PACE Trial’s Forbidden Fruit: Is The Data Really Poisonous?

Duchesnea_indica1

A Mock strawberry: No it’s not poisonous, despite what you may have heard. Just tasteless.

A freedom of information (FOI) request was submitted to Queen Mary University London (QMUL) in 2014 for a small portion of the PACE trial data (below I go into detail about precisely what data has been requested, and you can skip ahead if you want to). QMUL refused this request. The case went to the ICO who agreed with the requester and ordered QMUL to release the data. QMUL have appealed this decision and the tribunal will take place in 2016 with the court deciding whether QMUL have to release the data, or not. The outcome is impossible to predict, but it’s important. I wrote previously about why we must be allowed to see the data.

Here is my opinion: For ME/CFS, this tribunal case is one of the most important things that will happen in the whole of 2016. It’s outcome will affect millions of us for years to come. So I consider this important. Very important.

I’m not sure all ME/CFS patients realise how much PACE affects their lives. PACE is the cornerstone of the behavioural model that dominates how ME/CFS is perceived by government agencies including the NHS, the media and the public. It dominates how the disease is treated, not only in the UK but in many other countries around the world. It dominates how research money is spent (more behavioural studies rather than biomedical studies that might actually lead somewhere). It dominates social security policy that ultimately affects whether you get the support you need to live when you are crippled by the disease.

If you think that as PACE was studying those diagnosed with the Oxford criteria and therefore it doesn’t affect you, think again. The authors use the term myalgic encephalomyelitis in their protocol, their paper, and media statements, alongside chronic fatigue syndrome, and this important limitation to the study (uselessly broad criteria that mean people with other diseases are included in the study) has not held it back from being used to blight the lives of those with ME or CFS defined by a stricter set of criteria. So this matters to all of us no matter what we think of the names, or whether more than one disease is represented by these labels.

The study has been fraught with problems, the design was a shocker, there have been concerns over safety, reporting of results and misrepresentation of data, and the hiding of data that does not support the authors pet-theory of a behavioural model of disease. Without visibility of the data the authors conclusions cannot be put to test and undergo normal scientific scrutiny. So it is essential that we get to see the de-identified data.

In relation to this case, QMUL have said that they are “seeking….advice of patients…” No details are given of how QMUL is seeking this advice of patients. We have not been told how patients are being selected, how QMUL are presenting their request and what information they are providing the patients with, or how patients wanting to provide advice (me, for instance) can do so. This concerns me greatly as the authors of the PACE trial have repeatedly attempted to set themselves up as an unofficial mouthpiece for patients; they tell government agencies and the public what we apparently want and think, they have huge influence in this area, and yet none of them, to my knowledge actually formally represent any patient organizations – and given their research positions it would be inappropriate if they did. These are researchers who give treatment in clinics and in trials to patients. They do not formally speak for patients. And it’s just as well, as they make all kinds of statements without foundation:

QMUL and the PACE authors have repeatedly misled and propogated misinformation with regard to FOI requests for data from the trial, painting a picture of requesters are harassers and of individual patient’s personal data being at risk (click here for a list of examples that I have just started putting together – please leave a comment there if you have spotted others), but this is nothing more than a tactic designed to avoid transparency. Even if we trusted them to follow a transparent and appropriate process when contacting patients for advice, the statements they have already made are highly likely to have biased much of that patient feedback already.

I think it essential to ensure everyone knows exactly what data was requested. These are the data points, below – and only this data – that will be released should the tribunal reject QMUL’s appeal.

• Total SF-36 physical function scores at baseline and 52 weeks. Patients filled in a 10-item questionnaire and their answers were summed to give a total score between 0 and 100 points: it’s this total score that has been requested.

• Total Chalder Fatigue Questionnaire Likert scores at baseline and 52 weeks. Patients filled in an 11-item questionnaire and ‘Likert’ scoring yields a total score between 0 and 33 points.

• Total Chalder Fatigue Questionnaire bimodal scores at baseline and 52 weeks. The “bimodal” method of scoring this questionnaire yields a total score between 0 and 11 points.

• Whether the participant met the Oxford definition of CFS at 52 weeks (yes/no).

• Participant-rated Clinical Global Impression score. This is a rating from 1 to 7 of how the participant saw their health as having changed at 52 weeks, ranging from “very much worse” (7) to “very much better” (1).

• Doctor-rated Clinical Global Impression scores. As above, but rated by the doctor, not the patient.

