NEW TREATMENTS FOR ADDICTION

Behavioral, Ethical, Legal, and Social Questions

Committee on Immunotherapies and Sustained-Release Formulations for Treating Drug Addiction

Henrick J. Harwood and Tracy G. Myers, Editors

Board on Behavioral, Cognitive, and Sensory Sciences

Division of Behavioral and Social Sciences and Education

National Research Council

Board on Health Promotion and Disease Prevention

Board on Neuroscience and Behavioral Health

Institute of Medicine

NATIONAL RESEARCH COUNCIL AND INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions NEW TREATMENTS FOR ADDICTION Behavioral, Ethical, Legal, and Social Questions Committee on Immunotherapies and Sustained-Release Formulations for Treating Drug Addiction Henrick J. Harwood and Tracy G. Myers, Editors Board on Behavioral, Cognitive, and Sensory Sciences Division of Behavioral and Social Sciences and Education National Research Council Board on Health Promotion and Disease Prevention Board on Neuroscience and Behavioral Health Institute of Medicine NATIONAL RESEARCH COUNCIL AND INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions 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. The study was supported by Contract No. N01-OD-4-2139 between the National Academy of Sciences and the National Institute on Drug Abuse. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. Library of Congress Cataloging-in-Publication Data New treatments for addiction : behavioral, ethical, legal, and social questions / Committee on Immunotherapies and Sustained-Release Formulations for Treating Drug Addiction ; Henrick J. Harwood and Tracy G. Myers, editors. p. ; cm. “Board on Behavioral, Cognitive, and Sensory Sciences, Division of Behavioral and Social Sciences and Education, National Research Council [and] Board on Health Promotion and Disease Prevnetion, Board on Neuroscience and Behavioral Health.” Includes bibliographical references. ISBN 0-309-09128-4 (pbk.)—ISBN 0-309-52950-6 (pdf) 1. Substance abuse—Treatment. 2. Substance abuse—Chemotherapy. 3. Immunotherapy. [DNLM: 1. Substance-Related Disorders—therapy—United States. 2. Delayed-Action Preparations—therapeutic use—United States. 3. Immunotherapy—ethics—United States. 4. Immunotherapy—legislation & jurisprudence—United States. 5. Substance-Related Disorders—psychology—United States. WM 270 N5327 2004] I. Harwood, Henrick J. II. Myers, Tracy G. III. National Academies (U.S.). Committee on Immunotherapies and Sustained-Release Formulations for Treating Drug Addiction. IV. National Research Council (U.S.). Board on Behavioral, Cognitive, and Sensory Sciences. V. Institute of Medicine (U.S.). Board on Health Promotion and Disease Prevention. VI. Institute of Medicine (U.S.). Board on Neuroscience and Behavioral Health. RC564.N488 2004 616.86’061—dc22 2004008359 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. Printed in the United States of America. Copyright 2004 by the National Academy of Sciences. All rights reserved. Suggested citation: National Research Council and Institute of Medicine. (2004). New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions. Committee on Immunotherapies and Sustained-Release Formulations for Treating Drug Addiction. Henrick J. Harwood and Tracy G. Myers, Eds. Board on Behavioral, Cognitive, and Sensory Sciences, Division of Behavioral and Social Sciences and Education, National Research Council; and Board on Health Promotion and Disease Prevention, Board on Neuroscience and Behavioral Health, Institute of Medicine. Washington, DC: The National Academies Press.

