CONFLICT OF INTEREST IN MEDICAL RESEARCH, EDUCATION, AND PRACTICE

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Bernard Lo and Marilyn J. Field, Editors Committee on Conflict of Interest in Medical Research, Education, and Practice Board on Health Sciences Policy

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This study was supported by Contract No. N01-OD-4-2139, TO # 201 of the National Insti- tutes of Health, Contract No. 63229 of the Robert Wood Johnson Foundation, The Greenwall Foundation, the ABIM Foundation, Contract No. S07-2 of the Josiah Macy Jr. Foundation, Contract No. 1007182 of the Burroughs Wellcome Fund, and also the endowment fund of the Institute of Medicine, all contracts between the National Academies. Any opinions, find- ings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for the project. Library of Congress Cataloging-in-Publication Data Conflict of interest in medical research, education, and practice / Bernard Lo and Marilyn J. Field, editors ; Committee on Conflict of Interest in Medical Research, Education, and Practice, Board on Health Sciences Policy. p. ; cm. Includes bibliographical references and index. ISBN 978-0-309-13188-9 (hardcover) 1. Business and medicine. 2. Conflict of interests. I. Lo, Bernard. II. Field, Marilyn J. (Marilyn Jane) III. Institute of Medicine (U.S.). Committee on Conflict of Interest in Medical Research, Education, and Practice. IV. National Academies Press (U.S.) [DNLM: 1. Conflict of Interest. 2. Biomedical Research—ethics. 3. Education, Medical—ethics. 4. Ethics, Clinical. W 50 C748 2009] RA394.C665 2009 174.2—dc22 2009020634 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www. iom.edu. Copyright 2009 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Suggested citation: IOM (Institute of Medicine). 2009. Conflict of Interest in Medical Re- search, Education, and Practice. Washington, DC: The National Academies Press.

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“Knowing is not enough; we must apply. Willing is not enough; we must do.” — Goethe Advising the Nation. Improving Health.

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The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Acad- emy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding en- gineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi- dent of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Insti- tute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sci- ences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Coun- cil is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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COMMITTEE ON CONFLICT OF INTEREST IN MEDICAL RESEARCH, EDUCATION, AND PRACTICE BERNARD LO (Chair), Professor of Medicine and Director, Program in Medical Ethics, University of California, San Francisco WENDY BALDWIN, Director, Poverty, Gender and Youth Program, Population Council LISA BELLINI, Associate Dean for Graduate Medical Education and Associate Professor of Medicine, University of Pennsylvania LISA A. BERO, Professor, Department of Clinical Pharmacy and Institute for Health Policy Studies, University of California, San Francisco ERIC G. CAMPBELL, Associate Professor, Institute for Health Policy and Department of Medicine, Massachusetts General Hospital and Harvard Medical School JAMES F. CHILDRESS, Hollingsworth Professor of Ethics, Department of Religious Studies and Professor of Medical Education and Director, Institute for Practical Ethics, University of Virginia PETER B. CORR, General Partner, Celtic Therapeutics Management Company, L.L.P. TODD DORMAN, Associate Dean and Director, Continuing Medical Education, and Professor of Anesthesiology, Johns Hopkins Medical Center DEBORAH GRADY, Professor of Medicine and Director, Women’s Health Clinical Research Center and Associate Dean for Translational Research, University of California, San Francisco TIMOTHY S. JOST, Robert L. Willett Family Professor of Law, Washington and Lee University School of Law ROBERT P. KELCH, Executive Vice President for Medical Affairs, University of Michigan and Chief Executive Officer, University of Michigan Health System ROBERT M. KRUGHOFF, President, Consumer CHECKBOOK/Center for the Study of Services GEORGE LOEWENSTEIN, Herbert A. Simon Professor of Economics and Psychology, Department of Social and Decision Sciences, Carnegie Mellon University JOEL PERLMUTTER, Elliot Stein Family Professor of Neurology and Professor of Radiology and Physical Therapy, Washington University School of Medicine in St. Louis NEIL R. POWE, Professor of Medicine, Epidemiology, and Health Policy and Management and Director, Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins School of Medicine and Bloomberg School of Public Health 