• Meters walked in six minutes (the “six-minute walking test“) at baseline and 52 weeks.

• The group to which each participant was randomly allocated (i.e. APT, CBT, GET, or SMC).

As you can see, the data being talked about contains no personal information whatsoever. Personal details of participants such as name, gender, age, locality, will NOT be disclosed.

For more detail on these questionnaires, HERE is an excellent detailed explanation

A spreadsheet containing only the above data would be released. Here is a made up example of what a few rows of that data might look like with each row being the de-identified results from each patient:

Clipboard01

Click here for a larger image in a new window. As you can see this is data is handy if you want to analyse whether or not the PACE treatments were as effective as its authors claimed, it is entirely useless if you wanted to track down the patients from the trial (not that there is any evidence anyone would want to do that anyway).

If you have read, or been told, that the data is more than this, then you have been lied to. If you have been told that patients who took part in the trial can be identified from this information then you have also been lied to. It is patently ridiculous to suggest that anyone could be identified from this set of data, as there are no personal details whatsoever. With over 600 patients having taken part in the trial there is simply no way to pick anybody out, even if someone knew who had been in the PACE trial; and with over 250,000 CFS patients in the UK, there’s no way of picking out PACE trial patients with the sort of data that has been requested.

Something QMUL and the PACE authors have never explained is why anyone would want to identify and track down the patients from the trial. Without a suggested motive, it’s hard to see why the PACE data should be higher out of reach than other studies which release their de-identified data (quickly becoming the norm nowadays). What has been the experience of patients from the PACE trial who have chosen to reveal that they took part in the trial, I wonder?

I have seen several patients who took part in the PACE trials say so on social media and I have never seen anyone respond negatively at all. Rather, I have seen fellow patients thank them for taking part in research, I have seen fellow patients offer support if they are still sick, and I have seen fellow patients respect their privacy unless they want to talk about it more. The most common response I have seen is a “Like” on Facebook with many patients from the PACE trial who reported their participation getting double figure “Likes”. We are all patients who share this diabolical disease, and I think it is very unethical of the PACE authors to manufacture the illusion of some kind of wedge between us when there is not one.

To reinforce the point that the release of the PACE trial data would not lead to any patients being harassed, I want to remind everyone that the PACE trial had a sister trial called FINE that was conducted at the same time. Whereas the PACE trial was for mild to moderate patients, the FINE trial was intended for severe patients and those who could not get to their local ME/CFS clinic due to distance, but similar data was collected. The FINE trial failed just as badly as the PACE trial did, but unlike the PACE trial, the authors of FINE, to their credit, released several pieces of data equivalent the  data requested of PACE. In fact they released a whole bunch of other de-identified fields as well, and did so without even being asked and anyone can go access it without any problems. No patients who participated in the FINE trial have been identified, no one has even tried. What would possibly be the motive to do so? I’ve noticed that QMUL and the PACE authors sometimes like to say things which lack any logical foundation to justify them, and that seems to reflect their overall effort to simply hide the PACE study from scrutiny at all costs.

I hope patients, including those who took part in the study, are not fooled by this scaremongering, but I understand some will be. It is not their fault if they are, they should be able to trust the people running the trial, but clearly if you question what they are saying you can see they are misleading patients. I hope this article adds a little clarity to what data is really being asked for and leads people to think about the true motives behind QMUL’s extreme attempts to deny release of the annonymized trial data.  If you want to follow this topic as it progresses over the coming months I suggest following James Coyne, David Tuller, and myself and keeping an eye on our blogs.

Within the next week I will be publishing another blog post focusing on how ME/CFS charities are responding to the PACE trial scandal and this specific appeal case, and what patients might be able to do to ensure their views are heard.

 

PACE Trial’s Forbidden Fruit: Why We Must Be Allowed A Look Inside

Take my word for it, it's an apple...

Take my word for it, it’s an apple…

If you have any interest in science, open data, bioethics, freedom of information or ME/CFS then the rejection by King’s College London of Professor James Coyne’s request for data relating to their PACE trial will not have escaped your notice. Indeed, many in the science community seem to have noticed ME/CFS for the first time as a direct result, as some of the tweets later in this article may suggest.

First, do take a look at the letter from KCL. It’s short on pages, and long in absurd statements.

