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FactCheckFindsSeriousFlawsinADAReportConcerningSedationDentistry

TheAmericanDentalAssociationanditsCouncilonDentalEducationandLicensureissuedareport–“FrequentlyAskedQuestions–Resolution37”–designedtoinformADAmembersanddelegatesofthefactspertainingtoResolution37,aproposedrevisiontotheADA’sSedationandAnesthesiaGuidelines.WhatfollowsisasummaryofCDEL’sFAQandaFactCheckpreparedbyagroupofscientists,academics,anddentists–allADAmembers–whoareindependentofCDEL.Q.1.WhatwastheCouncil’sresponsetothedirectivesofthe2015HouseofDelegates?

CDEL’sCLAIMS:

• TheCouncilreliedonadetailedreport,titled“ReportontheRisksandBenefitsofUsingCapnographyinDentalPatientsUndergoingModerateSedation,”preparedatitsrequestbytheADA’sCouncilonScientificAffairs(CSA).

• TheCouncil“alsoconsideredcommentsreceived…”

THEFACTS:

The2015ADAHouseofDelegatesadoptedResolution77H,whichcalledonCDELtowork“incollaboration”withCSAtoconsiderthreeissuesembodiedinwhatisnowcalledResolution37.

1. AllowingdentiststohaveachoiceofoptionswhenitcomestomonitoringendtidalCO2formoderatesedation,“suchas:continuoususeofaprecordialorpretrachealstethoscope,continuousmonitoringofendtidalcarbondioxide,andcontinualverbalcommunicationwiththepatient.”

2. Therecommendedhoursandcontentofmoderatesedationcourses,includinga“possibleoptionofseparatecourserequirementsforenteralandparenteralroutesofsedation.”

3. TherationaleandguidelinesfortheuseofBodyMassIndexinconductingpatientevaluations,andthetimingofmedicalhistoryreview.

CONCLUSION:ThereissubstantialevidencethatCDELandCSAdidnotfulfillthe2015HouseofDelegatesmandate

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EVIDENCE:

• InitsFAQ,CDELpresentssummarizedevidencefromCSA’s“ReportontheRisksandBenefitsofUsingCapnographyinDentalPatientsUndergoingModerateSedation.”CDEL’spresentationincludeswhatitdescribesasthekeysummarystatement:“theevidencedemonstratesthatcapnographyinconjunctionwithstandardmonitoringimprovedsensitivityofdetectingadverserespiratoryeventsandreducestheriskofhypoxemiaduringmoderatesedationcomparedwithstandardmonitoringalone.”

CDELdoesnotrespondtothe2015HODresolutioncallingforCDELtoweighoptionsfordentistsotherthancapnography,suchasaprecordialorpretrachealstethoscope,whichmaybeequallyassafeandeffectiveascapnography,andpreferredbymanydentistsfortheireaseofoperationandcostsavings.

• EventhetitleoftheCSAreport,“RisksandBenefitsofUsingCapnography…”makesitabundantlyclearthattherisksandbenefitsofsuggestedalternativestocapnographywerenotreportedand,perhaps,notconsideredasmandatedbythe2015HOD.

• Whilethe2015HODmandatedthatCDELconsultwithCSAonthequestionofhowmanyhoursoftrainingformoderatesedationshouldberequired,andwhatthecontentofsuchtrainingshouldconsistof,neitherCDELnorCSAindicatethatanysuchcollaborationtookplace.Likewise,CSA’sownreportstotheADAofitsactivitiesincludesnomentionthatitwasconsultedandprovidedanopinionastothepossibleoptionofseparatecourserequirementsforenteralandparenteralroutesofsedation.

• DiscussingResolution37’sprovisionsforconsistentpatientevaluation

provisionsandtherationaleandguidelinesfortheuseofBodyMassIndex,CDEL’smakeszeromentionofconsultingwithCSAonthematter.Indeed,CDELcitesonlyitself,itsbeliefs,anditsinternaldiscussions–ignoringthe2015HODmandatethatitcollaboratewithCSA.Onceagain,inCSA’sownreportstotheADAofitsactivitiesprovidesnomentionthatitwasconsultedandprovidedanopiniononthisissue.

• AspartofthepubliccommentssubmittedtotheADApertainingtoResolution37,PamelaPorembskiD.D.S.,whoisthedirectoroftheADA’sCouncilonDentalPracticeinthePracticeInstitutesubmittedcomments

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onbehalfofamemberoftheCouncilonDentalPracticeonJuly7,2016:“Inmyopinion,andtheopinionofotherdelegates,thisadoptedresolution[HODResolution77H–2015]callsforevidencethatCSAhasstudiedtheavailablescience,literatureanddocumentationofallthreebulletpointsandhasmadeappropriateandscientificdeliberationtoCDELfortheirdeliberation…

“Giventheavailableevidence,thethreedocumentssubmittedtousfromCDEL,onecanonlyconcludethatCDELhasnotfulfilleditsmandateassetforthbythe2015HouseofDelegates.”

• InitsownFAQ,CDELacknowledgesinresponsetoQuestion#8:“…not

onecontrolledclinicalstudyhaseverbeenperformedtodemonstratetheoptimaltrainingtimefordentistswhoprovidemoderatesedation.”

• TheADA’spublishedpolicyonEvidence-BasedDentistry(EBD)isunambiguous:Evidence-based dentistry is an approach to oral health care that requires the judicious integration of systematic assessments of clinically relevant scientific evidence, relating to the patient's oral and medical condition and history, with the dentist's clinical expertise and the patient's treatment needs and preferences. ADAResolution37lacksbothevidence-basedsciencetosupportitsproposedrevisions,aswellastheclinicalexpertiseofdentists.ThevastmajorityofdentistsonbothADACouncils,CDELandCSA,donotusemoderatesedationtotreattheirpatientsandthushavelittleifanydirectexperiencewiththemethod.

Q.2.Whydoestheproposedguidelinenotoutlinetrainingbyrouteofadministration?

CDEL’sCLAIMS:

• TheCouncilcarefullystudiedthismatterandmaintainsthat“moderatelysedatedpatientsviaeitherrouterequirethesameattentivenessandmonitoring;thereshouldbenodifferenceinthetrainingrequirementsrelatedtoroutesofadministration.”

