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 is the former Chief of Clinical Pharmacology at the Walter Reed Army Institute of Research (WRAIR). His 35-year experience with carnitine, a naturally occurring substance with multiple medical benefits, 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.

About 30 years ago, he 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 more free 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.

Also, about 15 years later, recognizing that natural substances almost always lack sufficient patent protection to justify the costs and risks of conducting clinical research, 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 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 the need for Congress to enact the Doctornaut Act. Senator Bill Frist (R-TN) has expressed a strong interest in the latter concept.

THE FOUNDATION FOR INNOVATION IN MEDICINE

411 North Avenue East
Cranford, New Jersey 07016
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E-mail: fimdefelice@aol.com

(© 2004 The Foundation For Innovation In Medicine. All rights reserved.)