Researchers have removed the previously openly available anonymised patient data of the clinical trial FINE from their publication in PLOS One. The correction, issued on May 18th 2016 states:
“S1 Dataset was published in error. The error was corrected in the XML and PDF versions of this article on May 9, 2016. Please download this article again to view the correct version”.
The now removed S1 dataset was previously described by the authors around Alison Wearden, professor of Health Psychology at the University of Manchester, in their Data Availability statement:
“The authors have prepared a dataset that fulfills requirements in terms of anonymity and confidentiality of trial participants, and which contains only those variables which are relevant to the present study. Data are available as Supplementary Information”.
FINE was a “randomised controlled trial of a nurse-led self-help treatment, versus supportive listening, versus treatment as usual for patients in primary care with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)”, performed at the University of Manchester. It was funded by the British Medical Research Council (MRC) and the UK Department of Health.
These new restrictive developments are very important. FINE is considered as a sister CFS/ME therapy trial of the PACE trial (on which I previously reported), where the sharing of anonymised patient data to non-collaborators was repeatedly denied by the King’s College London and Queen Mary University London, with the consequence that now the courts are expected to decide upon this issue of clinical data sharing. A judge has already decreed that certain documents associated with PACE trial are to be released (information and list with links are available from the website by the lawyer and CFS/ME activist Valerie Eliot Smith).
Unlike PACE, the FINE trial was processed rather transparently and was not accused of questionable protocol changes mid-trial or of reclassifying patients who were relatively healthy to begin with, as recovered thanks to the therapy. Before FINE was performed and published in the prestigious journal BMJ (Wearden et al, 2010), its protocol was made available in BMC Medicine (Wearden et al 2006). Further analysis of FINE data was published in the now corrected PLOS One article (Goldsmith et al, 2015). According to PLOS guidelines on data availability (which PACE authors ignored, with the resulting editorial note of concern), the authors of FINE trial originally made a subset of anonymised patient data publicly available. As Lisa Crawley, Records Officer at the Manchester University declared to my source, who also approached her about information on FINE:
“Please note that we have not released our entire dataset. The data which are available in association with the PLOS-One article entitled “Therapist Effects and the Impact of Early Therapeutic Alliance on Symptomatic Outcome in Chronic Fatigue Syndrome” comprise a small, anonymised subset of our dataset containing only variables relating to the analysis presented in the paper”.
Instead, interested parties will now have to contact the FINE researchers at the Manchester University directly. The corrected PLOS One paper now declares in its Data Availability statement:
“Our ethical permission did not expressly permit us to share patient data, even anonymised patient data, in a public forum. Data will be made available to bona fide researchers on application to the principal investigator, Alison Wearden or the trial statistician, Graham Dunn. Alison Wearden can be
contacted at: Alison.email@example.com. Graham Dunn can be contacted at: Graham.firstname.lastname@example.org.”
The original FINE patient consent form from 2004 is available here, it is also very similar to the patient consent form of PACE. The patients were not specifically deciding on allowing or prohibiting the open sharing of their anonymised patient data, but the form makes references to UK Data Protection Act from 1998, which may or may not prevent such data release.
The reasons as to why Wearden and her colleagues decided to remove already published anonymised CFS/ME patient data are unclear. I will provide updates should I receive further information.
Update 23.05.2016. I received this statement from Alison Weardon, indicating that the unclear formulation of the FINE trial patient consent form was indeed decisive for the removal of the anonymised dataset from public domain:
“We published the PLOS One paper on therapist effects and therapeutic alliance and provided a de-identified dataset containing the variables used in the analysis.
On 10th March, I received a freedom of information request for a copy of the patient consent form for the FINE trial. The request referred to the ongoing case relating to the PACE trial, and raised the issue of whether in fact we had been correct to make the data relating to the therapist paper open to the public. We did not request permission to do so in our trial consent form.
The dataset supplied to support the PLOS-One article was supplied in good faith and in the belief (still held) that no patient or therapist would be identifiable from it. The Freedom of Information request made me wonder if we had acted correctly, given our ethical permissions. In consultation with my co-authors and after discussing with various colleagues, I decided that it would be better to remove the dataset from public access (while still being prepared to supply it to bona-fide researchers). I wrote to PLOS-One on 18th April asking them whether it would be possible to do this.
The contents of the paper have not been retracted. The dataset has not been retracted. There is nothing wrong with either of them. The only issue is whether or not we were right in publishing this dataset given the consent that we had obtained from the trial participants“.
Update 2.07.2016. The previously removed S1 dataset is now back, hence the change to the title of this article. The Correction note from June 1st 2016 reads:
“The dataset originally included as S1 Dataset was removed in consideration of possible restrictions for the public availability of the data related to the wording of the original consent form for the trial. Upon consultation with the authors’ university it has been established that the file may be publicly shared as it reports de-identified data. Please view S1 Dataset here.
The Data Availability statement for the article is revised to read: The authors have prepared a dataset that fulfills requirements in terms of anonymity and confidentiality of trial participants, and which contains only those variables which are relevant to the present study. Data are available as Supporting Information”.