• AreviewofCEcourseswasconducted:atleast11providerscurrentlymeetorexceed60hoursofinstructionand20patientexperiences.

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THEFACTS:

• TheADAhaspledgedtosetitspracticeandeducationalguidelinesbasedonevidenceandscience.

“Thepracticeofevidence-basedmedicinemeansintegratingindividualclinicalexpertisewiththebestavailableexternalclinicalevidencefromsystematicresearch,”theADAstatesinitspublishedpolicystatement.Carefulstudyofthematter–whichCDELassertsasitsjustificationforconcludingthat“thereshouldbenodifferenceinthetrainingrequirementsrelatedtoroutesofadministration”–fallsfarshortofconstitutingevidence-basedsubstantiation.(NotethatthevastmajorityofCDELmembersdonotprovidemoderateenteralsedationtotheirpatients.)Dentalresearchersandscientistswhohavepublishedonthetopicof“routeofsedation”haveconsistentlyconcludedtheexactoppositeofCDEL’scontention:Therearescientificallydemonstratedcrucialdifferencesintheresponseofpatients,andthusthesafetyprecautionsandnecessarytraining,whendentistsuseenteralversusparenteralroutesofsedation.See:http://GetTheScience.comtoreviewjustsomeofthepublished,peer-reviewedarticlesonthistopic.CDELdoesnotprovidecitationsandreferencestopublished,peer-reviewedstudiesthatsupportitscontentionandconclusions.

• Resolution37effectivelyblursthelinesbetweenminimalsedationascurrentlydefined,andmoderatesedation.Asaresult,evendentistswhoconfinetheirpracticestoprovidingminimalsedationmayberequired–inordertofullycomplywiththeguidelinesproposedinResolution37–toundergo60hoursofIVsedationtraining.

• WedonotknowwhatmethodCDELusedtoassertthat“atleast11providerscurrentlymeetorexceed60hoursofinstructionand20patientexperiences.”[Threeofthe11CEcourseproviderslistedbyCDELdonotlistIVsedationcourses:UniversityofAlabamaatBirmingham,AugustaUniversity,andDOCSEducation.]

CDEL’sassertionseemsillogicalonitsfacesincecurrentADAguidelinespertainingtotrainingformoderateenteralsedationcallforonly24didactic

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hoursand3patientexperiences(alongwithtenclinicalexperiences,ofwhichsevencanbevideos.)

CDELseemstobereferringtoexistingeducationalprogramsaimedexclusivelyatlicensingrequirementsfordentistswhowillprimarilyprovideparenteralsedation.Therearefewerthan150seatsperyearavailablenationwidetodentistswhoseektoacquiresuchparenteralsedationtraining.Therearenoknowncoursesofferedbyanycredibleeducationalinstitution,for-profitornonprofit,thatprovide60hoursofdidactictrainingand20livecasestothosedentistswishingonlytobecertifiedtoprovidemoderateenteralsedation.ShouldResolution37beapprovedbythe2016ADAHOD,the8(verified)parenteralCEcoursesthatCDELcites–basedoncurrentenrollmentcapacity–wouldrequireapproximately200yearstocertifythemorethan30,000dentistswhocurrentlyadministerenteralmoderatesedation,andtheirsuccessors.

[ForMore,SeeQuestion#7andtherelatedFACTCHECK.]

CONCLUSION:TherecommendationsofCDELdonotcomportwiththeADA’sPolicyonEvidence-BasedDentistry,lackingpeer-reviewed,science-backedsubstantiation,orclearclinicalevidence.ShouldCDEL’srecommendationsbeadoptedbytheADA2016HOD,therewillnotbenearlyenoughcoursestomeetthedemandofdentistswhowillneedtobecertifiedascompetenttoadministermoderateenteralsedation.

Q.3.Whyistheconcomitantadministrationoftwodifferentoralmedicationsconsideredmoderatesedation?

CDEL’sCLAIMS:

• TheCouncilstatesthatpotentiationcreatesaneteffectthatisgreaterthantheMRDofeachdrugalone.Itcitesthe2012ADAGuidelinesforTeachingPainControlandSedationtoDentistsandDentalStudents,whichstatethatgivingenteraldrugsabovetheMRDisconsideredmoderatesedation.“Therefore,exceedingtheMRDisalreadyconsideredtobemoderatesedation.”CDELsaysitcouldfindonlythreepublishedpapersrelatedtopotentiationand

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oralsedation:from1986,2007,and2009.Twoofthethreepaper’sofferindirectsupportforitsposition.

THEFACTS:

• CDELagainfailstoadheretotheADA’sownpolicyonevidence-baseddentistry,whichclearlystatesthatintheabsenceofsufficient“clinicallyrelevantscientificevidence,”itmustrelyon“thedentist’sclinicalexperienceandthepatient’streatmentneedsandpreferences.”The1986,2007,and2009studiesareinsufficienttojustifytheproposedchangesembodiedinResolution37,whichCDELtacitlyacknowledges.YetCDELentirelyignorestheextensiveclinicalevidencethatspeakstothedemonstratedsafetyandefficacyofusingpotentiationincompliancewithexistingADAguidelines,meetingtheneedsandpreferencesofliterallymillionsofdentalpatients.ShouldResolution37beapprovedbythe2016HOD,theimpactonroutinedentalprocedureswouldbeunquantifiable.Beforeadentistcouldadministerapatienttwodrugsofanytypeandpotency,thedentistwouldhavetoreceivetheequivalentofanIVsedationpermit:i.e.aminimumof60hoursofinstructionandatleast20individually-managedpatients.CONCLUSION:AdoptingResolution37anditsrestrictionsontheadministrationoftwodifferentoralmedicationswithoutextensiveadditionaltraining,violatestheADA’spolicytoactinaccordancewiththe“patient’streatmentneedsandpreferences.”Thescientificjustificationformakingitmuchharderfordentiststousepotentiation–currentlyawidespreadpractice–isskimpyatbest.

Q.4.Howdothe2016proposedGuidelinesdifferfromtheversionconsideredbythe2015ADAHouseofDelegates?

