Equipoise is an essential condition to justify a clinical trial. The term, describes a state of uncertainty: the data suggest but do not prove a drug's safety and efficacy The only way to resolve this uncertainty is further study In many cases, a clinical trial seems to be the most efficient way to prove safety and efficacy Equipoise is therefore not an esoteric philosophic construct applied to research ethics. Rather, since it is vital for the justification of clinical trials, it (...) is part of how society regulates medical progress. Where there is equipoise, drug design and development proceeds according to Food and Drug Administration and Health and Human Services regulations. When that equipoise ends, a drug is either not approved or becomes standard care. (shrink)

ABSTRACT In this essay, Paul Lauritzen examines Richard B. Miller's liberal account of pediatric ethics by asking if the duty to promote a child's basic interests is substantial enough to secure the well‐being of children. This question is raised in light of two case studies: daytime TV talk shows that broadcast interviews with sexually active children, and a medical study conducted to test the effect of growth hormone treatment on adult height in peripubertal children. In both cases, Lauritzen argues, children (...) are subjected to potential harms that are not easily explained, and therefore not easily prevented, by appeals to basic interests. (shrink)

Placebo-controlled trials are held by many, including regulators at agencies like the United States Food and Drug Administration, to be the gold standard in the assessment of new medical interventions. Yet the use of placebo controls in clinical trials has been the focus of considerable controversy. In this two-part article, we challenge a number of common beliefs concerning the value of placebo controls. Part I critiques statistical and other scientific justifications for the use of placebo controls in clinical research. The (...) continued use of placebo controls in clinical trials on diseases for which accepted treatment exists raises equally important ethical, legal, and regulatory issues for which various justifications have been given. Defense of this practice relies on normative as well as empirical myths.In their attack on the prevailing use of placebo controls, Kenneth Rothman and Karin Michels emphasize that this practice stands in violation of the World Medical Association's guidelines on the ethics of human experimentation, most commonly known as the Helsinki Declaration. (shrink)

In the specialized area of pediatric endocrinology, the use of human growth hormone (hGH) both for children who have a growth hormone abnormality and for the treatment of non-hGH-deficient children who are short is a current clinical reality that raises important ethical questions. Generally speaking, the use of hGH for those children who are clearly lacking it is an efficacious intervention based upon established clinical criteria. The use of hGH for children who are short, but have no growth hormone abnormality (...) is ethically and clinically more controversial. The moral conundrum of how to gain knowledge about new medical treatments that may be beneficial to children while, at the same time, ethically enrolling them in clinical trials with placebo arms in order to gain such knowledge will continue to be a contentious issue in the conduct of research and in the delivery of health care. In addition, there are questions about what ought to be studied and whether a physical characteristic such as short stature ought to be viewed as a circumstance of less than optimal health. (shrink)