drug promotion - what we know

8/6/2019 Drug Promotion - What We Know

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WHO/EDM/PAR/2004.3

Drug promotion

what we know, what we have yet to learn

Reviews of materials in the WHO/HAIdatabase on drug promotion

Pauline Norris

Andrew Herxheimer

Joel Lexchin

Peter Mansfield


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Thisdocumenthasbeenproducedwith the financial assistanceof theEuropeanCommunity.TheviewsexpressedhereinarethoseoftheauthorsandcanthereforeinnowaybetakentoreflecttheofficialopinionoftheEuropeanCommunity.

WorldHealthOrganizationandHealthActionInternational2005

Allrightsreserved.

Thedesignationsemployedandthepresentationofthematerialinthispublicationdonotimply the expression of any opinion whatsoever on the part of the World HealthOrganizationandHealthActionInternationalconcerningthelegalstatusofanycountry,territory,cityorareaorofitsauthorities,orconcerningthedelimitationofitsfrontiersor

boundaries.Dottedlinesonmapsrepresentapproximateborderlinesforwhichtheremaynotyetbefullagreement.

Thementionofspecificcompaniesorofcertainmanufacturersproductsdoesnot implythat theyareendorsedor recommendedby theWorldHealthOrganizationandHealthAction International inpreference toothersofa similarnature thatarenotmentioned.Errorsandomissionsexcepted, thenamesofproprietaryproductsaredistinguishedbyinitialcapitalletters.

TheWorldHealthOrganizationandHealthActionInternationaldonotwarrantthattheinformationcontainedinthispublicationiscompleteandcorrectandshallnotbeliableforanydamagesincurredasaresultofitsuse.

Thenamedauthorsaloneareresponsiblefortheviewsexpressedinthispublication.


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Acknowledgements

Pauline Norris is a Senior Lecturer and Leader, Clinical/Pharmacy PracticeResearch, in the School of Pharmacy, University of Otago, Dunedin, NewZealand.A sociologist andhealth services researcher, sheworksonpharmacyandmedicinerelated issues.Her areasof interest include improving antibioticuse, evaluating pharmacy services, and the influence of ethnicity and socioeconomicstatusonmedicineuse.ShehaswrittencriticalreviewsoftheresearchbasedarticlesincludedintheWHO/HAIdrugpromotiondatabase.

Contact:DrPaulineNorris,SeniorLecturer,SchoolofPharmacy,Universityof

Otago,POBox913,Dunedin,NewZealand.Tel:+6434797359, fax:+6434797034,email:[email protected]

AndrewHerxheimer taught clinicalpharmacologyand therapeutics atLondonUniversityuntil1991.Healso founded theUKDrugandTherapeuticsBulletin in1962 and edited it until 1992. Since then he has worked in the CochraneCollaborationandisnowEmeritusFellowoftheUKCochraneCentreinOxford.He is cofounder of the charityDIPEx, aDatabase of Personal Experiences ofillness(www.dipex.org).ChairoftheInternationalSocietyofDrugBulletinsuntil1996,AndrewHerxheimer is interested inallaspectsofprovidingprofessionals

andthepublicwithunbiasedandclearinformationaboutthebenefitsandharmsof therapeutic anddiagnostic interventions.Hehasa continuing interest in allaspectsofpharmaceuticalpromotion,andinthestrategiesthatsociety,especiallydoctorsandhealthservices,canusetocontrolorcounterit.

Contact:DrAndrewHerxheimer,9ParkCrescent,LondonN32NL,UK.Tel:+442083465470,fax:+442083460407,email:[email protected]

Joel Lexchin is an Associate Professor in the School of Health Policy and

ManagementatYorkUniversity inToronto,Canada,andisalsoadoctor intheEmergencyDepartment at theUniversityHealthNetwork in Toronto.He hasbeen involved in researchingandwritingaboutpharmaceuticalpolicy forover20yearsandhaspublishedover45peerreviewedarticlesinthisarea.Hismainfocus hasbeen on promotion to doctors, directtoconsumer advertising, theregulatory approval process and the direction of research funded by thepharmaceuticalindustry.Heisresponsiblefordesigningthedatabase,collectingthematerialthatappearsinitandcompiledthefirst2200entries.

Contact:DrJoel Lexchin, School ofHealthPolicy andManagement,Atkinson

Faculty of Liberal and Professional Studies, York University, 4700 Keele St.Toronto, Ontario, Canada M3J 1P3. E mails: [email protected] [email protected]


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Peter R. Mansfield is a General Practitioner and a Research Fellow in theDepartmentofGeneralPracticeat theUniversityofAdelaide,Australia.He isDirectorofHealthySkepticism(www.healthyskepticism.org).ThiswasformerlycalledtheMedicalLobbyforAppropriateMarketingInc(MaLAM),whichPeterMansfieldfoundedin1983toimprovehealthbyreducingharmfrommisleading

drugpromotion.Hisprofessionalinterestsincludegeneralmedicalpracticeandresearch,educationandadvocacyonpharmaceuticalmarketing.

Contact:DrPeterMansfield,34MethodistSt,WillungaSA,5172,Australia.Tel.andfax:+61885571040,email:[email protected]

Particular thanksaredue toMargaretEwen (HAIEurope),andRichardLaingandHansHogerzeil(WHODepartmentofEssentialDrugsandMedicinesPolicy)for their contributions to settingup thedatabase and to thismanual.Zulham

HamdanattheWHOCollaboratingCentreatUniversitiSainsMalaysiadesignedandmaintainsthewebsite.

Comments about the database and the reviews shouldbe forwarded toHAIEuropeinthefirstinstance:

HealthActionInternationalEuropeJacobvanLennepkade334T1053NJAmsterdamTheNetherlands

Phone+31206833684Fax:+31206855002Email:[email protected]

DrugPromotionDatabaseURL:http://www.drugpromo.info/


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Review3.Whatimpactdoespharmaceuticalpromotionhaveonbehaviour? . 333.1 Impactofpromotiononindividualprescribingpractices........................................33 3.2 Selfreportedreasonsforprescribingchanges ...........................................................34 3.3 Prescribingbythosewhorelyoncommercialinformation .....................................36

3.4

Prescribing

and

exposure

to

promotion .....................................................................38

3.5 Exploringtheimpactofsamplesonprescribing .......................................................41 Summary...................................................................................................................................41 3.6 Impactofpromotiononoverallsales..........................................................................42 3.7 Impactofpromotionandindustryfundingonrequestsforformularyadditions453.8 DTCAandconsumersdecisions.................................................................................46 3.9 Impactofsponsorshiponcontentofcontinuingmedicaleducationcourses........483.10 Impactofindustryfundingonresearch .....................................................................48 3.11 Doesfundingaffecttheresearchagenda? ..................................................................54 3.12 Doauthorsrevealfundingsources?............................................................................54 Summaryofconclusions.........................................................................................................54

Review4.Whatinterventionshavebeentriedtocounterpromotional

activities,andwithwhatresults?............................................................................... 574.1 Guidelines,codesandregulationsforprintedandbroadcastmaterial .................57 4.2. TheFairbalancerequirement ....................................................................................61 4.3 Guidelinesforsalesrepresentatives............................................................................62 4.4 Guidelinesforpostmarketingsurveillance...............................................................63 4.5 Guidelinesonconflictofinterestinresearch .............................................................64 4.6 Guidelinesforpackageinsertsandcompendia.........................................................64 4.7 Guidelinesaboutgifts ...................................................................................................65 4.8 Guidelinesfortraineedoctorsandforhospitals .......................................................66

4.9

Knowledge

of

these

guidelines

and

their

effect

on

attitudes...................................67

4.10 Educationaboutpromotion..........................................................................................68 4.11 Monitoring/counteringpromotion ..............................................................................70 4.12 Researchasanintervention..........................................................................................71 Summaryofconclusions.........................................................................................................72 Directionsforfutureresearch.................................................................................................73

Finalconclusions........................................................................................................... 73

References....................................................................................................................... 75


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vii

Executive summary

Pharmaceutical manufacturers spend vast sums of money on promotion,including sales representatives,samples,advertisements inbroadcastandprintmedia,andsponsorshipofeducationaleventsandconferences.IntheUSAalone,almostUS$21billionwas spentonpromotion in2002. Indeveloping countriessalesrepresentativesarefrequentlytheonlysourceofdruginformation.

ThisreportispartofaprojectondrugpromotionbeingcarriedoutbyWHOandHAIEurope.Thisstageoftheprojectinvolvedcollectingandanalysingexistinginformation onpromotion.Adatabase (http://www.drugpromo.info) including

over2700journalarticles,booksandothermaterialhasbeendeveloped.Researchstudiesfromthedatabasewereanalysedandtheseformthebasisofthisreport.

Whatattitudesdoprofessionalandlaypeoplehavetopromotion?

Research suggests that doctors attitudes to promotion vary, and do notnecessarilymatch theirbehaviour. Their opinions differ on the value of salesrepresentatives,onwhethertheyshouldbebannedduringmedicaltraining,andonwhetherdoctorsareadequately trained to interactwith them.Mostdoctorsthinkinformationfrompharmaceuticalcompaniesisbiased,butmanythinkitis

useful.Health professionals find small gifts from drug companies acceptable.Doctorswhoreportrelyingonpromotiontendtobeolder,andmorelikelytobegeneral practitioners. Opinions about directtoconsumer advertising ofprescription medicines (DTCA) are mixed. Most companies, the advertisingindustryandthemediafavourit,whiledoctorsgenerallyopposeit.Consumersandpatientsaredividedontheissue.

Studiesonpeoplesattitudestopromotionrelytoomuchonquantitativesurveys,ontheuseofconvenient,accessiblesamples,andondescribingtheprevalenceofattitudes rather than relationshipsbetween attitudes and other characteristics.

Qualitativestudiesareneededinthisarea.

What impact does pharmaceutical promotion have on attitudes and

knowledge?

Doctors themselves report that they often use promotion as a source ofinformationaboutnewdrugs.Doctorsinprivatepractice,orwhograduatedlongago report the highest use of promotion as a source of drug information.Promotioninfluencesattitudesmorethandoctorsrealise.


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Thereisnoresearchinthedatabaseontheimpactofpromotionontheattitudesofothergroups,suchasconsumers,pharmacists,nursesordrugstorestaff,allofwhomare importantdecisionmakersaboutmedicines.Suchresearchwouldbeusefulfordevelopinginterventionsforthesegroups.

Whatimpactdoespharmaceuticalpromotionhaveonbehaviour?

