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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Hillsborough Law – Shifting the Balance in Favour of Truth

Continue reading “Hillsborough Law – Shifting the Balance in Favour of Truth”

Spreading the Word

privateeye-hammond-dec2016-web

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”

The OMEGA Petition – Email to Professor Holgate

This email has been sent to Professor Holgate of MEGA. Many thanks to all those who signed. (Whoops! missed a few… Total signatures now updated to 221)

((Please note that we are not the organisers of the OMEGA petition.))

Dear Professor Holgate – We comprise a number of M.E. patients and carers, 218 in all. Please see our signatures at the end of this email..

We are writing because we notice your suggestion in your letter to Professor Jonathan Edwards that OMEGA (the petition opposing the MEGA study) has attracted so many signatures due to the support of Invest In ME. We are writing to assure you that we patients and carers are able to look at the evidence and make up our own minds on such issues.

Here are some of the grave concerns that we have about the MEGA study as it has been proposed. It seems likely that you have heard many of them before but in view of your professed perplexity about the OMEGA petition, we want to make sure you are aware of the issues. For the same reason, we are copying this to the other members of the MEGA team and to those you copied in to your letter to Professor Edwards. We are also sending a copy to Professor Edwards himself, and the email will be posted online at the Spoonseeker blog.

Our concerns about MEGA include the following:

Patients from the NHS CFS/ME clinics (apparently the intended source for MEGA) will not yield a representative sample of people with M.E. The reasons for this include:

  • Most severely affected patients cannot access the clinics and so will not be included in the study.
  • There will be an inevitable selection bias towards the mildly affected because
    • the clinics will tend to select such patients as those most likely to respond to the behavioural therapies on offer, and
    • the more severely affected patients will be more likely to reject such therapies – and hence the clinics – as inappropriate.
  • Other more severely affected patients will no longer be on the clinic’s system
    • either because they have not responded well to the therapies, dropped out, and not been followed up (as feedback suggests is often the case) or
    • they are among the long term sick who are no longer on the system because treatment is time-restricted

There has been a suggestion, following representations from patients, Continue reading “The OMEGA Petition – Email to Professor Holgate”

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”

Big Data Danger

This post comes mainly courtesy (again) of the astute Steve Hawkins, who responded to my concerns in the Getting Airborne post about the possible dangers of a MEGA Biobank. Over to Steve:

On the ‘big data’ front, I think that all genuine physical measurements will be useful if used in the right way. The danger comes from any extraction/filtering that uses diagnosis as the reference field. If they do that – and I’m sure Crawley and Co would, because they think they can diagnose without biomarkers – the results would be garbage, as there would be many conditions given the wrong name but appearing together.

On the other hand, filtering on key concrete signs like PEM, POTS, bedbound, etc. would pull up useful groupings whatever the ostensible diagnosis.

In the wider scheme of things, there are now a number of entrepreneuring projects aiming to collect ALL big medical data, and link all medical databases together. I read a good piece on this recently by one bioinformatician who is setting up a giant server, but I don’t seem to have bookmarked it. Here is a conference on getting all genomic information into ‘the cloud’ for free searching and filtering: And one from The Lancet, on the astronomical amount of data that is about to flow from mobile phones whose apps have turned into our version of Star Trek’s ‘tricorder’. All this info will go into ‘the cloud’:

So we’re getting to the stage where all data is useful: so long as it is faithfully produced. Sadly, we know from PACE that data will have to be graded by association with researcher, and those who cannot be trusted will have their data discarded. There is nothing they can do about this: if their name is on their shoddy work, it will go nowhere, and all the data they collected will be wasted.

There lies the danger of MEGA: not that it will pollute the big data, but that any good data it contains will be at risk of being discarded by everyone but Crawley and her associates. That is why patients should NOT let their data be associated with MEGA while Crawley is involved.

I think Steve has nailed it there, and as it seems unlikely that Prof Crawley will be willing to part company with MEGA, I still believe that we should sign the OMEGA (Opposing MEGA) petition to demonstrate our strength of feeling against the proposal as it stands. The original pro-MEGA petition has now been closed – perhaps because they realised that more people were taking their signatures off than were putting them on – but the OMEGA team are still promoting their counter petition. Here is their latest blog. Scroll to the end for the link to their petition or just click here.

