A Mock strawberry: No it’s not poisonous, despite what you may have heard. Just tasteless.
A freedom of information (FOI) request
was submitted to Queen Mary University London (QMUL) in 2014 for a small portion of the PACE trial data (below I go into detail about precisely what data has been requested, and you can skip ahead
if you want to). QMUL refused this request. The case went to the ICO who agreed with the requester and ordered QMUL to release the data. QMUL have appealed this decision and the tribunal will take place in 2016 with the court deciding whether QMUL have to release the data, or not. The outcome is impossible to predict, but it’s important. I wrote previously about why we must be allowed to see the data
Here is my opinion: For ME/CFS, this tribunal case is one of the most important things that will happen in the whole of 2016. It’s outcome will affect millions of us for years to come. So I consider this important. Very important.
I’m not sure all ME/CFS patients realise how much PACE affects their lives. PACE is the cornerstone of the behavioural model that dominates how ME/CFS is perceived by government agencies including the NHS, the media and the public. It dominates how the disease is treated, not only in the UK but in many other countries around the world. It dominates how research money is spent (more behavioural studies rather than biomedical studies that might actually lead somewhere). It dominates social security policy that ultimately affects whether you get the support you need to live when you are crippled by the disease.
If you think that as PACE was studying those diagnosed with the Oxford criteria and therefore it doesn’t affect you, think again. The authors use the term myalgic encephalomyelitis in their protocol, their paper, and media statements, alongside chronic fatigue syndrome, and this important limitation to the study (uselessly broad criteria that mean people with other diseases are included in the study) has not held it back from being used to blight the lives of those with ME or CFS defined by a stricter set of criteria. So this matters to all of us no matter what we think of the names, or whether more than one disease is represented by these labels.
The study has been fraught with problems, the design was a shocker, there have been concerns over safety, reporting of results and misrepresentation of data, and the hiding of data that does not support the authors pet-theory of a behavioural model of disease. Without visibility of the data the authors conclusions cannot be put to test and undergo normal scientific scrutiny. So it is essential that we get to see the de-identified data.
In relation to this case, QMUL have said that they are “seeking….advice of patients…” No details are given of how QMUL is seeking this advice of patients. We have not been told how patients are being selected, how QMUL are presenting their request and what information they are providing the patients with, or how patients wanting to provide advice (me, for instance) can do so. This concerns me greatly as the authors of the PACE trial have repeatedly attempted to set themselves up as an unofficial mouthpiece for patients; they tell government agencies and the public what we apparently want and think, they have huge influence in this area, and yet none of them, to my knowledge actually formally represent any patient organizations – and given their research positions it would be inappropriate if they did. These are researchers who give treatment in clinics and in trials to patients. They do not formally speak for patients. And it’s just as well, as they make all kinds of statements without foundation:
QMUL and the PACE authors have repeatedly misled and propogated misinformation with regard to FOI requests for data from the trial, painting a picture of requesters are harassers and of individual patient’s personal data being at risk (click here for a list of examples that I have just started putting together – please leave a comment there if you have spotted others), but this is nothing more than a tactic designed to avoid transparency. Even if we trusted them to follow a transparent and appropriate process when contacting patients for advice, the statements they have already made are highly likely to have biased much of that patient feedback already.
I think it essential to ensure everyone knows exactly what data was requested. These are the data points, below – and only this data – that will be released should the tribunal reject QMUL’s appeal.
• Total SF-36 physical function scores at baseline and 52 weeks. Patients filled in a 10-item questionnaire and their answers were summed to give a total score between 0 and 100 points: it’s this total score that has been requested.
• Total Chalder Fatigue Questionnaire Likert scores at baseline and 52 weeks. Patients filled in an 11-item questionnaire and ‘Likert’ scoring yields a total score between 0 and 33 points.
• Total Chalder Fatigue Questionnaire bimodal scores at baseline and 52 weeks. The “bimodal” method of scoring this questionnaire yields a total score between 0 and 11 points.
