Historical Background
Although there has been some regulation of hypodermic syringes in the United States since they were invented in the nineteenth century, they were widely
TABLE 9.6
Adult and adolescent male AIDS cases, by race/ethnicity and transmission category, 2003
| White, not Hispanic | Black, not Hispanic | Hispanic | ||||||||||
| 2003 | Cumulative through 2003* | 2003 | Cumulative through 2003* | 2003 | Cumulative through 2003* | |||||||
| Transmission category | No. | % | No. | % | No. | % | No. | % | No. | % | No. | % |
| Male-to-male sexual contact | 7,679 | 66 | 244,758 | 73 | 4,699 | 34 | 93,413 | 37 | 3,054 | 43 | 57,128 | 43 |
| Injection drug use | 1,051 | 9 | 31,164 | 9 | 2,454 | 18 | 80,282 | 32 | 1,290 | 18 | 44,277 | 33 |
| Male-to-male sexual contact and injection drug use | 793 | 7 | 28,795 | 9 | 548 | 4 | 19,182 | 8 | 311 | 4 | 9,313 | 7 |
| Hemophilia/coagulation disorder | 56 | 0 | 3,964 | 1 | 6 | 0 | 599 | 0 | 9 | 0 | 453 | 0 |
| Heterosexual contact: | 454 | 4 | 7,010 | 2 | 2,047 | 15 | 24,428 | 10 | 799 | 11 | 9,021 | 7 |
| Sex with injection drug user | 76 | 1 | 2,221 | 1 | 253 | 2 | 6,410 | 3 | 141 | 2 | 2,195 | 2 |
| Sex with person with hemophilia | 4 | 0 | 38 | 0 | 2 | 0 | 29 | 0 | 0 | 0 | 11 | 0 |
| Sex with HIV-infected transfusion recipient | 4 | 0 | 177 | 0 | 11 | 0 | 205 | 0 | 7 | 0 | 109 | 0 |
| Sex with HIV-infected person, risk factor not specified | 370 | 3 | 4,574 | 1 | 1,781 | 13 | 17,784 | 7 | 651 | 9 | 6,706 | 5 |
| Receipt of blood transfusion, blood components, or tissue | 30 | 0 | 3,227 | 1 | 49 | 0 | 1,205 | 0 | 28 | 0 | 646 | 0 |
| Other/risk factor not reported or identified | 1,640 | 14 | 14,519 | 4 | 3,932 | 29 | 33,905 | 13 | 1,544 | 22 | 12,659 | 9 |
| Total | 11,703 | 100 | 333,437 | 100 | 13,735 | 100 | 253,014 | 100 | 7,035 | 100 | 133,497 | 100 |
| Asian/Pacific Islander | American Indian/Alaska Native | Total | ||||||||||
| 2003 | Cumulative through 2003* | 2003 | Cumulative through 2003* | 2003 | Cumulative through 2003* | |||||||
| Transmission category | No. | % | No. | % | No. | % | No. | % | No. | % | No. | % |
| Male-to-male sexual contact | 254 | 56 | 4,084 | 69 | 93 | 58 | 1,299 | 56 | 15,859 | 48 | 401,392 | 55 |
| Injection drug use | 26 | 6 | 292 | 5 | 22 | 14 | 370 | 16 | 4,866 | 15 | 156,575 | 21 |
| Male-to-male sexual contact and injection drug use | 19 | 4 | 227 | 4 | 15 | 9 | 392 | 17 | 1,695 | 5 | 57,998 | 8 |
| Hemophilia/coagulation disorder | 2 | 0 | 72 | 1 | 1 | 1 | 32 | 1 | 74 | 0 | 5,130 | 1 |
| Heterosexual contact: | 42 | 9 | 305 | 5 | 11 | 7 | 92 | 4 | 3,371 | 10 | 40,947 | 6 |
| Sex with injection drug user | 3 | 1 | 55 | 1 | 2 | 1 | 28 | 1 | 477 | 1 | 10,930 | 1 |
| Sex with person with hemophilia | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 7 | 0 | 80 | 0 |
| Sex with HIV-infected transfusion recipient | 1 | 0 | 8 | 0 | 1 | 1 | 3 | 0 | 24 | 0 | 505 | 0 |
| Sex with HIV-infected person, risk factor not specified | 38 | 8 | 241 | 4 | 8 | 5 | 61 | 3 | 2,863 | 9 | 29,432 | 4 |
| Receipt of blood transfusion, blood components, or tissue | 3 | 1 | 118 | 2 | 0 | 0 | 9 | 0 | 111 | 0 | 5,219 | 1 |
| Other/risk factor not reported or identified | 110 | 24 | 792 | 13 | 19 | 12 | 130 | 6 | 7,274 | 22 | 62,217 | 9 |
| Total | 456 | 100 | 5,890 | 100 | 161 | 100 | 2,324 | 100 | 33,250 | 100 | 729,478 | 100 |
| *Includes persons with a diagnosis of AIDS, reported from the beginning of the epidemic through 2003. Cumulative total includes 1,316 males of unknown race or multiple races. | ||||||||||||
available until the 1970s. Needles could be purchased without a prescription and without limits on quantities purchased.
