Freedom of information and unpublished data from a randomised controlled trial on ME/CFS

12 June 2013 by

zCCQueen Mary University of London v the Information Commissioner (1) and Robert Courtney (2) First Tier Tribunal EA/2012/0229 read judgment

Rosalind English has recently posted here on incomplete academic work in the climate change field. This appeal is closely related, in that it concerns a university’s claim to hold on to data from a publicly-funded randomised controlled trial pending peer-reviewed publication.

Between 2005 and 2010 Queen Mary ran a trial into the efficacy and safety of the current treatments for Chronic Fatigue Syndrome/Myalgic Encephalopathy, namely Adaptive Pacing Therapy , Cognitive Behaviour Therapy and Graded Exercise Therapy. £5m of public money was spent, and the perceived benefits (and some of the detriments) were written up into a major article published in the Lancet in March 2011. The upshot, said this article, was that CBT and GET could be safely added to current medical care with a moderate improvement in outcomes. This recommendation has already fed into an interim review of the NICE guidelines on CFS/ME.

However, the data on deterioration within the trial had not been fully published. You could not see how many patients deteriorated in response to each therapy, just the net deterioration over the whole cohort. Our appellant, Mr Courtney, is evidently a bit sceptical about the results of this trial. As he pointed out, the deterioration data had a 20 point difference, whereas the improvement had only to be modest – an 8 point difference. And, he said, how can patients sensibly form a view on treatment without knowing how much deterioration that specific treatment might cause?

So Mr Courtney asked for a full set of the deterioration data for each therapy. Queen Mary sought to withhold it on the basis of section 22 of the Freedom of Information Act 2000 – information intended for future publication. And, after a hiccup before the Information Commissioner, they succeeded before the FTT.

Like most of the exemptions in Part II of FOIA,  withholding the requested information must be shown to be in the public interest. So, given that (a) the data existed and (b) the main trial results had already been published, what on earth was the public interest in withholding it, however temporarily?

QM said that, because they had undertaken the work which generated the raw data, they should have the opportunity to present in the context of a full scientific commentary tested by peer review. Conversely, premature publication of provisional research results “particularly if made in a lower ranking journal” might undermine the credibility of the final conclusions. (Here we are very much in the territory of the UEA climate change scientists not wanting the sceptics to get the raw data before UEA has said its piece). Without peer review, QM would be “casting clinicians and patients adrift” – “the data could be manipulated”‘; there is a need for “sufficiently robust scientific contextualisation.”

There is something in all of this, but it is also a little bit over the top. It is quite understandable that the researchers might want a short priority period for publication of their research.  But their wishes should not be driven by the desire of private top-ranking journals to have an exclusive on the data – as Mr Courtney rightly argued, that is a matter of private interest, not public interest.

The FTT found for the University. The additional time sought by it was necessary to finalise the analysis, commentary and peer review process. Hence, the withholding of this data fell within section 22 and was in the public interest.

This sort of issue does not seem to have come before the FTT or the courts before. There is an Information Commissioner’s decision on section 22 (see here) where, one infers, a rival academic wished to get hold of a PhD student’s thesis deposited with Liverpool University – the application was refused. The PhD student wished to publish the thesis in book form, and wanted a period in which to see if she could do so. The public interest was rather limited; the student had privately paid to do the PhD, so unlike the QM case, public money was not involved. The IC decision is also very coy about the nature of the thesis, so one cannot tell whether it is of wider public or narrowly academic interest. On the other hand, one cannot be too sorry that the applicant lost, given the more general interest in wider academic publication of scholarly work – better that it be in a published book rather than in a university archive.

One final observation. QM nearly got itself into trouble in this case because of its curious publication strategy. It is odd to publish research about the merits of a given set of treatments, without having finalised one’s analytical work on the therapy-specific demerits. From a medical ethics perspective, I wonder to what extent the clinicians and patients appreciated that to some extent the 2011 Lancet publication was work-in-progress – because that is the implication of QM’s arguments on this appeal.

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  1. DrK-di987 says:

    If this research was undertaken by funding granted by the BBSRC (Biotechnology and Biological Sciences Research Council), as is likely, then it is also likely that they are going against the requirements of the funding, as a foundation stone of science research council funding is “Members of the community are expected and encouraged to practise and promote data sharing”.

