PACE Trial’s Forbidden Fruits: An open letter to AYME

sitting-on-fence-1

On 1st February, I wrote to each of the ME/CFS charities in the UK asking them to back patients up in calling on Queen Mary University of London (QMUL) to release anonymized PACE trial data. Lots of other patients joined the effort and contacted the charities too and this was important as collectively we patients can be heard. Most of the charities responded quickly and made public statements that QMUL should release the data. But one of these charities not only did not take action but did not reply to me or other patients I have spoken with.

Despite my chasing them up, the Association of Young People with ME (AYME) ignored my message for over two weeks. I was about to publish this blog post when they finally acknowledged receipt of my message, but their reply failed to address my concerns. I have today sent them the letter that appears below. If you have yet to contact AYME on this issue, I encourage you to contact them to ensure your view is heard. The email address they have requested people contact them on is info@ayme.org.uk .

 

Dear board of Trustees,

As you are an ME/CFS charity I contacted you to make sure you were aware of how I, and many other patients, feel about the importance of anonymous data from the PACE trial being released and asked you to take action in support of patients. A copy of that letter can be found in my earlier blog post. Thank you for acknowledging my original message today, I hope we can have a constructive dialogue on this matter. Largely, I am left guessing at your thinking on these matters, which is unfortunate, but I will address some of the possibilities here in case any of them are relevant to your own considerations.

The value in a letter to QMUL

I stated in my previous letter that “Even if they [QMUL] do not contact you I think you should contact them so that patients’ views are accurately conveyed.” You may be thinking that QMUL would not be likely to submit evidence to the tribunal hearing that does not support their position. A reasonable assumption. However, should you decided to write a letter, and make it public, it could then be used by the side defending the Information Commissioner’s decision that the data be released. It would be a powerful statement of support for a patient who is representing the interests of all ME/CFS patients. So there is no question as to the value of such a letter. I have now reached out to Mr Mathees who has confirmed that a letter would be useful. Should you need to hear from Mr Mathees directly, I can ask him to contact you.

I would also reiterate that QMUL have stated that they are interested in the view of patients, therefore you have a duty to report the consensus among patients and I maintain that a letter to QMUL expressing the desire from patients that the data be released, would be important for them to receive.

No risk of re-identification

Although there are patient participants who are in favour of the anonymous data being released, it is possible that some individual patient participants may have contacted you with concerns, perhaps following contact from those at QMUL who are keen to avoid transparency that would result in further scientific scrutiny. If this has occurred then have you engaged with them to explain that the Information Commissioner considers there to be no risk of re-identification when he ordered the data to be released? Here is a link to his decision notice in which he provides detailed explanations for his decision to reject QMUL’s arguments on re-identification. He is very clear in rejecting the merits of those arguments. If you have not already done so, you must surely take the time to read the decision notice to ensure you can dispel any misinformation patients might hold when contacting you on the matter, and so that you understand these matters yourselves.

The general consensus

As a charity you likely hear a wide range of views from patients, but it would not be appropriate to try and stand behind such a generally true position in this case. Patients’ views have been expressed in an 11,900-signature petition hosted by the ME patient-advocacy organisation #MEAction, which included 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)”, and with the growing controversy over the PACE trial, release would clearly still be in the interests of the vast majority of patients even if a minority were against it. With so many patients and charities all united in their position that the PACE data be released, it would surely be a mistake for AYME to be the only charity not to support that.

Release of anonymous data does not require consent

One of QMUL’s arguments has been that patient participants did not consent to the data, anonymized or not, being released and you may rightly be uncertain as to whether you can call on the data to be released if that would mean consent being broken. The Information Commissioner’s decision notice examines this very question in great detail, about whether or not consent would be broken were this data released. Pages 21 and 22:

(b) Would disclosure of the withheld information constitute an actionable breach of confidence?
70. In order to determine whether disclosure would constitute an actionable breach of confidence the Commissioner considered the following questions:
(i) Does the withheld information possess the necessary quality of confidence?
(ii) Was the withheld information imparted in circumstances importing an obligation of confidence?
(iii) Would unauthorised disclosure cause a detriment to the party providing the information or to another party?
(iv) If parts (i)-(iii) are satisfied, would the public authority nevertheless have a defence to a claim for breach of confidence based on the public interest in the disclosure of the withheld
information?​
The document then provides a summary of QMUL’s arguments put to the Commissioner on this question which is a bit lengthy, and having considered those arguments the Commissioner gives his decision, which I will quote for you here:
75. In order for section 41 to apply it is necessary for all of the relevant elements of the test of confidence to be satisfied. Therefore if one or more of the elements is not satisfied then section 41 will not apply. The Commissioner has explained, in relation to the application of section 40(2), why he does not consider it possible to reliably identify an individual as the subject of the withheld information from its contents or if it is linked with other material available to the general public. In such circumstances he does not consider that there can be an expectation of confidence or that disclosure would cause detriment by way of an invasion of privacy. Therefore it follows that there can be no breach of confidence to action and section 41 does not apply.​
In short: the legal requirements of the Data Protection Act do not apply to anonymised data and so it is not considered “personal data” under law. Therefore no consent is required to release it. It is important that any patient participants are pointed to this information so they understand that it is not personal data that could reveal their identity, and that their consent was not required for anonymized data to be released. Indeed, the PACE authors have already released some of the de-identified data, both in their published papers (individual data on adverse events are given in the appendix of White et al, 2011 and to an outside research team who are currently writing a new paper for publication. So even if we believed QMUL’s masquerade that de-identified data is subject to the consent agreement (which it is not, as has been demonstrated above) then they have already broken that consent agreement at least twice. If any patients have raised concerns with AYME over consent issues have you made the patient participants aware that some de-identified data has already been released without consent being requested by QMUL?

 

Sitting on the fence

Many patients have been in contact with you about this matter by letter and via social media. In your acknowledgement to my message you state:

As the Chief Executive of the Association of Young People with ME (AYME), I acknowledge receipt of your email.

 We will support the outcome of the legal process relating to this action, and are taking steps to add the petition to our website, as soon as possible. The petition will sit in the members-only area of our site and will be available for our members to access as they wish and respond should they choose.

The matter will be further discussed at our next board of Trustees meeting, to be held in early March, and we will issue a further statement after this time.

I presume that this statement is AYME’s interim position as the board have not yet met to discuss this properly. However, as you made this statement I must point out the significant problems with. Your statement is concerning as supporting the outcome of the legal process is the very definition of sitting on the fence. The judges do not require your support. Patients do. As a patient charity you cannot faithfully take an impartial position as you should be committed to speaking up on behalf of patient’s interests in the hope of achieving a better outcome for us. Adopting a passive role would clearly not be a credible outcome in a situation where patients have made their position so very clear.

Additionally, although I welcome the fact you will be putting a link to the petition in your members area, this petition campaign ended some time ago. We don’t need more individual patients to sign the petition, we need charities to back up patients.

If the data are released (only 9% of appeals against the ICO are upheld by tribunals (2014/15 figures) so the ICO’s decision is likely to stand), it is probable that re-analysis will show that recovery rates have been exaggerated several-fold; further critical attention would follow from the scientific community and people will ask who supported the data not being released. There is already a strong and widely held perception that AYME is not on the side of patients and it would be a shame if that perception was reinforced by your inaction. I therefore urge you to publicly ask QMUL to withdraw their appeal of the Information Commissioner’s decision and release all anonymised trial data.

I would suggest that AYME can safely stand behind the ICO’s existing decision, and should do so in the interest of patients. I encourage you to do this in your own interests also. This is a watershed moment for ME/CFS and recent events have put a spotlight on the charities and drawn in many outside observers. The scrutiny of your decision is more intense as you are the last to announce it and anything other than certain support for patients would be in stark contrast with the position of the other charities. Everyone is watching to see what action you take.

Sincerely,
Clark Ellis


Previous posts in this series:
Part 1: Why We Must Be Allowed A Look Inside
Part 2: Is The Data Really Poisonous?
Part 3: Charities Must Echo Patient Calls For Data Release
Part 4: The Fruit Of Your Labour

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11 thoughts on “PACE Trial’s Forbidden Fruits: An open letter to AYME

  1. You are so patient and reasonable. Is their mission to support patients? If so, they are not doing it. I can’t comment, not being in their patient cohort, but it is NOT in their interest to appear to support the side that wants to maintain darkness over scientific data.