The university focused a lot on the damage to reputation and potential criticism of the authors, however if the data is sound, if it supports their assertions about PACE as they have published then there should be no anxiety over this whatsoever. Indeed, if the authors scientific method is sound then release of the data would vindicate them, and would surely enhance their reputations. If the serious allegation of “improper motives” as they put it, has any validity be it by those who wish for openness or those arguing for concealment, the only way to determine this is to release the data. At present we have a claim the evidence is compelling but a contradictory argument that it must be accepted in blind faith. The brief glimpses we have been allowed so far have already shown that the PACE authors have repeatedly misrepresented PACE by telling everyone it is an apple when it is not. When is an apple not an apple? When it is an orange. 

First there was the ‘recovery’ paper where they redefined the word recovery to mean someone who is still so disabled at the end of the trial (average age, 38) that they are on a par with those suffering from Class II heart failure, and may even be worse off at the end of the study than when they started. Recovery to the authors means someone who has scored only 60 out of 100 on a physical function score, even though you could enter the study with a better physical function of 65. (Yep, you could actually get worse in this study according to the trial’s two primary outcomes and they would still count you as recovered – a success).  See David Tuller’s blog for more on this.

Then they claimed follow up showed CBT and GET were effective when in fact the underlying data showed a null result. No more effective than standard medical care. See James Coyne’s blog for more on this.

Now they are labelling legitimate request for data as vexatious, of no value, as having improper motives. They will say anything to avoid releasing the data. They want you to see an apple when in fact it is an orange. And from a distance it may really look like an apple. If you only look at the title of their paper and don’t read it objectively you can easily be fooled. But what they don’t want you to do, what they can’t allow you to do, is bite into the apple. If you do so you will discover that it’s not an apple at all. It is an orange. It was always an orange. They consider PACE to be a forbidden fruit; you may only look, you cannot touch, you certainly cannot bite into it, for they you would have true knowledge, and knowledge can be a dangerous thing.

I promised you some choice tweets, and here they are, people from the scientific community who are most disturbed by KCL’s rejection of Professor Coyne’s request. I am not aware of these people having shown an interest in ME/CFS before (though I apologise to any of them if I am wrong about that):

The university states that it believes it is “entitled to take into account the wider dealings and publicity surrounding the project when considering the motive behind this request”. I would say that you can’t have your cake and eat it (I don’t feel the need to stretch the apple/orange analogy any further). If we are going to consider the wider publicity surrounding the project then we must also consider how the rest of the scientific community feel about this, as well as the patients – that’s what this is all about, I’ll happily remind you; patients are sick with this dreadful disease, they live with it night and day and they deserve to be heard also. More than 11,000 people have signed a petition for misleading PACE claims to be retracted, so there is a clear public interest in this data being made available. It was heavily funded by the public purse and has been highly influential in determining the treatment that patients with ME/CFS get, both under the NHS in the UK and also in many other countries across the world. This really matters because there is a lot of money being wasted if the PACE treatments don’t actually work, and to make matters worse there is strong reason to suspect the treatments make many patients worse. A survey of 1,428 patients by the ME Association found that 74 per cent reported that graded exercise therapy (GET) made their condition worse. I can speak from personal experience of the harm GET causes, it made me much more ill but the NHS clinic that gave me it were totally disinterested when this happened – you can read a short page about my experience on MEAction.net

The final part of the letter that I will highlight is the claim that Professor Coyne’s request is vexatious and may lead to harassment of the authors. It seems that no PACE author’s mouth ever opens without the word harassment or vexatious or some other slur on patients being voiced. There are around a quarter million patients with this disease in the UK, which includes many children, as well as adults (to put that into perspective there are around 100,000 with multiple sclerosis, so ME/CFS is a very common disease). Worldwide we are talking about millions. Even if these claims of harassment were true – and I have not seen evidence that they are – it would still be unethical to smear all patients by voicing such claims ad nauseum. The truth though is far more disturbing: these comments come out over and over again because it is very effective at stealing the voice of patients who have been raising concerns about the quality of the PACE trial and the harms of GET. What Professor Coyne and the science community are experiencing now, is exactly the same as patients have had to put up with for years now.

Sadly, with all the bad press that PACE has been getting lately, I am sure these claims of harassment, or abuse, and vaguely described bad behaviour will be voiced loudly in the very near future. Probably in a national newspaper. I would be surprised if we didn’t hear these slurs in the next week, or two at most. Patients are used to this. As if living with this horrid disease weren’t enough, we get collectively slagged off on a very regular basis. It is cruel. I lost my life age 27, and I am hurt by this, but I can’t tell you how bad I feel for children who have to put up with this as well. It is a great injustice, and in my opinion everyone has a responsibility to study these PACE papers carefully, to listen to the criticisms being raised and to reason this through in their minds. And if a certain conclusion cannot be reached without seeing the data the PACE studies are based on then people must insist that the data is released. I am grateful to Professor Coyne and a number of others who have done this, and I hope others join them.


