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In this document, we aim to respond point-by-point to the concerns raised by Professors Armitage, Collins and colleagues in their complaint to COPE dated 23 October 2014.

In each response, we use the section heading used in the letter of 23 October, then attempt to disambiguate the various complaints being made. We note the section(s) of the COPE code of conduct to which the section refers and provide our response to each alleged breach of the relevant section.

 

1.Publishing incorrect side-effect claims despite being advised they were misleading”:

We understand this complaint to be that an editor said in an editorial meeting, in the light of reviewer Smeeth’s comments, that it didn’t matter if the numbers (complaining of muscle pain in statin vs control groups) were wrong as this could be highlighted in the Rapid Responses to the article online, as follows

  1. that there are low editorial standards at The BMJ, with the editors failing to protect the academic record, as detailed in point C.
  2. that this error persists and has not been corrected.
    Response: the issue has been raised in rapid responses, making the distinction between myopathy, myalgia and myositis, all of which appear under a heading “Myopathy”. Abramson responded on 20 December saying the argument is ‘semantic’. In our view, the complaint in part concerns the use of a short heading (Myopathy) to cover multiple conditions that are then enumerated individually in the text (myopathy, muscle pain, musculoskeletal disorders overall and injuries). The Heath panel also commented on this issue, saying “The panel thought that including three different definitions of muscle problems, widely ranging in severity, all under a heading of the more serious myopathy, might lead to the reader to conflate these. However, as Abramson et al point out in their submission to the panel (SP23), myopathy and myalgia can be conflated in the opposite direction by referring to severe problems as if they included milder ones and this can also lead to misinterpretation.”.
     The Editor has again discussed this issue with Abramson, a copy of whose response can be read (attached).
  3. This section refers to items in the COPE Code of Conduct as follows:
    1.1. Editors should be accountable for everything published in their journals.
    Response:
    The Editor in Chief and her staff do indeed hold themselves accountable for all the content published in the journal
  4. 1.6. [This means the editors should ] maintain the integrity of the academic record;
    Response: 
    In areas of disagreement between one reviewer and an author, or indeed between one reviewer and another, we believe an editor can reasonably decide to let the point be debated post-publication. In this case, there seems to be continuing debate on precisely how best to represent this issue.
  5. 1.8. [This means the editors should ] always be willing to publish corrections, clarifications, retractions and apologies when needed. 
    Response: 
    We believe The BMJ has shown itself very willing to correct and clarify all the issues raised around the publication of these articles. It seems from our detailed analysis (below) that one point may have been missed from the private concerns that were sent to the journal by Professor Collins in letters to the editor marked “not for publication” or mentioned in conversation or via third parties. We apologise wholeheartedly for all such omissions. We would once again urge Professor Collins and colleagues, as COPE has urged, to make any remaining criticisms or concerns public in the pages of the journal. We do not feel a retraction was required on this occasion, and this conclusion was supported by the Heath panel.

  6. 8.1. Editors should take all reasonable steps to ensure the quality of the material they publish, recognising that journals and sections within journals will have different aims and standards.
    Response: 
    The Heath panel concluded that the journal’s processes were broadly appropriate, as did our internal review [published alongside this response]. We did however note a number of areas where we could improve our processes to make them even more robust and rigorous, and we have put this into practice. We will continue to review our processes and improve them where we can.
  7. 12.1. Errors, inaccurate or misleading statements must be corrected promptly and with due prominence.
    Response: 
    We believe errors and inaccuracies have indeed been corrected with due prominence. Although there was an interval of several months between publication of the Abramson article and its correction, discussion around the article was ongoing on the journal’s website during this period. In general the pace of corrections and retractions is regrettably slow (see Steen RG:J Med Ethics 2011;37:249-253 doi:10.1136/jme.2010.040923)

 

2. “Publishing a misleading “correction” of other incorrect side-effect claims
In essence, we read this complaint as follows. That in drafting a correction, the editor chose not to listen adequately to reviewer Smeeth on the subject of how to present the number of people complaining of side effects and also did not take adequate account of the views of Zhang et al. who felt moved thereafter to submit a further Rapid Response in clarification.

  1. In complaining about this process of reviewing the correction and deciding what it should say, the complaint refers to items in the COPE Code of Conduct as follows:

    1.6.  [This means the editors should ] maintain the integrity of the academic record;

    7.1  Editors should strive to ensure that peer review at their journal is fair, unbiased and timely.
    Response:
    Once again we had a disagreement between parties and had to decide how to proceed. On this occasion, the authors of the Zhang et al. study said the correction was fine as drafted but reviewer Smeeth felt it was not. The Editor made a decision to publish in a timely way with minor amendments to address Smeeths concern but without final resolution on this point; and to encourage further public discussion of this issue. The correspondence about the correction, between Fiona Godlee and the authors of Zhang et al., and Fiona Godlee and Liam Smeeth, is provided with this document.
  2. 8.1. Editors should take all reasonable steps to ensure the quality of the material they publish, recognising that journals and sections within journals will have different aims and standards.
    Response: Every effort was indeed made to ensure the quality of the articles and the correction, and where our critical event audit identified how processes could be improved we have amended them.
  3. 17.1 Editors should have systems for managing their own conflicts of interest as well as those of their staff, authors, reviewers and editorial board members
    Response:
    We are unsure of the relevance of this section of the code to the issue of the handling of the correction.In relation to the correction we believe we consulted the appropriate parties and asked the panel to consider its suitability. In terms of the editor’s own conflicts of interest, she highlighted in the editorial announcing the convening of the Heath panel “as the editor responsible for publishing the articles, I have a vested interest in not retracting them unless the case for doing so is completely clear. So I have decided that the right thing to do is to pass this decision to an independent panel.” We therefore feel that the issues of conflict of interest have been adequately handled with regard to the correction and the question of retraction.