Thisisthemostimportantandmostdifficultareatoresearch.Peoplemaynotbeawarehowmuchpromotion influences them,and/or theymaybeunwilling toreportthis.

Researchclearlyshowsthatdoctorswhoreportrelyingmoreonpromotiontendtoprescribelessappropriately,prescribemoreoftenandadoptnewdrugsmorequickly.Samplesappeartoinfluenceprescribing,butmoreresearchisneededonthisissue.Studieswhichlookattheimpactofpromotiononoverallsalesusually

show increased sales after promotional activities. Pharmaceutical funding fordoctors,suchasresearchfunding,increasesrequestformedicinesmadebythesecompanies to be added to hospital formularies. DTCA is associated withincreased requests from patients for advertised medicines. Sponsorship mayaffectthecontentofcontinuingmedicaleducation.

The pharmaceutical industry hasbecome a muchmore significant source offunding for academic research. Industry funding tends tobe associatedwithinfluenceover thechoiceof topic, secrecy,delayedpublicationandconflictsofinterest.Pharmaceuticalcompanyfundedresearchismorelikelytoshowresults

favourabletotheproductbeingstudiedthanresearchfundedfromothersources.

Moreresearch isneededon thepublichealthconsequencesofdrugpromotion.For example, thismight explore causal relationshipsbetween promotion andprescribing of drugswhich have little or no place in rational prescribing, orwhich have serious adverse consequences when overprescribed, such asantibiotics.More research is needed on the effect of promotion indevelopingcountries.

What interventions have been tried to counter promotional activities,

andwithwhatresults?

This reportdoesnotdescribe thewhole rangeof interventions thathavebeenused,onlythosewhichhavebeenthesubjectofevaluativeresearch.

Many studies show that printed advertisements do notmeet regulations andguidelines in force in various countries. Neither selfregulatory systems norreviewbyjournaleditorsprovideeffectivecontrolondrugadvertising.Studiesofpromotionbydrugcompanyrepresentativessuggest thattheguidelinesandregulationsthatshouldcontrolthemareineffective.Theonlyreportedregulatory

system for postmarketing surveillance that has been studied has not beensuccessful.Manyorganizations lackadequatepolicies fordealingwithconflictsof interest.Guidelines for regulating contactsbetween companies andmedical


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trainees vary greatlybetween institutions. There is conflicting evidence aboutwhether these affect the attitudes of trainee doctors, and if sowhether theseeffectspersistovertime.Educationaboutpromotionappearstochangeattitudesand can improve skills. Its impact on prescribing has not yet been tested.Publication of descriptions of deceptive promotion can leadmanufacturers to

improvetheirpromotionalpractices.

Interventionsneed tobedesignedusing the current evidencebaseaboutdrugpromotion,and theseneed tobeevaluatedandpublished.Researchcomparingtheeffectofdifferentregulatoryframeworksisurgentlyneeded.

Conclusions

There isawiderangeofevidenceondifferenttopics,usingarangeofdifferentdesigns, suggesting that promotion affects attitudes andbehaviour.However

there are gaps in the evidence, andmore highquality studies are needed toestablishcausalrelationshipsbetweenpromotionandattitudesandbehaviourofdoctors and others, to provide more nuanced information about peoplesattitudestopromotion,andtoinvestigatetheimpactofinterventionstoregulateorcountertheeffectofpromotion.


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x


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Introduction

1

Introduction

Itisincreasinglyimportanttounderstandtheeffectsthatdrugpromotionhasonprescribing and the use ofmedication given the growing amounts ofmoneycompaniesaredevotingtothisactivity.In2002,almostUS$21billionwasspentonpromotion in theUSA, includingoverUS$2.6billionondirecttoconsumeradvertising (DCTA)i. These amounts are at least 30 times what nationalgovernmentsspendondrug information (forexample, in Italy:US$4475/doctorby thepharmaceutical industryversusUS$180/doctorby the government)ii. InCanada in 2000 therewere over 3.4million visitsby sales representatives to

doctors,

leaving

behind

21.5

million

drug

samplesiii

and

in

the

USA

companies

organizedover300000eventsfordoctorsiv.Salesrepresentativesarefrequentlytheonly sourceof informationaboutmedicines indeveloping countrieswheretheremaybeasmanyasonerepresentativeforeveryfivedoctorsv.

Attemptstocontrolpromotionhavelargelyreliedonacombinationofvoluntarycodes adopted by industry associations and medical organizations. On thesurface,voluntary selfregulatory codes from thepharmaceutical industrymaylook like a sensible approach to controlling the promotional activities ofcompanies; lackinggovernmentindustryadversariness, theyhave thepotentialtobeamoreflexibleandcosteffectiveoption.Inahighlycompetitiveindustry,thedesireofindividualcompaniestopreventcompetitorsfromgaininganedgecouldbeharnessed to serve thepublic interest through a regime ofvoluntaryselfregulationrunbyatradeassociation.However,likemanytheoriesthisoneproves tobe unsupportedby the evidence. Themission of trade associations,such as Pharmaceutical Research andManufacturers ofAmerica (PhRMA), isprimarily to increase sales and profit. From the business perspective, selfregulation ismostly concernedwith the control of anticompetitive practices.Therefore, when industrial associations draw up their codes of practice theydeliberatelymake themvagueordonotcovercertain featuresofpromotion toallowcompaniesawide latitude.Manymisleadingadvertising tacticsaregoodfor business. As a result voluntary codes tend to be reactive, they lacktransparency,theyomitlargeareasofconcern,andtheylackeffectivesanctions.

iCanadianMedicalAssociationJournal2003;169:699.iiCentroStudiFarmindustria,Indicatorifarmaceutici,Farmindustria,Rome,1998,p.186.iiiCBCDisclosure,Targetingdoctors.Graph: top50drugsby totalpromotionaldollars.Availableat:www.cbc.ca/disclosure/archives/0103_pharm/resources.htmlivScottLevin.RxsandRSVPs:pharmaceuticalcompaniesholdingmorephysicianmeetingsandevents.July9,2001.Availableat:

http://www.quintiles.com/products_and_services/informatics/scott_levin/

press_releases/press_release/1,1254,244,00.html.vLexchinJ.Deceptionbydesign:pharmaceuticalpromotioninthethirdworld.Penang:ConsumersInternational,1995.


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Drug promotion:What we know, what we have yet to learn

2

Codes frommedical associationsmay have stronger provisionsbut they areunenforceableand relyonmoral suasion for theirpower. In the few countrieswherepromotionisdirectlycontrolledbygovernment,resourcelimitationsmeanthatonlyasmallfractionofactivitiescanbemonitoredvi.

If promotion leads tobetter prescribing,more rational use ofmedications orimprovedcosteffectivenessthentherewouldbenoconcern.Whiletheevidenceisnotconclusive,whatthereisallpointsinthedirectionofastrongassociationbetweenrelianceonpromotionand lessappropriateoveralluseofprescriptiondrugsvii.Heavypromotionofnewdrugsleadstowidespreadprescribingandusebefore the safety profile of these products is fully understood. Newer,moreexpensivemedicinesdisplaceolder,lesscostlyoneswithoutanyevidenceofanimprovementintherapeuticoutcomesviii.

Backgroundtotheproject

The impetus foramajorprojectonpharmaceuticalpromotionoriginatedat theMay1999meetingoftheWHO/PublicInterestNongovernmentalOrganizationsRoundtable on Pharmaceuticals.Unethical and inappropriate drug promotionhas been a continuing concern of both NGOs and the WHO. At the 1997RoundtableonWHOsEthicalCriteriaforMedicinalDrugPromotiontherewasfirm agreement that inappropriate promotion of medicinal drugs remains aproblembothindevelopinganddevelopedcountries.

Although there is an abundance of information about drug promotion it hadnever been fully documented and as such organizations, governments,individuals and otherswere restricted in their ability to access thebreadth ofknowledge that hadbeen accumulated, to analyse it, to learn from it and toexpandon it.Therefore, the firstphaseof thepromotionprojectwas tocollect,analyseandmakepubliclyaccessibleaswidearangeofmaterialaspossiblethatdescribed, analysed, reported or commented on any aspect of pharmaceuticalpromotion.

This

drug

promotion

project

is

a

collaboration

between

the

WHO

Department

of

EssentialDrugs andMedicines Policy (EDM) andHealthAction International(HAI)Europe.

viLexchinJ,KawachiI.Voluntarycodesofpharmaceuticalmarketing:controllingpromotionorlicensingdeception. In:DavisPed.Contestedground:publicpurposeandprivateinterestintheregulationofprescriptiondrugs.NewYork:OxfordUniversityPress,1996:221235.vii

Wazana

A.

Physicians

and

the

pharmaceutical

industry:

is

a

gift

ever

just

a

gift?

JAMA

2000;283:373380.viiiLexchinJ.Shoulddoctorsprescribenewdrugs?InternationalJournalofRiskandSafetyinMedicine2002;15:21322.


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Introduction

3

Developmentofthedrugpromotiondatabase

InOctober 2002 the drug promotionweb sitewas freely accessible online athttp://www.drugpromo.info.Themain feature, thedatabaseofdrugpromotion

material,currentlycontainsapproximately2700entries.

Forthisproject,promotionwasbroadlydefinedusingtheWHOdefinition:allinformationalandpersuasiveactivitiesbymanufacturers,theeffectofwhichistoinduce the prescription, supply, purchase and/or use of medicinal drugs.Materialonpromotionwas sought frombooks,journal articles,magazine andnewspaper stories, articles from drugbulletins/newsletters, videos, radio andtelevisiontranscripts,andguidelinesfromorganizationsandprofessionalbodies.

MaterialforinclusioninthedatabasewasidentifiedprimarilyfromaMEDLINE

searchgoingback to1January1970.DrJoelLexchin,adrugpromotionexpertfromToronto,was theprincipal investigatorandcompiled theentries.MelissaRaven,apublichealth specialist fromFlindersUniversity,SouthAustralia,hasbeenupdatingthedatabasesincemid2002.

Additionalmaterialwas foundby scanning the list of references in the itemsfoundthroughtheMEDLINEsearch,throughcontactsintheEDrugdiscussiongroupandfromotherexpertsindrugpromotion.Materialwasonlyincludedifitwas currently possible to obtain the item andwas excluded if it came fromsources such as unpublished articles where there was no contact address

available,or articles frommagazines thathadgoneoutofproduction, etc.Allmaterialthatfittedthesecriteriawasincludedregardlessofwhoproducedit,i.e.,government, industry, NGOs, etc. Note advertisements for drugs were notincludedunlesstherewasacommentaryontheadvertisement,eitherpositiveornegative. Onlymaterial in English hasbeen includedbut there are plans toexpandthedatabasetocovermaterialinFrenchandGerman.