Several PACE authors have conflicts of interest concerning disability claims and health insurance. ME/CFS is typically a long lasting or life long condition. By categorizing ME/CFS as mental health condition, the obligations of the health insurer and health carer provider is greatly reduced. Is this is why they won’t stop pretending that psychotherapy and exercise are effective? Is this is why they engage in biological denialism and pretend to not see the biomedical literature that contradicts their hypotheses? Is this why they are trying to hide data from skeptics?
David Tuller has also written on this
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And also here, more background on the pernicious role of the powerful role of the health insurance industry, and how cost -cutting governments have implemented swingeing social security cuts by following their methods:
“The aim of the centre is to transform the ideology of welfare and so help develop the market for Unum’s products. In 2005, the centre produced a monograph The Scientific & Conceptual Basis of Incapacity Benefits (TSO, 2005) written by Aylward and his colleague Gordon Waddell. It provides the framework for the 2006 welfare reform bill. Its methodology is the same one that informs the work of Unum.”
Thank you Leonid for following up on this and keeping everyone updated.
A.B. above makes a very good point.
It appears what we are witnessing here is a grand cover up by the PACE team with the removal of this previously publicly available data on the sister FINE trial which is one (of many) of their arguments used by the PACE team to avoid providing the equivalent data by numerous requesters including ME sufferers and scientists .
This seemingly unimportant issue should be of great concern to the worldwide science community given the reliance that will be placed on it by the PACE team for continued refusal to abide by the principle of transparency and open data.
It appears that this is political manoeuvring as PACE is too big to fail as can be seen in the report ‘In the Expectation of Recovery’ which some of your previous work is mentioned.
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“Note that it is not acceptable for the authors to be the sole named individuals responsible for ensuring data access.”
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I would like to extend my sincere gratitude to the researchers who have withdrawn the data set, which is, of course, easily available on the internet. Apparently nobody has told these brilliant researchers that the internet has a memory like an elephant. I very much look forward to their continued missteps as the PACE people try to unstick themselves from their nice little tar baby.
Richard Nixon also tried to cover up his many crimes four decades ago. We all know how well that worked out…
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The only problem with Dr. Weardons’ statement is that the ICO has already ruled (not only in general but also in regards to PACE specifically) that anonymized datasets do not need specific consent forms for properly anonymized data to be released.
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They are attempting to create a problem where none exists, so that data can continue to be withheld from skeptics wishing to perform an independent analysis. They are currently engaged in a legal battle with the ICO over this.
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Thanks, Leonid, for the excellent round-up of data shenanigans with the FINE trial. It is important to note that although FINE did not engage in the egregious data manipulation that PACE did, the authors did in fact revise their primary outcomes to make their results appear better. Let’s be clear: At the protocol-designated primary outcome of 70 weeks, FINE had completely NULL results. However, in publishing the report, the authors engaged in serious “outcome-switching.” The authors falsely claimed in the published paper, that the 20-week assessment point AND the 70-week point were in fact co-primary outcome points. Since they had modest but transient improvements in fatigue at 20 weeks–these had disappeared by 70 weeks–the paper cited this as a co-primary outcome in order not to report completely NULL results. In fact, the FINE protocol, published in the journal BMC Medicine in 2006, declared flatly “short-term assessments of outcome [i.e. at 20 weeks] in a chronic health condition such as CFS/ME can be misleading.” That’s why only the 70-week assessment, not the 20-week assessment, was designated as THE “primary outcome point.”
In an accompanying editorial, BMJ did not call out FINE on this outcome-switching and in fact repeated it by citing this purportedly “positive” result, while only later mentioning the completely NULL results at 70 weeks. The authors subsequently published, in a letter to the editor, a non-peer-reviewed, post-hoc re-scoring of the fatigue scale that demonstrated modest improvements at 70 weeks. Since then, they have claimed this as their main finding, routinely failing to mention that this was a post-hoc re-scoring that was presumably not peer-reviewed. This isn’t quite as bad as what the PACE authors did–but it’s still plenty dishonest and anti-scientific. Alison Wearden, like the PACE authors, has never explained these discrepancies.
Not surprisingly, the PACE authors have never mentioned the NULL findings in any of their published work, despite having for years referred to FINE as its “sister trial.” I covered the whole pathetic story of how FINE was “disappeared” last fall, on Virology Blog: http://www.virology.ws/2015/11/09/trial-by-error-continued-why-has-the-pace-studys-sister-trial-been-disappeared-and-forgotten/
Keep up the good work, Leonid!!
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I have been in contact with Manchester University. Today I received an email that stated:
‘There has been no breach of the Data Protection Act. There has been a concern about whether the original patient consents for this project allowed for publication of data (even in anonymised form), but I believe that this is close to being resolved and that it is likely that the dataset will be returned to the PLOS site in the near future.’
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If the authors were to submit the paper in its present form — without providing anonymised data — would it be acceptable for publication in PLoS?