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New working papers
There are three new working papers covering Aboriginal issues for a trial, the economics of the illicit heroin market and various aspects of trial design and evaluation.
'It will kill us faster than the white invasion'. Views on alcohol and other drug problems and HIV/AIDS risk in the Canberra/Queanbeyan Aboriginal community and on the suitability of a 'heroin trial' for Aboriginal heroin users
Glenda Humes, Michele Moloney, Francesca Baas Becking and Gabriele Bammer
From the point of view of the Feasibility Research into the Controlled Availability of Opioids, the aim of this study was to look carefully at the possible impact of a trial on local Aboriginal heroin users and the local Aboriginal community generally. The questions relating to the feasibility study were subsumed under a broader consideration of unmet needs, particularly regarding service provision for people with problems with alcohol and other drug use and for people at risk of HIV/AIDS.
Nineteen Aboriginal community leaders and 28 service providers were interviewed. Among the community leaders 53 percent thought a 'heroin trial' was appropriate for Aboriginal heroin users, 42 percent did not and 5 percent did not know. Of the service providers 53 percent thought a trial was appropriate, 25 percent did not, 4 percent thought 'maybe' and 18 percent did not know. Three of the service providers were Aboriginal and all thought that a trial was appropriate. In general, both the advantages and disadvantages of the trial proposal were seen to apply equally to Aboriginal and non-Aboriginal users. Thus the question of whether or not a trial is appropriate for Aboriginal heroin users is subsumed under the broader question of whether or not a trial should proceed at all.
Both the community leaders and the service providers thought that alcohol and other drug use was an issue for the Aboriginal community. The community leaders saw alcohol and yandi (cannabis) as the drugs of most concern. Non-Aboriginal services generally have few Aboriginal clients and are not well known in the community. The reasons for this need to be carefully explored. The Aboriginal community leaders also made a number of suggestions for ways in which services could be improved. A number of possibilities for increasing Aboriginal involvement and awareness of Aboriginal culture and issues were suggested. Raising awareness among young people and establishing an Aboriginal community centre were suggested as prevention strategies. Initiatives in this area require serious and long-term commitment, need to be under Aboriginal control and must be adequately resourced.
Both community leaders and service providers see the Aboriginal community to be at risk from HIV/AIDS and there was a perception that the risks are similar in the Aboriginal and non-Aboriginal communities. Many community leaders reported fears that HIV/AIDS could have a significant negative impact on the community. The risks of spread through unsafe sexual practices, especially among young people, were a particular worry. Intoxication was seen to play an important role in increasing these dangers. There was a feeling among Aboriginal community leaders that they had no solutions for adequately dealing with this issue. This is an important area that needs to be urgently addressed.
The other issues considered in this study are reported in:
Moloney, M.; Humes, G.; Baas Becking, F.; Bammer, G. 1993 'Finding Out For Ourselves'. An analysis of the needs of ACT/Queanbeyan Aboriginal People, especially with regard to alcohol and other drug problems and HIV/AIDS risk. Winnunga Nimmityjah, NCEPH, Australian Institute of Criminology.
Economic issues in a trial of the controlled provision of heroin J.R.G. Butler and Amanda L. Neil
This paper discusses some economic issues that may be investigated as part of a proposed trial of the controlled provision of heroin in the Australian Capital Territory. Such a trial would provide an opportunity to gather empirical evidence on some aspects of the operation of the market for heroin. Specifically, it would enable the investigation of the extent to which purity, rather than price, is the equilibrating mechanism in this market. If purity is an important equilibrating mechanism, then provision of heroin of constant purity to trial participants would yield important health benefits to those participants. However, if purity on the black market is increased in economic retaliation against a trial, there may be unintended adverse effects on the health of black market users in the short run. In the long run, stabilisation of purity on the black market may be associated with an improvement in the health status of non-trial users. An important issue that cannot be addressed in the context of the proposed trial is the price elasticity of demand for heroin, that is, the responsiveness of demand for heroin to a change in its price. The use of prespecified criteria to determine eligibility for participation in a trial will preclude any estimation of the increase in demand for heroin attributable to a fall in its price.
