Conflict of Conflict of Interest Interest

CurriculumCurriculumEric Jackson, PharmDEric Jackson, PharmD

University of Connecticut School of University of Connecticut School of MedicineMedicine

Department of Family MedicineDepartment of Family Medicine

DisclosureDisclosure

I currently have no relationships I currently have no relationships of any kind with any company of any kind with any company whose products or services in whose products or services in

any way relate to the practice of any way relate to the practice of medicine, medical education or medicine, medical education or

research.research.

Importance of TopicImportance of Topic

Our Institution’s COI Policy applies Our Institution’s COI Policy applies to both GME and UMEto both GME and UME

Implementation of the ACA and need Implementation of the ACA and need for faculty to comply with Open for faculty to comply with Open Payments (Physician Payments Payments (Physician Payments Sunshine Act)Sunshine Act)

Need to address the so-called Need to address the so-called “Hidden Curriculum”“Hidden Curriculum”

Topics to CoverTopics to Cover Resources for crafting & implementing Resources for crafting & implementing

strong COI policies & curricula at strong COI policies & curricula at medical schools & academic medical medical schools & academic medical centerscenters

Open Payments Program (PPSA)Open Payments Program (PPSA) University of Connecticut SOM University of Connecticut SOM

Conflict of Interest PolicyConflict of Interest Policy Conflict of Interest CurriculumConflict of Interest Curriculum

AMSA PharmFree (AMSA PharmFree (Just MedicineJust Medicine) ) InitiativeInitiative

““Hidden” CurriculumHidden” Curriculum

RESOURCESRESOURCES

Crafting and Implementing Crafting and Implementing Strong COI PoliciesStrong COI Policies

The Prescription Project The Prescription Project Advancing Medical Practice and Advancing Medical Practice and

PolicyPolicy Launched by the Launched by the Pew Charitable TrustsPew Charitable Trusts in in

2007.2007. Led by Led by Community CatalystCommunity Catalyst in partnership in partnership

with the Institute on Medicine as a Profession. with the Institute on Medicine as a Profession.

Promotes policy change among:Promotes policy change among: Academic Medical CentersAcademic Medical Centers Professional Medical SocietiesProfessional Medical Societies Public and Private payersPublic and Private payers

Seeks toSeeks to Eliminate COIEliminate COI created by industry marketing and created by industry marketing and Expand the use of Expand the use of evidence-based medicineevidence-based medicine

Policy Guide for Academic Policy Guide for Academic Medical Centers and Medical Centers and

Medical SchoolsMedical Schools**

Conflict of Interest ToolkitConflict of Interest Toolkit CompetenciesCompetencies

Accept the fact that marketing by Accept the fact that marketing by pharmaceutical and medical device pharmaceutical and medical device manufacturers is designed to influence manufacturers is designed to influence physician behaviorphysician behavior

Recognize when marketing is occurring, even in Recognize when marketing is occurring, even in the guise of educationthe guise of education

Acknowledge one’s own COI when unavoidableAcknowledge one’s own COI when unavoidable Effective Teaching MethodsEffective Teaching Methods Teaching OpportunitiesTeaching Opportunities

**March 2013/Conflict-of-Interest Curricula/Community CatalystMarch 2013/Conflict-of-Interest Curricula/Community Catalyst

COI Curriculum Toolkit - COI Curriculum Toolkit - continuedcontinued

The general competenciesThe general competencies can be can be taught in specific domains including taught in specific domains including practices related to:practices related to: Small giftsSmall gifts Pharmaceutical samplesPharmaceutical samples CMECME Speakers bureausSpeakers bureaus Ghostwriting and ‘honorary’ authorshipGhostwriting and ‘honorary’ authorship Purchasing/vendor relationshipsPurchasing/vendor relationships Consulting & research contracts with Consulting & research contracts with

pharmaceutical & medical device companiespharmaceutical & medical device companies

Attitudes About GiftsAttitudes About Gifts

““That stuff doesn’t influence me at all. I don’t That stuff doesn’t influence me at all. I don’t even remember the name of the drug on my even remember the name of the drug on my pen.”pen.”

• 85% of medical students in one study believed it 85% of medical students in one study believed it improper for politicians to accept a gift.improper for politicians to accept a gift.

• Only 46% thought it improper for them to accept Only 46% thought it improper for them to accept gifts of similar value from a drug company.gifts of similar value from a drug company.

Palmisano P et al. J Med Edu 1980;55:453-5.Palmisano P et al. J Med Edu 1980;55:453-5.

