Communicating About Comparative Effectiveness Research: A Health Affairs Symposium On The Issues

Abstract

The United States is pursuing an agenda of increased comparative effectiveness research in an effort to identify high-value health care. One of many issues connected with the research is how findings will be communicated, particularly if they pertain to prescription drugs and if the findings could be useful for promotional purposes yet fall short of the standard of "substantial evidence" required by the Food and Drug Administration (FDA) under federal law. To surface and air the relevant issues, this article posits a hypothetical case study of comparative effectiveness research involving a fictional migraine drug. A symposium of analyses and responses follows from various stakeholders representing the FDA; the Patient-Centered Outcomes Research Institute, and pharmaceutical companies; an attorney for the industry; academic specialists in the area of pharmaceutical law and policy; a proponent of academic detailing, or university or non-commercial-based education of prescribers based on medical evidence; a payer; a bioethicist; and an official from an organization representing patients with chronic diseases and disabilities.