Dosage errors may have tilted clinical heroin trial, B.C. court hears

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Participants in a clinical trial fighting to receive prescription heroin may have failed conventional treatments only because they received inadequate dosages, a lawyer for the federal government has told a B.C. Supreme Court judge.

Lorne Lachance made his arguments on Wednesday, the second day of an injunction hearing that will determine whether select participants of the Vancouver-based heroin study will be able to receive a prescription version of the drug while a larger constitutional challenge is before the courts.

Last fall, Health Canada authorized applications for 21 of the participants – severe heroin addicts who have failed numerous times at conventional treatments such as methadone – to receive three-month supplies of diacetylmorphine (prescription heroin) upon their exits from the trial.

The drug is administered in a supervised, medical setting two to three times daily. However, federal Health Minister Rona Ambrose deemed the decision a mistake and within two weeks introduced regulations that banned doctors from prescribing "dangerous drugs like heroin, cocaine, ecstasy and LSD."

On Wednesday, Mr. Lachance referenced the expert opinion of Meldon Kahan, a Toronto-based addiction medicine physician of more than 30 years.

In a sworn affidavit, Dr. Kahan said methadone dosages administered during the North American Opiate Medication Initiative (NAOMI) might not have been enough to relieve withdrawal symptoms and cravings.

The study, led by researchers from Providence Health Care and the University of British Columbia, had concluded that participants on heroin-assisted therapy fared better overall than those on methadone maintenance therapy. Benefits included improved health, reduced criminal activity and ongoing involvement with the health-care system.

"In NAOMI, methadone doses were titrated slowly, whereas higher doses could have been more effective in reducing illicit heroin use and retaining patients in treatment," wrote Dr. Kahan, who has not personally treated the addicts.

He claimed in his affidavit this was also true of European trials. Heroin-assisted treatment has been tested in clinical trials around the world and is currently offered in Switzerland, Denmark, Germany, the Netherlands and Britain.

The five plaintiffs in the case – all participants in a followup study by the same researchers called the Study to Assess Longer-term Opioid Medication Effectiveness (SALOME) – have not sufficiently proven that they have tried, and failed, at all other options, Mr. Lachance said.

"What we're saying to you is these five plaintiffs have not proven to the court at all that they have tried appropriate doses of methadone or any of the other treatments," he said, "and that those are the recognized and licensed treatment for this illness in Canada.

Mr. Lachance also questioned the claim that the addicts would suffer irreparable harm if not given prescription heroin. On Tuesday, Joseph Arvay, the lawyer for Providence Health Care, had argued that the plaintiffs would likely relapse into illicit heroin use in Vancouver's Downtown Eastside. Mr. Lachance called that claim speculative, and a hypothetical assertion.

Also on Tuesday, Mr. Arvay argued that the recently enacted federal regulations violate the addicts' Charter rights. He specifically invoked Section 7 (the right to life, liberty and security of the person) and Section 15 (the right to equal protection and equal benefit of the law without discrimination). "Heroin addicts are one of the most vilified and stigmatized groups in our society," he said. "We say these provisions perpetuate prejudice against them by demonizing the one treatment that might save their lives."

"I ask you to imagine: What if the illness in question was HIV or AIDS and the government imposed a blanket prohibition on the only medication that seemed to be safe or effective?"

The hearing is scheduled to run through Thursday.

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