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Tell our charities: QMUL must release PACE data

Discussion in 'Action Alerts and Advocacy' started by ClarkEllis, Feb 1, 2016.

  1. ClarkEllis

    ClarkEllis

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    I don't usually post my blog around forums, but I need your help. I am trying to encourage people to contact the UK me/cfs charities asking them to support patients in calling for the PACE data to be released.

    As many of you know, there was a request for data from the trial which the Information Commissioner agreed should be released, and he agreed there was no risk of patients from the trial being identified if it was released. Queen Mary University London (QMUL) are appealing this decision and it will be heard at a tribunal later this year. I am concerned that QMUL may try and present a one-sided view of patient opinion on the matter at the appeal hearing and perhaps will ask selected charities who they think will support them to make statements that don't reflect the true wishes of patients.

    So I am calling on patients to contact the me/cfs charities in the UK to ensure their call for the data to be released is heard. You can read more about this here, where I have written a template letter and provided links to the main UK charities contact pages:
    https://autodidactauthor.wordpress....ies-must-echo-patient-calls-for-data-release/

    I am aware that some of these charities that I list on my blog have done a good job in challenging the problems with PACE and in calling for data transparency, while others have done a very poor job to date. I am not wishing to create a divisive situation where criticisms (however valid) are aired, but rather I am interested in each of the charities having the opportunity to accurately reflect patient opinion. I actually think the charities people consider to have failed patients on PACE in the past are the ones that most need to hear from patients now, so there can be no excuses for failing us.

    I hope people can support me in this.
    Thank you
     
  2. Esther12

    Esther12 Senior Member

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    Good idea. QMUL's reference to "consulting patients" always sounded like a sham, so encouraging patient groups to point out that actually patients quite like having access to accurate data and unspun results sounds like a great idea.
     
  3. JohnCB

    JohnCB Immoderate

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    I don't know. Usually appeals revolve around points of law. Sometimes an appeal is based upon new evidence but I don't think that is the case here. In this case it is QMUL saying they don't like the order to reply to the FOI request. QMUL will be trying to persuade the appeal panel that the original decision was wrong for some legal reason. I doubt that the judge or commissioner or whover heads the appeal body will be looking at public opinion. Of course there is no harm in any charity or body interested in the matter making a public statement but I would have thought the appeal will be unlikely to look at this kind of thing. I imagine it will be lawyers arguing about laws. In the first instance it will be the QMUL lawyer arguing that the ICO's original decision was incorrect in some way.
     
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  4. Esther12

    Esther12 Senior Member

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    To me it seems like QMUL's case is so weak on the arguments, that they're going to have to try to politicise it and create the impression that the moral thing to do is not release the data.
     
  5. Sasha

    Sasha Fine, thank you

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    What we want to avoid is any possible pretence by QMUL that they speak for patients and that's what our charities should be helping with - preventing such a pretence.
     
  6. Sasha

    Sasha Fine, thank you

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  7. Sasha

    Sasha Fine, thank you

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    Bump!
     
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  8. charles shepherd

    charles shepherd Senior Member

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    Happy to clarify the MEA position on the FOI request relating to PACE trial data:


    The ME Association (MEA) has always supported the free release of all data from the PACE Trial - with the exception of any information that could identify an individual participant.

    The MEA has written about the PACE Trial in a critical but constructive way for some years and will continue to do so.

    Our most recent letter to Lancet Psychiatry, covering the paper on long term follow up in the PACE trial, is here:

    http://www.meassociation.org.uk/201...hed-in-the-lancet-psychiatry-18-january-2016/

    It is surely to the benefit of all patients with this devastating illness that research data is clearly seen and exchanged between researchers throughout the world.

    In that way our chances of a cure and better treatment are enhanced.

    We have also published the results of the largest ever survey of patient evidence on the safety and efficacy of CBT, GET and Pacing.

    These results, yet again, demonstrate that many people with ME/CFS are made worse as a result of receiving graded exercise therapy (GET).

    The MEA has therefore called on NICE to with draw their recommendation in the 2007 NICE guideline on ME/CFS that GET should be a first line treatment for people with mild or moderate ME/CFSMEA report on CBT, GET and Pacing:http://www.meassociation.org.uk/how-you-can-help/introduction-to-our-cbt-get-and-pacing-report/

    Conclusions and recommendations from the MEA report re CBT, GET and Pacing:

    RECOMMENDATIONS
    Our part 1 recommendations are based on the full results from our survey in respect of the three main therapeutic approaches to illness management, and are as follows:

    Cognitive Behavioural Therapy (CBT)

    We conclude that CBT in its current delivered form should not be recommended as a primary intervention for people with ME/CFS.

    CBT courses, based on the model that abnormal beliefs and behaviours are responsible for maintaining the illness, have no role to play in the management of ME/CFS and increase the risk of symptoms becoming worse.

    The belief of some CBT practitioners that ME/CFS is a psychological illness was the main factor which led to less symptoms improving, less courses being appropriate to needs, more symptoms becoming worse and more courses being seen as inappropriate.

