GUIDANT INDEPENDENT PANEL BEGINS DELIBERATIONS
Robert Myerburg, professor of Medicine and Physiology at the University of Miami and recently appointed chair of Guidant's Independent Panel, notified the company yesterday that he has completed recruiting panel members.
The roster of panel members include: 1) George Apostolakis, professor of nuclear science and engineering and professor of engineering systems at Massachusetts Institute of Technology; 2) George Beller, professor of cardiology at University of Virginia Health System; 3) John DiMarco, professor of medicine at University of Virginia Health System; 4) David Feigal, research professor of the Arizona Biodesign Center at Arizona State University; 5) Kenneth Goodman, associate professor of medicine and philosophy and director of the bioethics program in the University of Miami Ethics Program; and 6) Sharon Hunt, professor of medicine at Stanford University School of Medicine, among others.
The panel will hold its first meeting August 30-31. Its deliberations will continue through early winter. According to Guidant, it will first review and analyze and then provide specific recommendations to the company regarding four core issues defined in the formal charter of the Independent Panel: 1) surveillance and interpretation of low-frequency trends among life-sustaining implantable devices that may affect patient safety and physician decisions for device management; 2) reassessment of benefit and risk to patients in light of new information about marketed devices; 3) device component failure analysis and estimation of its frequency; and 4) development of more transparent, understandable and clinically useful communication processes to physicians and patients, including triggers for communication, timing, and novel methods of transferring information. The panel is expected to present a complete report within six months.