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PACE vs FOIA: Access Denied

April 9, 2014

This may not sound like a very sexy topic – but if you keep reading, you might be pleasantly surprised. It might even merit a minor geek-alert – but geeks can be good for your health in unexpected ways.

Introduction

Anyone who is following the efforts of many patients/advocates from the Myalgic Encephalomyelitis/Chronic Fatigue Syndrome community  (ME/CFS – estimated 20m patients worldwide) to extract the full data from the controversial PACE trial is likely to find this post of interest, plus anyone who cares about open access to the vast store of information held by states and their subsidiary bodies. And those of you who manage to read the whole post might might even conclude that some public authorities believe the word “of” in “Freedom of Information” is actually spelt “f-r-o-m”.

Moving on: so why is the PACE trial so important? This trial matters because, despite its poor results,  the trial investigators have used it to underpin the flawed model of ME/CFS as a psychosocial rather than a medical disorder; its influence extends throughout the world. The investigators are still refusing (under various guises) to release all the data generated by the trial, (eg. the data on deterioration rates) which are essential for an impartial assessment of the results. This is where access to information becomes a priority.

As I am not a scientist, I asked an acquaintance to review this post for me. This person agreed (although preferred not to be credited) and, in addition, made the following observation:

The results of the PACE trial were poor. After treatment with cognitive behavioural therapy (CBT) or graded exercise therapy (GET) there were no clinically significant improvements in objectively measured disability, and no significant improvements in employment, or welfare benefit claims. At best, only an additional 11-15% of participants reported a clinically significant improvement in their symptoms when CBT or GET were added to standardised medical care. However, these results were obtained without a placebo control group against which to compare improvements, which the best medical trials are expected to include.

Many ME/CFS patients/advocates believe that, despite the poor results, the trial has been spun in a way which is unrealistically positive and therefore serves the investigators’ own interests in proving their hypothesis to be correct. This was amply demonstrated in the first article about the trial from The Lancet in March 2011. As Craig Maupin recently observed in the CFS Report Op-Ed of March 2014: “[M]uch of the scrutiny on the definition of CFS and current efforts of the IOM to revise the definition for CFS, stem from historical and clear evidence that personal attributions played a role in the “evaporation” and “abandonment” of a devastating disease.” It seems, therefore, that every generation produces another batch of psychiatric converts who retain control of the radio station.

Freedom of Information Act (FOIA)

Any citizen from anywhere in the world can request information from a UK “public authority” under the Freedom of Information Act 2000 (FOIA) except for Scotland which is covered by its own Act from 2002. The US has a similar statute from 1966 and other countries have their own systems. It is a constitutional necessity for any country which claims to operate under democratic principles.

“Public authority” is defined in Section 3 of FOIA. Unfortunately, the format in which information can be requested from individual authorities is not standardised; some are much more user-friendly than others. However, Section 16 of FOIA imposes a specific duty on all public authorities to provide reasonable advice and assistance to requestors.

The PACE trial

This was conducted at various centres, led by the team at St Bartholomew’s Hospital (Barts) in London under Dr Peter D White, Professor of Psychological Medicine. The relevant “public authority” for Barts is Queen Mary, University of London (QMUL) therefore all FOIA requests are handled by QMUL, instructed by the team at Barts.

Despite numerous requests, QMUL has consistently refused to disclose certain parts of the data from the PACE trial. Broadly speaking, the Barts’ team appears to be selectively releasing information which reflects the trial’s “success” rather than presenting a full, honest and balanced account. They have failed to report on the primary outcomes that were laid out in the trial protocol. In scientific publishing, this is not good practice. Best practice would have been to publish the protocol-proposed outcomes; the current situation renders the authors vulnerable to accusations of ‘cherry-picking’ data.

This was a publicly-funded trial (£5m/US$8.3m) which was completed four years ago yet the full results are still being withheld from the public who paid for it.

