WHAT THE NEEDLES SAID

Yale Scientists Couldn't Test Drug Users For HIV So They Followed The
Hypodermics Instead - And Proved The Worth Of One Of The Nation's First
Legal Needle Exchanges. A Decade Later, Countless Lives Have Been Saved As
A Result.

On a balmy day in November 1990, a battered van that once delivered loaves
of bread to Yale University dining halls set off on a voyage through New
Haven's inner-city neighborhoods. Its cargo?

Clean syringes for the city's drug users.

No one knew whether needle exchange would do what was expected of it--slow
the spread of AIDS--because supporters lacked the scientific evidence to
confirm what intuitively made sense, that clean needles were less likely to
spread disease.

What they did know was that other approaches had fallen short. They'd been
handing out condoms, bleach kits for cleaning needles, and brochures with
advice on preventing HIV infection.

But drug users who used needles still made up 80 percent of the AIDS cases
in New Haven.

A lot was riding on the program.

It had taken three years of coalition and consensus building to persuade a
wary state legislature to pass a bill exempting the program from laws that
made needle possession a crime. Scientific data on the efficacy of clean
needles were scarce and weak, and distributing clean needles was a
political minefield.

To succeed, the needle exchange had to win the trust of New Haven's drug users.

That's why the outreach workers on the van were elated that day, November
13, as they reached their first stop on Congress Avenue in the Hill
neighborhood. "We had people waiting for us," remembered Dominick
Maldonado, one of the city's first AIDS outreach workers.

Kaveh Khoshnood, Ph.D., assistant professor of epidemiology, then a
graduate student in public health, was also on the van. "We had no idea
whether people were going to come to this official program but, indeed,
they came," he recalled. "The word got out rather quickly that this program
was legit, that you wouldn't get arrested by the cops. It was reassuring to
know that people trusted the program and trusted the staff."

Before a year had passed, needle exchange proponents would have more cause
for elation.

A study by Yale faculty would prove that the program reduced the incidence
of new HIV infections by a third.

The study would be a watershed in the history not only of needle exchange,
but also of public health--the first that addressed the key question of
whether clean needles would prevent AIDS. Other communities across the
country would follow New Haven's example.

The reaction would not be entirely positive.

The coalition that came together around needle exchange--local politicians,
local health officials and Yale students and faculty--would withstand
pressure from federal officials who felt that distributing syringes
encouraged drug use.

Last November, city officials and Health Department staff joined Yale
faculty to celebrate 10 years of New Haven's needle exchange program.

Over the past decade the rate of infected needles in the city has dropped
from 65 percent to below 40 percent.

More than 1,000 drug users have found their way into treatment through the
needle exchange program.

And the drop in the number of new AIDS cases, from 121 in 1991 to 38 in the
fiscal year ending July 2000, is due in large part to programs such as the
needle exchange. New Haven's needle exchange van still plies the streets of
the city, offering syringes on its regular route.

Nationally, the number of needle exchange programs has grown to more than
150, according to the North American Syringe Exchange Network, a support
organization based in Tacoma, Wash.

The New Haven program's beginnings go back to the mid-1980s. "Very little
was being done to educate the drug users on the street about the dangers of
HIV," said Maldonado, then a drug counselor.

At the urging of Alvin Novick, M.D., a Yale professor of biology,
then-Mayor Biagio DiLieto created the Mayor's Task Force on AIDS in 1986.
He provided funding and a full-time coordinator. Soon the city health
department hired three full-time outreach workers to work with drug users,
one of whom was Maldonado. "Immediately we hit the streets," Maldonado
said. "At the time we just had the bleach, the water, the pamphlets and the
condoms." But the health workers had begun to think about needle exchange.
"We were called crazy," Maldonado said. "We were told it was political
suicide, that this would never happen in Connecticut."

The model for needle exchange came in 1984 from Amsterdam, a city known for
its tolerant attitude toward drug use. When an inner-city pharmacist
stopped selling syringes, the city's Junkie Union, worried about hepatitis
B infection, organized its own syringe exchange.

