What should be done about the MEGA (ME/CFS Epidemiology and Genetics Alliance) project? Concerns and response

Update October 21, 2016: Professor Jonathan Edwards is now urging signing the petition opposing MEGA. Find the petition here.

7976304-special-edition-stampEarly this morning some thoughtful comments were approved at my PLOS Mind the Brain blog concerning the MEGA (ME/CFS Epidemiology and Genetics Alliance) project. After careful consideration, I felt these comments should not be left simply buried there, but put into a larger conversation. Below I have posted them, along with a directly relevant statement from Dr. Charles Shepherd.

I am not a ME/CFS patient or parent of a patient, I’m not even a resident of the UK. But I have been drawn into a long and complex struggle, starting with a comment that I made on Twitter, a rejection of Simon Wessely’s direct message to me that I should not get involved in the controversy over the PACE trial, and my making of a request for data that the PACE investigators had promised would be available as a condition of publishing in PLOS One. The PACE investigators publicly labeled my legitimate request as “vexatious” and almost a year later have not turned the data over.

mega-image-481x230At the outset, I should note that Professor George Davey Smith has key responsibility for the genomics section of this complex project. I have the greatest respect for his intellect and intellectual integrity. I have learned immensely from him.

However, I have serious concerns about other personnel involved in this project in terms of their recent conduct as physicians and scientists. Among other issues, the nature of their role in the project needs to be clarified. Conditions need to be in place that they will not use their role to inflict further abuse and bad science on the patient and scientific communities. Other personnel must step in and demonstrate that patients have an appropriate role in the design, implementation, and interpretation of the data published in peer-reviewed journals in a timely fashion. Patients should be heard, welcomed to  high-level participation in research, and not just used.

Concerns, criticisms and questions about the MEGA study are being expressed by the ME/CFS [   Myalgic encephalomyelitis)/Chronic Fatigue Syndrome] patient community on internet discussion forums.

Some clear inaccuracies are circulating, but there are some big issues yet to be settled.

If we are going to make progress in trying to sort out the different clinical and pathological sub-groups/phenotypes that currently come under the very messy umbrella of ME/CFS, as well as those with unexplained chronic fatigue, AND in the process develop diagnostic biomarkers that could then be used as objective diagnostic tests to identify specific sub-groups of patients that come under this ME/CFS umbrella, ALONG WITH helping to identify specific forms of treatment that are aimed at these specific sub-groups, we are going to have to look at the whole spectrum of patients who are currently being diagnosed with ME, CFS or ME/CFS, and possibly unexplained chronic fatigue as well. –Dr Charles Shepherd


“I think the project must be welcome but I am surprised by this sort of canvassing for support. So far no details are available of who would do what. Surely patients are entitled to judge a project on the basis of a written application, just as scientists do” – Professor Jonathan Edwards

A comment left at the PLOS Mind the Brain

There are now also concerns about Esther Crawley’s involvement in the MEGA project, which is presented as an omics and big data approach to stratifying ME/CFS patients.

Esther Crawley and Peter White are involved in this project as ME/CFS experts, despite significant patient opposition. That these are even involved calls into question the integrity of the rest of the team. White has engaged in fraud in the PACE trial. Crawley’s unethical behaviour is well described in this blog’s article.

That aside, the concern is that they (or other BPS model proponents) will introduce flawed definitions of the illness and its symptoms into the project. Crawley and White certainly have a history of downplaying, ignoring, or psychologizing physical symptoms of this illness, or simply conflating this life destroying illness with the not uncommon and often transient symptom of tiredness. On the project’s petition page, the important symptom “post-exertional malaise”, which is an objectively measurable, typically delayed, decline in function with an increase in symptom severity, is referred to as “post-exertional stress”. Redefining words and concepts in a misleading manner is something the PACE authors have done repeatedly, so one wonders if we’re already seeing the redefinition of an important physical symptom to make it fit into a narrative preferred by PACE authors and their colleagues. A vague term such as “post-exertional stress” certainly fits well into a “health anxiety” narrative of patients supposedly worrying excessively about ordinary muscle soreness after exercise, and mistaking this for symptoms of an illness.

Such a narrative would be particularly easy to construct if permissive case definitions were used. The project plans to recruit patients from NHS referral centers, which are operating according to the BPS / PACE paradigm, with NICE criteria which are permissive. NICE instructs doctors to only refer patients to these centers when they are mildly or moderately affect and believe that CBT and GEt are appropriate. For this, and other reasons, it is likely that this recruitment strategy will exclude or underrepresent the more severely ill.

In a large and important project, a solid foundation of knowledge and methodology is more important than ever.

There are also concerns about the patient advisory groups. Patient involvement is important according to MEGA study authors, and two patient advisory groups will be created. No details have been given on how patient representatives will be chosen. It would be problematic if the authors chose patient representatives that are not considered trustworthy by the larger patient community.

We suspect they will be drawn from the AFME and AYME charities. Many patients don’t trust these organizations. Crawley is medical officer of AYME, and AFME has a history of collaborating with PACE authors and generally being lenient and ignoring problems with the BPS approach and the PACE trial. AFME approved of the removal of actometers from the PACE trial with dubious justifications. It was repeatedly mentioned that patient advisors in the MEGA project will be able to prevent certain data from being collected and certain tests being performed. Will we see important questions not being asked, important data not being collected, important tests not being done because these undemocratic patient advisor groups with ties to the PACE authors believe that doing so is in the best interest of patients?

In general it is a problem that communications go through the untrusted intermediary AFME.

ME/CFS Research in the UK needs to divorce completely from the failing BPS model of the illness. Patients hate it, it’s scientifically flawed, and has produced no results when reasonably standards of evidence are applied. Consider that over 12000 patients signed a petition to the Lancet against the PACE trial, while the MEGA study has collected only 2130 signatures (with number of signatures essentially having stopped). The distrust of the BPS model is so great that any project touched by its influence becomes tainted. The MEGA study team should reconsider its current approach and whom it collaborates with.

Give this MEGA project a chance to fly – don’t try to strangle it at birth, says Dr Charles Shepherd | 3 October 2016

The MEGA (ME/CFS Epidemiology and Genetics Alliance) ‘big data’ research study – some comments from Dr Charles Shepherd following last week’s third annual scientific meeting of the UK CFS/ME Research Collaborative.

I can understand all the concerns, criticisms and questions about the MEGA study that are being expressed by the ME/CFS patient community on internet discussion forums.

I can also assure people that they will be transferred back to those at the CMRC (CFS/ME Research Collaborative) who are involved in preparing what is probably going to be the largest ever research grant application relating to ME/CFS here in the UK.

There are clearly a number of key decisions still to be made. And .if anyone followed the proceedings at the CMRC conference in Newcastle last week. they will know that I raised the crucial issue of patient selection criteria (narrow or broad) with Professor George Davey Smith and Dr Esther Crawley during the discussion section.

The key point I want to make at this stage is that the MEGA study is an important and complex new item of ME/CFS research that is going to make use of a wide range of relatively new and exciting technologies – metabolomics, proteomics, genomics, epigenetics etc.

The MEGA study will also involve some very high profile BIOMEDICAL scientists of international repute – several of whom are completely new to ME/CFS.

Researchers who will be involved include:

* Genomics – Prof George Davey-Smith (Bristol), Prof Chris Ponting (Edinburgh), Prof Colin Smith (Brighton)
* Epigenetics – Prof Caroline Relton (Bristol)
* Proteomics – Mr Tony Bartlett (Somalogic)
* Metabolomics – Dr Rick Dunn (Birmingham)
* Routinely collected data – Prof Andrew Morris (Edinburgh) and Prof David Ford (Swansea)
* Infection – Prof Paul Moss (Birmingham)
* Sleep – Prof Jim Horne (Loughborough)
* Pain – Prof Maria Fitzgerald (UCL)
* Prof Julia Newton (Newcastle)

The MEGA study has also attracted the very positive attention of the Wellcome Trust _ the largest provider of non governmental funding for biomedical research here in the UK and the largest research funding charity in the world

Wellcome Trust: >https://wellcome.ac.uk

And the numbers of patients involved is going to be huge – around 10,000 adults and 2,000 children.

However, when it comes to the aims and objectives of the research, there are some serious misunderstandings and inaccuracies being circulated on the internet as to how this ‘big data’ is going to be collected, analysed and used. This is NOT a treatment trial in any sense of the word and it has nothing to do with PACE, CBT or GET.

If we are going to make progress in trying to sort out the different clinical and pathological sub-groups/phenotypes that currently come under the very messy umbrella of ME/CFS, as well as those with unexplained chronic fatigue, AND in the process develop diagnostic biomarkers that could then be used as objective diagnostic tests to identify specific sub-groups of patients that come under this ME/CFS umbrella, ALONG WITH helping to identify specific forms of treatment that are aimed at these specific sub-groups, we are going to have to look at the whole spectrum of patients who are currently being diagnosed with ME, CFS or ME/CFS, and possibly unexplained chronic fatigue as well.

So the numbers need to be huge and a study of this nature may also need to include people with chronic fatigue states whom we will then want to exclude for both our benefit and for their benefit.

In my opinion, getting this right will clearly be dependent on having very detailed clinical information accompanying the biological samples – as is the case with the ME/CFS Biobank where we can check what diagnostic criteria (and symptoms) accompanies each individual blood sample that has been collected and stored.

I am not yet clear as to how this will be done in this study, which Is why I asked the question on patient selection at the conference. The nearest information we have was the reply from Dr Esther Crawley in which she stated that patients will meet NHS diagnostic criteria for ME/CFS and will be recruited from the NHS hospital-based referral centres for people with ME/CFS

So I would ask the ME/CFS patient community to see how the protocol develops and what information and inclusion criteria are going to be used.

If you are happy with the final research proposal, then there will obviously be ways of expressing public support.

If not, there will be ways of saying so as well!

As Professor Jonathan Edwards has said on the Phoenix Rising forum:

“I think the project must be welcome but I am surprised by this sort of canvassing for support. So far no details are available of who would do what. Surely patients are entitled to judge a project on the basis of a written application, just as scientists do”

So I hope that those people who are wanting to simply strangle this proposal before it has even been properly finalised will think very carefully about what they are doing – especially if this is mainly because they disagree with the inclusion of certain specific researchers.

It is difficult enough getting new and distinguished scientists and researchers, and major research funders such as the Wellcome Trust, interested in this subject without trying to scare them off almost as soon as they express a serious desire to get stuck into in a huge multidisciplinary project such as this, and the protocol is still being developed.

If people want to express concerns, criticisms, or have questions to ask, then I suggest that this should be done in the form of an open letter to the Board of the CMRC, which could be signed by anyone expresing such concerns, rather than a petition.

Dr Charles Shepherd
Hon Medical Adviser
The ME Association

So far, Dr. Shepherd’s statement has attracted numerous comments, which you can see by going to the website. However, I would like to, reproduce one comment by a noted patient citizen scientist.

Simon McGrath October 3, 2016 at 5:35 pm

Thanks, Charles.