DISCLOSURES: I am an Associate postgraduate law student at QMUL and have been since 2011. I have twice been an outpatient at the “specialist CFS/ME” Unit at Barts from 2000-02 and 2012-2014 (recently discharged for the second time). I also took part in Peter White’s early research into Post-Viral Fatigue Syndrome, after I had a bout of glandular fever/mononucleosis (caused by the Epstein-Barr virus) in the late 80’s/early 90’s. I am still very sick.

The result of my recent request to QMUL

One of the reasons given by QMUL for withholding information was that the material requested was intended for future publication. This is a legitimate exemption from providing material and is set out in Section 22 of FOIA. The Medical Research Council (MRC) has policy guidelines on how this should be handled.  The purpose of my request was to ascertain what was still awaiting publication and when and therefore how much longer QMUL could still claim this exemption from disclosure.

If you are able to plough through the email trail below, you will see that my request was not apparently successful. I could have continued the process and appealed it but, as the main purpose of my request had been achieved (and I doubt an appeal would succeed), I’m not going to pursue it. The timetable for the relevant outstanding publication is now more clearly defined and can be referenced in any future requests. Because the Section 22 exemption cannot be argued indefinitely by a public authority, this information is important.

QMUL did supply a list of trial-related publications, as I requested. However, a more detailed list of papers is set out at the conclusion of this post. It was provided by the acquaintance who reviewed this post for me and I am very grateful for their contribution.

The Kennedy case

As an aside, there has been a recent Supreme Court decision in the case of Kennedy v Charity Commission ([2014] UKSC 20. This case is already a potential game-changer on the issue of access to information generally and is likely to be appealed to the European Court of Human Rights. However, at this juncture, it probably doesn’t resolve our QMUL problem so I won’t discuss it further here. For anyone who is interested, here is the link to a fairly short article on the Kennedy case (which also includes a link to the full judgment – probably not so great for the brain-fogged among us).

Finally –

I know that many people may be unable to read much further than this (or may have lost the will to live already) so my final comment is this: information is arguably our most valuable tool in bringing about change for the abuse and neglect of ME/CFS patients which spans more than half a century. However, as with all good tools, it must be properly honed and used with respect and integrity otherwise it can cause significant damage. Information is of little use unless it can be skilfully processed and thereby transformed into useful knowledge. We need to understand better how to seek it, to filter it effectively, to interpret it wisely and, above all, to surmise what might be the most productive use (if any) of our accumulated knowledge base.

Each of us will have a different take on each piece of information but we need to reach a much broader consensus about firstly, what information is, or is not, of value and secondly, how best to utilise what we learn along the way. I have already discussed this issue in a previous post  https://valerieeliotsmith.wordpress.com/2014/03/10/turning-the-page-and-the-smith-checking-the-facts-and-why-we-need-to-broaden-the-debate/ . I cannot emphasise enough how important this is, not just to the ME/CFS community but for all of us, since – as John F Kennedy observed in 1963 – “we all inhabit this small planet”.

If you can’t face reading any further (although it may not be quite as dry as you anticipate!), then I would just briefly direct you to paragraphs 1 & 2 of the message in the trail below entitled QMUL to VES – 17 March (some of the formatting goes a bit haywire from here onwards: apologies for that).

Thank you to those of you who have read this far. I wish you well – whether or not you are able to continue reading.

 


 

The recent exchange between me (VES) and QMUL regarding PACE trial publications (plus a fuller list of publications at the end):-

VES to QMUL – 24 January 2014

Dear Mr Smallcombe

I understand that an application for the data concerning deterioration rates in the 2005-10 PACE Trial was refused by the First Tier Tribunal under Section 22 FOIA on 22 May 2013  Queen Mary University of London v the Information Commissioner (1) and Robert Courtney (2) First Tier Tribunal EA/2012/0229 read judgment

This refusal was on the grounds that the information requested was intended for future publication and that the public interest in maintaining the exemption outweighed the public interest in disclosure.

I would be grateful if you would supply me with full details of the publications(s) where this data has been/will be used.

This request is being made under the Freedom of Information Act 2000.

Thank you for your assistance.

