PACE and the interests of trial participants

disabled courtA tribunal has recently ruled that anonymous data from the controversial PACE trial must be released, rejecting an appeal from Queen Mary University of London (QMUL).

The data in question has been discussed on this blog before and you can read here to understand exactly what data we are talking about. It includes no personal identifiers.

The release of this data would allow for a reanalysis of the primary outcome measures according to the thresholds pre-specified in the researcher’s own published protocol. The recovery analysis in their published papers diverged from their own protocol, and included them lowering the recovery thresholds – this had the effect that more patients appeared to “recover” than if they had stuck to the planned thresholds for recovery. It’s possible that against the original recovery thresholds PACE may fail to demonstrate any significant recovery in patients – which would make the trial a failure.

QMUL can potentially appeal the tribunal’s decision and try again to block the release of the data that would allow this analysis. QMUL have already spent over £200,000 on legal fees on this tribunal case alone, which seems extraordinary considering they are a public institution. Following the tribunal’s decision they released this statement on their website: Disclosure of PACE trial data under the Freedom of Information Act

Prior to the tribunal, QMUL released a similar statement in which they said they were “seeking…the advice of patients”: Release of individual patient data from the PACE trial which led me to write to ME/CFS charities asking them to speak on behalf of patients. I asked patients to do the same, and you did! The effort was a success with 29 charities across the globe writing to QMUL on the request of patients to call on them to release the data and drop their appeal. This was submitted to the tribunal as evidence of the public interest in the data being released. Regarding the clear public interest in the release of the data, the tribunal stated:

“There can be no doubt about the Public Interest in the subject matter which is evident throughout the course of this appeal, and beyond, and we are grateful for the assistance that has been given to us in this regard.”

It was surprising that QMUL chose to ignore such strong public interest in the release of the data, which included thousands of patients, patient organizations, and academics. It appears they were not sincere in their wish to take account of the advice of patients, after all and I note that in their most recent statement, this time they do not invite the views of patients. But their most recent statement does say this (my emphasis added):

“We are studying the decision carefully and considering our response, taking into account the interests of trial participants and the research community.”

Perhaps QMUL will be consulting with participants then. QMUL surely do not mean to decide what is in the interests of participants without consulting them? To not consult participants would seem quite remarkable to me, but for all I know QMUL have been keeping participants informed and are seeking their views following the tribunal decision.

Given the Judge has ruled that they “…are satisfied that the risk of identification has been anonymised to the extent that the risk of identification is remote”, and that there is “…a strong public interest in releasing the data…” it is hard to see how QMUL could claim the interests of participants could be furthered by another appeal.

It must never be forgotten that trial participants are also patients, and members of the public too. However, this has not stopped QMUL in its various submissions from making a number of accusations of harassment from patients. In a separate FOI case, under a section they entitled “Harassment,” QMUL have pointed to the 12,000 strong petition calling for PACE claims to be retracted – most of those signatures are patients and some may be from patient participants in the PACE trial.

QMUL has accused patients in their “further skeleton” submission to the tribunal, where they claim “’highly critical’ and ‘vitriolic’ patient/activist groups” have tried to discredit the research.

One such activist group, according to QMUL, is the patient forum Phoenix Rising. Professor Jonathan Edwards, a member of the Phoenix Rising Board of Directors, appears to have been displeased with this accusation, as evidenced by his submission to the tribunal, referred to in the tribunal’s decision:

“Professor Edwards takes issue with the assertions that Phoenix Rising is allowing inappropriate behaviour, and further takes issue with the  term  ‘activist’ being used for its audience. He distinguishes highly motivated data requesters from those acting inappropriately or unreasonably. He accepts that certain individuals have expressed their frustrations with the misinterpretation of the PACE trial on the website in abusive terms, but this pales  in  comparison with four years of “intelligent and measured critique” provided by the other patients. Rather, the campaign to discredit or hijack the issue has come from the PACE authors and their colleagues in a series of attacks in review articles in the national press, online and in public presentations.”

The tribunal decision notice shows that one of QMUL’s arguments against disclosure of the anonymous PACE data was that “It would cause unwarranted distress to participants and open them to criticism or harassment.”

