Placebo and the Helsinki Declaration--what to do?
The Helsinki Declaration is the 'gold standard'--a directive, not a law, on how to conduct controlled studies in humans in conformity with ethical principles. In spite of many discussions about their unsuitability some articles have remained unchanged in the most recent (sixth) revision of the Declaration. The demand to use "the best treatment" excludes use of placebo in the control group and presents an obstacle to the scientific evaluation of a number of drugs and treatments in general. The use of placebo is justified whenever its use does not cause irreversible damage or considerable suffering to the well informed patient. It must be, is, and will be used in the controlled clinical trials of treatments of a great number of diseases especially those which have a tendency to spontaneous improvement, even healing, or have a pronounced psychological component.
Croatian Bioethics Committee for Medicine, Zagreb, Croatia. bvrhovac@post.hinet.hr
Bozidar
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Vrhovac
D026686:Beneficence; D018849:Controlled Clinical Trials as Topic / Q000941:ethics* / Q000379:methods; D004341:Drug Evaluation / Q000941:ethics; D006381:Helsinki Declaration; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D015990:Placebo Effect; D010919:Placebos
D010919:Placebos