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1、VIOXXWITHDRAWAL:LearningvaluablelessonsfromrofecoxibEricJTopolMDProvostandChiefAcademicOfficerChair,DepartmentofCardiovascularMedicineClevelandClinicFoundationCleveland,OHRobertMCaliffMDProfessorofMedicineAssociateViceChancellorforClinicalResearchDirector,DukeClini
2、calResearchInstituteDukeUniversityMedicalCenterDurham,NCVIOXXWITHDRAWALMerck&CotakestheselectiveCOX-2inhibitorrofecoxiboffworldwidemarketTopicVIOXX:NewopportunitiesOpportunitytomovemedicalprofessionintherightdirectionSystemoutofkilterforsometimeTherapeuticknowledgehas
3、advancedbeyondtheFDAandmedicalmarketingsystemscurrentlyinplaceCaliffVIOXX:GreatconceptCOX-2targetrepresented"theultimateofbiomedicalscience"COX-2inhibitors,introducedafewyearsagoforthetreatmentofpainandinflammation,hadcomparableefficacybutimprovedGIsafetyandtolerabilit
4、ycomparedwithNSAIDsShort-term,biomarker-basedstudiesbroughtdrugtomarketCaliffDirect-to-consumeradvertisingMerck&Coledthewayin"direct-to-consumer"advertisingwiththedrugButissuesbegantoariseearlyabouttheincreasedcardiovascularriskOutcomestudiesinpatientswitharthritisandc
5、ardiovasculardiseasewereneededCaliffVIOXX:OutcomestudiesneededMerck&Corefusedtoconductthenecessaryoutcomestudies-TopolCompanylaunchedthreestudieslookingatnoncardiovascularoutcomes,butmeasuringcardiovasculareventsAPPROVEtrialOnestudy--AdenomatousPolypPreventiononVIOXX(A
6、PPROVE)--testedrofecoxib25mgvsplacebointhepreventionoftherecurrenceofcolorectalpolypsin2600patientswithahistoryofcolorectaladenomaRESULTSStudyshowedanincreasedrelativeriskforMIandstrokewithrofecoxib,whichbecameevidentafter18monthsoftreatment45confirmedeventsintherofecox
7、ibgroup(1.48%)vs25intheplacebogroup(0.75%)VIOXX:RiskandbenefitRofecoxibwithdrawnSeptember30,2004"Thisisjustoneofmanytypesofdrugsthataregiventopeopleforyearswithabsolutelynounderstandingofwhatthechronicbalanceofriskandbenefitisbecauseit'sneverbeenstudied."-CaliffButalsot
8、henorm,notanexceptionVIOXX:Topol'sthoughtsIntheVIOXXGastrointestinalOutcomesResearch(VIGOR)study--whichindicat
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