One document submitted by Alem Matthees as part of the evidence to the tribunal was a document collating the publicly available comments from PACE trial participants who had voluntarily come forward to express their views in public. A copy can be found here. It was submitted to dispute the claims of QMUL that patient participants were in danger of being harassed, and shows that in all cases where patient participants have come forward they have not been harassed, but rather have been praised, thanked and supported. This is no surprise, as we are all patients and we all just want to get better.

The Judge, considering this, and other evidence, found QMUL’s assessment of activist behaviour to be “grossly exaggerated” and QMUL were forced to admit at the hearing that “no threats have been made either to researchers or participants.”

But understandably, patients – including patient who are participants in the PACE trial – may feel rather upset with QMUL about their negative stereotyping of patients.

The tribunal decision includes a sentence about the responsibility of QMUL to participants when it comes to information about the anonymous data, the Information Commissioner pointing out that ” It would be up to QMUL to explain to participants that their data has been anonymised so that they could not be identified from it so as to allay fears that they themselves [QMUL] seem to be attempting to stoke up.”

Again, this makes you wonder what QMUL have been telling patient participants, if anything.


 

 

image credit: welsnet
creative commons licence
changes made to original image

PACE Trial’s Forbidden Fruit: AYME Make Final Statement

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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

PACE Trial’s Forbidden Fruit, Part 3: Charities Must Echo Patient Calls For Data Release

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I recently wrote about the Freedom of Information (FOI) request that the Information Commissioner upheld, ordering Queen Mary University of London (QMUL) to release the data requested from the PACE trial. I provided an example of exactly what data was requested to demonstrate that the release would not include any personal identifiers of patients from the trial. I also highlighted the scaremongering of the PACE authors and their institutions that is misleading people into thinking the data is personal data when it is not. Before that, I wrote about why we must be allowed to see the data.

QMUL released a statement about the case, stating that they were seeking advice of patients, but they have not explained how this advice is going to be sought or under what conditions.

Many ME/CFS patients will obviously want to have their opinions taken into account. It is clearly a matter that patients feel strongly about. A recent petition concerning the PACE trial, signed by over 11,000 people (mostly, it is reasonable to assume, patients) 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)”

My suspicion is that QMUL and the PACE authors will seek the support of ME/CFS charities who have supported them in the past. But our charities should neither support the withholding of the data nor passively wait to be contacted: they should be all over this issue. Patients rightly expect the charities to speak up on their behalf, to earn the donations and membership fees we give them. The charities must ensure that the PACE authors can’t just cherry-pick the advice from patients that suits them.

Previously, some of the charities have done a good job of challenging the flaws in the PACE trial and others have fallen short. Some past statements suggest that some ME/CFS charities may not understand the problems with the trial. However, this is too important for the charities to fail to inform themselves of all the facts. There is now plenty of well written information about the problems with PACE. Whereas patients may be too sick to do the necessary reading and thinking, our charities have a duty to study the facts. They must not allow themselves to be be misled by the PACE authors or sit on the fence through ignorance; either will be unacceptable to patients, who will not forgive such a failure on this key topic. Charities representing patients, particularly, but not exclusively in the UK, can have an important impact and I am calling on them to stand up for patients on this crucial issue.

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I encourage readers to contact ME/CFS charities and ask them to contact QMUL to tell them that patients want the data released. Crucially, not just the charities that have been supportive of patients already but also those that some may feel have let them down on this issue before. Judge each charity by its subsequent actions. Below are the contact details of a list of the larger UK charities which you may wish to contact.

I will be writing to ME/CFS charities who represent UK patients in two week’s time to ask what their official stance is, and what they are doing about it. I hope that they will publish their letters to QMUL on their own websites so that I can link to it. If you also want to post a copy of your email/letter/the gist of your phone-call, then feel free to do that here – I think it would be good to have the views of patients on the public record.

Here is what I will be sending to each of the below charities. Feel free to copy the text – adapting it if you like – to save yourself some time.

