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Cancer Treatment and Research Series Editor: Steven T. Rosen Charles Bennett Courtney Lubaczewski Bartlett Witherspoon Editors Cancer Drug Safety and Public Health Policy A Changing Landscape Indexed in PubMed/Medline Cancer Treatment and Research Volume 184 Series Editor Steven T. Rosen, Duarte, CA, USA Thisbookseriesprovidesdetailedupdatesonthestateoftheartinthetreatmentof different forms of cancer and also covers a wide spectrum of topics of current research interest. Clinicians will benefit from expert analysis of both standard treatmentoptionsandthelatesttherapeuticinnovationsandfromprovisionofclear guidance on the management of clinical challenges in daily practice. The research-orientedvolumesfocusonaspectsrangingfromadvancesinbasicscience throughtonewtreatmenttoolsandevaluationoftreatmentsafetyandefficacy.Each volume is edited and authored by leading authorities in the topic under consideration. In providing cutting-edge information on cancer treatment and research,theserieswillappealtoawideandinterdisciplinaryreadership.Theseries is listed in PubMed/Index Medicus. Charles Bennett (cid:129) Courtney Lubaczewski (cid:129) Bartlett Witherspoon Editors Cancer Drug Safety and Public Health Policy A Changing Landscape 123 Editors CharlesBennett CourtneyLubaczewski Collegeof Pharmacy Collegeof Pharmacy University of SouthCarolina University of SouthCarolina Columbia, SC,USA Columbia, SC,USA Bartlett Witherspoon Collegeof Pharmacy University of SouthCarolina Columbia, SC,USA ISSN 0927-3042 ISSN 2509-8497 (electronic) Cancer Treatment andResearch ISBN978-3-031-04401-4 ISBN978-3-031-04402-1 (eBook) https://doi.org/10.1007/978-3-031-04402-1 ©TheEditor(s)(ifapplicable)andTheAuthor(s),underexclusivelicensetoSpringerNature SwitzerlandAG2022 Thisworkissubjecttocopyright.AllrightsaresolelyandexclusivelylicensedbythePublisher,whether thewholeorpartofthematerialisconcerned,specificallytherightsoftranslation,reprinting,reuseof illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmissionorinformationstorageandretrieval,electronicadaptation,computersoftware,orbysimilar ordissimilarmethodologynowknownorhereafterdeveloped. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publicationdoesnotimply,evenintheabsenceofaspecificstatement,thatsuchnamesareexemptfrom therelevantprotectivelawsandregulationsandthereforefreeforgeneraluse. The publisher, the authors, and the editorsare safeto assume that the adviceand informationin this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, expressed or implied, with respect to the material contained hereinorforanyerrorsoromissionsthatmayhavebeenmade.Thepublisherremainsneutralwithregard tojurisdictionalclaimsinpublishedmapsandinstitutionalaffiliations. ThisSpringerimprintispublishedbytheregisteredcompanySpringerNatureSwitzerlandAG Theregisteredcompanyaddressis:Gewerbestrasse11,6330Cham,Switzerland Preface Policy is a critical area of research in the field of oncology. Understanding the factorsthatdeterminethequalityofcareisimportantforprovidingcomprehensive treatment. Serious adverse events associated with antibiotics, the topic of the chapter by Champigneulle, Bennett, Bennett, and Martin, threaten the health of patients and limit their quality of life. On the other hand, copies of patented biologicals called biosimilars, discussed by Nagai, Witherspoon, and Bennett, exist as an alternative treatment option for cancer patients. Both of these chapters assess the cost and benefits of commonly utilized treatment options in order to ensure the best patient outcome. It is important that the information provided about these drugs is the most accurate. Chen, Yang, and Bennett describe how better transparency is needed in disseminating safety information to providers and patients. Citizen petitions are a way to report recorded safety data. Possible action suggested in these petitions describedbyMartin,Ray,andBennettincludelabelchangesorboxedwarnings.As illustrated by Taylor and colleagues, there are concerns in safe reporting of these adverse events. Lawsuits and fear of jeopardizing existing collaborations could make clinicians hesitant to share their findings. Therearecorrelationsbetweendrugsandadversereactionsthataredocumented byclinicians.OneofthesereactionsnotedbyBennett,Witherspoon,andCarsonis nephrogenic fibrosis following treatment with GBCAs. This disease limits the quality of life so it is important to consider if taking the medication is worth the risk. Different adverse drug reactions can occur with different medications such as the link between rituximab and leukoencephalopathy discussed by Bennett, Witherspoon, and Carson. This clinical and epidemiologic data is essential for providerstoreceivesotheycanmakedecisionsinthebestinterestoftheirpatient’s safety. Thereisavariousmethodologythatcanbeusedtocompilethissafetydata. As