Physician Relationships with The Pharmaceutical Industry Steven R. Craig, MD, FACP June 22, 2010.

Physician Relationships with The Pharmaceutical Industry

Steven R. Craig, MD, FACPJune 22, 2010

Physicians & ThePhysicians & The Pharmaceutical Pharmaceutical IndustryIndustry Background: Why is this topic important?Background: Why is this topic important? Overview: Physician-Industry InteractionsOverview: Physician-Industry Interactions Types of Interactions with PhysiciansTypes of Interactions with Physicians Research on Effects of These Interactions Research on Effects of These Interactions Guidelines on Proper Interactions – The UI Guidelines on Proper Interactions – The UI

Health Care PolicyHealth Care Policy Practical Applications of This PolicyPractical Applications of This Policy

Physician-Industry Physician-Industry InteractionsInteractions

Why is this Important?Why is this Important?

Very Much in the News Today!Very Much in the News Today!

JAMA: April 16, 2008JAMA: April 16, 2008

Extent of Physician-Extent of Physician-IndustryIndustry

InteractionsInteractions Prescription Drugs ~9% of total Prescription Drugs ~9% of total

health care costs in USAhealth care costs in USA Estimates:Estimates:

$11 billion/yr on promotion & $11 billion/yr on promotion & marketingmarketing~20% of industry revenues~20% of industry revenues~$5 billion spent by PSRs ~$5 billion spent by PSRs $8–13 K/yr spent on each physician$8–13 K/yr spent on each physician

Types of Interactions: Types of Interactions: Physicians & The Pharmaceutical Physicians & The Pharmaceutical IndustryIndustry

High Point: ~1 PSR per 15-30 physicians High Point: ~1 PSR per 15-30 physicians in USin US

Interactions with Industry have started Interactions with Industry have started early:early: Average ~4 interactions/yr for Med Studs Average ~4 interactions/yr for Med Studs Average ~6 interactions/yr for Residents Average ~6 interactions/yr for Residents

Why start early: Industry research Why start early: Industry research confirmsconfirmsvalue of early positive interactionsvalue of early positive interactions

Traditional Types of Traditional Types of Industry Interactions with Industry Interactions with

PhysiciansPhysicians GiftsGifts Pharmaceutical SamplesPharmaceutical Samples Educational SupportEducational Support Research SupportResearch Support

Effect of Industry Effect of Industry Gifts to Gifts to PhysiciansPhysicians

“ “When a gift or gesture of any size is When a gift or gesture of any size is bestowed, it imposes on the recipient a bestowed, it imposes on the recipient a sense of indebtedness. The obligations sense of indebtedness. The obligations to directly reciprocate, whether or not to directly reciprocate, whether or not the recipient is directly conscious of it, the recipient is directly conscious of it, tends to influence behavior. Feelings of tends to influence behavior. Feelings of obligation are not related to the size of obligation are not related to the size of the gift or favor.”the gift or favor.”

Katz, D. Am J Bioethics 3:39-46, 2003.Katz, D. Am J Bioethics 3:39-46, 2003.

““Effect of Exposure to Small Effect of Exposure to Small Pharmaceutical Promotional Items on Pharmaceutical Promotional Items on

Treatment Preferences”Treatment Preferences”Archives Internal Medicine May 11, 2009Archives Internal Medicine May 11, 2009

Randomized, controlled experiment involving Randomized, controlled experiment involving 352 M3 & M4 students at 2 U.S. medical 352 M3 & M4 students at 2 U.S. medical schoolsschools

UPenn (restricted) vs. UMiami (less restricted)UPenn (restricted) vs. UMiami (less restricted)differing policies re pharmaceutical marketingdiffering policies re pharmaceutical marketing

Students at UMiami evidenced more positive Students at UMiami evidenced more positive attitudes toward industry marketing & more attitudes toward industry marketing & more influence from promotional itemsinfluence from promotional items

Pharmaceutical Industry FreebiesPharmaceutical Industry FreebiesCollected by One Hospital in One Collected by One Hospital in One

WeekWeek

Types of Interactions:Types of Interactions:Pharmaceutical SamplesPharmaceutical Samples

Possible BenefitsPossible Benefits:: May allow patients to try new drug May allow patients to try new drug

free until clear it is effective & well free until clear it is effective & well toleratedtolerated

May allow indigent patients access May allow indigent patients access to expensive, newer medicationsto expensive, newer medications

Effect of Interactions:Effect of Interactions:Pharmaceutical SamplesPharmaceutical Samples

BUTBUT:: Samples often used by Physicians Samples often used by Physicians

& Office Staff& Office Staff Only the newest & most expensive Only the newest & most expensive

drugs are sampleddrugs are sampled May influence choice of more May influence choice of more

expensive drugs for long-term expensive drugs for long-term treatmenttreatment

Effect of Interactions:Effect of Interactions:Pharmaceutical Samples Pharmaceutical Samples

For low income patients, there are better For low income patients, there are better ways to provide needed meds:ways to provide needed meds: 1. Generic medication samples program 1. Generic medication samples program

