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Published online by Cambridge University Press: 13 April 2010
1 In recent years, there have been several proposed and actual programs in North America that permit early access by AIDS patients and others suffering from life-threatening and seriously debilitating conditions: treatment Investigational New Drugs (INDs), parallel tracking, open arms, etc. Unless indicated otherwise, I am not distinguishing among them.
2 Dixon, John, Catastrophic Rights: Experimental Drugs and AIDS (Vancouver: New Star Press, 1990), p. 35.Google Scholar
3 It is not clear to me either what Dixon's exact conclusion is about the public interest or the premises involved. At the end of the book he says two things that reduce the force or scope of his claims. First he says that a catastrophic right cannot be overridden if the trials only contribute to medical knowledge, rather than being necessary. Certainly no single trial will be necessary in this sense, and of course no single patient will be necessary for a trial. Second, he seems to suggest that Canadian public interest cannot override catastrophic rights because the public interest is being safeguarded by trials in the U.S. This point requires much more discussion about harmonization and sovereignty among national drug regulatory systems, and about other factors of implementation.
4 Russell, John, “Access to Experimental Therapies and AIDS,” Dialogue, 30, 3 (Summer 1991): 399–418CrossRefGoogle Scholar, and Dixon, John, “Real Rights and Plausible Efficiencies: Reply to John Russell,” Dialogue, 30, 4 (Fall 1991): 615–30.CrossRefGoogle Scholar
5 Russell, “Access to Experimental Therapies,” p. 410.
6 Ibid., p. 408.
7 Ibid., p. 412; emphasis mine.
8 Ibid., p. 414.
9 Dixon, “Real Rights and Plausible Efficiencies,” p. 629.
10 Ibid., p. 623; emphasis in the original.
11 Ibid..
12 Russell, “Access to Experimental Therapies,” pp. 412–13.
13 Ibid..
14 The most widely quoted estimate of the cost of drug development is US$240 million. This figure reflects some complex accounting, plus the funds expended on all drug research, including the multitude of candidate discoveries that fall by the wayside before approval.
15 Some high-profile cases can give the erroneous impression that governments bear the costs of drug development. For example, both ddI (2′, 3′-dideooxyinosine) for the treatment of AIDS and taxol for the treatment of ovarian cancer are notable for having been discovered in U.S. government labs. Even in these cases, however, the development costs, the “D” part of “R & D,” were largely borne by corporate sponsors–and the “D” is the expensive part.
16 Perhaps surprisingly, there have been very few successful suits against drugs that were actually in clinical trials. But unapproved drugs that become widely available raise additional problems.
17 In the case of AIDS trials, historical controls are especially suspect because over the last few years a number of drugs have been approved–and even more have been used–for treating the opportunistic infections and other conditions associated with HIV infection. Thus any historical population will likely differ markedly from the current patient population with respect to medication.
18 Redelmeier, D. A. and Tversky, A., “Discrepancy between Medical Decisions for Individual Patients and for Groups,” New England Journal of Medicine, 332 (April 19, 1990): 1162–64;CrossRefGoogle Scholar the quoted passage appears on p. 1163. Also, for an illuminating discussion of ethical and other problems of RCTs, see Hellman, S. and Hellman, D. S., “Of Mice but Not Men: Problems of the Randomized Clinical Trial” (New England Journal of Medicine, 324 [May 30, 1991]: 1585–89)CrossRefGoogle Scholar and Passamani, E., “Clinical Trials: Are They Ethical?” (New England Journal of Medicine, 324 [May 30, 1991]: 1589–92)CrossRefGoogle ScholarPubMed, and related correspondence in the New England Journal of Medicine, 325 (November 21, 1991): 1513–15.CrossRefGoogle Scholar
19 As a high U.S. government official allegedly pointed out, “It seems that the best way to eliminate a disease condition is to set up a clinical trial. The patients tend to disappear.” For a discussion of some of the difficulties of recruiting patients for clinical trials, see Wittes, R. E. and Friedman, M. A., “Accrual to Clinical Trials,” Journal of the National Cancer Institute, 80, 12 (August 17, 1988): 884–85CrossRefGoogle ScholarPubMed, and Gelber, R. D. and Goldhirsch, A., “Can a Clinical Trial Be the Treatment of Choice for Patients with Cancer?,” Journal of the National Cancer Institute, 80, 12 (August 17, 1988): 886–87.CrossRefGoogle ScholarPubMed
20 Russell, “Access to Experimental Therapies,” p. 413. Russell says that this is “an important problem that has not yet been given much attention by anyone.”
21 “Accelerated approval” was introduced in the U.S. in 1991. The regulations for this measure were not established until the end of 1992 (Federal Register, 57, 239, Part 8 [57 FR 58942; December 11, 1992], pp. 58, 942ff).
22 John Russell has suggested that charitable foundations focussed on particular diseases (e.g., cancer societies, heart foundations) could play a useful role here (personal communication, 1992).
23 For an excellent discussion of trial designs, see Martin, T. Schechter, Open Arms and Alternative Clinical Trial Designs: Report Prepared by Martin T. Schechter with Response by the Canadian AIDS Society (Ottawa: Health and Welfare Canada, December 1990), Supply and Services Canada Cat. No. H42-2/39–1990.Google Scholar
24 Trials conducted by co-operative medical groups such as the Oncology Clinical Trial Groups may be carried out to a similar degree of rigour. However, in general, results reported in the medical literature are rarely up to GCP standards.
25 Delaney made this suggestion, among others, when he participated in a panel discussion at the annual meeting of the Drug Information Association in Chicago, July 1993.
26 User fees have been in effect for some time in the United Kingdom, and the United States instituted them in 1993. Also, the U.K. regulatory system is partially privatized.
27 Another problem I have not addressed here: drawing the line between catastrophic and non-catastrophic situations. See, for example, Schechter, Open Arms and Alternative Clinical Trial Designs.
28 Dixon, “Real Rights and Plausible Efficiencies,” pp. 618-19. Similarly, Schechter uses such a justification in Open Arms and Alternative Clinical Trial Designs. See also Kwitney, Jonathan, Acceptable Risks (New York: Poseidon Press, 1992).Google Scholar
29 Special thanks to one of this journal's referees whose comments and criticisms were particularly valuable.