Substantial contribution and accountability: best authorship practices for medical writers in biomedical publications.

OBJECTIVE: To provide clarity on the professional medical writer as author or contributor by examining what "a substantial contribution" and "accountability" mean with respect to authorship in a biomedical publication. These terms relate to criteria 1 and 4 of the International Committee of Medical Journal Editors (ICMJE) authorship guidelines. METHODS: We reviewed the ICMJE and Good Publication Practice authorship guidelines, which recommend that individuals not meeting all four authorship criteria should be acknowledged as contributors. We also surveyed and assessed selected journals for published guidance on authorship versus contributorship. RESULTS: We found that journals often vary in their authorship guidelines for medical writers. Notwithstanding, and to assist in determining the contribution made by the medical writer, we have expanded on current guidelines to develop recommendations for important intellectual contribution to the design of the work (developing the protocol, choosing endpoints) or the interpretation of data for the work (developing the discussion, interpreting new statistical output), which should result in inclusion of the medical writer as an author, as well as when accountability is relevant. If the medical writer does not qualify as an author, then their inclusion in the acknowledgements section is appropriate. CONCLUSIONS: Authors and contributors have a responsibility to create a publication that is accurate and true to the study results, but only authors must provide a substantial contribution and are accountable for that contribution. Contributions made by authors and non-author contributors should be fully described in the publication, to enable the reader to assess credit and responsibility.

Publication ethics from the ground up.

It is relatively easy to begin policy documents with a general assertion that ethics will be followed. Less obvious is how to ensure that day-to-day activities are consonant with ethical standards. We suggest that using day-to-day publication activities as the driver for building policies and procedures can promote ethical practices from the ground up. Although basic principles of ethical publication practice may seem straightforward to some, for others this information may require explanation, interpretation and context. Effective policy development includes big-picture items as well as more day-to-day tactical responsibilities such as those discussed below. Research questions, disciplinary practices, applications and team structures may vary. Thus, no single publication plan or policy solution is right for all teams. It is up to team members to review guidelines for best practices and find the optimal implementation for their situations. Experts in publication management, planning and writing can help large teams manage publication activities. These experts have an obligation to maintain and enhance their skills continually. A strong acumen in publication best practices will allow these publication professionals to better address any possible ethical dilemmas in the future.

Proceedings from the 9th Annual Meeting of International Society for Medical Publication Professionals Roundtable Session: key insights.

INTRODUCTION: During the 9th Annual Meeting of the International Society for Medical Publication Professionals (ISMPP, April 29-May 1, 2013 in Baltimore, MD), ∼650 participants attended two of 13 available roundtable sessions. Participants included medical publication professionals from industry, communication agencies, and journals. DISCUSSION TOPICS: Roundtable participants discussed how to best interpret and implement various guidances, such as Good Publication Practices 2 (GPP2), the International Committee of Medical Journal Editors (ICMJE) guidelines, and the Physician Payment Sunshine Act. The impact of and compliance with Corporate Integrity agreements (CIAs) on medical publication planning practices was debated. Roundtable participants also discussed ways of advancing both advocacy for the medical publication professional field and internal and external collaborations. The development of review manuscripts, publications from regions newly emerging in publication planning, medical devices publications, and real-world experience publications were discussed. Participants also considered the benefits and uncertainties of new technologies in medical publications such as multimedia and social media. SUMMARY: This is the first ever article to be published following the well-attended ISMPP roundtable sessions. The objective of this manuscript is to summarize key learnings that will aid continued discussions about challenges and opportunities facing medical publication professionals.

Absence of a clinically relevant interaction between etanercept and digoxin.

Etanercept, a soluble recombinant human tumor necrosis factor receptor (TNFr), is effective and well tolerated in the treatment of rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and psoriasis. The primary objective of this study was to investigate the potential pharmacokinetic and pharmacodynamic interaction between digoxin and etanercept at steady state. In a crossover, open-label, nonrandomized, 3-period study, 12 healthy male subjects received loading oral doses of digoxin 0.5 mg every 12 hours on day 1 and 0.25 mg every 12 hours on day 2, followed by a daily maintenance dose of 0.25 mg for a total of 27 days. Etanercept was administered as a twice-weekly 25-mg subcutaneous dose beginning on day 9 and continuing up to day 37 for a total of 9 doses. All ratios of maximum plasma concentration (C(max)) and area under the plasma concentration versus time curve (AUC) for pharmacokinetics of digoxin fell within the confidence interval of 0.8 to 1.25. Although not considered clinically relevant, the mean C(max) and AUC of etanercept were 4.2% and 12.5% lower, respectively, when etanercept was given with digoxin than when administered alone. There were no clinically relevant changes in the electrocardiogram (ECG) parameters, and adverse events did not increase when both drugs were combined. In conclusion, there is no clinically relevant interaction between etanercept and digoxin, and both drugs can be safely coadministered without the need for a dosage adjustment.

Global transcription profiling of estrogen activity: estrogen receptor alpha regulates gene expression in the kidney.

Estrogen receptors (ERs) are expressed in numerous organs, although only a few organs are considered classical targets for estrogens. We have completed a systematic survey of estrogen regulation of approximately 10,000 genes in 13 tissues from wild-type and ERbetaKO mice treated sc with vehicle or 17beta-estradiol (E2) for 6 wk. The uterus and pituitary had the greatest number of genes regulated by E2, whereas the kidney had the third largest number of regulated genes. In situ hybridizations localized E2 regulation in the kidney to the juxtamedullary region of the cortex in both the mouse and rat. The ED(50) for gene inductions in the kidney was 3 micro g/kg.d, comparable with the 2.4 micro g/kg.d ED(50) for c-fos induction in the uterus. E2 regulations in the kidney were intact in ERbetaKO mice, and the ERalpha-selective agonist propylpyrazole triol acted similarly to E2, together suggesting an ERalpha-mediated mechanism. Several genes were induced within 2 h of E2 treatment, suggesting a direct activity of ERalpha within the kidney. Finally, the combination of the activation function (AF)1-selective agonist tamoxifen plus ERalphaKO(CH) mice expressing an AF1-deleted version of ERalpha allowed delineation of genes with differing requirements for AF1 or AF2 activity in the kidney.