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DENNIS F. THOMPSON, Alfred North Whitehead Professor of Political Philosophy, Department of Government and Professor of Public Policy, John F. Kennedy School of Government, Harvard University DAVID A. WILLIAMS, Chief of the Division of Hematology/Oncology, Director, Clinical and Translational Research, Children’s Hospital Boston and Leland Fikes Professor of Pediatrics, Harvard Medical School Committee Consultants and Background Paper Authors JASON D. DANA, Assistant Professor, Department of Psychology, University of Pennsylvania MICHAEL DAVIS, Senior Fellow, Center for Study of Ethics in the Professions and Professor of Philosophy, Humanities Department, Illinois Institute of Technology JOSEPHINE JOHNSTON, Research Associate, Hastings Center, Garrison, New York IOM Staff MARILYN J. FIELD, Senior Program Officer FRANKLIN BRANCH, Research Associate ROBIN E. PARSELL, Senior Program Assistant (from January 2008) AFRAH ALI, Senior Program Assistant (until November 2007) ANDREW POPE, Director, Board on Health Sciences Policy i

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Acknowledgments In preparing this report, the committee and project staff benefited greatly from the assistance and expertise of many individuals and groups. Important information and insights came from four public meetings that the committee organized to collect information and perspectives from a range of academic, professional, consumer, patient, and other organiza- tions and individuals. A number of speakers at these meetings also shared their knowledge at other times during the course of the study. Appendix A includes the agendas of the public meetings and a list of organizations that submitted written statements of views. The committee appreciates the contributions of the authors of the background papers that appear as Appendix C (Michael Davis at Illinois Institute of Technology and Josephine Johnston at the Hastings Center) and Appendix D (Jason Dana at University of Pennsylvania). Our project officer at the National Institutes of Health, Walter Schaffer, was always helpful in getting our questions answered. We also called on Daniel Wolfson at the American Board of Internal Medicine Foundation for information. In addition, Ariel Winter of the Medicare Payment Advisory Commission helped by answering questions about the commission’s work. Mary Nix at the Agency for Healthcare Research and Quality provided data from the National Guidelines Clearinghouse that we could not obtain online. An undoubtedly incomplete list of others who assisted the committee’s work includes David Atkins, James Bernat, Carol Blum, David Blumenthal, Deborah Briggs, Laura Brockway-Lunardi, Robert Campbell, Roger Chou, Vivian Coates, Allan Coukel, Bette Crigger, Susan Ehringhaus, Brian Eigel, ii

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iii ACKNOWLEDGMENTS Susan Gilbert, Marianne Hockema, Cato Laurencin, Jeffrey Leiden, Martha Liggett, Kathleen Lohr, Peter Lurie, Charlene May, Jennifer Padberg, James Severson, Mark Sommerfeld, Gabriel Sullivan, and Myrl Weinberg. The committee and project staff also appreciate the work of copy editor Michael Hayes. Within the National Academies, we particularly acknowledge the assistance of Clyde Behney, Judy Estep, Robert Giffin, Janice Mehler, Abbey Meltzer, Amy Packman, Donna Randall, Bronwyn Schrecker, and Jackie Turner.

