A renewed, ethical defense of placebo-controlled trials of new treatments for major depression and anxiety disorders
Graduate studies at Western
Journal of Medical Ethics 35 (6):384-389 (2009)
|Abstract||The use of placebo as a control condition in clinical trials of major depressive disorder and anxiety disorders continues to be an area of ethical concern. Typically, opponents of placebo controls argue that they violate the beneficent-based, “best proven diagnostic and therapeutic method” that the original Helsinki Declaration of 1964 famously asserted participants are owed. A more consequentialist, oppositional argument is that participants receiving placebo might suffer enormously by being deprived of their usual medication(s). Nevertheless, recent findings of potential for suicidality in young people treated with antidepressants, along with meta-analyses suggesting that antidepressants add no significant clinical benefit over placebos, warrant a re-evaluation of the arguments against placebo. Furthermore, the nature of placebo treatment in short-term clinical trials is often not well understood, and lack of understanding can foster opposition to it. This paper will show how scientific justifications for placebo use are morally relevant. The fundamental ethical importance of placebo controls is discussed in relation to several aspects of clinical trials, including detection of adverse events, accurate assessment of clinical benefit, advancing understanding of the heterogeneity of depression and anxiety disorders and respecting informed consent requirements. Prohibiting the use of placebo controls is morally concerning in that such prohibitions allow for the possibility of serious adverse public health consequences. Moral worries that research participants receiving placebo are being unduly jeopardised will be shown to be exaggerated, especially in relation to the net benefits for end-users to be gained from the quality of data resulting from using placebo controls|
|Keywords||info:mesh/Informed Consent info:mesh/Clinical Trials as Topic info:mesh/Depressive Disorder, Major info:mesh/Antidepressive Agents info:mesh/Research Design info:mesh/Humans Humans Antidepressive Agents Placebos Anxiety Disorders Depressive Disorder, Major Research Design Informed Consent Clinical Trials as Topic info:mesh/Anxiety Disorders info:mesh/Placebos|
|Categories||categorize this paper)|
|Through your library||Configure|
Similar books and articles
Franklin G. Miller & Howard Brody (2002). What Makes Placebo-Controlled Trials Unethical? American Journal of Bioethics 2 (2):3 – 9.
James A. Anderson (2006). The Ethics and Science of Placebo-Controlled Trials: Assay Sensitivity and the Duhem-Quine Thesis. Journal of Medicine and Philosophy 31 (1):65 – 81.
Stanisław Pużyński (2004). Placebo in the Investigation of Psychotropic Drugs, Especially Antidepressants. Science and Engineering Ethics 10 (1):135-142.
Bozidar Vrhovac (2004). Placebo and the Helsinki Declaration — What to Do? Science and Engineering Ethics 10 (1).
Jeremy Sugarman (2004). Using Empirical Data to Inform the Ethical Evaluation of Placebo Controlled Trials. Science and Engineering Ethics 10 (1):29-35.
Carlo Petrini (2009). Ethical Issues in the Difference Between Placebo-Controlled and Active-Controlled Trials. American Journal of Bioethics 9 (9):56-58.
Lawrence Scahill, Mary Solanto & Joseph McGuire (2008). The Science and Ethics of Placebo in Pediatric Psychopharmacology. Ethics and Behavior 18 (2 & 3):266 – 285.
John Davis, William Giakas, Jie Que, Pavan Passad & Stefan Leucht (2011). Should We Treat Depression with Drugs or Psychological Interventions? A Reply to Ioannidis. Philosophy, Ethics, and Humanities in Medicine 6 (1):8-.
Beatrice Alexandra Golomb (2009). Control Theory: Placebo-Controlled Drug Trials Have Problems. Active-Controlled Drug Trials Are Not Always the Solution. American Journal of Bioethics 9 (9):67-69.
Olov Lindahl & Lars Lindwall (1982). Is All Therapy Just a Placebo Effect? Theoretical Medicine and Bioethics 3 (2):255-259.
Piotr Zaborowski & Adam Górski (2004). Informed Consent and the Use of Placebo in Poland: Ethical and Legal Aspects. Science and Engineering Ethics 10 (1).
Gordon C. S. Smith & Jill P. Pell (2003). Parachute Use to Prevent Death and Major Trauma Related to Gravitational Challenge: Systematic Review of Randomised Controlled Trials. Bmj 327 (7429):1459--61.
Added to index2010-09-13
Total downloads3 ( #213,731 of 739,349 )
Recent downloads (6 months)1 ( #61,538 of 739,349 )
How can I increase my downloads?