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Turner June 5 2013 Letter to President Kaler

Turner June 5 2013 Letter to President Kaler

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Published by MarkingsonCase
Letter from Leigh Turner to President Eric Kaler June 5 2013
Letter from Leigh Turner to President Eric Kaler June 5 2013

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Published by: MarkingsonCase on Jun 05, 2013
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06/05/2013

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June5,2013EricKaler,PhDPresident,UniversityofMinnesota202MorrillHall100ChurchStreetS.E.UniversityofMinnesotaMinneapolis,MN55455DearPresidentKaler:ThankyouforyourletterofMay29,2013.WhileIappreciatereceivingyourresponsetomyletter,thesubstanceofyourmessageisinaccurateandunconvincing.WhenaskedtoinitiateaninvestigationintothedeathofDanMarkingsonandtheclinicalstudyinwhichhewasenrolled,thestandardresponsefromseniorofficialsattheUniversityofMinnesotaistoclaimthatnoadditionalreviewisrequiredbecauseMarkingson’sdeathhasalreadybeenthoroughlyinvestigatedbytheOfficeofGeneralCounsel,UniversityofMinnesotaIRB,FDA,HennepinCountyDistrictCourt,MinnesotaBoardofMedicalPractice,andtheOfficeoftheMinnesotaAttorneyGeneral.Yourresponseechoesseveralofthesefamiliartalkingpointseventhoughtheyhaveallbeendiscredited.Mypreviouslettertoyouprovidesabriefsummaryofwhythereneedstobeanindependent,impartialinvestigationofDanMarkingson’sdeath,theCAFÉstudy,andpossiblepsychiatricresearchmisconductattheUniversityofMinnesota.Here,Ilimitmyselftorebuttingtheclaimsyoumakeinyourletter.YoumentionthatthedeathofDanMarkingsonhas“beenthesubjectofproceedings”beforetheUniversityofMinnesota’sOfficeofGeneralCounsel.TheOfficeofGeneralCounselisnotanimpartialinvestigativebody.Tothecontrary,themandateoftheOfficeofGeneralCounselisto“zealouslyrepresent”theUniversityofMinnesota.InthelawsuitbroughtagainsttheuniversitybyDanMarkingson’smother,MaryWeiss,theOfficeoftheGeneralCounseldefendedtheUniversityofMinnesota.TheUniversityofMinnesota’sOfficeofGeneralCounseladvocatesfor,defends,andadvancestheinterestsoftheUniversityofMinnesota.Itisnotasuitableinternalbodyforimpartiallyinvestigatingcomplaintsthatfacultymembershaveengagedinresearchmisconduct.MarkRotenberg,theuniversity’sformerGeneralCounsel,shouldneverhavebeenallowedtoserveastheUniversity’slegalcounsel,in-house“investigator”,anddefactopublicspokespersondeployedtorebuffcallsforanindependentinquiryintoDanMarkingson’sdeath.TheUniversityofMinnesotamuststopmisusingtheOfficeofGeneralCounselinthismanner.
 
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ItistruethatDanMarkingson’scasewasthesubjectoflegalproceedingsbeforetheHennepinCountryDistrictCourt.WhatyourletterfailstoacknowledgeisthatinthiswrongfuldeathlawsuittheUniversityofMinnesotawonsummaryjudgmentonthebasisthatitisstatutorilyimmunefromliability.Asyoumustknow,tobedeemedstatutorilyimmunefromliabilityisnotavindicationofconduct.Onthecontrary,itsimplymeansthattheUniversityofMinnesotadidnothavetodefenditselfagainstthelawsuitbroughtbyMs.Weiss.SuchanoutcomeshouldneverbeportrayedasanexonerationoftheUniversityofMinnesota.TheMinnesotaBoardofMedicalPracticerespondedtocomplaintsaboutDr.StephenOlsonandDr.CharlesSchulz.Unfortunately,yourletteromitsseveralkeypoints.Themedicallicensingboarddoesnotinvestigateuniversitiesandinstitutionalreviewboards.ThereisthereforenomeaningfulbasisforsuggestingthattheMinnesotaBoardofMedicalPracticeinvestigatedtheUniversityofMinnesota.TheMinnesotaBoardofMedicalPracticeissuedformlettersstatingthat“thefactsofthecasedidnotprovideasufficientbasisfortheBoardtotakedisciplinaryorcorrectiveaction”inresponsetothefiledcomplaints.However,thereisnopublicrecordoftheBoard’sdeliberations,thescopeofitsinvestigationandtheissuesitaddressed,theevidenceitgathered,andthereasoningthatinformeditsconclusions.WhatisamatterofpublicrecordisthattheMinnesotaBoardofMedicalPracticedoesnotinvestigateuniversities,institutionalreviewboards,andinstitutionalresearchgovernancestructures.WithregardtotheFDA,theEstablishmentInspectionReportissuedbytheFDAfailedtoacknowledgethenumerousreportsdocumentingthatDanMarkingsonwaspsychoticandlackedthecapacitytomakehisownmedicaldecisions.AsmyMay13lettertoyounotes,onatleastthreeoccasionsshortlybeforeMarkingsonwasenrolledintheCAFÉstudyhewasjudgedtolackdecision-makingcapacity.Inaddition,thepersonwhoenrolledhiminthestudywasunqualifiedtoassessdecision-makingcapacityofprospectiveresearchparticipants,underconsiderablepressuretorecruitstudyparticipants,and,astheclinicaltrialcoordinatorforthetrial,hadaseriousconflict-of-interest.AnindependentinvestigationofDanMarkingson’sdeathandthestudyinwhichhewasenrolledmustexaminehowandwhyMarkingsonwas“consented”intoaclinicalstudywhenhewasdiagnosedaspsychotic,lackedinsightintohisdiseaseandmentalstate,andwasdeemedunabletomakeinformeddecisionsaboutadministrationofantipsychoticdrugs.TheFDAInspectionReportfailstoaddressthepapertraildocumentingthevariousoccasionsMarkingsonwasdeemedmentallyincompetenttomakehisownmedicaldecisions.TheFDAInspectionReportalsofailstonotethatMarkingsonwasenrolledintheCAFÉstudydespitehismother’srepeatedobjections.ItispossiblethatthissignificantflawintheFDA’sinspectionreportisconnectedtotheFDAinvestigator’sfailuretointerviewDanMarkingson’smother,MaryWeiss,andensurethathervoicewastakenintoconsideration.Imustdrawtoyourattentiontwoimportantomissionsinyourletter.First,in2009,theMinnesotaStateLegislaturepassedalawthatrestrictsindividualsundercivilcommitmentordersfrombeingenrolledinpsychiatricdrugstudies.Thisstatute,asI’msureyouknow,iscommonlyreferredtoas“Dan’sLaw.”IencourageyoutoreflectuponwhyitwasnecessaryfortheMinnesotaStateLegislaturetopassthislaw.

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