Tag: CFS

My letter to the BMJ regarding their lax editorial approach to bogus therapy paper

Here it is. I think it is pretty self-explanatory (nonetheless, I have added some additional context below the fold):

Date: Sep 11, 2019
To: <Fiona Godlee>, Editor in Chief, BMJ

RE: BMJ’s scientifically and ethically indefensible decision about Bristol’s Lightning Process study

Dear Dr Godlee,

First of all, thank you for the work that you do as editor in chief of the BMJ. I do not at all mean this as faint praise. While my colleagues and I have expressed our concerns, I believe it is important to note that editing a journal is not always easy. Editors play a crucial part in the production line of science and your own contributions, and those of your editorial colleagues, need to be acknowledged.

Secondly, I feel obliged to add my voice to those others who have written to you about the paper “Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial” and, particularly, the associated correction that was published.

You will be familiar with the details of our concerns as outlined in previous emails.

From my own perspective, I have been investigating the issues around controversial therapies and human factors (i.e., error risks) in research for nearly two decades. You will be aware that expectancy effects and confirmation biases are very problematic in clinical therapy research in general. They create particular chaos with therapies that are controversial to begin with.

The so-called ‘Lightning Process’ is undoubtedly one such therapy. In fact, it comprises a number of modalities that are normally classified as pseudosciences. It is based largely on so-called Neuro-Linguistic Programming (NLP), which is a completely discredited practice. The creator of the ‘Lightning Process’ is an advocate and provider of several pseudoscientific therapies (e.g., cranial osteopathy; applied kinesiology; hypnotherapy). All told, there is nothing to suggest that the ‘Lightning Process’ is a promising clinical modality. It has no scientific plausibility; it exists because commercially-minded providers of pseudoscientific treatments have successfully identified a market for it. In that regard, it occupies the same space as, say, crystal therapy.

In offering that description, I do not intend to be pejorative. I merely wish to point out that any hypothesis that the ‘Lightning Process’ is effective for any condition constitutes an “extraordinary claim.” By all means should extraordinary claims be tested. Studies of crystal therapy, for example, should be conducted. However, you will appreciate that in science, “extraordinary claims require extraordinary evidence.” Research purporting to establish the efficacy of the ‘Lightning Process’ needs to exhibit a truly compelling evidentiary standard. The claims made inherently challenge our mainstream understanding of human biology. If the ‘Lightning Process’ is in fact shown to work, we will need to re-write our physiology and neurology textbooks.

On the face of it, the evidence contained in this particular paper is far from extraordinary. In fact, as per your own published correction, the study bypassed the normal requirement for prospective registration. This immediately raises the red flag of reporting bias. The evidence accrued from the paper cannot be relied upon because the authors were able to select to report it, without pre-registering their intentions.

In short, confirmation bias was not prevented. Your request to the authors that they tell you whether or not they were biased is very insufficient.

The data produced in light of this procedural and methodological lapse by no means meet the standard of “extraordinary evidence”.

As I understand it, this paper would not have been published had you known about its irregularity at the time of initial review. Therefore it should not be published now. Therefore it should be retracted.

A serious problem with not retracting this paper is that its existence will strongly encourage other researchers to play fast and loose with pre-registration, in the knowledge that their findings can still be published in a BMJ journal. The paper will stand as a high-profile exemplar of ambiguous editorial commitment to scientific rigour.

Kind regards,

Professor Brian Hughes, PhD, FPsSI
School of Psychology
National University of Ireland, Galway

For context, my email is part of a now lengthy correspondence following an Open Letter to the BMJ arising from the correction of the ‘Lightning Process’ paper. I was one of several international scientists to co-sign the original letter, which called for the paper to be properly retracted. Afterwards, several individual signatories provided their personal perspectives as I have done above.

It is worth noting that I deliberately focused on the matter of confirmation bias, as it reflected a point that I felt would benefit from greater emphasis and about which I feel well qualified to comment. 

However, there are a number of other problematic issues relating to this paper. These include the very poor methodology employed in the study, where (again) self-report methods are relied upon in the absence of adequate blinding in a clinical trial. This makes the study wholly unreliable, and raises questions about the quality of peer review used by the journal.

