Dimensions Of The Problem

Although no changes in the primary routes of transmission (sexual contact, injection drug use, blood/blood products, perinatal) have been observed over the years, the proportion of cases by exposure mode and the distribution of new cases across demographic characteristics (e.g., sex, ethnicity/race, geographic location) have changed drastically over the last 13 years. As we discuss in this report, the proportion of AIDS cases attributed to the exposure category labeled men who have sex with men by the Centers for Disease Control and Prevention (CDC) has declined steadily over the past 13 years (from 74 percent in 1981 to 47 percent in 1993), while the proportion of cases attributed to injection drug use has steadily increased during that period (from 12 percent in 1981 to 28 percent in 1993). The proportion of heterosexual cases has also increased over the years (from 1 percent in 1981 to 9 percent in 1993), and women are disproportionately affected in this latter category (of all new AIDS cases reported in 1993, heterosexual contact accounted for 4 percent of AIDS cases among men and 37 percent among women). Injection drug use has been tied to the majority of AIDS cases among heterosexuals and is a major risk factor associated with pediatric cases. Furthermore, the rate of AIDS cases linked to injection drug use is disproportionately high for African Americans and Hispanics.

Injection drug users represent a sizable population. Estimates of current injection drug users in the United States range from 1.1 to 1.9 million people (Turner et al., 1989; Office of Technology Assessment, 1990; Research Triangle Institute, 1989; Valdiserri et al., 1993), and more than 3.2 million people have injected drugs at some point in their lives (National Institute on Drug Abuse, 1991). There is of course substantial variation across the country in the number of injectors within specific geographic areas. For example, typically high rates of injection drug use are observed in the Northeast, Miami, and Puerto Rico; moderate rates in the West; and low rates in the Midwest.

The experiences of several large urban areas have shown how infection among injection drug users can explode rapidly after the introduction of the virus into that population. For example, within two years the HIV prevalence¹ rates in Edinburgh, Scotland, soared from 5 percent in 1983 to 57 percent in 1985 (Robertson et al., 1986); the rates in Bangkok, Thailand, increased from 1 to 43 percent in one year (Berkelman et al., 1989); and by 1985, seroprevalence estimate rates as high as 69 percent were reported in Milan, Italy (Titti et al., 1987; Angarano et al., 1985). Similarly in the United States, the virus spread rapidly in New York City in the early 1980s, with seroprevalence stabilizing at between 55 and 60 percent in 1984 through 1987 (Des Jarlais et al., 1989). The main factor associated with the accelerated increase in HIV infection among injection drug users is the widespread sharing of needles or syringes, which is in part a consequence of the restricted availability of sterile injection equipment. Moreover, it is a matter of concern that epidemiologic data indicate that, given the large number of injection drug users and their comparatively high incidence of HIV, the basic elements necessary for the rapid diffusion of the virus are apparent. That is, communities of injection drug users with high levels of both HIV infection and risk behaviors (i.e., involving drugs and sex) can serve as a bridge across distinct populations and efficiently impact the infection rate of other groups for which the HIV prevalence rates are currently relatively low. The epidemiologic data do indicate that the HIV epidemic in this country is now clearly driven by infections occurring in the population of injection drug users, their sexual partners, and their offspring.

Responses To The Epidemic

The magnitude of the epidemic and the severity of the health consequences posed by HIV infection within the population of injection drug users, their sexual partners, and their offspring are not at issue. What is being strenuously debated in the United States is whether certain AIDS prevention programs, directed at this highly vulnerable population, should be implemented with the assistance of the federal government.

Needle exchange programs, in which used needles are exchanged for new, sterile ones, are widely used in many industrialized countries (e.g., France, the Netherlands, Great Britain, Australia, Canada) as part of public health efforts to reduce the spread of HIV and other blood-borne infections among drug users, their sexual partners, and the general population.

In the United States, although approximately 75 needle exchange programs have been initiated in 55 cities, many are small and the programs have not yet been endorsed by the federal government as a viable intervention for AIDS prevention. The debate in the U.S. Congress has been intense between members who are particularly interested in AIDS prevention initiatives and members who are concerned that the use of federal funds to implement needle exchange programs would have the unintended effect of increasing injection drug use in those communities already plagued by drug abuse. To date, the impasse between these two camps has blocked any use of federal funds for needle exchange program services.

Indeed, the use of appropriated funds by the Department of Health and Human Services to support needle exchange programs has been specifically prohibited or restricted by the language contained in a series of statutes² enacted by Congress since 1988. The U.S. General Accounting Office (1993) recently analyzed the legal authority applicable to the federal support of research and services related to needle exchange. It concluded, primarily on the basis of language contained in section 514 of the "General Provisions" of the 1993 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Act, that, although the Department of Health and Human Services is restricted from using certain funds to support the funding of needle exchange programs directly, it does have the authority to conduct demonstration and research projects that involve the provision of needles. Nevertheless, the ban on federal support for needle exchange program services still remains in effect: "… unless the Surgeon General of the United States determines that such programs are effective in preventing the spread of HIV and do not encourage the use of illegal drugs" (U.S. Congress, 1992a). This current prohibition applies regardless of the legal standing of the programs operating in individual states. As a result, needle exchange programs across the country cannot use federal funds to support services involving the provision of needles, but must rely on funding from state, municipal, and private sources.

The Charge To The Panel

This unresolved debate led Congress to request, through the ADAMHA Reorganization Act (U.S. Congress, 1992b) that the National Academy of Sciences undertake a study to determine the effectiveness of needle exchange and bleach distribution programs on the spread of HIV in order to allow the Surgeon General to determine whether federal funds can be used to carry out such programs (P.L. 102-394, Section 514). More specifically, the mandate called for the study to make determinations of the following:

1.

