Teaching Professionalism Teaching Professionalism

to Residents: to Residents:

The Management of Conflict of The Management of Conflict of

Interest in MedicineInterest in Medicine

NORMAN B. KAHN, JR. MDCOUNCIL OF MEDICAL SPECIALTY SOCIETIES

UMKC SCHOOL OF MEDICINE

MAY 27, 2011

Pre-test – 1 of 2 What agencies’ codes or laws guide the

behaviors and relationships of: PhysiciansPhysicians with pharmaceutical and medical device industries Physician organizations Physician organizations with pharmaceutical and medical device

manufacturers Pharmaceutical representatives Pharmaceutical representatives with physicians Medical device company representatives Medical device company representatives with physicians Pharmaceutical and medical device companies Pharmaceutical and medical device companies with the public Continuing medical education providersContinuing medical education providers Academic Medical Centers Academic Medical Centers with Industry Residency Programs Residency Programs with Industry

Pre-test – 2 of 2 What are consequences of violations of codes or

laws governing behaviors and relationships of: PhysiciansPhysicians with the pharmaceutical and medical device

industries Physician organizations Physician organizations with pharmaceutical and medical device

manufacturers Pharmaceutical representatives Pharmaceutical representatives with physicians Medical device company representatives Medical device company representatives with physicians Pharmaceutical and medical device companies Pharmaceutical and medical device companies with the public Continuing medical education providersContinuing medical education providers Academic Medical Centers Academic Medical Centers with Industry Residency Programs Residency Programs with Industry

Is Medicine a Business, a Profession, or Both? The practice of medicine in the US is a lucrative

field of work, with many opportunities to enhance personal income

Medicine is a profession, in which professionals enter into an implied contract with society, accepting certain responsibilities in exchange for certain privileges (conditional autonomy, relative wealth)

The natural consequence of the perceived failure of the profession to fulfill its part of the social contract results in consumerism, with calls for external (governmental) regulation

ProfessionalismProfessionalism -The Social Contract• Professionalism:

– Altruism • Making sure the needs of patients come first

– Voluntary self-regulation• ACGME, ACCME-SCS, AAMC, ACME, AANC, ACPE, AMA,

CMSS, PhRMA, AdvaMed

– Transparency • Peers – disclosure• Patients• Public

Codes, Standards and Laws in Codes, Standards and Laws in the Arena of Conflict of Interestthe Arena of Conflict of Interest AMAAMA – Council on Ethical and Judicial Affairs – Ethical Opinion 8.061, Gifts to

Physicians from Industry – guides physicians AAMCAAMC – Report of the Task Force on Industry Funding of Medical Education – guides

Academic Medical Centers ACCMEACCME – Standards for Commercial Support: Standards to Ensure the

Independence of CME – governs CME Providers (also nursing and pharmacy) ACGMEACGME – Principles to Guide the Relationships Between Graduate Medical

Education and industry – guides residency programs AdvaMedAdvaMed – Code of Ethics on Interactions with Health Professionals – guides

representatives of device manufacturers PhRMAPhRMA – Code on Interactions with Health Professionals – guides representatives of

pharmaceutical companies PPSAPPSA – Physician Payments Sunshine Act – requires companies to disclose

payments to physicians FDAFDA – oversees drug and device manufacturers OIGOIG – oversees drug and device manufacturers CMSSCMSS – Code for Interactions with Companies – guides specialty societies

Watchdogs over the Profession

1.1. Legislative Branch of Government Legislative Branch of Government - Senate Finance and Aging Committees

2.2. Executive Branch of Government Executive Branch of Government – current rules are for companies (FDA, OIG), soon will write rules for physicians (PPSA)

3.3. The Public Media The Public Media – New York Times, Wall Street Journal, Washington Post, Blogs, etc.

4.4. The Professional Media The Professional Media – JAMA April 1, 2009, etc.

5.5. The Institute of Medicine The Institute of Medicine – April 28, 2009 Report on Conflict of Interest in Medical Research, Education and Practice