In short, why exactly did the journal fail to pick up on such an elementary methodological weakness?

People will have varying opinions about why this happens so frequently. I have written before about how some fields come to be characterised by mass incestuous deference to eminent researchers and their acolytes, and about how unpoliced pandering frequently diminishes the quality of science by neutering peer review. 

I suspect I will need to write about that issue again…

…and again…

and again.

For those interested, you can find out more information about the so-called ‘Lightning Process’ here

Human Factors in ME/CFS research

I will be speaking in Belfast tonight, at the Hope 4 ME & Fibro NI annual conference, on the topic of human factors in ME/CFS research. Here’s one of my slides…

Boom!

The full title of my presentation is Off the PACE and not NICE: Challenges with Evidence in ME/CFS.

(I tweaked that subtitle a couple of times. For reasons.)

I plan to look at the nature of research error as it affects medical and healthcare research more broadly, and — of course — research into ME/chronic fatigue syndrome more specifically. Let’s just say that there is plenty of material to discuss.

Other speakers at the event include Caroline Kingdon of the London School of Hygiene and Tropical Medicine, and David Systrom of Brigham & Womens Hospital, Boston, and Harvard Medical School, who is the keynote.

As always, the organisational efforts of Hope 4 ME & Fibro NI, led by the unstoppable Joan McParland, have been hugely impressive.

Proceedings will be recorded so stay tuned for a video in due course…

If you spend 20 years gaslighting your patients, perhaps you should think twice before accusing *them* of trolling *you*

This week we learned that online activists are silencing scientists in the UK:

Reuters contacted a dozen professors, doctors and researchers with experience of analysing or testing potential treatments for chronic fatigue syndrome. All said they had been the target of online harassment because activists objected to their findings. Only two had definite plans to continue researching treatments…

The idea of critics or activists challenging researchers and seeking to hold science to account isn’t new. Most researchers say they are happy to engage in discussion. But with social media, email and internet now accessible from almost every home, mass communication gives online activists a voice with unprecedented power. In the field of CFS/ME research, it’s often personal. Those at the centre of it say it’s gotten out of control.

The good news is that these poor put-upon scientists are not going down alone. They have defenders. For example, rushing to their aid on the pages of The Times was none other than that paragon of fact-checking, Mr Rod Liddle:

Yep. That Rod Liddle.

Far be it from me to say anything bad about Mr Liddle. I will leave it to Wikipedia to explain how his various writings have been described as racist, homophobic, transphobic, ablist, misogynistic, Islamophobic and anti-Semitic, and regularly just hurtful to whatever vulnerable minority or target group he chooses in the moment. I know, Wikipedia might be wrong. Bad Wikipedia.

Nonetheless, we can certainly say that Mr Liddle is very much on the side of the silenced scientists. I won’t quote him directly. Instead, I will direct you to Frances Ryan’s eloquent riposte over at The Guardian, where she identifies the vilification of myalgic encephalomyelitis/chronic fatigue syndrome patients as just yet another form of 21st-century hate speech.

But won’t somebody please think of those poor scientists?

Who are they, exactly? Well, here’s an old group photo that contains some of them:

A group of people who were definitely *not* trolling anybody.
(Pic: Adapted from @BenMcNevis via Twitter)

Yep, there they are, attending a meeting on “Malingering and Illness Deception” way back in 2001 (and yes, I edited the image to blur their faces and remove their names, as a courtesy).

For 20 years, they have promoted a psychogenic model of ME/CFS. Their theory dismisses sufferers as psychiatric patients whose condition is all in the mind, rather than persons debilitated by authentic physical illness or disease.

But those terms though. “Malingering“? “Illness Deception“? Seriously? Even if the psychogenic theory were true, such labels are not very nice ways to describe patients. You might even consider them, well, abusive.

As it happens, the psychogenic theory is in fact highly unlikely to be true. The theory is defended by an ever dwindling (predominantly British) cohort of professionally interconnected psychomedical practitioners, and stands in increasing contrast to, say, the scientifically informed positions listed by the ME International Consensus Panel, the US National Academy of of Medicine and Centers for Disease Control and Prevention, and the World Health Organization.

