Reflections on the Design of Clinical Trials: A Conversation With Raymond J. Lipicky, MD.

Abstract

Raymond Lipicky was born in Cleveland, OH. He received an MD from the University of Cincinnati in 1960 and completed an internship and residency at Barnes Hospital at the Washington University School of Medicine in St. Louis, MO. He trained in cardiology at Strong Memorial Hospital in Rochester, NY, and in 1966 joined the faculty of the University of Cincinnati, where he became Director, Division of Pharmacology, and Professor of Medicine and Pharmacology. From 1979 until 2002, he served at the FDA, initially as Medical Officer, and later as Director, Division of Cardiovascular and Renal Products. He maintained an appointment as Visiting Scientist at the Marine Biological Laboratory, Woods Hole, MA. He received the FDA Award of Merit in 1988 and 1997. ### Dr Rutherford asks: How did your career lead you to become the Director of the FDA’s Cardiovascular and Renal Products Division? Dr Lipicky replies: For 13 years I was at the University of Cincinnati, and I was a tenured Professor of Medicine and Pharmacology and Director of the Division of Clinical Pharmacology. I decided that academic medicine was morphing into a business whose goals I could no longer support. The practice of medicine was not something I wished to pursue, and decisions in the pharmaceutical industry were driven by the need to make a profit (also something I could not support). My primary research interests were in basic science with funded National Institutes of Health and Muscular Dystrophy grants. One of the projects was Drug Effects on Electrically Excitable Membranes, with the primary assay being the squid giant axon. I spent summers at the Marine Biological Laboratory in Woods Hole, MA, which had the only daily source of live squid in the USA. During those summers I collaborated a lot with the Biophysics Laboratory at the National Institutes of Health. The FDA had a basic science laboratory located in Washington, DC, that had a job vacancy and I went …