This page lists some of the information that has been put forward by the PACE authors and their institutions, and which some readers may find misleading. Quoted text, links to the sources and some quick remarks are provided.
“We have received many requests for access to individual patient data collected in the PACE trial.”
The wording makes it sound like it is individual PERSONAL data being talked about. For clarity, the phrase, “individual patient data” in this case really means de-identified trial data for each participant. So for the 6 minute walking test for example: the number of meters each patient walked. But importantly, this data wouldn’t tell us who the patient was, or anything of that sort. You might have got the impression from the above statement that it would. Not so.
In the same document:
“We are however also concerned for the rights and welfare of trial participants. Participants did not give consent to the public release of their data when they entered the trial.”
And the author’s themselves have made the same kind of potentially misleading claim here too:
“…the safe-guarding of personal medical data was an undertaking enshrined in the consent procedure and therefore is ethically binding; so we cannot publicly release these data.”
These two sets of statements are misleading because as the Information Commisioner’s Office Anonymization Code of Practice, states that, “Data protection law does not apply to data rendered anonymous in such a way that the data subject is no longer identifiable.” As is the case with the PACE trial data. In other words patient’s consent is not required because the personal data (that belongs to the patient) has been stripped out already.
Patients own their personal data and would rightly need to consent to its release, but it is not personal data that is being disputed here. QMUL seem happy to muddy the water though to confuse people into thinking QMUL are working to protect them when there is actually no protection needed. The obvious question then: who’s interests are QMUL really working to protect?
Further, they are inconsistent in their stance as the PACE authors have already released the data to other researchers (i.e. individual data to Cochrane) seemingly without consent of patients, so their claims about the importance of consent from patients does not tally with their actions.
“It is important to remember that simple methods of anonymization does not always protect the identity of a person, as they may be recognized from personal and medical information.”
On the face of it it appears a reasonable statement, but it is misleading because it suggests that anonymization of the PACE trial data is more complicated than it really is. The author’s are relying on patients not knowing the details to catch them out on this point. No personal information has been requested so that clears that one up. And the use of the phrase “medical information” makes it sound like it is personal medical information, when it is not, it is de-identified medical information that has been requested. Neither of which could be used to identify any individual.
“One of the resultant refusals, relating to Decision Notice FS50565190, is due to be tested at the First-tier Tribunal (Information Rights) during 2016.”
Reading this statement you might conclude that the ICO refused the FOI request. Not so. QMUL originally refused when the request was made to them. This refusal was overturned by the ICO who ordered QMUL to release the data. QMUL have no legal right to refuse the ICO. The right they have is to apply for an appeal, which they have done, which is why there is now a tribunal case to be held.
In the same document:
“The data consists of (sensitive) personal data which was disclosed in the context of a confidential relationship, under a clear obligation of confidence. This is not only in the form of explicit guarantees to participants but also since this is data provided in the context of medical treatment, under the traditional obligation of confidence imposed on medical practitioners. See generally, General Medical Council, ‘Confidentiality’ (2009) available at http://www.gmc-uk.org/guidance/ethical_guidance/confidentiality.asp The information has the necessary quality of confidence and release to the public would lead to an actionable breach.”
The claim that the data consists of “sensitive” personal data is worse than misleading – it is simply not true, as I have demonstrated in my recent blog.
Moving on, although the relationship between the patient and the trial staff would of course included an “obligation of confidence” in some respects, but when it comes to research data this obligation only extends as far as the personal data which includes identifiers, de-identified research data is not personal data, as explained above.”
“We have yet to release any raw data. It’s part of our patient’s consent form. We promised that we would keep it confidential. We think it’s really important for our trial — A, for if we do a long-term follow up, which I hope we will. B — When you make a promise to participants, and say ‘I’m going to protect your data, I’m not going to release it to any member of the public,’ we keep that promise. We made a promise and we have to keep it.”
This statement above is from Peter White. It’s not true as I will let Peter White himself explain by quoting him from another source (Virology blog):
“We have received numerous Freedom of Information Act requests over the course of many years…We have provided these data when we were able to (e.g. the 13% figure mentioned above came from our releasing these data).” This refers to data which showed that 13% of patients had already “recovered” on entry into the trial. It seems it is one answer when it suits them, and the opposite answer when it doesn’t.
“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 CFS/ME community is “very small” is it? Really?
In 2004 the population of England between 18 and 60 was 28.5 million. (using stats from http://www.ons.gov.uk/ons/publications/re-reference-tables.html?edition=tcm%3A77-315018 – The number will obviously be even greater as there has been more than a decade of population growth since, but this is what I could find and it’s good enough to illustrate the point here.)
So using a prevalence of 0.5% of the population (it will certainly be closer to 1% (especially if you use the Oxford criteria that includes just about everyone who has ever experienced fatigue) but I feel very generous. so I’m going with 0.5%) with ME/CFS this would be 142,500 patients in England. Of course, the study included patients from Scotland too as they had a clinic up in Edinburgh, so the number will be closer to 200,000 but I don’t have those stats handy. Let’s call it an embarrassingly generous 175,000 patients in England and Scotland. That is around double the figure for Multiple Sclerosis. Even with these figures that are generous in favour of the PACE authors claims, the idea that the CFS/ME community is very small, or even small is clearly make believe. It is a huge community.
Now the PACE trial was very big for an ME/CFS study, with around 640 patients taking part, which is about 1 in 273 patients according to the above figures. Clearly then, the idea that the “risk is maximized by the fact the CFS/ME community is a very small percentage of the population” is not true, it is incredibly misleading; the way they go on you’d be forgiven for thinking that only 10 people live in the country and 5 of them took part in their trial. Ridiculous.
All these examples may not seem that extreme, and I’m not saying they are, many of them are quite subtle, but together they add up to scaremongering. These statements when read by those who may not possess all the facts, can clearly result in them being mislead.