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Ethical Issues Placebo

Ethical Issues Placebo - Research E THICAL ISSUES IN...

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ETHICAL ISSUES IN ALZHEIMER’S DISEASE Placebo Control COMMON QUESTIONS When is it unethical to use placebos in med- ical re s e a rc h ? Gi ven that there are drugs currently approve d for treating Alzheimer’s disease, is it ethical to a l l ow individuals with Alzheimer’s to re c e i ve a placebo when participating in a re s e a rch study? BACKGROUND INFORMATION A placebo is an inactive substance that is used in medical re s e a rch. In many clinical trials, part i c i- pants re c e i ve either the drug under inve s t i g a t i o n or a placebo. Neither the people administering the t reatment nor the participants know who is get- ting the actual drug. This method provides re- s e a rchers with a well-defined control gro u p against which they can compare the effect of the d rug. Many scientists prefer placebo-contro l l e d studies because the results are often easier to inter- p ret and the studies re q u i re fewer participants and less time. Howe ve r, if a clearly beneficial tre a t- ment, or “s t a n d a rd of care,” exists for a part i c u l a r disease, it cannot ethically be withheld fro m re s e a rch participants. In these circumstances, peo- ple in the control group re c e i ve the drug consid- e red the standard of care, and re s e a rchers compare the safety and effectiveness of the new dru g against that of the standard tre a t m e n t . ASSOCIATION POSITIONS In order to address this issue as it relates to clini- cal trials in Alzheimer re s e a rch, the Association’s Ethics Ad v i s o ry Panel met on April 27, 1998, with the Internal Ethics Committee of the Alz- h e
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