 

Valerie Eliot Smith

 

QMUL to VES – 10 February

Dear Valerie Smith

Thank you for your email. The results of these data are contained in a paper which was submitted for publication last year, and which has been independently reviewed and was sent back to the first author for further analyses and revision on 3rd January this year, with an invitation to resubmit the revised paper. The authors are currently revising the paper and undertaking the requested further analyses, with a view to the revised paper being resubmitted for further consideration for publication by the journal.

Yours sincerely

Paul Smallcombe

Records & Information Compliance Manager

 

VES to QMUL – 17 February

Dear Mr Smallcombe

Thank you for your response to my request.

I would like my request to proceed to an Internal Review for the following reasons:

1. I asked for the name of the publication(s) in which QMUL (via the authors of the proposed article) expects the article to be published. You did not answer that question. I would like their name(s).

2. You mention the “authors” of the article but do not name them. I would like their names.

3. Paragraph 13 of the judgment in QMUL v ICO and Robert Courtney (see my email of 24 January) states: “[I]n 2012 another primary paper was published and 3 other papers will be published in 2013 including that with the requested data.” I would like the references for the paper published in 2012 and the 3 papers which were to be published in 2013 containing the “requested data” in Mr Courtney’s case. Given your answer to my original request, it is not possible to distinguish between all the papers which are being referred to and their connection (if any) to the paper to which you refer in your answer.

4. Paragraph 14 of the above judgment (dated 22 May 2013) states: “The Tribunal notes the stage at which the process had reached (sic) by the time the evidence was submitted in this case (namely revised due to internal review and almost ready for submission to a journal) and the evidence from the Editor of journal confirming that the University were intending to submit the data to them as part of an article. In light of the scale of the project and the clear evidence of a structure and timetable to the analysis of the data and the publication of the conclusions from this analysis, we are satisfied that the timescale is reasonable, and that subject to consideration of the public interest as set out below it is reasonable to withhold the information until date of publication.” I would like clarification as to whether the timetable which you have set out relates to the “structure and timetable” mentioned in this paragraph or whether it refers to a different timetable.

5. You have given an extensive timescale for publication of an unspecified article in your reply. That timescale is completely open-ended. Mr Courtney’s request for data in the above case (which was refused on the basis that it was intended for future publication) was made on 29 March 2012 ie. nearly two years ago. It appears that this unspecified article is no nearer completion than when the original request was made by Mr Courtney. I would like clarification of this point.

In support of my request, I refer to the following:

-The 2012 ECtHR Grand Chamber decision in Gillberg v Sweden http://www.bailii.org/eu/cases/ECHR/2012/569.html

-The PACE Trial was publicly-funded by the Medical Research Council and was completed nearly four years ago. It is therefore likely that Article 10 rights under the European Convention on Human Rights (freedom to impart and receive information without interference by public authority) will now be engaged.

Thank you for your assistance.

Valerie Eliot Smith

 

QMUL to VES – 20 February

Dear Valerie Eliot Smith

I am writing to you for clarification on part 4 of your new request. Please clarify to which timetable(s) you are referring in your email.

Please note that we will be unable to process your request any further until we receive a response; the ‘clock will be stopped’ in the meantime.

Yours sincerely

Paul Smallcombe

Records & Information Compliance Manager

 

VES to QMUL – 21 February

Dear Mr Smallcombe

 

Thank you for your reply. I note that the clock is stopped until you receive my response.

 

I also note that you have referred to my request for an internal review as a “new request”. Perhaps you could clarify where you think we are in the process. From my point of view, I was asking for the matter to move to an internal review as it stands. Your response did not give the information which I was requesting so I was repeating my request for the internal review and highlighting the areas which now need clarification.

 

With reference to point 4 in my last email, I was asking whether the timetable for publication of the unspecified article which you set out in your response is the same one as in the “structure and timetable” which is mentioned in Paragraph 14 of the QMUL v ICO and Robert Courtney judgment (see reference in my email of 24 January). Your answer does not make it clear whether it is the same timetable as in the judgment (and therefore the same article(s) ) or a different one. This is why I am seeking an internal review.

 

I hope that clarifies the matter.

 

Thank you for your assistance.

 

Valerie Eliot Smith

 

QMUL to VES – 17 March

Dear Valerie Eliot Smith

 

Thank you for your correspondence.

