FIM, The Foundation for Innovation in Medicine, was established in 1976 by Stephen L. DeFelice, M.D. It is a nonprofit foundation whose primary 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 huge negative factors that retard the availability of new medical breakthrough therapies that can eliminate or at least ameliorate those conditions which ail us. To make matters worse we have a cultural blind spot to the importance of clinical studies. In fact, we view them with suspicion.
FIM has asked patients (we all are or will be patients someday) the fundamental question, Regarding your health, 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. Only an innovative, vibrant clinical research environment can fulfill these wishes.
The very good news is that medical technology is exploding but the very bad news is that only a very small percentage of it is being or will be clinically tested to determine its medical value.
Can we reduce the barriers for patients to volunteer in clinical studies? It would be socially-politically impossible because of our powerful, negative national reaction against bad events that inevitably occur in clinical studies. For example, not too long ago a single death that occurred at the University of Pennsylvania and another at Johns Hopkins, fed by the media, created a national uproar where the physician investigators were chastised and also resulting in the creation of increased barriers to conduct future clinical studies.
THE DOCTORNAUT ACT: What then could be a socially acceptable remedy to effectively diminish the barriers to clinical research? FIM believes it is the Doctornaut Act. In his first book, Drug Discovery: The Pending Crisis, published in 1972, Dr. DeFelice proposed the establishment of physician volunteers for clinical research or “Doctornauts” (a term he later coined) who would have the right to volunteer for clinical research much more freely than normal volunteers taking greater risks. This would significantly reduce the barriers to participate in both low and high risk clinical studies. Once established, many more potential medical therapies will be tested followed by a dramatic acceleration of discovery of new breakthrough medical therapies which is what we all want.
Who would object to physicians taking risks to help their patients? It’s a noble act in these days of pervasive cynicism. Also, physicians better than others, are able to judge the risk- benefits of a potential new therapy.
In addition, doctornauts will significantly reduce health care costs. There will be an increase in the discovery of both high and low cost therapies and they will compete with each other in the marketplace.
FIM takes the position that, if the Doctornaut Act is enacted, both the accelerated discovery of medical breakthroughs and reduction of health care costs will happen within a relatively short period of time. FIM is unaware of any other strategy that offers this promise.
FIM, under the CURE – CARE VERSUS HEALTH CARE INITIATIVE, is currently in the process of establishing a consensus among various institutions and organizations to educate the Congress about the urgency to pass the Doctornaut Act. It is a wonderful opportunity for Congress to cut through the extremely complicated health care debate with the uncomplicated simple, easy to pass Doctornaut Act.
ORPHAN DRUGS and The Carnitine Story:
The book, Orphan Drugs, was published in early 1980. The carnitine story chapter was completed by Dr. DeFelice in the late 70’s. Here he describes his early experience with carnitine including the cultural lessons he learned. He calls carnitine, The Great Teacher regarding our medical discovery system and further convinced him of the need for the Doctornaut Act. He continues to be involved with carnitine and the Great Teacher continues to uncover other barriers to clinical research such as the CMS does not honor the Orphan Drug Act and, by so doing, defies the will of Congress and deprives the elderly of new therapies.Read
THE NREA or NUTRACEUTICAL RESEARCH AND EDUCATION ACT:
This is a special mission of FIM because of its particular interest in natural substances. 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 English Dictionary where he is cited for coining the term. It is also in the Webster Collegiate Dictionary and others.
Very little clinical research is conducted on specific nutraceutical products sold (far less than 1/2 per cent) principally due to a simple economic reason – the difficulty in obtaining a sufficiently secure proprietary position such as a patent. 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 clinical benefits and the safety of the products being taken.
In 1996 FIM held a conference entitled, THE NEED FOR A RESEARCH-INTENSIVE NUTRACEUTICAL INDUSTRY: WHAT CAN CONGRESS DO? (The Claims-Research Connection). The major consensus called for a need for companies to have some type of proprietary position to make exclusive nutraceutical claims.
Subsequently 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.
Dr. DeFelice had numerous discussions with Congressman Frank Pallone (D-NJ) after which he introduced the Nutraceutical Research and Education Act in Congress in 1999. Surprisingly, there was little interest from any segment of the health sector. FIM, however, intends to renew its effort if the appropriate time arrives Read