ADDICTS NERVOUS ABOUT QUALIFYING FOR HEROIN TRIAL

North America's landmark experiment in giving heroin to long-term addicts
is just days away from beginning in Vancouver.

It is already provoking some difficult debates. Some say authorities have
an ethical obligation not to send users back to their old misery at the end
of 12 months, if it turns out that getting prescription heroin makes a
dramatic difference to their lives. Others say huge numbers of people in
the Downtown Eastside won't even be considered for the trial, because of
the lengthy list of eligibility requirements.

Shelley Atomic gets up every morning hoping this will be the day. What
she's looking forward to is the day she finds out whether she'll be one of
the lucky ones to try a new and completely different way of kicking her
13-year heroin habit -- by going to a clinic every day to get prescription
heroin.

It's not for the free drugs, says the 36-year-old Atomic, a tight bundle of
quick words, wiry hair, and sharp angles to her thin face and body, as she
stands in front of the city's supervised-injection site on East Hastings
waiting to fix.

"I'm just trying to get my life back."

Atomic hopes that if she gets her heroin every day from a pharmacist
instead of a dealer, and if she gets help slowly weaning herself off the
drug, she'll be able to kick her habit.

The idea is so exciting that she's gone onto high alert to try to get
herself on the program. She's got sources promising to let her know the
minute the posters advertising enrolment, due to go up any day, appear.

She's also gone carefully over the list of everything that could possibly
disqualify her.

So far, so good.

But, still, she doesn't know for sure if she'll be one of the 158 chosen
for the trial or, more crucially, one of the 88 from that number chosen to
get prescription heroin.

Intense anticipation, braced for disappointment -- that's the emotional
world these days not just for Shelley Atomic, but for a host of drug users,
health advocates, researchers and others as Vancouver prepares to set off a
small bomb in North America by conducting the first trial outside Europe in
prescribing heroin to users.

Only two other trials, one in Switzerland, one in the Netherlands, have
been completed so far.

In both cases, researchers concluded that prescribing heroin to longtime
users -- people who had tried to quit or to switch to methadone, and failed
- --produced significant improvements. They were less likely to be arrested,
more likely to hold down jobs and lead stable lives, and were even more
likely to stay with treatment and quit heroin altogether. As a result, both
countries created permanent treatment programs that provide prescription
heroin.

Now, Vancouver is about to begin its part in what is supposed to be a
national trial that will also include, at some point, Montreal and Toronto.

The trial, officially called the North American Opiate Medications
Initiatives, has been almost a decade in the making. Along the way, the
researchers in the three American cities who had planned to participate
dropped out. According to public and private reports, they realized they
had no chance of getting funding from any American agency to do a trial
giving out illegal drugs. It just wouldn't be politically acceptable.

But Canadians forged ahead.

It's been five years since Dr. Michael O'Shaughnessy, director of the B.C.
Centre for Excellence in HIV/AIDS Research, first publicly mentioned
participating in the trial. It's three years since the research project was
granted an unprecedented $8.1 million from the Canadian Institutes for
Health Research, which rated the project among the top five of the 80
submissions that year. And it's two years since the researchers started
looking for a site.

This week, Health Canada spokesman Paul Duchesne said the federal ministry
did its final review of the site last week and the letter of exemption from
the Canadian Narcotics Act will be issued in early February.

(The medical leaders of the trials, Dr. Martin Schechter and Dr. David
Marsh, declined to be interviewed for this story because of a dispute with
The Vancouver Sun about publication conditions.)

For international addictions experts, it's a landmark moment.

"It's going to go down in history as a very important piece of scientific
research," said Dr. Alex Wodak, the director of alcohol and drug service at
Sydney's St. Vincent's Hospital in Australia and a prominent figure in drug
research.

Wodak said he's not surprised it has taken so long, given the likelihood
that the U.S. has exerted considerable opposition, as it did when
Australians proposed a heroin trial in 1997.

"I would bet any amount of money the U.S. has exerted extreme pressure on
Canada to abort this trial," said Wodak.

Anyone looking at the small and unremarkable site for the trial would be
hard-pressed to imagine it as the epicentre of an international moral
battlefield.

The old brick and marble building at the corner of Abbott and Hastings,
kitty-corner from Woodward's and across the street from a favoured roosting
spot for dealers, is a rooming house that also used to house a religious
mission.

NAOMI has taken over the 3,000 square feet on the ground floor from the
mission.

One small portion will be the area where the 70 users getting methadone
will pick up their doses. The other section, for those getting heroin, now
consists of a waiting room decorated with a few low-cost framed prints, an
injection room that contains little more than a stainless steel table,
mirrors and chairs, and an enclosed area where the trial's on-site
pharmacist will work.

The most high-tech part of the operation is the gas-station-style security
pass-through between the pharmacist's area and the injection room.

In spite of its unprepossessing appearance, it's a beacon of hope for many
in the Downtown Eastside.

This is the program that's going to create real change, says the
neighbourhood's best-known user, Dean Wilson, who sits on the trial's
advisory committee.

That's because unlike the injection site it won't just give people a place
to fix, said Wilson, whose life was famously profiled in the documentary
Fix as he fought to establish the injection site. This trial will give them
the drugs, which will allow people to knock the chaos out of their lives.

"This is the one that's going to stop the crime," said Wilson.

But, in spite of that positive outlook, the trial has raised some deeply
divisive issues.

One is ethics.