WhileWHOandHAIbelievethepresentdatabaseisavaluableresourceonwhatisknownaboutdrugpromotion,itneedstoevolvewithuseandexperience.Wewelcomecommentsbyusers.Wealsoneedtobroadeninvolvement,forexample,

throughpharmaceuticalcompaniesproviding theirresearchon the influenceofdrugpromotion(currentlynotusuallyaccessibleoutsideofthecompany).Thatway,thedatabasewouldgiveamorecompletepictureofwhatisknownandnotknownaboutdrugpromotion.


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Databaseentries

Dependingonthesourceofthematerial,eachentryhasbeencataloguedinsomeorallofthefollowingfields:

Author

Title

Source(address,emailaddressetcofgroup/organizationproducingthematerial)

Websiteaddresseswhereavailable,includingsiteswherejournalarticlesthatareavailableonlinecanbeobtained

Abstract

Keywords

Datematerialproduced(forjournalentriescompleteidentifyingdatae.g.year,journalvolumeandpagenumbers).

Entries on studies that generated new data and/or reported specificmethodological designs include notes on strengths or potentialweaknesses inhow the studywascarriedoutand the limitation in thegeneralizabilityof the

results.

Entrycontent isdescribed in twoways: throughkeywordsandalsobyputtingeachentryintooneormore groups.Thesegroupsareanadditionalmethodofbroadly describing the main topics covered by the entry. A stepbystepdemonstration of searching the database is included on theweb site to assistusers.

Potentialdatausers

Healthprofessionals

Doctors,pharmacistsandotherhealthcareworkerswillbeabletoseewhatpromotional techniques the pharmaceutical industry uses, and howpromotion influences the choice of drugs and the appropriateness ofprescribing.

Healthprofessionalassociations

Thesegroupscanusethedatabasetoseewhatguidelinesothergroupshaveadoptedforinteractionbetweenhealthprofessionalsandthepharmaceutical

industrytohelpthemformulatepolicies.


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Introduction

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Governmentsandotherregulatorybodies

Thedatabasewillenableregulators toseewhatmethodshavebeen tried tocontrolpromotionandtheirsuccessesandfailures.

Academicresearchers

Thedatabaseenablesresearcherstoseewhichpromotionalissueshavebeeninvestigated,themethodologyothershaveusedandwhatareasareprioritiesforfurtherresearch.Inaddition,theycanlookattrendsinpromotionovera30yearperiod.

Educators

Thedatabasewillbe avaluable sourceof information for thosewho teachmedical and pharmacy students, nurses and other health science studentsabouttheinfluenceofdrugpromotion.

Consumerorganizations

Thesegroups canuse thedatabase tohelp them lobby foreffective controloverpharmaceuticalpromotionandtohelpeducateconsumersandpatientsabout the influence that promotion has over the choices that healthprofessionals make. They can also use the material to become betteracquaintedwithemergingissues.

Pharmaceuticalindustry

Pharmaceuticalcompanieswillbeabletoseewhatcriticismshavebeenmadeabouttheirpromotioninordertohelpthemdevelopbetterinternalcontrols.The database will also help pharmaceutical industry associations tostrengthentheirvoluntarycodes.

Publicandprivatesectorpayers,andprovidersofdevelopmentaid.

Thesegroups can seehowpromotionaffectsdruguseand, therefore,drugcosts.

Reviewsofdatabasematerial

Aspartoftheproject,fourreviewswereproducedbasedonsomeofthedatabasematerial.These reviewswerewritten toprovideanoverviewofwhat isand isnotknowninfourkeyareas:

Review1. Whatattitudesdopeople(professionalandlay)havetopromotion?Issues covered include attitudes to pharmaceutical company salesrepresentatives, gifts and sponsorship of conferences. Attitudes ofdoctors,consumersandotherstodirecttoconsumerdrugadvertisingarealso reviewed. In addition, there are reviews of differences in doctorsattitudes to promotion andwhether they think that promotion affectstheirprescribing.


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Review2. Whatimpactdoespharmaceuticalpromotionhaveonattitudesandknowledge?

In addition to studies on the effect of promotion on attitudes andknowledge, this review looks at how much doctors report using

promotion

as

a

source

of

information

(either

for

all

drugs,

or

particularly

fornewdrugs).

Review3. Whatimpactdoespharmaceuticalpromotionhaveonbehaviour?Thisreviewlooksattheevidenceforseveraldifferentpossibleeffectsofpromotion on behaviour. These are the impact of promotion onindividualprescribingbehaviour,onoveralldrugsales,andonrequestsforformularyadditions;theeffectofdirecttoconsumerdrugadvertisingon consumers decisions, the effect of promotion on the content ofcontinuingmedicaleducation(CME)courses,andtheimpactofindustry

funding

on

research

outcomes.

Review4. Whatinterventionshavebeentriedtocounterpromotionalactivities,andwithwhatresults?

This review reports on research on interventions to control or counterpromotion,andtheeffectsofsuchinterventions.Itisnotacomprehensivereview of interventions,because there aremanydescriptive reports ontheseinthedatabase.

The purpose of the reviews was to allow users of the database tounderstandtheresearchthathasbeendoneonpromotion,thestrengths

and weaknesses of that research, and to suggest directions for futureresearch.Thereviewswerelodgedonthewebsiteinmid2003.

Methodology

Thereviewssummarisetheresearchevidenceand,therefore,theydonotincludeall of thematerial contained in the database. Only entriesbased on originalresearch,systematicreviewsormetaanalysesare included.Suchentriesallhadwritten methodological notes. They were identified and extracted from the

databasebysearchingallentriesthatincludedamethodologicalnote.ThissearchtookplaceinNovember2001.Studiesthatwerepurelydescriptiveofpromotionwereexcluded,andallstudieswhich touched insomewayon the four reviewquestionswere then included. The reviewswere drafted, and inJuly 2002 afurthergroupofrelevantnewerstudieswereaddedtothereviews.Itisintendedthatthereviewswillbeupdatedperiodicallyasthedatabasegrows.


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Review 1

7

Review 1.

What attitudes do professional and laypeople have to promotion?

Findingoutwhatpeoplethinkaboutpromotion,andwhateffecttheythinkithason them, is importantbecause itcanhelpus todevelop relevant interventions.However,researchonthistopiccannotprovideevidenceabouttheactualeffectsofpromotion.Promotionmayaffectpeopleinwaysthattheydonotknowabout,orarereluctanttotellothersabout.

Thisreviewdescribesstudiesthatexaminewhatpeoplethinkaboutpromotion.Studiesabouthowpeopleusepromotionandothersourcesofdruginformationarenotincludedhere;thesecanbefoundinReview2.

Researchonattitudestopromotionreliesheavilyonsurveymethods.Ittendstoprovide estimates of how many people agree with or disagree with certainstatements, mostly about the appropriateness and effect of various forms ofpromotion. There are somemore complex studies, which attempt to exploreothervariablesassociatedwithdifferentattitudestopromotion.Thesetrytofind

out

what

kinds

of

people

have

different

opinions

on

promotion.

Such

studies

are

moreuseful.

Thereislittlequalitativeresearchonpeoplesattitudestopromotion,andthisisamajorgap.Inordertounderstandpeoplesperspectivesandvaluesmoreclearly,indepth interviews are needed. People shouldbe express themselves in theirown way about what they think about promotion and how it affects them.Ethnographic research, inwhich the researcher spends timewith doctors andtries tounderstandhowpromotion fits into theirworking lives,wouldalsobeuseful.

1.1Attitudesdonotnecessarilymatchbehaviour

Severalstudiesshow that findingoutwhatpeople thinkaboutpromotionmaynotbeagoodwaytopredicttheirbehaviour.Forexample,PeayandPeays1984paper1suggestsadoctorsviewoftheworthinessofaninformationsourcemaynot be reflected in how often s/he uses it. Sales representatives and othercommercialsourceswerenotevaluatedhighly,butsalesrepresentativeswerethemost frequentsourceof first informationaboutmedicines,andwereoneof the

most frequentlymentioned sources of information needed to prescribe.Othercommercial sourceswere also oftenmentioned as sources of first informationabout a drug. Similarly, Gambrill and BridgesWebb found that 56% of the


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8

Australiandoctorsintheirstudyreportedthattheyusedsalesrepresentativesasaregularsourceof information,butonly17%rankedthemas themostuseful2.McCue et al.3 surveyed generalpractitioners (GPs), internists and surgeons inNorth Carolina, about their attitudes towards and use of different sources of

information

about

new

drugs.

Although

only

27.7%

of

the

respondents

viewed

drug sales representatives as accurate and accessible sources of informationaboutnewdrugs,theywereusedmorefrequentlythanothersources.Thisstudyhadalowresponserate.

1.2 Studies of the prevalence of different attitudes to promotion

(excludingdirecttoconsumeradvertising)

These are studies that simply assesspercentages ofpeoplewho report certain

attitudesorbeliefsaboutpromotion.Somedostarttoexploredifferenceswithintheirsamples,butthisisnottheirmainobjective.Manyofthesestudieslookattheattitudesofmedicalstudents,doctorsintrainingprogrammes,theirtrainers,orpatients.Few studies look atpracticingdoctors,or at thepublic ingeneral.Studies are oftenbased at one or two institutions (usually in theUSA and/orCanada),orarewrittenquestionnairessenttodirectorsoftrainingprogrammesaround theUSA and/orCanada.Most studies focus ondoctors in training ortheir trainers, examining and discussing what is an appropriate relationshipbetweenpromotionandtraining.

Surveysoftheprevalenceofdifferentattitudesinclude:Hodges4wholookedatpsychiatryresidents,internsandclerksinsevenCanadianhospitals;Sergeantetal.5wholookedatfamilymedicineresidentsinOntario;Aldiretal.s6surveyofpracticingandresidentdoctorsinNortheasternOhio,USA,abouttheirviewsofpromotion;BarnesandHolcenbergs7surveyofmedicalandpharmacystudentsat theUniversityofWashington in1970;BlakeandEarlys8surveyofMissouripatients about their attitudes to gifts givenby pharmaceutical companies todoctors; Madhaven et al.9, who surveyed West Virginia doctors about theirattitudetogiftsfromtheindustry;andKeims10surveyofdirectorsofemergencymedicineprogrammes,and residents in theseprogrammes,about theirattitude

tointeractionswiththepharmaceuticalindustry.Othersinclude:Mainousetal.11,whosurveyed649adults inKentuckyabouttheirattitudestodoctorsacceptinggiftsfromthepharmaceuticalindustry;Reederetal.12,whosurveyedallchiefsofUS emergencymedicine residency programmes; Strang et al.13who surveyedCanadiandoctors;Lichsteinetal.14whosurveyeddirectorsof internalmedicineresidencyprogrammes;andDunnetal.15whosurveyedOntariophysicians.

