Lessons from the controversy over statins

Abstract

As the chair of the Committee on Publication Ethics (COPE), I would like to respond to the remarks of Richard Horton in his Offline Comment1Horton R Offline: Lessons from the controversy over statins.Lancet. 2016; 388: 1040Summary Full Text Full Text PDF PubMed Scopus (17) Google Scholar (Sept 10, p 1040) about the role and actions of COPE, in which he highlighted the statins Review by Collins and colleagues.2Collins R Reith C Emberson J et al.Interpretation of the evidence for the efficacy and safety of statin therapy.Lancet. 2016; (published online Sept 8.)http://dx.doi.org/10.1016/S0140-6736(16)31357-5Google Scholar COPE is an international inter disciplinary organisation, not just a UK one, whose remit is the provision of education and advice to members with questions about publication ethics. We do have a process whereby an individual can bring to our attention complaints about journal processes, but we cannot interfere in editorial decisions, or investigate the underlying issues of a complaint because we have neither the resources nor—more importantly—the appropriate level of subject-specific expertise. Horton states that “COPE declined to act further”; however, this is incorrect. COPE did request details of processes at the British Medical Journal (BMJ), in accordance with our remit. The guidance issued from COPE’s review (I was not part of this having recused myself because of a potential conflict of interest) offered constructive criticism about how BMJ had managed the peer review process.3BMJStatins—a call for transparent data.http://www.bmj.com/campaign/statins-open-dataDate: 2016Google Scholar BMJ had already addressed those issues following their own independent review and COPE was satisfied with the procedural changes that were implemented. Because it is not appropriate for COPE to make any specific judgment about effects on public health, COPE also recommended that Collins and colleagues engaged in open dialogue on the specific issues in the medical literature. We note this has now happened with the publication of their Review in The Lancet. Putting the correction of Richard Horton’s Comment to one side, and instead looking for useful lessons, COPE would be willing to discuss his suggestion for an independent tribunal. This tribunal would probably need public funding and the ability to apply sanctions and, to a degree, the ability to become a regulator for the research community. This is not COPE’s remit, but we are interested in being part of the discussion on such an approach. For information about COPE see http://publicationethics.org/ For information about COPE see http://publicationethics.org/ I am the Chair of COPE. At PLOS I worked previously with one of the BMJ staff who subsequently handled the complaint from Rory Collins and colleagues to the BMJ. I have co-authored a paper with Fiona Godlee, the BMJ Editor in Chief. Offline: Lessons from the controversy over statinsControversy over the safety and efficacy of statins has harmed the health of potentially thousands of people in the UK. After publication of disputed research and tendentious opinions about statin use among people at low risk of cardiovascular disease in 2013, patients already taking statins were more likely to stop their medication both for primary prevention (an 11% increased risk of stopping treatment) and secondary prevention (a 12% increased risk). Over 200 000 patients were estimated to have stopped taking a statin in the 6 months after adverse media coverage. Full-Text PDF Lessons from the controversy over statins – Editor’s replyI’m grateful to Virginia Barbour for responding to the criticisms of the Committee on Publication Ethics (COPE). And I very much welcome her endorsement of the idea for an independent tribunal to consider allegations of research or publication malpractice. However, if she had quoted my words fully and fairly, I think she would have to agree that the claim that “COPE declined to act further” in response to “a direct request [to] conduct an independent investigation”1 was correct. COPE did decline to act further, and this refusal has led to the current exchange. Full-Text PDF Lessons from the controversy over statins – Authors’ replyVirginia Barbour states in her letter that, with respect to the submission to the Committee on Publication Ethics (COPE) in October, 2014, by a group of senior doctors and scientists, she had “recused myself because of a potential conflict of interest”. However, that is not strictly accurate; Barbour only recused herself in September, 2015, 8 months after she had adjudicated on the submission in January, 2015. Full-Text PDF