Minimizing Harm and Maximizing Benefit During Innovation in Health Care: Controlled or Uncontrolled Experimentation?

ABSTRACT: However one chooses to define progress in health care, it can only be achieved by changing the status quo: that is, by innovation. Because innovations have frequently proved either useless or positively harmful to health service users, it is important to consider how harm can be minimized and benefit maximized. In general, these objectives are pursued using controlled experimentation when the innovations involve drugs. For innovations involving almost every other form of health care, relatively uncontrolled experimentation is the rule, and this situation is actively promoted by those who support free trade in the health care marketplace. An informed public discussion is required to help assess which of these two approaches to innovation in health care is most likely to protect the interests of current and future health service users. For a variety of reasons, critics of perinatal care are in a potentially strong position to play a leading role in the debate that is required, but new alliances between health service users, health professionals, and researchers are required if this potential is to be realized successfully