“NO ONE ASKED THE BABY” – AN ETHICAL ISSUE IN PLACEBO-CONTROLLED TRIALS IN PREGNANT SMOKERS

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Peter Selby Selby
Bhushan M. Kapur
Richard Hackman
Gideon Koren

Keywords

Ethics, placebo-controlled trial, consent, nicotine

Abstract

This  case  report involving a  placebo-controlled nicotine patch trial  illustrates the  difficult issue of conducting placebo studies in pregnancy, when one of the two patients involved cannot be asked to consent.

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References

1. Dempsy D, Jacob P, Benowitz NL. Accelerated metabolism of nicotine and cotinine in pregnant smokers. J Pharmacol Exp Ther 2002; 301: 594-8.
2. Fuchs FD, Klag MJ, Whelton PK. The classics: a tribute to the fiftieth anniversary of the randomized clinical trial. J Clin Epidemiol 2000;53:335-42.
3. Shapiro AK, Shapiro E. The placebo: is it much ado about nothing? In: Anne Harrington, editor. The placebo effect. Cambridge: Harvard University Press; 1997. p. 12-36.
4. Windsor R, Boyd N, Orleans T. A meta- evaluation of smoking cessation intervention research among pregnant women: Improving the science and art, Health Educ Res. 1998; 13(3), 419-438.
5. Fisher S, Greenberg RP. How sound is the double- blind design for evaluating psychotropic drugs? J Nerv Ment Dis 1993; 181:345-50.
6. Koren G: Ethics of drug research in pregnancy, infancy and childhood. In: G. Koren, editor. Textbook of Ethics in Pediatric Research, Malabar, Fla; Krieger; 1993. p. 171-81.

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