• Whether the participant met the Oxford definition of CFS at 52 weeks (yes/no).
• Participant-rated Clinical Global Impression score. This is a rating from 1 to 7 of how the participant saw their health as having changed at 52 weeks, ranging from “very much worse” (7) to “very much better” (1).
• Doctor-rated Clinical Global Impression scores. As above, but rated by the doctor, not the patient.
• Meters walked in six minutes (the “six-minute walking test“) at baseline and 52 weeks.
• The group to which each participant was randomly allocated (i.e. APT, CBT, GET, or SMC).
As you can see, the data being talked about contains no personal information whatsoever. Personal details of participants such as name, gender, age, locality, will NOT be disclosed.
For more detail on these questionnaires, HERE is an excellent detailed explanation
A spreadsheet containing only the above data would be released. Here is a made up example of what a few rows of that data might look like with each row being the de-identified results from each patient:
Click here for a larger image in a new window. As you can see this is data is handy if you want to analyse whether or not the PACE treatments were as effective as its authors claimed, it is entirely useless if you wanted to track down the patients from the trial (not that there is any evidence anyone would want to do that anyway).
If you have read, or been told, that the data is more than this, then you have been lied to. If you have been told that patients who took part in the trial can be identified from this information then you have also been lied to. It is patently ridiculous to suggest that anyone could be identified from this set of data, as there are no personal details whatsoever. With over 600 patients having taken part in the trial there is simply no way to pick anybody out, even if someone knew who had been in the PACE trial; and with over 250,000 CFS patients in the UK, there’s no way of picking out PACE trial patients with the sort of data that has been requested.
Something QMUL and the PACE authors have never explained is why anyone would want to identify and track down the patients from the trial. Without a suggested motive, it’s hard to see why the PACE data should be higher out of reach than other studies which release their de-identified data (quickly becoming the norm nowadays). What has been the experience of patients from the PACE trial who have chosen to reveal that they took part in the trial, I wonder?
I have seen several patients who took part in the PACE trials say so on social media and I have never seen anyone respond negatively at all. Rather, I have seen fellow patients thank them for taking part in research, I have seen fellow patients offer support if they are still sick, and I have seen fellow patients respect their privacy unless they want to talk about it more. The most common response I have seen is a “Like” on Facebook with many patients from the PACE trial who reported their participation getting double figure “Likes”. We are all patients who share this diabolical disease, and I think it is very unethical of the PACE authors to manufacture the illusion of some kind of wedge between us when there is not one.
To reinforce the point that the release of the PACE trial data would not lead to any patients being harassed, I want to remind everyone that the PACE trial had a sister trial called FINE that was conducted at the same time. Whereas the PACE trial was for mild to moderate patients, the FINE trial was intended for severe patients and those who could not get to their local ME/CFS clinic due to distance, but similar data was collected. The FINE trial failed just as badly as the PACE trial did, but unlike the PACE trial, the authors of FINE, to their credit, released several pieces of data equivalent the data requested of PACE. In fact they released a whole bunch of other de-identified fields as well, and did so without even being asked and anyone can go access it without any problems. No patients who participated in the FINE trial have been identified, no one has even tried. What would possibly be the motive to do so? I’ve noticed that QMUL and the PACE authors sometimes like to say things which lack any logical foundation to justify them, and that seems to reflect their overall effort to simply hide the PACE study from scrutiny at all costs.
I hope patients, including those who took part in the study, are not fooled by this scaremongering, but I understand some will be. It is not their fault if they are, they should be able to trust the people running the trial, but clearly if you question what they are saying you can see they are misleading patients. I hope this article adds a little clarity to what data is really being asked for and leads people to think about the true motives behind QMUL’s extreme attempts to deny release of the annonymized trial data. If you want to follow this topic as it progresses over the coming months I suggest following James Coyne, David Tuller, and myself and keeping an eye on our blogs.
Within the next week I will be publishing another blog post focusing on how ME/CFS charities are responding to the PACE trial scandal and this specific appeal case, and what patients might be able to do to ensure their views are heard.