文档介绍：该【lessons from theranos – restructuring biomedical innovation 2022 rishub karan das 】是由【贾赦】上传分享，文档一共【3】页，该文档可以免费在线阅读，需要了解更多关于【lessons from theranos – restructuring biomedical innovation 2022 rishub karan das 】的内容，可以使用淘豆网的站内搜索功能，选择自己适合的文档，以下文字是截取该文章内的部分文字，如需要获得完整电子版，请下载此文档到您的设备，方便您编辑和打印。JournalofMedicalSystems(2022)46:25
/s10916-022-01813-3
HEALTHPOLICY
Lessonsfrom Theranos–RestructuringBiomedicalInnovation
Rishub Karan Das1  ·Brian Christopher Drolet2
Received:21March2022/Accepted:24March2022/Publishedonline:4April2022
©TheAuthor(s),underexclusivelicencetoSpringerScience+BusinessMedia,LLC,partofSpringerNature2022
Abstract
Afterraisingmorethan$700million,ElizabethHolmes,thefounderandchiefexecutiveofcerofahealthcarestartup
oncevaluedat$10billion,wasfoundguiltyonfourchargesofdefraudinginvestors. Foundedin2003,
privatelyheldcorporationthataimedtodisruptthediagnosticsindustrywithrapid,direct-to-consumerlaboratorytesting
usingonly“adropofblood”andthecompany’,
Theranosbroughtitspaneloflaboratoryteststopatientswithoutpre-marketrevieworvalidationfrompeer-reviewed
’dubiousoperationsandinaccuratetestresultsexposedthefailedventure
tenuousrelationshipbetweenhealthcareandthepublic–theimportanceofwhichcannotbeunderstatedinthesettingof
theCOVID-,we
mustalignstakeholderincentivesbetweenindustryandacademicbiomedicalinnovationtorebuildtrustwithourpatients.
Keywords Theranos ·Diagnostics ·Biomedicalinnovation ·Venturecapital ·Funding ·Research
Afterraisingmorethan$700million,ElizabethHolmes,thebeunderstatedinthesettingoftheCOVID-
founderandchiefexecutiveofcerofahealthcarestartupmedicalsystemsaddressanationalpublichealthcrisisand
oncevaluedat$10billion,wasfoundguiltyonfourchargespervasivestructuralinequities,wemustalignstakeholder
ofdefraudinginvestors[1]. Foundedin2003,-
wasaprivatelyheldcorporationthataimedtodisruptthevationtorebuildtrustwithourpatients.
diagnosticsindustrywithrapid,direct-to-consumerlabo-JuxtaposedwithHolmes’verdict,theBidenadminis-
ratorytestingusingonly“adropofblood”andthecom-trationcommenceditsplantopurchaseanddistribute280
pany’-homeCOVID-
inregulatorypolicy,Theranosbroughtitspaneloflabora-highlightthediscordancebetweenprivateandacademicbio-
toryteststopatientswithoutpre-marketrevieworvalida-
tionfrompeer--averseacademicandregulatoryprocessestoef-
intoTheranos’dubiousoperationsandinaccuratetestresultscientlybringroutine,direct-to-consumerlaboratorytesting
,administrativeandbureaucratic
-
furtherdisruptinganalreadytenuousrelationshipbetweenencyhaveresultedinsubstantialdelaysintheapprovaland
healthcareandthepublic–theimportanceofwhichcannotdistributionofat-homeCOVID-,cumber-
someregulatorypolicyintheUnitedStateshascreatedan
oligopolyandinfatedunitpriceswhencomparedtoother
,thesesamepolicieswouldhaveprevented
TheranosfromreleasingtheirownCOVID-19testsifthe
*
RishubKaranDascompanywerestillinoperations.
rishub.******@
Healthcarestartupsarepowerfulforcesofdisruption
1VanderbiltUniversitySchoolof Medicine,Nashville,TN,giventheirabilitytoeasilypivotandactfuidlyonnew
,$-
2Departmentof PlasticSurgery,VanderbiltUniversityingwasinvestedinhealthcarecompanies–a164%increase
MedicalCenter,Nashville,TN,USA
Vol.:(0123456789)13
25Page2of3JournalofMedicalSystems(2022)46:25
fromtheyearprior[2]. Thiscapitalislargelyallocatedwithtowardinnovationthatoccursoutsideofthetraditionalaca-
,privatecorporationsshould
toevaluatethereliability,safety,andefcacyofnewmedi-communicatewitheditorsabouttheirstudiestounderstand
calinterventionsandproducts,ourpatientsandtheirtrustinhowmethodologycanbeimprovedtomeetpublication
chargesrelatedtoTheranos’longstandingnegativecon-graduatestudentsthatprovideamutuallybenefcialoppor-
sequencestopatientssetsadangerousprecedentforwhattunitytoconducthighqualityresearchthatcontributesto
.
