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

1
Teaching Professionalism to Residents The
Management of Conflict of Interest in Medicine

• Norman B. Kahn, Jr. MD
• Council of Medical Specialty Societies
• UMKC School of Medicine
• May 27, 2011

2
Pre-test 1 of 2

• What agencies codes or laws guide the behaviors
  and relationships of
• Physicians with pharmaceutical and medical device
  industries
• Physician organizations with pharmaceutical and
  medical device manufacturers
• Pharmaceutical representatives with physicians
• Medical device company representatives with
  physicians
• Pharmaceutical and medical device companies with
  the public
• Continuing medical education providers
• Academic Medical Centers with Industry
• Residency Programs with Industry

3
Pre-test 2 of 2

• What are consequences of violations of codes or
  laws governing behaviors and relationships of
• Physicians with the pharmaceutical and medical
  device industries
• Physician organizations with pharmaceutical and
  medical device manufacturers
• Pharmaceutical representatives with physicians
• Medical device company representatives with
  physicians
• Pharmaceutical and medical device companies with
  the public
• Continuing medical education providers
• Academic Medical Centers with Industry
• Residency Programs with Industry

4
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

5
Professionalism -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

6
Codes, Standards and Laws in the Arena of
Conflict of Interest

• AMA Council on Ethical and Judicial Affairs
  Ethical Opinion 8.061, Gifts to Physicians from
  Industry guides physicians
• AAMC Report of the Task Force on Industry
  Funding of Medical Education guides Academic
  Medical Centers
• ACCME Standards for Commercial Support
  Standards to Ensure the Independence of CME
  governs CME Providers (also nursing and pharmacy)
• ACGME Principles to Guide the Relationships
  Between Graduate Medical Education and industry
  guides residency programs
• AdvaMed Code of Ethics on Interactions with
  Health Professionals guides representatives of
  device manufacturers
• PhRMA Code on Interactions with Health
  Professionals guides representatives of
  pharmaceutical companies
• PPSA Physician Payments Sunshine Act requires
  companies to disclose payments to physicians
• FDA oversees drug and device manufacturers
• OIG oversees drug and device manufacturers
• CMSS Code for Interactions with Companies
  guides specialty societies

7
Watchdogs over the Profession

• Legislative Branch of Government - Senate Finance
  and Aging Committees
• Executive Branch of Government current rules
  are for companies (FDA, OIG), soon will write
  rules for physicians (PPSA)
• The Public Media New York Times, Wall Street
  Journal, Washington Post, Blogs, etc.
• The Professional Media JAMA April 1, 2009, etc.
• The Institute of Medicine April 28, 2009 Report
  on Conflict of Interest in Medical Research,
  Education and Practice

8
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 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
9

• 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.

10
The Federal Government at Work Grassley seeks
information about medical school policies for
disclosure of financial ties

• 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."
•  

11
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

12
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 physicians 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

13
AMA CEJA -Consequences of Violation

• Potential loss of membership in AMA
• Potential loss of membership in specialty society

14
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

15
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

16
AdvaMed 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

17
AdvaMed CodeConsequences of Violation

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

18
ACCMEAccreditation 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

19
ACCMEConsequences of Violation

• Probation, then
• Loss of accreditation to offer CME programming
  for AMA PRA CME credit

20
AAMCReport 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

21
AAMCConsequences of Violation

• AAMC recommendations, intended to lead to
• Institutional policies and compliance

22
ACGMEPrinciples 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

23
ACGMEConsequences of Violation

• Guiding principles
• Monitored through Institutional Reviews

24
FDAUS Food and Drug Administration

• Oversees drug and device manufacturers
• Approves drugs and devices for approved
  (on-label) uses
• Assures efficacy
• Monitors safety

25
FDA -Consequences of Violation

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

26
OIGOffice of the Inspector General,
US Department of Health and Human Services

• Oversees drug and device manufacturers
• Protects 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

27
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

28
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

29
CMSS Code

• Principles for Society Interactions
• Common Definitions
• Independence Free of Company Influence
• Transparency to Physicians and the Public
• Disclosure of Corporate Support
• Key Leaders Without Relationships

30
CMSS 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

31
CMSS Code

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

32
CMSS Code

• Society Journals
• Editor without relationships
• Adherence to ICMJE Standards
• Advertising
• No adjacency
• Adherence to ACCME Standards for Commercial
  Support

33
CMSS 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

34
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)

35
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?

36
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

37
PhRMA Code 7

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

38
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.

39
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.

40
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

41
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

42
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

43
Post-test

• What agencies laws or codes guide the behaviors
  and relationships of
• Physicians with the pharmaceutical and medical
  device industries
• Physician organizations with pharmaceutical and
  medical device manufacturers
• Pharmaceutical representatives with physicians
• Medical device company representatives with
  physicians
• Pharmaceutical and medical device companies with
  the public (2)
• Continuing medical education providers
• Academic Medical Centers with Industry
• Residency Programs with Industry

44
Post-test - answers

• What agencies laws or codes guide the behaviors
  and relationships of
• Physicians with the pharmaceutical and medical
  device industries - AMA Ethical Opinions
• Physician organizations with pharmaceutical and
  medical device manufacturers - CMSS Code
• Pharmaceutical representatives with physicians -
  PhRMA Code
• Medical device company representatives with
  physicians - AdvaMed Code
• Pharmaceutical and medical device companies with
  the public (2) - FDA, OIG
• Continuing medical education providers - ACCME
  Standards for Commercial Support of CME
• Academic Medical Centers with Industry - AAMC
  Report on Industry Funding of Medical Education
• Residency Programs with industry - ACGME
  Principles to Guide the relationships Between GME
  and Industry