1 The Canadian AIDS Society (CAS) recently recommended completely unrestricted access to experimental therapies by catastrophic patients. The CAS definition of a catastrophic patient apparently includes anyone living with a “life-threatening” illness. See Canadian AIDS Society, “Response by the Canadian AIDS Society to Open Arms and Alternative Clinical Trial Designs,” appended in Schechter, Martin T., Open Arms and Alternative Clinical Trial Designs: Report to the Expert Advisory Committee on HIV Therapies (Ottawa: Health and Welfare Canada, 1990), p. 43–47Google Scholar. Professor Schechter examines some of the procedures being introduced or under consideration in Canada and the U.S. for enhancing access to experimental therapies (p. 7, 25 and passim). Nussbaum, Bruce's recent book, Good Intentions: How Big Business and the Medical Establishment Are Corrupting the Fight Against AIDS (New York: Atlantic Monthly Press, 1990)Google Scholar, chronicles, among other things, recent U.S. decisions to provide enhanced access to experimental therapies.

2 The following discussion is indebted to Feinberg, Joel's contributions to the analysis of paternalism in Harm to Self (New York: Oxford University Press, 1986), p. 19–21.Google Scholar

3 Although I will not pursue it in any detail, it should be noted that this position could also provide the basis for liberalizing access to experimental therapies by the terminally but not yet catastrophically ill.

4 Dixon may endorse a narrower principle than the principle of efficiency: “while there is a compelling public interest case for limiting catastrophic rights, it can only justify limitations of such rights that will materially advance the achievement of the specific and vital goal of protecting the ability of medical science to find an effective cure or treatment for AIDS” (p. 64). We should be concerned that this statement may provide less than adequate scope for medical science than the principle of efficiency, since what “will materially advance … the specific and vital goal of protecting the ability of medical science to find cures” is at least vague and open to narrower interpretation than the principle of efficiency. The principle of efficiency does not require any demonstration that the activities of researchers will in fact be consistent with materially advancing the protection of medical science's capacity to develop catastrophic therapies (as Dixon's statement might be read to endorse); it merely states that medical science should be free to undertake activities that the strongest available considerations suggest will be most efficacious in contributing to the promotion of safe and effective catastrophic therapies. Though the evidence is equivocal, that Dixon intends a narrower principle than this is suggested by some of his proposals for permitting access to experimental therapies. These will be discussed below. As well, we must protect not only the ability of medical science to find cures for catastrophic illnesses; we need to recognize that production and distribution of safe and effective catastrophic therapies are the ultimate regulating ends of the vital public interest. These must be explicitly recognized, since it may be appropriate at times to discount efficient medical scientific practice against these ends. Although Dixon does not explicitly make this point, it is clearly implied in much of what he says.

5 Dixon generally writes as though the interests of PLWAs who are not yet catastrophic patients (i.e., future catastrophic patients) are the same as PLWAs who are presently catastrophic patients (i.e., those with an AIDS-rclated illness or signs that such an illness is imminent). This is implausible. The foregoing discussion shows that non-catastrophically ill PLWAs should regard any retreat from the principle of efficiency as a threat to their own well-being, and thus should reject the idea of a catastrophic right. The same thing might also be said about many PLWAs who are catastrophic patients according to Dixon's definition. Aside from those who are facing imminent death, say, with less than a year to live, it may be that PLWA catastrophic patients, who often have a number of years to live, would be better served by a commitment to vigorous and efficient validation and production of new therapies according to the principle of efficiency. If so, that substantially reduces the size of the population of those for whom it would be reasonable to want a catastrophic right, among PLWAs at least. The remaining individuals would be the strongest candidates for the special measures I mentioned above. If measures can be devised that accommodate their interests within the principle of efficiency, a catastrophic right would then be otiose. Schechter's attempt to frame a “catastrophic threshold” represents a plausible attempt to define this group (see Open Arms, p. 32). It remains to be determined, however, to what extent his proposals for enhanced access would be constrained by the principle of efficiency. See Dixon, Catastrophic Rights, p. 74, and also at p. 117–18 where the question of a conflict is implicit in the discussion of the proper scope of a catastrophic right, and might even have been used to support the limitation of a catastrophic right to symptomatic PLWAs, but the issue is essentially overlooked.

