Why I am signing the petition to oppose MEGA

mega

MEGA has many facets: is it a thing of beauty or are its flaws too great?

MEGA is a proposed study into ME/CFS. There are good and bad aspects to it, so reaching a conclusion on whether to support it, or not, is not straightforward. But after careful consideration I have decided I am going to sign the petition opposing the study.

The MEGA alliance asked patients to endorse their study by signing a petition in support of them gaining funding to take the project forward (yes, there are two separate petitions). In the bit at the bottom were details about who was involved which includes the principal investigator of the PACE trial, and another researcher who has spoken highly of PACE and is running a trial similar to PACE in kids. Both promote a biopsychosocial (BPS) model of the disease.After some debate, someone launched a counter petition opposing the study. Right now what we have is a binary choice:

– Support the petition endorsing the study

OR

– Support the petition in opposition to the study.

You can of course do nothing but then you get no say at all, stuff just happens to you.

There are lots of potential problems with MEGA and these have been discussed on Facebook pages, blogs and forums such as Phoenix Rising. But these are the things that for me mean that I cannot support MEGA:

* Peter White’s involvement – he led the PACE trial. He promotes a BPS model of the disease that his own research does not support.

* Esther Crawley’s involvement – she ran a treatment trial of the Lightning Process on children with ME. She is now doing a graded exercise therapy trial on children despite there being concerns over the safety of the treatment.

* AYME involvement – Esther Crawley is an adviser for this organization so there is a clear conflict of interest. In my view AYME does a bad job of representing the interests of patients, one recent example I wrote about on my blog this spring.

I also have concerns over the definition that will be used to pick patients for the study, though I believe this may be something that those involved in the study may be willing to change, so it is not currently a reason why I am signing the petition. I don’t see any realistic prospect of them resolving the three issues above though, hence I will be signing the petition to oppose MEGA.

Some have pointed out that there are some good people involved in this study too, and I agree that is the case. There are researchers involved who have a track record of carrying out good quality science and I hope these people will do research into ME/CFS in some form. I want to find myself in a position where I can support them wholeheartedly.

I would like to specifically state that every patient I have interacted with wants these new researchers involved. The concerns are solely with certain individuals and organizations that I feel have let patients down over the years.

It has also been pointed out that as well as mental health questionnaires for 12,000 patients we will also get some omics data, and I think if genuine patients are picked this will be very interesting. The problem though is that patients are being asked if they want this study as it is and we are not being given a one or the other option. We are being told we get the good bits but must also accept the bad bits.

Given the new researchers involved are not considered experts in ME/CFS the study will be dependent on the advice of the so called experts White and Crawley. This could limit the good side of what we could potentially get out of this study and given its size and cost, if this study is not done properly it will set in stone an omics view of the disease forever. No one is going to be given funding to do something similar on this scale again if this study fails to show compelling evidence of something going on in omics. So the stakes are high.

Additionally, omics research takes time, a lot more time than it takes for mental health questionnaire and chalder fatigue scale results from the same study to be published and start being applied to all of us. If lots of people without ME/CFS but with mental health problems are entered into the study (highly likely based on the definition they tell us they will use) then a lot of those 12,000 study participants will demonstrate mental health dysfunction and not have ME/CFS.

It would probably seem quite reasonable to add these questionnaires to the study (it’s not hugely expensive). But off the back of the biggest ever study of mental health in ME/CFS (even though that is not the primary aim of the study) White, Crawley and other researchers who promote behavioral models of the disease will use this data to further research in that area rather than biological models.

So the question is, are you willing to take the risk of endorsing the bad as part of the deal to potentially get something good? Right now, as it stands, I cannot support it.

Some people who I like and respect a lot are in support of MEGA. I understand their reasons, and I too would love to support large-scale biomedical research into ME/CFS from some of the names involved in this project. I have found it very tempting to ignore the major problems I’ve raised, because of my desire for some of the big names involved in this project to have a crack at the disease. But I simply can’t do so under the present circumstances, I feel the downsides are currently too significant.

It was also very tempting to sit on the fence. This is not the same situation as PACE, for instance. This is not PACE 2. PACE was 100% bad, there were no redeeming features. MEGA, in contrast has both good and bad features. But I felt it was my responsibility to reach a conclusion and to voice it and my conclusion is that there is too much bad wrapped up with the good.

Also, as you can remove your signature from these petitions if you change your mind, if the issues blocking my support of MEGA are resolved — and I hope they are — I will happily withdraw my signature and support the study. That gives me the confidence to make a decision based on the information I have right now.

I welcome comment on my blog from both sides of the debate, it’s not something that patients should fight over, it’s OK to disagree on such important matters. There is no clear right or wrong, and even if we disagree on this I am sure we will continue to agree on a great deal else.

