The Information Commissioner’s Office (ICO) has ordered Queen Mary University of London to release anonymized PACE trial data to an unnamed complainant. Queen Mary has 28 days to appeal the decision.
The report outlines the scope of the data requested, Queen Mary’s arguments for refusing to release the data and the Commissioner’s justification for siding with the patient requesting the data be released.
Among the reasons cited by researchers for initially denying the request was the fear that the “vocal minority” of patients online would actively attempt to de-anonymize the data and reveal trial participants’ identities.
The complainant initially requested the release of data from Queen Mary under the Freedom of Information Act on March 24, 2014 (Queen Mary has initially responded that they would not release that data since the associated costs would exceed £450). On June 18, 2014, the complainant requested and internal review after which Queen Mary maintained its original position to withhold the data. In December, the complainant contacted the ICO with concerns about how the request had been handled. On October 27, 2015, the Information Commissioner sided with the complainant and order the release of the data.
The complainant requested a version of the dataset that includes the following variables, with all potentially identifying data removed:
• SF-36 physical function scores (range 0-100 points) [baseline and 52-week followup];
• CFQ fatigue Likert scores (range 0-33 points) [baseline and 52-week followup];
• CFQ fatigue bimodal scores (range 0-11 points) [baseline and 52-week followup];
• Oxford criteria CFS caseness (does participant meet criteria, yes or no) [52-week followup only];
• Participant-rated CGI scores (range 1-7) [52-week followup only];
• Doctor-rated CGI scores (range 1-7) [52-week followup only];
• 6MWT walking distances (in meters) [baseline and 52-week followup];
• The group which each participant was allocated to after randomisation (i.e. either to APT, CBT, GET, or SMC).
Queen Mary’s reasons for denying the request
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]”This isn’t a purely scientific debate; this is going to the heart of the integrity of the scientists who conducted this study.”[/pullquote] The reasons cited for Queen Mary’s denial of the request relate to sections of the Act that allow researchers to withhold data prior to publication of the papers on which they are based. In this case, the researchers claimed that since they were continuing to publish papers, they were exempt from releasing the data. They also cited an exemption on the basis that the data contained sensitive medical information from which it was possible to identify the trial participants. They also claimed that if they released the data it might harm their ability to recruit patients for research studies in the future.
In its discussion of personal information, Queen Mary cited the problem of the “motivated intruder” who might try to identify patients based on anonymized data. Specifically they claimed that maintaining anonymity could be especially difficult given the passions of the “vocal minority,” that is, the online patient community. Queen Mary’s reasons for denying the FOI reveal a group of researchers who feel themselves besieged by what they feel is a politically motivated campaign, not the normal discourse of science:
“The PACE trial has been subject to extreme scrutiny and opponents have been against it for several years. There has been a concerted effort by a vocal minority whose views as to the causes and treatment of CFS/ME do not comport with the PACE trial and who, it is QMUL’s belief, are trying to discredit the trial. Indeed, as noted by the editor of the Lancet, after the 2011 paper’s publication, the nature of this comprised not a ‘scientific debate’ but an “orchestrated response trying to undermine the credibility of the study from patient groups [and]… also the credibility of the investigators and that’s what I think is one of the other alarming aspects of this. This isn’t a purely scientific debate; this is going to the heart of the integrity of the scientists who conducted this study.”
Michael Sharpe further explained:
[pullquote align=”full” cite=”” link=”” color=”” class=”” size=””]”…one sees a fairly small, but highly organised, very vocal and very damaging group of individuals who have…hijacked this agenda and distorted the debate so that it actually harms the overwhelming majority of patients”[/pullquote] Richard Horton:
“I think the first thing to say here is that we recruited 640 patients into this trial and there wasn’t a high rate of refusal of taking part in the trial and those patients remarkably, a vast majority of them stayed right through to the end of the trial, they accepted the treatments and they completed our outcome data. So I think it’s very important to remember that if you go out there to the clinics that most patients with chronic fatigue syndrome, all they want is the evidence for what they have to do. There is parallel to that, a very vociferous series of websites and so on, it’s not really the same world as the ordinary patient coming to the clinic. They have been quite hostile in many ways to the findings of the trial and unfortunately also to the people who’ve undertaken the trial and collaborated with the trial,”
“I think this is where one sees a real fracture in the patient community. One is seeing a very substantial number of patients very willing to engage in this study, desperate to get good evidence on which to base their future treatment but one sees a fairly small, but highly organised, very vocal and very damaging group of individuals who have I would say actually hijacked this agenda and distorted the debate so that it actually harms the overwhelming majority of patients,”.
This community actively seeks to identify and attack those who are associated with the PACE trial.”
