On 2015 Dec 12, Alem Matthees commented:

With reference to James C Coyne's comment about KCL rejecting his request for trial data as 'vexatious':

There are crucial facts and context missing from QMUL's (and now KCL's in part) narrative of anti-science harassment against the PACE trial. They appear to conflate all significant criticism with harassment without any regard for the validity of the comments made.

In addition to James Coyne PhD, other senior academics and research scientists have also expressed significant concerns over how the trial was conducted, analysed, or reported. Their assessments are outlined in a series of articles written by David Tuller DrPH (lecturer in journalism and public health at UC Berkeley) see http://www.virology.ws/mecfs/ . Six of them wrote an open letter to the editor of the Lancet, outlined some main problems and called for a fully independent re-analysis of the results. Similarly, over 11,000 individuals signed a petition calling for the retraction of questionable claims (made in relation to the 'normal range' for fatigue and physical function that overlapped with trial entry criteria for severe disabling fatigue), and called for the release of de-identified individual-level trial data so other researchers can re-analyse the results, see http://my.meaction.net/petitions/pace-trial-needs-review-now . As Tuller, Coyne, and others have noted elsewhere, accusations of campaigns of harassment appear to arise whenever legitimate questions are asked about the trial.

As the person who submitted the FOIA request in ICO decision notice FS50558352, I wish to comment. It had absolutely nothing to do with James Coyne. It was my own attempt to clarify confusion about the timing and nature of changes to the PACE trial recovery criteria, which had reached the level of parliamentary debate in the UK House of Lords in 2013, but has not been conclusively resolved. The revised recovery criteria is asserted to be pre-specified but there is good evidence that it is post-hoc and unapproved. I provided QMUL with background about how the confusion arose and then asked specific questions to conclusively resolve the matter.

QMUL presented to the ICO a detailed narrative of harassment and argued that any disclosure under the FOIA is unnecessary as they have procedures for review and dissemination. The ICO accepted QMUL's arguments about feeling harassed, deferred to their authority and judgement, focused on subjective interpretations of tone and circumstances, but did not consider the justifications for the request or the evidence that the procedures for review and dissemination were inadequate in this case. The evidence justifying the request in the first place was deemed outside the scope of the investigation simply because it involved details about the PACE trial. S.14(1) is supposed to account for the justifications for a request in order to judge whether the level of alleged disruption or annoyance caused by the request is justified. With all due respect to the ICO in general (and not to diminish my appreciation for their unequivocal support for my other request), it is difficult to successfully argue that a request or any burden it places on a public authority is justified when the evidence which justifies it is precluded out of the investigation.

Therefore in my opinion, the consideration of evidence was imbalanced, and the ICO staff involved with that particular case were misled by a one-sided presentation of the evidence. QMUL's threshold for examples of harassment apparently includes moderated BMJ Rapid Responses and published letters to the editor etc, without any regard for the validity of the points made in the correspondence. The BMJ encourages patient involvement and does not publish responses it deems inappropriate. It appears that QMUL view all significant criticism of the PACE trial to be a form of harassment simply because they dislike or disagree with it.

It is not harassment to express legitimate concerns about research e.g. major deviations from a published trial protocol, ask sincere questions, disagree with the interpretation of research(ers), highlight factual errors, or be somewhat frank when it is called for. These are all legitimate activities and scrutiny is part of science. It is unclear how disclosing details about methodology could discredit any trial if it was conducted and reported properly. Ben Goldacre's (co-founder of AllTrials) compare-trials.org project expects details about the timing and nature of changes to protocols to be routinely disclosed.

QMUL have misguided assumptions about my beliefs and motives. I maintain that they have no convincing evidence that I intended to harass them instead of seek information to resolve an ongoing confusion and controversy in the patient community. My FOIA request was not perfect, but it is all online so people can judge for themselves whether it was unreasonable given the relevant circumstances of a possible post-hoc analysis being described as pre-specified : https://www.whatdotheyknow.com/request/timing_of_changes_to_pace_trial .

On 2015 Dec 11, James C Coyne commented:

The university considers that there is a lack of value or serious purpose to your request. The university also considers that there is improper motive behind the request. The university considers that this request has caused and could further cause harassment and distress to staff. The university considers that the motive and purpose behind this request is polemical. The university notes the view of the Information Commissioner in decision FS50558352 that the request in that case was ‘more focussed on attacking and attempting to discredit the trial than in obtaining useful information on the topic.’

I believe this response is a blatant rejection of the authors' responsibility to share data when requested. The paper should be provisionally retracted until the data are shared.

