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June5,2013EricKaler,PhDPresident,UniversityofMinnesota202MorrillHall100ChurchStreetS.E.UniversityofMinnesotaMinneapolis,MN
55455DearPresidentKaler:ThankyouforyourletterofMay29,2013.WhileIappreciatereceivingyourresponsetomyletter,thesubstanceofyourmessageisinaccurateandunconvincing.WhenaskedtoinitiateaninvestigationintothedeathofDanMarkingsonandtheclinicalstudyinwhichhewasenrolled,thestandardresponsefromseniorofficialsattheUniversityofMinnesotaistoclaimthatnoadditionalreviewisrequiredbecauseMarkingsonsdeathhasalreadybeenthoroughlyinvestigatedbytheOfficeofGeneralCounsel,UniversityofMinnesotaIRB,FDA,HennepinCountyDistrictCourt,MinnesotaBoardofMedicalPractice,andtheOfficeoftheMinnesotaAttorney
General.Yourresponseechoesseveralofthesefamiliartalkingpointseventhoughtheyhaveallbeendiscredited.Mypreviouslettertoyouprovidesabriefsummaryofwhythereneedstobeanindependent,impartialinvestigationofDanMarkingsonsdeath,theCAFstudy,andpossiblepsychiatricresearchmisconductattheUniversityofMinnesota.Here,Ilimitmyselftorebuttingtheclaimsyoumakeinyourletter.YoumentionthatthedeathofDanMarkingsonhasbeenthesubjectofproceedingsbeforetheUniversityofMinnesotasOfficeofGeneralCounsel.TheOfficeofGeneralCounselisnotanimpartialinvestigativebody.Tothecontrary,themandateoftheOfficeofGeneralCounselistozealouslyrepresenttheUniversityofMinnesota.InthelawsuitbroughtagainsttheuniversitybyDanMarkingsonsmother,MaryWeiss,theOfficeoftheGeneralCounseldefendedthe
UniversityofMinnesota.TheUniversityofMinnesotasOfficeofGeneralCounseladvocatesfor,defends,andadvancestheinterestsoftheUniversityofMinnesota.Itisnotasuitableinternalbodyforimpartiallyinvestigatingcomplaintsthatfacultymembershaveengagedinresearchmisconduct.MarkRotenberg,theuniversitysformerGeneralCounsel,shouldneverhavebeenallowedtoserveastheUniversityslegalcounsel,in-houseinvestigator,anddefactopublicspokespersondeployedtorebuffcallsforanindependentinquiryintoDanMarkingsonsdeath.TheUniversityofMinnesotamuststopmisusingtheOfficeofGeneralCounselinthismanner.
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ItistruethatDanMarkingsonscasewasthesubjectoflegalproceedingsbeforetheHennepinCountryDistrictCourt.WhatyourletterfailstoacknowledgeisthatinthiswrongfuldeathlawsuittheUniversityofMinnesotawonsummaryjudgmentonthebasisthatitisstatutorilyimmunefromliability.Asyoumustknow,tobedeemedstatutorilyimmunefromliabilityisnotavindicationofconduct.Onthecontrary,itsimplymeansthattheUniversityofMinnesotadidnot
havetodefenditselfagainstthelawsuitbroughtbyMs.Weiss.SuchanoutcomeshouldneverbeportrayedasanexonerationoftheUniversityofMinnesota.TheMinnesotaBoardofMedicalPracticerespondedtocomplaintsaboutDr.StephenOlsonandDr.CharlesSchulz.Unfortunately,yourletteromitsseveralkeypoints.Themedicallicensingboarddoesnotinvestigateuniversitiesandinstitutionalreviewboards.ThereisthereforenomeaningfulbasisforsuggestingthattheMinnesotaBoardofMedicalPracticeinvestigatedtheUniversityofMinnesota.TheMinnesotaBoardofMedicalPracticeissuedformlettersstatingthatthefactsofthecasedidnotprovideasufficientbasisfortheBoardtotakedisciplinaryorcorrectiveactioninresponsetothefiledcomplaints.However,thereisnopublicrecordoftheBoardsdeliberations,thescopeofitsinvestigationandtheissuesitaddressed,theevidenceit
gathered,andthereasoningthatinformeditsconclusions.WhatisamatterofpublicrecordisthattheMinnesotaBoardofMedicalPracticedoesnotinvestigateuniversities,institutionalreviewboards,andinstitutionalresearchgovernancestructures.WithregardtotheFDA,theEstablishmentInspectionReportissuedbytheFDAfailedtoacknowledgethenumerousreportsdocumentingthatDanMarkingsonwaspsychoticandlackedthecapacitytomakehisownmedicaldecisions.AsmyMay13lettertoyounotes,onatleastthreeoccasionsshortlybeforeMarkingsonwasenrolledintheCAFstudyhewasjudgedtolackdecision-makingcapacity.Inaddition,thepersonwhoenrolledhiminthestudywasunqualifiedtoassessdecision-makingcapacityofprospectiveresearchparticipants,underconsiderablepressuretorecruitstudyparticipants,and,astheclinicaltrialcoordinatorforthetrial,hada
seriousconflict-of-interest.AnindependentinvestigationofDanMarkingsonsdeathandthestudyinwhichhewasenrolledmustexaminehowandwhyMarkingsonwasconsentedintoaclinicalstudywhenhewasdiagnosedaspsychotic,lackedinsightintohisdiseaseandmentalstate,andwasdeemedunabletomakeinformeddecisionsaboutadministrationofantipsychoticdrugs.TheFDAInspectionReportfailstoaddressthepapertraildocumentingthevariousoccasionsMarkingsonwasdeemedmentallyincompetenttomakehisownmedicaldecisions.TheFDAInspectionReportalsofailstonotethatMarkingsonwasenrolledintheCAFstudydespitehismothersrepeatedobjections.ItispossiblethatthissignificantflawintheFDAsinspectionreportisconnectedtotheFDAinvestigatorsfailuretointerviewDanMarkingsonsmother,MaryWeiss,andensurethathervoicewastakenintoconsideration.