 

With reference to the numbered parts of your request, I am pleased to provide the following responses:

1. This information will be published, however, we do not have the information as to where as a matter of fact. It was submitted in 2013 as planned but has been returned for revision and will be resubmitted to the journal by no later than 03/04/2014. Since it has not yet been accepted for publication we cannot be sure we know the name of the journal where it will eventually be published.

 

2. Similarly all authors need to agree to co-author the resubmitted article. Since this has not yet occurred, again we cannot be sure of the final list of names of co-authors.

If the paper had been accepted by the date of your request or even by the date of our reply, we would be in a position to disclose the requested information. Releasing this information now would not add anything to any wider public debate or understanding about the information contained in the paper, nor is there any suspicion of wrongdoing or anything of that nature.

 

3. We can confirm that the following paper was published in 2012 in relation to the PACE trial:

McCrone P, Sharpe M, Chalder T, Knapp M, Johnson AL, Goldsmith KA, White PD. Adaptive pacing, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome: A cost-effectiveness analysis. PLoS ONE 2012 7(7): e40808. doi:10.1371/journal.pone.0040808.

 

Furthermore, the following five papers concerning the PACE trial were published in 2013:

Cella M, White PD, Sharpe M, Chalder T. Cognitions, behaviours and co-morbid psychiatric diagnoses in patients with chronic fatigue syndrome. Psychological Medicine 2013;43:375-380. doi:10.1017/S0033291712000979

 

White PD, Johnson AL, Goldsmith K, Chalder T, Sharpe MC. Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychological Medicine 2013;43:2227-235. doi:10.1017/S0033291713000020 http://journals.cambridge.org/repo_A89sxPko

 

Bourke JH, Johnson AL, Sharpe M, Chalder T, White PD. Pain in chronic fatigue syndrome; response to rehabilitative treatments in the PACE trial. Psychological Medicine 2013; Page 1- 8. (online) doi:10.1017/S0033291713002201

 

Cox D, Burgess M, Chalder T, Sharpe M, White P, Clark L. Training, supervision and therapists’ adherence to manual-based therapy. International Journal of Therapy and Rehabilitation 2013;20:180-186.

 

Walwyn R, Potts L, McCrone P, Johnson AL, DeCesare JC, Baber H, Goldsmith K, Sharpe MC, Chalder T, White PD. A randomised trial of adaptive pacing therapy, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome (PACE): Statistical analysis plan. Trials 2013;14:386. DOI: 10.1186/1745-6215-14-386 http://www.trialsjournal.com/content/14/1/386

 

None of these include the deterioration rate data which was requested by Mr. Courtney because, as explained, the relevant paper is still under review.

 

4. QML stated in its submissions to the First Tier Tribunal that the paper containing the requested data was being prepared and was expected to be submitted for external peer review in early 2013 with possible acceptance and publication by a scientific journal later in 2013. We also outlined which other papers had been published or were in the process of being prepared for publication at that time. It has always been the same paper to which we have referred, on the same timetable.

 

5. The timescale is not open-ended, although it is not possible to say exactly when the publication will occur. As stated in our previous reply, the paper is going through the normal peer-review process, which can be a long process and is not within the control of Queen Mary. The intention to publish this paper and its data has always existed since Mr. Courtney’s request.

 

If you are dissatisfied with this response, you may ask Queen Mary to conduct a review of this decision.  To do this, please contact the College in writing (including by fax, letter or email), describe the original request, explain your grounds for dissatisfaction, and include an address for correspondence.  You have 40 working days from receipt of this communication to submit a review request.  When the review process has been completed, if you are still dissatisfied, you may ask the Information Commissioner to intervene. Please see www.ico.org.uk for details.
Yours sincerely

 

Paul Smallcombe

Records & Information Compliance Manager

 

VES to QMUL – 21 March

Dear Mr Smallcombe
Thank you for your response to my request and for the clarification. I will not be pursuing this request any further.
Thank you for your assistance.
Yours sincerely
Valerie Eliot Smith


