It’s interesting how they extended the judgment period and used an additional primary outcome after the original end of the trial.”

12 There was no control group used in the trial. These authors do not appear to have learned anything from past endeavours.

Note: It amazes me that they have the cheek to conclude these measly effect sizes as ‘moderate’. What on earth would they be for recovery?!

– Russell Fleming

Mistreatment of Children with ME/CFS – Request for Information

I am posting this request from Craig Robinson which first appeared on Facebook yesterday. I think it is important so please get in touch if you can help.

*REQUEST FOR HELP – PSYCHIATRIC MISTREATMENT OF CFS/ME CHILDREN*

I can’t tell you why (legal reasons) but I can assure you that this is for a very good cause. I need as many examples as possible where CFS/ME patients (children please) have been mistreated by the psychiatric profession or psychiatrists in general. All examples will be useful, whatever the scale of the mistreatment or abuse. Please do not assume that I know anything! I can assure you that your name will not attach to anything. It is best if you send on cases which are referenced to publicly available documents. Sorry to put upon you in this way but I want to get this as right as possible. Many thanks Craig – PS pm me if you prefer. xx

Obviously it is not appropriate to speculate publicly exactly what this is about but I would just like to add that Craig is a very good guy and I’m sure he has the best interests of children with ME very much in mind when making this request. If you are on Facebook, please get in touch with him directly as he requests. If you are not on Facebook, you are welcome to pass information on to him through me – the best way to do it is probably to leave a brief comment here, including your email address (which will not be published) on the comments form then I’ll get back to you and we can correspond via email.

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”

Door to Freedom Revisited

Following my earlier post about the tenuous argument put forward for the recent PACE Trial Freedom of Information Act refusal, I’ve been digging a bit deeper and I think it is now absolutely clear that the ‘evidence’ cited in the refusal notice totally fails to support QMUL’s case. It also appears that it has been deliberately quoted out of context by QMUL to create a misleading impression.

Just to remind you, here is my summary of the argument used for refusing the request:

“The argument seems to go like this: in spite of the fact that this specific request is not onerous and in spite of the fact that the complainant has not previously made an FOI request, he has been adjudged to be part of a coordinated campaign to discredit PACE (because he has talked to other people about PACE on the internet). Therefore the issue has been judged not on this specific request but on the overall burden of PACE-related FOI requests on QMUL, which are accepted not to be overwhelming but have nevertheless caused ‘disproportionate irritation and stress’ to Prof White and his team and are therefore vexatious. Therefore the request for this important piece of information is refused.”

What got me looking at things more closely was this comment by Chrisb on the Phoenix Rising forum in response to my post:

“Mr Spoonseeker has referred to and dealt with the point about the sheer weight of requests but I think there is another point.

“The Guidance apparently states that “if a public authority has reason to believe that several different requesters are acting in concert as part of a campaign to disrupt the organisation by virtue of the sheer weight of FOIA requests being submitted……”

“This guidance appears to be primarily, and quite reasonably, directed at and applicable to an entirely different type of campaign where the object is to bring about the disruption of the organisation, rather than a bona fide attempt to obtain information. Has any evidence been presented with the purpose of demonstrating that the requesters intent was disruption of the organisation of QMUL rather than obtaining the information which we believe to be the real object of the request?

“Given the Commissioner’s acceptance that this particular request on its own would not impose a significant burden, the onus of proof to establish whether the person was acting in concert with others, whose intent was disruption, ought to be significantly higher.

“In order to show that the request constituted part of a campaign one might expect it to be necessary to adduce evidence of a campaign predating the request. It seems to me that the examples quoted by QMUL probably were made after the request and in response to the initial refusal. Alternatively one might attempt to show a link to subsequent requests, but as I recall it there was no such attempt.”

In actual fact I had attempted to deal with most of this issue in my earlier post as follows: Continue reading “Door to Freedom Revisited”

Consultation – New NICE Guidelines on Multimorbidity

NICE have recently issued draft guidelines relating to multimorbidity, the not entirely appealing way in which doctors refer to the issue of patients having more than one health condition. There is a consultation period which still has a few days to run – the deadline is 12 May at 5pm. Comments from individuals as well as organisations are welcome, and I finally got round to sending in a few thoughts of my own (as a patient who has ME and also other conditions). I think it is good that NICE  have recognised the need to deal with this subject and they have focussed on the important issues of treatment interactions and coordination of care, but there are other issues they haven’t addressed. Much of what I have to say relates to matters I’ve raised in previous blogs, not least the tendency of doctors to assume that complex sets of symptoms are likely to be somatised/psychogenic. Here’s the feedback I submitted:

I don’t feel that the interaction of multiple health conditions has been given due weight in these guidelines. Obviously treatment interactions are important and it is good to see this issue thoroughly addressed in the guidelines. As a patient with multimorbidities, however, I find that little consideration is given to the interactions of the health conditions themselves and the associated effect on symptoms. I have spoken to other patients with multimorbidities and they have had the same experience. If the patient raises the subject of a symptom which is not normally associated with condition A, there is a tendency for the specialist consultant just to say ‘oh, that’s probably due to condition B’ and show no further interest. Meanwhile GPs are so overloaded that they tend to refer any complex issues back to the consultants, so they don’t get addressed. The problem of interpreting multiple symptoms also leads to delays in diagnosis and to misdiagnosis.

Another important and associated issue which is not addressed in these guidelines is the inclination of many doctors to leap to the conclusion that patients who have multiple symptoms (which do not fit the clinical picture of a specific pathology) must therefore have a somatised condition. I refer you to this NHS web page as an example of this unfortunate perspective which I fear is prevalent. As you will see, the advice given on this official NHS site is to keep such patients away from other doctors, to persuade them to dismiss any new symptoms as also somatic, and to develop a ‘therapeutic alliance’ with a close relative to enforce the doctor’s perspective. This imposition of the (often erroneous) doctor’s perspective upon the patient (often enlisting close relatives to overrule the patient) seems to be the antithesis of NICE’s declared intention (as described on Prof Haslam’s blog) of putting patients ‘in the driving seat’. It leads to misdiagnosis and/or late diagnosis of multi morbidities and also of rare diseases as described in the recent Rare Disease UK report. I believe that this issue needs to be urgently addressed, not least because it also leads to the misallocation of valuable mental health resources.