I agree this study has huge potential and it’s great to see new biomedical talent come into the mecfs field.

“the reply from Dr Esther Crawley in which she stated that patients will meet NHS diagnostic criteria for ME/CFS and will be recruited from the NHS hospital-based referral centres for people with ME/CFS” I didn’t hear that (looking forward to the conference videos being posted) but it reassures me too.

Equally, I don’t think MEGA have made a great job of communicating the study to patients, and I understand why many feel aggrieved at being asked to back a study. I like the idea of an open letter.

Maximize your productivity by controlling your breathing?

Updated October 11, 2016 to include a discussion at the end of whether the self-help industry is largely women selling their products to other women.

Nirvana only a breath away?

Garbage claims about office Zen by Gerbarg

I say it over and over again: So much bad advice being sold to consumers with a pitch that what is being offered is more sciencey than the rest, but so little time to blog about it.

We need to recognize more quickly the click bait of wannabe self-help gurus and move on.

We need to practice quick dismissal of nonsense that intrudes into our social media news feeds. Simple as that, mindlessly delete it and get back to your life.

The common pitch of wannabe self-help gurus

With only minor variation, you are being repeatedly told:

  • You are not being as productive, likable, successful, and loved as you could, and you probably won’t live as long as you could, either.
  • [Implicit message: you are a loser, even if you don’t think so, and if you don’t think so, you are more of a loser.]
  • Fortunately, I have a novel, simple, effective, and easily implementable solution.
  • [That usually turns out to be not new, not simple, not effective, but intrusive to the point you will want to abandon it anyway.]
  • If you do not succeed at first with my advice, of course I have an app that can make it work better.

Fortunately, this time one of my trusted go-to’s had the time to dismiss some claims quickly. But first, here are the claims:

Escape being a loser with coherent breathing [Or: Breathing, the part of your life that you can control ]

breathing-the-part-you-can-control“For maximum productivity, you want to breathe in a way that will keep you in the parasympathetic zone so you are calm and stress-free, but not too far into it to the point where your mind is mush,” Gerbarg said.


To achieve office zen, Gerbarg suggests a breathing practice called Coherent Breathing, which features equal-length inhalations and exhalations at a very slow pace, without holding your breath. For most adults, the ideal breathing rate is four and a half to six full breaths per minute.


Of course, it can be difficult to get used to such slow breathing. Gerbarg suggests practicing with a breath-pacing app (popular options include Breathing Zone for iOS and Paced Breathing for Android. If starting at five full breaths per minute proves difficult, start with six before bringing the pace down. New hardware devices such as the Spire clip-on breath and fitness tracker also offer real-time feedback on breathing patterns, which could make it easier to reach goals.


The best part is that unlike some breathing exercises, which are evident to anybody in a room, this technique is relatively discreet after a little practice. Try it any time you are looking for a brain boost or to keep your cool-whether you’re in the middle of a meeting or being peppered with questions during a big presentation.

For those over six feet tall, the rate drops to about three and a half to four breaths per minute.

James Heathers: A go-to to the rescue

I’m drawing on the expertise of James Heathers, who played a pivotal role in our thoroughgoing critique of Barbara Fredrickson’s claims that loving-kindness meditation extended life through its effects on cardiac vagal tone. James went on to write an excellent technical guide for anyone attempting to use heart rate variability as a biological outcome. And no, heart rate variability and cardiac vagal tone are not biomarkers, only biological variables that vary greatly with the circumstances under which they are assessed.


Charles Bukowski

Although James and I are in regular contact on social media, I have only met James once, at a meeting I arranged at the infamous Boston dive bar,  Bukowski’s Tavern. James looked much like the picture on his Facebook fan page.


James Heathers

I’m inclined to dismiss rumors he does not always looked this way, especially when he works at his day job in a stylish suit, allegedly as a high-end junk bond day trader.

Anyway, I highly recommend going to his Facebook Fan page and liking it, so you can keep up on all his devastating critiques. Warning: as you can see in the one that follows a brief summary of something I found on the Internet, he is rather indelicate in his approach and does not mince words. That’s why I like him so much.

From James Heather’s Facebook Fan page


It’s weird to see this in print – the crapulent, lazy, swollen assumptions that I see in academic work. For some reason, part of my brain thinks that bad science being communicated at bad angles is solely for people who don’t do physiology.

You can’t sell out my stuff! My crew deal in facts! They aren’t purveyors of empty sensationalist garbage!

Well, some of them are, I guess.

And you know the funny thing?

There’s no discovery here. This book is four years old. Research on breathing like this was well described in the early 90s. And god only knows how old meditative traditions with slow breathing are.

For some reason, the awful newspaper which needs to obtain/syndicate/buy content about random health bollocks just happened to be in the market for some garbage about breathing. The author has written half a dozen books about various curlicues of lies and silliness.

I hate everything about this, and everyone involved should walk quietly out to sea and stay there.

So there. ‘Nuff said.

Updated October 11, 2016: Is the self-help industry largely women selling self-help to other women?

I came across an interesting interview with  Ruth Whippman, author of “America the Anxious: How Our Pursuit of Happiness is Creating a Nation of Nervous Wrecks.” Ruth was asked “Q: Are specific groups of Americans particularly preoccupied with achieving happiness?” Her reply had an interesting observation:

The self-help industry in America is female-dominated; approximately 80 percent of all self-improvement books are bought by women. There is a natural inclination among women to try to improve themselves and their lives, which isn’t a bad thing. But embedded in that is the belief that women need to be improved. Consider the titles of the “Women who __ too much” series: “Women Who Love Too Much,” “Women Who Think Too Much,” “Women Who Do Too Much” and so on. The culture tends to blame women for life’s problems. It is who women apologize too much or don’t “lean in.” The implication is women should try harder. If you’re not getting paid enough, you should be better at negotiating your salary and not worry about the system. The culture’s tendency is to downplay the structural and systemic realities.

Overcoming perverse disincentives to honest, transparent reporting of science

I was impressed by a Student Blog posted  by Ulrike Träger in PLOS’ Early Career Research Community  0000-0002-4493-1136

Reforming scientific publishing to value integrity

I personally recommend that my readers follow that blog. It consistently has exceedingly fresh and interesting material, and the early career bloggers need to be recognized and encouraged for what they are doing. They are also often more in touch with recent developments that are being missed by more established investigators busy doing things the old way. See for instance –capture1



Investigators in my cohort have handed early career investigators a demoralizing mess. They need our support in cleaning it up and fixing how science is produced and disseminated and corrected.

I’ve taken the liberty of singling out a couple of passages and provided minimal commentary. If you like the sampling, go to the original blog post  for more.

 We need to deal with honest, transparently reported science being considered boring, even if it proves more durable and dependable. Solid science is built with what might be seen as a lot of just bricks in the wall .

A study published in PLOS Biology that investigates on what factors scientists’ reputations are judged.

When comparing a scientist that produces boring, but reproducible studies with a scientist that publishes exciting, but not reproducible studies, the public perceived the boring scientist as “smarter, more ethical, a better scientist, more typical, and more likely to get and keep a job.” Scientists given the same choices agreed that the boring, but certain scientist was smarter, more ethical and the better scientist. But in a departure from the public’s opinion, scientists found the exciting but unreliable scientist to be more likely to get a job and be more celebrated by peers. This is a stark contrast to the public’s view of science, which seems to favor well-done science over flawed science. Worryingly, when scientists were asked which of the two model scientists they would rather be, more said they wanted to be a scientist that produces exciting results, even though the majority knew that publishing reproducible research is better overall. While one survey of 313 researchers does not represent the whole science community, these results paint a surprising picture of scientists’ priorities.

We need to stop worshiping the journal impact factor and wean ourselves from pay-walled journals. We need-

Valuing science based on scrutiny from an open access community. A lot of scientific journals only let paying subscribers view their publications, which limits exposure to research published in these journals. Open access policies allow anyone interested in a study to access the research, without barriers. More importantly, not just the access should be free but also the peer review process.

We need to give post publication peer review greater incentive and link it inseparably and directly to the already published papers being reviewed.

Peer review before publication is a key step in checking the quality of science, however the current peer review system is imperfect. I believe that post-publication peer review should be a key process to improve science integrity. Ideally both pre- and post-publication peer review would be made available alongside the published manuscript for increased transparency in the scientific process. A few publications have introduced open reviews including EMBO, BMJ Open and F100research. Alternatively, you can find online journal clubs like PubPeer where articles are discussed post-publishing, or leave comments on articles post-publication.

Or organize your own PubMed Commons journal club.

missing-pieceWe need to do a better job of making negative and inconclusive data widely available.

Currently, a lot of sound science remains unpublished, as negative or inconclusive data are less likely to be published due to reporting bias. A 2010 study in PLOS ONE showed that 82% of papers published between 2000 and 2007 in the United States included positive results only, in spite of the value of negative data. By publishing negative or null results the scientific literature captures a more complete picture of a particular field, and includes more balanced information. I feel a well-done study with negative results deserves the same recognition as a positive one, as it still expands human knowledge and saves resources for other researchers. For example, publishing what isn’t the cause of a given disease will prevent other scientists from spending time and money looking into the same thing. The PLOS Missing Pieces Collection includes negative, null or inconclusive results, and is a great platform for scientists who conduct an experiment and yield a result of this type. In addition, PLOS ONE is a journal that does publish negative, null, or inconclusive results. Replication studies also receive limited recognition in spite of their importance to advancing the scientific field. They are key in validating scientific findings, but few scientists risk doing them as it is hard to publish them for their “lack of innovation,” – a notion we should start to forget.

See also

What is open access?

What is open peer review?


Contemplating American hype: Donald Trump and Barbara Fredrickson

Over the top versus effective self-promotion, where is the line? An author’s dilemma

When I’m teaching science writing workshops, one of the first points I emphasize is that good science doesn’t sell itself. Many decent manuscripts receive desk rejections because the authors fail to sufficiently promote themselves and the value of what’s in the manuscript. Authors cannot assume that editors even read their manuscripts in making decisions not to send them out for review. I then go on to discussing strategies for authors grabbing the editor’s attention with the title, abstract, and cover letter.

See my recent blog post:

Coyne of the Realm on the Daily Show and teaching scientific writing

For many, Self-promotion is initially a daunting task. A lot of academics are attracted to what they do because their job doesn’t seem to involve any salesmanship – they just have to do good science and report it transparently. If that is their attitude, they may be uncomfortable giving a pitch for their work and worry about the ethics of this kind of thing

I think that authors effectively pitching their manuscripts to editors is a necessity if the going to get the attention they deserve. Where I draw an ethical line is when authors make statements in the pitch simply because they will attract the kind of attention that is needed. Having to pitch a manuscript does not free authors from having to believe what they are saying is true.

What I’m teaching abroad, I often get confronted with the retort that self-promotion is not an American strength, but a vice some participants don’t want to acquire. I don’t deny the two sides to self-promotion, but I suggest people from outside the culture find the limits of their comfort zone and test these limits. They can safely act like an American without becoming one.

king-hokumAmericans do seem to have a knack for spinning hype and hokum. Maybe that is reflected in the latter term being a distinct American contribution to English.

