Pubdate: Sat, 22 Nov 2014
Source: Globe and Mail (Canada)
Copyright: 2014 The Globe and Mail Company
Author: Andrea Woo
Page: A4


North American first comes after more than a year of battles between
doctors and federal Health Minister

In a North American first, heroin addicts in Vancouver will soon
receive prescription heroin outside of a clinical trial.

Doctors at the Providence Crosstown Clinic received shipment of the
drug this week for 26 former trial participants and will begin
administering the drugs next week. In all, 120 severely addicted
people have received authorization from Health Canada to receive the
drugs; the rest are expected to get them soon.

This development comes after more than a year of battles between
Vancouver doctors and federal Health Minister Rona Ambrose. Doctors
who had been prescribing heroin within the trial sought authorization
to continue prescribing it afterward to keep the addicts from illicit
heroin use and associated harms. But in October, 2013, Ms. Ambrose
objected to Health Canada's approval of the treatment and introduced
regulations to make prescribing the drug (chemical name
diacetylmorphine) outside of a clinical trial illegal.

Providence and five plaintiffs, represented by the Pivot Legal
Society, launched a constitutional challenge and sought an injunction
while the case is before the courts. After a three day hearing in May,
B.C. Supreme Court Chief Justice Christopher Hinkson granted the
injunction, saying risks associated with severe heroin addiction "will
be reduced if [the addicts] receive injectable diacetylmorphine
treatment from Providence physicians."

David Byres, vice-president of Acute Clinical Programs at Providence
Health Care, said it is "exciting" to be able to move forward with a
course of action that has been proven effective in clinical trials not
only in Canada, but around the world.

"The patients are so desperate for treatment, so desperate to be able
to no longer be addicted," Mr. Byres said Friday. "It's a great thing
to be able to help them, and help with the addiction that has taken
over their entire lives."

With prescription heroin, patients attend the clinic two or three
times a day, at set times, to receive the pharmaceutical-grade drug
and sterilized supplies with which to inject it. They then must sit in
a lounge-like area for 20 minutes so nurses can monitor them for
adverse effects.

Several European studies have shown that for the small subsection of
severe addicts who do not respond to repeated attempts at more common
treatments, such as methadone, prescription heroin resulted in a
reduction of illicit drug use and criminal activity and physical and
mental health improvements. Employment satisfaction and social
reintegration also improved.

The 2005-2008 North American Opiate Medication Initiative (NAOMI), led
by researchers from Providence and the University of British Columbia,
produced the same results. A follow-up study by the same researchers
called the Study to Assess Longer-term Opioid Medication Effectiveness
(SALOME) seeks to find whether hydromorphone - a powerful but legal
pain medication - is as effective a treatment as prescription heroin.
The double-blind trials' severely addicted 202 participants were split
in half, with one half receiving hydromorphone and the other heroin.

As participants cycled out of SALOME, some had stabilized enough so
that methadone became a sufficient treatment. For the others, doctors
applied to Health Canada to continue prescribing heroin outside of the
trial, as it has already been proven effective and hydromorphone is
still being studied. Health Canada sought the advice of an independent
expert on opioid dependence and in September, 2013, began approving
the trial doctors' requests.

Since Ms. Ambrose banned the use of prescription heroin in October,
about 30 of the severely addicted patients have left the Providence
doctors' care, with some relapsing into illicit heroin use. However,
the clinic is optimistic it can re-engage them, Mr. Byres said.

Adrienne Smith, a health and drug policy lawyer with the Pivot Legal
Society, said Pivot is looking forward to making arguments at trial
about the plaintiffs' constitutional rights to access lifesaving treatments.

"The minister made the decision to change the regulations preventing
them from getting this medication based on ideology and not evidence,"
Ms. Smith said. "The minister's decision put the lives of heroin users
in jeopardy."
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