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Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published reports as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Claudia R. Adkison, Emory University School of Medicine Robert Baron, University of California, San Francisco School of Medicine Paul Citron, Medtronic, Inc. (Retired) F. Sessions Cole, Washington University School of Medicine Peter Densen, University of Iowa Carver College of Medicine Thomas J. Fogarty, Fogarty Engineering Leo T. Furcht, University of Minnesota Linda Golodner, National Consumers League Henry T. Greely, Stanford University Law School Allen S. Lichter, American Society of Clinical Oncology Joseph Loscalzo, Brigham and Women’s Hospital Alan Nelson, American College of Physicians Foundation ix

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x REVIEWERS Philip A. Pizzo, Stanford University School of Medicine Richard Schilsky, University of Chicago Medical Center Larry J. Shapiro, Washington University in St. Louis School of Medicine Harold Sox, Annals of Internal Medicine and American College of Physicians Jeremy Sugarman, Johns Hopkins Medical Institutions P. Roy Vagelos, Merck & Co., Inc. (Retired) Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by David Challoner, Univer- sity of Florida, and Judith L. Swain, National University of Singapore and University of California, San Diego. Appointed by the National Research Council and the Institute of Medicine, these individuals were responsible for making certain that an independent examination of this report was car- ried out in accordance with the institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Preface Hardly a week goes by without a news story about conflicts of inter- est in medicine. While this committee met, colleagues and friends sent me many news reports and journal articles on the topic. These reports—even if one expects that initial news reports may not always have the stories quite straight—served as continual reminders that conflicts of interest cre- ate deep concerns about the integrity of medicine and medical research and raise questions about the trustworthiness of physicians, researchers, and medical institutions. As I look back over our deliberations, several themes stand out. First, as with all Institute of Medicine (IOM) reports, the committee was charged with making recommendations that were based on evidence and convinc- ing reasons. Although the committee members were aware of powerful anecdotes and had personal beliefs about the issues, we repeatedly asked whether the evidence supported our conclusions and recommendations. If it did not, we developed a reasoned case on the basis of the committee’s experience and the judgment of the committee members about the argu- ments for the use of different approaches presented in the literature or in statements submitted to the committee. Second, it is a challenge to craft policy recommendations that strike the right balance between addressing egregious cases and creating burdens that stifle relationships that advance the goals of professionalism and generate knowledge to benefit society. The committee tried to consider the possibility that well-intentioned policies may have unintended adverse consequences. Third, regulation alone may have limited effectiveness in the absence of a culture of professionalism xi

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xii PREFACE and other incentives that are aligned to promote professional behavior. The committee considered how a variety of organizations—including those that accredit health care institutions and license health care professionals, publish the findings of medical research, use practice guidelines, and pay for medical care—can buttress the conflict of interest policies implemented by institutions that carry out medical research, provide education and patient care, and develop practice guidelines. This report cannot and did not attempt to resolve all issues related to conflicts of interest in medicine. In view of our expansive charge, we tried to address central questions rather than the many details of this complex topic. For example, we focus on conflicts that involve financial interests because they are at the heart of concerns and debates about conflicts of interest. Furthermore, because relationships with pharmaceutical, medical device, and biotechnology companies have created the greatest concern and were central in the discussions that led the IOM to pursue this study, we focused on those relationships. The committee expects that many of the recommendations and analyses in our report will also apply more generally to professional and institutional relationships with other commercial enti- ties, such as insurers and vendors of nonmedical products. The committee could not resolve some important issues like harmoniz- ing the different requirements for the disclosure of financial relationships because they would require much more time and additional expertise. Instead, to standardize aspects of disclosure policies and procedures, the committee recommended a focused consensus development process that would involve multiple stakeholders on the issue. Our committee was diverse, involving members with different profes- sional backgrounds and areas of expertise. These different perspectives led to spirited discussions and debates. Each of us listened to points of view and information that we had not previously considered. We tried to listen to and understand other viewpoints and be open to new perspectives, even if in the end we did not agree on all issues. Appendix F describes the differ- ent views on one issue, a proposal by some committee members for broader requirements for public disclosure. In general, the committee hoped that by explaining our reasoning on difficult issues our audiences would better ap- preciate the multiple considerations that a sound conflict of interest policy should address. As chair, I want to personally thank the committee members for their hard work and their willingness to engage on difficult topics. I am deeply grateful to them for the time and effort that they took from their busy schedules to devote to this project. This report is truly a collaborative ef- fort and is much the better, I think, for the back-and-forth discussions. I also want to personally thank our IOM staff for their tremendous efforts in making this report possible. Robin Parsell skillfully handled meeting

