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

[Barry]

"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" ... means nothing. Dropping bound women into water to see if they would float, was once deemed best evidence they were witches. To take incredibly slim indications, and call them best evidence, is dreadfully irresponsible and wrong, especially when so many real people's lives have been, and are being, shattered by such dogma.

[Debra nice]

FANTASTIC LETTER " thank you very much 👏 from #pwme. Simon wessely never liked to think he's wrong!.I feel he was the one "VEXATIOUS" TO ME PEOPLE. He never liked us ME PEOPLE. Shocking he as got away with harming.

[RichasAA]

This is a remarkably polite and civilised discussion, my assumption is that it is being strictly moderated (good).

Meanwhile can we not that Wessely has been deeply associated with private insurance firms attempting to reject disability claims. That he was deeply involved in the development of the Work Capability Assessment and the ESA with the knock on to PIP and more.

Essentially private and then state insurers for the disabled, dealing with income replacement insurance or state benefits have spent decades trying to minimise their costs by denigrating the disabled as either liars or scroungers or in the US in particular defining a physical illness that has potentially decades of income replacement insurance as a psychological one capped at six months.

They never quite managed that so instead the insured faced regular reviews, lies and surveillance. Many falsely denied their insurance, others ground down over time to accept a one off settlement.

The medical position taken by Wessely and co that "entirely coincidentally" lined up entirely with the firms paying them's self interest and the governments keen to reduce disability payments under our social security system is still being maintained.

They get honours, we get financially stiffed and for some that denil of benefits leads to suicide.

On the plus side we get the film I Daniel Blake aand those that helped set up this system get condemned to hell. Pity they get to live so well in the mean time.

[Ro]

@Barry: Dr. Wessely seems to be admitting here that he has nothing but crumbs to offer patients. The irony is that Dr. Wessely & Co's biopsychosocial model has dominated the scene and financially impeded biomedical research that could instead lead to useful and significant outcomes for people with CFS/ME. This case fascinates me, and I do look forward to reading a book on the matter in the not-too-distant future.

[Matt]

The PACE Trial is dead. Its design, execution and interpretation are fundamentally flawed. History will inevitably record its infantile stupidity.

Patients have reported and continue to report harm from GET.

No large scale and independent investigation into this harm has been conducted.

Studies showing abnormal and damaging physical responses to exercise are now varied and numerous.

The point at which those obsessed with GET as a treatment can claim to have simply been wrong and step aside is evaporating. We have begun to witness a career protecting, self-serving, rear guard action that wastes money, destroys lives and will inevitably bring shame upon British psychiatry. At a time when the mental health need in the UK is so high and terrifyingly unmet, you will be able to say 'We wasted our resources on failure, negligence and vanity'.

The IACFS/ME conference this year presented so much compelling and overlapping research from around the globe that for the first time, understanding the nature of this illness and the search for a cure seem closer than they ever have.

The Science Media Centre may have conned the liberal media into oppressing the oppressed for the time being. But the facts are still the facts. Every time the Wessely School acts on ME/CFS, another error and another injustice is committed, each time generating more and more evidence.

Never before have so many strong, academic, journalistic, advocate and educated patient voices been heard in chorus, opposing the Scientific failures and inaccuracies of 'Oxford CFS'.

The AHRQ have moved to disregard studies on Oxford CFS when considering the ME/CFS literature.

The IACFS/ME, a conference full of renowned ME/CFS researchers applauded when PACE - a crime against science and humanity was torn into pieces and rightfully so. We the patients applaud along with them.

[Maya]

Brilliantly written, thank you so so much. Hugely valuable, deeply appreciated.

[John]

I can't think of any other reason for a knight to respond to a US law professor's blog post but utter desperation.

And why a knight didn't think a US law professor would respond with a total take down is beyond me.

Wessely is way too use to getting his way with the message. Bigly.

[DGP]

We know beyond any doubt that this is a physiological disease and it is backed up with recent credible medical research done by award winning doctors. Also, that there have been decades of disservice done to patients who are truly, devastatingly ill but are unable to get the help they desperately need because of so much psychological and self-serving falsehood. So I suppose my satisfaction comes from the fact that I believe that God is judge, sovereign, all-powerful and all-knowing... and Simon Wessely and many others have a lot of innocent blood on their hands that they will someday have to answer for. If they choose not to believe that themselves, then I suppose someday we will see, won't we?? Because if I'm wrong about God then I have only wasted my life, but if they’re wrong about God then they've wasted eternity... in which case they will still have to answer for what they have done.

