An Open Letter to Dr. Simon Wessely, Defender of the PACE Study

Dear Dr. Wessely:

I was surprised to see the president of the Royal College of Psychiatrists post a comment on a U.S. law blog.  I suppose this means that I have gotten your attention in the discussion of Chronic Fatigue Syndrome (ME/CFS), and that you feel compelled to respond to criticism of the PACE Study.  That is a good thing.

Regrettably, your comment was petty and defensive, without engaging the actual issues relevant to PACE’s misleading conclusions.  I will not revisit the study’s many scientific and methodological flaws, which have been well addressed by Dr. Keith Geraghty (here) and by Dr. David Tuller in his Virology Blog investigation (here). As you know, dozens of top scientists and clinicians have condemned the study in an open letter to The Lancet, stating that its flaws “have no place in published research.”

Instead, I want to address your rhetoric, which is unworthy of a serious scholar.

You begin by accusing me of not obtaining the “full facts of the dispute before rushing to judgment” – as though the facts are obscure or difficult to locate, when they have actually been discussed at length on numerous platforms. Moreover, my post linked to Dr. Geraghty’s well-documented article, which explains some of PACE’s errors in detail. Your comment relies on innuendo to suggest that there is information I did not consider, when you have no way of knowing what information I did or did not review. (For the record, I have read everything you mention, and much more.)

Even so, you do not point out a single inaccuracy in the Geraghty article. Nor do you specify any other facts that need to be considered.

Tellingly, you do not refute the two problems I specifically identified in my post:  The PACE researchers’ preexisting interest (similar to your own) in arriving at a predetermined outcome, and their resistance to sharing data until compelled by a judicial order.

Regarding conflicts of interest, you argue that “it’s an old trial with consent forms from 2003.” That might be, but the PACE authors promised in their protocol to abide by the Declaration of Helsinki (obviously in effect in 2003) which requires investigators to disclose “any possible conflicts of interest” in obtaining informed consent. the PACE authors failed to tell prospective participants about their close relationships to disability insurers with a clear interest in the results of the study.

Regarding data transparency, you refer to “previous legal rulings” and say that the recent disclosure order is “still contested.”  That is untrue.  The latest order was issued by the relevant FOIA tribunal, which rejected the PACE team’s stated reasons for refusing to disclose their data, and which supersedes any earlier decisions. Queen Mary University of London wisely chose not to appeal, accepted the tribunal ruling, and turned over the requested material. As a legal matter, the issue is settled.

But in any case, so what?  The data are the data – completely apart from the merits of the disclosure ruling – and they clearly show that the PACE results were wildly overstated. It is understandable that the researchers wanted to keep this information from the public, as they managed to do for five years. But that is why there are laws and courts to adjudicate these matters.

This is all of a piece, however, with your reputation for disparaging those who disagree with you.  You have referred to PACE critics as “anti-science,” when in fact they have sought nothing more than scientific accountability for the study’s lapses and increased biomedical research into ME/CFS (as  endorsed by last year’s major reports from the U.S. Institute of Medicine and the National Institutes of Health). You ignore the work of prominent U.S. scientists, in laboratories at Columbia and Stanford Universities, who have made progress identifying potential biomarkers for ME/CFS, which undermines your theory that the illness arises from “false beliefs.” Do you believe that Professors Ronald Davis, Ian Lipkin, Mady Hornig, Vincent Racaniello, Ellen Clayton, and Bruce Levin are anti-science, despite their appointments at prestigious U.S. universities?

You have claimed that “activist” ME/CFS patients pose a serious threat to you, famously saying that you felt “safer” in Afghanistan than studying ME/CFS, and insisting “that is not a joke.” You stood by when the press reported that patients were “considered to be as dangerous and uncompromising as animal rights extremists,” which is flatly untrue. You helped spread stories about a “campaign of intimidation” against you and the PACE authors, which were tremendously exaggerated, to say the least. 

For years, these claims of harassment were invoked to resist disclosure of the underlying PACE data, until the tribunal ruled that the evidence simply didn’t support the claims. The FOIA tribunal found that the purported campaign of intimidation boiled down to one instance of heckling at a seminar, and referred to the researchers’ “apocalyptic” argument as “grossly exaggerated” and a “vast logical leap.”

Finally, you point to your own blog post, which ironically undermines your very point.  You compare the PACE Trial to an ocean liner plotting a course from Southampton to New York, and express satisfaction that it made the trip “successfully across the Atlantic,” despite course corrections along the way.  But surely you realize that a randomized controlled study is not supposed to have a fixed destination, but rather should follow wherever the evidence – or the current, to maintain the metaphor -- leads.  You thus virtually admit that the PACE Trial was always intended to reach a particular result, and that adjustments along the way were necessary to get it there.  Just so.