 

UPDATE:

It didn’t take long. An hour or two after publication, we got a troll smearing ME/CFS patients (for avoidance of doubt, I am not referring to the first tweet below but the reply by AS):

Professor Coyne, of course, has bitten the fruit of the ME/CFS world and knows this for what it is. I encourage others to do so. ME/CFS patients are not “nut cases” they don’t send “death threats” “letter bombs” and you don’t need police protection from us. We are, like you, just normal people. I have a family, and friends and I consider myself a nice guy. Before I was ill I worked in quality management for an international software firm. I was very good at it. I just got randomly unlucky and got this disease. I was young and thought I would never get ill. Even my grandparents are healthy in their 90s so I just didn’t think this could happen to me.  People like this guy want you to believe I am a terrorist though. Why is that?

I will continue to call people out who attack patients in this way and make unethical smears against a population that is undeserving of it. We actually deserve your compassion and support.

Food Poisoning: National Health Service 0 – uBiome 1

ARS_Campylobacter_jejuni

The culprit

Food poisoning is not a lot of fun. Especially when your immune system is dysfunctional as mine is from ME/CFS.

It was my mother’s birthday in August, and we took her for a meal in a nice village pub near Bath, England. I ordered a very tasty looking quail for the starter. It was a char-grilled piece and around half way through I turned it over and noticed that the other half was barely cooked. In fact the middle was completely raw. I had already eaten a great deal of it without really paying attention. Stupid!

Anyway, I thought it was likely to give me food poisoning but there wasn’t much I could do but wait and see. I didn’t have to wait long. Around four or five hours later my stomach was very angry. I felt extremely nauseous, though strangely did not vomit. It was terrible at the other end though…that’s all I’m going to say about symptoms. This went on for three days in which time I didn’t eat anything else. Then I started to improve a bit and thought the ordeal was over. Not so quick.

I started eating some mild foods, and then some stronger foods after a couple of days, but after about three or four days later I began feeling worse again. It got so bad I had to stop eating altogether for a second time. This time for a little over two days. I repeated the same process again but after around a week I started getting ill for a third time!! What the fuck!?!

By this time I had been to the doctors half a dozen times. My stomach in particular was so painful and I had provided two stool tests which came back normal. I was told that sometimes they couldn’t culture things very well. This NHS had no plan B for dealing with this, it’s good that the doctors were sympathetic but what I really needed was an avenue we could go down to figure things out, and there simply wasn’t one. Great. It seems ridiculous to me, to be trying to grow the bug in a dish when we are so rubbish at it! With ME/CFS I am used to having to doctor myself, so I sat down and gave it some thought. Could uBiome help, I wondered?
16S rRNA sequencing should pick up whatever is in the sample, it doesn’t need to be alive, it doesn’t need to be grown. I had a spare uBiome kit lying around so I sent off a sample.

I then had another four days without any food. Even in the days between when I had had food it had been very bland and not very nutritious. I was very weak, had lost a lot of weight and was pretty desperate and so I held out as long as I could in the hope of killing whatever it was off. Fasting for four days is not easy, especially when you are sick with food poisoning, ulcerative colitis and ME/CFS. But I managed it. I couldn’t do any longer, I had to eat. After this I was well enough to eat bland food for two weeks, then move onto more advanced food. I am still not right now, a month and a half on. I’d say 80% better. Progress is very slow.

My uBiome results arrived yesterday. It didn’t take me long to spot the problem: Campylobacter ureolyticus.
This was not present in any of my previous uBiome tests, and Campylobacter is a very common cause of food poisoning, especially via poultry; the avian intestinal tract having been identified as the main environmental niche. It is also a pathogen that was originally identified via molecular, rather than classical culture techniques, suggesting we aren’t great at growing it…The two most common species of Campylobacter recorded to cause gastroenteritis are C. jejuni and C. coli but there is acknowledgement that C. ureolyticus might be under reported, with some studies suggesting C. ureolyticus (24.4%) occurs more frequently than C. coli (6.7%). The most common species identified being C. jejuni (72.4%).

I think that is a pretty awesome result. The NHS couldn’t figure it out, but uBiome could. Maybe one day the NHS will catch up?

