The Placebo Effect and the Pharmaceutical Industry
- PDF / 113,227 Bytes
- 7 Pages / 612 x 794 pts Page_size
- 50 Downloads / 292 Views
Int J Pharm Med 2005; 19 (4): 219-225 1364-9027/05/0004-0219/$34.95/0 © 2005 Adis Data Information BV. All rights reserved.
The Placebo Effect and the Pharmaceutical Industry Lee Grant and David Roblin Pfizer Ltd, Sandwich Laboratories, Sandwich, England
Abstract
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.
The word ‘placebo’ is derived from the Latin for ‘I will please’. It occurs as part of Psalm 116 and this passage, which begins with the words ‘Placebo Domino in regione vivorum’, was used in the 14th century as Catholic vespers for the dead. People who wanted these words spoken at a funeral of a family member were often charged exorbitant fees. In this way the term became associated with words that were insincere but nonetheless comforting. In 1811, Quincy’s Lexicon-Medicum defined a placebo as ‘an epithet given to any medicine adapted more to please than benefit the patient’, and in the 18th century it entered medical terminology as a description of a fake remedy. Prior to the end of World War II, it was commonplace to use a placebo as part of a ‘benevolent deception’ using an assortment of sugar pills. In fact, one viewpoint was that ‘for some unintelligent or inadequate patients life is made easier by a bottle of medicine to comfort their ego’.[1] The acceptance of new therapeutic options was at this time based largely on the clinical experience of a number of recognised experts and not subject to rigorous scientific process. This attitude changed following World War II, when it was appreciated that unbiased and well-designed scientific evaluation was critical to the safe and effective development of new medicines. This was encapsulated in the emergence of the double-blind, randomised, controlled trial; a key component being the recognition of and allowance for a potential and significant placebo effect. In 1955 Henry Beecher published a key pa-
per in the Journal of the American Medical Association (JAMA) that, at the time, was used to justify the existence of this significant placebo effect.[2] Although subsequently found to be flawed for a number of reasons, its conclusion that 30% of study participants experience a ‘placebo effect’ has often been quoted in subsequent publications. This review discusses factors contributing to the placebo response and why it is such an important consideration when designing drug studies. The primary source of information
Data Loading...
