Patient Outcomes Research Teams: Managing Conflict of Interest

Molla S. Donaldson and Alexander M. Capron, Editors

Committee on Potential Conflicts of Interest in Patient Outcomes Research Teams

Institute of Medicine

NATIONAL ACADEMY PRESS
Washington, D.C. 1991



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Patient Outcomes Research Teams: Managing Conflict of Interest Patient Outcomes Research Teams: Managing Conflict of Interest Molla S. Donaldson and Alexander M. Capron, Editors Committee on Potential Conflicts of Interest in Patient Outcomes Research Teams Institute of Medicine NATIONAL ACADEMY PRESS Washington, D.C. 1991

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Patient Outcomes Research Teams: Managing Conflict of Interest 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 this report were chosen for their special competences and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the academy’s 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Support for this project was provided by the U.S. Department of Health and Human Services (grant 5 R09 HS05526 04 and DHHS 91-RF092981 01D) the Pharmaceutical Manufacturers Association, and Dartmouth Medical School. The project was begun under the auspices of the Council on Health Care Technology; after June 1990 it was completed in the Division of Health Care Services of the Institute of Medicine. Library of Congress Catalog Card No. 91-61419 International Standard Book Number 0-309-04482-0 Additional copies of this report are available from: National Academy Press 2101 Constitution Avenue, NW Washington, DC 20418 S332 Printed in the United States of America This serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staatlichemuseen in Berlin.

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Patient Outcomes Research Teams: Managing Conflict of Interest COMMITTEE ON POTENTIAL CONFLICTS OF INTEREST IN PATIENT OUTCOMES RESEARCH TEAMS ALEXANDER M. CAPRON (Chair),* Pacific Center for Health Policy and Ethics, University of Southern California, Los Angeles BERNARD BARBER, Professor Emeritus, Sociology, Columbia University, New York, New York DAVID BLUMENTHAL, Senior Vice President, Brigham and Women's Hospital, Boston, Massachusetts JOHN W. BROWN, Chairman, President, and Chief Executive Officer, Stryker Corporation, Kalamazoo, Michigan BARBARA C. HANSEN,* Director of the Obesity and Diabetes Research Center and Professor of Physiology, University of Maryland School of Medicine, Baltimore THOMAS S. INUI,* Professor, Departments of Medicine and Health Services, and Head, Division of General Internal Medicine, University of Washington, Seattle RONALD W. LAMONT-HAVERS, Deputy Director for General Affairs, Cutaneous Biology Research Center, and Senior Consultant, Division of Research Affairs, Massachusetts General Hospital, Boston MARK NOVITCH, Executive Vice President, The Upjohn Company, Kalamazoo, Michigan MICHAEL R. POLLARD, Principal, Michaels and Wishner, P.C., Washington, D.C. STUDY STAFF Division of Health Care Services KARL D. YORDY, Director KATHLEEN N. LOHR, Deputy Director MOLLA S. DONALDSON, Study Co-Director CLIFFORD GOODMAN, Study Co-Director HOLLY DAWKINS, Research Assistant THERESA N. NALLY, Senior Secretary *   Member, Institute of Medicine

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Patient Outcomes Research Teams: Managing Conflict of Interest Acknowledgments A number of individuals contributed to thoughtful and provocative discussions at the committee's June workshop, including those who graciously served with committee members on panels and reacted to challenges posed by three scenarios. They were Marilyn Bergner, Bruce Brennan, Peter Budetti, C. K. Gunsalus, Peter Hutt, David Korn, Bryan Luce, Barbara McNeil, Barbara Mishkin, Lawrence Morris, David Pryor, and Earl Steinberg. Marcia Angell served as both a rapporteur and a lead commentator for a roundtable discussion. The committee thanks the scholars who prepared background papers for this study under considerable time constraints. They include David Asch, Paul Gebhard, Judith Lave, Barbara McNeil, Michael Roberts, Frank Samuel, and John Wennberg. We also thank J. Jarrett Clinton, then acting director of the Agency for Health Care Policy and Research and Christine Williams of Senator George Mitchell's office for informative presentations at the Institute of Medicine (IOM) workshop. Fred Telling and John Wennberg provided the committee with their insights and experience during committee meetings. Ira Raskin, acting director of the Medical Treatment Effectiveness Program (MEDTEP) at the time, also gave a presentation to the committee on the program of outcomes research and provided considerable assistance during this project. Several individuals critiqued the manuscript. During review by the National Research Council, eight reviewers provided extensive and helpful suggestions for strengthening the report. We also appreciate the comments of IOM Council members Edward Brandt and Harold Luft whose timely and creative suggestions are always greatly appreciated. Ira Raskin and Claire Maklan of MEDTEP reviewed a draft of Chapter 2 and provided valuable assistance in clarifying it. John Wennberg and Chris Pashos reviewed the descriptions of their patient outcomes research teams at Dartmouth and Harvard, respectively, and helped ensure their accuracy.

