Ethics Governance
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| Article - Abstract. To view full article click on the article title. | |
eMJA: Goldney & Stoffell, Ethical issues in placebo-controlled trials in Alzheimer's disease Ethics Ethical issues in placebo-controlled trials in Alzheimer's disease Robert D Goldney and Brian F Stoffell MJA 2000; 173: 147-148 The use of placebos and the dubiousness of patients' ability to give informed consent give rise to various ethical concerns The use of placebos in clinical drug trials is the most conclusive method of elucidating the effectiveness of new medications. However, it has long been recognised that there are significant ethical issues with such trials, as some patients will be given no specific therapy.1,2 Few would argue against the use of placebos in drug trials when there are no effective treatments available. However, there comes a time in the treatment of most illnesses when one or other treatment is recognised as effective. It is then that ethical questions arise in the use of placebos in evaluating other new treatments for the same condition. For example, it is difficult to justify the use of placebos in trialling new medications for treating depression. Gold standards such as tricyclic antidepressants, or the now well-established selective serotonin reuptake inhibitors, are generally used as benchmarks in studies examining the efficacy of new antidepressants. How well established do new treatments have to be before they themselves become the standard against which other new drugs should be investigated rather than subjecting patients to the risk of having no treatment at all? This situation is addressed in Section 12.4 of the recently published National Health and Medical Research Council (NHMRC) Statement on ethical conduct in research involving humans,3 which states: "The use of a placebo alone or the incorporation of a non-treatment control group is ethically unacceptable in a controlled trial where: (a) other available treatment has already been clearly shown to be effective; and (b) there is risk of significant harm in the absence of treatment. Full Article: http://www.mja.com.au/public/issues/173_03_070800/goldney/goldney.html |
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2006 Ethics-Governance.com |
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