CDEL’sCLAIMS:

• TheCouncilstatesthat2015’sResolution77and2016’sResolution36arevirtuallyidentical.Themainexceptionisthatthe2016proposedrevisionseliminatereferencestosedationandanesthesiaforchildren.CDELandtheADAdeferexclusivelytotheguidelinessetbytheAmerican

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AcademyofPediatricsandtheAmericanAcademyofPediatricDentistry(AAPD).

THEFACTS:

• CDELfailstoofferanexplanationforthischange.CDEL’sabdicationofresponsibilityforprovidingitsownpediatricguidelinesraisesimportantunaddressedquestions:1. TheAAPD’sguidelinesgivedentiststheoptionofmonitoringsedation

patientsusingcapnographyorprechordialauscultation.Whythen,doesCDELinsistonmorestringentmonitoringregulationsforadults(capnography)thanitdoesforchildren,whoaregenerallyatgreaterrisk?IfCDELisseriousaboutprotectingpublicsafety,shouldn’tthatapplytoallmembersofthepublic,regardlessoftheirage?

2. Manygeneralpractitionersprovidepediatricsedation,yetarenotmembersofAAPDandhavenotcompletedaPediatricresidency.CDELandResolution37leaveADAgeneraldentalmemberswithoutpediatricsedationguidance.Why?

3. TheCDELproposalmuddiesthewaterwhenitcomestothedefinitionof“children.”Whatageisachildforthepurposesofdentaltreatments?TheADApreviouslydefinedachildas13yearsoryounger.Ithasrescindedthatdefinition.CDELandtheADAnowpuntthequestionofagetotheAAPD,whichinturn,basesitsdefinitionontheAmericanAssociationofPediatrics’(AAP)definition.AAPdefinesachildasanyoneunder21yearsofage.Assuch,isa20-year-oldpatienta“child,”andifso,mustgeneraldentistsnowobtainPALScertificationinadditiontoACLSformoderatesedation?CDELismumonthesequestions.

CONCLUSION:LiketheexplanationforvirtuallyeverycomponentofResolution37,politicalposturing–notscience–appearstobethesolemotivationforCDEL’sdecisiontoallowtheAAPDtosetallguidelinesforpediatricsedation.CDELdoesnotevenfeignascience,evidence-based,orclinicalrationaleforallowingdentistsflexibilitywhenitcomestotheirchoiceofmethodsformonitoringsedatedchildren(capnographyorprechordialauscultation),butnotadults.

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Q.5.InwhatwayswerethedentalanesthesiologycommunitiesnotifiedthattheGuidelineswereunderrevision?Wasthereanopportunitytocommentontheproposal?

CDEL’sCLAIMS:

• TheCouncilnotesthatitheldateleconferenceofferingin-personandphonedopportunitiestotestifyonApril21,2016.Italsoprovidedtwowrittencommentperiods.Theteleconferenceandcommentopportunitieswerepromotedviamultiplechannels,includingdirectemailnotification.CDELlists18dentalanesthesiologycommunitiesofinterestasthosethatwerecontactedandinvitedtoparticipate.Atotalof33writtenandoralcommentswerereceivedand“systematicallyreviewedbytheCouncil.”

THEFACTS:

• CDELoffersnoexplanationforwhytheonlycommunitiesofinterestthatitcontactedwere“anesthesiologycommunities.”Certainly,thosecommunitiesneededtobeincluded.YetthecommunitythatwillbemostgreatlyimpactedifResolution37isapproved,namelypatients,wasnotnotifiedofthehearingorcommentperiods,andwasnotinvitedtoshareitsviews.AstheADA’s“PolicyonEvidence-BasedDentistry”makesclear,thetreatmentneedsandpreferencesofpatientsmustbeconsideredwhenestablishingpracticeguidelines.Forthesecondconsecutiveyear,CDELundertooknostudytodeterminetheimpactResolution37wouldhaveonpatients,patientsatisfaction,andaccesstocare.[ForMore,SeeQuestion#12andtherelatedFACTCHECK.]TheADA’smissionistobepatient-centered,workingforthe“improvementoforalhealthforthepublic.”YetthepublicwasdecidedlyexcludedfromCDEL’sdeliberations.

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• CDELprovidesnodetailsaboutitssystematicreviewandhowitwasconducted.WereallrespondentstreatedequallyordidtheCouncilgivemorecredencetosomegroupsandlesstoothers?

Ofthe18groupsinvited,oneinparticular,AcademyofGeneralDentists(AGD),representsthelargestnumberofdentistswhoarelikelytofeeltheimpactofResolution37,shoulditbeapprovedbythe2016HOD.AGDmembersnumbermorethan40,000,andaftertheADAitself,AGDisthelargestdentalassociationintheUnitedStates.TheAGDstronglyopposesResolution37andtheadditionalburdensitwouldplaceonitsmembersandpatients.AGDtestifiedtothatandsubmitteddetailedwrittencommentstoCDEL.AGDmembersregularlyusemoderateenteralsedationinthetreatmentoftheirpatients,unlikemostothermembersofCDEL’scommunitiesofinterest.CDELdoesnotdisclosehowits“systematic”reviewofthetestimonyandwrittencommentsofthecommunitiesofinterestweighedtheAGD’scommentsandthevastclinicalexperiencerepresentedbyAGDmembersversus,forexample,theargumentsoftheAmericanAssociationofDentalBoards,theAmericanSocietyofAnesthesiologists,orStateBoardsofDentistry–alsoconsideredbyCDELcommunitiesofinterest.[ForMore,SeeQuestion#8andtherelatedFACTCHECK.]ItshouldbenotedthatwhilemostmembersofCDELarealsomembersoftheAmericanAssociationofOralandMaxillofacialSurgeons(AAOMS),whichstronglysupportsResolution37,AAOMSisnotlistedamongthecommunitiesofinterestthatCDELcontacted.

CONCLUSION:Cosmetically,CDELmadeanefforttosolicitthecommentsandtestimonyofexpertsonthetopic.Butsomeofits“experts”werefarlessinformedonthetopic–andrepresentedfarlessclinicalexperiencewithsedationdentistry–thanothers.