In this blog post of contrast some distinctly American hype. We will see that the boundary line between satire and reality gets quite blurred in American self-promotion. But there are rewards to be had.

The first specimen is a spoof scientific paper written by a psychologist in the style of American presidential candidate Donald Trump. It can almost pass for the real thing.

The second specimen is the abstract of a successful grant application by American psychologist Barbara Fredrickson. If you didn’t know its source, it can easily be taken as a spoof. But whether you like it or not, it succeeds admirably, because the grant got funded, along with a number of similar grants by Fredrickson. I don’t like the rhetoric of the abstract and it helps calibrate my comfort zone.

Matt Crawford, the author of the first specimen disavows much thought having gone into a quickly written piece. Yet it is making the rounds and even showed up on the Democratic Underground.com.

trumpThis piece got circulated on the Internet without the real author, social psychologist Matt Crawford having his name attached. He’s from the American Midwest, got his PhD at Indiana University. He spent a lot of his career at Victoria University, Wellington, New Zealand and apparently he has contracted some modesty, perhaps from the raw oysters.

The piece is meant to be enjoyed, not carefully analyzed, but it does capture some features of the bombastic self-promotion of Donald Trump, but also some key features of a hyped article or grant application. You can see the overenthusiastic introduction documented with a very selective review of the available evidence. Then there is a vague method section, followed by thoroughly obfuscating results section. Is all very gushy, but leaves the reader at the mercy of the author in terms of the reader not having the details to make independent judgment

A title for a really good piece of research, just the best, really


An affective intervention to reverse the biological residual of low childhood SES grant funded by the National Institute of Aging

The Fredrickson abstract was obtained from a freely accessible database, of the current and past NIH research portfolio, RePORT.

It takes a little practice to learn to navigate RePORT, especially the drop-down menus, but it can be an invaluable resource for so many purposes. In this case, I was seeking an example of how a successful American researcher pitched her projects to funding agencies.

Of course, we don’t get to see the unsuccessful proposals, but I think it is it is apparent that what succeeds in the United States might be beyond the comfort zone of grant applicants from other countries and culture.

The abstract is intended to shock and awe reviewers. Maybe like to spoof Trump piece, the abstract shouldn’t be subject to careful analysis, because it doesn’t stand up to scrutiny. But it’s a fine example of something worth considering. Maybe it has some elements worth emulating by some authors, but it also sets the boundary conditions around self-promotion that some won’t want across.

In textbook fashion, the abstract creates a tension by defining a serious threat to life and well-being. It then identifies the proposed research as offering a solution – loving kindness meditation for the poor. The abstract claims a miraculous effect of this meditation on trendy biological parameters. The abstract wraps up with a resounding promise, surely intended to bring reviewers to their feet and a standing ovation.

This research stands to identify evidence-based interventions to drastically reduce the disease burden that disproportionately affects Americans raised in low SES households.

Wow! We must fund the study because we won’t want to pass on this opportunity to help the poor.

 DESCRIPTION (provided by applicant): Individuals raised in low socioeconomic (SES) households have been found to bear 20%-40% increased risk of costly chronic and infectious diseases and all-cause mortality, even after accounting for adulthood SES. Illuminating the biological mechanisms of these health risks, recent research has determined that severe and chronic stress endured early in life can embed a decades-long “biological residue” within the immune system, as reflected in leukocyte basal gene expression profiles, leukocyte telomere length, and levels of chronic inflammation indexed by C-reactive protein. These biological risk factors are further exacerbated by behavioral proclivities, namely, impulsivity (indexed by delay discounting) and mistrust, which are also more probable among those reared in low SES households. The overarching goal of the proposed research is to investigate whether and how this identified biological residue can be reversed in midlife. An innovative upward spiral theory of lifestyle change positions warm and empathic emotional states as key pathways to unlocking the body’s inherent plasticity to reverse entrenched biological risk factors. The PI’s team has identified an affective intervention – the ancient practice of loving-kindness meditation (LKM) – that produces salubrious biological effects in healthy midlife adults. The innovation of the present study lies in testing this affective intervention in a sample of midlife adults on poor health trajectories by virtue of having low childhood SES plus present-day pathogenic behavioral tendencies (i.e., impulsivity and mistrust). A dual-blind placebo-controlled randomized controlled trial (RCT) is designed to provide proof of principle that early-established biological risks factors are mutable, not permanent. It targets three Specific Aims: (1) To test whether LKM, through its effects on positive emotions, can reverse the biological residue of low childhood SES as reflected in (a) leukocyte basal gene expression (up-regulation of pro-inflammatory genes and down-regulation of antiviral and antibody genes), (b) leukocyte telomere length, and (c) C-reactive protein; (2) to identify plausible behavioral and biological moderators of the hypothesized benefits of LKM in this at-risk sample, with candidate moderators being (a) time spent meditating and (b) metabolic profile; and (3) to identify plausible biological, behavioral, and psychological mediators of the hypothesized biological benefits of LKM-induced positive emotions in this at-risk sample, with candidate mediators being improvements in (a) cardiac vagal tone, (b) delay discounting, and (c) mistrust. This research stands to identify evidence-based interventions to drastically reduce the disease burden that disproportionately affects Americans raised in low SES households.

Just what basis in pilot work is for these astounding claims? Barbara Fredrickson and colleagues conducted an RCT of the kind proposed in this abstract.

You may be familiar with one high profile report of the study. You  probably don’t know that it was an RCT, and certainly not an RCT published twice, without either publication acknowledging the other. Only recently, a brief corrigendum in Psychological Science  acknowledged the duplicate publication of the same data, but without an apology.


Two publications that are not acknowledged to be from the same data set scrambles efforts to integrate studies to obtain any estimate of the overall effectiveness of loving kindness meditation. Meta-analyses assume that effect sizes being entered come from independent studies.

But what Barbara Fredrickson did was worse. You have to read the original Psychological Science to discover that it is an RCT. Reporting does not conform to the universally accepted CONSORT reporting standards. The first item of the CONSORT checklist concerns whether the title or abstract acknowledges that a report comes from a clinical trial. That’s to facilitate retrieval and systematic searches. Disclosure that the study is a clinical trial is left to a supplement.

Furthermore, the Psychological Science article is a mediational analysis of how loving kindness meditation influences cardiac vagal tone, which is misrepresented as a biomarker. If you carefully examined the analyses, as we did  in published commentary, you can find that practicing loving kindness meditation did not affect cardiac vagal tone.

Then there is a second paper from the same data set that was published in Biological Psychology. The findings are reported in that article contradict what is declared in the Psychological Science article, which is not cited. Again, there is no evidence that practicing loving kindness meditation is beneficial to health.

Curiously, Bethany Kok, the first author on both of these articles doesn’t bother to cite them in her subsequent publications concerning loving kindness meditation.

Sometimes magicians conjuring up successful grants and papers in prestigious journals don’t want you to notice what they’re doing and certainly don’t want to explain their magic.

I nonetheless suggest that authors who are inhibited in their self-promotion consider the strategies that were employed here and sort out what is within their comfort zone to emulate. Choose carefully!

Bristol Uni refuses to disclose how much money paid for quack therapy in SMILE clinical trial

video-screenshot-parkerThe University of Bristol has refused to provide basic information concerning how much Phil Parker, a proponent of a quack therapy, was paid for training and treatment provided to patients provided in a clinical trial conducted by Professor Dr. Esther Crawley. I reproduce the response to the Freedom of Information Request below.

  • I previously blogged  about Esther Crawley’s MAGENTA trial of graded exercise for chronic fatigue syndrome in children and adolescents. I raised numerous concerns about the risk and benefits of parents enrolling their children in this trial.
  • I pointed to Crawley’s previous ignoring of the basic rights of children enrolled in another trial, the SMILE trial.
  • I raised issues about the financial transactions between Crawley and Phil Parker, a proponent of the quack Lightning Process treatment. In response to consumer complaints, Phil Parker had been disciplined by the UK Advertising Standards Authority and forced to remove claims about his ability to treat and even cure chronic fatigue syndrome from his website.
  •  Aside from a scientifically unwarranted clinical trial of a quack treatment, Esther Crawley failed in her responsibility to parents and the children participating in the SMILE trial by not publishing the results in a timely fashion. There was no basis for promising any clinical benefit to the children, and so the value of participating in the trial was confined to the contribution to science from any resulting peer-reviewed publications that presented results. Only unselected and therefore unscientific testimonials were published. [See my blog post for further details.


The Freedom Information Request reproduced below was intended to obtain information about the money flowing to Parker and also any plans to publish the SMILE trial data.

——– Forwarded Message ——–

Subject: Re: SMILE study
Date: Mon, 3 Oct 2016 12:08:19 +0100
From: University of Bristol FOI mailbox <freedom-information@bristol.ac.uk>
To: John Peters <johnpetpub@gmail.com>

Dear Mr Peters

Thank you for your recent Freedom of Information request, as below:

This request concerns this study:

The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomized controlled trial (SMILE study)  


The Principal Investigator is listed as Esther Crawley and I am writing to you as the presumed responsible public authority.

  1. Please give the total cost of the study.
  1. In the trial protocol (1), it is stated: ‘Families currently pay approximately £620 to attend the Lightning Process course.’ Please say how much was paid for children in the study to attend ‘Lightning Process’ courses. If possible, please give the cost per child attending and the overall cost.
  1. Please say if any discount or special deal was arranged with the providers of ‘Lightning Process’ courses. If there was a discount or special deal negotiated, please say what it was.
  1. It is said that Phil Parker, the creator of this intervention, receives commission on each course undertaken. Please state whether you are aware of any commission paid for any of the courses provided as part of the study. If you are aware, please say what commission was paid. Please also state if there was any discount or special deal done with Phil Parker regarding his commission, and if so what it was.

In response to parts 1-3, this information is held by the University but is exempt from disclosure under section 22(1) of the Freedom of Information Act as it is information intended for future publication. Further information about the SMILE and documents containing the information you have requested are due for publication but there is no fixed date for publication at present.

If it assists, the study protocol is in the public domain and available at: https://www.ncbi.nlm.nih.gov/pubmed/24370208

The University does not hold any recorded information in relation to part 4.

Review procedure

If you are not satisfied with the University’s response to your request you may ask the University to review the response by writing to:

Director of Legal Services

Secretary’s Office

University of Bristol

Senate House

Tyndall Avenue

Bristol BS8 1TH

Email: freedom-information@bristol.ac.uk

enclosing a copy of your original request and explaining why you are requesting a review. The full review procedure is set out at:  http://www.bristol.ac.uk/secretary/foi/review-procedure/

Your request for internal review should be submitted to us within 40 working days of receipt of a response.