I believe this is really important. We have limited energy, but if we don’t spend it to do this then QMUL will find it easier to present a one-sided view of what patients want that will not represent us well.

My email:

I am writing, as an ME/CFS patient/member of your charity, to express my concern about the PACE trial and Queen Mary University of London’s (QMUL’s) actions to deny release of trial data that the Information Commissioner has ordered them to release. I understand that QMUL are seeking the “advice of patients” which I assume may include contacting you for a statement or evidence of what patients’ advice on the matter is. Even if they do not contact you I think you should contact them so that patients’ views are accurately conveyed.

Patients’ views have been expressed in an 11,000-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)”.

I believe that it is crucial that our UK ME/CFS charities stand up for patients and for transparency in the science that affects our lives: patients expect no less of our charities at this crucial time. The Information Commissioner has already concluded in his ruling that the data release poses no risk to trial patients being identified.

In common with the petition signatories, my view is that the PACE trial was flawed and the de-identified data must be released to the public at once. I believe QMUL should drop their appeal before the tribunal hearing and comply with the Information Commissioner’s decision. I hope that you will contact QMUL and express to them that this is a widely held view among patients, and one that you support.

I hope that you will post any letter that you send to QMUL on your website. I have written a blog post on this topic and will link to any public statements that you make on this issue.

Sincerely,

Contact details for the larger UK ME/CFS charities:

The charities are listed in alphabetical order. While some informed themselves early about the problems with PACE and have, to their great credit, actively campaigned to protect patients from the misinformation that surrounds it, others have not. The latter charities in particular now need to realise that they must act in a way that reflects reality and patients’ needs before they lose their reputations for good: and all charities now need to come together and speak with one voice. Please write and tell them!

Action for ME
AYME
Invest in ME
ME Association
ME Research UK
Tymes Trust

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PACE Trial’s Forbidden Fruit: Is The Data Really Poisonous?

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A Mock strawberry: No it’s not poisonous, despite what you may have heard. Just tasteless.

A freedom of information (FOI) request was submitted to Queen Mary University London (QMUL) in 2014 for a small portion of the PACE trial data (below I go into detail about precisely what data has been requested, and you can skip ahead if you want to). QMUL refused this request. The case went to the ICO who agreed with the requester and ordered QMUL to release the data. QMUL have appealed this decision and the tribunal will take place in 2016 with the court deciding whether QMUL have to release the data, or not. The outcome is impossible to predict, but it’s important. I wrote previously about why we must be allowed to see the data.

Here is my opinion: For ME/CFS, this tribunal case is one of the most important things that will happen in the whole of 2016. It’s outcome will affect millions of us for years to come. So I consider this important. Very important.

I’m not sure all ME/CFS patients realise how much PACE affects their lives. PACE is the cornerstone of the behavioural model that dominates how ME/CFS is perceived by government agencies including the NHS, the media and the public. It dominates how the disease is treated, not only in the UK but in many other countries around the world. It dominates how research money is spent (more behavioural studies rather than biomedical studies that might actually lead somewhere). It dominates social security policy that ultimately affects whether you get the support you need to live when you are crippled by the disease.

If you think that as PACE was studying those diagnosed with the Oxford criteria and therefore it doesn’t affect you, think again. The authors use the term myalgic encephalomyelitis in their protocol, their paper, and media statements, alongside chronic fatigue syndrome, and this important limitation to the study (uselessly broad criteria that mean people with other diseases are included in the study) has not held it back from being used to blight the lives of those with ME or CFS defined by a stricter set of criteria. So this matters to all of us no matter what we think of the names, or whether more than one disease is represented by these labels.

The study has been fraught with problems, the design was a shocker, there have been concerns over safety, reporting of results and misrepresentation of data, and the hiding of data that does not support the authors pet-theory of a behavioural model of disease. Without visibility of the data the authors conclusions cannot be put to test and undergo normal scientific scrutiny. So it is essential that we get to see the de-identified data.