[Art Vandelay]

As other commenters have pointed out, Wessely's response to these excellent questions is yet more obfuscation and waffle. If past experience is any guide, he will now claim that he has successfully dealt with the issues raised and that "there's nothing to see here".

When it comes to the BPS school, the crowd has finally cottoned on that the Emperor is wearing no clothes and, Prof Wessely, they are indeed pointing and laughing at you.

[Sue Wilson]

It took a legal trial for PACE related people to tell the truth that there have not been threats and aggression against them. So nothing short of taking an oath to tell the truth, the whole truth and nothing but the truth will lead to honest answers to questions.

[Sue Wilson]

Following much balanced reading of letters from both PACE supporters and PACE critics, one thing jumps out at me. The PACE authors did not adhere to the Helsinki agreement. Surely (legally?) this is an overriding factor that makes the whole PACE trial invalid and should require it's findings to be retracted?

[Keith Bradbury]

It has all been said above. My only other very personal offering are that this man's views have ruined my life for 31 years.

[Nasim Marie Jafry]

Prof Edwards says, 'but in the UK there is a worrying lack of colleagues prepared to stand up for good science' - this is indeed a problem and is one of the reasons that Wessely and co have been able to dominate the ME narrative for past 25 years. It beggars belief that - because Simon himself simply believes that ME is perpetuated by false illness beliefs - he has been enabled to influence (often potentially harmful) treatment so heavily in UK. As I have said a thousand times I have seen this play out, I have seen the narrative shaped. I was diagnosed in an NHS neurology clinic in 1984 after becoming severely ill - like others - after an outbreak of Coxsackie B4 in west of Scotland in early 80s. Since then my illness has been traduced by this hijacking core of doctors, who simply don't listen and happily conflate ME with chronic fatigue ( though in the small print they might acknowledge they are not the same thing). Their beliefs are endlessly parroted by a sycophantic mainstream media, resulting in a highly misinformed public. Thank goodness for international science/journalists and for those UK doctors like Prof Edwards who are willing to speak up for truth. According to the PACE team, myself and other longterm classic ME suffererers apparently have a synchronisation of somatisation - amazing how we have managed to sustain our beliefs for over thirty years. Amazing!

[Craig Morris]

Thank you so much to the people standing up for those too weak to speak for themselves or who have done in the UK but whose weak voices have been ignored. Go USA! Hopefully some US science can pierce the shroud of ignorance and indifference hovering over UK medicine.

[Anton Mayer]

I'm glad there are academics who are willing to defend patients from PACE trial pseudoscience. The public has been misled, with disastrous results.

[Dr Paul]

I'm an historian and also have ME. Professor Wessely's adhering to a discredited theory is very familiar to me. I have been involved in a dispute over a minor aspect of British political history of the mid-twentieth century, and have seen adherents of a rival point of view been disproved on many occasions, with their methodology convincingly refuted, their evidence shown to be based on secondary details, and their findings proven to be faulty. Nonetheless, the rival school has never accepted this and continues to promote its ideas. It is the same thing with the Wesselyans: it takes a big man to accept that he has been barking up the wrong tree for several decades: his whole professional reputation would be undermined, not to mention his ego.

The dispute in which I have been involved has few consequences beyond the odd paper or appointment refused or PhD award delayed; the refusal of the Wesselyans to consider that they are wrong, however, still impacts upon thousands of ME cases in Britain. I do not believe that the Wesselyans are arguing in good faith these days: the evidence increasingly proves that their psychological explanation for ME is wrong and that it is a physiological condition. They are merely defending their reputation, despite its being one which grows more tatty each year. If any Wesselyan does declare that he has been getting it wrong, then I will be happy. But I somehow feel that we will be waiting a long time before that happens.

