The question is whether or not the intervention is proven effective already. If it is not (and I assume it is not because that is why you are studying it) then you don’t know whether people who receive it will receive benefit or harm. In your question you seem to be assuming that those in the control group will suffer some disadvantage. But if the intervention you are studying is ineffective or harmful, then the control group will actually be either better off or no worse off than the intervention group. So under those circumstances there should be no ethical problem, and then the gain in validity is well worth it since there is no downside.
You mention that the study is an in-house addiction study. Therefore I assume that when you say “untreated” you mean untreated by the cognitive treatment you are studying, but that likely those patients are 1) in house, and 2) therefore exposed to all kinds of services and interactions, that may be therapeutic. Those in house now are receiving something, right? (what is standard care in that setting locally, and will patients receive it?) In which case your study is “new cognitive treatment” vs usual care.
In addictions there is a long history of surprises—in the 1970s, when “standard care” was weeks of inpatient treatment, there was an RCT comparing that to ONE BRIEF counseling session. The clinical outcomes were similar. It was not unethical to do the study. And if we didn’t have that information, millions of patients would have been subjected to unnecessary (and potentially harmful and costly) inpatient treatment (I am not saying that inpatient treatment is never indicated, but that it was likely used for many who didn’t need it).
Controlled and placebo controlled are also not the same. Do you envision an attention placebo control (one in which controls receive the same time with a counselor but not receiving cognitive therapy) or a study where one group receives therapy/counseling and the other does not?
There are other treatments for addiction. And cognitive behavioral interventions can be effective under some circumstances but presumably not yet known in the setting or circumstance in which you are testing it. The existence of a therapy does not necessarily make a controlled trial unethical---it depends on whether a delay would make a meaningful difference (imagine a placebo-controlled trial of a medication for rhinitis symptom. Even if a therapy is available elsewhere, it is not unethical to study it in a controlled fashion if its effectiveness is not proven. See Temple and Ellenberg who conclude that “placebo-controlled trials are not uniformly unethical when known effective therapies are available; rather, their acceptability is determined by whether the patient will be harmed by deferral of therapy. If patients are not harmed, such trials can ethically be carried out.” Ann Intern Med http://www.annals.org/content/133/6/455.abstract
(Director, Clinical Addiction, Research and Education (CARE) Unit)
Editor, Evidence-based Medicine (EBM)
Professor of Medicine and Epidemiology
Section of General Internal Medicine
Boston University Schools of Medicine and Public Health
Boston, MA 02118-2335
617 414 6910 (Sarah)
617 414 7744 (direct)
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From: Evidence based
health (EBH) [mailto:[log in to unmask]] On Behalf Of Dr. Amy Price
Sent: Monday, February 28, 2011 12:05 AM
To: [log in to unmask]
Subject: Placebo ethics
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,
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