In the 1970s and 1980s most states and the District of Columbia criminalized the possession or sale of syringes without a prescription. Syringes had been sold alongside cocaine kits and marijuana paraphernalia at "head shops" (stores selling materials utilized by drug users) in cities across the country. As part of a larger project to get tough on drug use and eliminate head shops, laws were passed to limit the sale of syringes.
As it became recognized that dirty needles/syringes were causing HIV transmission in the late 1980s, syringe-exchange programs began in some cities. Since then they have provided a publicly visible and measurable means of reducing HIV transmission among intravenous (IV) drug users. However, despite the positive impact of SEPs, these largely voluntary efforts may not meet the need for syringes. Furthermore SEPs are illegal in a number of states. Efforts are underway, supported by advocacy and scientific groups, to decriminalize syringe sales, to legalize SEPs, and to obtain public funding for their operations.
TABLE 9.7
Adult and adolescent female AIDS cases, by race/ethnicity and transmission category, 2003
| White, not Hispanic | Black, not Hispanic | Hispanic | ||||||||||
| 2003 | Cumulative through 2003* | 2003 | Cumulative through 2003* | 2003 | Cumulative through 2003* | |||||||
| Transmission category | No. | % | No. | % | No. | % | No. | % | No. | % | No. | % |
| Injection drug use | 557 | 29 | 13,695 | 41 | 1,277 | 17 | 35,767 | 37 | 385 | 18 | 11,695 | 37 |
| Hemophilia/coagulation disorder | 3 | 0 | 117 | 0 | 5 | 0 | 128 | 0 | 3 | 0 | 60 | 0 |
| Heterosexual contact: | 809 | 42 | 13,877 | 41 | 3,253 | 44 | 40,193 | 42 | 1,055 | 50 | 15,294 | 48 |
| Sex with injection drug user | 220 | 12 | 5,293 | 16 | 525 | 7 | 12,526 | 13 | 218 | 10 | 6,103 | 19 |
| Sex with bisexual male | 47 | 2 | 1,701 | 5 | 118 | 2 | 1,885 | 2 | 54 | 3 | 701 | 2 |
| Sex with person with hemophilia | 12 | 1 | 314 | 1 | 3 | 0 | 103 | 0 | 1 | 0 | 42 | 0 |
| Sex with HIV-infected transfusion recipient | 4 | 0 | 334 | 1 | 25 | 0 | 230 | 0 | 7 | 0 | 114 | 0 |
| Sex with HIV-infected person, risk factor not specified | 526 | 28 | 6,235 | 19 | 2,582 | 35 | 25,449 | 26 | 775 | 37 | 8,334 | 26 |
| Receipt of blood transfusion, blood components, or tissue | 18 | 1 | 1,868 | 6 | 60 | 1 | 1,477 | 2 | 25 | 1 | 604 | 2 |
| Other/risk factor not reported or identified | 522 | 27 | 4,127 | 12 | 2,734 | 37 | 18,796 | 20 | 630 | 30 | 3,901 | 12 |
