Disclosures No relationships or conflicts to report

Industry Relationships: Necessary for Systematic Quality Improvement QCOR May 2010 Jack Lewin, M.D., CEO The 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 :

Source: to38.1 (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 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!

Is there a role for industry? Yes

Does industry have business motives? Of course so…

? If you accept industry funding, can you be… unbiased ethical

Industry relationships can be managed effectively They provide value when ethically structured

OK for research but not for CME?

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

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 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 RegistrationTravel U.S.Non-U.S.U.S.Non-U.S. Me31.53%37.96%39.15%35.06% My practice26.11%8.36%24.21%8.17% Industry7.18%32.69%7.83%38.68% University16.60%9.39%20.93%11.39% Other18.58%11.59%7.88%6.70% Source: ACC Market Intelligence Research n=1,110 physician attendees at ACC.10 March 26 - April 28, 2010

CMSS Code for Interaction with Companies Source: released April 2010www.cmss.org

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.