The Needle Exchange Report

Does needle exchange work to reduce AIDS? Does it encourage drug use? Here are the answers from the Federal Government itself.

The Clinton Administration's Internal Reviews of Research on Needle Exchange Programs

Previously Unreleased Documents Plus Background Material

Made public March 7,1995 by: The Drug Policy Foundation, Washington, D.C. New York

Contents

"Talking Points" on needle exchange

4 pages. (Provided along with internal reviews; origin uncertain)

Agency reviews submitted Dec. 10, 1993

48 pages. Reviews by Clinton administration health agencies of University of California report on needle exchange programs (Centers for Disease Control and Prevention, Nat'l Institutes of Health, Substance Abuse Mental Health Administration, Health Services and Resources Administration, Food and Drug Administration).

"Update" submitted Nov. 22,1994

8 pages. Update of research and events in the field since 1993 review.

Legal barriers to federal funding of needle exchanges

2 pages. Appendix of March 1993 report by General Accounting Office (GAO).

These "talking points" were provided along with the Clinton administration's reviews, but their origin is uncertain.

Needle exchange talking points

Origins of the University of California study

Former drug czar Bob Martinez and former Centers for Disease Control (CDC) director Bill Roper decide in Summer '91 that objective review of data on needle exchange programs (NEPs) is needed

University of California (UC), Berkeley and UC San Francisco agree to do the work

Study is funded by CDC through a Cooperative Agreement with the Association of Schools of Public Health

Pls are Arthur Reingold (UC Berkeley) and Philip R. Lee (UC San Francisco)

Lee leaves 7/1/94 to be Assistant Secretary for Health; replaced as Pl by Peter Lurie, formerly Project Director

Approximate total cost of study $400,000

Work begins 4/1/92

The University of California study

3 volumes, >700 pages

Entailed review of 2000 documents, visits to 23 programs in 15 cities in 4 countries, interviews with almost 250 individuals, mail survey of programs not visited, mathematical modeling of cost-effectiveness

Conclusions:

available [data] provide no evidence that needle exchange programs increase the amount of drug use by needle exchange program clients or change overall community levels of non-injection and injection drug use." (page 18 of report Summary)

Multiple lines of evidence suggest that it is likely that NEPs decrease the rate of new HIV infection: (page 26)

1. Biologic plausibility; removing potentially infected syringes from circulation and replacing them with clean ones must decrease new infections

2. Behavioral data: 10/14 studies showed a decrease in HIV risk behavior (the sharing of syringes) and none showed an increase

3. Three- to four-fold decrease in new hepatitis B infections [with later data this increased to seven- to eight-fold for hepatitis B and C infection]

4. Mathematical models from New Haven (33% decrease in new HIV infections) and by the UC study model (15-17%

Recommendations (page 27):

The federal government should repeal the ban on the use of federal funds for needle exchange services."

Substantial federal funds should be committed to both providing needle exchange services and to expanding research into these programs.

State governments in the ten states and the District of Columbia that have prescription laws should repeal these laws.

States should repeal the paraphernalia laws as they apply to syringes.

Report released 9/30/93

About 12,000 copies of various volumes of the report distributed

The first review

On October 15, 1993, Joe Boufford, Principal Deputy Assistant Secretary for Health (Lee's office), writes to CDC Director David Satcher requesting a review of the UC report and providing opinions and recommendations for federal action in response to needle exchange.

CDC consults with NIH (NIDA), FDA, HRSA and SAMSHA (Substance Abuse Mental Health Services Administration). Their comments are attached as tabs to the review.

Conclusions:

The UC research team has done a careful and scientifically sound compilation and review of all the available data on needle exchange and the availability of needles and syringes to injection drug users." (page 1) The UC team used stringent scientific standards in its analysis and interpretation of the collected published and unpublished studies ... The UC report is the most extensive and comprehensive study of needle exchange ever published." (page 6)

After reviewing several lines of evidence similar to the four points listed above, the review concludes: Taken together, these observations indicate that NEPs are likely to reduce HIV transmission, even though the epidemiologic studies of NEPs do not definitively demonstrate decreases or increases in HIV transmission." (page 2) Several findings strongly support the conclusion that NEPs reduce HIV transmission." (page 10)

No data exists indicating increases related to NEPs in either drug use or in the number of discarded syringes." (page 2) We agree with the UC team conclusion that available data are quite limited but provide no evidence of any NEP-related increases in community levels of drug use." (page 10)

"... we believe that the benefits of NEPs as a component of a comprehensive HIV prevention program for drug users exceed the theoretical risks of such programs." (page 2)

"We conclude that the ban on Federal funding of NEPs should be lifted to allow communities and States to use Federal funds to support NEPs as components of comprehensive HIV prevention programs." (page 2)

"We also recommend that States consider the repeal of laws requiring a physician's prescription to buy needles and syringes and the removal of criminal penalties for the possession of needles and syringes" (page 2)

Fate of the first review

Review signed by Satcher and sent to Boufford on December 10, 1993.

Review has never been made public.

Rep. Henry Waxman obtained a copy, but only under condition that it not be released to the public.

Review not disclosable under the Freedom of Information Act; a request by San Francisco Chronicle for the review was denied recently.

Only real press coverage is reference to the coverup on CNN in August 1994 and in San Francisco Chronicle in December 1994.

The second review

In fall 1994, Brian Biles of the Office of the Assistant Secretary for Health, wrote to CDC asking for an update on information since the University of California Report.

This second review, much shorter and less expansive than the first review, is sent to the Associate Director for HIV/AIDS (James Curran) by the Assistant Director for Substance Abuse and HIV Prevention (T. Stephen Jones) on November 22, 1994, and presumably forwarded on to the Office of the Assistant Secretary for Health.

The review contains the following:

Summary of new evidence from New York City showing a decrease in HIV transmission among NEP clients that concludes that although the numbers are small, the evidence is plausible." (page 1 ).

Three additional studies with evidence of decreases in HIV risk behavior (page 3).

No evidence of increased drug use in a San Francisco study (page 3).

New data showing that the decrease in hepatitis B and C infections associated with needle exchange is now seven- to eight-fold. 'this study demonstrates more clearly than any previous research that use of NEPs is associated with decreases in blood borne infections." (Page 4)

Data from Montreal showing higher HIV infection rates, higher rates of HIV risk behaviors and higher rates of new HIV infection among NEP clients that "require further study." (page 5) This finding is most reasonably interpreted as showing that NEPs are reaching the drug users at highest risk for HIV (a good thing).

No formal recommendations with respect to federal policy.

The existence of this review has never been made public.

Public health significance

Approximately 1/3 of all AIDS cases occur among injections drug users, their sex partners and their children.

Only about 15% of injectors are in drug treatment on any given day.

Over 10,000 drug users, their sex partners and their children contract HIV each year. This is 1-2 preventable HIV infections per hour. Needle exchange may decrease new HIV infections by 33%, according to the New Haven mathematical model.

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Centers for Disease Control and Prevention (CDC) Atlanta, GA 30333

December 10, 1993

SUBJECT: Review of University of California Report on needle Exchange and recommendations on Needle Exchange

On October 15 you requested that the Center for Disease Control and Prevention (CDC) review the University of California research report on needle exchange and provide opinions and recommendations for Federal action in response to needle exchange.

The UC report and recommendations were reviewed by CDC staff. CDC also requested and received comments on the UC report and recommendations for needle exchanges from the National Institutes of Health, the Substance Abuse Mental Health Services Administration, the Health Services and Resources Administration, and the Food and Drug Administration. The comments attached to the review were provided by the Principal[sic] AIDS Coordinators of the four agencies. Directors of these agencies have not been asked for final concurrence on the review.

I am pleased to submit the attached review (Tab A).

David Satcher

Attachment

Tab A - Review of University of California Report on Needle

Exchange and Recommendations on Needle Exchange

REVIEW OF UNIVERSITY OF CALIFORNIA REPORT ON NEEDLE EXCHANGES AND RECOMMENDATIONS ON NEEDLE EXCHANGE.

1. ISSUE

On October 15, 1993, the Principal Deputy Assistant Secretary for Health requested that the Centers for Disease Control and Prevention (CDC) review the University of California (UC) research report on needle exchange (executive summary at Tab A) and provide recommendations and opinions on Federal action in response to needle exchange to the Principal Deputy Assistant Secretary for Health and the Surgeon General.

The UC report and recommendations were reviewed by CDC staff. The CDC also requested and received comments on the UC report and recommendations and opinions on Federal action in response to needle exchange from the National Institutes of Health (NIH) (Tab B), the Substance Abuse Mental Health Services Administration (SAMHSA) (Tab C), the Health Services and Resources Administration (HSRA) (Tab D), and the Food and Drug Administration (FDA) (Tab E). Comments on this report to you were also requested from these agencies. The agencies were not asked for final concurrence on the CDC response. The attached comments (Tabs B-E) were provided by the Principal AIDS Coordinators of the four agencies.

2. SUMMARY

The UC research team has done a careful and scientifically sound compilation and review of all the available data on needle exchange and the availability of needles and syringes to injection drug users (IDUs). The UC team also gathered new data through surveys of needle exchange programs (NEPs), key informant interviews, and focus groups of IDUs.

NEPs are intended to decrease human immunodeficiency virus (HIV) transmission associated with injection drug use by replacing used, potentially HIV-infected syringes with sterile ones. They also can help IDUs obtain drug treatment and other public health services. The emergence of more than three dozen NEPs in the United States suggests an increasing acceptance of these programs as part of a community response to the dual epidemics of injection drug use and HIV infection. However, in some communities, NEPs have been very controversial. Some law enforcement, drug treatment, and community leaders are concerned that these programs give "the wrong message" about drug use and may reduce law enforcement agencies' ability to combat drug use and associated violence. Other concerns are that NEPs have not been shown to be effective in eliminating HIV transmission and may draw scarce resources away from other, possibly more effective, programs such as drug treatment.

