Heroin-Assisted Treatment Works. Why Is Canada Denying It to Patients?
By Scott Bernstein
Imagine you have a chronic illness. After exhausting all resources, and failing all available treatments, you participate in a clinical trial of a new treatment. And, success—the treatment works. Your energy is back, you hold a steady job, your relationships improve, you feel strong and happy.
Then, the clinical trial ends. Despite international research ethics that state you should be allowed to continue on clinical trial medicines and other treatments if they work, your right to this medicine is denied.
What would you do?
With the support of Pivot Legal Society, five Canadian patients faced with this problem—Deborah Bartosch, Charles English, Douglas Lidstrom, Larry Love, and David Murray—are suing their federal government on behalf of all Canadians who could benefit from this treatment.
All five patients are currently enrolled in the Study to Assess Longer-Term Opioid Medication Effectiveness, or SALOME, a clinical trial that is looking at the efficacy of providing injectable hydromorphone, a legal drug in Canada and the United States, and whether it works as well as diacetylmorphine, the chemical name for heroin.
Heroin-Assisted Treatment is a medical intervention that provides the pharmaceutical-grade drug by prescription to people with long-term opioid dependency who have not responded to traditional treatments, like methadone, or abstinence-based programs. Since the first study in Switzerland in the early 1990s, supervised treatment with diacetylmorphine has been demonstrated to be cost-effective, reduce illicitdrug use and criminal activity, promote the health and well-being of patients, and—in many cases—to lead to abstinence for the small group of patients for whom other forms of treatment are not effective. From 2005 to 2008, Canada ran its own heroin-assisted treatment study (NAOMI) that confirmed the European results, but a treatment program never was put in place.
The doctors at Providence Health Care, the institution that has been hosting the SALOME trial, know the vast amount of research supporting heroin-assisted treatment. While the evidence is still out on hydromorphone’s efficacy, they believe the most ethical course of action is to provide heroin treatment to the patients like these five. To do so, they applied to Canada’s federal Special Access Programme (SAP) for access to diacetylmorphine. The SAP allows doctors to request access to drugs that are unavailable for sale in the country when a patient has a serious or life-threatening condition.
The process took months, with Health Canada repeatedly asking the doctors for more data. On several occasions, we thought that the department would say no. But in September, 21 SAP requests were approved. Almost immediately, the Canadian Minister of Health, Rona Ambrose, took exception to Health Canada’s decision, and two weeks later she passed new regulations prohibiting Health Canada from approving diacetylmorphine through the SAP, contrary to all the medical evidence.
For several years, we have been working with these five, and other SALOME study participants, to ensure they have continued access to this life-saving treatment. Now, with the federal government going against their own experts and removing the opportunity for these patients to continue receiving treatment, it is time to take action.
On November 14, in conjunction with Providence Health Care, these five patients filed a lawsuit in the Supreme Court of British Columbia asking for a declaration that the new amendments to regulations governing the SAP violate the Canadian Charter of Rights and Freedoms, and the constitutional rights of people across Canada who are addicted to heroin—for whom other addiction treatment is not effective.
An addictions specialist once told me that “addictions thrive in a context of instability, insecurity and shame.” Heroin treatment programs provide security and they reverse stigma. With the federal government’s mean-spirited new regulations, it is obvious to me that we must challenge them and fight to uphold human rights and dignity.
That is why we’re headed to court.
Pivot Legal Society is a grantee of the Open Society Foundations.
Until February 2017, Scott Bernstein was a program officer for the Global Drug Policy Program.