Doctors in British Columbia are calling on Health Canada to permit prescription heroin for severely addicted patients exiting a groundbreaking clinical trial, insisting a promising alternative is not yet supported by scientific evidence.
The calls come as the first participants exit the SALOME trial, a three-year project launched by researchers from Providence Health Care and the University of B.C. in late 2011 to determine whether hydromorphone – a powerful but legal opiate – is as effective as diacetylmorphine (prescription heroin) in helping severely addicted heroin users.
A 2005-2008 study (NAOMI) by the same researchers, published in the New England Journal of Medicine, concluded supervised, prescribed heroin is a safe and effective treatment for the small demographic of people with chronic heroin addiction who have not benefited from conventional treatments such as methadone. Participants who took prescription heroin were more likely to stay in treatment, reduce illegal drug use and avoid illegal activities, researchers found.
Unexpectedly, a small sample of participants given hydromorphone yielded similar results – and they could not discern which drug they were given. This prompted the researchers to launch SALOME in 2011 to test whether hydromorphone is as effective as prescription heroin.
But as the first participants began cycling out of SALOME early this year, doctors in charge of their exit strategies faced a problem: They could either prescribe conventional drugs like methadone – which no trial participant had succeeded with – or hydromorphone, a drug whose effectiveness had not yet been proven as the trial is ongoing. Prescription heroin, while proven in NAOMI to be effective, remains a controlled substance in Canada.
Citing the urgency of those SALOME participants' exit plans, those doctors are now applying to Health Canada's Special Access Programme (SAP) for what they say is critical treatment for their patients.
Patricia Daly, chief medical health officer and vice-president of public health at Vancouver Coastal Health, said doctors are reluctant to prescribe hydromorphone as it isn't specifically approved for heroin addiction treatment.
"I've written to Health Canada and asked that [the patients] be allowed to get injectable diacetylmorphine – that's injectable heroin – because we've demonstrated in a research study, published in the New England Journal, that's an effective treatment," she said.
David Byres, vice-president of acute clinical programs at Providence Health Care, said doctors wanting to make an evidence-based decision on hydromorphone simply cannot at this point.
"There is no completed, randomized control trial, with it all analyzed to say, 'Here it is. Here's the solid evidence that hydromorphone can be used for that purpose,' " he said, adding there is "a high sense of urgency to have a decision made."
Dave Murray, a long-time user who has participated in both NAOMI and SALOME trials, says prescription heroin makes him "feel alright" in a way methadone never could, allowing him to get his life on track and even volunteer.
But Mr. Murray will exit the SALOME trial at the end of this month and transition to hydromorphone – a drug he has never tried before.
"I don't know how I'm going to react to this new drug in my system," he said, admitting to feeling nervous. "[Prescription heroin] works for me. I hope the hydromorphone is going to be good for me."
The Pivot Legal Society is advocating for 22 SALOME participants, as well as the B.C. Association of People on Methadone, and will represent them individually in a judicial review should Health Canada decline their applications.
Health Canada acknowledged the doctors' applications but said in a statement it would not comment on SAP applications, citing privacy concerns.