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 groundbreaking 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.
Researchers hope to submit their final report to Health Canada by January, 2015, and release it to the public that March.
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