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A Study Activities During 2006, the Institute of Medicine’s (IOM’s) Board on Health Sci- ences 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 research- ers 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 evalu- ate these principles and policies. 285

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286 CONFLICT OF INTEREST 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 prac- tice 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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APPENDIX A 287 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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288 CONFLICT OF INTEREST 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  Daniel Duffy, M.D., Senior Adviser to the President, American F. 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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APPENDIX A 289 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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290 CONFLICT OF INTEREST 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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APPENDIX A 291 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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292 CONFLICT OF INTEREST 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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APPENDIX A 293 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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294 CONFLICT OF INTEREST Discussion (all participants) 5:00 Public Comments 5:30 Adjourn