Communicating About Comparative Effectiveness Research: A Health Affairs Symposium on the Issues
One of many issues connected with comparative effectiveness research is how the 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 FDA under federal law.
Authors: Various, with funding provided by the National Pharmaceutical Council
Publication: Health Affairs, 31, No. 10 (2012)
Abstract (from Health Affairs): 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, one article in this issue of Health Affairs posits a hypothetical case study of comparative effectiveness research involving a fictional migraine drug. A symposium of analyses and responses to this study 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.
The National Pharmaceutical Council (NPC) provided funding for this issue and contributed to the article, "Communication About Results of Comparative Effectiveness Studies: A Pharmaceutical Industry View."
This issue follows up on related topics raised during a conference hosted by NPC, the National Health Council and WellPoint in February 2012. NPC Chief Science Officer Dr. Robert Dubois explains the concerns about CER communications in a brief video.