The fear was that the online patient community would take this successfully de-anonymized data and publish it online:
“…must further consider this greater risk presented for identification with this data set from the highly motivated requestor who will likely publish it on a CFS/ME group website, such as Phoenix Rising, where it will be available to all CFS/ME activists seeking to discredit the PACE trial and its researchers, as has been demonstrated, since they do not agree with the PACE trial outcomes. The risk is maximised by the fact that the CFS/ME patient community is a very small percentage of the population (e.g. estimates at less than 1%) and the PACE trial population already known to be part of that is relatively large and possibly including members of the above. The risk that additional information could be combined with the individual level data to allow identification must be considered not at all far-fetched, although QMUL need not be expected to know exactly what additional information there is presently.”
the request is merely one of a series of requests for similar access to this same medical treatment information, upheld by the ICO on several occasions, including a request by the complainant found vexatious (see FS50558352) as part of a campaign by a small group of CF/MSE activists to discredit research and researchers whose results they do not agree with.
While some participants have volunteered to share their experiences being a part of the PACE trial on social media, there is no evidence of any concerted campaign that “actively seeks to identify and attack those who are associated with the PACE trial.”
Queen Mary also argued that release of the data might diminish trust, make it difficult to recruit patients for future trials, and hamper its ability to conduct future research in the area. And that the release of such data could have wider repercussions for the ability of researchers in general to recruit participants for clinical trials.
In his decision, the Commissioner found that QMUL failed to provide any plausible mechanism through which patients could be identified, even in the case of a “motivated intruder.” He was also not convinced that there is sufficient evidence to determine that releasing the data would result in the mass exodus of a significant number of the trial’s 640 participants nor that it would deter significant numbers of participants from volunteering to take part in future research.
Editor’s note: this article has been updated to better explain the scope of the data being requested and the commissioner’s finding that QMUL provided no plausible mechanism through which participants could be identified given the limited scope of the complainant’s request.
17 thoughts on “Government orders release of PACE trial data”
Mr Horton needs to understand that, if this trial didn’t have the problems that it does and it actually proved CBT/GET valid treatments, then I think a lot of people would be much more open to them. I have been open to them in the past and tried courses of CBT/GET on THREE occasions, each time leading to exacerbated symptoms and relapse. I think that is where a lot of us who dispute the findings of the PACE trial are coming from. If the treatment worked and the data wasn’t spurious, based on a single out-dated method of diagnosis, while failing to chart common neurological signs and symptoms associated with ME/CFS, then there’d be no reason to seek to discredit the trial.
If you believe the data is of poor quality and fails to support the claims that use it as a foundation, then it legitimately and rationally must be disputed and if necessary, discredited. If those in privileged positions disagree with that belief, then it is right for them to do so, but morally one must go forward with one’s beliefs regardless. It is right and responsible to be able to scrutinise scientific data that pertains to the health of millions. Conversely, it is logically wrong to give so much credence to ad verecundiam (arguments from authority) and dismiss patients, their representatives, or interested parties based on a loosely defined group, a subjective perception of intent or unsubstantiated accusations of vexatiousness.
When you make claims about ‘groups’ of people, you run the risk of marginalising the legitimacy of individuals or smaller groups of people within such a banner. Mr Horton, for that and to maintain any semblance of impartiality – a virtue that should surely be intrinsic to the role of ‘Scientific Journal Editor’ you should rightfully apologise.
Very well said! If indeed CBT and GET worked so well, the CFS/ME community would be over the moon. We’re not crazy, but that seems to be the underlying assumption of many in the medical profession. If something helped, we’d be thrilled. We are desperate for help. But when the very treatment which is recommended, instead of helping, actually exacerbates a devastating illness, sometimes with severe consequences, people are going to be vocal about it. It used to be common medical practice to drain blood from patients try to “help” them and many died. If patients had objected, they probably would have been characterized as being unduly vocal etc. as the CFS/ME community now is.
It makes no sense, unless, of course, one believes that CFS/ME patients don’t want to be well so are obstinately refusing to acknowledge the validity of CBT/GET. I suggest the PACE researchers take a look at the well-documented studies showing the extreme debilitation suffered by people with CFS/ME after the 2-day exercise stress test. It’s not all in our heads. Biomarkers for the devastation caused by CFS/ME abound, and they do not go away with CBT/GET. Perhaps the PACE researchers should try a little CBT themselves, to try to open their minds to the reality of CFS/ME.
Wow! My jaw has just dropped to the floor! HIGH FIVE team!
I know we’re not out of the woods yet, but this is SO satisfying!