Making the Most of MEGA

In an earlier post, I published an email from Leeds ME Network to Sonya Chowdhury, CEO of Action for ME, expressing reservations about the presence of Profs White and Crawley on the team of the proposed MEGA biomedical research project. Here is the latest update from Leeds ME Network:

In response to our letter to Sonya Chowdhury, we have just received what appears to be a standard letter referring to the latest updates on the MEGA petition page at Change.org. Leeds ME Network have now responded in turn with the following email, slight variations of which will be sent to Ms Chowdhury; Stephen Holgate the CMRC Chair; Dr Charles Shepherd at ME Association; and ME Research UK. Our email follows:

We are grateful to the MEGA team for letting us know about the proposed CFS/ME biomedical research project. We believe it is very important that this study goes ahead but in view of some of the less than helpful research which has taken place in the past (in particular, of course, we are thinking of the PACE trial) we hope you will understand why we patients are keen to voice our concerns about the proposal.

1) The impression has been given that patients for the study group will all be drawn from the NHS Clinics. It seems clear that such a sample would be heavily biased towards less severely affected patients and that the sample would therefore be unrepresentative of the total patient population.

The reasons for this are as follows: Continue reading “Making the Most of MEGA”

A Broader Picture

The last draft post I wrote about the MEGA petition was superseded by events before I finished it, so I’ll try and crack on with this one before the same thing happens again. Of course ‘cracking on’ in ME terms is still kind of slow but I’ll see if I can break the tortoise barrier.

So, what’s happened recently?

Well, we’ve been told that Peter White is retiring from research and will only be an ‘advisor’ to MEGA from now on. This perspective appears to be endorsed by the latest list of MEGA personnel, which no longer includes him. I can only give a muted ‘hurrah’ to this one. Advice is dangerous stuff and you can still do a lot of damage with it. His PACE Trial is swiftly becoming a watchword for bad science (see here, here, and here). Is he really the sort of ME ‘expert’ that either we patients or the MEGA team want around to guide this latest project?

It really is astonishing that MEGA apparently do still want him around after all he has done, and that they clearly expect patients to put up with it. It seems to me that if a passing Martian was given a brief course in English and the full facts, then even he (or she) would swiftly understand why we don’t want Prof White anywhere near this project. Why do the MEGA team not get this?

People with ME have  been left on the scrapheap for decades. I myself have been ill for over thirty years. That’s over half my life. I have no children because of it. I lost my job. My life is very limited. Yet I am one of the relatively lucky ones. I can sit and tap at this keyboard – as long as I take plenty of rests to fend off the shoulder and eye pain and overall exhaustion. There are plenty of others who have to spend all their lives in bed, who can’t stand the light, who can’t even talk to their loved ones. We’ve all heard about Whitney Defoe whose birthday it recently was. He is not alone in his suffering. The vast majority of the severely ill are left to fend for themselves as best they can. Rarely do doctors come near them and they wouldn’t know what to do if they did.

And all this time, all these decades, so little research has been done, in large part because of the fairy story dreamed up by the PACE researchers and their associates: the fairy story that Continue reading “A Broader Picture”

MEGA Update

Here’s the latest from the MEGA petition site:

3 Oct 2016 — Two members of the Alliance have retired from the group: Simon Collins, University of Bristol, will be changing universities; Prof Peter White, Queen Mary University, London, is retiring from research at the end of this year and will have an advisory role.

We will be launching a series of blogs this week from MEGA members outlining why they joined MEGA and what their expertise and field/discipline has to offer.

Which doesn’t seem to me to make a whole lot of difference unfortunately. It does make you wonder why, after the PACE trial, anyone running a research study would want to take advice from Peter White… And Esther Crawley remains involved. The other day, at the CMRC conference, she was seeking to justify her use of GET on children by saying there is ‘good evidence that it works for adults’. It doesn’t seem like she’s paying much attention to the recent slippage in the reputation of PACE.