CONCLUSION:These studiesdonot suggestanyclearpatterns inattitudes topromotion.Furtherresearchwouldberequiredtodetermineifvariationsinthefindingsdepend on thepopulation surveyed, and on theway questionswere

asked,whoaskedthequestions,andinwhatcontext.


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Review 1

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1.3 Do trainers and trainees think that sales representatives should be

bannedduringmedicaltraining?

Most (71%) psychiatry trainees surveyed by Hodges disagreed that salesrepresentatives shouldbebanned frommaking presentations in their trainingprogramme4.Mostdirectors of internalmedicine residencyprogrammes (67%)felt that thebenefits of sales representatives outweighed the negative effects.Fortytwo per cent felt that curtailing sales representative interactions withresidents would jeopardise company sponsorship of other departmentalactivities14.OftheinternalmedicinefacultyandresidentssurveyedbyMcKinneyet al.16, 52%of faculty and66%of residentsagreed thatpresentationsby salesrepresentativesshouldbebannedattheirinstitutions.

CONCLUSION:Only threestudies in thedatabaseaddress thisquestion:sometrainersandtraineesdo,othersdonotthinkthatsalesrepresentativesshouldbebanned,andqualitativestudieswouldbeneededtodiscovertheirreasons.

1.4 Do doctors think they have enough training to deal with sales

representatives?

Seventy per cent of psychiatry trainees did not feel they had had sufficienttraining about interacting with sales representatives4. Only 10% of internal

medicinefaculty

and

residents

surveyed

by

McKinney

et

al.

16felt

they

had

had

enough training for professional interviewswith sales representatives.On theotherhand,90%ofthepracticingdoctorsand87%oftheresidentsinAldiretal.sstudy felt that they had had sufficient training to critically understandinformationfromcompanies6.

CONCLUSION:Only three studies in thedatabaseaddressed thisquestion. Intwostudiesthevastmajorityindicatedthattheydidnothaveadequatetrainingtointeractwithrepresentatives.However,inanotherstudythevastmajoritysaidthat they had sufficient training to critically understand information from

pharmaceuticalcompanies.

This

discrepancy

may

arise

from

differences

in

the

framingof thequestions, forexample, locating thedeficiency in the trainingasopposedtointheindividual.

1.5 Do doctors think that sales representatives have a valuable role in

medicaleducation?

Twentynine per cent of psychiatry trainees agreed that sales representativeshavean importantteachingrole(although inthetextthis isdescribedas more

than 40%)4. Eighty per cent of the US emergency medicine chief residentsthought that their residencyprogrammebenefited from interactionswith salesrepresentatives. Only six chief residents indicated very strong opposition to


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allowing residents to interactwith sales representatives12. In Bucci and Freysstudy17 of US family practice residency programmes, 48.3% of programmedirectors felt that sales representatives were a valuable drug informationresourceforresidents,and55.1%felttheywerevaluableforpracticingdoctors.

In Dunns study of Ontario physicians, about 10% of doctors ratedpharmaceuticalhandoutsasanimportantorveryimportantcontinuingmedicaleducation resource (10.9%ofprimarycaredoctorsand12.2%ofhospitalbasedspecialists)15.Hayesetal.18surveyedgeneralpractitioners intheUKabouttheirinvolvement in and attitudes towards industry involvement in continuingmedicaleducation.They found thatmostGPs (90%)hadhadmeetingsat theirpracticeforwhichpharmaceuticalcompaniesorganizedtheeducationalcontent.Thecharacteristicofthesewhichwasmostdisliked,particularlybytrainersandthoseinpracticeformorethaneightyears,wasthepromotionalaspect.

CONCLUSION:Thestudiesreportedhereallaskquitedifferent(andrelativelyuseless)questions.Opinionsabout thevalueofsalesrepresentativesaremixed;againdifferencesmayhave resulted from theway inwhich thequestionwasframed,andmoreresearchwouldbeneededtoclarifythis.

1.6 What do health professionals think about the quality of the

informationprovidedbysalesrepresentativesandadvertisementsabout

drugs?

Thirtytwopercentof thepsychiatry traineessurveyedbyHodgesagreed thatsalesrepresentativesprovideusefulandaccurateinformationonnewdrugs(25%for established drugs)4. Fiftyeight per cent of family medicine residents inSergeantetal.s study5 felt that the literatureprovidedby sales representativeswasuseful.

NinetytwopercentoftheCanadiandoctorssurveyedbyStrangetal.13feltthatsales representativeshadproductpromotion as theirmajor goal, and 80% feltthey overemphasised medicines effectiveness. Fortyseven per cent of the

doctors inEaton andParishs study19 felt that theywerenot able to obtain anunbiased assessmentof anewly introduceddrug.Mostof them felt thatmostdruginformationwastoocommercialandthereforebiased.

InaNewZealand study,Thomsonetal.20 found that58outofa sampleof67doctorssawsalesrepresentatives.Inresponsetoanopenendedquestionaboutwhy,56ofthemgaveareasonrelatedtolearningaboutneworexistingproducts.ThedirectorofthePharmaceuticalManufacturersAssociationofNewZealanddescribedasurveyofdoctors,inalettertotheeditoroftheNewZealandMedicalJournal21. Without giving methodological details, he claimed that most New

Zealanddoctors felt thatsalesrepresentativesareagoodsourceof informationaboutdrugsandrecognisepractitionersinformationneeds,butareoverbiasedtowardstheirownproducts.


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Incontrast,only16%ofUKGPssurveyedbyHayesetal.foundvisitsbysalesrepresentatives to be educationally valuable18. University and communitypracticedoctorssurveyedbySheareretal.22rateddirectmail,journaladvertisinganddetailersas the three least reliablesourcesofdrug information.Doctors in

community

hospitals

ranked

the

representatives

they

saw

higher

than

university

hospitaldoctors ranked those repswhom they saw.Whelanetal.23 report thatstaffmembersinafamilymedicineresidencytrainingprogrammeinCanadadidnotratesalesrepresentativesasaveryusefulsourceof information inresponsetodruginformationquestions.Theyratedthempoorlyonallaspects:frequencyof use, availability, ease of use, understandability, helpfulness, extensiveness,and howmuch confidence they had in them.AmongCockerill andWilliamsOntario pharmacists24, a minority of the respondents (25%) said salesrepresentativeswereanimportantsourceofinformation,whileonly17%thoughtadvertisementsandpromotionalliteraturewere.Drugsalesrepresentativeswere

never

mentioned

as

sources

of

information

for

the

complex

clinical

case

studies

usedbyBoerkampet al.25.Themajorityofpsychiatrists shown advertisementsforpsychotropicsbyLionetal.26didnotfindthemattractiveorinformative.

SixtyeightpercentofdoctorsworkinginaTurkishcitysurveyedbyGldalandSemin27 thought the information providedby representatives was unreliable.Ninetyfourpercentfeltareliablesourceofinformationaboutdrugs,otherthanpharmaceuticalcompanies,wasneeded.

Benseman28 found that the 45 New Zealand doctors he surveyed expressed

varying

degrees

of

anger

and

frustration

at

the

waste

involved

in

the

material

theywere sentbydrug companies.Almost all felt that companymaterialwasbiased and should notbe taken at face value.However they preferred drugcompany sponsoredjournals to academicjournals,because they found themmorerelevanttogeneralpractice.

Mackowiak et al.29 surveyed a small convenience sample of US communitypharmacistsandasmallsampleofpharmacystudentsaboutadvertisementsforoverthecounter drugs in pharmacyjournals. In theUSA, advertisements foroverthecounter medicines are regulatedby the Federal Trade Commission.Theymustbe truthful andnotmisleading.This is a lower standard than thatenforced for prescription drugs. Around half the pharmacists, and students,surveyed by Mackowiak regarded the advertisements they were shown asmisleadingandnottruthful.Howevertheyalsoreportedhigh levelsofrelianceon them.Most respondents (90%ofpharmacistsand81%of students) thoughtregulations for overthecounter products shouldbe the same as prescriptionproducts.

InastudyofhealthcareprovidersinAfrica30,commissionedbytheInternationalFederation of Pharmaceutical Manufacturers Associations and the USPharmaceutical Manufacturers Association, 95% of those who receivedcompanyprovided information reported finding it helpful. The design of thisstudyisnotwelldescribed.


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CONCLUSION:Doctorsopinions on theusefulnessof information fromdrugcompaniesvarybutmostbelievethatsuchinformationisbiased.

1.7Whatdoothergroupsofpeoplethinkofpromotionalinformation?

Journalistswhowroteaboutmedicinesclaimedtobecriticalofmaterialfromthedrug industry ina studybyvanTrigtetal.31.Companieswerenot consideredimportant sources for drug information in general,but themanufacturerwasseenasamajorsourceofinformationwhenanewdrugwasregisteredorbecameavailable.

CONCLUSION:Onlyonestudy in thedatabaseaddresses thisquestion. Moreresearchisneeded.

1.8 What are doctors views of pharmaceutical company support of

conferencesandspeakers?

Most of the psychiatry trainees surveyedbyHodges4 (77%) agreed that salesrepresentatives support important conferences and speakers. Most familymedicine residents surveyed by Sergeant et al.5 agreed that the content ofcontinuingmedicaleducationactivitiesshouldbesetbythedoctorsorganizingthem,ratherthanthecompanysponsoringthem.

CONCLUSION:Only two studies in thedatabase address thisquestion.Moreresearchisneeded.

1.9 Do trainee doctors plan to see sales representatives in their future

practice?

Most (76%) family medicine residents in one Canadian centre surveyed bySergeant et al. planned to see representatives in their future practice5. Asignificant minority (42%) of the Canadian psychiatry trainees surveyed byHodges4 said theywould notmaintain the same degree of contactwith salesrepresentativesifnogiftsweredistributed.

