Pubdate: Fri, 20 Dec 2013
Source: Globe and Mail (Canada)
Copyright: 2013 The Globe and Mail Company
Contact:  http://www.theglobeandmail.com/
Details: http://www.mapinc.org/media/168
Author: Andrea Woo
Page: S3

PATIENTS STILL WAITING FOR HEROIN

Group of 21 addicts granted prescriptions for the drug have not
received them and are hoping an injunction will move things along

Twenty-one hard-to-treat addicts won a lottery of sorts when they were
given approval this fall to receive prescription heroin to help manage
their dependencies - a treatment available in other countries but new
to Canada.

However, the federal government wasn't happy that Health Canada's
Special Access Programme (SAP) granted the prescriptions and Health
Minister Rona Ambrose slammed the door shut on anyone else getting
similar access in the future.

But the group of 21 continues to wait: Their doctors have not yet
received the shipments of diacetylmorphine - the technical name for
heroin - and a legal group representing them, and others in their
situation, is hoping an injunction will move things along while the
matter is before the court.

Pivot Legal Society wants an injunction to grant patients an exemption
from the new federal regulations barring doctors from prescribing what
Ms. Ambrose said this fall are "dangerous drugs like heroin, cocaine,
ecstasy and LSD."

"We know the answer is not to treat heroin addiction with heroin," she
said at the time.

But Pivot lawyer Scott Bernstein said the matter is urgent and can't
wait for the courts. He noted patients have not been doing well, with
some relapsing into illicit heroin use.

"Legal cases take time and the one thing our clients don't have is a
lot of time," he said. "They're in the circle of health care now and
their situation is very precarious because they're not getting the
treatment they need. We need to go into the injunction to say,
'There's an emergency situation. We can't wait a year, or two years,
or three years, for this thing to be resolved by the court.' "

The battles stems from the ground breaking Study to Assess Long-term
Opioid Maintenance Effectiveness (SALOME), an ongoing study by
researchers from Providence and the University of B.C. to determine
whether hydromorphone - a powerful but legal opiate - is as effective
as heroin in helping severely addicted heroin users.

A previous study by the same researchers, the North American Opiate
Medication Initiative (NAOMI), found prescribing pharmaceutical-grade
heroin is a safe and effective treatment for the small demographic of
people who have repeatedly failed with conventional treatments, such
as methadone. Participants were more likely to stay in treatment,
reduce illegal drug use and avoid illegal activities to support their
habits, researchers found.

In both studies, doctors were concerned by a lack of an exit strategy
for participants. While some could not differentiate between
hydromorphone and heroin - suggesting hydromorphone could be an
effective, legal substitute for heroin - doctors are reluctant to
prescribe as a heroin addiction treatment as the SALOME study is
ongoing. That means there is no evidence yet that hydromorphone, a
pain medication, is a safe and effective treatment for heroin addiction.

The study participants have all failed at conventional treatments an
average of 11 times.

Doctors submitted applications to the SAP earlier this year to
prescribe heroin to dozens of study participants. The department
consulted with an independent addictions specialist - who noted
NAOMI's positive findings for the therapy reflected those of other
countries, including Switzerland, Germany and Britain - and approved
21.

Ms. Ambrose blasted the decision and quickly introduced the new
legislation. While the 21 approvals were permitted to go forward,
their doctors have not yet received the three-month supplies of
diacetylmorphine due largely to regulatory hurdles, Mr. Bernstein said.

The battle made its way into B.C. Supreme Court in November, where
five of the addicts, in conjunction with Providence Health Care, filed
a lawsuit asking for a declaration that the new regulations violate
their Charter rights to life, liberty and security of the person.

Meanwhile, the Data Safety Monitoring Board has reviewed SALOME at the
researchers' request and reduced the study sample size to 202 from
322, said Eugenia Oviedo-Joekes, a University of B.C. professor and
principal investigator of SALOME. This will help reduce costs and
produce results faster.

Some addicts who were on the waiting list are not happy about that,
because SALOME provides an opportunity to get off illicit drugs, Dr.
Oviedo-Joekes said. However, the good news is that if hydromorphone
does prove to be safe and effective, it will be available one year
earlier, she said.
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