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
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
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.
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
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
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>