Sheldon Baker10.28.11
Stephen L. DeFelice, MD, is the founder and chairman of the Foundation for Innovation in Medicine, a non-profit organization established in 1976 to accelerate medical discovery by establishing a more productive clinical research community. He is also credited with coining the term “nutraceutical,” which is now in the Oxford English dictionary. A graduate of Temple University, Dr. DeFelice received his MD 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 was the former chief of clinical pharmacology at the Walter Reed Army Institute of Research. He was a member of the Harvard School of Public Health's International Faculty on the management of biomedical research and the Tufts' Faculty on the principles of clinical research. He was also a member of the team that brought lithium into the U.S. and was the doctor responsible for its launch. His 40-year experience with carnitine, a naturally occurring substance with multiple medical benefits, sparked his interest and determination to encourage medical discovery. Largely through his efforts it is now FDA approved as an orphan drug for various types of carnitine deficiencies as well as for renal dialysis patients. He is currently involved in clinical research on carnitine in ovarian cancer patients. 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.
Health E-Insights: In 1989, you created the term “nutraceutical.” In your estimation, have nutraceuticals changed?
Dr. DeFelice: For the record I coined the term “nutraceutical” while strolling at the Piazza Navona late at night in Rome in the early 80s. A nutraceutical is a food or part of a food such as a dietary supplement that has a medical or health benefit including the prevention and treatment of disease. The best way to establish the effectiveness of a nutraceutical is in a clinical study. Poll after poll tells us that the American people understandably look to natural substances mainly to prevent and treat diseases such as cancer and heart disease. Of course, there are other uses such as improving energy levels by combining nutraceuticals with exercise. Because of the disappointing performance of pharmaceutical discovery ask yourself, when was the last cure? And with an increasing sophisticated population I am not surprised at all at the healthy rate of growth of the industry and its future prospects.
Health E-Insights: Did you expect the nutraceutical industry to grow to the size it has?
Dr. DeFelice: I believe that the supplement industry, except for a very brief period of time, is basically unchanged. Way back, the Foundation for Innovation in Medicine (FIM), held a number of nutraceutical conferences with the objective of changing the system. The food and dietary supplement industries are basically commodity low profit margin ones unlike the pharmaceutical industry, which is a high profit proprietary (patents and clinical research) driven one. In 1989, I persuaded Congressman Frank Pallone (New Jersey) to introduce the NREA or Nutraceutical Research and Education Act. The purpose was to encourage nutraceutical clinical research based on the principles of the Orphan Drug Act, which grants a company a right to make an exclusive claim on their product if it is demonstrated to be effective in a clinical study. For your information I brought carnitine, which is a nutraceutical and a pharmaceutical, in the U.S. and because of the Orphan Drug Act, managed to work with Dr. Claudio Cavazza of Sigma Tau to obtain FDA approval for rare fatal carnitine deficiency diseases mainly occurring in children. Unfortunately, there was no support from any quarter for the NREA.
Health E-Insights: In what direction do you see the supplement industry moving?
Dr. DeFelice: Largely because of our conferences, which stressed the importance of conducting clinical studies to determine whether nutraceuticals are reasonably effective and safe, companies did step up to the plate and sponsored clinical studies, a number of which were disappointing. But there were reasons for such results largely due to the fact that these studies were conducted using pharmaceutical standards, which are often times inappropriate for nutraceutical clinical studies. For example, let’s take vitamin E and its cardio protective effect which I reviewed in my book, The Carnitine Defense. A substantial part of my career has been in the pharmaceutical clinical research sector. With a trained eye to evaluate data, there is little doubt in my mind that the clinical studies supported by laboratory findings which I reviewed were impressively persuasive regarding its positive cardio protective effect. Then what happens? Clinical studies were conducted with vitamin E alone, which did not demonstrate clinical activity. But vitamin E, like a meal, does not work solely by itself. It works in combinations with other substances and the study should have been conducted with such combinations and not vitamin E alone. Make no mistake about it: the vitamin E story had a tremendous negative impact on the nutraceutical movement.
Health E-Insights: If you had the power to change the industry, what might you do?
Dr. DeFelice: If I had the power to change the industry I would urge them as they did with DSHEA, to gather their forces together to have the NREA enacted. This would not only bring more demonstrated clinical benefits for both healthy and patients, but also by establishing proprietary positions with their products, substantially increase the industry profit margins which could be used to further sponsor clinical studies. FIM is in the process of attempting to persuade Congress to pass the Doctornaut Act. We are now dealing with major congressional and other players for support. If enacted, this will inevitably lead to the same objectives of the NREA including studies on how nutraceuticals can increase the efficacy and safety of pharmaceuticals, a desperately needed initiative. I hope my nutraceutical colleagues will join me in supporting this effort. Visit the FIM website at www.fimdefelice.org for details.
Health E-Insights: What do you value most in your day-to-day life?