If you are not satisfied with the outcome of the internal review you may also contact the Information Commissioner’s Office at:

Wycliffe House

Water Lane





Best wishes

Freedom of Information Team

University of Bristol


Simon Wessely’s muddled views of the good psychotherapy trial: I. Misunderstanding control groups

A large clinical trial might be said to resemble an ocean liner…Very occasionally there is a shipwreck – Simon Wessely

Sir Simon Wessely is apparently still hawking cruises on a wrecked ship that can’t be salvaged. I urge refunds.

 After a long career, Wessely is in the twilight of his influence and relevance. His tired defense of the design of the PACE trial suggests that he is out of touch with contemporary thinking about psychotherapy trials and risks to their validity. But he still chastises those who disagree with his assessment of the PACE trial.

 I invite readers to read and decide….

If you haven’t read Julie Rehmeyer’s excellent article in STAT Bad science misled millions with chronic fatigue syndrome. Here’s how we fought back, you should at least bookmark it for reading later. A mathematics and science writer who happens to be a patient, Julie Rehmeyer’s piece has proven to be the right article at the right time to bring the controversy into the public eye over chronic fatigue syndrome (hereafter CFS/ME)* and what is widely seen as the demolished credibility of the 5 million pound PACE clinical trial of cognitive behavioral therapy (CBT) and graded  exercise therapy (GET) for chronic fatigue syndrome. The article has been rightfully republished and is receiving wide commentary in conventional and social media.

Rehmeyer’s article’s uniformly warm reception was marred only by a chilly comment from Sir Simon Wessely that began:

Sorry to spoil the party but some cold facts are necessaey [sic]

This blog post is the first in a series. I will respond to some of Wessely’s odd pronouncements about evaluating clinical trials and his dismissive defense of the PACE trial.

Wessely starts by lecturing his readers that they should check the PACE trial against the CONSORT checklist, which you can find here.

The PACE trial remains an excellent trial and a model of how to deliver a complex intervention RCT. Read the 2012 Lancet paper again. Check it against the CONSORT statement. You will see it is 100% compliant.

consortThis is a puzzling suggestion. The CONSORT checklist evaluates whether particular aspects of a clinical trial are reported in an article, not whether those aspects were competently implemented in the trial. For instance, an author could say that “Data for patients who did not respond to treatment as we hoped were discarded.” That would meet the criteria for disclosing whether or not analyses were conducted on an intention-to-treat  basis, but it would be a gross violation of best research practices. As we’ll see, simply relying on CONSORT to decide whether the PACE trial was properly done, would miss some egregious questionable research practices.

Wessely’s comment echoes a similarly condescending comment in his earlier Mental Elf blog, to which he provided a link in his comment on Julie’s article:

I am struck that some of the critics are not familiar with the fundamental strengths of the randomised control trial, and why medicine continues to value it so highly. Likewise, some show unfamiliarity with the core methodological components that contribute to the integrity of a clinical trial, and whose violation calls into question the findings, as compared to what one might call secondary less important features. In other words, what distinguishes a good trial whose results are likely to be sound from one in which there is a definite risk of bias.

Wessely simply doesn’t get it. The PACE trial is now being scrutinized by a large international audience who won’t tolerate being patronized.

Chris Chambers  recently remarked:

 What’s happened instead is that technology has empowered the new generation to speak freely and publicly on scientific issues, to critique poor quality science and practices, to bust fraud, and to break the bounds of peer review. Twitter in particular has shaken the traditional academic hierarchy to its core. On Twitter a PhD student with thousands of followers suddenly has a greater voice than an Ivy League professor who might have no social media presence at all.

Here are a few of the aspects of the PACE trial comparison of the active treatments – (CBT) and (GET)– to a control condition that Wessely encourages us to ignore.

  1. Inadequacy of the control group. All four of the conditions in the trial involved providing patients with “standardized specialty medical care” (SSMC). One condition provided only SSMC and served as the control/comparison for evaluating the CBT and GET.

The condition is grossly inadequate as a control group because it is deficient at the basic level of contact time – patients assigned to SSMC received only 3 medical sessions of 30 minute duration. In contrast, patients assigned to CBT or GET have access to these three medical sessions of SSMC plus 15 sessions of either CBT or GET.

The Lancet article describes SSMC:

 Standardised Specialist Medical Care SSMC will be given to all participants. This will include visits to the clinic doctor with general, but not specific advice, regarding activity and rest management, such as advice to avoid the extremes of exercise and rest, as well as pharmacotherapy for specific symptoms and comorbid conditions. SSMC is standardised in the SSMC Doctor’s Manual. As well as this, SSMC participants, like all other participants, will already have received the Patient Clinic Leaflet (PCL). The PCL is a generic leaflet explaining what CFS/ME is, its likely causes, and available treatments. There will be no additional therapist involvement.

 So, the patients assigned to SSMC got a pamphlet. In general, clinical and health psychologists researchers are convinced that getting a pamphlet is an inert intervention. So much so, that pamphlets are routinely provided as control inventions where researchers are intent on making their active intervention appear effective. And routinely criticized as an inadequate control condition.

In contrast to SSMC, the active treatments were delivered with a strong induction of positive expectations. Alem Matthees, the patient who obtained release of the PACE data with a FOI remarked in an email to me:

The CBT manuals for PACE assert with confidence that the therapy was safe and powerful (etc), and aimed the therapies at changing patients’ perceptions about their symptoms. Similarly, the GET manuals stated exercise reverses the pathophysiology responsible for symptoms and that most patients feel “much better” after therapy. No such equivalent in the other manuals. So it is difficult to separate any genuine benefit from methodological artefacts arising from placebo response and other reporting bias. If we assume subjective measures are important (which they are) and there is some genuine benefit (which there probably is), we must still consider the use of objective measures.

  1. The study was not blinded. Patients assigned to either CBT or GET knew they were getting more treatment. In contrast, patients assigned to the control group received only the SSMC.  They could see that they have gone to the bother of signing up for clinical research with the expectation that they would get more than SSMC, but now they are being left in that treatment with the added burden of all the research assessments.

The lack of blinding potentiates the problems of a control condition lacking the frequency and intensity of contact provided with the active treatment.

  1. Bolstering of positive expectations with a newsletter. A newsletter sent to patients while enrollment in the trial was still ongoing strengthened positive expectations and increased a sense of obligation from patients assigned to the control group. This effort was not specified in the original protocol. If this were a drug trial being scrutinized by the FDA, this would be a blatant protocol violation.

I noted in an earlier blog:

Before the intervention phase of the trial was even completed, even before accrual of patients was complete, the investigators published a newsletter in December 2008 directed at trial participants. An article appropriately reminds participants of the upcoming two and one half year follow-up. But then it acknowledges difficulty accruing patients, but that additional funding has been received from the MRC to extend recruiting. And then glowing testimonials appear on p. 3 of the newsletter about the effects of their intervention.

“Being included in this trial has helped me tremendously. (The treatment) is now a way of life for me, I can’t imagine functioning fully without it. I have nothing but praise and thanks for everyone involved in this trial.”

“I really enjoyed being a part of the PACE Trial. It helped me to learn more about myself, especially (treatment), and control factors in my life that were damaging. It is difficult for me to gauge just how effective the treatment was because 2007 was a particularly strained, strange and difficult year for me but I feel I survived and that the trial armed me with the necessary aids to get me through. It was also hugely beneficial being part of something where people understand the symptoms and illness and I really enjoyed this aspect.”

Taken together with the acknowledgment of the difficulty accruing patients, the testimonials solicit expression of gratitude and apply pressure on participants to endorse the trial by providing a positive evaluation of their outcome in the self-report measures they were provided. Some minimal effort is made to disguise the conditions from which the testimonials come. However, references to a therapist and, in the final quote above, to “control factors in my life that were damaging” leave no doubt that the CBT and GET favored by the investigators is having positive results.

Adequacy of control groups is of crucial importance. The US Agency for Healthcare Research and Quality (AHRQ) undertook a comprehensive systematic review and meta-analysis of meditation programs for psychological stress and well-being. I covered the agency’s report and the JAMA: Internal Medicine article in a recent blog post, Mindfulness research’s huge problem with uninformative control groups. The AHRQ report and JAMA article concluded that the widespread impression that meditation is an effective way of reducing stress and improving well-being largely comes from trials with inadequately matched control groups. When meditation, including mindfulness, iscompared to suitable active treatments, there is insufficient evidence of any superiority.

The same could be said for the PACE trial, but I’m just getting started. In my next blog post, I will take a critical look in a second comment on Julie’s article at Simon Wessely’s endorsement of outcomes switching as an admirable feature of the interpretation of clinical trials. What he says:

In essence though they decided they were using a overly harsh set of criteria that didn’t match what most people would consider recovery and were incongruent with previous work so they changed their minds – before a single piece of data had been looked at of course. Nothing at all wrong in that- happens in vast numbers of trials. The problem arises, as studies have shown, when these chnaged [sic] are not properly reported. PACE reported them properly. And indeed I happen to think the changes were right – the criteria they settled on gave results much more congruent with previous studies and indeed routine outcome measure studies of which there are many.


Albrecht Dürer’s Knight, Death and the Devil

In a subsequent blog post, I’ll be arguing that Simon’s justification is factually incorrect and inconsistent with best research practices. Until my next post, for a condemnation of outcomes switching in pharmaceutical trials, see my recent blog post, Study protocol violations, outcomes switching, adverse events misreporting: A peek under the hood. I report on criticism by prominent senior psychiatrists of bad research practices in trials of antidepressants. After writing that blog post, I signed a letter with the senior psychiatrists demanding retraction of one of these papers the blog discussed. The paper reported data from a ghost written trial of antidepressants characterized by protocol violations, outcomes switching and adverse events misreporting. I’ve heard no evidence that the PACE trial was ghostwritten, but I think there is ample evidence of its sharing these other sins.

**I am using this term with some reservation, because it’s familiar to readers and because that is how a set of diverse conditions is named in the bulk of the scientific and in the media.  But for an excellent critique of the term, see another excellent article in STAT,  Why we shouldn’t call it ‘chronic fatigue syndrome’ . I expect we will see a retirement of the term “chronic fatigue syndrome.”



Coyne of the Realm on the Daily Show and teaching scientific writing

During the recent Democratic National Convention in Philadelphia, I was fortunate to get a ticket to a filming of the Daily Show. I came away with some great insights for teaching my scientific writing course.

14232402_10211124730580979_880852685714409702_nThe Daily Show audience was lead into the auditorium at Annenberg Center hours before the show would begin. Eventually a staffer came out and announced that we were going to be the laugh track for the show. We would be expected to show great enthusiasm on cue. She engaged the audience with a calculated abrasiveness. For instance, she said that some members of the audience might have small gifts for the host Trevor Noah. The staff would later collect them. But if anybody tried to give Trevor a sketch that they had drawn, the staff would ridicule it in the back room without passing it on to him.

Being part of a laugh track is no fun. For many of us, the idea of the laugh track conjures up an obviously canned audience response stuck into sitcoms on TV decades ago. Laugh tracks have mostly fallen out of fashion. Fortunately, this experience was different.

To warm us up, a comedian came out and casually engaged the audience. He would pick out seemingly random people and ask their names and from where they came. He would then instigate a lively exchange, gently poking fun at them and involving the rest of the audience.