The extent to which the programs promote, directly or indirectly, the abuse of drugs through providing information or devices (or both) regarding the manner in which the adverse health consequences of such abuse can be minimized.

2.

In the case of individuals participating in the programs, the number of individuals who have engaged in the abuse of drugs prior to admission to the programs and the number of individuals who have not engaged in such abuse prior to such admission.

3.

The extent to which participation in the programs has altered any behaviors constituting a substantial risk of contracting acquired immune deficiency syndrome or hepatitis, or of transmitting either of the diseases.

4.

The number of programs that provide referrals for the treatment of such abuse and the number of programs that do not provide such referrals.

5.

The extent to which programs safely dispose of used hypodermic syringes and needles.

In response to this request of Congress, the National Research Council/Institute of Medicine established the Panel on Needle Exchange and Bleach Distribution Programs and outlined its charge as follows:

The panel will gather and analyze the relevant research regarding the effect of such programs on rates of drug use, the behavior of drug users, and the spread of AIDS and other diseases, such as hepatitis, among intravenous drug users and their partners. In addition, the panel will examine closely related issues of importance to the research and service communities, such as the characteristics associated with effective exchange programs, and will provide recommendations for future research directions and methods applicable to the evaluation of syringe exchange and bleach programs. In the latter task, the study will identify the relevant evaluation hypotheses and delineate the most appropriate methodologies for testing such hypotheses. The panel is authorized, but not committed, to asses the potential risks and benefits associated with the implementation of such programs if it judges the data adequate to make such an assessment.

The charge gives special attention to the first three of the five tasks specified in the congressional mandate. The panel addressed tasks 4 and 5 as specified in the mandate by relying primarily on the research findings of two large-scale studies, undertaken with support from the federal government, that devoted a substantial amount of attention to these issues (U.S. General Accounting Office, 1993; Lurie et al., 1993).

The panel's charge refers to both needle exchange and bleach distribution programs, and a brief characterization of these programs will shed some light on the panel's scope of work. Diverse AIDS prevention programs have been implemented in attempts to reduce the spread of HIV among injection drug users, their sexual partners, and their offspring. These include, but are not limited to, educational, testing and counseling, needle exchange, and bleach distribution programs. A review of the services and devices delivered by needle exchange and bleach distribution programs (see Chapter 3) makes it clear that these programs do have many common elements and are not mutually exclusive. That is, the majority of the needle exchange programs distribute bleach, educational material, and condoms and make referrals to drug treatment and other services. Bleach programs typically dispense bleach, condoms, and educational materials and provide treatment and other referrals (e.g., primary care, public services). Both types of AIDS prevention programs attempt to prevent the transmission of the virus through the use of infected equipment and sexual risk behaviors. Both types of programs adopt multiple strategies in an attempt to reduce high-risk behaviors (e.g., injection and sexual behaviors). The primary distinguishing characteristic between them is that needle exchange programs provide as one of their main services the exchange of sterile needles for the return of used ones, whereas bleach distribution programs provide a readily available disinfectant (i.e., household bleach) to clean needles not meant to be reused.

A recent public health bulletin (Centers for Disease Control and Prevention, 1993), which was issued jointly by the National Institute on Drug Abuse of the National Institutes of Health, the Center for Substance Abuse Treatment of the Substance Abuse and Mental Health Services Administration, and the Centers for Disease Control and Prevention, makes it clear that the use of bleach can play a role in reducing risk of HIV transmission, but it does not always sterilize the injection equipment. Specifically, the bulletin states that sterile, never-used needles and syringes are safer than bleach-disinfected, previously used needles and syringes, which in turn are safer than used needles and syringes that have not been disinfected with bleach. The bulletin also emphasizes that those individuals who continue to inject drugs should be made aware of the limitations associated with using bleach and encouraged to always use sterile injection equipment and warned to never reuse or share needles, syringes, and other injection equipment. Given that disposable needles and syringes are not intended for reuse (their design does not easily allow for efficient disinfection), some have argued that preventive interventions should have as a goal to get every injection drug user to comply with the same standards that are upheld for patient care by the health care delivery system and the medical profession—that is, a new needle and syringe for every injection (Jones, 1994).

The Panel's Report

References

• Angarano, G., G. Pastore, L. Monno, T. Santantonio, N. Luchena, and O. Schiraldi 1985. Rapid spread of HTLV-III infection among drug addicts in Italy. Lancet 2(8467):1302. [PubMed: 2866362]
• Berkelman, R.L., W.L. Heyward, J.K. Stehr-Green, and J.W. Curran 1989. Epidemiology of human immunodeficiency virus infection and acquired immunodeficiency syndrome. American Journal of Medicine 86:761-770. [PubMed: 2658580]
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• Centers for Disease Control and Prevention, Centers for Substance Abuse Treatment, National Institute on Drug Abuse 1993. HIV/AIDS Prevention Bulletin April 19.
• Des Jarlais, D.C., S.R. Friedman, D. Novick, J.L. Sotheran, P. Thomas, et al. 1989. HIV-1 infection among intravenous drug users in Manhattan, from 1977 through 1987. Journal of the American Medical Association 261:1008-1012. [PubMed: 2915408]
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Footnotes

^1. Prevalence denotes the proportion of a population that is currently (or at a specified point in time) infected. Incidence denotes the rate of occurrence of new cases of infection per unit of time.

^2. These statutes include the Comprehensive Alcohol Abuse, Drug Abuse, and Mental Health Amendments Act of 1988, the Health Omnibus Programs Extension of 1988, the Ryan White Comprehensive AIDS Resources Emergency Act of 1990, and the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Acts of 1990 and 1991.