Everything You Need to Know About Conflicts of Interest

First, we need to understand what is really meant by “conflict of interest” and how it can differ from accusations of outright fraud. “Conflict ... Skiptomaincontent SaraGorman,Ph.D.,MPH,andJackM.Gorman,MD DenyingtotheGrave EverythingYouNeedtoKnowAboutConflictsofInterest Istransparencytheonlysolution? PostedJanuary11,2017 Share Tweet Email Note:Thisisthefirstinstallmentofa3-partblogpostonconflictsofinterestandbiasinmedicineandscience.Thisentryismostlyaboutfinancialconflictsofinterest.Thesecondentryisaboutotherkindsofhiddenbiasesthatplaguescientistsanddoctors,andthethirdwilloffersuggestionsaboutwhatconsumersandscientistscandotocombattheseproblems. Source:Pixabay InSeptemberof2016,ashockingexposeinTheNewYorkTimesrevealedthateverythingwethoughtweknewaboutsugar,fat,andheartdiseasewaswrong.Andnotonlywasitwrong,buttheinformationwehadbeenusingtoguideourdecisionsaboutwhattoeatandwhattofeedourkidshadbeenmanipulatedinwhatcanonlybedescribedasaconspiracybetweenscientistsandthesugarindustry. Needlesstosay,peoplewereoutraged.AsonereaderofTheNewYorkTimesarticlecommented,“ThiswasaconspiracyofscientificFRAUD.Thesugarcompaniesthatdidthisshouldbesuedfor$BILLIONSforthehealthharmthattheycaused.”Itwasn’tlongbeforecomparisonstothetobaccoindustrystarted:“Sugaristhenewtobaccoandhasbeenforawhile.Thearticleisjustthetipoftheiceberg,”commentedanotherNYTreader. Andthen,inthemidstofelectionseason,cametheconspiracytheories:“FYI..HillaryverywellfundedbyBigSugarsoyoucanbetnothingwillhappenasaresultofthesefindings.WithHillaryintheWhiteHouse,we'llallbeeatingcakeanyway-It'sawinwinforeveryone!” Thisnewswasdefinitelyunsettling.Inanageofincreasingtransparencyandavailabilityofinformation,itistroublingtothinkthatwemightstillbemakingimportantdecisionsaboutournutritionbasedonevidencederivingfromseriousconflictsofinterest.AndwhiletheHarvardpaperreferencedinthisNewYorkTimesstudydidappearbeforemodernrulesaboutdisclosureofconflictofinterestinscientificresearch,anotherstudypublishedjustthisyearquestioningthevalidityofthenewWHOsugarguidelineswasalsofoundtobeheavilyfundedbythesugarindustry,andthescientistsinvolvedwerelessthancompletelyforthcomingabouthowthisfundingmayhaveaffectedtheirviewpoint. Inthewakeofthesugardebacle,it’sbecomeclearthatweneedtotakeastepbackandre-examineourcurrentsystemofhandlingconflictofinterestinscienceandmedicine.Isitworking?Well,wehaveachievedmuchgreaterlevelsoftransparencyaroundindustryfundingofscienceandmedicine.Buttransparencyonitsowndoesnotseemtobeenough. IthasbecomeincreasinglyclearoverthepastfewdecadessincetheHarvardsugarstudythatscientistsanddoctorsarepronetobiasesbasedonfinancialincentivesandindustrysponsorship.Thosedataseemrelativelyclearanddonotneedtoberehearsedhere.Thestandardresponsetothisproblemhasbeensimplytoincludedisclosurestatementsattheendofscientificpapers. Butdoesreadingthewords:“ThisstudyhasbeenfundedinpartbyKraftFoods”actuallyhelpjournaleditors,reviewers,sciencejournalists,andthegeneralreaderunderstandwhetherandhowthestudymightbebiased? Theansweris...Probablynot. Becauseonitsown,transparencydoesn’thelpusverymuch.Inreality,outrightfraudlikewesawinthesugarstudyisthankfullyquiteuncommon,butbiasesthatsubtlyaffectscientificstudiesarequitecommon.Ofcourse,thesetypesofsubtleinfluenceandbiasaremuchmoredifficulttodetect,especiallyforanaverageconsumerofscientificstudiesandnews.Nottomentionthatthesedisclosuresfocussolelyonfinancialconflictsofinterests,leavingtheconsumernoopportunitytounderstandwhatkindsofpowerfulnon-financialbiasesmaybeaffectingthestudyresults. Sowedesperatelyneedtheanswerstotwointerrelatedquestions: 1.Howshouldpotentialbiasesbecommunicatedtothegeneralpublicinawaythatmaximizesconsumerawarenessbutminimizesopportunitiesforextremesuspicionthatcanultimatelyleadtosciencedenial? 