Importantly,CDELrepeatedits2015postureintotallyexcludingpatientsfromitscommunitiesofinterestandfailingtomakeevenacosmeticattempttostudythepracticalandfinancialimpactthatResolution37,ifapproved,willhaveonpatientsandtheiraccesstocare.

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Q.6.Manydentistsholdsedationpermitsissuedbyastatedentalboard.Aredentists’sedationpermitsinjeopardyiftheproposedrevisedADAGuidelinesareadopted?

CDEL’sCLAIMS:

• TheCouncilmaintainsthatthestatelegislaturesanddentalboardsalonehavetheauthoritytoestablishpermit/licenserequirementsbywhichdentistswithanesthesiapermitsorlicensesmustabide.“Thestateboardsdeterminetherequirementsfordentistswhoadministersedation,nottheADA.”

THEFACTS:

• CDEL’sanswerisdisingenuousatbestandmorelikely,outrightdeception.Inmanystates,theADAguidelinesarepartoftheregulatorylanguage,sotheyautomaticallybecomegoverninglaw.Inotherstates,itisallbutaforegoneconclusionthatthedentalboardwillembracetheADAguidelinesandthelegislaturewillvotethemintolaw.ThetruthfulansweristhatifResolution37isapprovedbythe2016HOD,withinafewyears,thousandsortensofthousandsofdentistsnationwidewillberequiredbylawtoobtainnew,stricter,sedationpermitsorsimplystopofferingmoderateenteralsedationtotheirpatients.

CONCLUSION:WhiletheADA,technically,doesnotsetstatestandardsforthosewhoadministersedationandanesthesia,itsguidelines,asadoptedbytheHOD,dobecomelawalmostautomaticallyinmorethanhalfofthestates.ManythousandsofdentalpermitswillbeinjeopardyifResolution37isapproved.

Q.7.WhatCEopportunitiesareavailabletomeethisnewguideline?

CDEL’sCLAIMS:

• TheCouncilsaysitis“aware”ofatleast11CEcourseswithahands-oncomponentthat“may”offerthecoursecontentanddurationasproposedinResolution37.

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CDELaddsthatitis“confident”thatprovidersofCEonthesubjectofsedationandanesthesiawillenrichtheireducationalofferingstocomplywiththenewguidelines,shouldResolution37beapprovedbythe2016HOD.

CDELgoesontolistthe11courseproviders,includingnon-profitandfor-profiteducators.

THEFACTS:

• GiventhatResolution37,ifapprovedwillrequirethetrainingorretrainingoftensofthousandsofdentists,CDEL’sobviouslackofhardresearchtobackits“confidence”thatcoursesexistorwillbecreatedtomeettheeruptivenewdemandishighlyquestionable.NordoesCDELweighinonthequestionhere,oranywhereinitsFAQ,ofhowmuchsuchcourseswillcost,howmanydaysawayfromtheirpracticedentistswillneedtotaketofulfillthecourserequirements,whattravelexpenseswillbenecessarytoattendthecourses,andwhatdentistsshoulddowhentheyareunabletofindavailableseats.[ForMore,SeeQuestion#12andtherelatedFACTCHECK.]AsnotedintheFACTCHECKforQuestion#2,the8verifiedCEcoursesthatCDELreferences(outofthe11CDELerroneouslylisted)refertoexistingeducationalprogramsaimedexclusivelyatlicensingrequirementsfordentistswhowillprimarilyprovideparenteralsedation.Therearefewerthan150seatsperyearavailablenationwidetodentistswhoseektoacquiresuchparenteralsedationtraining.Moreover,thecoursesareNOTdesignedtopreparedentiststoprovideenteralsedation.Therearenoknowncoursesofferedbyanycredibleeducationalinstitution,for-profitornonprofit,thatprovide60hoursofdidactictrainingand20livecasestothosedentistswishingonlytobecertifiedtoprovidemoderateenteralsedation.CDELmadenoefforttoexplainwhat,specifically,courseprovidersshouldteachduringthe36hoursofadditionaldidactictrainingthatResolution37wouldrequire.(Neithertheadditionaltrainingnecessarytooperatecapnographyequipment,northeadditionalfocusonrescuingpatientsfromalevelofsedationdeeperthanintended,requires36hoursontopofthe24hourscurrentlyrequiredby

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existingADAguidelines,veterandentaleducatorspointout.Formoreinformation,seethetranscriptoftheNationalDentalTownHallheldonOctober10,2016,featuringapaneloffourdentalluminaries.Thetranscriptisavailableat:http://tinyurl.com/Dionne-Transcript.)CONCLUSION:Therearenotandwillnotbesufficientcourses(fordecadestocome)tomeettheneedsofthedentalprofession,shouldResolution37anditsstrictersedationpermitrequirementsbeapproved.CDEL’s“confidence”isnotbasedonathoroughinvestigationofthecapabilitiesofCEproviders.

Q.8.IprovidedcommenttoCDEL;whywasmyadviceoverlooked?

CDEL’sCLAIMS:

• TheCouncilanswersthatwhileit“didnotagreewithallpointsmade,”allinputwassystematicallyreviewedandconsidered.

Inresponsetothefeedbackitreceived,theCouncilacknowledgesthat“themajorityofevidence”itreliedoncameintheformofexpertopinion.

Itfurtherexplainsthat“notonecontrolledclinicalstudyhaseverbeenperformedtodemonstratetheoptimaltrainingtimefordentistswhoprovidemoderatesedation,”addingthatsuchastudy“maybenearlyimpossibletofundorconductortobeclearedbyaninstitutionalreviewboard.”CDELpointstoitsowncouncilmembers’“expertiseincontemporaryeducationalprinciples,”adding,“WerelyonourAnesthesiologyCommitteeexperts…toevaluateanesthesiologyinformationandprovideCDELwiththebestrecommendations.”

THEFACTS:

Whiletherearenotrandomizedcontrolledtrialsorpublished,peer-reviewedstudiesthatbearoneverysingleaspectofADAResolution37,thereare–contrarytoCDEL’sassertion–numerousscientificandevidence-basedjournalarticlesdetailingresearchthatcontradictsCDEL’sposition.

