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This volume covers a wide range of topics concerning methodological, epistemological, and regulatory-ethical issues around pharmacology. The book focuses in particular on the diverse sources of uncertainty, the different kinds of uncertainty that there are, and the diverse ways in which these uncertainties are (or could be) addressed. Compared with the more basic sciences, such as chemistry or biology, pharmacology works across diverse observable levels of reality: although the first step in the causal chain leading to the therapeutic outcome takes place at the biochemical level, the end-effect is a clinically observable result-which is influenced not only by biological actions, but also psychological and social phenomena. Issues of causality and evidence must be treated with these specific aspects in mind. In covering these issues, the book opens up a common domain of investigation which intersects the deeply intertwined dimensions of pharmacological research, pharmaceutical regulation and the related economic environment. The book is a collective endeavour with in-depth contributions from experts in pharmacology, philosophy of medicine, statistics, scientific methodology, formal and social epistemology, working in constant dialogue across disciplinary boundaries.
List of contents
Part I. Epistemology.- 1. Defining Aspects of Mechanisms: Evidence-Based Mechanism (Evidence for a Mechanism), Mechanism-Based Evidence (Evidence from a Mechanism), and Mechanistic Reasoning.- 2. Causal Insights from Failure: Post-Marketing Risk Assessment of Drugs as aWay to Uncover Causal Mechanisms.- 3. Extrapolating from Model Organisms in Pharmacology.- 4. "Mechanistic Versus Statistical Extrapolation in Preclinical Research in Psychiatry: Challenging the Received View".- 5. Analogy-Based Inference Patterns in Pharmacological Research.- 6. "In Silico Clinical Trials: a Possible Response to Complexity in Pharmacology".- 7. "Uncertainty in Drug Discovery: Strategies, Heuristics and Technologies".- 8. "Caught in the Amber": a Sketch of Chemical Underdetermination.- Part II. Methods.- 9. A Millian Look at the Logic of Clinical Trials.- 10. "Learning by Difference: Placebo Effects and Specific Efficacy in Pharmacological RCTs".- 11. "An Evidence-Hierarchical Decision Aid for Rankingin Evidence-Based Medicine".- 12. "Assessing Drug Safety Assessment: Metformin Associated Lactic Acidosis".- 13. Robust Biomarkers: Methodologically Tracking Causal Processes in Alzheimer's Measurement.- 14. "Modelling Individual Response to Treatment and its Uncertainty: a Review of Statistical Methods and Challenges for Future Research".- Part III. Decisions.- 15. Values in Pharmacology.- 16. "Humbug, the Council of Pharmacy and Chemistry, and the Origin of "the Blind Test" of Therapeutic Efficacy".- 17. On the Normative Foundations of Pharmaceutical Regulation.- 18. After Disclosure.- 19. Sex, Drugs, and how to Deal with Criticism-The Case of Flibanserin.
About the author
Prof. Barbara Osimani is Associate Professor of Logic and Philosophy of Science at the Polytechnic University of the Marche and is currently heading an ERC project, which also runs at the Munich Center for Mathematical Philosophy, LMU: "Philosophy of Pharmacology: Safety, Statistical Standards, and Evidence Amalgamation".
She is interested in scientific inference in research contexts characterised by strategic behaviour and she is developing a "Formal Epistemology of Medicine" in order to analyse issues arising in medical research, with a special focus on the complex interaction of methodological, social and regulatory as well as ethical dimensions in medicine. She worked on the precautionary principle, evidence hierarchies, causal assessment of pharmaceutical harm, and statistical inference. Her recent papers analyse issues around philosophy of evidence (reliability, bias, reproducibility, coherence) from a Bayesian perspective. Within her ERC project:"Philosophy of Pharmacology: Safety, Statistical Standards, and Evidence Amalgamation" she developed a Bayesian framework for the integration of heterogenous items of evidence for the purpose of causal assessment of drug-induced harm ("E-Synthesis")
Dr. La Caze is a lecturer at the School of Pharmacy, University of Queensland. He completed his PhD in the philosophy of science at The University of Sydney. His research focusses on philosophy of science, philosophy of medicine and ethics. He is particularly interested in exploring philosophical approaches to challenges that arise in interpreting and applying biomedical research.
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