EDITORIAL

Conflicts of interest: a matter of transparency Linked Comment: Clark et al. Int J Clin Pract 2015; 69: 270–2. Linked Comment: Mayes et al. Int J Clin Pract 2015; 69: 384–5. Linked Comment: Stossel et al. Int J Clin Pract 2015; 69: 385–6.

In a prior editorial entitled ‘Pharmaism: a tale of two perspectives’ (1), we outlined some of the points about the perception of conflicts of interests (COI) among persons involved with medication development and commercialisation. It was written in response to two papers published in the same issue of the International Journal of Clinical Practice (2,3). In this issue, Clark et al. discuss the problem of COI in non-pharmacological research (4). This is important as many of the key conflicts they describe underly all research, including those involving pharmacological interventions and medical devices. For example, career advancement has quite rightly depended on being successful, and academic success is often measured in terms of the quality and quantity of the scientific papers one has produced, the amount of external funding one has obtained and external recognition of these achievements. These metrics are not evil per se, but they do lead at times to bad behaviours such as the misreporting of data, selective reporting of data, making up data, and gaming the peer review system. Part of the solution to managing COI involves transparency and disclosure. As Clark et al. note, journals play a vital role in addressing competing interests. Disclosures are central to the peer review and publication process. Several examples of disclosure problems encountered during the peer review process in the past year by the International Journal of Clinical Practice have included: (i) a report of a clinical trial that was disclosed as being funded by a grant from a professional organisation but was in turn funded by an undisclosed commercial firm; (ii) a supplement sponsored by a disclosed commercial organisation but where initially none of the authors acknowledged any writing assistance or any other relationships with the funder; (iii) a supplement sponsored by a disclosed commercial organisation but where initially some of the authors disclosed relationships with the funder but not with other firms with whom they had relationships. In many of these cases, it became apparent that the authors were confused with what was meant by disclosure and COI. Culturally for some, disclosure is interpreted in a negative way,

ª 2015 John Wiley & Sons Ltd Int J Clin Pract, March 2015, 69, 3, 267–269

and that disclosure is akin to a confession that someone did something wrong. A lesson learned from this is that education about the usefulness of transparency is needed. Clark et al. succinctly conclude that ‘. . .creating a culture of openness around COI in research may be a step towards more frankness among researchers about these conflicts. Working to normalise the multiple pulls researchers experience as “competing” rather than ‘conflicting’ interests may remove stigma and guilt that create reluctance to report and discuss issues related to COI. . .’ (4). Recent correspondence informs us that COI remains a ‘hot button’ issue (5,6). As Mayes et al. point out, ‘Over the past two decades, a deep suspicion has emerged in the healthcare community about the influence of private industry—particularly the pharmaceutical industry—over doctors, researchers, regulators and policymakers’ (5). Evaluation of this is complex, as medical professionals have many interests and roles. Putting aside for now the issues related to medication or device choices for individual patients, competing interests range from non-financial administrative and personnel issues to the fiscal viability of clinics, departments and hospitals. Stossel et al. note that ‘. . . we know of no empirical evidence or convincing rationale for why industry interactions should be considered uniquely “conflicting.” Every relationship is dogged by misaligned incentives, complex motivations and mixed motives.’ (6). From a journal editor’s point of view, the best way to manage COI is to be aware of the possibility of it, to ensure that authors disclose, and that we are mindful of issues that can arise from perceived and actual COIs. Editors or editorial board members are never involved in editorial decisions about their own research work. Journal editors, editorial board members and other editorial staff (including peer reviewers) withdraw from discussions about submissions where any circumstances might prevent him/her offering unbiased editorial decisions. When making editorial decisions about peer-reviewed articles where an editor is an author or is acknowledged as a contributor, affected editors or staff members exclude themselves and are not involved in the publication

Transparency is desired

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References

Editorials

decision. This is disclosed in the paper when published. When editors are presented with papers where their own interests may impair their ability to make an unbiased editorial decision, he/she deputises decisions about the paper to a suitably qualified individual.