| Total | 1,909 | 100 | 33,684 | 100 | 7,329 | 100 | 96,361 | 100 | 2,098 | 100 | 31,554 | 100 |
| Asian/Pacific Islander | American Indian/Alaska Native | Totals | ||||||||||
| 2003 | Cumulative through 2003* | 2003 | Cumulative through 2003* | 2003 | Cumulative through 2003* | |||||||
| Transmission category | No. | % | No. | % | No. | % | No. | % | No. | % | No. | % |
| Injection drug use | 6 | 6 | 121 | 13 | 23 | 39 | 242 | 43 | 2,262 | 20 | 61,621 | 38 |
| Hemophilia/coagulation disorder | 0 | 0 | 8 | 1 | 0 | 0 | 3 | 1 | 11 | 0 | 318 | 0 |
| Heterosexual contact: | 56 | 55 | 459 | 51 | 22 | 37 | 228 | 41 | 5,234 | 45 | 70,200 | 43 |
| Sex with injection drug user | 11 | 11 | 104 | 12 | 4 | 7 | 92 | 16 | 985 | 9 | 24,148 | 15 |
| Sex with bisexual male | 3 | 3 | 78 | 9 | 1 | 2 | 29 | 5 | 223 | 2 | 4,402 | 3 |
| Sex with person with hemophilia | 0 | 0 | 4 | 0 | 0 | 0 | 2 | 0 | 16 | 0 | 465 | 0 |
| Sex with HIV-infected transfusion recipient | 1 | 1 | 20 | 2 | 0 | 0 | 3 | 1 | 37 | 0 | 705 | 0 |
| Sex with HIV-infected person, risk factor not specified | 41 | 40 | 253 | 28 | 17 | 29 | 102 | 18 | 3,973 | 34 | 40,480 | 25 |
| Receipt of blood transfusion, blood components, or tissue | 4 | 4 | 101 | 11 | 1 | 2 | 15 | 3 | 108 | 1 | 4,076 | 2 |
| Other/risk factor not reported or identified | 36 | 35 | 212 | 24 | 13 | 22 | 70 | 13 | 3,946 | 34 | 27,181 | 17 |
| Total | 102 | 100 | 901 | 100 | 59 | 100 | 558 | 100 | 11,561 | 100 | 163,396 | 100 |
| *Includes persons with a diagnosis of AIDS, reported from the beginning of the epidemic through 2003. Cumulative total includes 338 females of unknown race or multiple races. | ||||||||||||
As of the end of 2002, it was legal for a person to sell syringes to a person known to be a drug user in nineteen states and Puerto Rico, there was a "reasonable claim to legality" (some reason to claim the practice legal) in twenty-two states, and such sales were clearly illegal in nine states, the District of Columbia, and the Virgin Islands ("Preventing Blood-Borne Infections through Pharmacy Syringe Sales and Safe Community Syringe Disposal," Journal of the American Pharmaceutical Association Supplement, November/December 2002). States, however, have enabled their health departments to establish SEPs even where sale of syringes is prohibited, according to the CDC. Some cities have permitted SEPs to be established by declaring a local state of health emergency.