In relation to this case, QMUL have said that they are “seeking….advice of patients…” No details are given of how QMUL is seeking this advice of patients. We have not been told how patients are being selected, how QMUL are presenting their request and what information they are providing the patients with, or how patients wanting to provide advice (me, for instance) can do so. This concerns me greatly as the authors of the PACE trial have repeatedly attempted to set themselves up as an unofficial mouthpiece for patients; they tell government agencies and the public what we apparently want and think, they have huge influence in this area, and yet none of them, to my knowledge actually formally represent any patient organizations – and given their research positions it would be inappropriate if they did. These are researchers who give treatment in clinics and in trials to patients. They do not formally speak for patients. And it’s just as well, as they make all kinds of statements without foundation:

QMUL and the PACE authors have repeatedly misled and propogated misinformation with regard to FOI requests for data from the trial, painting a picture of requesters are harassers and of individual patient’s personal data being at risk (click here for a list of examples that I have just started putting together – please leave a comment there if you have spotted others), but this is nothing more than a tactic designed to avoid transparency. Even if we trusted them to follow a transparent and appropriate process when contacting patients for advice, the statements they have already made are highly likely to have biased much of that patient feedback already.

I think it essential to ensure everyone knows exactly what data was requested. These are the data points, below – and only this data – that will be released should the tribunal reject QMUL’s appeal.

• Total SF-36 physical function scores at baseline and 52 weeks. Patients filled in a 10-item questionnaire and their answers were summed to give a total score between 0 and 100 points: it’s this total score that has been requested.

• Total Chalder Fatigue Questionnaire Likert scores at baseline and 52 weeks. Patients filled in an 11-item questionnaire and ‘Likert’ scoring yields a total score between 0 and 33 points.

• Total Chalder Fatigue Questionnaire bimodal scores at baseline and 52 weeks. The “bimodal” method of scoring this questionnaire yields a total score between 0 and 11 points.

• Whether the participant met the Oxford definition of CFS at 52 weeks (yes/no).

• Participant-rated Clinical Global Impression score. This is a rating from 1 to 7 of how the participant saw their health as having changed at 52 weeks, ranging from “very much worse” (7) to “very much better” (1).

• Doctor-rated Clinical Global Impression scores. As above, but rated by the doctor, not the patient.

• Meters walked in six minutes (the “six-minute walking test“) at baseline and 52 weeks.

• The group to which each participant was randomly allocated (i.e. APT, CBT, GET, or SMC).

As you can see, the data being talked about contains no personal information whatsoever. Personal details of participants such as name, gender, age, locality, will NOT be disclosed.

For more detail on these questionnaires, HERE is an excellent detailed explanation

A spreadsheet containing only the above data would be released. Here is a made up example of what a few rows of that data might look like with each row being the de-identified results from each patient:

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Click here for a larger image in a new window. As you can see this is data is handy if you want to analyse whether or not the PACE treatments were as effective as its authors claimed, it is entirely useless if you wanted to track down the patients from the trial (not that there is any evidence anyone would want to do that anyway).

If you have read, or been told, that the data is more than this, then you have been lied to. If you have been told that patients who took part in the trial can be identified from this information then you have also been lied to. It is patently ridiculous to suggest that anyone could be identified from this set of data, as there are no personal details whatsoever. With over 600 patients having taken part in the trial there is simply no way to pick anybody out, even if someone knew who had been in the PACE trial; and with over 250,000 CFS patients in the UK, there’s no way of picking out PACE trial patients with the sort of data that has been requested.

Something QMUL and the PACE authors have never explained is why anyone would want to identify and track down the patients from the trial. Without a suggested motive, it’s hard to see why the PACE data should be higher out of reach than other studies which release their de-identified data (quickly becoming the norm nowadays). What has been the experience of patients from the PACE trial who have chosen to reveal that they took part in the trial, I wonder?

I have seen several patients who took part in the PACE trials say so on social media and I have never seen anyone respond negatively at all. Rather, I have seen fellow patients thank them for taking part in research, I have seen fellow patients offer support if they are still sick, and I have seen fellow patients respect their privacy unless they want to talk about it more. The most common response I have seen is a “Like” on Facebook with many patients from the PACE trial who reported their participation getting double figure “Likes”. We are all patients who share this diabolical disease, and I think it is very unethical of the PACE authors to manufacture the illusion of some kind of wedge between us when there is not one.

