Editor—The contributions by Lièvre et al and Pocock and Evans make important points about the ethical problems surrounding early termination of trials for non-scientific reasons.1,2 But their argument about the responsibilities of sponsors goes too far.
The Declaration of Helsinki makes it clear that sponsors and investigators do have obligations to the participants enrolled into the trial. These include fair treatment, avoiding exploitation and unnecessary harm, and treating patients with respect. Among other things, this entails not starting a patient off on a treatment, observing that the treatment is beneficial, and stopping the treatment of that patient for purely commercial reasons. Sponsors and investigators should recognise that the risk assumed by trial participants, and the altruism of such participants, places obligations on sponsors to complete a beneficial course of treatment even after the close of the trial. The argument is more complex when considering treatment for chronic disease or for prevention of disease in the long term.
None of this implies an obligation on sponsors with regard to patients not yet randomised or the patient population at large. There is no obligation on sponsors to conduct trials or market their products where there is no foreseeable profitable market for them. Moreover, sponsors normally have to choose among various products to develop and then market, and this choice is always in the light of opportunity costs.3
There is a public interest in completing trials, in having the best evidence base available and ensuring that treatments are available for as wide a range as possible of conditions. This public interest does not, however, impose moral obligations on companies. Companies are a social solution to meeting this collective interest, harnessing the power of competition to deliver treatments efficiently. The problem Lièvre et al identify is a problem of market failure, rather than of morals.
The solution is a political one: states have a responsibility to address market failure. This lesson has been learnt in the case of orphan drugs; we should generalise it to apply to other cases of market failure in research and development.4
References
- 1.Lièvre M, Menard J, Bruckert E, Cogneau J, Delahaye F, Giral P, et al. Premature discontinuation of clinical trial for reasons not related to efficacy, safety or feasibility. BMJ. 2001;322:603–606. doi: 10.1136/bmj.322.7286.603. . (10 March.) [DOI] [PMC free article] [PubMed] [Google Scholar]
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