The CDC concurs with the UC findings that (1) NEPs are effective in removing used, sometimes HIV-contaminated needles and syringes from circulation and replacing them with sterile ones, (2) IDUs using NEPs decrease HIV drug-risk behaviors (e.g., decreased sharing of injection equipment, decreased frequency of injection), (3) NEPs are effective in recruiting IDUs to enter drug treatment, (4) HIV prevalence in syringes returned to NEPs decreases, and (5) mathematical models of NEPs estimate substantial decreases in HIV transmission among NEP clients. Taken together, these observations indicate that NEPs are likely to reduce HIV transmission, even though the epidemiologic studies of NEPs do not definitively demonstrate decreases or increases in HIV transmission. The existing epidemiologic studies are limited in their ability to detect such changes. No data exists indicating increases related to NEPs in either drug use or in the number of discarded syringes. W8 endorse the UC report recommendation that additional research and evaluation on NEPs is a high priority to further assess the impact of these programs-s and the relative effectiveness of various models of delivery of NEP services.

Two other issues have prompted reconsideration of Federal policy on needle exchange: (1) the magnitude of the HIV epidemic among IDUs and the related epidemics among their sex partners and newborns in many areas of this country and (2) the limitations of alternative intervention options to prevent drug-related HIV transmission (e.g., limited capacity of drug treatment available to IDUs and limitations of bleach disinfection of injection equipment). Based on these observations and the weight of data presented in the UC report, we believe that the benefits of NEPs as a component of a comprehensive HIV prevention program for drug users exceed the theoretical risks of such programs. We conclude that the ban on Federal funding of NEPs should be lifted to allow communities and States to use Federal funds to support NEPs as components of comprehensive HIV prevention programs. We recommend that NEPs receiving Federal funds be linked to substance abuse treatment programs and other HIV prevention services. We also recommend that such programs be required to include evaluation components to validate their effectiveness.

Increasing the ability of IDUs to obtain and possess sterile needles and syringes should decrease HIV transmission for those who will not or cannot stop injecting drugs. Therefore, we also recommend that States consider the repeal of laws requiring a physician's prescription to buy needles and syringes and the removal of criminal penalities[sic] for the possession of needles and syringes, while maintaining the criminal penalties on other drug use equipment. Additional evaluation of these interventions is crucial.

3. BACKGROUND

The substantial role of injection drug use in the HIV/AIDS epidemic

One-third of reported U.S. AIDS cases are related directly or indirectly to injection drug use[1]. A disproportionate number of AIDS cases among people of color in the United States is related to infection drug use. In 1992, almost half of all AIDS cases reported among African Americans (49 percent) and Hispanics (48 percent) were directly or indirectly related to injection drug use.

The majority of reported AIDS cases among women and children in the United States are related to injection drug use. Among adult and adolescent women reported with AIDS in this country, nearly three-quarters (71 percent) were directly or indirectly related to injection drug use; 50 percent of women with AIDS reported injecting drugs and an additional 21 percent reported sexual contact with a male who injected drugs. Two-thirds (66 percent) of children with perinatally acquired AIDS had mothers who reported injecting drugs themselves and/or having sex with an IDU.

Preventing HIV/AIDS associated with injection drug use

Use of drug injection equipment (especially needles and syringes) by more than one person (often called "sharing" or "multiperson use") is the primary mechanism for the spread of HIV related to injection drug use. Sexual transmission among IDUs also occurs. Several cultural and social factors are associated with the multiperson use of needles and syringes and other injection equipment. However, legal restrictions on the purchasing and possession of needles and syringes by IDUs are central factors in the multiperson use of needles and syringes. IDUs' access to and legal ability to possess sterile needles and syringes are limited by a variety of State and Federal laws, including (1) prescription laws[2], (2) drug paraphernalia laws[3], and (3) the

[1]AIDS cases associated with injection drug use include AIDS cases among a) heterosexual men and all women who report injecting drugs, b) men who have sex with men who also inject drugs, c) men and women who do not inject drugs but have heterosexual relations with drug injectors, and d) newborn children whose mothers inject drugs or have sex with male drug injectors.

[2]A State law that requires a physician's prescription as a condition for sale of needles and syringes in pharmacies (in 10 States and the District of Columbia}.

Federal Mail Order Drug Paraphernalia Control Act[4]. In States without prescription laws, the selective refusal of some pharmacists to sell needles and syringes to persons who might be IDUs is an additional barrier.

In its July 1991 report on "The Twin Epidemics of Substance Use and HIV, n the National Commission on AIDS recommended: "Remove legal barriers to the purchase and possession of injection equipment. Such legal barriers... limit the availability of new/clean injection equipment and therefore encourage the sharing of injection equipment, and the increase in HIV transmission.

Prevention and treatment for drug dependency and addiction are important HIV prevention strategies. However, only 10 to 20 percent of all drug users are in drug treatment programs at any given time. Drug treatment capacity is not expected to increase substantially in the near future, and the capacity will remain smaller than that required to provide drug treatment for all who need it and are willing to start. In addition, a substantial proportion of IDUs are unable or unwilling to stop injecting drugs and start drug treatment.

Outreach programs are another component of HIV prevention for IDUs. In addition to providing condoms and advising drug users to start drug treatment and to decrease drug use, since the mid-1980s, outreach workers have advocated the use of household bleach to disinfect drug-injection equipment (particularly needles and syringes). In April 1993, the CDC, the Center for Substance Abuse Treatment (CSAT) of SAMHSA, and the National Institute on Drug Abuse (NIDA) of NIH issued an HIV Prevention Bulletin describing the limitations of bleach disinfection of needles and syringes and indicating that (1) sterile, never-used needles-and syringes are-safer than bleach-disinfected, previously used needles and syringes and (2) bleach disinfection is useful only when there is no other safer option. In this statement, Public Health Service (PHS) agencies clearly pointed out the limitations of one of the few HIV risk-reduction interventions for IDUs who share needles and syringes.

[3]A State (or local) law that places criminal penalties on the possession and distribution of needles and syringes and other equipment used in the consumption or manufacture of drugs (in 46 States and the District of Columbia.

[4]The Act includes needles and syringes in the list of drug paraphernalia that cannot be transported by the U.S. Postal Service or any other means of interstate conveyance.

4. LEGAL RESTRICTIONS OF FEDERAL FUNDING OF NEEDLE EXCHANGE PROGRAMS IS THE UNITED STATES

Congress has included provisions in at least six laws restricting the use of Federal funds for NEPs. For example, the FY 1994 Appropriations Act for the Department states that "no funds appropriated under this Act shall be used to carry out any program of distribution of sterile needles for hypodermic injection of any illegal drug, 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, except that such funds may be used for such purposes in furtherance of demonstrations or studies authorized in the ADAMHA Reorganization Act (Public Law 102-321)."

5. THE UNIVERSITY OF CALIFORNIA REPORT ("THE PUBLIC HEALTH IMPACT OF NEEDLE EXCHANGE PROGRAMS IN THE UNITED STATES AND ABROAD")

This project was carried out by a team of researchers at the School of Public Health of the University of California, Berkeley, and the Institute for Health Policy Studies at the University of-California, San Francisco. The study began in April 1992 and was supported by funds from the CDC through a cooperative agreement with the Association of Schools of Public Health.

The project staff gathered nearly 2,000 "data sources," including journal articles (475), conference abstracts (381), reports (236), and unpublished materials (159). Between May and September 1992, the team carried out site visits to 15 cities (10 in the United States, -3-in Canada, and 2 in Europe). During these site visits, structured observations of 33 needle exchange sessions were made. In addition, 110 key informants (including NEP staff, public health officials, and community leaders supporting and opposing the NEP) were interviewed, and 18 focus groups of clients and non-clients of the-NEPs (12-9 IDUs ~ participated in the focus groups or individual interviews) were held by the UC project staff. UC project staff obtained extensive information on the budgets of the NEPs visited. To obtain a more complete picture of the NEPs in the United States, the project staff conducted a postal survey of 20 NEPs not visited.

The major findings of the UC study are presented in a Summary, Conclusion, and Recommendations document (43 pages). The detailed analysis and findings of the UC study are presented in Volume One (519 pages). Volume Two, a city-by-city description of NEP activities and related information from the site visits to nine U.S. and three Canadian cities, will be available in late December 1993.

Drafts of all chapters of the UC report were reviewed by a distinguished panel of expert reviewers representing a range of opinions on needle exchange (Dr. Mindy Fullilove, Dr. Don Des Jarlais, Dr. Ed Kaplan, Dr. Herbert Kleber, Dr. Douglas Owens, Dr. Beny Primm, and Ms. Beth Weinstein).

The UC teas used stringent scientific standards in its analysis and interpretation of the collected published and unpublished studies on NEPs and needle and syringe availability. The UC report is the most extensive and comprehensive study of needle exchange ever published.

6. NEEDLE EXCHANGE PROGRAMS IN THE UNITED STATES AND CANADA

The information in this section on NEPs in the United States and Canada is derived from the UC report.

The first NEP to provide comprehensive services in the United States opened in 1988 in Tacoma, Washington. As of September 1, 1993, there were at least 37 NEPs operating in 30 cities in 12 States. By June 1993, more than 5.4 million syringes had been distributed (almost always in exchange for used syringes) by NEPs in the United States. In calendar year 1992, U.S. NEPs distributed more than 2.4 million syringes.

