FREE-HEROIN TRIALS BLASTED BY EXPERTS

'Safety, Ethical Problems' In Dispensing Drug

A controversial program to give free heroin to addicts in the
Vancouver area is under fire from some addiction experts.

Under the trial program -- to be funded by the Canadian Institutes of
Health Research in Vancouver, Toronto and Montreal -- 470 addicts
would be prescribed up to 1,000 milligrams of heroin and/or unlimited
methadone per day.

Two physicians at Toronto's Centre for Addiction and Mental Health
have written scathing critiques of the North American Opiate
Medication Initiative to Diane Fafard, ethics policy adviser for the
CIHR in Ottawa.

"The NAOMI trial has serious design flaws and major safety and ethical
problems," wrote Drs. Meldon Kahan and Kay Shen in a letter dated Dec.
21.

The doctors have 20 years' experience in the field of addiction
research. They write in their letter that they are in favour of "harm
reduction" efforts, but say the trials are wrong-headed.

In Vancouver, addiction expert Dr. Stan deVlaming has written to
Providence Health Care vice-president Yvonne Lefebvre saying he "and
other addiction physicians here in Vancouver share similar concerns."

Vancouver NAOMI spokes-man Jim Boothroyd said that investigators "are
aware of the criticisms" and a process is in place to answer concerns
raised by critics.

"If it is deemed necessary, the investigators will formally address
the concerns," Boothroyd said, adding that the first enrolments are
scheduled for Jan. 17 in Vancouver, but final approval has not yet
been granted.

Heroin addicts who have failed methadone treatments will receive an
unrestricted amount of methadone, or methadone and heroin. The addicts
will inject heroin two to three times per day for one year, then be
tapered off the drug.

The trial, which has the blessing of the federal government, Vancouver
Mayor Larry Campbell and Vancouver police, is the first of its kind in
North America. It was patterned after a similar trial in Europe and
will involve 158 local drug-users for 21 months.

The drugs will be dispensed, under the supervision of a nurse, in the
Downtown Eastside at Hastings and Abbott.

The Toronto doctors have a series of concerns, including "strong
evidence" that the combination of large amounts of heroin and
methadone "put subjects at significant risk for acute and chronic hypoxia."

Hypoxia is a lack of oxygen in the blood and/or tissues of the body.
It can lead to death.

The doctors suggested reducing the heroin dose and restricting
methadone to no more than 10-20 mg. They also recommended that
patients who were taking sedatives should get lower doses of both drugs.

The doctors warned that some patients who are addicted to legal
heroin-like drugs could be put on the program and become addicted to
heroin.

They said the eligibility criteria are too broad, allowing in addicts
who only briefly tried the methadone treatments.

"The trial should only recruit patients who continue to inject heroin
daily despite at least four months of methadone treatment, at a dose
of at least 100 mg for one month or more," they wrote.

The doctors wrote that the trial will set back heroin-addiction
research for years to come.