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Phoenix Rising tells QMUL: release the PACE trial data

Mark Berry, Acting CEO of Phoenix Rising, presents the Board of Directors’ open letter to Queen Mary University of London (QMUL) urging them to release the PACE trial data, and hopes that other non-UK organisations will join British charities in the same request… 

ME-CFS-PACE-dataOn 1 February, ME/CFS patient Clark Ellis wrote an open letter to seven major British ME/CFS charities to ask them to contact QMUL.

He wanted them to write their own open letters to request QMUL to abandon its appeal against the Information Commissioner’s decision that it must release PACE trial data to a patient who had requested it for independent analysis. All other attempts over the years to obtain this key data have failed.

Although Phoenix Rising is a US-based non-profit, we think it important that all charities act to support the release of the data so that the controversy over the PACE trial can be resolved and patients can base their treatment decisions on sound information.

Clark Ellis’s action has already succeeded in winning open letters to QMUL from the ME Association, Invest in ME, Action for MEME Research UK, the Tymes Trust, the 25% ME GroupHope 4 ME & Fibro NI, and the Welsh Association of ME & CFS Support. We hope that we will be only the first of many more organisations from outside the UK to join this action.

Those groups without the time or resources to draw up their own letter are encouraged to write to QMUL, endorsing any of the other letters already published online by other organisations. Groups joining the growing list of organisations calling on QMUL to release the data are asked to publish their action on their websites, and to contact Clark Ellis to let him know that they have done so.

Below is the text of the letter that we sent to QMUL on Monday 8th March, to the Records and Information Compliance Manager and to Professor Simon Gaskell, the Principal of QMUL.

 

Dear Sir/Madam,Re: Freedom of Information Act request to QMUL for release of PACE trial data

According to a public statement made by the PACE investigators on 18 December on QMUL’s website:

“We are currently seeking further ethical and scientific advice, as well as the advice of patients, on how best to provide independent decisions about appropriate access to relevant data in a way that balances the rights of trial participants, and future progress of the trial analysis and follow up, with the public interest in releasing trial data.”​

Phoenix Rising is a patient-led non-profit that provides the world’s largest internet forum for patients with ME/CFS. We have over 14,000 members and are therefore well placed to contribute to the “advice of patients” that you and the investigators are seeking in relation to the trial.

In this capacity, we strongly advise you to immediately release the anonymised PACE trial data to the independent investigators who have requested it and to abandon your appeal against the Information Commissioner’s decision that you should release it to Mr Alem Matthees.

You will be aware of the serious problems with the PACE investigators’ handling of the study’s data analysis. These problems include abandoning protocol-specified main outcome analyses partway through the trial when the trend towards the eventual poor overall outcome could already have been apparent. The replacement analyses included “normal ranges” for fatigue and physical function with such low thresholds that patients could worsen during the trial and yet be in the “normal ranges” for these measures. The threshold for patients’ “recovery” of physical function on the SF-36 scale was dropped from a score of 85/100 to 60/100: that is, below the threshold for trial entry (65/100) and close to the mean score for patients with Class II congestive heart failure (57/100). These changes will inevitably have produced inflated and misleading estimates of clinical effectiveness and recovery, making it impossible for patients and clinicians to make informed decisions about treatment.

Such flaws, and the PACE authors’ failure to adequately address them, have caused a catastrophic loss of confidence in the trial among patients worldwide. This loss of confidence is now shared by an increasing number of scientists as the failure to release the data gains public attention. The scale of this loss is demonstrated by open calls for the release of the data to independent investigators, in sources including:

There is no risk to trial participants that their rights to privacy will be infringed by release of the requested anonymised data, as the Information Commissioner has already ruled. The PACE investigators have had over five years to analyse and publish on the basis of the trial data and it is long since time that they allowed other researchers access. The International Committee of Medical Journal Editors now propose a new norm — that study authors must share the anonymised individual patient data underlying their published results within 6 months of publication — and they base that proposal on “an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk”. We agree. We do not believe that patients risked their health in the PACE trial so that its authors could evade scrutiny of their questionable analyses by preventing other researchers from reanalysing the data.

The PACE trial cost £5 million of public money and the controversy surrounding it can only be resolved by releasing the data. As Dr Richard Smith said, concerning the failure to release the PACE data so far: “QMUL and King’s are making a mistake… the inevitable conclusion is that they have something to hide.” It is clearly and overwhelmingly in the public interest, the interest of patients, and the interest of QMUL’s own reputation that you now release the data. We urge you to do so without further delay.

Yours sincerely,

Mark Berry,
Acting CEO, Phoenix Rising
On behalf of the Board of Directors

Support Phoenix Rising

Phoenix Rising is a registered 501 c.(3) non profit. We support ME/CFS and NEID patients through rigorous reporting, reliable information, effective advocacy and the provision of online services which empower patients and help them to cope with their isolation.

There are many ways you can help Phoenix Rising to continue its work. If you feel able to offer your time and talent, we could really use some more authors, proof-readers, fundraisers, technicians etc. and we'd love to expand our Board of Directors. So, if you think you can help then please contact Mark through the Forum.

And don't forget: you can always support our efforts at no cost to yourself as you shop online! To find out more, visit Phoenix Rising's Donate page by clicking the button below.

