From Silos to Multilingual Science

The history of medicines regulation is punctuated with sudden swings in focus mandated by a public injured by medicines and skeptical of regulators' abilities to protect them. As stakeholder communities and the science that undergirds medicines have both grown more sophisticated, seemingly conflicting mission equities, such as public health protection vs. promotion or population vs. individual patient product development focus, have created new challenges to defining the mission and role of twenty-first-century medicines regulators. The role of medicines regulators as a nationally focused, retrospective assessor of data is rapidly shifting to that of a prospective generator of public data and tools to help drive what has now become a global product development and regulatory enterprise that is fast gaining recognition as an integral part of any truly effective twenty-first-century health-care system. This article discusses this evolution and describes how regulatory science will help to both drive and define it.

The main objectives of the study were to evaluate personal bibliographic software, Pro-Cite (version 1.4) as a tool to manage bibliographic information in a research laboratory. The research focused on four areas, including: evaluation of the use of Pro-Cite by research staff; evaluation of the use of Pro-Cite to maintain a library accessions register; determination of the feasibility of using Pro-Cite as a backup catalogue; and an assessment of Pro-Cite’s capabilities as software to mount a Divisional database. The research design incorporated applied research and case study methodology. The population covered in the study included fifteen scientific staff and two library staff using the software Pro-Cite,at the CSIRO Division of Biomolecular Engineering, Parkville, Australia. The study has been reported in a thesis, which was submitted by the author in partial fulfilment of the requirements for a Master of Business in Information Technology.

The ability of powerful and well-funded interest groups to steer scientific research in ways that advance their goals has become a significant social concern. This steering ability is increasingly being recognized in the peer-reviewed scientific literature and in findings of deliberative scientific bodies. This paper provides a case study that illustrates some of the major strategies that can be used to structure and advance a controversial research field. It focuses on hormesis, described as a type of dose-response relationship in toxicology and biology showing low-dose stimulation but high-dose inhibition, or the reverse. Hormesis proponents tout its significance, arguing that substances toxic at high doses and beneficial at lower doses should be regulated less stringently. We identify five strategies employed by hormesis proponents to foster its acceptance: (1) creating institutions focused on supporting hormesis; (2) developing terminology, study designs, and data interpretations that cast it in a favorable light; (3) using bibliometric techniques and surveys to attract attention; (4) aggressively advocating for the phenomenon and challenging critics; and (5) working with outside interest groups to apply the hormesis phenomenon in the economic and political spheres. We also suggest a number of oversight strategies that can be implemented to help promote credible and socially responsible research in cases like this one.