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About the Foundation


Stephen L. DeFelice, MD


DeFelice Commentaries


NREA, Nutraceutical Research and Education Act


Television Debates
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Senator Harkin on FIM




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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.




CLINICAL RESEARCH AND NUTRACEUTICAL BRAND NAMES AND TRADEMARKS

by Stephen L. DeFelice, M.D.

There is currently a great deal of confusion regarding the nature and dynamics of the nutraceutical market mainly due to its newness and because it is different than the traditional pharmaceutical, OTC and health food markets. In fact, to date, there is no bona fide U.S. nutraceutical company. In order to diminish the confusion, and establish a foundation for company participation in this enormous health sector, it is essential to understand its basic dynamics.

The unique dynamics of the nutraceutical health sector first dawned on me in 1983. The NIH convened a consensus group of medical experts to assess the potential role of calcium for the prevention of osteoporosis. After extensive deliberation, the consensus group concluded that calcium was indicated for the prevention of post-menopausal osteoporosis. At that time, little did I realize that this single event marked the beginning of the Nutraceutical Revolution.

About three months after the NIH consensus group issued its recommendations, I was sitting at home during cocktail time reading various lay publications. All contained articles on calcium and osteoporosis, long after the NIH consensus group report was made public. It suddenly occurred to me that, because of the continuing mass media coverage beginning after the consensus group report, the majority of people in the United States were very well aware of the calcium-osteoporosis connection.

This was indeed a unique event, and I wondered about the reasons why. Not even the largest pharmaceutical or food company spending multi-millions of advertising dollars could have achieved this high level of national awareness of a single product.

I then decided to evaluate the dynamics of this unique phenomenon. Its principle characteristics were the following:

1. Published clinical data on the calcium-osteoporosis connection were evaluated by medical experts.

2. Based on such clinical data, medical experts recommended the use of calcium for the prevention of post-menopausal osteoporosis.

3. The mass media communicated with and enthusiastically embraced the recommendations of the medical experts.

4. The mass media then, almost instantaneously, communicated this medical-expert message to the general public including practicing physicians, their patients and relatives.

5. Physicians and patients then began to communicate with each other about this message.

6. Following the mass media educational effort, sales of calcium began to rise and are continuing to do so - over 15 years later.

I then wondered whether this was simply an oddball phenomenon or a reliable sign of the beginning of a new health sector where the mass media, based on the results of clinical data supported by medical experts, would become the major national promotional organ for nutraceuticals. Then the fiber and fish oil nutraceutical phenomena occurred. The dynamics were similar to that of the calcium phenomenon and continued with other nutraceuticals such as folic acid and vitamin E. To be sure, other products such as St. John's Wort and Echinacea, where sufficient clinical support their efficacy and safety were not published, also captured media attention. But, increasingly, products supported by the results of clinical research which dominate the headlines are being accepted by physicians and the public.

Shortly after the calcium phenomenon, I wondered whether it would be possible to connect the brand name and trademark of a product to the mass media educational phenomenon. "Could it be," I said to myself, "that it is now possible, based on clinical studies, to launch a product and quickly establish its brand name trademark for very little cost by using the mass media, and not advertising, as the primary vehicle for promotion?"

My experience in the pharmaceutical sector taught me that medical journals use the scientific or generic pharmaceutical name of a product in their publications rather than the commercial brand name. This policy, in part, is due to the fact that penicillin is penicillin regardless of the companies that sell it. The trademark is irrelevant from a medical point-of-view. It primarily serves as a marketing function to establish specific product recognition. But nutraceuticals are quite different than pharmaceuticals. One company's soup or cereal may be similar to another's, but they are not exactly the same. If, for example, a study was done with a specific cereal or botanical nutraceutical, with a more or less similar but not exactly the same products on the market, the medical journals must logically mention the trademark of the clinically evaluated product in order to distinguish it from the other products that are not exactly the same and have not been clinically evaluated. A company with a potential competitive product must perform clinical research on its product and establish comparable efficacy, if a medical journal is both to publish the study as well as mention its brand name.

There are three recent case histories which clearly demonstrate the media's pattern of promoting a specific nutraceutical product's brand name based on the results of clinical studies. They are Ocean Spray Cranberry Juice, Benecol and Intelligent Quisine. All three products were clinically evaluated and the results published. All partook in the nutraceutical dynamics scenario and all achieved some degree of national recognition without much, if any, advertising. (It is interesting to note, by the way, that both Bencol and Intelligent Quisine were not in distribution when the media trumpeted their messages. It is self-evident that it is best to have one's product in distribution before trademark promotion.)

In conclusion, it is quite clear that the trademarks of nutraceuticals can achieve national recognition without much advertising and at little cost. It is not clear, however, why company management has not caught on. The most likely reason is that certain characteristics of the nutraceutical OTC market are different than the ethical OTC and health food markets. The former is not advertising or unsubstantiated claims driven. It is media driven based on clinical studies of specific products. And, I can tell you from personal experience, companies are not secure in dealing with media. It is much easier to control advertising than media. On the other hand, the media has been consistent and friendly to nutraceutical products, be they generic or brand, which are supported by clinical data and published in reputable medical journals.

To repeat, we continue to await the birth of the first truly nutraceutical company. It's exact nature has yet to be determined but you can be sure that it will rely on mass media to establish its brand name and trademarks.