1 Citrome L, Karagianis J, Maguire GA, Nierenberg AA. Pharmaism: a tale of two perspectives. Int J Clin Pract 2014; 68: 659–61. 2 Tagore A. Drug promotion tactics-yet another pharma deception? Int J Clin Pract 2014; 68: 662–5. 3 Barton D, Stossel T, Stell L. After 20 years, industry critics bury skeptics, despite empirical vacuum. Int J Clin Pract 2014; 68: 666–73. 4 Clark AM, Choby A, Ainsworth K, Thompson DR. Addressing conflict of interest in non-pharmacological research. Int J Clin Pract 2015; 69: 270–2.

L. Citrome New York Medical College, Valhalla, NY, USA Email: [email protected]

5 Mayes C, Lipworth W, Kerridge I. Clarifying the costs of conflicts of interest.Int J Clin Pract 2015; 69: 384–5. 6 Stossel T, Barton DW, Stell L. Response to clarifying the costs of conflicts of interest. Int J Clin Pract 2015; 69: 385–6.

Disclosures

Leslie Citrome has engaged in collaborative research with, or received consulting or speaking fees from Alexza, Alkermes, AstraZeneca, Avanir, Bristol-Myers Squibb, Eli Lilly, Forest, Forum, Genentech, Janssen, Jazz, Lundbeck, Merck, Medivation, Mylan, Novartis, Noven, Otsuka, Pfizer, Reckitt Benckiser, Reviva, Shire, Sunovion, Takeda, Teva and Valeant. doi: 10.1111/ijcp.12638

No external funding or writing assistance was utilised in the production of this editorial. In the past 36 months,

EDITORIAL

Venous thromboembolism and problems related to its continuous medical surveillance Linked Comment: Nutescu et al. Int J Clin Pract 2015; 69: 321–7.

Medical surveillance of VTE

Venous thromboembolism (VTE) is a multifactorial disease that requires constant attention in our daily clinical practice because to its relevant morbidity and mortality and to its considerable economic burden because of costs involved in its short and long term management (i.e. diagnosis, acute treatment, long term treatment, follow-up) (1,2). Main outcomes of VTE considered in daily practice are mortality for VTE, recurrences for VTE (i.e. pulmonary embolism, EP and deep vein thrombosis, DVT), bleedings, mortality for bleeding and overall mortality according to data provided from international guidelines, clinical registries, randomised clinical trials and validated clinical experiences (3,4). There is less consensus about routinary follow-up and its timing for patients with recent VTE and related doubts are because of multiple confounding symptoms and clinical signs presents in the clinical evolution of VTE. Guidelines, in fact, suggest timing for instrumental examinations to check VTE’s regression/extension and timing to monitor efficacy of ongoing anticoagulant treatment after a recent VTE, in particular for antivitamin K drugs (5,7). In daily clinical practice, patients with recent VTE may often show multiple clinical signs or symptoms that may be referred both to VTE’s complications but also to

other diseases so inducing several doubts in physicians that are usually prone to exclude VTE’s recurrences as soon as possible. In this field, little is known about rehospitalisations for recurrent VTE and/or for suspected recurrent VTE, in particular in frail patients in which subjective and objective symptoms of recent VTE are still present and in which benefits of antithrombotic treatment are late to appear. These extratroubles expose patients and physicians to several doubts and frequently to re-admit in hospital patients to confirm/exclude VTE’s recurrences, to improve clinical surveillance and in order to optimise antithrombotic treatment. However, this correct and safe approach induces an increased resource utilisation with its related costs for physicians involved in emergency room as in primary care services. Data available in the Literature on this topic are focused on patients readmitted in hospital only for recurrent VTE that seem to be nearly 25% but full information about the rate of rehospitalisation for discrete VTE or suspected recurrent VTE in daily clinical practice is poor. In a following article written by Nutescu et al. (8) this goal was focused by a retrospective analysis utilising a database used to monitor information about ª 2015 John Wiley & Sons Ltd Int J Clin Pract, March 2015, 69, 3, 267–269

Conflicts of interest: a matter of transparency.

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