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Access to Experimental Drugs in Terminal Illness. Ethical Issues
  1. Anthony Byrne
  1. Department of Palliative Medicine, University Hospital of Wales

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    Udo Schuklenk, New York, Pharmaceutical Products Press, 1998, 228 pages, US$60.

    Availability of, and equitable access to, therapeutic drugs have never been more topical or eagerly debated than at present. Public discontent, professional turmoil and political imperative have spawned exhaustive dicta on these issues, describing quasi-innovative frameworks for consensus such as evidence-based practice, clinical governance and integrated health care. However, controversies over autonomy, resource allocation and discrimination remain. In his book Udo Schuklenk proposes to highlight some of these issues, and more, in the context of those suffering from terminal illness, with particular emphasis on ethical issues arising from current health care practice.

    A thorough critique of such subject matter requires one to bridge the apparently inextricable but potentially disparate disciplines of ethics and clinical/pharmaceutical practice. That the author aims to achieve this so explicitly and precisely is both refreshing and reflective of his knowledge base. At the outset Dr Schuklenk explains his intent to explore the issues of the title using AIDS as the context of discussion and argument. He contends that observations made and conclusions drawn are applicable to the wider community with terminal illness, the choice of AIDS acting simply as a “real-world case study”. The framework he chooses leads us logically and resolutely through ethical theories of paternalism and autonomy, appraisal of clinical trials and issues of cost, as all the while the author reflects on their implications for availability of experimental drugs to those with incurable disease.

    The section addressing issues of paternalism is extensive in its breadth of thought, discussion and selected criticism of such theory. The author summarises precisely the often complex and conflicting paradigms of strong and weak paternalism espoused by Kant, Mill and Young among others. Whilst finding consistency and plausibility in the paternalists' definitions of autonomy, he faults their reasoning on intervention. Mill, for example, considered it reasonable to intercede if the individual was unaware of potential adverse reactions. The author assumes that the level of risk is irrelevant, only that the possibility of risk be clear. It is on the strength of this assumption that he disclaims the right of any paternalistic interference. He contests that AIDS patients are well informed and articulate. Hence they are ethically capable of the authentic decision to take undefined risks with experimental drugs. Several issues are of concern in this context. The assumption that magnitude of risk is irrelevant to those with incurable disease, because nothing could be worse than their inevitable death, represents a tenuous nexus for the recurrent arguments in favour of accessibility to unproven drugs. The expectations of those with terminal illness in terms of prognosis, treatment potential and quality of life are often surprisingly high, suggesting that levels of possible treatment-burden rank as highly as potential benefit. The author also imputes a high level of knowledge and understanding to his patient group. This may be true of an articulate minority of AIDS sufferers but neglects the reality of the majority, including intravenous drug abusers and those in the developing world.

    In addressing issues of restricted treatment access via clinical trials, Dr Schuklenk uses a landmark trial of AZT therapy as a template for discussion. He adeptly describes the nature and clinical pitfalls of the trial and uses it as an opportunity to address ethical issues surrounding general conduct of clinical trials. It is an excellent exposé of devastatingly poor research practice and clearly defines the parameters for acceptable trial design and implementation. The arguments made in this chapter sit easily with the concept of well-constructed clinical trials which are all-inclusive,—akin to the UK paediatric oncology paradigm where most treatment is trial-based—allowing the greatest accumulation of knowledge and flow of information. Surprisingly the author concludes that experimental drugs of no proven value, should be easily accessible to terminally ill patients because all current clinical trials are coercive, restrictive and mis/uninformative, whilst terminally ill patients do not have the time for altruism. This assumes a likelihood that unproven drugs have any potential benefit, and certainly fewer burdens, although the potential for misinformation, unfathomable clinical outcomes and immeasurable impact on quality of life would appear greater with unfettered access. Thus, contrary to his conclusions, the author does not clearly show that, on the basis of historically bad research practice, lack of prohibition would equate with patient autonomy.

    Having argued in favour of free access to experimental drugs for the terminally ill on the basis of autonomy, incompetent trials structure and inadequate “standard treatment” (prognosis can't get any worse), Dr Schuklenk does not shirk issues of cost. He argues in favour of absorption of these costs into health care budgets, at least to the same level as standard treatments (which, he argues, don't work anyway) in societies without universal health care. That terminally ill (and specifically AIDS) patients may represent marginalised sections of society further mandates for such action, although the impact on other services in the “real world” of rationing is not discussed. The section ends with a concise, well-judged review of the essential need for adequate information-gathering and dissemination to all sections of the community.

    There is much of merit in the structure of this book and ultimately it is a passionate, if not unflawed, argument in favour of free access to experimental drugs for AIDS patients. However, discussion frequently centres on a small, specific subgroup and the conclusions drawn do not transfer easily to the greater population of those with terminal illness. In that sense the content does not fulfil the expectations raised by the title, and those with an appetite for a broad, objective look at the many ethical issues surrounding therapeutics in the terminally ill may not be fully satiated by this contribution.

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