Teaching Professionalism to Residents: The Management of Conflict of Interest in Medicine
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Transcript of Teaching Professionalism to Residents: The Management of Conflict of Interest in Medicine
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