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Conflict of Interest in Medical Research, Education, and Practice
A
Study Activities
During 2006, the Institute of Medicine’s (IOM’s) Board on Health Sciences Policy began to discuss threats to public trust in biomedical research and medicine created by certain types of financial relationships between pharmaceutical, medical device, and biotechnology companies and researchers based in universities and federal agencies. As the discussion expanded, others expressed concerns about conflicts of interest in medical education, especially continuing medical education. The IOM was also approached about whether it would examine financial relationships and conflicts of interest as they affect the publication of research and the development of clinical practice guidelines.
In response, the IOM developed a proposal for a broad-ranging study that would examine conflicts of interest across medical research, medical education, clinical practice, and practice guideline development. It secured funding for the study from both public and private sources and appointed a 17-member committee to oversee the study. The charge to the committee was to develop a consensus report that would
examine and describe conflicts of interest involving health care professionals and industry in different contexts, including, for example, the conduct of research, the education of health care professionals, the development of practice guidelines, the provision of patient care, and the management of academic and other institutions;
propose principles to inform the design of policies, guidelines, and other tools to identify and manage conflicts of interest in these contexts without damaging constructive collaboration with industry; and
consider methods to disseminate, promote, implement, and evaluate these principles and policies.
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Conflict of Interest in Medical Research, Education, and Practice
The committee met six times between November 2007 and October 2008. It held public sessions at its first four meetings to hear views from a wide range of experts and interested parties. The May 2008 meeting included a workshop on conflict of interest issues in basic research and another on conflict of interest issues in the development of clinical practice guidelines. The agendas for the public meetings are listed below. The committee also invited written statements of views from approximately 50 additional organizations; those that submitted statements are listed.
INSTITUTE OF MEDICINE COMMITTEE ON CONFLICT OF INTEREST IN MEDICAL RESEARCH, EDUCATION, AND PRACTICE
Keck Center of the National Academies
November 5–6, 2007—Open Sessions
November 5
3:00
Welcome and Introductions
Bernard Lo, M.D., Committee Chair
3:10
Overview of Conflicts of Interest in Medical Research, Education, and Practice
Robert Steinbrook, M.D., National Correspondent, New England Journal of Medicine
Eric Campbell, Ph.D., Associate Professor, Institute for Health Policy, Massachusetts General Hospital, and Harvard University
Greg Koski, M.D., Ph.D., Senior Scientist, Institute for Health Policy, Massachusetts General Hospital, and Harvard University
Peter Lurie, M.D., M.P.H., Deputy Director, Public Citizen’s Health Research Group
Discussion
5:00
Adjourn
November 6
8:30
Welcome and Introductions
8:35
Perspectives from Industry
Garry A. Neil, M.D., Group President, Johnson & Johnson
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Conflict of Interest in Medical Research, Education, and Practice
8:50
Discussion with Study Sponsor
Christine Cassel, M.D., President, American Board on Internal Medicine Foundation
9:05
Conflict of Interest in Medical Research
Cary P. Gross, M.D., Associate Professor of Medicine, Yale University
David Korn, M.D., Senior Vice President for Biomedical and Health Sciences Research, Association of American Medical Colleges
Discussion
10:10
Break
10:30
Conceptual Issues in Conflict of Interest
Ezekiel J. Emanuel, M.D., Ph.D., Chair, Department of Bioethics, Magnuson Clinical Center, National Institutes of Health
Discussion
11:10
Discussion with Study Sponsor
Elias A. Zerhouni, M.D., Director, National Institutes of Health
Noon
Adjourn
INSTITUTE OF MEDICINE COMMITTEE ON CONFLICT OF INTEREST IN MEDICAL RESEARCH, EDUCATION, AND PRACTICE
Keck Center of the National Academies
January 21, 2008—Open Session
1:00
Welcome, Introductions, and Statement About the Meeting
Bernard Lo, M.D., Committee Chair
1:10
Conflict of Interest in Medical Education
Suzanne Fletcher, M.D., M.Sc., Professor Emerita of Ambulatory Care and Prevention, Harvard Medical School
Michael Steinman, M.D. (by conference call), Assistant Professor of Medicine, San Francisco Veterans Affairs Medical Center and University of California, San Francisco
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Conflict of Interest in Medical Research, Education, and Practice
Discussion
2:10
Conflict of Interest in Medical Education
Murray Kopelow, M.D., Chief Executive, Accreditation Council for Continuing Medical Education
Ingrid Philibert, M.H.A., M.B.A., Senior Vice President, Department of Field Activities, Accreditation Council for Graduate Medical Education
F. Daniel Duffy, M.D., Senior Adviser to the President, American Board of Medical Specialties
Discussion
3:10
Break
3:30
Perspectives from Industry
Paul Citron, Ph.D., Retired, Vice President for Technology Policy and Academic Affairs, Medtronic
Cathryn Clary, M.D., Vice President, U.S. External Medical Affairs, Pfizer, Inc.