SEP Statistics
The first programs in the United States were opened in San Francisco in 1987 and Tacoma, Washington, in 1988. By September 1, 1993, at least thirty-seven SEPs were operating in thirty cities in twelve states. The CDC publishes data on SEPs and updates its tallies from time to time. The most recent survey available from the CDC was published in 2001 with data from 1998 ("Syringe Exchange Programs," Morbidity and Mortality Weekly Report, vol. 50, no. 19, Atlanta, GA: CDC, May 18, 2001). In 1998 a total of 131 SEPs were known to be operating in eighty-one cities in thirty-one states, the District of Columbia, and in Puerto Rico. SEPs had nearly doubled in number since the 1994-95 period, when
TABLE 9.8
Pediatric AIDS cases by selected characteristics, 1994-2003
| Year of report | ||||||||||
| 1994 | 1995 | 1996 | 1997 | 1998 | 1999 | 2000 | 2001 | 2002 | 2003 | |
| Child's race/ethnicity | ||||||||||
| White, not Hispanic | 80 | 76 | 49 | 28 | 30 | 20 | 14 | 20 | 22 | 15 |
| Black, not Hispanic | 226 | 217 | 171 | 144 | 100 | 83 | 90 | 91 | 68 | 62 |
| Hispanic | 34 | 24 | 20 | 14 | 11 | 14 | 17 | 15 | 18 | 8 |
| Asian/Pacific Islander | 1 | 1 | 0 | 2 | 2 | 0 | 1 | 1 | 1 | 1 |
| American Indian/Alaska Native | 4 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 1 |
| Perinatal transmission category | ||||||||||
| Mother with, or at risk for, HIV infection: | ||||||||||
| Injection drug use | 131 | 94 | 82 | 59 | 29 | 28 | 32 | 26 | 10 | 7 |
| Sex with injection drug user | 70 | 48 | 44 | 31 | 16 | 20 | 12 | 11 | 11 | 6 |
| Sex with bisexual male | 8 | 10 | 5 | 4 | 2 | 5 | 2 | 5 | 2 | 5 |
| Sex with person with hemophilia | 2 | 2 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 1 |
| Sex with HIV-infected transfusion recipient | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Sex with HIV-infected person, risk not specified | 81 | 95 | 53 | 57 | 51 | 31 | 44 | 47 | 39 | 38 |
| Receipt of blood transfusion, blood components, or tissue | 5 | 3 | 3 | 3 | 2 | 1 | 0 | 3 | 1 | 0 |
| Has HIV infection, risk not specified | 48 | 68 | 53 | 38 | 42 | 34 | 31 | 34 | 48 | 33 |
| Child's diagnosis statusa | ||||||||||
| HIV infection | 148 | 158 | 138 | 117 | 103 | 79 | 95 | 91 | 77 | 75 |
| AIDS | 198 | 162 | 102 | 75 | 40 | 41 | 27 | 36 | 34 | 15 |
| Totalb | 346 | 320 | 240 | 192 | 143 | 120 | 122 | 127 | 111 | 90 |
| Note: Since 1994, the following 25 states have had laws and regulations requiring confidential name-based HIV infection reporting: Alabama, Arizona, Arkansas, Colorado, Idaho, Indiana, Louisiana, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Jersey, North Carolina, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Utah, Virginia, West Virginia, Wisconsin, and Wyoming. | ||||||||||
| Data include children with a diagnosis of HIV infection. This includes children with a diagnosis of HIV infection only, a diagnosis of HIV infection and a later AIDS diagnosis, and concurrent diagnoses of HIV infection and AIDS. | ||||||||||
| aStatus in the surveillance system as of June 2004. | ||||||||||
| bIncludes children of unknown or multiple race. | ||||||||||
sixty-eight facilities were known to exist. The number of syringes exchanged had increased from eight million to 19.4 million in the same period. Most SEPs are thought to be members of the North American Syringe Exchange Network (NASEN), based in Tacoma, Washington. NASEN conducted a survey in 2000 in which it obtained responses from 127 programs, of which eighty-nine operated legally, twenty-six illegally, and twelve had uncertain legal status (National Surveys of Syringe Exchange Programs, NASEN, http://www.nasen.org/). Because many SEPs operate illegally or have doubts about their status, some of those responding to surveys do not permit disclosure of details of their operations.
CDC-published surveys for 1997 and 1998 show that of 107 SEPs responding in 1998, thirty-nine were large and twelve were very large—as measured by number of syringes exchanged. The twelve largest SEPs in 1998 were responsible for 62.4% of syringe exchanges; the thirty smallest (exchanging fewer than ten thousand syringes each) accounted for less than 1% (0.6%) of syringes exchanged. Exchanges increased 11.2% between 1997 and 1998 overall. Growth was greatest for the smallest programs (31.3%), least for the large programs (1%); the very largest had a growth of 17.3% and medium-sized exchanges of 10.9% from 1997 to 1998.
In addition to syringes, virtually all SEPs offered information about safer injection methods and referral to substance abuse treatment programs.
Professional/Scientific Support for SEPs
THE PUBLIC HEALTH PERSPECTIVE.
The Centers for Disease Control and Prevention, in "Changing Syringe Laws Is Part of Strategy to Help Stem HIV Spread" (HIV/AIDS Prevention, December 1997), pointed out that drug users must have access to clean syringes and drug treatment as part of a complete HIV prevention plan. One way to make this happen is to change the drug paraphernalia laws so that clean needles and syringes are available to intravenous drug users.