CONCLUSION:Only two Canadian studies from 1994 and 1996 address thisquestion.Datafromrecentgraduateswouldbeuseful.


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1.10 Whatareprofessionalsandpatientsattitudestotheappropriateness

ofgifts?

Most(55%)ofthefamilymedicineresidentssurveyedbySergeantetal.saidthattheywould attend a private dinnerwith a sales representative paid forby acompany.Thirtysixpercentfeltthatgiftsfromsalesrepresentativestodoctorsresulted inhigherdrugcostsforpatients5.ThedoctorssurveyedbyAldiretal.felt that smallergiftsweremore appropriate thanmorevaluableones6.Of theCanadian doctors surveyed by Strang et al.13 85% agreed that salesrepresentativesshouldbeabletoofferfreesamples,but74%felttheyshouldnotbeabletoofferallexpensespaidtripstomeetingsorganizedbycompanies.

MorethanhalfoftheresidentssurveyedbyKeimetal.10,reportedacceptinggiftssuchastextbooksbecausetheyneededfinancialassistancewiththeireducation.Seventyeightpercentofprogrammedirectorsand92%of studentsbelieved itwasappropriatetoaccepttextbooksfromdrugsalesrepresentatives.Keimetal.found that thosewhoweremore sensitive tobioethical issues ingeneralwereless willing to accept noneducational gifts. Twentyfive per cent of residentdoctors in Virginia surveyedby Sigworth et al.32 said they would not wantpatientstoknowthattheyhadreceivedgiftsandawardsfromdrugcompaniesandwouldtrytohidethis.

In a simplebut clever research design, Palmisano and Edelstein33 asked 100medicalstudentsand100familyplanningnursesabouttheproprietyofvariouspeopleacceptinggifts.Ofthe50medicalstudentswhowereasked,85.4%feltitwasimproperforagovernmentofficialtoacceptaUS$50giftfromsomeonewhowantedtogainacontract.Oftheother50students,46%feltitwasimproperforamedicalstudent toacceptaUS$50gift fromadrugcompany.Thenursesweredividedintothreegroupsandaskeddifferentversionsofthequestion.Ofthosewhowereasked,97%felt itwas improperforthegovernmentofficialtoacceptthegift,64%feltitwasimproperforaresidentdoctortoacceptthegift,butonly30%feltitwasimproperforanursepractitionertoacceptthegift.Amongstthe

Turkish doctors surveyedbyGldal and Semin27 33% felt that giftswere notethical,36% felt theywerenotethical in some respects,and21% felt thatgiftswereethical.

Sixtyfourper cent of thepatients surveyedbyBlake andEarly8believed thatgifts would increase the costs ofmedicines. They approvedmore of doctorsaccepting some gifts, like drug samples, medical books,ballpoint pens andconference expenses, than others, such as dinners, baby formula and golftournaments.Men, older people and thosewith tertiary educationweremorelikelytodisapproveofgifts.Theyweremorelikelytodisapproveofgifts(except

free samples) if they felt that these influencedprescribing and increased cost.Onelimitationofthisstudywasthatmanypatientswereunawarethatsuchgiftsweregiven,sohadlittletimetoconsidertheiropinionofthemwhilecompleting


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thequestionnaire.InMainousetal.sKentuckystudy11manymorepeople(82%)wereawarethatdoctorsreceivedofficebasedgiftsthanpersonalgifts(32%).Thisstudy used a populationbased sample, rather than a practicebased sample.Substantialminoritiesofpeoplefeltthatgiftshadanegativeeffectonhealthcare

costs

(42%

for

personal

and

26%

for

office

gifts)

and

health

care

quality

(23%

for

personal and 13% for office gifts). Thesebeliefsweremore common amongstrespondentswithhigherlevelsofeducation.

Gibbonsetal.34askeddoctorsandpatientsabout the same listof10gifts,andfoundthatpatientsratedthegiftsaslessappropriateandmorelikelytoinfluenceprescribing thandoctorsdid.Thosewith higher levels of education (i.e. thosewhohadcompletedhighschool)weremorelikelytothinkthatthecostofgiftswaspassedontopatients.Beforethesurveyabouthalfofthepatients(54%)wereawarethatdoctorsacceptedsuchgifts.Ofthosewhowerepreviouslyunawareof

this,

24%

said

that

learning

about

them

had

changed

their

perception

of

the

medicalprofession.

CONCLUSION: Seven studies in the database address the question ofprofessionalsattitudestogifts.Thestudiesavailablesuggestthatthereisarangeofviewsaboutgiftsbutatendencyforgiftsthatweresmallerormorerelevanttohelping patients to be regarded as more acceptable. There is evidence thatprofessionals believe that their acceptance of gifts goes below communitystandardsandtheirownstandardsforotherpeopleinpositionsofresponsibility.

Three

studies

in

the

database

address

the

question

of

lay

peoples

attitudes

to

gifts.Thestudiesavailable suggest thatonlyaminorityareaware thatdoctorsreceive personal gifts, so only aminority disapprove,but peoplewith higherlevelsofeducationweremorelikelytodisapprove.

1.11 Do health professionals feel that discussions with sales

representativesaffectprescribing?

Thirtyfive per cent of the psychiatry trainees inHodges study4 agreed that

discussions with sales representatives did not influence their prescribingbehaviour.Thisattitudewaslessprevalentamongmoreseniortrainees.AmongtheCanadianfamilymedicineresidentsintheSergeantetal.5study,34%agreedand43%disagreedthatsalesrepresentativesinfluencedtheirprescribinghabits.Inemergencymedicine,Keimetal.10foundthat75%ofprogrammedirectors,butonly 49% of residents, believed that marketing techniques affect residentsprescribing practices. Seventy per cent of the Canadian doctors surveyedbyStrangetal.13 agreed that sales representatives affectedphysiciansprescribinghabits. Thirtyone per cent of the internal medicine residency programmedirectors surveyed by Lichstein et al. were concerned, and 13% were very

concerned, about the impact of sales representatives on the attitudes andprescribing behaviours of their residents14. Most directors of family practiceresidencyprogrammesintheUSA(56%)feltthattheinformationandresources


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provided by sales representatives affected the prescribing of residents andpracticingdoctors17.

Bansinathetal.35statethatonly56%ofIndiancardiologistsreportthatmedical

sales

representatives

had

played

a

role

in

their

decisions

to

prescribe

brand

or

generic drugs. Sixtythree per cent of doctors in a Turkish city surveyedbyGldal and Semin27 felt that information from sales representatives did notinfluence their prescribing. Those who found information from salesrepresentativesreliabletendedtoreportthatthisinformationhadmoreinfluenceonthem.

American general practitioners surveyed by Pitt and Nel36 rated salesrepresentatives as the third most important influence on their prescribingdecisions,advertisementsas fifthandgiftsassixth.However, thisstudyhada

low

response

rate

and

excluded

journal

articles

in

the

list

of

possible

influences.

Clinical pharmacists involved in family medicine residency programmes,surveyedbyHume and Shaughnessy37, rated sales representatives, alongwithjournal articles, as the third most important source of drug informationinfluencingtheprescribingoffamilymedicineresidents.

InSigworthetal.s32studyofresidentdoctorsinVirginiain2000,91%reportedthat sales representatives had some effect on their prescribing. The authorssuggestthatthishighratecouldbetheresultofrecentpublicityanddiscussiononthese issues,althoughtheresidentshadnothadformaleducationalsessions

on

drug

promotion.

CONCLUSION: Many doctors denied that they were influenced by drugrepresentatives: in threestudiesofresidents34,49and91%believedtheywereaffected, in three groups of programme directors 75, 31 and 56% did so. Theavailabledatasuggestthatdoctorsmaybemorewillingtosaythatotherdoctorsareinfluencedthantheyarethemselves,butthisremainsahypothesis.

1.12 Dopeoplefeelthatacceptinggiftsinfluencesprescribing?

Most (56%) of the psychiatry trainees surveyedbyHodges felt that acceptinggiftsdidnot influence theirprescribing4. In theAldiretal. study6 fewdoctorsthought that a gift of a textbook influenced prescribing habits (less than 6%).Similarly, they felt that lunchesordinnersprovidedby the industryhad littleinfluence on them, although they did feel that free samples affected theirprescribing.InBarnesandHolcenbergsstudy,60%ofmedicalstudentsand75%of pharmacy students felt that promotional practices influenced prescribing7.PatientssurveyedbyBlakeandEarly8alsofeltthatgiftsfromthepharmaceuticalindustrytodoctorswerelikelytoinfluenceprescribing(6%saiditneverdid,18%

said

rarely,

43%

sometimes,

and

16%

frequently).

They

were

more

likely

to

disapprove of gifts (except free samples) if they felt that they influencedprescribing and increased cost. One limitation of this study was that many


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patientswereunawarethatsuchgiftsweregiven,sohad littletimetoconsidertheiropinionofthemwhilecompletingthequestionnaire.

EighteenpercentoftheTurkishdoctors inGldalandSeminsstudy27feltthat

gifts

strongly

affected

prescribing,

12%

felt

they

had

a

medium

effect,

44%

low,

and27%feltthattheyhadnoeffectonprescribing.

Madhaven et al.9, found that physiciansweremore likely to think that otherdoctors prescribingwasinfluencedbygifts,thanthattheirownwas.Theyalsofounddoctorswithmorepatientswerelesslikelytoagreethatmostdoctorsareinfluencedby gifts and less likely to think it is inappropriate to accept gifts.Banks and Mainous38 surveyed medical school faculty at the University ofKentucky,USA.Ofalistofgiftsgivenbysalesrepresentatives,nonewereseenasinfluencingprescribingbymorethanhalfoftherespondents,althoughpersonal

relationships

with

sales

representatives

were

seen

as

influencing

prescribing

by

66% of faculty. PhD staffweremore likely thanMD staff to think that giftsinfluenced prescribing, and to oppose the acceptance of gifts. Most internalmedicine faculty and residents surveyedbyMcKinney et al.16 felt thatdoctorscouldbecompromisedbyacceptinggifts(67%and77%).Howeversome(23%offaculty members and 15% of residents) believed that doctors could not becompromised regardless of the value of the gift received. In Cockerill andWilliams24surveyofOntariopharmacists,50%felttherewasaconflictofinterestinacceptingbenefitsfromthedrugindustry.Thoselicensedafter1980werelesslikelytothinkso.