Further reading, for geeks:
O’Donovan D et al. Virulence. 2014;5. Campylobacter ureolyticus: a portrait of the pathogen.

Magna Carta’s 800th Birthday

800 years ago, king John, put his seal to The great charter. His barons demanded this of him; they had had enough of his tyranny.

No longer would they allow him to lock them up without charge, to hold their families hostage, murder who he liked,  steal their lands and possessions, extort them with taxes and have control over who was appointed in the powerful church.

Stephen Langton, the Archbishop of Canterbury had just returned from exile in France, and was instrumental in Magna Carta coming about. He was there when it was sealed.

800 years ago today it was either agree to the charter or have civil war. And the French were waiting in the wings to invade if given half a chance.

Stephens brother Simon (briefly Archbishop of York at the time of Magna Carta) also played a key part, and would later be Chancellor in France and encourage an invasion  of England by the French Prince when king John reneged on Magna Carta.

It seems we have a lot to thank the Langtons for. And yet the history books wrongly state they were born in Langton by Wragby, in Lincolnshire.

The mistake comes from Powicke who in 1928 gives a reference to a manuscript talking of a mill at Langton which he claims is Langton by Wragby. However, manuscripts of this time rarely identified the specific village as the context (the names involved, the other places mentioned) made it clear which Langton village was being written about. In this case, you have a mill (which of course, requires water) which cannot have been at Langton by Wragby as it has no river.

The brothers actually came from Langton by Horncastle where there is a river and a mill as seen in other deeds in relation to the Langtons, including one in 1236 in which Simon Langton is sorting out the dowrie of his brother Walter’s widow. And other deeds exist showing their father Henry Langton, also at Langton by Horncastle. 

There appear to be no deeds which talk of any Langtons at Langton by Wragby in the time period (1100-1300) which is no surprise as it was very small at the time of Domesday and probably was not a significant settlement in the following centuries.

History books should not be taken at face value. Mistakes are often made and it’s important to use your own brain to evaluate the evidence and see if you agree with the conclusions reached. Much like scientific research, such as the PACE trial in chronic fatigue syndrome, that concluded graded exercise therapy (GET) leads to recovery in patients, when in face the opposite is true, as shown in the recently published survey conducted by the ME Association which found the majority of patients had a decline in health following GET.

Thankfully, we are free to challenge erroneous conclusions, in large part due to the work of the Langtons and the Barons in opposition to king John 800 years ago, though with our rights ever being eroded in this modern age, and the voices of individuals increasingly drowned out, you have to wonder if it isn’t time for a new Magna Carta. As was the case 800 years ago though, people have to be pushed very hard before they finally say, enough is enough.

Gut Wars: Diversity

Following on from my recent guest blog for uBiome, I decided to take a closer look specifically at my gut diversity. Here are the counts for comparison between my first test in March 2014, shortly after antibiotic treatment, and a year later in March 2015:

diversity
Interesting, I’m sure you’ll agree.

This has me wondering what normal is? I mean, uBiome’s norm when looking across all their samples, I wonder what that looks like. I don’t know the answer to that at the moment, and it may not be that relevant for the average person, but if you’ve been on antibiotics or had some other loss of gut diversity then it would certainly be useful to know. Though even some results from just a handful of “healthy” people would give a fair indication, I’d bet.

It is almost certainly an improvement that I now have twice the level of species diversity I had a year ago (leaving aside which species these actually are, as that is also likely important), but how much further have I to go? Is the norm 100, 150, or 500?

If you’re reading this and you have taken a uBiome test then I’d love it if you posted your stats for comparison. It’s quick and easy.

The easiest and quickest way to find this info is to click “Raw Taxonomy” in your uBiome dashboard. Then Ctrl+F to run a search for “phylum (beware that Subphylum and Superphylum will be counted if you don’t specify the leading inverted commas in your search) and then “class – “order – “family – “genus – one at a time and see how many hits you get in each case. I suggest using Chrome browser rather than Firefox which won’t return more than 100 hits.

Alternatively you can put your results into a spreadsheet, great instructions for which can be found on Richard Sprague’s blog. This option makes it easy to get those counts but also to manipulate your data in any other way you fancy going forward.

So do me a favour and post your diversity counts.