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Patient Outcomes Research Teams: Managing Conflict of Interest The help of several members of the IOM staff should also be acknowledged. In addition to providing advice and encouragement throughout the study, Kathleen Lohr, deputy director of the Division of Health Care Services, contributed a wealth of expertise on issues of health services research. Malin Van Antwerp reviewed a draft of the report, and Annetine Gelijns helped with the description of outcomes and epidemiologic research in the pharmaceutical industry. We appreciate the editorial work by Leah Mazade on an early draft of the report. We are indebted to the expert staff efforts of Theresa Nally, the project secretary, and to Lisa Chimento and Nina Spruill, financial analysts. We would particularly like to thank Karl Yordy, Director of the Division of Health Care Services for his guidance throughout the study. Finally, financial support for this study was provided by the U.S. Public Health Service, Department of Health and Human Services; the Pharmaceutical Manufacturers Association; and the Dartmouth Medical School.

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Patient Outcomes Research Teams: Managing Conflict of Interest Preface The ability to assess the probable outcomes of alternative medical responses to disease or disability is obviously a matter of great interest to patients, physicians, and payers alike. Yet surprisingly little reliable information has been available to guide choices among treatments or to determine which treatments are appropriate for health insurance coverage. The field of health services research has yet to catch up with the remarkable developments in clinical science and the changes they have wrought in health care. In recent years, however, health services researchers have developed increasingly sophisticated means of assessing outcomes. A major means is through multidisciplinary groups known as patient outcomes research teams (PORTs) which focus their combined expertise in fields from clinical care to decision analysis on the outcomes and costs of alternative practice patterns in treating a particular medical condition. Beginning with meta-analysis of the existing literature on treatment for the condition, each PORT constructs means of measuring the connection between practice variations and a range of appropriate outcome measures that go beyond simple mortality and morbidity data. This model is then used to analyze both large data sources (from hospitals, insurance carriers, state health departments, and the like) and the results of specially conducted interviews and chart reviews. After its findings are disseminated, a PORT also evaluates their effects on the choices made by physicians and patients. In their size and complexity as well as in their direct connection with the actual practice of medicine, PORTs differ from traditional clinical research. If well conducted, their findings are likely to have a major influence on clinicians' practice patterns and third-party payers' reimbursement policies. Even if every PORT does not become the recognized arbiter of the "best alternative" to achieve a specified outcome for its particular disease, all PORTs can reasonably be expected to wield considerable influence.

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Patient Outcomes Research Teams: Managing Conflict of Interest Accordingly, it is important that both the public and health professionals be able to rely on the objectivity of PORTs and the reliability of their findings. Yet, as Dr. J. Michael Fitzmaurice, then director of the agency within the Department of Health and Human Services (DHHS) responsible for funding PORTs, observed in a letter to Dr. Samuel Thier, president of the Institute of Medicine, once PORTs are perceived as ideal evaluators, "designers and manufacturers of drugs and devices as well as the developers and proponents of new diagnostic and therapeutic procedures will quickly recognize [their] potential . . . to significantly influence the adoption and dissemination of their innovations." Should PORTs add prospective studies of such new products or procedures to their evaluations along with the retrospective data on existing alternatives? Or should they participate in separate studies of new treatments or lend their expertise in designing such studies to permit them to incorporate the PORT's latest thinking about appropriate ways to measure patient outcomes? Should a PORT supplement its governmental support with funds from insurance companies or other entities that have an interest in health care expenditures (such as patients' groups) in order to extend the reach of its studies or the vigor of its dissemination efforts? Should members of a PORT accept fees from, hold stock or officerships in, or otherwise be involved with any concern having a proprietary interest in the field under study? What about PORT members' involvement with professional groups that advocate a particular treatment for a disease or that have a financial or intellectual stake in certain treatment alternatives? The potential for conflicts of interest—of which the foregoing are only a sample—to bias, or to be perceived as biasing, the findings of a PORT should concern anyone who hopes to see our knowledge of clinical effectiveness improve. Although it would be imprudent to dismiss out of hand all possibilities of support for PORTs from private companies or third-party payers, accepting such support could make it "problematic" for PORTs "to maintain the impartial and unbiased stance that is essential to the long term effectiveness and viability of the program," as Dr. Fitzmaurice stated in his letter requesting that the IOM undertake this study. In response to that request, our committee has probed the concept of conflicts of interest, both financial and otherwise, as it has been used in recent years, especially as concerns biomedical researchers. Based upon our evaluation of the areas of special concern regarding the work of PORTs, we recommend not a set of rules and regulations for DHHS but points for all parties—the PORTs, the federal sponsors, the research community, the health care industry, and Congress—to consider in avoiding, ameliorating, and administering potential conflicts of interest. We expect that our suggestions will be implemented in such a way as to build upon, rather than to duplicate, existing measures that research institutions and other groups have adopted regarding conflicts of interest. We also place