US Pharmaceutical Facts US Pharmaceutical Facts - 2001- 2001

Source: www.nofreelunch.orgSource: www.nofreelunch.org• The “research-based” drug industry spent > The “research-based” drug industry spent >

$15.5 billion on promotion - more than it $15.5 billion on promotion - more than it spent on R&Dspent on R&D

• 22% employed in R&D vs. 39% in marketing22% employed in R&D vs. 39% in marketing• 60 million “details” made by 83,000 drug reps60 million “details” made by 83,000 drug reps

• 1,300 reps added by Astra-Zeneca for Nexium1,300 reps added by Astra-Zeneca for Nexium

• > $10,000 per year is spent by the > $10,000 per year is spent by the pharmaceutical industry on each US pharmaceutical industry on each US physician.physician.

• Nearly one PR for every 11 practicing MDs.Nearly one PR for every 11 practicing MDs.

How Does Pharma Market Its How Does Pharma Market Its Drugs & How Much Does it Drugs & How Much Does it

Spend?Spend?

CME vs. Pharmaceutical CME vs. Pharmaceutical MarketingMarketing

• ““Medical education Medical education is a powerful is a powerful tool that can deliver your message to tool that can deliver your message to key audiences and get those key audiences and get those audiences to take action that audiences to take action that benefits your product.”benefits your product.”

Spokesman for a Medical Education and Spokesman for a Medical Education and Communication Company (MECC)Communication Company (MECC)

COI Curriculum Toolkit - COI Curriculum Toolkit - continuedcontinued

Effective Teaching MethodsEffective Teaching Methods Lecturing - least effective/most often used (84%)Lecturing - least effective/most often used (84%) Small group discussions using case-based Small group discussions using case-based

examples more likely to be effective.examples more likely to be effective. Teaching OpportunitiesTeaching Opportunities

Early on emphasizes importance by the facultyEarly on emphasizes importance by the faculty Orientation Orientation Courses on Ethics and “Doctoring’Courses on Ethics and “Doctoring’

Just before students begin their 3Just before students begin their 3rdrd year year clerkshipsclerkships

In 4In 4thth year after students finish residency year after students finish residency interviews but before match results are knowninterviews but before match results are known

Residency TrainingResidency Training ““No Free Lunch” & supervised encounters with No Free Lunch” & supervised encounters with

MSR’sMSR’s

Open PaymentsOpen PaymentsOpen Payments website: Open Payments website:

go.cms.gov/openpaymentsgo.cms.gov/openpayments Will create greater transparency around the Will create greater transparency around the

financial relationships of manufacturers, financial relationships of manufacturers, physicians, and teaching hospitals physicians, and teaching hospitals Makes no assumptions nor draws conclusions Makes no assumptions nor draws conclusions

about information being collected & reported by about information being collected & reported by industryindustry

Provides an opportunity for providers & institutions Provides an opportunity for providers & institutions to check the accuracy of info reported about themto check the accuracy of info reported about them

Access to preliminary data begins in August 2014Access to preliminary data begins in August 2014 Release dates:Release dates:

Aggregate data - September 30, 2014Aggregate data - September 30, 2014 Detailed data on individuals - January 31, 2015Detailed data on individuals - January 31, 2015

UConn SOMUConn SOMConflict of Interest Policy*Conflict of Interest Policy*

Purpose: to define parameters of Purpose: to define parameters of appropriate interactions between appropriate interactions between students & faculty with industry students & faculty with industry representatives.representatives.

Liaison Committee on Medical Liaison Committee on Medical Education requires Education requires affiliation affiliation agreements with voluntary physiciansagreements with voluntary physicians..

Adherence to this policy is expected Adherence to this policy is expected in in all educational settings.all educational settings.

**Included in Academic Policies and Procedures Manual – Updated 7/3/13Included in Academic Policies and Procedures Manual – Updated 7/3/13

COI Policy StatementCOI Policy Statement

Any interaction between members Any interaction between members involved with the undergraduate involved with the undergraduate medical education program and medical education program and

industry representatives industry representatives which are which are or could be perceived as COI’sor could be perceived as COI’s must must

be disclosed and appropriately be disclosed and appropriately managedmanaged

Scope of PolicyScope of Policy

Gifts & MealsGifts & Meals Consulting Consulting

RelationshipsRelationships Industry Sponsored Industry Sponsored

SpeakersSpeakers DisclosureDisclosure Pharmaceutical Pharmaceutical

SamplesSamples Purchasing & Purchasing &

FormulariesFormularies

Industry Sales RepsIndustry Sales Reps Attendance at Attendance at

Industry-Sponsored Industry-Sponsored Lectures & MeetingsLectures & Meetings

Industry Support for Industry Support for Scholarships Scholarships Funds for TraineesFunds for Trainees

Disclosure Disclosure requirement in SOM requirement in SOM CurriculumCurriculum

UConn SOMUConn SOMConflict Of Interest Conflict Of Interest

CurriculumCurriculum COI covered inCOI covered in

OrientationOrientation Human Development & HealthHuman Development & Health PCM 1PCM 1

