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Heroin addiction: the science and ethics of the new treatment pluralism
As approaches to treating heroin addiction grow in number, their ethics and their meaningful contribution to the science in this field need more careful consideration
Matt D Gaughwin and Philip Ryan
MJA 1999; 170: 129-130
Introduction -
Questions of ethics -
Questions of science -
Ways forward -
References -
Authors' details
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| Introduction | There is a new pluralism of approaches to treating heroin addiction. Many trials are concerned with relatively small populations of heroin users, among whom researchers hope to demonstrate, by various methods, that one drug or treatment is effective and safe, and perhaps better than, another. At the other extreme are clinics which offer treatments -- such as ultrarapid opiate detoxification (UROD), in which heroin addicts are given opiate antagonists while anaesthetised so that they do not consciously experience withdrawal symptoms -- at a price, and not necessarily with a special interest in evaluation and research. Such approaches have their place, but they can never address the question of how much of what treatments we need to help stem the tide of heroin problems in the community. That question has scientific and ethical implications about the design of trials and treatments and the application of the results of trials to communities. | ||
Questions of ethics | |||
|
There are two categories of ethical issues associated with the new
treatment pluralism. Firstly, ethics as they relate to individuals
and, secondly, ethics as they relate to populations.
The proponents of trials, and perhaps the ethics committees that consider these trials, are more concerned with ethics in relation to the individual trial participants. The ethical obligations of treating clinicians, whether they are working in franchised clinics or research institutions, are clear. They must adequately inform patients about the treatments, which must be as safe as they can be. Whether a procedure such as anaesthesia should be used at all for a clinical condition that is not life threatening was raised by Hall and Mattick,1 and countered by Seivewright and Greenwood,2 who said that the same argument is not used for childbirth or dental treatment. There is an important ethical discussion yet to be had about the extent to which we should introduce new elective procedures which require anaesthesia. Importantly, the risk -- perhaps increased risk -- of death from heroin overdose (as a consequence of reduced opiate tolerance) that can accompany poor compliance with naltrexone means that there is a great responsibility to inform patients being treated with naltrexone about that specific risk. There is also an urgent ethical responsibility to decide whether that risk is too great for some or all participants, and thus to act to reduce or eliminate the risk even if that means stopping or modifying trials and treatments. Also, there is yet to be a comprehensive ethical discussion about the allocation of resources for these new treatments. We do not deny that there is a place for new treatments. Rather, in the face of inadequate resources for existing proven treatments (such as methadone), the effect of introducing new treatments or trials on the ability of heroin addicts seeking help to actually obtain that help needs to be considered. Addiction to opiates is a multifaceted problem which may require multifaceted solutions. If we accept a humanitarian view of treatment, including treatment within trials, we must accept our ethical obligation to offer a treatment that we know works if a trial participant or a patient in a UROD clinic "drops out" of a new treatment. Some heroin users, desperate for help, hardly have a choice, and will enrol in a trial of an unknown treatment because standard treatments (such as methadone maintenance) are relatively unavailable. The other, often neglected, dimension is that of public health ethics. Trials which are publicly funded have special ethical obligations to ensure, as far as possible, that the questions being asked, and the design and evaluation of trials, are in the public's best interest -- that is, what a public given the chance to deliberate adequately about the issue would choose. Because there are no standards for deliberation about public health issues such as heroin addiction,3 propsals for trials may be approved or denied at the discretion of those who hold the relevant power. Thus, the ACT heroin trial was halted by the Prime Minister and Cabinet, while State governments, such as the South Australian government, announced trials of rapid opiate detoxification4 without comprehensive consultation and deliberation with the public, heroin addicts or the clinicians who treat them. The idiosyncrasy of such approaches must militate against sustainable solutions to the problem of heroin addiction, and raises the ethical question of how rational and reasonable approaches to this problem can be given a "fair go". If there has not been meaningful public deliberation about proposals, we believe their proponents can not claim that they are ethical trials in a public sense. | |||
Questions of science | |||
|
This emergence of a pluralism of approaches to heroin problems brings
with it scientific difficulties. As more and more treatments are
trialled, we increase the difficulty and the cost of designing
studies that can determine which collection or combinations of
treatments are better than others. This does not negate the value of
small trials, but it does raise the question of the relationship
between trials and evaluation of treatments as a whole.
The diversity of treatments and trials is wide, ranging from uncontrolled small case series through modest-sized randomised trials to modest treatment programs. It is the view of one researcher that ". . . we are likely to get poorly designed, incompatible trials . . . which produce inconclusive results, ie a null effect in a study lacking adequate power".5 Indeed, a pilot study of naltrexone treatment in New South Wales6 concluded that about 450 participants would be needed for a randomised trial of adequate power -- considerably more than the 100-200 participants proposed for the randomised trials in SA and NSW. Many trials are of short duration, whereas the problem of addiction often occurs over many years. Thus, deciding when to measure outcomes becomes an important issue. Trials risk being irrelevant to the real world of addiction if they ask questions or evaluate outcomes relevant to the short term only. As in cancer epidemiology, we should develop standards for evaluating endpoints in heroin addiction trials so that we might, as with cancer, agree that after a certain period someone is "cured" of their addiction. Or, if we consider addiction to be a chronic relapsing condition, we might perhaps model trials for heroin addiction on those for treating diseases such as epilepsy or diabetes. Moreover, we must never forget that there can be a vast gulf between efficacy demonstrated in clinical trials and meaningful control of a public health problem. | |||
Ways forward | |||
|
The new pluralism in treatments for heroin addiction is fragmented
and uncoordinated, with no particular strategic direction. This is
not surprising given the lack of an agreed strategic framework on
which to design treatments and trials in the area of drug addiction.
However, a strategic framework will be successful only if all those
with an interest in the problem -- experts and non-experts alike -- are
justly and fairly engaged in ways which consider and account for the
diversity of views about heroin. It is encouraging that the National
Drug and Alcohol Research Centre has recently been contracted to
coordinate the trials of new pharmacological treatments (Associate
Professor Richard Mattick, Director of Research, National Drug and
Alcohol Research Centre, University of New South Wales, personal
communication). Perhaps this Centre might take on the wider role of
considering the ethical and scientific questions we have raised
here.
In summary, the new pluralism in treatments for heroin addiction poses some dilemmas. We should welcome the opportunities they may offer, but approach them cautiously and comprehensively so that we avoid the traps of ill-considered science and ill-considered ethics. | |||
| References |
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| Authors' details |
Department of Public Health, University of Adelaide, Adelaide, SA.
Matt D Gaughwin, PhD, FAFPHM, Senior Clinical Lecturer; Philip Ryan, MB BS, FAFPHM, Lecturer.
Reprints will not be available from the authors. ©MJA 1999
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