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