    Our results indicate that graded exercise therapy should form no part of any activity management advice employed in the delivery of CBT, as this also led to a negative impact on outcomes.

    There is a clear need for better training among practitioners. The data indicates that deemed lack of knowledge and experience had a direct effect on outcomes and remained a key factor even where courses were held in specialist clinics or otherwise given by therapists with an ME/CFS specialism.

    However, our results did indicate that when used appropriately the practical coping component of CBT can have a positive effect in helping some patients come to terms with their diagnosis and adapt their lives to best accommodate it.

    CBT was also seen to have a positive effect in helping some patients deal with comorbid issues – anxiety, depression, stress – which may occur at any time for someone with a long-term disabling illness.

    An appropriate model of CBT – one that helps patients learn practical coping skills and/or manage co-morbid issues such as those listed above – could be employed, where appropriate, for ME/CFS as it is for other chronic physical illnesses such as multiple sclerosis, Parkinson’s disease, cancer, heart disease, and arthritis etc.; and we recommend all patients should have access to such courses as well as access to follow-up courses and/or consultations as and when required.

    Graded Exercise Therapy (GET)

    We conclude that GET should be withdrawn with immediate effect as a primary intervention for everyone with ME/CFS.

    One of the main factors that led to patients reporting that GET was inappropriate was the very nature of GET itself, especially when it was used on the basis that there is no underlying physical cause for their symptoms, and that patients are basically ill because of inactivity and deconditioning.

    A significant number of patients had been given advice on exercise and activity management that was judged harmful with symptoms having become worse or much worse and leading to relapse.

    And it is worth noting that, despite current NICE recommendations, a significant number of severe-to-very severe patients were recommended GET by practitioners and/or had taken part in GET courses.

    The other major factor contributing to poor outcomes was the incorrect belief held by some practitioners that ME/CFS is a psychological condition leading to erroneous advice that exercise could overcome the illness if only patients would ‘push through’ worsening symptoms.

    We recognise that it is impossible for all treatments for a disease to be free from side-effects but, if GET was a licensed medication, we believe the number of people reporting significant adverse effects would lead to a review of its use by regulatory authorities.

    As a physical exercise-based therapy, GET may be of benefit to a sub-group who come under the ME/CFS umbrella and are able to tolerate regular and progressive increases in some form of aerobic activity, irrespective of their symptoms. However, identifying a patient who could come within that sub-group is problematic and is not possible at present.

    Some patients indicated that they had been on a course which had a gentle approach of graded activity rather than a more robust and structured approach of graded physical exercise. There were some reports that patients were told they should not exercise when they felt too unwell to do so. These led, for some, to an improvement in symptoms or to symptoms remaining unaffected.

    However, we conclude that GET, as it is currently being delivered, cannot be regarded as a safe and effective form of treatment for the majority of people with ME/CFS. The fact that many people, including those who consider themselves severely affected, are being referred to specialist services for an intervention that makes them either worse or much worse is clearly unacceptable and in many cases dangerous.

    GET should therefore be withdrawn by NICE and from NHS specialist services as a ‘one size fits all’ recommended treatment with immediate effect for everyone who has a diagnosis of ME/CFS. This advice should remain until there are reliable methods for determining which people who come under the ME/CFS umbrella are likely to find that GET is a safe and effective form of management.

    Pacing

    Pacing was consistently shown to be the most effective, safe, acceptable and preferred form of activity management for people with ME/CFS and should therefore be a key component of any illness management programme.

    The benefit of Pacing may relate to helping people cope and adapt to their illness rather than contributing to a significant improvement in functional status. Learning coping strategies can help make courses more appropriate to needs even if they do not lead to immediate or even longer term improvement in symptoms.

    For some, improvement may be a slow process so, whilst they may be somewhat better by the end of the course, the improvement is not enough to take them into a better category of severity for some time, perhaps not until they have self-managed their illness for a few years.

    Pacing can be just as applicable to someone who is severely affected, as to someone who is mildly or moderately affected, although additional measures need to be taken to ensure that a person who is severely affected has equal access to services.

    However, proposed increases in activity, both mental and physical, must be gradual, flexible and individually tailored to a patient’s ability and circumstance, and not progressively increased regardless of how the patient is responding.

    There must be better training for practitioners who are to deliver such management courses and all patients should have access to suitable courses, follow-up courses and/or consultations as and when required.
     
  9. jimells

    jimells Senior Member

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    An "angry mob" shouting from their beds would let the appeals body know that their decision will be scrutinized very closely. That knowledge might encourage them to closely study the case, rather than applying the rubber stamp supplied by establishment VIPs like Sir Simon.
     
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  10. Sasha

    Sasha Fine, thank you

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    Thanks, @charles shepherd.

    I hope the MEA will write to QMUL about the 11,000 patients' view that the PACE data should be released? As Clark Ellis explains in his post, there's no possibility of it identifying any patients (the ICO agreed).
     