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{ 14 comments… add one }

  • Comet March 7, 2016, 7:26 pm

    A huge thank you to everyone involved in this endeavor. You really make a difference. :heart:

  • Esther12 March 7, 2016, 7:37 pm

    Excellent. Thank you Mark.

    The thread title makes it sound like PR got put in charge… that would be nice!

    I really wonder what the PACE researchers were planning when they said that they were seeking the “advice of patients” – 'the specially selected handful of eight patients who owe know won't try to check the evidence before just trusting us'?

  • aimossy March 7, 2016, 10:38 pm

    Fabulously well written letter. Thank you Phoenix Board of Directors and thanks Mark.

  • ClarkEllis March 8, 2016, 2:15 am

    Well done Phoenix Rising; great letter. You're the first US-based organization to write to QMUL urging data release. Joining 8 from the UK, 2 from Belgium and 1 from Ireland. So far. I hope other organizations across the world follow your lead – for that to happen, patients must ask the organizations in their country to step up and represent them on this.

  • Daisymay March 8, 2016, 6:03 am

    Excellent letter, thank you.

  • moosie March 8, 2016, 6:16 am

    Really brilliant letter. Very clear. Thank you very much.

  • Bob March 8, 2016, 6:58 am

    THANK YOU Phoenix Rising.

  • Bob March 8, 2016, 6:59 am

    BTW, the petition has now reached 12,075 ! :rocket::rocket::rocket:

  • Battery Muncher March 8, 2016, 7:14 am

    Superb effort! Thank you to all involved

  • Sasha March 8, 2016, 7:16 am
    Bob

    BTW, the petition has now reached 12,075 ! :rocket::rocket::rocket:

    Technically, that's :star::star::star::star::star::star::star::star::star::star::star::star:

    It just never stops, even though it's now closed! :) People feel strongly about this.

  • jimells March 8, 2016, 8:30 am

    Here is a reply from Solve regarding an email I sent in February:

    From: <CEO@solvecfs.org>
    Cc: Jeryldine Saville , Zaher Nahle
    Subject: FW: Free the Data! (PACE Trial)
    Date: Mar 2, 2016 1:37 PM

    Jim, thank you for taking the time to write to us. And I/we are in complete agreement with your statements. We are highly engaged with the NIH and will continue to be. Not only do we need additional funds for this disease research, but we must be certain that the currently planned intramural study adheres to the highest research standards.

    And, yes, we very much want to see the PACE data released and are forcefully adding our voice in that regard.

    We understand clearly that there are so very many patients, like you, who are extremely limited in the level of activity you can take regarding advocacy for this disease. We who are healthy (or healthy-ish) are grateful that we CAN take advocacy forward on behalf of the many, many like you who cannot. We take on that obligation and responsibility with fervor.

    Best to you, Carol

    Carol Head
    President
    CEO@SolveCFS.org

    Solve ME/CFS Initiative | Working to make ME/CFS widely understood, diagnosable and treatable

    —–Original Message—–
    From: Jim Ellsworth
    Sent: Saturday, February 13, 2016 11:52 AM
    To: solvecfs <solvecfs@solvecfs.org>
    Subject: Free the Data! (PACE Trial)

    Hello,

    Thank you for your quick and forceful response to the recently released NIH Clinical Center study protocol. It definitely helps my morale to see your organization standing up to the NIH and demanding that they use proper methodology and criteria for researching our illness.

    As you know, there are many patients who, being confined to the house, have little we can do besides paying very close attention to every detail affecting the research and political climate. Not much escapes our attention. Your organization's voice and connections, when added to our eyes and ears, are a powerful force.

    I am writing today to ask you to add your voice to the chorus of calls for release of the PACE trial data. The ME Association has publicly posted their February 9 letter to Queen Mary University of London (1). Dr Shepherd's letter thoroughly explores the issues and could serve as the basis of your own letter.

    The Wessely School acts as an immovable object. But together the patient, academic, and advocacy communities are an immovable force that is quickly building strength. Just yesterday (Feb 12) "Action for ME" issued a statement supporting release of the data (2). Not even a psychiatrist can muddle the meaning of their words: "Action for M.E. strongly supports the release of anonymised data from the PACE trial."

    We're getting close, but we are not quite strong enough to shove the Wessely School out of the ME research arena. One more good push should do it. Please add your voice and reputation to the call to "FREE THE DATA" to make sure it happens.

    Jim Ellsworth
    Littleton, Maine

    (1) http://www.meassociation.org.uk/201…o-release-of-pace-trial-data-9-february-2016/

    (2) https://www.actionforme.org.uk/news/sharing-research-data-board-of-trustees-states-our-position/

  • Sasha March 8, 2016, 8:35 am

    Well done, @jmells!

  • taniaaust1 March 9, 2016, 6:46 pm

    this is a great letter speaking up for us. Well done Mark and thanks :)
    ………….

    Maybe one of the australians could send this link to the aussie ME/CFS associations and get them to add to this call. (I just tried to email mine about this but cant use my email at all as I've messed up my password yet again :confused: )

  • Janice Hargreaves March 14, 2016, 10:01 am

    Thank you so much for taking the time and putting in the effort to write such a brilliant letter. It gives me hope. Many, many thanks. I've recently discovered this site and am still in awe at how much useful information I am finding on it. It makes my heart sing!