Resource Materials

Note:  These pre-read materials were submitted by participants in the Summit as recommended resources on the topic of physician-industry collaboration.  In the event other participants would like to recommend additional articles, please email Debbie Witchey at dwitchey@hlc.org.

 
INNOVATION = Earlier Detection + Advanced Technology + Better Treatment Protocols

Medical Research and Innovation

• Measuring the Gains from Medical Research: An Economic Approach by Kevin M. Murphy and Robert H. Topel
• A preview of the first 45 pages of the book is available on Google Books (see link)

Codes

• American College of Cardiology Industry Relationships and Code of Ethics
• Principles for Relationships with Industry
• Code of Ethics
• Partnership Policies for the CardioSmart National Health Initiative

• Accreditation Council for Continuing Medical Education (ACCME Policies)
• ACCME Standards for Commercial Support: Standards to Ensure the Independence of CME Activities ("SCS") (updated 2004)
• ACCME® Accreditation Policies including Information for Provider Implementation

• AdvaMed Issues & Advocacy Materials
• AdvaMed's Board-Approved Disclosure Positions – Physician Payment Disclosure Legislation
• AdvaMed's Sunshine One-Pager – Physician Payment Disclosure Legislation
• Code of Ethics on Interactions with Health Care Professionals (July 1, 2009)

• BIO Press Release and Statement in Support of PhRMA’s revised Code on Interactions with Healthcare Professionals (February 19, 2009)
• BIO Encourages Its Members to Adopt Code of Conduct to Govern Interactions With Healthcare Professionals:  Members Should Maintain “Highest Standards” For Ethical Business Practices Related to Interactions

• Council of Medical Specialty Societies Policies and Positions
• AMA CEJA 1 A 10 CMSS Comments (June 9, 2010)
• Code for Interactions with Companies
• Ethics Statement

• PhRMA Principles and Guidelines
• Revised Clinical Trial Principles Reinforce PhRMA’s Commitment To Transparency and Strengthen Authorship Standards
• Principles on Conduct of Clinical Trials: Communication of Trial Results
• Code of Interactions with Healthcare Professionals

Conflicts of Interest

• ACRE Response to NIH Proposed COI and Transparency Policy (posted by Thomas Sullivan as published on Policy and Medicine, July 22, 2010)

• AHA Ban on Industry Posters and Presenters: Conflict of Interest Run Amuck? (posted by Thomas Sullivan as published on Policy and Medicine, June 17, 2010)

• Association of American Medical Colleges
• In the Interest of Patients: Recommendations for Physician Financial Relationships and Clinical Decision Making (June 2010)
• Protecting Patients, Preserving Integrity, Advancing Health:  Accelerating the Implementation of COI Policies in Human Subjects Research (February 2008)
• Protecting Subjects, Preserving Trust, Promoting Progress II (October 2002)
• Protecting Subjects, Preserving Trust, Promoting Progress - Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research (December 2001)
• ASCO Requests Changes to the NIH Proposed Conflict of Interest Rules: Unrealistic to Request Investigators to Reduce or Eliminate all COI’s (posted by Thomas Sullivan as published on Policy and Medicine, August 25, 2010)

• Health Industry Practices that Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers
• The Journal of the American Medical Association (JAMA. 2006; 295: 429-433)
• Authors:  Troyen A. Brennan, M.D., M.P.H.; David J. Rothman, Ph.D.; Linda Blank; David Blumenthal, M.D., M.P.P.; Susan C. Chimonas, Ph.D.; Jordan J. Cohen, M.D.; Janlori Goldman, J.D.; Jerome P. Kassirer, M.D.; Harry Kimball, M.D.; James Naughton, M.D.; Neil Smelser, Ph.D.

• Institute of Medicine of the National Academies, Conflict of Interest in Medical Research, Education and Practice  
• Released on April 21, 2009
• Authors Bernard Lo and Marilyn J. Field, Editors
• Link to online report: http://books.nap.edu/openbook.php?record_id=12598

• Is the Campaign on Conflict of Interest In Medicine an Attack on Patient Rights? (posted by Thomas Sullivan as published on Policy and Medicine, August 19, 2010)

• Managing Financial Conflict of Interest in Biomedical Research
• Author: Sally J. Rockey, Ph.D. and Francis S. Collins, M.D.
• Published in the Journal of American Medical Association (May 24, 2010)

• University of Minnesota: Conflict of Interest Policy in Patient Care (posted by Thomas Sullivan as published on Policy and Medicine, August 6, 2010)

Industry Collaboration

• Activities Concerning the Interactions between Private Industry and Medical Practice, Medical Education and Medical Innovation
• Author: Thomas P. Stossel – includes list of writings on this topics

• Partners Commission on Interactions with Industry – Report, April 2009
• Partners Healthcare, Founded by Brigham and Women’s Hospital and Massachusetts General Hospital

Federal Policy, Legislation and Congressional Testimony 

• Examining the Relationship between the Medical Device Industry and Physicians: Testimony of Gregory E. Demske, Assistant Inspector General for Legal Affairs
• Office of Inspector General, Department of Health and Human Services
• February 27, 2008, 10:30 a.m., 628 Dirksen Senate Office Building

• Final Health Care Reform Sunshine Language – Transparency Reports and Reporting of Physician Ownership or Investment Interests  

• "Physician Payments Sunshine Act of 2009" – text of Sens. Grassley-Kohl Bill

• The Role of Medical Liability Reform in Federal Health Care Reform
• The New England Journal of Medicine (NEJM, 361;1 - July 2, 2009)
• Authors: Michelle M. Mello, J.D., Ph.D., M.Phil., and Troyen A. Brennan, M.D., J.D., M.P.H.

Case Studies – Patient Care

• Case Study: Aetna’s Embedded Case Managers Seek to Strengthen Primary Care
• Author:  Martha Hostetter
• Published in Quality Matters, August/September 2010

• A Comprehensive Case Management Program to Improve Palliative Care
• Authors: Claire M. Spettell, Ph.D., Wayne S. Rawlins, M.D., M.B.A., Randall Krakauer, M.D., Joaquim Fernandes, M.S., Mary E.S. Breton, B.S., J.D., Wayne Gowdy, B.S., Sharon Brodeur, R.N., B.S., M.P.A., Maureen MacCoy, B.S.N., M.B.A., and Troyen A. Brennan, M.D., M.P.H.
• Published in Journal of Palliative Medicine (Volume 12, Number 9, 2009)

• Opportunities to Improve the Quality of Care for Advanced Illness: An Aetna Pilot Program Shows How It Can Be Done
• Authors: Randall Krakauer, Claire M. Spettell, Lonny Reisman, and Marcia J. Wade
• Published in Health Affairs, Perspective: Quality (Volume 28, Number 5)

• Translating Research into Practice: Transitional Care for Older Adults
• Authors: Mary D. Naylor Ph.D. R.N., Penny Hollander Feldman Ph.D., Stacen Keating Ph.D. R.N., Mary Jane Koren M.D. M.P.H., Ellen T. Kurtzman M.P.H. R.N., Maureen C. Maccoy M.B.A. R.N. and Randall Krakauer M.D. FACP FACR
• Published in Journal of Evaluation in Clinical Practice (July 15, 2009)