Severely entrenched addicts who were recently granted Health Canada authorization to receive prescription heroin – a first in the country – will explore their legal options after the federal government announced it has banned the practice, effective immediately.
Federal Health Minister Rona Ambrose made the announcement at a Toronto news conference on Thursday, bringing to a halt her department's recent decision to permit the prescription of diacetylmorphine (heroin) to select addicts in Vancouver.
B.C. doctors had submitted applications to Health Canada's Special Access Programme (SAP) requesting the drug for roughly 35 patients exiting a clinical trial. These patients had failed at conventional treatments, such as methadone, an average of 11 times each, the doctors said, and prescription heroin has been proven in numerous clinical trials worldwide to be a safe and effective second-line treatment for such addicts.
After seeking independent expert advice, Health Canada approved 20 of the applications over the last two weeks. But on Thursday, Ms. Ambrose slammed the door on the practice, closing what she called a "loophole" in the SAP by banning doctors from using it to prescribe heroin, cocaine, LSD, magic mushrooms and other illegal drugs.
"The Prime Minister and I do not believe we are serving the interests of those who are addicted to drugs or those who need our help by giving them the very drugs they are addicted to," she said.
The B.C. doctors had renewed their calls for allowing prescription heroin in light of the ongoing SALOME trial, a three-year project led by researchers from Providence Health Care and the University of British Columbia. The Vancouver-based trial aims to determine whether hydromorphone – a powerful but legal pain medication – is as effective as prescription heroin in treating severely addicted heroin users.
A previous study (NAOMI) by the same researchers, published in the New England Journal of Medicine, had concluded prescription heroin is a safe and effective treatment for the limited group that did not benefit from conventional treatments. Participants who took prescription heroin were more likely to stay in treatment, reduce illegal drug use and avoid illegal activities, researchers found.
In both trials, doctors planning participants' exit strategies faced a problem: Following the trials, they could either prescribe methadone – which no participant had benefitted from despite repeated efforts – or hydromorphone, a drug whose safety and effectiveness in addiction treatment won't be known until late 2014. For this reason, they submitted the SAP requests.
Ms. Ambrose said the 20 approved applications will go ahead, but won't be renewed when the three-month shipments are up. No new applications will be approved. She dismissed the claims of harm reduction advocates, doctors and researchers who say prescription heroin is a valid drug to treat addicts who have failed at conventional treatments.
"If there are physicians who believe that, they can go to their college of physicians at the provincial level and make that case for the ability to prescribe," she said. "The SAP is not for that."
However, Martin Schechter, principal investigator of the NAOMI study, said that's not how it works. "The fact is, unless the federal government gives exemptions for this to be used, those doctors are subject to arrest," he said. "It is not up to the provincial colleges alone to authorize this treatment."
Scott Bernstein, a lawyer for the Pivot Legal Society, which is representing 22 SALOME patients as well as the B.C. Association of People on Methadone, said he will explore all legal options once the exact details of the new regulations are known. He said he is concerned by the fact the government can "close off" Health Canada's ability to make decisions.
"Ms. Ambrose doesn't have any medical education," he said. "Taking this decision out of the hands of experts … and making a decision based on politics – is that how we want to approve medical care in this country?"