2. $4.00/month generic med programs 2. $4.00/month generic med programs

3. Industry programs to provide expensive3. Industry programs to provide expensive meds free to low income individuals meds free to low income individuals (Indexed at (Indexed at www.phrma.org/pap or or www.needymeds.comwww.needymeds.com))

Types of Interactions:Types of Interactions:Educational SupportEducational Support

1. Information detailing of 1. Information detailing of medicationsmedications2. Industry-sponsored conferences2. Industry-sponsored conferences3. Industry support for CME 3. Industry support for CME conferencesconferences

Effects of Interactions:Effects of Interactions:Educational SupportEducational Support

1. Information Detailing Meds1. Information Detailing Meds

** Concerns about information Concerns about information accuracyaccuracy

** Information not balancedInformation not balanced * Better sources of information on new* Better sources of information on new meds & comparative drug data exist meds & comparative drug data exist

The Medical LetterThe Medical Letter

The Prescriber’s LetterThe Prescriber’s Letter

Therapeutics InitiativesTherapeutics Initiatives

Drug & Therapeutics Bulletin (UK)Drug & Therapeutics Bulletin (UK)

Effects of Interactions:Effects of Interactions:Educational SupportEducational Support

2. Industry-Sponsored Conferences2. Industry-Sponsored Conferences

Great Potential for BiasGreat Potential for Bias*Promotional vs. educational intent*Promotional vs. educational intent

*Appropriate faculty? *Appropriate faculty? *Reasonable faculty honoraria? *Reasonable faculty honoraria? *Paying travel, lodging, meals expenses*Paying travel, lodging, meals expenses

*Funding student/resident *Funding student/resident participationparticipation

Effects of Interactions:Effects of Interactions:Educational SupportEducational Support

3. Sponsorship of CME Conferences3. Sponsorship of CME Conferences:: Still Some Potential for BiasStill Some Potential for Bias *Unrestricted vs. restricted grants *Unrestricted vs. restricted grants

*Selection of Speakers: Speakers Bureaus*Selection of Speakers: Speakers Bureaus

*Financial disclosure by speakers*Financial disclosure by speakers

*Balanced presentation, approved uses*Balanced presentation, approved uses

*Audiovisual support*Audiovisual support

*Separate promotional displays *Separate promotional displays Must adhere to strict ACCME standardsMust adhere to strict ACCME standards

Types of Interactions:Types of Interactions:Support for ResearchSupport for Research

Basic Research & DevelopmentBasic Research & Development Phase I, II, III Clinical Trials Phase I, II, III Clinical Trials Phase IV Clinical Trials Phase IV Clinical Trials

vs. Marketing / Promotional vs. Marketing / Promotional StudiesStudies

Effects of Interactions:Effects of Interactions:Support for ResearchSupport for Research

Need to assure only rigorously reviewed, Need to assure only rigorously reviewed, IRB-approved researchIRB-approved research

Drug/device developers should not Drug/device developers should not conduct studies of their own productsconduct studies of their own products

Concerns about physician payment for Concerns about physician payment for participation & enrollment of patientsparticipation & enrollment of patients

Final published works must disclose:Final published works must disclose:1. extent of pharmaceutical 1. extent of pharmaceutical

companycompany involvement involvement2. authors’ industry affiliations2. authors’ industry affiliations

New Guidelines on Proper New Guidelines on Proper Physician-Industry Physician-Industry

InteractionsInteractions

Why New Guidelines Developed:Why New Guidelines Developed:* Increasing physician awareness of * Increasing physician awareness of professional & ethical obligations to professional & ethical obligations to patientspatients

* Increasing public concern about potential* Increasing public concern about potential abuses abuses

* Increasing government examination * Increasing government examination ofof physician-industry interactions physician-industry interactions

New Guidelines on Proper New Guidelines on Proper Physician-Industry Physician-Industry

InteractionsInteractions

AMA & other Physician Professional SocietiesAMA & other Physician Professional Societies ACGME (Residency Programs)ACGME (Residency Programs) AMSA Pharm Free CampaignAMSA Pharm Free Campaign Pharma (Pharmaceutical Industry)Pharma (Pharmaceutical Industry) AAMC (Medical Schools): Comprehensive AAMC (Medical Schools): Comprehensive

recommendations released June 2008recommendations released June 2008 New comprehensive UI policy: Released January New comprehensive UI policy: Released January

20092009 Patient Protection & Affordable Care Act:Patient Protection & Affordable Care Act:

Signed March 30, 2010 Signed March 30, 2010

Task Force Guidelines Task Force Guidelines Approved Approved

by AAMC Executive Councilby AAMC Executive Council

AAMC Task ForceAAMC Task ForceRecommended Recommended

GuidelinesGuidelines Academic Medical Centers (AMCs) Academic Medical Centers (AMCs)

should adopt policies on appropriate should adopt policies on appropriate industry interactions across all sitesindustry interactions across all sites

Take leadership roleTake leadership role AMCs should educate students, AMCs should educate students,

residents, faculty & staff on these residents, faculty & staff on these policiespolicies