Needle exchange has provoked intense political debate at the national level and in some States (e.g., California, New York) and cities (e.g., Baltimore, New York City, Boston, Berkeley). Nonetheless, in many cities (e.g., Seattle, Tacoma, San Francisco, Honolulu,- New Haven), large-scale NEPs have been established with substantial community support. In New York City, after years of intense political debate, five NEPs were legally opened in 1992 and now distribute about one million syringes a year. The UC team collected U.S. public opinion polls that-at- included questions regarding needle availability needle cleaning. These public opinion polls indicate that approximately half of the general public has supported harm reduction efforts, including needle cleaning, legalization of needles sales, needle exchange, and needle distribution. While this public support has tended to increase over time and has been somewhat higher for needle exchange than for needle distribution, needle exchange remains a controversial issue.

Substantial variations exist among U.S. NEPs in legal status, administrative structure, and sources of funding. Nineteen U.S. NEPs are "legal,"[5] eight are "illegal-tolerated,"[6] and six are "illegal-underground."[7] Six U.S. NEPs are administered by State or local governments, six by community-based organizations (CBOs with government sponsorship, eight by CBOs without government sponsorship, and thirteen by what the UC report called "activist" organizations. Private donations are a major source of funding at 19 U.S. NEPs, more than any other source of funding. Fourteen NEPs are financially supported by foundation grants, 12 by funds from a CBO and/or activist organization administering the NEP, 12 by city or county government, and 4 by State governments. Fifteen U.S. NEPs depend entirely on volunteer staff, and all but seven NEPs use volunteers. Twenty-seven of 33 U.S. NEPs surveyed or visited have "one-for-one rules" (one sterile syringe is given out for each syringe turned in). Seventeen NEPs provide 'starter needles" (one or more [usually three] syringes provided to new NEP clients without requiring turn-in of used syringes). Ten NEPs have limits on the number of syringes that can be exchanged. Rules governing the exchange procedures are generally well enforced.

U.S. NEPs serve ethnically diverse IDU populations that generally reflect local ethnic and racial patterns. The mean age of U.S. NEP clients ranges from 33-41 years with a mean duration of drug injection ranging from 7-20 years. NEPs successfully reach IDUs who are not enrolled in drug treatment, with studies in the United States reporting one-third to one-half of NEP clients having no prior exposure to drug treatment. NEP clients are at significant risk for drug-related HIV transmission with 10 to 60 percent reporting some needle sharing and about one-third reported sharing needles in the month preceding interview.

U.S. NEPs are reaching thousands of IDUs in the 30 cities in which they operate. In addition to needle exchange, a variety of public health services are provided on site or are available by referral, including drug treatment, HIV counseling and testing, primary medical care, tuberculosis and sexually transmitted disease screening and treatment, and social services. The UC team found that among NEPs visited with data on these activities, six NEPs had referred more than 2,000 drug users to drug treatment and that more than 800 drug users had started drug treatment after referral by four NEPs.

[5]An NEP in a State that does not have a prescription law or an NEP that has a specific exemption to the prescription law.

[6]In a state with a prescription law, an NEP which a locally elected body (e.g., city council) has voted to support or approve.

[7]In a State with a prescription law, an illegal-underground NEP which has not been supported by a locally elected body.

The median annual budget of U.S. and Canadian needle exchange programs visited is relatively low at 5169,000, with government run programs tending to have larger budgets. Some NEPs are more expensive because they also provide substantial additional services such as drug treatment referrals.

The UC team extensively reviewed the previously published mathematical models that estimated the impact of NEPs on HIV transmission, and developed additional models of the effectiveness and cost-effectiveness of NEPs in the United States. These efforts, in agreement with other independent reviews (e.g., the General Accounting Office [GAO] review), confirmed the theoretical and technical validity of the model used to estimate the impact of the New Haven NEP. Applied to other cities, a simplified version of this model predicted reductions ranging from 17 to 70 percent in new drug-related HIV infections among NEP clients. In one of the cities, the estimated cost-per-HIV-infection-averted by NEPs was between S3,700 and $12,000. These estimated costs of preventing an HIV infection compare very favorably with the costs of other lifesaving programs and are much less than the present value of the lifetime costs of medical care for a person with HIV infection ($119,000) .

The UC report also reviews the development of NEPs in Canada, where the federal government provided leadership and initial funding (requiring provincial matching funds) for HIV prevention programs for drug users, including NEPs. In Canada all NEPs are legal, and there has been very limited community or professional opposition to the NEPs. Since the first Canadian NEPs were opened in 1989, the number of cities with active NEPs has steadily increased to a total of 28 cities in early 1993. More than 2.5 million syringes were distributed through December 1992 by the five Canadian NEPs visited by the UC team.

7. IMPACT OF NEEDLE EXCHANGE PROGRAMS ON DRUG USE

Accurate measurement of drug use patterns and numbers of drug users in communities is technically very challenging, in part because drug use is-an illegal activity. Therefore-, it is extremely difficult to quantitatively assess the impact of NEPs on community drug use.

The UC report provides data on both the behavior of NEP clients and community measures of drug use. The UC report clearly documents that substantial numbers of IDUs (both clients and non-clients of the NEP) have been referred to drug treatment programs, a substantial step in reducing drug use by those individuals and in the community. The UC report presents the results of 26 evaluations in the United States and abroad that provide information on changes in drug-risk behavior among IDUs who were using NEPs; 16 of the 26 were judged to be of acceptable scientific quality. Although not definitive, the majority of these studies found that drug-related risk behaviors for HIV transmission were significantly reduced among NEP clients.

In addition, the UC team reviewed national drug use indicators and the findings of IDU focus groups. The limited data for U.S. cities with NEPs from the Drug Abuse Warning Network (DAWN), Drug Use Forecasting (DUF) system, and Uniform Crime Reports do not show clear trends in patterns of drug use in those cities with NEPs. The IDU focus groups conducted in cities with NEPs consistently indicated that the participants believed that NEPs would have little effect on drug use in the community.

We agree with the UC team conclusion that available data are quite limited but provide no evidence of any NEP-related increases in community levels of drug use. However, the limitations of both available research methods and existing data addressing this issue underline the need for continuing evaluation and research on the impact of NEPs on drug use. Additional evaluation and research and the development of new research methods in this area should be a component of Federally supported NEPs.

A key concern of NEP opponents is that these programs will directly or indirectly increase drug use. Opponents view NEPs as directly increasing drug use by providing the means (needles and syringes) to inject drugs. They also see NEPs as indirectly promoting drug use by appearing to condone and facilitate drug use and thereby undermining the credibility of society's message that using drugs is illegal, unhealthy and morally wrong. However, no study in the United States or abroad was found that showed that NEPs increase community drug use.

8. IMPACT OF NEEDLE EXCHANGE PROGRAMS ON PREVENTING HIV INFECTION

A major question in the policy debate over NEPs is their effectiveness in preventing-HIV infection among IDU-s-and-their contacts. Several findings strongly support the conclusion that NEPs reduce HIV transmission. First, the process of needle exchange removes used, often HIV-contaminated, needles and syringes from the hands of IDUs and replaces them with sterile needles and syringes. Second, NEPs are often effective in referring NEP client and non-client IDUs to drug treatment programs. Third, NEP clients report decreases in their HIV drug risk behaviors. Fourth, mathematical models of the impact of NEPs in New Haven and other cities consistently estimate substantial reductions (ranging from 17 to 70 percent) in HIV transmission for the IDUs using NEPs and their sex partners and children. Fifth, there is some evidence that hepatitis B infection is reduced by NEPs. On the other hand, epidemiologic studies which directly address HIV prevalence and incidence in relation to NEPs have been methodologically weak. One case-control study (in Amsterdam) found no protective effect of the NEP on HIV seroconversion among IDUs. However, the Amsterdam study was not primarily designed to test NEP effectiveness and included only a limited number (31) of new HIV infections. We concur with the UC conclusion that the relationship between NEPs and HIV infection may be very difficult to determine conclusively.

9. REVIEW OF UNIVERSITY OF CALIFORNIA RECOMMENDATIONS

In this section, the recommendations of the UC study are reviewed.

"Recommendations for the federal government

The federal government should repeal the ban on the use of federal funds for needle exchange services.

Substantial federal funds should be committed both to providing needle exchange services and to expanding research into these programs.

CDC comment:

Both recommendations are reasonable and appropriate with the minor modifications indicated in this section.

Given the significance of injection drug use in HIV transmission in the United States, it is important to implement NEPs as one possible component of comprehensive HIV prevention programs for drug users. Comprehensive programs should include increases in drug treatment, street and community outreach to drug users, and effective school and community-based programs to prevent initiation of drug use. The ban on Federal funding of NEP-s should be removed-to allow States-and-communities the option of including NEPs in comprehensive programs. NEPs will be more readily integrated into comprehensive programs when there is evidence of substantial local support for NEPs as indicated by any of the following: requests for an NEP from a State or local HIV community planning process; substantial funding for NEPs from local and/or State government or nongovernmental organizations; and efforts to reform the laws limiting the sale or possession of needles and syringes.

The PHS should fund additional evaluations of NEPs[8] to gather more data on the impact of these programs and to assess the relative effectiveness of various models of delivery of NEP services. Additional research is needed on the initiation of drug use and drug injection and changes in community drug use, particularly in communities with high prevalence of drug use, as they relate to NEPs and other interventions that increase the availability of sterile needles and syringes. PHS agencies supporting research on NEPs should develop and promote the use of standardized data elements, methods of data collection, and protocols for evaluation and analysis.

State governments in the ten states and the District of Columbia that have prescription laws should repeal these laws.

- States should repeal the paraphernalia laws as they apply to syringes.

CDC comment:

Both recommendations are reasonable and appropriate with the modifications indicated in this section.