Student Professional CompetencyStudent Professional Competency**

Ability to identify potential COI’s arising Ability to identify potential COI’s arising fromfrom The influence of marketing & advertisingThe influence of marketing & advertising Financial & organizational arrangementsFinancial & organizational arrangements

*Included under ‘Integrity’ in the Code of Professionalism for Medical *Included under ‘Integrity’ in the Code of Professionalism for Medical StudentsStudents

OrientationOrientation

Planned for next yearPlanned for next year One hour session using team-based One hour session using team-based

learning to assess initial learning to assess initial understanding, provide some learning understanding, provide some learning materials, have students work as a materials, have students work as a team through a typical case that they team through a typical case that they may encounter as a first year student, may encounter as a first year student, and then to end with a post-test. and then to end with a post-test.

Goal: provide a brief introduction to Goal: provide a brief introduction to COI issues before students begin SCP. COI issues before students begin SCP.

Human Development & Human Development & HealthHealth

Year 1: Health Law & EthicsYear 1: Health Law & Ethics First session (2 hours): First session (2 hours):

Introduction & Overview of HLEIntroduction & Overview of HLE Doctors, Patients & SocietyDoctors, Patients & Society

One Goal: One Goal: Recognize legal & ethical issuesRecognize legal & ethical issues as part of as part of

dynamic relationships between doctor-dynamic relationships between doctor-patient and doctor-societypatient and doctor-society

Assigned Reading for first sessionAssigned Reading for first session ACP Ethics Manual: Ann Intern Med ACP Ethics Manual: Ann Intern Med

2012;156:73-104.2012;156:73-104.

ACP Ethics Manual, 6ACP Ethics Manual, 6thth EditionEdition

Physician-Industry Relations & Physician-Industry Relations & GiftsGiftsDetermining AppropriatenessDetermining Appropriateness

• What is the What is the purposepurpose of the industry offer? of the industry offer?• What would my What would my patients or the publicpatients or the public think think

about this arrangement?about this arrangement?• What would my What would my colleaguescolleagues think about this think about this

arrangement?arrangement?• What would What would I think if my own physicianI think if my own physician

accepted this offer?accepted this offer?• How would I feel if the relationship was How would I feel if the relationship was

disclosed through the media? disclosed through the media? “Sunshine “Sunshine Test”Test”

Human Development & Human Development & HealthHealth

Year 2: Pharmaceutical Law & Year 2: Pharmaceutical Law & PolicyPolicy Part 1Part 1: Regulation of drug development, : Regulation of drug development,

intellectual property & costs of pharmaceuticalsintellectual property & costs of pharmaceuticals Deals with intellectual property and drug approval Deals with intellectual property and drug approval

processes processes Drug licensing & approval process aims to insure Drug licensing & approval process aims to insure

safety & efficacy while protecting the interests safety & efficacy while protecting the interests (patents) of developers.(patents) of developers.

Part 2Part 2: Industry-provider Relationships & COI’s: Industry-provider Relationships & COI’s Health industry behaviors that create COI’sHealth industry behaviors that create COI’s UnderstandUnderstand the effects of industry marketing on the effects of industry marketing on

physician education & practice andphysician education & practice and Marketing’s relationship to medical professionalismMarketing’s relationship to medical professionalism

** Both parts are required for top score on Curriculum in AMSA Scorecard Both parts are required for top score on Curriculum in AMSA Scorecard

PCM 1PCM 1

Group discussion using scenarios to get Group discussion using scenarios to get students thinking about the complexities of students thinking about the complexities of clinician-pharmaceutical industry clinician-pharmaceutical industry interactions.interactions. Most students interact with Pharm reps from the Most students interact with Pharm reps from the

moment they start having clinical encounters & moment they start having clinical encounters & have seen the gifts (big & small) reps leave at have seen the gifts (big & small) reps leave at clinical sites.clinical sites.

One scenario has a student reporting to his SCP on One scenario has a student reporting to his SCP on a Tuesday afternoon just in time for lunch a Tuesday afternoon just in time for lunch provided by a rep detailing his new BP lowering provided by a rep detailing his new BP lowering med “Tekturna” med “Tekturna”

Pharm Rep Lunch Pharm Rep Lunch ScenarioScenario

Should the student Should the student Politely decline lunch & listen to the talk?Politely decline lunch & listen to the talk? Enjoy the food & listen to the talk?Enjoy the food & listen to the talk?