Why should this study which cost so much public money, and has so many important ramifications for pwME in respect of treatment and welfare benefits, be exempt from having data published. The reasons given by SMUL were ridiculous, almost laughable. Well done to the complainant for their persistence in the face of such opposition, we commend you.
I leave a reaply. Woork and study ME on a good way?
Thanks for this. I find it entertaining to watch the psychobabblers running helter-skelter like a bunch of scared rabbits.
“Queen Mary also argued that release of the data might diminish trust, make it difficult to recruit patients for future trials, and hamper its ability to conduct future research in the area. And that the release of such data could have wider repercussions for the ability of researchers in general to recruit participants for clinical trials.”
Ending psychobabble research is certainly one of my goals.
QMUL are concerned that future recruitment to trials will be harmed if patient data aren’t kept secret. I’m happy to be corrected, but I thought the original plan was to let the government benefits department have unrestricted access to participants’ medical notes.
Wow well done all my long term ME friends!
So many us us did PACE & GET and went from mild ME to severe as a result and have never recovered.
Trust be we would love a life if body allowed. Take my advice from an Ex Advance Personal Trainer & Sports Therapist taking part in triathlons before becoming ill
My understanding is that data should normally be kept from a study and released if anyone asks for it as long as it is anonymised. I do wonder whether we could collect case studies on a website of those patients who believe they have been harmed by GET in order to create a contract sing body of evidence. Whilst clearly the sample would be self selecting it would be a contrasting view point. I’m also worried by the posts that suggests a political campaign rather than engagement with biomedical issues that many of us quote where there is a clear body of evidence. Given the researchers have PhDs is should not be beyond their wit to defend and discuss around the points we continue to make. Some recognition of different criteria and possibility of different subgroups with patients who may be depressed and benefit from GET as opposed to those people with ME who do not benefit and end up with post exertional malaise due to increased lactate levels would be really helpful.
I can understand the initial reluctance of the team at QMUL to release the data in a form where patients might be identifiable – but surely that should not have been an insurmountable problem? Given the controversy provoked by the declared results, of both the initial trial and its follow-up study, I had thought the scientists and researchers involved would have been only to keen to get the data out into the public domain so that their conclusions could be verified but (and please correct me if I’m wrong) this appears not to be the case. And I think most people would agree with Michael Sharpe’s quote (above): “So I think it’s very important to remember that if you go out there to the clinics that most patients with chronic fatigue syndrome, all they want is the evidence for what they have to do.” Exactly what I want. Evidence, not nebulous conclusions. Unfortunately, the evidence most sufferers have is from experience, rather than experimentation, and that evidence does not correspond with the findings of the PACE trial. As to the “vocal minority”, I believe it might be larger if more CFS patients had sufficient energy to protest.
What I don’t understand, is why, on the basis that these interventions work, they have not been rolled out across the country and offered to everyone who has CFS/ME. My personal experience is that I have never had such treatment made available to me. Yes, I have talked about it and my GP is incredibly supportive, but the medical professionals who have been involved in my care do not think that I need it/it would benefit me. Yes, I have also had a psychological assessment and the same conclusion was reached. I understand completely that it has been beneficial to some, which, for them, is brilliant.
These guys are not doing normal science. This is not a normal scientific trial.
If you start, as they do, on the basis that CFS/ME is caused by some deconditioning, but also a lot of worry about exercise, generalised anxiety incl about symptoms, all causing nervous arousal and so called functional symptoms, then a major aim of the “therapy” will be to calm the patient and undermine the cause of anxiety by whatever means, incl, untruths, propaganda etc..
Thus such clinical excursi are aimed at treating a nocebo state, where the nervous system is so aroused as to create physical symptoms, with an appropriate placebo. Placebo vs nocebo. Objective discusssion of the condition or the trial will undermine the placebo – belief in the trial, confidence, will increase anxiety and therefore symptoms.
Talking up the outcome by changing goalposts, releasing positive feedback mid trial etc will boost confidence, counteract patient anxiety and lead to better outcomes, which is the object of the exercise.
It is not science but headology, subjective therapy for what they are still seeing as a subjective illness, albeit with real physical symptoms – a false illness state if no longer spoken of as a false illness belief. No objective illness = no objective trial.
My suggestion – do the triage, do the investigations, do the exclusion diagnosis, find such patients as fit in the above category – truly the worried well, perhaps- and leave the rest of us alone, whether we have b cell abnormalities, ME of late stage Lyme, HHV6, euthyroid hypothyroidism, candida (not a myth Sharpey) adrenal insufficiency, food allergy etc etc. But you won’t find out who is who if you refuse to do diagnosis on the grounds that you already know that we are all basically anxiety ridden hypochondriacs, needing a few well chosen emollient untruths to GET us back on the right track and if you persist in believing that to test and treat is to connive in our “false illness” state.