At one point, he asked a guy if he was married to the woman sitting next to him. The man replied “no, we’re just on a first date.” The comedian asked the audience to encourage the guy to ask the woman to marry him. They did so with great excitement, after comedian whipped them up and egged them on a bit.

Much of the banter was simply silly and would have fallen flat in other circumstances. But the comedian managed to provoke an increasingly energized and enthusiastic response from the audience in the back-and-forth exchanges.

The comedian orchestrated a few practice greetings of the star Trevor Noah before he arrived, with the audience encouraged to take to their feet, cheer, and wave their hands over their heads and clap. I was amused to see Vincent Price, the University Pennsylvania Provost, sitting a few seats away, jump up and down like a hungry trained seal working for a fish from his trainer.

The audience was eventually deemed ready to actually greet Trevor. He dashed out onto the stage and adeptly fielded deliberately odd questions from the audience before the start of the actual filming of the show.

When the show was closer to starting, a large, mysterious director who had mostly stayed in the shadows, emerged to signal the audience to arise. It did so with genuine excitement and apparent spontaneity.

After filming the first segment of the show, the director and some staff reviewed it and were dissatisfied. They required second takes of some interactions with the audience. We complied and I doubted the later TV audience would know what they saw was restaged.

In the second segment, Leon Panetta was given a rousing welcome from the audience as he came onto the stage. Panetta was first the Chief of CIA and then Secretary of Defense under Obama. He was well prepared for being poked by Trevor and much funnier than I would’ve guessed.

But the director halted the taping because the audience was apparently off in its timing. So we provided Take 2 of Panetta’s entrance with more excitement.

For the finale of the show, the audience needed to serve as a wildly cheering backdrop for Trevor Noah’s exit. This too required a second take. Someone sent me a screenshot from the video available on the web in which I can clearly be seen doing my part.

me on daily show

Coyne of the Realm teaching the scientific writing class

Some readers may have attended one of my workshops on “Writing high impact papers and what to do when your manuscript gets rejected.” I’ve been teaching the workshop for years around the world, most recently at the European Health Psychology Conference in Aberdeen, Scotland. Before that was Melbourne. Lund, Sweden is upcoming in November, Amsterdam and Valencia are after the first of the year.

melbourne ad

Poster from Writing Workshop at World Congress Cognitive and Behavioural Therapies, Melbourne, July 2016

A takeaway message of  the workshop is that in the current competitive environment, doing solid science and writing in proper English is insufficient to get your work the attention it deserves. Up to 40% of all manuscripts in some fields are summarily sent back without review to authors, often without anyone, even the editor having read them.

So, it’s incumbent on authors to make a compelling pitch for their paper, using three tools that they have: the title, abstract, and their cover letter. Each of these three is usually written only as a quick afterthought, after the manuscript is otherwise ready for submission. That could be a fatal mistake for any hopes of the manuscript getting out for review.

having to sell yourselfWhat, I have to stoop to marketing my work? How dreadful. Academia often attracts people who want simply do their science, not engage in public relations or self-promoting. They could be disappointed when this is not enough to get published in the particular journals where they would get the recognition they crave.

There may be some self-selection into academia, but are also some strong cultural differences, with some Europeans and Asians loathe to emulate Americans, whom they see as loud, brash, overbearing and unduly confident and impressed with themselves. My Dutch audiences, particularly, recall having been raised with an attitude of “kop boven het tall corn flower cut2maaiveld uitsteken– roughly translated as ‘the tall cornflower gets cut.’

Maybe, but like the audience on the Daily Show, you can get worked up for a role you have to play, particularly when you don’t take yourself too seriously. I know, getting your manuscript out for review and then into print is serious business. But take it all as dead serious play and it will hurt less when things don’t go as planned. Pump up for Take 2. Take the promotion of your manuscript as an orchestrated performance.

My workshops give participants background on the current publishing environment as well as strategies for to identify and reach the readership which will be most appreciative of their work. I rely on workshop slide presentations that have been continuously refined over the years and I have didactics to go with them. But what is most distinctive and engaging is a lot of back and forth interaction with the audience. I term it call and response. The workshop participants pitch me their soundbites, rough sketches of their ideas, and elevator pitches.  They get my response and we go back and forth with escalating focus and contagious enthusiasm.

Influenced by my having a bit part on the Daily Show, I deliberately shifted my presentation style in Aberdeen, relying much less on my slides and much more on spontaneous interaction with the audience. In the afternoon, I ignored the slides except to consult them at break to see if I had missed anything.

Taking a tip from the comedian, I started with a casual interaction with the audience, questioning them about who they were, what their stage of their career, their where they were from and their experiences publishing papers or trying to. I had no illusions of being Trevor Noah or his warm up comedian, but I got the need to loosen up the workshop participants.

Then I launched into individual call and response  interactions with them. I am sure many participants came away thinking that they had not known how excited they could be about their work, once was put into better focus. Hopefully their enthusiasm will prove contagious when it comes to submitting their papers and getting them reviewed.

I’m careful not to embarrass or confront participants in the workshop about it, but I have come to strongly suspect that many junior and even senior authors submit their manuscripts without giving much thought to why an editor should be interested in it or get excited about it.

 Capturing this for web-based courses

 I now realize that the web-based courses that I am planning need to have the sriracha sauce of some of these live exchanges. So…

My film crew and I are setting up some 90 minute sessions at colleges and universities in the larger Philadelphia area. For a limited time, we will come for free and I will instigate this kind of back and forth, call and response sequences to be captured on the film. I expect to have a good time, and I expect that the audiences will too. Maybe they’ll even be more likely to get the papers out for review

If you’re lucky, I’ll see you there. Otherwise, you can go to my CoyneoftheRealm website and sign up to receive a free 15 minute sampling of the course that will soon be coming available.




Outgoing Vice President of Dutch Academy of Science warns of sharing data with “your enemies”

On one of his last days in office before being retired, Dr. Jos van der Meer, the Vice President of the the Royal Netherlands Academy of Arts and Sciences warned of the reputational damage risked by scientists who share their data outside their circle of close colleagues.

Dr. van der Meer made his remarks to an interviewer from the Dutch daily de Volkskrant :

“Put everything on the internet, there is always someone who discovers something. You will find in every study a mistake. It will go to details and I predict that it be enlarged in order to send the entire study to the dump. ” For the availability of data from clinical trials, there is much to do. Van der Meer knows. “There is a widespread view that conditions should be attached.” Van der Meer said that the research leaders shared indeed in recent years at the request data with colleagues. “But to give all data to your enemies.” Enemies? “Yes, there are people who have apparently interest to label this as a bad study. It is a personal vendetta against two renowned scientists. ” Apparently there is a setting error in your brain and you can turn that back with this treatment Emeritus Professor Jos van der Meer, expert on CFS Positive effect Psychiatrists Sir Simon Wessely and Peter White have become the face of the wrong turn taken by science according to patients. And that’s really strange, says Van der Meer, because the effect of behavioral therapy has been much more researched, and the conclusions were unanimous. His own research in the Nijmegen Radboud University Nijmegen Medical Centre a few years earlier than the British study also found positive impact of behavioral therapy. That that this treatment works does not mean the disease is between the ears, Van der Meer stressed. “Apparently there is a setting error in your brain and you can turn it back with the treatment.”

Dr. van der Meer’s opinions about routine data sharing are quite at odds with those of the Dutch government and scientific community. Like much of the rest of the world, the Dutch have embraced the necessity of data sharing in order for scientists and the public who fund science to get the full benefit of research.

His remarks were timed to give last-minute support to his long friend and ally Peter White in the UK. White is one of the PACE investigators facing an order from the UK Lower Tribunal to release the data from the controversial PACE trial. The widely criticized study evaluated exercise therapy and cognitive behavioral therapy (CBT) for chronic fatigue syndrome.

Apparently Dr. van der Meer was unaware that Peter White’s co-investigator Michael Sharpe had already just disclosed that results of the PACE trial were substantially poorer when evaluated with the originally declared scoring of primary outcome variables. The unanticipated revelation demonstrated the need to share the PACE data for independent reevaluation, particularly given the clinical and public health importance that has been attached to it.

Dr. van der Meer also took advantage of the occasion to spin the interpretation of CBT research for which he was senior author.

Prins, J. B., Bleijenberg, G., Bazelmans, E., Elving, L. D., de Boo, T. M., Severens, J. L., … & Van der Meer, J. W. (2001). Cognitive behaviour therapy for chronic fatigue syndrome: a multicentre randomised controlled trial. The Lancet, 357(9259), 841-847.

He failed to disclose that a decade later release of the objective performance data from his study had revealed that CBT did not affect objective performance measures. See PubMeds Commons comment here by Tom Kindlon. Only subjective self-report data showed evidence of any improvement, which are quite vulnerable to uncontrolled nonspecific influences in an unblinded study. If these data had been available earlier to independent researchers, considerable misrepresentation by the original investigators could be countered.

Dr. van der Meer also has made claims that CBT restores prefrontal cortical brain volume in patients with chronic fatigue.

De Lange, F. P., Koers, A., Kalkman, J. S., Bleijenberg, G., Hagoort, P., Van der Meer, J. W., & Toni, I. (2008). Increase in prefrontal cortical volume following cognitive behavioural therapy in patients with chronic fatigue syndrome. Brain, 131(8), 2172-2180.

The uncontrolled, grossly underpowered study has received withering criticism [ 1 2 ]. I would wager that these results would not be replicated in an adequately powered, more appropriately designed, preregistered and transparently reported study.

Dr. van der Meer also misrepresented evaluations of CBT for chronic fatigue syndrome conducted by those not directly involved in the studies who did not share the original investigators’ conflicts of interest. Contradicting his claim of uniformly positive results, the July 2016 updated review provided by the US Agency for Healthcare Research and Quality concludes there is “low strength of evidence that CBT improves fatigue” and “low strength of evidence that quality of life is not impacted by CBT”

A true fossil, after his retirement, Dr. van der Meer will be on permanent display next to the bugs in amber at the Naturalis Biodiversity Center in Leiden.

Chronisch vermoeiden op zoek naar erkenning [Literally “Chronically fatigued looking for recognition] Here is a link to the actual article.

 The article is in Dutch and below is a rough translation made by a colleague [corrections welcomed].

Chronically fatigued looking for recognition. A major study of chronic fatigue syndrome in 2011 led to much controversy. Now the fire flares up again after a remarkable statement of the British court. By Ellen de Visser September 6, 2016

The controversy between patients and scientists on chronic fatigue has reached a peak after a remarkable court ruling. A British court has determined that all the data from a study of treatments for the disease should be released to an Australian patient. The university has yet to end in question this week to appeal. Patients have since the publication of that study, five years ago in The Lancet, serious doubts about the claims. The so-called PACE study, the largest study ever done on the effect of treatment for chronic fatigue, showed that patients can recover from the disease by two types of therapy: an exercise and a form of behavior therapy. contempt The results received worldwide attention. For chronic fatigue syndrome (CFS), from which millions of people worldwide suffer, for a long time there was no cure. The disease is characterized by extreme fatigue, but also muscle and joint pain and memory problems.