Specifically, what happens at the end of the 12-month trial to the 88 users
who've been getting regular and legal heroin for 12 months?

The Dutch study proved twice over that people are better off getting
heroin. The researchers there, in a somewhat controversial part of the
trial, took all the people who had improved dramatically on heroin in the
first 12 months and put them into a program of methadone-only for another year.

"They observed the people deteriorate over the following year. Month by
month, they deteriorated," said Wodak. That kind of impact in research
trials is "something we agonize over endlessly," he said.

But some say it would be irresponsible and, in fact, unethical to allow
Vancouver's trial subjects to go through that.

Activists such as Wilson and Ann Livingston, the executive director of the
Vancouver Area Network of Drug Users, say that if the trial results are
positive, they will pressure health officials to create a permanent
treatment program that begins the day the trial ends.

"If most of them are doing well, would you knock them off? That's bad
medicine," said Wilson. "After the first six months, if we see some
positive trends, I'll be pushing for it."

Wilson might not be a trained ethicist, but his comments capture the
sentiments of some who are.

"If the trends are obvious enough halfway through a trial, then it's
unethical to withhold treatment," said Barry Beyerstein, a specialist in
psychopharmacology from Simon Fraser University.

Some research trials even specify that if an experimental treatment shows
dramatic results one way or the other -- deaths or remarkable cures -- the
trial has to be ended. If the results are positive, the new treatment has
to be offered to the general population.

However, Beyerstein and others agree it's not the responsibility of
scientific researchers to ensure that treatment is made available -- as
painful as that sounds.

That's the position of the trial's in-house ethics specialist.

Tim Christie, who holds a PhD in philosophy and is responsible for the
trial staff's ethics training, said there is undoubtedly a moral
"obligation to continue providing access."

But it's policymakers -- federal Health Minister Ujjal Dosanjh and his
bureaucrats -- who will have to decide that when the first part of the
trial ends a year from now.

"That's the tension between research and policy," Christie acknowledged.

But one researcher said scientists can't just sit back. Dr. Suzanne
Brissette, a researcher at the Universite de Montreal, which will be
leading the Montreal section of the trial, highlighted the trial's ethical
dilemma three years ago in a paper for the Canadian HIV/AIDS Legal Network.

Although researchers can't control policy, "it is nevertheless the
responsibility of the researchers to try to convince policymakers that this
kind of treatment should be pursued if it proves effective," she wrote.

But preceding the issue of what happens to the people in the trial is the
dilemma of all those who can't even get into it.

Greg Liang has been doing drugs for almost 20 years. The quiet and
competent-sounding 37-year-old, who grew up in Burnaby, says
matter-of-factly that he "used to create a lot of crime."

He went on methadone seven years ago to try to get off heroin. But, as with
many people on the methadone program, it hasn't been totally successful and
he still uses heroin intermittently. Like many people on methadone, he also
finds methadone harder to kick and more addictive than heroin.

He would desperately like to try an alternative approach to kick both
drugs. But he won't qualify for the program. Neither will most of the
people he knows in the Downtown Eastside. Even Dean Wilson, who's been a
heroin addict for most of his life, won't qualify.

That's because the trial won't accept people unless they've "failed" on a
methadone program.

Due to a relaxation of regulations surrounding the methadone program, the
numbers of people signing up for methadone jumped in the past few years,
from 2,500 in 1997 to 8,124 in 2004.

In addition, the trial won't accept people who are facing criminal charges
or are on probation -- which affects a huge proportion of users in the
Downtown Eastside.

"I can't think of anybody who would qualify," said Liang. "The ones who
aren't on methadone are out doing crime. They've got to support their habit."

He's worried that that will skew the trial's results, because of the kind
of people who will be disproportionately admitted.

"It's so restricted we're scared it might not work out. Some people have
HIV, Hep C, their lives are garbage and they just want free drugs. I wish
they'd cater more to people who are making a real effort."

That's echoed by Robert Weppler, who works with users in the Commercial
Drive area in a program called Peer to Peer.

"A lot of the people I think would be the best people are on the meth program."

Wodak acknowledged it's tough on the community when a trial is this rigorous.

The Swiss trial allowed a wider ranger of people to participate.
Vancouver's trial, he said, is more like the Dutch trial, where scientists
aimed for what's known as an "ideal world" trial in science research.

But in the end, he said, a rigorous trial produces results that no one can
challenge -- and that's what everyone wants.

[sidebar]

NAOMI'S CRITERIA:

How the NAOMI trial will work:

- - Researchers will choose 158 people to participate in the study. They will
be assigned to three groups.

- - Seventy of them will be randomly assigned to get methadone. The remaining
88 will get heroin and methadone. A small sub-group within that will get a
substance called hydromorphone, which is similar to heroin, but can be
distinguished from illegal heroin. That will help researchers determine
whether the recipients are taking illegal heroin as well as the hydromorphone.

- - They will have to be over 25, have been heroin addicts for at least five
years, and live in the Downtown Eastside. They can't currently be involved
in methadone treatment but must have tried it at least twice in the past,
unsuccessfully.

- - Since the researchers want people to stay in the study, they won't accept
anyone on probation or with criminal charges pending. People will also be
screened, to eliminate those most likely to drop out if they are assigned
to the methadone group.

- - Everyone in the trial will get access to therapy and social programs,
such as job training, housing placement, and education.

- - Treatment will last 12 months and data collection will continue for
another 12 months.