I’ll just finish this post off with a quick look at which of my bacteria went extinct in the last year. Given my diversity has vastly increased, I’m not expecting many. Here’s the species level data (courtesy of Richard Sprague’s analyser):

2014-2015-extinct

The disappearance of C. butyricum is interesting, it can be pathogenic but it is also widely used as a pro-biotic in Asia as a treatment for it’s misbehaving cousin C. diff. And as you can guess from its name it is a butyrate producing bacteria. Last year C. butyricum made up more than 1% of my total gut flora, which is much more than usual. Now it is gone. In fact, many of my clostridium have been kicked out, half of these now-extinct species are clostridium, many of which are normal in the human gut but also can be pathogenic. Last year the clostridium genus made up 8.63% of my gut whereas now it is at a normal level (1.56%), so probably good on the whole.

B. catenulatum is gone too, which seems a shame. I guess it has been out competed by the other species of bifidobacterium that I introduced over the last year.

L. lactis, often present in dairy products such as cheese, is gone. Why? No idea.

I’m pissed to see R. bromii is gone. It’s considered a cornerstone species and I was pleased that after my antibiotics, when I first tested, there was a tiny amount still holding on. But now it is gone. Why are my ruminococcus abandoning me? I’ll be looking at which cornerstone species are missing from my gut next. R. bromii is not the only one, and these key species being absent does not bode well for my future gut health.

That aside for now, when you consider that these 19 species pictured above were missing from my second sample, it makes my increase in species level diversity even more impressive! I started with 55 species, lost 19 of these and gained 73 new species. I must be doing something right – or at least, More things right, than wrong!

Physical or Mental: Why it Matters

This is the second in a three part series of articles looking at related issues. The first article can be found here, and explores Dr Sykes’ reply to the ME Association regarding the Science Media Centre’s recently coverage of new biological evidence in ME/CFS.

This article is going to explore the broader topic of why it matters whether the disease is considered physical or psychological.

Dr Sykes believes that, “Any organisation serious about CFS/ME should not care whether the causes of and treatments for an illness are physical, psychological, or a combination of the two.”

What an extraordinary statement. I would have to argue the opposite: Any organization serious about ME/CFS absolutely must care.

An example outside of ME/CFS

In 1980 the claim was still being made that incest occurred in fewer than one in a million women, and that its impact was not particularly damaging. (Bessel Van der Kolk, Traumatic stress, 1996 P61, quoting H Kaplan et al 1980 Comprehensive Textbook of Psychiatry – the leading U.S. textbook of psychiatry at the time).

It was the promotion of such attitudes that enabled child sexual abuse to continue to be hidden and denied, adding insult to injury to the victims, and we have only recently begun to see things how they really are, and to give it the serious attention it deserves. We still have some way to go even in 2015, with revelations of historic sex abuse, and cover ups printed almost daily in the UK press.

They were wrong about child sexual abuse, and they are wrong about ME/CFS.

Suppose we diverted at least half the money used to protect children against sexual abuse to investigating and treating why they believe they have been abused. Does any serious organization think that would be reasonable?

No, didn’t think so.

The lens of money can show that matters of cause and treatment are not matters of indifference and cannot be lightly dismissed as something not to be cared about.

As the first article in this series highlighted: a common tactic of those promoting psychological models of ME/CFS, is to avoid the subject of physical aetiology by changing the subject to the acceptance of psychological illness in general, portraying those who do not think ME/CFS is psychological as mental health bigots, believing mental health is inferior to, or less real than, physical health.

By pretending that this is the issue, it derails the original topic and puts all the focus and attention on this non-relevant issue, rather than where it should be – that ME/CFS, like other diseases with non-psychological aetiology and symptoms, such as cancer, ought to be researched and treated accordingly. And that core psychological treatments would be inappropriate for such a disease, in the same was as chemotherapy would not be an appropriate treatment for mental health illnesses such as depression.

The profession of psychiatry is usually the source of — and the perpetuator of — such destructive attitudes. But the problem is one of stated belief, not title, and there are a growing number of psychiatrists who are stating clearly that ME/CFS is a biological disease, and this number will grow as the psychological dogma about ME/CFS becomes increasingly untenable.

Why it matters

Maintaining the false view that ME/CFS is psychological has the following repercussions:

* The limited research funding there is will continue to be spent on mental health studies that will continue to prove fruitless (around 80% of research to date has been on mental health studies and they have failed to deliver: see Graham McPhee’s excellent analysis of this reality), while biological studies remain unfunded and thus, no progress is made.

* A further reason to care if the causes are physical, psychological or mixed should be apparent to everyone. If it is loudly declared that this may be a psychological and not a physical disease you will undoubtedly discourage research funding. Organisations are going to be reluctant to fund research into a disease that may have no physical origin.