Two years later needle exchange remained a radical idea in the United
States, and only one such program was operating here. The AIDS Brigade, the
nation's first needle exchange, was a rag-tag, underground operation run by
a Yale student of public health.

And it was based in New Haven.

Jon Stuen-Parker is a testament to the eclectic admissions policies of the
School of Medicine. In his self-published autobiography, From Jail to Yale,
he describes his transformation from an addict who broke into pharmacies to
steal drugs, to convict, to medical student.

His tenure at Yale was anything but conventional. He started in 1980, and
by 1983 he and fellow medical students had begun educational outreach to
drug users.

In his hometown of Boston, Stuen-Parker had begun another outreach program,
again trying to educate drug users about the dangers of AIDS. The spark to
his activism, he said, was a guest speaker at the medical school who
angered him by saying, "Don't waste your time trying to educate the
addicts. They'll never change their behavior."

By 1986 Stuen-Parker and some of his classmates had opened a storefront
outreach center for drug users on York Street in New Haven. Later that year
Stuen-Parker was asked to leave the medical school after failing Step I of
the medical boards three times.

He attributed his failure to dyslexia, but school officials recommended
that he spend more time hitting the books and less time on his outside
activities. Stuen-Parker said that before his expulsion, he refused a
request from school officials to shut down his outreach center.

He continued his studies toward a public health degree, which he received
in 1992. He also continued his outreach until a Boston drug user's act of
generosity showed him another approach to harm reduction. At an outreach
meeting the drug user handed out seven clean syringes. "They were going for
$5 apiece, but he felt he wanted to give something back," said
Stuen-Parker. Soon Stuen-Parker was using his earnings as a Boston cabbie
to buy syringes legally in Vermont and exchange them in Boston and New
Haven shooting galleries. "You'd walk in the door and people would be
sitting there with needles in their arms," Stuen-Parker said.

Khoshnood, then a public health student interested in AIDS prevention,
recalled meeting Stuen-Parker on a Friday night in 1988 at the corner of
Chapel and College streets to discuss needle exchange. "I wasn't ready to
go out on the street.

I just wanted information, but Jon wasn't going to spend a lot of time
explaining things to me," Khoshnood said. Instead, Stuen-Parker took
Khoshnood to a housing project on Dixwell Avenue, where Stuen-Parker handed
out clean needles and collected dirty syringes in a bucket. The bucketful
of needles sat in a corner of the storefront outreach center on York
Street. "We weren't that careful, now that I think back," Khoshnood said.
"We did start using thick gloves." Much later those needles would play a
role in the government-sanctioned needle exchange program.

City health officials were aware of the underground exchange, but were
taking a different course.

Where Stuen-Parker could be provocative--he courted arrest by handing out
needles in sight of police officers--the city's AIDS workers wanted to
build support for needle exchange.

To those promoting needle exchange, Stuen-Parker was a mixed blessing. "He
took chances before we did," said Maldonado. "But Jon became very
possessive of needle exchange.

He felt no one could do it but him." Stuen-Parker, however, said his AIDS
Brigade was always open to working with others. "We hoped our actions would
create a green light for others to do needle exchange," he said. "We wanted
to get others involved." But he felt the New Haven outreach workers weren't
doing enough, that they seldom appeared in the drug-using community.

When it came time to approach the state legislature for permission to
embark on a needle exchange program, city officials kept Stuen-Parker at
arm's length. "We weren't about to be extolling the virtues of the
underground exchange," said Elaine O'Keefe, who headed the city Health
Department's AIDS division and is now health director for the town of
Stratford. "Even if we felt their work had public health merit, aligning
with the radical fringe would have diminished our credibility in the state
legislature and with other decision makers whose support was critical."
Tensions persisted between Stuen-Parker and the city's AIDS workers.

Two members of the AIDS Brigade, Khoshnood and Peter Fisher, left to form
their own needle exchange, AIDS Community Educators, which collaborated
with the city program.

Stuen-Parker eventually returned to Boston, where he runs the National AIDS
Brigade, which provides clean syringes and runs education programs around
the country and abroad.

To make their case before the legislature, Maldonado, O'Keefe and AIDS task
force coordinator Sher Horosko enlisted as much support as possible, even
from the city's drug users.