CONCLUSION: Inmoststudiesmostdoctorsdenied that theywere influencedbygifts.Theavailabledatasuggestthatdoctorsmaybemorewillingtosaythatotherdoctorsareinfluencedthantheyarethemselvesbutthishypothesismeritsmoreresearch.Theonlystudyonpatientsattitudesfoundtheyweremorelikelyto disapprove of gifts (except free samples) if they felt that they influencedprescribing.

1.13 Ethicsandpromotion

SeventyfourpercentoftheemergencymedicineresidentssurveyedbyKeimetal.10feltthatsalesrepresentativessometimescrossedethicalboundariesbygivinggifts. Fourteen per cent of internal medicine residency programme directorsreportedobservingunethicalactivitiesbysalesrepresentatives10.Theseincludeddetailing in clinical areas, making false claims, giving monetary gifts, andconductingunauthorisedstudies.

AstudybyPoirieretal.39ofpeoplewhomakedecisionsaboutformulariesinUSprivate hospitals, found that most (93%) felt that providing nonmonetary

benefits

to

doctors

to

influence

formulary

decisions

or

product

use

was

unethical.

Therespondentsincludedchairsofpharmacologyandtherapeuticscommittees,directors of pharmacy, and pharmacists involved in evaluating drugs for


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inclusioninformularies.Morepharmaciststhandoctorsratedprovidingmealstoinfluencedecisionsasunethical(22%versus12%).

AUSstudybyLaPumaetal.40examinedpaymentstodoctorstoparticipate in

post

marketing

research

on

new

medicines.

Most

of

the

doctors

they

surveyed

(64%) felt itwas acceptable tobepaid a fee for eachpatient enrolled inpostmarketing research.Mostpatients (56%) felt that thiswasunacceptable.Fewerdoctorsthanpatientsfeltthatpatientsshouldbeinformedifthedoctorwasbeingpaidafeeperpatientenrolled(75%versus86%).

CONCLUSION:Only four studieshaveaddressed this issueandeachof themlooked at different aspects of the question, making it hard to draw anyconclusions.Fromonestudyitappearsthatdoctorsthinkthatitismoreethicaltoacceptfeesforenrollingpatientsinclinicaltrialsthandopatients.

1.14Attitudestodirecttoconsumeradvertisingofprescriptiondrugs

Since the introduction of directtoconsumer advertising of prescriptionmedicines (DTCA) in the USA in the 1980s, there have been phenomenalincreases in spendingon it.Oneestimatewas that in 1999,US$1.6billionwasspentonDTCA41.

Doctors

Petroshius et al.42 describe the results of a questionnaire delivered to doctors(general practitioners, family practitioners, internists and dermatologists) bysalesrepresentativesaspartoftheirnormalvisits.Theyfoundolderdoctorsandinterniststobe lesssupportiveofadvertisingofdrugsandcosmeticdrugsthanotherdoctors.ThiswasespeciallythecasewithDTCA.Thoseagedover50hadanegative response to DTCA (mean response was 2.84 on a scale from 1 forstrongly agree, to 5 for strongly disagree). The authors found that doctorsattitudestowardsDTCAweregoodpredictorsofwhethertheypaidattentiontosuchadvertisements,andhowtheysaidtheywouldrespondtopatientenquiriesand requests foradvertiseddrugs.This studyobviouslyexcludeddoctorswhodonotreceivesalesrepresentatives.

CutrerandPleilfoundlargelynegativeattitudestowardsDTCAofprescriptionmedicinesamongtheTexasdoctorstheysurveyed43.Howevertheirresponseratewas very low (17%).Doctors felt thatDTCAwould increase the demand fordrugs,andincreasequestioningbypatients.

LipskyandTaylor44 surveyeda2% sampleofactivemembersof theAmericanAcademyofFamilyPhysiciansabouttheirattitudestoDTCA.Doctorsreportedanaverageof6.9patients in theprevious sixmonthswho requesteda specificprescriptiondrug,althoughthearticleisnotexplicitaboutwhetherdoctorswereasked specifically about requests that resulted fromDTCA.Eightyper cent ofthose surveyedwere opposed to printDTCA and 84% opposed tobroadcast


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18

DTCA.While therewas some agreement about possible positive outcomes ofDTCA (56% agreed that it encourages patients to seek medical advice forconditions thatmay otherwise gountreated, and 73% that it alertspatients tonewproducts),therewasalsoconsensusaboutpossiblenegativeoutcomes(89%

disagreed

that

DTCA

enhances

the

doctor

patient

relationship,

71%

agreed

that

DTCApressuresdoctorstousedrugstheymightnotordinarilyuse,and72%feltDTCAdiscouragestheuseofgenerics).

CONCLUSION:DoctorsarelargelyopposedtoDTCA.

Consumers

Lipton, a public relations executive from the USA, reports on a survey ofconsumersattitudestoDTCA45.Themethodologyofthestudyisnotdescribed.Half of the people thought that DTCA would provide them with more

informationaboutprescriptiondrugs.Thosewhowerebettereducated,younger,andthosewithhigherincomeswerelesslikelytofeelthatDTCAwouldincreasetheirknowledgeaboutspecificdrugs.

Bell,KravitzandWilkes46surveyed329adults inSacramento,California,abouttheirawareness,knowledgeandattitudestoDTCA.Theyaskedwhetherpeoplerememberedadvertisementsfor10differentdrugs,andfoundrecognitionvariedbetween 8% and 72% for different drugs. Men reported seeing feweradvertisements than women. There was greater awareness of advertisementsamongst sufferersof the conditions treatedby the advertisedmedicines.More

positive attitudes to DTCA were correlated with greater awareness of DTCadvertisements.Theauthors found significantpublicmisconceptionsabout theregulatoryframeworkforDTCA.FiftypercentofrespondentsbelievedthatDTCadvertisementshad tobesubmitted to thegovernment forpriorapproval,43%thought that only completely safe prescription drugs couldbe advertised toconsumers,21%thoughtthatonlyextremelyeffectivedrugscouldbeadvertisedto consumers, and 22% thought the advertising of prescription drugs withserious sideeffects wasbanned. None of thesebeliefs are true. People fromminority ethnicgroupsweremoremisinformed thanwhites.PositiveattitudestowardsDTCAwerepositivelycorrelatedwiththesemisconceptions.

Prevention magazine carries out regular surveys which include consumersknowledge or and attitudes to DTCA. Telephone interviews with arepresentativesampleof1,222adultsintheUSAweredescribedinthe2000/2001report41. Lower levels of awareness of DTCA advertising (i.e., reporting everhavingseenaDTCadvertisement)were foundamongstethnicminorities, lowincomeconsumers,andthosenottakingprescriptionmedicines.Ninetyonepercentofrespondentsreportedhavingseenanadvertisementforatleastoneof10highly advertisedmedicines (such asClaritin,Xenical). Fiftysevenper centofconsumers thought DTCA gave them the necessary information to ask their

doctorsabouttherisksofthemedicines(62%foraskingaboutbenefits).


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MagazinePublishersofAmerica47surveyedallergysufferersintheUSA.Intheirsample,34%hadseenadvertisementsforallergymedicinesinmagazines,while36%hadseensuchadvertisementsonTV.Nineteenpercentwereabletoidentifythebrand foradvertisements ineachmedium.Since less is spentonmagazine

advertising

than

TV

advertising,

the

authors

argue

that

advertising

in

magazines

is more costeffective. They also report that the perceived believability ofadvertisements for medicines has declined since restrictions on DTCA wererelaxedin1997.

MaddoxandKatsanis48surveyedconsumersinaCanadiancitythatwasexposedtoDTCAadvertisingfromtheUSA.Theyconstructedtwoscenariosinvolvingafictitiousdrug.PatientswhoweregiventhescenariowheretheyheardaboutthedrugthroughDTCA,askedtheirdoctorforit,andreceivedaprescription,weremoreconfident in theirdoctors than thosewhosescenariowas that theyheard

about

the

medicine

from

their

doctor

first.

This

study

had

a

rather

low

response

rate,andthediscussionandconclusionsincludeassertionsthatdonotappeartobejustifiedbythefindings.

Rockwell describes the attitudes of a sample of viewers of a US cable TVchannel49.Heisthepresidentofthischannel,whichshowsprogrammesintendedforandadvertisedtohealthprofessionals.Advertisementsforprescriptiondrugshavebeenshownduringtheseprogrammessince1983.Theprogrammesprovedtobepopularwiththegeneralpublicwhosubscribedtothischannel.Asurveyofthe nonprofessional viewers of these programmes found that 95% of them

thought

DTCA

would

make

patients

aware

that

useful

treatments

exist.

Rockwell

suggests that negative public attitudes toDTCA found in other studies are aresultof fearof theunknown,but thosewhohavebeenexposed toDTCAarepositive towards it.However it seems untenable to assume that peoplewhowatch programmes intended for healthprofessionals are representative of thegeneralpopulation.

Alperstein andPeyrot50 surveyed 440people inBaltimore,USA.They found amoderatelevelofawarenessofDTCA.Thirtyfivepercentofpeoplehadheardof prescription drug advertising, and given a prompt, 42% were aware ofadvertisementsforSeldane(anantihistamine).MostrespondentsfeltthatDTCAcould help educate consumers (70%), while aminority agreed with possibleobjectionstoDTCA.Twentyeightpercentfeltitwouldconfuseconsumers,21%thataskingforanadvertisedproductwouldupsetadoctor,and12%thatDTCAwould weaken the doctorpatient relationship. Respondents of higher socioeconomicstatusweremoreawareofDTCAadvertising.Thosewhoweremoreawareoftheadvertisementswerelesslikelytobelievethatthedoctorshouldbethe sole source of information about drugs, that DTCA would confuseconsumers,andthatitwouldweakenthedoctorpatientrelationship.

CONCLUSION:MostoftheavailablestudiesreportmostlypositiveattitudestoDTCAamongstconsumers.Theapparentpositiveattitudescouldhaveresultedfrom theways the questionswere framed or thepopulationwere sampled or


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20

whoundertookthestudies.SocialandeducationaldifferencesseemtoinfluenceacceptanceofDTCA:thelesseducatedmayacceptitmorereadily.

Others

Mintzesandcolleagues51conductedamailsurveyofexpertsinNewZealand,theUSA andCanada, on their views ofDTCA, and the evidence that supportedtheseviews.(DTCAisallowedintheUSAandNewZealand,andCanadiansareexposed to significant crossborder broadcast DTCA). The experts includedpeople from health professional organizations, NGOs, government, thepharmaceuticalindustry,advertisingandthemedia.OpinionsaboutDTCAweredividedby sector. Those from the pharmaceutical and advertising industrieswereoverwhelminglypositive,patientrepresentativesshowedalesserdegreeofsupport, andother expertshadnegativeopinionsofDTCA.Most respondentsfeltthattheinformationDTCAprovidedaboutdrugrisksandbenefitswaspoor.