Subsequent discussion with preceptor Subsequent discussion with preceptor aboutabout Validity of info provided about the Validity of info provided about the

medicationmedication Relevance of info to a specific patient Relevance of info to a specific patient

encounteredencountered Pros & Cons of using samplesPros & Cons of using samples

Revitalizing ProfessionalismRevitalizing ProfessionalismAMSA’s PharmFree InitiativeAMSA’s PharmFree Initiative

Revitalizing ProfessionalismRevitalizing ProfessionalismAMSA’s AMSA’s

““Just Medicine”Just Medicine” Initiative Initiative

AMSA Just Medicine AMSA Just Medicine Campaign Campaign

Established in 2002 to advocate forEstablished in 2002 to advocate for Evidence-based rather than Evidence-based rather than

marketing-based prescribing practicemarketing-based prescribing practice Global access to essential medicinesGlobal access to essential medicines Removal of conflicts of interest in Removal of conflicts of interest in

medicinemedicine Name changed to Name changed to “Just Medicine” “Just Medicine” as it as it

addresses much more than COIs. addresses much more than COIs.

Just Medicine ScorecardJust Medicine Scorecard(AMSA & The Pew Charitable (AMSA & The Pew Charitable

Trusts)Trusts) First released in 2007, revised in 2008First released in 2007, revised in 2008 Letter grade assigned to COI Policies at Letter grade assigned to COI Policies at

AMC’sAMC’s Based on implementation of recommendations Based on implementation of recommendations

in the AAMC Report on Industry Funding of in the AAMC Report on Industry Funding of Medical Education to mitigate/eliminate COI’s.Medical Education to mitigate/eliminate COI’s.

Schools adopting ‘strong’ policies (A or B)Schools adopting ‘strong’ policies (A or B) 30% in 200930% in 2009 72% in 2013 !!72% in 2013 !!

We received a ‘B’ on the 2013 ScorecardWe received a ‘B’ on the 2013 Scorecard

AMSA Scorecard 2013AMSA Scorecard 2013UConn SOM CommentaryUConn SOM Commentary

Policy significantly improved & is Policy significantly improved & is fairly strong overallfairly strong overall

Model domains:Model domains: Gifts & Meals Gifts & Meals Purchasing & FormulariesPurchasing & Formularies Industry Support for Industry Support for

Scholarships/Funds for trainees Scholarships/Funds for trainees Medical School Curriculum*Medical School Curriculum* Policies specify an oversight mechanismPolicies specify an oversight mechanism

AMSA Scorecard 2013AMSA Scorecard 2013UConn SOM CommentaryUConn SOM Commentary

Recommendations for improvement:Recommendations for improvement: Address consulting relationshipsAddress consulting relationships

Policy seems mainly aimed at trainee Policy seems mainly aimed at trainee interactions with industryinteractions with industry

Does not address consulting relationshipsDoes not address consulting relationships Address explicit policies regarding off-site Address explicit policies regarding off-site

education supported by industry.education supported by industry. Rather than asking trainees to pay attention Rather than asking trainees to pay attention

to who funds the offsite event,to who funds the offsite event, Just prohibit attendance at all industry-Just prohibit attendance at all industry-

supported eventssupported events

Scorecard Grade Looks Scorecard Grade Looks GoodGood

But What About the “Hidden But What About the “Hidden Curriculum”?Curriculum”? During the clinical years of medical During the clinical years of medical

school, students often see concerning school, students often see concerning interactions, opinions, & expectations interactions, opinions, & expectations when it comes to when it comes to attending/resident/student interactions attending/resident/student interactions & relationships with industry. & relationships with industry.

The AMSA Scorecard project was born The AMSA Scorecard project was born from these concerns when a few med from these concerns when a few med students thought, ‘I wonder if medical students thought, ‘I wonder if medical schools have specific COI policies”.schools have specific COI policies”.

Hidden CurriculumHidden Curriculum

Trainees tend to do as we do, not as Trainees tend to do as we do, not as we say.we say.

Actions speak louder than wordsActions speak louder than words COI Curriculum should be reflected COI Curriculum should be reflected

in all of our academic & clinical in all of our academic & clinical activitiesactivities

Just Medicine FellowJust Medicine FellowComment on the ScorecardComment on the Scorecard

““My hope is that pre-med My hope is that pre-med applicants look at the applicants look at the

Scorecard to gauge the Scorecard to gauge the values and interests of the values and interests of the medical schools they apply medical schools they apply

to.”to.”

In ConclusionIn Conclusion Our Institutional COI Policy is strongOur Institutional COI Policy is strong The Medical School COI Curriculum is The Medical School COI Curriculum is

‘fairly strong’ and is improving‘fairly strong’ and is improving AMSA’s Just Medicine Campaign & AMSA’s Just Medicine Campaign &

Scorecard came primarily from Scorecard came primarily from concerns about experiences during concerns about experiences during clinical rotations.clinical rotations.

Questions or Comments?Questions or Comments?ejackson2@stfranciscare.orgejackson2@stfranciscare.org