Horng-How ethical is the Placebo Surgery

Horng-How ethical is the Placebo Surgery - S OUND ING BOA...

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SOUNDING BOARD N Engl J Med, Vol. 347, No. 2 · July 11, 2002 · www.nejm.org · 137 Sounding Board I S P LACEBO S URGERY U NETHICAL ? URGICAL procedures are often introduced into practice without rigorous evaluation. Moreover, clinical trials of surgery have seldom included place- bo surgery as a control, owing to ethical concerns. In 1959, the Journal published the results of a pla- cebo-controlled trial of ligation of the internal tho- racic artery for the treatment of angina. 1 In this issue of the Journal, Moseley et al. report on a placebo- controlled trial of arthroscopic surgery for osteoarthri- tis of the knee. 2 In both studies, the surgical interven- tions were no more effective than placebo operations. A major difference between the use of placebo surgery 43 years ago and its use now, however, is the degree of attention to the ethical aspects of conducting clinical research. THE ETHICS OF CLINICAL RESEARCH The idea of using placebo surgery is apt to elicit an immediate negative judgment, because it appears to violate the fundamental ethical principles of benefi- cence and nonmaleficence. 3 Doctors should not ex- pose patients to risks if there is no prospect of possible benefits. With respect to surgery, this means that sur- geons should not invade the body except for the pur- pose of cure or amelioration. In a recent ethical cri- tique of placebo surgery for Parkinson’s disease, Clark asserted, “The researcher has an ethical responsibility to act in the best interest of subjects.” 4 Although this statement reflects a commonly artic- ulated moral stance with regard to clinical research, it confounds the ethics of clinical research with the ethics of clinical care. The randomized, controlled trial is not a form of individualized medical therapy; it is a scientific tool for evaluating treatments in groups of research participants, with the aim of improving the care of patients in the future. Clinical trials are not de- signed to promote the medical best interests of en- rolled patients and often expose them to risks that are not outweighed by known potential medical benefits. Accordingly, the use of placebo surgery must be eval- uated in terms of the ethical principles appropriate to clinical research, which are not identical to the ethical principles of clinical practice. 5 Clinical research involves an inherent tension be- tween the ethical values of pursuing rigorous science and protecting participants from harm. 6 To avoid ex- ploiting research subjects, clinical trials must satisfy several ethical requirements. 5 Clinical trials are uneth- S ical if they are not designed to answer valuable scien- tific questions with the use of valid research methods. In addition to having scientific merit, clinical trials
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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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Horng-How ethical is the Placebo Surgery - S OUND ING BOA...

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