The city health workers wanted to know why addicts shared needles.

The answer was disarmingly simple.

Needles were hard to come by, and mere possession could land a drug user in
jail. "They told us, 'We share needles because we don't have access to
them. If we had them there would be no need for sharing,' " Maldonado said.

The group had a tough sell even in New Haven, where the task force itself
was divided on the issue.

Resistance to needle exchange was strongest among clergy in the
African-American communities hardest hit by drugs. "It had the appearance
of giving approval to drug use," said State Rep. Bill Dyson, a New Haven
Democrat who shepherded the needle exchange bill through the state
legislature. Nevertheless, advocates built a consensus.

In the winter of 1989 a delegation of public health officials, outreach
workers, expert witnesses and city leaders made the case for needle
exchange before the state legislature's health committee.

The committee turned them down. "We were told not to come back," O'Keefe
recalled.

Over the next year the group marshaled more support.

Quick to come on board was the new police chief, Nicholas Pastore. "We
wanted to do our best to take dirty needles off the streets so they
wouldn't endanger children or police and firefighters," said Pastore, now a
research fellow in New Haven for the Washington-based Criminal Justice
Policy Foundation. "I also believe fewer people should be coming into the
criminal justice system for these kinds of reasons."

In the summer of 1990, New Haven needle exchange advocates returned to
Hartford. "There was just a larger coalition," said Khoshnood. "We had
physicians, we had public health officials, we had the police, we had
policy makers.

It was a critical mass." The health committee reversed itself and the full
legislature approved a needle exchange program in New Haven, with funding
of $25,000. But there were strings attached.

The program would have to evaluate its results within a year. The
legislature wanted to know how many needles came back to the program,
whether the program led to changes in drug users' behavior, how many users
entered treatment and whether the program encouraged drug use.

At the time there were scarce data on needle exchanges.

A handful of programs were operating in the United States--in Washington,
Colorado, Oregon, California and New York--but most evaluations came from
abroad. "The research that was done in Britain and Australia was often
based on self-reported behavior, often based on small sample sizes and
often unpublished," said Peter Lurie, M.D., M.P.H., a leading researcher on
the public health implications of the AIDS epidemic.

When the evaluation of New Haven's needle exchange was published, Lurie was
working with the Prevention Sciences Group at the University of
California-San Francisco.

Novick, who chaired the city's AIDS task force, went to his friend Edward
H. Kaplan, Ph.D., then an assistant professor in the School of Management.
Kaplan's mathematical modeling approach to HIV infection had caught
Novick's eye and the two had become collaborators. City health officials,
more concerned with implementing the program than analyzing it, reluctantly
asked Yale to evaluate their program. "We were very against the
evaluation," Maldonado said. "We didn't feel it was a time to do research."

The city health workers imposed two conditions that shaped Kaplan's study.
Drug users could not be tested for HIV infection. "The fear was you would
scare people away," Kaplan said. The next condition, he recalled, went
roughly like this: "You can't have a whole bunch of Yale students climbing
all over the clients with surveys the size of telephone books." In other
words, the people who would use the exchange, benefit from it and serve as
the prime source of information about its effects on their behavior were
off limits.

And, in addition to the other restrictions, the $25,000 the state had
allocated for the program was barely enough to cover costs, let alone fund
a study.

For Kaplan, who had written a paper entitled "Needles That Kill," the
solution was obvious. "You want to look at this from the perspective of the
needles," he said. "It was like looking at malaria from the perspective of
the mosquito." His idea? "We can't test people," he said. "Is it OK if we
test needles?" If needle exchange reduced the number of new HIV infections,
it stood to reason that used needles would be less likely to carry traces
of HIV.

There was only one problem.

Kaplan didn't know whether laboratory science was up to the task. He sought
help from Edwin C. Cadman, M.D., then chair of the Department of Internal
Medicine at the medical school.

Cadman, in turn, went to an epidemiologist who was struggling with his
postdoctoral work and looking for a new project.