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine 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 Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts 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 engineers. 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 engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president 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 Institute 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 Sciences 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 Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions COMMITTEE ON IMMUNOTHERAPIES AND SUSTAINED-RELEASE FORMULATIONS FOR TREATING DRUG ADDICTION HENRICK J. HARWOOD (Chair), The Lewin Group, Fairfax, VA ALEXANDER M. CAPRON, Pacific Center for Health Policy and Ethics, University of Southern California JONATHAN P. CAULKINS, Heinz School of Public Policy and Management, Carnegie Mellon University JAMES W. CORNISH, Philadelphia Department of Veterans Affairs Medical Center and University of Pennsylvania Department of Psychiatry LEWIS E. GALLANT, National Association of State Alcohol and Drug Abuse Directors, Inc., Washington, DC SHIRLEY Y. HILL, University of Pittsburgh School of Medicine MARTIN Y. IGUCHI, Drug Policy Research Center, RAND Corporation, Santa Monica, CA THOMAS R. KOSTEN, Yale University Medical School JOSEPH O. MERRILL, Harborview Medical Center and University of Washington S. MICHAEL OWENS, University of Arkansas for Medical Sciences CHARLES R. SCHUSTER, Department of Psychiatry and Behavioral Neurosciences, Wayne State University, Detroit, MI ZILI SLOBODA, Institute for Health and Social Policy, University of Akron KATHRYN E. STEIN, Macrogenics, Inc., Rockville, MD ELLEN M. WEBER, University of Maryland School of Law TRACY G. MYERS, Study Director WENDY E. KEENAN, Senior Project Assistant

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions BOARD ON BEHAVIORAL, COGNITIVE, AND SENSORY SCIENCES ANNE C. PETERSEN (Chair), W.K. Kellogg Foundation, Battle Creek, MI LINDA MARIE BURTON, Center for Human Development and Family Research, Pennsylvania State University STEPHEN J. CECI, Department of Human Development, Cornell University EUGENE K. EMORY, Department of Psychology, Emory University ROCHEL GELMAN, Center for Cognitive Science, Rutgers University ANTHONY W. JACKSON, Asia Society, Los Angeles PETER LENNIE, Center for Neural Science, New York University MARCIA C. LINN, Graduate School of Education, University of California, Berkeley ELISSA L. NEWPORT, Department of Brain and Cognitive Sciences, University of Rochester MICHAEL L. RUTTER, Institute of Psychiatry, University of London ARNOLD SAMEROFF, Center for Human Growth and Development, University of Michigan JAMES W. STIGLER, Department of Psychology, University of California, Los Angeles WILLIAM A. YOST, Office of Research and the Graduate School, Loyola University, Chicago CHRISTINE R. HARTEL, Board Director

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions BOARD ON HEALTH PROMOTION AND DISEASE PREVENTION JAMES W. CURRAN (Chair), School of Public Health, Emory University RONALD BAYER, School of Public Health, Columbia University WILLIAM V. CORR, National Center for Tobacco-Free Kids, Washington, DC HELEN B. DARLING, National Business Group on Health, Washington, DC STEPHEN B. FAWCETT, Department of Human Development and Family Life, University of Kansas JONATHAN E. FIELDING, Department of Health Services, Los Angeles County, CA LAWRENCE O. GOSTIN, Georgetown University Law Center ELLEN R. GRITZ, M.D. Anderson Cancer Center, University of Texas, Houston GEORGE J. ISHAM, HealthPartners, Inc., Minneapolis, MN MARK SCOTT KAMLET, School of Public Policy and Management, Carnegie Mellon University JOYCE SEIKO KOBAYASHI, Denver Health Medical Center ROXANNE PARROTT, College of Arts and Sciences, Pennsylvania State University THOMAS A. PEARSON, School of Medicine and Dentistry, University of Rochester IRVING ROOTMAN, Human and Social Development, University of Victoria DAVID J. TOLLERUD, School of Public Health, University of Louisville KATHLEEN E. TOOMEY, Georgia State Health Department WILLIAM A. VEGA, Behavioral and Research Training Institute, Robert Wood Johnson Medical School PATRICIA WAHL, School of Public Health and Community Medicine, University of Washington LAUREN A. ZEISE, Office of Environmental Health Hazard Assessment, California Environmental Protection Agency, Oakland ROSE MARIE MARTINEZ, Board Director