Public Health Service policy recommends that IV drug users be counseled and encouraged to stop using and injecting drugs, if possible, through substance abuse treatment, including relapse prevention. Failing this, however, drug users should follow various preventive measures, such as:
- Never reusing or sharing syringes, water, or drug preparation equipment
- Using only syringes obtained from a reliable source (e.g., pharmacies)
- Using a new, sterile syringe to prepare and inject drugs
- Safely disposing of syringes after one use
FOREIGN PERSPECTIVES.
Susan F. Hurley, Damien J. Jolley, and John M. Kaldor, in "Effectiveness of Needle-Exchange Programmes for Prevention of HIV Infection" (The Lancet, June 21, 1997), studied cities around the world with and without NEPs. They found that, on average, HIV increased 5.9% in cities without NEPs and decreased by 5.8% in cities with NEPs.
They also observed that "NEPs led to a reduction in HIV incidence among injecting drug users" and that their findings "strongly support the view that NEPs are effective." The researchers concluded that with their findings "and the interpretation of previous studies by the Panel on Needle Exchange and Bleach Distribution Programs [National Research Council and Institute of Medicine], the view that NEPs are not effective no longer seems tenable."
INSTITUTIONAL SUPPORT.
The National Academy of Sciences, American Medical Association, American Public Health Association, National Institutes of Health Consensus Panel, CDC, American Bar Association, and President George Herbert Walker Bush's and President Bill Clinton's AIDS Advisory Commissions—virtually every established medical, scientific, and legal body that has studied the issue of needle exchange programs—agree on the validity of improved access to sterile syringes to reduce the spread of infectious diseases, including HIV/AIDS. In July 1997 the U.S. Conference of Mayors endorsed federal and state policy changes to improve access to sterile syringes.
Fifteen of the top twenty most widely circulated U.S. newspapers have editorialized in favor of SEPs or syringe deregulation. Public opinion has been moderately in favor of SEPs. A 2000 Kaiser Family Foundation poll found 58% of the population favor SEPs and 61% favor allowing users to purchase needles at pharmacies.
The Political Debate
Needle exchange has led to intense political debate in the United States, particularly in some states (California and New York) and cities (Baltimore, Maryland; New York City; Boston, Massachusetts; and Berkeley, California). However, in many cities (Seattle, Washington; Tacoma, Washington; San Francisco, California; Honolulu, Hawaii; and New Haven, Connecticut), large-scale SEPs were set up with substantial community support.
Those who support SEPs stress the importance of the programs as gateways to counseling, education, and other referral services for addicts. This comprehensive approach is known as "harm reduction." Supporters also say that SEPs facilitate proper disposal of injection equipment and serve as outlets to supply addicts with materials that help to curb the spread of HIV.
Those opposing SEPs fear that needle programs will increase drug use by providing the means (needles and syringes) to inject drugs, although no American or foreign study has shown that SEPs increase drug use. Opponents also believe providing SEPs would appear to condone drug use and therefore undermine the message that using drugs is illegal, unhealthy, and morally wrong. In addition, they maintain that SEPs may draw scarce resources away from other, possibly more effective, programs, such as drug treatment.
Some opponents claim that needle exchange programs are not in fact exchanges, but giveaways. They say that participants rarely exchange dirty needles for clean ones, meaning that the dirty needles are still on the streets. However, SEPs typically operate on the principle of a one-for-one exchange.
Banning Federal Funds
In 1988 Congress passed the Health Omnibus Programs Extension Act (PL 100-607), banning the expenditure of federal funds for needle exchange. At the same time, Congress authorized funding for research into needle exchange programs. Under the conditions of the Department of Health and Human Services Appropriations Act of 1997 (PL 105-78), lifting the ban and using federal funds to support SEPs depended on a determination by the Secretary of Health and Human Services (HHS) that such programs reduce transmission of HIV without encouraging the use of illegal drugs.