“Chronically tired? Get up and move, the newspapers headed. Patients felt insulted by that message, they regarded the findings as a lack of recognition. They assume that their disease is not psychological but has a physical cause, and set their sights on the two British psychiatrists who suggested otherwise. Remarkably, in recent years there was more and more support from scientists around the world who openly voiced strong criticism of the study design, statistical analysis of the data and the interpretation of the data. The study could obviously not be blinded, so patients knew which treatment they received, and halfway they were told in a newsletter which treatments were a government commission favorite. The result was based purely on subjective data. All the objective data, for example the outcome of a walk test, could not support the findings. Criteria for participation in the study would have been dubious. Forty professors recently wrote an open letter to the Lancet in which they insist that the results should be reviewed by independent scientists. The study shows, according to them “major flaws” and thus there are “serious concerns” about the reliability of the conclusions. Good science does not need protection Slogan activists Withholding data Attempts to obtain the underlying data, encountered long time opposition by the researchers involved and the university, Queen Mary University London.

The Australian CFS patient Alem Matthees continued until the British personal data authority agreed with him a year ago. The university appealed to the court, but drew the short straw. The university believes that the release of the data damages the relationship of trust with the patients because privacy has been promised to them. But the patient data are anonymous, according to the court it is not are likely that will lead to problems. Scientists found that the withholding of data at a time of open access cannot be accepted. “Good science does not need protection,” that was the slogan of the activists during the trial.

But Emeritus Professor Jos van der Meer, expert in the field of CFS, warns of the consequences of disclosure of research data. “Put everything on the internet, there is always someone who discovers something. You will find in every study a mistake. It will go to details and I predict that it be enlarged in order to send the entire study to the dump. ” On the availability of data from clinical trials is much to do, Van der Meer knows. “There is a widespread view that conditions should be attached.” Van der Meer said that the research leaders shared indeed in recent years at the request data with colleagues. “But to give all data to your enemies.” Enemies? “Yes, there are people who have apparently interest to label this as a bad study. It is a personal vendetta against two renowned scientists. ” Apparently there is a setting error in your brain and you can turn that back with this treatment Emeritus Professor Jos van der Meer, expert on CFS Positive effect Psychiatrists Sir Simon Wessely and Peter White have become the face of the wrong turn taken by science according to patients. And that’s really strange, says Van der Meer, because the effect of behavioral therapy has been much more researched, and the conclusions were unanimous. His own research in the Nijmegen Radboud University Nijmegen Medical Centre a few years earlier than the British study also found positive impact of behavioral therapy. That that this treatment works does not mean the disease is between the ears, Van der Meer stressed. “Apparently there is a setting error in your brain and you can turn it back with the treatment.”

London University [Queen Mary London] has slightly more than one week to appeal, Alem Matthees let us know via email. The chance of this is small: the case can only go to a higher court if there has been “an error of law” and the law is misapplied. Once the data to Matthees released, anyone can retrieve them. “I am convinced that the researchers did not cheat (note from me: he uses the strange word gefoezeld)” Van der Meer said. Again no access to research data. The American professor James Coyne, affiliated with the University of Groningen, has requested information from the PACE study. He requested last year, researchers at King’s College London to provide him data from a follow-up study published in 2012 in Plos One, the cost-effectiveness of the treatments in question. The university refuses inspection. The letter of reply, which Coyne has put on his blog, the university wrote that Coyne has “no serious reasons” that he only wants to use the data for a polemic and ‘reputational damage’ threat. That refusal has once again led to angry reactions from fellow scientists. “If the university is looking for reputational damage,” twittered the British professor Chris Chambers, “then it is enough to clog research.”

Clinical psychologists’ divided loyalties in providing psychotherapy to clients who feel coerced to participate

Psychologists face ethical dilemmas in conflicts between their loyalty to their clients versus to those who employ the psychologists to provide therapy under conditions in which clients perceive or actually face coercion to participate in therapy as a condition for receiving benefits.

  • Are professional organizations entering into troubled waters when they collaborate with institutions intent on restricting social benefits to the unemployed and disabled?
  •  The Mental Health Foundation (MHF) believes that UK clinical psychologists are insensitive to these ethical conflicts.
  •  An exchange on these issues between the MHF and a group representing clinical psychologists in the UK that notably included the British Psychological Society ended unsatisfactorily.

The Mental Health Foundation charged:

We believe your collusion with the government is now threatening to undermine the ethical integrity of the “psy” professions among service user/survivors and professionals.


It is not possible to consider this issue without considering the context of sanctions, cuts and persecution which is endemic in the current system. You fail to acknowledge that attending this proposed therapy may not be explicitly linked to conditions/sanctions but will feel so for many of its prospective clients who are on benefits. There is a structural power imbalance between job centre employees and those on benefits. With their income under threat, those on benefits will be especially susceptible to cues, suggestibility and positive reinforcement when attending job centres. Many on benefits have experienced oppressive power relations for much of their lives. Saying no in relation to an apparent free choice in this context is hugely difficult, especially when saying no has uncertain consequences.


We are concerned that under-qualified and inexperienced staff, such as job centre coaches, will be in a position to make referrals to Health and Work programs. This is exacerbated by the fact that referrals are likely to be to IAPT workers, many of whom themselves lack in-depth training and experience of severe mental health issues. Inappropriate referrals are increasingly likely in a target-driven culture.

IAPT Refers to the Improving Access to Psychological Therapies  Program. My recent Mind the Brain blog post –  A skeptical look at The Lancet behavioural activation versus CBT for depression (COBRA) study criticized an article by 14 mental health investigators which claimed that less trained clinicians could provide a simplified behaviour activation therapy with no loss in effectiveness over trained clinical psychologists providing cognitive behaviour therapy for depression. I argued that the clinical trial reported in the article was rigged to demonstrate that less trained clinicians were more cost-effective than fully trained clinical psychologists.

The MWF acknowledged that professional organizations have gone on record as opposing coercion to participate in psychotherapy. However, MWF accused the professional organizations of ignoring the genuine threat to clients.

What is the Mental Wealth Foundation?

Mental Wealth Foundation is a broad, inclusive coalition of professional, grassroots, academic and survivor campaigns and movements. We bear collective witness and support collective action in response to the destructive impact of the new paradigm in health, social care, welfare and employment. We oppose the individualisation and medicalisation of the social, political and material causes of hardship and distress, which are increasing as a result of austerity cuts to services and welfare and the unjust shift of responsibility onto people on low incomes and welfare benefits. Our recent conference focused on Welfare Reforms and Mental Health, Resisting the Impact of Sanctions, Assessments and Psychological Coercion.

The MWF lists its member organizations as

  • Mental Health Resistance Network
  • Disabled People Against Cuts
  • Recovery in the Bin
  • Boycott Workfare
  • The Survivors Trust
  • Alliance for Counselling and Psychotherapy
  • College of Psychoanalysts
  • Psychotherapists and Counsellors for Social Responsibility
  • Psychologists Against Austerity
  • Critical Mental Health Nurses’ Network
  • Free Psychotherapy Network
  • Psychotherapists and Counsellors Union
  • Social Work Action Network (Mental Health Charter)
  • National Unemployed Workers Combine
  • Merseyside County Association of Trades Union Councils
  • Scottish Unemployed Workers’ Network

combatworkfareThe three-part exchange is reproduced below. It starts with a letter of concern from the MWF coalition. A response follows from a group of psychological organizations including the BPS. The third part of the exchange is an expression of dissatisfaction from the MWF of the insensitivity in the response from the psychological organizations and their failure to set up a meeting.

Open letter to therapy’s professional bodies on the psychocompulsion of welfare claimants – from the Mental Wealth Foundation

 21st March 2016


British Association for Behavioural and Cognitive Psychotherapies

British Association for Counselling and Psychotherapy

British Psychoanalytic Council

British Psychological Society

United Kingdom Council for Psychotherapy

Professional bodies scrutinise Government ‘therapists in job centres’ plans

We write in response to your joint public statement of 7 March 2016 outlining the outcome of your meetings with the Government’s new Joint Health and Work Unit and your scrutiny of the Government’s plans to place therapists in job centres [1].

There is no indication that any consultation has taken place with members of your organisations with knowledge of these matters nor with service users, clients and their representative organisations. This lack of consultation and opportunity for wider reflection has contributed to your organisations departing from your own ethical structures and frameworks, and being seen as agents of harmful government policy [2]. It is by now generally accepted that the consequences of the DWP and government policy in this area are far reaching for physically and mentally disabled people on social security benefits. Inexplicably your organisations’ scrutiny of government plans has failed to recognise this.

The joining of Government Health and Work Departments is not helpful, and current DWP policy intended to reduce the socio-economic causes of mental illness to the one simple fact of unemployment is clinically and intellectually ridiculous. The resulting policy promoting work as cure, which your organisations are now supporting, is offensive and dangerous. It is wrong for therapy organisations to buy into the unthinking praise for ‘work’ that often forms part of the rhetoric of governments.

While for some clients improving employment prospects may be an objective, for many others this is not the case and may be profoundly damaging. Indeed, for some people, their mental health problems may have begun because of work e.g. through experiences of bullying in the workplace. This one size fits all approach is simplistic. Premature return to work can result in loss of confidence and relapses affecting future ability to get back to work. This can also lead to prolonged periods without benefits and no income [3].

You state that plans must be aimed at improving mental health and wellbeing rather than as a means of getting people back to work. These are not the aims and objectives being expressed by the people who are implementing the programme right now, involving targeting ‘hard to help’ clients who are likely to be people with enduring physical or mental health difficulties. For example in the Islington pilot project Councillor Richard Watts has stated, “We think there is much more that health services can do to promote the idea of employment for people with health conditions.” In the Islington CCG Commissioners’ report in November calling for employment services in GP surgeries to reach ‘hard to help’ claimants, they state that, “to improve the system we need to…maximise the contribution of all local services to boost employment, making it a priority for health, housing, social care and training. We need to open up how we talk to people about employment, including asking healthcare professionals to have conversations about work with patients, as part of their recovery. We need to give professionals the information and tools to help them to do this.” [4]. For all clients, establishing a trusting relationship is the first priority, involving respecting their current needs, perspectives and autonomy.

Jobs advertised on the BACP website in November 2015 have the explicit aim of getting clients back to work and engaging with employment services e.g. “your role will include: producing tailored health action plans for each client, focusing on improving their health and moving them closer to work…generate health and wellbeing referrals to ensure continued engagement with employment advisers” [5]. Similarly G4S advertise jobs for BABCP accredited CBT practitioners with job roles including: “Targeted on the level, number and effectiveness of interventions in re-engaging Customers and Customer progression into work” [6].

We respectfully submit that information about these jobs was known to all of your organisations when you issued your joint statement. This inconsistency is seriously misleading.