* Harmful and ineffective treatments will continue to be promoted, their benefits being overstated.

* The public perception will continue to be that ME/CFS patients are malingerers, who would be back at work and off the taxpayers back if only they would take antidepressants, cognitive behaviour therapy or graded exercise therapy.

* General Practitioners believe they can diagnose as a psychosomatic condition and not have to investigate if anything else is wrong or if other symptoms need treatment.

* Appropriate existing medications for symptoms such as pain will continue to be difficult for patients to access, as doctors are led to believe that these symptoms are psychosomatic.

* Insurance companies will continue to deny payouts on the grounds that mental health illnesses are not covered.

* Government benefits agencies will continue to deny benefits.

* State services such as the police, schools and the national health service, will treat people according to whether the disease is labelled as physical or mental, with broad ranging implications. An example of this has come to light today, spotted by a member of the ME Association, in which the Home Office has told Chief Police Officers that, when assessing recruits for the service, they should regard Chronic Fatigue Syndrome as akin to somatoform, factitious and dissociative disorders. The illness is listed in the circular as among “Conditions affecting mental and psychiatric health”. The side-tracking of topics occurs so regularly that it is evident that it is not an isolated instance, nor an intellectual failure to grasp what the biological research shows, but rather an intentional effort to derail the whole process, the effect being that further biological research is sabotaged and the status quo is maintained, which favours some in the psychiatric profession to the detriment of patient’s health.

Plainly, the idea that it doesn’t matter, simply does not hold water.

I think some patients and advocates are too inclined to imagine the best intentions of people promoting a psychological view of ME/CFS; some believe that these psychiatrists, though they may be wrong, truly believe what they are saying. I disagree. In fact, I think this does a great disservice to them. These are people who have worked hard over many years to gain their qualifications; they had to complete college and then attend medical school, like other doctors. Then they had to do an additional four years residency in general psychiatry, and many that work in the field of ME/CFS then went on to complete additional specialized fellowship training after that. So we mustn’t disrespect such people by labelling them as being a bit slow on the uptake.

The reality is that the evidence suggests these people know full well that ME/CFS is not psychological in nature or disease process; but the other reality we also must recognise, is that they have invested a heck of a lot of their lives in the idea that it is.

As biological evidence for ME/CFS has increased in recent years, we have begun to see the psychological position shift gradually to emphasise the mixture of the psychological with the biological. This is their new default position (or is becoming so), designed to maintain their money and status as long as they can, against the onslaught of biological evidence which threatens to marginalize their relevance.

There is a need, I think, to recognise that we face disingenuous arguments here, and this type of argument needs to be managed differently to how you would if it was a genuine belief. And just as importantly, we must stick to task and topic; not allowing them to hijack our narrative.

These psychiatrists are not going to abandon their high status, their high income, and throw away years of hard work and admit that all the work with their name on it was wrong. Bye bye relevance, bye bye career, bye bye grants and salaries. No, we mustn’t pretend that ME/CFS exists in a vacuum without money, status and ego. It would be unrealistic to expect anyone with such vested interests to change their tune. The truth is that we are looking at self-preservation here.

So we are dealing with a profession with a track record of getting things dangerously wrong, with the promotion of falsehoods as fact, that in hindsight are obviously wrong, but which at the time prove very effective at kidnapping public perception, hiding the truth and hamstringing attempts toward progress.

As with the sexual abuse scandals, I think society will look back at the treatment of ME/CFS patients with the same sort of disgust – vulnerable people, many supremely sick, being neglected and abused – a substantial number of them being children. Many having suffered for decades, some dying of old age in the end, never being treated as they should be, and far too many taking their own lives because of it all. But right now, at this moment, it is still in the shadows, torches are coming switched on and beginning to expose some of it, but you can tell there is a lot more that remains in darkness. In time the light will expose it all.

Until then, when we are corresponding with anyone who promotes a psychological view of ME/CFS — whether by letter, email, on the phone, on the radio, on television, or in person — we must ensure there is no room to pervert and modify what we say about ME/CFS. We have ever increasing evidence of the biological nature of the disease, and we know they don’t feel comfortable focusing on that; so we must maintain a strict focus on the topic and not allow it to be moved to more comfortable — and non-relevant — territory.

The final article in this series will explore many of the traps that are set for us, and strategies for avoiding them

Who Told You That?

The ME Association recently wrote to the Science Media Centre in complaint of the remarkable level of bias shown against the recent biological research published in Science Advances by Hornig, Lipkin et al, showing cytokine changes in patients with ME/CFS.

