Pubdate: Thu, 30 Dec 2004 Source: Province, The (CN BC) Copyright: 2004 The Province Contact: http://www.canada.com/vancouver/theprovince/ Details: http://www.mapinc.org/media/476 Author: Steve Berry, The Province Bookmark: http://www.mapinc.org/hr.htm (Harm Reduction) Bookmark: http://www.mapinc.org/heroin.htm (Heroin) Bookmark: http://www.mapinc.org/find?136 (Methadone) FREE-HEROIN TRIALS BLASTED BY EXPERTS 'Safety, Ethical Problems' In Dispensing Drug A controversial program to give free heroin to addicts in the Vancouver area is under fire from some addiction experts. Under the trial program -- to be funded by the Canadian Institutes of Health Research in Vancouver, Toronto and Montreal -- 470 addicts would be prescribed up to 1,000 milligrams of heroin and/or unlimited methadone per day. Two physicians at Toronto's Centre for Addiction and Mental Health have written scathing critiques of the North American Opiate Medication Initiative to Diane Fafard, ethics policy adviser for the CIHR in Ottawa. "The NAOMI trial has serious design flaws and major safety and ethical problems," wrote Drs. Meldon Kahan and Kay Shen in a letter dated Dec. 21. The doctors have 20 years' experience in the field of addiction research. They write in their letter that they are in favour of "harm reduction" efforts, but say the trials are wrong-headed. In Vancouver, addiction expert Dr. Stan deVlaming has written to Providence Health Care vice-president Yvonne Lefebvre saying he "and other addiction physicians here in Vancouver share similar concerns." Vancouver NAOMI spokes-man Jim Boothroyd said that investigators "are aware of the criticisms" and a process is in place to answer concerns raised by critics. "If it is deemed necessary, the investigators will formally address the concerns," Boothroyd said, adding that the first enrolments are scheduled for Jan. 17 in Vancouver, but final approval has not yet been granted. Heroin addicts who have failed methadone treatments will receive an unrestricted amount of methadone, or methadone and heroin. The addicts will inject heroin two to three times per day for one year, then be tapered off the drug. The trial, which has the blessing of the federal government, Vancouver Mayor Larry Campbell and Vancouver police, is the first of its kind in North America. It was patterned after a similar trial in Europe and will involve 158 local drug-users for 21 months. The drugs will be dispensed, under the supervision of a nurse, in the Downtown Eastside at Hastings and Abbott. The Toronto doctors have a series of concerns, including "strong evidence" that the combination of large amounts of heroin and methadone "put subjects at significant risk for acute and chronic hypoxia." Hypoxia is a lack of oxygen in the blood and/or tissues of the body. It can lead to death. The doctors suggested reducing the heroin dose and restricting methadone to no more than 10-20 mg. They also recommended that patients who were taking sedatives should get lower doses of both drugs. The doctors warned that some patients who are addicted to legal heroin-like drugs could be put on the program and become addicted to heroin. They said the eligibility criteria are too broad, allowing in addicts who only briefly tried the methadone treatments. "The trial should only recruit patients who continue to inject heroin daily despite at least four months of methadone treatment, at a dose of at least 100 mg for one month or more," they wrote. The doctors wrote that the trial will set back heroin-addiction research for years to come. - --- MAP posted-by: Derek