Equipoise and the Criteria for Reasonable Action

Hellman D. , “Evidence, Belief, and Action: The Failure of Equipoise to Resolve the Ethical Tension in the Randomized Clinical Trial,” Journal of Law, Medicine & Ethics 30 (2002): 375–380.

See e.g., Hellman S. and Hellman D. S. , “Of Mice but not Men: Problems of the Randomized Clinical Trial,” N. Engl. J. Med. 324 (1991): 1585–1591; Marquis D. , “Leaving Therapy to Chance,” The Hastings Center Report 13, no. 4 (1983): 40–47; and Gifford F. , “The Conflict between Randomized Clinical Trials and the Therapeutic Obligation,” The Journal of Medicine and Philosophy 11 (1986): 347–366.

London A. J. , “Clinical Equipoise: Foundational Requirement or Fundamental Error?” Forthcoming in Steinbock B. , ed., The Oxford Handbook of Bioethics (New York: Oxford University Press, in press). See also London A. J. , “Two Dogmas of Research Ethics and the Integrative Approach to Human-Subjects Research,” Journal of Medicine and Philosophy, forthcoming.

See Hellman , supra note 1.

Id., at 379.

Freedman B. , “Equipoise and the Ethics of Clinical Research,” N. Engl. J. Med. 317 (1987): 141–145. See also Miller P. B. and Weijer C. , “Rehabilitating Equipoise,” Kennedy Institute of Ethics Journal 13, no. 2 (2003): 93–118.

Id., at 143.

See Marquis , supra note 2, at 40.

Ashcroft R. , “Equipoise, Knowledge, and Ethics,” Bioethics 13 (1999): 314–326, at 317.

See Hellman , supra note 1, at 375.

See London , supra note 3.

It is worth emphasizing that indifference is a distinct relationship from both agnosticism and conflict. As we understand agnosticism, this is a state in which an agent has not yet endorsed an all-things-considered assessment of the relative merits of options for choice. This state provides the occasion for further inquiry and analysis. Indifference, on the other hand, represents a judgment that the options available to the agent are equivalent in value for the purposes of the choice problem at hand. If one is indifferent between two cans of cola, one is not in a state of agnosticism about which can would be most preferred after further inquiry. Rather, there is no need for further inquiry because one has judged that one can is as good as the other for the purpose at hand. Conflict, however, arises when an agent recognizes more than one value or commitment as relevant to determining what ought to be done, each value or commitment provides a determinate ranking or evaluation of the options, but these evaluations cannot be jointly satisfied. See Levi I. , Hard Choices (New York: Cambridge University Press, 1986). In the technical parlance of decision theory, when a set of values is conflicted, the set as a whole lacks the property of completeness which can be paraphrased as the property that for any pair of objects x and y in an agent's choice set that are not identical, either (a) x is at least as good as y or (b) y is at least as good as x. Conflict should not, therefore, be equated with indifference since in conflict, neither (a) nor (b) is being asserted, whereas in the case of indifference, both are. See also Sen A. , Collective Choice and Social Welfare (Amsterdam: Elsevier Science Publishers, 1970). As Isaac Levi has argued, one response to conflict might be to assume a position of agnosticism and attempt to resolve the conflict through further inquiry. Alternatively, if conflict is intransigent, or if time is limited, one might have to engage in decision making under unresolved conflict. It is our contention that clinical equipoise should be understood as a method for making decisions under unresolved conflict. We therefore think it is a mistake to equate the state of equipoise with indifference or to limit the use of randomization to cases in which either the broader medical community, the treating physician, or the individual research participant is indifferent between the available treatment options. For an example involving the latter case, see Veatch R. , “Indifference of Subjects: An Alternative to Equipoise in Randomized Clinical Trials,” in Bioethics, Paul Frankel E. Miller F. D. Jr. , and Paul J. , eds., (Cambridge: Cambridge University Press, 2002): 295–323.

See London , supra note 3.

See Freedman , supra note 8, at 144.

See London , supra note 3. Here our argument follows Freedman , supra note 7; Kadane J. B. , ed., Bayesian Methods and Ethics in a Clinical Trial Design (New York: John Wiley & Sons, Inc., 1996); and Miller and Weijer , supra note 7.

Gifford F. , “Freedman's ‘Clinical Equipoise’ and ‘Sliding-Scale All-Dimensions-Considered Equipoise,’” Journal of Medicine and Philosophy 25 (2000): 399–426, at 404.

Similar efforts to accommodate patient preferences are offered by Veatch R. , supra note 16; and by Miller and Weijer , supra note 7.

Id., at 108.

Chard J. A. and Lilford R. J. , “The Use of Equipoise in Clinical Trials,” Social Science and Medicine 47, no. 7 (1998): 891–898.

See Kadane , supra note 20.

See Chard and Lilford , supra note 24, at 891–892.

Miller and Weijer , supra note 7, offer a more conceptual rendering of Chard and Lilford's decision-theoretic theory, requiring that (1) equipoise in the expert medical community obtain before a trial is initiated and (2) equipoise in the mind of the individual clinician obtain before a patient can be offered enrollment in that trial. Similarly, Miller and Weijer argue that the “particular circumstances of the particular patient” must be the focus of the physician's treatment decision. Moreover, they acknowledge that data alone is insufficient to make treatment recommendations, but argue that the individual physician's evidence, beliefs, and values invoked in the decision must be clinically significant and open to “professional, impersonal validation.”

See Kadane , supra note 20, at 9.

See Kadane , supra note 20, particularly chapter 2.