Contents


About the Foundation


Stephen L. DeFelice, MD


DeFelice Commentaries


NREA, Nutraceutical Research and Education Act


Television Debates
and Videos


Library


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Board of Directors


Senator Harkin on FIM




Google

Home


The Patient Always
Gets Screwed


Promising Ovarian Cancer Therapy Blocked

Carnitine-Ovarian Cancer Promise and a Failed Attempt at a Clinical Study


When Was The Last Cure?


Translational Science - How Doctornauts Can Help


Senator Tom Harkin (D-IA) has been one of the leaders in Congress on Translational Science.


Doctornauts Barry Marshall and Lukas Wartman: Living Proof of the Urgent Need for the Doctornaut Act



View the Discussion Draft of the Doctornaut Act Prepared by Former Senator Bill Frist.




THE NATURE OF THE NUTRACEUTICAL REVOLUTION IN THE YEAR 2000

January 1, 2000

by Stephen L. DeFelice, M.D.

The U.S. craze for the medical miracles of nutraceuticals (dietary supplements, foods and medical foods) continues. The forces that drive this craze are not clear and difficult to quantify. What is clear is that the Nutraceutical Revolution has its own momentum, is international in scope and is unstoppable. The result is a mixed one. Though a multitude of potentially beneficial products is presently available, very few of these have been clinically tested to properly assess their medical-health benefits and risks.

The first time that I entered a health food store was in Greenwich Village during the late 60's. It was a well organized and consumer friendly store. I vividly remember being impressed, both with the number of products freely available for purchase, the variety of ingredients contained therein, and the abundance of medical-health claims made on such products. After having observed this fascinating establishment, I remember saying to myself, "All of these products are purportedly natural substances. That means some of them, when taken for the right conditions, can help people with medical-health problems, but we just don't know which ones work. Also, there is little doubt that some of these products are harmful. But we just don't know which ones are. It's a dilemma."

That was my opinion in the late 60's, and it remains so.

Yet people continue to embrace dietary supplements and dietary products at an unprecedented pace in a search to prevent or eliminate their diseases or other conditions that ail them. Even physicians have begun to join the bandwagon, albeit it on a more limited and rational basis.

People purchase products that make medical-health claims despite the fact that such claims often unsubstantiated or more often, false. They do not demand "the proof". This phenomenon is characterized by ignorance and unfounded credibility regarding the purchase and consumption of such products.

Those few products or ingredients that may have medical-health
merit such as calcium, fiber, and low fat diets, are old news; and even these have significant limitations. The calcium message regarding its beneficial impact on osteoporosis is at best limited and oftentimes misleading. Calcium itself is clearly overrated for this use -- but few say so. Though embraced until recently, the fiber anti-cancer data are now questionable. The fiber-prevention-of heart attacks clinical data continue to be promising. But, with respect to fiber and the heart, just try asking people how much daily fiber should they take and what specific fiber products will deliver the cardiac promise. This may be a case where the promise is real but the available delivery systems inadequate.

We have all been bombarded, saturation style, with messages regarding the importance of low-fat and low-cholesterol diets on cardiovascular health. What is the truth about these entities? The answer is that there are little convincing clinical data which demonstrate that recommended diets and specific dietary products have had a beneficial impact on cardiac health. There is, in fact, an alarming possibility that the marketing effort behind the messages has played a large role in the current U.S.-obesity and heart disease epidemics. Obesity, we should not forget, is a leading cause of cardiovascular disease and death in the United States.

There have been all too few products (a handful, perhaps!) such as Ocean Spray Cranberry Juice often taken for the prevention of recurrent urinary tract infections in women, where clinical studies support the claims of the specific products sold.

There is little doubt that there is indeed a substantial amount of adverse effects and toxicity currently going on. Large numbers of nutraceutical enthusiasts are, in some way, suffering from the consumption of these products. The problem is, unlike pharmaceuticals, there is no organized system to detect these bad effects. They are largely undetected. When a patient with hepatic or liver failure visits a doctor, the doctor does not think to ask whether the patient is taking a dietary supplement. The physician, instead, usually thinks of viruses or drug toxicity as potential causes of the liver disease.

In addition to obvious detrimental effects, there can be adverse effects that are not considered serious or ├Čtoxic├« problems in themselves but can have a constant and pervasive negative impact which are frequently more damaging on the quality of life than temporary liver damage. Take, for example, calcium. A powerful marketing machine, based on reasonable clinical data, has convinced millions of women to take calcium to help prevent post-menopausal osteoporosis. This same marketing machine, among others, has failed to tell women that constipation commonly occurs with calcium supplementation. (Medical literature, by the way, is strangely silent on this issue.) It is common knowledge that bowel regularity is something that many individuals are keenly conscious of and the interruption of which can lead to mild or significant emotional distress. There is little doubt that a constipatory product will not only impact negatively on the well-being and happiness of the person taking the calcium supplement but, as with infectious diseases such as the common cold and tuberculosis, spread this negativity to those that are near such as family, friends and colleagues at work.

