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Judge Dismisses QMUL’s Appeal, University Must Release PACE Data

After spending over £200,000 in legal fees, Queen Mary’s request to not release anonymised data from the PACE trial has been denied.

The controversy surrounding QMUL’s PACE trial deepens as the University’s appeal to prevent the release of raw data from the trail was rejected by a tribunal.

The PACE clinical trial began in 2002 with the intention of testing the effectiveness of current treatments for Chronic Fatigue Syndrome (CFS). The results were published in 2011 and stated Cognitive Behavioural Therapy (CBT) and graded exercise therapy can help to treat CFS when added to specialist medical treatment but adaptive pacing therapy did not promote improvement.

The results caused upset among CFS suffers leading Alem Matthees to launch a Freedom of Information request to obtain the data from the trial. QM has stated that it believes the data which is being asked for cannot be satisfactorily anonymized putting patient confidentiality at risk. In addition, the university does not have permission from participants to publish the data:

“Participants did not give consent to the public release of their data when they entered the trial. In particular, we are concerned to ensure that there is no risk of misuse of the data such as through inadvertent personal identification.”

In October 2015, the Commissioner rejected Queen Mary’s claims and required the university to disclose the desired research.

After this decision, QMUL launched an appeal to prevent the publication of the requested data which was again dismissed. In regards to anonymizing the results, the Commissioner’s report stated:

“It is unclear why satisfactory anonymization was impossible when Mr Matthees has specifically excluded the personalized PIN references of participants from his request.”

In regards to fears of self-identification, the report asserted:

“Whilst it is possible that some participants could self-identify, this is insufficient to label them identifiable… Identification is more than making an educated guess about identity.”

A further Freedom of Information request has revealed the financial cost of Queen Mary’s appeal. The university has incurred, in total, £245,745.27 (incl. VAT) in legal fees. The spending breaks down as such:

Mills & Reeve LLP: £149,482.30 (ex VAT)
Timothy Pitt-Payne QC: £48,320.00 (ex VAT)
Disbursements/expenses (Mills & Reeve LLP): £6,985.43 (ex VAT)

In response to the tribunal decision, QMUL responded thusly:

“In complying with the Tribunal’s decision, we remain mindful of the interests of trial participants and acknowledge the assurance given by the Tribunal that participants will be adequately protected from personal identification by the disclosure of this information. No names or addresses of any participants have been released. We will continue to engage with other universities and bodies to debate the broader implications of the decision for clinical research.”

Image: Davey Brett


  1. John Buckley John Buckley 6th October 2016

    As VAT was payable on the legal fees plus the costs of supplying expert witnesses the financial implications are understated.

  2. Adrian Adrian 6th October 2016

    Patients working with a couple of statistician professors have posted a reanalysis of the recovery claims made by QMUL on the viroloogy website:

    QMUL published a paper on recovery where they changed the definition of recovery and claimed a ‘22%’ recovery rate. However, the changed criteria defined recovery below the entry levels for the trial.

    The patients reanalysis used the original definitions of recovery defined by QMUL and published in the trial protocol. This showed no significant recovery from any trial arm.

    Perhaps QMUL spend so much money on keeping the data from the public domain because it demonstrates that they have mislead patients about the success of treatments they are pushing (and selling to the NHS).

    Even after such spin has been revealed QMUL continue to push misleading results with Prof White accusing patients and 2 statistics professors of ‘tweaking’ the definition of recovery because they used the definition that White had come up with at the beginning of the trial.

    This should lead to huge questions about the whether QMUL have acted in an ethical manner.

    • Findlow Findlow 7th October 2016

      In addition to the reference above, may I suggest readers take a look at the following, which gives a comprehensive summary of the background to, and murky politics surrounding the PACE trial. I think people so far unaware of this might be surprised and very shocked at the implications. The profound impact of these policies on those who have ME/CFS, however, are all too evident.

  3. Hannah Hannah 6th October 2016

    Maybe the QMUL could use the study as an example/teaching aid to students of what not to do in trials.
    For example
    1. Use a definition too broad so people without CFS/ME could be included.
    2. Change protocol part way through to enhance results.
    3. Deem participants to be recovered when they have deteriorated in some areas.
    4. Prevent transparency by blocking independent peer review to validate results (at a large cost to the University)
    5. Generally fudge results to make them align to hypothesis and what the people paying for the study wanted to see.

  4. Georgina Harris Georgina Harris 6th October 2016

    The reputation of QMUL, governs the perceived quality of degrees from QMUL.
    Questions for students to ponder- .
    1- why did it take 9 years for Prof White et al to carry out an exercise and cognitive behaviour trial of 650 patients- 9 years and 5 million pounds. The study was a low tech. study of a common disease, of “treatments” carried out at NHS clinics throughout the UK.
    2- the design of the study has been widely criticised by high ranking academics – e.g David Tuller’s comment she on virology blog. What does QMUL make of these critisums of the study by one of its Professors. Prof. Peter White resigned the day before the release of the PACE raw data, after putting up a paper confirming that if the raw data was analysed as per the trial protocol published in 2007, then the results were 3 times less promising than published in 2011- a drop from 60% to 20%. The preliminary re-analysis by other academics found using the PaCE original trial protocol to analysis the trial raw data revealed CBT and GET to have no statistically significant impact on the health of participants. Will QMUL be taking steps to undo the harm caused to people with CFS by the misleading 2011 articles.
    3- 4 of the PACE authors say that they have interests in the insurance industry – does QMUL think this might have encouraged the changing of use of the word “recovery” – so that severely disabled people were labelled recovered?
    How will QMUL ensure that the insurance and other industry groups don’t influence our degree programs?
    4- Do other papers published by QMUL have similar definitions of recovery?
    5- Did the trial authors provode media releases about the trial, to the Sciemce Media Centre? Who vets the quality of media releases by QMUL staff?
    6- Is there someone at QMUL, responsible for ensuring the media publishes accurate representations of its professors work?
    7- QMUL Released the raw data to “friendly colleagues” eg the Cochrane review panel continuing 3 of the authors. Given that raw data had already been released why did QMUL spend thousands of pounds fighting the release of the raw data?
    8- Academics soundly critised the design, implementation and interpretation of the trial. The authors didn’t respond to the issues raised, will QMUL ever respond to the critics comments?
    9- who at QMUL is responsible for the academic integrity of works published by its staff?
    10-Peter White retired the day before the raw dats was released, who is now responsible for answering about his work?
    11- How does QMUL view the work by Prof White? The PaCE trial is only one study done by Prof. White- will QMUL be taking a close look at papers published by him before and after the PaCE trial ?

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