 

3. “Publication of inaccurate editorial and media statements accompanying the published “correction”

We read this complaint as being that the Editorial said that a statement about side effects was missed by peer reviewers when in fact this statement was inserted by the authors after review, in a version of the article that was not re-reviewed. Specifically, we interpret the complaint as being that the editor knew this but that she published an editorial saying something she knew to be untrue, repeated this statement to the media, and took 11 days to correct it, in breach of the following COPE guidelines:

  1. 8.1. Editors should take all reasonable steps to ensure the quality of the material they publish, recognising that journals and sections within journals will have different aims and standards.
    12.1. Errors, inaccurate or misleading statements must be corrected promptly and with due prominence.
    Response: Professors Armitage, Collins and colleagues highlight notes on the manuscript tracking system from the Analysis editor noting that the error was introduced in the revised article that was not peer reviewed. Although this note was made before publication of the Editorial, unfortunately the Editor-in-Chief did not appreciate this point in time to amend the editorial before publication, nor at the point at which she issued the press release and discussed the matter with Professor Collins on the Today programme. This issue was corrected subsequently in less than two weeks, as soon as it was clear that it needed to be.

 

4. “Inappropriate use of Abramson to review the accompanying paper by Malhotra

This complaint concerns the delay in making the review of Malhotra paper available, when the reviews of the Abramson paper were made available much earlier.

  1. There is an implication that this was a deliberate delay due to reluctance on the part of the journal, and a disbelief in the description of a ‘technical problem’.
    Response When presenting peer review reports for articles, it is the journal’s preference to present the comments separate from the article. However, the peer review of the Malhotra article was provided as comments within a PDF, which could not be easily displayed. It was therefore necessary to prepare a version of his comments that could be seen in the context in which they were provided but read easily and reliably by users of The BMJ’s website. This is what is now provided as a Data Supplement to the article at http://www.bmj.com/content/bmj/suppl/2014/07/07/bmj.f6340.DC1/See_peer_review_for_this_article.pdf . As this is a non-standard presentation it took us some time. We reject the suggestion that we were deliberately delaying posting of the reports.
  2. The complaint is that use of Abramson to review Malhotra’s article is in breach of the following COPE guidelines:
    7.1  Editors should strive to ensure that peer review at their journal is fair, unbiased and timely.
    Response:
    While it is not ideal with hindsight to have had Abramson review the article by Malhotra, it is not unusual to have two authors of related articles review each others work. In the light of our critical event audit we are making every effort to ensure that in future in such cases we seek a wider range of opinions; see the document detailing our audit.
    Best practice for editors {Described by COPE as “more aspirational and [were] developed in response to requests from editors for guidance} would include: ensuring that appropriate reviewers are selected for submissions (i.e. individuals who are able to judge the work and are free from disqualifying competing interests)
    Response:
    As above, we would agree that best practice would include avoiding such reviewer-author pairs.

 