If you are still reading, I hope that you will consider answering the following questions:  You claim that ME/CFS arises from “unhelpful illness beliefs,” but how can that theory be falsified?  What would it take to convince you that you are wrong?  Unless you can satisfactorily answer these questions, I fear that you fall into Thomas Kuhn’s category of those who are unwilling to give up their paradigm in the face of new information.

ME/CFS research deserves serious attention from scientists and physicians, which is finally happening in the United States and elsewhere.  Patients deserve respect. Your insistence on defending the indefensible PACE trial, and your patronizing jabs at critics, disserve everyone, including yourself.

Sincerely,

Steven Lubet

Comments

[Anne]

Thank you for this excellent response to Simon Wessely's complacency.

[Richard]

Touchdown Lubet. I've always been curious with regards to Simon's attitude to PACE. I wonder whether his defence of the trial and its authors is a case of loyalty and legacy protection or if he truly believes that PACE was a piece of scientific art. Which is worse, a conflict of interest clouding his judgement or a total lack of awareness as to what is required to design and undertake a successful and enlightening clinical trial? Neither reflect well on him or the trial authors.

[David Tuller]

Excellent, Steven, and a terrific point about Dr. Wessely's ocean liner. Dr. Wessely needs to understand that the kind of linguistic pirouettes he and his colleagues have perfected to avoid ever addressing the real problems with the PACE study are no longer working. Everyone can see through their misrepresentations. Everyone can see that the PACE authors manipulated their data, weakened their main measures, and then reported outcomes much better than those they would have gotten had they stuck to the protocol--which was, after all, the plan upon which they received funding and approvals. They--and their colleagues and enablers, like Dr. Wessely and Lancet editor Richard Horton--have been exposed as the cheerleaders for the anti-science, anti-reality faction.

The PACE authors might have salvaged their reputations, honor and dignity had they published their original findings and acknowledged that their favored therapies DO NOT WORK. Dr. Wessely, as their colleague and mentor, would have salvaged his own reputation, honor and dignity had he urged them to do so. Instead, they all covered up what we now know to be the truth--PACE was a complete bust.

[Trish Davis]

Thank you. I do hope SW reads this and ponders his position.
He seems to have no understanding of how science works. Rather he is determined to continue believing and promulgating a disproved theory and denigrating patients.
I say it is a disproved theory because all the trials - FINE, PACE and other smaller ones, show that the treatments based on his theory of false illness beliefs and de-conditioning do not demonstrate any long term benefit. They are null trials. He also ignores completely the mounting evidence of measurable physical malfunctioning in ME patients and the many reports of serious worsening of patients' condition after attempting graded exercise.
To defend bad science in the face of all its failings is indefensible.
This is not the behaviour of a rational doctor.

[Tanya Marlow]

Wow. Thank you for this.
You've said what patients have been trying to express for years - much appreciated. The British psychiatrists who advocate behavioural therapies for ME don't have a lot of science to back them, but they sure do well on the spin - and every new outlet here laps it up unquestioningly. It's so good to have this rhetoric exposed.
From an ME patient in the UK, who was made permanently disabled by Graded Exercise Therapy - the therapy Simon Wessely claims cures ME patients.

[Sue Wilson]

It makes me hugely emotional (unusually so!) after years of being stigmatised with ME that very experienced professionals - lawyers, journalists, scientists and more - are speaking up to reveal the truth about ME on behalf of patients and for the reputation of good science. Your integrity is greatly appreciated. A big thank you.

[Simon Wessely]

Dear Dr Lubet
I am afraid that I did indeed jump to the conclusion that you had not looked in the detail I would have expected at the "case for the defence". Your blog seemed to me not to reflect what I know about the subject in general and PACE in particular, which is why I made what I am perfectly happy to accept was an erroneous conclusion. In a way I am now more, not less, surprised, by your blog, because I do think that the story is not as simple as you lay out, and you haven't convinced me otherwise.
The PACE authors have indeed responded to the many claims and allegations about PACE, most of which were sadly repeated in the comments that have appeared in response to your blog and my brief interjection. They will respond in due course to a couple of new claims - i will leave that to them.
I am also happy to clarify my use of the word "contested". I am not a lawyer, and I can see that could easily have been interpreted in a way I didn't intend. I meant that the field of consent, data sharing, open data and the like is indeed an area that is contested, as is clear from numerous articles, blogs, letters and so on that have appeared in the last few months on this, as I am sure you know. You write in a clear cut way in which "PACE is bad/wrong" etc and no reasonable person would think otherwise. But I have to differ on that and I know I am not alone. My reading is that this area is nothing like as clear cut. I suspect that there will be more cases, judgements and decisions still to come, and we are a long way short of knowing how this will end.
I also take issue with your reading of my nautical analogy. It was not about the evidence - the results are the results - but about how a trial is conducted. and on that matter, unlike the law, I do claim some expertise.