described by Yarnold and colleagues, these methods include logistic regression with an independent variable, attributes with identical level of influence, and equivalent coefficients. Another way to investigate adverse drug data is the ANTICIPATE methodology presented by Bennett, Schooley, and Hoque. This facilitatessystemicanalysisoffoursADRsamongchronickidneydiseasepatients. v vi Preface Important components of this method include signal detection, cost analyses, and toxicityeradicationrecommendations.Reportingthroughthesemethodscanleadto consequencesbyclinicians.ThesearedescribedbyLubaczewskiandcolleaguesto include loss of clinician jobs and costly legal settlements. These findings highlight the importance of Data Safety Monitoring Boards and anonymous reporting to encourage clinicians to report all findings imperative to patient well-being. Alter- native adverse event reporting platforms including vaccine databases and social media are highlighted by Bennett and Champigneulle. Additionally, the relevance ofutilizinggeneticmarkerstoidentifyat-riskpatientsisdescribedbyA.Bennett.In sum, these twelve chapters in this edition highlight some important parts of oncology drug reactions and their reporting. We are pleased to have had the opportunity to edit this work. Columbia, USA Charles Bennett, M.D., Ph.D. Courtney Lubaczewski Bartlett Witherspoon, MBA Contents 1 Fluoroquinolone-Associated Disability and Other Fluoroquinolone-AssociatedSeriousAdverseEvents:Unexpected Toxicities Have Emerged in Recent Years . . . . . . . . . . . . . . . . . . . 1 Charles L. Bennett, Oscar Champigneulle, Andrew Bennett, Bartlett Witherspoon, and Cecilia Bove 2 Biosimilar Epoetin in the United States: A View from the Southern Network on Adverse Reactions . . . . . . . . . . . . . 41 Sumimasa Nagai, Bartlett Witherspoon, Chadi Nabhan, and Charles L. Bennett 3 Policing of Drug Safety Information Dissemination Under the False Claims Act. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Brian Chen, Tony Yang, and Charles L. Bennett 4 Translating Research into Health Policy: The Citizen Petition Experience with the Food and Drug Administration. . . . . . . . . . . . 61 Paul Ray and Charles L. Bennett 5 Systemic Barriers and Potential Concerns from Reporting Serious Adverse Drug Reactions. . . . . . . . . . . . . . . . . . . . . . . . . . . 75 Matthew A. Taylor, Ashley C. Godwin, Shamia Hoque, and Charles L. Bennett 6 Was There Something Rotten in Denmark: Nephrogenic System Fibrosis Cases Occurring in Copenhagen . . . . . . . . . . . . . . 87 Charles L. Bennett, Bartlett Witherspoon, Kenneth R. Carson, and Henrik S. Thomsen 7 Rituximab-Associated Progressive Multifocal Leukoencephalopathy: A Twenty-Year Update. . . . . . . . . . . . . . . . 103 Charles L. Bennett, Bartlett Witherspoon, and Kenneth R. Carson 8 Maximum Accuracy Machine Learning Statistical Analysis—A Novel Approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113 Shannon Ugarte, Paul Yarnold, Paul Ray, Kevin Knopf, Shamia Hoque, Matthew Taylor, and Charles L. Bennett vii viii Contents 9 Investigating Severe Adverse Reactions: Examples of the ANTICIPATE Methodology at Work. . . . . . . . . . . . . . . . . . 129 Charles L. Bennett and Shamia Hoque 10 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). . . . . . . . . . . . . . . . . . . . 141 CourtneyR.Lubaczewski,NancyF.Olivieri,WilliamR.Hrushesky, and Charles L. Bennett 11 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151 Oscar Champigneulle and Charles L. Bennett 12 Investigating Novel Genetic Markers for Fluoroquinolone Associated Disorders. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161 Andrew Bennett Index .... .... .... .... .... ..... .... .... .... .... .... ..... .... 167 Editors and Contributors About the Editors Charles Bennett, M.D. Ph.D. 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 UniversityofChicagoPritzgerSchoolofMedicinebeforecompletinghisPh.D.and MastersInPublicPolicydegreeswithhonorsinsocialscienceattheRANDPardee GraduateSchoolofPublicPolicyinSantaMonica,California.Hehasleda20-year National Institutes of Health funded pharmacovigilance called the Research on Adverse Drug events And Reports (RADAR) and subsequently called to Southern NetworkonAdversedrugReactions(SONAR)attheUniversityofSouthCarolina 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 Ben- nettM.D.Ph.D.MPP.Shewasaco-authoronthe2021PLOSOnearticleonharms to physicians who report serious adverse drug reactions. Bartlett Witherspoon, MBA is a third-year medical student at the Medical UniversityofSouthCarolinaandagraduateofVanderbiltUniversity’sMaster’sin BusinessAdministration program. Heisanactiveco-investigatorwithDr.Bennett andtheSONARprojectandhasbeenaleadco-investigatoronpublishedmanuscripts onfluoroquinolone-associateddisabilityandonbiosimilaroncologyproducts. ix