Although the major focus of the UC report was NEPs, there is ample evidence of the importance of allowing access to sterile needles and syringes for drug users who will not or cannot stop injecting drugs. In the United States and other countries, difficulty in obtaining and/or possessing needles and syringes contributes to multiperson use of needles and syringes and thereby to HIV transmission. NEPs can provide only a part of the increased access to needles and syringes that is needed to prevent HIV infection in IDUs, their sex partners and children. Changing the prescription and paraphernalia laws would increase IDU access to sterile needles and syringes with little or no expenditure of public funds.

An ongoing CDC and Connecticut evaluation of 1992 changes in the prescription and drug paraphernalia laws in Connecticut[9] provides convincing evidence of the potential benefit of these recommendations. The evaluation found (1) steady increases of "non-prescription" purchases of needles and syringes from pharmacies, (2) that IDUs reported their primary source of needles and syringes shifted from street/black-market purchases to pharmacy purchases and (3) that sharing ("multiperson use") of needles and syringes decreased from 52 percent prior to the new laws to 32 percent 8 to 12 months after the new laws were implemented. Similar increases in pharmacy purchases and decreases in sharing of needles and syringes were found in France after a prescription law was repealed in 1987.

[9]In 1992, Connecticut removed all criminal penalties for (a) the sale, without a prescription, of up to 10 needles and syringes and (b) the possession of up to 10 needles and syringes.

The implementation of these recommendations is primarily the responsibility of State governments. We recommend that the Federal government and others support strong evaluation studies of the impact of changes in these laws on drug use patterns and HIV transmission risk behaviors. The use of standardized research methods yielding comparable results should be encouraged.

"Recommendations for local governments and communities

Local governments should enter into discussions with local community groups to develop a comprehensive approach to preventing HIV in injection drug users. their sex partners. and their offspring. This approach should include needle exchange programs and the expansion of drug treatment services.

Local communities should seek to further increase sterile syringe availability by encouraging the sale, distribution. or exchange of syringes by pharmacists."

CDC comment:

Both recommendations are reasonable and appropriate.

The experience with implementing NEPs in the United States and other countries indicates that NEPs are better accepted and operate more efficiently when there is extensive community involvement in planning how the NEP services will be provided. NEPs should be components of comprehensive, multifaceted HIV prevention programs for IDUs.

Pharmacy sale of sterile needles and syringes is-an--important component in increasing the availability of sterile injection equipment to IDUs. Retail pharmacies could provide widespread access to sterile needles and syringes, especially in areas where NEPs would be impractical (e.g., rural areas). Pharmacists are important "gate keepers" for the availability of sterile needles and syringes. Many pharmacists will need training to realize the importance of their public health role in helping ensure the availability of sterile needles and syringes to IDUs.

10 . INCREASING THE AVAILABILITY OF STERILE NEEDLES AND SYRINGES

CDC believes that increasing the availability of sterile needles and syringes is appropriate Federal policy for the following reasons:

(1) HIV transmission associated with injection drug use is a major contributor to the growth of the current AIDS epidemic in the United States. Injection-related HIV transmission has caused increases in the number of AIDS cases among women and children, in heterosexually acquired HIV infections and in cases of tuberculosis.

(2) Restrictions on access to and the possession of needles and syringes increase the multiperson use ("sharing") of drug injection equipment that transmits HIV.

(3) A recent bulletin from the CDC, NIDA, and CSAT indicates that bleach disinfection of used drug injection equipment is not as safe as using sterile needles and syringes. Such disinfection is recommended only when sterile needles and syringes are not available.

(4) Evaluation of NEPs in the United States and other countries indicates that these programs can provide services to large numbers of IDUs, remove millions of used needles and syringes from circulation, and increase access to drug treatment and other high priority public health services.

(5) The preponderance of evidence indicates that NEPs diminish HIV transmission without increasing drug use.

(6) Evaluation of changes in the prescription and drug paraphernalia laws in Connecticut indicates that drug users change their usual source of needles and syringes from street and "black market" purchases to purchases -from pharmacies and substantially decrease sharing of injection equipment.

We recommend that the PHS adopt a policy goal of increasing the availability of sterile needles and syringes for IDUs. This specific HIV prevention strategy would be one component of comprehensive, multifaceted HIV prevention programs for IDUs. The following activities should be considered to implement this policy:

Allow Federal funding of NEPs, especially when these NEPs would also provide their clients with access to HIV counseling and other priority public health programs (e.g., drug treatment and tuberculosis screening and treatment). Programs that receive Federal funding should have substantial evaluation and/or research components, either as part of the project or as a separately funded activity.

Continue funding for research and evaluation studies of the impact of NEPs on HIV risk behaviors and HIV infection.

(1) the repeal of State laws requiring a physician's prescription for the purchase of sterile needles and syringes, (2) the repeal of State and municipal laws and regulations making the possession of needles and syringes a crime, and 3) the removal of needles and syringes from the list of materials covered by the Federal Mail Order Drug Paraphernalia Control Act. Evaluations of the impact of these changes should be funded

Work with the professional associations of pharmacists and pharmacies to develop policies that increase the pharmacy-based availability of sterile needles and syringes.

Attachments

Tab A

Tab B

Tab C

Tab D

Tab E

Executive Summary University of California needle exchange report

Review of the University of California report by the National Institutes of Health

Review of the University of California report by the Substance Abuse Mental Health Services

Administration

Review of the University of California report by the Health Services and Resources Administration Review of the University of California report by the Food and Drug Administration

EXECUTIVE SUMMARY

THE UNIVERSITY OF CALIFORNIA REPORT (THE PUBLIC HEALTH IMPACT OF NEEDLE EXCHANGE PROGRAMS IN THE UNITED STATES AND ABROAD

CONCLUSIONS

How and Why did Needle Exchange Programs Develop?

Needle exchange programs have continued to increase in number in the U.S. and by September 1, 1993 at least 37 active programs exist. The evolution of needle exchange programs in the U.S. has been characterized by growing efforts to accommodate the concerns of local communities. increasing likelihood of being legal, growing institutionalization, and increasing federal funding of research, although a ban on federal funding for program services remains in effect.

How do Needle Exchange Programs Operate?

About one-half of U.S. needle exchange programs are legal, but funding is often unstable and most programs rely on volunteer services to operate. All but six U.S. needle exchange programs require one-for-one exchanges and rules governing the) exchange of syringes are generally well enforced. In addition to having distributed over 5.4 million syringes, U.S. needle exchange programs provide a variety of services ranging from condom and bleach distribution to drug treatment referrals.

Do Needle Exchange Programs Act as Bridges to Public Health Services?

Some needle exchange programs have made significant numbers of referrals to drug abuse treatment and other public health services, but referrals are limited by the paucity of drug treatment slots. Integrating needle exchange programs into the existing public health system is a likely future direction for these programs.

How Much Does It Cost to Operate Needle Exchange Programs?

The median annual budget of U.S. and Canadian needle exchange programs visited is relatively low at $169,000, with government-run programs tending to be more expensive. Some needle exchange programs are more expensive because they also provide substantial non-exchange services such as drug treatment referrals. The annual cost of funding an average needle exchange program would support about 60 methadone maintenance slots for one year.

Who Are the IDUs who Use Needle Exchange Programs?

Although needle exchange program clients vary from location to location, the programs generally reach a group of injection drug users with long histories of drug injection who remain at significant risk for human immunodeficiency virus (HIV) infection. Needle exchange program clients in the U.S. have had less exposure to drug abuse treatment than IDUs not using the programs.

What Proportion of All Injection Drug Users in a Community Uses the Needle Exchange Program?

Studies of adequately-funded needle exchange programs suggest that the programs do have the potential to serve significant proportions of the local injecting drug user population. While some needle exchange programs appear to have reached large proportions of local drug injectors at least once, others are reaching only a small fraction of them. Consequently other methods of increasing sterile needle availability must be explored.

What Are the Community Responses to Needle Exchange Programs?

Unlike in many foreign countries, including Canada, proposals to establish needle exchange programs in the U.S. have often encountered strong opposition from a variety of different communities. Consultation with affected communities can address many of the concerns raised.

Do Needle Exchange Programs Result in Changes in Community Levels of Drug Use?

Although quantitative data are difficult to-obtain, those available provide no evidence that--needle exchange programs increase the amount of drug use by needle exchange program clients or change overall community levels of non injection and injection drug use. This conclusion is supported by interviews with needle exchange program clients and by injecting drug users not using the programs who did not believe that increased needle availability would increase drug use.

Do Needle Exchange Programs Affect the Number of Discarded Syringes?

Needle exchange programs in the U.S. have not been shown to increase the total number of discarded syringes and can be expected to result in fewer discarded syringes.

Do Needle Exchange Programs Affect Rates of HIV drug and/or Sex Risk Behaviors?

The majority of studies of needle exchange program clients demonstrate decreased ratios of HIV drug risk behavior, but not decreased ratios of HIV sex risk behavior.

What is the Role of Studies of Syringes in injection Drug Use Research?

The limitations of using the testing of syringes-as a measure of injecting drug users' behavior or behavior change can be minimized by following syringe characteristics over time,. or by comparing characteristics of syringes returned by needle exchange program clients with those obtained from non-clients of the program.

Do Needle Exchange Programs Affect Rates of Diseases Related to Injection Drug Use Other than HIV?

Studies of the effect of needle exchange programs on injection-related infectious diseases other than HIV provide limited evidence that needle exchange programs are associated with reductions in subcutaneous abscesses and hepatitis B among injecting drug users.

Do Needle Exchange Programs Affect HIV Infection Rates?

Studies of the effect of needle exchange programs on HIV infection rates do not and, in part due to the need for large sample sizes and the multiple impediments to randomization, probably cannot provide clear evidence that needle exchange programs decrease HIV infection rates. However, needle exchange programs do not appear to be associated with increased rates of HIV infection.

Are Needle Exchange Programs Cost-effective in Preventing HIV Infection?

