Dr Heaney has research contracts from the following companies: Eli Lilly and Co., General Mills, GlaxoSmithKline, Lane Laboratories, Mead Johnson, National Dairy Council, Proctor and Gamble Pharmaceuticals, Rhodia, and Roots, Inc. He serves as a consultant for Bayer, General Mills, GlaxoSmithKline, and National Dairy Council. Dr Heaney is also a member of the Speaker's Bureau for the Eli Lilly and Co. and National Dairy Council. He is an emeritus member of the Board of Trustees for the National Osteoporosis Foundation. Please note that the research contract and consultant income is not retained by Dr Heaney but is paid to Creighton University
Is the Use of Placebo Controls Ethically Permissible in Clinical Trials of Agents Intended to Reduce Fractures in Osteoporosis?
Article first published online: 1 JUN 2003
Copyright © 2003 ASBMR
Journal of Bone and Mineral Research
Volume 18, Issue 6, pages 1105–1109, June 2003
How to Cite
Brody, B. A., Dickey, N., Ellenberg, S. S., Heaney, R. P., Levine, R. J., O'brien, R. L., Purtilo, R. B. and Weijer, C. (2003), Is the Use of Placebo Controls Ethically Permissible in Clinical Trials of Agents Intended to Reduce Fractures in Osteoporosis?. J Bone Miner Res, 18: 1105–1109. doi: 10.1359/jbmr.2003.18.6.1105
- Issue published online: 2 DEC 2009
- Article first published online: 1 JUN 2003
- placebo controls;
- active controls;
- clinical trials
Substantial progress has been made in developing treatments that reduce the risk of fractures in osteoporosis. However, available treatments are only partially effective, they are not widely used, and there is need to search for more effective means of fracture prevention. Currently known effective means of reducing fractures were found using randomized placebo-controlled trials. The use of placebo controls in clinical trials has been a subject of significant controversy in recent years. The Declaration of Helsinki revision of October 2000 caused great concern among clinical investigators about the future use of placebo controls if known effective therapeutic agents are available. A working group of ethicists, clinical trial design experts, and clinical investigators examined the current state of knowledge of osteoporosis treatment and trials. They concluded that if placebo controls put subjects at substantial risk of serious outcomes, they are not ethically permissible. Placebo controls in osteoporosis trials with fracture as the measured outcome are permissible only under narrowly defined conditions. Placebo controls may be used if competent, well-informed patients refuse approved therapies for sound reasons, there is a reasonable basis for substantial disagreement or lack of consensus among professionals about whether approved treatments are better than placebos, or subjects are refractory to known effective agents. Active control trials are permissible and desirable if they can be designed and conducted in ways that overcome the interpretive difficulties often associated with such trials.