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PACE Trial’s Forbidden Fruit: AYME Make Final Statement

by-their-fruit

By their fruits you will know them

Following an action from patients asking their representing organizations to support their interests, ten have come out in support by writing to Queen Mary University London calling on them to release the anonymous PACE trial data.

One, the Association of Young People with ME (AYME) ignored patients at first. I wrote them an open letter, and they  finally said they would discuss the issue at their Board meeting in March and make a final statement on the matter. That statement, which I just received by email, is copied below:

QMUL research data: Chair of Trustees states Board’s final decision

In recent weeks, the Board of Trustees of the Association of Young People with ME (AYME) has received requests from individuals within the ME community that they write to Queen Mary University London (QMUL), asking them to release the anonymised PACE data to researchers. At the board meeting, held on the 3 March, the matter was discussed, with the board unanimously agreeing on the following:

The QMUL data has already been released to and reanalysed by the Cochrane Collaboration (perhaps the most rigorous of research teams), which came to the same conclusion as the original researchers. This release to a bona fide researcher who has an ethical duty of care for the data complies with a condition of MRC funding.  For the same reasons, it remains open to other bona fide researchers to request the data, subject to the same ethical undertakings.  Therefore there is no requirement for AYME to write to QMUL and we will not be doing so.

AYME continues to care for, connect with and campaign on behalf of all children and young people affected by M.E./CFS, and this decision is fully in line with our work. No further comment will be made regarding our position on this matter.

M Ellis Chair of Trustees, on behalf of the Board

[to avoid confusion M Ellis is their Chair and is unrelated to myself]

This is a very surprising statement as it flies in the face of patients’ interests. AYME have isolated themselves by taking a stance in opposition to all the other charities. When the PACE data is released, and if it shows that ‘recovery’ was inflated several-fold by the post-hoc changes in recovery criteria then everyone’s first question will be, who took action to keep that a secret? And the second question will be, why?

I will investigate and attempt to answer that second question in my next blog posts. As a patient I cannot accept a charity that has conflicts of interest that trump patients’ interests. It’s time to bring the facts into the light.

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

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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

PACE Trial’s Forbidden Fruits: The Fruit of Your Labour

 

food-healthy-man-personIn the most recent post in this series I encouraged ME/CFS patients to contact UK charities and ask them to write open letters to Queen Mary University of London (QMUL) calling on them to release anonymized data from the PACE trial. Despite QMUL’s absurd stance on sharing data from the PACE trial, they had stated that they were seeking “patient advice” on the matter so I was sure they would welcome contact from charities that are in direct contact with patients. Perhaps as a result they will finally realise their stance is causing harm to science and distress to patients. They should drop their appeal of the Information Commissioner’s decision that the data must be released.

The response from readers was incredible with lots of patients joining the effort. Results have been dramatic with eight UK charities taking action so far!

  • ME Association: has written to QMUL in support of the FOI request which the university are appealing. A copy of that letter can be viewed on their website.
  • 25% ME Group: have written a letter (Word doc) to QMUL asking them to arrange release of the PACE trial data following the requests of patients and academics. They also raise concerns about harms experienced by their members from the PACE therapies.
  • Action for ME: published a statement that they strongly support the release of anonymised data from the PACE trial and will be writing a letter to QMUL that they will make public. Additionally, all future research funded by AfME will obligate researchers to share anonymised raw data.
  • Hope 4 ME & Fibro NI: has written to QMUL in support of the other requests for the anonymized PACE trial data to be released. A copy of their letter on their Facebook page.
  • Invest in ME: has written to the both the medical research council and the Lancet demanding that the data be released. Their statement and letters can be read on their website.
  • Tymes Trust: has written to QMUL asking them to reconsider their decision to fight the Information Commissioner’s decision that the data be released. Particularly in light of the risks to children being asked to take part in the PACE-for-children study (MAGENTA). Read a copy of the letter on their Facebook page.
  • Welsh Association of ME & CFS Support: has written to QMUL asking them to release the data and cooperate with a truly independant investigation, urging them not to delay and face up to the inevitable. Copy of letter on their website.
  • ME Research UK: has written to QMUL recommending they release the anonymised data and highlighting PACE trial’s controversial history and the movement in science toward accessibility of data. Their statement can be read on their website.

Outside of the UK

The Dutch Citizen’s Initiative for ME are the first (I hope of many) organizations outside the UK to join the UK charities in speaking up for patients in their country by writing to QMUL (and the Lancet) calling on them to release the anonymized trial data and carry out an independent review of the findings. You can read their letter here on their Facebook.

The Irish ME Trust have written to QMUL calling on them to urgently reconsider their position and release the anonymous PACE trial data. You can read their open letter here (dropbox).