I object, however, to those who hold that the dietary supplement and diet craze have had little impact on U.S. health. It is not unreasonable to assume, for example, that vitamin E, folic acid, and the ingestion of vegetables can be helpful; and let's not forget the underestimated and powerful placebo effect.

The placebo effect is an extremely powerful one. In carefully controlled pharmaceutical clinical studies where placebo is compared to the drug that is being tested, placebo responses, as measured by clinical improvement, generally range from 30 to 60%. We know that many of those that seek relief from dietary supplements often are pleased with the results. This is, however, oftentimes not due to the clinical effectiveness of the dietary supplement itself but to a placebo effect. "The National Nutraceutical Placebo Effect" is not fully appreciated and embraced. It helps people with their problems and, by the way, significantly reduces health care costs.

And now, let's talk about the very good news. The current clinically demonstrated medical-health value of dietary supplements, foods and medical foods coupled with the benefits of the national placebo effect are paltry and miniscule in scope compared to the true medical-health promise of nutraceuticals. Let's look at three examples of such promise in the areas of cancer, heart disease and diabetes.

1. Adriamycin-carnitine and cancer: Adriamycin is an extremely effective chemotherapeutic agent against certain types of cancer cells. The problem with this drug is that, in addition to killing cancer cells, it kills heart cells too. This cardiotoxicity problem limits the dose of adriamycin that can be given to a patient with cancer thereby severely limiting its capacity to kill tumor cells. As a result, the patient is robbed of the true medical potential of this drug.

Carnitine, a naturally occurring substance that is present in high concentrations in everyone's heart, keeps your heart pumping by driving fatty acids into the mitochondria (the furnaces of your cells) where they are metabolized to produce energy. Animal studies report that carnitine can dramatically block the cardiotoxicity of adriamycin. There are some preliminary clinical studies that also support this possibility but the definitive study has not yet been done.

What does this mean? There is the possibility that a cancer patient can take carnitine supplementation to protect his heart while the dose of adriamycin is increased to much higher levels than normal resulting in the death of more cancer cells. If this be true, then many patients with cancer could be either cured or at least survive for significantly longer periods of time.

2. Alcohol-folic acid, women and coronary artery disease: A study was published in JAMA which reported that women who take moderate amounts of alcohol plus folic acid have a reduction of cardiovascular events such as heart attacks by approximately 80 percent. The effect of this combination substantially exceeds the positive effects of other nutraceuticals and even highly touted cardioprotective pharmaceuticals. The data on men have not yet been published. What does this mean? If these clinical findings are real then we can dramatically reduce heart attacks to levels never seen before.

Also, one can wonder whether the addition of vitamin E along with other cardiovascular nutraceuticals as well as pharmaceuticals could drive this figure closer to -- shall I say, "zero"?

3. Magnesium-complications of diabetes: Over 50 percent of diabetics have magnesium deficiency. When this happens many pathologic biologic processes can happen such as increased blood clotting, constriction of small arteries and insulin resistance. All of these events can lead to decreased delivery of oxygen to body tissue which plays a major role in diabetic complications such as heart attack, loss of limbs, blindness, kidney failure, etc. There is reasonable clinical evidence that magnesium supplementation can reverse these processes. Also, large clinical studies have shown that magnesium deficiency is associated with an increased incidence of diabetes.

What does this mean? There is the possibility that magnesium supplementation can help reduce the incidence and severity of diabetes including its complications. Also, there is the possibility that other cardiovascular nutraceuticals such as alcohol-folic acid, vitamin E and carnitine can further help ameliorate the diabetic condition.

There are many, many other nutraceutical opportunities. For example, statins are important pharmaceuticals that lower cholesterol and reduce heart attacks. They also, however, deplete the heart of CoQ-10, an important substance for cardiac health. Perhaps supplementation with CoQ-10 can increase the clinical effectiveness of the statins.

And now the bad news: Current federal laws and regulations profoundly discourage financial investment in nutraceutical clinical research which is unnecessary to demonstrate the clinical efficacy or effectiveness and safety of specific nutraceutical products. Penicillin in a test tube is undiscovered until it is clinically tested and proven to be of value. To correct this situation, FIM has proposed the NREA (The Nutraceutical Research & Education Act) which is based on the principles of the successful Orphan Drug Act. The NREA grants a ten year exclusivity period for the medical-health claim to the sponsor based on the results of clinical studies conducted on the specific product evaluated. Congressman Frank Pallone, Jr. (D-NJ) has recently introduced the NREA in Congress which, if enacted, will encourage substantial investment in clinical research and rapidly lead to new nutraceutical discovery, If not enacted, we will continue to live with the status quo which is highly detrimental to the health of the vast majority of Americans.

What is urgently needed is more clinical research to prove the benefit of all nutraceutical possibilities.