We are glad that you oppose conditionality, coercion and sanctions. Clearly such punitive measures have no place in the therapeutic relationship. We fail to share your reassurance from the government that these measures will not be pursued against clients. DWP have repeatedly claimed that sanctions are a last resort and only happen in a tiny minority of cases. The reality is that millions of people have been sanctioned. In the twelve months to September 2015 alone, over 350,000 ESA and JSA claimants were sanctioned [7]. In the Employment Support Allowance Work Related Activity Group the majority of sanctions were of people who have been placed in the group specifically because they are experiencing mental health issues and research shows that benefit sanctions on people with mental health problems has increased by 600% [8].

It is not possible to consider this issue without considering the context of sanctions, cuts and persecution which is endemic in the current system. You fail to acknowledge that attending this proposed therapy may not be explicitly linked to conditions/sanctions but will feel so for many of its prospective clients who are on benefits. There is a structural power imbalance between job centre employees and those on benefits. With their income under threat, those on benefits will be especially susceptible to cues, suggestibility and positive reinforcement when attending job centres. Many on benefits have experienced oppressive power relations for much of their lives. Saying no in relation to an apparent free choice in this context is hugely difficult, especially when saying no has uncertain consequences [9] .

Attempts to coerce people into work are detrimental not only to their health but to their safety and, in many cases, present a risk to life. The extreme fear and distress caused by the current welfare reforms, including changes in disability benefits and the new Work Capability Assessments, is widely reported including instances that have led to suicide [10]. Therapy alongside this coercive system breaches the ethical principle of non-maleficence.

You state that there must be choice as to location of therapy. There is a clear danger in putting DWP representatives into GP surgeries, community centres and food banks that are seen as safe havens for people on low incomes and benefits. The presence of DWP compromises this. DWP/Maximus workers in the GP surgery, with access to medical records, will serve as a deterrent to people visiting their family doctor. The model currently in use in Islington allows Remploy/Maximus workers to access and write into GP records; this jeopardises any commitment to client privacy and confidentiality [11].

The choice of method of therapy is an illusion and therapists of all modalities are subject to the stresses of an unjust target driven culture [12]. We are concerned that under-qualified and inexperienced staff, such as job centre coaches, will be in a position to make referrals to Health and Work programs. This is exacerbated by the fact that referrals are likely to be to IAPT workers, many of whom themselves lack in-depth training and experience of severe mental health issues. Inappropriate referrals are increasingly likely in a target-driven culture.

We are not reassured that the feasibility trials planned by the government will contribute to knowledge and understanding and are not reassured by your echoing what government is saying. Instead you and government must listen to the voices of survivors who describe the reality of government plans on their lives and are fighting for services with a vision of humanity beyond work [13].

It is clear from your public statement that you have failed to critically examine and scrutinise the ongoing activities of the Government Joint Work and Health Unit. We call on you to cease your engagement with this unit and instead hold a national stakeholder event which is guaranteed to involve the participation of representative organisations for service users and therapists with direct knowledge of the area, as well as professional bodies like yours. There should be no government involvement in such an event. From it, a representative group can be selected that will adequately represent the views of service users and therapists to the appropriate government departments as well as to the opposition.


  1. http://www.bacp.co.uk/media/index.php?newsId=3906
  2. https://www.opendemocracy.net/ournhs/dr-lynne-friedli-robert-stern/why-we-re-opposed-to-jobs-on-prescription
  3. https://www.morningstaronline.co.uk/a-a3e3-Joblessness-branded-a-mental-illness#.VuKWT4SFDzI
  4. http://www.islingtonccg.nhs.uk/Downloads/CCG/BoardPapers/20151111/4.3%20Health%20and%20Employment%20Programme.pdf
  5.  ‘Mental Health Advisor – Job Details’ Retrieved from http://www.bacp.co.uk/jobs/jobs.php November 21st, 2015. Available athttps://www.dropbox.com/s/a6p9mod1jb08dne/Mental%20Health%20Advisor%20-%20Job%20Details.docx?dl=0
  6.  http://careers.g4s.com/jobs/Cognitive-Behavioural-Therapist_58526/6 crisis
  7. https://www.gov.uk/government/statistics/jobseekers-allowance-and-employment-and-support-allowance-sanctions-decisions-made-to-september-2015
  8. http://www.independent.co.uk/news/uk/politics/benefit-sanctions-against-people-with-mental-health-problems-up-by-600-per-cent-a6731971.html
  9. For a fuller discussion of these issues, see http://mh.bmj.com/content/41/1/40.
  10. http://jech.bmj.com/content/early/2015/10/26/jech-2015-206209.full
  11. Para 4.3 http://democracy.islington.gov.uk/documents/s6740/Health%20and%20work%20-%20HWB%20update%20Jan%202016%20final.pdf
  12. http://www.pulsetoday.co.uk/home/finance-and-practice-life-news/gps-told-to-inform-patients-dwp-will-obtain-their-fit-note-records/20030820.article.http://files-eu.clickdimensions.com/hscicgovuk-amnje/files/emed3dpnlettertogppracticesv1.0.pdf?_cldee=Y29yYWwuam9uZXNAbmhzLm5ldA%3d%3d&urlid\
  13. http://www.theguardian.com/healthcare-network/2016/feb/17/were-not-surprised-half-our-psychologist-colleagues-are-depressed
  14. http://recoveryinthebin.org/2016/03/10/welfare-reforms-and-mental-health-resisting-sanctions-assessments-and-psychological-coercion-by-denise-mckenna-mental-health-resistance-network-mhr

Letter from psy-organisations to MWF, dated 24th March 2016:

Dear members of the Mental Wealth Foundation,

Thank you for your letter,

It might be useful if we started by clarifying a number of points that we have made repeatedly to the Department for Work and Pensions. We do not believe that anyone should be coerced into therapy and would denounce any coercion or sanctioning in relation to ‘job centre therapy’. As a result of ethical concerns raised last summer around coercion and sanctioning in relation to ‘job centre therapy’ we, as professional psychological therapy organisations, immediately contacted the Department for Work and Pensions. We were also acutely aware of, and remain acutely aware of, the wider context of sanctions and cuts.

Work is not always good for people’s mental health and wellbeing and we too recognize that poor quality, stressful and insecure employment can be detrimental and profoundly damaging. We also do not believe that employment should be viewed as a universally beneficial health outcome. At the same time, however, good employment can help people, by adding security and purpose to people’s lives, thus enhancing their mental well being. There should indeed not be a ‘one size fits all’ approach and we do not support a policy of work as cure.

We share the view that clients should have their current needs, perspective and autonomy respected but we also make it clear that we do not believe the role of therapists should be to get people back to work. Instead, we believe that the role of the therapist should always be to work with clients to help them resolve their mental health issues. We also do not believe people should receive psychological therapy in an environment where they feel uncomfortable and we do not believe client’s privacy should be compromised.

It is nevertheless important to recognise that access to psychological therapy remains restricted and people are suffering needlessly because of this. It is also the case that rates of mental health problems among people who are unemployed remain unacceptably high. There are likely to be a multitude of reasons for this, from loss of sense of purpose, to the stresses of the sanctions regime – and we wish to see all of these factors tackled. Improving voluntary access to psychological therapy for jobcentre clients is therefore a policy which deserves proper consideration and as organisations which represent psychological therapists, we recognise that the provision of appropriate, voluntary, therapy can play a role in alleviating distress.

The DWP has repeatedly told us that there will be no coercion involved or sanctioning of clients who do not wish to enter psychological therapy. It has also said that clients will have
a choice of where they can access their therapy. We have also secured a promise of a thorough evaluation of their planned small-scale co-location feasibility trial, which should provide a clear indication of whether people’s health and wellbeing is genuinely being improved in both the short and the long term. We suggest it is prudent to review these evaluations before prejudging a project that could provide genuine help to jobcentre clients who experience issues with their mental health.

We also note that your letter conflates different projects. Our organisations are concerned with the provision of therapy to jobcentre clients. We are mindful that other projects have
been initiated in regard to the co-location of work coaches in GPs surgeries, and that other organisations have engaged in scrutiny of these projects. We do not believe we are the most appropriate organisations to comment on those proposals, given they do not involve therapeutic coaches or psychological therapy – which is why our joint response made no mention of those plans.

We would also ask you to note that any past job adverts for positions outside of our organisations should in no way be regarded as the official opinion of any of our organisations individually or collectively.

Yours sincerely,

The British Association for Behavioural and Cognitive Psychotherapies
The British Association for Counselling and Psychotherapy
The British Psychoanalytic Council
The British Psychological Society
The UK Council for Psychotherapy

The MWF replied on 12 April 2016, raising further issues and proposing a meeting for further dialogue. At the time of writing, this and other requests to meet face-to-face have gone unacknowledged. 


Mental Wealth Foundation

Mental Health Resistance Network; Disabled People Against Cuts; Recovery in the Bin; Boycott Workfare; The Survivors Trust; Alliance for Counselling and Psychotherapy; College of Psychoanalysts; Psychotherapists and Counsellors for Social Responsibility; Psychologists Against Austerity; Free Psychotherapy Network; Psychotherapists and Counsellors Union; Critical Mental Health Nurses’ Network; Social Work Action Network (Mental Health Charter); National Unemployed Workers Combine; Merseyside County Association of Trades Union Councils; Scottish Unemployed Workers’ Network; National Health Action Party


British Association for Behavioural and Cognitive Psychotherapies; British Association for Counselling and Psychotherapy; British Psychoanalytic Council; British Psychological Society; United Kingdom Council for Psychotherapy

Professional bodies scrutinise Government ‘therapists in job centres’ plans

Thank you for your response of 24 March 2016. We would like to reiterate our invitation to a dialogue around these issues. We are a unique alliance of 17 diverse organisations, representing clients, therapists, campaigners and academics with a unique breadth and depth of perspective. We would very much like to share this wealth of experience and expertise with you; and to understand your position better. We think your members would expect you to meet with us, given the very diverse range of organisations that have united in order to communicate with you.

We appreciate your assurances that you oppose as unethical any coercion or sanctioning connected with psychological therapy’s contribution to the government’s workfare programmes. We also welcome your statement that “[you] do not believe the role of therapists should be to get people back to work”, and that the therapeutic value of employment is conditional both on individual circumstance and the nature of any particular employment and its environment.

At the same time, we are aware that as members of the New Savoy Partnership four of your organisations have welcomed recent workfare proposals, have initiated collaboration between DoH and DWP on Health and Work pilots, and have invited Lord Freud as Minister of Welfare Reform to open a number of your recent annual conferences. Your ‘Joint Pledge on Welfare’  states:

“We welcome the opportunity the Work Programme provides to support more people with mental health conditions into appropriate and sustainable employment.  Specifically, we will develop our expertise to help people with mental health conditions find, enter and remain in employment.” (emphasis added)

We cannot see how your position differs in any significant aspect from that of the DWP and you seem to have allowed yourselves to be drawn into becoming active partners in the government’s workfare policies. We believe – and we know many of your members agree – that the “psy” professions are being let down by our professional bodies going along with government aims and schemes, instead of using their professional knowledge together with service user experience to influence the proper provision of therapeutic services in more appropriate settings, for the benefit of clients and the profession. Clearly your views do in fact differ significantly from ours. Isn’t this something better explored at a meeting?