In a February 1997 report to Congress, then HHS Secretary Donna E. Shalala announced that a review of the scientific literature indicated that needle exchange programs "can be an effective component of a comprehensive strategy to prevent HIV and other blood-borne infectious diseases in communities that choose to include them." For example, Preventing HIV Transmission: The Role of Sterile Needles and Bleach (Washington, DC: National Research Council and Institute of Medicine, September 1995) concluded that SEPs have beneficial effects on reducing behaviors such as multiperson reuse of syringes. This report estimated a reduction in risk behaviors of 80% and a reduction in HIV transmission of 30% or greater.
In April 1998 Secretary Shalala reported that a review of research findings indicated that needle exchange programs "do not encourage the use of illegal drugs." In addition, SEPs can reduce drug use through effective referrals to drug treatment and counseling.
RELUCTANCE TO LIFT THE BAN.
Both Congress and two presidents (Bill Clinton and George W. Bush) have been very reluctant to lift the ban on federal monies for needle exchange programs. To approve of such programs might appear to give official sanction to a strategy some voters consider equivalent to promoting drug use. Some legislators fear that approving such a policy would be the first step along the road to the legalization of drugs.
President Bill Clinton, who saw drug abuse increase during his term in office, was very reluctant to approve any program that could be perceived as being weak on drugs. George W. Bush opposed needle-exchange programs while running for the presidency in 2000. In response to the AIDS Foundation of Chicago, then Governor Bush stated that "needle exchange programs signal nothing but abdication, that these dangers are here to stay" ("2000 Candidate Questionnaire," AIDS Foundation of Chicago, http://www.aidschicago.org/advocacy/candidate_00.php). The Bush administration has, since taking office, consistently opposed lifting the ban on funding SEPs.
Others fear that approval of syringe exchange programs, while perhaps good policy, is only an inadequate first step toward the comprehensive drug treatment program needed to reduce drug addiction.
THE AMERICAN BAR ASSOCIATION AND STATE LEGISLATION RELATED TO NEEDLE POSSESSION.
A report prepared by the AIDS Coordinating Committee of the American Bar Association (ABA) outlined the ABA's stance on the deregulation of syringes (Deregulation of Hypodermic Needles and Syringes as a Public Health Measure: A Report on Emerging Policy and Law in the United States, Washington, DC, 2001). The ABA supports the deregulation of needle exchange programs and the relaxation of laws concerning the sale and possession of syringes.
The association advocates an approach that extends beyond SEPs. They advocate laws that allow IV users to obtain needles from any pharmacy whenever they are needed. There are several advantages of this approach. One is that it sidesteps the objection that states should not fund SEPs because it sends the "wrong message." Legalizing possession of syringes would allow users to purchase needles directly from pharmacies like any other purchase, thus not involving the government or government funds.
A second benefit is that such policies would allow much greater access to needles than SEPs allow. Because of the stigma attached to IV drug use, many users do not want to enter SEPs and be identified as addicts. Also, it is often inconvenient for users to get to SEPs, which may be located many miles from where they live. In addition, users may not be able to get as many needles as they need at once, considering that some users inject a dozen or more times a day.
The ABA identifies three types of deregulation that have been passed in state legislatures. In Oregon and Alaska, syringes are "completely deregulated"—that is, they can be bought and sold by anyone, under any circumstances. Next are states that have "unrestricted pharmacy sales," where anyone can buy as many needles as desired without a prescription so long as it is at a pharmacy. Finally, a number of states have passed "10 and under deregulation," which allows the sale and possession of up to ten syringes.
As of spring of 2005, thirteen states allowed users increased access to syringes. Alaska, Hawaii, New Mexico, Oregon, and Washington have completely deregulated the sale of syringes. Ohio, Rhode Island, and Wisconsin allowed unrestricted pharmacy sales. Connecticut, Maine, Minnesota, New Hampshire, and New York have enacted deregulation of the purchase/sale of ten or fewer syringes. The regulatory environment, however, continues to be in flux, with some regulations intended to be temporary, to be renewed only after studies show their effectiveness in controlling HIV/AIDS. Trends are in the direction of deregulation under pressure from medical authorities who clearly see a benefit in drug users having access to clean needles and in other mechanisms, such as SEPs, that minimize infection.
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