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Patient Outcomes Research Teams: Managing Conflict of Interest primary emphasis on self-regulation, voluntary disclosure, and the responsibilities of the principal investigator for the ethical conduct of his or her PORT. We view these suggestions as a first response to what are still largely anticipated rather than actual problems in new and rapidly evolving areas of research. We hope that by providing a structure for analyzing and perhaps overcoming problems, our suggestions will contribute to what we see as the great promise of PORTs in both improving patient well-being and satisfaction and increasing the efficiency of health care resource allocation. We are certain, however, that our suggestions will themselves need to be monitored and revised in light of experience. Given the novelty of the subject, the committee was particularly blessed by the creative and tireless work of Molla Donaldson, ably advised and assisted by Holly Dawkins, Kathleen Lohr, and Karl Yordy of the IOM staff. Clifford Goodman, then Director of the Council for Health Care Technology, and Maria Elena Lara, also at the Council, did the initial staff work for the committee. Dr. Goodman drafted one of the scenarios. We are also grateful for the suggestions and analysis of the participants in our workshop, especially those who wrote background papers (several of which are appended to this report) and those who participated in panels. Alexander Morgan Capron Committee Chair

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Patient Outcomes Research Teams: Managing Conflict of Interest Contents     SUMMARY   1 1   INTRODUCTION   9     Outcomes Research   9     The Institute of Medicine Study   11     Structure of the Report   11 2   PATIENT OUTCOMES RESEARCH TEAMS   13     The Medical Treatment Effectiveness Program   13     PORT Research Topics   14     PORT Structure   14     PORT Methods   14     Special Aspects of PORT Research   18     Summary   20 3   CONFLICT OF INTEREST   27     Defining Conflict of Interest   27     Financial Relationships That May Give Rise to Conflicts of Interest   29     Academic and Professional Conflicts of Interest   31     Addressing Conflict of Interest   32     Effects of University-Industry Collaboration   33     Relevant Efforts in Other Sectors   34     Summary   41 4   SOURCES OF SPECIAL CONCERN ABOUT CONFLICTS OF INTEREST IN PORTS   47     Eleven Issues of Special Concern for Conflict of Interest in PORTS   47     Summary   59

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Patient Outcomes Research Teams: Managing Conflict of Interest 5   MANAGING CONFLICTS OF INTEREST: GENERAL MODELS AND APPROACHES   61     Two Models of Conflict-of-Interest Management   61     General Approaches to Dealing with Conflicts of Interest   63     Summary   68 6   POINTS TO CONSIDER   69     Assumptions   70     Considerations for PORTs and their Institutions   71     Considerations for AHCPR   79     Considerations for the Health Services Research Community   84     Considerations for Industry   85     Considerations for Congress   87     Concluding Remarks   88     REFERENCES   93     APPENDICES   99 A   Agenda and Summary of IOM Invitational Workshop   99 B   Workshop Participants   104 C   Scenarios and Rapporteur Summaries   110     C1 Scenario   110     C2 Discussion of Scenario I by David Blumenthal   112     C3 Scenario II   115     C4 Discussion of Scenario II by Marcia Angell   118     C5 Scenario III   121     C6 Discussion of Scenario III by Michael Pollard   122 D   Background Papers and Presentations   125     D1 PORT Research Compared to Clinical Research: Conflicts of Interest in Patient Outcomes Research by David Asch   125     D2 PORTs: Their Impact on Health Services Research, Technology Innovation, and Payment Policy by Judith Lave   136     D3 The Evolution and Current Status of Conflict of Interest Regulation in Biomedical Science by Barbara McNeil and Michael Roberts   148     D4 The Structure and Methods of PORTs: Sources of Bias by John Wennberg   162