disclosures no relationships or conflicts to report
TRANSCRIPT
Disclosures
No relationships or conflicts to report
Industry Relationships:Necessary for Systematic Quality Improvement
QCORMay 2010
Jack Lewin, M.D., CEOThe American College of Cardiology
History and Evolution of Industry Support
The good (bad) old days
The Changing Environment
• OIG – DOJ
• House and Senate Oversight Committees
• Voluntary Industry Changes
• Physician Sunshine Act
Need for Industry Support
Medical Societies and Industry Funding
• Scientific Publications• Expositions at Meetings• Research Grants/Funding• CME Funding• Quality of Care Projects• Other (philanthropy)
The Real Question
What should national policy be for future support of medical
education, scientific publication and research?
• Public support for CME, scientific research and publication is scarce
• Industry funds most research and advances in care
• RWI and intellectual conflicts should be addressed
• Restricting expert participation can be good or bad with respect to societal needs for quality improvement
The Real Question
How are we doing in
systematic quality improvement?
Beth McGlynn
RAND study in NEJM
The Quality of Health Care Delivered to Adults in the United States; N Engl J Med 2003 348: 2635-2645
Source: http://www.dartmouthatlas.org/
13.5 to 38.1 (63)11.5 to < 13.5 (53)10.0 to < 11.5 (75)
8.5 to < 10.0 (53)3.5 to < 8.5 (62)
Not Populated
Variation in Care Variation in Care PCI Rates per 1,000 Medicare Enrollees (2002 – 2003)
National Academy of Sciences (NAS)
explosion and acceleration of knowledge
Changing pressures of practice
Government to the rescue?
No way!No way!
Is there a role for industry?
YesYes
Does industry have business motives?
Of courseOf course
so…
?If you accept industry funding, can you be…
unbiased
ethical
Industry relationships can be managed effectively
They provide value when ethically structured
How do we manage vs. restrict?
Relationships With Industry
• Disclosure
• Managing relationships
vs. Restricting participation
• ACC Industry Forum
• ACC OIG – DOJ discussions
• ACC Web site
What the ACC has done
Full disclosure on acc.org
Complete transparency
2008 Industry Forum
Sen. Chuck Grassley (R-IA) speaks at ACC’s 2008 Industry Forum
Principles for Relationships with Industry
The ACC must self-regulate in nine areas of operation:
Advertising
Charitable donations
Clinical document development
Continuing medical education
Exposition
Governance
Government grants/foundation support
Registries
Sponsorship
1
2
3
4
5
6
7
8
9
Disclosure of Relationship
• Level/value
• Relevance
• Timing and Frequency
• Type
New Challenges In Addressing Patient Education and
Adherence
• National health initiative designed to improve heart health
• Key Principles– Engage people in the active management of
their own heart health.– Empower individuals to make better, heart-
healthier lifestyle choices.
• How it works: – Strengthens the doctor/patient relationship by
delivering patient-centered tools to doctors’ offices.– Provides a comprehensive, web-based platform with
information and smart, practical tools for patients– Uses community-based events to provide everyday
strategies to improve heart health– Works with national consumer products companies to
help deliver CardioSmart strategies to people at risk for heart disease.
• Industry partners must: – Show a substantial and credible commitment to
CardioSmart goals and objectives and offer products and/or services that relate to encouraging heart healthy behaviors.
– Be approved through the ACC’s review process, which includes initial approval by the College’s Patient-Centered Care Committee followed by approval by the Executive Committee of the Board of Trustees.
– Not require or expect any endorsement by the ACC, either actual or implied, of any product or service.
• Industry partners must: – Commit to the complete editorial independence of the
ACC.– Abide by the ACC’s overarching “Principles of
Relationships with Industry”– Ensure that food products and over-the-counter
medications that make scientific claims related to health (including heart health) are substantiated by the appropriate Federal governing body (such as the FDA or USDA).
Fries with that?
Photo credit: Brynne Shaw For The Washington Post
McDonald’s in Cleveland Clinic
Bumps in the Road
www.AFibProfessional.org
Prystowsky,
Ellenbogen,
Cannon,
HRS,
ACC,
etc.
We’re all in this together!
Lessons• Not just CME!
• Competing clinical views need to be aired and balanced
• Disclosure and transparency is broader than individuals
Managing RWI is the key!
At the ACC.10 and i2 Summit 2010, who paid for meeting registration, travel?
Who paid?Meeting Registration Travel
U.S. Non-U.S. U.S. Non-U.S.
Me 31.53% 37.96% 39.15% 35.06%
My practice 26.11% 8.36% 24.21% 8.17%
Industry 7.18% 32.69% 7.83% 38.68%
University 16.60% 9.39% 20.93% 11.39%
Other 18.58% 11.59% 7.88% 6.70%
Source: ACC Market Intelligence Research
n=1,110 physician attendees at ACC.10March 26 - April 28, 2010
CMSS Code for Interaction with Companies
Source: www.cmss.org; released April 2010
Our ongoing commitment to an evolving process
Our Commitment to Science
ACC and its members are committed to an unbiased and balanced review of the
science
… regardless of funding sources.
The ACC must and will continue to manage our relationships with industry
responsibly, ethically and in the best interests of patient care.
Our Commitment to Patients
“The best interest of the patient is the only interest to
be considered.”
– William Mayo, M.D.