As I have written about before (here, here, here, here, and here), ME/CFS is a chronic, inflammatory, physically and neurologically disabling and likely immune-mediated disease, involving disruption and dysfunction of multiple bodily systems.

That is, unless you are in the UK’s crazy ME/CFS psycho-vortex. In that topsy-turvy place, ME/CFS is an example of “malingering” or “illness deception”. Basically, the disease is just an opinion. An idea the patient dreamed up in their free time. After all, patients have so much free time — you would too, if you were restricted to lying in your bed, unable to move, for several decades.

Photo by Pixabay on Pexels.com

Note that the “Malingering and Illness Deception” conference pre-dated, by several years, the much beleaguered PACE Trial, which is so often held up as providing key evidence to support the use of psychosocial therapies for ME/CFS. According to Reuters,

…[the PACE trial] sought to evaluate the effectiveness of different types of therapy in CFS/ME patients…the results found that cognitive behavioural therapy – designed to help patients change their thinking and behaviour – and graded exercise therapy – in which patients are encouraged to start from very low levels of daily activity and then incrementally raise them – are safe and moderately effective treatments for some people.

It is striking how the Reuters reporter so readily accepts that the PACE Trial simply “found” what it said it found, just because the authors said so in the original research report. In reality, the PACE Trial has been described as flawed by several high-profile authoritative reviews, and is extensively described as such in subsequent scientific and medical literature (although not, it seems, extensively enough for the Reuters reporter to find it using, I don’t know, maybe the internet? Perhaps their broadband was down that day…).

Pro-tip: Next time, try PubMed.
(Photo by rawpixel.com on Pexels.com)

It is notable that most of the high-profile figures who promote the PACE Trial held their views long before the PACE Trial was ever conducted. They wrote papers about their views, authored books about their views, designed therapies based on their views, developed psychometric instruments drawing on their views, and — yes — organised conferences among themselves in order to discuss their views. These views are core to their professional identities. For many, these views are the only reason they have professional identities.

Rather than providing evidence to support a new understanding of ME/CFS, the PACE Trial was conducted long after the investigators’ conclusions were formed. PACE was not the source from which insights were sprung. It was practically the last act in the play. And according to one of its authors, the PACE Trial pretty much amounts to the very last thing he will have to do with ME/CFS:

[He] no longer conducts research into CFS/ME treatments, focusing instead on helping severely ill cancer patients. “It’s just too toxic,” he explained. Of more than 20 leading research groups who were publishing treatment studies in high-quality journals 10 years ago, [he] said, only one or two continue to do so.

(Of course, an alternative view could be that research prospects are drying up because the field of psychogenic treatments for ME/CFS is scientifically unsustainable. The model is proving to be anachronistic; it is increasingly hard to get research funding for the stuff.)

Photo by Pixabay on Pexels.com

It is absolutely true that much of the discourse surrounding ME/CFS is deeply fraught and highly contentious. There is a lot of anger. There is serious pressure. There is extensive name-calling and criticism that targets individuals. Things can get messy. No doubt about it.

That said, though, we should remember what is going on here.

Namely: patients with serious physical disabilities are being told, by a small coterie of academic health professionals, that their illness is a figment of their imaginations. That’s pretty incendiary. But then they are told that, as a consequence of their “illness deception”, they must be treated effectively as psychiatric cases. They must be given psychological and behavioural therapy, instead of biophysical medicine.

It is quite the double-whammy. Many of these patients are bed-ridden for decades, emaciated and debilitated, unable to study or work or hold down a normal family life. And yet they are told: “We do not believe you are really ill. You are malingering. And precisely because you are malingering, you now will be prevented from receiving proper treatment.

I don’t know about you, but that pretty much sounds like trolling to me.

These practitioners have basically been gaslighting their patients for twenty years.

All of which makes it just a little pathetic to watch them now leverage their press contacts to publicly complain that they are the ones being insulted by, ugh, mere sick people.

A final word: We have all been trolled on the internet. I have been trolled on the internet. In fact, just about every time I write about ME/CFS, I get trolled, sometimes on Twitter, sometimes by email. And I can tell you this. The folks who troll me are far from critics of the PACE Trial.

Very far indeed.

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