Transcript Strategic Plan 2010-2014 - UMKC School of Medicine

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
Pre-test – 1 of 2
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What agencies’ codes or laws guide the
behaviors and relationships of:
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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
Pre-test – 2 of 2

What are consequences of violations of codes or
laws governing behaviors and relationships of:
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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
Is Medicine a Business,
a Profession, or Both?
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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
Professionalism The Social Contract
•
Professionalism:
–
Altruism
•
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Voluntary self-regulation
•
–
Making sure the needs of patients come first
ACGME, ACCME-SCS, AAMC, ACME, AANC, ACPE, AMA,
CMSS, PhRMA, AdvaMed
Transparency
•
•
•
Peers – disclosure
Patients
Public
Codes, Standards and Laws in
the Arena of Conflict of Interest
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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
Watchdogs over the Profession
1.
Legislative Branch of Government - Senate
Finance and Aging Committees
2.
Executive Branch of Government – current rules
are for companies (FDA, OIG), soon will write rules for
physicians (PPSA)
3.
The Public Media – New York Times, Wall Street
Journal, Washington Post, Blogs, etc.
4.
5.
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
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/25ybaes
http://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.
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."
PPSA
Physician Payments Sunshine Act
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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
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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
American Medical Association
Council on Ethical and Judicial Affairs
Ethical Opinion 8.061 - Gifts to Physicians from Industry (1998)
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Guides the behavior of physicians when offered gifts from industry
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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”
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AMA CEJA Consequences of Violation
Potential loss of membership in AMA
 Potential loss of membership in specialty
society
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PhRMA
Pharmaceutical Research and Manufacturers of America
Code on Interactions with Health Professionals (2009)
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Guides the behaviors of pharmaceutical representatives
in relationships with individual physicians
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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
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PhRMA Code –
Consequences of Violation
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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
AdvaMed
Advanced Medical Technology Association
Code of Ethics on Interactions with Health Professionals (2009)
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Guides employees of medical device
manufacturers in relationships with
physicians
Similar provisions to PhRMA Code, plus…
 Royalty arrangements
 Demonstration of new products
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AdvaMed Code
Consequences of Violation
Voluntary Code
 Annual attestation to AdvaMed
 Listing on AdvaMed website
 Risk of government intervention
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ACCME
Accreditation Council for Continuing Medical Education
Standards for Commercial Support: Standards to Ensure the
Independence of CME Activities (2004)
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Guides providers of CME programming
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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
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ACCME
Consequences of Violation
Probation, then …
 Loss of accreditation to offer CME
programming for AMA PRA CME credit
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AAMC
Report of the Task Force on Industry
Funding of Medical Education
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Guidance to Medical Schools and Academic Health
Centers
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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
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AAMC
Consequences of Violation
AAMC recommendations, intended to lead
to …
 Institutional policies and compliance
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ACGME
Principles to Guide the Relationships Between
Graduate Medical Education and Industry
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Promote Professionalism in residency programs and
sponsoring institutions
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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, costbenefit analyses in prescribing, and how to manage
relationships with industry representatives
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ACGME
Consequences of Violation
Guiding principles
 Monitored through Institutional Reviews
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FDA
US Food and Drug Administration
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Oversees drug and device manufacturers
Approves drugs and devices for approved
(“on-label”) uses
 Assures efficacy
 Monitors safety
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FDA Consequences of Violation
“Black box” warnings
 Consumer alerts
 Drug recalls
 Fraud and criminal investigations
 Civil and criminal penalties
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OIG
Office of the Inspector General,
US Department of Health and Human Services
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Oversees drug and device manufacturers
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“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
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OIG –
Consequences of Violation
Fraud and criminal investigations
 Civil and criminal penalties
 Significant (compared with FDA):
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 Very
large fines (more than “the cost of doing
business”)
 Potential incarceration of responsible parties
CMSS
Council of Medical Specialty Societies
Code for Interactions With Companies (4-17-10)
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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
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CMSS Code
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Principles for Society Interactions
 Common
Definitions
 Independence = Free of Company Influence
 Transparency = to Physicians and the Public
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Disclosure of Corporate Support
 Key
Leaders Without Relationships
CMSS Code
 Accepting
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Charitable Donations
No company influence
 Awarding
of Company-supported Research
Grants
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No company influence
 Accepting
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Sponsorships from Companies
No company names on visibility items
 Licensing
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No product endorsements
CMSS Code
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Clinical Practice Guidelines
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Best evidence
No company support or influence
Majority of panel without relationships
Chair without relationships
CMSS Code
 Society
Journals
Editor without relationships
 Adherence to ICMJE Standards
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 Advertising
No adjacency
 Adherence to ACCME Standards for Commercial
Support
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CMSS Code
 Society
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Educational Grants and Society CME
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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
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Meetings
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
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Giveaways of modest, educational value only
No obligate pathway
No key leader participation
CMSS Code –
Consequences of Violation
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Voluntary Adherence by Specialty Societies
Complaints about potential violations will be
directed to the Specialty Society
The failure of professional voluntary selfregulation breeds external regulation (see
PPSA)
What are the consequences of?
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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?
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Serving on a pharmaceutical company speakers
bureau?
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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?
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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
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“Speaker training is an essential activity
because the FDA holds companies
accountable for the presentations of their
speakers.”
PhRMA Code 7, cont.
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“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.
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“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?
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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
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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?
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Accepting a textbook from a pharmaceutical
representative?
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Disclosure on company website
State-specific regulations (may or may not be permitted)
Accepting research funding from pharmaceutical
companies?
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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?
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Accepting a royalty for a drug based on your
scientific discovery?
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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:





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

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
Post-test - answers
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What agencies’ laws or codes guide the behaviors and
relationships of:
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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