Discussion
4:15
General Discussion
5:00
Adjourn
INSTITUTE OF MEDICINE COMMITTEE ON CONFLICT OF INTEREST IN MEDICAL RESEARCH, EDUCATION, AND PRACTICE
Board Room, National Academy of Sciences
March 13, 2008—Open Session
8:15
Welcome and Chair’s Statement
Bernard Lo, M.D., Committee Chair
8:30
Statements from Organizations
Consumers Union
Gail Shearer, Director, Health Policy Analysis
John Santa, M.D., Consultant and Associate Professor, Oregon Health Sciences University and Portland State University
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Conflict of Interest in Medical Research, Education, and Practice
Center for Science in the Public Interest
Merrill Goozner, Director, Integrity in Science
Alpha-One
John Walsh, President
Questions and Discussion
9:25
Statements from Organizations
Pharmaceutical Research and Manufacturers Association
Alan Goldhammer, Ph.D., Deputy Vice President, Regulatory Affairs
AdvaMed (Advanced Medical Devices Association)
Kris Rapp, Vice President, Global Ethics & Compliance for Hospira, Inc.
BIO (Biotechnology Industry Organization)
Jonca Bull, M.D., Director, Clinical and Regulatory Affairs, Genentech
North American Association of Medical Education and Communication Companies
Karen M. Overstreet, Ed.D., R.Ph., Past President and President, Indicia Medical Education, LLC
Questions and Discussion
10:25
Break
10:45
Lessons Learned I: Developing and Implementing Medical School Conflict-of-Interest Policies
Philip A. Pizzo, M.D., Carl and Elizabeth Naumann Dean and Professor of Pediatrics and of Microbiology and Immunology, Stanford University School of Medicine
Joseph B. Martin, M.D., Ph.D., Edward R. and Anne G. Lefler Professor of Neurobiology, and Dean, Harvard Medical School, 1997–2007
Questions and Discussion
Follow-up Questions and Discussion for Earlier Panels
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Conflict of Interest in Medical Research, Education, and Practice
12:00
Lunch break
1:00
Statements from Organizations
American Medical Association
Mark A. Levine, M.D., Chair, Council of Ethical and Judicial Affairs
American College of Physicians
Joel S. Levine, M.D., Chair, Board of Regents and Senior Associate Dean for Clinical Affairs, University of Colorado School of Medicine
American Psychiatric Association
Carolyn B. Robinowitz, M.D., President and Clinical Professor of Psychiatry at Georgetown and George Washington Universities
American College of Cardiology
John C. Lewin, M.D., C.E.O.
