August 8th, 2016: Understanding and Remembrance Day for Severe Myalgic Encephalomyelitis
Jody Smith joins with other ME voices in honor of Understanding and Remembrance Day for Severe Myalgic Encephalomyelitis.
Discuss the article on the Forums.

PACE trial data release: MEA writes to QMUL

Discussion in 'General ME/CFS Discussion' started by charles shepherd, Feb 9, 2016.

  1. charles shepherd

    charles shepherd Senior Member

    From: The ME Association
    Tuesday 9 February 2016
    Attention: Records and Information Compliance Manager, QMUL
    Copy to: Professor Simon Gaskell, Principal, QMUL

    Dear Sir/Madam

    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    The Freedom of Information (FOI) request for release of so far unpublished data from the PACE trial, along with the refusal of Queen Mary University of London (QMUL) to comply with this request, is currently causing a great deal of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:

    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:

    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.

    Yours sincerely

    Dr Charles Shepherd
    Hon Medical Adviser, MEA

    7 Apollo Office Court
    Radclive Road
    Buckingham MK18 4DF


    luludji, Sidereal, JaneH and 28 others like this.
  2. A.B.

    A.B. Senior Member

    Is there any chance for the ME Association to get involved in the tribunal hearing over QMUL's appeal of the court ordered release of PACE data?

    The hearing will take place on 20-22 of April in London.

    My understanding is that the data will then be publicly available. We're one step from winning.

    Getting the data released is crucial not just for PACE but also for future studies, and transparent science in general. Researchers are more honest if manipulative research can easily be exposed.
    Last edited: Feb 9, 2016
    L'engle, JaneH, Ellie_Finesse and 2 others like this.
  3. charles shepherd

    charles shepherd Senior Member

    Thanks AB - yes, I am aware of these dates and points noted

    We are also involved in some other initiatives regarding what is happening here and I hope you will appreciate that I cannot go into further details on this aspect on a public forum

    L'engle, JaneH, Countrygirl and 17 others like this.
  4. Sasha

    Sasha Fine, thank you

    Delighted to see this letter, @charles shepherd. Excellent example for other charities.

    Now is not the time for any charity to remain silent on this issue.
  5. charles shepherd

    charles shepherd Senior Member

  6. Gijs

    Gijs Senior Member

    Their data (PACE) will not be disclosed. White and Chalder will invent something. These people get away with anything. They can say and do whatever they want. It is all about the money, power and prestige. White thinks he is Jesus or better GOD!
  7. jimells

    jimells Senior Member

    northern Maine
    @charles shepherd your fine letter has given me an idea for a slogan.

    (Your letter has been noted by Dr Coyne, although you might want to tighten your helmet strap before reading his tweet...)
    sarah darwins likes this.
  8. charles shepherd

    charles shepherd Senior Member

    Re 25% Group: Posted on MEA Face book page

    Shared with permission from Simon Lawrence

    The 25% ME GROUP would like to say that we support and endorse this letter and hope it will help to get the information released
    Sean, halcyon, L'engle and 10 others like this.
  9. charles shepherd

    charles shepherd Senior Member

    As The MEA is now being asked if any of our members who took part in the PACE trial, or anyone else who did and took part in our questionnaire that provided the information for our 2015 report on efficacy and safety of CBT, GET and Pacing, has contacted us to express concerns or objections to anonymised data from the PACE trial being released for independent analysis, it's probably simpler if I just make a short public satement:

    The answer is no.

    All the messages we have received via email, MEA Facebook etc, have been in full support of the letter that we have sent to QMUL.

    I would add that the FOI department at QMUL has acknowledged receipt of our letter this afternoon.

    mango, Valentijn, AndyPR and 10 others like this.

See more popular forum discussions.

Share This Page