Issues for designing and evaluating a 'heroin trial'. Three discussion papers. Report on a workshop on trial evaluation (G. Bammer and D.N. McDonald) An evaluation of possible designs for a heroin trial (R.G. Jarrett and P.J. Solomon) Service provision considerations for the evaluation of a heroin trial. A discussion paper (D.N. McDonald, G. Bammer, D.G. Legge and B.M. Sibthorpe)
Three discussion papers about the design and evaluation of a trial to provide heroin to dependent users in a controlled manner are presented. They raise a number of difficult issues that need to be taken into consideration before the trial design can be finalised.
The first is a report on a workshop on trial evaluation held in June 1993. The bulk of the discussion involved the advantages and disadvantages of three evaluation designs: the randomised controlled trial design, a modified randomised controlled trial design, and the cross-over design. The types of comparisons that could be incorporated in these designs were also discussed. It was agreed that oral methadone would be the 'control' group. This could be compared with injectable heroin, or injectable heroin plus oral methadone, or with a group which had a range of choices between heroin and/or methadone and injectable, oral and smokable routes of administration. The impact of choice of study population on the generalisability of the results and on the types of outcome measures that could be used was also discussed. While there was little support for non-experimental designs, discussion of such designs clarified the limitations of the experimental approaches.
The second paper involves the statistical consideration of alternative trial designs in the case where participants can elect not to be allocated to certain treatments. It was shown that this necessarily leads to a loss of power, but that substantial improvements can be made over the 'intention to treat' analysis. Given the scenario of three possible treatments-heroin only, heroin plus methadone, and methadone only-and the likelihood that some participants will not accept allocation to treatment with methadone only, two possibilities for allocation were explored. The first was to ask,before allocation to a treatment, whether or not participants would continue to participate if they were allocated to the methadone only treatment. Those who would continue to participate would then be randomly allocated to one of the three possible groups; those who would not would be randomly allocated to either heroin only or heroin plus methadone. The second possibility would be to randomly allocate participants to one of the three arms initially, then to ask those allocated to the methadone only arm whether or not they would continue to participate. If not, they would be randomly re-allocated to either heroin only or heroin plus methadone. Statistically, the first design has clear advantages over the second. This was the design considered as the modified randomised controlled trial design in the workshop reported in the first paper.
The third discussion paper deals with potential conflicts between the provision of an effective service to participants in a 'heroin trial' and the constraints that may be imposed by the need for rigorous evaluation. In particular, the incompatibilities between a health development approach to service provision and a randomised controlled trial are explored. Two issues that are especially important, and that are a good illustration of the difficulties, are client choice and individualised treatment. A set of principles of practice is identified.
The design and evaluation of a trial of controlled provision of heroin to dependent users is an important part of the feasibility considerations. As the three discussion papers illustrate, there are many difficulties that will need to be resolved for a trial to go ahead. The final considerations about trial design and evaluation will also need to include information gathered in other components of the feasibility study about numbers of dependent heroin users in Canberra, possible outcome measures and the preferences of potential trial participants.
Political Developments
There has been some discussion of controlled availability around the country.
On November 26, 1993 The Australian Parliamentary Group on Drug Law Reform launched its 'Charter for Drug Law Reform'. Among other things, in its preamble the members of the group recognise that 'prohibition is a greater threat to personal and community health than a system of controlled availability'. One of the Group's short-term goals is 'the adoption of a process including consultation and prescription by medical practitioners for selected illicit drugs'.
On December 16, 1993 the Council of the Law Society of New South Wales, which represents approximately 12,000 solicitors in New South Wales, adopted a policy on drug law reform. As reported in Caveat, a Law Society Bulletin in January 1994, part of the policy statement is that: 'The medical trial in relation to the availability of heroin upon prescription to registered heroin addicts (presently being reviewed by the National Centre for Epidemiology and Population Health, Australian National University and which may be trialed in the Australian Capital Territory) should be considered and supported by Governments'.
