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

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

Take my word for it, it’s an apple…

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

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

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

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

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

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

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

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

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

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


 

UPDATE:

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

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

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

10 thoughts on “PACE Trial’s Forbidden Fruit: Why We Must Be Allowed A Look Inside

  1. Pingback: Apparently, I’m a dangerous, activist nutcase | me, mine and other bits

  2. Beautifully written and argued! Thank you.

    It seems to me that there are some in the medical world (and many elsewhere) who do not understand what it takes to be scientific. Scientists can spend years, even a lifetime, working at one idea, only for evidence to turn up that the idea is wrong. Or they can present their findings only for some youngster to find a major error in their analysis. Science, like mathematics, is harsh. But that doesn’t mean that they are regarded badly by their colleagues: well, not unless they have been hiding data and refusing to release details of their analysis – then they are in trouble. To be a scientist a person needs to have a deep desire to find the truth: a good reputation comes as a consequence of this.

    It also baffles me why there are some in the medical profession or in research who believe that becoming a patient robs people of their intellect, as though there aren’t any patients with ME capable of analysing such data. But then, how sophisticated do you have to be to understand that a measure of recovery cannot be below an entry level for a trial?

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    • Thank you Graham, that’s very kind of you. I agree with your comments, it’s really important that those who do understand science (and there are many good scientists thankfully) challenge bad science when they see it, and I suspect there is no trial out there that is so prominent and influential, yet so poor, as PACE.

      I also I agree with your point that patients must not be excluded from the analysis of science. How many of the millions worldwide with ME/CFS would be working or training to be scientists if they weren’t sick. Many already are qualified but too sick tools down the job on a regular basis.

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  3. Great article aimclarkellis! It sums up the scientific issues so clearly, and the way patients’ voice (ALL patients’ voices) have been silenced by stereotyping them as crazy militant activists. Well done!

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  4. A brilliant essay. You say it all.

    For the record, in the US the best estimate for the number of patients with “ME/CFS” (Canadian definition 2003) is over one million. Even CDC admits that 85% of them – that’s over 850,000 people – have no diagnosis, 27 years since the name “chronic fatigue syndrome” was created and the history of M.E. (myalgic encephalomyelitis, known in the US as epidemic neuromyesthenia) discarded. What an epic failure.

    What will it take for this disease to get the recognition necessarily to understand its causes and find treatments? How long can it remain buried by “biopsychosocial” researchers who insist it is really “false illness beliefs” and that patients who collapse trying to follow the prescription of graded exercise are only afflicted by “persistent refusal syndrome”? How can anybody take this claptrap seriously?

    Oh dear. I have criticized the gods of psychosomatic medicine. Poor babies.

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