Cadman, now dean of the John A. Burns School of Medicine at the University
of Hawaii at Manoa, offered to find a lab and money in his budget for the
needle exchange evaluation. The postdoc mulled over the proposal for about
an hour. "We decided," said Robert Heimer, Ph.D., now associate professor
of epidemiology, "that using the very newly emerging polymerase chain
reaction technology would be a feasible and scientifically exciting way to
try to do this. Nobody had tried to look at HIV in white blood cells
sitting for who knows how long in the barrel of a needle." To see if it
could be done, Heimer turned to the bucket of needles that had been
gathering dust in a corner of the AIDS Brigade's storefront.

Working with the needle exchange team, Kaplan and Heimer devised an
elaborate system to track the needles.

They bought European-made syringes that would stand apart from domestic
ones. Each needle had an ID number. Drug users signed up for the program
anonymously and were given an identity of their choosing, often a pseudonym
that showed some humor, such as "Bugs Bunny" or "Dan Quayle." Khoshnood,
who knew many drug users from his years with the underground exchange,
conducted a brief interview with each client to gather demographic data.
Users received one clean syringe for each dirty syringe they returned to
the van. Logbooks recorded who took a needle and who returned it, when and
where the needle left the van and when and where it was returned.

Incoming needles went to Heimer's lab for testing.

Once a week, data from the lab went to Kaplan's office. "The level of
infection went down as the number of needles in circulation went up,"
Kaplan said. He found another correlation. The longer a needle was in
circulation, the more likely it was to come back HIV positive. "The most
compelling data were the testing data, which demonstrated that the
percentage of infected needles had decreased," said Heimer. "Ed, with his
mathematical modeling, had concluded that there was a one-third reduction
in new infections."

About 700 of the city's estimated 2,000 injection drug users participated
in the needle exchange.

Kaplan used a statistical sampling design, then applied "circulation
theory" to gauge the impact of clean needles. Preliminary results found
that 44 of 48 needles--92 percent--from a shooting gallery tested positive
for HIV. A test of 160 needles from the street found 67.5 percent to
contain HIV. As the program continued, a sampling of 581 street needles
found that only half tested positive.

Six months after the exchange began, 26 percent of needles returned to the
program showed traces of HIV. New infections, Kaplan reported, had dropped
by a third. Without needle exchange, he projected, 64 drug users out of a
thousand would become infected with HIV. Once syringes became available
through needle exchange, HIV would infect only 43 in a thousand.

In July 1991, Heimer and Kaplan announced their results. "When the report
came out and hit the front page of The New York Times, that was a huge
deal," said Lurie, now deputy director of Public Citizen's Health Research
Group in Washington, D.C. "That put needle exchange research and the
programs themselves on a vastly more secure footing.

It added a measure of credibility to the programs and provided a scientific
basis that had not been there before.

It provided a number that people could use, and still do use, as an
estimate of the effectiveness of needle exchange--the well-known one-third
reduction." Other communities approached New Haven for help in starting
their own needle exchanges. "We could have been on the road every other
week," said O'Keefe, the former AIDS division director. "There was a heavy
demand placed on the New Haven program to go out and speak to other
communities and groups that were trying to get needle exchanges in place."
The Yale study led David Dinkins, mayor of New York City at the time, to
reverse his opposition to needle exchange.

Kaplan and then-Mayor John Daniels of New Haven, a former opponent of
needle exchange, sang its praises on national television programs.

But attacks quickly followed.

Bob Martinez, the nation's drug czar in the early 1990s, weighed in against
the Yale study and its authors.

He called the study flawed and said that there was no evidence the needle
exchange slowed the spread of AIDS. Charles Rangel, a Democratic
congressman from New York City and a critic of needle exchanges, asked the
General Accounting Office to review Heimer and Kaplan's research.

The Centers for Disease Control and Prevention (CDC) commissioned a report
on needle exchange from scientists at the University of California. Their
report, with Lurie among the authors, included a chapter on the New Haven
evaluation project.

Both reviews confirmed the study's conclusions. The CDC report went
further, saying the Yale study understated the value of needle exchange.
Kaplan's modeling approach won him the prestigious Franz Edelman Award from
the Institute of Management Sciences. But the attacks continued.