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions BOARD ON NEUROSCIENCE AND BEHAVIORAL HEALTH KENNETH B. WELLS (Chair), School of Medicine, University of California, Los Angeles SID GILMAN, Department of Neurology, University of Michigan NANCY E. ADLER, Department of Psychiatry and Pediatrics, University of California, San Francisco PAUL S. APPELBAUM, University of Massachusetts Medical School WILLIAM E. BUNNEY, JR., Department of Psychiatry and Human Behavior, University of California, Irvine HOWARD L. FIELDS, Department of Neurology, University of California, San Francisco RICHARD G. FRANK, Harvard Medical School ALAN I. LESHNER, American Association for the Advancement of Science, Washington, DC KAREN MATTHEWS, University of Pittsburgh School of Medicine BRUCE S. MCEWEN, Harold and Margaret Milliken Hatch Laboratory of Neuroendocrinology, The Rockefeller University KATHLEEN R. MERIKANGAS, Division of Intramural Research Programs, National Institute of Mental Health EMMANUEL MIGNOT, Center for Narcolepsy, Stanford University DAVID REISS, George Washington University Medical Center RHONDA J. ROBINSON-BEALE, CIGNA Corporation, Eden Prairie, MN MICHAEL L. RUTTER, Institute of Psychiatry, University of London MARLEEN WONG, Los Angeles Unified School District CHARLES ZORUMSKI, Department of Psychiatry, Washington University ANDREW M. POPE, Acting Board Director

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions Contents     PREFACE   xi     EXECUTIVE SUMMARY   1 1   INTRODUCTION AND BACKGROUND   7      Committee Charge and Report,   8      Medical Basis of Immunotherapy,   9 2   CLINICAL TRIALS   16      FDA Process,   16      Phase IV Considerations,   17 3   TREATMENT, FINANCING, AND COSTS   23      Specialty Addiction Treatment Settings,   24      Primary Care Settings,   26      Previous Pharmacotherapies Lessons Learned,   29      Cost and Economic Issues,   33 4   BEHAVIORAL RESPONSES AND CONSENT   37      Unintended Behavioral Consequences,   37      Consent and Vulnerable Populations,   44     REFERENCES   54

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions     APPENDIXES         A  Vaccines and Depot Medications for Drug Addiction: Rationale, Mechanisms of Action, and Treatment Implications Paul R. Pentel   63     B  What Will We Learn from the FDA Clinical Trials Process and What Will We Still Want to Know About Immunotherapies and Depot Medications to Treat Drug Dependence? Thomas R. Kosten and Henry R. Kranzler   98     C  Putting Addiction Treatment Medications to Use: Lessons Learned George E. Woody and Laura McNicholas   125     D  Adoption of Drug Abuse Treatment Technology in Specialty and Primary Care Settings Cindy Parks Thomas and Dennis McCarty   140     E  The Use of Immunotherapies and Sustained-Release Formulations in the Treatment of Drug Addiction: Will Current Law Support Coercion? M. Susan Ridgely, Martin Y. Iguchi, and James R. Chiesa   173     F  Ethical Issues in Immunotherapies and Depot Medications for Substance Abuse Thomas H. Murray   188     G  Costs and Benefits of Immunotherapies or Depot Medications for the Treatment of Drug Abuse Mark A. R. Kleiman   213     H  Anticipating Unintended Consequences of Vaccine-Like Immunotherapies and Depot Medications for Addictive Drug Use Robert J. MacCoun   241     I  Vaccines and Immunotherapies to Control Addiction in Minors: The Legal Framework Frances H. Miller and Kaley Klanica   276     J  Biographical Sketches of Committee Members and Staff   300

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions Preface This report is the work of the Committee on Immunotherapies and Sustained-Release Formulations for Treating Drug Addiction. The committee was established in 2002 by the National Academies in response to a request from the National Institute on Drug Abuse (NIDA). NIDA is funding the development of new types of medications to treat drug addiction and sought the advice of the National Research Council and Institute of Medicine about the behavioral, ethical, legal, and social issues likely to arise as a result of the unique characteristics of these medications, if and when they become available. The charge to the committee was to identify issues that will be raised in determining who should be given these medications and under what circumstances, given the fundamental issue of therapeutic safety. This study was not intended to be a safety review of immunotherapies and sustained-release formulations, which are still under development. However, safety formed a necessary backdrop for all of the issues the committee considered. The availability of these medications will raise a host of issues, and this report only represents an initial effort identifying the most important ones. Some of these issues will marry traditional vaccine concerns (e.g., establishing and monitoring safety, ensuring efficacy, etc.) with traditional drug abuse treatment issues (e.g., ensuring patient adherence to treatment, use in a variety of settings). The committee was not expected to achieve consensus about how all of the issues should be addressed. Rather, it was expected to achieve consensus about what the issues are likely to be, why they are important, and which are likely to be the most pressing.

