The ME Association has today written to Queen Mary University London to support the release of data from the PACE trial that has been requested under the Freedom of Information Act but refused.
A copy of this letter has also been sent to Professor Simon Gaskell, Principal of Queen Mary University London.
TEXT OF LETTER
From: The ME Association
Tuesday 9 February 2016
Attention: Records and Information Compliance Manager, QMUL
Copy to: Professor Simon Gaskell, Principal, QMUL
Freedom of Information Act request for release of PACE trial data from QMUL
The Freedom of Information (FOI) request for release of so far unpublished data from the PACE trial, along with the refusal of Queen Mary University of London (QMUL) to comply with this request, is currently causing a great deal of concern and comment from people with ME/CFS.
And we understand that QMUL has now appealed to the First-tier Tribunal to reverse the Information Commissioner's order to release this data.
QMUL statement dated December 18 on release of PACE trial data: www.qmul.ac.uk/media/news/items/smd/168729.html
As a national information and support charity for people with ME/CFS, The ME Association (MEA) has a duty to make sure that organisations involved in both clinical care and research are aware of the views of the patient community.
QMUL has confirmed in their 18 December statement that they would like to hear the advice of people with ME/CFS on the issue of providing appropriate access to relevant research data.
We are therefore writing to QMUL to state that all the feedback we are receiving indicates that people with ME/CFS want to see this data released – with, of course, an exemption being made in relation to any information that could identify individual participants in the PACE trial.
The views of people with ME/CFS have also been expressed in a petition signed by over 11,800 people so far.
The wording of the petition includes a call for “the study authors… to give independent researchers full access to the raw data (anonymised by removing trial identifiers and all other data superfluous to the calculation, such as age, sex or location)”.
PACE trial petition: http://my.meaction.net/petitions/pace-trial-needs-review-now
The MEA takes exactly the same position.
We also believe that those involved in medical and scientific research have a duty to be transparent in what they do.
Researchers should therefore be willing to share their research data in order to confirm or refute the findings from a study, or to add to the knowledge that might accrue from further independent analysis of the data.
It is clearly of benefit to people with ME/CFS that all relevant research data is open and available and can be exchanged between researchers on international basis.
In addition, open data from research studies and clinical trials is something that will encourage people with ME/CFS to take part in research.
Non-disclosure is likely to discourage people from doing so.
It is also worth noting that in addition to this FOI request being supported by the Information Commissioner, a growing number of academics and health professionals are calling for release of the data.
In particular, Dr Richard Smith, former editor of the British Medical Journal, has made a very strong case for release of the PACE trial data in a BMJ commentary dated 15 December 2015.
Dr Smith stated:
QMUL and King’s are making a mistake.
Firstly, the inevitable conclusion is that they have something to hide. This is the age of transparency, and, whether people like it or not, what is not transparent is assumed to be wrong, corrupt, or biased until proved otherwise.
Secondly, QMUL and King’s are going against basic scientific principles. In Popperian science we pose falsifiable hypotheses and then do all we can to tear them down. Hypothesis are never true, they are simply not falsified. This process should include other scientists being able to manipulate the data.
The refusal of two universities to release data relates to the current debate within universities over freedom of speech. In several universities students have stopped the appearance of speakers who have views—on, for example Islam or transgender people—that the students don’t like. This is a dangerous development. Democracies depend on free speech, and universities should be bastions of free speech—and the whole point and value of free speech is that you hear views that may disgust, distress, and anger you.
Finally, the universities may have failed to notice that customs around sharing data in science are changing rapidly. We have recognised that huge value is lost by scientists taking their datasets to the grave with them. More and more funders of research require the release of data they have funded, and journals like F1000Research require authors not just to make their data available on request but actually to submit their data with their study so that anybody can use the data either to confirm or refute the study or do other studies.
I fear that QMUL and King’s are defending the indefensible and like King Canute failing to stop a tide that is coming in fast.
We have already made our views very clear on what we feel are significant methodological flaws in the way the PACE trail was carried out along with our concerns about the way in which the results have been reported in both the scientific journals and in the lay press.
MEA letter to Lancet Psychiatry covering long term follow up to PACE trial:
MEA letter regarding recovery data from PACE trial:
Disclosure of the PACE trial data will help to resolve many of the controversies, disagreements and uncertainties that surround the PACE trial.
The MEA is therefore asking QMUL to reconsider their decision and agree to release of the PACE trial data in line with current scientific opinion on the sharing of research data.
Dr Charles Shepherd
Hon Medical Adviser, ME Association
7 Apollo Office Court
Buckingham MK18 4DF