How did this landmark decision in Canadian addiction treatment become possible? Let's take a look back...
The group of patients who participated in NAOMI faced a big hurdle upon exiting the study; Health Canada had disallowed the compassionate use of prescription heroin, making Canada the very first country to implement a diacetylmorphine study yielding positive results, then deny compassionate use of the drug for patients post study, citing other available drugs as alternatives (methadone).
However, a glimmer of hope came from one unexpected finding of the NAOMI study, and lead to the start of yet another new study, known as SALOME (Study to Assess Long-Term Opioid Medication Effectiveness).
During the NAOMI trials, a small group of patients were also given injectable hydromorphine, yet the patients could not differentiate between the effects of the injectable diacetylmorphine and the injectable hydromorphine. Curious, NAOMI investigators were determined to test whether using injectable hydromorphine as a treatment option could provide the same benefits achieved with diacetylmorphine treatment, minus legal hurdles and seemingly endless stigma associated with Heroin; be it prescription or not.
Not deterred by Health Canada's recent denial of compassionate use of diacetylmorphine, the study team applied for research funding to allow the continued investigation into the effectiveness of injectable opiates as a viable treatment option for opiate addiction.
The team received the required approval and funding by the Canadian Institutes of Health Research in 2009, and right away began applying for the necessary exemptions needed to legally import prescription grade heroin necessary for the study from Europe.
In December 2011, SALOME officially began. The study was tasked with comparing two similar medications: diacetylmorphine, and hydromorphine. Of the 202 study participants, half were given diacetylmorphine, the other half given hydromorphine; with neither participants, clinicians or research team being aware of which one was being administered to whom. SALOME also looked into whether patients treated with those medications can successfully be switched to and maintained on methadone.
In early 2013, Physicians began applying to the Federal Special Access Program to ensure that the patients participating in SALOME were able to continue accessing diacetylmorphine treatment after the study concludes. By Fall, Health Canada had indeed approved the special access for a small portion of patients, but within days, things began to take a bad turn.
In October 2013, Health Minister Rona Ambrose changed policy, suddenly banning the authorization of drugs such as Heroin under the Federal Special Access Program (as well as Cocaine, LSD and Ecstacy). These new regulations barred physicians from prescribing diacetylmorphine to opiate addicts who have had no previous success with other treatments such as Methadone, leaving struggling patients little to no options.
Determined to obtain the best and most effective treatment, a group of 5 recovering addicts and SALOME study participants took legal action in an attempt to gain continued access to the lifesaving medication. Taking their battle all the way to the B.C. Supreme Court, the group of 5 eventually had a ground breaking ruling after Chief Justice Christopher Hinkson granted an injunction in their favour, stating that harms would be reduced if given access to injectable diacetylmorphine.
"The constitutional challenge was mounted by the Providence Health Care Society and five patients who argued that their health improved while they were in a government-funded study called the Study to Assess Longer-term Opioid Medication Effectiveness (SALOME).
Smith represents the patients but not the Providence Health Care Society.
Hinkson’s ruling has narrow scope, meaning the lab-produced heroin will be available only for the 202 former patients with severe opiate addictions who participated in the SALOME study. Before they can receive the heroin this winter, they must prove they still medically require it," Smith said.
Physicians, as well as patients were more than relieved to hear the news, as the addicts in question have not been fairing well since the government's decision to deny compassionate care of diacetylmorphine treatment. Forced to return to other options that they have previously found ineffective (such as methadone), some patients are struggling with cravings and relapse. There has been plenty of relief in knowing that the treatment they found success in will once again be made available to them, just in time for christmas.
Heroin and intravenous drug users suffer some of the worst stigma of all. However simply because one is addicted to heroin or other opiates does not mean they should no longer be entitled to the best, most effective treatment for their disease. It does not mean they morally weak or lesser than anyone else. Those suffering from addiction are people, just like the rest, and deserve to be treated with the same dignity, respect, and compassionate care that would be provided under any other circumstance.
The chance at addiction recovery is one damn good christmas gift, in my opinion!