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See:http://GetTheScience.comtoreviewjustsomeofthepublished,peer-reviewedarticlesonthistopic.Also,notethecitationsofotherrelatedresearchatthebottomofeacharticlepostedatGetTheScience.com.CDELfailstoprovidecitationsorreferencestopublished,peer-reviewedstudiesthatsupportthemajorassertionscontainedinResolution37.

• CDELoffersnoexplanationforhow–intheadmittedabsenceofevenonecontrolledclinicalstudy–itsettledonResolution37’s250%increaseintherequirednumberofdidactichoursthatwillgoverndentistswishingtoprovidemoderateenteralsedation,shouldthe2016HODapprovethenewguidelines.[Resolution37alsoincreasesthenumberofcasesrequiredtobecertifiedformoderateenteralsedationby100%andlivecasesby667%.]

• CDELpresentszeroevidencesubstantiatingthatthecurrentADAguidelines,adoptedbythe2007and2012HOD,areinadequatetoprovideforpatientsafety.

• CDELindicatesthatitfavoredtheexpertopinionsofitsownmembersandmembersofCDEL’sAnesthesiologyCommitteeoverthoseofotherexpertsandorganizationsthatsubmittedtestimonyandwrittencommentsopposedtoResolution37.

Doingso,onceagain,fliesinthefaceoftheADA’s“PolicyonEvidence-BasedDentistry,”whichdoesnotplacetheexpertiseofADAmemberswhoareappointedtovariousADACouncilsandCommitteesaheadofscience,peer-reviewedresearch,theclinicalexperienceofdentists,orthetreatmentneedsandpreferencesofpatients.ServiceonADACouncilsandCommitteesisvitaltotheorganizationbutdoesnotconfersuperiorknowledgeorexpertiseonCouncilandCommitteemembers.• AmongthosewhoseexpertviewsandclinicalexperienceCDELconsidered

butfeltsufficientlycompetenttoignoreinpartorinfullare:

o AcademyofGeneralDentistryrepresentingmorethan40,000dentists,includingthelargestnumberofdentistsofanydentalgroup(otherthantheADA,itself)thatalreadyusemoderateenteralsedationintheirpractices.

o AmericanAcademyofPediatricDentistryrepresenting9,900memberswhoserveasprimarycareandspecialtyprovidersformillionsofchildren

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frominfancythroughadolescence.

o AmericanDentalSocietyofAnesthesiologyrepresenting5,000memberswhoprimarilyengageinthepracticeofanesthesiologyindentistry,eitherlocalorgeneral.

o AmericanSocietyofDentistAnesthesiologistsrepresentingapproximately4,500dentistswhohavecompletedaminimumoftwoyearsoffull-timepostdoctoraltrainingindentalanesthesiology.

o DOCSEducation,whichhastrainedmorethan20,000dentistsinsedationdentistrytechniquesthatcomplywithexistingADAguidelinesandstateregulations.Morethan20millionAmericanshavereceivedcarefromDOCSEducation-traineddentists,whoconformtothecurrentADAGuidelines,withoutincident.

o RicklandG.Asai,DMD,11thDistrictADATrusteerepresentingAlaska,Idaho,Montana,Oregon,andWashington.Dr.Asai,anadvocateforaccesstoaffordabledentalcare,isoneofeightADATrusteeswhoinAugust2016votedagainstallowingResolution37tocomebeforethe2016HOD.

o TheCaliforniaDentalAssociationrepresentedbyGayleMathe,CDAPublicAffairs.

o IdahoStateDentalAssociationrepresentedbySusanMiller,executivedirector,andJohnE.HiselJr.,DDS.

o TexasAcademyofGeneralDentistryrepresentedbyBrookeElmore,DDS,FAGD,TAGDAdvocacyCouncilChair.

o Dr.MarkWalker,chairofaneight-membertaskforceorganizedbyDr.LindaWilliamsandcomposedofrepresentativesfromeachofthefivestatesinADADistrictXI.Dr.Williams,CaucusChair,ADADistrictXI,submittedseparatewrittencommentstoCDEL.

o RaymondDionne,DDS,PhD,aleadingpainscientistanddentaleducatorwhohaspublishedmorethan100scientificmanuscriptsrelatedtohisworkonpainandpaincontrol.Hiscareerincludesmorethan20yearsofprivatepracticeexperienceandmorethan30yearsofclinicalresearch.HewasaninvestigatorintheNationalInstituteofDentalandCraniofacialResearchfor25years,wherehealsoservedasChiefofthePainandNeurosensoryMechanismsBranchandClinicalDirector.

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o FredQuarnstrom,DDS,FASDA,FAGD,FICD,FACD,CDC,whohastaught253nitrousoxidesedationcoursesand117oralconscioussedationcourseswithorwithoutnitrousoxidesedation.Dr.Quarnstromhaspublishedmorethan50papersonsedationandwrittenchaptersinthreebooksonfearandpaincontrol.

o AnthonyCarroccia,DDS,MAGD,ABGD,ageneraldentistwhopossessesaComprehensiveConsciousSedationPermitinTennesseeandservesontheTDACommitteeforAnesthesia,SedationandScopeofPractice.Dr.Carrocciateachesnitrousoxide-oxygenmonitoringcoursestoassistantsandadministrationtohygienists.In2009,Dr.CarrocciawasnamedtheNationalSedationSafetyDentistoftheYear.

o MartinElson,DDS,ImmediatePastPresidentoftheRhodeIslandOralandMaxillofacialSurgeonsandChristyD.Durant,Esq.,LegalCounselfortheRhodeIslandOralandMaxillofacialSurgeons.

o RockyL.Napier,DMD,FACD,FICD,FPFA,amemberoftheAmericanAcademyofPediatricDentistryandAmericanAcademyofPediatrics,andPresident-ElectoftheSouthCarolinaDentalAssociation.Dr.Napierprovidedmorethan$640,000offreeanduncompensatedcarein2015alone.