Wall Street Journal: Wall Street Journal: Medicare spending on spinal fusion surgery went from costing Medicare $343 million in 1997 to $2.24 billion in 2008. Five senior spine surgeons at Norton Hospital in Louisville, KY, performed the third-most spinal fusions on Medicare patients in the country and received more than $7 million from Medtronic in the first nine months of this year alone.http://tinyurl.com/27xsbqt

San Francisco Chronicle:San Francisco Chronicle:An article was referenced by ProPublica concerning Stanford faculty members who still receive funding from industry, in apparent contradiction to Stanford's rigorous conflicts of interest policies.http://tinyurl.com/25ybaeshttp://deansnewsletter.stanford.edu/#4

“Researchers fail to reveal full drug pay,” New York Times, June 8, 2008

A Senate Finance Committee investigation revealed that Dr. Joseph Biederman, an influential Harvard child psychiatrist whose work helped fuel a 40-fold increase of pediatric bipolar diagnoses between 1994 and 2003, failed to disclose $1.6 million in drug company payments between 2000 and 2007. Two faculty colleagues underreported their $1 million+ earnings, as well.

“Medical device maker paid UW surgeon $19 million,” Milwaukee

Journal-Sentinel, January 16, 2009

University of Wisconsin orthopedic surgeon Dr. Thomas Zdeblick received more than $19 million from Medtronic medical device company between 2003 and 2007, a Senate Finance Committee investigation revealed, though Zdeblick only disclosed receiving “more than $20,000” per year to his university.

WASHINGTON --- Senator Chuck Grassley asked 23 medical schools and 33 medical societies for information about their policies for conflicts of interest and requirements for disclosure of financial relationships between faculty members and the drug industry.

 

 "There's a lot of skepticism about financial relationships between doctors and drug companies," Grassley said.  "Disclosure of those ties would help to build confidence that there's nothing to hide.  Requiring disclosure is a common sense reform based on the public dollars and public trust at stake in medical training, medical research and the practice of medicine." 

The Federal Government at WorkGrassley seeks information about medical school policies for disclosure of financial ties

PPSA PPSA Physician Payments Sunshine Act Became law March 23, 2010 Requires drug and device manufacturers to disclose on

their websites payments to physicians In response to investigation and publication of names,

relationships and amounts of money paid by industry to, but not disclosed by, physicians

Implied violations of Professionalism Altruism – did these physicians put their interests before the

interests of their patients? Voluntary self-regulation – did the profession regulate its

members to prevent abuses? Transparency – these physicians did not fully disclose their

relationships and the payments they received

AMA CEJA AMA CEJA American Medical AssociationCouncil on Ethical and Judicial AffairsEthical Opinion 8.061 - Gifts to Physicians from Industry (1998)

Guides the behavior of physicians when offered gifts from industry

Gifts must benefit patients Non-substantial value Related to physician’s work No CME or travel subsidy directly to docs No token consulting relationships Trainee scholarships to training institution, which selects trainees and conferences No “strings attached”

AMA CEJA AMA CEJA -Consequences of Violation

Potential loss of membership in AMA Potential loss of membership in specialty

society

PhRMA PhRMA Pharmaceutical Research and Manufacturers of AmericaCode on Interactions with Health Professionals (2009)

Guides the behaviors of pharmaceutical representatives in relationships with individual physicians

No support for entertainment/recreation Support for CME Promotional education Consultants Speakers Bureaus Clinical Practice Guidelines No non-educational or non-practice related gifts, but

educational items are OK

PhRMA Code – Consequences of Violation Voluntary Code All PhRMA member companies and more have

signed on to the PhRMA Code Annual attestation to PhRMA Listing on PhRMA website Risk of federal and state government regulation

FDA OIG MA, VT, others

AdvaMedAdvaMed Advanced Medical Technology AssociationCode of Ethics on Interactions with Health Professionals (2009)

Guides employees of medical device manufacturers in relationships with physicians

Similar provisions to PhRMA Code, plus… Royalty arrangements Demonstration of new products

AdvaMed CodeConsequences of Violation

Voluntary Code Annual attestation to AdvaMed Listing on AdvaMed website Risk of government intervention