"I don't think we were quite prepared for the politics of it all," said
Kaplan. "The program generated data that suggested it did work. That led to
Rob [Heimer] and myself being painted as activists and advocates." Kaplan
offered to discuss his findings with officials at the Office of National
Drug Policy, but received no reply.

"When we began the work, people opposed to needle exchange said there is no
evidence it works," Heimer said. "After our report they had to modify that
statement to say there is no good scientific evidence.

After the various panels of inquiry had concluded that our work was
scientifically valid and independently verified, they were left saying that
needle exchange sends the wrong message.

The debate had been taken out of the realm of science and placed entirely
in the realm of politics and morality."

The years that followed saw a few victories for needle exchange.

The state of Connecticut implemented five other programs and legalized
over-the-counter sales of syringes.

Other communities, most notably New York City, followed New Haven's example.

As of last year 158 needle exchanges were operating in 36 states, the
District of Columbia and Puerto Rico, the North American Syringe Exchange
Network reports.

In 1998, however, President Bill Clinton disappointed advocates by refusing
to allow federal funding of needle exchanges.

And threats to the availability of clean needles remain.

Bridgeport police argued that the 1992 state law legalizing
over-the-counter sale of needles covered only drug users participating in
needle exchange programs.

A federal judge found otherwise and in January 2001 enjoined the police
from arresting people for possession of syringes.

The New Haven needle exchange program has left a legacy of lessons for
other communities as well. The long period of consensus building and the
support of Daniels, the city's first African-American mayor, and police
chief Pastore were crucial to the program's success.

And there were by-products. The van offered more than needles.

About one in seven of the original 700 program participants entered drug
treatment, according to city officials. And there was no evidence that the
needle exchange encouraged drug use. The van's client base, which included
people of all social classes from 26 communities in Connecticut, remained
stable.

Kaplan and Heimer's methodology remains a landmark in evaluating needle
exchanges. "In terms of proving the efficacy of needle exchange, I don't
think it gets much better than this," said Lurie. "The Yale research was,
for its time and in some ways still, the most sophisticated attempt to
evaluate needle exchange, not only because the methods were sophisticated,
but also because it tried to answer the central question around needle
exchange--whether the programs really reduced the incidence of HIV."

"This was as good a documentation of effectiveness as had ever been seen,"
said Michael H. Merson, M.D., dean of public health at the medical school,
recalling the excitement generated by the New Haven study.

In 1991, when Kaplan and Heimer announced their results, Merson was working
on international AIDS programs at the World Health Organization.

Despite their effectiveness, Merson sees little willingness in this country
to embrace needle exchange programs as part of federal harm reduction
measures. Although the Clinton administration declined to fund them,
federal officials endorsed needle exchanges as an effective prevention
measure. Merson expects little support from the Bush administration. "It's
evident, at least for the foreseeable future, that there isn't going to be
any change in federal policy that would allow federal funds to be used for
needle exchange programs," Merson said. "What is unfortunate is that there
are effective prevention interventions against HIV, such as needle exchange
programs or distributing condoms in schools, which are judged morally
rather than from the public health perspective. That is why this epidemic
continues to be a major problem in this country."

Although the New Haven program is active, the city's original needle
exchange van is long gone. Painted with bright murals by a Yale librarian
and city high school students to cover its police-blue hue, the first van
has been replaced several times.

The new van runs a regular route five days a week through the city's
neighborhoods and even makes house calls.

From July to September of 2000, 518 drug users availed themselves of the
van. The number of people using the van may have declined since passage of
the 1992 state law that allows pharmacists to sell syringes without
prescriptions. The van still leads drug users to treatment programs and
since 1997 it has operated with the Community Health Care Van, staffed by a
physician assistant and outreach workers. "It is clear that needle exchange
does have an impact," said Matthew F. Lopes, M.P.H. '77, director of the
city Health Department's AIDS division. "Connecticut has been forward
thinking in allowing it to exist for 10 years."

Kaplan was even more emphatic when he spoke at the ceremony marking the
program's 10th anniversary last fall. "In simple terms," he said, "the
program has saved lives."