As for the rest, I stand by my comments. In answer to the question asked by another contributor, yes, I stand by my opinion of the PACE trial and in particular the key findings as laid out in the 2012 Lancet paper. I am of course aware of the hostility such sentiments engender from some quarters. I have looked at the responses since I posted, and they contain few surprises. Yes, it would be easier just to leave well alone and walk away. But it is because I do believe that the studies of CBT and GET for CFS (including but certainly not restricted to the PACE trial) are sound, and currently remain the best evidence that we have for anything that can offer at least some help for sufferers, that I think it is worth putting up with the slings and arrows that inevitably follow.
So to conclude, I genuinely apologise for my opening suggestion, which was made in good faith, but am happy to accept was erroneous. As for the rest, I think it's one of those "we will have to agree to disagree"
SW

[Aaaa]

Excellent Letter.
I've always suspected Wessely was deluded, this doesn't change my mind.

I wonder will he suddenly be too busy to reply.

[Steve L.]

Dear Dr. Wessely: Thanks for your civil and measured reply.

I understand that you intended the nautical analogy to apply only to the conduct of the study, rather than the results. But surely you know that the choice of a metaphor can be unintentionally revealing.

Be well,

SL

[clark ellis]

I had rather got the impression that Simon Wessely was an impartial observer, but as you point out he shares the same views as the PACE investigators and they quote his prior research in the PACE papers.

What's more, he did actually have involvement in the PACE trial itself.

He is mentioned by name three times in The Lancet paper's acknowledgements, 2011. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/fulltext (MY BOLDING below).
"The centre leaders were BA, TC, Eleanor Feldman, GM, MM, HO, Tim Peto, MS, PDW, DW, and SIMON WESSELY. The centres were at St Bartholomew's Hospital, London; Western General Hospital, Edinburgh; King's College Hospital, London; John Radcliffe Hospital, Oxford; Royal Free Hospital, London and the Frenchay Hospital, Bristol (all UK)."

"...specialist medical care doctors: Janet Andrews, Michael Broughton, Frauke Fehse, Eleanor Feldman, Janet Gray, Michael E Jones, Tara Lawn, Brian Marien, Tim Peto, Angharad Ruttley, Alastair Santhouse, Adrian Vos, and SIMON WESSELY. Kathy Fulcher, Tom Meade, C L Murphy, Anthony J Pinching, and Rajesh Shah contributed and provided advice about the study, and Kurt Kroenke, Jan Scott, Peter Tyrer, and SIMON WESSELY commented on an early draft of the report."

And in the PACE trial's protocol, 2007, he is mentioned three more times. “The authors thank Professors Tom Meade, Anthony Pinching and SIMON WESSELY for advice about design and execution.”

So to summarize, it appears from these acknowledgements that he was involved in the PACE protocol's design and its execution, he led one of the CFS centers used in the study and he was one of the standard medical care doctors involved in one of the arm of the study itself, and he commented on a pre-publication version of The Lancet paper.

Given his position at the Science Media Center, and its heavy promotion of the PACE trial, I also wonder if he had any involvement in this area, but I do not know. I hope that if Simon Wessely replies to this blog he will answer this question also.

[Trish Davis]

The Titanic comes to mind.

[Ro]

Thank you. I too would like to know what is needed to convince Dr. Wessely that he is wrong.

[David Tuller]

It is true, as Dr. Wessely says, that the PACE authors claim to have responded to the various concerns about their study. However, their answers, which they have repeated in multiple venues, have been unsatisfactory and non-responsive. That they disclosed their conflicts of interest in The Lancet is not a legitimate response to why they did not disclose the same conflicts of interests--their work with disability insurance companies--to prospective participants before the study, as required by The Declaration of Helsinki. They have said that a reviewer asked them to conduct the contested "normal range" analyses--but they have never explained why they used the wrong statistical method to obtain these ranges and ended up with a sample in which 13 percent met one or both of these "normal range" thresholds at baseline. They responded to my investigation in a letter to Virology Blog: http://www.virology.ws/2015/10/30/pace-trial-investigators-respond-to-david-tuller/
And I rebutted their responses here: http://www.virology.ws/2015/10/30/david-tuller-responds-to-the-pace-investigators/
It is clear that they have provided linguistic jujitsu and obfuscation to all the concerns raised, notwithstanding Dr. Wessely's insistence otherwise. The medical world in the UK has accepted these non-responses as legitimate and sufficient. I find them utterly inadequate, as do all the experts who signed the open letter to The Lancet.