To reinforce the point that the release of the PACE trial data would not lead to any patients being harassed, I want to remind everyone that the PACE trial had a sister trial called FINE that was conducted at the same time. Whereas the PACE trial was for mild to moderate patients, the FINE trial was intended for severe patients and those who could not get to their local ME/CFS clinic due to distance, but similar data was collected. The FINE trial failed just as badly as the PACE trial did, but unlike the PACE trial, the authors of FINE, to their credit, released several pieces of data equivalent the  data requested of PACE. In fact they released a whole bunch of other de-identified fields as well, and did so without even being asked and anyone can go access it without any problems. No patients who participated in the FINE trial have been identified, no one has even tried. What would possibly be the motive to do so? I’ve noticed that QMUL and the PACE authors sometimes like to say things which lack any logical foundation to justify them, and that seems to reflect their overall effort to simply hide the PACE study from scrutiny at all costs.

I hope patients, including those who took part in the study, are not fooled by this scaremongering, but I understand some will be. It is not their fault if they are, they should be able to trust the people running the trial, but clearly if you question what they are saying you can see they are misleading patients. I hope this article adds a little clarity to what data is really being asked for and leads people to think about the true motives behind QMUL’s extreme attempts to deny release of the annonymized trial data.  If you want to follow this topic as it progresses over the coming months I suggest following James Coyne, David Tuller, and myself and keeping an eye on our blogs.

Within the next week I will be publishing another blog post focusing on how ME/CFS charities are responding to the PACE trial scandal and this specific appeal case, and what patients might be able to do to ensure their views are heard.

 

PACE Trial’s Forbidden Fruit: Why We Must Be Allowed A Look Inside

Take my word for it, it's an apple...

Take my word for it, it’s an apple…

If you have any interest in science, open data, bioethics, freedom of information or ME/CFS then the rejection by King’s College London of Professor James Coyne’s request for data relating to their PACE trial will not have escaped your notice. Indeed, many in the science community seem to have noticed ME/CFS for the first time as a direct result, as some of the tweets later in this article may suggest.

First, do take a look at the letter from KCL. It’s short on pages, and long in absurd statements.

The university focused a lot on the damage to reputation and potential criticism of the authors, however if the data is sound, if it supports their assertions about PACE as they have published then there should be no anxiety over this whatsoever. Indeed, if the authors scientific method is sound then release of the data would vindicate them, and would surely enhance their reputations. If the serious allegation of “improper motives” as they put it, has any validity be it by those who wish for openness or those arguing for concealment, the only way to determine this is to release the data. At present we have a claim the evidence is compelling but a contradictory argument that it must be accepted in blind faith. The brief glimpses we have been allowed so far have already shown that the PACE authors have repeatedly misrepresented PACE by telling everyone it is an apple when it is not. When is an apple not an apple? When it is an orange. 

First there was the ‘recovery’ paper where they redefined the word recovery to mean someone who is still so disabled at the end of the trial (average age, 38) that they are on a par with those suffering from Class II heart failure, and may even be worse off at the end of the study than when they started. Recovery to the authors means someone who has scored only 60 out of 100 on a physical function score, even though you could enter the study with a better physical function of 65. (Yep, you could actually get worse in this study according to the trial’s two primary outcomes and they would still count you as recovered – a success).  See David Tuller’s blog for more on this.

Then they claimed follow up showed CBT and GET were effective when in fact the underlying data showed a null result. No more effective than standard medical care. See James Coyne’s blog for more on this.

Now they are labelling legitimate request for data as vexatious, of no value, as having improper motives. They will say anything to avoid releasing the data. They want you to see an apple when in fact it is an orange. And from a distance it may really look like an apple. If you only look at the title of their paper and don’t read it objectively you can easily be fooled. But what they don’t want you to do, what they can’t allow you to do, is bite into the apple. If you do so you will discover that it’s not an apple at all. It is an orange. It was always an orange. They consider PACE to be a forbidden fruit; you may only look, you cannot touch, you certainly cannot bite into it, for they you would have true knowledge, and knowledge can be a dangerous thing.