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xiii PREFACE and other logistics, and Franklin Branch provided research assistance in many areas. Marilyn Field was unstinting in her background research, drafting and revising of the manuscript, and high standards for our work. And I want to thank Lindsay Parham, my research assistant at the Univer- sity of California at San Francisco, for her expert help with background research. Bernard Lo, M.D., Chair Committee on Conflict of Interest in Medical Research, Education, and Practice

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Contents SUMMARY 1 1 INTRODUCTION 23 Overview and Themes of the Report, 27 Historical and Policy Context, 33 Organization of Report, 43 2 PRINCIPLES FOR IDENTIFYING AND ASSESSING CONFLICTS OF INTEREST 44 What Is a Conflict of Interest?, 45 What Are the Purposes of Conflict of Interest Policies?, 48 Why Not Examine the Motives of the Decision Maker or the Validity of the Decision?, 50 Should Policies Also Require That Professionals Avoid the “Appearance of Conflict of Interest”?, 52 How Can Conflicts of Interest Be Assessed?, 52 How Can Conflict of Interest Policies Be Evaluated?, 56 Conclusion, 60 3 POLICIES ON CONFLICT OF INTEREST: OVERVIEW AND EVIDENCE 62 Overview of Conflict of Interest Policies, 64 Disclosure: An Essential but Insufficient Element of Policy, 67 Prohibiting or Eliminating Conflicts of Interests, 79 x

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xi CONTENTS Evaluating and Managing Conflicts of Interest, 80 Recommendations, 87 4 CONFLICTS OF INTEREST IN BIOMEDICAL RESEARCH 97 Collaboration and Discovery in Biomedicine, 98 Industry Funding and Relationships in Biomedical Research, 101 Concerns About Relationships with Industry, 102 Responses to Concerns About Conflicts of Interest in Research, 110 Recommendations, 116 5 CONFLICTS OF INTEREST IN MEDICAL EDUCATION 122 Background and Context, 124 Learning Environments in Medical Schools and Residency Programs, 127 The Learning Environment in Accredited Continuing Medical Education, 140 Ghostwriting, Speakers Bureaus, and Independence of Publications and Presentations, 153 Recommendations, 157 6 CONFLICTS OF INTEREST AND MEDICAL PRACTICE 166 The Broader Context: Physician Payment, Self-Referral, and Conflicts of Interest in Medical Practice, 167 Industry Promotional Activities and Practicing Physicians, 170 Responses to Concerns About Industry Relationships and Conflicts of Interest in Community Practice, 175 Recommendations, 183 7 CONFLICTS OF INTEREST AND DEVELOPMENT OF CLINICAL PRACTICE GUIDELINES 189 Background and Context, 190 Groups That Develop Clinical Practice Guidelines, 196 Financial Relationships in Guideline Development, 198 Policies on Conflicts of Interest in Clinical Practice Guideline Development, 204 Recommendations, 210 8 INSTITUTIONAL CONFLICTS OF INTEREST 216 What Are Institutional Conflicts of Interest?, 218 Extent of Institutional Relationships with Industry, 219 Responses to Institutional Conflicts of Interest, 221 Special Challenges in Managing Institutional Conflicts of Interest, 224 Recommendations, 226

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xii CONTENTS 9 ROLE OF SUPPORTING ORGANIZATIONS 230 How Supporting Organizations Can Influence Medical Institutions, 232 Recommendations, 235 REFERENCES 240 APPENDIxES A Study Activities 285 B U.S. Public Health Service Regulations: Objectivity in Research (42 CFR 50) 295 C Conflict of Interest in Four Professions: A Comparative Analysis 302 D How Psychological Research Can Inform Policies for Dealing with Conflicts of Interest in Medicine 358 E The Pathway from Idea to Regulatory Approval: Examples for Drug Development 375 F Model for Broader Disclosure 384 G Committee Biographies 392 INDEx 401

