Cancer Drug Safety and Public Health Policy: A Changing Landscape (Cancer Treatment and Research, 184)

By Charles Bennett, Courtney Lubaczewski, Bartlett Witherspoon This book offers a wide-ranging description and analysis of recent developments and current trends in health policy with regard to cancer drug safety. The book opens with an overview of pharmacovigilance for cancer blockbuster drugs, covering both general considerations and efforts to develop a structured framework for the identification and reporting of adverse drug reactions (ADRs). A number of important examples of serious ADRs to hematology and oncology drugs are then reviewed, with evaluation of the lessons learned and the policy implications of the ensuing legal cases and their settlements. Further, the difficulty of reporting such blockbuster side effects in the medical literature is explored in an empirical study. Significant advances have been achieved in analytic methods for the identification of ADRs, and here there is a particular focus on the value of optimal discriminant analysis. Finally, the impacts on pharmacovigilance and drug safety of the huge fines paid under the U.S. False Claims Act relating to the defrauding of governmental programs also receive careful attention – these fines are playing an important role in changing the landscape for pharmaceutical safety. Product Details Publisher ‏ : ‎ Springer; 1st ed. 2022 edition (December 1, 2022) Language ‏ : ‎ English Hardcover ‏ : ‎ 178 pages ISBN-10 ‏ : ‎ 3031044010 ISBN-13 ‏ : ‎ 978-3031044014