I promised you some choice tweets, and here they are, people from the scientific community who are most disturbed by KCL’s rejection of Professor Coyne’s request. I am not aware of these people having shown an interest in ME/CFS before (though I apologise to any of them if I am wrong about that):

The university states that it believes it is “entitled to take into account the wider dealings and publicity surrounding the project when considering the motive behind this request”. I would say that you can’t have your cake and eat it (I don’t feel the need to stretch the apple/orange analogy any further). If we are going to consider the wider publicity surrounding the project then we must also consider how the rest of the scientific community feel about this, as well as the patients – that’s what this is all about, I’ll happily remind you; patients are sick with this dreadful disease, they live with it night and day and they deserve to be heard also. More than 11,000 people have signed a petition for misleading PACE claims to be retracted, so there is a clear public interest in this data being made available. It was heavily funded by the public purse and has been highly influential in determining the treatment that patients with ME/CFS get, both under the NHS in the UK and also in many other countries across the world. This really matters because there is a lot of money being wasted if the PACE treatments don’t actually work, and to make matters worse there is strong reason to suspect the treatments make many patients worse. A survey of 1,428 patients by the ME Association found that 74 per cent reported that graded exercise therapy (GET) made their condition worse. I can speak from personal experience of the harm GET causes, it made me much more ill but the NHS clinic that gave me it were totally disinterested when this happened – you can read a short page about my experience on MEAction.net

The final part of the letter that I will highlight is the claim that Professor Coyne’s request is vexatious and may lead to harassment of the authors. It seems that no PACE author’s mouth ever opens without the word harassment or vexatious or some other slur on patients being voiced. There are around a quarter million patients with this disease in the UK, which includes many children, as well as adults (to put that into perspective there are around 100,000 with multiple sclerosis, so ME/CFS is a very common disease). Worldwide we are talking about millions. Even if these claims of harassment were true – and I have not seen evidence that they are – it would still be unethical to smear all patients by voicing such claims ad nauseum. The truth though is far more disturbing: these comments come out over and over again because it is very effective at stealing the voice of patients who have been raising concerns about the quality of the PACE trial and the harms of GET. What Professor Coyne and the science community are experiencing now, is exactly the same as patients have had to put up with for years now.

Sadly, with all the bad press that PACE has been getting lately, I am sure these claims of harassment, or abuse, and vaguely described bad behaviour will be voiced loudly in the very near future. Probably in a national newspaper. I would be surprised if we didn’t hear these slurs in the next week, or two at most. Patients are used to this. As if living with this horrid disease weren’t enough, we get collectively slagged off on a very regular basis. It is cruel. I lost my life age 27, and I am hurt by this, but I can’t tell you how bad I feel for children who have to put up with this as well. It is a great injustice, and in my opinion everyone has a responsibility to study these PACE papers carefully, to listen to the criticisms being raised and to reason this through in their minds. And if a certain conclusion cannot be reached without seeing the data the PACE studies are based on then people must insist that the data is released. I am grateful to Professor Coyne and a number of others who have done this, and I hope others join them.


 

UPDATE:

It didn’t take long. An hour or two after publication, we got a troll smearing ME/CFS patients (for avoidance of doubt, I am not referring to the first tweet below but the reply by AS):

Professor Coyne, of course, has bitten the fruit of the ME/CFS world and knows this for what it is. I encourage others to do so. ME/CFS patients are not “nut cases” they don’t send “death threats” “letter bombs” and you don’t need police protection from us. We are, like you, just normal people. I have a family, and friends and I consider myself a nice guy. Before I was ill I worked in quality management for an international software firm. I was very good at it. I just got randomly unlucky and got this disease. I was young and thought I would never get ill. Even my grandparents are healthy in their 90s so I just didn’t think this could happen to me.  People like this guy want you to believe I am a terrorist though. Why is that?

I will continue to call people out who attack patients in this way and make unethical smears against a population that is undeserving of it. We actually deserve your compassion and support.