Dear All,
Amy - thank you for this interesting, and important, question.
If there is a current evidence-based (effective) established therapy, it is unethical to use 'placebo' controls. We should use the established, EB therapy.
I would be surprised whether, in the field of addiction, there is not an established therapy. If there is an established therapy whose effectiveness is in doubt, then you might consider requiring your experimental therapy to demonstrate SUPERIORITY to the established (but doubtful) therapy.
It is a myth that placebo controls offer higher validity than 'active' controlled trials (see http://www.ncbi.nlm.nih.gov/pubmed/19998192). The myth is propagated by failure to understand what placebos are, and by confusion between two dichotomies: placebo/active controls and superiority/noninferiority trials (see paper for details that can get slightly technical).
This myth not only leads to unethical trials, but is arguably responsible for a large proportion of the increase in healthcare costs over the last decade (see Morgan, S. G. , Bassett, K. L. , Wright, J. M. , Evans, R. G. , Barer, M. L. Caetano, P. A. et al. (2005) “Breakthrough” drugs and growth in expenditure on prescription drugs in Canada. British Medical Journal 331:7520 , pp. 815-816).
Best wishes,
Jeremy
________________________________________
From: Evidence based health (EBH) [[log in to unmask]] On Behalf Of Dr. Amy Price [[log in to unmask]]
Sent: Monday, February 28, 2011 5:04 AM
To: [log in to unmask]
Subject: Placebo ethics
Dear All,
I am working on a five site in-house addiction study that offers cognitive rehabilitation treatment. For the sake of validity etc it is suggested that we do this as placebo, randomised, double blind study . My concern is that even though I can arrange for controls to have access to the experimental treatment following the study, in reality this is not likely to be happen as they are institutionalized for only 30 days. The downside is the controls who are in need will go untreated and the ineffectiveness of the placebo may discourage them from further treatment and in addition they will not receive the benefits of early intervention for this condition. Even wait listing 50% of them after initial baselines would provide similar ethical concerns. I am certain the double blind with placebo will pass IRB protocols etc. What I am wondering is would the greater strength of the controlled study outweigh the disadvantages for the few who are excluded from early intervention and what would others do given these circumstances?
I appreciate the depth and breadth of the wisdom and experience represented on this listserve. Ethics and best practice are important to me and I will consider carefully the information you have time to share.
Thank you for your help with this,
Amy
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