Showing promise in B.C., prescription heroin now in peril

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At 59, Doug Lidstrom says he is close to overcoming the heroin addiction that has dominated three-quarters of his life. Participation in a groundbreaking clinical trial has helped stabilize his habits and, perhaps within weeks, he will be among the first in North America to receive prescription heroin to help further combat his addiction.

But a swift decision by the federal government announced this week has halted Health Canada's authorization of doctors to prescribe the drug. This means when doctors run out of Mr. Lidstrom's three-month supply of diacetylmorphine (heroin) – which hasn't arrived yet – the Vancouver resident must turn back to the conventional treatments that have failed him many times before.

In her announcement Thursday, Health Minister Rona Ambrose described the change as the closing of a "loophole" that allowed for the exploitation of a federal program. By banning doctors from prescribing "dangerous drugs like heroin, cocaine, ecstasy and LSD," effective immediately, Ms. Ambrose made good on a vow of two weeks earlier, when her department first authorized the applications: to ensure it never happened again.

"This is turning me into a yo-yo," Mr. Lidstrom said. "It's playing with people's lives."

The Pivot Legal Society, which is representing Mr. Lidstrom and others in his position, will be exploring legal options that could include a constitutional challenge, said lawyer Scott Bernstein.

While illicit injection drug use in Vancouver has declined over the past 15 years, it remains a hot-button issue, largely due to the longstanding epidemics in the Downtown Eastside and politically charged harm-reduction measures such as Insite, the supervised injection site that recently marked its 10th anniversary.

The issue was again thrown into sharp focus mid-week with the release of a B.C. coroners report into the death of actor Cory Monteith, confirming he died in a Vancouver hotel room from a combination of injected heroin and alcohol. Ms. Ambrose invoked his name in her announcement. – "to make the point it touches on all aspects of our community," she said.

Prescription heroin has been proven in numerous clinical trials worldwide to be a safe and effective second-line treatment for people like Mr. Lidstrom, who have failed to benefit from conventional treatments such as methadone. Switzerland became the first country to offer supervised, injectable heroin treatment in 1994. Denmark, Germany, the Netherlands and the United Kingdom have since followed suit.

In 2005, researchers at Providence Health Care and the University of British Columbia launched a three-year heroin study of their own (NAOMI), finding entrenched addicts who received prescription heroin in a supervised, medical setting experienced more physical and mental-health improvements and were more likely to stay in treatment and reduce illegal drug use and criminal activity than those on methadone. Employment satisfaction and social reintegration also improved.

Eugenia Oviedo-Joekes, a UBC professor and principal author of an article on the study published in the New England Journal of Medicine, said prescription heroin is a crucial option for the small subsection of addicts who don't respond to anything else – about 10 per cent of all people in substitution treatment, according to European figures.

"Heroin assistance treatment has a very small, but very important, role in the addiction treatment system," she said. "It is not meant as a first-line treatment; it is meant to continue the care of people we cannot reach with what is available."

An unexpected result of the NAOMI study was that a small group given hydromorphone – a powerful but legal painkiller – yielded the same benefits as from prescription heroin, and users could not discern which drug they were given. This prompted the researchers in 2011 to launch SALOME, an ongoing followup study to determine whether hydromorphone is as effective as prescription heroin in treating severe heroin addiction.

With both trials, doctors were concerned about the lack of an exit strategy for participants. As they cycled out, doctors could either prescribe methadone – which participants had failed with an average of 11 times – or hydromorphone, whose safety and effectiveness won't be known until the trial concludes and results are analyzed late next year. For this reason, they submitted applications to Health Canada's special access program, which allows doctors to access non-marketed or otherwise unapproved drugs for patients with serious or life-threatening conditions.

"Opioid dependence is a serious illness with significant morbidity and mortality," said Scott MacDonald, physician lead at the Providence Crosstown Clinic, where SALOME continues. "Conservatively, [it has] a mortality [rate] of 2 to 4 per cent a year, and if you add in the complicating factors of this neighbourhood, it may be as high as 10 per cent. That's significant mortality, and that is the mandate of the SAP. And I think the SAP office agrees, because they approved the applications."

Larry Love, a SALOME participant and addict for nearly 48 years, said he has seen a marked change in participants, with most gaining weight and spending their money on food and clothing rather than drugs.

"I've been looking at everybody that goes in there and everyone has gone up the ladder, not down. Everybody has benefitted – every single person," the 62-year-old said. "[Before,] I was always broke. I was in a state of depression. I was living downtown, in a single room. Life was hell. Since being in SALOME, I've managed to move out of the downtown core. I never go without a meal. I always have a dollar in my pocket."

Before coming to its decision, Health Canada sought the advice of Michael Lester, an independent expert who has specialized in opioid dependence treatment for nearly 20 years. In a 2013 report prepared for Health Canada, obtained by The Globe and Mail, Dr. Lester called prescription heroin "a promising treatment of last resort" for this population, noting there is no other "next step" for people who have failed multiple treatment attempts with methadone.

It "decreases the harm to the individual and their communities by allowing [heroin addicts] to obtain and use a legal supply of diacetylmorphine that minimizes the medical risks and social costs of diacetylmorphine dependence," he wrote.

Heroin-assisted treatment at Vancouver's Crosstown Clinic works like this: Patients visit two or three times a day, at set times, and sign in. Nurses ensure they are in a safe condition – those who are drunk are turned away, for example – then provide a measured dose of pharmaceutical-grade heroin and sterilized supplies with which to inject it. The patient sits at a table along the mirror-lined injection room and administers the drug himself. He then sits in a lounge-like area for 20 minutes – this is mandatory – so nurses can monitor him in the event of any adverse effects.

During these visits, Mr. Lidstrom also consults with social workers, counsellors and doctors. This is the first time he has been able to develop a relationship with a doctor, he says, and be honest about his addiction. The daily structure has restored some stability in his life and made his relationship with his children and grandchildren "a lot more comfortable."

At a provincial health ministers meeting in Toronto on Friday, B.C. Health Minister Terry Lake said the B.C. government is reluctant to close the door on innovative thinking when it comes to tackling the challenging issue of severe drug addiction. He called prescription heroin a "compassionate use of a medication" to help people in an exceptional circumstance.

"We have to think outside of the box sometimes," he said. "I know that the thought of using heroin as a treatment is scary, but I think we have to take the emotion out of it and let science inform the discussion."