CONCLUSION:CDEL’srelianceonitsownmembers,membersappointedtoitsAnesthesiologyCommittee,andhand-selectedoutsideexpertsraisesimportantquestionsofbias.WhydidCDELgivetherecommendationsofcertainindividualsandgroupslegitimacytothetotalorpartialexclusionofotherclearlyqualifiedexpertsandorganizations,suchasthoselistedabove?CDELoffersnospecificswhatsoeveraboutwhatits“systematic”evidentiaryreviewprocessconsistedof,nordoesitprovideadetailedlistofpublishedcitationstosupportisconclusionsandrecommendations.ThelackoftransparencyinCDEL’sprocess–especiallyafterinvitingpubliccommentandtestimony–underminestheCouncil’scredibility,andcallsintoseriousquestionthescientific,evidence-basedvalidityofResolution37.

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Q.9.Whyisthenewdefinitionofoperatingdentistproposed?

CDEL’sCLAIMS:

• TheCouncilsaysthatchangingthedefinitionto“operatingdentist”from“qualifieddentist”–asproposedinResolution37–isintendedtobringclarityinthefaceofsomestatelegislaturesandregulatorswhohavesetspecificdefinitionspertainingtotheclinicaloperativedentistwhoworkswithananesthesiaprovider.CONCLUSION:ThisisachangethatappearsbenignandunlikelytoimpactADAmembersortheirpatients.IftheredefinitionwasproposedseparatelyfromtheotherprovisionsofResolution37,itisunlikelythenewterminologywouldfacemeaningfulopposition.

Q.10.HowmanystatescurrentlyrequiredentiststomonitorexpiredCO2viacapnographyduringmoderatesedation?

CDEL’sCLAIMS:

• TheCouncilnotesthatatleast15states“mention”capnographyintheirlawsorindentalboardpolicyformoderatesedation,“eitherasarequirement,amonitoringoption,orasaproposedregulation.”

THEFACTS:

• CDELcouldhave,butchosenotto,describealongwitheachofthe15statesitciteswhetherthementionsarespecificallyaboutmonitoringasarequirement,option,orproposal.Itmakesadifference,especiallyinclarifyinganissueascontentiousasResolution37.

GivenCDEL’sopenadvocacyforResolution37,itissafetoassumethatifamajorityofthe15statesnotedbyCDELcurrentlyrequirecapnography,CDELwouldhavesaidasmuch.

CONCLUSION:Thirty-fivestatesdoNOTcurrentlyevenmentioncapnographyasamonitoringoption.Moreover,CDELfailstoinformADAmemberswhichstate

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orstatesabsolutelyrequireit.CDEL’slackoffulldisclosureonthismattersmacksmoreofapanelofbiasedadvocatesthananimpartialcouncilofexpertstryingtopresentunbiasedfactstothe2016HOAandotherADAmemberssothattheycanmakeaninformeddecision.

Q.11.Whatistheapproximatecostofacapnography?Q.12.Willthesenewguidelinesincreasethecostofdentalcareordecreaseaccesstocareforsomepatients?

CDEL’sCLAIMS:

• TheCouncilstates,“ingeneral,acapnographcanrangeinpricefrom$800-$3,000.”[Question11]

CDELthencitesitsownestimatetoconclude,“Theequipmentneededtomonitorend-tidalCO2shouldnotappreciablyincreasethecostofdeliveringmoderatesedationordecreaseitsavailabilitytopatients.”[Question12]CDELlabelsthe$800-$3,000equipmentcostas“areasonableinvestmenttoidentifymorerespiratorycomplicationsandsupportriskmanagementandpatientsafety.”

• CDELstatesunequivocally,“Thereisnoevidence*demonstratingthatthecostofcarewillincrease,thatpatientaccesstosedationwilldecreaseorthatthenumberofsedationpermitswilldecrease”shouldthe2016HODapproveResolution37.

THEFACTS:

• CDELdeliberatelyignoresthesalientfactthatthecostofcapnographyequipmentistheleastonerousofthecostsassociatedwithResolution37.ShouldResolution37beapprovedbythe2016HOD,dentistswhowishtoprovidetheirpatientsmoderateenteralsedationwillhavetobuythecapnographyequipment;trainthemselvesandtheirteamonitscorrectusage;paytuitiontoenrollina60-hourcoursetoqualifythemtoprovidemoderateenteralsedation;beawayfromtheirpracticeforanextendedtimeto

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completethecourseanditsrequirementtoparticipatein20livetrainingcases;andpayfortravel,meals,andhotelshouldthecoursebeofferedinan‘away’venue. CDELalsodoesnotcalculatethecoststodentistsofbeingunabletoprovidemoderateenteralsedationtopatientsifthedentistsareunabletoenrollinacourseonatimelybasis,eitherduetothedentists’ownschedulingconflicts,orthelackofavailabilityofsufficientCEproviders.

• CDELcanonlyclaim*that“thereisnoevidencedemonstratingthatthecostofcarewillincrease”becauseitmadenoeffortin2015or2016toconductevenasuperficialeconomicimpactstudytodeterminetherealcostsofResolution37todentists,andhowthosecostswillbepassedalongtopatients.WhiletheADA’smission,since1859,hasbeentobea“patient-centered”association,CDEL’sassertion–withoutoneiotaofsupportingevidence–thatResolution37willnotimpactthecostoravailabilityofcaredishonorsthatmissionstatement.Oneneedn’tbeaneconomisttounderstandthatwhendentistsarerequiredtoinvestheavilyinadditionalout-of-officeeducation–suchasrequiredbyResolution37,impacteddentistswillneedtofindawaytorecouptheirexpensesandlostproduction.Charginghigherfees,withtheconcomitantburdenthatplacesonpatients,iscertaintoreduceaccesstocare.GivenResolution37’srequirementsthatincreasethenumberofdidactichoursrequiredtoprovidemoderateenteralsedationby250%;thenumberofcasesby100%;andthenumberoflivecasesby667%;itisonlylogicaltobelieve–despiteCDEL’sunsupportedcontention–thatmanydentistswillopt,instead,tosimplystopobtainingsedationpermits.*In2015andagainin2016,TEAM1500issuedasummaryofitsowneconomicimpactstudyforecastingtheeffectondentistsandpatients,shouldADAResolution37(originallycalledResolution77)beapproved.ThestudywasconductedbetweenJuneandSeptember2015,drawingondataandcalculationsobtainedfromacross-sectionofpracticingoralhealthcareprofessionals,dentalschoolacademics,regulatoryexperts,andfinancialforecasters.ThestudywasheadedbyDeanRotbart,aPulitzerPrize-nominatedfinancialjournalistandformerinvestigativereporteratTheWallStreetJournal.