2.Howdoweaccountfornon-financialconflictsofinterestinscienceandmedicine? Whatisconflictofinterest? First,weneedtounderstandwhatisreallymeantby“conflictofinterest”andhowitcandifferfromaccusationsofoutrightfraud.“Conflictofinterest”hastodowithaperson’sinvolvementwithanentitythatcouldcorrupthisorherdecision-makingorjudgmentabouttheissueathand. Goingbacktothesugarexample,iftheHarvardauthorshadsimplybeenfundedtoundertakeastudyevaluatingtherelationshipbetweensugarandheartdiseasebythesugarindustrybuttherewasnoproofofanyfurtherinvolvementbytheindustryinthestudyitself,thenwecouldsaythataconflictofinterestmightbepresent. Aconflictofinterestisbynaturespeculative.Whenauthorsdeclare“competinginterests”toamedicaljournal,theyarenotadmittingsomeformofguilt.Theyaresimplydisclosingthefactthatotherinterestscouldhaveinfluencedtheirstudy. Inthehealthcarefield,these“otherinterests”areverybroad.Theyrefertoliterallyanythingotherthananinterestinimprovingthehealthofthepublicthrough“pure”scientificfindings. Theoretically,wecouldimagineascenarioinwhichaprincipalinvestigator’sstudyofanewcancerdrugisbiasedbythefactthathismotherhascancerandheisdesperatetofindanewmedicationthatmightincreasesurvivaltime.Ofcourse,thisisnotthekindof“conflict”thatscientistsareaskedtoreporttoscientificandmedicaljournals.Insteadthefocushasbeenontransparentreportingofmonetarytiesthatcouldtheoreticallyresultinbiasedstudyresults. Aretransparencyanddisclosuretheonlyanswerstoconflictofinterestinmedicineandscience? Onanintuitivelevel,thismakesgreatsenseandofcoursetransparencyisalwaysagoodthing.Butwhensomethinglikethesugar“conspiracy”isuncovered,itbecomesimmediatelyclearthatmostpeopleareutterlyconfusedaboutwhatindustrysponsorshipofscientificresearchreallymeans,whatthetruethreatstounbiasedscienceare,andbasicallyhowtointerpretinformationaboutpotential“conflictsofinterest”whenevaluatingscientificevidence. WhenNYTbrokethestoryaboutsugarinSeptember,anoutpouringfromthegeneralpublicrevealedthat,infact,thedifferencebetween“conflictofinterest”and“fraud”issometimesconfused.Itwasasthoughpeoplewereassumingthateverycaseofindustrysponsorshipmustbeexactlylikethesugarexample-thatindustrysponsorshipinandofitselfwillalwaysresultinoutrightfraud. ThefactthatthesugarindustrysponsoredtheHarvardstudyinandofitselfmayormaynothavebeentheproblem.Whatreallyindictedtheindustryandthescientistsinthatcasewasthecorrespondencethatrevealedthatsugarexecutiveshadblatantlyaskedthescientiststomanipulatetheirdatainfavorofaconclusionthecompanyfavored. Thisisobviouslyanextremeexampleandonethatisthankfullyuncommon.Moreoftenwearefacedwithsituationsinwhichindustrysponsorshipofscienceispresentandthatsponsorshiphasthecapacitytosubtlyinfluencetheopinionsandbehaviorsofscientistsandhealthcareprofessionals. Source:Pixabay