Further details of all the papers published since the trial
For anyone who is still reading (and still awake!), this is the list of all the PACE trial-related papers to date. It includes some items which were not mentioned by QMUL in their response. Again, I am greatly indebted to the source who very generously made it available for inclusion in this post.These are the main papers, in chronological order:

Published trial protocol (2007): White PD, Sharpe MC, Chalder T, DeCesare JC, Walwyn R; PACE trial group. Protocol for the PACE trial: a randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise, as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy. BMC Neurol. 2007 Mar 8;7:6. http://www.biomedcentral.com/ 1471-2377/7/6

Main PACE trial results paper (2011):
White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, DeCesare JC, Baber HL, Burgess M, Clark LV, Cox DL, Bavinton J, Angus BJ, Murphy G, Murphy M, O’Dowd H, Wilks D, McCrone P, Chalder T, Sharpe M; PACE trial management group.
Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial.
Lancet. 2011 Mar 5;377(9768):823-36.
http://www.thelancet.com/ journals/lancet/article/ PIIS0140-6736(11)60096-2/ abstract

Cost-effectiveness analysis (2012):
McCrone P, Sharpe M, Chalder T, Knapp M, Johnson AL, Goldsmith KA, White PD.
Adaptive pacing, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome: A cost-effectiveness analysis.
PLoS ONE 2012 7(7): e40808.
http://www.plosone.org/ article/info%3Adoi%2F10.1371% 2Fjournal.pone.0040808

‘Recovery’ paper (or, to be more accurate: “alleged recovery”, or “not actually a recovery”!) (2013):
White PD, Johnson AL, Goldsmith K, Chalder T, Sharpe MC.
Recovery from chronic fatigue syndrome after treatments given in the PACE trial.
Psychological Medicine 2013;43:2227-35.
http://journals.cambridge.org/ abstract_S0033291713000020

Statistical Analysis Plan (2013):
Walwyn R, Potts L, McCrone P, Johnson AL, DeCesare JC, Baber H, Goldsmith K, Sharpe M, Chalder T, White PD.
A randomised trial of adaptive pacing therapy, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome (PACE): statistical analysis plan.
Trials. 2013 Nov 13;14:386.
http://www.trialsjournal.com/ content/14/1/386

And these are minor/secondary PACE-related papers, in chronological order:

Lawn T, Kumar P, Knight B, Sharpe M, White PD.

Psychiatric misdiagnoses in patients with chronic fatigue syndrome.
JRSM Short Rep. 2010 Sep 6;1(4):28.

Cella M, Sharpe M, Chalder T.
Measuring disability in patients with chronic fatigue syndrome: reliability and validity of the Work and Social Adjustment Scale.
J Psychosom Res. 2011 Sep;71(3):124-8.

Cella M, White PD, Sharpe M, Chalder T.
Cognitions, behaviours and co-morbid psychiatric diagnoses in patients with chronic fatigue syndrome.
Psychological Medicine 2013;43:375-380.

Bourke JH, Johnson AL, Sharpe M, Chalder T, White PD.
Pain in chronic fatigue syndrome; response to rehabilitative treatments in the PACE trial.
Psychol Med. 2013 Aug 23:1-8. [Epub ahead of print]

Cox D, Burgess M, Chalder T, Sharpe M, White P, Clark L.
Training, supervision and therapists’ adherence to manual-based therapy.
International Journal of Therapy and Rehabilitation 2013;20:180-86.

For anyone who is still reading – you deserve a medal. Thank you – and I really really wish you well!
14 Comments leave one →
  1. April 10, 2014 00:19

    You wrote:

    *…. I am an Associate postgraduate law student at QMUL and have been since 2011. I have twice been an outpatient at the “specialist CFS/ME” Unit at Barts from 2000-02 and 2012-2014 (recently discharged for the second time). I also took part in Peter White’s early research into Post-Viral Fatigue Syndrome, after I had a bout of glandular fever/mononucleosis (caused by the Epstein-Barr virus) in the late 80′s/early 90′s. I am still very sick……*.

    I find it very stupid, when you suffer from ME and then going to Barts…..