Multiple mathematical models of needle exchange program impact support the findings of the New Haven Model. These models suggest that needle exchange programs can prevent significant numbers of infections among clients of the programs, their drug an sex partners, and their children. In almost ail cases, the cost per HIV infection averted is far below the $119,000 lifetime cost of treating an HIV-infected person.

RECOMMENDATIONS

Recommendations for the federal government

The federal government should repeal the ban on the use of federal funds for needle exchange services.

Substantial federal funds should be committed both to providing needle exchange services and to expanding research into these programs.

Recommendations for state governments

State governments in the ten states and the District of Columbia that have prescription laws should repeal these laws.[1]

States should repeal the paraphernalia laws as they apply to syringes.[2]

Recommendations for local governments and communities

Local governments should enter into discussions with local community groups to develop a comprehensive approach to preventing HIV in injecting drug users, their sex partners, and their offspring. This approach should include needle exchange programs and the expansion of drug treatment services

Local communities should seek to further increase sterile syringe availability by encouraging the sale, distribution, or exchange of syringes by pharmacists.

Recommendations for researchers

Descriptions of the "kinetics" and determinants of needle use patterns: injection drug users sources of needles. methods of disposal of needles, frequency of needle re-use, and needle-sharing patterns. How do these change when a needle exchange program or other changes in needle availability are implemented?

Evaluations of "natural experiments" in which needle availability laws

pharmacy based syringe sale, distribution, or exchange and to identify the barriers to their participation.

Assessments of the effects of design features of needle exchange programs (e.g., administering bodies, site characteristics, opening hours, and program rules} upon process measures of needle exchange programs (e.g., needles distributed, drug treatment referrals discarding of needles).

Ethnographic and other qualitative research to assess the factors involved in drug use initiation and in transitions between various routes of drug use.

Case-control studies of the relationship between use of the needle exchange program and acute hepatitis 8, particularly in cities with active surveillance for the infection.

Large, multi-center case-control studies within existing cohorts of injecting drug users to assess whether use of the needle exchange program is associated with hepatitis B or HIV seroconversion

Mathematical modeling using program data and behavior change evaluations to determine which aspects of program design determine effectiveness and cost-effectiveness.

[1]Prescription laws preclude the purchase of a syringe without a prescription. limiting sterile syringe availability and creating a risk of arrest for needle exchange program staff and clients.

[2]Paraphernalia laws exist in 46 states and the District of Columbia and preclude the possession or distribution or syringes except for legitimate medical purposes. Conviction under a paraphernalia law is a felony or a misdemeanor

Department of Health & Human Services

Public Health Service

National Institutes of Health

Bethesda, Maryland 20892

To: James W. Curran, M.D. Ph.D.

Assistant Surgeon General

From: Deputy Director

Office of AIDS Research

Subject: Comments on the CDC's Draft Response on Needle Exchange

We have reviewed the draft CDC response to the Office of the Assistant Secretary for Health and the Surgeon General regarding the University of California report on needle exchange. In addition to the comments provided in our earlier review of the report (included as Tab B in the CDC draft response), we provide the following comments that are specific to the draft CDC response letter:

1. Agency Position Issue

Page 1: The second paragraph implies that the NIH, along with SAMHSA, HRSA, and the FDA, has provided "recommendation for needle exchange." This is either inaccurate or misleading. We suggest that the wording "And recommendations for needle exchange" be dropped from the sentence.

2. Research

The CDC draft response appropriately includes an emphasis on the need for increasing research and evaluation of needle exchange programs (NEPs) and other related aspects of HIV and drug abuse.

However, in light of the reported gaps in information concerning the efficacy and impact of needle exchange programs, requiring evaluation to be an integral component of any federally funded NEP becomes critical if we are to take an iterative approach to this issue.

The following text changes are recommended:

Page 2: In the last sentence of the second paragraph the word "include" should be change (sic) to "require";

Page 11: The first sentence of the last paragraph should be "The PHS should require substantial evaluation be part of any federally funded NEP so as to continue to gather more data on the impact..."; and,

Page 15: The last sentence of the first paragraph should be changed to read, "Programs that receive Federal funding should be required to have substantial evaluation and/or research components, either as part of the project or as a separately funded activity."

3. Agency Designation

Page 4: The fourth paragraph lists the CDC, CSAT and NIDA as co-sponsors of a bleach use guidance. For parity , all agencies should be designated. This could be achieved by indicating CSAT/SAMHSA and NIDA/NIH, or by stating, " The National Institute on Drug Abuse, part of the National Institutes of Health,..."

Please feel free to contact me if you have any questions of need further information.

Jack Whitescarver, Ph.D.

Department of Health and Human Services

National Institutes of Health

Bethesda, Maryland

Building 1

Room 201

(301) 496-0357

TO: Associate Director AIDS/HIV, CDC

PROM: Deputy Director, - Office of AIDS Research, NIH

SUBJECT: NIH comments on- the University of California Report,

" Public Health Impact of Needle Exchange Programs in the United States and Abroad. "

We have reviewed the report, "The Public Health Impact of Needle Exchange Programs in the United states and Abroad, " from a research perspective, We have provided several points for your consideration in your response on needle exchange to the Assistant Secretary for Health:

1. This report is a good initial analysis of this issue and serves as a useful starting point for further examination;

2. Utilizing needle/syringe exchange (NSE) programs as an HIV prevention strategy is a complex issue. The current state of the science with respect to this issue is neither complete nor comprehensive, .requiring further study on this, as well as, alternative behavioral interventions;

2. There are a number of significant issues and problems with respect to needle exchange program that the data available to the University of California have not addressed (see attached analysis);

3. The report appropriately suggests a substantial federal commitment to research in this area. Such support should include, but should not be limited to, .funding for: 1) building substantiai evaluation and/or research components into existing NSEs; 2) research demonstration projects that address NSE program: design issues; 3. research on other forms of need~e/syringe distribution (e.g., pharmacy or vending machinP strategies); and, 4) research on the relationships and impact of NSEs on other prevention strategies (e.g., bleach use) and other non-injecting at-risk populations (e.g., non-injecting drug users who trade sex or money for drugs). In addition, until more is definitively known and has been time tested, any NSE service programs funded should have appropriate research and/or evaluation components built into them as a prerequisite for Federal funding.

For a more detailed analysis of the specific research issues and questions that remain unanswered by the report, we have attached comments on the report provided by the National Institute on Drug Abuse.

Attachment

Jack Whitescarver, Ph. D.

Sent by Xerox Telecopier 7021:11-12-93 :10:48 AM : 4432317 4027789;#

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

National Institutes of Health

National Institute on Drug Abuse

5500 Fishers Lane

Rockville, Maryland 20857

Memorandum

Date: November 12, 1993

To: Jack Whitescarver, Ph.D.

Deputy Director

Office of AIDS Research

National Institutes of Health

From: Acting Chief

Clinical Medicine Branch

Division of Clinical Research

National Institute on Drug Abuse

Thru: Associate Director for AIDS

National Institute on Drug Abuse

Topic: Comments on University of California Report, " The Public Health Impact of Needle Exchange Programs in the United States and Abroad"

In general, medical/public health interventions, like medications, may be evaluated within a framework that examines safety, efficacy, side effects, deleterious effects and both positive and negative interactions with other treatments or conditions. With respect to any of the effects, questions include what subpopulations are likely to experience the effect and how long it is likely to last, including recommendations with respect to the length of treatment. In fact, to the degree to which this Report provides the equivalent of a section of the Physician's Desk Reference(PDR) devoted to needle/syringe exchange (NSE) it will be helpful all who are concerned with the implications of NSEs.

Viewing this Report in the aforementioned framework it becomes clear that with respect to overall "effects" NSE is associated in the aggregate with reductions in self reports of needle-related HIV risk behavior.

However, a major problem with the existing data examined by the Report is the lack of sensitivity of the data to detection of adverse effects of NSE on individuals or subpopulations and interaction with, for example, the various modalities of drug abuse treatment. There is no equivalent of studies that search for individuals who purport to have experienced "adverse reactions" or negative consequences or interactions that may be attributable to participation in NSE. It is questionable whether in the context of medications development the Federal Government would approve and/or provide funds for a medication for which this type of data were not available.

In the spirit of seeking the information that would be needed for a complete PDR section on needle/syringe exchange, we will review some concerns about the potential adverse impact and interactions of NSE.

One major concern of critics of NSEs as an AIDS intervention effort is the degree to which the availability of sterile needles/syringes would server to promote drug use. While the needle exchange studies reported from around the world from the last two world AIDS conferences do not, and perhaps cannot, prove that the presence and/or use of a needle exchange does not increase drug use, there have been no reports that confirm such an increase. However, there are a number of direct and indirect ways in which drug use maybe promoted for individuals and subpopulations that have not been addressed by existing data. For example, one wonders what happens to the drug use of individuals who seek drug treatment through an NSE and are told that there is no slot available for them.

Analogous to that for needle/syringe exchange, the criticism of the potential for increasing injection drug use was raised for bleach distribution. This particular criticism (although not all criticisms) with respect to bleach was, in the aggregate and within limits, refuted by the results of the National AIDS Demonstration Research data which is consistent with the model that when contact is established with drug users, trust is build, information is imparted and risky behavior is reduced, despite the fact that safe needle use is also being assisted at the same time(XXXXXXXXXXXXXXX). Nonetheless, the demonstration of beneficial effects does not preclude the simultaneous existence of deleterious effects.

NSEs may not be uniformly effective in acting as a bridge to other public health services, depending on such factors as to what degree the services are "on-site" versus "remote" as well as "immediately available" versus "requiring waiting". Studies of the service linkage process suggest that higher rates of successful engagement with other services will be attained for those services that are on-site and immediately available. It would be useful to attempt to characterize users and non-users of additional services and to delineate those factors that affect these decisions.

