| Update on unethical use of placebos in randomised trials. | |
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MedLine Citation:
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PMID: 12812185 Owner: KIE Status: MEDLINE |
Abstract/OtherAbstract:
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The most recent (Fifth) revision of the Declaration of Helsinki, adopted in October 2000 by the World Medical Association (WMA), reinforces the longstanding prohibition against offering placebo instead of effective therapy. The WMA left no doubt that if a beneficial treatment for a condition has already been recognised, it is unethical to offer placebo in place of such treatment to anyone in a study of the same condition. We have previously drawn attention to the discrepancy between the spirit of the Declaration and the common practice of using placebo controls in randomised trials even if effective treatment exists. Despite the mandates of the Declaration of Helsinki and concern from ethicists and scientists, the US Food and Drug Administration (FDA) continues to demand and defend placebo-controlled evidence of efficacy and safety for the development of many new pharmaceuticals, even if effective therapy exists. We suggest that the FDA's arguments defending their practice are insufficient to justify medical research that violates the Declaration of Helsinki. |
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Authors:
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Karin B Michels; Kenneth J Rothman |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Bioethics Volume: 17 ISSN: 0269-9702 ISO Abbreviation: Bioethics Publication Date: 2003 Apr |
Date Detail:
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Created Date: 2003-06-17 Completed Date: 2003-07-28 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 8704792 Medline TA: Bioethics Country: England |
Other Details:
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Languages: eng Pagination: 188-204 Citation Subset: E |
Affiliation:
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Department of Epidemiology, Harvard School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA. kmichels@rics.bwh.harvard.edu |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Government Regulation Guidelines as Topic Helsinki Declaration* Humans Internationality Placebos* Randomized Controlled Trials as Topic / ethics* Research Design* United States United States Food and Drug Administration |
| Chemical | |
Reg. No./Substance:
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0/Placebos |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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