Over recent months, dozens of adverts for DWP financed mental health advisor and employment coach posts have invited applications from people accredited by you, including as we have already pointed out, those in Therapy Today. These job descriptions are explicit that the role is to get people off benefits and into work. Our concern remains that no action has been taken to inform or protect your members or their clients about involvement in work of this nature which breaches ethical practice.

The top-down nature of policymaking causes alienation and distrust of government workfare policies with a reliance on expert think-tank research, “evidence-based” reports, and a reluctance to engage in any real collaboration with either service users or practitioners.   We are offering you an opportunity to do something different. We believe it is within your role and responsibility, as national professional bodies representing psychological therapies, counselling and psychotherapy in the UK, to hold open an independent arena of public debate on issues of national policy.

We believe your collusion with the government is now threatening to undermine the ethical integrity of the “psy” professions among service user/survivors and professionals. A year ago, our joint letter to the Guardian signed by 440 psychologists, psychotherapists and counsellors raised the alarm about the probability of mandatory psychological therapy coming into being through the co-location of IAPT workers in Job Centres. A year on, the development of Health and Work projects under the DWP’s workfare banner is promoting more, not less fear, demoralisation, and distrust among the members of the organisations the MWF umbrella represents.

As survivors and witnesses of the impact of these developments, we are compelled to act against welfare to work policies and associated government-sanctioned psychological coercion which harms service users and professionals alike. You didn’t reply to our call to cease engagement with the Government Joint Work and Health Unit, and to hold a national event where all stakeholders views can be heard. We would like our campaign to include open debate with the professional bodies whose interests must surely include upholding the ethical values of psychological practice, for the sake of all.

We look forward to your response to our offer.






Is the Science Media Centre briefing on cognitive behaviour therapy trustworthy?


The UK Science Media Centre (SMC) offered to journalists (and any citizen scientists too busy or too lacking in confidence to make their own critical appraisals) a briefing on cognitive behavior therapy .

I offer a quick critical appraisal of the “three top experts” advertised as giving an honest appraisal.

I conclude that what would be offered is highly biased. Any organization making claims that such an evaluation is trustworthy is itself untrustworthy. Please read on and decide if you agree with me.

Meta-lesson: When you encounter a source that screams to you that it is trustworthy, maybe you should be particularly skeptical and simply move on to alternative sources.

The announcement

September 2, 2016

CBT – does it really work?

Journalists came along to the Science Media Centre to discuss issues such as:

  • What exactly is CBT and how does it work? Is it just talking?
  • Where do we have robust evidence of CBT working really well?
  • What about issues like placebos and double-blind RCTs – does it matter if we don’t have the same level of rigour as for drugs?
  • Are there concerns about CBT being overused or misused? Can it cause harm? How do we ensure practitioners have sufficient training in its use?
  • How cost-effective is CBT? Are we using it enough?
  • Can we see a future where psychological therapies replace pharmacological ones for many mental illnesses?

The SMC invited in three top experts to give an honest appraisal of the evidence, to discuss how CBT fits into the wider picture and to explain the pros and cons of this therapy.


Prof. Rona Moss-Morris, Professor of Psychology as Applied to Medicine, King’s College London’s Institute of Psychiatry, Psychology & Neuroscience

Prof. Michael Sharpe, Professor of Psychological Medicine Research, University of Oxford

Prof. Dame Til Wykes, Professor of Clinical Psychology and Rehabilitation, King’s College London’s Institute of Psychiatry, Psychology & Neuroscience

Prof  Til Wykes

I have learned to be  skeptical of UK expertise offered with Dame or Sir in the title. So, having been declared a vexatious American, I’ll simply call her Professor Wykes. But given she is deemed a Dame, I will do her the honor of starting with her first.

Professor Wykes has written an Evidence-based Mental Health commentary that repeatedly screams “Take me seriously.”

 Wykes T. Cognitive-behaviour therapy and schizophrenia. Evidence Based Mental Health. 2014 Aug 1;17(3):67-8.

She attests to the quality of the evidence that she considered:

So is CBTp effective?

All the meta-analyses described here were carried out rigorously. They allow us to draw a picture of a therapy that developed from its roots in medication-resistant positive symptoms to the wealth of new targets and then to the more radical—the prevention of psychosis. Only one recent meta-analysis does not show beneficial effects after accounting for methodology. This odd one out is odd for very good reasons and provides us with a backdrop to understand the treatments required in the future.

For instance in a paradigm changing study for people with continuing symptoms but who refuse medication, Morrison et al19 demonstrated successful treatment by CBTp. This is the first time such an RCT has been carried out and the authors are to be commended on their rigour and particularly on reporting adverse events (2 in the CBTp group vs 6 in the control group). The study challenges the belief that CBTp is only an adjunct to medication treatment in more chronic populations—although we cannot yet conclude that CBTp should be recommended until we have more and larger trials.

I have written extensively about the Morrison et al study in blog posts  [1, 2] and in a letter to The Lancet in which I complained about its quality and the study having been registered after it was already well in progress.

The Morrison et al. study:

  • Lacked an adequate comparison control group.
  • Claimed to be evaluating CBT for psychotic patients refusing medication, but in the course of the psychological treatment, most patients received some antipsychotic medication.
  • Had more authors than patients maintained in follow-up.
  • Relied on voodoo statistics that ignored the large attrition from an already small sample in arriving at a positive conclusion.

I could go on but I think you get the picture of what I think of this study.

Keith Laws also delivered devastating blog posts about the study (such as 1 and  2) with excellent accompanying music selections. With Peter McKenna, Professor Laws also published a  letter in the Lancet. Professor Laws and his colleagues  also authored the meta-analysis that Wyke dismissed as “the odd one out” that “is odd.”

Despite Wyke’s evaluation, Professor Laws’ meta-analysis is much more consistent with what has been offered by the Cochrane collaboration. He and his colleagues delivered a devastating reply to Wykes that leaves the Dame looking rather silly and ill-informed:

Keith R Laws, KR,  McKenna, PJ Jauhar, S The odd one out. Evidence Based Mental Health.

They say:

 Professor Wykes discusses the effectiveness of CBT, contrasting the positive findings of her and co-workers’ meta-analysis in 2007 (Wykes et al, 2007) with our recent finding, in a meta-analysis using similar inclusion criteria, of small effects on positive symptoms that became nonsignificant in blind studies (Jauhar et al, 2014). As well as these two ‘comprehensive’ meta-analyses, she considers three recent selective meta- analyses by: Burns et al (2014), van der Gaag et al (2014) and Turner et al (2014). Wykes makes the point that our meta-analysis differs in its conclusions from these others. We would like to clarify why this may be the case, specifically with regard to inclusion/exclusion criteria and the reporting of effect sizes

It is not immediately apparent why Wykes rejects the obvious explanation for why our meta-analysis had weaker findings than her similarly comprehensive meta-analysis – more recent studies over the intervening years have largely been negative. This interpretation is supported by the fact that only 1 of the 11 studies included in our meta- analysis since Wykes et al 2007, has documented a significant impact of CBT on positive symptoms. Moreover, in the one significant study (van der Gaag et al, 2011) the authors noted that blinding was compromised. It seems inherently unlikely that CBT would somehow work better in treatment- resistant than treatment-responsive patients. To maintain that CBT works against delusions and hallucinations requires rejection of the finding from a comprehensive meta-analysis of little effect against positive symptoms in favour of those of a much smaller one, which employed rather convoluted inclusion and exclusion criteria.

understand-coverProfessor Wykes is on Twitter as @TilWykes, where she lavishly praises a volume she co-authored with other members of the British Psychological Society, Understanding Psychosis and Schizophrenia.

I have offered to debate the authors of this book, but they have consistently refused. In their absence, I have presented detailed critiques in blog posts [1, 2 3] and what I think is at least an entertaining slideshow from an invited presentation at the Royal Edinburgh.

 Prof. Michael Sharpe

 Professor Sharpe has been getting a lot of media attention as one of the authors of The Lancet PACE trial of cognitive behavior therapy and graded exercise for chronic fatigue syndrome. He and his co-authors claimed that would be damaging to their reputations to release the data in response to a Freedom of Information Act request. I did not make my request for that data under the FOIA. I took advantage of the authors having published another study in PLOS One, where acceptance was contingent on the data being available. The authors still have not complied, but they unkindly  labeled me as vexatious for having made the request

While praising the strength of the results and winning praises from the likes of Professor Sir Simon Wessely, these authors and their universities spent over £250,000 resisting the release of their data. Just days before the data were released as ordered, Professor Sharpe publicly conceded that rates of improvement were substantially lower than reported in The Lancet. The discrepancy was due to the outcomes having been switched in The Lancet.

Among the many other problems in the credibility faced by Professor Sharpe and his co-authors is that the prestigious  US Agency for Healthcare Research & Quality has declared Sharpe et al’s case identification used in the PACE trial deficient.

Using the Oxford case definition results in a high risk of including patients who may have an alternate fatiguing illness or whose illness resolves spontaneously with time. In light of this, we recommended in our report that future intervention studies use a single agreed upon case definition, other than the Oxford (Sharpe, 1991) case definition.

Prof. Rona Moss-Morris

 In blogging about the PACE trial, I have said numerous things about Prof. Rona Moss-Morris, not all of them flattering, but never as unflattering as what I have said about Professors Wyke and Sharpe. Here I will only say that Professor Moss-Morris was brought in by the Science Media Centre to offer an expert reaction to the follow-up report from the PACE trial.

I provided a  heavily accessed blog post on follow-up study, an invited critical letter with Keith Laws to The Lancet Psychiatry, as well as a slideshow for a hastily prepared pub talk in Edinburgh that is now received over 14,000 views. I obviously don’t like the follow up study and you can look at any of these materials to see my reasons.

You can go to the Science Media Centre to see  Professor Moss-Morris’ expert opinion. She was quite embarrassed to have been brought in and declared a conflict of interest generally missing in this kind of publicity campaign:

Declared interests

Prof. Rona Moss-Morris: “Two authors of this study, Trudie Chalder and Kimberley Goldsmith, are colleagues of mine at King’s College London. I work with Trudie on other CFS work and with Kimberley on different work.  I published a small study on GET in 2005. I am a National Advisor for NHS England for improving access to psychological therapies for long-term conditions and medically unexplained symptoms. Peter White (another author of the present study) is Chair of trial steering committee for an HTA NIHR-funded RCT I am working on with people with irritable bowel syndrome.”

So, here you have me offering an evaluation of a media event that I did not actually attend. How vexatious of me, but I at least offer ample documentation of my complaints and concerns. Take issue with me in comments here if you like or you can simply swallow what the Science Media Centre feeds to you.

Institutions and websites like SMC which brand themselves as trusted sources should offer independent critical evaluations of claims that investigators are making about their favorite interventions. Otherwise, they are serving as l public relations machines.