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AmongTEAM1500’sfindings:

o Higherdentalfeesandlongerwaittimestoseeaqualifieddentistwilldrivepatientsawayenmasse.Withinfiveyears,anestimated250,000patientswhocurrentlyvisitadentistonaregularbasiswillstopgoing.

o ThecostoftrainingrequiredbyResolution37willrunashighas$50,000ormoreperdentist,whentuition,travel,andlostproductivityareincluded.

o Thetotalnumberofdentistsavailabletoprovidesedationdentistrywill

declineby5%to7%annually,factoringintheretirementandattritionofexistingdentists.Withinfiveyears,thenumberofgeneraldentistswhoarequalifiedtoprovidemoderateenteralsedationcoulddeclinebymorethan30%nationwide.

TEAM1500,formedin2006,advocatesonbehalfofpatientsandaccesstoaffordablehealthcare.TEAMisanabbreviationofTrustforEqualAccessMedicine.Thegroupisacoalitionofmorethan1,500healthcareprovidersandothersconcernedwithpatients’rights.

CONCLUSION:CDEL’sfocusonthecostofcapnographyequipmentinthesetwoFAQquestionsisaformofmisdirection.Itisthetrainingcosts,lostproduction,andrelatedtravelexpensesthatneedconcerndentists,notonlyfortheirowneconomicwell-beingbutalsoforthefinancialwell-beingoftheirpatients.

CDEL’scontentionthat“thereisnoevidence”demonstratingtheeconomicimpactondentistsandtheirpatientsignoresathree-monthindependentanalysisundertakenbyaformerWallStreetJournalreporterandapatients’rightsgroup.In2015and2016,CDEL,itself,madenoeffortwhatsoevertoconductastudytogaugethelikelyimpactofResolution37onpatients.

Q.13.WhenandwhyweretheSedationandAnesthesiaGuidelinesdeveloped?

CDEL’sCLAIMS:

• TheCouncilstatesthattheGuidelines,whichhavebeenrevisedtentimessincetheywerefirstestablishedin1971,areintendedto“assistdentistsinthedeliveryofsafeandeffectivesedationandanesthesia.Therevisions“reflectemergingpracticeandscientificprinciples.”

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THEFACTS:

• TheexistingADAGuidelinesgoverningtheuseandteachingofsedationandanesthesiawerelastsignificantlyrevisedin2007andapprovedbythe2007HOD.(In2012,theGuidelineswereminimallyrevisedagainbytheHOD.)Incompliancewiththe2007/2012Guidelinesandapplicablestateregulations,tensofmillionsofpatientshavereceivedmoderateenteralsedationtreatmentssafely,effectively,andwithoutincident.The2007/2012Guidelines,inaccordancewiththestatedpurposeforsuchguidelines,doreflectemergingpracticeandscientificprinciplesandarewidelysupportedbythedentistswhoregularlyadministermoderateenteralsedation.

• TherevisionstotheuseandeducationguidelinesproposedinResolution37,unlikethoseadoptedin2007/2012,doNOTreflectemergingpracticeandscientificprinciples–andtheyareopposedbyvirtuallyalldentistswhoactuallyadministermoderateenteralsedationtopatients.Moreover,thereisnosupportivesciencewhatsoeverforthepreponderanceoftherecommendedrevisions,andCDELhasnotproducedanysupportiveevidence-basedresearchtosubstantiateitsrecommendedGuidelinerevisions.TheexistingpracticeandclinicalevidencepertainingtosedationandanesthesiaoverwhelminglynegatetheneedforResolution37.TherevisionscontainedinResolution37wereconceivedanddraftedbyoralsurgeons,academics,andotherADAspecialistswhodoNOTprovidepatientsmoderateenteralsedation.TheseCouncilandCommitteemembersdonotqualifyasrepresenting“emergingpractice”clinicians.CONCLUSION:CDEL’scharteristoupdatetheADA’suseandteachingguidelinesforsedationasneeded.InResolution37,CDELhasproposedbroadunneeded,unjustified,andscientificallyunsoundchangestotheexistingADA2007/2012Guidelinesthathaveproven–aboveandbeyonddispute–toprotectpatientswhendentistsadministermoderateenteralsedationinaccordancewiththeexistingGuidelines.

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Q.14.WhatistheprocessforproposingrevisionstotheHouseofDelegates?

CDEL’sCLAIMS:

• TheCouncilnotesthatinkeepingwithadirectivefromtheHouseofDelegates,itreviewstheADA’ssedationandanesthesiaguidelineseveryfiveyears.Itcites“changesinpracticeandscience”toexplainthereasonstheguidelineshaverecentlybeenupdatedmorefrequently.CDELnotesthatalongwithitsAnesthesiologyCommittee,itsseeksinputfromthe“anesthesiacommunitiesofinterest.”ItfurtherexplainsthatitsAnesthesiologyCommittee,whichcarefullystudiestheissuesandprovidestechnicalandscientificinputtoCDEL,includes“representativesfrom”:

o AmericanAcademyofPeriodontologyo AmericanAssociationofOralandMaxillofacialSurgeonso AmericanDentalSocietyofAnesthesiologyo AmericanSocietyofDentistAnesthesiologistso AmericanSocietyofAnesthesiologistso AmericanAcademyofPediatricDentistry

Thisyear,CDELadds,amemberoftheADA’sCouncilonScientificAffairsalsoparticipatedincommitteemeetings.CDELwritesthatit“considerstheCommittee’srecommendationsandcirculatesproposedrevisionstoitsdentalanesthesiologycommunitiesofinterest.”

THEFACTS:

• ThecompositionofCDELanditsAnesthesiologyCommitteeisheavilyweightedtowardoralsurgeonsandotherspecialists,andgreatlyunderrepresentedbygeneraldentistsandthosewhoregularlyusemoderateenteralsedationinaclinicalsetting.