Respondents feltDTCA increased expenditure onmedicines,butbeliefs abouttheimpactondoctorpatientcommunicationvariedaccordingtosector.

Inanotherstudy,mostofthe97CanadianDrugDirectoratepersonnelsurveyed52believedthatmoreprescriptiondruginformationwasneededforconsumers,butonlyaquarterof these thoughtadvertisingwasanappropriatemechanism forthis.

AmonkarandLively53mailedasurveytopharmacistsinoneOhiocounty.Theirstudyachieveda low response rate.Fortytwopercentof respondentsdidnot

thinkDTCA on televisionwasbeneficial to consumers.Althoughmost (75%)thought that advertisingmay inform patients about available treatments, andsome(32%)thought itmay improvepatientpharmacistcontact,most(90%)feltthere shouldbeprior review of advertisementsby an independentpanel, andmost(87%)feltadvertisingwouldprobably leadpatientstopressuredoctorstoprescribeadvertiseddrugs.

CONCLUSION:SurveysofexpertsbeliefsaboutDTCAsuggestthatthebeliefsexpresseddependonwhat sector the expertbelongs to,with industry expertsexpressingpositivebeliefs,patientadvocateshavingmixedbeliefsandmedical

expertshavingnegativebeliefs.

1.15 Studiesofdifferencesinattitudestopromotion(excludingDTCA)

Peay and Peays 1984 study1 found two reasonably clear patterns amongstdoctors. Thosewho reported usingjournals as important information sourcesevaluated journals more highly and commercial sources lower than otherdoctors.Thosedoctorswhoreportedusingcommercialsourcesratedthesemorehighlyandjournalslowerthanotherdoctors.Therewasagroupofabout15%ofdoctorswhoconsistentlyandexclusively reliedoncommercialsourcesofdruginformation. Those who cited sales representatives as providing information


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21

needed toprescribemedicineswere older, and thosewho citedjournalswereyounger.

AlthoughLinn andDaviss study54wasdone in 196970, there isno reason to

believe

that

the

findings

are

not

still

relevant.

Linn

and

Davis

found

that

doctors

who preferred to use medical journals as a source of advice had moreconservative attitudes in other areas than those who preferred salesrepresentativesorotherdoctors.Theformerwere lesspositiveabouttheuseofnonmedical sources of advice (such as friends and family), and the use ofmedicinesinresponsetodailysocialstress.

Amongst theNew Zealand doctors surveyedby Thomson et al.20 thosewhoreported peer advicebeing less readily available reported seeingmore salesrepresentatives. Cockerill and Williams24 surveyed Ontario pharmacists and

found

that

60%

of

them

placed

no

restrictions

on

visits

from

sales

representatives.Howeverthosewhobecamelicensedafter1980weremorelikelytohave restrictions.AndaleebandTallman55surveyeddoctors in four teachinghospitalsinPennsylvaniaandfoundthatdoctorswhotreatedahighervolumeofpatientsweremorepositivetowardssalesrepresentatives.Theywerealsomorelikely to think that theyprovided informationalandeducational support.Thisstudy had a low response rate. Stinson andMueller56 carried out a survey ofAlabamahealthprofessionals,whichincluded309doctorsaswellasotherhealthprofessionals. They found that doctors with more years of professionalexperiencereportedusingsalesrepresentativesandunsolicitedmedicalliterature

more

often

than

others,

and

that

general

or

family

practitioners

reported

using

themmorethanotherspecialists.

Evans andBeltramini57 found in their survey that respondentGPsweremorelikely tosolicit informationaboutprescriptiondrugs fromsales representativesthan specialists were, and that older doctors were more likely to use salesrepresentatives for information thanyoungerdoctors.Overall thedoctors theysurveyedpreferrednonindustrysourcesofprescriptiondrug information.Thisstudyhadalowresponserate,andresponsebiaswasnotassessed.

County doctors in Oppenheim et al.s study58 tended to rely more on salesrepresentativesasasourceofinformationonprices,comparedtootherdoctors;county physicians and faculty members had limited knowledge of medicinepricesandtendedtooverestimatethem.MillerandBlumalsofoundthatdoctorshad limitedknowledgeof thepriceofadvertisedprescriptionmedicines59.Thisstudy of doctors attending a continuingmedical education event had a lowresponserate.

Santell et al.60 surveyed hospital pharmacy directors and sales directors ofpharmaceuticalmanufacturing firms about the role of sales representatives inhospitals.The response ratewas low,particularly for the salesdirectors.Mostsales directors thought that sales representatives met the needs of hospitalpharmacistsmore than 80% of the time,butmosthospitalpharmacydirectors


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22

thoughttheyweremet lessthan61%ofthetime.Therewasdisagreementbothaboutwhatserviceswereimportantandhowoftentheywereprovided.

Hull andMarshall61 report on an international study ofGPs sources of drug

information.

They

claim

that

sales

representatives

are

seen

as

very

important

in

Sweden, Finland and Yugoslavia (now Serbia and Montenegro) and notimportantintheUKandBelgium.Thereareverylownumbersinthestudy,andnodetailsaregivenabouttheselectionprocess,sotheresultsshouldbeviewedwithagreatdealof caution.However, the study raises the important issueofpotentiallylargenationaldifferencesinattitudestopromotion,whichshouldbetakenintoaccountwhendesigninginterventions.

CONCLUSION:Doctorsappear to fall intodifferentgroupswith regard to themost used sources of drug information. The available evidence suggests that

those

who

rely

more

on

information

from

industry

tend

to

be

older,

less

conservative,seemorepatients,aregeneralistsratherthanspecialists,have lessaccess to peer support andmore positive attitudes to the use of drugs. Thefinding that older doctors and general practitioners rely more heavily oncommercial sources of information comes from multiple sources but otherobservationsaboutdifferencesbetweenthoseusingnonindustryversusindustrysourceslackconfirmatoryevidencefrommorethanonestudy.

Summaryofconclusions

Doctors attitudes to promotion vary, and do not necessarily match theirbehaviour.Theiropinionsdifferonthevalueofsalesrepresentatives,onwhetherthey shouldbebanned duringmedical training and onwhether doctors areadequatelytrainedtointeractwiththem.

Mostdoctors think information frompharmaceutical companies isbiased,butmany think it is useful. Health professionals find small gifts from drugcompanies acceptable.Mostbelieve that drug representatives or gifts do notinfluencethempersonally,butdoinfluencemanycolleagues.Fewpatientsknow

that

doctors

receive

promotional

gifts,

and

so

few

disapprove.

Doctorswho rely on promotion tend tobe older, less conservative, seemorepatients,aregeneralpractitionersratherthanspecialists,havelessaccesstopeersandhaveamorepositiveattitudetowardsmedicines.

OpinionsaboutDTCAaremixed.Mostcompanies,theadvertisingindustryandthemediafavourit,whiledoctorsandothers(e.g.government,NGOsandhealthprofessional organizations) generally oppose it. Consumers and patients aredivided: some, especially the less educated,wouldwelcomemore information

from

whatever

source,

while

others

distrust

commercial

bias.


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34/102


24

Qualitative researchcouldalsohelp toexplorewhat survey respondentsmeanwhentheysaythattheyorothersareinfluencedbypromotion.Dotheyincludeinformed (i.e. a positivemeaning) or do they interpret the question tomeanundulyornegativelyinfluenced?

Ethnographic research, which examines medical subcultures, would alsobeextremely helpful in exploring attitudes to promotion. It appears that doctorsvary substantially in their views of, and use of, promotion. How do thesedifferencescomeabout?Whatunderlies them?Do they reflectoveralldifferentpolitical and social views?Are they reflected in different social organizations(such as professional organizations, social networks, etc)?Whatbrings aboutchanges in thesevalues?Dodoctorsmovebetween themduring theirworkinglives?Whatfactorsenhanceorimpedethismovement?


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Review 2

25

Review 2.

What impact does pharmaceuticalpromotion have on attitudes and

knowledge?

Manydescriptivestudiesclearlyshowthatmuchpromotionalmaterialcontainsinaccuracies,oratleastpresentsveryselectiveaccountsoftheevidenceaboutthedrugpresented62,63,64.Thequestionthisreviewaddressesiswhetherandhowfarpromotion (including these inaccuracies andbiases) affects the attitudes and

knowledgeofthosewhoareexposedtoit.

Verylittleresearchhaslookedspecificallyattheeffectofpromotiononattitudes,muchmore has examined the effect of promotion on knowledge. The studiesherearepartofa fieldof research into thedeterminantsofprescribing howdoctorslearnaboutdrugs,andhowtheycometoprescribenewproducts.

Mostofthestudiesdiscussedinthisreviewarereallyabouthowmuchdoctorsreport using promotion as a source of information (either for all drugs, orparticularlyfornewdrugs)ratherthanabouteffectsofpromotiononattitudesor

knowledge.Theyareincludedbecausetheyprovideinformationrelevanttothequestionofwhetherpromotionaffectsprescribersknowledge.

Some studies look directly at the impact of promotion on attitudes andknowledge,byusinganexperimentalapproach65,by interviewingpeopleaboutprevious exposure66, orby followingup participants in apromotional event67.Othersapproachthequestioninamoresophisticatedorindirectway.Ziegleretal.62lookatwhetherdoctorsnoticeandremembererrorsinpromotion.Sansgiryet al.68 look at whether consumers are aware of information missing fromadvertisements.Others63,64lookatdoctorsattitudesorknowledgeinareaswhere

there isdisagreementbetween commercial and scientific information and inferthe impactofpromotionfromthis.Ferryetal.69directlyassessedknowledgeofprescribingfortheelderlyandlookedatitinrelationtoselfassessedrelianceonpromotion.

Themethods that havebeen used in this area are not capable of producingcertainty about causal relationships. Firstlyboth exposure to promotion, andknowledgeandattitudesaboutdrugs,areoftenassessedusingselfreportdata.Secondly therelationshipbetweenthem isoftenalsoassessedusingselfreport.That is, doctors are asked how much their prescribing is influenced by

promotion. Selfreport canbemisleadingwhen doctorsbeliefs are inaccurate(e.g., theymaybelieve that theyareexposed lessoften than theyare),orwhen


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26

their answers to questions arebiased towardsbeingmore socially acceptablethanwhattheyreallybelieve.