Sidney C. Smith Jr., M.D., Professor of Medicine and Director, Center for Cardiovascular Science and Medicine, University of North Carolina, Chapel Hill
American Medical Student Association
Brian Palmer, M.D., M.P.H., Past President and Psychiatry Resident, Massachusetts General Hospital/McLean Hospital
Questions and Discussion
2:30
Break
3:00
Lessons Learned II: Developing and Implementing Conflict-of-Interest Policies
David Korn, M.D., Senior Vice President for Biomedical and Health Sciences Research Association of American Medical Colleges
Leo Furcht, M.D., Past President, Federation of American Societies for Experimental Biology and Allen Pardee, Professor and Head of Laboratory Medicine and Pathology, University of Minnesota School of Medicine
Harold C. Sox, M.D., International Committee of Medical Journal Editors, and Editor, Annals of Internal Medicine
Questions and Discussion
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Conflict of Interest in Medical Research, Education, and Practice
4:15
Continued Questions and Discussion and Public Comment
5:00
Adjourn
Organizations Submitting Written Statements
In addition to the organizations presenting statements during the March meeting, the following organizations provided written statements to the committee:
Accreditation Council for Continuing Medical Education
Alliance for Continuing Medical Education
Alzheimer’s Association
American Academy of Family Physicians
American Academy of Ophthalmology
American Academy of Orthopedic Surgeons
American Academy of Pediatrics
American Board of Medical Specialties
American Society of Hematology
American Thoracic Society
Coalition for Healthcare Communication
Infectious Diseases Society of America
National Kidney Foundation
North American Spine Society
Society for Academic Continuing Medical Education
INSTITUTE OF MEDICINE COMMITTEE ON CONFLICT OF INTEREST IN MEDICAL RESEARCH, EDUCATION, AND PRACTICE
Lecture Room, National Academy of Sciences
May 22, 2008—Open Session
Conflict of Interest in Basic and Translational Research
8:15
Welcome, Introductions, and Chair’s Statement
Bernard Lo, M.D., Committee Chair
8:35
Additional Perspectives on Professional Society Policies
Kenneth Kaushansky, M.D., President, American Society of Hematology and Chair and Helen M. Ranney Professor, Department of Medicine, University of California, San Diego
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9:00
Perspectives on Financial Relationships and Conflicts of Interest in Basic and Early-Stage Translational Research: Part 1
Leslie Z. Benet, Ph.D., Professor, Department of Biopharmaceutical Sciences, University of California, San Francisco
Gail Cassell, Ph.D., Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company
Edward Benz, M.D., (by telephone), President, Dana-Farber Cancer Institute
Discussion
10:10
Break
10:30
Perspectives on Financial Relationships and Conflicts of Interest in Basic and Early-Stage Translational Research: Part 2
Hamilton Moses III, M.D., Chair, The Alerion Institute
Leo Furcht, M.D., Past President, Federation of American Societies for Experimental Biology and Allen Pardee, Professor and Head of Lab Medicine and Pathology, University of Minnesota School of Medicine
Discussion
11:25
Financial Disclosures and Trust in Health Care Professionals
Mark Hall, J.D., Professor of Law and Public Health,
Wake Forest University School of Law
Kevin Weinfurt, Ph.D., Associate Professor of Psychiatry and Behavioral Sciences, and of Psychology and Neuroscience, Duke Clinical Research Institute
Discussion
Noon
Lunch break
Conflict of Interest in Clinical Practice Guidelines
1:00
Welcome, Introductions, and Chair’s Statement
Bernard Lo, M.D., Committee Chair
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Conflict of Interest in Medical Research, Education, and Practice
1:15
Individual and Organizational Financial Relationships with Industry
Elizabeth Boyd, Ph.D., Assistant Vice President for Research, Compliance and Policy, University of Arizona
Discussant: Mary Nix, M.S., Health Scientist Administrator, National Guideline Clearinghouse, Agency for Healthcare Research and Quality
Discussion
2:00
Organizational Policies, Practices, and Challenges in Developing and Implementing Conflict-of-Interest and Related Policies
Dina Michels, Esq., Vice President and General Counsel, American Society of Clinical Oncology
Murray Sagsveen, J.D., General Counsel, American Academy of Neurology
Sidney C. Smith, Jr., M.D., American College of Cardiology, and Professor of Medicine and Director, Academic Center for Cardiovascular Disease
Mary Barton, M.D., M.P.P., Scientific Director, U.S. Preventive
Services Task Force, and University of North Carolina
Discussants:
Fran Visco, President, National Breast Cancer Coalition
Alvin Lever, M.A., C.E.O., American College of Chest Physicians
Sandra Zelman Lewis, Ph.D., Assistant Vice President, American College of Chest Physicians
Henry Masur, M.D., Chief, Department of Critical Care
Medicine, National Institutes of Health Clinical Center
John C. Ring, M.D., Director, Policy Research and Development, American Heart Association
3:00
Break
3:20
Continued Discussion of Organizational Policies and Practices
4:00
Systematic Reviews and Other Strategies to Protect Against Bias in Guidelines Development
Holger Schunemann, M.D., Ph.D., Associate Professor of Medicine, University of Buffalo, and Italian National Cancer Institute, Rome, Italy
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Conflict of Interest in Medical Research, Education, and Practice
Discussion (all participants)
5:00
Public Comments
5:30
Adjourn