Healthy Skepticism Library item: 20265

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Gupta S, Fugh-Berman A, Scialli AR
Ethics and Eplerenone
J Med Ethics;
http://www.ncbi.nlm.nih.gov/pubmed/23015747

Abstract:

The use of a placebo arm in clinical trials is unethical if there is
an active comparator that is acceptably safe and effective. We argue
that reasonable evidence of effectiveness and safety of an inexpensive
alternative to an expensive therapy is sufficient to require that the
inexpensive therapy be included as a comparator when the expensive
therapy is tested, and that use of an inactive placebo comparator only
is not ethical. For example, studies of the expensive drug,
eplerenone, for congestive heart failure have not included a
spironolactone arm, although there is reasonable evidence that
spironolactone would be safe and effective, and spironolactone is
inexpensive. The requirement to study inexpensive therapies is based
on avoidance of unnecessary cost in medical care as an example of non-
maleficence. Several ethical actors in the design, conduct and
publication of clinical trials and their results bear responsibility
for the appropriate conduct of clinical trials. That responsibility
includes protecting study subjects from being asked to participate in
clinical trials that serve primarily to promote the use of new and
expensive therapies.