AAMC Task ForceAAMC Task ForceRecommended Recommended

GuidelinesGuidelines

Policies should address:Policies should address:Gifts Gifts Pharmaceutical Samples Pharmaceutical Samples Site access by Pharmaceutical RepsSite access by Pharmaceutical Reps

CME CME Participation in Industry-Sponsored Participation in Industry-Sponsored ProgramsPrograms

AAMC Task Force AAMC Task Force RecommendedRecommended Guidelines Guidelines (continued)(continued)

Policies should address (continued):Policies should address (continued):Educational Funds/Scholarships from Educational Funds/Scholarships from IndustryIndustryFood Food Professional TravelProfessional Travel

Manuscript Writing (ghostwriting) Manuscript Writing (ghostwriting) Purchasing DecisionsPurchasing Decisions

University of Iowa Health Care University of Iowa Health Care Conflict Conflict of Interest & Conflict of of Interest & Conflict of Commitment:Commitment:Policy Regarding Interactions with Policy Regarding Interactions with IndustryIndustry

January 20, 2009January 20, 2009

Specifics of UI PolicySpecifics of UI Policy

No gifts of any size may be acceptedNo gifts of any size may be accepted No foodNo food (within Iowa or at national meetings)(within Iowa or at national meetings) Travel stipends, educational scholarships, Travel stipends, educational scholarships,

visiting professorships, GME stipends, etc.visiting professorships, GME stipends, etc. Medical or educational equipment, Medical or educational equipment,

supplies, resources, or programmingsupplies, resources, or programming Drug samplesDrug samples Training assistanceTraining assistance

Specifics of UI Policy Specifics of UI Policy (cont.)(cont.)

Consulting expertise: must be formal Consulting expertise: must be formal contract & approved by DEO and VPMAcontract & approved by DEO and VPMA

Honoraria & Speakers’ BureausHonoraria & Speakers’ Bureaus Industry displaysIndustry displays Continuing Medical EducationContinuing Medical Education Separate Separate Conflict of Interest in ResearchConflict of Interest in Research

policypolicy Publishing Publishing

P.L. 111 - Patient Protection andP.L. 111 - Patient Protection and Affordable Care Act Affordable Care Act (signed March 30, (signed March 30,

2010)2010)

Public reporting 1Public reporting 1stst advocated by Senators advocated by Senators Grassley and KohlGrassley and Kohl

By 2013, Industry must report to Secretary By 2013, Industry must report to Secretary HHS all payments to Physicians & HospitalsHHS all payments to Physicians & Hospitals

Includes reporting of any physician Includes reporting of any physician ownership & research activitiesownership & research activities

Penalties if not full disclosurePenalties if not full disclosure Secretary must report this information Secretary must report this information

yearly to the public, to Congress, and to the yearly to the public, to Congress, and to the statesstates

So, What’s a M3 Student to So, What’s a M3 Student to Do?Do?

Don’t accept any gifts, food, med samples: MayDon’t accept any gifts, food, med samples: Mayneed to make preceptors aware of CCOM need to make preceptors aware of CCOM policiespolicies

Any Industry offers of assistance to attend Any Industry offers of assistance to attend conferences, other educational support must be conferences, other educational support must be approved by UICCOMapproved by UICCOM

Review independent resources to learn more Review independent resources to learn more about medications about medications ((Medical Letter, Prescriber’s Letter, etc.)Medical Letter, Prescriber’s Letter, etc.)

Know rules & watch for signs of bias in CME and Know rules & watch for signs of bias in CME and in published medical literature in published medical literature

Scenario 1:Scenario 1:

What should you do?What should you do?

You are completing your family medicineYou are completing your family medicinepreceptorship with a practicing physician preceptorship with a practicing physician in rural Iowa. The clinic staff invites you in rural Iowa. The clinic staff invites you to join them for lunch and announces to join them for lunch and announces that food is provided each day by one of that food is provided each day by one of the pharmaceutical reps who visits their the pharmaceutical reps who visits their office and also provides medication office and also provides medication samples for their patients.samples for their patients.

Scenario 2:Scenario 2:

What should you do?What should you do?

You are completing your surgery clerkship You are completing your surgery clerkship and the residents on service invite you to and the residents on service invite you to join them in attending a dinner meeting join them in attending a dinner meeting that night being held at a really nice local that night being held at a really nice local restaurant. A restaurant. A nationally-recognized surgeon is going to nationally-recognized surgeon is going to speak on treatment of intra-abdominal speak on treatment of intra-abdominal infections. Food and drinks are being infections. Food and drinks are being provided by a pharmaceutical company provided by a pharmaceutical company that manufactures an antibiotic marketed that manufactures an antibiotic marketed to treat these types of infections.to treat these types of infections.

Scenario 3:Scenario 3:

What should you do?What should you do?

While on your internal medicine While on your internal medicine clerkship, clerkship,

your attending physician offers you a your attending physician offers you a free Washington Manual of Medical free Washington Manual of Medical Therapeutics.Therapeutics.

He explains that he has been provided a He explains that he has been provided a supply of these books to distribute to supply of these books to distribute to residents & students free by Accura residents & students free by Accura Pharmaceuticals. Pharmaceuticals.

QUESTIONS?

THE END