    Can you figure out what they’re afraid of? Do they get money from this somehow? Is it NOT in their best interests for some reason to support the side of proper treatment? Do they have a reason, strong or not? Or are they just dithering when other organizations are acting?

    The sooner the PACE ‘study’ is examined and validated or invalidated, the sooner everyone can stop worrying about it.

    I have no particular faith in the outcome – I’ve been sick for 27 years, during which nothing much has happened – and yet huge patient efforts have been made. In the States the tide may be turning a bit. I think ME/CFS research will discover a host of results that will be useful for other diseases as well. It was just my bad luck to be in the forefront of ‘too complicated, so it must be mental.’ I WISH I had a brain with the ability to be that complicated on command.

    Sorry – too tired to be coherent. You’re doing an impressive job here.

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    • My understanding is that AYME is guided by the charity’s medical advisor, Dr. Esther Crawley. Dr. Crawley is leading MAGENTA – a trial investigating the effectiveness and cost effectiveness of Graded Exercise Therapy compared to Activity Management for paediatric CFS/ME. As these were two arms of the PACE trial, and as Dr. Crawley has declared no risk anticipated to the trial participants by taking part in the trial, there may be a conflict of interest for AYME in their view regarding release of the PACE trial data.

      Liked by 1 person

      • Exposing conflicts of interest is in EVERYONE’S best interest. At least here you have some information. The conflicts are not always easy to find – and reveal. Researchers realize they may have past or future ties to other research, and don’t want to shoot themselves in the foot by aligning themselves with one side or the other – until something hits the fan and they HAVE to.

        Bad enough research hasn’t produced much all these years, but the underlying money web has made things worse. In the States, money has been diverted from CFS research for years.

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    • Thank you, I try to be as patient and reasonable as I can. This stuff matters to me and so many others, it impacts out lives directly, so it is hard, but I want to give each charity the chance to do the right thing. If a charity fails patients I think that would need to be exposed and talked about in a big way, and certainly people have contacted me with information on potential conflicts of interest that may affect AYME’s decision on this matter, but I will wait to see what they do before I decide what to make of that information. If they do the right thing, I will praise them for it. All eyes are on AYME now as the other EIGHT main UK charities have taken action to support patients. It would be quite remarkable if AYME went against everyone else.

      I am so sorry you have been sick with this horrid disease for as long as that. I agree a lot of the findings from quality biomedical research into ME will find applications elsewhere also. It’s such a sensible disease to fund research in but there have been people that have held things back for way too long. But things are changing. We won’t accept it any more. Patients deserve medals for what they have put up with so far, and even more so for the calm and determined way they are going about making sure things change. I don’t know if everyone has cottoned on yet, but what people could get away with in the past at the expense of ME/CFS patients is no more – patients will not accept it any longer, we will challenge misbehaviour wherever it occurs.

      Liked by 1 person

      • ME/CFS is very scattered here in the US – there are all kinds of organizations claiming to be THE voice of the patients.

        I am intrigued by ‘nine charities’ somehow covering the whole. And what is a ‘charity’ in this sense? What we call a non-profit? An organization with a tax-exempt status that advocates for people with the disease in general?

        I tend to think of a ‘charity’ as a group whose mission it is to directly aid the target group – I don’t think we have anyone or any group which provides funds and services to CFS sufferers. There are plenty of patient advocacy groups, but the many people with the disease have to depend on Social Security disability (which can be very hard to obtain) and long-term disability insurance through their employers while they were still working, and too many people damage that coverage because they try to deal with their symptoms by going to a part-time status which has no coverage in disability insurance.

        I’m curious how that works. You have national health insurance – and it has been very ineffective, first trying to tell people it was in their heads, and then that if they just exercised hard enough they’d be well. ‘Blaming the victims’ saves money – but doesn’t solve the problem.

        Most of us just try to cope somehow – the problem with having a disease that robs you of both brain function and energy, and immerses you in pain.

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  2. Pingback: PACE Trial’s Forbidden Fruits: An Open Letter To AYME – The York ME Community

  3. Pingback: PACE Trial’s Forbidden Fruits: The Fruit of Your Labour | The Self-Taught Author

  4. Pingback: PACE Trial’s Forbidden Fruit: AYME Make Final Statement | The Self-Taught Author

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