Stephen L. DeFelice, M.D. is the founder and chairman of FIM, the Foundation for Innovation in Medicine, a nonprofit organization established in 1976 whose purpose is to accelerate medical discovery by establishing a more productive clinical research community.
A graduate of Temple University, Dr. DeFelice received his M.D. from Jefferson Medical College in Philadelphia. He was an NIH fellow in endocrinology, diabetes and metabolic disease at Jefferson and a fellow in clinical pharmacology at St. Vincent’s Hospital and Medical Center in New York City. Dr. DeFelice was the former Chief of Clinical Pharmacology at the Walter Reed Army Institute of Research (WRAIR). He was a member of the Harvard School of Public Health’s International Faculty on the Management of Biomedical Research and the Tufts’ Faculty on the Principles of Clinical Research. He was also a member of the team that brought lithium into the United States and was the doctor responsible for its launch. His 40-year experience with carnitine, a naturally occurring substance with multiple medical benefits, sparked his interest and determination to encourage medical discovery. Largely through his efforts it is now FDA approved as an Orphan Drug for various types of carnitine deficiencies as well as for renal dialysis patients. He is currently involved in clinical research on carnitine in ovarian cancer patients. His experience taught him that the promise of medical technology is exploding but the barriers, costs and risks of clinically testing their promise, a critical step in medical discovery, are also exploding.
About 40 years ago, his first book “Drug Discovery: the Pending Crisis” was published to alert our country to the fact that medical discovery was, and would continue to be, significantly retarded because of the formidable barriers to conduct clinical research. He first proposed the idea of physician volunteers or “doctornauts” (a term he coined) who would be substantially freer than others to volunteer for clinical studies. This simple act would lead to the clinical testing of more potential medical breakthrough discoveries and help significantly reduce health care costs.
Unfortunately, there was little interest in the subject of encouraging clinical research. There was and remains, instead, a pervasive emotional fear about clinical research itself. The thalidomide tragedy was still fresh in the minds of Americans and somehow this fear, coupled with the rise of consumerism which stresses the importance of safety, became closely connected with the image of clinical research.
Also, about 15 years later, recognizing that natural substances, which offer the greatest medical promise, almost always lack sufficient patent protection to justify the costs and risks of conducting clinical research let alone to obtain FDA approval, he wrote another book, “From Oysters to Insulin: Nature and Medicine at Odds” to sound the alarm. He proposed ways to reduce the costs and risks of clinical research including applying the principles of the Orphan Drug Act coupled with the establishment of doctornauts. Unfortunately, history repeated itself, and there was little interest.
With the recent national concern about our health care system, Dr. DeFelice believes that, unlike in the past, this is an opportune time for Congress to consider and enact the Doctornaut Act.