"Frontline"DangerousPrescriptions

• 清晰：BD
• 类型：
• 主演：Will Lyman
• 年代：2003 / 美国 / Andrew,Liebman
• 导演：Andrew Liebman
• 国家/地区：美国
• 时长：120分钟
• 语言/字幕：国语对白 中文字幕
• 年代：2003
• 更新时间：2024-04-08 01:13:33
• 详细介绍： DavidArcherhadhighcholesterolbutwasotherwiseingood… DavidArcherhadhighcholesterolbutwasotherwiseingoodhealthinthefallof2000whenhebegantakingBaycol,acholesterol-lowering"statin"drugthattheFoodandDrugAdministration(FDA)hadrecentlyapprovedtobesoldatadosagefourtimeshigherthantheoriginallyapproveddose.Abouttwomonthsafterstartingthehigher-dosagedrug,Archerwouldbedead.WhatDavidArcherhadn'tknownwasthatmorethanfivemonthsbeforehisdeath,thedrug'smanufacturer,Bayer,hadreceivedstrongindicationsthatBaycolmightbemanytimesmorelikelythanotherstatindrugstocausearare,life-threateningmusclewastingsideeffectknownasrhabdomyolisis.FollowingArcher'sdeath,itwouldbeanothereightmonthsbeforeBayerwouldvoluntarilyremovethedrugfromthemarketinAugust2001becauseofthissideeffect.DavidArcherisnotalone.HeisjustoneofthetensofthousandsofAmericanswhohavebecomeillordiedaftertakingmedicationsapprovedbytheFDA.Formanyconsumers,FDAapprovalsignifiesthatadrugorproducthasbeenfoundtobesafe.ButjusthowmuchdoestheaverageAmericanknowabouttheFDAapprovalprocessandwhattheagencycan--andcannot--do?HowgoodistheFDA'ssystemforidentifyingdrugsthatcauseharm?Andwhathappenswhenaharmfulproductmakesitswayintoconsumers'hands?In"DangerousPrescription,"FRONTLINE®investigatestheintegrityofAmerica'sdrugsafetysystem.ThroughinterviewswithcurrentandformerFDAofficials,critics,apharmaceuticalindustryrepresentative,andconsumers,theone-hourdocumentaryexaminestheFDA'shandlingofseveraldrugsthatwereapprovedbutlaterwerepulledfromthemarketaftercausinginjuriesandevendeaths.Theprogramalsoexaminestherolethatdrugcompaniesplayintheapprovalandmonitoringofprescriptiondrugs,andquestionswhethertheFDA'scurrentsystemisadequateforprotectingthepublic."IthinkAmericansneedtorecognizethateverytimetheyputapillintheirmouth--especiallyanewpillthatthey'venevertakenbefore--it'sanexperiment,"saysDr.RaymondWoosley,vicepresidentforHealthSciencesattheUniversityofArizona.Since1997,morethanadozendrugshavebeentakenoffthemarketduetoseveresideeffectsorinjuries.It'sastatisticthatmaysurprisethemanyU.S.consumerswhobelievethatFDAapprovalguaranteesadrug'ssafety.Notso,sayscientistsandindustryobservers."Whenadruggoesonthemarket,onlyabout3,000patientshaveeverbeengiventhatdrug,"saysWoosley,whodirectsanationalcenterthatstudiesdrugsideeffects."Wewillneverknowallthetoxicitythatcanoccur,especiallytheone[patient]in10,000oronein20,000thatcouldbeseriouslyharmed.Ourdetectionwillonlyhappenafterthedrugisonthemarketandexposedtoahugenumberofpatients."Atthatpoint,agencyofficialssay,theFDAdependsalmostcompletelyonasystemthatreliesonindividualdoctorsandcliniciansthroughoutthecountrytospotserioussideeffectsorinjuriesandvoluntarilyreportthemtotheFDA'sOfficeofDrugSafety."IntheUnitedStates,theinitiatorofthereportdoessoonavoluntarybasis,"confirmsPaulSeligman,directoroftheFDA'sOfficeofDrugSafety."It'scriticalthatwegetthesereports.There'snootherwaytheFDAhasforunderstandingwhat'sgoingonwithamedicineonceit'sbeenmarketed."Inmostcases,doctorswillreportsideeffectsnottotheFDAbuttothedrug'smanufacturer;whenthishappens,thecompanyisrequiredbylawtoreporttheinformationtotheFDAwithin15daysofreceivingit.ThisistheFDA's"MedWatch"system,butsomeobserversandindustryinsidersseeaflawinit."TheFDAiswhollydependentontrust--trustingthatthecompanyisprovidingallthetruth,allthetime,"retiredFDAdrugreviewerDr.LeoLutwaksays."Andthatthecompanyisnothidinginformation.Andthatthecompanyisnotcoveringupinformation."In"DangerousPrescription,"FRONTLINErecountshowBayerdelayednotifyingtheFDAofthesuspectedlinkbetweenitscholesterol-loweringBaycoldrugandahigherriskofrhabdomyolisiswhileitconductedstudiestoseeifthesuspicionscouldbeconfirmed.Atthesametime,BayercontinuedtosellandaggressivelypromoteBaycol,whichcost30percentlessthanitsmaincompetitor,Lipitor.WhentheFDAapprovedthereleaseofthehigher-dosageBaycol--knownasBaycol.8--inthesummerof2000,theagencywasunawarethatBayerhadinformationsuggestingthatpatientsonBaycolhadasignificantlyhigherriskofdevelopingrhabdomyolisisthanpatientsonotherstatindrugs.BayerdeclinedtobeinterviewedbyFRONTLINE.FRONTLINEalsorecountsthebiggestsafetydisasterintheFDA'shistory:theapprovalandremovalofthedietdrugsknownasFenPhen.FenPhenwasacombinationoffenfluramine(alsosoldunderthebrandnamePondimin)andphentermine.Reduxwasaslightlymodifiedversionoffenfluraminecalleddexfenfluramine.In"DangerousPrescription,"FRONTLINEspeakswithscientistsandformerFDAofficialswhosaytheagencyhadevidenceofthedangersofReduxbeforethedrugwasreleasedbutchosetoapproveitanyway.Dr.StuartRich,acardiologistattheRushHeartInstituteinChicago,recallsthattheFDA'sdecisionoverwhethertoapproveReduxforU.S.distributionoccurredaroundthesametimethatheandhiscolleaguesinFrancewerewrappingupathree-yearEuropeanstudyofthedrug.Thestudyshowedastrongcorrelationbetweenpulmonaryhypertensionanddietdrugs--particularlyRedux."Whatwasparticularlyshockingtomewasthatontheheelsofreportingthatthisdrugcausedafatal,incurablediseaseinEurope,thatthecompanywasplanningtoputitontheAmericanmarketplace,"RichtellsFRONTLINE."WhenIhadheardthis,I'dsaid,'Well,youcantry,butit'snevergonnagetinthiscountry.TheFDAwouldneverpermitadrugthathadlittlebenefit[and]terribleriskontheAmericanmarketplace.'"Dr.Lutwak,thenstillemployedattheFDAasadrugreviewer,agreed."Ithoughtitwasanopenandshutcase,"hesays."Thiswasadangerousgroupofdrugswithverylittle,ifany,benefit."FRONTLINErecountstheinternalreviewprocessthatledtheFDAtoapproveReduxovertheconcernsandobjectionsofitsowndrugreviewers--adecisionthatLutwaksayslefthim"disturbed."AlthoughLutwakeventuallyagreedtoanapprovalofReduxwithanumberofrestrictions,hewasquiteworried."Ibecameconcernedaboutthesystem,"hesays."AndIwasparticularlyconcernedaboutthepotentialeffectonthousandsandmillionsofpeoplewhowouldbeusingthedrug."In"DangerousPrescription,"viewersmeetNorthDakotacardiologistDr.JackCrary,oneofthefirstdoctorstoreportaconnectionbetweenFenPhenandReduxandadifferentserioussideeffect--heartvalveproblems.Craryrecallswonderinginthespringof1997whytheFDAwasfailingtoactonthemanyreportshehadsenttoRedux'smanufacturer,Wyeth,abouttheheartvalveissue."Itwasfrustrating,"Crarysays."IwasfrustratedenoughthatIcalledtheFDAinMay[1997],andthepersonItalkedtoattheFDAknewnothingaboutit."Itwasn'tuntilCraryandhiscolleaguesheldapressconferenceinlateJune1997toannouncetheirfindingsthattheFDAwouldkickintohighgear;withinweeks,ReduxandPondiminweretakenoffthemarket--somesixmonthsafterCraryfirstnotifiedWyethoftheproblem.Morethan200,000AmericanseitherhavesuedorareplanningtosueWyethinconnectionwithFenPhen.Todate,thecaseshavecostWyethnearly$13billion;ultimately,thecosttothecompanycouldbemuchhigher.WyethdeclinedtobeinterviewedbyFRONTLINE.ThedocumentaryalsoexaminestheimpactofthePrescriptionDrugUserFeeAct--legislationpassedbyCongressthatallowsdrugcompaniestopayafeeofmorethan$500,000witheachdrugapplicationsothattheFDAcanhiremoredrugreviewers--therebyspeedingupthedrugapprovalprocess.CriticssaythelawhaspushedtheFDAtooclosetothepharmaceuticalcompaniesitischargedwithregulating.FRONTLINEspeakswithaformerFDAsafetyofficer,whorecountsbeingpressuredtotonedownoralternegativedrugreviewsinordertospeedapprovalofanewdrug.Anothertellsofsufferingagencyretributionandretaliationforrecommendingagainstadrug'sapproval."ThissystemhascreatedaveryunhealthyrelationshipbetweentheindustryandtheFDA,wheretheFDAsays,'Wehavetobenicetothesepeoplebecausetheyarepayingourbills,'"saysSidneyWolfeofPublicCitizen'sHealthResearchGroup."ThecultureattheFDAhasbecome'pleasetheindustry,avoidconflict,lookuponourroleasgettingasmanydrugsapprovedaspossible.'"It'sachargeFDAofficialsstronglydeny."Wedon'treallyfeelpressuretopleasetheindustry...wejustrejectthatwe'reactuallyinfluencedbythat,"saysStevenGalson,actingdirectoroftheFDA'sdrugdivision.But,admitsGalson,"Oursystemisn'tperfect....Ithinkthelessonis,there'salotofroomforustogointermsofmakingimprovementswiththesystem."Galson'swordsareoflittlecomforttopeoplelikeMarleeSiewert,oneoftheNorthDakotapatientswhoseFenPhen-relatedheartvalveproblemsledtotheweightlossdrugsbeingremovedfromthemarket.Siewertwilllikelyneedsurgerytoreplaceherleakyheartvalve."Iammad,angry,frustratedforthefactthattheytookagoodpartofmylifeaway,"shesays."Theymayhavetakenagoodsectionofmylifeaway.AndIdounderstandthat[drugcompanies]areinthebusinesstomakemoney,butI'minthebusinesstolive." 详情