Two belgian organizations, ME-Gids.net and WUCB (Wake up call beweging) have come forward to demand release of the PACE data, writing to both QMUL and the Lancet, calling on them both to realize that they can no longer defend the indefensible. Read the letter on their website.

Phoenix Rising, a US-based non-profit with membership representing much of the world has written to QMUL: release the PACE trial data.

The European ME Alliance (EMEA), an organisation of a dozen national patient organisations and charities in thirteen European countries campaigning for better research into the disease have written to QMUL urging them to reverse their totally unacceptable position and release the anonymous PACE trial data. You can read their letter here.

Their website lists 12 organizations, but I think one or two may be missing from the website. Here are the ones listed and I will update this if anyone is able to inform me of any that are missing.

1. Belgium ME/CFS Association (Nieuwrode, Belgium)
2. Foreningen for Myalgisk Encefalomyelitis (Denmark)
3. The Finnish Association of CFS (Finland)
4. Fatigatio e.V. (Germany)
5. Het Alternatief (Holland)
6. Icelandic ME Association (Iceland)
7. The Irish ME Trust (Ireland)
8. Norges ME-forening (Norway)
9. Liga SFC (Spain)
10. Riksföreningen för ME-patienter (RME) (Sweden)
11. Verein ME/CFS Schweiz (Switzerland)
12. Invest in ME (UK)

Three more Dutch me/cfs organizations ME/CVS Vereniging, ME/CVS Stichting Nederland, Steungroep ME en Arbeidsongeschiktheid have written to QMUL to release the PACE trial data. You can read their joint letter here.

Emerge Australia have written to QMUL and you can read their letter here.

ME/CFS Australia (SA) have written to QMUL. Here is their letter.

That makes twenty-nine patient organizations so far, from fifteen (I think) different countries. It is a global issue so if you are impacted by PACE in your country then I encourage you to speak to your national patient representing organizations and ask them to join the action.

This is a massive blow to QMUL’s war on transparency and avoidance of scientific accountability. We know that QMUL had contacted selected charities in the hope of securing their support, but have been rejected. Instead, charities are sticking up for the patients, and standing up for better science. They are doing the right thing and they deserve credit for that. It’s a sign of progress. Don’t forget to thank them for listening to us.

The one UK charity who failed to stand up for patients, ignoring us for weeks before making a worrying interim statement, was the Association of Young People with ME. You can read by open letter to them here and I suggest patients in the UK contact them to make sure they understand what patients expect from them. They hold their board meeting in March at which point a final position will be reached.

A charity must be judged by its fruits; their actions  not their name or friendly looking logo. If you are a supporter of AYME then unless they promptly resolve this situation you may wish to reassess whether AYME deserve that support. Consider if one of the charities listed above would represent your interests better. Although one charity may let us down, we won’t let one rotten apple spoil the barrel; bad fruit belongs in the bin. The many charities above listened to you, they acted in your interests and you made that happen by communicating with them. Now you get to enjoy the fruit of your labour. Enjoy the win, get a taste for more.

The success of this action has also attracted the interest of other non-profits outside the UK whose members are just as unequivocal that the PACE data must be released. I consider this action a success already in the UK, but I hope more organizations outside the UK step up for patients and join the action.

What this win demonstrates is that patients in the UK and all over the world can make a difference. We all know there are hundreds of thousands of us in the UK and millions across the world. It is time to start utilizing our numbers. When I first got sick in 2008 the community had big divisions, but worse than that, no one believed we could make our voices heard, even on topics where there was agreement. That situation has changed over the last year or so.

I have seen more and more patients join social media, understanding that it is a powerful platform where we can make our voices heard from our beds, from our small communities. The charities have become more effective, working on their wording, focusing tighter on the major issues, and putting patient interests above other loyalties. In addition there are new groups like the ME Action Network who help organize people to campaign more effectively.

No longer are good petitions signed by just a handful of patients. No longer do only two or three patients respond to a well conceived campaign to contact agencies or charities. Taking action, spending that limited energy we have on trusted campaigns now pays off because collectively our voices are too loud to ignore. It is the single most important advantage that we have as patients with this disease: there are so many of us that if we get organized, if we take part and believe we can make a difference, then we cannot be ignored.

If you took part in this action – contacting the charities, sharing and discussing the campaign on social media, or telling family and friends about it – then well done. If you didn’t, then that may be because you didn’t know if it would bring results. If so, I understand why. But things have changed, and this result is evidence of that. We can make a difference. If you take anything away from this win, let it be that: You can make a difference if you take action.


 

Small update regarding AYME: They have now tweeted (see below) asking patients to contact them about their stance on the PACE trial. The address they quote is the same one I used previously. Nevertheless, I would encourage patients to contact them as requested asking them to support patients by calling on QMUL to release the PACE trial data. You can find a template message in my previous blog post, or you can write your own.


 

main image: creative commons zero license, from Pexels