    It’s your own fault – So don’t complain.

    Like

    • April 10, 2014 09:45

      Thank you for your comment, jevaner.

      You will notice that the passage you quoted was headed “DISCLOSURES”. It is therefore a simple statement of fact for the purposes of full transparency, not a complaint.

      Like

  2. April 10, 2014 15:27

    I remain friendly to Dr Peter White, even though I may have a different scientific notion on immunological treatment of ME CFS.
    Notwithstanding I think it inopportune to chastise him, or his co-authors, on the publication of a scientific paper before it is published. Yes, there are questions in the PACE trial that are, and remain , unanswered but this is a matter that should be discussed separately from a paper that is unpublished.

    Like

    • April 11, 2014 07:46

      Thank you for your comment, Dr Enlander.

      This post deals with two main topics: the well-documented background to the PACE trial and the reluctance of the trial team, via QMUL, to disclose the full data generated by the trial.

      As you will see from the email “QMUL to VES – 17 March”, no information has yet been given regarding the impending scientific paper. The details of the authors and publication are not available therefore it is not possible to comment or “chastise” anyone.

      I welcomed your comments to the Institute of Medicine’s public meeting on 27 January regarding the proposed re-definition of ME/CFS; in particular “In this area, where the ‘evidence’ has long been grossly distorted, and to date has produced a flawed, inaccurate model of this very serious physical disease, such criteria may well describe other conditions or disease models that are, simply put, not the disease described by [Dr Melvin] Ramsay……Dictatorial direction will continue to do a grave disservice to a long-suffering patient community”.

      http://forums.phoenixrising.me/index.php?threads%2Fdr-enlanders-comments-at-the-iom-delivered-by-jay-spero.27875%2F

      The ME/CFS patient community appreciates your valuable work on its behalf.

      Like

    • April 14, 2014 01:34

      When it comes to the matters like whether patients should be allowed access to results for the PACE trial’s protocol defined criteria for recovery ( https://www.whatdotheyknow.com/request/pace_trial_recovery_rates_and_po ) or other pertinent data, then this is not a matter of a scientific disagreement, but a moral one. White et al.’s attempts to keep patients ignorant is shameful and deserving of chastisement.

      Like

      • April 14, 2014 09:07

        Thank you for your comment, eindt, and for providing this link. I hope that as many people as possible will actually take the trouble to read it.

        Best wishes.

        Like

    • May 18, 2014 12:26

      WordPress seems to be playing up at the moment so I have been asked to post the following as the person trying to reply to Dr Enlander has been unable to for technical reasons.

      Comment from Geoff Jones:

      “Valerie didn’t chastise Dr White but I certainly would as he and his ilk are directly responsible for causing serious harm to many ME sufferers, including Sophia Mirza, Emily Collingridge and notably the recent case of Karina Hansen in Denmark. This isn’t just a matter of scientific debate, real lives are being destroyed due to White and his school of thought. To quote Edmund Burke, ‘The only thing necessary for evil to triumph is for good men to do nothing’. The ME community is extremely grateful for all your good work Dr Enlander but I don’t believe White deserves your friendship.”

      Like

  3. May 6, 2014 09:20

    Dear Val,
    FD 23/4553/1
    I did a FOIA today for this file above here at this link: http://discovery.nationalarchives.gov.uk/SearchUI/Details?uri=C10027241
    Closed extracts: 63 pages (the open file is available at FD 23/4553).
    This record is closed
    Closed For 73 years
    Opening date: 01 January 2071

    Could you please submit one too for this file and let me know what goes… Thanks, Francesca

    Like

Trackbacks

  1. The PACE Trial: David Tuller investigates – Part 1 | valerieeliotsmith
  2. PACE Trial article follow-up: the momentum continues | valerieeliotsmith
  3. More PACE: How the Spin got Spun (and the Information Commissioner gets tough…) | valerieeliotsmith
  4. ME experts call for independent review of the controversial PACE Trial | valerieeliotsmith
  5. Queen Mary University of London to appeal Information Commissioner’s decision on disclosure of PACE Trial data | valerieeliotsmith

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