The conduct of clinical trials involving placebo in developing countries in the presence of an existing effective treatment triggered an intense debate on the standard of care to be provided to those populations. Charges of exploitation of vulnerable groups and double standards have been raised by several scholars. In response to these concerns, the Declaration of Helsinki was revised in 2000, 2008 and 2013, eventually endorsing the golden standard instead of the local standard of care. The European Union adopted a (...) strategy on the Marketing Authorization of medicinal products tested in third countries, improved with Regulation 536/2014 on clinical trials on medicinal products for human use. Additional rules have been enacted by other international organizations. The present paper has the aim of analyzing scope and content of existing international and regional standards on placebo. (shrink)

The concept of clinical equipoise restricts the use of placebo controls in clinical trials when there already exists a proven effective treatment. Several critics of clinical equipoise have put forward alleged counter-examples to this restriction—describing instances of ethical placebo-controlled trials that apparently violate clinical equipoise. In this essay, we respond to these examples and show that clinical equipoise is not as restrictive of placebos as these authors assume. We argue that a subtler appreciation for clinical equipoise—in particular the distinction between (...) de facto and de jure interpretations of the concept—allows the concept to explain when and why a placebo control may be necessary to answer a question of clinical importance. (shrink)