[Professor Jonathan Edwards]

Many thanks to Steven Lubet for a measured critique.

In response to 'Ro' I think we can be fairly sure now that convincing Dr Wessely is not an option. He has made it very clear in the media (and also in personal correspondence) that he simply does not understand the basic requirements of trial methodology. He makes comments that reveal such a lack of understanding repeatedly, as have Dr Peter White, Dr Sharpe and a number of close colleagues. If they are not capable of understanding then at least that explains the poverty of the study design and how it came to be published. It seems that in the psychiatry community issues such as systematic bias are not understood.

The problem we now face is in ensuring that people with this lack of understanding are not involved in further research of this sort. Internationally it seems that perceptions have changed significantly, but in the UK there is a worrying lack of colleagues prepared to stand up for good science. (I seem to remember ironically someone else being lauded for such an act.) I suppose that now that I have emeritus status at UCL I can say what I think and that may not be easy for others, but the silence is beginning to be deafening.

[Jamie McMillan]

I am not surprised that Wessely feels bound to defend what has been shown to be probably the clearest example of prejudice-driven science since Kammerer faked his Midwife Toad results in the 1920s. It is either that or accept that his support of rigged science has shown him unfit to lead a scientific body.

It is hard to decide whether he is now doing more harm to patients or to medical science as a whole. The most honourable thing to do would be to step down.

[Uab9876]

The PACE authors have never addressed most of the criticism of the PACE trial. They have done their best to restrict access to data from the trial so that patients are denied their right to get accurate information about treatments. Answers have always avoided the major questions and continue to do so.

In doing this the PACE authors and others such as Wessely have run a campaign that has the effect of stigmatizing patients. The press stories about harassment are not accidental the SMC boasted about organizing the in one annual report.

We also have minutes from the MRC concerning a meeting where it is declared that the worst form of harassment was FoI requests and parliamentary questions. This is not harassment this is people using the basic methods to bring accountability to those who are in public positions and paid for by the tax payer. Perhaps the scandal here should be that those taking public jobs and money are calling democratic mechanisms to keep people accountability harassment.

If people like Wessely and White resent and refuse measures of basic accountability they should resign from their public positions.

[zephyr]

@ Jonathan Edwards "Wessely does not understand the basic requirements of trial methodology." A bit unfortunate, as he was director of the Clinical Trials Unit which ran and oversaw PACE, and co-author of a standard textbook, Clinical Trials in Psychiatry.

@ clark ellis See above. He's all over the trial - planning, execution, analysis, media spin, you name it. Probably a case of strategic anonymity. They had enough problems recruiting patients, but just imagine the response if his name had been on the tin.

[Neil Harris]

Mr Wessely can never backtrack from his views around M.E./CFS. He'd be undermining the career he's made out of perpetuating the myth of M.E./CFS as a psychiatric illness. He's even got a knighthood out of it. He's a hero among psychiatrists for successfully hijacking the illness and providing many of his colleagues themselves with careers. What would he be doing without his work on the illness? Probably working in Harley Street, selling old snake oil in new bottles. But he wouldn't be able to ring up the Times or the Guardian and get them to publish articles attacking his critics, or get away with publishing bogus studies in once respected journals.

[Noreen Murphy]

@ Dr. Wessely "I do believe that the studies of CBT and GET for CFS (including but certainly not restricted to the PACE trial) are sound".
Therein lies some of the problem. You *believe*. Fortunately, beliefs are not science. But it suits you to continue with your false beliefs.

@ Prof. Lubet I notice Dr. Wessely didn't answer your questions. But then, how could he?

Sadly, he still has clout in the U.K. and continues to wield it to the detriment of patients.

[Giles Meehan]

So, this man has tellingly refused to answer your question: would any evidence ever be able to persuade him that he is wrong? I wonder if the only time he changes his beliefs and rhetoric is when his reputation amongst his peers is threatened. In the meantime, tens of thousands of sufferers in the UK are harmed and bullied by medics.