The Author

STEPHEN L. DEFELICE, M.D. is the founder and Chairman of FIM, the Foundation for Innovation in Medicine. FIM is a nonprofit organization established in 1976 whose purpose is to accelerate medical discovery by establishing a more productive clinical research community.

Dr. DeFelice has a long history of involvement in various sectors of medical research and discovery both domestically and internationally. He played a critical role in bringing lithium to the United States.

He brought carnitine into the U.S. and conducted the first clinical study on the drug. It's now approved by the FDA for the treatment of Carnitine Deficiency, a rare, debilitating and sometimes fatal disease in children. Carnitine is also FDA approved for the treatment of renal dialysis patients. Early in his career, Dr. DeFelice discovered a potential new therapy for the treatment of ovarian cancer involving carnitine and doxorubicin. After many years he is now personally sponsoring a clinical study in patients with late stage ovarian cancer resistant to standard therapy and with a certain rendezvous with death.

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 is the former Chief of Clinical Pharmacology at the Walter Reed Army Institute of Research (WRAIR). His 35-year experience with carnitine sparked his interest and determination to encourage medical discovery. 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.

Almost forty years ago, Dr. DeFelice wrote the book "Drug Discovery: the Pending Crisis" 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 freer than others to volunteer for clinical research. This simple act would lead to the clinical testing of more potential medical discoveries.

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 became closely connected with the image of clinical research.

Fifteen years later, recognizing that natural substances almost always lack sufficient patent protection to justify the costs and risks of conducting clinical research, Dr. DeFelice released the 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 the concept of physician volunteers or doctornauts for clinical research. Unfortunately, history repeated itself, and there was and remains little interest in the critical need for a creative and low-cost clinical research system that would dramatically lead to new discoveries to prevent, treat and cure disease.

Today medical technology is progressing at leaps and bounds offering the promise to deal mighty blows to many diseases but so are the barriers to clinical research. As examples, single deaths at the University of Pennsylvania and Johns Hopkins Universities shut down, delayed and generally increased the costs and risks of testing exciting potential medical breakthroughs by our brightest scientists and physicians.

FIM is now involved in two initiatives: The NREA or The Nutraceutical Research and Education Act (Dr. DeFelice coined the term "nutraceutical" and was given credit in the Oxford English Dictionary) and the need for Congress to enact the Doctornaut Act. Senator Bill Frist (R-TN) had expressed a strong interest in the latter concept.