8 August 2003

Heroin trials - old and new.

HEROIN TRIALS - AN ABRIDGED HISTORY - AND A DUTCH ADDITION.

van den Brink W, Hendriks VM, Blanken P, Koeter MWJ, van Zwieten BJ, van Ree JM. Medical prescription of heroin to treatment resistant heroin addicts: two randomised controlled trials. BMJ 2003;327 310-0

Dear Colleagues,

It is fascinating to track the history of heroin prescription over the past 25 years. We first find an English report in an American journal. Next, almost 20 years later came another English description in an Australian journal. After that the major Swiss trials were reported in Anglo-American journals while this latest Dutch trial is in the BritishMedical Journal. It is indeed a global problem.

Most of these trials took treatment resistant heroin addicts and permitted pharmaceutical heroin to be injected with supervision under trial conditions. Some used comparisons with methadone but one used a six month delay as a 'chronological control' group. Patients were permitted realistically high doses of heroin, consistent with their pre-treatment street use, up to one gram daily. There were small trials of 30 to 50 patients such as Perneger and Hartnoll, while the main Swiss trial enrolled 1146 subjects.

There was a practice of prescribing morphine and heroin to addicted patients in the US, England and probably Australia prior to the 1940s but records have been lost and details are mired in history and even mythology. The Swedish prescribing of stimulants in the 1960s was similar in some ways. There appeared to be no prominence of adverse reports from coroners or others at the time but little else can be gleaned from a scientific stand point. There were reports of rapid opiate detoxification (bromides) under sedation from Hong Kong in the British Medical Journal of 1899 and at least one death was reported from that era.

The report by van der Brink and colleagues in the British Medical Journal describes 550 methadone patients who were still using illicit heroin in 6 Dutch cities. They were randomised either to remain in methadone treatment or to receive heroin (injectable if they usually injected, inhaled powder if they normally inhaled - making two separate trials). Despite being allowed up to a gram per day in three divided doses, patients chose to take only half that in an average of 2 daily supervised doses. The mean methadone dose was around 70mg daily, with a maximum permitted of 150mg. Although higher than average doses in some areas, this was probably still inadequate, just as occurs with methadone patients in every country.

Follow-up rates were as high as 95%. Outcomes of numerous aspects of social, mental and physical integration were examined by independent researchers using a modified Addiction Severity Index (ASI). Improvements were marked in both groups but almost twice as much in the groups permitted heroin as well as methadone (~45% vs. ~25% 'response' rate = 40% improvement in ASI). The differences were significant. The rather unfortunate end to the trial was a compulsory 2 months without prescribed heroin, during which the good progress was reversed.

Those decrying a heroin trial in Australia are just delaying the inevitable while the consequences of unchecked drug use cause untold damage to the security and prosperity of our community. There has been no report of increased drug addiction or other adverse sequelae of drug use in regions where heroin has been prescribed. Also, in the largest and longest controlled trial in Switzerland, only a small expansion has occurred, disproving any 'floodgates' effect. Politicians should note that a referendum on such policies was resoundingly successful, especially in the older age groups.

Comments by Andrew Byrne ..

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