Inconsistent of infrequent users of the NSEs may remain and be stabilized at high risk behavior levels. With respect to the inconsistent or infrequent users of the NSEs, it will be important to determine the factors influencing periods of use versus non-user. More over, looking at NSEs as an "innovation" with respect to injection drug user, the literature of models of [LINE LOST IN COPYING - Ed.] middle and late adopters of NSEs may be useful in terms of delineating populations with distinct patterns of motivations, risk factors and responses to the NSEs.

Change or lack of change in the micro-structure, i.e., details, of behaviors associated with drug use may negate beneficial effects of NSEs. In looking at drug risk behaviors, it is important to attempt to assess whether NSEs affect rate of sharing of cookers, cotton, water, etc. as well as such practices as frontloading, backloading and booting. With respect to drug risk behaviors it is thus important to examine NSE effects on behavioral norms of (1) non-NSE-users and (2) drug using non-injectors as well as (3) NSE users.

NSE users may sell paraphernalia or exchange it for drugs or sex. In fact, the possibility should be examined that non-injectors may use the NSEs as a source for paraphernalia that may used in transactions with injectors.

The rate at which NSE users (versus NSE non-users) initiate new injectors and influence other IDUs to utilize or not utilize the NSE should be examined. Moreover, questions of the influence of the NSE on injections frequency should be examined closely. For individuals, the availability of clean paraphernalia may remove one brake on increasing the frequency of injection.

Certainly, NSE effects on the number of IDUs entering drug treatment need to be examined. However, the fate of IDUs who have used the NSE prior to entry into drug treatment should also be examined. NSE participants or injections drug users whose network includes NSE participants may relapse to needle use and/or drop out of drug treatment at a higher rate than NSE non-users.

NSE effects on social network may lead to problems. Since NSEs imply a high rate of flow of IDUs through the neighborhood surrounding the site, there may be a tendency for dealers, operators of shooting galleries and/or crack houses and prostitutes to relocate to the same area. If possible, these effects and their implications should be assessed. The potential effects of NSEs on setting up bridges between networks of IDUs in high and low HIV seroprevalence neighborhoods should be examined. If NSEs serve to create such bridges they would, especially through inconsistent seropositive users, serve as conduits to facilitate viral spread. If data are generated on local changes in seroprevcalence and/or seroincidence over time in areas surrounding NSEs, (including baseline levels prior to the establishment of the NSE and changes during the growth of the NSE), then some of these questions may be able to be addressed. Data pertinent to the perceived effects of participation in the NSE on the sexual, social and drug-using networks of the individuals would also be helpful in beginning to address these hypotheses.

Additional network effects may occur or existing network effects may be potentiated if NSE sites are located close to drug treatment programs (methadone or drug free programs), hospitals, psychiatric facilities, homeless shelters or other facilities that attract concentrations of individuals who are vulnerable to initiating drug injections, relapsing to drug use or injections, having sex with injections users or becoming victims of crime associated with injections users.

As is addressed in the Report, the surveyed NSEs varied greatly in along many parameters including estimates of the proportions of injection drug users reached by the program, the amount of education offered, the degree to which injection equipment beyond needles/syringes were distributed, emphasis on drug treatment referrals, costs, the extent of ongoing evaluation, acceptance by the local community, legal acceptance/tolerance, etc. These are major program design and feasibility that could determine differences between highly effective programs and those with a substantial negative impact. Support for grams without consideration of these issues would be the equivalent of support for all treatment programs in any area in the absence of standards and quality assurance.

Finally, the interrelationships between NSEs and the use of bleach need to be examined. For example, we have evidence that even IDUs who use bleach tend to not use it effectively. Does the existence of needles from NSEs decrease the probability that IDUs will even attempt to use bleach if the share? Will they feel that the needles are at least relatively safer and thus real that bleach use is not necessary? Does the distribution of bleach increase the probability that IDUs will share NSE distributed needles? Are NSEs attempting to intervene in terms of education with respect to bleach use?

This, of course is not an exhaustive list of questions or issues, but is meant to represent a set of problems whose existence has not been addressed by the data available to the University of California study.

However, even in the absence of Federal Support, NSE is a growing part of HIV prevention efforts. This Report appropriately suggests a substantial Federal commitment to research in this area. With respect to the funding of services, it appears reasonable, as the Report suggests, that the ban on funding be lifted.

Nonetheless, it would appear prudent in light of the incomplete data and the aforementioned set of concerns that no services e funded that do not included a substantial evaluation component with appropriate instrumentation and methodologies to identify adverse as well as beneficial contribution of these programs to HIV and other infectious disease transmission and drug use patterns. Perhaps as a prelude to defining standards for Federal funding of NSE services, there should be funding for incorporating evaluation in existing NSEs and setting up research/demonstrations projects that address NSE program design issues.

Beyond the issue of NSEs per se, the argument is made in this Report in favor of immediate implementation of the entire variety of interventions that increase the availability of sterile needles/syringes, including pharmacy sales and the abolition of prescription and paraphernalia laws. Given the stated priority of the objective, presumably this support would extend to other forms of needle/syringe distribution, e.g., vending machines like those used in Europe.

While the objective appears reasonable, it would be helpful if the Report addressed more of the complexities of this issue so that sterile needle/syringes are not viewed as a "magic bullet" that obviates the need to continue work on behavioral interventions. For example, there have been extensive observations of "secondary sharing" in which addicts in groups use frontloading and backloading to distribute "cooked" drugs to their syringes. In these situation if an addict brings his/her own syringe, but has previously used the syringe even once and engaged in "booting" (drawing blood back into the syringe and reinjecting after initial injection to make sure that any residual drug in the syringe is used), blood may be distributed to others' syringes. Moreover, contaminants of "cookers', "cotton" and "rinse water" may be similarly distributed.

Finally, all strategies for distributing needles/syringes may not be equivalent. For example, it is questionable whether pharmacies will provide other forms of injections equipment, HIV education, HIV testing and counseling, referral to drug treatment programs, on-site medical car, etc. Similarly, these service would presumable not be available through such distribution sources as vending machines.

Sander G. Ganser, M.D., M.P.H.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Memorandum

Date

From: Special Assistant to the Acting Administrator,

SAMHSA

Subject: Draft Response an Needle Exchange

To: James W. Curran, M.D., M.P.H

Associate Director for HIV/AIDS CDC

Thank you for the opportunity to review the latest draft oz response to the University of California, San Francisco report The Public Health Impact of Needle Exchange Programs in the United States and Abroad."

We concur in the response and appreciate the inclusion of our previous comments on the report-being included as an appendix.

Myron L. Belfer, M.D.

N0V-12-93 ~T 13.26 ADAMHA/IOA FAX N0. 3014430284 P.02

DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

Substance Abuse and Mental Health Services Administration

Rockville MD

TO: Associate Director HIV/AIDS CDC

FROM: Special Assistant to the Acting Administrator, SAMHSA

SUBJECT: Response on Needle Exchange

In general we are fully supportive of the University of California report on "The Public Health Impact of Needle Exchange Programs in the United States and Abroad." The report and its . recommendations are a valuable contribution to our understanding of the important role of needle exchange in addressing the spread of HIV/AIDS. We look forward to the opportunity to develop the appropriate implementation of the report's recommendations.

Attached are specific comments on the University of California report prepared by the Center for Substance Abuse Treatment. These comments reflect concerns that we believe should be acknowledged in any overall commentary on the report.

Thank you for the opportunity to comment on the University of California report.

In response to your request, I Will serve as the SAMHSA contact person regarding this report. My telephone number is (301) 443-5305 and my facsimile number is 3Q1-443-0284.

Myron L. Belfer, M. D .

Attachment

cc:

T. Stephen Jones, M.D.

Center for Disease Control Prevention

November 9, 1993

NOTE TO: George Lewis

RE Comments on Needle Exchange Study

As you may be aware, Beny asked me to review this report during the early of it's preparation earlier this year. While the final summary report does reflect many of the changes we recommended, there are several noteworthy areas which warrant some attention.

Page 4, Paragraph 4. The report indicates that, "although NEPs may make referral to drug treatment an important part of their services, they acknowledge that many IDUs, including some in drug treatment programs, continue to inject drugs and share injection equipment. They therefore seek to reduce the harm associated with these practices...". While there may be some injecting drug users in certain treatment modalities who continue to inject drugs, the reference here implies that this practice has more significance than the evidence warrants. More importantly, the statement, in a somewhat convoluted fashion, implies that referral to treatment in contrast to NEP does not offer assurance that drug users will not inject drugs.

Page 11, Paragraph 5. The report notes that. NEPs vary greatly with respect to the emphasis they place upon making referrals to drug treatment and other public health services. This stems in part from the desire to make the NEP "user friendly", the recognition that many active IDUs express no interest in entering drug treatment, and the related belief that an over emphasis on drug treatment could alienated potential NEP clients." This assertion for which two literature references are cited is a dangerously misleading generalization. First it is unclear what the authors mean by "user-friendly". This implies that drug treatment is somehow not user friendly which is clearly not the case. Secondly, the references to drug treatment are based published papers which were published before OTI/CSAT came into existence, a development which has had an enormous effect on the nature and quality of national drug treatment services. We must remember that many of staff of these NEPs are only casually familiar with the various treatment modalities, the behavioral characteristics of drug using populations and are generally not qualified to make determinations about who is interested in treatment or not. In point of fact many drug users are not interested in treatment, enter treatment for many other reasons, e.g. secure primary care or to take a respite from their addiction lifestyle, other than to address their addictions. It does not follow, even from the limited evidence provided in the cited studies, that emphasizing or overemphasizing treatment produces alienation. finally, the determination of who should be referred or not should never be left to so-called perceptions of staff regarding "readiness for treatment".

