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.

Autorentext

Charles L Bennett, MD PhD MPP, SmartState Chair and Frank P and Josie M Fletcher Chair of Medication Safety and Efficacy and Director, SmartState Center for Medication Safety and Efficacy, is also a Visiting Scholar at the City of Hope National Cancer Institute Designated Comprehensive Cancer Center in Duarte, California and is the co-editor of this book, Cancer Policy (2nd Edition). Dr. Bennett is a Phi Beta Kappa and High Honors graduate in mathematics from Swarthmore College, earned his medical degree in 1981 from the University of Pennsylvania Perelman School of Medicine, and completed internal medicine, hematology, and oncology training at the Michael Reese Hospital and the University of Chicago Pritzger School of Medicine before completing his PhD and Masters In Public Policy degrees with honors in social science at the RAND Pardee Graduate School of Public Policy in Santa Monica, California. He has led a 20- year National Institutes of Health funded pharmacovigilance called the Research on Adverse Drug events And Reports (RADAR) and subsequently called to Southern Network on Adverse drug Reactions (SONAR) at the University of South Carolina College of Pharmacy.

Courtney Lubaczewski is a fourth-year undergraduate at the University of South Carolina Honors College and the co-editor of Cancer Policy with Charles L Bennett MD PhD MPP. She was a co-author on the 2021 PLOS One article on harms to physicians who report serious adverse drug reactions.

Bartlett Witherspoon, MBA is a third-year medical student at the Medical University of South Carolina and a graduate of Vanderbilt University's Master's in Business Administration program. He is an active co-investigator with Dr. Bennett and the SONAR project and has been a lead co-investigator on published manuscripts on fluoroquinolone-associated disability and on biosimilar oncology products.

Inhalt

Fluoroquinolone-Associated Disability and Other Fluoroquinolone Associated Serious Adverse Events: Unexpected Toxicities Have Emerged in Recent Years.- Biosimilar Epoetin in the United States: A View from the Southern Network on Adverse Reactions.- Policing of Drug Safety Information under the False Claims Act.- Translating Research Into Health Policy: The Citizen Petition Experience with the Food and Drug Administration.- Systemic Barriers and Potential Concerns from Reporting Serious Adverse Drug Reactions.- Was there Something Rotten in Denmark: Nephrogenic System Fibrosis Cases Occuring in Copenhagen.- Rituximab-associated Progressive Multifocal Leukoencephalopathy: A fatal adverse drug reaction.- Maximum Accuracy Machine Learning Statistical Analysis - A Novel Approach.- Investigating Severe Adverse Reactions: Examples of the ANTICIPATE Methodology at Work.- Consequences to patients, clinicians, and manufacturers when very serious adverse drug reactions are identified (1997-2019): A qualitative analysis from the Southern Network on Adverse Reactions (SONAR).- Moderna, Pfizer-BioNTech, and Johnson & Johnson/Janssen Post-Covid Vaccine Hematological Adverse Events Including Cerebral Venous Sinus Thrombosis (CVST), Thrombotic Thrombocytopenia (VITT), Blood Clots, Increased Vaginal/Menstrual Bleeding and/or Miscarriage, Stillbirth Delivery, or Premature Birth.- Investigating Novel Genetic Fluoroquinolone Associated Disorders.