5. “Questionable independence of The BMJ’s review of published errors

  1. We see the essence of this complaint as being that the Heath panel wasn’t in fact independent of the journal, and that its Terms of Reference come from the Editor. Response: We appreciate the concern that the panel was not entirely independent of all connections with the journal. We would note, however, that there is no guidance or best practice on appointing such a panel, as it is an unprecedented move. Our aim in appointing the panel was to have it act in lieu of an ombudsman. The panel was given access to all information and asked to evaluate all issues. It acted completely independent of input from the editorial team, and reached its own conclusions.
  2. That the panel was not sufficiently rigorous in considering the harm caused.
     Response: In our view the panel was extremely rigorous. In fact, the independent retractionwatch website noted This is the most detailed justification for a journal’s decision not to retract a paper that we’ve seen in a long time, perhaps ever.”  But the panel was not tasked with considering whether or not statins should be prescribed and for whom.
  3. That the panel members are biased on the issues at hand and members did not declare all relevant papers and COIs, related to litigation and to collaboration with Abramson.
    1. an undeclared paper by the chair (Heath) claiming statins cause cancer in the elderly.  Response:  We read this paper differently, as saying people on statins don’t die of cardiovascular events but do die of cancers, suggesting that there is little life-saving effect of statins, but not that the statins are a cause of cancer. It says “"The most likely reason [for the observed phenomenon] is substitution of cause of death."
    2. A paper by panel member Hippisley-Cox on statins and their side-effects (about cataracts, inter alia) is not specifically declared.
      Response:  This article is, we believe, declared in the panel’s materials, thus: “In 2010 we published an observational study in the BMJ to quantify unintended effects of statins which is referenced in the Abramson paper8” -  8. Hippisley-Cox J, Coupland C. Unintended effects of statins in men and women in England and Wales: population based cohort study using the QResearch database. BMJ 2010;340:c2197.
    3. Two other undeclared papers by a panel member that made similar claims about the efficacy of statins to those made in the Abramson paper.
      Response: This concerns articles by panel member Furberg, who conflicts of interest declaration states “Publication of a large number of studies of statin and other lipid studies” but does not enumerate them.
    4. Undeclared litigation work by panel member Furberg.
      Response: Professor Furberg declares that he has done no litigation work in the past decade related to the safety statins. Professor Furberg also asked the journal to note that he has been a co-author and collaborator with the Oxford group on multiple articles in the past 7 years, and might therefore be expected to be biassed in their favour, but he aims for balance.
    5. This is in breach of COPE guidelines:
      17.1 Editors should have systems for managing their own conflicts of interest as well as those of their staff, authors, reviewers and editorial board members
      Response: The BMJ does indeed have such systems, and declares conflicts of interest for staff (listed for editors on their profile pages), authors (on each paper), reviewers (on each review) and editorial board members (listed for board members on their profile pages) .
      17.2. Journals should have a declared process for handling submissions from the editors, employees or members of the editorial board to ensure unbiased review
      Response:
      The BMJ does indeed have such systems, and if we have missed any we will correct them (please see below). But we are unsure of the relevance of this guideline in the context of the panel.

 

6. “BMJ links to public statements in support of its own position”

  1. The timeline published with the panel’s report links to a supporting letter with 500 signatories without pointing out that journalist Jeanne Lenzer coordinated it and we pay her for some work.
    Response: The Editor was not aware of Lenzer’s role in coordinating the letter and certainly did not commission or pay her to do so. Lenzer was at the time a freelance journalist known to do some work for the BMJ and declares that she helped coordinate the open letter after she was approached by a group of concerned physicians.
  2. That Lenzer had attempted to publish this letter elsewhere without declaring that she sometimes works for The BMJ.
    Response: As noted above, Lenzer was not acting for the journal in this regard.
  3. That Lenzer published a 2013 paper listing Abramson as a collaborator and with a member of the panel as a co-author.
    Response: As Lenzer was not involved in the work of the panel, her work with a panel member and with Abramson does not appear to be relevant. Her co-author was panel member Furberg. As noted above (point 5Cc) his conflicts of interest declaration states “Publication of a large number of studies of statin and other lipid studies” but does not enumerate them in detail. However, our understanding is that in fact Furberg had no interaction with Abramson in his role as an external reviewer of this paper.
  4. This is in breach of COPE guidelines:
    17.1 Editors should have systems for managing their own conflicts of interest as well as those of their staff, authors, reviewers and editorial board members
    Response:
    This issue is primarily addressed above  (point 5Cd).  We note that as panel member Furberg is a member of The BMJ’s editorial advisory board, he has a generic conflicts of interest statement in addition to the one prepared specifically for the Heath panel.
    17.2. Journals should have a declared process for handling submissions from the editors, employees or members of the editorial board to ensure unbiased review  
    Response: As noted above we do have such systems but are unsure of the relevance here, as the Lenzer submission reported by Professors Armitage, Collins and colleagues was not submitted to The BMJ.

 

7. “Inaccurate statements about materials posted with the review panel report
Both the panel report and the accompanying editorial say that all relevant material is published, but it is not.

  1. A submission to the panel about a letter by Malhotra and others to NICE was not posted.
    Response: As we understand it, Professor Collins wrote privately to the panel to ask about this issue and the panel declined to respond in private, preferring to discuss all these issues openly. Now that this matter is being made public, the panel have advised the journal that they did not consider the letter to NICE and Professor Collins complaint about it relevant to their work.
  2. The claim to have redacted things for legal reasons is untenable - and one piece of redacted claim is reiterated.
    Response: The journal takes legal advice when it believes content might be defamatory or otherwise in breach of good practice. It did so on this occasion, and redacted those parts of statements that were highlighted by counsel as problematic. We continue to decline to publish this statement on legal advice. 
  3. This is in breach of COPE guidelines:
    14.1. Editors should encourage and be willing to consider cogent criticisms of work published in their journal.

Response: We believe we have shown the journal to be very willing to consider and respond to cogent criticisms. We do, however, also have to take legal advice and respond to it.
15.1 Editors should respond promptly to complaints and should ensure there is a way for dissatisfied complainants to take complaints further. This mechanism should be made clear in the journal and should include information on how to refer unresolved matters to COPE.
Response:
The journal has responded promptly and on numerous occasions to these complaints. We also make plain how to take matters further, and note that this complaint is via COPE.
17.1 Editors should have systems for managing their own conflicts of interest as well as those of their staff, authors, reviewers and editorial board members.

Response: We believe we have responded on this point, above, and are unsure how it applies to this specific concern.