Page 12, Conclusion. There are a number of reasons why referrals to drug treatment are limited other than the paucity of drug treatment slots. One important consideration which may be a limiting factor to referrals may in fact have more to do with how various NEPs have evolved in relation to drug treatment programs in the same area. It is abundantly clear that these programs have not been in philosophical agreement regarding how to address the needs of the addict.

Page 13, Conclusion. I don't think there is any serious disagreement that the cost of NEPs are substantially cheaper than any form of treatment including methadone. It is also true that NEP is cheaper than coronary angioplasty, renal dialysis and a range of other health care expenditure. The reference made to methadone seems to suggest that there is contrast, or perhaps imply that there is tacit substitution effect. The reference made to methadone should be deleted since its incorporation in the context of the conclusion is largely irrelevant.

Page 14, Paragraph 5. Our understanding of injecting drug use among women is not as well developed as for men. While there is evidence which suggest that men initiate women, this is by no means an absolute. the fact remains that there are IDU populations of women which operate independently from those of men. Our limited knowledge of injecting behaviors among women clearly indicates that there may be other factors involved with respect to injecting behavior which may make it problematic to apply NEP directed at male IDUs to female IDUs.

Page 16, Conclusion. The conclusion tragically fails to appreciate the full range of antipathy and fear which African Americans communities have for the "symbolic sanctioning" of drug abuse by endorsing NEP in their communities. After years of "Just Say No", the perception of many leaders in these communities is that NEP represents a step back and not forward. Irrespective of whether this perception is valid or not, the presence of these compelling beliefs cannot be dismissed lightly. It is insulting to these communities, also contrary to all of our Public Health platitudes around cultural sensitivity to dismiss these visceral community concerns by stating that "newer African American organizations established specifically to address HIV prevention generally support NEP as did several mayors..." This statement literally indicates that the view of traditional leaders from the African American communities and from church leaders can and should be ignored in favor of those who support NEP. This statement by it's intent, fosters divisiveness and is antithetical to efforts made by other segments of public health including those concerned with preventing HIV disease to engage and not alienate the African American community.

Page 18, Conclusion. The overall issue here is the question which frames this section, "Do NEPs result in changes in community levels of drug use?" Clearly this is very complex question which could not be answered within the scope of the study, but one which nonetheless warrants a poignant level of inquiry. However, the conclusion seems to go beyond the paucity of evidence to conclude that there is "no evidence that NEPs increase the amount of drug use by NEP clients or change overall community levels of non-injection and injection drug use." This convoluted logic would have us believe that if it cannot be established that NEP has an effect on drug use, then the absence of correlates, irrespective of methodological limitations, is tantamount to saying it has no effect. This conclusion is further supported by indicating that interview with NEP clients and by IDUs not using NEP, confirmed that they did not believe that increase needle availability would increase drug use. It is not clear how these two groups would qualify to speculate on new incidence, especially by younger members of the community. In general, this ipso facto logic is not only distressing, but raises very real questions overall scientific validity of this report.

Page 21, Conclusion. Though the majority of studies cited indicated a decreased rate of HIV drug risk behavior, the real issue here which is not addressed are whether these behavioral changes are sustainable overtime. While there are clearly compelling finding of short term behavioral change, these indications do not provide definitive conclusions regarding the effectiveness of NEP overtime. The proper statement of this conclusion should insert the caveat that the studies reviewed do not conclusive evidence at this time that these behaviors are sustained overtime.

Warren

Department of Health and Human Services

Public Health Service

MEMORANDUM

Date: November 16, 1993

From: Associate Administrator for AIDS

HRSA

Subject: CDC Report on the Public Health Impact of Needle Exchange Programs

To: James Curran, M.D.

Associate Director for HIV/AIDS, CDC

We at HRSA have reviewed this very thorough report on needle exchange programs and concur with its major finding and recommendations. We believe that needle exchange programs definitely have a place in what must necessarily be a comprehensive approach to the prevention of HIV infection among drug users. In addition, we were pleased that the report went beyond needle exchange programs per se to discuss the need for changes in current prescription and paraphernalia laws at the State level.

Thank you for giving us the opportunity to review this excellent report.

G. Stephen Bowen, M.D., M.P.H.

Assistant Surgeon General

Department of Health and Human Services

Public Health Service

MEMORANDUM

Date: December 2,, 1993

From: Associate Administrator for AIDS

HRSA

Subject: Draft Response on Needle Exchange

To: James Curran, M.D., M.P.H.

Associate Director for HIV/AIDS, CDC

In general we think the CDC's draft response to Jo Ivey Boufford, M.D. concerning the University of California report on needle exchange programs did an excellent job of covering the salient issues. We do have a number of specific comments, which follow:

page 2, paragraph 2:

We suggest adding a sentence to the effect that : "Substance abuse treatment programs also require substantial funding increases in order to accommodate the needs of individuals who decide they want to enter treatment as a result of their involvement in needle exchange and other outreach efforts to IDUs.

page 7, first paragraph:

We think it is important to mention the fact that needle exchange remains an issue of special concern issue among African-American and other minority politicians and community leaders. Whether or not we think this concern is justified, we need to acknowledge that it exists.

page 8, last paragraph:

We think it should be acknowledged that the degree to which new HIV infections are reduced is strongly affected by (1) the "penetration" of needle exchange in a particular city and (2) the complexity of the drug-using populations and network in particular communities (i.e., the number of, and kinds of connections between, drug injection networks).

page 9, "Impact of Needle Exchange Programs on Drug Use":

Again, we think it is crucial to acknowledge and discuss the fact that many African-American and other minority politicians and community leaders fear that needle exchange programs condone drug use and should be opposed on those grounds.

The last paragraph in this section should provide more specific data to address this concern.

page 10, last paragraph:

The fifth sentence should read, "Third, NEP clients report decreases in their HIV drug-risk behaviors."

We disagree that the relationship between NEPs and HIV infection may be impossible to study conclusively, particularly since "conclusiveness" depends on the criteria being used. This issue could be studied with several replications (different cities or neighborhoods) to obtain better data than now exist on this point.

page 11, last paragraph:

We suggest adding a sentence to the effect that, "The CDC should develop and foster the use of standardized data elements, methods of data collection, and protocols for evaluation/analysis."

page 12 first paragraph:

In the last sentence, we suggest adding the phrase, "using standardized methodologies."

page 15, first paragraph:

Again, we suggest adding to the last sentence's phrase about the use of standardized data collection and evaluation methodologies.

We appreciate the opportunity to review this response.

G. Stephen Bowen, M.D., M.P.H.

Assistant Surgeon General

MEMORANDUM

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

Food and Drug Administration

Date: Dec 2, 1993

From: Nancy L. Stisic, Health Program Coordinator

Office of AIDS an special Health Issues (HF- 12)

Subject: Comments on Draft CDC Response on Needle Exchange Programs

To: Associate Director for HIV/AIDS

We appreciate the opportunity to review the CDC draft response on Needle Exchange. Dr. Wykoff has requested that I review the document on behalf of the Office. I have no further commetns concerning the Needle Exchange Program other than the comments provided to Dr. T. Stephen Jones on November 12, 1993.

November 22, 1994

From: Assistant Director for Substance Abuse and HIV Prevention,

Office of the Associate Director for HIV/AIDS

To: Associate Director for HIV/AIDS

Re: Request for Update on Needle Exchange Studies and Laws Related to Needle and Syringe Sale and/or Possession

1. Background

The following information is provided in response to the request of Brian Biles, Office of the Assistant Secretary for Health, for an update on (a) studies of needle exchange programs (NEPs) since the 1993 release of the University of California (UC) three-volume, 700 page report on NEPs[1] and (b) recent developments related to laws related to NEPs and possessions and/pr sale of syringes.

2. New York City NEP evaluation reported at 1994 APHA Conference

* At the 1994 American Public Health Association (APHA) Conference, Dr. Don Des Jarlais presented and estimate of an approximate 50% reduction in rates of new HIV infections among injecting drug users (IDUs) using NEPs in New York City (NYC).

* This estimate was based on several small follow-up studies of HIV incidence among IDUs using NEPs compared to HIV incidence among IDUs in a vaccine preparedness cohort and cohort studies in methadone maintenance.[2] A manuscript based the APHA oral presentation is being prepared. Until this study is more fully described, it is difficult to assess the basis for this estimate of NEP impacting NYC. However, although the numbers are small, the estimate is plausible.

3. Legal aspects of needle exchange, possession, and sale of syringes

* In 1993 and 1994, three states (Maryland, Massachusetts, and Rhode Island) enacted laws authorizing pilot NEPs; two states (Connecticut and Hawaii) enacted laws expanding existing NEP legislation.

* In September 1994, the Mayor and City Council o Los Angeles declared a "local state of emergency." The declaration was based on "... finding that an emergency in connection with the AIDS epidemic and the transmission of HIV through contaminated needles does exist, and that this emergency threatens to cause extraordinary loss of life."[3] This state of emergency was used as a basis for authorizing support for "responsible" NEPs.

* In 1993 and 1994, similar declarations of states of emergency have been made in nine other California cities and counties - Alameda, Berkeley, Marin, Oakland, Salinas, San Francisco, Santa Clara, Sonoma, and West Hollywood.

* A major reason for NEPs is the existence of several laws that restrict the purchase, distribution, and possession of syringes. These laws include "prescription laws," under which a prescription is required to purchase syringes and "drug paraphernalia laws," which establish felony and/or misdemeanor criminal penalties for the possession and/or distribution of syringes for nonmedical purposes. About nine states have prescription laws and more than 40 states have drug paraphernalia laws. In 1993, Maine repealed its prescription law.

