Clinical trials and equipoise essay sample

Conducting clinical medical trials entails many ethical dilemmas. Tests of novel drugs and treatments require theoretical equipoise; a state where the researcher uses a fiction whereby he assumes an uncertainty about the benefits of any medical treatment. This fiction creates obvious problems because researchers usually have some idea about treatment efficacy (Lilford, Jackson, 1995). Stang et al., take issue with the ethics of using a placebo in randomized clinical trials to prove the efficacy of new drugs (2005). The objection revolves around the fact that for many diseases effective treatments are available and withholding therapy may be seen as unethical. Freedman divides equipoise into two forms: theoretical and clinical. Theoretical equipoise requires an equal balance of probability of success of treatment. In practical matters, this is violated regularly as even an investigators hunch about a drug may have ethical implications. Clinical equipoise resolves this problem by deferring to the clinicians treatment habits (Freedman, 2005).
Another ethical dilemma that arises in scientific research is the harmful effects of potential treatments. Wood and Darbyshire recount a terrible incident where every participant receiving a drug ended up in the Intensive Care Unit (2006). Testing had shown no toxic effects at significantly higher doses and the drug was presumed safe. They ultimately conclude that protocols need to be set in place to prevent administration errors and that even trials gone horribly wrong provide valuable research material. Parkins et al performed another study posing ethical conundrums (1998). Firstly the study used infants; a particularly vulnerable class of test subject. Furthermore, their experiment subjected the children to hypoxia: something known to have negative consequences. The conclusions of the experiment showed there a significant portion of infants became hypoxemic and it is impossible to predict to whom it would happen. The clinical value of the experiment is suspect.

Works Cited:

Lilford R. J., Jackson J. (1995) Equipoise and the ethics of randomization. Journal of the
Royal Society of Medicine. 88. 552-559. http://www. ncbi. nlm. nih. gov/pmc/articles/pmid/8537943/9
Miller, F. G., Brody, H. (2003). Against clinical equipoise: therapeutic misconception in
the ethics of clinical trials, The Hastings Center Report, 33(3), 19-28.
Parkins, K. J., Poets, C. F., O’Brien, L. M., Stebbens, V. A., Southall, D. P. (1998) Effect of
exposure to 15% oxygen on breathing patterns and oxygen saturation in infants:
an interventional study, The British Medical Journal, 316(7135), 887-12.
Stang A., et al. (2005) Is it always unethical to use a placebo in a clinical trial? PLoSMed,
2(3). e72. http://www. ncbi. nlm. nih. gOv/pmc/articles/pmid/15783259/
Wood, A. J. J., Darbyshire, J. (2006) Injury to research volunteers – the clinical research
nightmare, The New England Journal of Medicine, 354(18), 1869-1873.