Coming to a pharmacy near you

Injection drug users cannot distinguish between heroin and a legal substitute, according to a Canadian clinical study released on Friday.
The North American Opiate Medication Initiative (NAOMI) study tested the effect of prescribing opiates to addicts in Vancouver and Montreal. Though the study was not specifically designed to test the legal opiate hydromorphone as a treatment for addiction, study representative Julie Schneiderman said they had enough clinical evidence to begin prescribing the drug. While no proposal has yet been put forward, Schneiderman said study organizers had begun looking for funding to open a clinic.
“Hydromorphone is a legal drug in Canada,” said Schneiderman. “And off-label use doesn’t require federal approval.” Because the drug is not currently approved for addiction treatment, this usage is referred to as “off-label.” However doctors are allowed to prescribe drugs using their own judgment, including for “off-label” uses.
Dr. Dan Small, president of the Portland Hotel Society, which helps run a safe injection facility in Vancouver, disagrees with the study’s findings. “That part of the treatment arm, Dilaudid (hydromorphone), is 26 people. You cannot draw scientific conclusions from 26 people. What that means is you need to go and do further research and that’s where they are going to end up. We are going back to where we started again.”
Dr. Small added, “there is a college of physicians which in no way is going to let [doctors] use Dilaudid to treat addiction. It’s not going to happen. If a doctor were to do that they would be taken out of practice.”
The NAOMI had an unethical side to it,” said Dr. Small. “After 15 months they cut everybody off of heroin, and what happened to those people? They resumed illicit drug use, they resumed the terrible things people have to do to get drugs, like the survival sex trade.”
This is the first study of its kind in North America, but the NAOMI results contribute to a pre-existing body of international research supporting prescribed heroin as a treatment for severe opiate addiction. Switzerland, The Netherlands, Germany, and Spain have all run studies similar to NAOMI and heroin maintenance has been used to treat addicts in the United Kingdom since 1926.
Because hydromorphone is legal, a clinic using this drug would not have to rely on an exemption to federal drug laws, like the one that allows Vancouver’s Insite, the only safe injection site in North America, to function. Proponents hope this will help them get around the Federal government’s opposition to programs like Insite, which the government has challenged in court.
Only the most severely addicted, who had not benefited from conventional addiction treatments, such as detox and methadone programs, were accepted into the study. Vancouver and Montreal have the largest proportion of Canada’s 60,000-90,000 heroin addicts.
The clinical trial exists through a temporary exemption from Canada’s drug laws. The Canadian Institutes of Health Research has funded the $8.1 million project, one of the largest grants ever awarded by the institute.

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