* In 1992, Connecticut partially repealed it drug paraphernalia and prescription laws. The new laws allow purchase of as many as 10 syringes without a prescription and possession of as many as 10 syringes without a medical condition. A CDC and Connecticut Health Department evaluation of the impact of these new laws found that IDUs reported substantially less multiperson use ("sharing") of injection equipment. Also, after the change in the laws, more than 80% of Connecticut pharmacies sell syringes without a prescription and, for drug injectors, there was a dramatic shift from "black market" sources of syringes to purchases in pharmacies[4].

4. Limitations of bleach disinfection and recommendation to use sterile syringes

Several studies published in a special section of the July 1994 "Journal of AIDS" indicate that while bleach disinfection can reduce the HIV transmission risk of IDU reuse of syringes, it is not as safe as using a new, sterile syringe. The following quotation summarizes the argument:

We reiterate that IDUs who cannot stop injecting drugs should use sterile needles and syringes; ideally only once and then safely dispose of them. IDUs should be told never to re-use injection equipment that had been previously used by someone else.... If one re-uses injection equipment, consistent and thorough cleaning of equipment with disinfectants, such as full-strength household bleach for longer rather than shorter periods of time, should decrease, but may not eliminate the HIV transmission risk[5].

The following sections present additional information on NEPs that has become available since the release of the UC report.

5. Decreases in HIV risk behaviors among NEP clients

The following data from San Francisco and New York, cities with high volume NEPs, indicate decreases in HIV risk behaviors reported by NEP clients:

* Decrease in needle-sharing rates associated with increased use of the NEP among street recruited San Francisco IDUs[6].

* Reduction in needle-sharing rates among IDUs attending NEPs in New York City[7].

* Reductions in the proportions of IDUs attending drug detoxification programs in New York City who injected with a use syringe and who lent used syringes to others, associated with the opening of NEPs in that city.

6. No evidence of an increase in drug use in San Francisco, a city with a high-volume NEP

The San Francisco NEP opened in 1987. It is a now one of the highest volume NEPs in the United States; 343,888 syringes were exchanged during the Spring of 1992. The following data come from repeated surveys (from 1988 to 1992) of IDUs in San Francisco:

* The median number of injections decreased from 1.9 per day in the Fall of 1987 to 0.7 per day in the Spring of 1992.[6]

* The mean age of IDUs in the repeated surveys in San Francisco increased from 36 years in the Spring of 1987 to 42 years in the Spring of 1992[6].

* The proportion of San Francisco IDUs reporting that they first injected drugs in the previous year decreased from 3.0% in the Spring of 1989 to 1.1% in the Spring of 1992[6].

Taken together, the last two finding suggest that significant numbers of persons have not begun injecting drugs in a city with a high-volume NEP.

7. Increase in estimated reduction of HIV incidence among IDUs using the New Haven NEP

Earlier estimates derived from mathematical models indicated that the rate of HIV infection among clients of the NEP in New Haven, CT, was reduced by 33% by their use of the NEP. Updated estimates from that model suggest that the reduction is more than 40%[9].

8. Lower incidence of hepatitis B and C among IDUs using the Tacoma NEP

A study of hepatitis B and C among IDUs in Tacoma, Washington, using multivariate analysis to adjust for the demographic characteristics of the IDUs found that, compared with nonusers of the NEP, IDUs who had ever used the Tacoma NEP were seven times less likely to become infected with hepatitis B and eight times less likely to become infected with hepatitis C[10]. This study demonstrates more clearly than any previous research that use of NEPs is associated with decreases in blood -borne infections.

9. Substantial entry in to drug treatment of New Haven NEP clients

Between September 1992 and July 1993, 112 of 596 NEP clients (19%) in New Haven entered drug treatment. In addition, 205 IDUs who did not exchange syringes were referred to drug treatment by the NEP[11].

10. Substantial IDU utilization of high-volume NEPs

One issue about NEPs is how much they will be used by IDUs. Studies from tow cities with high-volume NEPs, New York City and San Francisco, indicate that substantial proportions of IDUs surveyed report use of the NEPs.

* Des Jarlais reported data indicating that in 1993 nearly half (46%) of IDUs surveyed in New York City had used an NEP[2].

* Surveys of IDUs in San Francisco in the Spring of 1992 found that 45% "usually" obtained their syringes from the San Francisco NEP[6].

11. Increasing Number of NEPs in the United States

The UC report found at least 37 active NEPs in the United States as of September 1993. As of October 1994, an estimated 70 NEPs were in operation in the United States[12].

12. Support from the general public for NEPs for AIDS prevention

In the first national opinion poll on NEPs, a 1994 national telephone survey of 1,001 people, the majority (55%) of respondents favored "Implementing needle exchange programs to reduce the spread of diseases such as AIDS."[13]

13. Support for federal funding of NEPs from the National Academy of Sciences

A study on AIDS behavioral research published in 1994 by the Institute of Medicine, described NEPs as "highly promising" and called for the lifting of the ban on the use of federal funds for NEP services. "The weight of evidence suggests that needle exchange does more good than harm," concluded the authors[14].

14. High HIV seroconversion among Montreal IDUs

The highest levels of HIV seroprevalence among IDUs in Canada have been reported from Montreal. Bruneau reports from the St. Luc IDU cohort that among 850 IDUs recruited 1989-1993, the half (54%) reporting use of a Montreal NEP had higher HIV seroprevalence (18.2% vs. 5.6%) compared with nonattenders. Among the 507 IDUs with multiple visits to the study site, the seroconversion rate was higher (11.6 vs 3.5 per 100 person-years [p<0.0001]) among IDUs using NEP[15].

A study of incarcerated IDUs found that IDUs using a Montreal NEP reported higher rates of HIV risk behaviors (vs. IDUs who did not use a NEP). Montreal NEP attenders were more likely than non-attenders, to have same sex partners, to work in the sex industry, to report injecting with needles used by an HIV-infected IDU, and re-use borrowed injection equipment without cleaning[16].

The higher HIV seroprevalence, HIV seroconversion, and HIV risk factors among IDUs attending the Montreal NEP require furthers study.

15. Comments and conclusions

Since the 1993 release of the UC report:

* The number of U.S. NEPs has increased, and more states and localities have approved NEPs by legislation or declaration of sates of emergency;

* In communities with high-volume NEPs, substantial proportions of IDUs report using the NEP;

* Biological evidence suggests decreases of bloodborne virus transmission among NEP clients, with the evidence stronger for hepatitis than HIV;

* There is additional evidence that in most cities with NEPs, NEP clients have lower rates of HIV risk behaviors; and

* Higher HIV seroconversion rates among IDUs using the Montreal NEP were documented and must be further investigated.

Appendix IV

Legal Barriers to Federal Funding of Needle Exchange Programs

EXCERPTED FROM March 1993 report by General Accounting Office (GAO), titled "NEEDLE EXCHANGE PROGRAMS -- Research Suggests Promise as an AIDS Prevention Strategy.

Since 1988, Congress has passed at least six laws (in addition to the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) Reorganization Act of 1992) that contain provisions prohibiting or restricting use of federal funding for needle exchange programs and activities. These provisions are contained in:

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, 1991, and 1993 (the Appropriations Act of 1992 did not contain such a provision).

The Comprehensive Alcohol Abuse, Drug Abuse, and Mental Health Amendments Act of 1988 required states, as a condition for receiving ADAMHA block grant funds under title XIX of the PHS Act, to agree that funds would not be used to carry out any programs of distributing sterile needles for the hypodermic injection of any illegal drug or distributing bleach for the purpose of cleansing needles for such hypodermic injection ...."

This provision was repealed by the ADAMHA Reorganization Act (1992).

The Health Omnibus Programs Extension of 1988 authorizes funds and programs aimed at combating the AIDS epidemic and preventing its transmission. Among other things, the act authorizes grants and contracts through the Director of the National Institute of Allergy and Infectious Diseases to assist public and nonprofit private entities in conducting research and training in advanced diagnostic, prevention, and treatment methods for AIDS. These grants may be used to operate demonstration projects in long-term monitoring and outpatient treatment of HIV-infected individuals. The act also authorizes funds for AIDS education. Additionally, the Director of the National Institutes of Health is to establish projects to promote cooperation among public health agencies and with private entities in research concerned with the diagnosis, prevention, and treatment of A[DS. The act provides further:

None of the funds provided under this Act or an amendment made by this Act shall be used to provide individuals with hypodermic needles or syringes so that such individuals may use illegal drugs, unless the Surgeon General of the Public Health Service determines that a demonstration needle exchange program would be effective in reducing drug abuse and the risk that the public will become infected with the etiologic agent for acquired immune deficiency syndrome."

The Ryan White Comprehensive AIDS Resources Emergency Act of l990 (42 U.S.C. § 300ff et seq.) authorizes grants to localities disproportionately affected by the HIV epidemic. The act prohibits use of funds made available under this Act, or an amendment made by this Act . . . to provide individuals with hypodermic needles or syringes so that such individuals may use illegal drugs."

The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Acts of l990 and 1991 contained identical prohibitions regarding needle exchange programs (section 520 of P.L. 101-166 and section 512 of P.L. 101-517). The provision stated:

None of the funds appropriated under this Act shall be used to carry out any program of distributing sterile needles for the hypodermic injection of any illegal drug unless the President of the United States certifies that such programs are effective in stopping the spread of HIV and do not encourage the use of illegal drugs."

In contrast, the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Act of 1993, states in section 514 of the General Provisions":

Notwithstanding any other provision of this Act, no funds appropriated under this Act shall be used to carry out any program of distributing sterile needles for the hypodermic injection of any illegal drug 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, except that such funds may be used for such purposes in furtherance of demonstrations or studies authorized in the ADAMHA Reorganization Act (P L. 102-321)."