The Placebo Effect and the Pharmaceutical Industry
- 43 Downloads
The placebo effect has long been recognised in medical practice and numerous definitions of the placebo effect and its cause have been proposed. While having a significant impact on study design, it can also be of such a magnitude that pivotal trials demonstrating the superiority of a drug over placebo are difficult to achieve.
This review discusses the factors contributing to the placebo response and why it is such an important consideration for the pharmaceutical industry when designing drug studies. The ethical use of placebos will also be considered, with particular reference to the Declaration of Helsinki and the rights of an individual against the rights of a study population as a whole.
KeywordsPlacebo Irritable Bowel Syndrome Sertraline Placebo Effect Placebo Response
Both authors are current employees of Pfizer Ltd.
- 1.The humble humbug. Lancet 1954; ii: 321.1Google Scholar
- 3.Brody H. Placebos and the philosophy of medicine: clinical, conceptual and ethical issues. Chicago (IL): University of Chicago Press, 1980Google Scholar
- 7.Evans D. Placebo: the belief effect. London: Harper Collins, 2003Google Scholar
- 12.Miller CA, Hooper CL, Bakish D. A comparison of placebo response with major depressive disorder in patients. J Psychopharmacol Bull 1997; 33 (4): 647–51Google Scholar
- 23.Committee for Proprietary Medicinal Products. Note for guidance on the clinical investigation of medicinal products for the treatment of urinary incontinence [online]. Available from URL: http://www.emea.eu.int/pdfs/human/ewp/001801en.pdfcessed 2005 Oct 14]Google Scholar