CBT/GET to no effect graduate, never feared exercise, life ruined since 1985, autoimmunity in family, no tests for 14 years, tests done – plenty wrong. ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Where do this group of Psychiatrists get the impression that those who are against PACE, CBT and GET are a small minority of antagonists?!! Most of the ME Community are against them!!
Where do they get the impression other trials will not get participants? Other trials have been recruiting hundreds of participants for decades with results that defy the PACE trial and it’s psychosomatic nature.
If this trial and these psychiatrists are removed from CFS/ME completely, we will then make biological progress, with more funding into positive future treatments, from positive research that is nothing to do with Psychiatry and rightly so!
Statisticians will be able to analyse the data according to the original protocol. This doesn’t just mean respecting the pre-defined (but then altered) outcome scale boundaries. Perhaps even more crucial is the intention-to-treat principle. As Derek Pheby said shortly after PACE publication in 2011:
‘The analysis was ostensibly on the basis of treatment intention. This is the correct way to analyse the results of a randomised controlled trial, because if the analysis only involves those subjects who complete the trial, it disregards any participants who drop out because of adverse effects, and may therefore give an unjustifiably favourable impression of the treatment under examination.
‘The authors state, though: “We excluded participants from the intention-to-treat population for whom we had no primary outcome data in the final analysis.”
‘In other words, this was not an intention-to-treat analysis at all, since only data regarding participants who stayed the course long enough for outcomes to be assessed were included in it.’
I suspect that this issue is key to the refusal to release the data.
All I can say is thank you for fighting for us affected with M.E.
The last few weeks have been disturbing to say the least.
Like many other M.E suffers I never asked to be diagnosed with this illness that has robbed me of any quality of life and that of my children.
I just wish I could write better but unfortunately I have lost that ability also.
Why do we accept that ME is CFS. Its not, the criterion is different even if the Psychiatrist’s don’t understand. Psychiatry is a belief system, and I speak as a psychiatric nurse. If they were good at dealing with the mentally ill we might have more faith in them. As it is they provide confidence for the general public without ever providing probity. If they had the same scrutiny that school teachers endure not many of them would hold their posts for more than a few minutes.
I think many of the problems with an “ME” diagnosis are how similar the symptoms are to post viral fatigue and since I attended a training event encouraging GPs and practice nurses to “diagnose” ME, I suspect many have had a wrong diagnosis.
This could account for many, who have been told they have ME, but recovered after several months. After all, one of the criteria was to have had chronic fatigue for over 6 months and have no explained other cause. My daughter feel ill suddenly over around a week, so no deconditioning there. In fact she was desperate to have life and keep up with her peers at age 16 but nothing worked and even our supportive GP had never received any training on it.
Just by observation, living 24 hrs a day with the sufferer soon made me realise that no matter how gradually we tried to improve activities, the more she relapsed. Even now, I am overwhelmed with her springback positivity, only to be dashed physically by her body just not letting the brain fullfill it’s ambitions.
The very worse thing about the PACE trial is how so-called health professionals take it as a given, unquestioned, and that it therefore MUST be right. We were once convinced the Earth was flat!
This puts people like my daughter between a rock and hard place, because through the PACE trial she loses credibility and assumptions are made by the uneducated, or more so, the EXPERIENCED who have either lived with it or observed it at close hand.
Look at the disgraced Wakefield trial…of course any trial should be up for questioning as are the ones who set up these trials.
As for the small vociferous few…vocal few, they are the vocal ones. Then there are the many sufferers of ME who have no support, or have lost support and yet they have no energy left to fight. They are the silent majority who do question PACE but their voices are not recorded. My daughter never ventures into these places because she finds it depressing, so there is one for you at least.
When I did some training in research I was told trials had to be triangulated on, from another perspective for their evidence to be surely valid, so why has this not happened to the PACE trial?
No researcher should consider their work so above scrutiny, they should welcome it to be challenged to give it credibility and value. They would then have nothing to fear.
Even IF ME was a mental health issue alone, even in mental health patients should be given the benefit of the doubt, innocent until proven guilty, and the PACE trial is partly responsible for labeling many sufferers of ME guilty of malingering when, as with my daughter, it is OBVIOUS the cannot function when SHE WANTS TO DO.
She recently lost her PIP claim, yet she cannot get out of bed for more than a couple of hours all week!
She WANTS to work, she is NOT deconditioned or demotivated. She is FRUSTRATED.
Help is declined the the genuine BECAUSE of the PACE trial being most likely flawed. It can only be so because it does not work for so many people.
Nevermind harming the PACE research, primarily the PACE “evidence” is hurting patients!!!
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