    Perhaps the BBSRC would take a position on this, if asked.

  2. Alan Rankin says:

    What is the intended date of publication for the data?

    1. Lofthouse Jnr. says:

      The problem is, the FOI Act does not implicitly demand an actual publication date is ever given.

  3. Finola Moss says:

    It would appear the present and former government are intent on continuing to offer the present non medical treatment of ME, based on the belief that it is largely a psychological disorder, this being supported by such remedies being shown to be effective by academic peer reviewed research. Anything adverse being withheld, as here, from the public.

    Therefore the integrity of all research financed by government has to be question, because of the conflict of interest of the government’s wish to justify and verify its treatment policies by academic approval, and academia’s need to be financed.

    Worryingly the proposed ‘future public exemption’ appears to be a means to avoid the scrutiny of research by FOIA notices as here.

  4. Simon says:

    Although the Tribunal found in favour of the University witholding information, that view does appear to be tempered by the pending publication of the requested data – see final sentence:

    “32. We are satisfied that knowing the basis upon which the conclusions in the March 2011 paper have been drawn, does enable the argument to be had as to the reliance that should be placed upon it by e.g. the regulators, in the absence of the full deterioration data. We remind ourselves that we are evaluating the consequences of disclosure now rather than at a date in the near future.”

    So perhaps the Tibunal might not take the same view in future if the requested data has not yet been submitted for publication and there is only a vague ‘intention to publish’.

  5. The research and the people claiming to have ME/CFS should start focussing on getting the lower bowel healthy enough to digest and absorb nutrients from the same wide variety of natural food especially fruit and vegetables that Adam and Eve ate.
    Lower intestinal upsets and an inability to absorb essential nutrients are the cause of ME/CFS.
    Putting patients onto a diet high in Marmite would kick them back to health.

    1. agapanthus says:

      As someone with ME/CFS for 8 years, and who is still working through various supportive measures, this is an extremely simplistic statement re the lower bowel. Actually I do agree that it’s part of the problem, but the evidence is not there to say that it is the ONLY part. I am doing bowel support and have been for several years, PLUS improving thyroid and adrenal function – these latter 2 are vital and for some will be the main issues. It is also likely for others that heavy metal toxins have affected their immune system. There may well be many other aspects too.

  6. Samuel Wales says:

    [I’m not sure whether previous post went through.]

    Thank you very much.

    There is a book about this trial:

    Many people have died from the disease.

  7. Similar FOI says:

    People may also be interested in this FOI for the same trial, for additional outcome measures laid out in the trial’s protocol:

    The researchers have made some substantial changes to the way in which they were going to release results, making it much easier for themselves to report a positive outcome for their treatments. Their new criteria for ‘recovery’ seems very likely to mislead patients.

  8. adrian says:

    Paragraph 22 of the judgement is interesting since QM tried to claim that it would impinge on their academic freedom not to have the right to pick and choose which results they publish. The court rejected this argument.

  9. adrian says:

    In the case of this trial its not just the deteriation data that they have failed to publish. They made many changes to the trial protocol all in their favour (that is all likely to make their results appear better). In some cases to the level where ‘recovered’ patients also meet the trial entry criteria.

    They have also refused FoI requests for data relating to data specified in the the original protocol including much stricter recovery criteria ( some of which were originally set by the ethics committee who approved the trial. They claim that these results didn’t exist which suggests a worrying lack of scientific curiosity. They data would be easily generated by changing threshold values within their statistics code.

    There are campaigns to try to force drug companies to publish all the results of their trials yet universities seem to be getting away with cherry picking which results they publish with no questions raised by these campaigns or the medical research council who fund the work.

  10. R Cox says:

    “I wonder to what extent the clinicians and patients appreciated that to some extent the 2011 Lancet publication was work-in-progress – because that is the implication of QM’s arguments on this appeal.” I wonder to what extent all the media assembled at the big SMC Press Conference ‘hurrah’ realised this too?

  11. Lofthouse Jnr. says:

    Highly relevant to attempts to get the Government and its partners (Marie Curie PLC) to make all of the data relating to the Liverpool Care Pathway available for public scrutiny.