ACCMEACCMEAccreditation Council for Continuing Medical Education Standards for Commercial Support: Standards to Ensure the Independence of CME Activities (2004)

Guides providers of CME programming

Independence of CME providers: CME planning and delivery is “free of the control of a commercial interest”

No exhibits or ads in CME space No bias in CME programming Disclosure and resolution of conflict of interest

Faculty Authors Planning committees To learners

ACCMEConsequences of Violation

Probation, then … Loss of accreditation to offer CME

programming for AMA PRA CME credit

AAMCAAMCReport of the Task Force on Industry Funding of Medical Education Guidance to Medical Schools and Academic Health

Centers

No gifts to physicians Limits drug detailing Assurance that CME complies with the ACCME-SCS Discourages faculty participation in industry speakers

bureaus Full transparency and Disclosure No ghostwriting

AAMCConsequences of Violation

AAMC recommendations, intended to lead to …

Institutional policies and compliance

ACGMEACGMEPrinciples to Guide the Relationships Between Graduate Medical Education and Industry

Promote Professionalism in residency programs and sponsoring institutions

Ethics curricula to include the ethics of gifts to physicians Full disclosure of commercial support of CME and

research Policies on contacts between residents and industry Teach residents the difference between education and

promotional, the purpose of formularies, guidelines, cost-benefit analyses in prescribing, and how to manage relationships with industry representatives

ACGMEConsequences of Violation

Guiding principles Monitored through Institutional Reviews

FDAFDAUS Food and Drug Administration

Oversees drug and device manufacturers

Approves drugs and devices for approved (“on-label”) uses

Assures efficacy Monitors safety

FDA -Consequences of Violation

“Black box” warnings Consumer alerts Drug recalls Fraud and criminal investigations Civil and criminal penalties

OIGOIGOffice of the Inspector General, US Department of Health and Human Services

Oversees drug and device manufacturers

“Protect[s] the integrity of the Department of Health and Human Services programs, as well as the health and welfare of the beneficiaries of those programs”

Audits Investigations Inspections

OIG –Consequences of Violation Fraud and criminal investigations Civil and criminal penalties Significant (compared with FDA):

Very large fines (more than “the cost of doing business”)

Potential incarceration of responsible parties

CMSS CMSS Council of Medical Specialty SocietiesCode for Interactions With Companies (4-17-10)

Guides the behaviors of specialty societies in relationships with industry

Thirty-four signers to date Commitment of the specialty society to

adopt policies and procedures consistent with the CMSS Code

CMSS CodeCMSS Code

Principles for Society InteractionsCommon Definitions Independence = Free of Company InfluenceTransparency = to Physicians and the Public

Disclosure of Corporate Support

Key Leaders Without Relationships

CMSS CodeCMSS Code

Accepting Charitable Donations No company influence

Awarding of Company-supported Research Grants

No company influence

Accepting Sponsorships from Companies No company names on visibility items

Licensing No product endorsements

CMSS CodeCMSS Code

Clinical Practice Guidelines Best evidence No company support or influence Majority of panel without relationships Chair without relationships

CMSS CodeCMSS Code

Society Journals Editor without relationships Adherence to ICMJE Standards

Advertising No adjacency Adherence to ACCME Standards for Commercial

Support

CMSS CodeCMSS Code Society Meetings

Educational Grants and Society CME Adherence to ACCME Standards for Commercial Support No company Input or Influence No bias in CME Balanced portfolio of support, including physicians pay for CME

Satellite Symposia Adherence to ACCME Standards for Commercial Support Evidence-based, peer reviewed presentations Modification of content of conflicted presenters Trained monitors No key leader participation

Exhibits Giveaways of modest, educational value only No obligate pathway No key leader participation

CMSS Code –Consequences of Violation

Voluntary Adherence by Specialty Societies Complaints about potential violations will be

directed to the Specialty Society The failure of professional voluntary self-

regulation breeds external regulation (see PPSA)

What are the consequences of?

Serving on a pharmaceutical company speakers bureau?

