The Ethics Committee and the Placebo Trial
A hospital ethics committee must decide whether to approve a trial for a new anti-nausea drug in 200 patients with a chronic condition. Standard treatment exists but is only partly effective; it costs $40 per dose and causes drowsiness. The new drug costs $400 per dose. The trial design gives 100 patients the new drug and 100 patients a placebo, with rescue medication available on request. The lead researcher argues that because rescue medication exists, no one is harmed. A committee member objects that patients in poorer districts are less likely to ask for rescue medication because they fear being seen as difficult patients. The committee has 60 minutes and must vote today.
1. Identify the central ethical conflict and explain how a utilitarian and a deontological committee member would each reason about approving the trial.
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The central conflict is between producing useful knowledge (does the drug work, and is it worth $400?) and protecting individual participants from avoidable suffering and from unequal burdens.
A utilitarian weighs total expected welfare. The trial could establish efficacy for a large future population and prevent wasted spending. Against this, 100 patients may experience nausea that rescue medication does not fully control, and the burden may fall unevenly on those least likely to request rescue. The utilitarian asks whether expected benefit, multiplied by the number of future patients, exceeds the summed harm to the 100. If the answer is yes, the trial is permitted, but the utilitarian should still insist on safeguards that reduce harm at low cost, such as proactive symptom checks rather than relying on patients to ask.
A deontologist asks whether each participant is treated as an end, not merely as a means. Randomising a patient to placebo when effective partial treatment exists uses that person as an instrument for knowledge. The deontologist may permit the trial only if consent is genuinely informed and if no participant is denied a treatment they are entitled to. The objection about poorer patients is especially serious here: if the design systematically exposes one group to more suffering, the rule being followed is not applied equally, which violates a duty of fairness.
Both traditions converge on a practical demand: the committee should not accept the researcher's claim that rescue medication removes all harm. It should require active monitoring and analysis by district before approving.
2. The researcher claims that because rescue medication is available, no participant is harmed. Assess this claim and state what evidence the committee would need to accept it.
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The claim equivocates on 'harm'. Availability of rescue medication is not the same as its use, and use is not the same as adequate relief. A participant who endures hours of nausea before requesting help has been harmed even if relief eventually arrives. The claim also ignores distribution: if poorer participants request rescue less often, the average harm may look acceptable while a subgroup is systematically worse off.
The committee should treat the claim as an empirical hypothesis, not a definitional truth. Evidence needed includes: (1) baseline rates of rescue requests in similar trials; (2) data showing whether request rates differ by district, income, or language background; (3) whether rescue medication actually resolves symptoms or merely reduces them; (4) a protocol for scheduled symptom checks so that relief does not depend on a patient's confidence to ask.
A sound judgement is that the claim is not yet justified. The committee could approve the trial conditionally, with mandatory proactive monitoring and a stopping rule if subgroup suffering exceeds a set threshold. This respects the researcher's goal while refusing to let a convenient assumption substitute for evidence.