    The ‘LCP’ forms part of MarieCurie’s portfolio, and was recommended by the DoH on the basis of the lowest level of evidence posslble, mainly the opinion of one of its authors. On the basis of this recommendation, it was sold as a ‘brand’ to all 22 EU countries, endorsed by the UK DoH.

    However, the authors of the pathway (at the Marie Curie Palliative Care Institute, Liverpool) have only collected patient anonymised data from a mere 0.04% of the patients placed on it in the UK anyway, rendering ALL assessments as to its merits or demerits (even their own) so statistically skewed and heavily biased as to render any meaningful assessment impossible. A staggering amount of public money has been awarded to ‘research’ into its use, but it is impossible to assess whether this has been well spent without these data.

    Given that there was no consent process attached to version 11 (rendering it incompatible with the Mental Capacity Act Code of Conduct), the government’s refusal to hold a full Public Inquiry with evidence on oath, coupled to its decision to convene in its place a mere ‘impartial review’, chaired by a self -confessed fan of Marie Curie, whose terms of reference do not even allow discussion of the LCP itself (let alone the full data) seems somewhat less than ‘transparent’ government, or indeed, a sufficiently rigorous scrutiny of all the facts.

    The government have already admitted that failure to train staff has led to non terminally ill patients being put on a mixture of drugs [acknowledged by pharmacologists and toxicologists as a euthanasic – see Dr Pou in Hurricane Katrina]..and has thus admitted offences under UK Health & Safety legislation- why then have they ordered only an ‘impartial review’, which states it ‘seeks to improve’ the pathway, rather than withdrawing it instantly. This panel are so intimately connected with the coalitions’ ‘End of Life Care Strategy’, on which they based almost all of their pledged NHS budget savings, they are effectively sitting in judgement of themselves. Given the quantum on the average 80 year old patient’s death, it is highly unlikely many pensioners who have lost partners with dementia would be able to bring charges of Corporate Manslaughter, but release of the already anonymised data by Marie Curie /The Department of Health might at least afford other patients the ability to assess its ‘merits’ and opt out of its use for ‘symptoms relief’. Even the authors have previously ‘got it wrong’ as far as using it on patients who only sought help for pain control – but that was settled out of court..

  12. Of course we now have the likelihood that information obtained in the course of, or derived from, a programme of academic research will have a specific “future publication” exemption by virtue of an amendment to section 22 of FOIA contained in the Intellectual Property Bill.

    1. Lofthouse Jnr. says:

      In the preamble to this bill, Viscount Leckie states that the Bill is compatible with convention rights ..can this actually be so , when the ‘intellectual property’ in many cases, (e.g. the Liverpool Care Pathway) is being used in a State healthcare system (or rather, all 22 EU State Healthcare Systems in Europe) and many of the most critical publications are not even available in English?. How can a patient assess the merits of a particular treatment without the data? One thinks of the Tuskegee syphillis experiments and wonders if there would have been any volunteers with all the data available to its victims…also of Phillipe Bouler’s ‘special medical treatment’ for disabled children in 1930s Germany….had he patented the CO showers, would the patients have been able to even ask what the risk/benefit ratios or morbidity rates actually were?

    2. Lofthouse Jnr. says:

      [the exemption is in Part 3 of the Bill ( page 20 of 19 Freedom of information: exemption for research
      After section 22 of the Freedom of Information Act 2000, insert—
      “22A Research
      (1) Information obtained in the course
      of, or derived from, a programme of
      research is exempt information if—
      (a) the programme is continuing with a view to the publication, by
      a public authority or any other person, of a report of the
      research (whether or not including a statement of that
      information), and
      (b) disclosure of the information under this Act before the date of
      publication would, or would be likely to, prejudice—
      (i) the programme,
      (ii) the interests of any indi
      vidual participating in the
      (iii) the interests of the authority which holds the
      information, or
      (iv) the interests of the author
      ity mentioned in paragraph (a)
      (if it is a different authority from that which holds the
      (2) The duty to confirm or deny does
      not arise in relation to information
      which is (or if it were held by
      the public authority would be) exempt
      information by virtue of subsection
      (1) if, or to the extent that,
      compliance with section 1(1)(a) would,
      or would be likely to, prejudice
      any of the matters mentione
      d in subsection (1)(b).”

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