On 2015 Dec 11, James C Coyne commented:

The university considers that there is a lack of value or serious purpose to your request. The university also considers that there is improper motive behind the request. The university considers that this request has caused and could further cause harassment and distress to staff. The university considers that the motive and purpose behind this request is polemical. The university notes the view of the Information Commissioner in decision FS50558352 that the request in that case was ‘more focussed on attacking and attempting to discredit the trial than in obtaining useful information on the topic.’

I believe this response is a blatant rejection of the authors' responsibility to share data when requested. The paper should be provisionally retracted until the data are shared.

On 2015 Dec 12, Alem Matthees commented:

With reference to James C Coyne's comment about KCL rejecting his request for trial data as 'vexatious':

There are crucial facts and context missing from QMUL's (and now KCL's in part) narrative of anti-science harassment against the PACE trial. They appear to conflate all significant criticism with harassment without any regard for the validity of the comments made.

In addition to James Coyne PhD, other senior academics and research scientists have also expressed significant concerns over how the trial was conducted, analysed, or reported. Their assessments are outlined in a series of articles written by David Tuller DrPH (lecturer in journalism and public health at UC Berkeley) see http://www.virology.ws/mecfs/ . Six of them wrote an open letter to the editor of the Lancet, outlined some main problems and called for a fully independent re-analysis of the results. Similarly, over 11,000 individuals signed a petition calling for the retraction of questionable claims (made in relation to the 'normal range' for fatigue and physical function that overlapped with trial entry criteria for severe disabling fatigue), and called for the release of de-identified individual-level trial data so other researchers can re-analyse the results, see http://my.meaction.net/petitions/pace-trial-needs-review-now . As Tuller, Coyne, and others have noted elsewhere, accusations of campaigns of harassment appear to arise whenever legitimate questions are asked about the trial.

As the person who submitted the FOIA request in ICO decision notice FS50558352, I wish to comment. It had absolutely nothing to do with James Coyne. It was my own attempt to clarify confusion about the timing and nature of changes to the PACE trial recovery criteria, which had reached the level of parliamentary debate in the UK House of Lords in 2013, but has not been conclusively resolved. The revised recovery criteria is asserted to be pre-specified but there is good evidence that it is post-hoc and unapproved. I provided QMUL with background about how the confusion arose and then asked specific questions to conclusively resolve the matter.

QMUL presented to the ICO a detailed narrative of harassment and argued that any disclosure under the FOIA is unnecessary as they have procedures for review and dissemination. The ICO accepted QMUL's arguments about feeling harassed, deferred to their authority and judgement, focused on subjective interpretations of tone and circumstances, but did not consider the justifications for the request or the evidence that the procedures for review and dissemination were inadequate in this case. The evidence justifying the request in the first place was deemed outside the scope of the investigation simply because it involved details about the PACE trial. S.14(1) is supposed to account for the justifications for a request in order to judge whether the level of alleged disruption or annoyance caused by the request is justified. With all due respect to the ICO in general (and not to diminish my appreciation for their unequivocal support for my other request), it is difficult to successfully argue that a request or any burden it places on a public authority is justified when the evidence which justifies it is precluded out of the investigation.

Therefore in my opinion, the consideration of evidence was imbalanced, and the ICO staff involved with that particular case were misled by a one-sided presentation of the evidence. QMUL's threshold for examples of harassment apparently includes moderated BMJ Rapid Responses and published letters to the editor etc, without any regard for the validity of the points made in the correspondence. The BMJ encourages patient involvement and does not publish responses it deems inappropriate. It appears that QMUL view all significant criticism of the PACE trial to be a form of harassment simply because they dislike or disagree with it.

It is not harassment to express legitimate concerns about research e.g. major deviations from a published trial protocol, ask sincere questions, disagree with the interpretation of research(ers), highlight factual errors, or be somewhat frank when it is called for. These are all legitimate activities and scrutiny is part of science. It is unclear how disclosing details about methodology could discredit any trial if it was conducted and reported properly. Ben Goldacre's (co-founder of AllTrials) compare-trials.org project expects details about the timing and nature of changes to protocols to be routinely disclosed.

QMUL have misguided assumptions about my beliefs and motives. I maintain that they have no convincing evidence that I intended to harass them instead of seek information to resolve an ongoing confusion and controversy in the patient community. My FOIA request was not perfect, but it is all online so people can judge for themselves whether it was unreasonable given the relevant circumstances of a possible post-hoc analysis being described as pre-specified : https://www.whatdotheyknow.com/request/timing_of_changes_to_pace_trial .