Imustdrawtoyourattentiontwoimportantomissionsinyourletter.First,in2009,theMinnesotaStateLegislaturepassedalawthatrestrictsindividualsundercivilcommitmentordersfrombeingenrolledinpsychiatricdrugstudies.Thisstatute,asImsureyouknow,iscommonlyreferredtoasDansLaw.IencourageyoutoreflectuponwhyitwasnecessaryfortheMinnesotaStateLegislaturetopassthislaw.
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Second,yourletterfailstomentiontheCorrectiveActionthattheMinnesotaBoardofSocialWorkissuedtothestudycoordinatorfortheCAFtrial.Accordingtothisdocument,JeanneKenney,thetrialcoordinator,regularlycompletedforms,gatheredinformation,andperformedtasksthatwerebeyondLicenseescompetenceandscopeofpracticeasaclinicalsocialworker.Kenneyalsomadenumerousdocumentationerrors,dispensedprescriptiondrugswithoutauthorization
andinviolationofUniversityofMinnesotapolicy,initialeddocumentswithadoctorsinitials,failedtorespondtofamilyconcernsinatimelyandeffectivemanner,failedtodocumentkeyinformationrelatedtomedicalinterventionsandtreatmentplans,prepareddocumentationthatconsistentlyfellbelowtheminimumstandardsofpracticeforaclinicalsocialworker,failedtodevelopaclearlyarticulated,consistentsetoftreatmentgoals,failedtodocumentinatimelymanneralarmingvoicemailmessagesfromfamilymembers,andeffectivelyinvalidatedDanMarkingsonsoriginalinformedconsentbyfailingtodisclosetohimnewinformationconcerningriskofhyperglycemiaanddiabetes.Ofparticularsignificance,theBoardofSocialWorkfoundthattherewerecriticalomissionsinLicenseesdocumentationthatwererelevanttosuicidepreventionandchemicaldependencytreatment.GiventhefindingsoftheMinnesotaBoardofSocialWork,itisnoteworthythatyouandothersenioradministratorsattheUniversityof
MinnesotafailtomentionthisdocumentwhenyoulistpriorinvestigationsofDanMarkingsonsdeath.TheCorrectiveActionissuedtoJeanneKenneyrevealstheneedforaninvestigationthatexaminesalllayersofoversightandincludesanalysisofthefacultymembersresponsibleforsupervisingtheclinicaltrialcoordinatorandconductingthestudy.ThereisanurgentneedforanindependentandimpartialinvestigationofDanMarkingsonsdeath,thestudyinwhichhewasenrolled,andpossiblepsychiatricresearchmisconductattheUniversityofMinnesota.CarlElliott,mycolleaguehereattheCenterforBioethics,makesanexhaustivecaseforsuchaninvestigation.SeniorofficialsattheUniversityofMinnesotaclaimthatMarkingsonsdeathwasfullyreviewed.However,anindependent,thoroughinvestigationhasnotoccurred.Ithereforeaskyoutoreconsideryourdecision,signthepetitioninitiatedbyMary
WeissandMikeHoward,andwritetoGovernorDaytonandrequestanindependentinvestigationofpossiblepsychiatricresearchmisconductattheUniversityofMinnesota.Whateveryoudecide,IwantmycorrespondencewithyoutodocumentthatinthestrongestpossibletermsIurgedyoutosupportsuchaninvestigation.Yourssincerely,LeighTurner,PhD
AssociateProfessorUniversityofMinnesotaCenterforBioethicsN520Boynton,410ChurchStreetSEMinneapolis,Minnesota,55455Phone:612.626.4830Email:[email protected]