Theranos’efectsonpatientbehaviorsandperceptionsSecond,collaborationbetweenindustryandacademic
-
-advisedmarketingholdersinbiomedicalinnovationallowsforefectiveutiliza-
campaignsandpressreleases,,
ofmedicaldiagnosestopromotetheirbusinessmodelandtheunprecedentedspeedandscaleofthedevelopmentofthe
,patientswereadvisedtotakeCOVID-19vaccinehingedonscience-industrycollabora-
controloftheirhealthandseekoutTheranos’panelofrou-,licensingitstechnologyto
tinelaboratorytestsbefore“itwastoolate.”Thecoreofresearchersusinganalogouslaboratorytestsintheirstudies
thismessageopposesevidence-basedguidelinesindiag-couldhaveexposedtheinaccuracyofthecompany’sprod-
nosticmethodology,
andredundanttestingforimprovedpost-predictiveandadministrativeburdensasacademiccentersalreadyhave
negativepredictivevalue[3]. Patientsshouldbeinvolvedprocessesinplaceforinstitutionalreviewandreporting.
intheirmedicalcare,anddirect-to-consumerdiagnosticsThird,investorduediligencemustberevitalizedinthe
,shareddecision-
withatrustedclinicianmustbeatthecoreofourhealthcareinvestedintothehealthcaresectoreveryyear,creatingthe
Theranos’equipmentprovidedinaccurateresultsfortowardpromising,well-validateddiagnosticsandinterven-
anestimatedoneoutoftentests,,cliniciansarenotroutinelyconsulted
,andmanyofthesetransactionsare
anecdotesofemotionaltraumafollowingfalsecancerdiag-madebasedonindustryrelationshipsratherthanqualityof
890,,treatmentdecisionsaninvestor’sfduciaryobligationtotheirlimitedpartners
madeusinginaccuratediagnosticsaredangerousandcan(.,pensionfunds,universityendowments)anddetrimen-
,executivesfrom
InsightsfromtheriseandfallofTheranoscanhelpmovecompaniesprovidedatatoprospectiveinvestorsregarding
ustowardasystemthatbalancesreliabilityandefciencytotheefcacyandfnancialviabilityoftheirproductsunder
--
ersinhealthcaresuchasprivatehealthcarecorporations,nally,biased,andintentionallyvaguetoencourageinvest-
investors,clinicians,payers,andpolicymakersaremoti-
,peer-reviewedresearchandpartner-
incentivesmaycurbadverseeventsafectingpatienttrustshipswithacademicmedicalcentersmustbeconsideredkey
First,evidenceandtransparencyshouldbethefoundationinvestments.
-Fundamentally,stealthresearchandtheconfictbetween
reviewprocessofersleadersinscienceandmedicinetheindustryandacademicinnovationafectpatientsandtheir
’trial
-valuedhealthcarestart-focusedonchargesrelatedtoinvestorfraud,theefectsof
upsrarelycontributetopeer-reviewedresearch[4]. WhenTheranosonthepublicaremoreinsidious,especiallyinthe
theydo,thecontributionsfromtheirstudiesaremarginalsettingoftheCOVID-19pandemicandotherrecenthigh-
-
concernsforintellectualpropertyindefenseoftheirlackduePharmaceuticalsandJohnson&
,companiesarenotrequiredtodis-aboutthevestedinterestsofourmedicalsystemsisanatural
closethespecifcmechanismsofproductsunderdevelop-defensemechanismagainsttheseheavilypublicizedfailures.
,
andreviewersmayhaveconservativeattitudesandbiasesachieveabalanceofboth,resourcesmustbeallocatedmore
13
JournalofMedicalSystems(2022)46:25Page3of325
&ExitsReport|-
togrow,policyandinstitutionalgovernancemustencour-://www.svb.com/trends-insights/reports/healthcare-
investments-and-exits.
,BornK,:
,;319(19):1975-://doi.
wehamperprogresstowardrebuildingtrustinhealthcareorg/10.1001/jama.2018.2202
,CahanEM, :Lackofpeer
‐;(January):1–
://doi.org/10.1111/eci.13072
Funding TheauthorshavenofnancialinteresttodeclareinrelationPublisher'sNote SpringerNatureremainsneutralwithregardto
.
References
..,et ://www.justice.
gov/usao-ndca/us-v-elizabeth-holmes-et-al.
13