2.1Reporteduseofpromotionasasourceofdruginformation

In a 1974 FDA survey in the USA, 64% of all doctors, and 80% ofGPs andpaediatriciansreportedusingmaterialsfromsalesrepresentativesasasourceofdrug information. Fifty per cent of doctors reported using journaladvertisements70.ChristensenandWertheimer71foundthatsalesrepresentativeswerereportedtobethefirstsourceofinformationforoneofthetwodrugstheystudied.Advertisements injournalswere the third source for theotherdrugs.Thissmallstudy(29doctors)isnowveryold(19756).

Two

studies

found

doctors

in

developing

countries

relied

very

heavily

on

industrybased sources of information.Ahmad and Bhutta72 found 95% of thedoctors they interviewed inKarachi reliedupon industrypromotionalmaterialastheirmainsourceofinformationaboutdrugs.Theyalsofoundextremelyhighlevels of irrationalprescribing anddispensing for children. Similarly,TomsonandAngunawela73describeheavy relianceon industry sourcesof information,and much polypharmacy in a peripheral clinic in Sri Lanka. In contrast, inOsiobes twoNigerian studies74,75 health professionals and health professionalfacultymembersreportedlowuseofcommercialinformation.

Some

differences

have

been

described

between

different

kinds

of

drug

information, andover time. InHatton et al.s study sales representativeswereusedmoreasasourceofgeneralinformationaboutdrugsratherthanpregnancyrelated information76.WilliamsandHensel77claim from their reviewof studieson sourcesof informationaboutdrugs, thatcommercial sourcesof informationhaddeclinedinimportanceovertime.Theydonotdescribethesearchmethodsthattheyusedtolocatethearticlesincludedintheirreview.Thestudiesincludedinthisreviewwereallsurveysandsocialacceptabilitybiascouldbethecauseoftheresults,i.e.overtimeitmayhavebecomelessacceptabletoclaimrelianceoncommercialsourcesofinformation.

Somestudieshaveexploreddifferencesbetweendoctorsinhowfartheysaytheyrelyoncommercialsourcesofdruginformation.InMcCueetal.sstudy3doctorswhohadbeenpracticingmorethan15yearsuseddrugsalesrepresentativesasasourceofinformationaboutnewdrugsmorefrequentlythanotherdoctorsdid.In Abate et al.s study78 academic medicine physicians used drug industrysourcesfortheirdruginformationquestionslessthanprivatepracticephysiciansdid. Drug sales representatives were rated the most important source ofinformationaboutadvancesinantirheumaticdrugsbydoctorswhoqualifiedinthe1950s,thesecondmostimportantbythosewhoqualified inorafter1960in

Murray

Lyons

study

of

GPs

in

Scotland79

.

Gaither

et

al.80

found

that,

among

the

108MichiganHealthMaintenanceOrganization (HMO)doctors theysurveyed,those who were not Board certified weremore likely to intend to use sales


37/102

Review 2

27

representativesand literaturefromthepharmaceutical industrythanothers, forinformation about a fictitious new drug. Also those with more than fivecolleaguesattheirworksitewerelesslikelytouseindustryliterature.

CONCLUSION:

Doctors

own

reports

suggest

that

promotion

is

often

used

as

a

sourceofdrug information, less sobydoctorswhoqualifiedmore recentlyorwhopracticeinanacademicratherthanaprivatesetting.

2.2 Reported use of promotion as a source of information in adopting

newmedicines

HibberdandMeadows81found85%oftheUKdoctorstheyinterviewedsaidtheyusedMIMS(acommercialsource)tolearnaboutnewdrugs,butmostusednon

commercial sources to findout about efficacy. Similarly, theBritishdoctors inEaton andParishs study82 reported using sales representatives as a source ofinformationaboutnewmedicines,butrelyingonthemlesstoestablishwhetheramedicinewasusefulandshouldbeprescribed.

Ina studyofBritishGPs,byStricklandHodgeandJepson83, three commercialsourceswere rated in the top five sources used to alert respondents of newmedicines,but five professional sourceswere themost popular for providinginformation to evaluate medicines. GPs who worked alone cited salesrepresentativesasasourceofinformationforevaluatingdrugsmoreoftenthan

GPswhoworkedingrouppractices.

InPeayandPeays1994paper84aboutspecialistsandhighriskmedicines, theyfound that commercial sources of information played little or no role in theadoptionofdrugsinthedoctorsprimaryareaofexpertise,butsuggestthatthesesourcesmayprovideinformationaboutnewdrugsoutsidethisareaofexpertise.

ManningandDenson85lookedathowUSinternalmedicinespecialistsfirstlearntaboutcimetidine.TheirstudywasperformedsoonaftercimetidinewaslaunchedintheUSAin1977.Salesrepresentativeswereratedasthesixthorseventhmost

commonly mentioned source in each stage of learning about cimetidine.However advertisements declined in importance. Theywere the eighthmostcommonsourceforfirstknowledgeofthedrug,tenthforlearningprinciplesofusingit,andthirteenthforprovidingupdateinformation.

Parboosinghetal.86inCanadainterviewedspecialistsattendingannualscientificmeetingsandaskedthemtoidentifytwoorthreechangestheyhadmadeintheirclinicalpractice inthelasttwoyears,andthefactorsinvolvedinthesechanges.Eightyone of the 192 changes made were changes in prescribing. Salesrepresentativeswerenotedasinitialsourcesofinformationforlessthan20%of

thechanges,andveryinfrequentlynotedasprecipitatingthechanges.Likeotherstudies, this suggests that commercial informationmaybemore important in


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28

alertingdoctorstodrugs,andlessimportantinlaterstagesofdecisionstoadoptnewmedicines.

Williamson87drawsonliteratureonriskassessmenttoexamineGPprescribingof

new

drugs.

He

concludes

that

the

level

of

risk

which

a

doctor

perceives

determineshowmuchexternalvalidationheorsherequiresinordertoprescribethedrug.Fromasmallsurvey,Kleinmanclaimstoshowthatdoctorspreferredinformation sourcesvarywith theperceived riskinessofmedicines.He arguesthatsalesrepresentativesare themost importantsource for lowriskdrugs,butarelessimportantforhigherriskdrugs.Bothstudiesaretoo limitedtoprovideconclusiveevidencebuttheirtheorydeservesmoretestingandtheirapproachofdrawing on other social science literature is one that other researchers shouldfollow.

A

US

survey

of

680

doctors88

found

that

9%

of

doctors

rarely

or

never

met

with

sales representatives. The study suggested that documented evidence of aproductsefficacyandapplicationswasthemajorfactor indoctorsdecisionstoswitch or increase the frequency of aparticularmedication. The report of thesurveyinPharmaceuticalExecutiveprovidesnodetailaboutthemethodsusedsothestudyishardtoevaluate.

Inoneofthefewqualitativestudiesonpromotion,Jonesetal.89 interviewed38consultants in Birmingham hospitals in the UK, and 56 GPs who regularlyreferredpatientstotheteachinghospital.Theyalsomonitoredtheprescribingof

specific

drugs

by

the

GPs,

and

in

the

hospital.

They

reported

that

sales

representatives were an important source of information for both GPs andspecialists.Jones et al. suggest that prescribers were not consistent in theirdefinition of prescribing a new drug. Theywere unsurewhether thismeantadding this drug to their regular prescribing repertoire, or whether it couldinvolveprescribingitonlyafewtimes.Inaddition,GPswereunsurewhethertoinclude new medicines that they were prescribingbecause the hospital hadstarted a patient on them. This suggests definitions need tobe very clear inquantitativestudiesinthisarea,sothatresultsareconsistent.

CONCLUSION:Selfreportsindicatethatpromotionisoftenusedasasourceofinformationaboutnewdrugs,especiallyforindicationsforwhichthedoctorhaslessexpertise.

2.3 Impactofpromotiononselfreportedattitudesandknowledge

Engle65carriedoutalargestudyontheeffectofasingleadvertiserpublicationondoctors attitudes and expected prescribing behaviour. Four firsteditionhardcoverbooks, about 100 pages longweremailed, one at a time, to 19,200

doctors.

These

were

on

topics

related

to

medicine

but

were

mostly

non

technical

and enjoyable to read.Thebooks each included 18pages of advertising for abroadspectrumantibiotic.Questionnairesweresenttorandomselectionsof1200


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Review 2

29

ofthedoctors45daysbeforethefirstbookwassent,andaboutonemonthaftereach of the otherbookswas sent.Engle compared the attitudes and expectedprescribingofreaders(thosewhohadreadatleastonebook,thosewhohadreadat least twobooks)withnonreaders (baselineand thosewhohadnot received

the

books).

Readers

were

significantly

more

positive

toward

the

company

that

sentthebooksthannonreaders,butnotmorepositivetowardothercompanies.Readersweremorelikelytoexpecttheirfrequencyofprescribingthecompanysproduct to increase.Thiswas statistically significantand seemed toaffectonlythe sponsors product. Engle suggests that the campaign may have beensuccessfulbecausethebookswereprobablyreadcovertocover,unliketechnicaljournals. This large and ambitious study provides before and after studyevidence that a promotional campaign can significantly affect prescribersattitudes.Thestudydesigncouldhavebeenimprovedbyincludingarandomlyselectedcontrolgroup.

Sandberg et al.66 present evidence that students given textbooks bypharmaceutical sales representativesareunlikely to remember thenameof thecompanyoritsproducts.Theyinterviewed205fourthyearmedicalstudents,ofwhom 90% had received one ormore textbooks from companies.Most couldrememberthetitleofthebook,butonly25%couldrememberthecompanyoraproductassociatedwith thegift.Mostof thestudentswere interviewedduringtheirpersonalinterviewforadmissiontoaresidency.Thisseemsafarfromidealinterview situation. Studentsmayhavebeenvery nervous and thismay haveaffected their recall,and theyare likely tohavehadastrongdesire togive the

answer

that

they

thought

the

interviewer

wanted.

More

importantly,

this

study

didnotexploreoneof thekeypointsaboutgivinggifts tostudents. It is likelythattheeffectsofgiftsonstudentsincludeestablishinghabits,e.g.awillingnessto receive gifts and the development of positive attitudes towards drugcompanies.Becauseprescribingcannotbe influenced immediately, thememoryofthelinkbetweenagiftandaspecificproductorcompanyislessimportant.

Spingarn et al.67 found that house staffwhohad attended aGrandRound onLyme disease, presented by a drug company, were more likely than n

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