You can read that letter and the reply here.

I will be focusing on the reply, which was certainly true to form. So cynical was the core of this reply that it was entirely irrelevant to the subject matter at hand. Perhaps this reflects a growing anxiousness about the ever increasing weight of biological evidence in ME/CFS.

After some opening blurb, rather than attempting to justifying the actions of the Science Media Centre, the author, Dr Sykes, launches with this:

“The first thing I want to say is that every scientist I speak to about CFS/ME stresses that this is a real and debilitating disease. It concerns me greatly that some sections of the media like to portray CFS/ME as though it’s not real, and this is something we fight very hard to counter. It is of equal concern that some in the community seem desperate to distance the condition from psychological diagnoses or treatments, as though mental health is somehow inferior to, or less real than, physical health. I do not know any credible scientist who would make that distinction.”

The reason this did not surprise me is because I have seen it used with such frequency; this specific example, in the world of ME/CFS, being one that has appeared so often that you can see it coming a mile away.

Or at least, you should.

IT GOES LIKE THIS:
First, a point is rightly made to the effect that ME/CFS is not psychological in aetiology.

Now, due to the scarcity of evidence to the contrary, it’s rather hard to defend against the stated truth – so what method do you use if you want to maintain your denial without having to justify your actions? You side-step it, discredit and insinuate at the same time. Perhaps even portray yourself as the victim – though any “victim” will do, including a fictitious one such as the non-consenting ventriloquized patient. And why not take the opportunity to throw in a bit of misinformation and propaganda as well?

Essentially, the reply contains these parts:
* imply that the complaint was made that psychological illness is not “real”.
* imply that the complaint was made that psychological illness is inferior to physical illness.
* focus all the attention on this and why it is wrong.

Of course, it certainly doesn’t matter that the these implications were not actually made in the first place – in fact, it is rather the point. The worst case scenario is that they are subsequently pulled up on it and are forced, perhaps, into accepting they “misinterpreted” the original complaint, and this is not all that likely to occur. But if it did, it’s no great loss, really; especially as that dialogue continues to keep the conversation off the original anxiety-inducing topic. What was the original complaint anyway – can anyone remember at this point?

Let me put Dr Sykes reply to one side for a moment. Back in time a bit, a journalist fed up with issues being avoided by politicians, asked Harold Wilson a question:

“Prime Minister, why do you always answer a question with a question?”

Quick as a flash Wilson – who had anticipated what was coming – demanded to know, “Who told you that?”

As with the example from Dr Sykes, this is not mere avoidance behaviour, it was clever not just because it avoids an answer but because it also implied that something vaguely wrong has been alleged by an anonymous person against the high status figure. Impressive on first hearing, it should nevertheless dawn on people that this is just a way of changing the subject.

In the same way, the swift movement away from the biological research findings onto the media insinuating that psychological illness may not be real, avoids the subject of physical aetiology and changes the subject to the acceptance of psychological illness in general. Anyone who now dares to question the psychological basis of ME/CFS is put in the position of being critical of the acceptance of mental health issues as real. Anyone who says my illness is physically real is placed on the hook of saying psychological illness is not real. A very dirty little tactic then.

In light of Dr Sykes understanding that “[ME/CFS is] a real and debilitating disease” it is disappointing that he didn’t give the ME Association’s complaint the seriousness it deserves by providing direct answers to specific questions. Unfortunately, Dr Sykes is not the first (nor will he be the last) to use such evasive tactics to derail the argument, and I think this highlights the need for ME charities and spokespeople to stick to the subject and be aware that attempts will be made to lead them off topic and into mental health.

There has been a lot more of this sort of thing going on lately, with many recent examples in the wake of the Institute of Medicine’s report and Lipkin’s new biological findings. But frankly, these little manoeuvres really aren’t all that clever and are entirely predictable – and therein lies the opportunity to avoid them. And avoiding them is important, as otherwise we make it all too easy for people like Dr Sykes to side-step an indefensible position in favour of territory that they feel more comfortable defending.

Some ME charities already understand this well. Some others, less so. I think there is room for improvement across the board; it’s time to up our game, and that is what I am calling on all ME charities and spokespeople to do.

The ME Association are right to question the lack of balance in the SMC’s recent offering to media, asking the question all journalists ought to be asking when the SMC offer them an “expert” opinion: Who told you that?

My next two articles in this series will broadly cover related issues.