Cadesky-Are Placebo Studies Ethical

Cadesky-Are Placebo Studies Ethical - 56 MJM 2001 6: 56-60...

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56 Copyright © 2001 by MJM CROSSROADS: WHERE MEDICINE AND THE HUMANITIES MEET MJM 2001 6: 56-60 Are Placebo-Controlled Studies Ethical in Psychiatric Research? Eric Cadesky *† , Hons. B.Sc. Although the general use of placebos dates back to the 16th century (1), they represent a relatively new method of testing drugs (2). With the current pressure on psychiatrists to treat patients quickly and inexpensively, drug companies are competing to gain licensure for their new products. In order for a drug to be approved, however, both the United States Food and Drug Administration and the Canadian Health Products and Food Branch require research with placebo controls (3,4). However, ethical aspects of such practice have been criticized in the academic and non-academic literature (e.g. 5-7). Thus, the question demands attention: Are placebo-controlled studies justifiable in psychiatric research? In this paper, I will argue that the use of placebos in psychiatric research can be ethical and that placebo arms provide valuable information for both researchers and patients. First, I will define the basic principles that underlie the ethical assessment of placebo trials. The second part of this review will examine and evaluate both the ethical and scientific criticisms laid against placebo-controlled trials. This will be followed by a discussion of the ethical and scientific merits of placebo arms. In the final section, I will offer practical guidelines on how to properly and ethically use placebo arms in psychiatric research. DEFINITION OF ETHICAL PRINCIPLES The use of placebo controls touches on four main ethical principles (for review see reference 8). Armed with these four principles, we can examine the ethical criticisms that have been laid against the use of placebo controls in research, as well as the ethical merits of this practice. The first principle is that of autonomy. This principle holds that individuals should be allowed to make independent choices, for themselves, that are in accordance with their own values and principles. This idea is manifest in the use of informed consent: Only those who act autonomously can make decisions on medical interventions pertaining to their health. The second principle is beneficence. It posits that we should perform acts that benefit others. The definition of ‘benefit’ can be made by a patient in conjunction with health care professionals. Paternalism, the third principle, is a special type of beneficence. It states that decisions regarding treatment should be made by those with professional knowledge; that is, decisions should be made for patients by physicians because they possess medical knowledge. Although paternalism was once the basis of medical decision making, its prevalence has declined in recent years because it can lead to the exclusion of a patient’s values: the exercise of medical paternalism can conflict with a patient’s ability to act autonomously. Further, enforcing one’s values on another may lead to
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This note was uploaded on 03/06/2011 for the course PSYCH 212 taught by Professor Dansullivan during the Spring '11 term at NYU.

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Cadesky-Are Placebo Studies Ethical - 56 MJM 2001 6: 56-60...

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