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Equipoise and the Criteria for Reasonable Action

Published online by Cambridge University Press:  01 January 2021

Emily L. Evans  and
Alex John London
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Extract

In her recent article, “Evidence, Belief, and Action: The Failure of Equipoise to Resolve the Ethical Tension in the Randomized Clinical Trial,” Deborah Hellman gives a new twist to an old objection against clinical equipoise. Roughly, clinical equipoise is the requirement that there exist credible uncertainty in the expert medical community regarding the preferred treatment for a particular condition. This uncertainty is widely regarded as a necessary condition for enrolling participants in a clinical trial. The old objection is that clinical equipoise represents an overly permissive, and therefore morally unacceptable, mechanism for resolving the fundamental tension in clinical research between fidelity to the interests of the individual research participant, and fidelity to the statistical and scientific methods that are necessary to produce generalizable data in a reliable manner. Hellman's new twist on this objection utilizes some of the rudimentary architecture of Bayesian statistical theory to argue that clinical equipoise focuses our moral attention on the wrong issue.

Type
Independent
Information
Journal of Law, Medicine & Ethics , Volume 34 , Issue 2 , Summer 2006 , pp. 441 - 450
Copyright
Copyright © American Society of Law, Medicine and Ethics 2006

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References

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.CrossRefGoogle Scholar
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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.CrossRefGoogle Scholar
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