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  11. charles shepherd

    charles shepherd Senior Member

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    The PACE trial research group are well aware of our position as a result of the public statements we have made in relation to the PACE trial and our correspondence to the medical journals in response to the findings that have been published

    And it is worth noting that the MEA is the only ME/CFS charity to have consistently written critical letters to the medical journals about the PACE trial and to get their letters published

    You may also recall that it was The MEA that organised a public petition opposing the PACE trial when it first started - because we did not believe it was going to tell us anything we do not know

    So I do not feel there is much to be gained from pointing this out to the PACE trial research group yet again. But I note your point and will discuss with MEA trustees.

    I am also involved in a number of other supportive initiatives/actions relating to this PACE trial data FOI request - but cannot place this information in the public domain
     
  12. Sasha

    Sasha Fine, thank you

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    I'm hugely appreciative of all of the MEA's effort on this, as I'm sure everyone must be. If people had paid proper attention to what you were saying when PACE was trying to get off the ground, we wouldn't have had the disaster for patients that we've had.

    I'm sure the PACE group are aware of the MEA's view on PACE in general but the gain from joining in with this particular action is that it will result in a public statement (if you also place your statement on your website) of your position on the release of the data, specifically, and will help set a norm for all of our charities to do the same. As you'll be aware, not all ME charities have taken the same line as the MEA in the past and this issue of the data release is crucial. It's time to show QMUL that all our charities stand with the patients and that they support the unprecedentedly powerful statement created by over 11,000 patients speaking with one voice on this.

    Thank you!

    Thank you, and good luck!
     
  13. charles shepherd

    charles shepherd Senior Member

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    Yes, this approach might have some impact if all the national charities could agree on a common public statement supporting the release of the PACE trial data

    As you probably know, organising and getting all the charities to agree on the wording for something like this can be a bit like herding cats

    And if there isn't widespread agreement, producing a statement that clearly does not have the support of nearly all of the main charities can turn into an own goal….
     
  14. ClarkEllis

    ClarkEllis

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    Thank you @charles shepherd for MEA's response.

    I agree that getting an agreement from all the charities on a signed statement would be difficult, and I would suggest it would be unnecessary in this instance. Individual statements from charities who accurately represent patient's wishes on the matter, sent to QMUL in reference to this specific case would mean they could not present a misleading version of patient opinion as they have often done in the past. And if they attempted to do so at the hearing then those defending the ICO's decision to release the data could point to such public statements to ensure the tribunal are aware that QMUL know how patients really feel.

    I'm tired and that paragraph may not be wholly clear as a result. I apologise if it is not, but I hopefully you get the gist.

    Thank you again for taking the time to put out a reply.
     
  15. ClarkEllis

    ClarkEllis

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  16. Sasha

    Sasha Fine, thank you

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    I don't think that a joint statement is necessary, or even desirable, and there might be some difficulty in coming up with one (herding cats, as you say). I think it would be just as powerful (and much more practical) if each charity made their own statement.

    What's important, I think, is that each charity makes a statement, though. I think this is a watershed moment on PACE and it's time for all charities to show that they, like the MEA and others, support patients in their powerful statement to get the data released. Once the data are released, everything will change on PACE.
     
  17. JaneH

    JaneH

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    Just to be clear, are we asking the charities to support us generally in our call for the anonymised data to be released from the PACE trial? Or are we asking them to support us in our call for the data to be released specifically in relation to the upcoming FOI request tribunal? (i.e. do we want them to refer to this FOI case in any letter that they send?)
     
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  18. Sasha

    Sasha Fine, thank you

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  19. ClarkEllis

    ClarkEllis

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    My primary aim is that charities make mention of and support this specific FOI request because it is at the most advanced stage and the hearing is approaching: https://www.whatdotheyknow.com/request/selected_data_on_pace_trial_part#incoming-508208 which the ICO have ordered QMUL to comply with https://ico.org.uk/media/action-weve-taken/decision-notices/2015/1560081/fs_50565190.pdf but which QMUL are appealed. The appeal tribunal is due to be heard in April (I forget the exact date but the tribunal service posted a notice about it recently).

    But it is also clear that patients and the wider scientific community expect all the de-identified data to be released, not just the small amount asked for in the above request, and there are several active requests for the whole data, and so I feel charity support of the above specific request is highly likely to be compatible with the broader calls for all the de-identified PACE data to be released. Thus my secondary aim is that charities call for all the de-identified data to be released also.

    Hope that is clearer but so let me know if it isn't.
     
  20. JaneH

    JaneH

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    Yes that is very clear thank you. However I'm not sure it was quite as clear in the suggested email text that you posted on your recent blog (which was otherwise an excellent email). My worry is that unless we make it crystal clear what it is we want our charities to do they might come up with some vague or ambiguous statement which would obviously be much less helpful/powerful than a statement that makes it clear that they support this specific FOI request. So perhaps some further correspondence with the ME charities might be necessary in order to clarify this?
     
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