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Boxes, Figures, and Tables BOxES 3-1 Model of Steps Used to Identify and Respond to a Conflict of Interest, 65 3-2 Risks and Potential Benefits to Consider in Assessing the Severity of a Researcher’s Conflict of Interest, 83 4-1 Examples of Biased Reporting in Clinical Research, 107 5-1 AAMC Recommendations on Site Access by Sales Representatives, 134 5-2 Example of a Solicitation of Industry Support (Educational Grants) for a Large Accredited Continuing Medical Education Program, 146 5-3 Settlements Involving Educational Activities and Speaking and Writing Arrangements, 149 6-1 Excerpts from Statements on Gifts by American Medical Association and American College of Physicians, 177 6-2 Summary of Selected Recent Revisions in the PhRMA Code on Interactions with Healthcare Professionals, 180 6-3 Examples of Prosecutions Involving Kickbacks to Physicians, 182 7-1 Cases and Controversies Involving Conflicts of Interest in Guideline Development, 200 xix

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xx BOXES, FIGURES, AND TABLES 7-2 Examples of Financial and Conflict of Interest Information Excerpted from Summaries in the National Guideline Clearinghouse, 202 7-3 Examples of Conflict of Interest Policy Descriptions Excerpted from Summaries in the National Guideline Clearinghouse, 206 7-4 Policies of American College of Chest Physicians on Industry Funding of Guideline Development, 208 7-5 Other Strategies for Limiting Bias in Clinical Practice Guideline Development, 209 8-1 Cases and Controversies Involving Institutional Conflicts of Interest, 217 9-1 Examples of Methods That Supporting Organizations Can Use to Strengthen Conflict of Interest Policies, 236 E-1 Case Example of Successful Collaboration in Drug Discovery and Development, 379 FIGURES 5-1 Sources of income reported by respondents (accredited providers of continuing medical education) to ACCME annual survey, 1998 to 2007, 128 6-1 Percent change in average net physician income, adjusted for inflation, 1995 to 2003, 168 E-1 Defining biomedical research from idea to market, 377 TABLES S-1 Report Recommendations in Overview, 16 1-1 Timeline of Selected Events Relevant to the Evolution of Conflict of Interest Principles, Policies, and Practices, 36 1-2 Selected Reports on Conflict of Interest Released Since 2000, 42 2-1 Criteria for Assessing the Severity of Conflicts of Interest, 53 2-2 Criteria for Evaluating Conflict of Interest Policies, 57

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xxi BOXES, FIGURES, AND TABLES 3-1 Percentage of Medical Schools Requiring Further Disclosures for Researchers with a Significant Financial Interest in Their Research, 69 3-2 Percentage of Medical Schools Citing Different Management Policy Options When Researchers Have a Significant Financial Interest in Their Research, 84 3-3 Candidate List of Categories of Financial Relationships with Industry to Be Disclosed, 93 4-1 Checklist for Reporting Clinical Trials from CONSORT 2001 Statement, 114 5-1 Third-Year Medical Students’ Interactions with Drug Companies, 130 5-2 Share of Total Accredited Continuing Medical Education Income, Instruction Hours, Participants, and Activities Accounted for by Major Types of ACCME-Accredited Providers, 141 5-3 Income, Expenses, and Source of Support as Percentage of Income, by Type of Accredited Provider of Continuing Medical Education, 2007, 144 7-1 Basic Elements of Process for Developing Evidence-Based Practice Guidelines, 193 7-2 Number of Clinical Practice Guidelines in the National Guideline Clearinghouse by Selected Types of Sponsors, as of March 16, 2009, 197 C-1 Summary of the Responses of Four Professions to Conflicts of Interest, 356

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