Previous posts related to MEGA:

MEGA Petition

Unsigning

Barefaced

Barefaced

Over the past 48 hours, many patients have been expressing concern about the involvement of Prof Peter White in the proposed MEGA biomedical ‘big data’ study of ME/CFS. It seems extraordinary that someone who believes in the simplistic ‘fear-avoidance’ model of ME/CFS should even wish to be involved in this study. Of what relevance is psychiatry to genomics?

Then, yesterday, came a timely reminder of why we can’t allow Prof White anywhere near this project. His Guardian article in defence of PACE was an extraordinary illustration of a) his refusal to accept the truth about his fatally flawed research and b) his determination to say whatever it takes to try to defend the trial, however much deceit this may involve.

It has long been obvious to those who have studied PACE that the trial involved blatant trickery, juggling outcome measures to produce the results they wanted, but these deceits were not always obvious to those unschooled in statistics and/or without the time to sit down and read through the details. Just recently, however, as the whole PACE edifice comes closer to collapse, the lies seem to be getting both more desperate and more transparent. Yesterday’s article contains a real transparent whopper, but I’ll work through the piece in order, saving the whopper for last:

  • White dismissively mentions an earlier post which claimed that sexism was part of the cause of ME patients’ mistreatment. He must surely be aware, however, that McEvedy and Beard, the two psychiatrists who first claimed ME to be a ‘hysterical’ condition cited ‘the high attack rate in females compared with males’ as part of their argument. Sexism therefore certainly played a part in the emergence of the PACE authors’ view of the condition.
  • White goes on to make several mentions of ‘fear’ among patients. “The idea of exercise was scary for some patients” he writes, though he seems to have forgotten his own 2005 study which demonstrated that “CFS patients without a comorbid psychiatric disorder do not have an exercise phobia”.
  • White speaks disparagingly of the newspaper articles which followed the various PACE announcements, accepting that headlines such as “just get out and exercise, say scientists” were harmful and misleading. At the time, however, he and his fellow PACE authors did little or nothing to try to correct such coverage. Furthermore, these very articles were written by journalists who had been briefed by the Science Media Centre, the shadowy organisation purporting to support “balance” in science reporting, which in turn was briefed by the PACE authors themselves and their associates.
  • White continues to quote his figure of 22% for ‘recovery’ in patients receiving GET or CBT, making clear that by ‘recovery’ he really means ‘remission’. (This was another sleight of hand. White and his fellow authors failed to correct media reports which – not unreasonably – assumed that ‘recovery’ meant ‘recovery’). Yet those of us who have been following the PACE saga know that the 22% result no longer stands. Alem Matthees, Tom Kindlon and their colleagues have shown in their reanalysis that the true result is only 7% for CBT and 4% for GET, a statistically insignificant outcome, being scarcely above the 3% figure for standard medical care which everyone on the trial received anyway (including those on CBT and GET.)

This leads on to the whopper, for White gives the impression in the Guardian article that Matthees and his team got their result by playing around with the figures. The implication is that this was a fiddle. In actual fact, of course, Matthees used the original trial protocol which White and his colleagues had said they would use but changed when (we can only assume) it failed to give them the results they wanted. Yes, there was fiddling going on, but it wasn’t Matthees that was doing it.

White must know that Matthees was using the original protocol. This was explicitly why Matthees requested the data – because White and his team had protested they didn’t have time to do the calculations themselves. White must have sat through – or at least paid close attention to – the Freedom of Information Tribunal which issued the order to release the data. It can’t have escaped his attention that it had been requested specifically to reanalyse the figures according to the PACE authors’ own original protocol. Yet in the Guardian article, White gave the impression that Matthees and his team had simply been making random tweaks to fiddle the figures. The only possible explanation for why he wrote it like that was to deliberately mislead Guardian readers. He must have known better. He did know better. He was telling a barefaced lie to try to save his reputation.

I’m sorry. A man who will do something like that is not to be trusted. It is totally unreasonable for the ME organisations who are supposed to be protecting patients’ interests to think it is OK for him to be involved in an important piece of biomedical research into this illness. Why they even talk to him any longer is beyond me. It is high time we move on from PACE – and move on from Peter White. We’re really suffering here. We deserve better.

 Note: I’ve been asked to include details of ‘unsigning’ in case you previously signed the MEGA petition and wish to un-sign pending further information about the study. I covered it here