The July 1992 ADAMHA Reorganization Act mandated that the Secretary of Health and Human Services, acting through the Director of the National Institute on Drug Abuse, request the National Academy of Sciences to conduct a study on the impact of needle exchange and bleach distribution programs on drug use behavior and the spread of the human immunodeficiency virus (HIV). In response to that legislative directive, in May 1993 the National Research Council (NRC) and the Institute of Medicine (IOM) of the National Academy of Sciences organized the Panel on Needle Exchange and Bleach Distribution Programs within the Commission on Behavioral and Social Sciences and Education.

The panel's overall charge was to determine the effectiveness of needle exchange and bleach distribution programs. More specifically, the panel was asked to gather and analyze the relevant research regarding the effect of such programs on rates of drug use, the behavior of injection drug users, and the spread of AIDS and other diseases, such as hepatitis, among injection drug users and their sexual partners. In addition, the panel was asked to examine related issues of importance to the research and service communities, such as the characteristics associated with effective exchange programs, and to provide recommendations for future research directions and methods applicable to the evaluation of needle exchange and bleach programs. In the latter task, the panel was asked to identify the relevant evaluation hypotheses and delineate the most appropriate methodologies for testing such hypotheses. The panel was authorized, but not committed, to assess the potential risks and benefits associated with the implementation of such programs if it judged the data adequate to make such an assessment. The panel first met in June 1993 and over two years worked to come to grips with the range of conceptual, methodological, and ideological issues associated with these controversial AIDS prevention programs.

From the outset we recognized the importance, whenever there is a proposal to institute, cancel, or substantially modify a public health policy, of taking both ethical and empirical concerns into account. The wisdom of a public policy depends not only on its consistency with social consensus, but also on pragmatic consequences. With this base, the panel attempted to distill the essence of the ongoing and sometimes acrimonious debate on whether the federal government should provide financial assistance for implementing needle exchange and bleach distribution programs.

Prohibitions, even those that are legally sound and represent well-intentioned efforts to limit the purchase or possession of equipment used to inject drugs, may be found to be ethically problematic. Furthermore, they may not be wise or proper when empirical judgments are warranted to accurately assess the effect of prevention programs on public health. The degree to which institutionalized needle exchange programs are considered ethical is based on measuring to whom they may be offensive and to what degree, whether drug abusers are encouraged to enter drug treatment programs, whether systematic harm is suffered by people of a particular social status, and whether a meaningful impact on reducing HIV transmission is made.

It became apparent early in our work that several concerned constituencies held strong and varied views about the soundness of integrating these types of health promotion and disease prevention programs as part of the nation's public health efforts to reduce the spread of HIV infection. Hence, we proceeded to educate ourselves as fully as possible and carefully consider the broad range of views involved.

The panel held several meetings and two workshops to which representatives of various community groups and researchers were asked to present their views on key issues. In its effort to gather and analyze the relevant scientific evidence, the panel invited both U.S. and foreign experts to participate in a two-day workshop (September 1993) devoted to the presentation and discussion of recent research on and experience with needle exchange and bleach distribution programs. A second workshop (January 1994) was designed to elicit the views of representatives of many of the communities with a stake in the outcome of the needle exchange and bleach distribution debate who have been actively engaged in the ongoing discussions.

As the panel was concluding its deliberations, the Assistant Secretary for Health made public statements that a number of unpublished needle exchange evaluation reports had raised doubts in his mind about the effectiveness of these programs. The panel deemed these statements to be significant in the public debate, therefore necessitating appropriate consideration in order for the panel to be fully responsive to its charge. We therefore reviewed the unpublished studies—by investigators in Chicago, Montréal, and San Francisco—that had raised concerns. As unpublished findings, these studies, though clearly salient, lack the authority provided by the peer review and publication process. For this reason, in the report we give special attention (in an appendix) to scrutinizing and describing in detail their results, as well as appraising their probative value.

This report is the collective product of a panel whose members represent a balance in both expertise and points of view. Its contents reflect the careful deliberations and final consensus of the members. The panel is particularly indebted to two members, David Cordray and Don Des Jarlais, whose contributions of time, energy, and expertise to the crafting of the report were indeed extraordinary. The committee also benefited from the quality and dedication of the NRC and IOM staff. These included Eugenia Grohman, Michael Stoto, and Alexandra Wigdor, who provided constructive advice and guidance throughout the project. Christine McShane contributed significantly to the presentation of the panel's views through both substantive and technical editorial work. Her contributions to the language and structure of the report go far beyond what her title of editor might imply. Special thanks are due to Susan McCutchen, who coordinated all of our meetings, planned the workshop sessions, updated successive drafts of the report and prepared it for production, kept track of the work flow, and generally kept our work team organized. Her commitment and support at every stage of the panel's work was indispensible to the project. We are appreciative of and grateful for the efforts of these talented people.

Lincoln E. Moses, Chair

Jacques Normand, Study Director

David Vlahov, Member

Panel on Needle Exchange and Bleach Distribution Programs