Dr. DeFelice: As I mentioned previously, what I value most is looking forward to the day. First thing in the morning, I take my specially prepared carnitine solution which fuels my energy supply. My main professional activity is to change our current anti-innovative medical discovery system to a positive one. I learned to hate disease as a young teenager and want to see the beast conquered. Unfortunately, I have not met anyone who hates disease. Our culture, unfortunately, accepts it with resignation. The Doctornaut Act and how to get Congress to pass it is what occupies the working part of my day and long walks and writing the rest. But then there is dinner time where good food, good spirits and good conversation, which I not only value, but demand.
Sheldon Baker wants to interview you. Contact Sheldon at sbaker@bakerdillon.com. Follow him on Twitter @NutraInk and visit his website at www.BakerDillon.com.
Health E-Insights: In 1989, you created the term “nutraceutical.” In your estimation, have nutraceuticals changed?
Dr. DeFelice: For the record I coined the term “nutraceutical” while strolling at the Piazza Navona late at night in Rome in the early 80s. A nutraceutical is a food or part of a food such as a dietary supplement that has a medical or health benefit including the prevention and treatment of disease. The best way to establish the effectiveness of a nutraceutical is in a clinical study. Poll after poll tells us that the American people understandably look to natural substances mainly to prevent and treat diseases such as cancer and heart disease. Of course, there are other uses such as improving energy levels by combining nutraceuticals with exercise. Because of the disappointing performance of pharmaceutical discovery ask yourself, when was the last cure? And with an increasing sophisticated population I am not surprised at all at the healthy rate of growth of the industry and its future prospects.
Health E-Insights: Did you expect the nutraceutical industry to grow to the size it has?
Dr. DeFelice: I believe that the supplement industry, except for a very brief period of time, is basically unchanged. Way back, the Foundation for Innovation in Medicine (FIM), held a number of nutraceutical conferences with the objective of changing the system. The food and dietary supplement industries are basically commodity low profit margin ones unlike the pharmaceutical industry, which is a high profit proprietary (patents and clinical research) driven one. In 1989, I persuaded Congressman Frank Pallone (New Jersey) to introduce the NREA or Nutraceutical Research and Education Act. The purpose was to encourage nutraceutical clinical research based on the principles of the Orphan Drug Act, which grants a company a right to make an exclusive claim on their product if it is demonstrated to be effective in a clinical study. For your information I brought carnitine, which is a nutraceutical and a pharmaceutical, in the U.S. and because of the Orphan Drug Act, managed to work with Dr. Claudio Cavazza of Sigma Tau to obtain FDA approval for rare fatal carnitine deficiency diseases mainly occurring in children. Unfortunately, there was no support from any quarter for the NREA.
Health E-Insights: In what direction do you see the supplement industry moving?
Dr. DeFelice: Largely because of our conferences, which stressed the importance of conducting clinical studies to determine whether nutraceuticals are reasonably effective and safe, companies did step up to the plate and sponsored clinical studies, a number of which were disappointing. But there were reasons for such results largely due to the fact that these studies were conducted using pharmaceutical standards, which are often times inappropriate for nutraceutical clinical studies. For example, let’s take vitamin E and its cardio protective effect which I reviewed in my book, The Carnitine Defense. A substantial part of my career has been in the pharmaceutical clinical research sector. With a trained eye to evaluate data, there is little doubt in my mind that the clinical studies supported by laboratory findings which I reviewed were impressively persuasive regarding its positive cardio protective effect. Then what happens? Clinical studies were conducted with vitamin E alone, which did not demonstrate clinical activity. But vitamin E, like a meal, does not work solely by itself. It works in combinations with other substances and the study should have been conducted with such combinations and not vitamin E alone. Make no mistake about it: the vitamin E story had a tremendous negative impact on the nutraceutical movement.
Health E-Insights: If you had the power to change the industry, what might you do?
Dr. DeFelice: If I had the power to change the industry I would urge them as they did with DSHEA, to gather their forces together to have the NREA enacted. This would not only bring more demonstrated clinical benefits for both healthy and patients, but also by establishing proprietary positions with their products, substantially increase the industry profit margins which could be used to further sponsor clinical studies. FIM is in the process of attempting to persuade Congress to pass the Doctornaut Act. We are now dealing with major congressional and other players for support. If enacted, this will inevitably lead to the same objectives of the NREA including studies on how nutraceuticals can increase the efficacy and safety of pharmaceuticals, a desperately needed initiative. I hope my nutraceutical colleagues will join me in supporting this effort. Visit the FIM website at www.fimdefelice.org for details.
Health E-Insights: What do you value most in your day-to-day life?
Dr. DeFelice: As I mentioned previously, what I value most is looking forward to the day. First thing in the morning, I take my specially prepared carnitine solution which fuels my energy supply. My main professional activity is to change our current anti-innovative medical discovery system to a positive one. I learned to hate disease as a young teenager and want to see the beast conquered. Unfortunately, I have not met anyone who hates disease. Our culture, unfortunately, accepts it with resignation. The Doctornaut Act and how to get Congress to pass it is what occupies the working part of my day and long walks and writing the rest. But then there is dinner time where good food, good spirits and good conversation, which I not only value, but demand.
Sheldon Baker wants to interview you. Contact Sheldon at sbaker@bakerdillon.com. Follow him on Twitter @NutraInk and visit his website at www.BakerDillon.com.