Serving as a consultant to a pharmaceutical company? Serving as faculty in a commercially supported CME

program? Attending a commercially supported CME program? Accepting a textbook from a pharmaceutical

representative? Accepting research funding from pharmaceutical

companies? Patenting a surgical device?

What are the consequences of? Serving on a pharmaceutical company speakers

bureau? Disclosure to boards, committees, audiences, and on

pharmaceutical company websites Establishing a paid relationship with a company that may

preclude the perception of independence Exclusion from related CME faculty roles, potentially from

practice guideline and performance measure development panels, limitation of NIH role as investigator or reviewer

Serving as a consultant to a pharmaceutical company? Disclosure as above Establishing a relationship as above May or may not be excluded from CME, guideline panels,

depending on the nature of the consultancy Potential limitation of NIH role as investigator or reviewer

PhRMA Code 7

“Speaker training is an essential activity because the FDA holds companies accountable for the presentations of their speakers.”

PhRMA Code 7, cont.

“While speaker programs offer important educational opportunities to healthcare professionals, they are distinct from CME programs, and companies and speakers should be clear about this distinction.

For example, speakers and their materials should clearly identify the company that is sponsoring the presentation, the fact that the speaker is presenting on behalf of the company, and that the speaker is presenting information that is consistent with FDA guidelines.”

PhRMA Code 7, cont.

“Beyond providing all speakers with appropriate training, companies should periodically monitor speaker programs for compliance with FDA regulatory requirements for communications on behalf of the company about its medicines.”

What are the consequences of?

Serving as faculty in a commercially supported CME program? No consequences, as the relationship of faculty is to

the CME Provider, not to the supporting company

Attending a commercially supported CME program? No consequences for attendees, but they should seek

and pay attention to faculty and planning committee disclosures of relationships

What are the consequences of?

Accepting a textbook from a pharmaceutical representative? Disclosure on company website State-specific regulations (may or may not be permitted)

Accepting research funding from pharmaceutical companies? Disclosure to boards, committees, audiences, on pharmaceutical

company websites May or may not result in exclusions, depending on whether the

research grant went to the physician or the institution which employs the physician

What are the consequences of? Accepting a royalty for a drug based on your

scientific discovery? Disclosure to boards, committees, audiences, on pharmaceutical

company websites Establishing a paid relationship with a company that may preclude the

perception of independence Exclusion from related CME faculty roles, and potentially from practice

guideline and performance measure development panels

Patenting a surgical device? Disclosure to boards, committees, audiences, on pharmaceutical

company websites Establishing a paid relationship with a company that may preclude the

perception of independence Exclusion from related CME faculty roles, and potentially from

practice guideline and performance measure development panels

Post-test What agencies’ laws or codes guide the behaviors and

relationships of: PhysiciansPhysicians with the pharmaceutical and medical device

industries Physician organizations Physician organizations with pharmaceutical and medical device

manufacturers Pharmaceutical representatives Pharmaceutical representatives with physicians Medical device company representatives Medical device company representatives with physicians Pharmaceutical and medical device companies Pharmaceutical and medical device companies with the public

(2) Continuing medical education providersContinuing medical education providers Academic Medical Centers Academic Medical Centers with Industry Residency Programs Residency Programs with Industry

Post-test - answers What agencies’ laws or codes guide the behaviors and

relationships of: PhysiciansPhysicians with the pharmaceutical and medical device industries - AMA

Ethical Opinions Physician organizations Physician organizations with pharmaceutical and medical device

manufacturers - CMSS Code Pharmaceutical representatives Pharmaceutical representatives with physicians - PhRMA Code Medical device company representatives Medical device company representatives with physicians - AdvaMed

Code Pharmaceutical and medical device companies Pharmaceutical and medical device companies with the public (2) -

FDA, OIG Continuing medical education providers Continuing medical education providers - ACCME Standards for

Commercial Support of CME Academic Medical Centers Academic Medical Centers with Industry - AAMC Report on Industry

Funding of Medical Education Residency Programs Residency Programs with industry - ACGME Principles to Guide the

relationships Between GME and Industry