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions The committee’s membership reflected wide-ranging areas of expertise, including bioethics, epidemiology and prevention, federal drug approval processes, federal drug policy, genetic aspects of drug addiction, legal issues related to substance use and abuse, risk analysis, state policy issues, financing, treatment delivery in medical and specialty addiction settings, and immunotherapy development. The work of the committee was immeasurably advanced because several members had direct experience in the development and testing of the types of medications being studied. Two members of the committee have worked to develop active and passive immunotherapies for treating drug dependence; another member has been part of a research group developing depot formulations to treat drug dependence. In forming this committee, the National Research Council (NRC) and the Institute of Medicine (IOM) did not view this work as a conflict of interest but as essential to the accomplishment of the charge from NIDA: to identify and define the behavioral, ethical, legal, and social questions that will be raised in determining who should be given vaccines or depot medications, and under what circumstances. The committee was not asked to recommend, approve, or disapprove support for the development of immunotherapies and sustained-release formulations for treating drug addiction. Nor was it asked to examine the safety or efficacy of these medications. These therapies are still early in development, and drug approval process of the Food and Drug Administration is ultimately responsible for such determinations. The committee was aided substantially in its work by a set of commissioned papers, included in this volume, which helped us complete the report. Drafts of these papers were presented at a public workshop in April 2003. We thank the paper authors: Martin Iguchi, Kaley Klanica, Mark Kleiman, Thomas Kosten, Henry Kranzler, Robert MacCoun, Dennis McCarty, Frances Miller, Thomas Murray, Cindy Parks Thomas, Paul Pentel, M. Susan Ridgeley, and George Woody. The committee’s review of the papers presented at the workshop was aided by several individuals who volunteered their time and expertise. We gratefully acknowledge the contributions of these individuals to the committee’s work: Jack Henningfield, Pinney Associates; Walter Ling, University of California at Los Angeles; David Smith, California Department of Alcohol and Drug Programs; Penny Ziegler, William J. Farley Center; Rick Sampson, American Institutes for Research; and Matthew Myers, Campaign for Tobacco-Free Kids. The committee is also grateful for assistance provided by NIDA staff. Timothy Condon, Jamie Biswas, and Cindy Miner briefed the committee early on about the agency’s goals for this project. They also very patiently

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions answered committee members’ many questions. We are also thankful to Susan Weiss, who ably served as the NIDA project officer for this study. At the National Research Council, Christine Hartel was instrumental in guiding and supporting the committee throughout its work. Wendy Keenan served as the skilled, professional, and always helpful senior project assistant, making invaluable contributions to the committee’s work. Finally, we thank the individual committee members. They volunteered their time and expertise working efficiently and cordially. They provided an exemplar of how an interdisciplinary process should work: debating ideas on their merit, sharing insights from various viewpoints, and being consistently respectful of each others’ expertise. 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 NRC’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 report 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 thank the following individuals for their review of this report: Warren K. Bickel, Department of Psychiatry, Ira Allen School, University of Vermont; Peter J. Cohen, Georgetown University Law Center and Physician Health Committee, Medical Society of the District of Columbia; Dorothy K. Hatsukami, Department of Psychiatry, University of Minnesota; Steven Hyman, Office of the Provost, Harvard University; Walter Ling, Department of Psychiatry and Integrated Substance Abuse Programs, University of California at Los Angeles; Eric Nestler, Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas; Charles P. O’Brien, Department of Psychiatry, School of Medicine, University of Pennsylvania; Harold Pollack, Department of Health Management and Policy, University of Michigan School of Public Health; and David J. Rothman, Center for the Study of Society and Medicine, Columbia University. 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 Herbert D. Kleber, Department of Psychiatry and Division on Substance Abuse, Columbia University, and Bernard Lo, Program in Medical Ethics, University of California at San Francisco. Appointed by the National Research Council, they were responsible for making certain that an independent

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions examination of this report was carried out in accordance with 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. Henrick J. Harwood, Chair Tracy G. Myers, Study Director