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 life-saving 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."