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