Whatdoweknowabouthowmoneyinfluencesscientistsanddoctors?Inotherwords,canmoneyorgiftsfromacertainindustryreallybiasscientistsanddoctorsthatmuch,evenintheabsenceofdirectrequeststhatstudiesfundedbyindustryshowfavorableresults,aswesawwiththesugarexample? Theanswertothisquestionisyes.Therearealreadyplentyofstudiesshowingthatmoneyfromindustry—evenrelativelysmallamounts—influencesscientificconclusionsandphysicianprescribing.Thisrealizationhasledtoevermorestringentreportinganddisclosurepoliciesinscienceandmedicine. Isindustrymoneytheonlythingthatcanbiasscientistsanddoctors? Inthepast30yearsorso,we’veseennotonlymanylawsarounddisclosurebutalsoapleaformorepublicsectorfundingforscientificresearchtoavoidtheundueinfluenceindustryinterestsmayhaveonscienceandmedicine. Butdothesesolutionsreallysolvetheproblem?Theyareastepintherightdirection.Buttheyarenotthecompleteanswertothisproblem.Why?Because“influence”isactuallyaquitecomplexandnuancedphenomenon. Interestingly,oneofthemainrespondentstoanothersugardebaclethisyearisDeanSchillinger,whowroteaneditorialcriticizingthemethodologyusedinanindustry-sponsoredreviewarticleaboutthenewWHOsugarguidelinesinAnnalsofInternalMedicine.Inhisresponsetothatreviewarticle,heactuallydisclosedthathewasapaidexpertwitnessforthecityofSanFranciscoinalawsuitbroughtbythebeverageindustrythepreviousyearwhenthecitymandatedwarninglabelsonsoftdrinks.Governmentfundingofscientificresearchmightbeslightlybetterthanindustrysponsorship,butweshouldnotbelieveforaminutethatthisapproachcompletelyeliminatesbias. Andinfact,therearemanysourcesofpotentialbiasthatdonotgetdisclosedundercurrenttransparencypoliciesforscienceandmedicine.Forexample,whatifaprominentdoctorwritesapopularbookabouttheimportanceofearlyandfrequentscreeningforcancer?Whatifthatdoctorisknownforherpositionthatannualmammogramsareessential?Whenthatsamedoctorpublishesapapershowingthatannualmammogramsresultinreducedratesofmetastaticbreastcancer,isn’titpossiblethataverysignificantbiasmayhavecreptinhere?Indeed,thatbiascouldevenbeviewedasfinancial,sinceperhapsthosepositivefindingscouldtranslateintoincreasedbooksalesforthedoctor.Butthiskindofbiaswouldnotneedtobedisclosedinthepaper. Or,totakeanotherexample,whatifapsychiatristhasabigprivatepracticebasedonacertaintypeoftreatment,saycognitive-behavioraltherapy(CBT)?Couldthatbeapotentialsourceofconflictofinterestinthatdoctor’snewstudyonthesuperiorityofCBTcomparedtodrugtherapy?Shouldsomeonewhodoesalotofbacksurgeriesbeallowedtowriteapaperinwhichbacksurgeryiscomparedtophysicaltherapy?Thesebiasesareinfactallultimatelytiedtofinancialgain,buttheydon’tgetdisclosedinpapers.Andthisisnottomentionawholerangeofotherkindsofbiasesthatareentirelynon-financialinnaturebutpotentiallyveryinfluential. Sowhatcanwedotobetterunderstandallthepotentialdriversofconflictsofinterestsandbiasesinmedicineandscience?Howcanhealthcareprofessionalsandscientistsalikebettermonitortheirownbiases?Andhowcaninformedconsumersdeterminewhetherandhowconflictsofinterestandbiasesmightbeplayingaroleinthesciencetheyconsumeandthemedicalcaretheyreceive? Thesearenoteasyquestionstoanswer,butwewilltrytotakethemonnextmonthinPartIIofthisseriesonconflictsofinterestinscienceandmedicine.Staytuned.Inthemeantime,ifyouwantmoreinformation,werecommendfollowingtwoexcellentsitesdevotedtoissuesaroundtransparency,fraud,andsciencegonewrongingeneral,RetractionWatchandBadScience. References http://www.nytimes.com/2016/12/19/well/eat/a-food-industry-study-tries-… http://www.nytimes.com/2016/09/13/well/eat/how-the-sugar-industry-shift… http://jama.jamanetwork.com/article.aspx?articleid=202867 http://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2… http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0… http://www.nytimes.com/2016/12/19/well/eat/a-food-industry-study-tries-… More references Share Tweet Email advertisement AbouttheAuthor SaraGorman,PhD,MPH, isapublichealthspecialist,and JackM.Gorman,MD, isapsychiatrist. 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