ThereisnomandatefromtheHouseofDelegatestoexcludegeneraldentists.NordoestheHODdictatethatinconsideringitsactions,CDELshouldonlyrelyon“dentalanesthesiologycommunitiesofinterest.”ThedominanceofspecialistsontheCommitteewarpstheobjectivityoftheentireprocess.Thelackoftransparency,especiallyasitpertainstothespecific

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changesin“practiceandscience”thatCDELcites,invitesquestionsastowhetherCommitteemembersareactingsolelyinthebestinterestsofpatientsafety.

• CDEL’swordingmightbeinterpretedtoindicatethattheAnesthesiologyCommitteeiscomprisedofdesignated“representativesfrom”thevariousanesthesiologygroupsitslists–meaningthattheoutsidegroupsselectedamembertorepresentthem.It’sunclearifthisisthecase.

AnotherinterpretationofCDEL’swordingisthatmembersoftheAnesthesiologyCommitteearealsomembersofthevariousoutsideanesthesiologyassociations,butnotofficiallydesignatedrepresentativeofthosegroups–andwithoutanysuchofficialstanding.

• The800-poundgorillaintheroom,whichCDELfailstoaddressinitsresponsetothisquestionandthroughoutits15-QuestionFAQ,iswhyCDELisfocusingon,andmakingrecommendationspertainingto,moderateenteralsedation,whentheoverwhelmingmajorityofdentalfatalitiescitedinthegeneralnewsmediaoverthepastdecadehavetakenplaceinpracticesusingdeepsedation/generalanesthesia–notmoderateenteralsedation.Ifthereisanyareaofdentistrythatcriesoutforcloserscrutinyandpossiblystrictertrainingandpracticeguidelinesitisdeepsedation/generalanesthesia.Oralsurgeryisthesoledisciplineinallfieldsofmodernmedicinethatallowsdoctorstoadministerdeepsedation/generalanesthesiawhilealsoperformingtheprocedure.LegislatorsinCaliforniaunanimouslyapprovedabillinAugust2016,popularlyknownasCaleb’sLaw,thatspecificallywouldestablishacommitteetostudythesafetyofpediatricanesthesia.Thebill’ssponsorshavestatedthattheyfindit“disconcerting”thatoralsurgeonsarenotrequiredtotreatpatientsusingaseparateanesthesiaprovider.Caleb’sLawdoesnotconcernmoderateenteralsedation.YetCDELanditsAnesthesiologyCommittee,comprisedprimarilyoforalsurgeons,doesnotevenraisetheissuesthatareatthecenterofCaleb’sLawandtragediesimpactingdentalvictimsinoralsurgeons’officesnationwide.Why?

CONCLUSION:CDELdoesnotappeartobeactinginthebestinterestsofalldentistsandtheirpatientsasitsonlypriority.CDEL’sarbitraryinclusionofsomeexpertsandevidence,andexclusionofothers,taintsitsrecommendationsandconclusions.

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Themostseriousissuefacingprofessionaldentistryandpublicsafetysurroundsdeepsedation/generalanesthesia–notmoderateenteralsedation.TheverycredibilityoftheADAasachampionofevidence-basedscienceandpublichealthisthreatenedbyCDEL’sactionandtheduplicityofResolution37.

Q.15.WhatinformationwasusedtodeveloptheproposedrevisedGuidelines?

CDEL’sCLAIMS:

• TheCouncilrespondsthatitsCommitteeonAnesthesiology“reliedoncurrentstandardsofcare,guidelinesofothermedicalanddentalorganizations,thescientificliterature,currentstateregulationsforsedation,andtheexpertiseofpractitioners,academiciansandstatedentalboardmembers…”

THEFACTS:

• Tensofthousandsofdentistsregularlyusemoderateenteralsedationintheirpractices,inaccordancewithexistingADAguidelinesandfullcompliancewithstateregulations,safelyandwithoutincident.TheexpertsthattheCommitteeonAnesthesiologyandCDELreliedupon,withscantfewexceptions,havelittleifanyexperiencewithmoderateenteralsedation.Asaresult,asmallgroupof“textbook”expertsisattemptingtodictatetoamultitudeofADAmemberswithsubstantialclinicalexperiencehowtobestprotecttheirpatients.

Anyefforttoreflexivelyimposesedationstandardsfromthemedicalcommunityonthedentalcommunityismisguided.Dentistryhasalonganddistinguishedrecordofsettingthestandardforsafe,effective,sedationandanesthesia.Manydentalsedationstandards,includingthecommonuseofNitrousOxide,donotconformtomedicalstandards.Likewise,dentistrystandsaloneamongallmedicalfieldsinpermittingasingledentisttoadministerdeepsedation/generalanesthesiawhilealsoperformingtheprocedure.AmongalltheexpertsCDELcites,notasinglegrouprepresentingthosewhoregularlyusemoderateenteralsedationsupportsResolution37ormaketheargumentthatrevisionstotheexistingADAsedationguidelinesareessentialtoprotectpatientsafety.

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Thoughit’sdoubtfulthatCDELintendstoinsultthelargegroupofdentistswhocurrentlyusemoderateenteralsedationintheirpractices,CDELignoresthetruth:ThesededicateddentistswhousemoderateenteralsedationwouldbetheveryfirsttodemandchangesintheexistingADAguidelinesiftheyfelttheirpatientswereatrisk.

• CDELassertsthat“currentstandardsofcare,”“thescientificliterature,”and“currentstateregulations”areamongthesourcesthattheCommitteeonAnesthesiologyanditreliedon.

Wefindnoobjectiveevidencetosupporttheassertionthatthesethreesources,inparticular,offervalidationoftherevisionsproposedinResolution37.Onlythoseexpertswhodon’tprovidetheirpatientswithmoderateenteralsedation–andhavenoprofessionalexperienceadministeringit–appearconvincedthattheexistingguidelinesgoverningthiscommonformofsedationareinsufficient.

CONCLUSION:CDELfailedtoweighorplacesufficientweightonthevastclinicalexperiencesofthetensofthousandsofdedicateddentistswhoregularlyusemoderateenteralsedationintheirpractices.Instead,theCouncilturnedto“textbook”expertswhoseemcompelledtorecommendthechangesproposedinResolution37forchangesakealone.ThereisnopublichealthcrisisinenteralsedationdentistryandnocompellingneedforResolution37.

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