专家谈万络退出全球市场PPT课件.ppt

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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