On January 4, 1994 the 26th Annual National Convention of the Young Liberal Movement of Australia passed the following motion.
The Convention acknowledges the rising cost to the community of the illegal drug trade in financial and social terms and the gravity of illegal opiate derivative usage, particularly among young people and calls for decisive action in the following areas:
a) calls upon State and Federal Governments to urgently review their current drug policies and adopt an approach of ACTIVE harm reduction and rehabilitation rather than complete prohibition and extinction as the latter is ineffective and counter productive;
b) calls upon State Governments to alter their classification of heroin in their poison regulations (or equivalent) to the status of schedule 8 or equivalent, rather than remain completely illegal to manufacture, prescribe, dispense, use or possess;
c) calls for an expansion of Commonwealth and State methadone programs and the inclusion of injectable heroin into these programs where deemed appropriate for specific patients by medical practitioners;
d) calls on State Governments to maintain registers of certified narcotic addicts for the purpose of allowing medical practitioners to legitimately prescribe those opiate derivatives deemed necessary for addict treatment with a view to eventual withdrawal from their habit;
e) believes that medical practitioners should be allowed to write prescriptions for heroin for certified addicts on a continuing basis in accordance with their professional judgment;
f) calls on State and Federal Governments to examine and repeal any laws that prohibit the manufacture of heroin by registered pharmaceutical companies who already produce dangerous drugs for human therapeutic use;
g) calls on the Federal Government to examine the Narcotics Act 1967 and repeal any sections that prevent bona fide medical practitioners from prescribing heroin in accordance with recommendation 5;
h) calls upon State Government to allow registered pharmacists to dispense heroin upon presentation of a bona fide prescription in accordance with any control procedures deemed necessary by the medical practitioner and the State Health Department.
The Canberra Times reported that, at the convention, the leader of the Liberal Party in the ACT, Kate Carnell, supported the controlled availability of heroin, but stressed that this was her own view and not necessarily that of the Liberal Party.
Changes to the Research Team
Deborah Tunnicliff has moved to part-time and the other half of her position has been filled by Miriam Hazel.
Nova Inkpen is working with David McDonald at the AIC on the analysis of some of the results of the studies with heroin users.
Further Information
For further information about the feasibility research contact: Dr Gabriele Bammer National Centre for Epidemiology and Population Health Australian National University Canberra ACT 0200
Phone: (02) 6125 0716 Fax: (02) 6125 0740
New Publications
Working Papers
Humes, G.; Moloney, M.; Baas Becking, F.; Bammer, G. 1993 'It will kills
us faster than the white invasion'. Views on alcohol and other drug problems
and HIV/AIDS risk in the Canberra/Queanbeyan Aboriginal community and on the
suitability of a 'heroin trial' for Aboriginal heroin users. Feasibility Research
into the Controlled Availability of Opioids Stage 2 Working Paper Number 6.
Butler, J.R.G. and Neil, A.L. 1994 Economic issues in a trial of the controlled
provision of heroin. Feasibility Research into the Controlled Availability of
Opioids Stage 2 Working Paper Number 7.
National Centre for Epidemiology and Population Health and Australian Institute
of Criminology 1994 Issues for designing and evaluating a 'heroin trial'. Three
discussion papers. Report on a workshop on trial evaluation (G. Bammer and D.N.
McDonald) An evaluation of possible designs for a heroin trial (R.G. Jarrett
and P.J. Solomon) Service provision considerations for the evaluation of a heroin
trial. A discussion paper (D.N. McDonald, G. Bammer, D.G. Legge and B.M. Sibthorpe)
Feasibility Research into the Controlled Availability of Opioids Stage 2 Working
Paper Number 8.
Reprints
Ostini, R.; Bammer, G.; Dance, P.; Goodin, R. 1993 ÔThe ethics of experimental
heroin maintenanceÕ. Journal of Medical Ethics, 19, 175-182.