6 It is important to remember that in making judgments about the efficacy of a drug, the larger the pooled sample of experimental results, the greater the likelihood of obtaining results which can accurately reveal subtle advantages or disadvantages over an existing therapy. In comparing a new drug (say, DDI) against a standard therapy, it is scientifically desirable to have a large sample of experimental results, since only then may it be possible to discover that a new therapy represents an advance over a standard the rapy. If we expect that medical progress on AIDS will be incremental (see note 8), the requirementof “indispensability,” as Dixon presents it, may undermine such progress ina variety of unforeseeable circumstances. Dixon defends this position, in part, by claimingthat national boundaries divide research activities in ways that make it plausible forcountries like Canada to forgo contributing to AIDS research that is not an indispensablepart of a research program. I think that the objections already raised are strongenough to allow us to reject this view, but it is worth responding to Dixon's reasoning here, which is based in the idea that in these matters Canada's fundamental and overriding obligation as a sovereign nation is to protect the rights and interests of its own citizens(p. 103). Many would think that this represents far too narrow an understanding of Canada's moral obligations and is inconsistent with and potentially damaging to efforts that should be encouraged to respond co-operatively on an international scale to what are surely shared moral responsibilities. Our best hopes for medical progress, and indeed for progress in ameliorating human hardship of all kinds, most probably lie in marshalling the commitments and resources of those countries, including Canada, that are in a position to contribute to these matters. The prevalence of AIDS in the Third World lends considerable urgency to the idea that Canada should take a cosmopolitan approach to its obligations to assist in the development of AIDS therapies.

7 See Schechter, Open Arms, for a recent critique of parallel track trials that develops many of these points. Schechter also points out that problems with recruiting into the clinical trial arm and with sample bias may be exacerbated in countries with relatively small populations of PLWAs, like Canada, since it may be more difficult to find enough persons who are either willing to enter or able to meet the trial criteria (p. 9). Under these circumstances, impediments to carrying out quick, valid trials would be increased.

8 Schechter suggests that caution is appropriate, noting “that of over 70 agents that have been put forward as possible AIDS therapies, only one [zidovudine or AZT] has reached the stage of demonstrated clinical effectiveness, while several.… have been shown to be potentially harmful” (Schechter, Open Arms, p. 13). Dixon is not optimistic about the prospects for decisive medical progress in the near to medium term. Hesays that “progress, when it comes, will most likely be incremental… making the disease yield its ground in inches” (Dixon, Catastrophic Rights, p. 59–60).

9 Bruce Nussbaum's account of the U.S. Food and Drug Administration precedent-settingdecision in 1989 to make the experimental drug, DDI, available outside clinical trials reflects many of the worries expressed here, even though he describes this decisionas a “win” for PLWAs. See his Good Intentions, p. 284–91, 310–13. Bristol-Myers, thedrug's licensee, actually proposed making the drug available outside clinical trials in what eventually became a de facto parallel track. The clinical trials subsequently became bogged down with recruitment and administrative problems, while thousand seventually received DDI in a non-trial setting. It is hard to imagine that Bristol-Myers was too worried about this state of affairs. At present, DDI is very widely available to PLWAs, though it still remains a scientifically non-validated drug, and there continue to be reports of problems putting together and completing effective trials for it. Although Nussbaum states that “anything that gets in the way of quickly developing safe and effective treatments is monstrous” (Nussbaum, Good Intentions, p. xiv), it never serious lyoccurs to him that wide availability of experimental therapies through parallel tracks and other means could have precisely this effect.

10 Nussbaum presents a revealing, even if often one-sided, account of how these forces have been working to impede the progress of AIDS research. One of his proposals deserves very careful attention, namely, a proposal for creating some sort of independent agency that would attempt to ensure accountability among drug regulators and researchers(Nussbaum, Good Intentions, p. 330f.).

11 See Schechter, Open Arms, for some important recent proposals for amending trials of AIDS therapies. Dixon agrees with Schechter that ways should be found to speed up the process of validating therapies. Schechter is quite sceptical about the scientific and moral wisdom of parallel tracks, although he offers a carefully qualified proposal for a pilot project to study their operation. Useful proposals for amending trials have also come from PLWA organizations (see Nussbaum, Good Intentions). The recent decision in Canada and the U.S. to release DDI for certain general treatment purposes, prior to completion of studies of this drug's efficacy, will have to be watched carefully to determineits effect on the validation process.

12 See Schechter, Open Arms, however, for an argument that contradicts some of Dixon'sclaims about the difficulties of obtaining an “honest null hypothesis” required to run an ethical placebo-controlled trial. See also note 8.

13 I am indebted to Dale Beyerstein, Hannes Jarka, David Lyons, the members of the Cornell Philosophy Graduate Students' Workshop and especially Richard N. Boyd for helpful comments on earlier versions of this paper.