[johnnyd]

Reading the blog and the Professor Wessely's reply-on record as saying PACE is sound (if that is so, it would have extraordinarily consequences to on the order of a million people or more, so I hope that none of us lose sight of the humanitarian issue)-an observation and question occurred to me:

First, as an observation, he cites nothing as evidence for this belief. Sorry, but this is not good enough in science, especially when the vast majority of Myalgic Encephalomyelitis patients strenuously object, and when there is strong evidence to support their belief this is a disease with a biological mechanism (rather than one more aptly described as incorrect beliefs or views; only "biological" in the sense all human function is biological--just as all biology is reducible to chemistry and so on). Where is the evidence?

Second why is Prof. Wessely's "belief" more sound than a patient's, or a biomedical researcher's, ipso facto? I submit it isn't. What would make it more, or less, is the quality of the evidence and logical reasoning behind it, which was not shared...

I believe you hit the nail on the head when you said the "biopyschosocial" model is fundamentally unfalsifiable. For instance, even using an inappropriate definition, the Oxford 1992, many groups in Britain have found evidence of HPA dysfunction, this evidence and evidence from biomedically oriented research groups (decreased NK activity, abnormal cytokine profiles, abnormal blood volume, increased neutrophil apoptosis, abnormal metabolomics--to name only a few) are explained away by the biopsychosocial model as some form of "advanced deconditioning." Furthermore because the biomedical studies often have small sample sizes, they explain these results away as poor investigations producing artifacts:

When realizes it is *because of* the dominance, and widespread adoption, of the "inappropriate illness beliefs" model that such biomedical studies are funded little in the first place this line of reasoning is exposed as dangerously arrogant and circular...

It is an unarguable fact that in the words of Lord Freud "We have gone for the biopyschosocial model." Indeed, from a pure, amoral, economic viewpoint this model has much to commend it: patients can be denied extended disability benefits and there is no need to invest money in the, comparatively, expensive and technologically demanding biomedical research. The fact that the medical community in the UK and to a large extent in the USA has adopted the "illness beliefs" model over the last two decades has had real consequences...

People are dead, who had things gone another way, might yet be alive.

I implore readers, don't accept the my verdict or that of Prof Wessely or even Dr. Tuller, or even Steven L. Read the PACE Trial series on virology blog and then the source documents, including the data now available that the PACE team spent over £200K (!) to keep secret. Decide for yourself. But please do decide. For researchers there is an excellent overview of M.E. by Dr Byron Hyde on Amazon and another by Dr. Kenny Demeirleir.

There is also an excellent history of the disease in the USA 1980~1996 by Hillary Johnson, named "Osler's Web." It is both thorough and highly readable.

Getting this issue wrong (whether due to conflicts of interest or just naively) will cost many lives, as I believe it already has...

[Miriam Wood]

One of my friends who has severe ME and lost a degree, a career and her plan to marry and have children to this overwhelming condition, once said that the only way to make Wessley understand the condition was if he had it himself. However she added that she would not wish this illness on her worst enemy. It really is true though. Until one experiences ME first hand and understands it from the inside out, how can someone like Wessely really know how terrible it is? Until he has felt so ill that he can't get out of his bed and feels like death warmed up and people tell him that he ought not to believe that he is physically ill, when he is told that he ought to be still out there working, not lying around imagining that he is ill, how can he understand what it is really like to loose everything. To experience this 'living death' is probably the only way that Wessely would be able to change his mind about ME and the method to combat it.

[Max Banfield]

Methods of measuring and treating the chronic fatigue syndrome and confirming that it has a physical basis and is not "an unhelpful illness belief" can be seen in my 1982 research, now published in the British Medical Journal here http://www.bmj.com/content/347/bmj.f5731/rr/680738

I have been doing this type of highly controversial research for almost 40 years and received massive amounts of ridicule and criticism but everyone copies my methods, and then invariably make mistakes which they can't fix but I can.

As an incidental comment; I don't feel unsafe when I walk the streets. Max Banfield

[1Canary]

I have read many several articles regarding the PACE study controversy this year (though certainly not an exhaustive review) + their associated reader comments. These articles include many comments posted by patients confirming their certainty that the misguided treatment approaches endorsed by PACE are not only unhelpful but downright dangerous. I'm struck by the fact that I've yet to see a single comment by a CFS/ME patient indicating such therapies have been helpful, including anyone who may have been part of PACE or any other such trial.