FIM, The Foundation for Innovation in Medicine, was established in 1976 by Stephen L. DeFelice, M.D. It is a nonprofit foundation whose purpose is to accelerate medical discovery by creating a more productive clinical research community.

The cost and risk to conduct clinical research, the critical step in medical discovery, are major factors that retard the availability of new therapies that can eliminate or ameliorate those conditions which ail us.

FIM has asked patients (by the way, we are all patients) the fundamental question, "Who represents you?" or "What do you want?" Their responses are summarized as follows: "If I have a disease, get rid of it", or "If I don't have a disease, I don't want to get it." In medical terms these responses deal with the treatment and prevention of disease, respectively.

In order to fulfill the patients' wishes, we must have more clinical research, a critical step in medical discovery, conducted on potential new therapies so that new medical discoveries are made at a more rapid pace.

Medical technology is exploding but only a small amount of it is being clinically tested to determine its medical value.

In FIM's experience, there is little interest or appreciation of the critical importance of clinical research, and one of our primary goals is to deliver this important message.

FIM is now involved in two initiatives, all of which deal with stimulating our clinical research system.

THE NREA or NUTRACEUTICAL RESEARCH AND EDUCATION ACT: A nutraceutical is a food, dietary supplement or medical food that has a medical - health benefit including the prevention and treatment of disease. Dr. DeFelice coined the term in 1989, and it is now in the Oxford, Webster Collegiate Dictionary and others.

Very little clinical research is conducted on specific nutraceutical products sold (far less than 1/2 per cent) mainly because of economic reasons. The potential medical or health values of these products are, therefore, largely unproven. As a result, patients and health care professionals are deprived of knowing the truth about the benefit and the safety of the products being taken.

Dr. DeFelice proposed the NREA which is based on the principles of the successful Orphan Drug Act. If a company conducts the clinical research on a specific product, it alone will have the exclusive right to make the medical claim regarding its efficacy. This marketing incentive, as happened with orphan drugs, will spur companies to invest in the clinical research necessary to demonstrate the safety and effectiveness of the nutraceuticals sold.

Congressman Frank Pallone (D-NJ) introduced the NREA in Congress in 1999 but there was little interest from any segment of the health sector. However, FIM is continuing to pursue the NREA effort.

THE PHYSICIAN VOLUNTEER or DOCTORNAUT ACT: Over a quarter of a century ago, Dr. DeFelice proposed the establishment of physician volunteers for clinical research or "doctornauts" (another term coined by Dr. DeFelice) who would have the right to volunteer for clinical research much more freely than normal volunteers. This would reduce the enormous barriers, costs and risks to participate in a clinical study. Once established, many more potential medical therapies will be tested and medical discovery dramatically accelerated which is, to repeat, what patients want.

FIM is currently in the process of establishing the consensus among various institutions and organizations to educate the Congress about the urgency to pass the Doctornaut Act.