Spotlight—Introducing a new Commentary series for the BJCP

We are launching a new series of Commentaries, which aim to identify emerging themes—pulling together related content that has recently been published in the Journal for Readers, Authors and Editors and placing this in the context of contemporaneous work in other Journals. Outside of the formal themed issues, currently, our readers may experience papers presented somewhat in isolation to other potentially related work. This could be partly because Authors submit their papers, not always entirely familiar with recent relevant works in the Journal. In parallel, much of the Editor's role involves handling submitted manuscripts, with each paper being handled in isolation to what might be related content that has been published in the Journal. Indeed, potentially related papers will often have been handled by other members of the Editorial Board. Thus, the idea of the launch of the Commentaries was to enhance the service for Readers and Authors by improving the engagement of the Editors in the overall output of the Journal, identify potential emerging themes, and to place this in the context of what is happening externally.

The first four Commentaries in the series highlight important and diverse themes in the Journal and reflect the Editors' wide range of interest. Robert Rissman and Elemer Szabadi engage with the issue of “How to prove pharmacology of immunomodulatory drugs in a phase 1 trial?”1 and the role of target engagement. They describe how Ellis and colleagues dealt with the challenge of demonstrating pharmacodynamic effects in healthy volunteers.2 This approach also meets the requirements of the Journal to demonstrate actual pharmacological effects beyond pharmacokinetics, tolerability, and safety. They achieved this by a target engagement assay of receptor occupancy of the Interleukin (IL)‐7 receptor in T‐lymphocytes following administration of an IL‐7 monoclonal antibody, with assessment of the phosphorylation status of IL‐7R downstream inhibition of STAT5 upon ex vivo IL‐7 exposure of PBMCs. Establishing the PK/PD relationship also better informs subsequent Phase II/proof of concept studies.

Engagement of drugs with the baby when taken by the mother during pregnancy usually represents an unwanted target, as discussed Li Wei and Adam Cohen in their Commentary: “Medicines use during pregnancy and harmful effects on offspring”.3 Indeed, concerning associations with cardiovascular malformations have recently been described with commonly used drugs such as fluoxetine,4 and paracetamol; the latter with fetal ductus arteriosus constriction or closure.5

Li Wei and Adam Cohen are joined by Anthonius de Boer on another Commentary, “A post approval look at anticoagulants”,6 and engage with the pharmaco‐epidemiological challenge of correctly identifying and ascribing rarer adverse events. Three papers using different approaches (eg, controlling for potential bias and different populations) are described—resulted in different associations of the newer direct acting anticoagulants (DOACs), and the vitamin K antagonists with bleeding and thrombotic events. Further newer methods such as sequence symmetry analysis recently published in the Journal are promising, but still have limitations.7

Moving from these issues of pharmacodynamics and pharmaco‐epidemiology with newer drugs, including the anticoagulants, to the usage of a very old drug, aspirin, Andrew Webb and Pietro Minuz consider, “What's new with the old drug Aspirin in older adults?”8 in their Commentary. A striking issue here, as reported by Ardoino et al was over‐engagement in the prescription of aspirin—with more than half the patients being prescribed aspirin inappropriately, mainly for low‐risk primary prevention in older patients, where it is no longer recommended.9

More Commentaries will follow from the Editors shortly. However, the process of actively engaging in the work published by the Journal and creating Commentaries need not be limited to the Editors. If, as Readers or Authors you spot/discern any themes, please do engage and contribute a Spotlight Commentary.

COMPETING INTERESTS

There are no competing interests to declare.

Webb AJ. Spotlight—Introducing a new Commentary series for the BJCP . Br J Clin Pharmacol. 2019;85:1387–1388. 10.1111/bcp.13930