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- W1920578545 abstract "Editor—Several advertisements have recently been placed in the national and local press by a private agency, requesting volunteers with manic depression to join a drug trial. This drug trial requires participants to stop all current drug treatment, albeit under psychiatric supervision. They are then randomised to one of three groups, receiving treatment with lithium, lamotrigine (at one of three doses), or placebo for one year.This poses three ethical problems. Firstly, advertising publicly for volunteers with serious mental illness is a dubious practice. Secondly, there is evidence that stopping lithium, as required by the trial, results in both relapse and a more severe pattern of illness.1,2 Thirdly, most participants in the trial will not be treated with an established mood stabilising drug. This would be unacceptable in trials for drugs to treat participants with life threatening infections or cancer. It is no more acceptable for severe mental illness.The use of placebo in trials of drugs for mental illness should be debated, and so should the issue of informed consent, rather than taken for granted as it is at present. Moreover, I would like to see Glaxo Wellcome accept responsibility for all episodes of mental illness that might have been prevented if its trial of lamotrigine (£60 ($96) a month and two years left on its patent) was being run more sensitively." @default.
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- W1920578545 date "1998-09-19" @default.
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- W1920578545 title "Safety of patients participating in drug trials" @default.
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- W1920578545 doi "https://doi.org/10.1136/bmj.317.7161.818a" @default.
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